Attached files
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EX-2.1 - ALBANY MOLECULAR RESEARCH INC | v183980_ex2-1.htm |
EX-31.2 - ALBANY MOLECULAR RESEARCH INC | v183980_ex31-2.htm |
EX-31.1 - ALBANY MOLECULAR RESEARCH INC | v183980_ex31-1.htm |
EX-32.2 - ALBANY MOLECULAR RESEARCH INC | v183980_ex32-2.htm |
EX-32.1 - ALBANY MOLECULAR RESEARCH INC | v183980_ex32-1.htm |
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 March 31, 2010
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For
the transition period from
to
Commission
file number: 0-25323
ALBANY
MOLECULAR RESEARCH, INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
14-1742717
|
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
|
incorporation
or organization)
|
Identification
No.)
|
21
Corporate Circle
PO
Box 15098
Albany,
New York 12212-5098
(Address
of principal executive offices)
(518)
464-0279
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last
report)
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 x No o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 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 ¨
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 “smaller reporting company” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer o
|
Accelerated
filer x
|
||
Non-accelerated
filer o
|
Smaller
reporting company o
|
Indicate
by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
Yes o No x
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date.
Class
|
Outstanding at April
30, 2010
|
||
Common
Stock, $.01 par value
|
31,807,521,
excluding treasury shares of 3,824,593
|
ALBANY
MOLECULAR RESEARCH, INC.
INDEX
Part I.
|
Financial
Information
|
3
|
||||
Item
1.
|
Condensed
Consolidated Financial Statements (Unaudited)
|
3
|
||||
Condensed
Consolidated Statements of Operations
|
3
|
|||||
Condensed
Consolidated Balance Sheets
|
4
|
|||||
Condensed
Consolidated Statements of Cash Flows
|
5
|
|||||
Notes
to Condensed Consolidated Financial Statements
|
6
|
|||||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
18
|
||||
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
24
|
||||
Item
4.
|
Controls
and Procedures
|
24
|
||||
Part II.
|
Other
Information
|
25
|
||||
Item
1.
|
Legal
Proceedings
|
25
|
||||
Item 1A.
|
Risk
Factors
|
25
|
||||
Item
6.
|
Exhibits
|
25
|
||||
Signatures
|
26
|
|||||
Exhibit Index
|
2
PART I
— FINANCIAL INFORMATION
Item
1. Condensed Consolidated Financial Statements
(Unaudited)
Albany
Molecular Research, Inc.
Condensed
Consolidated Statements of Operations
(unaudited)
Three Months Ended
|
||||||||
(Dollars in thousands, except for per share data)
|
March 31, 2010
|
March 31, 2009
|
||||||
Contract
revenue
|
$ | 38,892 | $ | 43,244 | ||||
Recurring
royalties
|
10,439 | 10,786 | ||||||
Total
revenue
|
49,331 | 54,030 | ||||||
Cost
of contract revenue
|
34,761 | 36,643 | ||||||
Technology
incentive award
|
1,043 | 1,105 | ||||||
Research
and development
|
2,763 | 3,385 | ||||||
Selling,
general and administrative
|
10,639 | 10,302 | ||||||
Total
operating expenses
|
49,206 | 51,435 | ||||||
Income
from operations
|
125 | 2,595 | ||||||
Interest
income, net
|
43 | 111 | ||||||
Other
(loss) income, net
|
(88 | ) | 328 | |||||
Income
before income tax expense
|
80 | 3,034 | ||||||
Income
tax expense
|
14 | 1,092 | ||||||
Net
income
|
$ | 66 | $ | 1,942 | ||||
Basic
earnings per share
|
$ | 0.00 | $ | 0.06 | ||||
Diluted
earnings per share
|
$ | 0.00 | $ | 0.06 |
See
notes to unaudited condensed consolidated financial statements.
3
Albany
Molecular Research, Inc.
Condensed
Consolidated Balance Sheets
(unaudited)
(Dollars and shares in thousands, except for per share data)
|
March 31,
2010
|
December 31,
2009
|
||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 55,203 | $ | 80,953 | ||||
Investment
securities
|
29,532 | 30,105 | ||||||
Accounts
receivable, net
|
29,165 | 23,616 | ||||||
Royalty
income receivable
|
9,800 | 7,101 | ||||||
Inventory
|
26,403 | 25,143 | ||||||
Unbilled
services
|
83 | 58 | ||||||
Prepaid
expenses and other current assets
|
9,956 | 8,780 | ||||||
Deferred
income taxes
|
4,751 | 4,708 | ||||||
Total
current assets
|
164,893 | 180,464 | ||||||
Property
and equipment, net
|
178,517 | 166,746 | ||||||
Goodwill
|
22,764 | 17,551 | ||||||
Intangible
assets and patents, net
|
2,512 | 2,461 | ||||||
Equity
investment in unconsolidated affiliates
|
956 | 956 | ||||||
Deferred
income taxes
|
1,304 | 1,166 | ||||||
Other
assets
|
4,070 | 4,348 | ||||||
Total
assets
|
$ | 375,016 | $ | 373,692 | ||||
Liabilities
and Stockholders’ Equity
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 21,358 | $ | 18,368 | ||||
Deferred
revenue and licensing fees
|
9,750 | 10,777 | ||||||
Accrued
pension benefits
|
218 | 218 | ||||||
Income
taxes payable
|
536 | 1,101 | ||||||
Current
installments of long-term debt
|
270 | 270 | ||||||
Total
current liabilities
|
32,132 | 30,734 | ||||||
Long-term
liabilities:
|
||||||||
Long-term
debt, excluding current installments
|
13,212 | 13,212 | ||||||
Deferred
licensing fees
|
6,824 | 7,143 | ||||||
Deferred
rent
|
1,315 | 1,354 | ||||||
Pension
and postretirement benefits
|
6,449 | 6,445 | ||||||
Environmental
liabilities
|
191 | 191 | ||||||
Total
liabilities
|
60,123 | 59,079 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
equity:
|
||||||||
Common
stock, $0.01 par value, 100,000 shares authorized, 35,633 shares
issued as of March 31 2010, and 35,467 shares issued as of December 31,
2009
|
356 | 355 | ||||||
Additional
paid-in capital
|
202,469 | 201,667 | ||||||
Retained
earnings
|
174,187 | 174,121 | ||||||
Accumulated
other comprehensive loss, net
|
(5,231 | ) | (4,642 | ) | ||||
371,781 | 371,501 | |||||||
Less,
treasury shares at cost, 3,825 shares as of March 31, 2010 and December
31, 2009
|
(56,888 | ) | (56,888 | ) | ||||
Total
stockholders’ equity
|
314,893 | 314,613 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 375,016 | $ | 373,692 |
See
notes to unaudited condensed consolidated financial statements.
4
Albany
Molecular Research, Inc.
Condensed
Consolidated Statements of Cash Flows
(unaudited)
Three Months Ended
|
||||||||
(Dollars in thousands)
|
March 31, 2010
|
March 31, 2009
|
||||||
Operating
activities
|
||||||||
Net
income
|
$ | 66 | $ | 1,942 | ||||
Adjustments
to reconcile net income to net cash (used in) provided by operating
activities:
|
||||||||
Depreciation
and amortization
|
4,149 | 4,331 | ||||||
Deferred
income tax benefit
|
(162 | ) | (4,309 | ) | ||||
Loss
on disposal of property, plant and equipment
|
— | 66 | ||||||
Stock-based
compensation expense
|
549 | 525 | ||||||
Provision
for bad debt
|
(66 | ) | — | |||||
Write
down for obsolete inventories
|
— | 331 | ||||||
Change
in assets and liabilities, net of effect of acquisition:
|
||||||||
Accounts
receivable
|
(4,453 | ) | 8,197 | |||||
Royalty
income receivable
|
(2,699 | ) | (3,713 | ) | ||||
Inventory,
prepaid expenses and other assets
|
(348 | ) | 685 | |||||
Accounts
payable and accrued expenses
|
(1,333 | ) | 158 | |||||
Income
tax payable
|
(565 | ) | 3,580 | |||||
Deferred
revenue and licensing fees
|
(1,346 | ) | 9,546 | |||||
Pension
and postretirement benefits
|
65 | (7 | ) | |||||
Other
long-term liabilities
|
(39 | ) | 614 | |||||
Net
cash (used in) provided by operating activities
|
(6,182 | ) | 21,946 | |||||
Investing
activities
|
||||||||
Purchases
of investment securities
|
(1,577 | ) | (261 | ) | ||||
Proceeds
from sales and maturities of investment securities
|
1,995 | 2,932 | ||||||
Purchase
of businesses, net of cash acquired
|
(18,462 | ) | (12 | ) | ||||
Purchase
of property, plant and equipment
|
(1,898 | ) | (8,654 | ) | ||||
Payments
for patent applications and other costs
|
(129 | ) | (97 | ) | ||||
Net
cash used in investing activities
|
(20,071 | ) | (6,092 | ) | ||||
Financing
activities
|
||||||||
Proceeds
from sale of common stock
|
254 | 192 | ||||||
Net
cash provided by financing activities
|
254 | 192 | ||||||
Effect
of exchange rate changes on cash flows
|
249 | (858 | ) | |||||
(Decrease)
increase in cash and cash equivalents
|
(25,750 | ) | 15,188 | |||||
Cash
and cash equivalents at beginning of period
|
80,953 | 60,400 | ||||||
Cash
and cash equivalents at end of period
|
$ | 55,203 | $ | 75,588 |
See
notes to unaudited condensed consolidated financial statements.
5
(All
amounts in thousands, except per share amounts, unless otherwise
noted)
Note
1 — Summary of Operations and Significant Accounting Policies
Nature
of Business and Operations
Albany
Molecular Research, Inc. (the “Company”) provides scientific services,
technologies and products focused on improving the quality of life. The
Company’s core business consists of a fee-for-service contract services platform
encompassing drug discovery, development and manufacturing and a separate
stand-alone research and development division consisting of proprietary
technology investments, internal drug discovery and niche generic active
pharmaceutical ingredient product development. With locations in the
U.S., Europe, and Asia, the Company provides customers with a range of services
and cost models.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with U.S. generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and Rule
10-01 of Regulation S-X. In accordance with Rule 10-01, the unaudited condensed
consolidated financial statements do not include all of the information and
footnotes required by U.S. generally accepted accounting principles for complete
consolidated financial statements. The year-end condensed consolidated balance
sheet data was derived from audited financial statements but does not include
all disclosures required by U.S. generally accepted accounting principles. In
the opinion of management, all adjustments (consisting of normal recurring
accruals and adjustments) considered necessary for a fair statement of the
results for the interim period have been included. Operating results for the
three months ended March 31, 2010 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2010. The
accompanying unaudited condensed consolidated financial statements should be
read in conjunction with the audited consolidated financial statements and notes
thereto included in our Annual Report on Form 10-K for the year ended
December 31, 2009.
The
accompanying unaudited condensed consolidated financial statements include the
accounts of the Company and its wholly-owned subsidiaries. All intercompany
balances and transactions have been eliminated during consolidation. Assets and
liabilities of non-U.S. operations are translated at period-end rates of
exchange, and the statements of operations are translated at the average rates
of exchange for the period. Unrealized gains or losses resulting from
translating non-U.S. currency financial statements are recorded in accumulated
other comprehensive (loss) income in the accompanying unaudited condensed
consolidated balance sheets.
Use
of Management Estimates
The
preparation of financial statements in conformity with U.S. generally accepted
accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, and disclosures of
contingent assets and liabilities, at the date of the financial statements, and
the reported amounts of revenues and expenses during the reporting
period. The most significant estimates included in the accompanying
consolidated financial statements include assumptions regarding the
collectibility of receivables, the valuation of inventory, and the fair value of
goodwill, intangible assets, and long-lived assets. Other significant estimates
include assumptions utilized in determining the amount and realizabilty of
deferred tax assets and assumptions utilized in determining actuarial
obligations in conjunction with the Company’s pension and postretirement health
plans. Actual results can vary from these estimates.
Contract
Revenue Recognition
The
Company’s contract revenue consists primarily of fees earned under contracts
with third-party customers and reimbursed expenses under such contracts. The
Company also seeks to include provisions in certain contracts that contain a
combination of up-front licensing fees, milestone and royalty payments should
the Company’s proprietary technology and expertise lead to the discovery of new
products that become commercial. Reimbursed expenses consist of chemicals and
other project specific costs. Generally, the Company’s contracts may be
terminated by the customer upon 30 days’ to one year’s prior notice,
depending on the terms and/or size of the contract. The Company analyzes its
agreements to determine whether the elements can be separated and accounted for
individually or as a single unit of accounting in accordance with FASB’s
Accounting Standards Codification (“ASC”) 605-25, “Revenue Arrangements with
Multiple Deliverables,” and ASC Topic 13 (formerly Staff Accounting Bulletin
(“SAB”) 104), “Revenue Recognition”. Allocation of revenue to individual
elements that qualify for separate accounting is based on the fair value of the
respective elements.
6
The
Company generates contract revenue on the following basis:
Full-time
Equivalent (“FTE”). An FTE
agreement establishes the number of Company employees contracted for a project
or a series of projects, the duration of the contract period, the price per FTE,
plus an allowance for chemicals and other project specific costs, which may or
may not be incorporated in the FTE rate. FTE contracts can run in one month
increments, but typically have terms of six months or longer. FTE contracts
typically provide for annual adjustments in billing rates for the scientists
assigned to the contract.
These
contracts involve the Company’s scientists providing services on a “best
efforts” basis on a project that may involve a research component with a
timeframe or outcome that has some level of unpredictability. There are no fixed
deliverables that must be met for payment as part of these services. As such,
the Company recognizes revenue under FTE contracts on a monthly basis as
services are performed according to the terms of the contract.
Time and
Materials. Under
a time and materials contract the Company charges customers an hourly rate plus
reimbursement for chemicals and other project specific costs. The Company
recognizes revenue for time and material contracts based on the number of hours
devoted to the project multiplied by the customer’s billing rate plus other
project specific costs incurred.
Fixed-Fee. Under a fixed-fee contract
the Company charges a fixed agreed upon amount for a deliverable. Fixed-fee
contracts have fixed deliverables upon completion of the project. Typically, the
Company recognizes revenue for fixed-fee contracts after projects are completed,
delivery is made and title transfers to the customer, and collection is
reasonably assured. In certain instances, the Company’s customers request that
the Company retain materials produced upon completion of the project due to the
fact that the customer does not have a qualified facility to store those
materials or for other reasons. In these instances, the revenue
recognition process is considered complete when project documents (batch
records, Certificates of Analysis, etc.) have been delivered to the customer and
payment has been collected.
Up-Front License
Fees, Milestone, and Royalty Revenue. The Company recognizes
revenue from up-front non-refundable licensing fees on a straight-line basis
over the period of the underlying project. The Company will recognize revenue
arising from a substantive milestone payment upon the successful achievement of
the event, and the resolution of any uncertainties or contingencies regarding
potential collection of the related payment, or if appropriate over the
remaining term of the agreement.
Recurring
Royalties Revenue Recognition. Recurring
royalties consist of royalties under a license agreement with sanofi-aventis
based on the worldwide sales of fexofenadine HCl, marketed as Allegra in the
Americas and Telfast elsewhere, as well as on sales of sanofi-aventis’
authorized generics. The Company records royalty revenue in the period in which
the sales of Allegra/Telfast occur, because we can reasonably estimate such
royalties. Royalty payments from sanofi-aventis are due within 45 days
after each calendar quarter and are determined based on sales of Allegra/Telfast
in that quarter, with the exception of Allegra D-12 which has a fixed royalty
amount through July 2010.
Long-Lived
Assets:
The
Company assesses the impairment of long-lived assets whenever events or changes
in circumstances indicate that their carrying value may not be recoverable.
Factors the Company considers important that could trigger an impairment review
include, among others, the following:
|
·
|
a
significant change in the extent or manner in which a long-lived asset is
being used;
|
|
·
|
a
significant change in the business climate that could affect the value of
a long-lived asset; and
|
|
·
|
a
significant decrease in the market value of
assets.
|
If the
Company determines that the carrying value of long-lived assets may not be
recoverable, based upon the existence of one or more of the above indicators of
impairment, the Company compares the carrying value of the asset group to the
undiscounted cash flows expected to be generated by the asset group. If the
carrying value exceeds the undiscounted cash flows an impairment charge is
recorded. An impairment charge is recognized to the extent that the carrying
amount of the asset group exceeds their fair value and will reduce only the
carrying amounts of the long-lived assets. The Company utilizes the assistance
of an independent valuation firm in determining the fair values.
7
Goodwill:
The
Company performs an annual assessment of the
carrying value of goodwill for potential impairment (or on an interim basis if
certain triggering events occur). A determination of impairment is made based
upon the comparison of the book value to the fair value of the related reporting
unit. If goodwill is determined to be impaired, the Company would be
required to record a charge to its results of operations. Factors the Company
considers important which could result in an impairment include the
following:
· significant
underperformance relative to historical or projected future operating
results;
· significant
negative industry or economic trends; and
· market
capitalization relative to net book value
See Note
6 for further information on the Company’s goodwill balances.
Note
2 — Business Combination
Acquisition
of Excelsyn Ltd.
On
February 17, 2010, the Company completed the purchase of all of the outstanding
shares of Excelsyn Ltd. (“Excelsyn”), a chemical development and manufacturing
facility located in Holywell, United Kingdom. The aggregate purchase
price was $18,462.
Excelsyn
provides development and large scale manufacturing services to large
pharmaceutical, specialty pharmaceutical and biotechnology customers throughout
Europe, Asia and North America. Manufacturing services include pre-clinical and
Phase I – III product development as well as commercial manufacturing services
for approved products. The acquisition of Excelsyn expands AMRI’s
portfolio of development and large scale manufacturing facilities as well as its
customer portfolio, with little overlap of customers between the two
companies.
A final
valuation will be completed to determine the fair value of the acquired property
and equipment and any potential identifiable intangibles, which may result in
changes to their estimated fair values, as well as changes to the allocated
goodwill fair value. The following table summarizes the preliminary
allocation of the purchase price to the estimated fair value of the net assets
acquired:
February 17,
2010
|
||||
Assets Acquired
|
||||
Accounts
receivable
|
$ | 1,030 | ||
Inventory
|
1,104 | |||
Prepaid
expenses and other current assets
|
750 | |||
Property
and equipment
|
14,130 | |||
Goodwill
|
5,771 | |||
Total
assets acquired
|
$ | 22,785 | ||
Liabilities
Assumed
|
||||
Accounts
payable and accrued expenses
|
$ | 4,323 | ||
Total
liabilities assumed
|
$ | 4,323 | ||
Net
assets acquired
|
$ | 18,462 |
Pro forma
financial information for the three months ended March 31, 2010, as if the
Excelsyn acquisition had been completed as of January 1, 2010, has been excluded
due to the immateriality of the operating results of Excelsyn in relation to the
Company’s consolidated operating results as a whole.
8
Note
3 — Earnings Per Share
The
shares used in the computation of the Company’s basic and diluted earnings per
share are as follows:
Three Months Ended
March 31,
|
||||||||
2010
|
2009
|
|||||||
Weighted
average common shares outstanding
|
31,168 | 31,016 | ||||||
Dilutive
effect of restricted stock
|
167 | 97 | ||||||
Weighted
average common shares outstanding
|
31,335 | 31,113 |
The
Company has excluded certain outstanding stock options and non-vested restricted
shares from the calculation of diluted earnings per share for the three months
ended March 31, 2010 and 2009 because the exercise price was greater than the
average market price of the Company’s common shares during that period, and as
such, these options and shares would be anti-dilutive. The weighted average
number of anti-dilutive options and restricted shares outstanding (before the
effects of the treasury stock method) was 1,906 for both the three months ended
March 31, 2010 and 2009. These amounts are not included in the
calculation of weighted average common shares outstanding.
Note
4 — Inventory
Inventory
consisted of the following at March 31, 2010 and December 31,
2009:
March 31,
2010
|
December 31,
2009
|
|||||||
Raw
materials
|
$ | 8,140 | $ | 7,415 | ||||
Work
in process
|
3,333 | 2,213 | ||||||
Finished
goods
|
14,930 | 15,515 | ||||||
Total
|
$ | 26,403 | $ | 25,143 |
Note
5 — Restructuring
AMRI
India
In
December 2009, the Company initiated a restructuring of its AMRI India locations
which consisted of closing and consolidating its Mumbai administrative office
into its Hyderabad location as part of the Company’s goal to streamline
operations and eliminate duplicate administrative functions. The
Company recorded a restructuring charge of approximately $364 in the fourth
quarter of 2009, including lease termination charges of $215, leasehold
improvement abandonment charges of $107 and administrative costs of
$42.
The
restructuring costs are included under the caption “Restructuring charge” in the
consolidated statement of operations for the year ended December 31, 2009 and
the restructuring liabilities are included in “Accounts payable and accrued
expenses” on the consolidated balance sheet at March 31, 2010 and December 31,
2009.
The AMRI
India restructuring activity was recorded in the Company’s Large Scale
Manufacturing (“LSM”) operating segment. The following table displays
AMRI India’s restructuring activity and liability balances within our LSM
operating segment:
Balance at
January 1,
2010
|
Paid
Amounts |
Foreign
Currency Translation Adjustments |
Balance at
March 31,
2010
|
|||||||||||||
Lease
termination charges
|
$ | 215 | $ | (165 | ) | $ | 4 | $ | 54 | |||||||
Administrative
costs associated with restructuring
|
11 | (7 | ) | — | 4 | |||||||||||
Total
|
$ | 226 | $ | (172 | ) | $ | 4 | $ | 58 |
Lease
termination charges and leasehold improvement abandonment charges relate to
costs associated with exiting the current facility.
The net
cash outflow related to the AMRI India restructuring for the quarter ended March
31, 2010 was $172. Anticipated cash outflows related to the AMRI
India restructuring for the remainder of 2010 is approximately $58, which
primarily consists of lease termination charges.
9
AMRI
Hungary
In May
2008, the Company initiated a restructuring of its Hungary
location. The goal of the restructuring was to realign the business
model for these operations to better support the Company’s long-term strategy
for providing Discovery Services in the European marketplace. The
Company recorded a restructuring charge of approximately $1,833 in the second
quarter of 2008, including termination benefits and personnel realignment costs
of approximately $901, losses on grant contracts of approximately $389, lease
termination charges of approximately $463 and administrative costs associated
with the restructuring plan of $80.
During
August 2009, the Company closed and consolidated its Balaton, Hungary facility
into the new facility in Budapest, Hungary as part of the Company’s goal to
streamline operations and to consolidate locations, equipment and operating
costs. As a result, the Company recorded a restructuring charge of
approximately $327 in the second quarter of 2009, including termination benefits
and personnel realignment costs of approximately $134, lease termination charges
of $182 and administrative costs associated with the restructuring plan of
$11.
The
restructuring costs are included under the caption “Restructuring charge” in the
consolidated statement of operations for the year ended December 31, 2009 and
the restructuring liabilities are included in “Accounts payable and accrued
expenses” on the consolidated balance sheet at March 31, 2010 and December 31,
2009.
The
following table displays AMRI Hungary’s restructuring activity and liability
balances within our Discovery/Development/Small Scale Manufacturing (“DDS”)
operating segment:
Balance at
January 1,
2010
|
Paid
Amounts |
Foreign
Currency Translation Adjustments |
Balance at
March 31, 2010
|
|||||||||||||
Termination
benefits and personnel realignment
|
$ | 55 | $ | (24 | ) | $ | (1 | ) | $ | 30 | ||||||
Losses
on grant contracts
|
246 | (93 | ) | (12 | ) | 141 | ||||||||||
Lease
termination charges
|
275 | — | (14 | ) | 261 | |||||||||||
Administrative
costs associated with restructuring
|
12 | — | (2 | ) | 10 | |||||||||||
Total
|
$ | 588 | $ | (117 | ) | $ | (29 | ) | $ | 442 |
Termination
benefits and personnel realignment costs relate to severance packages,
outplacement services, and career counseling for employees affected by this
restructuring. Losses on grant contracts represent estimated
contractual losses that will be incurred in performing grant-based work under
Hungary’s legacy business model. Lease termination charges relate to
costs associated with exiting the current facility.
Anticipated
cash outflows related to the Hungary restructuring for the remainder of 2010 is
approximately $180, which primarily consists of the lease termination charges
and incurring losses on grant contracts.
Note
6 — Goodwill and Intangible Assets
The
carrying amounts of goodwill, by the Company’s DDS and LSM operating segments,
as of March 31, 2010 and December 31, 2009 are as follows:
DDS
|
LSM
|
Total
|
||||||||||
March
31, 2010
|
$ | 14,347 | $ | 8,417 | $ | 22,764 | ||||||
December 31,
2009
|
$ | 13,199 | $ | 4,352 | $ | 17,551 |
The
increase in goodwill within the DDS segment from December 31, 2009 to March 31,
2010 is due to the goodwill recorded in association with the acquisition of
Excelsyn in February 2010. This increase was offset in part by a
decrease in goodwill due to the impact of foreign currency
translation. The increase in goodwill within the LSM segment from
December 31, 2009 to March 31, 2010 is primarily due to the goodwill recorded in
association with the acquisition of Excelsyn in February 2010, in addition to
the impact of foreign currency translation.
10
The
components of intangible assets are as follows:
Cost
|
Accumulated
Amortization
|
Net
|
Amortization
Period
|
||||||||||
March 31, 2010
|
|||||||||||||
Patents
and Licensing Rights
|
$ | 3,994 | $ | (1,482 | ) | $ | 2,512 |
2-16
years
|
|||||
December 31, 2009
|
|||||||||||||
Patents
and Licensing Rights
|
$ | 3,897 | $ | (1,436 | ) | $ | 2,461 |
2-16
years
|
Amortization
expense related to intangible assets was $74 and $60 for the three months ended
March 31, 2010 and 2009, respectively.
The
following chart represents estimated future annual amortization expense related
to intangible assets:
Year ending
December 31,
|
||||
2010
(remaining)
|
$ | 214 | ||
2011
|
226 | |||
2012
|
223 | |||
2013
|
212 | |||
2014
|
207 | |||
Thereafter
|
1,430 | |||
Total
|
$ | 2,512 |
Note
7 - Defined Benefit and Postretirement Welfare Plan
AMRI
Rensselaer previously provided retirement benefits under two non-contributory
defined benefit plans and a non-contributory, unfunded post-retirement welfare
plan. Future benefits under the defined benefit plans and for salaried
participants in the post-retirement welfare plan have been frozen.
Components
of Net Periodic Benefit Cost
Pension
Benefits
|
Postretirement
Benefits
|
|||||||||||||||
Three Months
Ended March 31,
|
Three Months
Ended March 31,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Service
cost
|
$ | — | $ | — | $ | 17 | $ | 20 | ||||||||
Interest
cost
|
308 | 313 | 16 | 16 | ||||||||||||
Expected
return on plan assets
|
(338 | ) | (362 | ) | — | — | ||||||||||
Recognized
net loss
|
59 | — | 2 | 6 | ||||||||||||
Net
periodic benefit cost (income)
|
$ | 29 | $ | (49 | ) | $ | 35 | $ | 42 | |||||||
Recognized
in Accumulated Other Comprehensive Loss (“AOCL”), pre-tax
|
||||||||||||||||
Net
actuarial loss
|
59 | — | 2 | 6 | ||||||||||||
Total
recognized in AOCL, pre-tax
|
$ | 59 | $ | — | $ | 2 | $ | 6 |
Employer
Contributions
The
Company currently anticipates making $218 of contributions during
2010.
Note
8 — Share-Based Compensation
During
the three months ended March 31, 2010 and 2009, the Company recognized total
share based compensation cost of $549 and $525, respectively.
The
Company grants share-based payments, including restricted shares, under its 2008
Stock Option and Incentive Plan, as well as its 1998 Employee Stock Purchase
Plan.
11
Restricted
Stock
A summary
of unvested restricted stock activity as of March 31, 2010 and changes during
the three months then ended is presented below:
Number of
Shares
|
Weighted
Average Grant Date
Fair Value
Per
Share
|
|||||||
Outstanding,
December 31, 2009
|
516 | $ | 10.08 | |||||
Granted
|
140 | $ | 8.90 | |||||
Vested
|
(90 | ) | $ | 9.09 | ||||
Forfeited
|
(8 | ) | $ | 9.73 | ||||
Outstanding,
March 31, 2010
|
558 | $ | 9.95 |
The
weighted average fair value of restricted shares per share granted during the
three months ended March 31, 2010 and 2009 was $8.90 and $8.37,
respectively. As of March 31, 2010, there was $4,160 of total
unrecognized compensation cost related to non-vested restricted shares. That
cost is expected to be recognized over a weighted-average period of 2.6
years.
Stock
Options
The fair
value of each stock option award is estimated at the date of grant using the
Black-Scholes valuation model based on the following assumptions:
For the Three Months Ended
|
||||||||
March
31, 2010
|
March
31, 2009
|
|||||||
Expected
life in years
|
5 | 5 | ||||||
Risk
free interest rate
|
2.42 | % | 1.76 | % | ||||
Volatility
|
46 | % | 48 | % | ||||
Dividend
yield
|
— | — |
A summary
of stock option activity under the Company’s Stock Option and Incentive Plans as
of March 31, 2010 and changes during the three month period then ended is
presented below:
Number of
Shares
|
Weighted
Exercise
Price
Per Share
|
Weighted Average
Remaining
Contractual Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding,
December 31, 2009
|
1,864 | $ | 19.66 | |||||||||||||
Granted
|
65 | 8.90 | ||||||||||||||
Exercised
|
— | — | ||||||||||||||
Forfeited
|
(4 | ) | 23.45 | |||||||||||||
Expired
|
(179 | ) | 24.63 | |||||||||||||
Outstanding,
March 31, 2010
|
1,746 | $ | 18.75 | 4.3 | $ | 3 | ||||||||||
Options
exercisable, March 31, 2010
|
1,333 | $ | 21.24 | 2.9 | $ | — |
The
weighted average fair value of stock options granted for the three months ended
March 31, 2010 and 2009 was $3.82 and $3.61, respectively. As
of March 31, 2010, there was $1,138 of total unrecognized compensation cost
related to non-vested stock options. That cost is expected to be recognized over
a weighted-average period of 2.4 years.
Employee
Stock Purchase Plan
During
the three months ended March 31, 2010 and 2009, 34 and 19 shares, respectively,
were issued under the Company’s 1998 Employee Stock Purchase Plan.
During
the three months ended March 31, 2010 and 2009, cash received from stock option
exercises and employee stock purchases was $254 and $191,
respectively. The actual tax benefit realized for the tax deductions
from stock option exercises and plan purchases was $0 and $5 during the three
months ended March 31, 2010 and 2009, respectively.
12
Note
9 — Operating Segment Data
The
Company has organized its sales, marketing and production activities into the
DDS and LSM segments. The Company’s management relies on an internal
management accounting system to report results of the segments. The system
includes revenue and cost information by segment. The Company’s chief operating
decision maker makes financial decisions and allocates resources based on the
information it receives from this internal system.
DDS
includes activities such as drug lead discovery, optimization, drug development
and small scale commercial manufacturing. LSM includes pilot to commercial scale
manufacturing of active pharmaceutical ingredients and intermediates and high
potency and controlled substance manufacturing, of our U.S. location is in
compliance with the Food and Drug Administration’s (“FDA”) current Good
Manufacturing Practices. Corporate activities include business development and
administrative functions, as well as research and development costs that have
not been allocated to the operating segments.
The
following table contains earnings data by operating segment, reconciled to
totals included in the unaudited condensed consolidated financial
statements:
Contract
Revenue
|
Milestone &
Recurring
Royalty
Revenue
|
Income
(Loss)
from
Operations
|
Depreciation
and
Amortization
|
|||||||||||||
For the three months ended March 31,
2010
|
||||||||||||||||
DDS
|
$ | 21,040 | $ | 10,439 | $ | 12,455 | $ | 2,382 | ||||||||
LSM
|
17,852 | — | 1,072 | 1,767 | ||||||||||||
Corporate
|
— | — | (13,402 | ) | — | |||||||||||
Total
|
$ | 38,892 | $ | 10,439 | $ | 125 | $ | 4,149 | ||||||||
For the three months ended March 31,
2009
|
||||||||||||||||
DDS
|
$ | 22,524 | $ | 10,786 | $ | 13,825 | $ | 2,641 | ||||||||
LSM
|
20,720 | — | 2,457 | 1,690 | ||||||||||||
Corporate
|
— | — | (13,687 | ) | — | |||||||||||
Total
|
$ | 43,244 | $ | 10,786 | $ | 2,595 | $ | 4,331 |
The
following table summarizes other information by segment as of March 31,
2010:
As of March
31, 2010
|
||||||||||||
DDS
|
LSM
|
Total
|
||||||||||
Total
assets
|
$ | 221,374 | $ | 153,642 | $ | 375,016 | ||||||
Goodwill
included in total assets
|
14,347 | 8,417 | 22,764 |
The
following table summarizes other information by segment as of December 31,
2009:
As of December
31, 2009
|
||||||||||||
DDS
|
LSM
|
Total
|
||||||||||
Total
assets
|
$ | 236,314 | $ | 137,378 | $ | 373,692 | ||||||
Goodwill
included in total assets
|
13,199 | 4,352 | 17,551 |
13
Note
10 — Financial Information by Customer Concentration and Geographic
Area
Total
contract revenue from DDS’s three largest customers represented approximately
22%, 9% and 6% of DDS’s total contract revenue for the three months ended March
31, 2010, and 18%, 11% and 7% of DDS’s total contract revenue for the three
months ended March 31, 2009. Total contract revenue from LSM’s
largest customer, GE Healthcare (“GE”), represented 41% and 26% of LSM’s total
contract revenue for the three months ended March 31, 2010 and 2009,
respectively. GE accounted for approximately 19% and 12% of the
Company’s total contract revenue for the three months ended March 31, 2010 and
2009, respectively. The increase in GE sales in 2010 is primarily due
to a return toward historical demand in 2010 as a result of its 2009 inventory
reduction efforts. This is expected to continue throughout 2010
causing full year 2010 sales to GE to be above amounts recognized in
2009. The DDS segment’s largest customer, a large pharmaceutical
company, represented approximately 12% and 9% of the Company’s total contract
revenue for the three months ended March 31, 2010 and 2009,
respectively.
The
Company’s total contract revenue for the three months ended March 31, 2010 and
2009 was recognized from customers in the following geographic
regions:
Three Months Ended March
31,
|
||||||||
2010
|
2009
|
|||||||
United
States
|
51 | % | 58 | % | ||||
Europe
|
37 | 19 | ||||||
Asia
|
11 | 22 | ||||||
Other
|
1 | 1 | ||||||
Total
|
100 | % | 100 | % |
Note
11 — Comprehensive Loss
The
following table presents the components of the Company’s comprehensive loss for
the three months ended March 31, 2010 and 2009:
Three Months Ended March
31,
|
||||||||
2010
|
2009
|
|||||||
Net
income
|
$ | 66 | $ | 1,942 | ||||
Other
comprehensive loss:
|
||||||||
Change
in unrealized (loss) gain on investment securities, net of
taxes
|
(23 | ) | 15 | |||||
Foreign
currency translation loss
|
(627 | ) | (4,983 | ) | ||||
Net
actuarial loss related to pension and postretirement
benefits
|
61 | 6 | ||||||
Total
comprehensive loss
|
$ | (523 | ) | $ | (3,020 | ) |
Note
12 — Legal Proceedings
The
Company, from time to time, may be involved in various claims and legal
proceedings arising in the ordinary course of business. Except as noted below in
regard to litigation relating to Allegra, the Company is not currently a party
to any such claims or proceedings which, if decided adversely to the Company,
would either individually or in the aggregate have a material adverse effect on
the Company’s business, financial condition, results of operations or cash
flows.
The
Company, through its former subsidiary AMR Technology that has been merged into
the Company, along with Aventis Pharmaceuticals Inc., the U.S. pharmaceutical
business of sanofi-aventis S.A., has been involved in legal proceedings
with several companies seeking to market or which are currently marketing
generic versions of Allegra. Beginning in 2001, Barr Laboratories, Inc., Impax
Laboratories, Inc., Mylan Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Dr.
Reddy’s Laboratories, Ltd./Dr. Reddy’s Laboratories, Inc., Ranbaxy Laboratories
Ltd./Ranbaxy Pharmaceuticals Inc., Sandoz Inc., Sun Pharma Global, Inc.,
Wockhardt, and Actavis Mid Atlantic LLC filed Abbreviated New Drug Applications
(“ANDAs”) with the Food and Drug Administration (“FDA”) to produce and market
generic versions of Allegra products.
In
response to the filings described above, beginning in 2001, Aventis
Pharmaceuticals filed patent infringement lawsuits against Barr Laboratories,
Impax Laboratories, Mylan Pharmaceuticals, Teva Pharmaceuticals, Dr. Reddy’s
Laboratories, Ranbaxy Laboratories Ltd./Ranbaxy Pharmaceuticals Inc., Sandoz,
Wockhardt, and Sun Pharma Global, Inc. Each of the lawsuits was filed
in the U.S. District Court in New Jersey and alleges infringement of one or more
patents owned by Aventis Pharmaceuticals. In addition, beginning on November 14,
2006, Aventis filed two patent infringement suits against Teva Pharmaceuticals
USA, Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc. in the Eastern
District of Texas based on patents owned by Aventis. Those lawsuits
were transferred to the U.S. District Court in New Jersey.
14
Further,
beginning on March 5, 2004, the Company, through its former subsidiary AMR
Technology, along with Aventis Pharmaceuticals, filed suit in the U.S. District
Court in New Jersey against Barr Laboratories, Impax Laboratories, Mylan
Pharmaceuticals, Teva Pharmaceuticals, Dr. Reddy’s Laboratories, Amino
Chemicals, Ltd., Ranbaxy Laboratories Ltd./Ranbaxy Pharmaceuticals Inc.,
DiPharma S.P.A., DiPharma Francis s.r.l., and Sandoz, asserting infringement of
U.S. Patent Nos. 5,581,011 and 5,750,703 that are exclusively licensed to
Aventis Pharmaceuticals relating to Allegra and Allegra-D
products. On December 11, 2006, the Company through its former
subsidiary AMR Technology and sanofi-aventis U.S. LLC, an affiliate of Aventis
Pharmaceuticals, also filed a patent infringement lawsuit in the Republic of
Italy against DiPharma Francis s.r.l. and DiPharma S.P.A. based on European
Patent No. 703,902 which is owned by the Company and licensed to
sanofi-aventis. In addition, on December 22, 2006, the Company
through its former subsidiary AMR Technology, filed a patent infringement
lawsuit in Canada against Novopharm Ltd., Teva Pharmaceutical Industries Ltd.,
Teva Pharmaceuticals USA, Inc., DiPharma S.P.A. and DiPharma s.r.l. based on
Canadian Patent No. 2,181,089. On March 20, 2007, the Company through its former
subsidiary AMR Technology filed a patent infringement lawsuit in Australia
against Alphapharm Pty Ltd based on Australian Patent No. 699,799. On
September 28, 2007, the Company, through its former subsidiary AMR Technology,
filed a patent infringement lawsuit in Australia against Arrow Pharmaceuticals
Pty Ltd, Chemists’ Own Pty Ltd, and Sigma Pharmaceuticals Limited based on
Australian Patent No. 699,799. On September 9, 2009, the Company
filed patent infringement lawsuits in the U.S. District Court in New Jersey
against Dr. Reddy’s Laboratories, Ltd, Dr. Reddy’s Laboratories, Inc., and
Sandoz, Inc. asserting infringement of U.S. Patent No. 7,390,906, seeking
statutory damages.
Aventis
Pharmaceuticals, the Company, and its former subsidiary AMR Technology have
entered into covenants not to sue on U.S. Patent No. 5,578,610 with defendants
other than Novopharm, DiPharma S.P.A., DiPharma Francis s.r.l., Alphapharm,
Arrow Pharmaceuticals Pty Ltd, Chemists’ Own Pty Ltd, and Sigma Pharmaceuticals
Limited. Aventis Pharmaceuticals exclusively licenses U.S. Patent No.
5,578,610 from the Company, but that patent has not been asserted in the
litigations in the U.S. However, the Company and Aventis
Pharmaceuticals have agreed that Aventis Pharmaceuticals will continue to pay
royalties to the Company based on that patent under the Company’s original
license agreement with Aventis Pharmaceuticals. Under the Company’s arrangements
with Aventis Pharmaceuticals, the Company will receive royalties until
expiration of the underlying patents (2013 for U.S. Patent No. 5,578,610 and
2015 for U.S. Patent No. 5,750,703) unless the patents are earlier determined to
be invalid.
On
November 18, 2008, the Company, its former subsidiary AMR Technology, Aventis
Pharmaceuticals, sanofi-aventis, Teva Pharmaceuticals, and Barr Laboratories
reached a settlement regarding the above-described patent infringement
litigations relating to Teva Pharmaceuticals and Barr
Laboratories. As part of the settlement, the Company entered into an
amendment to its licensing agreement with sanofi-aventis to allow sanofi-aventis
to sublicense patents related to ALLEGRA® and
ALLEGRA®D-12
to
Teva Pharmaceuticals and Barr Laboratories in the United
States. Subsequently, Teva Pharmaceuticals acquired Barr
Laboratories. The Company received an upfront sublicense fee from
sanofi-aventis of $10 million, and sanofi-aventis will pay royalties to the
Company on the sale of products in the United States containing fexofenadine
hydrochloride (the generic name for the active ingredient in ALLEGRA®) and
products containing fexofenadine hydrochloride and pseudoephedrine hydrochloride
(generic ALLEGRA®D-12) by
Teva Pharmaceuticals through 2015, along with additional
consideration. As provided in the settlement, Teva Pharmaceuticals
launched a generic version of Allegra D-12 in November 2009. The
Company will receive quarterly royalties through July 2010 for the branded
Allegra D-12 equal to the royalties paid for the quarter ended June 30,
2009. Thereafter, the royalty rate will revert to the rate in effect
prior to the signing of the sub-license amendment and the Company will also
receive a royalty on Teva’s sales of the generic D-12. The Company
and Aventis Pharmaceuticals have also dismissed their claims against Ranbaxy
Laboratories Ltd./Ranbaxy Pharmaceuticals Inc. and Sandoz, Inc. without
prejudice. The Company has also dismissed its claims against DiPharma
S.P.A. and DiPharma s.r.l. in Canada without prejudice.
On March
19, 2010, the Company and Sanofi-Aventis U.S. LLC filed a motion for a
preliminary injunction seeking to enjoin Dr. Reddy’s Laboratories, Ltd. and Dr.
Reddy’s Laboratories, Inc. from commercial distribution of a D-24
product.
Under
applicable federal law, marketing of an FDA-approved generic version of Allegra
may not commence until the earlier of a decision favorable to the generic
challenger in the patent litigation or 30 months after the date the patent
infringement lawsuit was filed. In general, the first generic filer is entitled
to a 180-day marketing exclusivity period upon FDA approval. The
launch of a generic product is considered an “at-risk” launch if the launch
occurs while there is still on-going litigation. Of the remaining
defendants in the pending litigation, Dr. Reddy’s Laboratories and Mylan
Pharmaceuticals have engaged in at-risk launches of generic fexofenadine
single-entity products.
15
Note
13 — Income Taxes
A tax
position is a position in a previously filed tax return or a position expected
to be taken in a future tax filing that is reflected in measuring current or
deferred income tax assets and liabilities. Tax positions are recognized only
when it is more likely than not (likelihood of greater than 50%), based on
technical merits, that the position would be sustained upon examination by
taxing authorities. Tax positions that meet the more likely than not threshold
are measured using a probability-weighted approach as the largest amount of tax
benefit that is greater than 50% likely of being realized upon
settlement.
During
the quarter ended March 31, 2010, approximately $486 of the reserve was
effectively settled. The remainder of the reserve at March 31, 2010
represents the amount of unrecognized tax benefits that, if recognized, would
favorably affect the effective tax rate for future periods.
The
Company classifies interest expense and penalties related to unrecognized tax
benefits as a component of income tax expense. As of March 31, 2010,
the Company has not accrued any penalties related to its uncertain tax position
as it believes that it is more likely than not that there will not be any
assessment of penalties. The total amount of accrued interest
resulting from such unrecognized tax benefits was $2 at March 31, 2010, none of
which was recognized in 2010.
The
Company files Federal income tax returns, as well as multiple state and foreign
jurisdiction tax returns. The Company’s Federal income tax returns have been
examined by the Internal Revenue Service through the year ended December 31,
2007. All significant state and foreign matters have been concluded for
years through 2005. Tax examinations that commenced during 2009 are in
process. Management of the Company believes that the reserves
associated with these tax positions are adequate to support any future tax
examinations.
The
Company intends to reinvest indefinitely any of its unrepatriated foreign
earnings. The Company has not provided for U.S. income taxes on these
undistributed earnings of its foreign subsidiaries because management considers
such earnings to be reinvested indefinitely outside of the U.S. If the
earnings were distributed, the Company may be subject to both foreign
withholding taxes and U.S. income taxes that may not be fully offset by
foreign tax credits.
Note
14 – Fair Value
The
Company uses a framework for measuring fair value in generally accepted
accounting principles and making disclosures about fair value
measurements. A three-tiered fair value hierarchy has been
established, which prioritizes the inputs used in measuring fair
value.
These
tiers include:
Level 1 –
defined as quoted prices in active markets for identical
instruments;
Level 2 –
defined as inputs other than quoted prices in active markets that are either
directly or indirectly observable; and Level 3 – defined as unobservable inputs
in which little or no market data exists, therefore requiring an entity to
develop its own assumptions.
The
following table presents the fair value of marketable securities by type and
their determined level based on the three-tiered fair value hierarchy as of
March 31, 2010:
Fair Value Measurements as of March 31, 2010
|
||||||||||||||||
Marketable Securities
|
Total
|
Level
1
|
Level
2
|
Level
3
|
||||||||||||
Obligations
of states and political subdivisions
|
$ | 25,616 | $ | — | $ | 25,616 | $ | — | ||||||||
U.S.
Government and agency obligations
|
1,616 | — | 1,616 | — | ||||||||||||
Auction
rate securities
|
2,300 | — | 2,300 | — | ||||||||||||
Total
|
$ | 29,532 | $ | — | $ | 29,532 | $ | — |
The
Company’s marketable securities are fixed maturity securities and are valued
using pricing for similar securities, recently executed transactions, cash flow
models with yield curves, broker/dealer quotes and other pricing models
utilizing observable inputs. The valuation for the Company’s fixed maturity
securities is classified as Level 2.
16
The
Company determines its fair value of financial instruments using the following
methods and assumptions:
Cash and cash equivalents,
receivables, and accounts payable: The carrying amounts
reported in the consolidated balance sheets approximate their fair value because
of the short maturities of these instruments.
Investment securities: Investment securities’ fair
values are based on quoted market prices of comparable
instruments. When necessary, the Company utilizes matrix pricing from
a third party pricing vendor to determine fair value pricing. Matrix
prices are based on quoted prices for securities with similar coupons, ratings,
and maturities, rather than on specific bids and offers for the designated
security.
Long-term debt: The carrying value of
long-term debt was approximately equal to fair value at March 31, 2010 and
December 31, 2009 due to the resetting dates of the variable interest
rates.
Nonrecurring
Measurements:
The
preliminary purchase accounting for the acquisition of Excelsyn required the
Company to record the assets acquired and the liabilities assumed with this
transaction at their estimated fair values. As these amounts have
been estimated by the Company at this time, a final valuation will be completed
to determine the final fair value of the assets acquired and the liabilities
assumed with this purchase.
Note
15 – Recently Issued Accounting Pronouncements
In
October 2009, the FASB issued ASU 2009-13, “Multiple-Deliverable Revenue
Arrangements”, which addresses how revenues should be allocated among all
products and services included in certain sales arrangements. It establishes a
selling price hierarchy for determining the selling price of each product or
service, with vendor-specific objective evidence (VSOE) at the highest level,
third-party evidence of VSOE at the intermediate level, and a best estimate at
the lowest level. It replaces “fair value” with “selling price” in revenue
allocation guidance. It also significantly expands the disclosure requirements
for such arrangements. ASU 2009-13 will be effective prospectively for sales
entered into or materially modified in fiscal years beginning on or after June
15, 2010. The FASB permits early adoption of ASU 2009-13, applied
retrospectively, to the beginning of the year of adoption. The
Company is currently evaluating the impact on its financial
statements.
17
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
Forward-Looking
Statements
The
following discussion of our results of operations and financial condition should
be read in conjunction with the accompanying Condensed Consolidated Financial
Statements and the Notes thereto included within this report. This quarterly
report on Form 10-Q contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended. These statements may be
identified by forward-looking words such as “may,” “could,” “should,” “would,”
“will,” “intend,” “expect,” “anticipate,” “believe,” and “continue” or similar
words and include, but are not limited to, statements concerning pension and
postretirement benefit costs, GE Healthcare, the Company’s collaboration with
Bristol-Myers Squibb (“BMS”), future acquisitions, earnings, contract revenues,
costs and margins, royalty revenues, patent protection and the ongoing Allegra
patent infringement litigation, Allegra royalty revenue, government regulation,
retention and recruitment of employees, customer spending and business trends,
foreign operations (including Singapore, India, Hungary and the United Kingdom),
clinical supply manufacturing, management’s strategic plans, drug discovery,
product commercialization, license arrangements, research and development
projects and expenses, selling, general and administrative expenses, goodwill
impairment, competition and tax rates. The Company’s actual results may differ
materially from such forward-looking statements as a result of numerous factors,
some of which the Company may not be able to predict and may not be within the
Company’s control. Factors that could cause such differences include, but are
not limited to, those discussed in Part I, Item 1A, “Risk Factors”, of the
Company’s Annual Report on Form 10-K for the year ended December 31, 2009,
as filed with the Securities and Exchange Commission on March 12, 2010, as
updated by Part II Item 1A, “Risk Factors,” in subsequent Forms
10-Q. All forward-looking statements are made as of the date of this
report, and we do not undertake to update any such forward-looking statements in
the future, except as required by law. References to “AMRI”, the “Company,”
“we,” “us,” and “our,” refer to Albany Molecular Research, Inc. and its
subsidiaries, taken as a whole.
Strategy
and Overview
We
provide contract services to many of the world’s leading pharmaceutical and
biotechnology companies. We derive our contract revenue from research and
development expenditures and commercial manufacturing demands of the
pharmaceutical and biotechnology industry. We continue to execute our
long-term strategy to develop and grow an integrated global platform from which
we can provide these services. We have research and/or manufacturing
facilities in the United States, Hungary, Singapore, India and the United
Kingdom. In 2008, we purchased an additional large-scale
manufacturing site in India and completed a 10,000 square foot expansion of our
Singapore Research Center. In 2009, we completed the expansion of our
Bothell, Washington and Budapest, Hungary facilities. Most recently,
in February 2010, we acquired Excelsyn Ltd. (“Excelsyn”), which we believe is a
well recognized leader in providing chemical development and manufacturing
services to the pharmaceutical industry in Europe.
We
continue to integrate our research and manufacturing facilities worldwide,
increasing our access to key global markets and enabling us to provide our
customers with a flexible combination of high quality services and competitive
cost structures to meet their individual outsourcing needs. We seek
comprehensive research and/or supply agreements with our customers,
incorporating several of our service offerings and spanning across the entire
pharmaceutical research and development process. Our research facilities
provide discovery, chemical development, analytical, and small-scale current
Good Manufacturing Practices (“cGMP”) manufacturing services. Compounds
discovered and/or developed in our research facilities can then be more easily
transitioned to production at our large-scale manufacturing facilities for use
in clinical trials and, ultimately, commercial sales if the product meets
regulatory approval. We believe that the ability to partner with a single
provider of pharmaceutical research and development services from discovery
through commercial production is of significant benefit to our customers.
Through our comprehensive service offerings, we are able to provide customers
with a more efficient transition of experimental compounds through the research
and development process, ultimately reducing the time and cost involved in
bringing these compounds from concept to market.
Our
global platform has increased our market penetration and was developed in order
to allow us to maintain and grow margins. In addition to our
globalization, we continue to implement process efficiencies, including our
continued efforts of process improvement and cost savings measures, along with
efforts to strengthen our sourcing. We believe these factors will
lead to improved margins.
18
We
conduct proprietary research and development to discover new therapeutically
active lead compounds with commercial potential. We anticipate that we would
then license these compounds and underlying technology to third parties in
return for up-front and service fees and milestone payments, as well as
recurring royalty payments if these compounds are developed into new commercial
drugs.
Our total
revenue for the three months ended March 31, 2010 was $49.3 million, as compared
to $54.0 million for the three months ended March 31, 2009.
Contract
services revenue for the first quarter of 2010 was $38.9 million, compared to
$43.2 million for the three months ended March 31, 2009. Recurring
royalty revenues, which are based on the worldwide sales of fexofenadine HCl,
marketed as Allegra in the Americas and Telfast elsewhere, as well as on sales
of sanofi-aventis’ authorized generics and estimates of sales of Teva’s
authorized generics, were lower in the first quarter of 2010 than in the first
quarter of 2009. Consolidated gross margin was 10.6% for the three
months ended March 31, 2010 as compared to 15.3% for the three months ended
March 31, 2009.
During
the three months ended March 31, 2010, cash used by operations was $6.2
million. The decrease of $28.1 million in cash flow from operations
from the three months ended March 31, 2009 resulted primarily from an increase
in the first quarter of 2009 of deferred revenue due to the receipt of the $10.0
million sub-licensing fee from sanofi-aventis in conjunction with the amended
licensing agreement, along with an increase in accounts receivable in 2010, as
well as lower net income in 2010. We spent $18.5 million on the
acquisition of Excelsyn and $1.9 million in capital expenditures, primarily
related to modernization of our lab and production equipment. As of
March 31, 2010, we had $84.7 million in cash, cash equivalents and investments
and $13.5 million in bank and other related debt.
Results
of Operations – Three Months ended March 31, 2010 Compared to Three Months Ended
March 31, 2009
Revenues
Total
contract revenue
Contract
revenue consists primarily of fees earned under contracts with our third party
customers. Our contract revenues for each of our
Discovery/Development/Small Scale Manufacturing (“DDS”) and Large-Scale
Manufacturing (“LSM”) segments were as follows:
Three Months Ended March
31,
|
||||||||
(in thousands)
|
2010
|
2009
|
||||||
DDS
|
$ | 21,040 | $ | 22,524 | ||||
LSM
|
17,852 | 20,720 | ||||||
Total
|
$ | 38,892 | $ | 43,244 |
DDS
contract revenues for the three months ended March 31, 2010, decreased $1.5
million to $21.0 million as compared to $22.5 million for the same period in
2009. This decrease is due primarily to a decrease in contract
revenue from development and small-scale manufacturing services of $2.3 million
due to lower demand from specialty pharma/biotech customers and more competitive
pricing in the overall current economic downturn. This decrease was
offset in part by an increase of $0.8 million in contract revenue from discovery
services due to an increase in demand for our international discovery
services. We currently expect DDS
contract revenue for the full year of 2010 to have limited growth over amounts
recognized in 2009 primarily due to incremental revenues from the Excelsyn
purchase in February 2010 along with an increase in demand for our international
discovery services, offset in part by lower U.S. revenue.
LSM
revenue for the three months ended March 31, 2010 decreased $2.9 million from
the same period in 2009 primarily due to a decrease of $2.6 million from a
decrease in demand for existing commercial products and a decrease of $2.4
million driven by the reduced demand for the production of clinical supply
material. These decreases were offset, in part by an increase in
sales to GE Healthcare (“GE”), LSM’s largest customer, of $2.1 million as they
return toward historical levels after reducing their purchases from us in 2009
in an effort to reduce their inventory levels. We expect LSM
contract revenue for the full year of 2010 to increase over amounts recognized
in 2009, primarily due to incremental revenues from the Excelsyn purchase in
February 2010, along with increases in sales to GE as they return toward
historical levels.
Recurring
royalty revenue
We earn
royalties under our licensing agreement with sanofi-aventis S.A. for the active
ingredient in Allegra. Royalties were as follows:
19
Three Months Ended March
31,
|
||||||
2010
|
2009
|
|||||
(in
thousands)
|
||||||
$ | 10,439 | $ | 10,786 |
Recurring
royalties, which are based on the worldwide sales of Allegra®/Telfast, as well
as on sales of sanofi-aventis’ authorized generics, decreased $0.3 million for
the three months ended March 31, 2010 from the same period in 2009 primarily due
to a decrease in sales of Allegra® in Japan.
The
recurring royalties we receive on the sales of Allegra®/Telfast have
historically provided a material portion of our revenues, earnings and operating
cash flows. Teva Pharmaceuticals launched a generic version of
Allegra D-12® in November 2009. As part of our amended licensing
agreement with sanofi-aventis, we will receive quarterly royalties through July
2010 for the branded Allegra D-12® equal to the royalties paid for the quarter
ended June 30, 2009. Thereafter, the royalty rate will revert to the
rate in effect prior to the signing of the sub-license amendment and we will
also receive a royalty on Teva Pharmaceuticals’ sales of generic Allegra
D-12®.
We
continue to develop our business in an effort to supplement the revenues,
earnings and operating cash flows that have historically been provided by
Allegra®/Telfast royalties. We forcefully and vigorously defend our
intellectual property related to Allegra®, and we continue to pursue our
intellectual property rights as patent infringement litigation
progresses.
Costs
and Expenses
Cost
of contract revenue
Cost of
contract revenue consists primarily of compensation and associated fringe
benefits for employees, as well as chemicals, depreciation and other indirect
project related costs. Cost of contract revenue for our DDS and LSM segments
were as follows:
Three Months Ended March
31,
|
||||||||
Segment
|
2010
|
2009
|
||||||
(in thousands)
|
||||||||
DDS
|
$ | 17,981 | $ | 18,380 | ||||
LSM
|
16,780 | 18,263 | ||||||
Total
|
$ | 34,761 | $ | 36,643 | ||||
DDS
Gross Margin
|
14.6 | % | 18.4 | % | ||||
LSM
Gross Margin
|
6.0 | % | 11.9 | % | ||||
Total
Gross Margin
|
10.6 | % | 15.3 | % |
DDS had a
contract revenue gross margin of 14.6% for the three months ended March 31, 2010
compared to contract revenue gross margin of 18.4% for the same period in
2009. The decrease in gross margin resulted from lower demand for
these services in relation to our fixed costs. We currently expect
DDS contract margins for the full year of 2010 to approximate percentages
recognized in the first quarter of 2010.
LSM’s
contract revenue gross margin decreased to 6.0% for the three months ended March
31, 2010 compared to 11.9% for the same period in 2009. This decrease
in gross margin is primarily due to a decrease in commercial sales which have
historically generated higher margins. We expect gross margins in the
LSM segment for the full year of 2010 to slightly increase over percentages
recognized for the full year of 2009.
Technology
incentive award
We
maintain a Technology Development Incentive Plan, the purpose of which is to
stimulate and encourage novel innovative technology developments by our
employees. This plan allows eligible participants to share in a
percentage of the net revenue earned by us relating to patented technology with
respect to which the eligible participant is named as an inventor or made a
significant intellectual contribution. To date, the royalties from Allegra are
the main driver of the awards. Accordingly, as the creator of the
technology, the award is currently payable primarily to Dr. Thomas D’Ambra,
our Chief Executive Officer and President of the Company. The incentive awards
were as follows:
20
Three Months Ended March
31,
|
||||||
2010
|
2009
|
|||||
(in
thousands)
|
||||||
$ | 1,043 | $ | 1,105 |
The
decrease in technology incentive award expense for the three months ended March
31, 2010 from the same period ended March 31, 2009 is due to the decrease in
Allegra royalty revenue. We expect technology incentive award expense
to generally fluctuate directionally and proportionately with fluctuations in
Allegra royalties in future periods.
Research
and development
Research
and development (“R&D”) expense consists of compensation and benefits for
scientific personnel for work performed on proprietary technology R&D
projects, costs of chemicals and other out of pocket costs and overhead costs.
We utilize our expertise in small molecule chemistry, biocatalysis and natural
product technologies to perform our internal R&D projects. The goal of these
programs is to discover new compounds with commercial potential. We would then
seek to license these compounds to a third party in return for a combination of
up-front license fees, milestone payments and recurring royalty payments if
these compounds are successfully developed into new drugs and reach the market.
In addition, R&D is performed at our large-scale manufacturing facility
related to the potential manufacture of new products, the development of
processes for the manufacture of generic products with commercial potential, and
the development of alternative manufacturing processes. Research and
development expenses were as follows:
Three Months Ended March
31,
|
||||||
2010
|
2009
|
|||||
(in thousands)
|
||||||
$ | 2,763 | $ | 3,385 |
R&D
expense decreased to $2.8 million for the three months ended March 31, 2010 from
$3.4 million for the three months ended March 31, 2009. This decrease
is primarily due to lower compensation costs in 2010 caused by a reduction of
research and development scientific resources. We currently expect research and
development expenses for the full year of 2010 to remain flat with amounts
recognized in 2009, as we manage overall R&D expenditures to move our most
advanced programs forward.
Projecting
completion dates and anticipated revenue from our internal research programs is
not practical at this time due to the early stages of the projects and the
inherent risks related to the development of new drugs. Our proprietary amine
neurotransmitter reuptake inhibitor program, which was our most advanced project
at that time, was licensed to BMS in October 2005 in exchange for up-front
license fees, contracted research services, and the rights to future milestone
and royalty payments. We also continue to utilize our proprietary
technologies to further advance other early to middle-stage internal research
programs in the fields of oncology, irritable bowel syndrome, obesity and CNS,
with a view to seeking a licensing partner for these programs at an appropriate
research or developmental stage.
We budget
and monitor our R&D costs by type or category, rather than by project on a
comprehensive or fully allocated basis. In addition, our R&D expenses are
not tracked by project as they benefit multiple projects or our overall
technology platform. Consequently, fully loaded R&D cost summaries by
project are not available.
Selling,
general and administrative
Selling,
general and administrative (“SG&A”) expenses consist of compensation and
related fringe benefits for marketing, operational and administrative employees,
professional service fees, marketing costs and costs related to facilities and
information services. SG&A expenses were as follows:
Three Months Ended March
31,
|
||||||
2010
|
2009
|
|||||
(in
thousands)
|
||||||
$ | 10,639 | $ | 10,302 |
21
SG&A
expenses for the three months ended March 31, 2010 increased $0.3 million from
the three months ended March 31, 2009. This increase is primarily
attributable to $0.9 million of transaction costs associated with the purchase
of Excelsyn in February 2010, in addition to incremental SG&A expense
associated with the purchase. These increases were partially offset
by cost savings from a reorganization of our large-scale India operations in
December 2009. SG&A expenses for the full year 2010 are expected
to increase from amounts recognized in 2009 primarily due to the addition of
incremental Excelsyn SG&A expenses, along with the one time transaction
costs associated with the purchase. Excluding these factors, SG&A
costs for 2010 would remain flat or slightly decrease from amounts recognized in
2009.
Interest
income, net
Three Months Ended March
31,
|
||||||||
(in thousands)
|
2010
|
2009
|
||||||
Interest
expense
|
$ | (36 | ) | $ | (91 | ) | ||
Interest
income
|
79 | 202 | ||||||
Interest
income, net
|
$ | 43 | $ | 111 |
Net
interest income decreased for the three months ended March 31, 2010 from the
same period in 2009 due to a decrease in balances of interest bearing assets and
overall decreased interest rates on our interest bearing
liabilities.
Other
(loss) income, net
Three Months Ended March
31,
|
|||||
2010
|
2009
|
||||
(in
thousands)
|
|||||
$ |
(88
|
)
|
$ | 328 |
Other
expense for the three months ended March 31, 2010 was $0.1 million as compared
to other income for the same period in 2009 primarily due to changes in rates
associated with foreign currency transactions.
Income
tax expense
Three Months Ended March
31,
|
|||||
2010
|
2009
|
||||
(in
thousands)
|
|||||
$ |
14
|
$ | 1,092 |
Income
tax expense decreased for the three months ended March 31, 2010, due primarily
to the decrease in pre-tax income as compared to amounts in 2009. In
addition, the decrease is attributable to a lower effective tax rate, which is
partially due to the reversal of reserves for uncertain tax positions in 2010,
as well as to changes in the composition of taxable income in relation to the
applicable tax rates at our various international locations.
22
Liquidity
and Capital Resources
We have
historically funded our business through operating cash flows, proceeds from
borrowings and the issuance of equity securities. During the first three months
of 2010, we used cash of $6.2 million in operating activities. The primary uses
of operating cash flows resulted primarily from increases in accounts receivable
and royalties receivable due to timing of cash collections and a decrease in
accounts payables due to the timing of customer payments.
During
the first three months of 2010, we used $20.1 million in investing activities,
resulting primarily from the use of $18.5 million for the acquisition of
Excelsyn in February 2010, along with $1.9 million for the acquisition of
property and equipment.
Working
capital was $132.8 million at March 31, 2010 as compared to $149.7 million as of
December 31, 2009. This decrease is primarily the result of the
use of cash and cash equivalents on our acquisition of
Excelsyn. There have been no significant changes in future maturities
on our long-term debt since December 31, 2009.
We
currently have a revolving line of credit in the amount of $45.0 million which
has a maturity date in June 2013. The line of credit bears interest
at a variable rate based on our Company’s leverage ratio. As of March 31, 2010,
the balance outstanding on the line of credit was $9.7 million, bearing interest
at a rate of 1.31%. The credit facility contains certain financial
covenants, including a maximum leverage ratio, a minimum required operating cash
flow coverage ratio, a minimum earnings before interest and taxes to interest
ratio and a minimum current ratio. Other covenants include limits on
asset disposals and the payment of dividends. As of March 31, 2010
and 2009, we were in compliance with all of the covenants under the credit
facility.
The
disclosure of payments we have committed to make under our contractual
obligations is set forth under the heading “Management’s Discussion and Analysis
of Financial Condition and Results of Operations—Liquidity and Capital
Resources” under Item 7 of our Annual Report on Form 10-K for the fiscal
year ended December 31, 2009. There have been no material changes to
our contractual obligations since December 31, 2009. As of March
31, 2010, we had no off-balance sheet arrangements as defined in Item 303(a)(4)
of the Securities and Exchange Commission’s Regulation S-K.
We
continue to pursue the expansion of our operations through internal growth and
strategic acquisitions. In February 2010, the Company acquired
Excelsyn Ltd. a chemical development and large scale manufacturing services
company in North Wales, UK. Under the terms of the agreement, AMRI
has purchased all of the outstanding shares of Excelsyn for $18.5 million in
cash, which was funded from existing cash and cash equivalents. We
expect that additional expansion activities will be funded from existing cash
and cash equivalents, cash flow from operations and/or the issuance of debt or
equity securities and borrowings. Future acquisitions, if any, could
be funded with cash on hand, cash from operations, borrowings under our credit
facility and/or the issuance of equity or debt securities. There can
be no assurance that attractive acquisition opportunities will be available to
us or will be available at prices and upon such other terms that are attractive
to us. We regularly evaluate potential acquisitions of other
businesses, products and product lines and may hold discussions regarding such
potential acquisitions. As a general rule, we will publicly announce
such acquisitions only after a definitive agreement has been
signed. In addition, in order to meet our long-term liquidity needs
or consummate future acquisitions, we may incur additional indebtedness or issue
additional equity or debt securities, subject to market and other
conditions. There can be no assurance that such additional financing
will be available on terms acceptable to us or at all. The failure to
raise the funds necessary to finance our future cash requirements or consummate
future acquisitions could adversely affect our ability to pursue our strategy
and could negatively affect our operations in future periods.
Critical
Accounting Policies and Estimates
Our
discussion and analysis of our financial condition and results of operations are
based upon our consolidated financial statements, which have been prepared in
accordance with U.S. generally accepted accounting principles. The preparation
of these consolidated financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingent assets and liabilities. On an
on-going basis, we evaluate our estimates, including those related to
inventories, goodwill, long-lived assets, pension and postretirement benefit
plans, income taxes and contingencies. We base our estimates on historical
experience and on various other assumptions that are believed to be reasonable
under the circumstances, the results of which form the basis for making
judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
We refer
to the policies and estimates set forth in the section “Management’s Discussion
and Analysis of Financial Condition and Results of Operations — Critical
Accounting Estimates” of our Annual Report on Form 10-K for the fiscal year
ended December 31, 2009. There have been no material changes or
modifications to the policies since December 31, 2009.
23
There
have been no material changes with respect to the information on Quantitative
and Qualitative Disclosures about Market Risk appearing in Part II,
Item 7A to the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2009.
Disclosure
Controls and Procedures
As
required by rule 13a-15(b) under the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), as of the end of the Company’s last fiscal quarter our
management conducted an evaluation with the participation of our Chief Executive
Officer and Chief Financial Officer regarding the effectiveness of our
disclosure controls and procedures. In designing and evaluating our disclosure
controls and procedures, we recognize that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and our management was required to
apply its judgment in evaluating and implementing possible controls and
procedures. Based upon that evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that, as of the end of the Company’s last
fiscal quarter, our disclosure controls and procedures were effective in that
they provide reasonable assurance that information required to be disclosed by
us in the reports we file or submit under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the
Securities and Exchange Commission’s rules and forms, including ensuring that
such information is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer as appropriate to allow
timely decisions regarding required disclosure. We intend to review and document
our disclosure controls and procedures, including our internal controls and
procedures for financial reporting, on an ongoing basis, and may from time to
time make changes aimed at enhancing their effectiveness and to ensure that our
systems evolve with our business.
Internal
Control Over Financial Reporting
There
were no changes in the Company’s internal control over financial reporting
identified in connection with the evaluation of such internal control that
occurred during the Company’s last fiscal quarter that have materially affected,
or are reasonably likely to materially affect, the Company’s internal control
over financial reporting.
24
Item
1. Legal Proceedings
In
addition to existing lawsuits we have previously filed related to Allegra patent
infringement, on March 19, 2010, the Company and sanofi-aventis U.S. LLC filed a
motion for a preliminary injunction seeking to enjoin Dr. Reddy’s Laboratories,
Ltd. and Dr. Reddy’s Laboratories, Inc. from commercial distribution of a d-24
product. Please refer to Part 1 – Note 12 for further details and
history on this litigation.
In
addition to the other information set forth in this report, you should carefully
consider the factors discussed in Part I, Item 1A Risk Factors in our Annual
Report on Form 10-K for the year ended December 31, 2009, which could materially
affect our business, financial condition or future results. The risks described
in our Annual Report on Form 10-K are not the only risks facing our
Company. Additional risks and uncertainties not currently known to us
or that we currently deem to be immaterial also may materially adversely affect
our business, financial condition and/or operating results.
Exhibit
|
||
Number
|
Description
|
|
2.1
|
Agreement,
dated February 17, 2010, by and among the Company and the shareholders of
Excelsyn Limited, for the sale and purchase of Excelsyn Limited and its
subsidiary, Excelsyn Molecular Development Limited.
|
|
31.1
|
Certification
of the Chief Executive Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of
1934.
|
|
31.2
|
Certification
of the Chief Financial Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of
1934.
|
|
32.1
|
Certification
of the 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 the Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
25
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.
ALBANY
MOLECULAR RESEARCH, INC.
|
|||
Date:
May 7, 2010
|
By:
|
/s/
Mark T. Frost
|
|
Mark
T. Frost
|
|||
Senior
Vice President, Administration, Chief Financial Officer
and
Treasurer
(Duly
Authorized Officer and Principal Financial
Officer)
|
26