Attached files
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EX-32.1 - EX-32.1 - Aptalis Pharma Inc | m68489exv32w1.htm |
EX-31.1 - EX-31.1 - Aptalis Pharma Inc | m68489exv31w1.htm |
EX-32.2 - EX-32.2 - Aptalis Pharma Inc | m68489exv32w2.htm |
EX-31.2 - EX-31.2 - Aptalis Pharma Inc | m68489exv31w2.htm |
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the quarterly period ended December 31, 2010
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number 333-153896
AXCAN INTERMEDIATE HOLDINGS INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware (State or Other Jurisdiction of Incorporation or organization) |
74-3249870 (I.R.S. Employer Identification No.) |
|
22 Inverness Center Parkway Suite 310 Birmingham, AL (Address of Principal Executive Offices) |
35242 (Zip Code) |
(205) 991-8085
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes o No þ Registrant has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934, but is not required to file such reports under such sections.
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate website, if any, every Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (paragraph 232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
Yes o No o (Registrant is not subject to the requirements of Rule 405 of Regulation S-T at this
time).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer and small reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer þ (Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
As of February 14, 2011, there were 100 shares of common stock of the registrant outstanding, all
of which were owned by Axcan MidCo Inc.
AXCAN INTERMEDIATE HOLDINGS INC.
INDEX
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Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning
of the U.S. federal securities laws. Statements other than statements of historical facts
including, without limitation, statements regarding our future financial position, business
strategy, budgets, projected costs and plans, future industry growth and objectives of management
for future operations, are forward-looking statements. In addition, forward-looking statements
generally can be identified by the use of forward-looking terminology such as may, will,
expect, intend, estimate, project, forecast, anticipate, believe or continue or the
negative thereof or variations thereon or similar terminology.
Although we believe that the expectations reflected in these forward-looking statements are
reasonable, we can give no assurance that such expectations will prove to have been correct.
Certain of the important factors that could cause actual results to differ materially from our
expectations, or cautionary statements, include, but are not limited to, those discussed in
Managements Discussion and Analysis of Financial Condition and Results of Operations in Item 2
of Part I of this Quarterly Report, Risk Factors in Item 1A of Part II of this Quarterly Report,
as well as elsewhere in this Quarterly Report on Form 10-Q.
We caution you not to place undue reliance on any forward-looking statements and we do not
undertake any obligation to publicly release any revisions to these forward-looking statements to
reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect
the occurrence of unanticipated events. All subsequent written and oral forward-looking statements
attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by
the cautionary statements.
3
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. | Financial Statements |
AXCAN INTERMEDIATE HOLDINGS INC.
Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars, except share related data)
December 31, | September 30, | |||||||
2010 | 2010 | |||||||
(unaudited) | (audited) | |||||||
$ | $ | |||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
150,736 | 161,503 | ||||||
Accounts receivable, net |
44,756 | 32,379 | ||||||
Accounts receivable from the parent company (Note 14) |
525 | 487 | ||||||
Income taxes receivable |
4,877 | 2,906 | ||||||
Inventories, net (Note 4) |
22,636 | 23,866 | ||||||
Prepaid expenses and deposits |
2,699 | 3,277 | ||||||
Deferred income taxes, net (Note 10) |
3,023 | 2,331 | ||||||
Total current assets |
229,252 | 226,749 | ||||||
Property, plant and equipment, net (Note 5) |
34,018 | 35,777 | ||||||
Intangible assets, net (Note 6) |
335,562 | 347,962 | ||||||
Goodwill, net |
73,361 | 73,540 | ||||||
Deferred debt issue expenses, net of accumulated amortization of $15,379 ($14,136 as at
September 30, 2010) |
19,200 | 20,443 | ||||||
Deferred income taxes, net (Note 10) |
8,175 | 8,706 | ||||||
Total assets |
699,568 | 713,177 | ||||||
Liabilities |
||||||||
Current liabilities |
||||||||
Accounts payable and accrued liabilities |
92,037 | 94,673 | ||||||
Income taxes payable (Note 10) |
6,839 | 3,446 | ||||||
Installments on long-term debt (Note 8) |
| 13,163 | ||||||
Deferred income taxes (Note 10) |
42 | 47 | ||||||
Total current liabilities |
98,918 | 111,329 | ||||||
Long-term debt (Note 8) |
581,823 | 581,312 | ||||||
Other long-term liabilities |
9,695 | 10,028 | ||||||
Deferred income taxes (Note 10) |
31,368 | 31,540 | ||||||
Total liabilities |
721,804 | 734,209 | ||||||
Shareholders Deficiency |
||||||||
Capital Stock (Note 11) |
||||||||
Common shares, par value $0.001; 100 shares authorized: 100 issued and outstanding as at
December 31, 2010, and September 30, 2010 |
1 | 1 | ||||||
Deficit |
(466,706 | ) | (468,152 | ) | ||||
9.05% Note receivable from the parent company (Note 14) |
(133,154 | ) | (133,154 | ) | ||||
Additional paid-in capital |
613,492 | 614,113 | ||||||
Accumulated other comprehensive loss |
(35,869 | ) | (33,840 | ) | ||||
Total shareholders deficiency |
(22,236 | ) | (21,032 | ) | ||||
Total liabilities and shareholders deficiency |
699,568 | 713,177 | ||||||
The accompanying notes are an integral part of the condensed consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
On behalf of the Board,
Director
|
Director |
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Table of Contents
AXCAN INTERMEDIATE HOLDINGS INC.
Condensed Consolidated Statements of Operations
(in thousands of U.S. dollars)
(unaudited)
(unaudited)
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
$ | $ | |||||||
Net product sales |
85,938 | 110,132 | ||||||
Cost of goods sold (a) |
17,423 | 26,628 | ||||||
Selling and administrative expenses (a) (Note 9) |
28,219 | 32,239 | ||||||
Management fees (Note 14) |
838 | 855 | ||||||
Research and development expenses (a) |
6,955 | 8,426 | ||||||
Depreciation and amortization |
13,573 | 16,693 | ||||||
Total operating expenses |
67,008 | 84,841 | ||||||
Operating income |
18,930 | 25,291 | ||||||
Financial expenses (Note 9) |
16,229 | 16,197 | ||||||
Interest income |
(192 | ) | (148 | ) | ||||
Loss (gain) on foreign currencies |
243 | (15 | ) | |||||
Total other expenses |
16,280 | 16,034 | ||||||
Income before income taxes |
2,650 | 9,257 | ||||||
Income taxes expense (benefit) (Note 10) |
1,204 | (189 | ) | |||||
Net income |
1,446 | 9,446 | ||||||
(a) | Excluding depreciation and amortization |
The accompanying notes are an integral part of the condensed consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
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Table of Contents
AXCAN INTERMEDIATE HOLDINGS INC.
Condensed Consolidated Shareholders Equity (Deficiency) and Comprehensive Income (Loss)
(in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
Common shares (number) |
||||||||
Balance, beginning and end of period |
100 | 100 | ||||||
$ | $ | |||||||
Common shares |
||||||||
Balance, beginning and end of period |
1 | 1 | ||||||
Deficit |
||||||||
Balance, beginning of period |
(468,152 | ) | (297,658 | ) | ||||
Dividends paid |
| (128 | ) | |||||
Net income |
1,446 | 9,446 | ||||||
Balance, end of period |
(466,706 | ) | (288,340 | ) | ||||
Additional paid-in capital |
||||||||
Balance, beginning of period |
614,113 | 619,053 | ||||||
Stock-based compensation expense |
491 | 1,476 | ||||||
Stock-based compensation plan redemptions |
(49 | ) | (271 | ) | ||||
Provision on interest receivable from the parent company |
(3,037 | ) | (3,037 | ) | ||||
Interest income from the parent company, net of taxes of $1,063 ($1,063 in 2009) |
1,974 | 1,974 | ||||||
Balance, end of period |
613,492 | 619,195 | ||||||
9.05% Note receivable from the parent company |
||||||||
Balance, beginning and end of period |
(133,154 | ) | (133,154 | ) | ||||
Accumulated other comprehensive loss |
||||||||
Balance, beginning of period |
(33,840 | ) | (24,478 | ) | ||||
Hedging contracts fair value adjustments, net of taxes of $0 ($42 in 2009) |
| (78 | ) | |||||
Foreign currency translation adjustments |
(2,029 | ) | (2,752 | ) | ||||
Balance, end of period |
(35,869 | ) | (27,308 | ) | ||||
Total shareholders equity (deficiency) |
(22,236 | ) | 170,394 | |||||
Comprehensive income (loss) |
||||||||
Other comprehensive loss |
(2,029 | ) | (2,830 | ) | ||||
Net income |
1,446 | 9,446 | ||||||
Total comprehensive income (loss) |
(583 | ) | 6,616 | |||||
Accumulated other comprehensive loss |
||||||||
Amounts related to foreign currency translation adjustments |
(35,869 | ) | (27,237 | ) | ||||
Amounts related to hedging contracts fair value adjustments |
| (71 | ) | |||||
Accumulated other comprehensive loss |
(35,869 | ) | (27,308 | ) | ||||
The accompanying notes are an integral part of the condensed consolidated financial
statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
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AXCAN INTERMEDIATE HOLDINGS INC.
Condensed Consolidated Cash Flows
(in thousands of U.S. dollars)
(unaudited)
(unaudited)
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
$ | $ | |||||||
Cash flows from operating activities |
||||||||
Net income |
1,446 | 9,446 | ||||||
Adjustments to reconcile net income to cash flows from operating activities |
||||||||
Non-cash financial expenses |
1,754 | 1,762 | ||||||
Depreciation and amortization |
13,573 | 16,693 | ||||||
Stock-based compensation expense (Note 9) |
491 | 1,476 | ||||||
Loss on disposal and write-down of assets |
30 | 25 | ||||||
Non-cash loss (gain) on foreign exchange |
39 | (479 | ) | |||||
Change in fair value of derivatives |
| (516 | ) | |||||
Deferred income taxes |
(1,601 | ) | (1,370 | ) | ||||
Changes in working capital items |
||||||||
Accounts receivable |
(12,608 | ) | (14,901 | ) | ||||
Accounts receivable from the parent company |
(38 | ) | | |||||
Income taxes receivable |
(1,937 | ) | 1,734 | |||||
Inventories |
1,127 | (4,868 | ) | |||||
Prepaid expenses and deposits |
568 | (264 | ) | |||||
Accounts payable and accrued liabilities |
(1,914 | ) | 20,114 | |||||
Income taxes payable |
2,766 | (338 | ) | |||||
Net cash provided by operating activities |
3,696 | 28,514 | ||||||
Cash flows from investing activities |
||||||||
Acquisition of property, plant and equipment |
(1,135 | ) | (1,129 | ) | ||||
Net cash used in investing activities |
(1,135 | ) | (1,129 | ) | ||||
Cash flows from financing activities |
||||||||
Repayment of long-term debt |
(13,163 | ) | (20,865 | ) | ||||
Stock-based compensation plan redemptions |
(49 | ) | (271 | ) | ||||
Dividends paid |
| (128 | ) | |||||
Net cash used in financing activities |
(13,212 | ) | (21,264 | ) | ||||
Foreign exchange loss on cash held in foreign currencies |
(116 | ) | (165 | ) | ||||
Net increase (decrease) in cash and cash equivalents |
(10,767 | ) | 5,956 | |||||
Cash and cash equivalents, beginning of period |
161,503 | 126,435 | ||||||
Cash and cash equivalents, end of period |
150,736 | 132,391 | ||||||
Additional information |
||||||||
Interest received |
192 | 148 | ||||||
Interest paid |
1,334 | 1,947 | ||||||
Income taxes received |
| 2,372 | ||||||
Income taxes paid |
2,285 | 1,856 | ||||||
The accompanying notes are an integral part of the condensed consolidated financial
statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
These interim financial statements should be read in conjunction with the annual consolidated financial statements.
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Table of Contents
AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
1. Governing Statutes, Description of Business and Basis of Presentation
Axcan Intermediate Holdings Inc., a corporation incorporated on November 28, 2007, under the
General Corporation Law of the State of Delaware and its subsidiaries (together the Company),
commenced active operations with the purchase, through a wholly-owned indirect subsidiary on
February 25, 2008, of all of the outstanding common shares of
Axcan Pharma Inc. at a price of $23.35 per share (the Acquisition),
a company incorporated under the Canada Business Corporation Act. The Company is involved in the research, development, production and
distribution of pharmaceutical products mainly in the field of gastroenterology.
The accompanying unaudited condensed consolidated financial statements are presented in U.S.
dollars, the reporting currency, and prepared in accordance with accounting principles generally
accepted in the United States of America (U.S. GAAP) for interim financial statements and with the
requirements of the Securities and Exchange Commission for reporting on Form 10Q. Accordingly, they
do not include all the information and footnotes required by U.S. GAAP for complete financial
statements. The interim financial statements and related notes should be read in conjunction with
the Companys audited financial statements for the fiscal year ended September 30, 2010. When
necessary, the financial statements include amounts based on informed estimates and best judgment
of management. The results of operations for the interim periods reported are not necessarily
indicative of results to be expected for the year. In the Managements opinion, the financial
statements reflect all adjustments (including those that are normal and recurring) that are
necessary for a fair presentation of the results of operation for the periods shown. Certain prior
period amounts have been reclassified to conform to the current period presentation. All
intercompany transactions and balances have been eliminated on consolidation.
2. Significant Accounting Policies
The following policies are interim updates to those discussed in Note 2 to the Companys audited financial statements for the fiscal year ended September 30, 2010.
Revenue recognition
Revenue is recognized when the product is shipped to the Companys customers, provided the Company
has not retained any significant risks of ownership or future obligations with respect to the
product shipped. Provisions for sales discounts and estimates for chargebacks, managed care and
Medicaid rebates, product returns and distribution service agreement fees are recorded as a
reduction of product sales revenues at the time such revenues are recognized. These revenue
reductions are established by the Company at the time of sale, based on historical experience
adjusted to reflect known changes in the factors that impact such reserves. In certain
circumstances, returns of products are allowed under the Companys policy and provisions are
maintained accordingly. These revenue reductions are generally reflected as an addition to accrued
liabilities. Amounts received from customers as prepayments for products to be shipped in the
future are reported as deferred revenue.
The Company presents, on a net basis, taxes collected from customers and remitted to governmental
authorities; that is, they are excluded from revenues.
ULTRASE and VIOKASE, the Companys pancreatic enzyme products (PEPs) have historically
accounted for approximately a 19% of the Companys net sales in the three years ended September 30,
2009. Prior to April 28, 2010, products that were marketed in the U.S. to treat exocrine pancreatic
insufficiency had been available before the passage of the Federal Food, Drug, and Cosmetic Act, or
FDCA, in 1938 and, consequently, there were marketed PEPs that had not been approved under the NDA
process by the FDA. In 1995, the FDA issued a final rule requiring that these PEPs be marketed by
prescription only, and, in April 2004, the FDA mandated that all manufacturers of exocrine
pancreatic insufficiency drug products file an NDA and receive approval for their products by April
2008 or be subject to regulatory action. In October 2007, the FDA published a notice in the Federal
Register extending the deadline within which to obtain marketing approval for exocrine pancreatic
insufficiency drug products to April 28, 2010, for those companies that were (a) marketing
unapproved pancreatic enzyme products as at April 28, 2004; (b) submitted NDAs on or before April
28, 2009; and (c) that continue diligent pursuit of regulatory approval. The FDA has required all
manufacturers with unapproved NDAs to cease distribution of unapproved products after April 28,
2010, until such time that NDA approval is granted. After this date, the unapproved products may
still be available on pharmacy shelves for a short time until stock is depleted. The FDA has stated
that it will continue to review NDAs that have been submitted by manufacturers of unapproved PEPs,
and will approve additional PEPs even after the April 28, 2010 deadline has passed, if they meet
the required safety, effectiveness and product quality standards. The Company completed the
submission for ULTRASE MT in the fourth quarter of fiscal year 2008. The submission of the
Companys rolling NDA for VIOKASE was completed in the first quarter of fiscal year
2010.
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
ULTRASE MT and VIOKASE did not receive NDA approval by the April 28, 2010 deadline and the Company
has ceased distributing the two products after that date, in compliance with the FDA guideline. The
Company recorded an additional $23,453,000 sales deductions reserve in its fiscal year ended
September 30, 2010. This reserve is for product returns and other sales deductions as an estimate
of Companys liability for ULTRASE MT and VIOKASE that may be returned by the original purchaser
under the Company DSAs or applicable return policies. The cease distribution order issued by the
FDA was not considered as a product recall. As at December 31, 2010, the remaining reserve was
$11,046,000 and was based on management estimates of ULTRASE MT and VIOKASE inventory in the
distribution channel, assumptions on related expiration dates of this inventory as well as
estimated erosion of ULTRASE MT and VIOKASE demand, based on competition from approved PEPs and the
resulting estimated sell-through of ULTRASE MT and VIOKASE, actual return activity and other
factors. In future periods, the Company will monitor and review the estimates and will
prospectively record changes to the reserve.
On November 28, 2010, the FDA issued complete response letters regarding the NDAs for ULTRASE MT
and VIOKASE. The letters require that unresolved deficiencies raised with respect to the
manufacturing and control processes at the manufacturer of the active ingredient for both ULTRASE
MT and VIOKASE be addressed before approval can be granted. The letters also require that
deficiencies identified in an FDA inspection of such manufacturer must be resolved before the NDAs
can be approved. The Company is in ongoing discussions with the FDA and continues to work with the
manufacturer of the active pharmaceutical ingredient to address the remaining open issues
identified by the FDA, as soon as possible.
3. Recently Issued Accounting Standards
In December 2010, the FASB amended guidance on disclosure of supplementary pro forma information
for business combinations and clarifies that when presenting comparative financial statements, a
public entity should disclose revenue and earnings of the combined entity as though the current
period business combinations had occurred as of the beginning of the comparable prior annual
reporting period only. The amendment also expands the supplemental pro forma disclosures to include
a description of the nature and amount of material, nonrecurring pro forma adjustments directly
attributable to the business combination included in the reported pro forma revenue and earnings.
This guidance is effective prospectively for business combinations entered into in fiscal years
beginning on or after December 15, 2010, with early adoption permitted. The Company will apply this
guidance for future acquisitions on its condensed consolidated financial statements.
In December 2010, the FASB issued guidance that modifies the Step 1 of the goodwill impairment test
for reporting units with zero or negative carrying amounts. For those reporting units, an entity is
required to perform Step 2 of the goodwill impairment test if qualitative factors indicate that it
is more likely than not that a goodwill impairment exists. This guidance is effective for fiscal
years and interim periods within those years, beginning after December 15, 2010. Early adoption is
not permitted. The Company is currently evaluating the impact of the adoption of this guidance on
its condensed consolidated financial statements.
In December 2010, the FASB issued guidance that clarified the recognition and classification of
annual fees mandated by the Patient Protection and Affordable Care Act as amended by the Health
Care and Education Reconciliation Act in the income statements of pharmaceutical manufacturers. The
guidance requires that the liability for the fee should be estimated and recorded in full upon the
first qualifying sale with a corresponding deferred cost that is amortized to expense using a
straight-line method of allocation unless another method better allocates the fee over the
calendar year that it is payable. The annual fee shall be presented as an operating expense. This
guidance is effective for calendar years beginning after December 31, 2010, when the fee initially
becomes effective. The adoption of this guidance is not expected to have a material impact on the
Companys condensed consolidated financial statements.
In March 2010, the FASB issued guidance related to revenue recognition that applies to arrangements
with milestones relating to research or development deliverables. This guidance provides criteria
that must be met to recognize consideration that is contingent upon achievement of a substantive
milestone in its entirety in the period in which the milestone is achieved. The guidance provides a
definition of substantive milestone and should be applied regardless of whether the arrangement
includes single or multiple deliverables or units of accounting. This guidance is effective
prospectively to milestones achieved in fiscal years, and interim periods within those years, after
June 15, 2010, with early adoption permitted. The adoption of this guidance did not have a material
impact on the Companys condensed consolidated financial statements.
In March 2010, the FASB amended the existing guidance on stock compensation to clarify that an
employee share-based payment award with an exercise price denominated in the currency of a market
in which a substantial portion of the entitys equity securities trades should not be considered to
contain a condition that is not a market, performance, or service condition. Therefore, such an
award should not be classified as a liability if it otherwise qualifies as equity. This guidance is
effective for fiscal years, and interim periods within those fiscal years, beginning on or after
December 15, 2010.The adoption of this guidance is not expected to have a material impact on the
Companys condensed consolidated financial statements.
In October 2009, the FASB amended the existing guidance on revenue recognition related to
accounting for multiple-element arrangements. This amendment addresses how to determine whether an
arrangement involving multiple deliverables contains more than one unit of accounting, and how the
arrangement consideration should be allocated among the separate units of accounting. This guidance
is effective prospectively for revenue arrangements entered into or materially modified in fiscal
years beginning on or
after June 15, 2010, and early adoption is permitted. The adoption of this guidance did not have a
material impact on the Companys condensed consolidated financial statements.
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
In April 2008, the FASB issued guidance that amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful life of a recognized
intangible asset. The intent of this guidance is to improve the consistency between the useful life
of a recognized intangible asset determined in accordance with the guidance on intangible assets
and the period of expected cash flows used to measure the fair value of the asset determined in
accordance with the amended guidance for business combinations and other authoritative guidance.
This guidance is effective for financial statements issued for fiscal years beginning after
December 15, 2008, and interim periods within those fiscal years. Early adoption is prohibited. The
adoption of this guidance did not have a material impact on the Companys condensed consolidated
financial statements.
In December 2007, the FASB issued guidance related to collaborative arrangements. The guidance
defines collaborative arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the arrangement and third
parties. The guidance also establishes the appropriate income statement presentation and
classification for joint operating activities and payments between participants, as well as the
sufficiency of the disclosures related to these arrangements. This guidance is effective for fiscal
years and interim periods within those fiscal years, beginning after December 15, 2008, and shall
be retrospectively to all prior periods presented for all collaborative arrangements existing as of
the effective date. The adoption of this guidance did not have a material impact on the Companys
condensed consolidated financial statements.
4. Inventories
December 31, | September 30, | |||||||
2010 | 2010 | |||||||
$ | $ | |||||||
Raw material and packaging material, net of reserve for obsolescence of $89 |
9,391 | 10,316 | ||||||
Work in progress, net of reserve for obsolescence of $429 |
109 | 595 | ||||||
Finished goods, net of reserve for obsolescence of $636 ($758 as at September 30, 2010) |
13,136 | 12,955 | ||||||
22,636 | 23,866 | |||||||
As disclosed in Note 2, the Companys PEPs did not obtain regulatory approval by the April 28, 2010
deadline established by the FDA. As a result, a charge of $44,883,000 was recorded during the
fiscal year ended September 30, 2010, to cost of goods sold to reduce inventories to their net
realizable value and for estimated loss for purchase and other materials and supply commitments
related to ULTRASE MT and VIOKASE products.
5. Property, Plant and Equipment
December 31, 2010 | ||||||||||||
Accumulated | ||||||||||||
Cost | depreciation | Net | ||||||||||
$ | $ | $ | ||||||||||
Land |
2,232 | | 2,232 | |||||||||
Buildings |
23,245 | 4,914 | 18,331 | |||||||||
Furniture and equipment |
8,711 | 3,851 | 4,860 | |||||||||
Automotive equipment |
30 | | 30 | |||||||||
Computer equipment and software |
18,595 | 10,920 | 7,675 | |||||||||
Leasehold and building improvements |
1,190 | 300 | 890 | |||||||||
54,003 | 19,985 | 34,018 | ||||||||||
September 30, 2010 | ||||||||||||
Accumulated | ||||||||||||
Cost | depreciation | Net | ||||||||||
$ | $ | $ | ||||||||||
Land |
2,240 | | 2,240 | |||||||||
Buildings |
23,252 | 4,490 | 18,762 | |||||||||
Furniture and equipment |
8,534 | 3,515 | 5,019 | |||||||||
Computer equipment and software |
18,419 | 9,588 | 8,831 | |||||||||
Leasehold and building improvements |
1,220 | 295 | 925 | |||||||||
53,665 | 17,888 | 35,777 | ||||||||||
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
6. Intangibles Assets
Trademarks, trademark licenses and manufacturing rights with a finite life
December 31, 2010 | ||||||||||||
Accumulated | ||||||||||||
Cost | amortization | Net | ||||||||||
$ | $ | $ | ||||||||||
Balance, beginning of period |
459,207 | 111,245 | 347,962 | |||||||||
Amortization |
| 11,455 | (11,455 | ) | ||||||||
Foreign exchange |
(1,186 | ) | (241 | ) | (945 | ) | ||||||
Balance, end of period |
458,021 | 122,459 | 335,562 | |||||||||
7. Segmented Information
The Company operates in a single field of activity, the pharmaceutical industry.
The Company operates in the following geographic areas:
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
$ | $ | |||||||
Total Revenue |
||||||||
United States |
||||||||
Domestic sales |
57,949 | 83,776 | ||||||
Foreign sales |
270 | 1,378 | ||||||
Canada |
||||||||
Domestic sales |
10,046 | 8,867 | ||||||
Foreign sales |
136 | | ||||||
European Union |
||||||||
Domestic sales |
14,850 | 14,024 | ||||||
Foreign sales |
2,687 | 1,840 | ||||||
Other |
| 247 | ||||||
85,938 | 110,132 | |||||||
Revenue is attributed to geographic areas based on the country of origin of the sales.
11
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
December 31, | September 30, | |||||||
2010 | 2010 | |||||||
$ | $ | |||||||
Property, plant, equipment and intangible assets |
||||||||
Canada |
289,807 | 299,180 | ||||||
United States |
11,725 | 13,906 | ||||||
European Union |
68,048 | 70,653 | ||||||
369,580 | 383,739 | |||||||
December 31, | September 30, | |||||||
2010 | 2010 | |||||||
$ | $ | |||||||
Goodwill |
||||||||
Canada |
61,887 | 61,887 | ||||||
European Union |
11,474 | 11,653 | ||||||
73,361 | 73,540 | |||||||
12
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
8. Long-term Debt
December 31, | September 30, | |||||||
2010 | 2010 | |||||||
$ | $ | |||||||
Senior notes secured by substantially all of the present and future assets
of the Company, bearing interest at 9.25% and maturing in March 2015 |
226,274 | 226,171 | ||||||
Term loans of $125,660 as at December 31, 2010, ($138,823 as at September
30, 2010), bearing interest at the one-month British Banker Association
LIBOR (0.26% as at December 31, 2010, and 0.26% as at September 30, 2010),
plus the applicable rate based on the consolidated total leverage ratio of
the Company and certain of its subsidiaries for the preceding twelve months,
secured by substantially all of the present and future assets of the
Company, payable in quarterly installments, maturing in February 2014 |
122,368 | 135,210 | ||||||
Senior unsecured notes, bearing interest at 12.75% and maturing in March 2016 |
233,181 | 233,094 | ||||||
581,823 | 594,475 | |||||||
Installments due within one year |
| 13,163 | ||||||
581,823 | 581,312 | |||||||
On February 25, 2008, the Company obtained various types of financing in connection with the
Acquisition. The Company issued $228,000,000 aggregate principal amount of its 9.25% senior secured
notes (the Senior Secured Notes) due March 1, 2015. The Senior Secured Notes were priced at
$0.98737 with a 10% yield to March 1, 2015. The Senior Secured Notes rank pari passu with the
Credit Facility.
The Company may redeem some or all of the Senior Secured Notes prior to March 1, 2011, at a
redemption price equal to 100% of the principal amount of the Senior Secured Notes redeemed plus a
make-whole premium and accrued and unpaid interest. On or after March 1, 2011, the Company may
redeem some or all of the Senior Secured Notes at the redemption prices (expressed as percentages
of principal amount of the Senior Secured Notes to be redeemed) set forth below:
Senior | ||||
Secured Notes | ||||
% | ||||
2011 |
106.938 | |||
2012 |
104.625 | |||
2013 |
102.313 | |||
2014 and thereafter |
100.000 |
Prior to March 1, 2011, the Company may also redeem up to 35% of the aggregate principal amount of
the Senior Secured Notes using the proceeds of one or more equity offerings at a redemption price
equal to 109.250% of the aggregate principal amount of the Senior Secured Notes plus accrued and
unpaid interest. If there is a change of control as specified in the indenture governing the Senior
Secured Notes, the Company must offer to repurchase the Senior Secured Notes at a price in cash
equal to 101% of the aggregate principal amount thereof, plus accrued and unpaid interest.
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
The Company has a credit facility for a total amount of $290,000,000 composed of available term
loans totaling $175,000,000 and of a revolving credit facility of $115,000,000 (Credit Facility).
The Credit Facility bears interest at a variable rate available composed of either the Federal
Funds Rate or the British Banker Association LIBOR rate, at the option of the Company, plus the
applicable rate based on the consolidated total leverage ratio of the Company and certain of its
subsidiaries for the preceding twelve months. The Credit Facility matures on February 25, 2014,
with payments on the term loans beginning in fiscal year 2008. As at December 31, 2010,
$175,000,000 of term loans had been issued and no amounts had been drawn during the quarter against
the revolving credit facility. The term loans were priced at $0.96 with a yield to maturity of
8.75%. The Credit Facility requires the Company to meet certain financial covenants, which were met
as at December 31, 2010. The credit agreement governing the Credit Facility requires the Company to
prepay outstanding term loans contingent upon the occurrence of events, subject to certain
exceptions, with: (1) 100% of the net cash proceeds of any incurrence of debt other than debt
permitted under the Credit Facility, (2) commencing with the fiscal year ended September 30, 2009,
50% (which percentage will be reduced to 25% if the senior secured leverage ratio is less than a
specified ratio) of the annual excess cash flow (as defined in the credit agreement governing the
Credit Facility) and (3) 100% of the net cash proceeds of all non-ordinary course asset sales or
other dispositions of property (including casualty events) by the Company or by its subsidiaries,
subject to reinvestments rights and certain other exceptions. Pursuant to the annual excess cash
flow requirements defined in the credit agreement, the Company was required to prepay $13,163,000
of outstanding term loans in the first quarter of fiscal year 2011 ($17,583,000 for the fiscal year
2009 which was paid in the first quarter of fiscal year 2010). As allowed by the credit agreement,
the prepayment has been applied to the remaining scheduled installments of principal in direct
order of maturity.
On May 6, 2008, the Company issued $235,000,000 of 12.75% senior unsecured notes due March 1, 2016,
(the Senior Unsecured Notes). The Senior Unsecured Notes were priced at $0.9884 with a yield to
maturity of 13.16%. The Senior Unsecured Notes are subordinated to the Credit Facility and Senior
Secured Notes.
The Company may redeem some or all of the Senior Unsecured Notes prior to March 1, 2012, at a
redemption price equal to 100% of the principal amount of the Senior Unsecured Notes redeemed plus
a make-whole premium and accrued and unpaid interest. On or after March 1, 2012, the Company may
redeem some or all of the Senior Unsecured Notes at the redemption prices (expressed as percentages
of principal amount of the Senior Unsecured Notes to be redeemed) set forth below:
Senior | ||||
Unsecured Notes | ||||
% | ||||
2012 |
106.375 | |||
2013 |
103.188 | |||
2014 and thereafter |
100.000 |
Prior to March 1, 2011, the Company may also redeem up to 35% of the aggregate principal amount of
the Senior Unsecured Notes using the proceeds of one or more equity offerings at a redemption price
equal to 112.750% of the aggregate principal amount of the Senior Unsecured Notes plus accrued and
unpaid interest. If there is a change of control as specified in the indenture governing the Senior
Unsecured Notes, the Company must offer to repurchase the Senior Unsecured Notes at a price in cash
equal to 101% of the aggregate principal amount thereof, plus accrued and unpaid interest.
Payments required in each of the next five twelve-month periods to meet the retirement provisions
of the long-term debt are as follows:
$ | ||||
2011 |
| |||
2012 |
19,567 | |||
2013 |
80,938 | |||
2014 |
25,156 | |||
2015 |
228,000 | |||
Thereafter |
235,000 | |||
588,661 | ||||
Unamortized original issuance discount |
6,838 | |||
581,823 | ||||
14
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
9. Financial Information Included in the Consolidated Operations
a) Financial expenses
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
$ | $ | |||||||
Interest on long-term debt (including amortization of original issuance discount of $511 ($516 in 2009) |
14,606 | 14,811 | ||||||
Interest and bank charges |
245 | 102 | ||||||
Interest rate swaps (Note 13) |
| (96 | ) | |||||
Financing fees |
135 | 135 | ||||||
Amortization of deferred debt issue expenses |
1,243 | 1,245 | ||||||
16,229 | 16,197 | |||||||
b) Other information
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
$ | $ | |||||||
Rental expenses |
884 | 904 | ||||||
Shipping and handling expenses |
1,338 | 1,616 | ||||||
Advertizing expenses |
1,527 | 3,897 | ||||||
Depreciation of property, plant and equipment |
2,118 | 2,004 | ||||||
Amortization of intangible assets |
11,455 | 14,689 | ||||||
Stock-based compensation expense |
491 | 1,476 | ||||||
Transaction and integration costs |
2,927 | 416 | ||||||
c) Employee benefit plan
A subsidiary of the Company has a defined contribution plan (the Plan) for its U.S. employees.
Participation is available to substantially all U.S. employees. Employees may contribute up to 15%
of their gross pay or up to limits set by the U.S. Internal Revenue Service. The Company may make
matching contributions of a discretionary percentage. The Company charged to operations
contributions to the plan totaling $167,000 for the three-month period ended December 31, 2010,
($216,000 for the three-month period ended December 31, 2009).
15
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
10. Income Taxes
The Company establishes a valuation allowance against deferred tax assets in accordance with U.S.
GAAP. As at December 31, 2010, the Company has a valuation allowance of $62,290,000 against the
Companys net deferred tax assets generated in the U.S. reporting unit and of $1,038,000 against
the deferred tax assets generated in its France reporting unit. In future periods, if the deferred
tax assets are determined by management to be more likely than not to be realized, the tax benefits
relating to the reversal of the valuation allowance will be recorded.
The Companys effective tax rates for the three-month period ended December 31, 2010, was 45.43%,
as compared to minus 2.04% in the prior years period. The effective tax rate for the three-month
period ended December 31, 2010, is affected by a number of elements, the most important being the
establishment of the valuation allowance of $5,048,000 against the Companys net deferred tax
assets mostly attributable to the U.S. reporting unit.
As at December 31, 2010, the Company had unrecognized tax benefits of $10,834,000 ($10,896,000 as
at December 31, 2009).
The following table presents a summary of the changes to unrecognized tax benefits:
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
$ | $ | |||||||
Balance, beginning of period |
11,485 | 10,409 | ||||||
Additions based on tax positions related to the current year |
8 | 7 | ||||||
Additions for tax positions of prior years |
433 | 506 | ||||||
Settlements |
(1,063 | ) | | |||||
Reductions for tax positions of prior years |
(29 | ) | (26 | ) | ||||
Balance, end of period |
10,834 | 10,896 | ||||||
The Company has historically recognized interest relating to income tax matters as a component of
financial expenses and penalties related to income tax matters as a component of income tax
expense. As at December 31, 2010, the Company had accrued $1,090,000 ($1,075,000 as at September
30, 2010) for interest relating to income tax matters. There were no amounts recorded for penalties
as at December 31, 2010.
The Company and its subsidiaries file tax returns in the U.S. federal jurisdiction and various
states, local and foreign jurisdictions including Canada and France. In many cases, the Companys
uncertain tax positions are related to tax years that remain subject to examination by relevant tax
authorities. The Company is subject to federal and state income tax examination by U.S. tax
authorities for fiscal years 2005 through 2010. The Company is subject to Canadian and provincial
income tax examination for fiscal years 2005 through 2010. There are numerous other income
jurisdictions for which tax returns are not yet settled, none of which is individually significant.
The Company is currently being audited by Canada Revenue Agency for fiscal year 2005 to fiscal year
2008.
The Company and its U.S. subsidiaries file as members of a U.S. Federal consolidated income tax
return, of which Axcan Holdings Inc. is the parent. The consolidated income tax liability is
allocated among the members of the group in accordance with a tax allocation agreement. The tax
allocation agreement provides that each member of the group is allocated its share of the
consolidated tax provision determined generally on a separate income tax return method.
As at December 31, 2010, and September 30, 2010, no provision has been made for income taxes on the
undistributed earnings of the Companys foreign subsidiaries that the Company intends to
indefinitely reinvest.
16
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
11. Stock Incentive Plans
Management equity incentive plan
In April 2008, the Companys indirect parent company adopted a Management Equity Incentive Plan
(the MEIP Plan), pursuant to which the indirect parent company grants options to selected
employees and directors of the Company. The MEIP Plan provides that a maximum of 3,833,307 shares
of common stock of the indirect parent company are issuable pursuant to the exercise of options.
The per share purchase price cannot be less than the fair value of the share of common stock of the
indirect parent company at the grant date and the option expires no later than ten years from the
date of grant. Vesting of these stock options is split into 3 categories: 1) time-based options:
50% of option grants generally vest ratably over 5 years and feature a fixed exercise price equal
to the fair value of common stock of the indirect parent company on grant date; 2) premium options:
25% of stock option grants with an exercise price initially equal to the fair value of common stock
on grant date that will increase by 10% each year and generally vesting ratably over 5 years; and
3) performance-based options: 25% of stock option grants with a fixed exercise price equal to the
fair value of common stock on grant date which vest upon the occurrence of a liquidity event (as
defined under the terms of the MEIP Plan) based on the achievement of return targets calculated
based on the return received by majority shareholders from the liquidity event. While the
time-based options and the premium options are expensed over the requisite service period, the
performance-based options will not be expensed until the occurrence of the liquidity event.
Special equity grant
In April 2008, the indirect parent company approved the Restricted Stock Unit grant agreement and
the penny option grant agreement (collectively Equity Grant Agreements) pursuant to which a
one-time grant of equity-based awards of either restricted stock units (RSUs) or options to
purchase shares of common stock of the indirect parent company for a penny (Penny Options) was
made to certain employees of the Company. A maximum of 1,343,348 shares of common stock of the
indirect parent company are issuable with respect to the special grants. As a result of the option
to allow the recipients to elect to have an amount withheld that is in excess of the required
minimum withholding under the current tax law, the special grants will be accounted for as
liability awards. As a liability award, the fair value on which the expense is based is remeasured
each period based on the estimated fair value and the final expense will be based on the fair value
of the shares on the date the award is settled. The RSUs and Penny Options expire no later than
four years and ten years respectively from the date of grant. One third of the granted RSUs and
Penny Options vested immediately on date of grant; one third vested on August 25, 2009, and the
remainder vested on August 25, 2010.
The carrying value of an RSU or Penny Option is always equal to the estimated fair value of one
common share of the indirect parent company. The RSUs and Penny Options entitle the holders to
receive common shares of the indirect parent company at the end of a vesting period. The total
number of RSUs and Penny Options granted were 1,343,348 with an initial fair value of $10, equal to
the share price at the date of grant. As at December 31, 2010, there were 1,157,986 outstanding
RSUs and Penny Options (1,172,396 as at September 30, 2010) of which 1,154,652 (1,167,396 as at
September 30, 2010) were vested.
Annual grant
In June 2008, the Companys indirect parent company adopted a Long Term Incentive Plan (the
LTIP), pursuant to which the indirect parent company is expected to grant annual awards to
certain employees of the Company (the participants). The value of an award is initially based on
the participants pay grade and base salary and is subsequently adjusted based on the outcome of
certain performance conditions relating to the fiscal year. Each award that vests is ultimately
settleable, at the option of the participant, in cash or in parent company common stock of
equivalent value. The awards vest (i) upon the occurrence of a liquidity event (as defined under
the terms of the LTIP) and (ii) in varying percentages based on the level of return realized by
majority shareholders as a result of the liquidity event.
The awards granted under this LTIP are classified as liabilities in accordance with the FASB issued
guidance on distinguishing liabilities from equity, since the award is for a fixed amount of value
that can be settled, at the option of the participant, in (i) cash, or (ii) a variable number of
parent company common stock of equivalent value.
The Company will not recognize any compensation expense until such time as the occurrence of a
liquidity event generating sufficient return to the majority shareholders (in order for the award
to vest) is probable. If such an event was probable as of December 31, 2010, the value of the
awards to be expensed by the Company would range between $6,175,000 and $7,410,000 depending on the
level of return expected to be realized by the majority shareholders.
17
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
12. Financial Instruments
Interest rate risk
The Company is exposed to interest rate risk on its variable interest bearing term loans. The term
loans bear interest based on British Banker Association LIBOR. As further disclosed in Note 13, the
Company may enter into derivative financial instruments to manage its exposure to interest rate
changes and reduce its overall cost of borrowing.
Currency risk
The Company is exposed to financial risk arising from fluctuations in foreign exchange rates and
the degree of volatility of the rates. The Company does not use derivative instruments to reduce
its exposure to foreign currencies risk. As at December 31, 2010, the financial assets totaling
$195,644,000 ($194,005,000 as at September 30, 2010) include cash and cash equivalents and accounts
receivable for CAN $5,294,000, 18,159,000 Euros and 1,385,000 Swiss francs respectively
(CAN$4,073,000, 18,658,000 Euros and 1,820,000 Swiss francs as at September 30, 2010). As at
December 31, 2010, the financial liabilities totaling $673,860,000 ($689,148,000 as at September
30, 2010) include accounts payable and accrued liabilities and long-term debt of CAN$7,363,000 and
6,554,000 Euros respectively (CAN$10,234,000 and 8,158,000 Euros as at September 30, 2010).
Credit risk
As at December 31, 2010, the Company had $129,578,000 ($134,299,000 as at September 30, 2010) of
cash with one financial institution. At times, such deposits may exceed the amount insured by the
Federal Deposit Insurance Corporation.
Fair value of the financial instruments on the balance sheet
The estimated fair value of the financial instruments is as follows:
December 31, 2010 | September 30, 2010 | |||||||||||||||
Fair | Carrying | Fair | Carrying | |||||||||||||
value | amount | value | amount | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Assets |
||||||||||||||||
Cash and cash equivalents |
150,736 | 150,736 | 161,503 | 161,503 | ||||||||||||
Accounts receivable from the parent company |
525 | 525 | 487 | 487 | ||||||||||||
Accounts receivable, net |
44,383 | 44,383 | 32,015 | 32,015 | ||||||||||||
Liabilities |
||||||||||||||||
Accounts payable and accrued liabilities |
92,037 | 92,037 | 94,673 | 94,673 | ||||||||||||
Long-term debt |
597,966 | 581,823 | 608,535 | 594,475 |
The following methods and assumptions were used to calculate the estimated fair value of the
financial instruments on the balance sheet.
a) Financial instruments for which fair value is deemed equivalent to carrying amount
The estimated fair value of certain financial instruments shown on the consolidated balance
sheet is equivalent to their carrying amount. These financial instruments include cash and cash
equivalents, accounts receivable, net, accounts receivable from the parent company, accounts
payable and accrued liabilities.
b) Long-term debt
The fair value of the long-term debt bearing interest at fixed rates has been established
according to market prices obtained from a large U.S. financial institution. The fair value of the
variable interest bearing term loan has been established based on broker-dealer quotes.
18
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
13. Derivates and Hedging Activities
Risk management objective of using derivatives
The Company is exposed to certain risk arising from both its business operations and economic
conditions. The Company principally manages its exposures to a wide variety of business and
operational risks through management of its core business activities. The Company manages economic
risks, including interest rate, liquidity and credit risk primarily by managing the amount,
sources, conditions and duration of its debt funding and the use of derivative financial
instruments. Specifically, the Company enters into derivative financial instruments to manage
exposures that arise from business activities that result in the payment of future known and
uncertain cash amounts, the value of which are determined by interest rates. The Companys
derivative financial instruments, if any, are used to manage differences in the amount, timing and
duration of the Companys known or expected cash payments principally related to the Companys
borrowings.
Cash flow hedges of interest rate risk
The Companys objectives in using interest rate derivatives are to add stability to interest
expense and to manage its exposure to interest rate movements. To accomplish this objective, the
Company primarily uses interest rate swaps as part of its interest rate risk management strategy.
Interest rate swaps designated as cash flow hedges involve the receipt of variable-rate amounts
from a counterparty in exchange for the Company making fixed-rate payments over the life of the
agreements without exchange of the underlying notional amount. During the three-month period ended
December 31, 2009, such derivatives were used to hedge the variable cash flows associated with
existing variable-rate debt.
The effective portion of changes in the fair value of derivatives designated and that qualify as
cash flow hedges is recorded in Accumulated Other Comprehensive Income and is subsequently
reclassified into earnings in the period that the hedged forecasted transaction affects earnings.
The ineffective portion of the change in fair value of the derivatives is recognized directly in
earnings.
Amounts reported in Accumulated Other Comprehensive Income related to derivatives will be
reclassified to interest expense as interest payments are made on the Companys variable-rate debt.
In March 2009, the Company entered into a pay-fixed, receive-floating interest rate swap of a
notional amount of $52,000,000 amortizing to $13,000,000 through February 2010. The Companys two
interest rate swaps with a combined notional amount of $63,000,000 that were designated as cash
flow hedges of interest rate risk matured during the quarter ended March 31, 2010, and the Company
has not entered into new derivative agreements.
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
The table below presents the effect of the Companys derivative financial instruments on the
consolidated operations as at December 31, 2010, and December 31, 2009.
Tabular disclosure of the effect of derivative instruments for the three-month periods ended
December 31, 2010, and December 31, 2009.
Location in the | For the | For the | ||||||||||
Condensed | three-month | three-month | ||||||||||
Consolidated | period ended | period ended | ||||||||||
Financial | December 31, | December 31, | ||||||||||
Statements | 2010 | 2009 | ||||||||||
$ | $ | |||||||||||
Interest rate swaps in cash flow hedging relationships |
||||||||||||
Loss recognized in other comprehensive income on
derivatives (effective portion), net of tax of $165 in
2009 |
OCI | | (306 | ) | ||||||||
Loss reclassified from accumulated comprehensive
income into income (effective portion) |
Financial expenses | | (351 | ) | ||||||||
Gain recognized in income on derivatives
(ineffective portion and amount excluded from
effectiveness testing) |
Financial expenses | | 447 | |||||||||
Interest rate swaps not designated as hedging instruments |
||||||||||||
Loss recognized in income on derivatives |
Financial expenses | | | |||||||||
14. Related Party Transactions
As at December 31, 2010, and September 30, 2010, the Company had a note receivable from its parent
company amounting to $133,154,000. During the three-month periods ended December 31, 2010, and
December 31, 2009, the Company earned interest income on the note amounting to $1,974,000 net of
taxes amounting to $1,063,000 and the related interest receivable from the parent company amounting
to $30,167,000 as at December 31, 2010 ($27,130,000 as at September 30, 2010) has been recorded in
the shareholders equity section of the consolidated balance sheet. This amount was subject to a
full provision which was also recorded in the statement of shareholders equity. As at December 31,
2010, the Company has an account receivable from the parent company amounting to $525,000 ($487,000
as at September 30, 2010).
During the three-month period ended December 31, 2010, the Company recorded charges pursuant to the
terms of a management fee arrangement with a controlling shareholding company amounting to $838,000
($855,000 during the three-month period ended December 31, 2009). As at December 31, 2010, the
Company accrued fees payable to a controlling shareholding company amounting to $859,000
($1,574,000 as at September 30, 2010).
During the three-month period ended December 31, 2009, the Company paid a dividend to its
parent company amounting to $128,000 to allow for the payment of certain group expenses.
20
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
15. Condensed Consolidating Financial Information
As of December 31, 2010, the Company had outstanding $228,000,000 aggregate principal amount of the
Senior Secured Notes. The Secured Notes are fully and unconditionally guaranteed, jointly and
severally by certain of the Companys wholly-owned subsidiaries.
The following supplemental tables present condensed consolidating balance sheets for the Company
and its subsidiary guarantors and non-guarantors as at December 31, 2010, and September 30, 2010,
the condensed consolidating statements of operations for the three-month period ended December 31,
2010, and the three-month period ended December 31, 2009, and the condensed consolidating statement
of cash flows for the three-month period ended December 31, 2010, and the three-month period ended
December 31, 2009.
Condensed consolidating balance sheet as at December 31, 2010
Axcan | Subsidiary | |||||||||||||||||||
Intermediate | Subsidiary | non- | ||||||||||||||||||
Holdings Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Assets |
||||||||||||||||||||
Current assets |
||||||||||||||||||||
Cash and cash equivalents |
68 | 87,681 | 62,987 | | 150,736 | |||||||||||||||
Accounts receivable, net |
| 29,503 | 15,253 | | 44,756 | |||||||||||||||
Accounts receivable from the parent company |
51 | 474 | | | 525 | |||||||||||||||
Intercompany receivables |
24,302 | 1,782 | 4,182 | (30,266 | ) | | ||||||||||||||
Income taxes receivable |
| 4,877 | | | 4,877 | |||||||||||||||
Inventories, net |
| 16,620 | 6,402 | (386 | ) | 22,636 | ||||||||||||||
Prepaid expenses and deposits |
19 | 1,978 | 702 | | 2,699 | |||||||||||||||
Deferred income taxes, net |
| 2,092 | 820 | 111 | 3,023 | |||||||||||||||
Total current assets |
24,440 | 145,007 | 90,346 | (30,541 | ) | 229,252 | ||||||||||||||
Property, plant and equipment, net |
| 25,859 | 8,159 | | 34,018 | |||||||||||||||
Intangible assets, net |
| 275,674 | 59,888 | | 335,562 | |||||||||||||||
Investments in subsidiaries |
(343,465 | ) | 846,055 | 78,175 | (580,765 | ) | | |||||||||||||
Intercompany advances |
822,753 | 98,425 | 685,017 | (1,606,195 | ) | | ||||||||||||||
Goodwill, net |
| 61,887 | 11,474 | | 73,361 | |||||||||||||||
Deferred debt issue expenses, net |
16,931 | 2,269 | | | 19,200 | |||||||||||||||
Deferred income taxes, net |
| | 8,175 | | 8,175 | |||||||||||||||
Total assets |
520,659 | 1,455,176 | 941,234 | (2,217,501 | ) | 699,568 | ||||||||||||||
Liabilities |
||||||||||||||||||||
Current liabilities |
||||||||||||||||||||
Accounts payable and accrued liabilities |
21,884 | 61,398 | 8,755 | | 92,037 | |||||||||||||||
Income taxes payable |
| 5,259 | 1,580 | | 6,839 | |||||||||||||||
Intercompany payables |
1,247 | 28,479 | 540 | (30,266 | ) | | ||||||||||||||
Deferred income taxes |
| 42 | | | 42 | |||||||||||||||
Total current liabilities |
23,131 | 95,178 | 10,875 | (30,266 | ) | 98,918 | ||||||||||||||
Long-term debt |
510,989 | 70,834 | | | 581,823 | |||||||||||||||
Intercompany advances |
8,775 | 1,514,043 | 83,377 | (1,606,195 | ) | | ||||||||||||||
Other long-term liabilities |
| 9,695 | | | 9,695 | |||||||||||||||
Deferred income taxes |
| 30,716 | 652 | | 31,368 | |||||||||||||||
Total liabilities |
542,895 | 1,720,466 | 94,904 | (1,636,461 | ) | 721,804 | ||||||||||||||
Shareholders Equity (Deficiency) |
||||||||||||||||||||
Capital stock |
||||||||||||||||||||
Common shares |
1 | 21,020 | 735,742 | (756,762 | ) | 1 | ||||||||||||||
Preferred shares |
| 78,175 | | (78,175 | ) | | ||||||||||||||
Retained earnings (deficit) |
(466,706 | ) | (341,795 | ) | 114,443 | 227,352 | (466,706 | ) | ||||||||||||
9.05% Note receivable from the parent company |
(133,154 | ) | | | | (133,154 | ) | |||||||||||||
Additional paid-in capital |
613,492 | 13,179 | 730 | (13,909 | ) | 613,492 | ||||||||||||||
Accumulated other comprehensive loss |
(35,869 | ) | (35,869 | ) | (4,585 | ) | 40,454 | (35,869 | ) | |||||||||||
Total shareholders equity (deficiency) |
(22,236 | ) | (265,290 | ) | 846,330 | (581,040 | ) | (22,236 | ) | |||||||||||
Total liabilities and shareholders equity
(deficiency) |
520,659 | 1,455,176 | 941,234 | (2,217,501 | ) | 699,568 | ||||||||||||||
21
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
Condensed consolidating balance sheet as at September 30, 2010
Axcan | Subsidiary | |||||||||||||||||||
Intermediate | Subsidiary | non- | ||||||||||||||||||
Holdings Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Assets |
||||||||||||||||||||
Current assets |
||||||||||||||||||||
Cash and cash equivalents |
864 | 104,608 | 56,031 | | 161,503 | |||||||||||||||
Accounts receivable, net |
| 19,262 | 13,117 | | 32,379 | |||||||||||||||
Accounts receivable from the parent company |
50 | 437 | | | 487 | |||||||||||||||
Intercompany receivables |
11,092 | 1,618 | 4,265 | (16,975 | ) | | ||||||||||||||
Income taxes receivable |
| 2,906 | | | 2,906 | |||||||||||||||
Inventories, net |
| 17,697 | 6,563 | (394 | ) | 23,866 | ||||||||||||||
Prepaid expenses and deposits |
48 | 2,385 | 844 | | 3,277 | |||||||||||||||
Deferred income taxes, net |
| 1,355 | 857 | 119 | 2,331 | |||||||||||||||
Total current assets |
12,054 | 150,268 | 81,677 | (17,250 | ) | 226,749 | ||||||||||||||
Property, plant and equipment, net |
| 27,383 | 8,394 | | 35,777 | |||||||||||||||
Intangible assets, net |
| 285,703 | 62,259 | | 347,962 | |||||||||||||||
Investments in subsidiaries |
(354,104 | ) | 830,813 | 78,175 | (554,884 | ) | | |||||||||||||
Intercompany advances |
826,431 | 91,811 | 679,391 | (1,597,633 | ) | | ||||||||||||||
Goodwill, net |
| 61,887 | 11,653 | | 73,540 | |||||||||||||||
Deferred debt issue expenses, net |
18,021 | 2,422 | | | 20,443 | |||||||||||||||
Deferred income taxes, net |
| | 8,706 | | 8,706 | |||||||||||||||
Total assets |
502,402 | 1,450,287 | 930,255 | (2,169,767 | ) | 713,177 | ||||||||||||||
Liabilities |
||||||||||||||||||||
Current liabilities |
||||||||||||||||||||
Accounts payable and accrued liabilities |
5,975 | 77,887 | 10,811 | | 94,673 | |||||||||||||||
Income taxes payable |
| 1,938 | 1,508 | | 3,446 | |||||||||||||||
Intercompany payables |
449 | 15,340 | 1,186 | (16,975 | ) | | ||||||||||||||
Installments on long-term debt |
5,546 | 7,617 | | | 13,163 | |||||||||||||||
Deferred income taxes |
| 47 | | | 47 | |||||||||||||||
Total current liabilities |
11,970 | 102,829 | 13,505 | (16,975 | ) | 111,329 | ||||||||||||||
Long-term debt |
510,663 | 70,649 | | | 581,312 | |||||||||||||||
Intercompany advances |
801 | 1,512,092 | 84,740 | (1,597,633 | ) | | ||||||||||||||
Other long-term liabilities |
| 10,028 | | | 10,028 | |||||||||||||||
Deferred income taxes |
| 30,618 | 922 | | 31,540 | |||||||||||||||
Total liabilities |
523,434 | 1,726,216 | 99,167 | (1,614,608 | ) | 734,209 | ||||||||||||||
Shareholders Equity (Deficiency) |
||||||||||||||||||||
Capital stock |
||||||||||||||||||||
Common shares |
1 | 21,020 | 735,742 | (756,762 | ) | 1 | ||||||||||||||
Preferred shares |
| 78,175 | | (78,175 | ) | | ||||||||||||||
Retained earnings (deficit) |
(468,152 | ) | (354,020 | ) | 98,657 | 255,363 | (468,152 | ) | ||||||||||||
9.05% Note receivable from the parent company |
(133,154 | ) | | | | (133,154 | ) | |||||||||||||
Additional paid-in capital |
614,113 | 12,736 | 689 | (13,425 | ) | 614,113 | ||||||||||||||
Accumulated other comprehensive loss |
(33,840 | ) | (33,840 | ) | (4,000 | ) | 37,840 | (33,840 | ) | |||||||||||
Total shareholders equity (deficiency) |
(21,032 | ) | (275,929 | ) | 831,088 | (555,159 | ) | (21,032 | ) | |||||||||||
Total liabilities and shareholders equity |
502,402 | 1,450,287 | 930,255 | (2,169,767 | ) | 713,177 | ||||||||||||||
22
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
Condensed consolidating operations for the three-month period ended December 31, 2010
Axcan | Subsidiary | |||||||||||||||||||
Intermediate | Subsidiary | non- | ||||||||||||||||||
Holdings Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Net product sales |
| 68,512 | 17,538 | (112 | ) | 85,938 | ||||||||||||||
Cost of goods sold |
3 | 10,956 | 6,585 | (121 | ) | 17,423 | ||||||||||||||
Selling and administrative expenses |
4,523 | 16,700 | 6,996 | | 28,219 | |||||||||||||||
Management fees |
838 | | | | 838 | |||||||||||||||
Research and development expenses |
| 6,806 | 149 | | 6,955 | |||||||||||||||
Depreciation and amortization |
| 11,721 | 1,852 | | 13,573 | |||||||||||||||
Total operating expenses |
5,364 | 46,183 | 15,582 | (121 | ) | 67,008 | ||||||||||||||
Operating income (loss) |
(5,364 | ) | 22,329 | 1,956 | 9 | 18,930 | ||||||||||||||
Financial expenses |
14,924 | 28,800 | 1,788 | (29,283 | ) | 16,229 | ||||||||||||||
Interest income |
(12,243 | ) | (1,911 | ) | (15,321 | ) | 29,283 | (192 | ) | |||||||||||
Dividend income |
| | (242 | ) | 242 | | ||||||||||||||
Loss (gain) on foreign currencies |
3,797 | (2,035 | ) | (157 | ) | (1,362 | ) | 243 | ||||||||||||
Total other expenses (income) |
6,478 | 24,854 | (13,932 | ) | (1,120 | ) | 16,280 | |||||||||||||
Income (loss) before income taxes |
(11,842 | ) | (2,525 | ) | 15,888 | 1,129 | 2,650 | |||||||||||||
Income taxes expense (benefit) |
(1,063 | ) | 2,160 | 99 | 8 | 1,204 | ||||||||||||||
Equity in earnings in subsidiaries |
12,225 | 16,910 | | (29,135 | ) | | ||||||||||||||
Net income |
1,446 | 12,225 | 15,789 | (28,014 | ) | 1,446 | ||||||||||||||
Condensed consolidating operations for the three-month period ended December 31, 2009
Axcan | Subsidiary | |||||||||||||||||||
Intermediate | Subsidiary | non- | ||||||||||||||||||
Holdings Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Net product sales |
| 95,023 | 16,106 | (997 | ) | 110,132 | ||||||||||||||
Cost of goods sold |
| 22,549 | 5,076 | (997 | ) | 26,628 | ||||||||||||||
Selling and administrative expenses |
343 | 24,401 | 7,495 | | 32,239 | |||||||||||||||
Management fees |
855 | | | | 855 | |||||||||||||||
Research and development expenses |
| 7,707 | 719 | | 8,426 | |||||||||||||||
Depreciation and amortization |
| 14,611 | 2,082 | | 16,693 | |||||||||||||||
Total operating expenses |
1,198 | 69,268 | 15,372 | (997 | ) | 84,841 | ||||||||||||||
Operating income (loss) |
(1,198 | ) | 25,755 | 734 | | 25,291 | ||||||||||||||
Financial expenses |
14,957 | 28,661 | 1,960 | (29,381 | ) | 16,197 | ||||||||||||||
Interest income |
(12,469 | ) | (1,995 | ) | (15,065 | ) | 29,381 | (148 | ) | |||||||||||
Loss (gain) on foreign currencies |
6,717 | (4,664 | ) | (139 | ) | (1,929 | ) | (15 | ) | |||||||||||
Total other expenses (income) |
9,205 | 22,002 | (13,244 | ) | (1,929 | ) | 16,034 | |||||||||||||
Income (loss) before income taxes |
(10,403 | ) | 3,753 | 13,978 | 1,929 | 9,257 | ||||||||||||||
Income taxes expense (benefit) |
(3,641 | ) | 3,841 | (389 | ) | | (189 | ) | ||||||||||||
Equity in earnings in subsidiaries |
16,208 | 16,296 | | (32,504 | ) | | ||||||||||||||
Net income |
9,446 | 16,208 | 14,367 | (30,575 | ) | 9,446 | ||||||||||||||
23
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
Condensed consolidating cash flows for the three-month period ended December 31, 2010
Axcan | Subsidiary | |||||||||||||||||||
Intermediate | Subsidiary | non- | ||||||||||||||||||
Holdings Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Cash flows from operating activities |
||||||||||||||||||||
Net cash provided by (used in) operating
activities |
(3,176 | ) | (755 | ) | 7,627 | | 3,696 | |||||||||||||
Cash flows from investing activities |
||||||||||||||||||||
Acquisition of property, plant and equipment |
| (643 | ) | (492 | ) | | (1,135 | ) | ||||||||||||
Intercompany advances |
| (7,975 | ) | | 7,975 | | ||||||||||||||
Net cash used in investing activities |
| (8,618 | ) | (492 | ) | 7,975 | (1,135 | ) | ||||||||||||
Cash flows from financing activities |
||||||||||||||||||||
Repayment of long-term debt |
(5,546 | ) | (7,617 | ) | | | (13,163 | ) | ||||||||||||
Stock-based compensation plan redemptions |
(49 | ) | | | | (49 | ) | |||||||||||||
Intercompany advances |
7,975 | | | (7,975 | ) | | ||||||||||||||
Net cash provided by (used in) financing
activities |
2,380 | (7,617 | ) | | (7,975 | ) | (13,212 | ) | ||||||||||||
Foreign exchange loss on cash held in foreign
currencies |
| 63 | (179 | ) | | (116 | ) | |||||||||||||
Net increase (decrease) in cash and cash
equivalents |
(796 | ) | (16,927 | ) | 6,956 | | (10,767 | ) | ||||||||||||
Cash and cash equivalents, beginning of period |
864 | 104,608 | 56,031 | | 161,503 | |||||||||||||||
Cash and cash equivalents, end of period |
68 | 87,681 | 62,987 | | 150,736 | |||||||||||||||
Condensed consolidating cash flows cash flows for the three-month period ended December 31, 2009
Axcan | Subsidiary | |||||||||||||||||||
Intermediate | Subsidiary | non- | ||||||||||||||||||
Holdings Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Cash flows from operating activities |
||||||||||||||||||||
Net cash provided by (used in) operating
activities |
(12,285 | ) | 19,713 | 21,086 | | 28,514 | ||||||||||||||
Cash flows from investing activities |
||||||||||||||||||||
Acquisition of property, plant and equipment |
| (1,100 | ) | (29 | ) | | (1,129 | ) | ||||||||||||
Intercompany advances |
29,998 | 22,879 | (5,328 | ) | (47,549 | ) | | |||||||||||||
Investments in subsidiaries |
| | (68,000 | ) | 68,000 | | ||||||||||||||
Net cash provided by (used in) investing
activities |
29,998 | 21,779 | (73,357 | ) | 20,451 | (1,129 | ) | |||||||||||||
Cash flows from financing activities |
||||||||||||||||||||
Repayment of long-term debt |
(8,791 | ) | (12,074 | ) | | | (20,865 | ) | ||||||||||||
Stock-based compensation plan redemptions |
(271 | ) | | | | (271 | ) | |||||||||||||
Intercompany advances |
(9,163 | ) | (37,852 | ) | (534 | ) | 47,549 | | ||||||||||||
Dividends paid |
(128 | ) | | | | (128 | ) | |||||||||||||
Issue of shares |
| 68,000 | | (68,000 | ) | | ||||||||||||||
Net cash provided by (used in) financing
activities |
(18,353 | ) | 18,074 | (534 | ) | (20,451 | ) | (21,264 | ) | |||||||||||
Foreign exchange gain (loss) on cash held in
foreign currencies |
| 72 | (237 | ) | | (165 | ) | |||||||||||||
Net increase (decrease) in cash and cash
equivalents |
(640 | ) | 59,638 | (53,042 | ) | | 5,956 | |||||||||||||
Cash and cash equivalents, beginning of period |
702 | 41,859 | 83,874 | | 126,435 | |||||||||||||||
Cash and cash equivalents, end of period |
62 | 101,497 | 30,832 | | 132,391 | |||||||||||||||
24
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AXCAN INTERMEDIATE HOLDINGS INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
(unaudited)
16. Subsequent Event
Acquisition of Eurand N.V. (Eurand)
On February 11, 2011, Axcan Holdings Inc. (Axcan Holdings), the Companys indirect parent, and
Axcan Pharma Holding B.V. (Axcan AcquisitionCo), an indirect subsidiary of the Company, pursuant
to a Share Purchase Agreement dated November 30, 2010 (as amended) acquired 95.6% (99.1% after giving effect to the additional shares that are guaranteed to be delivered under a notice of guaranteed delivery) of the outstanding
shares of Eurand N.V. (Eurand) for a purchase price of $12.00 per share in cash resulting in
total consideration of approximately $586,500,000 for 100% of such shares. As a result of the
acquisition, Eurand has become an indirect subsidiary. In addition, Axcan AcquisitionCo and other
direct and indirect subsidiaries of the Company acquired from Eurand substantially all of Eurands
assets, including the capital stock of Eurands direct and indirect U.S. and foreign subsidiaries,
in exchange for a seller note in an amount equal to the product of the number of all Eurand shares
remaining outstanding after giving effect to the closing of the Offer multiplied by the Offer price
of $12.00 per share, and transferred the capital stock of former Eurand U.S. subsidiaries to the
Company.
The aggregate equity purchase price of $586,500,000 plus acquisition costs (including related fees
and expenses) were funded by cash equity contributions amounting to $140,000,000 from affiliates of
TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term Loan Facility
(as defined below) under the Companys amended and restated credit agreement and related security
and other agreements and cash on hand from Axcan and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of
(i) a senior secured revolving credit facility in an aggregate principal amount of $115,000,000
(the Senior Secured Revolving Credit Facility) and (ii) a $750,000,000 senior secured term loan
facility (the Senior Secured Term Loan Facility and, together with the Senior Secured Revolving
Credit Facility, collectively, the Amended and Restated Senior Secured Credit Facilities). The
Company borrowed $500,000,000 of the amount available under the Senior Secured Term Loan Facility
at the closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at
the closing of the acquisition.
A portion of the proceeds of the equity and debt financings, together with cash on hand of Axcan
and Eurand, were also used to repay the outstanding term loan portion amounting to $125,660,000 of
the Companys existing senior secured credit facilities and to pay related fees and expenses. It
is expected that $250,000,000 of the Senior Secured Term Loan Facility will be available to be
drawn on or about March 14, 2011 to redeem or discharge the Companys existing 9.25% senior secured
notes due 2015.
Prior to the transaction, Eurand was a specialty pharmaceutical company that developed,
manufactured and commercialized enhanced pharmaceutical and biopharmaceutical products based on its
proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001
and has a pipeline of product candidates in development for itself and its collaboration partners.
Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom
release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was a
global company with facilities in the U.S. and Europe.
The transaction will be accounted for in accordance with the acquisition method of accounting for
business combinations under existing U.S. generally accepted accounting principles (GAAP). The
acquisition method of accounting requires, among other things, that assets acquired and liabilities
assumed be recognized at their fair values as of the acquisition date including acquired in-process
research and development assets.
Due to the significant limitations on access to Eurand information prior to the acquisition date
and the limited time since the acquisition date, the initial purchase allocation for the business
combination is incomplete at this time. As a result, the Company is unable to provide disclosures
of the amounts that will be recognized as of the acquisition date for the major classes of assets
acquired and liabilities assumed, including the information required for accounts receivable,
inventory, pre-acquisition contingencies, intangible assets and goodwill. Because the initial
purchase allocation for the business combination is incomplete at this time, the Company also
unable to provide the required pro forma disclosures of revenues and earnings of the combined
entity as at December 31, 2010. This information will be included in the Companys next quarterly
filing on Form 10-Q.
Through December 31, 2010, the Company has expensed $4,118,000 (including $1,070,000 expensed in
the fiscal year ended September 30, 2010) of costs relating to legal, financial and accounting
advisory services performed in connection with the transaction with Eurand, which are included in
selling and administrative expenses in the accompanying Statement of Condensed Consolidated Operations.
25
Table of Contents
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
You should read the following discussion in conjunction with the Condensed Consolidated Interim
Financial Statements and the related notes that appear in Part I, Item 1 of this Quarterly Report.
The results of operations for the three-month periods ended December 31, 2010, and December 31,
2009, reflect the results of operations for Axcan Intermediate Holdings Inc. and its consolidated
subsidiaries.
Unless the context otherwise requires, in this Managements Discussion and Analysis of Financial
Condition and Results of Operations, the terms Axcan, Company, we, us and our refer to
Axcan Intermediate Holdings Inc. and its consolidated subsidiaries.
This discussion contains forward-looking statements and involves numerous risks and uncertainties,
including but not limited to those described in Part 2, Item 1A of this Quarterly Report and Item
1A Risk Factors of our Annual Report on Form 10-K for the fiscal year ended September 30, 2010.
Actual results may differ materially from those contained in any forward-looking statements.
Overview
Our Business
We are a specialty pharmaceutical company focused on marketing and selling pharmaceutical products
used in the treatment of a variety of gastrointestinal, or GI, diseases and disorders, which are
those affecting the digestive tract. Our vision is to become the reference gastrointestinal
company, and we hope to achieve this through our mission: to improve the quality of care and health
of patients suffering from gastrointestinal diseases and disorders by providing effective therapies
for patients and specialized caregivers.
In addition to our marketing activities, we carry out research and development activities on
products at late stages of development. These activities are carried out primarily with respect to
products we currently market in connection with lifecycle management initiatives, as well as
product candidates in late stage of development that we acquired or licensed from third parties.
Our focus on products in late-stage development enables us to reduce risks and expenses typically
associated with new drug development.
We intend to enhance our position as the leading specialty pharmaceutical company concentrating in
the field of gastroenterology by pursuing the following strategic initiatives: 1) growing sales of
existing products; 2) launching new products; 3) selectively acquiring or in-licensing
complementary products; 4) pursuing growth opportunities through development pipeline; and 5)
expanding internationally.
Business Environment
While the ultimate end users of our products are the individual patients to whom our products are
prescribed by physicians, our direct customers include a number of large pharmaceutical wholesale
distributors and large pharmacy chains. The pharmaceutical wholesale distributors that comprise a
significant portion of our customer base sell our products primarily to retail pharmacies, which
ultimately dispense our products to the end consumers.
Increasingly, in North America, third-party payors, such as private insurance companies and drug
plan benefit managers, aim to rationalize the use of pharmaceutical products and medical
treatments, in order to ensure that prescribed products are necessary for the patients disorders.
Moreover, large drug store chains now account for an increasing portion of retail sales of
prescription medicines. The pharmacists and managers of such retail outlets are under pressure to
reduce the number of items in inventory in order to reduce costs.
We use a pull-through marketing approach that is typical of pharmaceutical companies. Under this
approach, our sales representatives actively promote our portfolio products by demonstrating the
features and benefits of our products to physicians and, in particular, gastroenterologists who may
prescribe our products for their patients. The patients, in turn, take the prescriptions to
pharmacies to be filled. The pharmacies then place orders, directly or through buying groups, with
the wholesalers, to whom we sell our products.
Our expenses are comprised primarily of selling and administrative expenses (including marketing
expenses), cost of goods sold (including royalty payments to those companies from which we license
some of our commercialized products), research and development expenses, financial expenses as well
as depreciation and amortization.
Since 2005, some U.S. wholesalers have changed their business model from one depending on drug
price inflation to a fee-for-service arrangement, whereby manufacturers pay wholesalers a fee for
inventory management and other services. These fees typically are a percentage of the wholesalers
purchases from the manufacturer or a fixed charge per item or per unit. The fee-for-service
approach results in wholesalers compensation being more stable and volume-based as opposed to
price-increase based. As a result of the move to a fee-for-service business model, many wholesalers
are no longer investing in inventory ahead of anticipated price increases and have reduced their
inventories from their historical levels. As a consequence of the new model, manufacturers now
realize the benefit of price increases more rapidly in return for paying wholesalers for the
services they provide, on a fee-for-service basis. Fees resulting from distribution services
agreements, or DSAs, are deducted from gross sales. We have had DSAs in place with our three
largest U.S. wholesalers since the first quarter of fiscal year 2009.
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In March 2010, the Health Care and Education Reconciliation Act of 2010 was enacted in the
U.S. This healthcare reform legislation contains several provisions that impact our business, which
include expanding rebate coverage to managed Medicaid and an increase to the rate of rebates for
all our drugs dispensed to Medicaid beneficiaries; expanding the 340(B) drug pricing program
requiring drug manufacturers to provide discounted product to reduce the Medicare Part D coverage
gap; and assessing a new fee on manufacturers and importers of branded prescription drugs paid for
pursuant to coverage provided under specified government programs. The impact of these changes is
further discussed below under the Affordable Care Act subsection.
On April 29, 2010, we announced that we had taken steps to cease the distribution of ULTRASE
MT and VIOKASE, effective April 28, 2010, in response to FDA guidance related to the
distribution of unapproved pancreatic enzyme products, or PEPs. The effects of ceasing to
distribute these product lines on our financial statements are summarized in the section
Unapproved pancreatic enzyme products (PEPs) event below.
Acquisition of Eurand N.V. (Eurand Acquisition)
On February 11, 2011 (the acquisition date), Axcan Holdings Inc. (Axcan Holdings), the
Companys indirect parent, and Axcan Pharma Holding B.V. (Axcan AcquisitionCo), an indirect
subsidiary of the Company, pursuant to a Share Purchase Agreement dated November 30, 2010 (as
amended) acquired 95.6% (99.1% after giving effect to the additional shares that are guaranteed to be delivered under a notice of guaranteed delivery) of the outstanding shares of Eurand N.V. (Eurand) for a purchase price of
$12.00 per share in cash resulting in total consideration of approximately $586.5 million for 100%
of such shares. As a result of the acquisition, Eurand has become an indirect subsidiary. In
addition, Axcan AcquisitionCo and other direct and indirect subsidiaries of the Company acquired
from Eurand substantially all of Eurands assets, including the capital stock of Eurands direct
and indirect U.S. and foreign subsidiaries, in exchange for a seller note in an amount equal to the
product of the number of all Eurand shares remaining outstanding after giving effect to the closing
of the Offer multiplied by the Offer price of $12.00 per share, and transferred the capital stock
of former Eurand U.S. subsidiaries to the Company.
The aggregate equity purchase price of $586.5 million plus acquisition costs (including related
fees and expenses) were funded by cash equity contributions amounting to $140.0 million from
affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term
Loan Facility (as defined below) under the Companys amended and restated credit agreement and
related security and other agreements and cash on hand from Axcan and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of
(i) a senior secured revolving credit facility in an aggregate principal amount of $115.0 million
(the Senior Secured Revolving Credit Facility) and (ii) a $750.0 million senior secured term loan
facility (the Senior Secured Term Loan Facility and, together with the Senior Secured Revolving
Credit Facility, collectively, the Amended and Restated Senior Secured Credit Facilities). We
borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the
closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the
closing of the acquisition.
A portion of the proceeds of the equity and debt financings, together with cash on hand of Axcan
and Eurand, were also used to repay the outstanding term loan portion amounting to $125.7 million
of our existing senior secured credit facilities and to pay related fees and expenses. It is
expected that $250.0 million of the Senior Secured Term Loan Facility will be available to be drawn
on or about March 14, 2011 to redeem or discharge our existing 9.25% senior secured notes due 2015.
Prior to the transaction, Eurand was a specialty pharmaceutical company that developed,
manufactured and commercialized enhanced pharmaceutical and biopharmaceutical products based on its
proprietary pharmaceutical technologies. Eurand has had six products approved by the FDA since 2001
and has a pipeline of product candidates in development for itself and its collaboration partners.
Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom
release profiles and taste-masking/orally disintegrating tablet (ODT) formulations. Eurand was a
global company with facilities in the U.S. and Europe.
The transaction will be accounted for in accordance with the acquisition method of accounting for
business combinations under existing U.S. generally accepted accounting principles (GAAP). The
acquisition method of accounting requires, among other things, that assets acquired and liabilities
assumed be recognized at their fair values as of the acquisition date including acquired in-process
research and development assets.
Due to the significant limitations on access to Eurand information prior to the acquisition date
and the limited time since the acquisition date, the initial purchase allocation for the business
combination is incomplete at this time. As a result, we are unable to provide disclosures of the
amounts that will be recognized as of the acquisition date for the major classes of assets acquired
and liabilities assumed, including the information required for accounts receivable, inventory,
pre-acquisition contingencies, intangible assets and goodwill. Because the initial purchase
allocation for the business combination is incomplete at this time, we are also unable to provide
the required pro forma disclosures of revenues and earnings of the combined entity as at December
31, 2010. This information will be included in our next quarterly filing on Form 10-Q.
Through December 31, 2010, we have expensed $4.1 million (including $1.1 million expensed in the
fiscal year ended September 30, 2010) of costs relating to legal, financial and accounting advisory
services performed in connection with the transaction with Eurand, which are included in selling
and administrative expenses in the accompanying Statement of Consolidated Operations.
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FINANCIAL OVERVIEW FOR THREE-MONTH PERIOD ENDED DECEMBER 31, 2010
This discussion and analysis is based on our unaudited condensed interim financial statements as at
December 31, 2010 and our audited annual consolidated financial statements and the related notes
thereto reported under U.S. GAAP. For a description of our products, see the section entitled
Business Products in Item 1, Part I in our Annual Report on Form 10-K for the fiscal year ended
September 30, 2010, filed with the Securities and Exchange Commission.
For the three-month period ended December 31, 2010, net product sales were $85.9 million ($110.1
million for the corresponding period of the preceding year), operating income was $18.9 million
($25.3 million for the corresponding period of the preceding year) and net income was $1.4 million
($9.4 million for the corresponding period of the preceding year). Net product sales in the United
States were $58.2 million (67.8% of net product sales) for the three-month period ended December
31, 2010, compared to $85.2 million (77.4% of net product sales) for the corresponding period of
the preceding year. In the European Union, net product sales were $17.5 million (20.4% of net
product sales) for the three-month period ended December 31, 2010, compared to $15.8 million (14.4%
of net product sales) for the corresponding period of the preceding year. In Canada, net product
sales were $10.2 million (11.9% of net product sales) for the three-month period ended December 31,
2010, compared to $8.9 million (8.1% of net product sales) for the corresponding period of the
preceding year.
Unapproved pancreatic enzyme products (PEPs) event
As previously disclosed, we ceased distributing our ULTRASE MT and VIOKASE product lines in the
U.S. effective April 28, 2010. ULTRASE MT and VIOKASE had accounted for approximately 19% of our
total net sales in the last three fiscal years ended September 30, 2009.
This action was taken as we did not receive FDA approval for ULTRASE MT or VIOKASE by April 28,
2010, the date mandated by the FDA to obtain approval for pancreatic enzyme products. We also
interrupted shipments of product from the United States to Canada and export markets to allow time
for the U.S. Food and Drug Administration to review our request confirming that applicable export
requirements were being met as the FDA does not currently allow any shipment of this product within
the U.S. As of December 31, 2010, this interruption of shipments was still in place.
We completed the initial submission of our NDA for ULTRASE MT and, in the fourth quarter of fiscal
2008, received a first complete response letter from the FDA. Further to the filing of our response
to this letter, we received a second complete response letter from the FDA in the fourth quarter of
fiscal 2009. On May 5, 2010 the FDA issued an additional complete response with respect to our NDA
for ULTRASE MT. As was the case with prior letters, the FDA requires that deficiencies raised with
respect to the manufacturing and control processes at the manufacturer of the active ingredient of
ULTRASE MT be addressed before approval can be granted. We have submitted our response to this
letter to the FDA that confirmed a November 28, 2010 Prescription Drug User Fee Act, or PDUFA, date
for our ULTRASE MT NDA.
The submission of our rolling NDA for VIOKASE was completed in the first quarter of fiscal year
2010. At the time we completed this submission, we requested a priority review and the FDA advised
us in the second quarter of fiscal year 2010 that it would not grant a priority review for this
NDA. The initial PDUFA date for VIOKASE was August 30, 2010. In August 2010, we received feedback
from the FDA regarding the timeline to review the VIOKASE NDA. At that time, the FDA
indicated that the review was progressing but postponed the PDUFA date to November 30, 2010, to
allow more time to complete their review.
On November 28, 2010, the FDA issued complete response letters regarding the NDAs for ULTRASE MT
and VIOKASE. The letters require that unresolved deficiencies raised with respect to the
manufacturing and control processes at the manufacturer of the active ingredient for both ULTRASE
MT and VIOKASE be addressed before approval can be granted. The letters also require that
deficiencies identified in an FDA inspection of such manufacturer must be resolved before the NDAs
can be approved. Based on information available to the Company, on or
about January 20, 2010, the manufacturer of the active pharmaceutical
ingredient to ULTRASE MT and VIOKASE received a warning letter from
the FDA noting that certain deficiencies previously identified by the
FDA in an inspection of such manufacturer have not yet been
resolved. Failure by the manufacturer to promptly correct these
violations may result in further regulatory action against the
manufacturer.
We are in ongoing discussions with the FDA and continue to work with the
manufacturer of the active pharmaceutical ingredient to address the remaining open issues
identified by the FDA. However, those remaining issues do not require
additional clinical studies.
As a result of taking steps to cease distribution of ULTRASE MT and VIOKASE and in accordance with
U.S. GAAP, we recorded an additional $23.4 million sales deduction reserve for the fiscal year
ended September 30, 2010. This additional reserve was an estimate of our liability, as of March 31,
2010, for ULTRASE MT and VIOKASE that may be returned by the original purchaser under
our DSAs or applicable return policies as well as other incremental sales deductions that may be
incurred in addition to those previously recorded for ULTRASE MT and VIOKASE
prior to the PEPs event. The cease distribution order issued by the FDA was not considered as
a product recall. This reserve was based on management estimates of ULTRASE MT and
VIOKASE inventory in the distribution channel, assumptions on related expiration dates
of this inventory as well as estimated erosion of ULTRASE MT and VIOKASE
demand, based on competition from approved PEPs and the resulting estimated sell-through of
ULTRASE MT and VIOKASE, actual return activity and other factors. Due to the
uncertainties relative to estimates, we have maintained the remaining PEP liability reserve balance
to $11.0 million as at December 31, 2010, ($11.0 million as at September 30, 2010) which is equal
to our estimate of sales value of the remaining inventory in the distribution channel as at
December 31, 2010.
The reserves that we have taken as a result of having ceased distribution of our PEPs reflect many
subjective estimates that were required to be made by management. These estimates include:
a) | The quantity and expiration dates of PEPs inventory in the distribution channel; |
b) | Short-term prescription demand during the period of time during which the products continued to be available at the pharmacy level; |
c) | Other factors. |
In future periods, we will continue to monitor and review the assumptions and estimates and will
prospectively record changes to the PEPs reserve.
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Financial highlights
December 31, | September 30, | |||||||
(in millions of U.S. dollars) | 2010 | 2010 | ||||||
$ | $ | |||||||
Total assets |
699.6 | 713.2 | ||||||
Long-term debt (a) |
581.8 | 594.5 | ||||||
Shareholders deficiency |
(22.2 | ) | (21.0 | ) | ||||
(a) | Including the current portion |
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
(in millions of U.S. dollars) | 2010 | 2009 | ||||||
$ | $ | |||||||
Net product sales |
85.9 | 110.1 | ||||||
EBITDA (1) |
32.2 | 42.0 | ||||||
Adjusted EBITDA (1) |
36.8 | 46.2 | ||||||
Net income |
1.4 | 9.4 | ||||||
(1) | A reconciliation of net income to EBITDA (a non-U.S. GAAP measure) and from EBITDA to Adjusted EBITDA (a non-U.S. GAAP measure) for the three-month periods ended December 31, 2010 and 2009 are as follows: |
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
(in millions of U.S. dollars) | 2010 | 2009 | ||||||
$ | $ | |||||||
Net income |
1.4 | 9.4 | ||||||
Financial expenses |
16.2 | 16.2 | ||||||
Interest income |
(0.2 | ) | (0.1 | ) | ||||
Income tax expense (benefit) |
1.2 | (0.2 | ) | |||||
Depreciation and amortization |
13.6 | 16.7 | ||||||
EBITDA d) |
32.2 | 42.0 | ||||||
Transaction, integration, refinancing costs
and other payments to third parties
a) |
3.3 | 1.8 | ||||||
Management fees b) |
0.8 | 0.9 | ||||||
Stock-based compensation expense c) |
0.5 | 1.5 | ||||||
Adjusted EBITDA d) |
36.8 | 46.2 | ||||||
a) | Represents integration and refinancing costs as well as due diligence costs related to certain non-recurring transactions, payments to third parties in respect of research and development milestones and other progress payments as defined within our credit agreement. | |
b) | Represents management fees and other charges associated with the Management Services Agreement with TPG. | |
c) | Represents stock-based employee compensation expense under the provisions of FASB guidance. |
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d) | EBITDA and Adjusted EBITDA are both non-U.S. GAAP financial measures and are presented in this report because our management considers them important supplemental measures of our performance and believes that they are frequently used by interested parties in the evaluation of companies in the industry. EBITDA, as we use it, is net income before financial expenses, interest income, income taxes and depreciation and amortization. We believe that the presentation of EBITDA enhances an investors understanding of our financial performance. We believe that EBITDA is a useful financial metric to assess our operating performance from period to period by excluding certain items that we believe are not representative of our core business. The term EBITDA is not defined under U.S. GAAP, and EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA, as we use it, is EBITDA adjusted to exclude certain non-cash charges, unusual or non-recurring items and other adjustments set forth below. Adjusted EBITDA is calculated in the same manner as EBITDA and Consolidated EBITDA as those terms are defined under the indentures governing our notes and Credit Facility further described in the section Liquidity and Capital ResourcesLong-term Debt and New Senior Secured Credit Facility. We believe that the inclusion of supplementary adjustments applied to EBITDA in presenting Adjusted EBITDA are appropriate to provide additional information to investors about certain material non-cash items and unusual or non-recurring items that we do not expect to continue in the future and to provide additional information with respect to our ability to meet our future debt service and to comply with various covenants in our indentures and Credit Facility. Adjusted EBITDA is not a measure of net income, operating income or any other performance measure derived in accordance with U.S. GAAP, and is subject to important limitations. EBITDA and Adjusted EBITDA have limitations as an analytical tool, and they should not be considered in isolation, or as substitutes for analysis of our results as reported under U.S. GAAP. Some of these limitations are: |
| EBITDA and Adjusted EBITDA do not reflect all cash expenditures, future requirements for capital expenditures, or contractual commitments; |
| EBITDA and Adjusted EBITDA do not reflect changes in, or cash requirements for, working capital needs; |
| EBITDA and Adjusted EBITDA do not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt; |
| Although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future, and EBITDA and Adjusted EBITDA do not reflect any cash requirements for such replacements; |
| Adjusted EBITDA reflects additional adjustments as provided in the indentures governing our secured and unsecured notes and new senior secured credit facilities; and |
| Other companies in our industry may calculate EBITDA and Adjusted EBITDA differently than we do, limiting its usefulness as a comparative measure. |
Because of these limitations, EBITDA and Adjusted EBITDA should not be considered as measures of
discretionary cash available to us to invest in our business. Our management compensates for these
limitations by relying primarily on the U.S. GAAP results and using EBITDA and Adjusted EBITDA as
supplemental information.
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Overview of results of operations
For the | For the | |||||||||||||||
three-month | three-month | |||||||||||||||
period ended | period ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
(in millions of U.S. dollars) | 2010 | 2009 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Net product sales |
85.9 | 110.1 | (24.2 | ) | (22.0 | ) | ||||||||||
Cost of goods sold a) |
17.4 | 26.6 | (9.2 | ) | (34.6 | ) | ||||||||||
Selling and administration expenses a) |
28.2 | 32.2 | (4.0 | ) | (12.4 | ) | ||||||||||
Management fees |
0.8 | 0.9 | (0.1 | ) | (11.1 | ) | ||||||||||
Research and development expenses a) |
7.0 | 8.4 | (1.4 | ) | (16.7 | ) | ||||||||||
Depreciation and amortization |
13.6 | 16.7 | (3.1 | ) | (18.6 | ) | ||||||||||
Total operating expenses |
67.0 | 84.8 | (17.8 | ) | (21.0 | ) | ||||||||||
Operating income |
18.9 | 25.3 | (6.4 | ) | (25.3 | ) | ||||||||||
Financial expenses |
16.2 | 16.2 | | | ||||||||||||
Interest income |
(0.2 | ) | (0.1 | ) | (0.1 | ) | (100.0 | ) | ||||||||
Loss on foreign currencies |
0.3 | | 0.3 | 100.0 | ||||||||||||
Total other expenses |
16.3 | 16.1 | 0.2 | 1.2 | ||||||||||||
Income before income taxes |
2.6 | 9.2 | (6.6 | ) | (71.7 | ) | ||||||||||
Income taxes expense (benefit) |
1.2 | (0.2 | ) | 1.4 | 700.0 | |||||||||||
Net income |
1.4 | 9.4 | (8.0 | ) | (85.1 | ) | ||||||||||
(a) | Exclusive of depreciation and amortization |
Net product sales
For the three-month period ended December 31, 2010, net product sales were $85.9 million compared
to $110.1 million for the corresponding period of the preceding year, a decrease of 22.0%.
This decrease was primarily derived from lower sales in the U.S., which amounted to $58.2 million
for the three-month period ended December 31, 2010, compared to $85.2 million for the corresponding
period of the preceding year, a decrease of 31.7%. The decrease in sales in the U.S. is due to the
effects of the unapproved PEPs event partially offset by an increase in mesalamine and sucralfate
product sales.
Net product sales in the European Union increased 10.8%, to $17.5 million for the three-month
period ended December 31, 2010, compared to $15.8 million for the corresponding period of the
preceding year. The increase in sales resulted primarily from the introduction of a new product,
FLEET PHOSPHO-SODA in our distribution channel.
Net product sales in Canada increased 14.6%, to $10.2 million for the three-month period ended
December 31, 2010, compared to $8.9 million for the corresponding period of the preceding year. The
increase in sales resulted primarily from higher sales volume of SALOFALK products.
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Net product sales are stated net of deductions for product returns, chargebacks, contract rebates,
DSA fees, discounts and other allowances. The following table summarizes our gross-to-net product
sales adjustments for each significant category:
For the | For the | |||||||||||||||
three-month | three-month | |||||||||||||||
period ended | period ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
(in millions of U.S. dollars) | 2010 | 2009 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Gross product sales |
107.8 | 145.3 | (37.5 | ) | (25.8 | ) | ||||||||||
Gross-to-net product sales adjustments |
||||||||||||||||
Product returns |
2.9 | 1.3 | 1.6 | 123.1 | ||||||||||||
Chargebacks |
10.9 | 14.8 | (3.9 | ) | (26.4 | ) | ||||||||||
Contract rebates |
5.1 | 14.6 | (9.5 | ) | (65.1 | ) | ||||||||||
DSA fees |
1.1 | 1.8 | (0.7 | ) | (38.9 | ) | ||||||||||
Discounts and other allowances |
1.9 | 2.7 | (0.8 | ) | (29.6 | ) | ||||||||||
Total gross-to-net product sales adjustments |
21.9 | 35.2 | (13.3 | ) | (37.8 | ) | ||||||||||
Total net product sales |
85.9 | 110.1 | (24.2 | ) | (22.0 | ) | ||||||||||
Product returns, contract rebates, DSA fees, discounts and other allowances totalled $21.9 million
(20.3% of gross product sales) for the three-month period ended December 31, 2010, compared to
$35.2 million (24.2% of gross product sales) for the corresponding period of the preceding year.
The decrease in total deductions as a percentage of gross product sales was mainly due to the
absence of PEPs sales in the quarter ended December 31, 2010 (excluding PEPs sales during the three-month period ended December
31, 2009, the sales deductions would have been 20.4%) and an additional reserve of $3.9 million for
chargebacks and rebates related to our URSO franchise to reflect the estimated impact of updated
pricing and contracting activities recorded in 2009. This decrease is partially offset by a higher
return rate on CANASA and URSO products (increase of $1.5 million) and the impact of Affordable
Care Act (increase of $1.7 million).
Affordable Care Act
The Patient Protection and Affordable Care Act of 2010 and the Health Care and Education
Reconciliation Act of 2010, known together as the Affordable Care Act, enacted in the U.S in March
2010 contain several provisions that could impact our business.
Although many provisions of the new legislation do not take effect immediately, several provisions
became effective during the fiscal year ended September 30, 2010. These include (1) an increase in
the minimum Medicaid rebate to States participating in the Medicaid program on our branded
prescription drugs; (2) the extension of the Medicaid rebate to Managed Care Organizations that
dispense drugs to Medicaid beneficiaries; and (3) the expansion of the 340(B) Public Health Service
Act drug pricing program, which provides outpatient drugs at reduced rates, to include certain
childrens hospitals, free standing cancer hospitals, critical access hospitals, and rural referral
centers.
In addition, beginning in 2011, the new law requires drug manufacturers to provide a 50% discount
to Medicare beneficiaries for any covered prescription drugs purchased during a Medicare Part D
coverage gap (i.e. the donut hole). Also, beginning in 2011, new fees will be assessed on all
branded prescription drug manufacturers and importers. This fee will be calculated based upon each
organizations percentage share of total branded prescription drug sales to U.S. government
programs (such as Medicare Parts B and D, Medicaid, Department of Veterans Affairs and Department
of Defense programs and TRICARE retail pharmacy program) made during the previous fiscal year. The
aggregated industry wide fee is expected to total $28 billion through 2019, ranging from $2.5
billion to $4.1 billion annually. The Internal Revenue Service, or IRS, has issued guidance for
calculating preliminary fees, but there is still uncertainty as to final implementation, since the
IRS has requested public comment and may make changes in response. The new law also imposes a 2.3%
excise tax on sales of certain taxable medical devices that are made after December 31, 2012,
including our FLUTTER mucus clearance device. Further, effective March 31, 2013, the law requires
pharmaceutical, medical device, biological, and medical supply manufacturers to begin reporting to
the federal government the payments they make to physicians and teaching hospitals, and physician
ownership interests in those entities. The law also provides for the creation of an abbreviated
regulatory pathway for FDA approval of biosimilars and interchangeable biosimilar products. While
creation of the biosimilars program is authorized as of passage of the legislation in 2010, the
process of creating the regulatory pathway for approval of biosimilars will likely be lengthy, and
the FDA is in the process of soliciting public input.
While certain aspects of the new legislation implemented in 2010 are expected to reduce our
revenues in future years, other provisions of this legislation may offset, at some level, any
reduction in revenues when these provisions become effective. In future years, based on our
understanding, these other provisions are expected to result in higher revenues due to an increase
in the total number of patients covered by health insurance and an expectation that existing
insurance coverage will provide more comprehensive consumer protections. This would include a
federal subsidy for a portion of a beneficiarys out-of-pocket cost under Medicare Part D. However,
these higher revenues will be negatively impacted by the branded prescription drug manufacturers
fee.
The impact in terms of additional reserves recorded has been $1.7 million for the quarter ended
December 31, 2010.
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Cost of goods sold
Cost of goods sold consists principally of the cost of raw materials, royalties and manufacturing.
We outsource most of our manufacturing requirements. For the three-month period ended December 31,
2010, cost of goods sold decreased $9.2 million (34.6%) to $17.4 million from $26.6 million for the
corresponding period of the preceding year. As a percentage of net product sales, cost of goods
sold for the three-month period ended December 31, 2010, decreased compared to the corresponding
period of the preceding year to 20.3% from 24.2% due to the unapproved PEPs event.
Excluding the cost of goods sold of the unapproved PEPs during the three-month period ended
December 31, 2009, cost of goods sold as a percentage of net product sales would have been 20.1%
compared to 20.3% for the three-month period ended December 31, 2010.
Selling and administrative expenses
Selling and administrative expenses, on an ongoing basis, consist principally of salaries and other
costs associated with our sales force and marketing activities. For the three-month period ended
December 31, 2010, selling and administrative expenses decreased $4.0 million (12.4%) to $28.2
million from $32.2 million for the corresponding period of the preceding year. The decrease in
selling and administrative expenses is mainly due to a reduction of PEPs marketing expenses,
patient programs and stock-based compensation. This decrease was partially offset by an increase in
non-recurring professional fees related to the Eurand Acquisition amounting to $3 million.
Management fees
Management fees consist of fees and other charges associated with the Management Services Agreement
with TPG. For the three-month period ended December 31, 2010, management fees decreased $0.1
million (11.1%) to $0.8 million from $0.9 million for the corresponding period of the preceding
year.
Research and development expenses
Research and development expenses consist principally of fees paid to outside parties that we use
to conduct clinical studies and to submit governmental approval applications on our behalf, as well
as the salaries and benefits paid to personnel involved in research and development projects. For
the three-month period ended December 31, 2010, research and development expenses decreased $1.4
million (16.7%) to $7.0 million, from $8.4 million for the corresponding period of the preceding
year. The decrease in research and development expenses is mainly due to the reduction in expenses
related to the development work on PEPs.
Depreciation and amortization
Depreciation and amortization consists principally of the amortization of intangible assets with a
finite life. Intangible assets include trademarks, trademark licenses and manufacturing rights. For
the three-month period ended December 31, 2010, depreciation and amortization decreased $3.1
million (18.6%) to $13.6 million from $16.7 million for the corresponding period of the preceding
year. This decrease is mainly due to the complete amortization and write-down of PEPs intangible
assets in fiscal year 2010.
Financial expenses
Financial expenses consist principally of interest and fees paid in connection with funds borrowed
for acquisitions. For the three-month periods ended December 31, 2010, and December 31, 2009,
financial expenses amounted to $16.2 million.
Interest income
For the three-month period ended December 31, 2010, total interest income increased $0.1 million
(100.0%) to $0.2 million from $0.1 million for the corresponding period of the preceding year. This
increase is mainly due to the increase in our cash and cash equivalent investments.
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Income taxes
For the three-month period ended December 31, 2010, income tax expense amounted to $1.2 million
compared to an income tax benefit of $0.2 million for the corresponding period of the preceding
year. The effective tax rate was 45.43%, for the three-month period ended December 31, 2010,
compared to minus 2.04% for the corresponding period of the preceding year. The effective tax rate
for the three-month period ended December 31, 2010, is affected by a number of elements, the most
important being the establishment of a valuation allowance of $5.0 million during the three-month
period ended December 31, 2010 against our net deferred tax assets mostly attributable to
the U.S. reporting unit. If, in future periods, the deferred tax assets are determined by
management to be more likely than not to be realized, the tax benefits relating to the reversal of
the valuation allowance will be recorded.
The difference between our effective tax rate and the statutory income tax rate is summarized as
follows:
For the | For the | |||||||||||||||
three-month | three-month | |||||||||||||||
period ended | period ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
(in millions of US dollars) | 2010 | 2009 | ||||||||||||||
% | $ | % | $ | |||||||||||||
Combined statutory rate applied to pre-tax income (loss) |
35.00 | 0.9 | 35.00 | 3.2 | ||||||||||||
Increase (decrease) in taxes resulting from: |
||||||||||||||||
Change in promulgated rates |
(1.24 | ) | (0.0 | ) | 0.79 | 0.1 | ||||||||||
Difference with foreign tax rates |
(44.73 | ) | (1.2 | ) | (7.98 | ) | (0.7 | ) | ||||||||
Valuation allowance |
190.42 | 5.0 | | | ||||||||||||
Tax benefit arising from a financing structure |
(139.96 | ) | (3.7 | ) | (39.70 | ) | (3.7 | ) | ||||||||
Non-deductible items |
15.23 | 0.4 | 4.96 | 0.5 | ||||||||||||
Non-taxable items |
| | (5.97 | ) | (0.6 | ) | ||||||||||
Investment tax credits |
(8.95 | ) | (0.2 | ) | (2.61 | ) | (0.2 | ) | ||||||||
State taxes |
3.55 | 0.1 | 3.37 | 0.3 | ||||||||||||
Other |
(3.89 | ) | (0.1 | ) | 10.10 | 0.9 | ||||||||||
45.43 | 1.2 | (2.04 | ) | (0.2 | ) | |||||||||||
Net income
For the three-month period ended December 31, 2010, net income decreased $8.0 million to $1.4
million from $9.4 million for the corresponding period of the preceding year. The decrease in net
income is mainly due to the decrease in net products sales related to the unapproved PEPs event.
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Balance sheets as at December 31, 2010, and September 30, 2010
The following table summarizes balance sheet information as at December 31, 2010, compared to
September 30, 2010.
December 31, | September 30, | |||||||||||||||
(in millions of U.S. dollars) | 2010 | 2010 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Cash and cash equivalents |
150.7 | 161.5 | (10.8 | ) | (6.7 | ) | ||||||||||
Current assets |
229.3 | 226.7 | 2.6 | 1.1 | ||||||||||||
Total assets |
699.6 | 713.2 | (13.6 | ) | (1.9 | ) | ||||||||||
Current liabilities |
98.9 | 111.3 | (12.4 | ) | (11.1 | ) | ||||||||||
Long-term debt |
581.8 | 581.3 | 0.5 | 0.1 | ||||||||||||
Total liabilities |
721.8 | 734.2 | (12.4 | ) | (1.7 | ) | ||||||||||
Shareholders deficiency |
(22.2 | ) | (21.0 | ) | (1.2 | ) | 5.7 | |||||||||
Working capital |
130.4 | 115.4 | 15.0 | 13.0 |
Working capital increased by $15.0 million (13.0%) to $130.4 million as at December 31, 2010, from
$115.4 million as at September 30, 2010. This increase was mainly due to cash flow generated from
operations.
Total assets decreased $13.6 million (1.9%) to $699.6 million as at December 31, 2010, from $713.2
million as at September 30, 2010. This decrease was mainly due to the amortization of the
intangible assets amounting to $11.5 million, a reduction in cash and cash equivalent amounting to
$10.8 million due to the prepayment of $13.2 million based on the annual excess cash flow
requirements for the fiscal year 2010 partially offset by an increase in accounts receivables
amounting to $12.4 million. Long-term debt increased $0.5 million (0.1%) to $581.8 million as at
December 31, 2010, from $581.3 million as at September 30, 2010.
Liquidity and Capital Resources
Cash requirements
As at December 31, 2010, working capital was approximately $130.4 million and $115.4 million as at
September 30, 2010. Cash generated from operations, which will be affected by the unapproved PEPs
event, is used to fund working capital, capital expenditures, milestone payments, debt service and
business development activities. We regularly review product and other acquisition opportunities
and may therefore require additional debt or equity financing. We cannot be certain that such
additional financing, if required, will be available on acceptable terms, or at all.
A significant portion of our sales were attributable to the ULTRASE and VIOKASE product lines. The
loss of revenues associated with these products is expected to continue to have a material negative
effect on our ability to generate cash used to fund our operations and meet our other capital
requirements. While there remain a number of uncertainties, including our ability to re-introduce
these products into the market, the timing of such re-introduction and the resulting sales levels,
management is continuing to evaluate the measures it could take to mitigate the negative effect of
the withdrawal of these products on its cash flows.
On February 11, 2011, Axcan Holdings, our indirect parent, and Axcan AcquisitionCo, an indirect
subsidiary of the Company, pursuant to a Share Purchase Agreement dated November 30, 2010 (as
amended) acquired 95.6% (99.1% after giving effect to the additional shares that are guaranteed to be delivered under a notice of guaranteed delivery) of the outstanding shares of Eurand for a purchase price of $12.00 per share
in cash resulting in total consideration of approximately $586.5 million for 100% of such shares.
As a result of the acquisition, Eurand has become an indirect subsidiary. In addition, Axcan
AcquisitionCo and other direct and indirect subsidiaries of the Company acquired from Eurand
substantially all of Eurands assets, including the capital stock of Eurands direct and indirect
U.S. and foreign subsidiaries, in exchange for a seller note in an amount equal to the product of
the number of all Eurand shares remaining outstanding after giving effect to the closing of the
Offer multiplied by the Offer price of $12.00 per share, and transferred the capital stock of
former Eurand U.S. subsidiaries to the Company.
The aggregate equity purchase price of $586.5 million plus acquisition costs (including related
fees and expenses) were funded by cash equity contributions amounting to $140.0 million from
affiliates of TPG Capital L.P. and certain co-investors, the proceeds from the Senior Secured Term
Loan Facility (as defined below) under the Companys amended and restated credit agreement and
related security and other agreements and cash on hand from Axcan and Eurand.
The amended and restated credit agreement and related security and other agreements is composed of
(i) a senior secured revolving credit facility in an aggregate principal amount of $115.0 million
(the Senior Secured Revolving Credit Facility) and (ii) a $750.0 million senior secured term loan
facility (the Senior Secured Term Loan Facility and, together with the Senior Secured Revolving
Credit Facility, collectively, the Amended and Restated Senior Secured Credit Facilities). We
borrowed $500.0 million of the amount available under the Senior Secured Term Loan Facility at the
closing of the acquisition. The Senior Secured Revolving Credit Facility remained undrawn at the
closing of the acquisition.
A portion of the proceeds of the equity and debt financings, together with cash on hand of Axcan
and Eurand, were also used to repay the outstanding term loan portion amounting to $125.8 million
of our existing senior secured credit facilities and to pay related fees and expenses. It is
expected that $250.0 million of the Senior Secured Term Loan Facility will be available to be drawn
on or about March 14, 2011 to redeem or discharge our existing 9.25% senior secured notes due 2015.
There are currently two rating agencies (Moodys and Standard & Poors) rating AIHs debt. These
ratings are revised from time to time.
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Contractual obligations and other commitments
The following table summarizes our significant contractual obligations as at December 31, 2010, and
the effect such obligations are expected to have on our liquidity and cash flows in future years.
This table excludes the payment of amounts already recorded on the balance sheet as current
liabilities as at December 31, 2010, and certain other purchase obligations as discussed below:
Less than | ||||||||||||||||||||
(in millions of U.S. dollars) | Total | 1 year | 1-3 years | 3-5 years | More than 5 years | |||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Long-term debt |
588.7 | | 100.5 | 253.2 | 235.0 | |||||||||||||||
Operating leases |
5.4 | 2.2 | 2.8 | 0.4 | | |||||||||||||||
Other commitments |
4.7 | 3.7 | 0.9 | 0.1 | | |||||||||||||||
Interest on long-term debt |
258.3 | 56.1 | 112.5 | 84.7 | 5.0 | |||||||||||||||
857.1 | 62.0 | 216.7 | 338.4 | 240.0 | ||||||||||||||||
Purchase orders for raw materials, finished goods and other goods and services are not included in
the above table. Management is not able to accurately determine the aggregate amount of such
purchase orders that represent contractual obligations, as purchase orders may represent
authorizations to purchase rather than binding agreements. For the purpose of this table,
contractual obligations for the purchase of goods or services are only included in other
commitments where there exist agreements that are legally binding and enforceable on us and that
specify all significant terms, including: fixed or minimum quantities to be purchased; fixed,
minimum or variable price provisions; and the approximate timing of the transaction. Our purchase
orders are based on current needs and are fulfilled by our vendors within relatively short
timetables. We do not have significant agreements for the purchase of raw materials or finished
goods specifying minimum quantities or set prices that exceed our short-term expected requirements.
We also enter into contracts for outsourced services; however, the obligations under these
contracts are not significant and the contracts generally contain clauses allowing for cancellation
without significant penalty. As milestone payments are primarily contingent upon successfully
achieving clinical milestones or on receiving regulatory approval for products under development,
they do not have defined maturities and therefore are not included in the above table.
The expected timing of payment of the obligations discussed above is estimated based on current
information. The timing of payments and actual amounts paid may differ depending on the timing of
receipt of goods or services, or, for some obligations, changes to agreed-upon amounts.
As more fully described in Note 10 to the condensed consolidated interim financial statements,
effective October 1, 2007, we adopted the provisions of the guidance issued by the FASB related to
accounting for uncertainty in income taxes. As at December 31, 2010, we had unrecognized tax
benefits of $10.8 million ($11.5 million as at September 30, 2010). Due to the nature and timing of
the ultimate outcome of these uncertain tax positions, we cannot make a reasonably reliable
estimate of the amount and period of related future payments. Therefore, our unrecognized tax
benefits with respect to our uncertain tax positions has been excluded from the above contractual
obligations table.
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Long-term debt and Credit Facility
On November 29, 2007, we entered into an Arrangement Agreement with Axcan Pharma Inc., pursuant to
which we agreed to, through an indirect wholly-owned subsidiary, acquire all of the common stock of
Axcan Pharma Inc. and enter into various other transactions in accordance with the Plan of
Arrangement (the Arrangement). On February 25, 2008, we obtained various types of financing in
connection with the Arrangement. We issued $228.0 million aggregate principal amount of senior
secured notes (Senior Secured Notes). The Senior Secured Notes were priced at $0.98737 with a
yield to March 1, 2015, of 10%. The Senior Secured Notes rank pari passu with our Credit Facility.
We may redeem some or all of the Senior Secured Notes prior to March 1, 2011, at a redemption price
equal to 100% of the principal amount of the Senior Secured Notes redeemed plus a make-whole
premium and accrued and unpaid interest. On or after March 1, 2011, we may redeem some or all of
the Senior Secured Notes at the redemption prices (expressed as percentages of principal amount of
the Senior Secured Notes to be redeemed) set forth below:
Year | % | |||
2011 |
106.938 | |||
2012 |
104.625 | |||
2013 |
102.313 | |||
2014 and thereafter |
100.000 |
Prior to March 1, 2011, we may also redeem up to 35% of the aggregate principal amount of the
Senior Secured Notes using the proceeds of one or more equity offerings at a redemption price equal
to 109.250% of the aggregate principal amount of the Senior Secured Notes plus accrued and unpaid
interest. If there is a change of control as specified in the indenture governing the senior notes,
we must offer to repurchase the Senior Secured Notes at a price in cash equal to 101% of the
aggregate principal amount thereof, plus accrued and unpaid interest.
We also obtained a Credit Facility for a total of $290.0 million composed of term loans totalling
$175.0 million and a revolving credit facility of $115.0 million. The Credit Facility bears
interest at a variable rate composed of either the Federal Funds Rate or the British Banker
Association LIBOR rate, at our option, plus the applicable rate based on our consolidated total
leverage ratio and certain of our subsidiaries for the preceding twelve months. The Credit Facility
matures on February 25, 2014, with quarterly payments on the term. As at December 31, 2010, $175.0
million of term loans had been issued and no amounts had been drawn against the revolving credit
facility. The term loans were priced at $0.96 with a yield to maturity of 8.75%. The Credit
Facility requires us to meet certain financial covenants, which were met as at December 31, 2010.
The credit agreement governing the Credit Facility requires us to prepay outstanding term loans
contingent upon the occurrence of these events, subject to certain exceptions, with: (1) 100% of
the net cash proceeds of any incurrence of debt other than debt permitted under the Credit
Facility, (2) commencing with the fiscal year ending September 30, 2010, 50% (which percentage will
be reduced to 25% if the senior secured leverage ratio is less than a specified ratio) of the
annual excess cash flow (as defined in the credit agreement governing the Credit Facility) and (3)
100% of the net cash proceeds of all non-ordinary course asset sales or other dispositions of
property (including casualty events) by us or by our subsidiaries, subject to reinvestment rights
and certain other exceptions. Based on these requirements, for fiscal year 2010, we were required
to prepay $13.2 million of outstanding term loans in the first quarter of fiscal year 2011 ($17.6
million for fiscal year 2009, was paid in the first quarter of fiscal year 2010). As allowed by the
credit agreement, the prepayment is applied to the remaining scheduled installments of principal in
direct order of maturity and the current portion of long-term debt was reduced accordingly.
On May 6, 2008, we issued $235.0 of 12.75% Senior Unsecured Notes due March 1, 2016. The senior notes were priced at $0.9884
with a yield to March 1, 2016 of 13.16%. The Senior Unsecured Notes are subordinated to the Credit
Facility and Senior Secured Notes.
We may redeem some or all of the senior notes prior to March 1, 2012, at a redemption price equal
to 100% of the principal amount of the Senior Unsecured Notes redeemed plus a make-whole premium
and accrued and unpaid interest. On or after March 1, 2012, we may redeem some or all of the Senior
Unsecured Notes at the redemption prices (expressed as percentages of principal amount of the
Senior Unsecured Notes to be redeemed) set forth below:
Year | % | |||
2012 |
106.375 | |||
2013 |
103.188 | |||
2014 and thereafter |
100.000 |
Prior to March 1, 2011, we may also redeem up to 35% of the aggregate principal amount of the
secured senior notes using the proceeds of one or more equity offerings at a redemption price equal
to 112.750% of the aggregate principal amount of the Senior Unsecured Notes plus accrued and unpaid
interest. If there is a change of control as specified in the indenture governing the senior notes,
we must offer to repurchase the senior notes at a price in cash equal to 101% of the aggregate
principal amount thereof, plus accrued and unpaid interest.
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Certain of our subsidiaries have been designated as guarantors with respect to the Credit Facility,
the Senior Secured Notes and the Senior Unsecured Notes. Our obligations under, and each of the
guarantors obligations under its guarantee of, the Credit Facility and the Senior Secured Notes
are secured by a first priority security interest in our assets and of such guarantor subsidiaries,
respectively.
We may from time to time seek to retire or purchase our outstanding debt through cash purchases in
open market purchases, privately negotiated transactions or otherwise. Such repurchases or
exchanges, if any, will depend on prevailing market conditions, our liquidity requirements,
contractual restrictions and other factors. The amounts involved may be material.
Operating leases
We have various long-term operating lease agreements for office space, automotive equipment and
other equipment. The latest expiry date for these agreements is in 2015.
Other commitments
Other operating commitments consist primarily of amounts relating to administrative services,
clinical studies and other research and development services.
Related party transactions
As at December 31, 2010, and September 30, 2010, we had a note receivable from our parent company
amounting to $133.2 million. The note receivable has been recorded in the shareholder equity
section of the consolidated balance sheet. During the three-month periods ended December 31, 2010,
and December 31, 2009, we earned interest income on the note amounting to $2.0 million net of taxes
amounting to $1.1 million and the related interest receivable from our parent company amounting to
$30.2 million as at December 31, 2010, ($27.1 million as at September 30, 2010) has been recorded
in the shareholders equity section of the consolidated balance sheet. This amount was subject to a
full provision which was also recorded in the statement of shareholders equity. As at December 31,
2010, we have an account receivable from our parent company amounting to $0.5 million ($0.5 million
as at September 30, 2010).
During the three-month period ended December 31, 2010, we recorded charges pursuant to the terms of
a management fee arrangement with a controlling shareholding company amounting to $0.8 million
($0.9 million during the three-month period ended December 31, 2009). As at December 31, 2010, we
accrued fees payable to a controlling shareholding company amounting to $0.9 million ($1.6 million
as at September 30, 2010).
During the three-month period ended December 31, 2009, we paid a dividend to our parent company
amounting to $0.1 million to allow for the payment of certain group expenses.
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Balance sheet arrangements
We do not have any transactions, arrangements and other relationships with unconsolidated entities
that are likely to affect our operating results, our liquidity or capital resources. We have no
special purpose or limited purpose entities that provide off-balance sheet financing, liquidity or
market or credit risk support, and do not engage in leasing, hedging, research and development
services, or other relationships that expose us to liability that is not reflected on the face of
the condensed consolidated interim financial statements.
Cash flows
Our cash flows from operating, investing and financing activities for the three-month periods ended
December 31, 2010, and December 2009 as reflected in the condensed consolidated statements of cash
flows, are summarized in the following table:
For the | For the | |||||||
three-month | three-month | |||||||
period ended | period ended | |||||||
December 31, | December 31, | |||||||
(in millions of U.S. dollars) | 2010 | 2009 | ||||||
$ | $ | |||||||
Net cash provided by operating activities |
3.7 | 28.5 | ||||||
Net cash used by investing activities |
(1.1 | ) | (1.1 | ) | ||||
Net cash used by financing activities |
(13.2 | ) | (21.3 | ) |
Cash flows provided by operating activities decreased $24.8 million to $3.7 million for the
three-month period ended December 31, 2010, from $28.5 million for the three-month period ended
December 31, 2009. The decrease in net cash provided by operating activities is mainly due to the
decrease in net product sales of $24.2 million during the three-month period ended December 31,
2010, compared to the corresponding period of the preceding year due to the unapproved PEPs event.
Cash flows used by investing activities amounted to $1.1 million of cash used in the three-month
period ended December 31, 2010, and in the three-month period ended December 31, 2009.
Cash flows used by financing activities decreased $8.1 million to $13.2 million of cash used in the
three-month period ended December 31, 2010, from $21.3 million of cash used in the three-month
period ended December 31, 2009. The decrease in cash used by financing, is mainly due to the
payment of $20.9 million of outstanding term-loans during the three-month period ended December 31,
2009, including the prepayment of $17.6 million, based on the annual excess cash flow requirements
for the fiscal year 2009, compared to the prepayment of $13.2 million during the three-month period
ended December 31, 2010, based on the annual excess cash flow requirements for the fiscal year
2010.
Significant accounting policies
Our consolidated financial statements are prepared in accordance with U.S. GAAP, applied on a
consistent basis. Some of our critical accounting policies require the use of judgment in their
application or require estimates of inherently uncertain matters. Therefore, a change in the facts
and circumstances of an underlying transaction could significantly change the application of our
accounting policies to that transaction, which could have an effect on our financial statements.
The policies that management believes are critical and require the use of complex judgment in their
application are discussed below.
Use of estimates
The preparation of financial statements in accordance with generally accepted accounting principles
requires management to make estimates and assumptions that affect the recorded amounts of assets
and liabilities and the disclosure of contingent assets and liabilities as at the date of the
financial statements and also affect the recognized amounts of revenues and expenses during the
fiscal year. Significant estimates and assumptions made by management include those related to the
charges to be recorded in conjunction with ceasing of distributing PEPs, allowances for accounts
receivable, inventories, reserves for product returns, rebates, chargebacks and DSA fees, the
classification of intangible assets between finite life and indefinite life, the useful lives of
long-lived assets, the expected cash flows used in evaluating long-lived assets, goodwill and
investments for impairment, stock based compensation costs, pending legal settlements and the
establishment of provisions for income taxes including the realizability of deferred tax assets.
The estimates are made using the historical information and various other relevant factors
available to management. We review all significant estimates affecting the financial statements on
a recurring basis and record the effect of any adjustments when necessary. Actual results could
differ from those estimates based upon future events, which could include, among other risks,
changes in regulations governing the manner in which we sell our products, changes in the
healthcare environment, foreign exchange and managed care consumption patterns.
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The charges that we have recorded as a result of having ceased distribution of our PEPs also
reflect many subjective estimates that were required to be made by management. These estimates
include:
a) | The quantity and expiration dates of PEPs inventory in the distribution channel; | |
b) | Short-term prescription demand during the period of time during which the products continued to be available at the pharmacy-level; | |
c) | Other factors. |
In future periods, management will monitor and review the assumptions and estimates and will
prospectively record changes to provisions reflected in the current fiscal year.
Revenue recognition
Revenue is recognized when the product is delivered to our customers, provided we have not retained
any significant risks of ownership or future obligations with respect to the product delivered.
Provisions for sales discounts and estimates for chargebacks, managed care and Medicaid rebates,
product returns and DSA fees are established as a reduction of product sales revenues at the time
such revenues are recognized. These revenue reductions are established by us at the time of sale,
based on historical experience adjusted to reflect known changes in the factors that impact such
reserves. In certain circumstances, product returns are allowed under our policy and provisions are
maintained accordingly. These revenue reductions are generally reflected as an addition to accrued
liabilities. Amounts received from customers as prepayments for products to be delivered in the
future are reported as deferred revenue.
The following table summarizes the activity in the accounts related to revenue reductions:
Reserves | ||||||||||||||||||||||||||||
related to the | ||||||||||||||||||||||||||||
Product | Contract | Charge- | DSA | Discounts | unapproved | |||||||||||||||||||||||
(in millions of U.S. dollars) | returns | rebates | backs | fees | and other | PEPs event | Total | |||||||||||||||||||||
$ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||
Balance as at September 30, 2010 |
13.4 | 6.1 | 8.1 | 1.3 | 0.2 | 11.0 | 40.1 | |||||||||||||||||||||
Provisions |
2.9 | 5.1 | 10.9 | 1.1 | 1.9 | | 21.9 | |||||||||||||||||||||
Settlements |
(2.8 | ) | (6.2 | ) | (7.1 | ) | (1.3 | ) | (1.7 | ) | | (19.1 | ) | |||||||||||||||
Balance as at December 31, 2010 |
13.5 | 5.0 | 11.9 | 1.1 | 0.4 | 11.0 | 42.9 | |||||||||||||||||||||
Product returns
We do not provide any form of price protection to our wholesale customers and we generally permit
product returns only if the product is returned in the six months prior to and twelve months
following its expiration date. Under our policy, credit for returns is issued to the original
purchaser at current wholesale acquisition cost less 10%.
We estimate the proportion of recorded revenue that will result in a return by considering relevant
factors, including:
| past product returns activity; | |
| the duration of time taken for products to be returned; | |
| the estimated level of inventory in the distribution channel; | |
| product recalls and discontinuances; | |
| the shelf life of products; | |
| the launch of new drugs or new formulations; and | |
| the loss of patent protection or new competition. |
Our estimate of the level of inventory in the distribution channel is based on inventory data
provided by wholesalers, third-party prescription data and, for some product return provisions,
estimated retail pharmacy information.
Returns for new products are more difficult to estimate than for established products. For
shipments made to support the commercial launch of a new product under standard terms, our estimate
of sales return accruals are primarily based on the historical sales returns experience of similar
products. Once sufficient historical data on actual returns of the product are available, the
returns provision is based on this data and any other relevant factors as noted above.
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The accrual estimation process for product returns involves in each case a number of interrelating
assumptions, which vary for each combination of product and customer. Accordingly, it would not be
meaningful to quantify the sensitivity to change for any individual assumption or uncertainty.
However, we do not believe that the effect of uncertainties, as a whole, significantly impacts our
financial condition or results of operations.
The accrued liabilities include reserves of $13.5 million as at December 31, 2010, ($13.4 million
as at September 30, 2010) for estimated product returns, excluding the additional provision related
to the unapproved PEPs event.
As at December 31, 2010, the product returns reserve related to the unapproved PEPs event amounted
to $11.0 million which represents primarily managements current estimate of the balance of ULTRASE
MT and VIOKASE inventory in the distribution channel. Due to the subjectivity of this estimate, we
prepared various sensitivity analyses to ensure our final estimate is within a reasonable range. A
change in assumptions that resulted in a 10% change in the quantity of ULTRASE MT and VIOKASE
inventory in the distribution channel would have resulted in a change in the return reserve of
approximately $1.1 million.
Rebates, chargebacks and other sales deduction
In the U.S., we establish and maintain reserves for amounts payable to managed care organizations,
state Medicaid and other government programs for the reimbursement of portions of the retail price
of prescriptions filled that are covered by these programs. We also establish and maintain reserves
for amounts payable to wholesale distributors for the difference between their regular sale price
and the contract price for the products sold to our contract customers.
The amounts are recognized as revenue reductions at the time of sale based on our best estimate of
the products utilization by these managed care and state Medicaid patients and sales to our
contract customers, using historical experience, the timing of payments, the level of reimbursement
claims, changes in prices (both normal selling prices and statutory or negotiated prices), changes
in prescription demand patterns, and the levels of inventory in the distribution channel.
Amounts payable to managed care organizations and state Medicaid programs are based on statutory or
negotiated discounts to the selling price. Medicaid rebates generally increase as a percentage of
the selling price over the life of the product. As it can take up to six months for information to
reach the Company on actual usage of the Companys products in managed care and Medicaid programs
and on the total discounts to be reimbursed, the Company maintains reserves for amounts payable
under these programs relating to sold products. We estimate the level of inventory in the
distribution channels based on inventory data provided by wholesalers and third-party prescription
data.
Revisions or clarification of guidelines related to state Medicaid and other government program
reimbursement practices which are meant to apply to prior periods, or retrospectively, can result
in changes to managements estimates of the rebates reported in prior periods. However, since the
prices of the Companys products are fixed at the time of sale and the quantum of rebates is
therefore reasonably determinable at the outset of each transaction, these factors would not impact
the recording of revenues in accordance with generally accepted accounting principles.
The accrual estimation process for managed care organizations, state Medicaid and other government
programs rebates involves in each case a number of interrelating assumptions, which vary for each
combination of products and programs. Accordingly, it would not be meaningful to quantify the
sensitivity to change for any individual assumption or uncertainty. However, we do not believe that
the effect of uncertainties, as a whole, significantly impacts the Companys financial condition or
results of operations.
Accrued liabilities include reserves of $5.0 million and $11.9 million as at December 31, 2010,
($6.1 million and $8.1 million as at September 30, 2010) for estimated contract rebates and
chargebacks.
If the levels of chargebacks, fees pursuant to DSAs, managed care, Medicaid and other government
rebates, product returns and discounts fluctuate significantly and/or if our estimates do not
adequately reserve for these reductions of net product revenues, our reported revenue could be
negatively affected.
Intangible assets and goodwill
Intangible assets with a finite life are amortized over their estimated useful lives according to
the straight-line method over periods varying from 6 months to 20 years. The straight-line method
of amortization is used because it reflects, in the opinion of management, the pattern in which the
intangible assets with a finite life are used. In determining the useful life of intangible assets,
we consider many factors including the intention of management to support the asset on a long-term
basis by maintaining the level of expenditure necessary to support the asset, the use of the asset,
the existence and expiration date of a patent, the existence of a generic version of, or competitor
to, the product and any legal or regulatory provisions that could limit the use of the asset.
The following table summarizes the changes to the carrying value of the intangible assets and
goodwill from September 30, 2010, to December 31, 2010:
Intangible | ||||||||
assets | Goodwill | |||||||
$ | $ | |||||||
Balance as at September 30, 2010 |
348.0 | 73.5 | ||||||
Depreciation and amortization |
(11.5 | ) | | |||||
Foreign exchange translation adjustments |
(0.9 | ) | (0.2 | ) | ||||
Balance as at December 31, 2010 |
335.6 | 73.3 | ||||||
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Research and development expenses
Research and development expenses are charged to operations in the period they are incurred. The
cost of intangibles that are purchased from others for a particular research and development
project that have no alternative future use are expensed at the time of acquisition.
Income taxes
Income taxes are calculated using the asset and liability method. Under this method, deferred
income tax assets and liabilities are recognized to account for the estimated taxes that will
result from the recovery or settlement of assets and liabilities recorded at their financial
statement carrying amounts. Deferred income tax assets and liabilities are measured based on
enacted tax rates and laws at the date of the financial statements for the fiscal years in which
the temporary differences are expected to reverse. A valuation allowance is provided for the
portion of deferred tax assets that is more likely than not to remain unrealized. Adjustments to
the deferred income tax asset and liability balances are recognized in net income as they occur.
We conduct business in various countries throughout the world and are subject to tax in numerous
jurisdictions. As a result of our business activities, we file a significant number of tax returns
that are subject to examination by various federal, state, and local tax authorities. Tax
examinations are often complex as tax authorities may disagree with the treatment of items reported
by us and this may require several years to resolve.
Changes in accounting standards
See Note 3 to our Condensed Interim Consolidated Financial Statements in Item 1 of Part 1 for a
description of recently issued accounting standards, including our expected adoption dates and
estimated effects, if any, on our results of operations, financial condition and cash flows.
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Item 3. | Quantitative And Qualitative Disclosure About Market Risk |
For quantitative and qualitative disclosures about market risk affecting us, see Quantitative and
Qualitative Disclosure about Market Risk in Item 7A of Part II of our Annual Report on Form 10-K
for the fiscal year ended September 30, 2010, which is incorporated herein by reference. As of
December 31, 2010, our exposure to market risk has not changed materially since September 30, 2010.
Item 4T. | Controls and Procedures |
Evaluation of disclosure controls and procedures
We conducted an evaluation under the supervision and with the participation of our management,
including our principal executive officer and principal financial officer, of the effectiveness of
the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of
December 31, 2010, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon
this evaluation, our principal executive officer and principal financial officer concluded that our
disclosure controls and procedures are effective to ensure that material information required to be
disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in Securities and Exchange Commission
rules and forms and is accumulated and communicated to our management, including our principal
executive officer and principal financial officer, as appropriate to allow timely decisions
regarding required disclosure.
Changes in internal control over financial reporting
In the ordinary course of business, we routinely enhance our information systems by either
upgrading our current systems or implementing new systems. During the period covered by the
Quarterly Report on Form 10-Q, no change occurred in our internal controls over financial reporting
during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is
reasonably likely to materially affect, our internal controls over financial reporting.
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PART II. OTHER INFORMATION
Item 1A. | Risk Factors |
This report contains forward-looking statements that involve risks and uncertainties. Our
actual results could differ materially from those discussed in this report. Factors that could
cause or contribute to these differences include, but are not limited to, those discussed below
and elsewhere in this report.
If any of the following risks, or other risks are not presently known to us or that we currently
believe to not be significant, develop into actual events, then our business, financial condition,
results of operations or prospects could be materially adversely affected. If that happens, the
market value of our bonds could decline, and bond holders could lose all or part of their
investment.
Risks Related to Our Business
Since
we ceased distributing pancreatic enzyme products (PEPs) in the United States, we have depended on three
categories of products for a large portion of our revenues; any material decline in the sales of
any of them or our inability to relaunch PEPs in the United States would have an adverse impact on
our business.
Any factor that adversely affects the sale or price of our key products could significantly
decrease our sales and profits. Mesalamine products (CANASA and SALOFALK), sucralfate products
(CARAFATE and SULCRATE) and ursodiol products (URSO, URSO 250, URSO DS, URSO FORTE and DELURSAN)
accounted for 25.3%, 16.7% and 18.0%, respectively, of our net product sales for fiscal year 2009
and for 28.4%, 24.4% and 12.6%, respectively, of our net product sales for fiscal year 2010. Our
ursodiol products do not enjoy patent protection or regulatory exclusivity in the United States,
Canada or France. As a result, competition from generic versions of these products in the United
States and Canada has had a negative sales impact on our URSO franchises since 2009. Although we
have undertaken measures to protect our URSO franchises, there can be no assurance that any such
measures will be successful, and overall sales of our ursodial products may continue to decline,
which would have an adverse impact on our financial position. With the exception of ursodiol
products, we believe that sales of these groups of products will continue to constitute a
significant portion of our total revenues until we launch additional products. Any significant
setback with respect to any one of these products, including shipping, manufacturing and supply,
regulatory issues, product safety, marketing, government licenses and approvals, intellectual
property rights problems, or generic or other forms of competition, could have a material adverse
effect on our financial position, cash flows or overall trends in results of operations.
PEPs (ULTRASE, VIOKASE and PANZYTRAT) historically represented a large portion of our revenues.
PEPs accounted for 27.5% of our net product sales for fiscal year 2009 and for 19.3% of our net
product sales for fiscal year 2010. We ceased distributing our ULTRASE and VIOKASE product lines in
the United States effective April 28, 2010. This action was taken because we did not receive FDA
approval for ULTRASE MT or VIOKASE by April 28, 2010, the date mandated by the FDA to obtain
approval for PEPs, due to manufacturing quality control issues with a third party supplier of the
active ingredient used in these products. We continue to work with the FDA to obtain approvals for
these drugs but in the meantime, other PEPs, including ZENPEP, are filling market demand for these
products. ULTRASE and VIOKASE accounted for 24.0% of our net product sales in fiscal year 2009 and
for 15.1% of our net product sales in fiscal year 2010. If ULTRASE MT and VIOKASE are not approved
(or even if approved, fail to regain market share), our financial position, cash flows and overall
trends in results of operations will continue to be adversely affected. Although we believe that
any such adverse effect could partially be mitigated by sales of ZENPEP, there can be no assurance
of such mitigation. See Risks Related to Our Pancreatic Enzyme Products below for more
information regarding the cessation of our distribution of ULTRASE and VIOKASE in the United
States.
The entry of generic versions of our CARAFATE and CANASA products in the United States could have a
material adverse impact on our financial position, cash flows or overall trends in results of
operations.
CANASA
CANASA does not have any patent protection in the United States. On November 5, 2007, clinical
investigation exclusivity previously granted pursuant to the Hatch-Waxman Act, covering a change in
the formulation of this drug from a 500 mg formulation to a 1,000 mg suppository formulation,
expired. As a result, if a generic mesalamine suppository were to be launched, it could have a
significant negative impact on sales of CANASA in the United States.
In June 2007, the FDA published draft guidance on the requirements it expects manufacturers seeking
approval of a mesalamine suppository to meet in order to obtain approval of mesalamine
suppositories. This draft guidance specifies that a request for regulatory approval of a mesalamine
suppository product must be supported by placebo and reference-drug controlled clinical studies
with clinical endpoints demonstrating safety and effectiveness in patients with ulcerative
proctitis. We cannot provide assurances that the FDA requirements reflected in this draft guidance
will be applied by the FDA or will be formally adopted in their current form.
In a July 2010 posting on clinicaltrial.gov that was updated in November 2010, Sandoz Inc.
disclosed that it had initiated in June 2010 a clinical trial to establish therapeutic equivalence
of a 1,000 mg rectal mesalamine suppository product to CANASA rectal suppositories, for the
treatment of mild to moderate ulcerative proctitis. The disclosure states that the trial is being
conducted in India and has an estimated duration of 18 months. Cadila Healthcare Inc. also recently
disclosed that it is conducting a similar clinical study in India to establish therapeutic
equivalence of a 1,000 mg rectal mesalamine suppository product to CANASA.
Generic competition against any of our products, including the launch of generic versions of
CANASA, could potentially lower prices, unit sales or both and could have a material adverse effect
on our financial position, cash flows or overall trends in results of operations.
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CARAFATE
CARAFATE does not have any patent protection or regulatory exclusivity in the United States.
In a public filing on May 7, 2010, K-V Pharmaceutical Company announced the sale of certain
intellectual property and other assets related to its Abbreviated New Drug Application (ANDA),
submitted with the U.S. Food and Drug Administration for the approval to engage in the commercial
manufacture and sale of 1 gm/10 mL sucralfate suspension, the active pharmaceutical ingredient in
our CARAFATE oral suspension product. We do not have any information on the status of this ANDA.
Generic competition against any of our products, including the launch of generic versions of
CARAFATE oral suspension, could potentially lower prices, unit sales or both and could have a
material adverse impact on our financial position, cash flows or overall trends in results of
operations.
The launch of a product that competes with our ursodiol product line in France could have a
material adverse impact on our financial position, cash flows or overall trends in results of
operations.
We reported net sales of $23.4 million, $20.8 million and $21.4 million for DELURSAN in fiscal
years 2010, 2009, and 2008, respectively. (In local currency, net sales of DELURSAN were 17.3
million, 15.4 million and 14.2 million in fiscal years 2010, 2009 and 2008, respectively.)
DELURSAN mainly competes with URSOLVAN (Sanofi-Aventis S.A.). However, we expect another competing
branded product to be launched in France by the end of calendar year 2011. An additional request
for marketing approval was submitted by another competitor for an ursodiol product, based on
well-established use (usage reconnu). Under this procedure, a company can submit for approval a
product similar to one that is already marketed by submitting evidence of therapeutic efficacy
based on published literature. If this other ursodiol product is launched, it could have a
significant negative impact on sales of DELURSAN in France.
Competition to DELURSAN, which made up approximately 6.6% of our net product sales in fiscal year
2010, could have a material adverse effect on our results of operations and financial condition.
Some of our key products face competition from generic or unbranded products.
Some of our key products, including products from our URSO, CANASA and CARAFATE product lines,
currently face competition from generic or unbranded products (such as ACTIGALL, its generics and
the launched generic in the case of URSO, and other mesalamine rectal dosage forms in the case of
CANASA and generic tablet forms of sucralfate, in the case of CARAFATE). Third-party payors and
pharmacists can substitute generic or unbranded products for our products even if physicians
prescribe our products by name. Particularly in the United States, government agencies and
third-party payors often put pressure on patients to purchase generic products instead of
brand-name products as a way to reduce healthcare costs.
Generic competition against any of our products or the products rights we have acquired as a result
of the acquisition Eurand N.V. (Eurand) could lower prices and unit sales and could therefore have
a material adverse effect on our results of operations and financial condition.
Future sales of our marketed products might be less than expected.
The degree of continued market acceptance of our products among physicians, patients, healthcare
payors and the medical community will depend upon a number of factors including:
| the timing of regulatory approvals and product launches by us or competitors, and any generic or over-the-counter competitors; | |
| perceptions by physicians and other members of the healthcare community regarding the safety and efficacy of the products; | |
| price increases, and the price of our products relative to other drugs or competing treatments; | |
| our ability to secure acceptable pricing where regulated; | |
| patient and physician demand; | |
| adverse side effects or unfavorable publicity regarding our products or other drugs in our class; | |
| the results of product development efforts for new indications; | |
| the scope and timing of additional marketing approvals and favorable reimbursement programs for expanded uses; | |
| availability of sufficient commercial quantities of the products; and | |
| our success in getting other companies to distribute our products outside our target markets. |
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The concentration of our product sales to only a few wholesale distributors increases the risk that
we will not be able to effectively distribute our products if we need to replace any of these
distributors, which would cause our sales to decline. The dependence of Eurands revenue stream on
the sales of ZENPEP has increased this risk.
The majority of our sales are to a small number of pharmaceutical wholesale distributors, which in
turn sell our products primarily to retail pharmacies, which ultimately dispense our products to
the end consumers. In fiscal year 2010, sales to Axcans main customer, Customer A, accounted for
29.9% of its net product sales, sales to Customer B accounted for 28.1% of its net product sales,
and sales to Customer C accounted for 12.2% of its net product sales
If any of these distributors cease doing business with us for any or all of our products, or
materially reduce the amount of product they purchase from us or use their market power to extract
pricing concessions or other terms unfavorable to us, and we cannot conclude agreements with
replacement wholesale distributors on commercially reasonable terms, we might not be able to
effectively distribute our products through retail pharmacies. The possibility of this occurring is
exacerbated by the consolidation occurring in the wholesale drug distribution industry, including
through mergers and acquisitions among wholesale distributors and the growth of large retail
drugstore chains. As a result, a small number of large wholesale distributors control a significant
share of the market. However, this risk is mitigated by the fact that we now have DSAs with our
three largest U.S. wholesalers.
In addition, Eurands revenue has depended upon a small number of customers. Eurands top two
customers together accounted for 27%, 29% and 38% of total revenues in 2007, 2008 and 2009,
respectively, and 11%, 16% and 43% of the accounts receivable balance as of December 31, 2007, 2008
and 2009, respectively. We were Eurands largest customer and accounted for 17%, 23% and 31% of
Eurands total revenues in 2007, 2008 and 2009, respectively, and 8%, 7% and 37% of Eurands
accounts receivable balance as of December 31, 2007, 2008 and 2009, respectively. Eurands second
largest customer in 2007 was GSK, and Cephalon in both 2008 and 2009, and each accounted for 10%,
7% and 8% of Eurands total revenues in those periods, respectively. The loss of any of former
Eurand customers may have an adverse effect on the business and operations of our combined company.
Wholesaler buying patterns may change, and this could have a detrimental effect on our future
revenue and financial condition.
Since fiscal year 2005, some wholesalers have changed their business model from one depending on
drug price inflation to a fee-for-service arrangement, or DSA, whereby manufacturers pay
wholesalers a fee for inventory management and other services. These fees typically are a
percentage of the wholesalers purchases from the manufacturer or a fixed charge per item or per
unit. The fee-for-service approach results in wholesalers compensation being more stable and
volume-based as opposed to price-increase-based. As a result of the move to a fee-for-service
business model, many wholesalers are no longer investing in inventory ahead of anticipated price
increases and have reduced their inventories from their historical levels. Under the new model, the
consequence of manufacturers using wholesalers is that they now realize the benefit of price
increases more rapidly in return for paying wholesalers for the services they provide, on a
fee-for-service basis. Fees resulting from distribution service agreements, or DSAs, are deducted
from gross sales. We have DSAs with our three largest U.S. wholesalers, which provide that these
wholesalers will maintain the levels of inventory of our products that they carry within specific
agreed upon target levels. A reduction in inventory levels by a pharmaceutical wholesale
distributor would result in a reduction in our sales to that wholesale distributor for the period
during which the reduction occurs, and would have a negative effect on our results of operations
for the period.
We deduct DSA fees, which totaled approximately $3.6 million and $5.6 million for fiscal year 2009
and fiscal year 2010, respectively, from our total revenues. If we enter into DSAs with additional
wholesalers, we will likely have to pay them DSA fees, which will further reduce our revenue in
future periods.
Generally, changes in wholesaler buying patterns may occur in the future, and these changes could
result in a reduction in our revenues and could have a detrimental effect on our overall financial
condition or results of operations.
We have historically used third parties to manufacture and test most of our products and product
candidates. This may increase the risk of not having sufficient quantity of our products or product
candidates, quantity at an acceptable cost or product with acceptable quality or in compliance with
standards and specifications. This could adversely affect sales of our products or result in the
clinical development or commercialization of our products or product candidates being delayed,
prevented or impaired.
With the exception of SALOFALK and LACTEOL, and other than as a result of additional manufacturing
capabilities resulting from our acquisition of Eurand, we have limited capabilities in
manufacturing our marketed pharmaceutical products. With the exception for products manufactured by
us and formely manufactured by Eurand, or products developed by Eurand for itself or collaborators
using its pharmaceutical technologies platforms, we do not expect to engage directly in the
manufacturing of products, but instead will continue to contract with third-party organizations.
There are a limited number of manufacturers capable of manufacturing our marketed products and our
product candidates. We could fail to contract or renew contracts with the relevant manufacturers or
could contract with manufacturers under terms and conditions that may not be entirely acceptable to
us.
We currently rely and expect to continue to rely on third parties for (i) the supply and testing of
certain of the active pharmaceutical ingredients used in our products and product candidates, and
(ii) the manufacturing, packaging and testing of certain of the finished products. The current
manufacturers of our products and product candidates and likely future third-party manufacturers
with whom we would enter into an agreement, are or could be sole suppliers of our products and
product candidates for a given period of time. These manufacturers are commonly referred to as
single-source suppliers. The bulk of our agreements for the manufacturing of our core products
expire at various dates over the next three to five years. Should we be unable to renew these
agreements under favorable terms or find suitable alternates or should any of these agreements be
violated by the manufacturers, our business may be materially adversely affected. Some of our contracts prohibit us from using alternate
manufacturers or suppliers for the products supplied under these contracts, which prevents us from
reducing dependence on single sources of supply. In addition, we currently purchase materials and
clinical supplies for some of our products and product candidates from third-party manufacturers on
a purchase order basis. Should any of these manufacturers be unable to supply us for any reason, we
may be delayed in identifying and qualifying replacements. In any event, identifying and qualifying
a new supplier or third-party manufacturer could involve significant cost, is associated with the
transfer of the active pharmaceutical ingredient or finished-product manufacturing process. In
addition, any change in manufacturing generally requires formal approval by the regulatory agency,
e.g., the FDA, prior to proceeding with manufacturing at the new site. This approval process
typically takes a minimum of 12 to 18 months and during that time we may face a shortage of supply
of our products.
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Reliance on third-party manufacturers entails risks to which we would not be subject if we
manufactured or tested products or product candidates ourselves; risks revolve around, without
being limited to, the following:
| Manufacturing of products may be difficult to scale-up when required, which could result in delays, inefficiencies and poor or low yields of quality products. | |
| Some of our contracts contain purchase commitments that require us to make minimum purchases that might exceed needs or limit the ability to negotiate with other manufacturers, which might increase costs. | |
| Cost involved in manufacturing certain products may lead to such products being prohibitively expensive. | |
| Delays in site transfers or scale-up to commercial quantities and any difficulty in manufacturing could delay clinical studies, regulatory submissions, approval and commercialization or continued commercialization of our products. | |
| In the event of a manufacturing change, the FDA and other comparable country regulators require testing and compliance inspections; new manufacturers may have to be educated to our products production process, which requires time. | |
| There is a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If the third parties that we engage to manufacture and/or test a product for commercial sale or for our clinical trials were to cease to continue to do so for any reason, we could experience delays in obtaining sufficient quantities of our products for us to meet commercial demand or in advancing production of our commercial products or our clinical trials while we identify and qualify replacement suppliers. | |
| If, for any reason, we were not able to obtain adequate supply of our product and product candidates or the drug substances used to manufacture them, it would be difficult for us to develop, transfer or manufacture our products ourselves and compete effectively. |
Our current and anticipated future dependence upon others for the manufacturing and testing of our
products and product candidates may adversely affect our profit margins and our ability to develop
products and commercialize additional products that receive regulatory approval in a timely and
competitive manner.
For example, the deficiencies raised by the FDA with respect to ULTRASE MT and VIOKASE were with
respect to the manufacturing and control processes at a third party manufacturer of the active
ingredient for these products.
We rely, and expect to continue to rely, on our third-party manufacturers for compliance with
applicable regulatory requirements for certain of our products and active pharmaceutical
ingredients. This may increase the risk of sanctions being imposed on us or on a manufacturer of
our products or product candidates, which could result in our inability to obtain sufficient
quantities of these products or product candidates.
Manufacturers are subject to the FDAs cGMP regulations and similar foreign standards, and we do
not have control over compliance with these regulations by our third-party manufacturers. Our
manufacturers may not be able to comply with cGMP regulations or other regulatory requirements or
similar regulatory requirements outside the United States.
Our manufacturers are subject to unannounced inspections by the FDA, state regulators and similar
regulators outside the United States. Our failure, or the failure of our third-party manufacturers,
to comply with applicable regulations could result in sanctions being imposed on us, including
| fines; | ||
| injunctions; | ||
| civil penalties; | ||
| failure of regulatory authorities to grant marketing approval of our product candidates; | ||
| delays, suspension or withdrawal of approvals; | ||
| suspension of manufacturing operations; | ||
| license revocation; | ||
| seizures or recalls of products or product candidates; | ||
| operating restrictions; and | ||
| criminal prosecutions. |
Any of these sanctions could significantly and adversely affect supplies of our products and
product candidates and might adversely affect our profit margins and our ability to develop product
candidates and commercialize any additional products that receive regulatory approval on a timely and competitive basis. See Risks Related to Our Pancreatic
Enzyme Products below for information on deficiencies raised by the FDA with respect to the
manufacturer of the active ingredient in ULTRASE MT and VIOKASE.
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We rely on third parties to conduct, supervise and monitor our clinical trials, and those third
parties may perform in an unsatisfactory manner, such as by failing to meet established deadlines
for the completion of such trials.
We rely on third parties such as contract research organizations, medical institutions and clinical
investigators to enroll qualified patients and conduct, supervise and monitor our clinical trials.
Our reliance on these third parties for clinical development activities reduces our control over
these activities. Our reliance on these third parties, however, does not relieve us of our
regulatory responsibilities, including ensuring that our clinical trials are conducted in
accordance with good clinical practice regulations, and the investigational plan and protocols
contained in the relevant regulatory application, such as the IND. In addition, such third parties
may not complete activities on schedule, or may not conduct our preclinical studies or clinical
trials in accordance with regulatory requirements or our trial design. If these third parties do
not successfully carry out their contractual duties or meet expected deadlines, our efforts to
obtain regulatory approvals for, and to commercialize, our product candidates may be delayed or
prevented.
Our business could suffer as a result of adverse drug reactions to the products we market.
Unexpected adverse drug reactions by patients to any of our products could negatively impact
utilization or market availability of our product.
Absence of long-term safety data may also limit the approved uses of our products, if any. If we
fail to comply with the regulatory requirements of the FDA and other applicable regulatory
authorities, or if previously unknown problems with any approved commercial products, manufacturers
or manufacturing processes are discovered, we could be subject to administrative or judicially
imposed sanctions or other setbacks, including:
| restrictions on the products, manufacturers or manufacturing processes; | ||
| warning letters and untitled letters; | ||
| civil penalties and criminal prosecutions and penalties; | ||
| fines; | ||
| injunctions; | ||
| product seizures or detentions; | ||
| import or export bans or restrictions; | ||
| voluntary or mandatory product recalls and related publicity requirements; | ||
| suspension or withdrawal of regulatory approvals; | ||
| total or partial suspension of production; and | ||
| refusal to approve pending applications for marketing approval of new products or of supplements to approved applications. |
The publication of negative results of studies or clinical trials may adversely impact our sales
revenue.
Studies or clinical trials on various aspects of pharmaceutical products are conducted by us and
also by academics or others, including government agencies. The results of studies or trials, when
published (as required by the FDA with respect to studies or trials of FDA-approved drugs and
devices), may have a dramatic effect on the market for the pharmaceutical product that is the
subject of the study. The publication of negative results of studies or clinical trials related to
our products or the therapeutic areas in which our products compete could adversely affect our
sales, the prescription trends for our products and the reputation of our products. In the event of
the publication of negative results of studies or clinical trials related to our products or the
therapeutic areas in which our products compete, our business, financial condition, results of
operation and cash flows could be materially adversely affected.
We may not realize the benefits of the acquisition, including anticipated cost-savings, and will
incur significant costs in connection with the acquisition and integration of Axcan and Eurand into
a single business.
The acquisition of Eurand involves the integration of two companies that have previously operated
independently. The acquisition of Eurand has diversified the business segments in which we operate
(including with respect to pharmaceutical technologies) and expanded the number of products under
development, as well as increased the number of collaborations and partnerships we need to manage,
the number of our employees and the number of our facilities and the regions in which we operate,
thereby presenting us with significant challenges as we work to manage the substantial increases in
scale resulting from the acquisition. We can give no assurance that the acquisition will perform in
accordance with our expectations or that our expectations with respect to integration and synergies
as a result of the acquisition will materialize.
The integration of Axcan and Eurand is expected to result in financial and operational benefits,
including increased revenues and a substantial amount of synergies from cost-savings and other
financial and operational benefits. We do not expect to achieve the full amount of such synergies
in the year following the acquisition, and there can be no assurance regarding when or the extent
to which we will be able to realize these increased revenues, cost-savings or other benefits. This
integration may also be difficult, unpredictable, and subject to delay. The acquisition is the most
complex that the company has tried to integrate and, as a result, we must integrate a large number
of systems, platforms, technologies, functions and processes, which could prove to be more
difficult than we anticipate. Difficulties associated with integrating Eurand could have a material
adverse effect on us. The focus on integration may place a significant burden on our management and
internal resources, and the diversion of management attention and any difficulties encountered in
the transition and integration process could harm our businesses, financial conditions and
operating results. In addition, events outside of our control, including but not limited to
regulatory changes or developments, could also adversely affect our ability to realize the
anticipated benefits and synergies from the acquisition.
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We have incurred, and expect to incur, significant costs in connection with integrating our
operations, products and personnel with those of Eurand. These costs may include costs for employee
redeployment, relocation or severance, reorganization or closure of facilities, combination of
research and development functions and integration of information systems. We expect to incur a
majority of such costs in advance of achieving expected synergies and cost-savings. Additional
unanticipated costs may be incurred in the integration of the businesses of Axcan and Eurand.
Although we expect that the elimination of duplicative costs, as well as the realization of other
efficiencies related to the integration of the businesses, may offset incremental transaction and
transaction-related costs over time, this net benefit will not be achieved in the near term, and
may not be achieved at all. There can be no assurance that we will be successful in these
integration efforts. The acquisition of Eurand may further exacerbate the risks and uncertainties
we face.
Uncertainty related to the acquisition could harm our business.
We are both highly dependent on the continuing efforts of our management team and key personnel. As
a result of the acquisition of Eurand, current and prospective Axcan and Eurand employees could
experience uncertainty about their future roles. This uncertainty may adversely affect our ability
to attract and retain key management, sales, marketing and R&D personnel. Uncertainty about the
effect of the acquisition by customers and suppliers could also have an adverse effect on us. These
uncertainties could cause customers, suppliers and others who deal with us to seek to change
existing business relationships.
We intend to continue to pursue additional acquisitions in the future as part of our strategy,
which will present certain risks to us.
A significant component of our strategy will continue to be growth through acquisitions of products
or businesses. However, we cannot be certain that we will be able to identify appropriate
acquisition candidates. Even if an acquisition candidate is identified, there can be no assurance
we will be able to successfully negotiate any such acquisition on favorable terms or at all,
finance such an acquisition or integrate such an acquired product or business into our existing
business. We face significant competition from other pharmaceutical companies for acquisition
candidates, which makes it more difficult to find attractive transaction opportunities for products
or companies on acceptable terms. Furthermore, the negotiation of potential acquisitions and the
integration of such acquired products or businesses could divert managements time and resources
and require significant financial resources to consummate. To consummate any acquisition, we may
need to incur additional debt or issue additional equity securities and, depending on market
conditions, we may not be able to obtain necessary financing for any acquisitions on terms
acceptable to us, or at all. We may also be required to pay external costs such as legal advisory,
market research consultancy and due diligence fees related to our pursuit and evaluation of
potential acquisitions, even if the acquisitions are never consummated. Failure to acquire new
products may diminish our rate of growth and adversely affect our competitive position.
Any acquisition transactions involve various inherent risks, such as assessing the value,
strengths, weaknesses, contingent and other liabilities, and potential profitability of the
acquisition; the potential loss of key personnel of an acquired business; the ability to achieve
operating and financial synergies anticipated to result from an acquisition and unanticipated
changes in business, industry or general economic conditions that affect the assumptions underlying
the acquisition. Any one or more of these factors could cause us not to realize the anticipated
benefits from the acquisition of businesses or products.
There is no assurance that we will continue to be successful in our licensing and third-party
marketing operations.
Certain of our products are sold and marketed by third parties and, in the case of the former
Eurand business, collaboration or co-development partners. Such third-party arrangements may not be
successfully negotiated in the future. Any such arrangements may not be available on commercially
reasonable terms. Even if acceptable and timely marketing arrangements are available, the products
we develop may not be accepted in the marketplace, and even if such products are initially
accepted, sales may thereafter decline. Additionally, our clients or marketing partners may make
important marketing and other commercialization decisions with respect to products we develop that
are not within our control. Our clients or marketing partners could also merge with or be acquired
by another company, or experience financial or other setbacks unrelated to our arrangement that
could affect their ability to perform their obligations under their agreement with us. As a result,
many of the variables that may affect our revenues, cash flows and net income are not exclusively
within our control. Furthermore, disputes may arise between us and a customer, licensee or
marketing collaborator and may involve the issue of the obligations of the customer, licensee or
marketing collaborator to continue to purchase our products and pay royalties on the sale of our
products. Such a dispute could result in expensive arbitration or litigation, which may not be
resolved in our favor.
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The success of our strategic investments, partnerships or development alliances and collaborators,
particularly those involving our pharmaceutical technologies, depends upon the performance of the
companies in which we invest, or with which we partner or co-develop products.
Our arrangements with collaboration partners and licensees are critical to our success in bringing
certain of our products and product candidates to market. In particular, we have invested and
expect to continue investing significant time and financial resources in the development of our
co-development products. We depend on our collaboration partners to conduct preclinical studies and
clinical trials, as may be necessary, and to provide funding for our development of these product
candidates. Furthermore, in most instances, we rely on collaborators to commercialize our
co-development products. If we or a significant number of our collaborators are unable to
commercialize our co-development products or experience significant delays in such
commercialization, our growth prospects will be materially harmed. The successful commercialization
of a product or product candidate will depend on numerous events or factors, including:
| successfully completing preclinical studies and clinical trials and any additional trials and tests required by the FDA, the EMA or other applicable regulatory authorities; | |
| receiving marketing approvals, to the extent required, from the FDA, the EMA or other applicable regulatory authorities; and | |
| obtaining commercial acceptance, if approved, from the medical community and third-party payors. |
We cannot control our collaborators or licensees performance or the resources they devote to our
projects, and some of our collaborators can terminate their agreements with us for no reason and on
limited notice. If a collaborator fails to perform as expected, we may have to use funds,
personnel, laboratories and other resources that we have not budgeted for, or we may not be able to
continue the particular project affected.
We generally expect a number of the new co-development agreements we enter into to terminate
without significant development activity. A collaboration partner may choose to use its own or one
of our competitors technologies to develop a way to reformulate its drug and thus withdraw its
support of our product candidate. Alternatively, we may develop a proprietary product candidate
that competes directly with products that we currently manufacture for a collaboration partner. In
addition, a collaboration partner could merge with or be acquired by another company, or experience
financial or other setbacks unrelated to our collaboration that could jeopardize the co-development
project. The loss of collaborators or projects could materially adversely affect our business,
growth prospects and financial condition.
Economic, governmental, industry and internal company factors outside our control affect each of
the companies in which we may invest or with which we may partner or co-develop products. Some of
the material risks relating to such companies include:
| the ability of these companies to successfully develop, manufacture and obtain necessary governmental approvals for the products that serve as the basis for our investments in, or relationship with, such companies | |
| the ability of competitors of these companies to develop similar or more effective products, making the drugs developed by these companies difficult or impossible to market; | |
| the ability of these companies to adequately secure patents for their products and protect their proprietary information; | |
| the ability of these companies to enter the marketplace without infringing upon competitors patents; | |
| the ability of these companies to finance their operations; | |
| the ability of these companies to remain technologically competitive; and | |
| the dependence of these companies upon key scientific and managerial personnel. |
Our operations could be disrupted if our information systems fail or if we are unsuccessful in
implementing necessary upgrades.
Our business depends on the efficient and uninterrupted operation of our computer and
communications systems and networks, hardware and software systems, and other information
technology. If our systems were to fail or we were unable to successfully expand the capacity of
these systems, or we were unable to integrate new technologies into our existing systems, including
as a result of the acquisition of Eurand, our operations and financial results could suffer.
Our quarterly results may fluctuate.
Our quarterly operating results have fluctuated in the past and may continue to fluctuate in the
future. Factors that could cause quarterly operating results to decline, many of which are not
within our control, include, for example, the size and timing of product orders, which can be
affected by customer budgeting and buying patterns, or the size and timing of expenses associated
with our development and marketing programs. As a result, if customer buying patterns cause revenue
shifts from one fiscal quarter to another, or if the development and marketing of our products or
product candidates causes our expenses to change from one fiscal quarter to another, our net
quarterly income may fluctuate. In particular, revenue from the pharmaceutical technologies
business is based on completion of relevant milestones and, therefore, is prone to a significant
fluctuation over time, which may have an adverse effect on our results of operations.
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Our business depends on key scientific, sales and managerial personnel for continued success
Much of our success to date has resulted from the skills of certain of our officers, scientific
personnel and sales force. High demand exists for senior management and other key personnel in the
pharmaceutical industry. The loss of any of these people may negatively impact our ability to
manage our company effectively and to carry out our business plan. If these individuals were no
longer employed by us, we might not be able to attract or retain employees with similar skills or
carry out our business plan. In particular, we rely on the contributions of our senior management
team, and their continued service is critical to our success. Our senior management team is
responsible for the development and implementation of our business strategy. The loss of service of
any member of our senior management team or key personnel could delay or prevent the successful
completion of our planned clinical trials or the commercialization of our product candidates. Of
our senior management team, only five have employment agreements.
Furthermore, for the acquisition of Eurand to be successful, we must continue to retain, motivate
and recruit former key executives and other former key employees of Eurand following the
acquisition. Such employee retention may be challenging as employees may experience uncertainty
about their future roles until, or even after, strategies with regard to the combined company are
announced or implemented. Eurands key employees are employed at will. If, despite retention
efforts, key employees of Eurand or Axcan depart because of issues relating to the uncertainty and
difficulty of integration or a desire not to remain with us after completion of the acquisition,
our ongoing business could be harmed. Additionally, the potential distraction of the acquisition
may adversely affect our ability to attract, motivate and retain executives and other key employees
and keep them focused on corporate strategies and goals, which could have an adverse impact on our
business.
We could face labor disruptions that would interfere with our operations, as we are subject to
collective bargaining or other labor agreements or arrangements.
Axcan employees located in Canada and France, as well as approximately 60% of former Eurands
employees (approximately 50% of the total number of our employees), are represented by collective
bargaining or other labor agreements or arrangements that may provide greater bargaining or other
rights to employees than do the laws of the United States. Such employment rights require us to
expend greater time and expense in making changes to employees terms of employment or carrying out
staff reductions. In addition, many of former Eurands employees are located in Italy and France,
and some of Axcans employees are located in France, where national strikes occur, and our
employees may strike even if they do not have a grievance against us. While we believe that our
relations with our employees are satisfactory, worker disruption on a local or national level or a
significant dispute with our employees (including those resulting from or related to our
acquisition of Eurand) could have a material adverse effect on our business, financial position,
results of operations and cash flows.
Risks Related to Our Pancreatic Enzyme Products
Our ULTRASE MT and VIOKASE PEPs may never be approved in the United States
We ceased distributing our ULTRASE and VIOKASE product lines in the United States effective April
28, 2010. ULTRASE and VIOKASE accounted for 24.0% of our net product sales in fiscal year 2009 and
for 15.1% of our net product sales in fiscal year 2010. This action was taken because we did not
receive FDA approval for ULTRASE MT or VIOKASE by April 28, 2010, the date mandated by the FDA to
obtain approval for PEPs. In April 2004, the FDA mandated that all manufacturers of PEPs file an
NDA and receive approval for their products by April 2008 or be subject to regulatory action. In
October 2007, the FDA published a notice in the Federal Register extending the deadline within
which to obtain marketing approval for PEPs until April 28, 2010, for those companies that (a) were
marketing unapproved PEPs as of April 28, 2004; (b) submitted NDAs on or before April 28, 2009; and
(c) continued diligent pursuit of regulatory approval.
We completed the initial submission of our NDA for ULTRASE MT and, in the fourth quarter of fiscal
2008, received a first complete response letter from the FDA. Further to the filing of our response
to this letter, we received a second complete response letter from the FDA in the fourth quarter of
fiscal 2009. On May 5, 2010 the FDA issued an additional complete response with respect to our NDA
for ULTRASE MT. As was the case with prior letters, the FDA requires that deficiencies raised with
respect to the manufacturing and control processes at the manufacturer of the active ingredient of
ULTRASE MT be addressed before approval can be granted. We submitted our response to this letter,
and the FDA confirmed a November 28, 2010 PDUFA date for our ULTRASE MT NDA.
The submission of our rolling NDA for VIOKASE was completed in the first quarter of fiscal 2010. At
the time we completed this submission we requested a priority review and the FDA advised us in the
second quarter of fiscal 2010 that it would not grant a priority review for this NDA. The initial
PDUFA date for VIOKASE was August 30, 2010. In August 2010, we received feedback from the FDA
regarding the timeline to review the VIOKASE NDA. At that time, the FDA indicated that the review
was progressing but postponed the PDUFA date to November 30, 2010 to allow more time to complete
their review. Since ULTRASE MT and VIOKASE have a common active ingredient manufacturer, the
deficiencies raised by FDA with respect to ULTRASE MT also applied to VIOKASE.
On November 28, 2010, the FDA issued complete response letters regarding the NDAs for ULTRASE MT
and VIOKASE. The letters indicate that certain deficiencies previously raised by the FDA with
respect to the manufacturing and control processes at the manufacturer of the active ingredient for
both ULTRASE MT and VIOKASE have not been resolved and that such deficiencies must be addressed
before approval can be granted. The letters also require that deficiencies identified in an FDA
inspection of such manufacturer must be resolved before the NDAs can be approved. Based on information available to the Company, on or
about January 20, 2010, the manufacturer of the active pharmaceutical
ingredient to ULTRASE MT and VIOKASE received a warning letter from
the FDA noting that certain deficiencies previously identified by the
FDA in an inspection of such manufacturer have not yet been
resolved. Failure by the manufacturer to promptly correct these
violations may result in further regulatory action against the
manufacturer.
We are in ongoing
discussions with the FDA and continue to work with the manufacturer of the active pharmaceutical
ingredient to address the remaining open issues identified by the FDA. We do
not believe that those remaining issues will require additional clinical studies.
There can be no assurance that ULTRASE MT and VIOKASE will be approved by the FDA. If ULTRASE MT or
VIOKASE are not approved on a timely basis, our financial position, cash flows and overall trends
in results of operations will continue to be adversely affected.
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If ULTRASE MT and VIOKASE are approved and relaunched, competition in the PEP market at that time
could be more intense than at the time when we ceased their distribution or at present.
If approved and relaunched, the level of competition that ULTRASE MT and VIOKASE will face in the
United States will be more intense than before April 28, 2010, when we ceased distributing these
products, or at present. In addition to ZENPEP, other branded PEPs have been approved and are
currently marketed in the United States: CREON (Solvay/Abbott) and PANCREAZE (McNeil
Pharmaceutical, Inc.). In order to relaunch ULTRASE MT and VIOKASE, we will need to re-establish
the market position for these products and succeed in having customers using other marketed
products start or restart using our products, which may prove difficult or impractical. These
efforts will likely result in increased marketing and other expenses. If we are not successful,
this would have a material adverse effect on our business and our financial results.
Furthermore, the relaunch of ULTRASE MT and VIOKASE, directly or indirectly, also could lead to a
decrease in sales of ZENPEP, which would compete with ULTRASE MT and VIOKASE in the PEP market. If
such a decrease cannot be offset by increased sales of ULTRASE MT or VIOKASE, it could have a
material adverse effect on our business and results of operations.
In addition, competition in the PEP market will significantly increase if Solpura (liprotamase) is
approved by the FDA. SOLPURA is Eli Lillys lead candidate for the treatment of EPI associated with
CF and pancreatectomy. In contrast to FDA-approved oral porcine derived PEPs on the market (ZENPEP,
CREON, and PANCREAZE), SOLPURA is an oral, non-porcine, pancreatic enzyme replacement therapy
currently under FDA review. On January 12, 2011, the FDA Gastrointestinal Drugs Advisory Committee
voted to recommend non-approval of SOLPURA. The committee raised questions about the degree of
efficacy of Solpura and recommended that additional studies be conducted prior to considering
approval of SOLPURA for EPI. However, the FDA is not required to follow the recommendation of its
advisory committees, and SOLPURA may be approved in the future.
If ULTRASE MT and VIOKASE are approved and relaunched, our future revenues and profitability will
be adversely affected if governmental, private third-party payors and other third-party payors,
including Medicare and Medicaid, do not sufficiently defray the cost of ULTRASE MT and VIOKASE to
the consumer.
Our future revenues and profitability will be adversely affected if governmental, private
third-party payors and other third-party payors, including Medicare and Medicaid, do not
sufficiently defray the cost of ULTRASE MT and VIOKASE to the consumer. If these entities do not
provide coverage and reimbursement for ULTRASE MT and VIOKASE or determine to provide an
insufficient level of coverage and reimbursement, ULTRASE MT and VIOKASE may be too costly for
general use, and physicians may not prescribe it. Many third-party payors cover only selected
drugs, making drugs that are not preferred by such payor more expensive for patients, and often
require prior authorization or failure on another type of treatment before covering a particular
drug.
In addition to potential restrictions on coverage, the amount of reimbursement for our products may
adversely affect results of operations. In the United States, there have been, and we expect there
will continue to be, actions and proposals to control and reduce healthcare costs. Government and
other third-party payors are challenging the prices charged for healthcare products and
increasingly limiting and attempting to limit both coverage and level of reimbursement for
prescription drugs.
If adequate coverage and reimbursement by third-party payors does not continue to be available, our
ability to successfully relaunch ULTRASE MT and VIOKASE may be adversely impacted. Any limitation
on the use of ULTRASE MT and VIOKASE or any decrease in the price of ULTRASE MT and VIOKASE will
have a material adverse effect on our business.
Additional Risks Related to Eurands Business
In addition to the risk factors described elsewhere in this section, we have become subject to
additional risks as a result of our acquisition of Eurands business and operations, including
those described below.
Eurand has a history of net losses and we may not achieve or maintain profitability of the Eurand
business.
Eurand incurred significant net losses since its formation in 1999, when it was established as a
company independent of American Home Products, now Pfizer. As of September 30, 2010, it had an
accumulated deficit of 41.8 million. Its net income (losses) were (6.7) million, 13.6 million
and (5.9) million in 2007, 2008 and 2009, respectively, and net income was 2.5 million for the
nine months ended September 30, 2010. Net income in 2008 of 13.6 million included a gain on
settlement of litigation of 24.4 million, which is not expected to recur. In addition, Eurand had
made, and we expect to continue to make, investments in research and development programs. We
expect that selling, general and administrative expenses will continue to be a significant
component of our cost structure and to incur increased expenses as we continue our research
activities, conduct development of or seek regulatory approvals for our product candidates, and
promote ZENPEP (pancrelipase) Delayed-Release Capsules, which was launched by Eurand in November
2009.
Eurands commercial launch of ZENPEP in the United States commenced in November 2009, but we expect
that associated expenses will precede revenues generated by the increased spending. If its launch
of ZENPEP is not successful, either because of competition from other PEPs, an inability to build
market share, increased selling or other expenses, or other difficulties, ZENPEP may not become
profitable.
Furthermore, before we ceased distribution of ULTRASE MT, Eurand licensed, manufactured and
supplied ULTRASE MT capsules to us and also received royalties based on a percentage of our net
sales of the product. Eurands revenues from us with respect to ULTRASE MT sales and royalties
accounted for approximately 36 million and 16 million, or 31% and 15%, respectively, of Eurands
revenues in Eurands fiscal year 2009 and the nine months ended September 30, 2010. Such revenues
ceased entirely in and following Eurands third fiscal quarter of 2010 due to the cessation of
distribution of ULTRASE MT.
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Even if developing and commercializing one or more of the former Eurand product candidates is
successful, former Eurands operations may not contribute to overall profitability of the combined
companies. Maintaining operating profitability of the former Eurand business and achieving its
profitability in the future will depend on the ability of the combined company to generate revenues
that exceed expenses. This will depend on numerous factors including those discussed under Risk
FactorsWe may not be able to acquire or successfully integrate Eurands operations and products
or any businesses or products we may acquire in the future. Furthermore, we may not realize the
anticipated benefits from any such acquisitions and the risk factors described elsewhere in this
report, many of which also apply to the former businesses and operations of Eurand. Even if
achieved, profitability of the former Eurand business may not be sustained or increased on a
quarterly or annual basis or at all.
If we are unable to obtain adequate reimbursement for ZENPEP from government health administration
authorities, private health insurers and other organizations, ZENPEP may be too costly for regular
use and our ability to generate revenues would be harmed.
Our future revenues and profitability will be adversely affected if governmental, private
third-party payors and other third-party payors, including Medicare and Medicaid, do not
sufficiently defray the cost of ZENPEP to the consumer. If these entities do not provide coverage
and reimbursement for ZENPEP or determine to provide an insufficient level of coverage and
reimbursement, ZENPEP may be too costly for general use, and physicians may not prescribe it. Many
third-party payors cover only selected drugs, making drugs that are not preferred by such payor
more expensive for patients, and often require prior authorization or failure on another type of
treatment before covering a particular drug.
In addition to potential restrictions on coverage, the amount of reimbursement for our products may
adversely affect results of operations. In the United States and elsewhere, there have been, and we
expect there will continue to be, actions and proposals to control and reduce healthcare costs.
Government and other third-party payors are challenging the prices charged for healthcare products
and increasingly limiting and attempting to limit both coverage and level of reimbursement for
prescription drugs.
If adequate coverage and reimbursement by third-party payors is not achieved, our ability to
successfully commercialize ZENPEP may be adversely impacted. While prior to fully establishing
reimbursement, we intend to deploy marketing strategies designed to make ZENPEP affordable for
patients, this will include, in certain circumstances, providing samples prior to obtaining
reimbursement. As samples are provided free of charge we may incur additional costs in advance of
generating revenue. In the event we are not able to successfully deploy such strategies, the market
share of ZENPEP, and our revenue, may suffer. Any limitation on the use of ZENPEP or any decrease
in the price of ZENPEP will have a material adverse effect on our business.
Any difficulties with, or interruptions of, our acquired manufacturing operations could delay our
output of products and harm our relationships with our collaborators. If we are unable to continue
to manufacture our existing products, our results of operations and future prospects will suffer.
Any difficulties with or interruptions of our acquired manufacturing operations could delay our
output of products and harm our relationships with our collaborators. We manufacture several
products at former Eurand facilities in Milan, Italy and Dayton, Ohio. Due to regulatory and
technical requirements, we have limited ability to shift production among our facilities or to
outsource any part of our manufacturing activities to third parties. Damage to any of our acquired
manufacturing facilities caused by human error, physical or electronic security breaches, power
loss or other failures or circumstances beyond our control, including acts of God, fire, explosion,
flood, war, insurrection or civil disorder, acts of, or authorized by, any government, terrorism,
accident, labor trouble or shortage, or inability to obtain material, equipment or transportation,
could interrupt or delay our manufacturing or other operations. Furthermore, all of former Eurand
employees in Europe are subject to collective bargaining agreements, and national labor disputes
could result in a work stoppage or strike by employees that could delay or interrupt our output of
products. Due to the nature of these collective bargaining agreements, we have no control over such
work stoppages or strikes by our employees in Europe, and a strike may occur even if our employees
do not have any grievances against us. Any interruption in manufacturing, whether due to
limitations in manufacturing capacity or arising from factors outside our control, could result in
delays in meeting contractual obligations and could have a material adverse effect on our
relationships with our collaborators and on our revenues.
The FDA, the EMA and other applicable authorities periodically inspect former Eurand manufacturing
facilities to ensure compliance with various regulations, including those relating to current good
manufacturing practice, or cGMP. In addition, the U.S. Drug Enforcement Administration, or DEA,
applicable EU authorities and other applicable regulatory authorities must approve our facilities
and processes for handling controlled substances. Those agencies may monitor our use of controlled
substances and we may be subject to inspections evaluating our compliance with the use and handling
of controlled substances. Our failure to comply with such requirements and standards of these
agencies could result in the suspension of our manufacturing or closure of our facilities, which
could have a material adverse effect on our business. In addition, we currently manufacture for
commercial distribution a number of drugs that are the subject of NDAs that have been approved or
other applicable regulatory approval held by our collaborators and licensees. We also use
third-party suppliers to provide bulk active drugs used in our products. Because our customers and
suppliers continue to be subject to FDA regulation, our continued development and manufacturing of
these products will continue to depend not only on our own compliance with FDA requirements but
also on the compliance of customers and suppliers over whom we have no control.
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Our competitors may develop products that are less expensive, safer or more effective than, and may
diminish or prevent the commercial success of, any product candidates that we may bring to market.
We face intense competition from pharmaceutical and biotechnology companies, including other drug
formulation companies, contract research organizations, academic institutions and government
agencies. Some of these competitors are also our collaboration partners.
Our competitors may be able to use alternative technologies that do not infringe upon our patents
to formulate the active materials in our products. If successful, products derived from alternative
technologies will compete against our products and product candidates. Examples of competing
technologies include the multipleparticle systems of Watson, Biovail and Elan; the
controlled-release tablet technologies of Elan and SkyePharma; and the solubility-enhancement
technologies of Elan, SkyePharma and Soliqs, a division of Solvay/Abbott. The products derived from
these technologies may be safer or more efficacious than some of former Eurand products and product
candidates.
Potential products being tested in the United States and Europe of which we are not currently aware
may also compete with product candidates using our drug formulation systems. Our collaboration
partners could choose a competing drug formulation system to use with their drugs instead of ours.
In addition, our collaboration partners themselves face competition with other major pharmaceutical
companies on products using our drug formulation technologies, which could adversely impact the
potential for our technologies and co-development products, as well as our royalty revenues and
business and financial condition.
Many of our competitors have greater capital resources, manufacturing and marketing experience,
research and development resources and production facilities than the company has. Many of them
also have more experience than we do in preclinical studies and clinical trials of new drugs and in
obtaining FDA, EMA and other applicable regulatory approvals or, as with some competitors, are
already established in the market. In addition, their success in obtaining patents may make it
difficult or impossible for our company to compete with them.
Major technological changes can happen quickly in the drug formulation and pharmaceutical
industries. our development of technologically improved or different products may make our
technologies and product candidates obsolete or noncompetitive.
In addition, with respect to products that we develop and manufacture for our collaborators, we
face the risk that such products or our collaborators other products may compete with our
proprietary products. Some of these products may target the same diseases and conditions that are
the focus of our drug development programs.
ZENPEP competes with currently marketed PEPs (to the extent such products are either approved or
are part of the inventory of unapproved PEPs that will remain on the market for a period of time),
and our competitors may have more resources available to them than us.
ZENPEP competes with currently marketed products for exocrine pancreatic insufficiency. This
competition, and the increased competition should ULTRASE MT and/or VIOKASE be approved by the FDA
and relaunched into the market, could affect the market acceptance of ZENPEP or require us to lower
the price of ZENPEP, which would negatively impact our margin and our ability to achieve
profitability of the ZENPEP franchise. Other companies with existing PEPs include Solvay
Pharmaceuticals acquired by Abbott Laboratories or Solvay/Abbott; and McNeil Consumer Healthcare, a
subsidiary of Johnson & Johnson. In addition, we understand that other commercial entities have or
have had synthetic product candidates in clinical development that could compete with ZENPEP. These
and other companies may have greater resources available than we do to support their products.
Solvay/Abbotts CREON (approved in May 2009) and Johnson & Johnsons PANCREAZE (approved in April
2010) compete with ZENPEP. In addition, if SOLPURA (liprotamase), Eli Lillys lead candidate for
the treatment of exocrine pancreatic insufficiency associated with CF and pancreatectomy, is
approved by the FDA, the competition ZENPEP faces will significantly increase.
The failure to maintain our existing co-development relationships on acceptable terms, or the
failure to develop and maintain new co-development relationships using our formulation
technologies, could adversely affect our ability to develop and commercialize our product
candidates and impair our future growth prospects.
Co-development agreements utilized to create relationships for the purpose of exploring development
opportunities with collaboration partners will continue to be important for our business. By way of
example, in 2009, Eurand entered into four co-development agreements with various collaborators and
we expect to continue to negotiate additional co-development agreements. In general, co-development
agreements involve feasibility studies and early-stage development activities whereby an hourly
service fee is paid for research and development and, in some instances, additional milestone
payments may be made based on the achievement of certain development goals within specified
timeframes. Accordingly, our receipt of revenue in a given period during the development phase is
dictated in part by the speed at which development goals are met and the time and resources that a
collaboration partner wishes to dedicate to development in such period. In some instances, we and
our collaboration partner decide to negotiate and include provisions in a co-development agreement
that will govern our relationship from development through commercialization. In other instances,
we and our collaboration partner elect to define our relationship for the development phases and,
if development is promising, may elect to enter into a subsequent agreement that further defines
their relationship for subsequent periods of a products or product candidates life. The
likelihood of completing development or progressing past development is highly uncertain
notwithstanding the inclusion of provisions that govern the relationship through commercialization.
Thus, the existence of such provisions, which could provide for the payment of royalties and sales
milestones based on the success of the product, is not indicative of the likelihood that we will
receive such payments. We believe that we currently are not substantially dependent on any
co-development agreements individually; however, the maintenance of such relationships is important
to our growth prospects because of the potential that a co-development relationship could evolve
into a licensing and supply relationship that could generate significant revenue from licensing fees, product sales,
sales milestone payments and/or royalties.
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Our obligations under our co-development agreements can include performance of development
activities, such as feasibility studies, formulation optimization, stability testing and scale-up
of the manufacturing process, supply of the product to the collaborator for clinical testing,
assistance in the preparation of regulatory filings by our collaborator and supply of the product
for sale by our collaborator. If we fail to meet certain of these obligations, we may lose our
rights to certain development fees and future royalty and milestone payments, and our collaboration
partners may have the right to terminate the agreement. In addition, many of our agreements allow
for the collaboration partner to terminate the agreement with limited notice and without penalty or
in the event the collaborator reasonably determines that the product does not justify continued
development or commercialization. We have completed work under some of these agreements without
developing a commercial product and, based on past experience, it is likely that a number of these
agreements will not progress to the stage where the product is actually commercialized. In
addition, even if our collaborators choose not to terminate an agreement, the risk still remains
that the collaborator could decide not to launch a particular product. The loss of a collaboration
partner, as a result of either our failure to meet our obligations or early termination by the
collaboration partner could affect our results of operations and future growth prospects.
Furthermore, our success is in part based upon a reputation that we are an attractive collaborator
for leading pharmaceutical companies seeking to enhance existing products or to develop new
products. For example, one of our co-development products, EUR-1000, is being developed in
collaboration with GlaxoSmithKline, or GSK (acquired Reliant Pharmaceuticals in December 2007), and
AMRIX is being commercialized in the United States by Cephalon, Inc. (acquired rights to AMRIX from
ECR Pharmaceuticals in August 2007). If we fail to meet our obligations under these and other
existing co-development agreements, we may diminish our reputation and decrease our potential
future co-development opportunities.
Finally, the process of establishing new co-development relationships is difficult, time-consuming
and involves significant uncertainty. We face, and will continue to face, significant competition
in seeking appropriate collaboration partners. Moreover, if we do establish co-development
relationships, our collaborators may fail to fulfill their responsibilities or may seek to
renegotiate or terminate their relationships with us due to unsatisfactory clinical results, a
change in business strategy, a change of control or other reasons. In many cases, our collaborators
may terminate their relationships with us with limited notice and without penalty or in the event
the collaborator reasonably determines that the product does not justify continued development or
commercialization. If we are unable to establish and maintain co-development arrangements on
acceptable terms, we may have to delay or discontinue further development of one or more of our
product candidates, seek regulatory approval or undertake commercialization activities at our own
expense or find alternative sources of funding, and our growth prospects will be materially harmed.
Risks Related to Regulatory Matters
If our products fail in clinical studies or if we fail, or encounter difficulties, in obtaining
regulatory approval for our new products or new indications of existing products or relaunching our
PEPs, we will have expended significant resources for no return.
If our products are not successful in clinical trials or if we do not obtain such regulatory
approvals, we will have expended significant resources for no return. Our ongoing clinical studies
might be delayed or halted or additional studies might be required, for various reasons, including
the following:
| Our products are found not to be effective. | |
| We are unable to demonstrate that a product candidates benefits outweigh its risks. | |
| We are unable to demonstrate that a product candidate presents an advantage over existing products. | |
| We do not comply with requirements concerning INDs, biologic license applications (BLAs) or NDAs, for the protection of the rights and welfare of human subjects. | |
| The FDA, the EMA or other applicable regulatory authorities may require additional or expanded trials or may disagree with the manner in which the results from preclinical studies or clinical trials are interpreted. | |
| We may experience delays in obtaining, or the inability to obtain or maintain, required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials. | |
| Patients experience unacceptable side effects or die during clinical trials. | |
| Patients do not enroll in the studies at the rate we expect or drop out of the studies. | |
| A drug is modified during testing. | |
| Patients experience serious or unexpected drug-related side effects during a clinical trial. | |
| Product supplies are delayed or are not sufficient to treat the patients participating in the studies. | |
| Failure by our manufacturers or suppliers to comply with any of the FDAs or other relevant foreign counterparts continuing regulations. | |
| A change in the approval policies or regulations of the FDA, EMA or other applicable regulatory authorities, or a change in the laws governing the approval process. |
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If we cannot obtain regulatory approvals for the products we are developing or may seek to develop
in the future, our sales and competitive position will suffer. This risk is most acute for products
that are currently in the development of the final formulation. There is no guarantee that we would
obtain regulatory approval, even if our clinical trials are successful. With respect to ULTRASE MT
and VIOKASE, for which we need to comply with the FDAs requirements in order to return to market,
we face the risk of not being able to obtain the FDAs approval on a timely basis or at all. PYLERA
is currently under filing review in the EU under centralized procedure and there is a risk of
delayed approval or non-approval. In addition, we are currently in discussions with the EMA with
respect to the regulatory process and filing requirements relating to ZENPEP in the EU. There can
be no assurance that the regulatory approval of ZENPEP by the EMA will be obtained on a timely
basis or at all.
Approval might entail ongoing requirements for post-marketing studies. Even if regulatory approval
is obtained, labeling and promotional activities are subject to continual scrutiny by the
regulatory agencies, in particular the FDA, and, in some circumstances, the Federal Trade
Commission. FDA enforcement policy prohibits the marketing of approved products for unapproved, or
off-label, uses. These regulations and the FDAs interpretation of them might impair our ability to
effectively market our products.
We, our third-party manufacturers and certain of our suppliers are also required to comply with the
applicable FDA cGMP regulations, which include requirements relating to quality control and quality
assurance, as well as the corresponding maintenance of records and documentation. Furthermore,
manufacturing facilities must be approved by regulatory authorities before they can be used to
manufacture our products and certain raw materials used therein, and they are subject to additional
inspections. If we or any of our manufacturers or suppliers fails to comply with any of the FDAs
or other relevant foreign counterparts continuing regulations, we could be subject to sanctions,
including:
| delays, warning letters and fines; | |
| product recalls or seizures and injunctions on sales; | |
| refusal to review pending applications; | |
| total or partial suspension of production; | |
| withdrawals of previously approved marketing applications; and | |
| civil penalties and criminal prosecutions. |
In addition, identification of side effects after a drug is on the market or the occurrence of
manufacturing problems could cause subsequent withdrawal of the product from the market,
reformulation of the drug, additional testing or changes in labeling of the product.
Sales of our products outside the United States and any of our product candidates that are
commercialized are subject to the regulatory requirements of each country in which the products are
sold. Accordingly, the introduction of our products and product candidates in markets outside the
United States will be subject to regulatory clearances in those jurisdictions. Approval and other
regulatory requirements vary by jurisdiction and may differ from the United States requirements. We
may be required to perform additional preclinical or clinical studies even if FDA approval has been
obtained. In addition, failures in European preclinical or clinical studies could impact our
filings in the United States. Many countries also impose product standards, packaging and labeling
requirements and import restrictions on our products. The approval by government authorities
outside of the United States is unpredictable and uncertain and can be expensive. Our ability to
market our approved products could be substantially limited due to delays in receipt of, or failure
to receive, the necessary approvals or clearances.
We may find it difficult to achieve market acceptance of our PEPs or products in our product
pipeline.
The commercial success of any of our product candidates for which we obtain marketing approval from
the FDA, Health Canadas Therapeutic Products Directorate, or TPD, the EMA, or other regulatory
authorities, as well as products that do not require approval for commercialization, will depend
upon the acceptance of these products by the medical community, including physicians, patients and
healthcare payors. The degree of market acceptance of any of our approved products will depend on a
number of factors, including:
| demonstration of clinical safety and efficacy compared to other products; | |
| the relative convenience and ease of administration; | |
| the prevalence and severity of any adverse side effects; | |
| limitations or warnings contained in a products FDA, TPD or EMA approved labeling; | |
| availability of alternative treatments for the indications we target; | |
| pricing and cost effectiveness compared to competing products, particularly generic products; | |
| the effectiveness of our or any future collaborators sales and marketing strategies; | |
| the effectiveness of our manufacturing and distribution plans; | |
| our ability to obtain sufficient third-party coverage or reimbursement; and | |
| the willingness of patients to pay out-of-pocket in the absence of third-party coverage. |
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If any of our product candidates are approved but do not achieve an adequate level of acceptance by
physicians, healthcare payors and patients, we may not generate sufficient revenue from these
products for such products to become or remain profitable. In addition, our efforts to educate the
medical community and third-party payors on the benefits of our product candidates may require
significant resources and may never be successful.
Our business is subject to limitations imposed by government regulations.
Governmental agencies in the countries in which we conduct business regulate pharmaceutical
products intended for human use. These regulations normally require extensive clinical trials and
other testing in addition to governmental review and final approval before products can be
marketed. Governmental authorities in such countries also regulate the research and development,
manufacture, distribution, promotion, testing and safety of products, and therefore, the cost of
complying with governmental regulations can be substantial.
Requirements for approval can vary widely from country to country. A product must normally be
approved by regulatory authorities in each country in which we intend to market it, prior to the
commencement of marketing in that country. There can be long delays in obtaining required
clearances from regulatory authorities in many countries after applications are filed. Therefore,
there can be no assurance that we will obtain regulatory approvals in such countries or that we
will not incur significant costs in obtaining or maintaining such regulatory approvals. Moreover,
the regulatory requirements applicable to our existing and future products may change.
Government regulations require the detailed inspection and control of research and laboratory
procedures, clinical studies, manufacturing procedures and marketing and distribution methods, all
of which significantly increase the level of difficulty and the costs involved in obtaining and
maintaining the regulatory approval for marketing new and existing products. Moreover, regulatory
measures adopted by governments provide for the possible withdrawal of products from the market
and, in certain cases, suspension or revocation of the required approvals for their production and
sale.
Failure to obtain necessary regulatory approvals; the restriction, suspension or revocation of
existing approvals; or any other failure to comply with regulatory requirements would restrict or
impair our ability to market our products and carry on our business.
Regulatory approval for our currently marketed products is limited by the regulatory authorities to
those specific indications and conditions for which clinical safety and efficacy have been
demonstrated.
Any regulatory approval is limited to those specific diseases and indications for which our
products are deemed to be safe and effective by the FDA, the TPD, the EMA, or other regulatory
authorities. In addition to approval required for new formulations, any new indication for an
approved product also requires regulatory approval. If we are not able to obtain regulatory
approval for any desired future indications for our products, our ability to effectively market and
sell or products may be reduced and our business may be adversely affected.
Our ability to promote the product is limited to those indications that are specifically approved
by regulatory authorities. Regulatory authorities further restrict communications by pharmaceutical
companies on the subject of off-label use. If our promotional activities fail to comply with these
regulations or guidelines, we may be subject to warnings from, or enforcement action by, these
authorities. In addition, our failure to follow rules and guidelines relating to promotion and
advertising may cause regulatory authorities to delay approval or refuse to approve a product, the
suspension or withdrawal of an approved product from the market, recalls, fines, disgorgement of
money, operating restrictions, injunctions or criminal prosecution, any of which could harm our
business.
Our approved products and pipeline products remain subject to ongoing regulatory requirements. If
we fail to comply with these requirements, we could lose these approvals, and the sales of any such
approved commercial products could be suspended.
After receipt of initial regulatory approval, each product remains subject to extensive regulatory
requirements, including requirements relating to manufacturing, labeling, packaging, adverse event
reporting, storage, advertising, promotion, distribution and recordkeeping. Furthermore, even if we
receive regulatory approval to market a particular product, such a product will remain subject to
the same extensive regulatory requirements. Even if regulatory approval of a product is granted,
the approval may be subject to limitations on the uses for which the product may be marketed or
other conditions of approval, or contain requirements for costly post-marketing testing and
surveillance to monitor product safety or efficacy, which could reduce our revenues, increase our
expenses and render the approved product not commercially viable. In addition, as clinical
experience with a drug expands after approval because it is typically used by a greater number and
more diverse group of patients after approval than during clinical trials, side effects and other
problems may be observed after approval that were not seen or anticipated during pre-approval
clinical trials or other studies.
Our approved products and pipeline products remain subject to ongoing regulatory requirements.
Following receipt of regulatory approval, any products that we market continue to be subject to
extensive regulation. These regulations affect many aspects of our operations, including the
manufacture, labeling, packaging, adverse-event reporting, storage, distribution, advertising,
promotion and record keeping related to the products. The FDA also frequently requires
post-marketing testing and surveillance to monitor the effects of approved products or place
conditions on any approvals that could restrict the commercial applications of these products. We
must also comply with the Prescription Drug Marketing Act, or PDMA, which governs the distribution
of prescription drug samples to healthcare practitioners since, as part of our commercialization
efforts, we provide physicians with samples. Among other things, the PDMA prohibits the sale,
purchase or trade of prescription drug samples. It also sets out record keeping and other
requirements for distributing samples to licensed healthcare providers. In addition, we must comply with the Medicaid Rebate Program, the Veterans Health Care Act of 1992 and the Deficit
Reduction Act of 2005. These laws governs product pricing for government reimbursement and sets
forth detailed formulas for how we must calculate and report the pricing of our products so as to
ensure that the federally funded programs will get the best price. Further, the subsequent
discovery of previously unknown problems with the product may result in restrictions on the
product, including withdrawal of the product from the market. If we fail to comply with applicable
regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory
approvals, product recalls, seizure of products, significant disbursements, operating restrictions
and criminal prosecution.
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In addition to FDA restrictions on marketing of pharmaceutical products, several other types of
state and federal laws have been applied to restrict certain marketing practices in the
pharmaceutical industry in recent years. These laws include anti-kickback statutes and false claims
statutes. The federal healthcare program anti-kickback statute prohibits, among other things,
knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in
return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any
healthcare item or service reimbursable under Medicare, Medicaid or other federally financed
healthcare programs. This statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on
the other. Violations of the anti-kickback statute are punishable by imprisonment, criminal fines,
civil monetary penalties and exclusion from participation in federal healthcare programs. Although
there are a number of statutory exemptions and regulatory safe harbors protecting certain common
activities from prosecution or other regulatory sanctions, the exemptions and safe harbors are
drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases
or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe
harbor. Our practices may not in all cases meet all of the criteria for exemption or safe harbor
protection from anti-kickback liability.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be
presented, a false claim for payment to the federal government, or knowingly making, or causing to
be made, a false statement to have a false claim paid. Several pharmaceutical and other healthcare
companies have been prosecuted under these laws for allegedly inflating drug prices they report to
pricing services, which in turn are used by the government to set Medicare and Medicaid
reimbursement rates, and for allegedly providing free products to customers with the expectation
that the customers would bill federal programs for those products. In addition, certain marketing
practices, including off-label promotion, may also violate false claims laws. The majority of
states also have statutes or regulations similar to the federal anti-kickback law and false claims
laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in
several states, apply regardless of the payor. Sanctions under these federal and state laws may
include civil monetary penalties, exclusion of a manufacturers products from reimbursement under
government programs, criminal fines and imprisonment.
Because of the breadth of these laws and the narrowness of the exemptions and safe harbors, it is
possible that some of our business activities could be subject to challenge under one or more of
such laws. Such a challenge could have a material adverse effect on our business, financial
condition and results of operations.
In addition, as part of the sales and marketing process, pharmaceutical companies frequently
provide samples of approved drugs to physicians. This practice is regulated by the FDA and other
governmental authorities, including, in particular, requirements concerning record keeping and
control procedures. Any failure to comply with the regulations may result in significant criminal
and civil penalties as well as damage to our credibility in the marketplace.
Risks Related to Our Industry
The pharmaceutical industry is highly competitive and is subject to rapid and significant
change, which could render our products obsolete or uncompetitive.
Competition in our business is intense and characterized by extensive research efforts and rapid
technological progress. Technological developments by competitors, regulatory approval for
marketing competitive products, including potential generic or over-the-counter products,
competitors superior marketing resources or other competitive factors could adversely affect the
commercial potential of our products and could have a material adverse effect on our revenue and
results of operations. We believe that there are numerous pharmaceutical and biotechnology
companies, including large well-known pharmaceutical companies, as well as academic research groups
throughout the world, engaged in research and development efforts with respect to pharmaceutical
products targeted at gastrointestinal diseases and conditions addressed by our current and
potential products. In particular, we are aware of products in research or development by
competitors that address the diseases targeted by our products. Developments by others might render
our current and potential products obsolete or noncompetitive. Competitors might be able to
complete the development and regulatory approval process sooner and, therefore, market their
products earlier than we can. They may succeed in developing products that are more effective or
less expensive to use than any that we may develop or license. These developments could render our
products obsolete or uncompetitive, which would have a material adverse effect on our business and
financial results.
Many of our competitors have greater financial resources and selling and marketing capabilities,
have greater experience in clinical testing and human clinical trials of pharmaceutical products,
and have greater experience in obtaining approvals from the FDA, the TPD, the EMA or other
applicable regulatory approvals.
Development of pharmaceutical products is expensive, time-consuming and subject to uncertainties,
and we may not realize a return on our investment in product development for a significant period
of time, if at all.
Developing pharmaceutical products is expensive, and there is typically a significant amount of
time prior to realizing a return on an investment in product development, if a return is realized
at all. To obtain regulatory approval for the sale of any product candidates, extensive clinical
trials must demonstrate that our products are safe and effective for use in humans. Clinical trial
costs are included in our research and development expenses and may take years to complete. We
cannot be sure that we or our collaboration partners will complete clinical testing within the time
we anticipate or that we or they will be able to do so without requiring significant resources or
expertise in excess of what we anticipate. Completion of clinical trials depends on various
factors, including the indication and size of the patient population and its proximity to clinical
sites, the nature of the clinical protocol, the eligibility of the criteria for trial, competition
for trial patients, availability of sufficient quantities of a product candidate, the assistance of
third parties, regulatory compliance and adequate financial resources.
Our future plans include significant investments in research and development, including clinical
trials, and related product opportunities. We believe that we must continue to dedicate a
significant amount of financial and operational resources to our research and development efforts
to grow our business and maintain our competitive position. However, we do not expect to receive
significant revenues from these investments for several years, if at all.
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Pricing pressures from, and other measures taken by, third-party payors, including managed care
organizations, government sponsored healthcare systems and regulations relating to Medicare and
Medicaid, Health Care and Education Reconciliation Act of 2010, pharmaceutical reimbursements and
pricing in general could decrease our revenues.
Our ability to successfully commercialize our products and product candidateseven if FDA, TPD or
EMA approval is obtaineddepends, in part, on whether appropriate reimbursement levels for the
cost of the products and related treatments are obtained from government authorities and private
health insurers and other organizations, such as health maintenance organizations, or HMOs,
managed-care organizations, or MCOs, and provincial formularies.
Third-party payors are increasingly challenging the pricing of pharmaceutical products. In
addition, the trend toward managed healthcare in the United States, the growth of organizations
such as HMOs and MCOs, and the recently enacted Health Care and Education Reconciliation Act of
2010, could significantly influence the purchase of pharmaceutical products, resulting in lower
prices and a reduction in product demand. One way in which MCOs and government sponsored healthcare
systems seek to control their costs is by developing formularies to encourage plan beneficiaries to
use preferred products for which the plans have negotiated favorable terms. Exclusion of a product
from a formulary, or placement of a product on a disfavored formulary tier, can lead to sharply
reduced usage in the patient population covered by the applicable MCO or government-sponsored
healthcare system. If our products are not included in an adequate number of formularies or if
adequate reimbursement levels are not provided, or if reimbursement policies increasingly favor
generic products, our market share and business could be negatively affected.
Recent reforms to Medicare added an out-patient prescription drug reimbursement for all Medicare
beneficiaries beginning in 2006. The U.S. federal government and private plans contracting with the
government to deliver the benefit, through their purchasing power under these programs, are
demanding discounts from pharmaceutical companies that may implicitly create price controls on
prescription drugs. These reforms may decrease our future revenues from product lines covered by
the Medicare drug benefit, thereby adversely affecting our results or operations and cash flows.
Uncertainty also exists regarding the reimbursement status of certain newly-approved pharmaceutical
products and reimbursement may not be available for some of our products. Any reimbursements
granted may not be maintained or limits on reimbursements available from third-party payors may
reduce the demand for, or negatively affect the price of, these products. If our products do not
qualify for reimbursement, if reimbursement levels diminish, or if reimbursement is denied, our
sales and profitability would be adversely affected.
In some countries, particularly those of the European Economic Area, the pricing of prescription
pharmaceuticals can be subject to government control, often resulting in lower pricing or
reimbursement rates than in the U.S. market. In these countries, pricing negotiations with
governmental authorities can take considerable time and delay the placing of a product on the
market. To obtain reimbursement or pricing approval in some countries, we may be required to
conduct a clinical trial that compares cost-effectiveness of our product candidate with other
available products. If reimbursement of our product is unavailable or limited in scope or amount,
or if pricing is set at unsatisfactory levels, our business could be adversely affected.
The Patient Protection and Affordable Care Act of 2010 and the Health Care and Education
Reconciliation Act of 2010, known together as the Affordable Care Act, enacted in the United States
in March 2010 contain several provisions that could impact our business.
Although many provisions of the new legislation do not take effect immediately, several provisions
became effective during fiscal year 2010. These include (1) an increase in the minimum Medicaid
rebate to States participating in the Medicaid program on our branded prescription drugs; (2) the
extension of the Medicaid rebate to Managed Care Organizations that dispense drugs to Medicaid
beneficiaries; and (3) the expansion of the 340B Public Health Service Act drug pricing program,
which provides outpatient drugs at reduced rates, to include certain childrens hospitals, free
standing cancer hospitals, critical access hospitals, and rural referral centers.
In addition, beginning in 2011, the new law requires drug manufacturers to provide a 50% discount
to Medicare beneficiaries for any covered prescription drugs purchased during a Medicare Part D
coverage gap (i.e., the donut hole). Also, beginning in 2011, new fees will be assessed on all
branded prescription drug manufacturers and importers. This fee will be calculated based upon each
organizations percentage share of total branded prescription drug sales to U.S. government
programs (such as Medicare Parts B and D, Medicaid, Department of Veterans Affairs and Department
of Defense programs and TRICARE retail pharmacy program) made during the previous year. The
aggregated industry wide fee is expected to total $28 billion through 2019, ranging from $2.5
billion to $4.1 billion annually. The IRS has issued guidance for calculating preliminary fees, but
there is still uncertainty as to final implementation, since the IRS has requested public comment
and may make changes in response. The new law also imposes a 2.3% excise tax on sales of certain
taxable medical devices that are made after December 31, 2012, including our FLUTTER mucus
clearance device. Further, effective March 31, 2013, the law requires pharmaceutical, medical
device, biological, and medical supply manufacturers to begin reporting to the federal government
the payments they make to physicians and teaching hospitals, and physician ownership interests in
those entities. The law also provides for the creation of an abbreviated regulatory pathway for FDA
approval of biosimilars and interchangeable biosimilar products. While creation of the biosimilars
program is authorized as of passage of the legislation in 2010, the process of creating the
regulatory pathway for approval of biosimilars will likely be lengthy, and the FDA is in the
process of soliciting public input.
The impact in terms of additional reserves recorded in contract rebates has been $1.8 million for
the fiscal year 2010. However, the full extent of this legislations longer-term impact on our
business remains to be seen.
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Uncertainties regarding the Affordable Care Act and third-party reimbursement may impair our
ability to continue to sell our products or form collaborations.
The continuing efforts of governmental and third-party payers to contain or reduce the costs of
healthcare through various means may harm our business. For example, in some foreign markets, the
pricing or profitability of healthcare products is subject to government control. In the United
States, there have been, and we expect there will continue to be, a number of federal and state
proposals to implement similar government control. The implementation or even the announcement of
any of these legislative or regulatory proposals or reforms could harm our business by reducing the
prices we are able to charge for our products, or impeding our ability to continue to achieve
profitability or form collaborations. In addition, the availability of reimbursement from
third-party payers determines, in large part, the demand for healthcare products in the United
States and elsewhere. Examples of such third-party payers are government and private insurance
plans. Significant uncertainty exists as to the reimbursement status of newly approved healthcare
products and third-party payers are increasingly challenging the prices charged for medical
products and services. Reimbursement from third-party payers may not be available or may not be
sufficient to allow us to continue to sell our products on a competitive or profitable basis.
Our relationships with customers and payors are subject to applicable fraud and abuse and other
healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties,
contractual damages, reputational harm, and diminished profits and future earnings.
Healthcare providers, physicians and others play a primary role in the recommendation and
prescription of our products. Our arrangements with third-party payors and customers may expose us
to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain
the business or financial arrangements and relationships through which we market, sell and
distribute our products. Applicable U.S. federal and state healthcare laws and regulations,
include, but are not limited to, the following:
| The federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. | |
| The federal False Claims Act imposes criminal and civil penalties, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. | |
| The federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services. | |
| Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industrys voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government. | |
| There are similar laws and regulations in countries outside the United States. |
Efforts to ensure that our business arrangements with third parties comply with applicable
healthcare laws and regulations could be costly. It is possible that governmental authorities will
conclude that our business practices may not comply with current or future statutes, regulations or
case law involving applicable fraud and abuse or other healthcare laws and regulations. If our
past, present or future operations, including activities conducted by our sales team or agents, are
found to be in violation of any of these laws or any other governmental regulations that may apply
to us, we may be subject to significant civil, criminal and administrative penalties, damages,
fines, exclusion from third-party payor programs, such as Medicare and Medicaid, and the
curtailment or restructuring of our operations. If any of the physicians or other providers or
entities with whom we do business are found to be not in compliance with applicable laws, they may
be subject to criminal, civil or administrative sanctions, including exclusions from government
funded healthcare programs.
Many aspects of these laws and regulations have not been definitively interpreted by the regulatory
authorities or the courts, and their provisions are open to a variety of subjective
interpretations, which increases the risk of potential violations. In addition, these laws and
regulations and their interpretations are subject to change. Any action against us for violation of
these laws or regulations, even if we successfully defend against it, could cause us to incur
significant legal expenses, divert our managements attention from the operation of our business
and damage our reputation.
Private civil litigation may be instituted against us in connection with alleged violation of the
federal or state laws and regulations discussed above, under a number of different theories. Such
litigation can result in significant expense and management distraction, as well as potential
monetary damages or equitable relief.
Changes in laws and regulations could affect our results of operations, financial position or cash
flows.
Our future operating results, financial position or cash flows could be adversely affected by
changes in laws and regulations such as (i) changes in the FDA, TPD or EMA (or their foreign
equivalents) approval processes that may cause delays in, or prevent the approval of, new products;
(ii) new laws, regulations and judicial decisions affecting product development, marketing,
promotion or the healthcare field generally; (iii) new laws or judicial decisions affecting
intellectual property rights and (iv) changes in the application of tax principles, including tax
rates, new tax laws, or revised interpretations of existing tax laws and precedents, which result
in a shift of taxable earnings between tax jurisdictions.
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We may be subject to investigations or other inquiries concerning our compliance with reporting
obligations under federal healthcare program pharmaceutical pricing requirements.
Under federal healthcare programs, some state governments and private payors investigate and have
filed civil actions against numerous pharmaceutical companies alleging that the reporting of prices
for pharmaceutical products has resulted in false and overstated average wholesale price, or AWP,
which in turn may be alleged to have improperly inflated the reimbursements paid by Medicare,
private insurers, state Medicaid programs, medical plans and others to healthcare providers who
prescribed and administered those products or pharmacies that dispensed those products. These same
payors may allege that companies do not properly report their best prices to the state under the
Medicaid program. Suppliers of outpatient pharmaceuticals to the Medicaid program are also subject
to price rebate agreements. Failure to comply with these price rebate agreements may lead to
federal or state investigations, criminal or civil liability, exclusion from federal healthcare
programs, contractual damages, and otherwise harm our reputation, business and prospects.
Future litigation and the outcome of current litigation may harm our business.
In general, and subject to the terms of each specific agreement, we have agreed to indemnify our
licensors, distributors and certain of our contract manufacturers for product liability claims and
there is a risk that we will be subject to product liability claims and claims for indemnification
under these agreements. A substantial portion of our revenues are derived and will continue to be
derived from activities in the United States, where pharmaceutical companies are exposed to a
higher risk of litigation than in other jurisdictions. For example, under the Drug Price
Competition and Patent Restoration Act of 1984, when a drug developer files an ANDA for a generic
drug, it must certify to the FDA that it believes its product will not infringe on any unexpired
patent that a patent holder has listed with the FDA as covering that brand-name product, or that
any such patent is invalid or unenforceable. The drug developer must also provide such
certification to the patent holder, who may challenge the developers certification of
non-infringement, invalidity or unenforceability by filing a suit for patent infringement. Such a
patent challenge within the first 45 days of notice of the ANDA certification can result in a
30-month stay of approval by FDA of the ANDA. Certain of our collaboration partners may have or
develop generic versions of existing or then existing drugs. Our development of any such generic
versions of drugs will be subject to this process. Should a patent holder commence a lawsuit
against us with respect to alleged patent infringement, the uncertainties inherent in patent
litigation make the outcome of such litigation difficult to predict. Litigation over patents could
result in delays in obtaining FDA approval to market our product candidates and diversion of
management resources and the costs resulting therefrom. Similar risks of the delay in obtaining
approvals in other applicable jurisdictions could result from patent related litigation.
Currently, we maintain claims-based product liability insurance coverage in respect of all our
products marketed in the United States. We cannot be certain that existing or future insurance
coverage available to us will be adequate to satisfy any or all future product liability claims and
defense costs in the United States.
Exposure relating to product liability claims may harm our business.
We face an inherent business risk of exposure to product liability and other claims in the event
that the use of our products results, or is alleged to have resulted, in adverse effects. While we
have taken, and will continue to take, what we believe are appropriate precautions, there can be no
assurance that we will avoid significant product liability claims. Although we currently carry
product liability insurance that we believe is appropriate for the risks that we face, there can be
no assurance that we have sufficient coverage, or can in the future obtain sufficient coverage at a
reasonable cost. An inability to obtain product liability insurance at an acceptable cost or to
otherwise protect against potential product liability claims could prevent or inhibit the growth of
our business or the number of products we can successfully market. Our obligation to pay
indemnities, the withdrawal of a product following complaints, or a product-liability claim could
have a material adverse effect on our business, results of operations, cash flows and financial
condition. For details regarding certain litigation matters in which we are currently involved, see
Part II Item 1. Legal Proceedings.
We deal with hazardous materials and must comply with environmental, health and safety laws and
regulations, which can be expensive, restrict how we do business and/or give rise to significant
liabilities.
We are subject to various environmental, health and safety laws and regulations, including those
governing air emissions, including greenhouse gases, water and wastewater discharges, noise
emissions, the use, management and disposal of hazardous, radioactive and biological materials and
wastes, and the cleanup of contaminated sites. The cost of compliance with these laws and
regulations could be significant. In the event of a violation of these laws and regulations,
including from accidental contamination or injury, we could be held liable for damages exceeding
our available financial resources. We could be subject to monetary fines, penalties or third-party
damage claims as a result of violations of such laws and regulations or noncompliance with
environmental permits required at our facilities. As an owner and operator of real property and a
generator of hazardous materials and wastes, we also could be subject to environmental cleanup
liability, in some cases without regard to fault or whether we were aware of the conditions giving
rise to such liability. In addition, we may be subject to liability and may be required to comply
with new or existing environmental laws regulating pharmaceuticals in the environment.
Environmental laws or regulations (or their interpretation) may become more stringent in the
future. If any such future changes to environmental laws and regulations require significant
changes in our operations, or if we engage in the development and manufacturing of new products or
otherwise expand our operations requiring new or different environmental controls, we will have to
dedicate additional management resources and incur additional expenses to comply with such laws and
regulations.
In the event of an accident, applicable authorities may curtail our use of hazardous materials and
interrupt our business operations. In addition, with respect to our manufacturing facilities, we
may incur substantial costs to comply with environmental laws and regulations and may become
subject to the risk of accidental contamination or injury from the use of hazardous materials in
our manufacturing process.
We maintain limited insurance coverage for the foregoing types of risks. In the event of
environmental discharge, contamination or accident, we may be held liable for any resulting
damages, and any liability could exceed our resources.
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If the FDA, EMA or other applicable regulatory agencies approve generic products that compete with
any of our products, sales of those products may be adversely affected.
The FDCA, FDA regulations and other applicable regulations and policies provide incentives to
manufacturers to create modified, non-infringing versions of a drug to facilitate the approval of
an ANDA or other application for generic substitutes. These manufacturers might only be required to
conduct a relatively inexpensive study to show that its product has the same active ingredient(s),
dosage form, strength, route of administration, and conditions of use, or labeling, as our product
and that the generic product is bioequivalent to ours, meaning it is absorbed in the body and to
the same extent as our product. These generic equivalents, which must meet the same quality
standards as branded pharmaceuticals, would be significantly less costly than ours to bring to
market and companies that produce generic equivalents are generally able to offer their products at
lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the
sales of a branded product is typically lost to the generic product. Accordingly, competition from
generic equivalents could materially adversely impact our revenues, profitability and cash flows
and substantially limit our ability to obtain a return on the investments we have made in those
products.
Risks Related to Intellectual Property
The four categories of products on which we have depended in the past two fiscal years for the
majority of our revenues are not covered by any issued patents.
majority of our revenues are not covered by any issued patents.
Other than limited patent protection relating to ZENPEP, we have no issued patents covering our
PEPs (ULTRASE, VIOKASE and PANZYTRAT), ursodiol products (URSO, URSO 250, URSO DS, URSO FORTE and
DELURSAN), mesalmine products (CANASA and SALOFALK) or sucralfate products (CARAFATE and SULCRATE).
These four categories of products accounted collectively for a substantial portion of our revenues
in fiscal years 2009 and 2010. While we believe that these product lines benefit from a variety of
regulatory, clinical, sourcing and manufacturing hurdles to competitive entry, our current patents
do not present any such hurdle, and there can be no assurance that any future patent that may issue
to us would provide any meaningful protection.
We rely on the intellectual property of others, and we may not be able to protect our own
intellectual property.
The continued success of our business will depend, in part, on our ability to obtain, protect and
maintain intellectual property rights and licensing arrangements for our and former Eurand
products. Some of the proprietary rights in some of our products are held by third parties, which
require us to obtain licenses for the use of such products. Despite these licenses, there can be no
guarantees that the rights or patents used by us will not be challenged by third parties.
Furthermore, an adverse outcome could lead to an infringement or other legal action being brought
against us directly, which regardless of its merit could be costly and time-consuming. Moreover,
third party licensors may breach their license agreements with us or may otherwise fail to perform
their obligations thereunder.
To protect our intellectual property, we have historically relied on patents, trademarks and trade
secrets, know-how and other proprietary information, as well as requiring our employees and
vendors, suppliers and collaboration partners to sign confidentiality agreements prohibiting them
from taking proprietary information and technology or from using or disclosing proprietary
information to third parties except in specified circumstances. However, confidentiality agreements
may be breached despite all precautions taken, and we may not have adequate remedies for any
breach. Third parties may gain access to our proprietary information or may independently develop
substantially equivalent proprietary information. Furthermore, the strength of patents and other
intellectual property rights in the pharmaceutical industry involves complex legal and scientific
questions and can be uncertain. We have filed and/or licensed patent applications related to
certain of our products (including with respect to certain co-development products and product
candidates), but such applications may fail to be granted, or, even if granted, may be challenged
or invalidated or may fail to provide us with any competitive advantages. Additionally, patent
applications in the United States and most other countries are confidential for a period of time
until they are published, and publication of discoveries in scientific or patent literature
typically lags actual discoveries by several months or more. As a result, we cannot be certain that
we were the first to conceive inventions covered by our patents and pending patent applications or
that we were the first to file patent applications for such inventions. Our inability to protect
and maintain intellectual property rights in our products may impair our competitive position and
adversely affect our sales and growth.
Litigation or third-party claims of intellectual property infringement could require substantial
time and money to resolve. Unfavorable outcomes to these proceedings could limit our intellectual
property rights and our activities.
Our commercial success depends upon our ability to develop and market products without infringing
the proprietary rights of third parties. As the pharmaceutical industry expands and more patents
are issued, the risk increases that our products or product candidates may give rise to claims of
infringement of the patent rights of others. Third-party patents (now or in the future) may cover
the materials or methods of treatment related to our products, and third parties may make
allegations of infringement, regardless of merit. Because patent applications can take many years
to issue, there may be currently pending applications which may later result in issued patents that
our products may infringe. We cannot provide any assurances that our products or activities, or
those of our licensors, will not infringe patents or other intellectual property owned by third
parties. We have been (and from time to time we may be) notified that third parties consider their
patents or other intellectual property infringed by, or otherwise relevant to, our products.
In addition, we may from time to time have access to confidential or proprietary information of
third parties that could bring a claim against us asserting that we have misappropriated their
technology (which, although not patented, may be protected by trade secrets) and that we have
improperly incorporated that technology into our products. Some of our employees have been employed
by other pharmaceutical or biotechnology companies that may allege violations of their trade
secrets by these individuals, irrespective of the steps that we may take to prevent such
violations.
If a lawsuit is commenced with respect to any alleged intellectual property infringement by us, the
uncertainties inherent in such litigation make the outcome difficult to predict, and the costs that
we may incur as a result may have an adverse effect on our profitability. Such litigation would
involve significant expense and would be a substantial diversion of the efforts of our scientific
and our management teams. During the course of any intellectual property litigation, there may be
public announcements regarding claims and defenses, and regarding the results of hearings, motions
and other interim proceedings or developments in the litigation. If securities analysts or
investors perceive these announcements as negative, the market price of the secured notes or any
other securities that we may issue from time to time may decline.
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Any such lawsuit that culminates in an adverse determination may result in the award of monetary
damages to the intellectual property holder and payment by us of any such damages, and/or an
injunction prohibiting all of our business activities that infringe the intellectual property, or
may require us to obtain licenses from third parties on terms that may not be commercially
acceptable to us, which would in each case adversely affect our profitability and our business. If
so, we may attempt to redesign our processes, products or technologies so that they do not
infringe, but that might not be possible. If we cannot obtain a necessary or desirable license, can
obtain such a license only on terms that we consider to be unattractive or unacceptable, or cannot
redesign our products or processes to avoid potential patent or other intellectual property
infringement, then we or our collaborators may be restricted or prevented from developing and
commercializing our products and our business will be harmed.
In October 2008, Eurand and Cephalon received Paragraph IV certification letters relating to ANDAs
submitted to the FDA by Mylan Pharmaceuticals, Inc. (Mylan) and Barr Laboratories, Inc. (Barr),
each requesting approval to market and sell a generic version of the 15 mg and 30 mg strengths of
AMRIX. In November 2008, Eurand received a similar certification letter from Impax Laboratories,
Inc. (Impax). In May 2009, Eurand received a similar certification letter from Anchen
Pharmaceuticals, Inc. (Anchen) Mylan, Impax, and Anchen alleged that U.S. Patent Number 7,387,793
(the 793 Patent), entitled Modified Release Dosage Forms of Skeletal Muscle Relaxants, issued
to Eurand, will not be infringed by the manufacture, use or sale of the product described in the
applicable ANDA and reserved the right to challenge the validity and/or enforceability of the 793
Patent. Barr alleged that the 793 Patent is invalid, unenforceable and/or will not be infringed by
its manufacture, use or sale of the product described in its ANDA. In late November 2008, Eurand
filed a lawsuit with Cephalon, in the U.S. District Court in Delaware against Mylan (and its
parent) and Barr (and its parent) for infringement of the 793 Patent. In January 2009, Eurand
filed a lawsuit with Cephalon in the U.S. District Court in Delaware against Impax for infringement
of the 793 Patent. In July 2009, Eurand filed a lawsuit with Cephalon in the U.S. District Court
in Delaware against Anchen (and its parent) for infringement of the 793 Patent. Subsequently, in
response to additional Paragraph IV certification letters regarding U.S. Patent Number 7,544,372,
(the 372 Patent) entitled Modified Release Dosage Forms of Skeletal Muscle Relaxants Eurand
and Cephalon also filed lawsuits against Mylan, Barr, and Anchen for the infringement of the 372
Patent. All cases were consolidated in one action in the U.S. District Court in Delaware, and were
tried in a bench trial in September-October, 2010. A decision is expected in April 2011. Under the
provisions of the Hatch-Waxman Act, the filing of these lawsuits stays FDA approval of each ANDA
until the earlier of a district court judgment in favor of the ANDA holder or 30 months from the
date of the plaintiffs receipt of the respective Paragraph IV certification letter.
On October 7, 2010, both Eurand and Anesta AG (Anesta), an indirect wholly owned subsidiary of
Cephalon, reached an agreement to settle the pending patent infringement litigation over AMRIX with
Impax. Under terms of the settlement, both Eurand and Anesta will grant to Impax a non-exclusive,
royalty-bearing license to market and sell a generic version of AMRIX in the United States
beginning one year prior to expiration of the 793 Patent, which is expected to expire in February
2025, or earlier under certain circumstances. The settlement does not affect the status of the
patent litigation with the other defendants set forth above. Cephalon is bearing the bulk of the
expenses associated with the litigation. We intend to continue to work with Cephalon and Anesta to
defend the AMRIX intellectual property rights, but there can be no assurance that these efforts
will be successful.
Based on information available to us, GSK received a Paragraph IV certification letter from a
generic drug manufacturer regarding an ANDA for a generic version of LAMICTAL ODT and claiming that
the U.S. Patent No. 7,815,937 (the 937 Patent) does not bar such a generic. The 937 Patent is
not owned by us and we believe that the patent does not cover the LAMICTAL product developed by us.
We are not involved with any patent infringement lawsuit regarding GSKs LAMICTAL ODT product and
do not have any opinion on the validity or strength of the 937 Patent. However, if a generic
version of LAMICTAL ODT is approved, it could have a material adverse effect on the revenue we
derive from GSK based on the LAMICTAL product.
Our intellectual property rights might not afford us with meaningful protection.
The intellectual property rights protecting our products might not afford us with meaningful
protection from generic and other competition. The laws of certain foreign countries do not protect
intellectual property rights to the same extent as the United States, which may render our
protection and enforcement of such rights difficult or impossible in such foreign jurisdictions. In
addition, because our strategy is to in-license or acquire pharmaceutical products that typically
have been discovered and initially researched by others, future products might have limited or no
remaining patent protection due to the time elapsed since their discovery. Competitors could also
design around any of our intellectual property or otherwise design competitive products that do not
infringe our intellectual property.
We also rely on trade secrets, proprietary know-how and technological advances, which we seek to
protect, in part, through confidentiality agreements with collaborative partners, employees and
consultants. These agreements might be breached and we might not have adequate remedies for any
such breach. In addition, our trade secrets and proprietary know-how might otherwise become known
or be independently developed by others. Any litigation that we become involved in to enforce
intellectual property rights could result in substantial cost to us. In addition, claims by others
that we infringe their intellectual property rights could be costly. Our patent or other
proprietary rights related to our products might conflict with the current or future intellectual
property rights of others. Litigation or patent interference proceedings, either of which could
result in substantial cost to us, might be necessary to defend any patents to which we have rights
and our other proprietary rights or to determine the scope and validity of other parties
proprietary rights. Furthermore, because of the substantial amount of discovery required in
connection with intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during any such litigation. The defense of patent
and intellectual property claims is both costly and time consuming, even if the outcome is
favorable. Any adverse outcome could subject us to significant liabilities to third parties, result
in the narrowing of our intellectual property rights (including a ruling that a patent of ours is
not valid or is unenforceable), require disputed rights to be licensed from third parties, or
require us to cease selling one or more of our products. We might not be able to obtain a license
to any third-party technology that we require to conduct our business, or, if obtainable, that
technology might not be available at a reasonable cost.
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Risks Related to General Economic and Financial Conditions
We are exposed to political, economic, regulatory and other risks that arise from operating a
multinational business.
multinational business.
We have operations in several different countries. For the fiscal years ended September 30, 2008,
2009 and 2010, approximately 27.0%, 24.5% and 27.9% of our revenues, respectively, were derived
from sources outside the United States. We expect our foreign operations to constitute a greater
percentage of our total in the future as we integrate the former Eurand business into our
operations. We are therefore exposed to risks inherent in international operations. These risks
include, but are not limited to
| changes in general economic, social and political conditions; | ||
| adverse tax consequences; | ||
| the difficulty of enforcing agreements and collecting receivables through certain legal systems; | ||
| inadequate protection of intellectual property; | ||
| required compliance with a variety of laws and regulations of jurisdictions outside of the United States, including labor and tax laws; | ||
| customers outside of the United States may have longer payment cycles; | ||
| changes in laws and regulations of jurisdictions outside of the United States; and | ||
| terrorist acts and natural disasters. |
In addition, we face several risks relating to compliance with international and U.S. laws and
regulations that apply to our international operations. These laws and regulations include data
privacy requirements, labor relations laws, tax laws, anti-competition regulations, import and
trade restrictions, export requirements, U.S. laws such as the Foreign Corrupt Practices Act, and
local laws which also prohibit corrupt payments to governmental officials or certain payments or
remunerations to customers. Given the high level of complexity of these laws and regulations,
however, there is a risk that some provisions may be inadvertently breached, for example through
fraudulent or negligent behavior of individual employees or our partners, our failure to comply
with certain formal documentation requirements or otherwise. Violations of these laws and
regulations could result in fines, criminal sanctions against us, our officers, our partners or our
employees, and prohibitions on the conduct of our business. Any such violations could include
prohibitions on our ability to offer our products in one or more countries and could materially
damage our reputation, our brand, our international expansion efforts, our ability to attract and
retain employees, our business and our operating results. Our success depends, in part, on our
ability to anticipate these risks and manage these difficulties.
Our business success depends in part on our ability to anticipate and effectively manage these and
other regulatory, economic, social and political risks inherent in multinational business. We
cannot provide assurances that we will be able to effectively manage these risks or that they will
not have a material adverse effect on our multinational business or on our business as a whole.
Currency exchange rate fluctuations may have a negative effect on our financial condition.
We operate internationally, but a majority of our revenue and expense activities, including our
debt service obligations, and capital expenditures are denominated in U.S. dollars. The other
currencies in which we engage in significant transactions are Canadian dollars and Euros. As a
consequence, we are exposed to currency fluctuations from purchases of goods, services and
equipment and investments in other countries, and funding denominated in the currencies of other
countries. In particular, we are exposed to the fluctuations in the exchange rate between the U.S.
dollar, the euro and the Canadian dollar. During fiscal year 2010, approximately 17.8% of Axcans
revenues was denominated in Euros, 9.0% of Axcans revenue was denominated in Canadian dollars,
while the remainder was denominated in U.S. dollars. We expect that our exposure to foreign
currency fluctuations, particularly with respect to the euro, will increase following the
acquisition of Eurand.
Fluctuations in currency exchange rates may affect the results of our operations and the value of
our assets and revenues, and increase our liabilities and costs, which in turn may adversely affect
reported earnings and the comparability of period-to-period results of operations. For example, in
fiscal year 2010, we experienced a positive foreign exchange effect on revenues of approximately
0.8%. Changes in currency exchange rates may affect the relative prices at which we and our
competitors sell products in the same market. Changes in the value of the relevant currencies also
may affect the cost of goods, services and equipment required in our operations.
In addition, due to the constantly changing currency exposures and the potential substantial
volatility of currency exchange rates, we cannot predict the effect of exchange rate fluctuations
on our future results and, because we do not currently hedge fully against all currency risks and
fluctuations between the U.S. dollar and the euro, such fluctuations may result in currency
exchange rate losses. Fluctuations in exchange rates could result in our realizing a lower profit
margin on sales of our product candidates than we anticipate at the time of entering into
commercial agreements. Adverse movements in exchange rates could have a material adverse effect on
our financial condition and results of operations.
For Axcan on a stand-alone basis, a 1% change in the value of foreign currencies as compared to the
U.S. dollar would have increased or decreased the translation of foreign sales by $0.9 million and
income by $0.1 million in fiscal year 2010.
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We might be impacted by unfavorable decisions in proceedings related to future tax assessments.
We operate in a number of jurisdictions and are from time to time subject to audits and reviews by
various taxation authorities with respect to income, consumption, payroll and other taxes and
remittances, for current as well as past periods. Accordingly, we may become subject to future tax
assessments by various authorities. Any amount we might be required to pay in connection with a
future tax assessment may have a material adverse effect on our financial position, cash flows or
overall results of operations. There is a possibility of a material adverse effect on the results
of operations of the period in which the matter is ultimately resolved, if it is resolved
unfavorably, or in the period in which an unfavorable outcome becomes probable and reasonably
estimable.
We are currently unable to accurately predict what our short-term and long-term effective tax rates
will be in the future.
We are subject to taxes in the United States and the various other jurisdictions in which we
operate. Significant judgment is required in determining our worldwide provision for taxes and, in
the ordinary course of business, there are many transactions and calculations where the ultimate
tax determination is uncertain. Our effective tax rates could be adversely affected by changes in
the mix of earnings (losses) in countries with differing statutory tax rates, changes in the
valuation of deferred tax assets and liabilities or changes in tax laws, as well as other factors.
Our judgments may be subject to audits or reviews by local tax authorities in each of these
jurisdictions, which could adversely affect our tax provisions.
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Item 6. | Exhibits. |
Exhibit No. | Exhibit | |
31.1
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AXCAN INTERMEDIATE HOLDINGS INC. |
||||
Date: February 14, 2011 | BY: | /s/ Steve Gannon | ||
Steve Gannon | ||||
Senior Vice President, Finance, Chief Financial Officer and Treasurer |
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EXHIBIT INDEX
Exhibit No. | Exhibit | |
31.1
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
32.2
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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