Attached files
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
[X]
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(D) OF
THE
|
|
SECURITIES
EXCHANGE ACT OF 1934.
|
For the
quarterly period ended December 31, 2009
[ ]
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from ___________ to ____________.
Commission
File Number 333-153896
AXCAN
INTERMEDIATE HOLDINGS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or Other Jurisdiction of Incorporation or organization)
|
74-3249870
(I.R.S.
Employer Identification No.)
|
22
Inverness Center Parkway
Suite
310
Birmingham,
AL
(Address
of Principal Executive Offices)
|
35242
(Zip
Code)
|
(205)
991-8085
(Registrant’s
telephone number, including area code)
_______________________
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes No
[X] 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 No
[X] (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 Accelerated
filer Non-accelerated
filer
[X] Smaller
reporting company
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes No
[X]
As of
February 9, 2010, there were 100 shares of common stock of the registrant
outstanding, all of which were owned by Axcan MidCo Inc.
1
AXCAN
INTERMEDIATE HOLDINGS INC.
INDEX
PART I. FINANCIAL
INFORMATION
|
4
|
Item 1. Financial
Statements.
|
4 |
Consolidated Balance Sheets
|
4
|
Consolidated Operations
|
5 |
Consolidated Shareholders’ Equity and
Comprehensive Income
|
6 |
Consolidated Cash Flows
|
7 |
Notes to Consolidated Financial
Statements
|
8 |
Item 2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
|
27 |
Item 3. Quantitative And
Qualitative Disclosure About Market Risk
|
40 |
Item 4T. Controls and Procedures
|
40 |
PART II. OTHER INFORMATION
|
41
|
Item 1 A. Risk Factors
|
41 |
Item 6. Exhibits.
|
42 |
SIGNATURES
|
43
|
EXHIBIT INDEX
|
44
|
2
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 “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in Item 2 of Part I
of this Quarterly Report, “Risk Factors” in Item 1A of Part II of this Quarterly
Report, as well as elsewhere in this Quarterly Report on Form 10-Q.
We
caution you not to place undue reliance on any forward-looking statements and we
do not undertake any obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after the date of
this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated
events. All subsequent written and oral forward-looking statements attributable
to us, or persons acting on our behalf, are expressly qualified in their
entirety by the cautionary statements.
3
PART
I. FINANCIAL INFORMATION
Item
1.
|
Financial
Statements.
|
AXCAN
INTERMEDIATE HOLDINGS INC.
Consolidated
Balance Sheets
(in
thousands of U.S. dollars, except share related data)
December
31,
2009
|
September
30,
2009
|
|||||||
(unaudited)
|
||||||||
|
|
|||||||
Assets
|
$ | $ | ||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
132,391 | 126,435 | ||||||
Accounts
receivable, net
|
71,672 | 57,124 | ||||||
Accounts
receivable from the parent company (Note 14)
|
306 | 306 | ||||||
Income
taxes receivable
|
1,486 | 3,391 | ||||||
Inventories,
net (Note 3)
|
49,377 | 44,706 | ||||||
Prepaid
expenses and deposits
|
3,122 | 2,868 | ||||||
Deferred
income taxes
|
15,262 | 15,852 | ||||||
Total
current assets
|
273,616 | 250,682 | ||||||
Property,
plant and equipment, net (Note 4)
|
38,470 | 39,344 | ||||||
Intangible
assets, net (Note 5)
|
405,166 | 421,290 | ||||||
Goodwill
|
165,568 | 165,823 | ||||||
Deferred
debt issue expenses, net of accumulated amortization of $10,413
($9,168
as at September 30, 2009)
|
24,166 | 25,411 | ||||||
Deferred
income taxes
|
11,638 | 12,052 | ||||||
Total
assets
|
918,624 | 914,602 | ||||||
Liabilities
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable and accrued liabilities
|
107,426 | 87,684 | ||||||
Income
taxes payable (Note 9)
|
2,215 | 2,493 | ||||||
Installments
on long-term debt (Note 7)
|
- | 30,708 | ||||||
Deferred
income taxes
|
1,167 | 137 | ||||||
Total
current liabilities
|
110,808 | 121,022 | ||||||
Long-term
debt (Note 7)
|
592,946 | 582,586 | ||||||
Other
long-term liabilities
|
9,497 | 9,448 | ||||||
Deferred
income taxes
|
34,979 | 37,782 | ||||||
Total
liabilities
|
748,230 | 750,838 | ||||||
Shareholders’
Equity
|
||||||||
Capital
Stock (Note 10)
|
||||||||
Common
shares, par value $0.001; 100 shares authorized: 100 issued and
outstanding as at December 31, 2009, and
September
30, 2009
|
1 | 1 | ||||||
Deficit
|
(288,340 | ) | (297,658 | ) | ||||
9.05%
Note receivable from the parent company (Note 14)
|
(133,154 | ) | (133,154 | ) | ||||
Additional
paid-in capital
|
619,195 | 619,053 | ||||||
Accumulated
other comprehensive loss
|
(27,308 | ) | (24,478 | ) | ||||
Total
shareholders’ equity
|
170,394 | 163,764 | ||||||
Total
liabilities and shareholders’ equity
|
918,624 | 914,602 |
The
accompanying notes are an integral part of the 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
|
4
AXCAN
INTERMEDIATE HOLDINGS INC.
Consolidated
Statements of Operations
(in
thousands of U.S. dollars)
(unaudited)
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
$
|
$
|
|||||||
Net
product sales
|
110,132 | 104,108 | ||||||
Cost
of goods sold (a)
|
26,628 | 25,454 | ||||||
Selling
and administrative expenses (a)
(Note 8)
|
32,239 | 32,005 | ||||||
Management
fees (Note 14)
|
855 | 163 | ||||||
Research
and development expenses (a)
|
8,426 | 7,050 | ||||||
Depreciation
and amortization
|
16,693 | 14,473 | ||||||
Total
operating expenses
|
84,841 | 79,145 | ||||||
Operating
income
|
25,291 | 24,963 | ||||||
Financial
expenses (Note 8)
|
16,197 | 19,325 | ||||||
Interest
income
|
(148 | ) | (223 | ) | ||||
Loss
(gain) on foreign currencies
|
(15 | ) | 130 | |||||
Total
other expenses
|
16,034 | 19,232 | ||||||
Income
before income taxes
|
9,257 | 5,731 | ||||||
Income
tax expense (benefit)
|
(189 | ) | 598 | |||||
Net
income
|
9,446 | 5,133 |
(a)
Excluding depreciation and amortization
The
accompanying notes are an integral part of the consolidated financial
statements.
These
interim financial statements should be read in conjunction with the annual
Consolidated Financial Statements.
5
AXCAN
INTERMEDIATE HOLDINGS INC.
Consolidated
Shareholders’ Equity and Comprehensive Income
(in
thousands of U.S. dollars, except share related data)
(unaudited)
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
Common
shares (number)
|
||||||||
Balance,
beginning and end of period
|
100 | 100 | ||||||
$
|
$
|
|||||||
Common
shares
|
||||||||
Balance,
beginning and end of period
|
1 | 1 | ||||||
Deficit
|
||||||||
Balance,
beginning of period
|
(297,658 | ) | (289,264 | ) | ||||
Dividends
paid
|
(128 | ) | - | |||||
Net
income
|
9,446 | 5,133 | ||||||
Balance,
end of period
|
(288,340 | ) | (284,131 | ) | ||||
Additional
paid-in capital
|
||||||||
Balance,
beginning of period
|
619,053 | 617,255 | ||||||
Stock-based
compensation expense
|
1,476 | 1,330 | ||||||
Foreign
currencies translation adjustments
|
- | (47 | ) | |||||
Stock-based
compensation plans redemption
|
(271 | ) | - | |||||
Provision
on interest receivable from the parent company
|
(3,037 | ) | (3,037 | ) | ||||
Interest
income from the parent company, net of taxes of $1,063 ($1,062 in
2008)
|
1,974 | 1,975 | ||||||
Balance,
end of period
|
619,195 | 617,476 | ||||||
9.05%
Note receivable from the parent company
|
||||||||
Balance,
beginning and end of period
|
(133,154 | ) | (133,154 | ) | ||||
Accumulated
other comprehensive loss
|
||||||||
Balance,
beginning of period
|
(24,478 | ) | (29,168 | ) | ||||
Hedging
contracts fair value adjustments, net of taxes of $42 ($130 in
2008)
|
(78 | ) | (242 | ) | ||||
Foreign
currencies translation adjustments
|
(2,752 | ) | 5,829 | |||||
Balance,
end of period
|
(27,308 | ) | (23,581 | ) | ||||
Total
shareholders' equity
|
170,394 | 176,611 | ||||||
Comprehensive
income
|
||||||||
Other
comprehensive income (loss)
|
(2,830 | ) | 5,587 | |||||
Net
income
|
9,446 | 5,133 | ||||||
Total
comprehensive income
|
6,616 | 10,720 | ||||||
Accumulated
other comprehensive loss
|
||||||||
Amounts
related to foreign currencies translation adjustments
|
(27,237 | ) | (23,634 | ) | ||||
Amounts
related to hedging contracts fair value adjustments
|
(71 | ) | 53 | |||||
Accumulated
other comprehensive loss
|
(27,308 | ) | (23,581 | ) |
The
accompanying notes are an integral part of the consolidated financial
statements.
These
interim financial statements should be read in conjunction with the annual
Consolidated Financial Statements.
6
AXCAN
INTERMEDIATE HOLDINGS INC.
Consolidated
Cash Flows
(in
thousands of U.S. dollars)
(unaudited)
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
$
|
$
|
|||||||
Cash
flows from operating activities
|
||||||||
Net
income
|
9,446 | 5,133 | ||||||
Non-cash
items
|
||||||||
Non-cash
financial expenses
|
1,762 | 1,758 | ||||||
Depreciation
and amortization
|
16,693 | 14,473 | ||||||
Stock-based
compensation expenses
|
1,476 | 1,330 | ||||||
Loss
on disposal and write-down of assets
|
25 | 11 | ||||||
Foreign
currencies fluctuations
|
(479 | ) | (1,638 | ) | ||||
Change
in fair value of derivatives
|
(516 | ) | 897 | |||||
Deferred
income taxes
|
(1,370 | ) | 1,325 | |||||
Changes
in working capital items
|
||||||||
Accounts
receivable
|
(14,901 | ) | (9,032 | ) | ||||
Accounts
receivable from the parent company
|
- | (713 | ) | |||||
Income
taxes receivable
|
1,734 | 9,744 | ||||||
Inventories
|
(4,868 | ) | 1,875 | |||||
Prepaid
expenses and deposits
|
(264 | ) | (2 | ) | ||||
Accounts
payable and accrued liabilities
|
20,114 | 12,167 | ||||||
Income
taxes payable
|
(338 | ) | 1,653 | |||||
Net
cash provided by operating activities
|
28,514 | 38,981 | ||||||
Cash
flows from investing activities
|
||||||||
Acquisition
of property, plant and equipment
|
(1,129 | ) | (1,298 | ) | ||||
Acquisition
of intangible assets
|
- | (10 | ) | |||||
Net
cash used in investing activities
|
(1,129 | ) | (1,308 | ) | ||||
Cash
flows from financing activities
|
||||||||
Repayment
of long-term debt
|
(20,865 | ) | (2,188 | ) | ||||
Stock-based
compensation plans redemption
|
(271 | ) | - | |||||
Dividends
paid
|
(128 | ) | - | |||||
Net
cash used in financing activities
|
(21,264 | ) | (2,188 | ) | ||||
Foreign
exchange loss on cash held in foreign currencies
|
(165 | ) | (1,109 | ) | ||||
Net
increase in cash and cash equivalents
|
5,956 | 34,376 | ||||||
Cash
and cash equivalents, beginning of period
|
126,435 | 56,105 | ||||||
Cash
and cash equivalents, end of period
|
132,391 | 90,481 | ||||||
Additional
information
|
||||||||
Interest
received
|
148 | 249 | ||||||
Interest
paid
|
1,947 | 3,137 | ||||||
Income
taxes received
|
2,372 | 16,761 | ||||||
Income
taxes paid
|
1,856 | 4,401 |
The
accompanying notes are an integral part of the consolidated financial
statements.
These
interim financial statements should be read in conjunction with the annual
Consolidated Financial Statements.
7
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
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 Presentation
Axcan
Intermediate Holdings Inc., a corporation incorporated on November 28, 2007,
under the General Corporation Law of the State of Delaware and its subsidiaries
(together the “Company”), commenced active operations with the purchase, through
a wholly-owned indirect subsidiary, of all of the outstanding common shares of
Axcan Pharma Inc., a company incorporated under the Canada Business Corporation
Act. On February 25, 2008, the Company, pursuant to a Plan of Arrangement dated
November 29, 2007, and through a wholly-owned indirect subsidiary, completed the
acquisition of all common shares of Axcan Pharma Inc. at a price of $23.35 per
share. The Company is involved in the research, development, production and
distribution of pharmaceutical products mainly in the field of
gastroenterology.
The
accompanying unaudited condensed consolidated financial statements are presented
in U.S. dollars, the reporting currency and prepared in accordance with
accounting principles generally accepted in the United States of America (U.S.
GAAP) for interim financial statements and with the requirements of the
Securities and Exchange Commission for reporting on Form 10Q. Accordingly, they
do not include all the information and footnotes required by US GAAP for
complete financial statements. The interim financial statements and related
notes should be read in conjunction with the Company’s audited financial
statements for the fiscal year ended September 30, 2009. 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 our 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.
The Company has evaluated significant events through February 10, 2010, the date
of issuance of these financial statements.
2. Recently
Issued Accounting Standards
In
January 2010, the FASB amended the existing authoritative guidance on
disclosures on fair value measurements and clarifies and provides additional
disclosure requirements related to recurring and non-recurring fair value
measurements. The new disclosures and clarifications of existing disclosures are
effective for interim and annual reporting periods beginning after December 15,
2009. The disclosure of the roll forward of activity in Level 3 measurements on
a gross basis would be effective for fiscal years beginning after December 15,
2010 and for interim periods within those fiscal years. The Company is currently
evaluating the impact of the adoption of the revised guidance on its
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 Company is currently evaluating the impact of
the adoption of this guidance on its consolidated financial
statements.
In August
2009, the FASB amended the existing guidance on fair value measurements and
disclosures to provide clarification in measuring the fair value of liabilities
in circumstances when a quoted price in an active market for the identical
liability is not available. In such circumstances, a reporting entity is
required to measure fair value using one or more of the following methods: 1) a
valuation technique that uses the quoted price of the identical liability when
traded as an asset or quoted prices for similar liabilities or similar
liabilities when traded as assets; and/or 2) a valuation technique that is
consistent with the principles of fair value measurements (e.g. an income
approach or market approach). This guidance is effective for reporting periods
including interim periods beginning after August 28, 2009. The adoption of this
guidance did not have a material impact on the Company’s consolidated financial
statements.
In June
2009, the FASB amended the existing authoritative guidance on consolidation
regarding variable interest entities for determining whether an entity is a
variable interest entity (“VIE”) and requires an enterprise to perform an
analysis to determine whether the enterprise’s variable interest or interests
give it a controlling financial interest in a VIE. According to the revised
guidance, an enterprise has a controlling financial interest when it has a) the
power to direct the activities of a VIE that most significantly impact the
entity’s economic performance and b) the obligation to absorb losses of the
entity or the right to receive benefits from the entity that could potentially
be significant to the VIE. The guidance also requires an enterprise to assess
whether it has an implicit financial responsibility to ensure that a VIE
operates as designed when determining whether it has power to direct the
activities of the VIE that most significantly impact the entity’s economic
performance. The guidance also requires ongoing assessments of whether an
enterprise is the primary beneficiary of a VIE, requires enhanced disclosures
and eliminates the scope exclusion for qualifying special-purpose entities. The
revised guidance is effective for fiscal years beginning after November 15,
2009, with early adoption prohibited. The Company is currently evaluating the
impact of the adoption of the revised guidance on its consolidated financial
statements.
8
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
2. Recently
Issued Accounting Standards (continued)
In May
2009, the FASB issued authoritative guidance on subsequent events. This guidance
establishes general standards of accounting for and disclosures of events that
occur after the balance sheet date but before financial statements are issued or
are available to be issued. Specifically, the guidance sets forth the period
after the balance sheet date during which management of a reporting entity
should evaluate events or transactions that may occur for potential recognition
or disclosure in the financial statements, the circumstances under which an
entity should recognize events or transactions occurring after the balance sheet
date in its financial statements and the disclosures that an entity should make
about events or transactions that occurred after the balance sheet date. The
guidance is effective for fiscal years and interim periods ended after June 15,
2009, and will be applied prospectively. The adoption of this guidance did not
have a material impact on the Company’s consolidated financial
statements.
In April
2009, the FASB amended the authoritative guidance on financial instruments to
require disclosures about fair value of financial instruments in interim as well
as in annual financial statements of publicly traded companies. The guidance is
effective for interim and annual periods ending after June 15, 2009, with early
adoption permitted for periods ending after March 15, 2009. The adoption of this
guidance did not have a material impact on its consolidated financial statements
since the Company has provided disclosures about fair value of financial
instruments in its interim financial statements prior to the issuance of this
guidance.
In April
2009, the FASB issued additional guidance on estimating fair value when the
volume and level of activity for an asset or liability have significantly
decreased in relation to normal market activity for the asset or liability.
Guidance on identifying circumstances that indicate a transaction is not orderly
was also issued and required additional disclosures. This guidance is to be
applied prospectively and is effective for interim and annual periods ending
after June 15, 2009, with early adoption permitted for periods ending after
March 15, 2009. The adoption of this guidance did not have a material impact on
the Company’s consolidated financial statements.
In April
2009, the FASB amended the guidance for investments in debt and equity
securities on determining whether impairment for investments in debt securities
is other than temporary and requires additional interim and annual disclosure of
other-than-temporary impairments in debt and equity securities. Pursuant to the
new guidance, an other-than-temporary impairment has occurred if a company does
not expect to recover the entire amortized cost basis of the security. In this
situation, if the company does not intend to sell the impaired security prior to
recovery and it is more likely than not that it will not be required to sell the
security before the recovery of its amortized cost basis, the amount of the
other-than-temporary impairment recognized in earnings is limited to the portion
attributed to the credit loss. The remaining portion of the other-than-temporary
impairment is then recorded in other comprehensive income. The guidance is
effective for interim and annual periods ending after June 15, 2009, with early
adoption permitted for periods ending after March 15, 2009. The adoption of this
guidance did not have a material impact on the Company’s consolidated financial
statements.
In April
2009, the FASB amended the guidance on business combinations previously revised
in December 2007 to require that an acquirer recognize assets acquired and
liabilities assumed in a business combination that arise from contingencies, at
fair value at the acquisition date, if fair value can be determined during the
measurement period. If the acquisition-date fair value of such an asset acquired
or liability assumed cannot be determined, the acquirer should apply guidance on
accounting for contingencies to determine whether the contingency should be
recognized at the acquisition date or after it. This guidance is effective for
assets or liabilities arising from contingencies in business combinations for
which the acquisition date is after the beginning of the first annual reporting
period beginning after December 15, 2008. The Company will apply this guidance
for future acquisitions.
In
November 2008, the FASB
issued
guidance that clarifies the accounting for defensive intangible assets acquired
in a business combination or an asset acquisition subsequent to their
acquisition except for intangible assets that are used in research and
development activities. A defensive intangible asset is defined as a separately
identifiable intangible asset which an acquirer does not intend to actively use
but intends to hold to prevent its competitors from obtaining access to them.
This guidance requires an acquirer in a business combination to account for a
defensive intangible asset as a separate unit of accounting and assign a useful
life in accordance with the guidance on the determination of useful life of
intangible assets. Defensive intangible assets must be recognized at fair value
in accordance with the revised guidance on business combinations. This guidance
is effective for intangible assets acquired on or after fiscal years beginning
after December 15, 2008, with early adoption prohibited. The adoption of this
guidance did not have a material impact on the Company’s 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 Company’s consolidated financial
statements.
9
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
2.
|
Recently
Issued Accounting Standards
(continued)
|
In March
2008, the FASB amended the guidance on disclosure requirements related to
derivative instruments and hedging activities. The new guidance requires that
objectives for using derivative instruments be disclosed in terms of underlying
risk and accounting designation. Pursuant to the new guidance, enhanced
disclosures are required about (a) how and why derivative instruments are used,
(b) how derivative instruments and related hedged items are accounted for and
(c) how derivative instruments and related hedged items affect an entity’s
financial position, financial performance and cash flows. The fair value of
derivative instruments and their gains and losses will need to be presented in
tabular format in order to present a more complete picture of the effects of
using derivative instruments. This guidance is effective for financial
statements issued for fiscal years and interim periods beginning after November
15, 2008. The adoption of this guidance did not have a material impact on the
Company’s consolidated financial statements (see Note 12).
In
December 2007, the FASB revised the authoritative guidance for business
combinations. The new guidance expands the definition of a business combination
and requires the acquisition method of accounting to be used for all business
combinations and an acquirer to be identified for each business combination.
Pursuant to the new guidance, all assets, liabilities, contingent considerations
and contingencies of an acquired business are required to be recorded at fair
value at the acquisition date. In addition, the guidance establishes
requirements in the recognition of acquisition cost, restructuring costs and
changes in accounting for deferred tax asset valuation allowances and acquired
income tax uncertainties. This guidance is to be applied prospectively to
business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December
15, 2008. Earlier adoption is prohibited. The Company will apply this guidance
for future acquisitions.
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 Company’s consolidated financial statements.
In
December 2007, the FASB amended the guidance on consolidation to establish new
accounting and reporting standards for the non-controlling interest in a
subsidiary and for the deconsolidation of a subsidiary. Specifically, the new
guidance requires the recognition of a non-controlling interest (minority
interest) as equity in the consolidated financial statements and separate from
the parent’s equity. The amount of net income attributable to the
non-controlling interest will be included in consolidated net income on the face
of the income statement. The guidance clarifies that changes in a parent’s
ownership interest in a subsidiary that do not result in deconsolidation are
equity transactions if the parent retains its controlling financial interest. In
addition, the guidance requires that a parent recognize a gain or loss in net
income when a subsidiary is deconsolidated. Such gain or loss will be measured
using the fair value of the non-controlling equity investment on the
deconsolidation date. The guidance also includes expanded disclosure
requirements regarding the interests of the parent and its non-controlling
interest. This guidance is effective for fiscal years and interim periods within
those fiscal years, beginning on or after December 15, 2008. Earlier adoption is
prohibited. The adoption of this guidance did not have a material impact on the
Company’s consolidated financial statements, because the Company has
wholly-owned subsidiaries.
In
September 2006, the FASB issued guidance on fair value measurements, which
defines fair value, establishes a framework for measuring fair value and expands
disclosures about fair value measurements and is effective for fair-value
measurements already required or permitted by other guidance for financial
statements issued for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. In February 2008, the FASB issued
guidance, that deferred the effective date of the guidance for fair value
measurement for one year for non-financial assets and non-financial liabilities,
except for items that are recognized or disclosed at fair value in the financial
statements on a recurring basis (at least annually). In October 2008, the FASB
issued guidance which clarifies the application of the guidance on fair value
measurements in determining the fair value of a financial asset when the market
for that asset is not active. This guidance was effective upon issuance,
including prior periods for which financial statements had not been issued. On
October 1, 2008, the Company adopted the guidance on fair value measurements for
financial assets and liabilities. The adoption of the guidance on fair value
measurements for financial assets and liabilities carried at fair value did not
have a material impact on the Company’s consolidated financial statements (see
Note 13). On October 1, 2009, the Company adopted the guidance on fair value
measurements for non-financial assets and liabilities. The adoption of the
guidance on fair value measurements for non-financial assets and liabilities did
not have a material impact on the Company’s consolidated financial
statements.
10
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
3.
|
Inventories
|
December
31,
2009
|
September
30,
2009
|
|||||||
$
|
$
|
|||||||
Raw
material and packaging material
|
10,223 | 8,416 | ||||||
Work
in progress
|
922 | 886 | ||||||
Finished
goods, net of reserve for obsolescence of $3,610 ($4,159 on September 30,
2009)
|
38,232 | 35,404 | ||||||
49,377 | 44,706 |
4.
|
Property,
Plant and Equipment
|
December
31, 2009
|
||||||||||||
Cost
|
Accumulated
depreciation
|
Net
|
||||||||||
$
|
$
|
$
|
||||||||||
Land
|
2,266 | - | 2,266 | |||||||||
Buildings
|
22,807 | 3,326 | 19,481 | |||||||||
Furniture
and equipment
|
7,986 | 2,598 | 5,388 | |||||||||
Computer
equipment
|
16,095 | 5,875 | 10,220 | |||||||||
Leasehold
and building improvements
|
1,232 | 117 | 1,115 | |||||||||
50,386 | 11,916 | 38,470 |
September
30, 2009
|
||||||||||||
Cost
|
Accumulated
depreciation
|
Net
|
||||||||||
$
|
$
|
$
|
||||||||||
Land
|
2,276 | - | 2,276 | |||||||||
Buildings
|
22,739 | 2,931 | 19,808 | |||||||||
Furniture
and equipment
|
8,321 | 2,598 | 5,723 | |||||||||
Computer
equipment
|
15,218 | 4,805 | 10,413 | |||||||||
Leasehold
and building improvements
|
1,181 | 57 | 1,124 | |||||||||
49,735 | 10,391 | 39,344 |
11
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
5.
|
Intangible
Assets
|
December
31, 2009
|
||||||||||||
Cost
|
Accumulated
amortization
|
Net
|
||||||||||
$
|
$
|
$
|
||||||||||
Trademarks,
trademark licenses and manufacturing rights with a finite
life
|
489,728 | 84,562 | 405,166 |
September
30, 2009
|
||||||||||||
Cost
|
Accumulated
amortization
|
Net
|
||||||||||
$
|
$
|
$
|
||||||||||
Trademarks,
trademark licenses and manufacturing rights with a finite
life
|
491,411 | 70,121 | 421,290 |
6.
|
Segmented
Information
|
The
Company operates in a single field of activity, the pharmaceutical
industry.
The
Company operates in the following geographic areas:
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
$
|
$
|
|||||||
Revenue
|
||||||||
United
States
|
||||||||
Domestic
sales
|
83,776 | 78,096 | ||||||
Foreign
sales
|
1,378 | 1,069 | ||||||
Canada
|
||||||||
Domestic
sales
|
8,867 | 8,773 | ||||||
Foreign
sales
|
- | 47 | ||||||
European
Union
|
||||||||
Domestic
sales
|
14,024 | 13,584 | ||||||
Foreign
sales
|
1,840 | 2,355 | ||||||
Other
|
247 | 184 | ||||||
110,132 | 104,108 |
Revenue
is attributed to geographic areas based on the country of origin of the
sales.
December
31,
2009
|
September
30,
2009
|
|||||||
$
|
$
|
|||||||
Property,
plant, equipment and intangible assets
|
||||||||
Canada
|
324,532 | 333,001 | ||||||
United
States
|
39,572 | 44,448 | ||||||
European
Union
|
79,532 | 83,185 | ||||||
443,636 | 460,634 |
12
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
|
6.
|
Segmented
Information (continued)
|
December
31,
2009
|
September
30,
2009
|
|||||||
$
|
$
|
|||||||
Goodwill
|
||||||||
Canada
|
61,887 | 61,887 | ||||||
United
States
|
91,400 | 91,400 | ||||||
European
Union
|
12,281 | 12,536 | ||||||
165,568 | 165,823 |
7. Long-term
Debt
December
31,
2009
|
September
30,
2009
|
|||||||
$
|
$
|
|||||||
Senior
notes secured by substantially all of the present and future assets of the
Company, bearing interest at 9.25% and maturing in March
2015
|
225,865 | 225,764 | ||||||
Term
loans of $138,823,000 at December 31, 2009, ($159,688,000 at September 30,
2009), $88,823,000 ($109,688,000 at September 30, 2009) bearing interest
at the one-month British Banker Association LIBOR (0.23% as at December
31, 2009, and 0.25% as at September 30, 2009) and $50,000,000 bearing
interest at the three-month British Banker Association LIBOR (0.25% as at
December 31, 2009, and 0.28% as at September 30, 2009), plus the
applicable rate based on the consolidated total leverage ratio of the
Company and certain of its subsidiaries for the preceding twelve months,
secured by substantially all of the present and future assets of the
Company, payable in quarterly installments, maturing in February 2014,
subject to interest rate swap agreements as further disclosed in Note
12
|
134,244 | 154,779 | ||||||
Senior
unsecured notes, bearing interest at 12.75% and maturing in March
2016
|
232,837 | 232,751 | ||||||
592,946 | 613,294 | |||||||
Installments
due within one year
|
- | 30,708 | ||||||
592,946 | 582,586 |
On
February 25, 2008, the Company obtained various types of financing in connection
with the acquisition of the common shares of Axcan Pharma Inc. The Company
issued $228,000,000 aggregate principal amount of its 9.25% Senior Secured Notes
due March 1, 2015. The Senior Secured Notes were priced at $0.98737 with a 10%
yield to March 1, 2015. The Senior Secured Notes rank pari passu with the Credit
Facility.
The
Company may redeem some or all of the Senior Secured Notes prior to March 1,
2011 at a redemption price equal to 100% of the principal amount of the Senior
Secured Notes redeemed plus a “make-whole” premium and accrued and unpaid
interest. On or after March 1, 2011, the Company may redeem some or all of the
Senior Secured Notes at the redemption prices (expressed as percentages of
principal amount of the Senior Secured Notes to be redeemed) set forth
below:
Senior
Secured
Notes
|
||||
%
|
||||
2011
|
106.938 | |||
2012
|
104.625 | |||
2013
|
102.313 | |||
2014
and thereafter
|
100.000 |
Prior to
March 1, 2011, the Company may also redeem up to 35% of the aggregate principal
amount of the Senior Secured Notes using the proceeds of one or more equity
offerings at a redemption price equal to 109.250% of the aggregate principal
amount of the Senior Secured Notes plus accrued and unpaid interest. If there is
a change of control as specified in the indenture governing the Senior Secured
Notes, the Company must offer to repurchase the Senior Secured Notes at a price
in cash equal to 101% of the aggregate principal amount thereof, plus accrued
and unpaid interest.
13
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
7. Long-term
Debt (continued)
The
Company also obtained a Credit Facility for a total amount of $290,000,000
composed of available term loans totaling $175,000,000 and of a revolving credit
facility of $115,000,000 (“Credit Facility”). The Credit Facility bears interest
at a variable rate available composed of either the Federal Funds Rate or the
British Banker Association LIBOR rate, at the option of the Company, plus the
applicable rate based on the consolidated total leverage ratio of the Company
and certain of its subsidiaries for the preceding twelve months. The Credit
Facility matures on February 25, 2014, with payments on the term loans beginning
in fiscal year 2008. As at December 31, 2009, $175,000,000 of term loans had
been issued and no amounts had been drawn against the revolving credit facility.
The term loans were priced at $0.96 with a yield to maturity of 8.75% before the
effect of the interest rate swaps as disclosed in Note 12. The Credit Facility
requires the Company to meet certain financial covenants, which were met as at
December 31, 2009. The credit agreement governing the Credit Facility requires
the Company to prepay outstanding term loans contingent upon the occurrence of
events, subject to certain exceptions, with: (1) 100% of the net cash proceeds
of any incurrence of debt other than debt permitted under the Credit Facility,
(2) commencing with the fiscal year ended September 30, 2009, 50% (which
percentage will be reduced to 25% if the senior secured leverage ratio is less
than a specified ratio) of the annual excess cash flow (as defined in the credit
agreement governing the Credit Facility) and (3) 100% of the net cash proceeds
of all non-ordinary course asset sales or other dispositions of property
(including casualty events) by the Company or by its subsidiaries, subject to
reinvestments rights and certain other exceptions. Pursuant to the annual excess
cash flow requirements for the fiscal year 2009 defined in the credit agreement,
the Company was required to prepay $17,583,000 of outstanding term loans in the
first quarter of fiscal year 2010. As allowed by the credit agreement, the
prepayment has been applied to the remaining scheduled installments of principal
in direct order of maturity.
On
February 25, 2008, as part of the acquisition financing, the Company also
obtained $235,000,000 in financing under a senior unsecured bridge facility (the
“Bridge Financing”) maturing on February 25, 2009. On May 6, 2008, the Bridge
Financing was refinanced on a long-term basis, by repaying the bridge facility
with the proceeds from the sale by the Company of $235,000,000 aggregate
principal amount of its 12.75% senior unsecured notes due March 1, 2016 (the
"Senior Unsecured Notes"). The Senior Unsecured Notes were priced at $0.9884
with a yield to maturity of 13.16%. The Senior Unsecured Notes are subordinated
to the Credit Facility and Senior Secured Notes.
The
Company may redeem some or all of the Senior Unsecured Notes prior to March 1,
2012 at a redemption price equal to 100% of the principal amount of the Senior
Unsecured Notes redeemed plus a “make-whole” premium and accrued and unpaid
interest. On or after March 1, 2012, the Company may redeem some or all of the
Senior Unsecured Notes at the redemption prices (expressed as percentages of
principal amount of the Senior Unsecured Notes to be redeemed) set forth
below:
Senior
Unsecured
Notes
|
||||
%
|
||||
2012
|
106.375 | |||
2013
|
103.188 | |||
2014
and thereafter
|
100.000 |
Prior to
March 1, 2011, the Company may also redeem up to 35% of the aggregate principal
amount of the Senior Unsecured Notes using the proceeds of one or more equity
offerings at a redemption price equal to 112.750% of the aggregate principal
amount of the Senior Unsecured Notes plus accrued and unpaid interest. If there
is a change of control as specified in the indenture governing the Senior
Unsecured Notes, the Company must offer to repurchase the Senior Unsecured Notes
at a price in cash equal to 101% of the aggregate principal amount thereof, plus
accrued and unpaid interest.
Payments
required in each of the next five twelve-month periods to meet the retirement
provisions of the long-term debt are as follows:
$ | ||||
2010
|
- | |||
2011
|
11,948 | |||
2012
|
20,781 | |||
2013
|
80,938 | |||
2014
|
25,156 | |||
Thereafter
|
463,000 | |||
601,823 | ||||
Unamortized
original issuance discount
|
8,877 | |||
592,946 |
14
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
8. Financial
Information Included in the Consolidated Operations
a)
|
Financial
expenses
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
$
|
$
|
|||||||
Interest
on long-term debt (including amortization of original issuance discount of
$516 for 2009 and 2008)
|
14,811 | 16,576 | ||||||
Interest
and bank charges
|
102 | 438 | ||||||
Interest
rate swaps
|
(96 | ) | 897 | |||||
Financing
fees
|
135 | 172 | ||||||
Amortization
of deferred debt issue expenses
|
1,245 | 1,242 | ||||||
16,197 | 19,325 |
b)
|
Other
information
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
$
|
$
|
|||||||
Rental
expenses
|
904 | 626 | ||||||
Shipping
and handling expenses
|
1,616 | 2,541 | ||||||
Advertizing
expenses
|
3,897 | 3,632 | ||||||
Depreciation
of property, plant and equipment
|
2,004 | 1,367 | ||||||
Amortization
of intangible assets
|
14,689 | 13,106 | ||||||
Stock-based
compensation expense
|
1,476 | 1,330 | ||||||
Transaction
and integration costs
|
416 | 1,096 |
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. During the three-month period ended December 31, 2009,
the Company charged to operations contributions to the plan totaling $216,401
($96,457 for the three-month period ended December 31, 2008).
15
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
9. Income
Taxes
Effective
October 1, 2007, the Company adopted the provisions of the guidance issued by
the FASB related to accounting for uncertainty in income taxes. The guidance
prescribes a recognition threshold and a measurement attribute for the financial
statement recognition and measurement of tax positions taken or expected to be
taken in a tax return. For those benefits to be recognized, a tax position must
be more-likely-than-not to be sustained upon examination by taxing authorities.
The adoption of the provisions of this guidance did not have a material impact
on the Company’s consolidated financial position and results of operations and a
cumulative effect adjustment to the opening balance of retained earnings was not
necessary. As at December 31, 2009, the Company had unrecognized tax benefits of
$10,896,000 ($10,409,000 as at September 30, 2009) of which $9,515,000 would be
treated as a reduction of Goodwill and $1,381,000 would favorably impact the
Company’s effective tax rate if subsequently recognized.
The
following table presents a summary of the changes to unrecognized tax
benefits:
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
|||||||
$
|
$
|
|||||||
Balance,
beginning of period
|
10,409 | 10,446 | ||||||
Additions
based on tax positions related to the current year
|
7 | 8 | ||||||
Additions
for tax positions of prior years
|
506 | 394 | ||||||
Reductions
for tax positions of prior years
|
(26 | ) | (1,285 | ) | ||||
Balance,
end of period
|
10,896 | 9,563 |
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 September 30, 2009, the Company had
accrued $648,868 for interest relating to income tax matters. As at December 31,
2009, the company had accrued $768,507 for interest relating to income tax
matters. There were no amounts recorded for penalties as at December 31,
2009.
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 Company’s 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 2009. The Company is subject to Canadian and
provincial income tax examination for fiscal years 2005 through 2009. There are
numerous other income jurisdictions for which tax returns are not yet settled,
none of which is individually significant. The Company is currently being
audited by Canada Revenue Agency for fiscal year 2005 to fiscal year
2008.
The
Company and its U.S. subsidiaries file as members of a U.S. Federal consolidated
Income tax return, of which Axcan Holdings Inc. is the parent. The
consolidated income tax liability is allocated among the members of the group in
accordance with a tax allocation agreement. The tax allocation agreement
provides that each member of the group is allocated its share of the
consolidated tax provision determined generally on a separate income tax return
method.
As at
December 31, 2009, and September 30, 2009, the Company had a provision of
$2,097,000 for income taxes on the undistributed earnings of the Company’s
foreign subsidiaries that the Company does not intend to indefinitely
reinvest.
16
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
10. Stock
Incentive Plans
Management
equity incentive plan
In April
2008, the Company’s indirect parent company adopted a Management Equity
Incentive Plan (the “MEIP Plan”), pursuant to which the indirect parent company
will grant 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 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 shall vest 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 each, equal to
the share price at the date of grant. As at December 31, 2009, there were
1,228,343 outstanding RSUs and Penny Options (1,275,220 as at September 30,
2009) of which 820,342 (851,490 as at September 30, 2009) were
vested.
Annual
grant
In June
2008, the Company’s 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 participant’s 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 FSAB issued guidance on distinguishing liabilities from equity, since the
award is for a fixed amount of value that can be settled, at the option of the
participant, in (i) cash, or (ii) a variable number of parent company common
stock of equivalent value.
The
Company will not recognize any compensation expense until such time as the
occurrence of a liquidity event generating sufficient return to the majority
shareholders (in order for the award to vest) is probable. If such an event was
probable as of December 31, 2009, the value of the awards to be expensed by the
Company would range between $5,625,000 and $6,750,000 depending on the level of
return expected to be realized by the majority shareholders.
17
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
11. 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 12, the Company may enter into derivative financial
instruments to manage its exposure to interest rate changes and reduce its
overall cost of borrowing.
Currencies
risk
The
Company is exposed to financial risk arising from fluctuations in foreign
exchange rates and the degree of volatility of the rates. The Company does not
use derivative instruments to reduce its exposure to foreign currencies risk. As
at December 31, 2009, the financial assets totaling $203,708,000 ($183,252,000
as at September 30, 2009) include cash and cash equivalents and accounts
receivable for CAN$4,817,000, 18,539,000 Euros and 1,500,000 Swiss francs
respectively (CAN$3,525,000, 19,014,000 Euros and 2,000,000 Swiss francs as at
September 30, 2009). As at December 31, 2009, the financial liabilities totaling
$700,372,000 ($700,978,000 as at September 30, 2009) include accounts payable
and accrued liabilities and long-term debt of CAN$7,242,000 and 8,136,000 Euros
respectively (CAN$11,432,000 and 8,044,000 Euros as at September 30,
2009).
Credit
risk
As at
December 31, 2009, the Company had $98,533,000 ($98,630,000 as at September 30,
2009) of cash with one financial institution.
Fair
value of the financial instruments on the balance sheet
The
estimated fair value of the financial instruments is as follows:
December
31, 2009
|
September
30, 2009
|
|||||||||||||||
Fair
value
|
Carrying
amount
|
Fair
value
|
Carrying
amount
|
|||||||||||||
$
|
$
|
$
|
$
|
|||||||||||||
Assets
|
||||||||||||||||
Cash
and cash equivalents
|
132,391 | 132,391 | 126,435 | 126,435 | ||||||||||||
Accounts
receivable from the parent company
|
306 | 306 | 306 | 306 | ||||||||||||
Accounts
receivable, net
|
71,011 | 71,011 | 56,511 | 56,511 | ||||||||||||
Liabilities
|
||||||||||||||||
Accounts
payable and accrued liabilities
|
107,426 | 107,426 | 87,684 | 87,684 | ||||||||||||
Long-term
debt
|
636,169 | 592,946 | 649,689 | 613,294 |
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 term loan is estimated to be equal to book value mainly due to
the variable nature of its interest rate.
12.
|
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
18
and
uncertain cash amounts, the value of which are determined by interest rates. The
Company’s derivative financial instruments are used to manage differences in the
amount, timing and duration of the Company’s known or expected cash payments
principally related to the Company’s borrowings.
19
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
12.
|
Derivates
and Hedging Activities (continued)
|
Cash
flow hedges of interest rate risk
The
Company’s objectives in using interest rate derivatives are to add stability to
interest expense and to manage its exposure to interest rate movements. To
accomplish this objective, the Company primarily uses interest rate swaps as
part of its interest rate risk management strategy. Interest rate swaps
designated as cash flow hedges involve the receipt of variable-rate amounts from
a counterparty in exchange for the Company making fixed-rate payments over the
life of the agreements without exchange of the underlying notional amount.
During the three-month period ended December 31, 2009, such derivatives were
used to hedge the variable cash flows associated with existing variable-rate
debt.
The
effective portion of changes in the fair value of derivatives designated and
that qualify as cash flow hedges is recorded in Accumulated Other Comprehensive
Income and is subsequently reclassified into earnings in the period that the
hedged forecasted transaction affects earnings. The ineffective portion of the
change in fair value of the derivatives is recognized directly in
earnings.
Effective
March 3, 2008, the Company entered into two pay-fixed, receive-floating interest
rate swap agreements, effectively converting $115,000,000 of variable-rate debt
under its secured senior credit facilities to fixed-rate debt. Through the first
two quarters of 2008, the Company’s two interest rate swaps were designated as
effective hedges of cash flows. For the quarter ended September 30, 2008, due to
the increased volatility in short-term interest rates and a realignment of the
Company’s LIBOR rate election on its debt capital repayment schedule, hedge
accounting was discontinued as the hedge relationship ceased to satisfy the
strict conditions of hedge accounting. On December 1, 2008, the Company
redesignated its $50,000,000 notional interest rate swap that matures in
February 2010 anew as a cash flow hedge using an improved method of assessing
the effectiveness of the hedging relationship. The Company’s $65,000,000
notional interest rate swap matured in February 2009. Effective March 2009, the
Company entered into a pay-fixed, receive-floating interest rate swap of a
notional amount of $52,000,000 amortizing to $13,000,000 through February 2010.
As of December 31, 2009, the Company had two interest rate swaps with a combined
notional amount of $63,000,000 that were designated as cash flow hedges of
interest rate risk. The weighted average fixed interest rate on these swaps was
1.91%.
Amounts
reported in Accumulated Other Comprehensive Income related to derivatives will
be reclassified to interest expense as interest payments are made on the
Company’s variable-rate debt. During the twelve-month period ending December 31,
2010, the Company estimates that an additional $109,000 of amounts presently
classified in Accumulated Other Comprehensive Income will be reclassified as an
increase to interest expense.
The table
below presents the fair value of the Company’s derivative financial instruments
as well as their classification on the Consolidated Balance Sheet as of December
31, 2009, and September 30, 2009.
The
tables below present the effect of the Company’s derivative financial
instruments on the Consolidated Operations as at December 31, 2009.
Tabular
disclosure of fair values of derivative instruments
Liability
Derivatives
|
|||||||||
December
31,
2009
|
September
30,
2009
|
||||||||
Balance
sheet location
|
Fair
value
|
Fair
value
|
|||||||
Derivatives
designated as hedging instruments
|
$
|
||||||||
Interest
rate swaps
|
Other
long-term liabilities
|
214 | 610 | ||||||
Total
derivatives designated as hedging instruments
|
214 | 610 |
Tabular
disclosure of the effect of derivative instruments for the three-month period
ended December 31, 2009
Location
in the
Consolidated
Financial
Statements
|
For
the
three-month
period
ended
December
31,
2009
|
||||
Interest
rate swaps in cash flow hedging relationships
|
$
|
||||
Loss
recognized in other comprehensive income on derivatives (effective
portion), net of tax of $165
|
OCI
|
(306 | ) | ||
Gain
(loss) reclassified from accumulated comprehensive income into income
(effective portion)
|
Financial
expenses
|
(351 | ) | ||
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
|
- |
20
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S. dollars, except share related
data)
(unaudited)
13.
|
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.
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.
Financial
assets and liabilities measured at fair value on a recurring basis as at
December 31, 2009, and September 30, 2009 are summarized below:
Quoted
prices in
active
markets for
identical
assets
and
liabilities
(Level
1)
|
Significant
other
observable
inputs
(Level
2)
|
Significant
unobservable
inputs
(Level
3)
|
Balance
at
December
31, 2009
|
|||||||||||||
$
|
$
|
$
|
$
|
|||||||||||||
Liabilities
|
||||||||||||||||
Derivative
financial instruments
|
- | 214 | - | 214 |
Quoted
prices in
active
markets for
identical
assets
and
liabilities
(Level
1)
|
Significant
other
observable
inputs
(Level
2)
|
Significant
unobservable
inputs
(Level
3)
|
Balance
at
September
30, 2009
|
|||||||||||||
$
|
$
|
$
|
$
|
|||||||||||||
Liabilities
|
||||||||||||||||
Derivative
financial instruments
|
- | 610 | - | 610 |
Derivative
financial instruments consist of interest rate swap agreements as more fully
described in Note 12 and are measured at fair value based on observable market
interest rate curves as of the measurement date.
14.
|
Related
Party Transactions
|
As at
December 31, 2009, and September 30, 2009, the Company had a note receivable
from its parent company amounting to $133,154,000. During the three-month period
ended December 31, 2009, the Company earned interest income on the note
amounting to $1,974,000 net of taxes amounting to $1,063,000 ($1,975,000 net of
taxes amounting to $1,063,000 during the three-month period ended December 31,
2008) The accumulated related interest on the note receivable from the parent
company amounting to $18,115,000 as at December 31, 2009, ($15,078,000 as at
September 30, 2009) has been recorded in the Shareholder’s equity section of the
consolidated balance sheet. As at December 31, 2009, the Company also recorded
an account receivable from the parent company amounting to $306,000 ($306,000 as
at September 30, 2009).
During
the three-month period ended December 31, 2009, the Company recorded management
fees from a controlling shareholding company amounting to $855,000 ($163,000
during the three-month period ended December 31, 2008). As at December 31, 2009,
the Company accrued fees payable to a shareholding company amounting to $802,000
($436,000 as at September 30, 2009).
During
the three-month period ended December 31, 2009, the Company paid a dividend to
its parent company amounting to $128,000.
21
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S .dollars, except share related
data)
(unaudited)
15.
|
Condensed
Consolidating Financial Information
|
As of
December 31, 2009, the Company had outstanding $228,000,000 aggregate principal
amount of the Senior Secured Notes. The Secured Notes are fully and
unconditionally guaranteed, jointly and severally by certain of the Company’s
wholly-owned subsidiaries.
The
following supplemental tables present condensed consolidating balance sheets for
the Company and its subsidiary guarantors and non-guarantors as at December 31,
2009, and September 30, 2009, the condensed consolidating statements of
operations for the three-month period ended December 31, 2009, and three-month
period ended December 31, 2008, and the condensed consolidating statement of
cash flows for the three-month period ended December 31, 2009, and the
three-month period ended December 31, 2008.
Condensed
Consolidating Balance Sheet as at December 31, 2009
Axcan
Intermediate
Holdings
Inc.
|
Subsidiary
guarantors
|
Subsidiary
non-
guarantors
|
Eliminations
|
Consolidated
|
||||||||||||||||
$
|
$
|
$
|
$
|
$
|
||||||||||||||||
Assets
|
||||||||||||||||||||
Current
assets
|
||||||||||||||||||||
Cash
and cash equivalents
|
62 | 101,497 | 30,282 | - | 132,391 | |||||||||||||||
Accounts
receivable, net
|
25 | 55,878 | 15,769 | - | 71,672 | |||||||||||||||
Accounts
receivable from the parent company
|
42 | 264 | - | - | 306 | |||||||||||||||
Short-term
intercompany receivables
|
18,415 | 1,135 | 21 | (19,571 | ) | - | ||||||||||||||
Income
taxes receivable
|
(1,966 | ) | 3,452 | - | - | 1,486 | ||||||||||||||
Inventories,
net
|
- | 41,447 | 7,930 | - | 49,377 | |||||||||||||||
Prepaid
expenses and deposits
|
- | 2,518 | 604 | - | 3,122 | |||||||||||||||
Deferred
income taxes
|
- | 14,202 | 1,060 | - | 15,262 | |||||||||||||||
Total
current assets
|
16,578 | 220,393 | 56,216 | (19,571 | ) | 273,616 | ||||||||||||||
Property,
plant and equipment, net
|
- | 29,619 | 8,851 | - | 38,470 | |||||||||||||||
Intangible
assets
|
- | 334,485 | 70,681 | - | 405,166 | |||||||||||||||
Investment
in subsidiaries
|
(216,217 | ) | 799,349 | 78,175 | (661,307 | ) | - | |||||||||||||
Intercompany
advances
|
868,274 | 105,914 | 664,349 | (1,638,537 | ) | - | ||||||||||||||
Goodwill
|
- | 153,287 | 12,281 | - | 165,568 | |||||||||||||||
Deferred
debt issue expense, net
|
22,282 | 1,884 | - | - | 24,166 | |||||||||||||||
Deferred
income taxes
|
3,093 | 5,321 | 3,224 | - | 11,638 | |||||||||||||||
Total
assets
|
694,010 | 1,650,252 | 893,777 | (2,319,415 | ) | 918,624 | ||||||||||||||
Liabilities
|
||||||||||||||||||||
Current
liabilities
|
||||||||||||||||||||
Accounts
payable and accrued liabilities
|
18,064 | 77,767 | 11,595 | - | 107,426 | |||||||||||||||
Income
taxes payable
|
1,480 | (584 | ) | 1,319 | - | 2,215 | ||||||||||||||
Short-term
intercompany payables
|
- | 18,512 | 1,059 | (19,571 | ) | - | ||||||||||||||
Deferred
income taxes
|
- | 1,170 | (3 | ) | - | 1,167 | ||||||||||||||
Total
current liabilities
|
19,544 | 96,865 | 13,970 | (19,571 | ) | 110,808 | ||||||||||||||
Long-term
debt
|
515,231 | 77,715 | - | - | 592,946 | |||||||||||||||
Intercompany
advances
|
10,061 | 1,545,089 | 83,387 | (1,638,537 | ) | - | ||||||||||||||
Other
long-term liabilities
|
1,129 | 8,368 | - | - | 9,497 | |||||||||||||||
Deferred
income taxes
|
(22,349 | ) | 60,257 | (2,929 | ) | - | 34,979 | |||||||||||||
Total
liabilities
|
523,616 | 1,788,294 | 94,428 | (1,658,108 | ) | 748,230 | ||||||||||||||
Shareholders’
Equity
|
||||||||||||||||||||
Capital
stock
|
||||||||||||||||||||
Common
shares
|
1 | 21,020 | 744,331 | (765,351 | ) | 1 | ||||||||||||||
Preferred
shares
|
- | 78,175 | - | (78,175 | ) | - | ||||||||||||||
Retained
earnings (deficit)
|
(288,340 | ) | (225,412 | ) | 56,285 | 169,127 | (288,340 | ) | ||||||||||||
9.05%
Note receivable from the parent company
|
(133,154 | ) | - | - | - | (133,154 | ) | |||||||||||||
Additional
paid-in capital
|
619,195 | 15,483 | 687 | (16,170 | ) | 619,195 | ||||||||||||||
Accumulated
other comprehensive loss
|
(27,308 | ) | (27,308 | ) | (1,954 | ) | 29,262 | (27,308 | ) | |||||||||||
Total
shareholders’ equity
|
170,394 | (138,042 | ) | 799,349 | (661,307 | ) | 170,394 | |||||||||||||
Total
liabilities and shareholders’ equity
|
694,010 | 1,650,252 | 893,777 | (2,319,415 | ) | 918,624 |
22
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S .dollars, except share related
data)
(unaudited)
15.
|
Condensed
Consolidating Financial Information
(continued)
|
Condensed
Consolidating Balance Sheet as at September 30, 2009
Axcan
Intermediate
Holdings
Inc.
|
Subsidiary
guarantors
|
Subsidiary
non-guarantors
|
Eliminations
|
Consolidated
|
||||||||||||||||
$
|
$
|
$
|
$
|
$
|
||||||||||||||||
Assets
|
||||||||||||||||||||
Current
assets
|
||||||||||||||||||||
Cash
and cash equivalents
|
702 | 41,859 | 83,874 | - | 126,435 | |||||||||||||||
Accounts
receivable, net
|
- | 41,151 | 15,973 | - | 57,124 | |||||||||||||||
Accounts
receivable from the parent company
|
42 | 264 | - | - | 306 | |||||||||||||||
Short-term
intercompany receivables
|
5,857 | 5,803 | 364 | (12,024 | ) | - | ||||||||||||||
Income
taxes receivable
|
- | 3,383 | 8 | - | 3,391 | |||||||||||||||
Inventories,
net
|
- | 39,162 | 5,688 | (144 | ) | 44,706 | ||||||||||||||
Prepaid
expenses and deposits
|
- | 2,289 | 579 | - | 2,868 | |||||||||||||||
Deferred
income taxes
|
588 | 14,960 | 304 | - | 15,852 | |||||||||||||||
Total
current assets
|
7,189 | 148,871 | 106,790 | (12,168 | ) | 250,682 | ||||||||||||||
Property,
plant and equipment, net
|
- | 29,846 | 9,498 | - | 39,344 | |||||||||||||||
Intangible
assets, net
|
- | 347,604 | 73,686 | - | 421,290 | |||||||||||||||
Investments
in subsidiaries
|
(231,940 | ) | 782,206 | - | (550,266 | ) | - | |||||||||||||
Intercompany
advances
|
898,272 | 128,793 | 669,195 | (1,696,260 | ) | - | ||||||||||||||
Goodwill
|
- | 153,287 | 12,536 | - | 165,823 | |||||||||||||||
Deferred
debt issue expense, net
|
23,371 | 2,040 | - | - | 25,411 | |||||||||||||||
Deferred
income taxes
|
3,962 | 4,653 | 3,437 | - | 12,052 | |||||||||||||||
Total
assets
|
700,854 | 1,597,300 | 875,142 | (2,258,694 | ) | 914,602 | ||||||||||||||
Liabilities
|
||||||||||||||||||||
Current
liabilities
|
||||||||||||||||||||
Accounts
payable and accrued liabilities
|
5,091 | 71,305 | 11,432 | (144 | ) | 87,684 | ||||||||||||||
Income
taxes payable
|
3,425 | (940 | ) | 8 | - | 2,493 | ||||||||||||||
Installments
on long-term debt
|
12,939 | 17,769 | - | - | 30,708 | |||||||||||||||
Short-term
intercompany payables
|
4,795 | 6,206 | 1,023 | (12,024 | ) | - | ||||||||||||||
Deferred
income taxes
|
588 | 257 | (708 | ) | - | 137 | ||||||||||||||
Total
current liabilities
|
26,838 | 94,597 | 11,755 | (12,168 | ) | 121,022 | ||||||||||||||
Long-term
debt
|
510,755 | 71,831 | - | - | 582,586 | |||||||||||||||
Intercompany
advances
|
19,224 | 1,593,115 | 83,921 | (1,696,260 | ) | - | ||||||||||||||
Other
long-term liabilities
|
262 | 9,186 | - | - | 9,448 | |||||||||||||||
Deferred
income taxes
|
(19,989 | ) | 60,511 | (2,740 | ) | - | 37,782 | |||||||||||||
Total
liabilities
|
537,090 | 1,829,240 | 92,936 | (1,708,428 | ) | 750,838 | ||||||||||||||
Shareholders’
Equity
|
||||||||||||||||||||
Capital
stock
|
||||||||||||||||||||
Common
shares
|
1 | 21,034 | 745,398 | (766,432 | ) | 1 | ||||||||||||||
Retained
earnings (deficit)
|
(297,658 | ) | (242,700 | ) | 37,332 | 205,368 | (297,658 | ) | ||||||||||||
9.05%
Note receivable from the parent company
|
(133,154 | ) | - | - | - | (133,154 | ) | |||||||||||||
Additional
paid-in capital
|
619,053 | 14,204 | 611 | (14,815 | ) | 619,053 | ||||||||||||||
Accumulated
other comprehensive loss
|
(24,478 | ) | (24,478 | ) | (1,135 | ) | 25,613 | (24,478 | ) | |||||||||||
Total
shareholders’ equity
|
163,764 | (231,940 | ) | 782,206 | (550,266 | ) | 163,764 | |||||||||||||
Total
liabilities and shareholders’ equity
|
700,854 | 1,597,300 | 875,142 | (2,258,694 | ) | 914,602 |
23
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S .dollars, except share related
data)
(unaudited)
15.
|
Condensed
Consolidating Financial Information
(continued)
|
Condensed
Consolidating Operations for the three-month period ended December 31,
2009
Axcan
Intermediate
Holdings
Inc.
|
Subsidiary
guarantors
|
Subsidiary
non-guarantors
|
Eliminations
|
Consolidated
|
||||||||||||||||
$
|
$
|
$
|
$
|
$
|
||||||||||||||||
Net
product sales
|
- | 95,023 | 16,106 | (997 | ) | 110,132 | ||||||||||||||
Cost
of goods sold
|
- | 22,549 | 5,076 | (997 | ) | 26,628 | ||||||||||||||
Selling
and administrative expenses
|
343 | 24,401 | 7,495 | - | 32,239 | |||||||||||||||
Management
fees
|
855 | - | - | - | 855 | |||||||||||||||
Research
and development expenses
|
- | 7,707 | 719 | - | 8,426 | |||||||||||||||
Depreciation
and amortization
|
- | 14,611 | 2,082 | - | 16,693 | |||||||||||||||
Total
operating expenses
|
1,198 | 69,268 | 15,372 | (997 | ) | 84,841 | ||||||||||||||
Operating
income (loss)
|
(1,198 | ) | 25,755 | 734 | - | 25,291 | ||||||||||||||
Financial
expenses
|
14,957 | 28,661 | 1,960 | (29,381 | ) | 16,197 | ||||||||||||||
Interest
expense (income)
|
(12,469 | ) | (1,995 | ) | (15,065 | ) | 29,381 | (148 | ) | |||||||||||
Loss
(gain) on foreign currencies
|
6,717 | (4,664 | ) | (139 | ) | (1,929 | ) | (15 | ) | |||||||||||
Total
other expenses (income)
|
9,205 | 22,002 | (13,244 | ) | (1,929 | ) | 16,034 | |||||||||||||
Income
(loss) before income taxes
|
(10,403 | ) | 3,753 | 13,978 | 1,929 | 9,257 | ||||||||||||||
Income
taxes expense (benefit)
|
(3,641 | ) | 3,841 | (389 | ) | - | (189 | ) | ||||||||||||
Equity
in earnings in subsidiaries
|
16,208 | 16,296 | - | (32,504 | ) | - | ||||||||||||||
Net
income
|
9,446 | 16,208 | 14,367 | (30,575 | ) | 9,446 |
Condensed
Consolidating Operations for the three-month period ended December 31,
2008
Axcan
Intermediate
Holdings
Inc.
|
Subsidiary
guarantors
|
Subsidiary
non-guarantors
|
Eliminations
|
Consolidated
|
||||||||||||||||
$
|
$
|
$
|
$
|
$
|
||||||||||||||||
Revenue
|
- | 87,984 | 17,450 | (1,326 | ) | 104,108 | ||||||||||||||
Cost
of goods sold
|
- | 17,929 | 8,599 | (1,074 | ) | 25,454 | ||||||||||||||
Selling
and administrative expenses
|
1,299 | 23,238 | 7,468 | - | 32,005 | |||||||||||||||
Management
fees
|
163 | - | - | - | 163 | |||||||||||||||
Research
and development expenses
|
- | 6,868 | 182 | - | 7,050 | |||||||||||||||
Depreciation
and amortization
|
- | 12,943 | 1,530 | - | 14,473 | |||||||||||||||
1,462 | 60,978 | 17,779 | (1,074 | ) | 79,145 | |||||||||||||||
Operating
income (loss)
|
(1,462 | ) | 27,006 | (329 | ) | (252 | ) | 24,963 | ||||||||||||
Financial
expenses
|
16,136 | 32,770 | 1,682 | (31,263 | ) | 19,325 | ||||||||||||||
Interest
income
|
(16,810 | ) | (155 | ) | (14,521 | ) | 31,263 | (223 | ) | |||||||||||
Loss on
foreign currencies
|
- | 29 | 101 | - | 130 | |||||||||||||||
(674 | ) | 32,644 | (12,738 | ) | - | 19,232 | ||||||||||||||
Income
(loss) before income taxes
|
(788 | ) | (5,638 | ) | 12,409 | (252 | ) | 5,731 | ||||||||||||
Income
taxes (benefit)
|
(29,122 | ) | 31,806 | (2,086 | ) | - | 598 | |||||||||||||
Equity
in earnings (loss) in subsidiaries
|
(23,201 | ) | 14,243 | - | 8,958 | - | ||||||||||||||
Net
income (loss)
|
5,133 | (23,201 | ) | 14,495 | 8,706 | 5,133 |
24
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S .dollars, except share related
data)
(unaudited)
15.
|
Condensed
Consolidating Financial Information
(continued)
|
Condensed
Consolidating Cash Flows for the three-month period ended December 31,
2009
Axcan
Intermediate
Holdings
Inc.
|
Subsidiary
guarantors
|
Subsidiary
non-guarantors
|
Eliminations
|
Consolidated
|
||||||||||||||||
$
|
$
|
$
|
$
|
|||||||||||||||||
Cash
flows from operating activities
|
||||||||||||||||||||
Net
cash provided by (used in) operating activities
|
(12,285 | ) | 19,713 | 21,086 | - | 28,514 | ||||||||||||||
Cash
flows from investing activities
|
||||||||||||||||||||
Acquisition
of property, plant and equipment
|
- | (1,100 | ) | (29 | ) | - | (1,129 | ) | ||||||||||||
Intercompany
advances
|
29,998 | 22,879 | (5,328 | ) | (47,549 | ) | - | |||||||||||||
Investments
in subsidiaries
|
- | - | (68,000 | ) | 68,000 | - | ||||||||||||||
Net
cash provided by (used in) investing activities
|
29,998 | 21,779 | (73,357 | ) | 20,451 | (1,129 | ) | |||||||||||||
Cash
flows from financing activities
|
||||||||||||||||||||
Repayment
of long-term debt
|
(8,791 | ) | (12,074 | ) | - | - | (20,865 | ) | ||||||||||||
Stock-based
compensation plans redemption
|
(271 | ) | - | - | - | (271 | ) | |||||||||||||
Intercompany
advances
|
(9,163 | ) | (37,852 | ) | (534 | ) | 47,549 | - | ||||||||||||
Dividends
paid
|
(128 | ) | - | - | - | (128 | ) | |||||||||||||
Issue
of shares
|
- | 68,000 | - | (68,000 | ) | - | ||||||||||||||
Net
cash provided by (used in) financing activities
|
(18,353 | ) | 18,074 | (534 | ) | (20,451 | ) | (21,264 | ) | |||||||||||
Foreign
exchange gain (loss) on cash held in foreign currencies
|
- | 72 | (237 | ) | - | (165 | ) | |||||||||||||
Net
increase (decrease) in cash and cash equivalents
|
(640 | ) | 59,638 | (53,042 | ) | - | 5,956 | |||||||||||||
Cash
and cash equivalents, beginning of period
|
702 | 41,859 | 83,874 | - | 126,435 | |||||||||||||||
Cash
and cash equivalents, end of period
|
62 | 101,497 | 30,832 | - | 132,391 |
Condensed
Consolidating Cash Flows for the three-month period ended December 31,
2008
Axcan
Intermediate
Holdings
Inc.
|
Subsidiary
guarantors
|
Subsidiary
non-guarantors
|
Eliminations
|
Consolidated
|
||||||||||||||||
$
|
$
|
$
|
$
|
|||||||||||||||||
Cash
flows from operating activities
|
||||||||||||||||||||
Net
cash provided by (used in) operating activities
|
(8,814 | ) | 155,816 | (108,021 | ) | - | 38,981 | |||||||||||||
Cash
flows from investing activities
|
||||||||||||||||||||
Acquisition
of property, plant and equipment
|
- | (1,097 | ) | (201 | ) | - | (1,298 | ) | ||||||||||||
Acquisition
of intangible assets
|
- | - | (10 | ) | - | (10 | ) | |||||||||||||
Intercompany
advances
|
2,058 | (46,050 | ) | 16,784 | 27,208 | - | ||||||||||||||
Net
cash provided by (used in) investing activities
|
2,058 | (47,147 | ) | 16,573 | 27,208 | (1,308 | ) | |||||||||||||
Cash
flows from financing activities
|
||||||||||||||||||||
Repayment
of long-term debt
|
(1,111 | ) | (1,077 | ) | - | - | (2,188 | ) | ||||||||||||
Intercompany
advances
|
8,379 | (56,800 | ) | 75,629 | (27,208 | ) | - | |||||||||||||
Net
cash provided by (used in) financing activities
|
7,268 | (57,877 | ) | 75,629 | (27,208 | ) | (2,188 | ) | ||||||||||||
Foreign
exchange loss on cash held in foreign currencies
|
- | (271 | ) | (838 | ) | - | (1,109 | ) | ||||||||||||
Net
increase (decrease) in cash and cash equivalents
|
512 | 50,521 | (16,657 | ) | - | 34,376 | ||||||||||||||
Cash
and cash equivalents, beginning of period
|
21 | 26,181 | 29,903 | - | 56,105 | |||||||||||||||
Cash
and cash equivalents, end of period
|
533 | 76,702 | 13,246 | - | 90,481 |
25
AXCAN
INTERMEDIATE HOLDINGS INC.
Notes to
Consolidated Financial Statements
(amounts
in the tables are stated in thousands of U.S .dollars, except share related
data)
(unaudited)
16. Subsequent
Event
In June
2007, the Company 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. On January 5, 2010, a settlement arrangement was entered
into with certain of these defendants pursuant to which an amount of $5,750,000
was paid to the Company.
26
Item
2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
You
should read the following discussion in conjunction with the Consolidated
Financial Statements and the related notes that appear in Part I, Item 1 of this
Quarterly Report. The results of operations for the three-month periods ended
December 31, 2009, and December 31, 2008, reflect the results of operations for
Axcan Intermediate Holdings Inc. and its consolidated subsidiaries.
Unless
the context otherwise requires, in this “Management’s Discussion and Analysis of
Financial Condition and Results of Operations”, the terms "Axcan", "Company",
"we", "us" and "our" refer to Axcan Intermediate Holdings Inc. and its
consolidated subsidiaries.
This
discussion contains forward-looking statements and involves numerous risks and
uncertainties, including but not limited to those described in Part 2, Item 1A
of this Quaterly Report and “Item 1A Risk Factors” of our Annual Report on Form
10-K for the fiscal year ended September 30, 2009,. Actual results
may differ materially from those contained in any forward-looking
statements.
Overview
Our
Business
We are a
specialty pharmaceutical company focused on marketing and selling pharmaceutical
products used in the treatment of a variety of gastrointestinal, or GI, diseases
and disorders. Our mission is to improve the quality of care and health of
patients suffering from gastrointestinal diseases and disorders by providing
effective therapies for patients and caregivers.
Our main
product lines include ULTRASE, PANZYTRAT and VIOKASE, which are pancreatic
enzyme products for the treatment of exocrine pancreatic insufficiency; URSO /
URSO 250, URSO FORTE / URSO DS, and DELURSAN, which are ursodiol products for
the treatment of certain cholestatic liver diseases; SALOFALK and CANASA, which
are mesalamine-based products for the treatment of certain inflammatory bowel
diseases; CARAFATE and SULCRATE, which are sucralfate products for the treatment
of gastric and duodenal ulcers; and PYLERA, a product for the eradication of
Helicobacter pylori in
patients with duodenal ulcer disease.
In
addition to our marketing activities, we carry out research and development
activities on products at various stages of development. These activities are
carried out primarily with respect to products we currently market in connection
with lifecycle management initiatives, as well as product candidates acquired or
licensed from third parties. By combining our marketing capabilities with our
research and development experience, we distinguish ourselves from other
specialty pharmaceutical companies that focus solely on product distribution and
we offer licensors the prospect of rapidly expanding the potential market for
their products on a multinational basis. As a result, we are presented with
opportunities to acquire or in-license products that have been advanced to the
later stages of development by other companies. Our focus on products in
late-stage development enables us to reduce risks and expenses typically
associated with new drug development.
We intend
to enhance our position as the leading specialty pharmaceutical company
concentrating in the field of gastroenterology by pursuing the following
strategic initiatives: 1) growing sales of existing products; 2) launching new
products; 3) selectively acquiring or in-licensing complementary products; 4)
pursuing growth opportunities through development pipeline; and 5) expanding
internationally.
Business
Environment
While the
ultimate end users of our products are the individual patients to whom our
products are prescribed by physicians, our direct customers include a number of
large pharmaceutical wholesale distributors and large pharmacy chains. The
pharmaceutical wholesale distributors that comprise a significant portion of our
customer base sell our products primarily to retail pharmacies, which ultimately
dispense our products to the end consumers.
Increasingly,
in North America, third-party payors, such as private insurance companies and
drug plan benefit managers, aim to rationalize the use of pharmaceutical
products and medical treatments, in order to ensure that prescribed products are
necessary for the patients’ disorders. Moreover, large drug store chains now
account for an increasing portion of retail sales of prescription medicines. The
pharmacists and managers of such retail outlets are under pressure to reduce the
number of items in inventory in order to reduce costs.
We use a
“pull-through” marketing approach that is typical of pharmaceutical companies.
Under this approach, our sales representatives actively promote our portfolio by
demonstrating the features and benefits of our products to physicians and, in
particular, gastroenterologists who may prescribe our products for their
patients. The patients, in turn, take the prescriptions to pharmacies to be
filled. The pharmacies then place orders, directly or through buying groups,
with the wholesalers, to whom we sell our products.
Our
expenses are comprised primarily of selling and administrative expenses
(including marketing expenses), cost of goods sold (including royalty payments
to those companies from which we license some of our commercialized products),
research and development expenses, financial expenses as well as depreciation
and amortization.
27
Since
2005, some U.S. wholesalers have changed their business model from one depending
on drug price inflation to a fee-for-service arrangement, whereby manufacturers
pay wholesalers a fee for inventory management and other services. These fees
typically are a percentage of the wholesaler’s purchases from the manufacturer
or a fixed charge per item or per unit. The fee-for-service approach results in
wholesalers’ compensation being more stable and volume-based as opposed to
price-increase based. As a result of the move to a fee-for-service business
model, many wholesalers are no longer investing in inventory ahead of
anticipated price increases and have reduced their inventories from their
historical levels. As a consequence of the new model, manufacturers now realize
the benefit of price increases more rapidly in return for paying wholesalers for
the services they provide, on a fee-for-service basis. Fees resulting from
distribution services agreements, or DSAs, are deducted from gross
sales. We have DSAs in place with our three largest U.S. wholesalers
since the first quarter of fiscal year 2009.
FINANCIAL
OVERVIEW FOR THE THREE-MONTH PERIOD ENDED DECEMBER 31, 2009
This
discussion and analysis is based on our audited annual consolidated financial
statements and the related notes thereto reported under U.S. generally accepted
accounting principles (“GAAP”). For a description of our products, see the
section entitled “Business Products” in Item 1, Part I in our Annual Report on
Form 10-K for the fiscal year ended September 30, 2009, filed with the
Securities and Exchange Commission.
For the
three-month period ended December 31, 2009, net product sales was $110.1 million
($104.1 million in three-month period ended December 31, 2008), operating income
was $25.3 million ($24.9 million in three-month period ended December 31, 2008)
and net income was $9.4 million ($5.1 million in three-month period ended
December 31, 2008). Net product sales in the United States were $85.2 million
(77.4 % of net product sales) for the three-month period ended December 31,
2009, compared to $79.2 million (76.1% of net product sales) for the
corresponding period of the preceding fiscal year. In Canada, net product sales
were $8.9 million (8.1% of net product sales) for the three-month period ended
December 31, 2009, compared to $8.8 million (8.5% of net product sales) for the
corresponding period of the preceding fiscal year. In the European Union, net
product sales were $15.8 million (14.4% of net product sales) for the
three-month period ended December 31, 2009, compared to $15.9 million (15.3% of
net product sales) for the corresponding period of the preceding fiscal
year.
Financial
highlights
(in
millions of U.S. dollars)
|
December
31,
2009
|
September
30,
2009
|
||||||
$
|
$
|
|||||||
Total
assets
|
918.6 | 914.6 | ||||||
Long-term
debt (a)
|
592.9 | 613.3 | ||||||
Shareholders’
equity
|
170.4 | 163.8 |
(a)
|
Including
the current portion
|
(in
millions of U.S. dollars)
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
||||||
$
|
$
|
|||||||
Net
product sales
|
110.1 | 104.1 | ||||||
EBITDA
(1)
|
42.0 | 39.3 | ||||||
Adjusted
EBITDA (1)
|
46.2 | 41.9 | ||||||
Net
income
|
9.4 | 5.1 |
28
(1) A
reconciliation of net income to EBITDA (a non-U.S. GAAP measure) and from EBITDA
to Adjusted EBITDA (a non-U.S. GAAP measure) for the three-month periods ended
December 31, 2009, and 2008 is as follows:
(in
millions of U.S. dollars)
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
||||||
$
|
$
|
|||||||
Net
income
|
9.4 | 5.1 | ||||||
Financial
expenses
|
16.2 | 19.3 | ||||||
Interest
income
|
(0.1 | ) | (0.2 | ) | ||||
Income
taxes expense (benefit)
|
(0.2 | ) | 0.6 | |||||
Depreciation
and amortization
|
16.7 | 14.5 | ||||||
EBITDA
d)
|
42.0 | 39.3 | ||||||
Transaction,
integration, refinancing costs and nonrecurring payments to third parties
a)
|
1.8 | 1.1 | ||||||
Management
fees b)
|
0.9 | 0.2 | ||||||
Stock-based
compensation expense c)
|
1.5 | 1.3 | ||||||
Adjusted
EBITDA d)
|
46.2 | 41.9 |
a)
|
Represents
integration and refinancing costs related to non recurring transactions,
payments to third parties in respect of research and development
milestones and other progress payments as defined within our credit
agreement.
|
b)
|
Represents
management fees and other charges associated with the Management Services
Agreement with TPG.
|
c)
|
Represents
stock-based employee compensation expense under the provisions of FASB
guidance.
|
d)
|
EBITDA
and Adjusted EBITDA are both non-U.S. GAAP financial measures and are
presented in this report because our management considers them important
supplemental measures of our performance and believes that they are
frequently used by interested parties in the evaluation of companies in
the industry. EBITDA, as we use it, is net income before financial
expenses, interest income, income taxes and depreciation and amortization.
We believe that the presentation of EBITDA enhances an investor’s
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”. We
believe that the inclusion of supplementary adjustments applied to EBITDA
in presenting Adjusted EBITDA are appropriate to provide additional
information to investors about certain material non-cash items and unusual
or non-recurring items that we do not expect to continue in the future and
to provide additional information with respect to our ability to meet our
future debt service and to comply with various covenants in our indentures
and credit facility. Adjusted EBITDA is not a measure of net income,
operating income or any other performance measure derived in accordance
with U.S. GAAP, and is subject to important limitations. EBITDA and
Adjusted EBITDA have limitations as an analytical tool, and they should
not be considered in isolation, or as substitutes for analysis of our
results as reported under U.S. GAAP. Some of these limitations
are:
|
|
·
|
EBITDA
and Adjusted EBITDA do not reflect all cash expenditures, future
requirements for capital expenditures, or contractual
commitments;
|
|
·
|
EBITDA
and Adjusted EBITDA do not reflect changes in, or cash requirements for,
working capital needs;
|
|
·
|
EBITDA
and Adjusted EBITDA do not reflect the significant interest expense, or
the cash requirements necessary to service interest or principal payments,
on our debt;
|
|
·
|
Although
depreciation and amortization are non-cash charges, the assets being
depreciated and amortized will often have to be replaced in the future,
and EBITDA and Adjusted EBITDA do not reflect any cash requirements for
such replacements;
|
|
·
|
Adjusted
EBITDA reflects additional adjustments as provided in the indentures
governing our secured and unsecured notes and new senior secured credit
facilities; and
|
|
·
|
Other
companies in our industry may calculate EBITDA and Adjusted EBITDA
differently than we do, limiting its usefulness as a comparative
measure.
|
Because
of these limitations, EBITDA and Adjusted EBITDA should not be considered as
measures of discretionary cash available to us to invest in our business. Our
management compensates for these limitations by relying primarily on the U.S.
GAAP results and using EBITDA and Adjusted EBITDA as supplemental
information.
29
Overview
of results of operations
(in
millions of U.S. dollars)
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
Change
|
|||||||||||||
$
|
$
|
$
|
%
|
|||||||||||||
Net
product sales
|
110.1 | 104.1 | 6.0 | 5.8 | ||||||||||||
Cost
of goods sold (a)
|
26.6 | 25.5 | 1.1 | 4.3 | ||||||||||||
Selling
and administration expenses(a)
|
32.2 | 32.0 | 0.2 | 0.6 | ||||||||||||
Management fees
|
0.9 | 0.2 | 0.7 | 350.0 | ||||||||||||
Research
and development expenses (a)
|
8.4 | 7.0 | 1.4 | 20.0 | ||||||||||||
Depreciation
and amortization
|
16.7 | 14.5 | 2.2 | 15.2 | ||||||||||||
84.8 | 79.2 | 5.6 | 7.1 | |||||||||||||
Operating
income
|
25.3 | 24.9 | 0.4 | 1.6 | ||||||||||||
Financial
expenses
|
16.2 | 19.3 | (3.1 | ) | (16.1 | ) | ||||||||||
Interest
income
|
(0.1 | ) | (0.2 | ) | 0.1 | 50.0 | ||||||||||
Loss
on foreign currency
|
- | 0.1 | (0.1 | ) | (100.0 | ) | ||||||||||
16.1 | 19.2 | (3.1 | ) | (16.1 | ) | |||||||||||
Income
before income taxes
|
9.2 | 5.7 | 3.5 | 61.4 | ||||||||||||
Income
taxes expenses (benefits)
|
(0.2 | ) | 0.6 | (0.8 | ) | (133.3 | ) | |||||||||
Net
income
|
9.4 | 5.1 | 4.3 | 84.3 |
(a)
|
Exclusive
of depreciation and amortization
|
Net
product sales
For the
three-month period ended December 31, 2009, net product sales were $110.1
million compared to $104.1 million for the corresponding period of the preceding
year, an increase of 5.8%.
This
increase was primarily derived from higher sales in the United States, which
amounted to $85.2 million for the three-month period ended December 31, 2009,
compared to $79.2 million for the corresponding period of the preceding fiscal
year, an increase of 7.6%. The increase in sales in the United States is mainly
due to the combined effect of price increases on our products announced during
the previous fiscal year, a change in prescription rates for these products
compared to the previous year and a slight increase in the wholesaler inventory
level. This increase was partially offset by increases in sales deductions as
well as the decrease in sale of certain of our URSO branded products resulting
from the entry on the U.S. market of a generic versions of URSO 250 and URSO
FORTE following their approval by the Office of Generic Drugs on May 13, 2009.
Net product sales also included the revenue earned on sales of our authorized
generic ursodiol product. On July 2, 2009, Axcan and Prasco Laboratories
announced that they had entered into an agreement under which Prasco would
market and sell an authorized generic of URSO 250 and URSO FORTE in the U.S.
market. At the time, we also announced a price increase for our URSO products in
the United States. Despite measures taken to defend our URSO franchise in this
market, we expect future sales to continue to decline.
Net
product sales in the European Union decreased 0.6%, from $15.9 million for the
corresponding period of the preceding fiscal year, to $15.8 million for the
three-month period ended December 31, 2009. The decline in sales resulted
principally from a decrease in sales of our LACTEOL products as a result of
seasonal fluctuations in the infant diarrheal market offset by the positive
impact of currency fluctuations compared to the preceding year as the value of
the Euro improved against the U.S. dollar by 11.3%.
Net
product sales in Canada increased 1.1%, from $8.8 million for the corresponding
period of the preceding fiscal year, to $8.9 million for the three-month period
ended December 31, 2009. The increase in sales resulted mostly from the positive
impact of currency fluctuations compared to the corresponding period of the
preceding year as the value of the Canadian dollar improved against the U.S.
dollar by 8.7%. This increase was partially offset by a decrease in
sales of our SALOFALK products.
30
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:
(in
millions of U.S. dollars)
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
Change
|
|||||||||||||
$
|
$
|
$
|
%
|
|||||||||||||
Gross
product sales
|
145.3 | 122.4 | 22.9 | 18.7 | ||||||||||||
Gross-to-net
product sales adjustments
|
||||||||||||||||
Product
returns
|
1.3 | 1.1 | 0.2 | 18.2 | ||||||||||||
Chargebacks
|
14.8 | 5.3 | 9.5 | 179.2 | ||||||||||||
Contract
rebates
|
14.6 | 8.6 | 6.0 | 69.8 | ||||||||||||
DSA
fees
|
1.8 | 0.9 | 0.9 | 100.0 | ||||||||||||
Discounts
and other allowances
|
2.7 | 2.4 | 0.3 | 12.5 | ||||||||||||
Total
gross-to-net product sales adjustments
|
35.2 | 18.3 | 16.9 | 92.3 | ||||||||||||
Total
net product sales
|
110.1 | 104.1 | 6.0 | 5.8 |
Product
returns, chargebacks, contract rebates, DSA fees, discounts and other allowances
totalled $35.2 million (24.2% of gross product sales) for the three-month period
ended December 31, 2009, and $18.3 million (15.0% of gross product sales) for
the corresponding period of the preceding fiscal year. The increase in total
deductions as a percentage of gross product sales was partly due to an increase
of 5.9% in chargebacks and 3.0% in contract rebates. The increase in chargebacks
and contract rebates is primarily due to the fact that we have fixed price
contracts with certain third-party payors which, as a result of price increases
announced during the preceding fiscal year, result in a greater rebate as a
percentage of sales being awarded under those contracts. Additionaly, during the
three-month period ended December 31, 2009, we recorded an additional reserve of
$3.9 million for chargebacks and rebates related liabilities related to our URSO
franchise to reflect the estimated impact of updated pricing and contracting
activities. Estimated chargebacks and rebates are recorded at the time revenue
is recognized and are based on the latest information available at that time,
including estimated inventory levels in the distribution channel.
In
addition, in May 2009, the Company entered into an agreement with the Department
of Defense, or DOD, to remain eligible for inclusion on the DOD’s formulary and
pursuant to which the Company agreed to pay rebates under the TRICARE retail
pharmacy program. The Company began accounting for these rebates in the third
quarter of fiscal year 2009. Under the contracting process it initiated in 2009,
the DOD further sought to claim rebates from a large
number of pharmaceutical manufacturers, including the Company, on all
prescriptions of covered drugs filled under TRICARE for prior
periods, starting as and from January 28, 2008. The DOD’s right to
claim rebates for these periods prior its rulemaking and contracting initiative
was challenged in a lawsuit instituted on behalf of pharmaceutical
manufacturers. During the three-month period ended December 31, 2009, an
additional provision of $1.6 million was recorded to account for the potential
unfavourable judicial decision in this lawsuit.
Deductions
also increased due to increases in DSA fees resulting from new DSA agreements
signed with two additional U.S. wholesalers during the previous fiscal
year.
Cost
of goods sold
Cost of
goods sold consists principally of the costs of raw materials, royalties and
manufacturing costs. We outsource most of our manufacturing requirements. For
the three-month period ended December 31, 2009, cost of goods sold increased
$1.1 million (4.3%) to $26.6 million from $25.5 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 December 31, 2009, decreased as
compared to the three-month period ended December 31, 2008, from 24.5% to 24.2%
due to product mix.
Selling
and administrative expenses
Selling
and administrative expenses, on an ongoing basis, consist principally of
salaries and other costs associated with our sales force and marketing
activities. For the three-month period ended December 31, 2009, selling and
administrative expenses increased $0.2 million (0.6%) to $32.2 million from
$32.0 million for the corresponding period of the preceding fiscal year. This
increase in selling and administrative expenses is mainly due to an increase in
our supporting programs as well as in the sales force headcount which was
increased in May 2009. This increase was partially offset by a decrease in
distribution costs.
Management
fees
Management
fees consist of fees and other charges associated with the management services
agreement between TPG and Axcan Holdings Inc., the indirect parent company of
Axcan Intermediate Holdings Inc. For the three-month period ended December 31,
2009, management fees increased $0.7 million to $0.9 million from $0.2 million
for the corresponding period of the preceding fiscal year as these fees were
previously not allocated to the subsidiaries of Axcan Holdings
Inc.
31
Research
and development expenses
Research
and development expenses consist principally of fees paid to outside parties
that we use to conduct clinical studies and to submit governmental approval
applications on our behalf, as well as the salaries and benefits paid to
personnel involved in research and development projects. For the three-month
period ended December 31, 2009, research and development expenses increased $1.4
million (20.0%) to $8.4 million, from $7.0 million for the corresponding period
of the preceding fiscal year. This increase is mainly due to the development
work on pancreatic enzyme products.
Depreciation
and amortization
Depreciation
and amortization consists principally of the amortization of intangible assets
with a finite life. Intangible assets include trademarks, trademark licenses and
manufacturing rights. For the three-month period ended December 31, 2009,
depreciation and amortization increased $2.2 million (15.2%) to $16.7 million
from $14.5 million for the corresponding period of the preceding fiscal year.
The increase for the period is due to the reduction of the remaining amortizable
life of some intangible assets to periods ranging from 6 months to 14 years, in
the third quarter of fiscal year 2009.
Financial
expenses
Financial
expenses consist principally of interest and fees paid in connection with funds
borrowed for acquisitions. For the three-month period ended December 31, 2009,
financial expenses decreased $3.1 million (16.1%) to $16.2 million from $19.3
million for the corresponding period of the preceding fiscal year. The decrease
in financial expenses is mainly due to the change in the fair value of
derivatives of $0.9 million and a reduction of the interest on long-term debt of
$1.8 million.
Interest
income
For the
three-month period ended December 31, 2009, total interest income decreased to
$0.1 million from $0.2 million for the corresponding period of the preceding
fiscal year due to lower interest rates in spite of increase in the cash and
cash equivalents.
Income
taxes
For the
three-month period ended December 31, 2009, income taxes benefits amounted to
$0.2 million, compared to income taxes expenses of $0.6 million for the
corresponding period of the preceding fiscal year. The effective tax rate was
minus 2.04% for the three-month period ended December 31, 2009, compared to
10.44% for the three-month period ended December 31, 2008. The effective tax
rate for the three-month period ended December 31, 2009, is affected by a number
of elements, the most important being the tax benefit arising from a financing
structure. The difference between our effective income tax rate and the
statutory income tax rate is summarized as follows:
(in
thousands of U.S. dollars)
|
For
the
three-month
period ended
December
31
2009
|
For
the
three-month
period ended
December
31
2008
|
||||||||||||||
%
|
$
|
%
|
$
|
|||||||||||||
Combined
statutory rate applied to pre-tax income (loss)
|
35.00 | 3.2 | 35.00 | 2.0 | ||||||||||||
Increase
(decrease) in taxes resulting from:
|
||||||||||||||||
Change
in promulgated rates
|
0.79 | 0.1 | - | - | ||||||||||||
Difference
with foreign tax rates
|
(7.98 | ) | (0.7 | ) | (11.93 | ) | (0.7 | ) | ||||||||
Tax
benefit arising from a financing structure
|
(39.70 | ) | (3.7 | ) | (64.02 | ) | (3.7 | ) | ||||||||
Non-deductible
items
|
4.96 | 0.5 | 7.58 | 0.4 | ||||||||||||
Non-taxable
items
|
(5.97 | ) | (0.6 | ) | (2.03 | ) | (0.1 | ) | ||||||||
Investment
tax credits
|
(2.61 | ) | (0.2 | ) | (4.49 | ) | (0.3 | ) | ||||||||
State
taxes
|
3.37 | 0.3 | 9.53 | 0.5 | ||||||||||||
Other
|
10.10 | 0.9 | 40.80 | 2.3 | ||||||||||||
(2.04 | ) | (0.2 | ) | 10.44 | 0.6 |
Net
income
For the
three-month period ended December 31, 2009, net income was $9.4 million compared
to $5.1 million for the corresponding period of the preceding fiscal year. The
increase of $4.3 million (84.3%) resulted mainly from a $3.1 million decrease in
financial expenses, a $0.8 million increase in income taxes benefits and a $0.4
million increase in operating income.
32
Balance
sheets as at December 31, 2009, and September 30, 2009
The
following table summarizes balance sheet information as at December 31, 2009,
compared to September 30, 2009.
December
31,
|
September
30,
|
|||||||||||||||
(in
millions of U.S. dollars)
|
2009
|
2009
|
Change
|
|||||||||||||
$
|
$
|
$
|
%
|
|||||||||||||
Cash
and cash equivalents
|
132.4 | 126.4 | 6.0 | 4.7 | ||||||||||||
Current
assets
|
273.6 | 250.7 | 22.9 | 9.1 | ||||||||||||
Total
assets
|
918.6 | 914.6 | 4.0 | 0.4 | ||||||||||||
Current
liabilities
|
110.8 | 121.0 | (10.2 | ) | (8.4 | ) | ||||||||||
Long-term
debt
|
592.9 | 582.6 | 10.3 | 1.8 | ||||||||||||
Total
liabilities
|
748.2 | 750.8 | (2.6 | ) | (0.3 | ) | ||||||||||
Shareholders’
equity
|
170.4 | 163.8 | 6.6 | 4.0 | ||||||||||||
Working
capital
|
162.8 | 129.7 | 33.1 | 25.5 |
Our cash
and cash equivalents increased by $6.0 million (4.7%) to $132.4 million as at
December 31, 2009, from $126.4 million at September 30, 2009. As at
December 31, 2009, working capital was $162.8 million, compared to $129.7
million at September 30, 2009, an increase of $33.1 million (25.5%). This
increase was mainly due to the reduction in instalments on long-term debt of
$30.7 million, an increase in accounts receivable of $14.6 million and an
increase in inventory of $4.7 million, partially offset by an increase in
accounts payable of $19.7 million. Pursuant to the annual excess cash flow
requirements for the fiscal year 2009 defined in the credit agreement, we were
required to prepay $17.6 million of outstanding term loans in the first quarter
of fiscal year 2010. The prepayment was paid in December 2009. In addition, as
allowed by the credit agreement, the prepayment has been applied to the
remaining scheduled installments of principal in direct order of maturity. The
current portion of long-term debt has been reduced accordingly.
Total
assets increased $4.0 million (0.4%) to $918.6 million as at December 31, 2009,
from $914.6 million as at September 30, 2009. Long-term debt increased $10.3
million (1.8%) to $592.9 million as at December 31, 2009, from $582.6 million as
at September 30, 2009, mostly due to the reclassification of $13.1 million from
short-term debt to long-term debt pursuant the allocation of the prepayment made
in December 2009 to the remaining scheduled installments of principal in direct
order of maturity.
Liquidity
and Capital Resources
Cash
Requirements
We
maintain a sufficient level of working capital, which was approximately $162.8
at December 31, 2009, and $129.7 at September, 2008. In 2010 and future periods,
we expect cash generated by operations together with existing cash and cash
equivalents to be sufficient to cover cash needs for working capital, capital
expenditures, milestone payments and debt services. 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.
Contractual
Obligations and Other Commitments
The
following table summarizes our significant contractual obligations as at
December 31, 2009, 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 at December
31, 2009, and certain other purchase obligations as discussed
below:
For
the twelve-month periods ending December 31,
|
||||||||||||||||||||
(in
millions of U.S. dollars)
|
2010
|
2011
|
2012
|
2013
|
2014
and thereafter
|
|||||||||||||||
$
|
$
|
$
|
$
|
$
|
||||||||||||||||
Long-term
debt
|
- | 11.9 | 20.8 | 80.9 | 488.2 | |||||||||||||||
Operating
leases
|
2.6 | 1.7 | 1.2 | 1.1 | 0.3 | |||||||||||||||
Other
commitments
|
17.2 | 2.0 | - | - | - | |||||||||||||||
Interest
on long-term debt
|
57.9 | 57.7 | 56.9 | 55.1 | 89.7 | |||||||||||||||
77.7 | 73.3 | 78.9 | 137.1 | 578.2 |
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 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
33
variable
price provisions; and the approximate timing of the transaction. Our purchase
orders are based on current needs and are fulfilled by our vendors within
relatively short timetables. We do not have significant agreements for the
purchase of raw materials or finished goods specifying minimum quantities or set
prices that exceed our short-term expected requirements. We also enter into
contracts for outsourced services; however, the obligations under these
contracts are not significant and the contracts generally contain clauses
allowing for cancellation without significant penalty. As milestone payments are
primarily contingent upon successfully achieving clinical milestones or on
receiving regulatory approval for products under development, they do not have
defined maturities and therefore are not included in the above
table.
The
expected timing of payment of the obligations discussed above is estimated based
on current information. The timing of payments and actual amounts paid may
differ depending on the timing of receipt of goods or services, or, for some
obligations, changes to agreed-upon amounts.
As more
fully described in Note 9 to the Consolidated Financial Statements, effective
October 1, 2007, we adopted the provisions of the guidance issued by the FASB
related to accounting for uncertainty in income taxes. As at December 31, 2009,
we had unrecognized tax benefits of $10.9 million ($10.4 million as at September
30, 2009) of which $9.5 million would be treated as a reduction of goodwill and
$1.4 million would favourably impact our effective tax rate if subsequently
recognized. Due to the nature and timing of the ultimate outcome of
these uncertain tax positions, we can not 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
November 29, 2007, we entered into an Arrangement Agreement with Axcan Pharma
Inc., pursuant to which we agreed to, through an indirect wholly-owned
subsidiary, acquire all of the common stock of Axcan Pharma Inc. and enter into
various other transactions in accordance with the Plan of Arrangement (the
“Arrangement”). On February 25, 2008, we obtained various types of financing in
connection with the Arrangement. We issued $228.0 million aggregate principal
amount of Senior Secured Notes. The Senior Secured Notes were priced at $0.98737
with a yield to March 1, 2015, of 10%. The Senior Secured Notes rank pari passu
with our credit facility.
We may
redeem some or all of the Senior Secured Notes prior to March 1, 2011 at a
redemption price equal to 100% of the principal amount of the Senior
Secured Notes redeemed plus a “make-whole” premium and accrued and unpaid
interest. On or after March 1, 2011, we may redeem some or all of the Senior
Secured Notes at the redemption prices (expressed as percentages of principal
amount of the Senior Secured Notes to be redeemed) set forth below:
Year
|
%
|
|||
2011
|
106.938 | |||
2012
|
104.625 | |||
2013
|
102.313 | |||
2014
and thereafter
|
100.000 |
Prior to
March 1, 2011, we may also redeem up to 35% of the aggregate principal amount of
the Senior Secured Notes using the proceeds of one or more equity offerings
at a redemption price equal to 109.250% of the aggregate principal amount of the
Senior Secured Notes plus accrued and unpaid interest. If there is a change of
control as specified in the indenture governing the senior notes, we must offer
to repurchase the Senior Secured Notes at a price in cash equal to 101% of the
aggregate principal amount thereof, plus accrued and unpaid
interest.
We also
obtained a Credit Facility for a total of $290.0 million composed of term loans
totalling $175.0 million and a revolving credit facility of $115.0 million
(“Credit Facility”). The Credit Facility bears interest at a variable rate
composed of either the Federal Funds Rate or the British Banker Association
LIBOR rate, at our option, plus the applicable rate based on our consolidated
total leverage ratio and certain of our subsidiaries for the preceding twelve
months. The Credit Facility matures on February 25, 2014, with quarterly
payments on the term. As at September 30, 2009, $175.0 million of term loans had
been issued and no amounts had been drawn against the revolving credit facility.
The term loans were priced at $0.96 with a yield to maturity of 8.75% before the
effect of the interest rate swaps as further disclosed in our Consolidated
Financial Statements. The Credit Facility requires us to meet certain financial
covenants, which were met as at December 31, 2009. The credit agreement
governing the Credit Facility requires us to prepay outstanding term loans
contingent upon the occurrence of these events, subject to certain exceptions,
with: (1) 100% of the net cash proceeds of any incurrence of debt other than
debt permitted under the Credit Facility, (2) commencing with
the year ending September 30, 2009, 50% (which percentage will be
reduced to 25% if the senior secured leverage ratio is less than a specified
ratio) of the annual excess cash flow (as defined in the credit agreement
governing the Credit Facility) and (3) 100% of the net cash proceeds of all
non-ordinary course asset sales or other dispositions of property (including
casualty events) by us or by our subsidiaries, subject to reinvestments rights
and certain other exceptions. Based on these requirements, for the fiscal year
2009, we were required to prepay $17.6 million of outstanding term loans in the
first quarter of fiscal year 2010.
On
February 25, 2008, as part of the Arrangement financing, we also obtained $235.0
million in financing under our senior unsecured
34
bridge
facility maturing on February 25, 2009. On May 6, 2008, our senior unsecured
bridge facility was refinanced on a long-term basis, by repaying the bridge
facility with the proceeds from our sale of $235.0 million aggregate principal
amount of the senior unsecured notes. The senior notes were priced at $0.9884
with a yield to March 1, 2016 of 13.16%. The Senior Unsecured Notes are
subordinate to the new senior secured credit facility and secured
notes.
We may
redeem some or all of the senior notes prior to March 1, 2012 at a
redemption price equal to 100% of the principal amount of the Senior
Unsecured Notes redeemed plus a “make-whole” premium and accrued and unpaid
interest. On or after March 1, 2012, we may redeem some or all of the Senior
Unsecured Notes at the redemption prices (expressed as percentages of principal
amount of the Senior Unsecured Notes to be redeemed) set forth
below:
Year
|
%
|
|||
2012
|
106.375 | |||
2013
|
103.188 | |||
2014
and thereafter
|
100.000 |
Prior to
March 1, 2011, we may also redeem up to 35% of the aggregate principal amount of
the Senior Secured Notes using the proceeds of one or more equity offerings at a
redemption price equal to 112.750% of the aggregate principal amount of the
Senior Unsecured Notes plus accrued and unpaid interest. If there is a change of
control as specified in the indenture governing the senior notes, we must offer
to repurchase the senior notes at a price in cash equal to 101% of the aggregate
principal amount thereof, plus accrued and unpaid interest.
Certain
of our subsidiaries have been designated as guarantors with respect to the
credit facility, the Senior Secured Notes and the senior unsecured notes. Our
obligations under, and each of the guarantors’ obligations under its guarantee
of, the credit facility and the Senior Secured Notes are secured by a first
priority security interest in our assets and of such guarantor subsidiaries,
respectively.
We may
from time to time seek to retire or purchase our outstanding debt through cash
purchases in open market purchases, privately negotiated transactions or
otherwise. Such repurchases or exchanges, if any, will depend on prevailing
market conditions, our liquidity requirements, contractual restrictions and
other factors. The amounts involved may be material.
Operating
leases
We have
various long-term operating lease agreements for office space, automotive
equipment and other equipment. The latest expiry date for these agreements is in
2014.
Other
commitments
Other
operating commitments consist primarily of amounts relating to administrative
services, clinical studies and other research and development
services.
Related
party transactions
As at
December 31, 2009, and September 30, 2009, we had a note receivable from our
parent company amounting to $133.2 million. During the three-month period ended
December 31, 2009, we have earned interest income amounting to $2.0 million, net
of taxes amounting to $1.1 million ($2.0 million net of taxes amounting to $1.1
million during the three-month period ended December 31, 2008). We have also
recorded a related interest on the note receivable from our parent company
amounting to $18.1 million as at December 31, 2009, ($15.1 million as at
September 30, 2009), which has been recorded in the shareholder’s equity section
of the consolidated balance sheet. As at December 31, 2009, we also recorded an
account receivable from our parent company amounting to $0.3 million ($0.3
million as at September 30, 2009).
During
the there-month period ended December 31, 2009, we recorded management fees from
a controlling shareholding company amounting to $0.9 million ($0.2 million in
three-month period ended December 31, 2008). As at December 31, 2009, we accrued
fees payable to a shareholding company amounting to $0.8 million ($0.4 as at
September 30, 2009).
During
the three-month period ended December 31, 2009, we paid a dividend to our parent
company amounting to $0.1 million to allow for the payment of certain group
expenses.
35
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 consolidated financial statements.
Cash
flows
Our cash
flows from operating, investing and financing activities for the three-month
periods ended December 31, 2009, and 2008 as reflected in the consolidated
statements of cash flows, are summarized in the following table:
(in
millions of U.S. dollars)
|
For
the
three-month
period
ended
December
31,
2009
|
For
the
three-month
period
ended
December
31,
2008
|
Change
|
|||||||||
$
|
$
|
$
|
||||||||||
Net
cash provided by operating activities
|
28.5 | 39.0 | (10.5 | ) | ||||||||
Net
cash used by investing activities
|
(1.1 | ) | (1.3 | ) | 0.2 | |||||||
Net
cash used by financing activities
|
(21.3 | ) | (2.2 | ) | (19.1 | ) |
Cash
flows provided by operating activities decreased $10.5 million from $39.0
million for the three-month period ended December 31, 2008, to $28.5 million for
the three-month period ended December 31, 2009. The decrease in net cash
provided by operating activities is due to the decrease in the changes in
working capital. The decrease was partially offset by the operating activities
in three-month period year ended December 30, 2009, compared the corresponding
period of the preceding fiscal year.
Cash
flows used by investing activities decreased by $0.2 million from $1.3 million
of cash used in the three-month period ended December 31, 2008, to $1.1 million
of cash used in the three-month period ended December 31, 2009.
Cash
flows used by financing activities increased $19.1 million from $2.2 million of
cash used in the three-month period ended December 31, 2008, to $21.3 million of
cash used in the three-month period ended December 31, 2009. The increase in
cash used by financing activities is mainly due to the prepayment in the
three-month period ended December 31, 2009, of $17.6 million of outstanding
term-loans, based on the annual excess cash flow requirements for the fiscal
year 2009, as defined in the credit agreement.
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 U.S. GAAP 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 year. Significant estimates and
assumptions made by management include the allocation of the purchase price of
acquired assets and businesses, allowances for accounts receivable and
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 records 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 health care environment, foreign exchange and managed care
consumption patterns.
36
Revenue
Recognition
Revenue
is recognized when the product is shipped to our customers, provided we have 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 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
shipped in the future are reported as deferred revenue.
The
following table summarizes the activity in the accounts related to revenue
reductions:
(in
millions of U.S. dollars)
|
Product
returns
|
Contract
rebates
|
Charge-
backs
|
DSA
fees
|
Discounts
and
other
|
Total
|
||||||||||||||||||
$
|
$
|
$
|
$
|
$
|
$
|
|||||||||||||||||||
Balance
as at September 30, 2009
|
17.2 | 9.8 | 9.0 | 1.0 | 0.7 | 37.7 | ||||||||||||||||||
Provisions
|
1.3 | 14.6 | 14.8 | 1.8 | 2.7 | 35.2 | ||||||||||||||||||
Settlements
|
(1.3 | ) | (8.8 | ) | (12.1 | ) | (1.0 | ) | (2.5 | ) | (25.7 | ) | ||||||||||||
Balance
as at December 31, 2009
|
17.2 | 15.6 | 11.7 | 1.8 | 0.9 | 47.2 |
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 6 months prior to
and 12 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
channels;
|
|
·
|
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 channels 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 $17.2 million as at December 31, 2009,
and September 30, 2009, for estimated product returns.
Rebates,
Chargebacks and other sales deductions
In the
United States, 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.
37
The
amounts are recognized as revenue reductions at the time of sale based on our
best estimate of the product’s 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 Company’s 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 management’s estimates of the rebates
reported in prior periods. However, since the prices of the Company’s 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 U.S.GAAP.
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
Company’s financial condition or results of operations.
Accrued
liabilities include reserves of $15.6 million and $11.7 million as at December
31, 2009, and $9.8 million and $9.0 million as at September 30, 2009,
respectively, for estimated contract rebates and chargebacks.
If the
levels of chargebacks, fees pursuant to DSAs, managed care, Medicaid and other
government rebates, product returns and discounts fluctuate significantly and/or
if our estimates do not adequately reserve for these reductions of net product
revenues, our reported revenue could be negatively affected.
Intangible
Assets and Goodwill
Intangible
assets with a finite life are amortized over their estimated useful lives
according to the straight-line method over periods varying from 5 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, 2009, to December 31, 2009:
Intangible
assets
|
Goodwill
|
|||||||
$
|
$
|
|||||||
Balance
as at September 30, 2009
|
421.3 | 165.8 | ||||||
Depreciation
and amortization
|
(14.4 | ) | - | |||||
Foreign
exchange translation adjustment
|
(1.7 | ) | (0.2 | ) | ||||
Balance
as at December 31, 2009
|
405.2 | 165.6 |
Research
and Development Expenses
Research
and development expenses are charged to operations in the period they are
incurred. The cost of intangibles that are purchased from others for a
particular research and development project that have no alternative future use
are expensed at the time of acquisition.
Income
taxes
Income
taxes are calculated using the 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
38
date of
the financial statements for the 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
2 to our 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.
Subsequent
Event
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. On January 5, 2010 a settlement arrangement was entered
into with certain of these defendants pursuant to which an amount of $5,750,000
was paid to us.
39
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, 2009, which is incorporated herein by reference. As of December 31, 2009,
our exposure to market risk has not changed materially since September 30,
2009.
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, 2009, 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, in the ordinary course of
business, we replaced our existing information system used to perform the
consolidation our financial statements with a new system. Other that the above
noted accounting system change, 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.
40
PART
II. OTHER INFORMATION
Item
1A.
|
Risk
Factors
|
Except for the updated risk factors
related to the pancreatic enzyme products (PEPs), there have been no material
changes to the risk factors disclosed in Part I, Item 1A of our Annual Report on
Form 10-K for the fiscal year ended September 30, 2009 aside from those
disclosed in Part I, Item 1A of our Quarterly Report on Form 10-Q for the
quarter ended December 31, 2009 and disclosed below. Additional risks and
uncertainties not currently known to us or that we currently deem to be
immaterial also may, in the future, materially adversely affect our business,
financial condition or results.
RISKS
RELATED TO OUR PANCREATIC ENZYME PRODUCTS (PEPs)
Our
revenues from ULTRASE and VIOKASE are subject to regulatory risk.
Existing
products to treat exocrine pancreatic insufficiency have been marketed in the
U.S. since before the passage of the Federal Food, Drug, and Cosmetic Act, or
FDCA, in 1938 and, consequently, there are currently marketed PEPs that have not
been approved by the FDA, including ULTRASE and VIOKASE. 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
until April 28, 2010 for those companies that were (a) marketing unapproved
pancreatic enzyme products as of April 28, 2004; (b) submitted NDAs on or before
April 28, 2009; and (c) that continue diligent pursuit of regulatory
approval.
We
reported net sales of $75.9 million, $58.6 million and $47.5 million for ULTRASE
in fiscal 2009, 2008, and 2007, respectively, and $23.7 million for the
three-month period ended December 31, 2009. We completed the submission of our
NDA for ULTRASE MT and, in the fourth quarter of fiscal 2008, received a first
complete response letter (formerly known as an ‘’approvable letter’’ prior to
recent amendments of the Food Drug and Cosmetics Act, or FDCA)
citing only certain chemistry, manufacturing and control data, or
CMC, work requirements to which we responded. Further to the filing
of our response, we received a second complete response letter in the fourth
quarter of fiscal 2009, again citing certain CMC work the FDA requested we
complete in order to obtain approval. This request was addressed in a complete
response letter we prepared in collaboration with our manufacturing partners and
filed with the FDA. We reported net sales of $22.7 million, $15.1 million and
$11.2 million for VIOKASE in fiscal 2009, 2008, and 2007, respectively, and $8.6
million for the three-month period ended December 31, 2009. The submission of
our rolling NDA for VIOKASE was completed in the first quarter of fiscal
2010. At the time we completed this submission we requested a
priority review and the FDA recently advised us in the
second quarter of fiscal 2010 that it would not grant a
priority review of this NDA.
We and
the manufacturer of the active pharmaceutical ingredient of ULTRASE MT and
VIOKASE are in ongoing discussions with the FDA to address the remaining open
issues identified by the FDA.
Although
the FDA may determine not to pursue immediate regulatory action against
companies that do not obtain regulatory approval of their PEPs prior to April
28, 2010, if we are unable to obtain FDA approval to market ULTRASE or VIOKASE
prior to such date,
|
·
|
we
may be subject to FDA regulatory action to remove these products from the
market,
|
|
·
|
certain
wholesalers and other clients may refuse to purchase or distribute these
products, and
|
|
·
|
governmental
and other third-party payors may no longer agree to reimburse or pay for
the cost of these drugs.
|
As a
result, our market for ULTRASE and VIOKASE may be significantly adversely
affected, or we may no longer be able to sell ULTRASE or VIOKASE in the U.S.,
which would impair our results of operations and liquidity.
Competition
in the PEP market could be more intense than expected.
We face
competition from PEPs which have been FDA-approved and the FDA may not remove
existing unapproved PEPs from the market in April 2010, even if they have not
been FDA-approved. The level of competition facing our ULTRASE and VIOKASE
products in the U.S. will depend on the number of manufacturers of PEP products
on the market. Two products have received NDA approval since the FDA mandated
that all manufacturers of exocrine pancreatic insufficiency drug products must
file an NDA and receive approval for their products. CREON®, which is marketed
by Solvay Pharmaceuticals, was approved by the FDA in May 2009 and the approved
product was recently launched. ZENPEP™, marketed by Eurand, was approved by the
FDA in August 2009 and was recently launched. Other manufacturers are believed
to be actively seeking FDA NDA approval for their product, including PANCREASE®,
marketed by Ortho-McNeil Pharmaceuticals, Inc., and PANCRECARB®, marketed by
Digestive Care, Inc. Accordingly, our ULTRASE and VIOKASE products face
competition from products which have already received FDA approval under an NDA,
and competition from approved products may further increase if other products
for which manufacturers are seeking approval obtain FDA approval before ULTRASE
MT or VIOKASE. Patient and physician acceptance of our products may be adversely
affected by the fact that they are not yet approved while other approved
products are available, which could also have a material adverse effect on our
business and our financial results.
Further,
despite the FDA’s announcement, its position is non-binding, and the agency may
determine not to pursue regulatory action against companies that fail to meet
any applicable deadline. If the FDA does not enforce its stated positions by the
applicable deadline, the level of competition that ULTRASE and VIOKASE will face
may be greater than we anticipate, as some non-approved PEP products might
remain on the market. In addition, the FDA could change its position or suspend
enforcement again as it did in October 2007.
41
Item
6.
Exhibit
No.
|
Exhibits.
Exhibit
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
31.2
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2
|
Certification
of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
42
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
AXCAN
INTERMEDIATE HOLDINGS INC.
|
Date: February
10, 2010
|
BY:
|
|
Steve
Gannon
|
||
Senior
Vice President, Finance, Chief Financial Officer and
Treasurer
|
43
EXHIBIT
INDEX
Exhibit
No.
|
Exhibit
|
31.1
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
31.2
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
32.1
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2
|
Certification
of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
44