Attached files
file | filename |
---|---|
EX-3.1 - EX-3.1 - Aptalis Pharma Inc | m70832exv3w1.htm |
EX-31.2 - EX-31.2 - Aptalis Pharma Inc | m70832exv31w2.htm |
EX-32.2 - EX-32.2 - Aptalis Pharma Inc | m70832exv32w2.htm |
EX-31.1 - EX-31.1 - Aptalis Pharma Inc | m70832exv31w1.htm |
EX-32.1 - EX-32.1 - Aptalis Pharma Inc | m70832exv32w1.htm |
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
o | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the quarterly period ended March 31, 2011
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
APTALIS PHARMA 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)
AXCAN INTERMEDIATE HOLDINGS INC.
(Registrants Former Name)
(Registrants Former Name)
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 o 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 o
(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 o
As of May 13, 2011, there were 100 shares of common stock of the registrant outstanding, all of
which were owned by Aptalis MidHoldings Inc.
APTALIS PHARMA INC.
INDEX
INDEX
Page 2
Table of Contents
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.
Page 3
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1 | Financial Statements |
APTALIS PHARMA INC.
Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars, except share related data)
Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars, except share related data)
March 31, | September 30, | |||||||
2011 | 2010 | |||||||
(unaudited) | (audited) | |||||||
$ | $ | |||||||
Assets |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
87,330 | 161,503 | ||||||
Accounts receivable, net |
75,717 | 32,379 | ||||||
Accounts receivable from the parent company (Note 18) |
526 | 487 | ||||||
Income taxes receivable |
3,672 | 2,906 | ||||||
Inventories, net (Note 7) |
63,450 | 23,866 | ||||||
Prepaid expenses and deposits |
5,620 | 3,277 | ||||||
Deferred income taxes, net (Note 13) |
6,107 | 2,331 | ||||||
Total current assets |
242,422 | 226,749 | ||||||
Property, plant and equipment, net (Note 8) |
90,268 | 35,777 | ||||||
Intangible assets, net (Note 9) |
731,013 | 347,962 | ||||||
Goodwill, net (Note 9) |
181,718 | 73,540 | ||||||
Deferred debt issue expenses, net of accumulated
amortization of $5,236 ($14,136 as at September 30,
2010) (Note 11) |
32,236 | 20,443 | ||||||
Deferred income taxes, net (Note 13) |
14,406 | 8,706 | ||||||
Total assets |
1,292,063 | 713,177 | ||||||
Liabilities |
||||||||
Current liabilities |
||||||||
Accounts payable and accrued liabilities |
131,762 | 94,673 | ||||||
Income taxes payable (Note 13) |
3,275 | 3,446 | ||||||
Installments on long-term debt (Note 11) |
8,918 | 13,163 | ||||||
Deferred income taxes (Note 13) |
620 | 47 | ||||||
Total current liabilities |
144,575 | 111,329 | ||||||
Long-term debt (Note 11) |
972,170 | 581,312 | ||||||
Other long-term liabilities |
11,252 | 10,028 | ||||||
Employees severance indemnities (Note 12) |
5,080 | | ||||||
Deferred income taxes (Note 13) |
95,501 | 31,540 | ||||||
Total liabilities |
1,228,578 | 734,209 | ||||||
Shareholders Equity (Deficiency) |
||||||||
Capital Stock (Note 14) |
||||||||
Common shares, par value $0.001; 100 shares
authorized: 100 issued and outstanding as at March 31,
2011, and September 30, 2010 |
1 | 1 | ||||||
Deficit |
(538,400 | ) | (468,152 | ) | ||||
9.05% Note receivable from the parent company (Note 18) |
(133,154 | ) | (133,154 | ) | ||||
Additional paid-in capital |
757,689 | 614,113 | ||||||
Accumulated other comprehensive loss |
(22,651 | ) | (33,840 | ) | ||||
Total shareholders equity (deficiency) |
63,485 | (21,032 | ) | |||||
Total liabilities and shareholders equity (deficiency) |
1,292,063 | 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.
On behalf of the Board,
Director | Director |
Page 4
Table of Contents
APTALIS PHARMA INC.
Condensed Consolidated Statements of Operations
(in thousands of U.S. dollars)
(unaudited)
Condensed Consolidated Statements of Operations
(in thousands of U.S. dollars)
(unaudited)
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Net product sales |
109,774 | 94,365 | 195,712 | 204,497 | ||||||||||||
Development fees |
599 | | 599 | | ||||||||||||
Royalties |
987 | | 987 | | ||||||||||||
Total revenue |
111,360 | 94,365 | 197,298 | 204,497 | ||||||||||||
Cost of goods sold (a) |
31,853 | 68,150 | 49,276 | 94,778 | ||||||||||||
Selling and administrative expenses (a) (Note 12) |
39,044 | 28,406 | 64,215 | 60,645 | ||||||||||||
Management fees (Note 18) |
730 | 1,000 | 1,568 | 1,855 | ||||||||||||
Research and development expenses (a) |
10,983 | 7,683 | 17,938 | 16,109 | ||||||||||||
Other research and development expenses attributable to
development fees (a) |
855 | | 855 | | ||||||||||||
Depreciation and amortization |
18,453 | 13,999 | 32,026 | 30,692 | ||||||||||||
Loss on disposal of product line (Note 6) |
7,365 | | 7,365 | | ||||||||||||
Transaction, restructuring and integration
costs (Notes 4 and 5) |
19,249 | | 22,297 | | ||||||||||||
Impairment of intangible assets and goodwill (Note 9) |
| 107,158 | | 107,158 | ||||||||||||
Total operating expenses |
128,532 | 226,396 | 195,540 | 311,237 | ||||||||||||
Operating income (loss) |
(17,172 | ) | (132,031 | ) | 1,758 | (106,740 | ) | |||||||||
Financial expenses (Note 12) |
30,145 | 16,385 | 46,374 | 32,582 | ||||||||||||
Loss on extinguishment of debt (Note 11) |
28,311 | | 28,311 | | ||||||||||||
Interest income |
(123 | ) | (159 | ) | (315 | ) | (307 | ) | ||||||||
Other income |
| (7,700 | ) | | (7,700 | ) | ||||||||||
Loss on foreign currencies |
633 | 1,408 | 876 | 1,393 | ||||||||||||
Total other expenses |
58,966 | 9,934 | 75,246 | 25,968 | ||||||||||||
Loss before income taxes |
(76,138 | ) | (141,965 | ) | (73,488 | ) | (132,708 | ) | ||||||||
Income taxes expense (benefit) (Note 13) |
(4,469 | ) | 21,795 | (3,265 | ) | 21,606 | ||||||||||
Net loss |
(71,669 | ) | (163,760 | ) | (70,223 | ) | (154,314 | ) | ||||||||
(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.
Page 5
Table of Contents
APTALIS PHARMA INC.
Condensed Consolidated Shareholders Equity (Deficiency) and Comprehensive Income (Loss)
(in thousands of U.S. dollars, except share related data)
(unaudited)
Condensed Consolidated Shareholders Equity (Deficiency) and Comprehensive Income (Loss)
(in thousands of U.S. dollars, except share related data)
(unaudited)
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Common shares (number) |
||||||||||||||||
Balance, beginning and end of period |
100 | 100 | 100 | 100 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Common shares |
||||||||||||||||
Balance, beginning and end of period |
1 | 1 | 1 | 1 | ||||||||||||
Deficit |
||||||||||||||||
Balance, beginning of period |
(466,706 | ) | (288,340 | ) | (468,152 | ) | (297,658 | ) | ||||||||
Dividends paid |
(25 | ) | | (25 | ) | (128 | ) | |||||||||
Net loss |
(71,669 | ) | (163,760 | ) | (70,223 | ) | (154,314 | ) | ||||||||
Balance, end of period |
(538,400 | ) | (452,100 | ) | (538,400 | ) | (452,100 | ) | ||||||||
Additional paid-in capital |
||||||||||||||||
Balance, beginning of period |
613,492 | 619,195 | 614,113 | 619,053 | ||||||||||||
Capital contribution |
140,000 | | 140,000 | | ||||||||||||
Stock-based compensation expense (recovery) |
5,272 | (2,367 | ) | 5,763 | (891 | ) | ||||||||||
Stock-based compensation plan redemptions |
(35 | ) | (57 | ) | (84 | ) | (328 | ) | ||||||||
Provision on interest receivable from the parent company |
(2,971 | ) | (2,971 | ) | (6,008 | ) | (6,008 | ) | ||||||||
Interest income from the parent company, net of taxes of
($1,040, $1,040 $2,103, $2,103) |
1,931 | 1,931 | 3,905 | 3,905 | ||||||||||||
Balance, end of period |
757,689 | 615,731 | 757,689 | 615,731 | ||||||||||||
9.05% Note receivable from the parent company |
||||||||||||||||
Balance, beginning and end of period |
(133,154 | ) | (133,154 | ) | (133,154 | ) | (133,154 | ) | ||||||||
Accumulated other comprehensive loss |
||||||||||||||||
Balance, beginning of period |
(35,869 | ) | (27,308 | ) | (33,840 | ) | (24,478 | ) | ||||||||
Hedging contracts fair value adjustments, net of taxes of
(nil, ($38), nil, $4) |
| 71 | | (7 | ) | |||||||||||
Foreign currency translation adjustments |
13,218 | (7,371 | ) | 11,189 | (10,123 | ) | ||||||||||
Balance, end of period |
(22,651 | ) | (34,608 | ) | (22,651 | ) | (34,608 | ) | ||||||||
Total shareholders equity (deficiency) |
63,485 | (4,130 | ) | 63,485 | (4,130 | ) | ||||||||||
Comprehensive income (loss) |
||||||||||||||||
Other comprehensive income (loss) |
13,218 | (7,300 | ) | 11,189 | (10,130 | ) | ||||||||||
Net loss |
(71,669 | ) | (163,760 | ) | (70,223 | ) | (154,314 | ) | ||||||||
Total comprehensive loss |
(58,451 | ) | (171,060 | ) | (59,034 | ) | (164,444 | ) | ||||||||
Accumulated other comprehensive loss |
||||||||||||||||
Amounts related to foreign currency translation adjustments |
(22,651 | ) | (34,608 | ) | (22,651 | ) | (34,608 | ) | ||||||||
Amounts related to hedging contracts fair value adjustments |
| | | | ||||||||||||
Accumulated other comprehensive loss |
(22,651 | ) | (34,608 | ) | (22,651 | ) | (34,608 | ) | ||||||||
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.
Page 6
Table of Contents
APTALIS PHARMA INC.
Condensed Consolidated Cash Flows
(in thousands of U.S. dollars)
(unaudited)
Condensed Consolidated Cash Flows
(in thousands of U.S. dollars)
(unaudited)
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Cash flows from operating activities |
||||||||||||||||
Net loss |
(71,669 | ) | (163,760 | ) | (70,223 | ) | (154,314 | ) | ||||||||
Adjustments to reconcile net income to cash flows from
operating activities |
||||||||||||||||
Non-cash financial expenses |
15,281 | 1,746 | 17,035 | 3,508 | ||||||||||||
Inventory stepped-up value expensed |
4,382 | | 4,382 | | ||||||||||||
Depreciation and amortization |
18,453 | 13,999 | 32,026 | 30,692 | ||||||||||||
Stock-based compensation expense (recovery) |
5,272 | (2,367 | ) | 5,763 | (891 | ) | ||||||||||
Loss on disposal of product line and write-down of assets |
7,365 | 56 | 7,395 | 81 | ||||||||||||
Impairment of intangible assets and goodwill (Note 9) |
| 107,158 | | 107,158 | ||||||||||||
Non-cash loss (gain) on foreign exchange |
(733 | ) | 522 | (694 | ) | 43 | ||||||||||
Change in fair value of derivatives |
| (105 | ) | | (621 | ) | ||||||||||
Deferred income taxes |
(5,633 | ) | 20,436 | (7,234 | ) | 19,066 | ||||||||||
Other non-cash adjustments related to unapproved PEPs
(Note 2) |
(3,706 | ) | 53,407 | (3,706 | ) | 53,407 | ||||||||||
Changes in working capital items |
||||||||||||||||
Accounts receivable |
(3,508 | ) | 17,661 | (16,116 | ) | 2,760 | ||||||||||
Accounts receivable from the parent company |
(1 | ) | (74 | ) | (39 | ) | (74 | ) | ||||||||
Income taxes receivable |
3,824 | (63 | ) | 1,887 | 1,671 | |||||||||||
Inventories |
2,978 | (3,065 | ) | 4,105 | (7,933 | ) | ||||||||||
Prepaid expenses and deposits |
1,011 | 466 | 1,579 | 202 | ||||||||||||
Accounts payable and accrued liabilities |
(14,595 | ) | (15,822 | ) | (16,509 | ) | 4,292 | |||||||||
Income taxes payable |
(3,639 | ) | 910 | (873 | ) | 572 | ||||||||||
Net cash provided by (used in) operating activities |
(44,918 | ) | 31,105 | (41,222 | ) | 59,619 | ||||||||||
Cash flows from investing activities |
||||||||||||||||
Acquisition, net of cash acquired (Note 4) |
(525,667 | ) | | (525,667 | ) | | ||||||||||
Disposal of intangible assets |
500 | | 500 | | ||||||||||||
Acquisition of property, plant and equipment |
(2,371 | ) | (2,333 | ) | (3,506 | ) | (3,462 | ) | ||||||||
Net cash used in investing activities |
(527,538 | ) | (2,333 | ) | (528,673 | ) | (3,462 | ) | ||||||||
Cash flows from financing activities |
||||||||||||||||
Issuance of long-term debt |
746,250 | | 746,250 | | ||||||||||||
Repayment of long-term debt |
(355,887 | ) | | (369,050 | ) | (20,865 | ) | |||||||||
Deferred debt issue expenses |
(22,963 | ) | | (22,963 | ) | | ||||||||||
Stock-based compensation plan redemptions |
(35 | ) | (57 | ) | (84 | ) | (328 | ) | ||||||||
Capital contribution |
140,000 | | 140,000 | | ||||||||||||
Dividends paid |
(25 | ) | | (25 | ) | (128 | ) | |||||||||
Net cash provided by (used in) financing activities |
507,340 | (57 | ) | 494,128 | (21,321 | ) | ||||||||||
Foreign exchange loss (gain) on cash held in foreign
currencies |
1,710 | (692 | ) | 1,594 | (857 | ) | ||||||||||
Net increase (decrease) in cash and cash equivalents |
(63,406 | ) | 28,023 | (74,173 | ) | 33,979 | ||||||||||
Cash and cash equivalents, beginning of period |
150,736 | 132,391 | 161,503 | 126,435 | ||||||||||||
Cash and cash equivalents, end of period |
87,330 | 160,414 | 87,330 | 160,414 | ||||||||||||
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.
Page 7
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
1. Governing Statutes, Description of Business and Basis of Presentation
On May 4, 2011, Axcan Intermediate Holdings Inc announced that it has changed its name to Aptalis
Pharma 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 provides innovative,
effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal
disorders. The Company has manufacturing and commercial operations in the United States, the
European Union and Canada. The Company also formulates and clinically develops, enhanced
pharmaceutical and biopharmaceutical products for itself and others using its proprietary
technology platforms including bioavailability enhancement of poorly soluble drugs, custom release
profiles, and taste-masking/orally disintegration tablet (ODT) formulations.
On February 11, 2011, the Company completed the acquisition of Eurand N.V. (Eurand) through a
wholly owned indirect subsidiary pursuant to a Share Purchase Agreement dated November 30, 2010 (as
amended) resulting in Eurand becoming an indirect subsidiary of the Company. Eurand is a specialty
pharmaceutical company that is engaged in the development, manufacturing and commercialization of
enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical
technologies.
As described in Note 4, the Eurand transaction has been accounted for in accordance with the
acquisition method of accounting for business combinations. Accordingly, the Companys condensed
consolidated financial statements reflect the assets, liabilities and results of operations of
Eurand from the date of acquisition.
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 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.
Page 8
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
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 were
still 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.
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 March 31, 2011, the remaining reserve was
$5,293,000 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 did not have a material impact on the Companys
condensed consolidated financial statements.
Page 9
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
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.
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. Acquisition of Eurand N.V. (Eurand)
Description of the transaction
On February 11, 2011 or 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 $589,555,000
for 100% of such shares. The Company acquired 100% of the outstanding shares of Eurand by March 31,
2011. 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, and transferred the capital stock of former Eurand U.S. subsidiaries
to the Company.
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 had 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 acquisition of Eurand will enable the
Company to leverage the combination of two leading specialty pharmaceutical players, expand its
gastroenterology product portfolio and provide the Company with a proprietary R&D growth engine and
technology platforms supported by an extensive patent portfolio to meaningfully diversify its
business and expand its geographic and manufacturing footprint.
Page 10
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(unaudited)
Fair value of consideration transferred
The table below details the consideration transferred to acquire Eurand:
Conversion | Form of | |||||||||||
Calculation | Fair Value | Consideration | ||||||||||
$ | ||||||||||||
Eurand common stock outstanding as of acquisition date |
48,359,433 | 580,313 | Cash | |||||||||
Mutiplied by cash consideration per common share outstanding |
12.00 | |||||||||||
Eurand stock options canceled for a cash payment(a) |
9,242 | Cash | ||||||||||
Total fair value of consideration transferred |
589,555 | |||||||||||
(a) | Each Eurand stock option, whether or not vested and exercisable on the acquisition date, was canceled for a cash payment equal to the excess of the per share value of the acquisition consideration over the per share exercise price of the Eurand stock option. |
The aggregate equity purchase price of $589,555,000 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 made through Aptalis Holdings Inc., 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 the Company 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 $147,000,000
(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
Senior Secured Revolving Credit Facility is comprised of $115,000,000 of existing revolving credit
commitments that were extended or issued on February 11, 2011, (the Extended Commitments ) and
$32,000,000 of existing revolving credit commitments that were not extended (the Unextended
Commitments) pursuant to the Senior Secured Revolving Credit Facility.
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 the Company 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. The remaining amount of $250,000,000 of the
Senior Secured Term Loan Facility was used on March 15, 2011 to redeem 100% of the Companys
existing 9.25% senior secured notes due 2015.
Basis of presentation
The transaction has been 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.
Assets acquired and liabilities assumed
A preliminary purchase price allocation has been made and the recorded amounts are subject to
change. The following recognized amounts are provisional and subject to change:
| Amounts and useful lives for identifiable intangible assets and property, plant and equipment, pending the finalization of valuation efforts; |
| Amounts for income tax assets and liabilities, pending finalization of estimates and assumptions in respect of certain tax aspects of the transaction, revision to fair value of acquired assets and liabilities, and the filing of Eurands pre-acquisition tax returns; and |
| The allocation of goodwill among reporting units. |
The Company will finalize the purchase price allocation as it obtains the information necessary to
complete the measurement process. Any changes resulting from facts and circumstances that existed
as of the acquisition date may result in retrospective adjustments to the provisional amounts
recognized at the acquisition date. The Company expects to finalize the purchase price allocation
no later than one year from the acquisition date.
Page 11
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements
(unaudited)
Resulting from the preliminary purchase price allocation, the following table summarizes the
estimated fair values of the assets acquired and liabilities assumed as of the acquisition date.
Amounts | ||||||||||||
Step-up to | recognized as of | |||||||||||
Book value | fair value | acquisition date | ||||||||||
$ | $ | $ | ||||||||||
Cash and cash equivalents |
63,888 | | 63,888 | |||||||||
Accounts receivable (a) |
22,662 | | 22,662 | |||||||||
Inventories (b) |
25,465 | 18,727 | 44,192 | |||||||||
Other current assets (c) |
6,552 | | 6,552 | |||||||||
Property, plant and equipment (d) |
44,652 | 10,874 | 55,526 | |||||||||
Identifiable intangible assets (d) |
7,053 | 406,876 | 413,929 | |||||||||
Current liabilities (e) |
(51,960 | ) | | (51,960 | ) | |||||||
Long-term debt, including current portion |
(3,394 | ) | | (3,394 | ) | |||||||
Deferred income taxes liabilities, net (f) |
(237 | ) | (61,012 | ) | (61,249 | ) | ||||||
Other non-current liabilities |
(8,489 | ) | 2,278 | (6,211 | ) | |||||||
Total identifiable net asssets |
106,192 | 377,743 | 483,935 | |||||||||
Goodwill (g) |
37,540 | 68,977 | 106,517 | |||||||||
Net assets acquired |
143,732 | 446,720 | 590,452 | |||||||||
Effective settlement of pre-existing relationships (h) |
(897 | ) | | (897 | ) | |||||||
Total fair value of consideration transferred |
589,555 | |||||||||||
(a) | As of acquisition date, the fair value of accounts receivable acquired approximated book value. The gross contractual amount receivable was $23,118,000 of which $456,000 was not expected to be collected. | |
(b) | Reflects the adjustment to step-up the carrying value of inventory acquired by $18,727,000 to estimated fair value as of February 11, 2011. The stepped-up value is recorded as a charge to cost of goods sold as acquired inventory is sold. | |
(c) | Includes prepaid assets and income tax receivable. | |
(d) | The amounts recorded for the major components of acquired identifiable intangible assets are as follows: |
Amounts | Weighted | |||||||
recognized as of | average useful | |||||||
acquisition date | lives (years) | |||||||
$ | ||||||||
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life |
413,929 | 17.04 | ||||||
Total identifiable intangible assets |
413,929 | 17.04 | ||||||
In addition, the estimated aggregate amortization expense for the five succeeding years will be $25,599,000 annually. | ||
(e) | Includes accounts payable, accrued liabilities and income taxes payable. | |
(f) | Comprises of current deferred tax assets $823,000, non current deferred tax assets $15,703,000, current deferred tax liabilities $3,000 and non current deferred tax liabilities $77,772,000. | |
(g) | The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is largely attributable to synergies expected to result from combining the operations of Eurand and the Company and intangible assets that do not qualify for separate recognition. The Company does not expect any portion of this goodwill to be deductible for tax purposes. The allocation of goodwill among reporting units is not complete, pending finalization of the Companys internal reporting structure and composition of its post-acquisition operating segments and reporting units. | |
(h) | The Company had entered into an exclusive development license and supply agreement with Eurand. No gain or loss was recognized in conjunction with the effective settlement of the contractual relationship between the Company and Eurand as a result of this acquisition. |
Page 12
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(unaudited)
Transaction related costs
During the six-month period ended March 31, 2011, the Company has expensed $11,292,000 (an
additional $1,070,000 was expensed in the fiscal year ended September 30, 2010) of costs relating
to legal, financial, valuation and accounting advisory services performed in connection with
effecting the transaction with Eurand, which are included in transaction and restructuring costs in
the accompanying Statement of Condensed Interim Consolidated Operations.
Actual and proforma information
The revenues derived from the Eurand entities for the period from the Acquisition Date to March 31,
2011 were $25,752,000 and loss before income taxes was $670,000, excluding the effects of the
non-recurring acquisition accounting adjustments described above.
The following table presents unaudited pro forma consolidated results of operations as if the
acquisition of Eurand had occurred as of October 1, 2009:
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Total revenue |
131,530 | 123,478 | 261,397 | 261,358 | ||||||||||||
Loss before income taxes |
(27,059 | ) | (108,865 | ) | (27,459 | ) | (117,070 | ) | ||||||||
Net loss |
(24,914 | ) | (130,002 | ) | (26,433 | ) | (134,781 | ) | ||||||||
The pro forma consolidated results of operations were prepared using the acquisition method of
accounting and are based on the historical financial information of the Company and Eurand. The pro
forma information does not reflect any synergies and other benefits that the Company may achieve as
a result of the acquisition, or the costs necessary to achieve these synergies. In addition, the
pro forma information does not reflect the costs to integrate the operations of the Company and
Eurand.
The pro forma information is not necessarily indicative of what the Companys consolidated results
of operations actually would have been had the transaction been completed on October 1, 2009. In
addition, the pro forma information does not purport to project the future results of operations of
the Company. The pro forma information reflects primarily the following pro forma adjustments:
| elimination of product sales and royalties between Eurand and the Company, an elimination of the Companys cost of sales for Eurand-sourced inventories, and the elimination of certain PEP-related charges stemming from intercompany transactions; | |
| elimination of Eurands historical intangible asset amortization expense; | |
| additional amortization expense related to the fair value of identifiable intangible assets acquired; | |
| additional depreciation expense related to the fair value adjustment to property, plant and equipment acquired; | |
| elimination of interest expense and amortization of deferred financing costs related to the Companys term loan under the legacy senior secured credit facilities and 9.25% senior secured notes due 2015 that were repaid as part of the acquisition transaction; | |
| additional interest expense and amortization of deferred financing costs associated with financing obtained under the Amended and Restated Senior Secured Credit Facilities obtained by the Company in connection with the acquisition transaction; | |
| reduction of interest income associated with cash and cash equivalents that were used to partially fund the acquisition; | |
| elimination of acquisition-related costs and acquisition-related restructuring charges; | |
| elimination of $4,382,000 of the acquisition accounting adjustment on Eurands inventory that was sold subsequent to the Aquisition Date, which will not have a continuing impact on the Companys operations. |
The pro forma effective tax rate differs from the statutory rate due to the relatively large impact
of actual permanent differences on relatively small pro forma income before tax, valuation
allowances on deferred tax assets in certain jurisdictions, and the expected impact of foreign
withholding taxes upon repatriation of foreign earnings.
Page 13
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(unaudited)
5. Restructuring and Integration
Acquisition related cost-rationalization and integration initiatives
The Company has initiated restructuring measures in conjunction with the integration of the
operations of Eurand. These measures are intended to capture synergies and generate cost savings
across the Company.
Restructuring actions taken thus far include workforce reductions across the Company and other
organizational changes. These reductions primarily come from the elimination of redundancies and
consolidation of staff in the sales and marketing, manufacturing, research and development, and
general and administrative functions, as well as from the planned closure of Eurands manufacturing
facility in Nogent-Oise, France.
During the quarter ended March 31, 2011, the Company recorded a restructuring expense in the amount
of $5,025,000 related to planned employee termination costs. Employee termination costs are
generally recorded when the actions are probable and estimable and include accrued severance
benefits and health insurance continuation, many of which may be paid out during periods after
termination.
The following table summarizes restructuring liability activity related to the Eurand acquisition
during the quarter ended March 31, 2011:
Liability | Balance | |||||||||||
Established | Payments | March 31,2011 | ||||||||||
$ | $ | $ | ||||||||||
Severance and related benefits |
5,025 | (132 | ) | 4,893 | ||||||||
The Company estimates to incur additional costs between $17,172,000 and $21,346,000 in connection
with planned employee termination costs. The restructuring actions taken thus far are expected to
be substantially completed by the end of 2012.
Through March 31, 2011, the Company has incurred integration costs of $5,980,000 representing
certain external, incremental costs directly related to integrating the acquired business and
primarily include expenditures for consulting and systems integration. Restucturing and integration
costs are included in transaction and restructuring costs in the accompanying Statement of
Condensed Consolidated Operations.
6. Disposal of the PHOTOFRIN/PHOTOBARR Product Line
On March 28, 2011, The Company entered into a definitive agreement with Pinnacle Biologics, Inc.,
which acquired all global assets and rights related to PHOTOFRIN/PHOTOBARR, including inventory,
for non-contingent payments amounting to $4,252,000. In addition to the non-contingent payments,
additional payments shall be made to the Company after the achievement of certain milestones
events. In addition, the Company will be paid royalties on annual net sales of PHOTOFRIN/PHOTOBARR.
During the quarter ended March 31, 2011, The Company recorded a loss of $7,365,000 as a result of
the disposal of the PHOTOFRIN/PHOTOBARR product line. Consideration for additional contingent
payments to be made to the Company shall be recorded as a gain in the period in which they are
received.
Page 14
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(unaudited)
7. Inventories
March 31, | September 30, | |||||||
2011 | 2010 | |||||||
$ | $ | |||||||
Raw material and packaging material, net of reserve for obsolescence of $2,498
(nil as at September 30, 2010) |
18,065 | 10,316 | ||||||
Work in progress, net of reserve for obsolescence of $927 (nil as at September 30, 2010) |
6,896 | 595 | ||||||
Finished goods, net of reserve for obsolescence of $1,122 ($758 as at September 30, 2010) |
38,489 | 12,955 | ||||||
63,450 | 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.
Include the adjustment to step-up the carrying value of inventory acquired by $18,727,000 to
estimated fair value as of February 11, 2011, less a charge to cost of goods sold as acquired
inventory is sold amounting to $4,382,000.
8. Property, Plant and Equipment
March 31, 2011 | ||||||||||||
Accumulated | ||||||||||||
Cost | depreciation | Net | ||||||||||
$ | $ | $ | ||||||||||
Land |
4,865 | | 4,865 | |||||||||
Buildings |
46,542 | 5,580 | 40,962 | |||||||||
Furniture and equipment |
37,303 | 5,206 | 32,097 | |||||||||
Automotive equipment |
30 | 1 | 29 | |||||||||
Computer equipment and software |
24,016 | 12,322 | 11,694 | |||||||||
Leasehold and building improvements |
1,190 | 569 | 621 | |||||||||
113,946 | 23,678 | 90,268 | ||||||||||
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 | ||||||||||
Page 15
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(unaudited)
9. Goodwill and Intangible Assets
The following table reflects the changes in carrying amount of goodwill from September 30, 2010 to
March 31, 2011:
March 31, | September 30, | |||||||
2011 | 2010 | |||||||
$ | $ | |||||||
Balance, beginning of period |
73,540 | 165,823 | ||||||
Acquisition of Eurand |
106,517 | | ||||||
Impairment |
| (91,400 | ) | |||||
Foreign exchange |
1,661 | (883 | ) | |||||
Balance, end of period |
181,718 | 73,540 | ||||||
As disclosed in Note 4, the amount recorded as goodwill for the acquisition of Eurand is
provisional and subject to the completion of the allocation of the consideration transferred to the
assets acquired and liabilities assumed.
The following table reflects the changes in the carrying amount of intangible assets:
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life
March 31, 2011 | ||||||||||||
Accumulated | ||||||||||||
Cost | amortization | Net | ||||||||||
$ | $ | $ | ||||||||||
Balance, as at September 30, 2010 |
459,207 | 111,245 | 347,962 | |||||||||
Acquisition of Eurand |
413,929 | | 413,929 | |||||||||
Assets written-off on disposal of Photofrin/Photobarr |
(11,749 | ) | (1,503 | ) | (10,246 | ) | ||||||
Amortization |
| 26,335 | (26,335 | ) | ||||||||
Foreign exchange |
6,483 | 780 | 5,703 | |||||||||
Balance, as at March 31, 2011 |
867,870 | 136,857 | 731,013 | |||||||||
September 30, 2010 | ||||||||||||
Accumulated | ||||||||||||
Cost | amortization | Net | ||||||||||
$ | $ | $ | ||||||||||
Balance, as at September 30, 2009 |
491,411 | 70,121 | 421,290 | |||||||||
Impairment |
(26,400 | ) | (10,642 | ) | (15,758 | ) | ||||||
Amortization |
| 52,465 | (52,465 | ) | ||||||||
Foreign exchange |
(5,804 | ) | (699 | ) | (5,105 | ) | ||||||
Balance, as at September 30, 2010 |
459,207 | 111,245 | 347,962 | |||||||||
Page 16
Table of Contents
APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Consolidated Financial Statements
(unaudited)
10. Segment Information
Prior to the acquisition of Eurand, the Company operated in one segment, pharmaceutical products.
Effective with the acquisition of Eurand, the Management of the Company is reassessing the
Companys internal reporting structure and composition of its operating segments for disclosure in
succeeding interim and annual reporting periods.
The Company operates in the following geographic areas:
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Total revenue |
||||||||||||||||
United States |
||||||||||||||||
Domestic sales |
80,078 | 68,371 | 138,027 | 152,147 | ||||||||||||
Foreign sales |
2,292 | 1,243 | 2,562 | 2,621 | ||||||||||||
Canada |
||||||||||||||||
Domestic sales |
8,099 | 7,862 | 18,145 | 16,729 | ||||||||||||
Foreign sales |
225 | | 361 | | ||||||||||||
European Union |
||||||||||||||||
Domestic sales |
16,430 | 14,691 | 31,280 | 28,715 | ||||||||||||
Foreign sales |
4,236 | 2,080 | 6,923 | 3,920 | ||||||||||||
Other |
| 118 | | 365 | ||||||||||||
111,360 | 94,365 | 197,298 | 204,497 | |||||||||||||
Revenue is attributed to geographic areas based on the country of origin of the sales.
March 31, | September 30, | |||||||
2011 | 2010 | |||||||
$ | $ | |||||||
Property, plant, equipment and intangible assets |
||||||||
Canada |
270,669 | 299,180 | ||||||
United States |
52,867 | 13,906 | ||||||
European Union |
497,745 | 70,653 | ||||||
821,281 | 383,739 | |||||||
March 31, | September 30, | |||||||
2011 | 2010 | |||||||
$ | $ | |||||||
Goodwill |
||||||||
Canada |
61,887 | 61,887 | ||||||
United States |
20,931 | | ||||||
European Union |
98,900 | 11,653 | ||||||
181,718 | 73,540 | |||||||
Page 17
Table of Contents
APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
11. Long-term Debt
March 31, | September 30, | |||||||
2011 | 2010 | |||||||
$ | $ | |||||||
Senior secured term loan of $748,125 as at March 31, 2011, ($0 as at
September 30, 2010), bearing interest at a rate per annum equal to an
applicable margin plus, at the Companys option, either (1) a base rate
determined by reference to the highest of (a) the prime rate of Banc of
America Securities LLC, (b) the federal funds effective rate plus 1/2 of
1.00% and (c) the one-month LIBOR rate plus 1.00% or (2) a LIBOR rate
determined by reference to the costs of funds for U.S. dollar deposits for
the interest period relevant to such borrowing adjusted for certain
additional costs. The applicable margins for borrowings under the Senior
Secured Term Loan Facility are 3.00% with respect to base rate borrowings
and 4.00% with respect to LIBOR borrowings. In addition, the LIBOR rate and
base rate for borrowings under the Senior Secured Term Loan Facility are
subject to a floor of 150 basis points and 250 basis points, respectively,
secured by substantially all of the present and future assets of the
Company, payable in quarterly installments, maturing in February 2017 |
744,626 | | ||||||
Term loans of $0 as at March 31, 2011, ($138,823 as at September 30, 2010),
bearing interest at the one-month British Banker Association LIBOR (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 |
| 135,210 | ||||||
Unsecured loan of 2,252 Euros as at March 31, 2011, with a variable interest
of 1.6% above Euribor. Euribor interest rate has a cap of 2.5% |
3,194 | | ||||||
Senior unsecured notes, bearing interest at 12.75% and maturing in March 2016 |
233,268 | 233,094 | ||||||
Senior notes bearing interest at 9.25%, redeemed on March 15, 2011 |
| 226,171 | ||||||
981,088 | 594,475 | |||||||
Installments due within one year |
8,918 | 13,163 | ||||||
972,170 | 581,312 | |||||||
On February 11, 2011, the Company entered into an amended and restated credit agreement and related
security and other agreements in connection with the Eurand Acquisition.
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 $147,000,000
(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 the Company and Eurand, were used to repay the
outstanding term loan portion amounting to $125,660,000 of the Companys existing senior secured
credit facilities. Following the repayment, all unamortized deferred financing fees of $2,653,000
and original issuance discount of $3,188,000 related to the term loan were written off and are
included in loss on extinguishment of debt in the accompanying Statement of Condensed Consolidated
Operations.
On February 25, 2008, 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. On March 15, 2011, $250,000,000 of the Senior
Secured Term Loan Facility was drawn to redeem the Companys Senior Secured Notes at a redemption
price of 106.938%. The aggregate redemption amount consisted of $228,000,000 in aggregate principal
amount, and $15,819,000 of redemption premium which is included in loss on extinguishment or debt
in the accompanying Statement of Condensed Consolidated Operations. Following the redemption all
unamortized deferred financing fees of $4,992,000 and original issuance discount of $1,659,000
related to these notes were written off and are included in loss on extinguishment of debt in the
accompanying Statement of Condensed Consolidated Operations.
Page 18
Table of Contents
APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
The Companys Amended and Restated Senior Secured Credit Facilities totaling $897,000,000 is
composed of a Senior Secured Term Loan Facility amounting to $750,000,000 and a Senior Secured
Revolving Credit Facility totaling $147,000,000. The Senior Secured Revolving Credit Facility is
comprised of $115,000,000 of existing revolving credit commitments that were extended or issued
(the Extended Commitments) and $32,000,000 of existing revolving credit commitments that were
not extended (the Unextended Commitments) pursuant to the Senior Secured Revolving Credit
Facility. The Amended and Restated Senior Secured Credit Facilities bear 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
principal amount of the Senior Secured Term Loan Facility amortizes in equal quarterly installments
in aggregate annual amounts equal to 1% of the original principal amount with payments beginning in
fiscal year 2011. The principal amount outstanding of the loans under the Senior Secured Term Loan
Facility will be due and payable on February 11, 2017. The principal amount of outstanding loans
under the Senior Secured Revolving Facility will be due and payable on February 11, 2016 with
respect to Extended Commitments and on February 25, 2014 with respect to Unextended Commitments.
As at March 31, 2011, $750,000,000 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 $0.995,
with a yield to maturity of 5.6%. The Amended and Restated Senior Secured Credit Facility requires
the Company to meet certain financial covenants, beginning quarter ending June 30, 2011. The
maintenance of these financial covenants is solely with respect to the Senior Secured Revolving
Credit Facility. The credit agreement governing the Amended and Restated Senior Secured 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 Amended and Restated Senior Secured Credit Facility, (2)
commencing with the fiscal year ending September 30, 2011, 50% (which percentage will be reduced 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 Senior Secured Term Loan 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 preceding 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).
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 |
Page 19
Table of Contents
APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Payments required in each of the next five twelve-month periods to meet the retirement provisions
of the long-term debt are as follows:
$ | ||||
2012 |
8,918 | |||
2013 |
8,918 | |||
2014 |
7,858 | |||
2015 |
7,500 | |||
2016 |
242,500 | |||
Thereafter |
710,625 | |||
986,319 | ||||
Unamortized original issuance discount |
5,231 | |||
981,088 | ||||
12. Information Included in the Consolidated Operations and Cash Flows
a) Financial expenses
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Interest on long-term debt (including
amortization of original issuance discount
of $510 and $1,020 in 2011($511 and $1,027
in 2010) |
17,166 | 14,568 | 31,772 | 29,379 | ||||||||||||
Interest and bank charges |
277 | 323 | 522 | 425 | ||||||||||||
Interest rate swaps (Note 16) |
| 113 | | 17 | ||||||||||||
Financing fees |
10,422 | 143 | 10,557 | 278 | ||||||||||||
Amortization of deferred debt issue expenses |
2,280 | 1,238 | 3,523 | 2,483 | ||||||||||||
30,145 | 16,385 | 46,374 | 32,582 | |||||||||||||
b) Other information
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Rental expenses |
973 | 973 | 1,857 | 1,877 | ||||||||||||
Shipping and handling expenses |
1,862 | 1,678 | 3,200 | 3,294 | ||||||||||||
Advertizing expenses |
2,512 | 3,957 | 4,039 | 7,854 | ||||||||||||
Depreciation of property, plant and equipment |
3,573 | 2,095 | 5,691 | 4,099 | ||||||||||||
Amortization of intangible assets |
14,880 | 11,904 | 26,335 | 26,593 | ||||||||||||
Stock-based compensation expense (recovery) |
5,272 | (2,367 | ) | 5,763 | (891 | ) | ||||||||||
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 $194,000 for the three-month period and $361,000 for the
six-month period ended March 31, 2011, ($186,000 for the three-month period and $402,000 for the
six-month period ended March 31, 2010).
Page 20
Table of Contents
APTALIS PHARMA INC.
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
d) Employees severance indemnities
The liability for severance indemnities relates primarily to Eurand s and now the Companys
employees in Italy. The unfunded severance indemnity liability is calculated in accordance with
local civil and labor laws based on each employees length of service, employment category and
remuneration. There is no vesting period or funding requirement associated with the liability. The
liability recorded on the balance sheet is the amount the employee would be entitled to if the
employee were to immediately terminate their employment involuntary.
e) Cash flows relating to interest and income taxes of operating activities
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Interest received |
115 | 159 | 307 | 307 | ||||||||||||
Interest paid |
18,678 | 27,172 | 20,012 | 29,119 | ||||||||||||
Income taxes received |
744 | | 744 | 2,372 | ||||||||||||
Income taxes paid |
3,160 | 752 | 5,445 | 2,608 | ||||||||||||
13. Income Taxes
The Company establishes a valuation allowance against deferred tax assets in accordance with U.S.
GAAP. As at March 31, 2011, the Company has a valuation allowance of $112,692,000 against the
Companys net deferred tax assets generated in the U.S. reporting unit and of $4,275,000 against
the deferred tax assets generated in its European 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 and six-month periods ended March 31, 2011,
were 5.9% and 4.5% respectively, as compared to minus 15.4% and minus 16.3% respectively in the
prior years periods. The effective tax rate for the three-month and six-month periods ended March
31, 2011, is affected by a number of elements, the most important being the establishment of the
valuation allowance of $29,585,000 against the Companys net deferred tax assets mostly
attributable to the U.S. reporting unit during the six-month period ended March 31, 2011.
As at March 31, 2011, with respect to uncertain tax positions, the Company had unrecognized tax
benefits of $12,110,000 ($11,485,000 as at September 30, 2010).
The following table presents a summary of the changes to unrecognized tax benefits:
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Balance, beginning of period |
10,834 | 10,896 | 11,485 | 10,409 | ||||||||||||
Acquisition of Eurand |
401 | | 401 | | ||||||||||||
Additions based on tax positions related to the current year |
8 | 8 | 16 | 15 | ||||||||||||
Additions for tax positions of prior years |
867 | 414 | 1,300 | 920 | ||||||||||||
Settlements |
| | (1,063 | ) | | |||||||||||
Reductions for tax positions of prior years |
| | (29 | ) | (26 | ) | ||||||||||
Balance, end of period |
12,110 | 11,318 | 12,110 | 11,318 | ||||||||||||
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 March 31, 2011, the Company had accrued $1,237,000 ($1,075,000 as at September 30,
2010) for interest relating to income tax matters. There were no amounts recorded for penalties as
at March 31, 2011.
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.
Page 21
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
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 March 31, 2011, 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.
14. 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 March 31, 2011, there were 1,086,247 outstanding RSUs
and Penny Options (1,172,396 as at September 30, 2010) of which 1,082,913 (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 March 31, 2011, the value of the awards
to be expensed by the Company would range between $6,000,000 and $7,200,000 depending on the level
of return expected to be realized by the majority shareholders.
Page 22
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
15. 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 16, the
Company may enter into derivative financial instruments to manage its exposure to interest rate
changes and reduce its overall cost of borrowing. As described in the subsequent events (Note 19),
the Company entered into two separate pay-fixed, receive-floating interest rate swaps on April 4,
2011.
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 has used derivative instruments historically to
reduce its exposure to foreign currencies risk. As at March 31, 2011, no foreign exchange contracts
were outstanding. As at March 31, 2011, the financial assets totaling $163,272,000 ($194,005,000
as at September 30, 2010) include cash and cash equivalents and accounts receivable for
CAN$7,472,000, 25,888,000 Euros and 1,403,000 Swiss francs respectively (CAN$4,073,000, 18,658,000
Euros and 1,820,000 Swiss francs as at September 30, 2010). As at March 31, 2011, the financial
liabilities totaling $1,112,850,000 ($689,148,000 as at September 30, 2010) include accounts
payable and accrued liabilities and long-term debt of CAN$8,328,000, 21,359,000 Euros and 29,000
Swiss francs respectively (CAN$10,234,000 and 8,158,000 Euros as at September 30, 2010).
Credit risk
As at March 31, 2011, the Company had $47,484,000 ($134,299,000 as at September 30, 2010) of cash
invested in 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:
March 31, 2011 | September 30, 2010 | |||||||||||||||
Fair | Carrying | Fair | Carrying | |||||||||||||
value | amount | value | amount | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Assets |
||||||||||||||||
Cash and cash equivalents |
87,330 | 87,330 | 161,503 | 161,503 | ||||||||||||
Accounts receivable from the parent company |
526 | 526 | 487 | 487 | ||||||||||||
Accounts receivable, net |
75,416 | 75,416 | 32,015 | 32,015 | ||||||||||||
Liabilities |
||||||||||||||||
Accounts payable and accrued liabilities |
131,762 | 131,762 | 94,673 | 94,673 | ||||||||||||
Long-term debt |
1,010,662 | 981,088 | 608,535 | 594,475 |
Page 23
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
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.
16. 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 and six-month
periods ended March 31, 2010, 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 had 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.
Page 24
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
The tables below present the effect of the Companys derivative financial instruments on the
consolidated operations as at March 31, 2011, and March 31, 2010.
Tabular disclosure of the effect of derivative instruments for the three-month and six-month
periods ended March 31, 2011, and 2010:
Location in the | For the | For the | ||||||||||
Condensed | three-month | three-month | ||||||||||
Consolidated | period ended | period ended | ||||||||||
Financial | March 31, | March 31, | ||||||||||
Statements | 2011 | 2010 | ||||||||||
$ | $ | |||||||||||
Interest rate swaps in cash flow hedging relationships |
||||||||||||
Gain (loss) recognized in other comprehensive income on
derivatives (effective portion, net of tax of $1 in 2010 |
OCI | | (3 | ) | ||||||||
Gain (loss) reclassified from accumulated comprehensive
income into income (effective portion) |
Financial expenses |
| (113 | ) | ||||||||
Gain (loss) recognized in income on derivatives
(ineffective portion and amount excluded from
effectiveness testing) |
Financial expenses |
| | |||||||||
Interest rate swaps not designated as hedging instruments
|
||||||||||||
Loss recognized in income on derivatives |
Financial expenses | | |
Location in the | For the | For the | ||||||||||
Condensed | six-month | six-month | ||||||||||
Consolidated | period ended | period ended | ||||||||||
Financial | March 31, | March 31, | ||||||||||
Statements | 2011 | 2010 | ||||||||||
$ | $ | |||||||||||
Interest rate swaps in cash flow hedging relationships |
||||||||||||
Gain (loss) recognized in other comprehensive income on derivatives
(effective portion), net of tax of $166 in 2010 |
OCI | | (309 | ) | ||||||||
Gain (loss) reclassified from accumulated comprehensive income
into income (effective portion) |
Financial expenses |
| (464 | ) | ||||||||
Gain (loss) 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 |
| | |||||||||
17. Fair Value Measurements
Effective October 1, 2008, the Company adopted the authoritative guidance for fair value
measurements. Fair value is defined as the exchange price that would be received for an asset or
paid to transfer a liability (an exit price) in the principal or most advantageous market for the
asset or liability in an orderly transaction between market participants on the measurement date.
The guidance also establishes a fair value hierarchy which requires an entity to maximize the use
of observable inputs and minimize the use of unobservable inputs when measuring fair value. The
guidance describes three levels of inputs that may be used to measure fair value:
Level 1 Quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or
liabilities; or other inputs that are observable or can be corroborated by observable market data
for substantially the full term of the assets or liabilities.
Level 3 Inputs that are unobservable and significant to the overall fair value measurement.
Page 25
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S. dollars, except share related data)
(unaudited)
If the inputs used to measure the financial assets and liabilities fall within the different levels
described above, the categorization is based on the lowest level input that is significant to the
fair value measurement of the instrument.
There are no financial assets and liabilities measured at fair value on a recurring basis as at
March 31, 2011, and September 30, 2010.
Interest rate swap agreements as more fully described in Note 16 and are measured at fair value
based on observable market interest rate curves as of the measurement date.
During the three-month period ended March 31, 2010, the Company recorded a goodwill impairment
charge of $91,400,000 and an intangible assets impairment charge of $15,758,000 related to the PEPs
event. The fair value measurement method used in the Companys impairment analysis utilized a
discounted cash flow model and market approach that incorporates significant unobservable inputs or
Level 3 assumptions. These assumptions include, among others, projections of the Companys future
operating results, the implied fair value using an income approach by preparing a discounted cash
flow analysis and other subjective assumptions.
18. Related Party Transactions
As at March 31, 2011, 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 March 31, 2011, and March
31, 2010, the Company earned interest income on the note amounting to $1,931,000 net of taxes
amounting to $1,040,000 and $3,905,000 net of taxes amounting to $2,103,000 for the six-month
periods ended March 31, 2011, and March 31, 2010. The related interest receivable from the parent
company amounting to $33,139,000 as at March 31, 2011, ($27,130,000 as at September 30, 2010) has
been recorded in the shareholders equity section of the condensed consolidated balance sheet. This
amount was subject to a full provision which was also recorded in the statement of shareholders
equity. As at March 31, 2011, the Company has an account receivable from the parent company
amounting to $526,000 ($487,000 as at September 30, 2010).
During the three-month period ended March 31, 2011, the Company recorded charges pursuant to the
terms of a management fee arrangement with a controlling shareholding company amounting to $730,000
and $1,568,000 during the three-month period and the six-month period ended March 31,
2011($1,000,000 during the three-month period and $1,855,000 during the six-month period ended
March 31, 2010). Also, during the three-month and six-month periods ended March 31, 2011, the
Company recorded fees from a controlling shareholding company amounting to $5,028,000 of which
$1,508,000 was accounted for as deferred debt issue costs, $2,514,000 as selling and administrative
expense and $1,006,000 as financing fees. As at March 31, 2011, the Company accrued fees payable to
a controlling shareholding company amounting to $770,000 ($1,574,000 as at September 30, 2010).
During the three-month and six-month periods ended March 31, 2011, the Company paid a dividend to
its parent company amounting to $25,000 ($128,000 during the six-month period ended March 31, 2010)
to allow for the payment of certain group expenses.
Page 26
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
19. Subsequent Events
Agreements with Mpex Pharmaceuticals Inc. for the acquisition and development of Aeroquin
On April 11, 2011, Axcan Holdings Inc., an indirect parent company of the Company, entered into a
series of agreements with Mpex Pharmaceuticals Inc. (Mpex) for the acquisition and development of
Aeroquin (the Aeroquin Transaction), a proprietary aerosol formulation of levofloxacin, which is
currently in Phase 3 clinical trials for the treatment of pulmonary infections in patients with
cystic fibrosis (CF). Under these agreements, Axcan Holdings has an option to acquire all of Mpexs
assets related to Aeroquin in a merger, with continued development of Aeroquin by Mpex under the
terms of a Development Agreement between the parties. Prior to the merger Mpex will transfer all of
its assets that are not related to Aeroquin to a newly formed company that will be owned primarily
by current Mpex stockholders. As a result of the Aeroquin Transaction, the Company made an initial
non-contingent payment of $12,000,000 on April 21, 2011. Additional remaining time-based,
non-contingent payments in relation with the Aeroquin Transaction amounting to $50,500,000 will be
paid in a number of additional installments, of which the final installment is due on November 1, 2013.
Under the terms of the Option Agreement dated April 11, 2011 among Axcan Holdings, Mpex, and Axcan
Lone Star Inc., a Delaware corporation and an indirect wholly-owned subsidiary of Axcan Holdings
and a direct wholly-owned subsidiary of the Company (Merger Sub), Axcan Holdings has an option to
terminate the Merger Agreement described below. This option may be exercised during a certain
period of time, which period in no event will end later than August 1, 2011.
Under the terms of the Agreement and Plan of Merger dated April 11, 2011 (the Merger Agreement)
among Axcan Holdings, Merger Sub, Mpex and certain stockholders of Mpex who will serve as
representatives of the Mpex security holders under the Merger Agreement, Merger Sub will merge with
and into Mpex, with Mpex surviving (the Surviving Company) as an indirect wholly-owned subsidiary
of Axcan Holdings and a direct wholly-owned subsidiary of the Company (the Merger). Pursuant to
the Merger Agreement, the aggregate merger consideration that the Mpex security holders will
receive, subject to the consummation of the Merger, consists of (i) the non-contingent payments
mentioned above; (ii) contingent payments of up to $195,000,000 if certain regulatory and
commercial milestones are met related to Aeroquin, and (iii) earn-out payments based on net sales
of Aeroquin. Indemnity obligations of the Mpex security holders will be satisfied by set-off
against a portion of the foregoing merger consideration payments.
Unless terminated pursuant to the Option Agreement described above, the Merger is expected to close
during the third quarter of 2011. The further development of Aeroquin will be conducted pursuant to
the terms of the Development Agreement dated April 11, 2011 among Axcan Holdings, Merger Sub, and
Mpex. Upon completion of the divestiture of assets and liabilities unrelated to Aeroquin (the
Divestiture) to a newly formed company (Spinco), Spinco will assume all of Mpexs obligations
under the Development Agreement. Under the Development Agreement, Mpex (and after the Divestiture,
Spinco) will be paid for the actual development costs of Aeroquin and will have primary
responsibility for conducting day-to-day development activities. Axcan Holdings and Merger Sub will
have input regarding development strategy. Pursuant to the Development Agreement, on April 12, 2011
Mpex was paid $9,196,000 for development expenses incurred by Mpex since November 15, 2010 and
$9,448,000 for estimated development costs to be incurred during the first three months of the
Development Agreement. All payments under the Development Agreement, Option Agreement and Merger
Agreement to Mpex or Mpex security holders, as applicable, will be made by or on behalf of Merger
Sub (or after the consummation of the Merger, the Surviving Company).
Equity investment in Axcan Holdings
Simultaneous with the execution of the Mpex agreements, Axcan Holdings received the proceeds of a
$55,000,000 equity investment from funds managed by Investor Growth Capital Limited. Axcan Holdings
will contribute the proceeds of the equity investment to its subsidiaries to fund a portion of the
cost of the Mpex transactions and a partial repayment on the Companys $133,154,000 note receivable
from its parent company.
Risk management measures undertaken to reduce exposure to interest rate fluctuations
On April 4, 2011, the Company entered into two separate pay-fixed, receive-floating interest rate
swaps. The first swap has a notional amount of $331,000,000 amortizing to $84,000,000 by its
maturity in December 2015. The second swap has a notional amount of $219,000,000 and matures in
December 2016. The interest rate swaps will effectively fix the Companys interest payments on the
hedged debt at 2.386% for the first swap and 3.18% for the second swap, respectively, inclusive of
a labor floor of 1.5%, plus the appropriate margin on each debt interest period. These swaps were
designated as cash flow hedges of interest rate risk.
Page 27
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
20. Condensed Consolidating Financial Information
As of March 31, 2011, the Company had outstanding $746,626,000 aggregate principal amount of the
Senior Secured Term Loan Facility. The Senior Secured Term Loan Facility is 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 March 31, 2011, and September 30, 2010, the
condensed consolidating statements of operations for the three-month and six-month periods ended
March 31, 2011, and March 31, 2010, and the condensed consolidating statement of cash flows for the
six-month periods ended March 31, 2011, and March 31, 2010.
Condensed consolidating balance sheet as at March 31, 2011
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Assets |
||||||||||||||||||||
Current assets |
||||||||||||||||||||
Cash and cash equivalents |
3,242 | 33,246 | 50,842 | | 87,330 | |||||||||||||||
Accounts receivable, net |
| 54,168 | 21,549 | | 75,717 | |||||||||||||||
Accounts receivable from the parent company |
52 | 474 | | | 526 | |||||||||||||||
Intercompany receivables |
42,041 | 11,324 | 16,999 | (70,364 | ) | | ||||||||||||||
Income taxes receivable |
| 3,260 | 412 | | 3,672 | |||||||||||||||
Inventories, net |
| 45,820 | 26,427 | (8,797 | ) | 63,450 | ||||||||||||||
Prepaid expenses and deposits |
123 | 4,109 | 1,655 | (267 | ) | 5,620 | ||||||||||||||
Deferred income taxes, net |
| 1,539 | 1,690 | 2,878 | 6,107 | |||||||||||||||
Total current assets |
45,458 | 153,940 | 119,574 | (76,550 | ) | 242,422 | ||||||||||||||
Property, plant and equipment, net |
| 41,390 | 48,878 | | 90,268 | |||||||||||||||
Intangible assets, net |
| 282,145 | 448,868 | | 731,013 | |||||||||||||||
Investments in subsidiaries |
(140,563 | ) | 1,212,795 | 184,298 | (1,256,530 | ) | | |||||||||||||
Intercompany advances |
1,064,659 | 269,998 | 641,954 | (1,976,611 | ) | | ||||||||||||||
Goodwill, net |
| 82,818 | 98,900 | | 181,718 | |||||||||||||||
Deferred debt issue expenses, net |
30,419 | 1,817 | | | 32,236 | |||||||||||||||
Deferred income taxes, net |
| 58 | 14,348 | | 14,406 | |||||||||||||||
Total assets |
999,973 | 2,044,961 | 1,556,820 | (3,309,691 | ) | 1,292,063 | ||||||||||||||
Liabilities |
||||||||||||||||||||
Current liabilities |
||||||||||||||||||||
Accounts payable and accrued liabilities |
6,126 | 94,673 | 31,230 | (267 | ) | 131,762 | ||||||||||||||
Income taxes payable |
| 3,097 | 178 | | 3,275 | |||||||||||||||
Intercompany payables |
2,051 | 59,090 | 9,223 | (70,364 | ) | | ||||||||||||||
Short-term portion of long term debt |
6,770 | 730 | 1,418 | | 8,918 | |||||||||||||||
Deferred income taxes |
| | 620 | | 620 | |||||||||||||||
Total current liabilities |
14,947 | 157,590 | 42,669 | (70,631 | ) | 144,575 | ||||||||||||||
Long-term debt |
898,647 | 71,747 | 1,776 | | 972,170 | |||||||||||||||
Intercompany advances |
22,894 | 1,724,026 | 229,691 | (1,976,611 | ) | | ||||||||||||||
Other long-term liabilities |
| 11,252 | | | 11,252 | |||||||||||||||
Employees severance indemnities |
| | 5,080 | | 5,080 | |||||||||||||||
Deferred income taxes |
| 27,711 | 67,790 | | 95,501 | |||||||||||||||
Total liabilities |
936,488 | 1,992,326 | 347,006 | (2,047,242 | ) | 1,228,578 | ||||||||||||||
Shareholders Equity (Deficiency) |
||||||||||||||||||||
Capital stock |
||||||||||||||||||||
Common shares |
1 | 29,519 | 1,075,397 | (1,104,916 | ) | 1 | ||||||||||||||
Preferred shares |
| 298,298 | | (298,298 | ) | | ||||||||||||||
Purchased price allocation at equity |
| | 19,167 | (19,167 | ) | | ||||||||||||||
Retained earnings (deficit) |
(538,400 | ) | (373,746 | ) | 119,668 | 254,078 | (538,400 | ) | ||||||||||||
9.05% Note receivable from the parent company |
(133,154 | ) | | | | (133,154 | ) | |||||||||||||
Additional paid-in capital |
757,689 | 121,215 | 943 | (122,158 | ) | 757,689 | ||||||||||||||
Accumulated other comprehensive loss |
(22,651 | ) | (22,651 | ) | (5,361 | ) | 28,012 | (22,651 | ) | |||||||||||
Total shareholders equity (deficiency) |
63,485 | 52,635 | 1,209,814 | (1,262,449 | ) | 63,485 | ||||||||||||||
Total liabilities and shareholders equity
(deficiency) |
999,973 | 2,044,961 | 1,556,820 | (3,309,691 | ) | 1,292,063 | ||||||||||||||
Page 28
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating balance sheet as at September 30, 2010
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma 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
(deficiency) |
502,402 | 1,450,287 | 930,255 | (2,169,767 | ) | 713,177 | ||||||||||||||
Page 29
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the three-month period ended March 31, 2011
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Net product sales |
| 89,191 | 20,496 | 87 | 109,774 | |||||||||||||||
Development fees |
| 497 | 102 | | 599 | |||||||||||||||
Royalties |
| 920 | 67 | | 987 | |||||||||||||||
Total revenue |
| 90,608 | 20,665 | 87 | 111,360 | |||||||||||||||
Cost of goods sold |
| 22,597 | 7,098 | 2,158 | 31,853 | |||||||||||||||
Selling and administrative expenses |
16,197 | 13,987 | 8,860 | | 39,044 | |||||||||||||||
Management fees |
730 | | | | 730 | |||||||||||||||
Research and development expenses |
| 8,392 | 2,591 | | 10,983 | |||||||||||||||
Other research and development expenses
attributable to development fees |
| 631 | 224 | | 855 | |||||||||||||||
Depreciation and amortization |
| 12,449 | 6,004 | | 18,453 | |||||||||||||||
Loss on disposal of assets |
| 7,365 | | | 7,365 | |||||||||||||||
Transaction and restructuring costs |
| 15,501 | 3,748 | | 19,249 | |||||||||||||||
Total operating expenses |
16,927 | 80,922 | 28,525 | 2,158 | 128,532 | |||||||||||||||
Operating income (loss) |
(16,927 | ) | 9,686 | (7,860 | ) | (2,071 | ) | (17,172 | ) | |||||||||||
Financial expenses |
28,087 | 30,659 | 2,245 | (30,846 | ) | 30,145 | ||||||||||||||
Loss of extinguishment of debt |
24,269 | 4,042 | | | 28,311 | |||||||||||||||
Interest income |
(14,119 | ) | (2,273 | ) | (14,577 | ) | 30,846 | (123 | ) | |||||||||||
Other income |
| | (241 | ) | 241 | | ||||||||||||||
Loss (gain) on foreign currencies |
(14,401 | ) | 9,620 | 470 | 4,944 | 633 | ||||||||||||||
Total other expenses (income) |
23,836 | 42,048 | (12,103 | ) | 5,185 | 58,966 | ||||||||||||||
Income (loss) before income taxes |
(40,763 | ) | (32,362 | ) | 4,243 | (7,256 | ) | (76,138 | ) | |||||||||||
Income taxes expense (benefit) |
(1,042 | ) | (1,788 | ) | (979 | ) | (660 | ) | (4,469 | ) | ||||||||||
Equity in earnings (loss) in subsidiaries |
(31,948 | ) | (1,374 | ) | | 33,322 | | |||||||||||||
Net income (loss) |
(71,669 | ) | (31,948 | ) | 5,222 | 26,726 | (71,669 | ) | ||||||||||||
Page 30
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the three-month period ended March 31, 2010
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Net product sales |
| 77,560 | 17,114 | (309 | ) | 94,365 | ||||||||||||||
Cost of goods sold |
| 61,535 | 6,586 | 29 | 68,150 | |||||||||||||||
Selling and administrative expenses |
1,002 | 20,902 | 6,502 | | 28,406 | |||||||||||||||
Management fees |
1,000 | | | | 1,000 | |||||||||||||||
Research and development expenses |
| 6,063 | 1,620 | | 7,683 | |||||||||||||||
Depreciation and amortization |
| 12,045 | 1,954 | | 13,999 | |||||||||||||||
Impairment of intangible assets and goodwill |
| 107,158 | | | 107,158 | |||||||||||||||
Total operating expenses |
2,002 | 207,703 | 16,662 | 29 | 226,396 | |||||||||||||||
Operating income (loss) |
(2,002 | ) | (130,143 | ) | 452 | (338 | ) | (132,031 | ) | |||||||||||
Financial expenses |
14,946 | 27,856 | 1,805 | (28,222 | ) | 16,385 | ||||||||||||||
Interest income |
(12,067 | ) | (1,935 | ) | (14,379 | ) | 28,222 | (159 | ) | |||||||||||
Other income |
| (7,700 | ) | | | (7,700 | ) | |||||||||||||
Loss (gain) on foreign currencies |
16,148 | (9,604 | ) | 117 | (5,253 | ) | 1,408 | |||||||||||||
Total other expenses (income) |
19,027 | 8,617 | (12,457 | ) | (5,253 | ) | 9,934 | |||||||||||||
Income (loss) before income taxes |
(21,029 | ) | (138,760 | ) | 12,909 | 4,915 | (141,965 | ) | ||||||||||||
Income taxes expense (benefit) |
37,612 | (15,169 | ) | (546 | ) | (102 | ) | 21,795 | ||||||||||||
Equity in earnings (loss) in subsidiaries |
(105,119 | ) | 18,472 | | 86,647 | | ||||||||||||||
Net income (loss) |
(163,760 | ) | (105,119 | ) | 13,455 | 91,664 | (163,760 | ) | ||||||||||||
Page 31
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the six-month period ended March 31, 2011
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Net product sales |
| 157,703 | 38,034 | (25 | ) | 195,712 | ||||||||||||||
Development fees |
| 497 | 102 | | 599 | |||||||||||||||
Royalties |
| 920 | 67 | | 987 | |||||||||||||||
Total evenue |
| 159,120 | 38,203 | (25 | ) | 197,298 | ||||||||||||||
Cost of goods sold |
| 33,556 | 13,683 | 2,037 | 49,276 | |||||||||||||||
Selling and administrative expenses |
20,723 | 27,636 | 15,856 | | 64,215 | |||||||||||||||
Management fees |
1,568 | | | | 1,568 | |||||||||||||||
Research and development expenses |
| 15,198 | 2,740 | | 17,938 | |||||||||||||||
Other research and development expenses
attributable to development fees |
| 631 | 224 | | 855 | |||||||||||||||
Depreciation and amortization |
| 24,170 | 7,856 | | 32,026 | |||||||||||||||
Loss on disposal of assets |
| 7,365 | | | 7,365 | |||||||||||||||
Transaction and restructuring costs |
| 18,549 | 3,748 | | 22,297 | |||||||||||||||
Total operating expenses |
22,291 | 127,105 | 44,107 | 2,037 | 195,540 | |||||||||||||||
Operating income (loss) |
(22,291 | ) | 32,015 | (5,904 | ) | (2,062 | ) | 1,758 | ||||||||||||
Financial expenses |
43,011 | 59,459 | 4,033 | (60,129 | ) | 46,374 | ||||||||||||||
Loss of extinguishment of debt |
24,269 | 4,042 | | | 28,311 | |||||||||||||||
Interest income |
(26,362 | ) | (4,184 | ) | (29,898 | ) | 60,129 | (315 | ) | |||||||||||
Other income |
| | (483 | ) | 483 | | ||||||||||||||
Loss (gain) on foreign currencies |
(10,604 | ) | 7,585 | 313 | 3,582 | 876 | ||||||||||||||
Total other expenses (income) |
30,314 | 66,902 | (26,035 | ) | 4,065 | 75,246 | ||||||||||||||
Income (loss) before income taxes |
(52,605 | ) | (34,887 | ) | 20,131 | (6,127 | ) | (73,488 | ) | |||||||||||
Income taxes expense (benefit) |
(2,105 | ) | 372 | (880 | ) | (652 | ) | (3,265 | ) | |||||||||||
Equity in earnings (loss) in subsidiaries |
(19,723 | ) | 15,536 | | 4,187 | | ||||||||||||||
Net income (loss) |
(70,223 | ) | (19,723 | ) | 21,011 | (1,288 | ) | (70,223 | ) | |||||||||||
Page 32
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating operations for the six-month period ended March 31, 2010
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Net product
sales |
| 172,583 | 33,220 | (1,306 | ) | 204,497 | ||||||||||||||
Cost of goods sold |
| 84,084 | 11,662 | (968 | ) | 94,778 | ||||||||||||||
Selling and administrative expenses |
1,345 | 45,303 | 13,997 | | 60,645 | |||||||||||||||
Management fees |
1,855 | | | | 1,855 | |||||||||||||||
Research and development expenses |
| 13,770 | 2,339 | | 16,109 | |||||||||||||||
Depreciation and amortization |
| 26,656 | 4,036 | | 30,692 | |||||||||||||||
Impairment of intangible assets and goodwill |
| 107,158 | | | 107,158 | |||||||||||||||
Total operating expenses |
3,200 | 276,971 | 32,034 | (968 | ) | 311,237 | ||||||||||||||
Operating income (loss) |
(3,200 | ) | (104,388 | ) | 1,186 | (338 | ) | (106,740 | ) | |||||||||||
Financial expenses |
29,903 | 56,517 | 3,765 | (57,603 | ) | 32,582 | ||||||||||||||
Interest income |
(24,536 | ) | (3,930 | ) | (29,444 | ) | 57,603 | (307 | ) | |||||||||||
Other income |
| (7,700 | ) | | | (7,700 | ) | |||||||||||||
Loss (gain) on foreign currencies |
22,865 | (14,268 | ) | (22 | ) | (7,182 | ) | 1,393 | ||||||||||||
Total other expenses (income) |
28,232 | 30,619 | (25,701 | ) | (7,182 | ) | 25,968 | |||||||||||||
Income (loss) before income taxes |
(31,432 | ) | (135,007 | ) | 26,887 | 6,844 | (132,708 | ) | ||||||||||||
Income taxes expense (benefit) |
33,971 | (11,328 | ) | (935 | ) | (102 | ) | 21,606 | ||||||||||||
Equity in earnings in subsidiaries |
(88,911 | ) | 34,768 | | 54,143 | | ||||||||||||||
Net income (loss) |
(154,314 | ) | (88,911 | ) | 27,822 | 61,089 | (154,314 | ) | ||||||||||||
Page 33
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating cash flows for the six-month period ended March 31, 2011
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Cash flows from operating activities |
||||||||||||||||||||
Net cash provided by (used in) operating activities |
(79,627 | ) | 40,262 | (1,857 | ) | | (41,222 | ) | ||||||||||||
Cash flows from investing activities |
||||||||||||||||||||
Acquisition,
net of cash acquired |
| | (525,667 | ) | | (525,667 | ) | |||||||||||||
Disposal of
intangible assets |
| 500 | | | 500 | |||||||||||||||
Acquisition of property, plant and equipment |
| (1,913 | ) | (1,593 | ) | | (3,506 | ) | ||||||||||||
Intercompany advances |
(330,397 | ) | (156,548 | ) | 52,341 | 434,604 | | |||||||||||||
Investments in subsidiaries |
(114,000 | ) | (339,621 | ) | (106,123 | ) | 559,744 | | ||||||||||||
Net cash used in investing activities |
(444,397 | ) | (497,582 | ) | (581,042 | ) | 994,348 | (528,673 | ) | |||||||||||
Cash flows from financing activities |
||||||||||||||||||||
Issuance of long-term debt |
673,615 | 72,635 | | | 746,250 | |||||||||||||||
Repayment of long-term debt |
(288,184 | ) | (80,515 | ) | (351 | ) | | (369,050 | ) | |||||||||||
Stock-based compensation plan redemptions |
(84 | ) | | | | (84 | ) | |||||||||||||
Defered debt issue expenses |
(21,014 | ) | (1,949 | ) | | | (22,963 | ) | ||||||||||||
Intercompany advances |
22,094 | 175,659 | 236,851 | (434,604 | ) | | ||||||||||||||
Dividends paid |
(25 | ) | | | | (25 | ) | |||||||||||||
Capital contribution |
140,000 | | | | 140,000 | |||||||||||||||
Issue of shares |
| 220,123 | 339,621 | (559,744 | ) | | ||||||||||||||
Net cash provided by (used in) financing activities |
526,402 | 385,953 | 576,121 | (994,348 | ) | 494,128 | ||||||||||||||
Foreign exchange loss on cash held in foreign
currencies |
| 5 | 1,589 | | 1,594 | |||||||||||||||
Net increase (decrease) in cash and cash
equivalents |
2,378 | (71,362 | ) | (5,189 | ) | | (74,173 | ) | ||||||||||||
Cash and cash equivalents, beginning of period |
864 | 104,608 | 56,031 | | 161,503 | |||||||||||||||
Cash and cash equivalents, end of period |
3,242 | 33,246 | 50,842 | | 87,330 | |||||||||||||||
Page 34
Table of Contents
APTALIS PHARMA INC.
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Notes to Condensed Consolidated Financial Statements
(amounts in the tables are stated in thousands of U.S .dollars, except share related data)
(unaudited)
Condensed consolidating cash flows cash flows for the six-month period ended March 31, 2010
Subsidiary | ||||||||||||||||||||
Aptalis | Subsidiary | non- | ||||||||||||||||||
Pharma Inc. | guarantors | guarantors | Eliminations | Consolidated | ||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Cash flows from operating activities |
||||||||||||||||||||
Net cash provided by (used in) operating activities |
(56,048 | ) | 92,699 | 22,968 | | 59,619 | ||||||||||||||
Cash flows from investing activities |
||||||||||||||||||||
Acquisition of property, plant and equipment |
| (3,089 | ) | (373 | ) | | (3,462 | ) | ||||||||||||
Intercompany advances |
45,791 | 166 | (86 | ) | (45,871 | ) | | |||||||||||||
Investments in subsidiaries |
| | (68,000 | ) | 68,000 | | ||||||||||||||
Net cash provided by (used in) investing activities |
45,791 | (2,923 | ) | (68,459 | ) | 22,129 | (3,462 | ) | ||||||||||||
Cash flows from financing activities |
||||||||||||||||||||
Repayment of long-term debt |
(8,791 | ) | (12,074 | ) | | | (20,865 | ) | ||||||||||||
Stock-based compensation plan redemptions |
(328 | ) | | | | (328 | ) | |||||||||||||
Intercompany advances |
18,870 | (65,081 | ) | 340 | 45,871 | | ||||||||||||||
Dividends paid |
(128 | ) | | | | (128 | ) | |||||||||||||
Issue of shares |
| 68,000 | | (68,000 | ) | | ||||||||||||||
Net cash provided by (used in) financing activities |
9,623 | (9,155 | ) | 340 | (22,129 | ) | (21,321 | ) | ||||||||||||
Foreign exchange gain (loss) on cash held in
foreign currencies |
| 11 | (868 | ) | | (857 | ) | |||||||||||||
Net increase (decrease) in cash and cash
equivalents |
(634 | ) | 80,632 | (46,019 | ) | | 33,979 | |||||||||||||
Cash and cash equivalents, beginning of period |
702 | 41,859 | 83,874 | | 126,435 | |||||||||||||||
Cash and cash equivalents, end of period |
68 | 122,491 | 37,855 | | 160,414 | |||||||||||||||
Page 35
Table of Contents
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
On May 4, 2011, Axcan Intermediate Holdings Inc. announced that it has changed its name to Aptalis
Pharma Inc.
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 and six-month periods ended March 31, 2011, and March
31, 2010, reflect the results of operations for Aptalis Pharma Inc. previously known as 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, Aptalis, Company, we, us and our
refer to Aptalis Pharma Inc. previously known as 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
Aptalis Pharma Inc. is a privately held, leading specialty pharmaceutical company providing
innovative, effective therapies for unmet medical needs including cystic fibrosis and
gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United
States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®,
PYLERA®, LACTEOL®, DELURSAN®, and SALOFALK®. Our vision is to become the reference specialty
pharma company providing innovative, effective therapies for unmet medical needs, including cystic
fibrosis and gastrointestinal disorders, and we hope to achieve this through our mission: to
improve health and quality of care by providing specialty therapies for patients around the world.
The Company will strive to improve patient quality of care thanks to a broad range of products in
cystic fibrosis and gastrointestinal disorders, a robust pipeline, technology platform,
manufacturing capabilities and a skilled team of professionals with deep understanding of our
customers needs.
In addition to our marketing activities, the Company also formulates and clinically develops
enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary
pharmaceutical technology platforms including bioavailability enhancement of poorly soluble drugs,
custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.
We intend to enhance our position as the leading specialty pharmaceutical company concentrating in
the field of cystic fibrosis and gastroenterology by pursuing the following strategic initiatives:
1) growing sales of existing products; 2) launching new products; 3) selectively acquiring or
in-licensing complementary late stage or in-market products from third parties; 4) pursuing growth
opportunities through development pipeline and through our pharmaceutical technologies business;
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 and
cystic fibrosis centers 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.
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.
Page 36
Table of Contents
Acquisition of Eurand N.V. (Eurand Acquisition)
On February 11, 2011 or 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 $589.6 million
for 100% of such shares. We acquired 100% of the outstanding shares of Eurand by March 31, 2011.
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, and transferred the capital stock of former Eurand U.S. subsidiaries
to the Company.
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 acquisition of Eurand will enable us to
leverage the combination of two leading specialty pharmaceutical players, expand our
gastroenterology product portfolio and provide us with a proprietary R&D growth engine and
technology platforms supported by an extensive patent portfolio to meaningfully diversify its
business and expand its geographic and manufacturing footprint.
Fair value of consideration transferred
The table below details the consideration transferred to acquire Eurand:
Conversion | Form of | |||||||||||
Calculation | Fair Value | Consideration | ||||||||||
(in millions of U.S. dollars) | ||||||||||||
Eurand common stock outstanding as of acquisition date |
48,359,433 | 580.3 | Cash | |||||||||
Mutiplied by cash consideration per common share outstanding |
12.00 | | ||||||||||
Eurand stock options canceled for a cash payment(a) |
9.3 | Cash | ||||||||||
Total fair value of consideration transferred |
589.6 | |||||||||||
(a) | Each Eurand stock option, whether or not vested and exercisable on the acquisition date, was canceled for a cash payment equal to the excess of the per share value of the acquisition consideration over the per share exercise price of the Eurand stock option. |
The aggregate equity purchase price of $589.6 million plus acquisition costs (including related
fees and expenses) were funded by cash equity contributions, made through Aptalis Holdings Inc.,
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
Aptalis 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 $147.0 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). The
Senior Secured Revolving Credit Facility is comprised of $115.0 million of existing revolving
credit commitments that were extended or issued on February 11, 2011 (the Extended Commitments)
and $32.0 million of existing revolving credit commitments that were not extended (the Unextended
Commitments) pursuant to the Senior Secured Revolving Credit Facility.
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 Aptalis and Eurand, were used to repay the outstanding term loan
portion amounting to $125.7 million of the Companys existing senior secured credit facilities. The
remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March 15,
2011 to redeem 100% of our existing 9.25% senior secured notes due 2015.
Basis of presentation
The transaction has been 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.
Page 37
Table of Contents
Assets acquired and liabilities assumed
A preliminary purchase price allocation has been made and the recorded amounts are subject to
change. The following recognized amounts are provisional and subject to change:
| Amounts and useful lives for identifiable intangible assets and property, plant and equipment, pending the finalization of valuation efforts; | |
| Amounts for income tax assets and liabilities, pending finalization of estimates and assumptions in respect of certain tax aspects of the transaction, revision to fair value of acquired assets and liabilities, and the filing of Eurands pre-acquisition tax returns; and | |
| The allocation of goodwill among reporting units. |
We will finalize the purchase price allocation as we obtain the information necessary to complete
the measurement process. Any changes resulting from facts and circumstances that existed as of the
acquisition date may result in retrospective adjustments to the provisional amounts recognized at
the acquisition date. We expect to finalize the purchase price allocation no later than one year
from the acquisition date.
Resulting from the preliminary purchase price allocation, the following table summarizes the
estimated fair values of the assets acquired and liabilities assumed as of the acquisition date.
Amounts | ||||||||||||
Book value as at | Step-up to | recognized as of | ||||||||||
(in millions of U.S. dollars) | February 11, 2011 | fair value | acquisition date | |||||||||
$ | $ | $ | ||||||||||
Cash and cash equivalents |
63.9 | | 63.9 | |||||||||
Accounts receivable (a) |
22.7 | | 22.7 | |||||||||
Inventories (b) |
25.5 | 18.7 | 44.2 | |||||||||
Other current assets (c) |
6.6 | | 6.6 | |||||||||
Property, plant and equipment (d) |
44.6 | 10.9 | 55.5 | |||||||||
Identifiable intangible assets (d) |
7.0 | 406.9 | 413.9 | |||||||||
Current liabilities (e) |
(52.0 | ) | | (52.0 | ) | |||||||
Long-term debt, including current portion |
(3.4 | ) | | (3.4 | ) | |||||||
Deferred income taxes liabilities, net (f) |
(0.2 | ) | (61.0 | ) | (61.2 | ) | ||||||
Other non-current liabilities |
(8.5 | ) | 2.3 | (6.2 | ) | |||||||
Total identifiable net assets |
106.2 | 377.8 | 484.0 | |||||||||
Goodwill (g) |
37.5 | 69.0 | 106.5 | |||||||||
Net assets acquired |
143.7 | 446.8 | 590.5 | |||||||||
Effective settlement of pre-existing relationships (h) |
(0.9 | ) | | (0.9 | ) | |||||||
Total fair value of consideration transferred |
589.6 | |||||||||||
(a) | As of acquisition date, the fair value of accounts receivable acquired approximated book value. The gross contractual amount receivable was $23.2 million, of which $0.5 million was not expected to be collected. | |
(b) | Reflects the adjustment to step-up the carrying value of inventory acquired by $18.7 million to estimated fair value as of February 11, 2011. The stepped-up value is recorded as a charge to cost of goods sold as acquired inventory is sold. | |
(c) | Includes prepaid assets and income tax receivable. | |
(d) | The amounts recorded for the major components of acquired identifiable intangible assets are as follows: |
Amounts | Weighted | |||||||
recognized as of | average useful | |||||||
(in millions of U.S. dollars) | acquisition date | lives (years) | ||||||
$ | $ | |||||||
Trademarks, trademark licenses, manufacturing rights and other intangible assets with a finite life |
413.9 | 17.04 | ||||||
Total identifiable intangible assets |
413.9 | 17.04 | ||||||
In addition, the estimated aggregate amortization expense for the five succeeding years will be
$25.6 million annually.
(e) | Includes accounts payable, accrued liabilities and income taxes payable. | |
(f) | Comprises of current deferred tax assets $0.8 million, non-current deferred tax assets $15.7 million and non-current deferred tax liabilities $77.7 million. |
Page 38
Table of Contents
(g) | The excess of purchase price over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the acquisition. The goodwill recorded as part of the acquisition is largely attributable to synergies expected to result from combining the operations of Eurand and the Company and intangible assets that do not qualify for separate recognition. The Company does not expect any portion of this goodwill to be deductible for tax purposes. The allocation of goodwill among reporting units is not complete, pending finalization of the Companys internal reporting structure and composition of its post-acquisition operating segments and reporting units. |
(h) | The Company had entered into an exclusive development license and supply agreement with Eurand. No gain or loss was recognized in conjunction with the effective settlement of the contractual relationship between the Company and Eurand as a result of this acquisition. |
Transaction related costs
During the six-month period ended March 31, 2011, we have expensed $11.3 million (an additional
$1.1 million was expensed in the fiscal year ended September 30, 2010) of costs relating to legal,
financial, valuation and accounting advisory services performed in connection with effecting the
transaction with Eurand, which are included in acquisition and restructuring costs in the
accompanying Statement of Condensed Interim Consolidated Operations.
Actual and proforma information
The revenues derived from the Eurand entities for the period from the Acquisition Date to March 31,
2011 were $25.7 million and loss before income taxes was $0.7 million, excluding the effects of the
non-recurring acquisition accounting adjustments described above.
The following table presents pro forma consolidated results of operations as if the acquisition of
Eurand had occurred as of October 1, 2009:
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Total revenue |
131.5 | 123.5 | 261.4 | 261.4 | ||||||||||||
Loss before income taxes (a) |
(27.1 | ) | (108.9 | ) | (27.5 | ) | (117.1 | ) | ||||||||
Net loss (a) |
(24.9 | ) | (130.0 | ) | (26.4 | ) | (134.8 | ) | ||||||||
The pro forma consolidated results of operations were prepared using the acquisition method of
accounting and are based on the historical financial information of the Company and Eurand. The pro
forma information does not reflect any synergies and other benefits that the Company may achieve as
a result of the acquisition, or the costs necessary to achieve these synergies. In addition, the
pro forma information does not reflect the costs to integrate the operations of the Company and
Eurand.
The pro forma information is not necessarily indicative of what the Companys consolidated results
of operations actually would have been had the transaction been completed on October 1, 2009. In
addition, the pro forma information does not purport to project the future results of operations of
the Company. The pro forma information reflects primarily the following pro forma adjustments:
| elimination of product sales and royalties between Eurand and the Company, an elimination of the Companys cost of sales for Eurand-sourced inventories, and the elimination of certain PEP-related charges stemming from intercompany transactions; | |
| elimination of Eurands historical intangible asset amortization expense; | |
| additional amortization expense related to the fair value of identifiable intangible assets acquired; | |
| additional depreciation expense related to the fair value adjustment to property, plant and equipment acquired; | |
| elimination of interest expense and amortization of deferred financing costs related to the Companys term loan under the legacy senior secured credit facilities and 9.25% senior secured notes due 2015 that were repaid as part of the acquisition transaction; | |
| additional interest expense and amortization of deferred financing costs associated with financing obtained under the Amended and Restated Senior Secured Credit Facilities obtained by the Company in connection with the acquisition transaction; | |
| reduction of interest income associated with cash and cash equivalents that were used to partially fund the acquisition; | |
| elimination of acquisition-related costs and acquisition-related restructuring charges; | |
| elimination of $4.4 million of the acquisition accounting adjustment on Eurands inventory that was sold subsequent to the Aquisition Date, which will not have a continuing impact on the Companys operations. |
The pro forma effective tax rate differs from the statutory rate due to the relatively large impact
of actual permanent differences on relatively small pro forma income before tax, valuation
allowances on deferred tax assets in certain jurisdictions, and the expected impact of foreign
withholding taxes upon repatriation of foreign earnings.
Page 39
Table of Contents
FINANCIAL OVERVIEW FOR THREE-MONTH AND SIX-MONTH PERIODS ENDED MARCH 31, 2011
This discussion and analysis is based on our unaudited condensed interim financial statements as at
March 31, 2011 and our audited annual consolidated financial statements and the related notes
thereto reported under U.S. GAAP. The results of Eurands business have been included in our
results of operations, financial condition and cash flows only for the period subsequent to the
completion of the acquisition. 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 March 31, 2011, total revenue was $111.4 million ($94.4 million
for the three-month period ended March 31, 2010), operating loss
was $17.1 million ($132.1 million
for the three-month period ended March 31, 2010) and net loss was $71.7 million ($163.7 million for
the three-month period ended March 31, 2010). For the six-month period ended March 31, 2011, total
revenue was $197.3 ($204.5 million for the six-month period ended March 31, 2010), operating income
was $1.8 million (operating loss of $106.8 million for the corresponding period of fiscal year
2010) and net loss was $70.2 million ($154.3 million for the corresponding period of fiscal year
2010). Total revenue in the United States was $82.4 million (74.0% of total revenue) for the
three-month period ended March 31, 2011, compared to $69.6 million (73.7% of total revenue) for
the corresponding period of the preceding fiscal year. In the European Union, total revenue was
$20.7 million (18.5% of total revenue) for the three-month period ended March 31, 2011, compared to
$16.8 million (17.8% of total revenue) for the corresponding period of the preceding fiscal year.
In Canada, total revenue was $8.3 million (7.5% of total revenue) for the three-month period ended
March 31, 2011, compared to $7.9 million (8.4% of total revenue) for the corresponding period of
the preceding fiscal year. Total revenue in the United States was $140.6 million (71.2% of total
revenue) for the six-month period ended March 31, 2011 compared to $154.8 million (75.7% of total
revenue) for the corresponding period of the preceding fiscal year. In the European Union, total
revenue was $38.2 million (19.4% of total revenue) for the six-month period ended March 31, 2011,
compared to $32.6 million (15.9% of total revenue) for the corresponding period of the preceding
fiscal year. In Canada, total revenue was $18.5 million (9.4% of total revenue) for the six-month
period ended March 31, 2011, compared to $16.7 million (8.2% of total revenue) for the
corresponding period of the preceding fiscal 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 March 31, 2011, 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 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.
Page 40
Table of Contents
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. |
The reserve related to the PEPs event, was $5.3 million as at March 31, 2011, ($11.0 million as at
September 30, 2010). This reserve includes a reversal of $3.7 million in the quarter-ended March
31, 2011 to reflect the estimated sales value of the remaining inventory in the distribution
channel as at March 31, 2011. In future periods, we will continue to monitor and review the
assumptions and estimates and will prospectively record changes to the PEPs reserve.
Financial highlights
March 31, | September 30, | |||||||
(in millions of U.S. dollars) | 2011 | 2010 | ||||||
$ | $ | |||||||
Total assets |
1,292.1 | 713.2 | ||||||
Long-term debt (a) |
981.1 | 594.5 | ||||||
Shareholders equity (deficiency) |
63.5 | (21.0 | ) | |||||
(a) | Including the current portion |
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | three-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Total revenue |
111.4 | 94.4 | 197.3 | 204.5 | ||||||||||||
EBITDA (1) |
(27.6 | ) | (111.8 | ) | 4.6 | (69.8 | ) | |||||||||
Adjusted EBITDA (1) |
35.9 | 50.0 | 72.7 | 96.2 | ||||||||||||
Net loss |
(71.7 | ) | (163.7 | ) | (70.2 | ) | (154.3 | ) | ||||||||
Page 41
Table of Contents
(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 and six-month periods ended March 31, 2011 and 2010 are as follows: |
For the | For the | For the | For the | |||||||||||||
three-month | three-month | six-month | six-month | |||||||||||||
period ended | period ended | period ended | period ended | |||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | 2011 | 2010 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Net loss |
(71.7 | ) | (163.7 | ) | (70.2 | ) | (154.3 | ) | ||||||||
Financial expenses |
30.2 | 16.3 | 46.4 | 32.5 | ||||||||||||
Interest income |
(0.1 | ) | (0.2 | ) | (0.3 | ) | (0.3 | ) | ||||||||
Income tax expense (benefit) |
(4.4 | ) | 21.8 | (3.3 | ) | 21.6 | ||||||||||
Depreciation and amortization |
18.4 | 14.0 | 32.0 | 30.7 | ||||||||||||
EBITDA h) |
(27.6 | ) | (111.8 | ) | 4.6 | (69.8 | ) | |||||||||
Transaction, integration, refinancing costs and other
payments to third parties a) |
21.0 | 2.6 | 24.3 | 4.4 | ||||||||||||
Management fees b) |
0.8 | 1.0 | 1.6 | 1.9 | ||||||||||||
Stock-based compensation expense excluding impact of the
unapproved PEPs event c) |
5.3 | 2.5 | 5.8 | 4.0 | ||||||||||||
Preliminary impairment of intangible assets and goodwill
related to the unapproved PEPs event d) |
| 107.2 | | 107.2 | ||||||||||||
Adjustments related to the unapproved PEPs event e) |
(3.7 | ) | 48.5 | (3.7 | ) | 48.5 | ||||||||||
Loss on extinguishment of debt |
28.3 | | 28.3 | | ||||||||||||
Loss on disposal of product line f) |
7.4 | | 7.4 | | ||||||||||||
Inventory stepped-up value expenses g) |
4.4 | | 4.4 | | ||||||||||||
Adjusted EBITDA h) |
35.9 | 50.0 | 72.7 | 96.2 | ||||||||||||
a) | Represents transaction, integration, restructuring and refinancing costs as well as due diligence costs related to the Eurand Acquisition as well as to certain other business development projects, 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 U.S. GAAP guidance. | |
d) | Intangible assets and goodwill write-downs related to the unapproved PEPs event. | |
e) | Adjustments and other write-downs related to the unapproved PEPs event, including a reduction of $3.7 million to the sales returns reserve during the three-month and six-month periods ended March 31, 2011 (additional returns provision of $10.4 million, inventory write-down of $28.1 million, accrual for purchases and other materials and supply commitments of $14.9 million and a stock-based compensation recovery of $4.9 million during the three-month and six-month periods ended March 31, 2010). | |
f) | Loss resulting from the disposal of the PHOTOFRIN/PHOTOBARR product line. | |
g) | As part of the purchase price allocation for Eurand Acquisition, the book value of inventory acquired was stepped up to fair value by $18.7 million as at Acquisition date. The stepped-up value is recorded as charge to cost of goods sold as acquired inventory is sold, until acquired inventory will be sold off. | |
h) | 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 Resources-Long-term Debt and New Senior Secured Credit Facility, except that in calculating Adjusted EBITDA, we do not include certain additional adjustments under the indenture and the Credit Facility that permit us to increase EBITDA and Consolidated EBITDA by including projected cost savings and synergies calculated on a pro forma basis that we expect to realize in future periods related to actions already taken or expected to be taken within twelve months of the end of the applicable period, including the Eurand Acquisition and related initiatives. 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: |
Page 42
Table of Contents
| 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.
Page 43
Table of Contents
Overview of results of operations
For the | For the | |||||||||||||||
three-month | three-month | |||||||||||||||
period ended | period ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Net product sales |
109.8 | 94.4 | 15.4 | 16.3 | ||||||||||||
Development fees |
0.6 | | 0.6 | | ||||||||||||
Royalties |
1.0 | | 1.0 | | ||||||||||||
Total revenue |
111.4 | 94.4 | 17.0 | 18.0 | ||||||||||||
Cost of goods sold a) b) |
31.9 | 68.2 | (36.3 | ) | (53.2 | ) | ||||||||||
Selling and administration expenses a) b) |
38.9 | 28.4 | 10.5 | 36.9 | ||||||||||||
Management fees |
0.8 | 1.0 | (0.2 | ) | (20.0 | ) | ||||||||||
Research and development expenses a) |
10.9 | 7.7 | 3.2 | 41.6 | ||||||||||||
Other Research and development expenses attributable to
development fees a) |
0.9 | | 0.9 | | ||||||||||||
Loss on disposal of product line |
7.4 | | 7.4 | | ||||||||||||
Depreciation and amortization |
18.4 | 14.0 | 4.4 | 31.4 | ||||||||||||
Transaction, restructuring and integration costs |
19.3 | | 19.3 | | ||||||||||||
Impairment of intangible assets and goodwill b) |
| 107.2 | (107.2 | ) | (100.0 | ) | ||||||||||
Total operating expenses |
128.5 | 226.5 | (98.0 | ) | (43.3 | ) | ||||||||||
Operating income (loss) |
(17.1 | ) | (132.1 | ) | 115.0 | 87.1 | ||||||||||
Financial expenses |
30.2 | 16.3 | 13.9 | 85.3 | ||||||||||||
Loss on extinguishment of debt |
28.3 | | 28.3 | | ||||||||||||
Interest income |
(0.1 | ) | (0.2 | ) | 0.1 | 50.0 | ||||||||||
Other income |
| (7.7 | ) | 7.7 | 100.0 | |||||||||||
Loss (gain) on foreign currencies |
0.6 | 1.4 | (0.8 | ) | (57.1 | ) | ||||||||||
Total other expenses |
59.0 | 9.8 | 49.2 | 502.0 | ||||||||||||
Income (loss) before income taxes |
(76.1 | ) | (141.9 | ) | 65.8 | 46.4 | ||||||||||
Income taxes expense (benefit) b) |
(4.4 | ) | 21.8 | (26.2 | ) | (120.2 | ) | |||||||||
Net income (loss) |
(71.7 | ) | (163.7 | ) | 92.0 | 56.2 | ||||||||||
a) | Exclusive of depreciation and amortization | |
b) | Including one time charges related to the unapproved PEPs event |
Page 44
Table of Contents
For the | For the | |||||||||||||||
six-month | six-month | |||||||||||||||
period ended | period ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Net product sales b) |
195.7 | 204.5 | (8.8 | ) | (4.3 | ) | ||||||||||
Development fees |
0.6 | | 0.6 | | ||||||||||||
Royalties |
1.0 | | 1.0 | | ||||||||||||
Total revenue |
197.3 | 204.5 | (7.2 | ) | (3.5 | ) | ||||||||||
Cost of goods sold a) b) |
49.3 | 94.8 | (45.5 | ) | (48.0 | ) | ||||||||||
Selling and administration expenses a) b) |
64.1 | 60.6 | 3.5 | 5.8 | ||||||||||||
Management fees |
1.6 | 1.9 | (0.3 | ) | (15.8 | ) | ||||||||||
Research and development expenses a) |
17.9 | 16.1 | 1.8 | 11.2 | ||||||||||||
Other Research and development expenses attributable to
development fees a) |
0.9 | | 0.9 | | ||||||||||||
Loss on disposal of product line |
7.4 | | 7.4 | | ||||||||||||
Depreciation and amortization |
32.0 | 30.7 | 1.3 | 4.2 | ||||||||||||
Transaction, restructuring and integration costs |
22.3 | | 22.3 | | ||||||||||||
Impairment of intangible assets and goodwill b) |
| 107.2 | (107.2 | ) | (100.0 | ) | ||||||||||
Total operating expenses |
195.5 | 311.3 | (115.8 | ) | (37.2 | ) | ||||||||||
Operating income (loss) |
1.8 | (106.8 | ) | 108.6 | 101.7 | |||||||||||
Financial expenses |
46.4 | 32.5 | 13.9 | 42.8 | ||||||||||||
Loss on extinguishment of debt |
28.3 | | 28.3 | | ||||||||||||
Interest income |
(0.3 | ) | (0.3 | ) | | | ||||||||||
Other income |
| (7.7 | ) | 7.7 | 100.0 | |||||||||||
Loss (gain) on foreign currencies |
0.9 | 1.4 | (0.5 | ) | (35.7 | ) | ||||||||||
Total other expenses |
75.3 | 25.9 | 49.4 | 190.7 | ||||||||||||
Income (loss) before income taxes |
(73.5 | ) | (132.7 | ) | 59.2 | 44.6 | ||||||||||
Income taxes expense (benefit) b) |
(3.3 | ) | 21.6 | (24.9 | ) | (115.3 | ) | |||||||||
Net income (loss) |
(70.2 | ) | (154.3 | ) | 84.1 | 54.5 | ||||||||||
a) | Exclusive of depreciation and amortization | |
b) | Including one time charges related to the unapproved PEPs event |
Net product sales
Net product sales in the U.S. amounted to $80.9 million for the three-month period ended March 31,
2011, compared to $69.6 million for the corresponding period of the preceding fiscal year, an
increase of $11.3 million (16.2%) and $139.2 million for the six-month period ended March 31, 2011,
compared to $154.8 million for the corresponding period of the preceding fiscal year, a decrease of
$15.6 million (10.1%). For the three-month period, the increase in sales in U.S. is due to the
inclusion of post-acquisition sales of legacy Eurand products ($19.1 million), higher sales volume
of Carafate products ($6.6 million) and the favourable impact of the sales returns reserve related
to the PEPs event ($14.1 million), partially offset by the absence of Ultrase and Viokase product
sales ($29.3 million). For the six-month period, the decrease in net products sales is due to the
absence of Ultrase and Viokase product sales ($59.9 million) partially offset by the favourable
impact of the sales returns related to the PEPs event (additional provision amounting to $10.4
million during the three-month period ended March 31, 2010 and reversal of $3.7 million during the
three-month period ended March 31, 2011), higher sales volume of Carafate products ($10.8 million)
and by the increase related to the inclusion of post-acquisition sales of legacy Eurand products
($19.1 million).
Net product sales in the European Union increased 22.6%, to $20.6 million for the three-month
period ended March 31, 2011, compared to $16.8 million for the corresponding period of the
preceding fiscal year and increased 16.6% from $32.6 million for the six-month period ended March
31, 2010 to $38.0 million for the six-month period ended March 31, 2011. The increase is mostly due
to the inclusion of post-acquisition sales of legacy Eurand products amounting to $5.1 million.
Net product sales in Canada increased 5.1%, to $8.3 million for the three-month period ended March
31, 2011, compared to $7.9 million for the corresponding period of the preceding fiscal year and
increased 10.8% from $16.7 million for the six-month period ended March 31, 2010 to $18.5 million
for the six-month period ended March 31, 2011. The increase in sales resulted primarily from higher
sales volume of SALOFALK.
Page 45
Table of Contents
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 | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Gross product sales |
133.3 | 133.7 | (0.4 | ) | (0.3 | ) | ||||||||||
Gross-to-net product sales adjustments |
||||||||||||||||
Product returns |
5.0 | 2.8 | 2.2 | 78.6 | ||||||||||||
Product returns related to unapproved PEPs event |
(3.7 | ) | 10.4 | (14.1 | ) | (135.6 | ) | |||||||||
Chargebacks |
9.2 | 10.7 | (1.5 | ) | (14.0 | ) | ||||||||||
Contract rebates |
8.5 | 11.3 | (2.8 | ) | (24.8 | ) | ||||||||||
DSA fees |
2.3 | 1.8 | 0.5 | 27.8 | ||||||||||||
Discounts and other allowances |
2.2 | 2.3 | (0.1 | ) | (4.3 | ) | ||||||||||
Total gross-to-net product sales adjustments |
23.5 | 39.3 | (15.8 | ) | (40.2 | ) | ||||||||||
Total net product sales |
109.8 | 94.4 | 15.4 | 16.3 | ||||||||||||
For the | For the | |||||||||||||||
six-month | six-month | |||||||||||||||
period ended | period ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Gross product sales |
241.1 | 279.0 | (37.9 | ) | (13.6 | ) | ||||||||||
Gross-to-net product sales adjustments |
||||||||||||||||
Product returns |
7.9 | 4.1 | 3.8 | 92.7 | ||||||||||||
Product returns related to unapproved PEPs event |
(3.7 | ) | 10.4 | (14.1 | ) | (135.6 | ) | |||||||||
Chargebacks |
20.1 | 25.5 | (5.4 | ) | (21.2 | ) | ||||||||||
Contract rebates |
13.6 | 25.9 | (12.3 | ) | (47.5 | ) | ||||||||||
DSA fees |
3.4 | 3.6 | (0.2 | ) | (5.6 | ) | ||||||||||
Discounts and other allowances |
4.1 | 5.0 | (0.9 | ) | (18.0 | ) | ||||||||||
Total gross-to-net product sales adjustments |
45.4 | 74.5 | (29.1 | ) | (39.1 | ) | ||||||||||
Total net product sales |
195.7 | 204.5 | (8.8 | ) | (4.3 | ) | ||||||||||
Product returns, contract rebates, DSA fees, discounts and other allowances totalled $23.5 million
(17.6% of gross product sales) for the three-month period ended March 31, 2011 and $45.4 million
(18.8% of gross product sales) for the six-month period ended March 31, 2011, compared to $39.3
million (29.4% of gross product sales) and $74.5 million (26.7% of gross product sales) for the
corresponding period of the preceding fiscal year.
The decrease in total deductions as a percentage of gross product sales was mainly due to the PEPs
event (additional provision amounting to $10.4 million during the three-month period ended March
31, 2010 and reversal of $3.7 million during the three-month period ended March 31, 2011) and
revenue related to pharmaceutical technology business acquired in the Eurand transaction that
doesnt have sales deductions. Excluding those two elements, the sales deductions would have been
22.2% during the three-month period ended March 31, 2011 and 21.3% during the six-month period
ended March 31, 2011 compared to 21.6% and 22.9% for the same periods last year.
Page 46
Table of Contents
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 $0.5 million for the three-month
period ended March 31, 2011 and $2.2 million for the six-month period ended March 31, 2011 compared
to $0.8 million in the three-month and the six-month periods of last year.
Development fees
For the three-month and six month periods ended March 31, 2011, development fees amounted to $0.6
million. These fees resulted from the inclusion of Eurands business in the post-acquisition
period. Development of a new pharmaceutical formulation generally includes the following stages:
| feasibility and prototype development; |
| formulation optimization and preparation of pilot clinical samples; |
| scale-up, validation and preparation of clinical samples for regulatory and commercial purposes; |
| clinical trials; and |
| preparation of documents and regulatory filings. |
The Company applies its proprietary pharmaceutical technologies in one of two ways either to
develop products on behalf of our collaborators or as internal programs. In both situations, the
Company is involved in all stages of the formulation development process and performs largely the
same types of work although, in general, the Company only performs clinical trials for the products
we develop internally. Clinical trials for co-developed products are typically performed by our
collaboration partners. For internal projects, we fund all of the development costs with a view
either to out-license the product once it is fully developed and has obtained the applicable
regulatory approvals, or to market it directly.
In our typical co-development contract, we generally receive development fees and milestones from
our collaborators. Most of our current co-development agreements provide for us to perform
development activities based on an hourly service fee. Our current co-development agreements also
typically include provisions for the receipt of milestone payments upon the achievement of certain
development and/or regulatory milestones including, by way of example, successful completion of
development phases, successful demonstration of bioequivalence, and acceptance and approval by the
applicable regulatory agencies. Milestone payments are usually structured as lump sum payments,
which are due if and when we reach certain mutually agreed-upon development milestones as set forth
in the agreements. In many cases, achievement of such milestone payments is based on factors that
are out of our control, including, among other things, regulatory approval of the product. In
addition, in many cases, decisions directly affecting the receipt of these payments are made at the
sole discretion of our collaborator. Due to the structure of our co-development agreements and the
inherent difficulty in predicting progress on development plans, our development fees may fluctuate
significantly from quarter to quarter. In addition, development fees will fluctuate depending on
the number of co-development agreements we enter into in a given year or quarter.
Page 47
Table of Contents
Royalties
For the three-month and six month periods ended March 31, 2011, royalties amounted to $1.0 million
and resulted from the inclusion of legacy Eurands business in the post-acquisition period. The
Company earns royalty revenues from its collaborators equal to a percentage of their product sales.
Cost of goods sold
Cost of goods sold consists principally of the cost of raw materials, royalties and manufacturing.
For the three-month period ended March 31, 2011, cost of goods sold decreased $36.3 million (53.2%)
to $31.9 million from $68.2 million for the corresponding period of the preceding fiscal year. As a
percentage of net product sales, cost of goods sold for the three-month period ended March 31,
2011, decreased compared to the corresponding period of the preceding fiscal year to 29.1% from
72.2% mostly due to the unapproved PEPs event. For the six-month period ended March 31, 2011, cost
of goods sold decreased $45.5 million (48.0%) to $49.3 million from $94.8 for the corresponding
period ended March 31, 2010. As a percentage of net product sales, cost of goods sold for the
six-month period ended March 31, 2011 decreased compared to the corresponding period of the
preceding fiscal year to 25.2% from 46.4% primarily due to provisions taken as a result of the
unapproved PEPs event.
Excluding the unapproved PEPs during the three-month period ended March 31, 2011, cost of goods
sold as a percentage of net product sales would have been 30.1% compared to 32.3% for the
three-month period ended March 31, 2010 and 25.8% compared to 26.1% for the six-month period ended
March 31, 2010. The decreases related to the unapproved PEPs event was partially offset by the
additional expense associated the inventory stepped up to fair value. As part of the purchase price
allocation for Eurand Acquisition, the book value of inventory acquired was stepped up to fair
value by $18.7 million as at Acquisition Date. The stepped-up value is recorded as charge to cost
of goods sold as acquired inventory is sold, until acquired inventory will be sold off. An amount
of $4.4 million was expensed during the three-month period ended March 31, 2011.
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
March 31, 2011, selling and administrative expenses increased $10.5 million (36.9%) to $38.9
million from $28.4 million for the corresponding period of the preceding fiscal year. For the
six-month period ended March 31, 2011, selling and administrative expenses increased $3.5 million
(5.8%) to $64.1 million from $60.6 million for the corresponding period of the preceding fiscal
year. The increases are mainly resulting from the inclusion of legacy Eurands business in the
post-acquisition period amounting to $11.1 million and an increase in non-cash stock-based
compensation expense. The increases were partially offset by a reduction of ULTRASE AND VIOKASE
products marketing expenses and patient programs.
Management fees
Management fees consist of fees and other charges associated with the Management Services Agreement
with TPG. For the three-month period ended March 31, 2011, management fees decreased $0.2 million
(20.0%) to $0.8 million from $1.0 million for the corresponding period of the preceding fiscal
year. For the six-month period ended March 31, 2011, management fees decreased $0.3 million (15.8%)
to $1.6 million from $1.9 million for the corresponding period of the preceding fiscal year.
Research and development expenses
Research and development expenses refer to internal research and development expense and 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 March 31,
2011, research and development expenses increased $3.2 million (41.6%) to $10.9 million, from $7.7
million for the corresponding period of the preceding fiscal year. For the six-month period ended
March 31, 2011, research and development expenses increased $1.8 million (11.2%) to $17.9 million,
from $16.1 million for the corresponding period of the preceding fiscal year. The increase in
research and development expenses is mainly due to the inclusion of expenses associated with Eurand
activities in the post-acquisition period amounting to $2.8 million. The increase was partially
offset by the reduction in expenses related to the development work on PEPs for the six-month
period ended March 31, 2011.
On March 14, 2011, we entered into an agreement with a third-party to jointly develop a new
combination product including Sucralfate. Under the terms of this agreement, we will pay a series
of contingent and non-contingent milestone based payments. Upon commercialization of the new
product, we will pay the third party to the arrangement a single digit royalty on net sales of the
new product. Additionally, the Company will pay the third party a single digit royalty on net sales
of Carafate, beginning on January 1, 2013, until December 31, 2019.
Other research and development expenses attributable to development fees
The Company incurs research and development expense on a number of external projects with third
parties that generate development fee revenues and consist principally of personnel cost. For the
three-month and six month periods ended March 31, 2011, research and development expenses
attributable to development fees amounted to $0.9 million and resulting from the inclusion of
expenses associated with Eurand activities in the post-acquisition period.
Page 48
Table of Contents
Loss on disposal of product line
On March 28, 2011, we entered into a definitive agreement with Pinnacle Biologics, Inc., which
acquired all global assets and rights related to PHOTOFRIN/PHOTOBARR, including inventory, for
non-contingent payments amounting to $4.2 million. In addition to the non-contingent payments,
additional payments shall be made to us after the achievement of certain milestones events. In
addition, the Company will be paid royalties on annual net sales of PHOTOFRIN/PHOTOBARR.
During the quarter ended March 31, 2011, we recorded a loss of $7.4 million as a result of the
disposal of the PHOTOFRIN/PHOTOBARR product line. Consideration for additional contingent payments
to be made to the Company shall be recorded as a gain in the period in they are received.
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 March 31, 2011, depreciation and amortization increased $4.4 million
(31.4%) to $18.4 million from $14.0 million for the corresponding period of the preceding fiscal
year. For the six-month period ended March 31, 2011, depreciation and amortization increased $1.3
million (4.2%) to $32.0 million from 30.7 million for the corresponding period of the preceding
fiscal year. These increases are mainly due to additional depreciation and amortization of
intangible assets recognized on the acquisition of Eurand.
Transaction, restructuring and integration costs
During the six-month period ended March 31, 2011, we have expensed $11.3 million (an additional
$1.1 million was expensed in the fiscal year ended September 30, 2010) of costs relating to legal,
financial, valuation and accounting advisory services performed in connection with effecting the
transaction with Eurand, which are included in acquisition and restructuring costs in the
accompanying Statement of Condensed Consolidated Operations.
We have initiated restructuring measures in conjunction with the integration of the operations of
Eurand. These measures are intended to capture synergies and generate cost savings across the
Company.
Restructuring actions taken thus far include workforce reductions across the Company and other
organizational changes. These reductions primarily come from the elimination of redundancies and
consolidation of staff in the sales and marketing, manufacturing, research and development, and
general and administrative functions, as well as from the planned closure of Eurands manufacturing
facility in Nogent-Oise, France.
During the quarter ended March 31, 2011, we recorded a restructuring expense in the amount of $5.0
million related to planned employee termination costs. Employee termination costs are generally
recorded when the actions are probable and estimable and include accrued severance benefits and
health insurance continuation, many of which may be paid out during periods after termination.
The Company estimates to incur additional costs between $17.2 million and $21.3 million in
connection with planned employee termination costs. The restructuring actions taken thus far are
expected to be substantially completed by the end of 2012.
Through March 31, 2011, the Company has incurred integration costs of $6.0 million representing
certain external, incremental costs directly related to integrating the acquired business and
primarily include expenditures for consulting and systems integration.
Impairment of intangible assets and goodwill
The value of goodwill and intangible assets with an indefinite life are subject to an annual
impairment test unless events or changes in circumstances indicate that the carrying amounts of
these assets may not be recoverable. The intangible assets with a finite life and property, plant
and equipment are subject to an impairment test whenever events or changes in circumstances
indicate that the carrying amounts of these assets may not be recoverable. As a result of the
unapproved PEPs event, we compared the carrying value of the intangible assets with a finite life
affected by the unapproved PEPs event to estimated future undiscounted cash flows. The change in
circumstances associated with the unapproved PEPs event also caused us to review the
carrying value of our long lived intangible assets including goodwill. Based on this review, a
preliminary impairment charge of $107.2 million was recorded for the three-month and six-month
periods ended March 31, 2010, reflecting charges of $91.4 million for the goodwill allocated to our
U.S. reporting unit and of $15.8 million related to finite life intangible assets.
Financial expenses
Financial expenses consist principally of interest and fees paid in connection with funds borrowed
for acquisitions. For the three-month period ended March 31, 2011, financial expenses increased
$13.9 million (85.3%) to $30.2 from $16.3 million for the corresponding period of the preceding
fiscal year. For the six-month period ended March 31, 2011, financial expenses increased $13.9
million (42.8%) to $46.4 million from $32.5 million for the corresponding period of the preceding
fiscal year. For the three-month period ended March 31, 2011, financial expenses included certain
one-time fees related to bridge financing and the renegotiation of our credit agreement. On
February 11, 2011, we entered into an amended and restated credit agreement and related security
and other agreements in connection with the Eurand Acquisition as described in the Long-term debt
and Credit Facility section below.
Page 49
Table of Contents
Loss on extinguishment of debt
In conjunction with the Eurand Acquisition, the proceeds of the debt and equity financing were used
to repay the outstanding term loan amounting to $125.7 million of our then existing senior secured
credit facilities. Subsequent to the Eurand Acquisition, we redeemed our existing 9.25% senior
secured notes of $228.0 million due 2015 at a premium of 106.938%. The difference between the net
carrying value and the repayment price of the outstanding term loan and 9.25% senior secured notes
was recognized as a loss on extinguishment of debt. For the three-month and six-month periods ended
March 31, 2011, loss on Extinguishment of Debt amounted to $28.3 million and comprised of the
write-off of the unamortized deferred financing fees, the original issuance discount and the
redemption premium.
Interest income
For the three-month period ended March 31, 2011, total interest income decreased to $0.1 million
from $0.2 million for the corresponding period of the preceding fiscal year. For the six-month
period ended March 31, 2011, and the six-month period ended March 31, 2010, total interest income
amounted $0.3 million.
Other income
In June 2007, we initiated a lawsuit under the U.S. Lanham Act against a number of defendants
alleging they falsely advertised their products to be similar or equivalent to ULTRASE® MT. During
the three-month and six-month periods ended March 31, 2010, an amount of $7.7 million was paid to
us pursuant to settlement arrangements entered into with the defendants in these matters.
Income taxes
For the three-month period ended March 31, 2011, income tax benefit amounted to $4.4 million
compared to income tax expense of $21.8 million for the corresponding period of the preceding
fiscal year. For the six-month period ended March 31, 2011, income tax benefit amounted to $3.3
million compared to income tax expense of $21.6 million for the corresponding period of the
preceding fiscal year. The effective tax rate was 5.9%, for the three-month period ended March 31,
2011, compared to minus 15.4% for the corresponding period of the preceding fiscal year. For the
six-month period ended March 31, 2011, the effective tax rate was 4.5% compared to minus 16.3% for
the corresponding period of the preceding fiscal year. The effective tax rate for the three-month
and six-month periods ended March 31, 2011, is affected by a number of elements, the most important
being the establishment of a valuation allowance of $29.5 million during the six-month period ended
March 31, 2011 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 | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(in millions of US dollars) | 2011 | 2010 | ||||||||||||||
% | $ | % | $ | |||||||||||||
Combined statutory rate applied to pre-tax income (loss) |
35.00 | (26.6 | ) | 35.00 | (49.7 | ) | ||||||||||
Increase (decrease) in taxes resulting from: |
||||||||||||||||
Change in promulgated rates |
(0.13 | ) | 0.1 | 0.07 | (0.1 | ) | ||||||||||
Difference with foreign tax rates |
(0.80 | ) | 0.6 | 0.56 | (0.8 | ) | ||||||||||
Valuation allowance |
(32.21 | ) | 24.5 | (31.71 | ) | 45.0 | ||||||||||
Tax benefit arising from a financing structure |
6.35 | (4.8 | ) | 2.40 | (3.4 | ) | ||||||||||
Non-deductible items |
(2.80 | ) | 2.1 | (23.96 | ) | 33.9 | ||||||||||
Non-taxable items |
| | | | ||||||||||||
Investment tax credits |
0.89 | (0.7 | ) | 0.28 | (0.4 | ) | ||||||||||
State taxes |
(0.29 | ) | 0.2 | 2.61 | (3.6 | ) | ||||||||||
Other |
(0.14 | ) | 0.1 | (0.61 | ) | 0.9 | ||||||||||
5.87 | (4.5 | ) | (15.36 | ) | 21.8 | |||||||||||
Page 50
Table of Contents
For the | For the | |||||||||||||||
six-month | six-month | |||||||||||||||
period ended | period ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
(in millions of US dollars) | 2011 | 2010 | ||||||||||||||
% | $ | % | $ | |||||||||||||
Combined statutory rate applied to pre-tax income (loss) |
35.00 | (25.7 | ) | 35.00 | (46.4 | ) | ||||||||||
Increase (decrease) in taxes resulting from: |
||||||||||||||||
Change in promulgated rates |
(0.09 | ) | 0.1 | | | |||||||||||
Difference with foreign tax rates |
0.79 | (0.6 | ) | 1.13 | (1.5 | ) | ||||||||||
Valuation allowance |
(40.26 | ) | 29.5 | (33.91 | ) | 45.0 | ||||||||||
Tax benefit arising from a financing structure |
11.63 | (8.5 | ) | 5.73 | (7.6 | ) | ||||||||||
Non-deductible items |
(3.44 | ) | 2.5 | (25.92 | ) | 34.4 | ||||||||||
Non-taxable items |
| | | | ||||||||||||
Investment tax credits |
1.24 | (0.9 | ) | 0.45 | (0.6 | ) | ||||||||||
State taxes |
(0.42 | ) | 0.3 | 2.56 | (3.3 | ) | ||||||||||
Other |
| | (1.32 | ) | 1.6 | |||||||||||
4.45 | (3.3 | ) | (16.28 | ) | 21.6 | |||||||||||
Net income
For the three-month period ended March 31, 2011, net loss decreased $92.0 million (56.2%) to $71.7
million from $163.7 million for the corresponding period of the preceding fiscal year. For the
six-month period ended March 31, 2011, net loss decreased $84.1 million (54.5%) to $70.2 million
from net loss of $154.3 million for the corresponding period of the preceding fiscal year. The
decreases in net loss are mainly due the additional charges related to the unapproved PEPs event
amounting to $175.1 million in the three-month and six-month periods ended March 31, 2010. The
decreases in net loss were partially offset by the loss on extinguishment of debt amounting to
$28.3 million and transaction and acquisition costs amounting to $19.3 million for the three-month
period and $22.3 million for the six-month period ended March 31, 2011.
Balance sheets as at March 31, 2011, and September 30, 2010
The following table summarizes balance sheet information as at March 31, 2011, compared to
September 30, 2010.
March 31, | September 30, | |||||||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||||||
$ | $ | $ | % | |||||||||||||
Cash and cash equivalents |
87.3 | 161.5 | (74.2 | ) | (45.9 | ) | ||||||||||
Current assets |
242.4 | 226.7 | 15.7 | 6.9 | ||||||||||||
Total assets |
1,292.1 | 713.2 | 578.9 | 81.2 | ||||||||||||
Current liabilities |
144.6 | 111.3 | 33.3 | 29.9 | ||||||||||||
Long-term debt |
972.2 | 581.3 | 390.9 | 67.2 | ||||||||||||
Total liabilities |
1,228.6 | 734.2 | 494.4 | 67.3 | ||||||||||||
Shareholders equity (deficiency) |
63.5 | (21.0 | ) | 84.5 | (402.4 | ) | ||||||||||
Working capital |
97.8 | 115.4 | (17.6 | ) | (15.3 | ) |
Working capital decreased by $17.6 million (15.3%) to $97.8 million as at March 31, 2011, from
$115.4 million as at September 30, 2010.
Total assets increased $578.9 million (81.2%) to $1,292.1 million as at March 31, 2011, from $713.2
million as at September 30, 2010. This increase was mainly due to the total assets acquired with
Eurand Acquisition amounting to $693.1 million as at March 31, 2011.
Long-term debt increased $390.9 million (67.2%) to $972.2 million as at March 31, 2011, from $581.3
million as at September 30, 2010. On February 11, 2011, the Company entered into an amended and
restated credit agreement and related security and other agreements in connection with the Eurand
Acquisition as described in the Long-term debt and Credit Facility section below.
Page 51
Table of Contents
Liquidity and Capital Resources
Cash requirements
As at March 31, 2011, working capital was approximately $97.8 million and $115.4 million as at
September 30, 2010. Cash generated from operations, 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.
On February 11, 2011 or Acquisition Date, Axcan Holdings Inc. (Axcan Holdings), our 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 $589.6 million
for 100% of such shares. We had acquired 100% of the outstanding shares of Eurand by March 31,
2011. 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, and transferred the capital stock of former Eurand U.S. subsidiaries
to the Company.
The aggregate equity purchase price of $589.6 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 Aptalis 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 $147.0 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). The
Company 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 Aptalis
and Eurand, were also used to repay the outstanding term loan portion amounting to $125.7 million
of the Companys existing senior secured credit facilities and to pay related fees and expenses.
The remaining amount of $250.0 million of the Senior Secured Term Loan Facility was used on March
15, 2011 to redeem 100% of the Companys 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.
Contractual obligations and other commitments
The following table summarizes our significant contractual obligations as at March 31, 2011, 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 March 31, 2011, and certain other purchase obligations as discussed below:
Less than | More than 5 | |||||||||||||||||||
(in millions of U.S. dollars) | Total | 1 year | 1-3 years | 3-5 years | years | |||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Long-term debt |
986.3 | 8.9 | 16.8 | 250.0 | 710.6 | |||||||||||||||
Operating leases |
5.9 | 2.7 | 3.0 | 0.2 | | |||||||||||||||
Other commitments |
3.8 | 2.9 | 0.8 | 0.1 | | |||||||||||||||
Interest on long-term debt |
445.5 | 76.8 | 155.6 | 163.3 | 49.8 | |||||||||||||||
1,441.5 | 91.3 | 176.2 | 413.6 | 760.4 | ||||||||||||||||
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.
Page 52
Table of Contents
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 at March 31, 2011, we had unrecognized tax benefits of $11.7 million ($11.3 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.
Long-term debt and Credit Facility
On February 11, 2011, the Company entered into an amended and restated credit agreement and related
security and other agreements in connection with the Eurand Acquisition.
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 $147.0 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 Aptalis and Eurand, were 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. Following the repayment, all unamortized deferred financing fees of $2.7
million and original issuance discount of $3.2 million related to the term loan were written off
and are included in loss on extinguishment of debt in the accompanying Statement of Condensed
Interim Consolidated Operations. The remaining amount of $250.0 million of the Senior Secured Term
Loan Facility was drawn on March 15, 2011 to redeem our existing 9.25% senior secured notes due
2015.
On February 25, 2008, the Company issued $228.0 million 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. On March 15, 2011, $250.0 million of the
Senior Secured Term Loan Facility was used to redeem 100% of the Companys Senior Secured Notes at
a redemption price of 106.938%. The aggregate redemption amount consisted of $228.0 million in
aggregate principal amount, $0.8 million accrued interest and $15.8 million of redemption premium
which is included in loss on extinguishment or debt in the accompanying Statement of Condensed
Interim Consolidated Operations. Following the redemption all unamortized deferred financing fees
of $5.0 million and original issuance discount of $1.7 million related to these notes were written
off and are included in loss on extinguishment of debt in the accompanying Statement of Condensed
Interim Consolidated Operations.
The Companys Amended and Restated Senior Secured Credit Facilities totaling $897.0 million is
composed of a Senior Secured Term Loan Facility amounting to $750.0 million and a Senior Secured
Revolving Credit Facility totaling $147.0 million. The Senior Secured Revolving Credit Facility is
comprised of $115.0 million of existing revolving credit commitments that were extended or issued
on February 11, 2011 (the Extended Commitments) and $32.0 million of existing revolving credit
commitments that were not extended (the Unextended Commitments) pursuant to the Senior Secured
Revolving Credit Facility. The Amended and Restated Senior Secured Credit Facilities bear interest
at a variable rate composed of either (i) the highest of the federal funds rate plus 0.5%, Bank of
America, N.A.s prime rate, or the one month British Banker Association LIBOR rate plus 1.00%, or
(ii) the British Banker Association LIBOR rate (subject to a floor) of 1.50% with respect to
borrowings under the Senior Secured Revolving Credit Facility, step-downs based on the companys
consolidated total leverage ratio). The principal amount of the Senior Secured Term Loan Facility
amortizes in equal quarterly installments in aggregate annual amounts equal to 1% of the original
principal amount with payments beginning in fiscal year 2011. The principal amount outstanding of
the loans under the Senior Secured Term Loan Facility will be due and payable on February 11, 2017.
The principal amount of outstanding loans under the Senior Secured Revolving Facility will be due
and payable on February 11, 2016 with respect to Extended Commitments and on February 25, 2014 with
respect to Unextended Commitments.
As at March 31, 2011, $750.0 million of term loans had been issued and no amounts are currently
drawn against the revolving credit facility. The term loans were priced at $0.995 with a yield to
maturity of 5.6%. The credit agreement governing the Amended and Restated Senior Secured Credit
Facilities requires the Company to meet certain financial covenants, beginning the quarter ending
June 30, 2011. The maintenance of these financial covenants is solely with respect to the Senior
Secured Revolving Credit Facility. The credit agreement governing the Amended and Restated Senior
Secured 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 agreement governing the Amended and
Restated Senior Secured Credit Facilities, (2) commencing with the fiscal year ended September 30,
2011, 50% (which percentage will be reduced 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
Senior Secured Term Loan 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 of our credit agreement in effect prior to the
Amended and Restated Senior Secured Credit Facilities, the Company was required to prepay $13.2
million of outstanding term loans in the first quarter of fiscal year 2011 ($17.6 million for the
fiscal year 2009 which was paid in the first quarter of fiscal year 2010).
On May 6, 2008, the Company issued $235.0 million 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 Amended and
Restated Senior Secured Credit Facilities.
Page 53
Table of Contents
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 |
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 March 31, 2011, 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 shareholders equity
section of the consolidated balance sheet. During the three-month periods ended March 31, 2011, and
March 31, 2010, we earned interest income on the note amounting to $1.9 million net of taxes
amounting to $1.0 million and $3.9 million net of taxes amounting to $2.1 million for the six-month
period ended March 31, 2011 and 2010. The related interest receivable from our parent company
amounting to $33.1 million as at March 31, 2011, ($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
March 31, 2011, we have an account receivable from our parent company amounting to $0.5 million
($0.5 million as at September 30, 2010).
Pursuant to the terms of a management fee arrangement with a controlling shareholding company, we
recorded charges amounting to $0.8 million and $1.6 million during the three-month and six-month
periods ended March 31, 2011 ($1.0 million and 1.9 million during the three-month and six-month
periods ended March 31, 2010). As at March 31, 2011, we accrued fees payable to a controlling
shareholding company amounting to $0.8 million ($1.6 million as at September 30, 2010). Also,
during the three-month and six-month periods ended March 31, 2011, we recorded fees from a
controlling shareholding company amounting to $5.0 million of which $1.5 million was accounted for
as deferred debt issue costs, $2.5 million as selling and administrative expense and $1.0 million
as financing fees. As at March 31, 2011, the Company accrued fees payable to a controlling
shareholding company amounting to $0.7 million ($1.6 million as at September 30, 2010).
During the six-month period ended March 31, 2010, we paid a dividend to our parent company
amounting to $0.1 million to allow for the payment of certain group expenses.
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.
Page 54
Table of Contents
Cash flows
Our cash flows from operating, investing and financing activities for the three-month periods ended
March 31, 2011, and March 31, 2010 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 | |||||||||||
March 31, | March 31, | |||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||
$ | $ | $ | ||||||||||
Net cash provided by (used by) operating activities
|
(44.9 | ) | 31.1 | (76.0 | ) | |||||||
Net cash used by investing activities
|
(527.5 | ) | (2.3 | ) | (525.2 | ) | ||||||
Net cash provided by (used by) financing activities
|
507.4 | (0.1 | ) | 507.5 |
Our cash flows from operating, investing and financing activities for the six-month periods ended
March 31, 2011, and March 31, 2010 as reflected in the condensed consolidated statements of cash
flows, are summarized in the following table:
For the | For the | |||||||||||
six-month | six-month | |||||||||||
period ended | period ended | |||||||||||
March 31, | March 31, | |||||||||||
(in millions of U.S. dollars) | 2011 | 2010 | Change | |||||||||
$ | $ | $ | ||||||||||
Net cash provided by (used by) operating activities
|
(41.2 | ) | 59.6 | (100.8 | ) | |||||||
Net cash used by investing activities
|
(528.7 | ) | (3.5 | ) | (525.2 | ) | ||||||
Net cash provided by (used by) financing activities
|
494.2 | (21.3 | ) | 515.5 |
Cash flows provided by operating activities decreased $76.0 million to $44.9 million of cash used
by operating activities from $31.1 million of cash provided by operating activities for the
three-month period ended March 31, 2010. Cash flows provided by operating activities decreased
$100.8 million to $41.2 million of cash used by operating activities from $59.6 million of cash
provided by operating activities for the six-month period ended March 31, 2010. The decreases in
net cash provided by operating activities are mainly due to the transaction and restructuring
costs, and financing fees related to Eurand Acquisition.
Cash flows used by investing activities increased $525.2 million to $527.5 million from $2.3
million for the three-month period ended March 31, 2010. Cash flows used by investing activities
increased $525.2 million to $528.7 million from $3.5 million for the six-month period ended March
31, 2010. The increases in cash flows used by investing activities are due to Eurand Acquisition.
Cash flows provided by financing activities increased $507.5 million to $507.4 million of cash
provided in the three-month period ended March 31, 2011, from $0.1 million of cash used in the
three-month period ended March 31, 2010. Cash flows provided by financing activities increased
$515.5 million to $494.2 million of cash provided in the six-month period ended March 31, 2011,
from $21.3 million of cash used in the six-month period ended March 31, 2010. On February 11, 2011,
the Company entered into an amended and restated credit agreement and related security and other
agreements in connection with the Eurand Acquisition as described in the Long-term debt and Credit
Facility section above.
Page 55
Table of Contents
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. Estimates are used when accounting for amounts recorded in connection with
acquisitions, including fair value determinations of assets and liabilities. Other 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.
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) | Assumptions regarding market share growth after an eventual re-launch of our PEPs; and |
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 |
7.9 | 13.6 | 20.1 | 3.4 | 4.1 | | 49.1 | |||||||||||||||||||||
Provisions related to the
unapproved PEPs event |
| | | | | (3.7 | ) | (3.7 | ) | |||||||||||||||||||
Eurand Acquisition |
7.3 | 7.8 | 0.9 | 1.9 | 0.2 | | 18.1 | |||||||||||||||||||||
Settlements |
(6.3 | ) | (13.2 | ) | (15.3 | ) | (2.3 | ) | (3.9 | ) | (2.0 | ) | (43.0 | ) | ||||||||||||||
Balance as at March 31, 2011 |
22.3 | 14.3 | 13.8 | 4.3 | 0.6 | 5.3 | 60.6 | |||||||||||||||||||||
Page 56
Table of Contents
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.
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 $22.3 million as at March 31, 2011, ($13.4 million as
at September 30, 2010) for estimated product returns, excluding the additional provision related to
the unapproved PEPs event. The increase is due to the integration of legacy Eurand products ($7.4
million) and additional reserve for URSO product ($2.4 million).
As at March 31, 2011, the product returns reserve related to the unapproved PEPs event amounted to
$5.3 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 $0.5 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.
Page 57
Table of Contents
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 $14.3 million and $13.8 million as at March 31, 2011, ($6.1
million and $8.1 million as at September 30, 2010) for estimated contract rebates and chargebacks.
The increase is mainly due to the integration of legacy Eurand products ($10.7 million) and
additional reserves related to the Affordable Care Act ($2.2 million) and TRICARE ($1.6 million).
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 March 31, 2011:
Intangible | ||||||||
assets | Goodwill | |||||||
$ | $ | |||||||
Balance as at September 30, 2010 |
348.0 | 73.5 | ||||||
Eurand Acquisition |
413.9 | 106.5 | ||||||
Depreciation and amortization |
(26.4 | ) | | |||||
Disposal of intangible assets |
(10.2 | ) | | |||||
Foreign exchange translation adjustments |
5.7 | 1.7 | ||||||
Balance as at March 31, 2011 |
731.0 | 181.7 | ||||||
Research and development expenses
Research and development expenses are charged to operations in the period they are incurred. The
costs 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.
Page 58
Table of Contents
Subsequent Events
Agreements with Mpex Pharmaceuticals Inc. for the acquisition and development of Aeroquin
On April 11, 2011, Aptalis Holdings Inc. (Aptalis Holdings), an indirect parent company of
Aptalis Holdings Inc. (the Company), entered into a series of agreements with Mpex
Pharmaceuticals Inc. (Mpex) for the acquisition and development of Aeroquin (the Aeroquin
Transaction), a proprietary aerosol formulation of levofloxacin, which is currently in Phase 3
clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis (CF).
Under these agreements, Aptalis Holdings has an option to not acquire all of Mpexs assets related
to Aeroquin in a merger, with continued development of Aeroquin by Mpex under the terms of a
Development Agreement between the parties. Prior to the merger Mpex will transfer all of its assets
that are not related to Aeroquin to a newly formed company that will be owned primarily by current
Mpex stockholders. As a result of the Aeroquin Transaction, the Company made an initial
non-contingent payment of $12.0 million on April 21, 2011. Additional remaining time-based,
non-contingent payments in relation with the Aeroquin Transaction amounting to $50.5 million will
be paid in a number of additional installments, of which the final installment is due on November 1,
2013.
Under the terms of the Option Agreement dated April 11, 2011 among Aptalis Holdings, Mpex, and
Axcan Lone Star Inc., a Delaware corporation and an indirect wholly-owned subsidiary of Aptalis
Holdings and a direct wholly-owned subsidiary of the Company (Merger Sub), Aptalis Holdings has
an option to terminate the Merger Agreement described below. This option may be exercised during a
certain period of time, which period in no event will end later than August 1, 2011.
Under the terms of the Agreement and Plan of Merger dated April 11, 2011 (the Merger Agreement)
among Aptalis Holdings, Merger Sub, Mpex and certain stockholders of Mpex who will serve as
representatives of the Mpex security holders under the Merger Agreement, Merger Sub will merge with
and into Mpex, with Mpex surviving (the Surviving Company) as an indirect wholly-owned subsidiary
of Aptalis Holdings and a direct wholly-owned subsidiary of the Company (the Merger). Pursuant to
the Merger Agreement, the aggregate merger consideration that the Mpex security holders will
receive, subject to the consummation of the Merger, consists of (i) the non-contingent payments
above, (ii) contingent payments of up to $195 million if certain regulatory and commercial
milestones are met related to Aeroquin, and (iii) earn-out payments based on net sales of
Aeroquin. Indemnity obligations of the Mpex security holders will be satisfied by set-off against
a portion of the foregoing merger consideration payments.
Unless terminated pursuant to the Option Agreement described above, the Merger is expected to close
during the third quarter of 2011. The further development of Aeroquin will be conducted pursuant to
the terms of the Development Agreement dated April 11, 2011 among Aptalis Holdings, Merger Sub, and
Mpex. Upon completion of the divestiture of assets and liabilities unrelated to Aeroquin (the
Divestiture) to a newly formed company (Spinco), Spinco will assume all of Mpexs obligations
under the Development Agreement. Under the Development Agreement, Mpex (and after the Divestiture,
Spinco) will be paid for its actual development costs of Aeroquin and will have primary
responsibility for conducting day-to-day development activities. Aptalis Holdings and Merger Sub
will have input regarding development strategy. Pursuant to the Development Agreement, on April 12,
2011 Mpex was paid $9.2 million for development expenses incurred by Mpex since November 15, 2010
and $9.4 million for estimated development costs to be incurred during the first three months of
the Development Agreement. All payments under the Development Agreement, Option Agreement and
Merger Agreement to Mpex or Mpex security holders, as applicable, will be made by or on behalf of
Merger Sub (or after the consummation of the Merger, the Surviving Company).
Equity investment in Aptalis Holdings
Simultaneous with the execution of the Mpex agreements, Aptalis Holdings received the proceeds of a
$55.0 million equity investment from funds managed by Investor Growth Capital Limited. Axcan
Holdings will contribute the proceeds of the equity investment to its subsidiaries to fund a
portion of the Mpex transactions and a partial repayment on the Companys $133.2 million note
receivable from its parent company.
Risk management measures undertaken to reduce exposure to interest rate fluctuations
On April 4, 2011, the Company entered into two separate pay-fixed, receive-floating interest rate
swaps. The first swap has a notional amount of $331.0 million amortizing to $84.0 million by its
maturity in December 2015. The first swap has a notional amount of $219.0 million and matures in
December 2016. The interest rate swaps will effectively fix the Companys interest payments on the
hedged debt at 2.386% for the first swap and 3.18% (including 150 bps LIBOR floor) for the second
swap, respectively, plus the appropriate margin on each debt interest period. These swaps were
designated as cash flow hedges of interest rate risk.
Page 59
Table of Contents
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
March 31, 2011, 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
March 31, 2011, 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.
Page 60
Table of Contents
PART II. OTHER INFORMATION
Item 1A. | Risk Factors |
There have been no material changes from the risk factors disclosed in our Form 10-Q for the quarterly period ended December 31, 2010.
Item 5. | Other Information |
Information regarding the restructuring initiatives we have undertaken as a result of our
acquisition of Eurand under Note 5 in the Notes to Condensed Consolidated Financial Statements
under Part I, Item 1 of this Quarterly Report on Form 10-Q is incorporated by reference herein.
Item 6. | Exhibits. |
Exhibit No. | Exhibit | |
3.1
|
Certificate of Amendment of the Certificate of Incorporation of Aptalis Pharma Inc. (f/k/a Axcan Intermediate Holdings Inc.) | |
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. |
Page 61
Table of Contents
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.
APTALIS PHARMA INC. |
||||
Date: May 13, 2011 | BY: | /s/ Steve Gannon | ||
Steve Gannon | ||||
Senior Vice President, Finance, Chief Financial Officer and Treasurer |
Page 62
Table of Contents
EXHIBIT INDEX
Exhibit No. | Exhibit | |
3.1
|
Certificate of Amendment of the Certificate of Incorporation of Aptalis Pharma Inc. (f/k/a Axcan Intermediate Holdings Inc.) | |
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. |
Page 63