Note 1 — Summary of Operations and Significant Accounting
Policies
Nature of Business and Operations
Albany Molecular Research, Inc. (the
“Company”) is a leading global contract research and manufacturing organization providing customers fully integrated
drug discovery, development, and manufacturing services. It supplies a broad range of services and technologies supporting the
discovery and development of pharmaceutical products, the manufacturing of Active Pharmaceutical Ingredients (“API”)
and the development and manufacturing of drug product for new and generic drugs, as well as research, development and manufacturing
for the agrochemical and other industries. With locations in the United States, Europe, and Asia, the Company maintains geographic
proximity to its customers and flexible 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 and nine month periods
ended September 30, 2016 are not necessarily indicative of the results that may be expected for any other period or for the year
ending December 31, 2016. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction
with the audited Consolidated Financial Statements and Notes thereto included in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2015.
The accompanying unaudited Condensed Consolidated
Financial Statements include the accounts of the Company and its wholly-owned subsidiaries as of and for the three and nine month
periods ended September 30, 2016. 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. Gains or losses resulting from translating non-U.S. currency financial statements
are recorded in the unaudited Condensed Consolidated Statements of Comprehensive Loss and in ‘Accumulated other comprehensive
loss, net’ in the accompanying unaudited Condensed Consolidated Balance Sheets. When necessary, prior years’ unaudited
Condensed Consolidated Financial Statements have been reclassified to conform to the current year presentation.
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 valuation of inventory, intangible assets,
and long-lived assets, assumptions associated with the Company’s accounting for business combinations and goodwill impairment
assessment, and the amount and realizability of deferred tax assets. Other significant estimates include assumptions utilized in
determining actuarial obligations in conjunction with the Company’s pension and postretirement health plans, assumptions
utilized in determining stock-based compensation, environmental remediation liabilities, as well as those utilized in determining
the value of both the notes hedges and the notes conversion derivative and the assumptions related to the collectability of receivables.
Actual results can vary from these estimates.
Contract Revenue Recognition
The Company’s contract revenue consists
primarily of amounts earned under contracts with third-party customers and reimbursed expenses under such contracts. Reimbursed
expenses consist of chemicals and other project specific costs. 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. Generally, the Company’s contracts may be terminated
by the customer upon 30 days’ to two years’ 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 the Financial Accounting Standards Board’s (the “FASB”) Accounting Standards
Codification (“ASC”) 605-25, “Revenue Arrangements with Multiple Deliverables,” and Staff Accounting Bulletin
(“SAB”) 104, “Revenue Recognition.” Allocation of revenue to individual elements that qualify for separate
accounting is based on the separate selling prices determined for each component, and total contract consideration is then allocated
based on relative fair value across the components of the arrangement. If separate selling prices are not available, the Company
will use its best estimate of such selling prices, consistent with the overall pricing strategy and after consideration of relevant
market factors.
The Company generates contract revenue
under the following types of contracts:
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 and when delivery is
made or title and risk of loss otherwise 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 have been delivered to the customer, as required under the arrangement,
or other customer-specific contractual conditions have been satisfied.
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 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 materials contracts based on the number of hours devoted to the project multiplied
by the customer’s billing rate plus other project specific costs incurred.
Recurring Royalty and Milestone Revenues
Recurring Royalty Revenue
.
Recurring royalties have historically related to royalties under a license agreement with Sanofi based on the worldwide net sales
of fexofenadine HCl, marketed as Allegra in the Americas and Telfast elsewhere, as well as on sales of Sanofi’s authorized
or licensed generics and sales by certain authorized sub-licensees. These royalty payments ceased in May 2015 due to the expiration
of patents under the license agreement. The Company currently receives royalties on net sales of generic products sold by Allergan,
plc (“Allergan”) in conjunction with a Development and Supply Agreement. The Company records royalty revenue in the
period in which the net sales of the product occur. Royalty payments from Allergan are due within 60 days after each calendar quarter
and are determined based on sales of the qualifying products in that quarter. The Company also receives royalties on certain other
products.
Up-Front License Fees and Milestone
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.
Proprietary Drug Development Arrangements
The Company has discovered and
conducted the early development of several new drug candidates, and has out-licensed certain of these candidates to partners
for further development in return for a potential combination of up-front license fees, milestone payments and recurring
royalty payments if compounds resulting from the Company’s intellectual property are successfully developed into new
drugs and reach the market. The Company does not anticipate milestone or recurring royalty payments under its current license
arrangements for proprietary drug candidates to have a significant impact on the Company’s consolidated
operating results, financial position, or cash flows.
Cash, Cash Equivalents and Restricted
Cash
Cash equivalents consist of money market
accounts and overnight deposits. For purposes of the consolidated statements of cash flows, the Company considers all highly liquid
investments with a maturity of three months or less when purchased to be cash equivalents. The Company’s cash and cash equivalents
are held principally at seven financial institutions and at times may exceed insured limits. The Company has placed these
funds in high quality institutions in order to minimize risk relating to exceeding insured limits.
Restricted cash balances at September 30,
2016 and December 31, 2015 are required pursuant to the Company’s Singapore lease agreements. The additional restricted cash
balance at December 31, 2015 was required as collateral for the letters of credit associated with the Company’s debt agreements.
Long-Lived Assets
The Company assesses the impairment of
a long-lived asset group whenever events or changes in circumstances indicate that its 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 group is being used;
|
|
·
|
a significant change in the business climate that could affect the value of a long-lived asset group; or
|
|
·
|
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 indicated. An impairment charge is recognized
to the extent that the carrying amount of the asset group exceeds its fair value and will reduce only the carrying amounts of the
long-lived assets.
Derivative
Instruments and Hedging Activities
The Company accounts for derivatives in
accordance with FASB ASC Topic 815, “Derivatives and Hedging,” which establishes accounting and reporting standards
requiring that derivative instruments be recorded on the balance sheet as either an asset or a liability measured at fair value.
Additionally, changes in a derivative’s fair value shall be recognized currently in earnings unless specific hedge accounting
criteria are met. The Company recognizes changes in fair value associated with non-qualified derivatives in ‘Other (expense)
income, net’ in the Condensed Consolidated Statements of Operations. If required hedge accounting criteria are met, then
changes in fair value are recorded in accumulative other comprehensive loss, net.
Recently Issued Accounting Pronouncements
In October 2016, the FASB issued Accounting
Standard Update (“ASU”) No. 2016-16, “Income Taxes (Topic 740): Intra-Entity Transfers of Assets other than Inventory,”
which requires entities to recognize the tax impacts of all intra-entity sales of assets other than inventory even though the pre-tax
effects of those transactions are eliminated in consolidation. The new standard is effective for fiscal years beginning after
December 15, 2017 and for interim periods therein with early adoption permitted. The new standard is required to be adopted
in a modified retrospective approach, with a cumulative-effect adjustment recorded in retained earnings to write off any unamortized
tax expense previously deferred and record any previously unrecognized net deferred tax assets. The Company is currently evaluating
the impact this ASU will have on its consolidated financial statements.
In August 2016,
the FASB issued ASU No. 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments,”
which provides clarification guidance on eight specific cash flow presentation issues that have developed due to diversity in practice.
The issues include, but are not limited to, debt prepayment or extinguishment costs, settlement of zero-coupon debt, proceeds from
the settlement of insurance claims, and cash receipts from payments on beneficial interests in securitization transactions. The
new standard is effective for fiscal years beginning after December 15, 2017 and for interim periods therein with early adoption
permitted. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements.
In May 2014, the
FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers: (Topic 606).” This ASU affects any entity that
either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial
assets unless those contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). This ASU
will supersede the revenue recognition requirements in ASC Topic 605, “Revenue Recognition,” and most industry-specific
guidance. In addition, the existing requirements for the recognition of a gain or loss on the transfer of nonfinancial assets that
are not in a contract with a customer (e.g., assets within the scope of ASC Topic 360, “Property, Plant, and Equipment,”
and intangible assets within the scope of ASC Topic 350, “Intangibles-Goodwill and Other”) are amended to be consistent
with the guidance on recognition and measurement (including the constraint on revenue) in this ASU. The core principle of the guidance
is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that
reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. In July 2015,
the FASB deferred the effective date of ASU No. 2014-09. This ASU is effective for annual periods and interim periods within
those annual periods beginning after December 15, 2017. Early adoption is not permitted.
In March 2016,
the FASB issued ASU No. 2016-08, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations
(Reporting Revenue Gross versus Net).” In April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts
with Customers (Topic 606): Identifying Performance Obligations and Licensing.” In May 2016, the FASB issued ASU No. 2016-12, “Revenue
from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients” and ASU No. 2016-11, “Revenue
Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission of SEC Guidance Because of Accounting Standards Updates
2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016 EITF Meeting.” These amendments provide additional
clarification and implementation guidance on the previously issued ASU No. 2014-09, “Revenue from Contracts with Customers
(Topic 606),” discussed above.
The amendments
in ASU No. 2016-08 clarify how an entity should identify the specified good or service for the principal versus agent evaluation
and how it should apply the control principle to certain types of arrangements. ASU No. 2016-10 clarifies the following two aspects
of ASU No. 2014-09; identifying performance obligations and licensing implementation guidance. ASU No. 2016-11 rescinds several
SEC Staff Announcements that are codified in Topic 605, including, among other items, guidance relating to accounting for consideration
given by a vendor to a customer, as well as accounting for shipping and handling fees and freight services. ASU No. 2016-12 provides
clarification to Topic 606 on how to assess collectability, present sales tax, treat noncash consideration, and account for completed
and modified contracts at the time of transition. In addition, ASU No. 2016-12 clarifies that an entity retrospectively applying
the guidance in Topic 606 is not required to disclose the effect of the accounting change in the period of adoption. The effective
date and transition requirements for these amendments are the same as the effective date and transition requirements of ASU No.
2014-09. The Company is currently assessing the impact of these ASUs and ASU No. 2014-09 on its consolidated financial statements.
In March 2016, the FASB issued ASU No.
2016-09, “Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting,”
which changes the accounting for share-based payment transactions, including income tax consequences, classification of awards
as either equity or liabilities, and classification in the statement of cash flows. The new standard is effective for fiscal years
beginning after December 15, 2016 and for interim periods therein with early adoption permitted. The Company is currently evaluating
the impact this ASU will have on its consolidated financial statements.
In February 2016, the FASB issued ASU No.
2016-02, “Leases (Topic 842).” The new standard establishes a right-of-use (“ROU”) model that requires
a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months.
Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the
income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods
within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases
existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with
certain practical expedients available. The Company is currently evaluating the impact this ASU will have on its consolidated financial
statements.
In July 2015, the FASB issued ASU No. 2015-11,
“Simplifying the Measurement of Inventory.” This ASU simplifies the measurement of inventory by requiring certain inventory
to be measured at the lower of cost or net realizable value. The amendments in this ASU are effective for fiscal years beginning
after December 15, 2016 and for interim periods therein. The Company does not expect this ASU to have a material impact on its
consolidated financial statements.
In August 2014, the FASB issued ASU No. 2014-15,
“Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s
Ability to Continue as a Going Concern,” which defines management’s responsibility to assess an entity’s ability
to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to
continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016, with
early adoption permitted. The Company does not expect this ASU to have a material impact on its consolidated financial statements.
In June 2014, the FASB issued ASU No. 2014-12,
“Compensation - Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That
a Performance Target Could Be Achieved after the Requisite Service Period.” This ASU requires that a performance target that
affects vesting and that could be achieved after the requisite service period, be treated as a performance condition. This ASU
is effective for annual periods and interim periods within those annual periods beginning after December 15, 2015. The adoption
of this ASU as of January 1, 2016 did not have a material impact on the Company’s consolidated financial statements.
Note 2 — 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 September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Weighted average common shares outstanding – basic and diluted
|
|
|
41,272
|
|
|
|
34,087
|
|
|
|
36,990
|
|
|
|
32,700
|
|
The Company has excluded certain outstanding
stock options, non-vested restricted stock and warrants from the calculation of diluted earnings per share for the three and nine
months ended September 30, 2016 and 2015 because of anti-dilutive effects. The weighted average number of anti-dilutive common
equivalents outstanding (before the effects of the treasury stock method) was 11,838 and 11,962 for the three months ended September
30, 2016 and 2015, respectively, and 11,815 and 12,028 for the nine months ended September 30, 2016 and 2015, respectively. These
amounts are not included in the calculation of weighted average common shares outstanding.
Note 3 — Business Acquisitions
Euticals
On July 11, 2016, the Company purchased
from Lauro Cinquantasette S.p.A. all of the capital stock of Prime European Therapeuticals S.p.A., ("Euticals") (such
acquisition, the “Euticals Acquisition”), a privately-held company headquartered in Lodi, Italy, specializing in custom
synthesis and the manufacture of active pharmaceutical ingredients with a network of facilities located primarily in Italy, Germany,
the U.S. and France.
The aggregate net purchase price was $279,376
(net of cash acquired of $20,784), which consisted of (i) the issuance of 7,051 unregistered shares of common stock subject to
a six month lock-up provision, valued at $91,765 (net of lock-up provision discount of $9,633), (ii) the issuance of two unsecured
promissory notes to Lauro Cinquantasette S.p.A. with a combined face value of €55,000, or $60,783, that were valued at $44,342
(net of an original issue discount of $16,441) (the “Euticals Seller Notes”), and (iii) $143,269 in cash. The purchase
price is subject to certain working capital and debt-like items adjustments which have not yet be finalized by the Company and
Lauro Cinquantasette S.p.A.
The aggregate purchase price has been preliminarily
allocated based on an estimate of the fair value of assets and liabilities acquired as of the acquisition date. The allocation
of acquisition consideration for Euticals is based on estimates, assumptions, valuations and other studies which have not yet been
finalized in order to make a definitive allocation. The Company is finalizing the allocation of purchase price to intangibles,
property and equipment, working capital, environmental remediation liabilities and income taxes. The following table summarizes
the allocation of the preliminary aggregate purchase price to the estimated fair value of the net assets acquired:
|
|
July 11, 2016
|
|
Assets Acquired
|
|
|
|
|
Accounts receivable
|
|
$
|
30,977
|
|
Prepaid expenses and other current assets
|
|
|
2,057
|
|
Inventory
|
|
|
107,200
|
|
Property and equipment
|
|
|
152,111
|
|
Intangible assets
|
|
|
64,099
|
|
Goodwill
|
|
|
69,502
|
|
Other long term-assets
|
|
|
2,006
|
|
Total assets acquired
|
|
$
|
427,952
|
|
|
|
|
|
|
Liabilities Assumed
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
59,859
|
|
Short-term borrowings
|
|
|
27,057
|
|
Deferred revenue
|
|
|
4,062
|
|
Income taxes payable
|
|
|
1,478
|
|
Deferred income taxes
|
|
|
29,823
|
|
Pension benefits
|
|
|
13,201
|
|
Environmental liabilities
|
|
|
11,716
|
|
Other long-term liabilities
|
|
|
1,380
|
|
Total liabilities assumed
|
|
|
148,576
|
|
Net assets acquired
|
|
$
|
279,376
|
|
The Company has attributed the goodwill
of $69,502 to an expanded global footprint and additional market opportunities that the Euticals business offers primarily within
the API, Discovery and Development Services (“DDS”) and Fine Chemicals (“FC”) segments. The goodwill is
not deductible for tax purposes. Intangible assets acquired consisted of customer relationships of $7,184, with an estimated life
of 9 years, developed technology of $49,179, with an estimated life of 16 years, and manufacturing intellectual property and know-how
of $7,736, with an estimated life of 18 years.
Whitehouse Laboratories
On December 15, 2015, the Company acquired
all the outstanding equity interests of Whitehouse Analytical Laboratories, LLC (“Whitehouse”), a leading provider
of testing services that includes chemical and material analysis, method development and validation and quality control verification
services to the pharmaceutical, medical device and personal care industries. Whitehouse offers a comprehensive array of testing
solutions for life sciences from materials and excipients, container qualification and container closure integrity testing, routine
analytical chemistry, drug delivery systems and device qualification programs, packaging, distribution, and stability and storage
programs. The aggregate net purchase price was $55,986 (net of cash acquired of $377), which included the issuance of 137 shares
of common stock, valued at $1,800, with the balance comprised of $53,924 in cash, plus a working capital adjustment of $262.
The purchase price was increased in the first quarter of 2016
by $262 due to the finalization of the net working capital adjustment. The purchase price was reduced in the first quarter of 2016
to recognize the discount associated with the 137 unregistered shares issued in conjunction with the Whitehouse acquisition in
the amount of $200. These adjustments resulted in a net increase of goodwill of $62.
Gadea Grupo
On July 16, 2015, the Company completed
the purchase of Gadea Grupo Farmaceutico, S.L. (“Gadea”), a contract manufacturer of complex active pharmaceutical
ingredients and finished drug product. Gadea operates within the Company's API and Drug Product (“DP”) segments.
The aggregate net purchase price was $127,572 (net of cash acquired of $10,961), which included the issuance of 2,200 shares of
common stock, valued at $40,568, with the balance comprised of $96,961 in cash, plus a working capital adjustment of $1,004. The
purchase price has been allocated based on the fair value of assets and liabilities acquired as of the acquisition date.
The purchase price was adjusted in the
first quarter of 2016 by $676 due to the finalization of the net working capital adjustment. The purchase price allocation was
adjusted in the first quarter of 2016, primarily due to the recognition of an environmental remediation liability of $1,542, and
a corresponding indemnification receivable from the seller of $771. The purchase price allocation was adjusted in the second quarter
of 2016 to reduce the estimated uncertain tax position liabilities associated with pre-acquisition tax years by $498, and to reduce
the corresponding indemnification receivable from the seller by $293. These adjustments resulted in a net increase of goodwill
of approximately $1,200.
The Company has attributed the goodwill
of $51,358 to an expanded global footprint and additional market opportunities that the Gadea business offers. The goodwill has
been allocated between business segments, with API of $30,879 and DP of $20,479, and is not deductible for tax purposes. Intangible
assets acquired consisted of customer relationships of $24,000 (with an estimated life of 13 years), a tradename of $4,100 (with
an indefinite estimated life), intellectual property of $11,900 (with an estimated life of 15 years), in-process research and development
of $18,000 (with an indefinite estimated life), and $200 of order backlog.
SSCI
On February 13, 2015, the Company completed
the purchase of assets and assumed certain liabilities of Aptuit's Solid State Chemical Information business, now AMRI SSCI, LLC
(“SSCI”), for total consideration of $35,850. SSCI brings extensive material science knowledge and technology and expands
the Company’s capabilities in analytical testing to include peptides, proteins and oligonucleotides. SSCI has been assigned
to the DDS segment.
Glasgow
On January 8, 2015, the Company completed
the purchase of all of the outstanding equity interests of Aptuit's Glasgow, U.K. business, now Albany Molecular Research (Glasgow)
Limited (“Glasgow”), for total consideration of $23,805 (net of cash acquired of $146). The Glasgow facility extends
the Company’s capabilities to sterile injectable drug product pre-formulation, formulation and clinical stage manufacturing.
Glasgow has been assigned to the DP segment.
Unaudited Pro Forma Statements of
Operations
The following table shows the unaudited
pro forma statements of operations for the three and nine months ended September 30, 2016, as if the Euticals Acquisition had occurred
on January 1, 2015, and as if the Gadea, Whitehouse, SSCI and Glasgow acquisitions had occurred on January 1, 2014. This pro forma
information does not purport to represent what the Company’s actual results would have been if the acquisitions had occurred
as of the dates indicated or what such results would be for any future periods.
|
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Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30, 2016
|
|
|
September 30, 2016
|
|
Total revenues
|
|
$
|
155,471
|
|
|
$
|
494,949
|
|
Net loss
|
|
|
(2,629
|
)
|
|
|
(29,719
|
)
|
|
|
|
|
|
|
|
|
|
Pro forma weighted average basic and diluted shares
|
|
|
42,115
|
|
|
|
41,998
|
|
|
|
|
|
|
|
|
|
|
Pro forma loss per share:
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.71
|
)
|
The following table shows the pro forma
adjustments made to the weighted average shares outstanding for the three and nine months ended September 30, 2016:
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30, 2016
|
|
|
September 30, 2016
|
|
Weighted average common shares outstanding – basic
|
|
|
41,272
|
|
|
|
36,990
|
|
Pro forma impact of acquisition consideration
|
|
|
843
|
|
|
|
5,008
|
|
Pro forma weighted average
common shares outstanding – basic and diluted
|
|
|
42,115
|
|
|
|
41,998
|
|
For the three and nine month periods ended
September 30, 2016, pre-tax net income was adjusted by reducing expenses by $14,911 and $19,873, respectively, for acquisition
related costs. For the three and nine months ended September 30, 2016, pre-tax net income was adjusted by reducing expenses by
$12,835 and $19,493, respectively, for purchase accounting related inventory costs. Pre-tax net income for the nine months ended
September 30, 2016 was adjusted by increasing expenses by $1,907 for purchase accounting related depreciation and amortization.
The Company partially funded the Euticals
Acquisition utilizing the proceeds from a $230,000 term loan that was provided for in conjunction with the Third Restated Credit
Agreement, entered into with JP Morgan Chase Bank, N.A. and Barclays Bank PLC, as administrative agents and collateral agents,
and the lenders party thereto (the “Third Restated Credit Agreement”), which was completed on July 7, 2016, along with
the issuance of the Euticals Seller Notes on July 11, 2016 (see Note 5). The Company did not have sufficient cash on hand to complete
the acquisition as of January 1, 2015. For the purposes of presenting the pro forma statements of operations for the three and
nine months ended September 30, 2016, the Company has assumed that it entered into the Third Restated Credit Agreement and issued
the Euticals Seller Notes on January 1, 2015 for an amount sufficient to fund the preliminary cash consideration to acquire Euticals
as of that date. The pro forma statements of operations for the three and nine months ended September 30, 2016 reflect the recognition
of interest expense that would have been incurred had the Third Restated Credit Agreement and the Euticals Seller Notes been entered
into on January 1, 2015. The Company has recorded $4,437 of pro forma interest expense on the Third Restated Credit Agreement and
the Euticals Seller Notes for the purposes of presenting the pro forma statements of operations for the nine months ended September
30, 2016.
During the three month period ended September 30, 2016,
the Company recognized income tax expense of $4,715 to establish a deferred tax liability associated with the original issue
discount recorded in conjunction with the issuance of the Euticals Seller Notes. For the purposes of presenting the pro forma
condensed combined statements of operations for the three and nine months ended September 30, 2016, the Company has assumed
that it would have been required to recognize this deferred tax liability on January 1, 2015, assuming a January 1, 2015
acquisition date. During the three month period ended June 30, 2016, the Company established a valuation allowance against
its U.S. deferred tax assets. For the purposes of presenting the pro forma condensed combined statements of operations
for the three and nine months ended September 30, 2016, the Company has assumed that it would have been required to establish
a valuation allowance against the combined U.S. deferred tax assets of the Company and Euticals on January 1, 2015, assuming
a January 1, 2015 acquisition date. In addition, the pro forma adjustments to net income incorporate, at the applicable
effective rates (including the effect of establishing a valuation allowance against the combined U.S. deferred tax assets of
the Company and Euticals), the tax effects of the pro forma pre-tax adjustments noted above.
The following table shows the unaudited
pro forma statements of operations for the three and nine months ended September 30, 2015, as if the Euticals Acquisition had occurred
on January 1, 2015, and as if the Gadea, Whitehouse, SSCI and Glasgow acquisitions had occurred on January 1, 2014. This pro forma
information does not purport to represent what the Company’s actual results would have been if the acquisitions had occurred
as of the date indicated or what such results would be for any future periods.
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30, 2015
|
|
|
September 30, 2015
|
|
Total revenues
|
|
$
|
172,348
|
|
|
$
|
517,038
|
|
Net loss
|
|
|
(2,668
|
)
|
|
|
(32,024
|
)
|
|
|
|
|
|
|
|
|
|
Pro forma weighted average basic and diluted shares
|
|
|
41,658
|
|
|
|
41,478
|
|
|
|
|
|
|
|
|
|
|
Pro forma loss per share:
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.06
|
)
|
|
$
|
(0.77
|
)
|
The following table shows the pro forma
adjustments made to the weighted average shares outstanding for the three and nine months ended September 30, 2015:
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30, 2015
|
|
|
September 30, 2015
|
|
Weighted average common shares outstanding - basic
|
|
|
34,087
|
|
|
|
32,700
|
|
Pro forma impact of acquisition consideration
|
|
|
7,571
|
|
|
|
8,778
|
|
Pro forma weighted average common shares outstanding –basic and diluted
|
|
|
41,658
|
|
|
|
41,478
|
|
For the three and nine month periods ended
September 30, 2015, pre-tax net income was adjusted by reducing expenses by $1,326 and $1,635, respectively, for acquisition related
costs. For the three and nine months ended September 30, 2015, pre-tax net income was adjusted by reducing and increasing expenses
by $3,081 and $21,064, respectively, for purchase accounting related inventory costs. For the three and nine months ended September
30, 2015, pre-tax net income was adjusted by increasing expenses by $473 and $2,910, respectively, for purchase accounting related
depreciation and amortization.
The Company partially funded the acquisition
of Euticals utilizing the proceeds from a $230,000 term loan that was provided for in conjunction with the Third Restated Credit
Agreement, which was completed on July 7, 2016, along with the issuance of the Euticals Seller Notes on July 11, 2016 (see Note
5). The Company did not have sufficient cash on hand to complete the acquisition as of January 1, 2015. For the purposes of presenting
the pro forma statements of operations for the three and nine months ended September 30, 2015, the Company has assumed that it
entered into the Third Restated Credit Agreement and issued the Euticals Seller Notes on January 1, 2015 for an amount sufficient
to fund the preliminary cash consideration to acquire Euticals as of that date. The pro forma statements of operations for the
three and nine months ended September 30, 2015 reflect the recognition of interest expense that would have been incurred had the
Third Restated Credit Agreement and the Euticals Seller Notes been entered into on January 1, 2015. The Company has recorded $2,218
and $ 6,655, respectively, of pro forma interest expense on the Third Restated Credit Agreement and the Euticals Seller Notes for
the purposes of presenting the pro forma statements of operations for the three and nine months ended September 30, 2015.
The Company partially funded the acquisition
of Whitehouse utilizing the proceeds from a $30,000 revolving line of credit pursuant to a $230,000 senior secured credit agreement
with Barclays Bank PLC (the “Credit Agreement”) that was completed in July 2015 (see Note 5). For purposes of presenting
the pro forma statements of operations for the three and nine months ended September 30, 2015, the Company has assumed that it
borrowed on the revolving line of credit on January 1, 2014 for an amount sufficient to fund the cash consideration to acquire
Whitehouse as of that date. The pro forma statements of operations for the three and nine months ended September 30, 2015 reflects
the recognition of interest expense that would have been incurred on the revolving line of credit had it been entered into on January
1, 2014. The Company has recorded $425 and $1,276, respectively, of pro forma interest expense on the revolving line of credit
for the purposes of presenting the pro forma statements of operations for the three and nine months ended September 30, 2015.
The Company partially funded the
acquisition of Gadea utilizing the proceeds from a $200,000 term loan pursuant to the Credit Agreement. The Company did not
have sufficient cash on hand to complete the acquisition as of January 1, 2014. For the purposes of presenting the pro forma
statements of operations for the three and nine months ended September 30, 2015, the Company has assumed that it entered into
the Credit Agreement on January 1, 2014 for an amount sufficient to fund the preliminary cash consideration to acquire Gadea
as of that date. The pro forma statements of operations for the three and nine months ended September 30, 2015 reflect the
recognition of interest expense that would have been incurred on the Credit Agreement had it been entered into on January 1,
2014. The Company has recorded $4,200 of pro forma interest expense on the Credit Agreement for the purposes of presenting
the pro forma statements of operations for the nine months ended September 30, 2015.
During the three month period ended September 30, 2016,
the Company recognized income tax expense of $4,715 to establish a deferred tax liability associated with the original issue
discount recorded in conjunction with the issuance of the Euticals Seller Notes. For the purposes of presenting the pro forma
condensed combined statements of operations for the three and nine months ended September 30, 2015, the Company has assumed
that it would have been required to recognize this deferred tax liability on January 1, 2015, assuming a January 1, 2015
acquisition date. During the three month period ended June 30, 2016, the Company established a valuation allowance against
its U.S. deferred tax assets. For the purposes of presenting the pro forma condensed combined statements of operations
for the three and nine months ended September 30, 2015, the Company has assumed that it would have been required to establish
a valuation allowance against the combined U.S. deferred tax assets of the Company and Euticals on January 1, 2015, assuming
a January 1, 2015 acquisition date. In addition, the pro forma adjustments to net income incorporate, at the applicable
effective rates (including the effect of establishing a valuation allowance against the combined U.S. deferred tax assets of
the Company and Euticals), the tax effects of the pro forma pre-tax adjustments noted above.
Note 4 — Inventory
Inventory consisted of the following as of September 30, 2016
and December 31, 2015:
|
|
September 30,
2016
|
|
|
December 31,
2015
(a)
|
|
Raw materials
|
|
$
|
69,229
|
|
|
$
|
36,628
|
|
Work-in-process
|
|
|
83,328
|
|
|
|
37,574
|
|
Finished goods
|
|
|
49,344
|
|
|
|
15,029
|
|
Total inventory
|
|
$
|
201,901
|
|
|
$
|
89,231
|
|
|
(a)
|
Certain adjustments have been made to December 31, 2015 inventory classifications to conform
to current year presentation.
|
Note 5 — Debt
Short-Term Borrowings
In connection with the Euticals Acquisition,
the Company assumed the short-term borrowing obligations of Euticals, consisting of multiple bank revolving lines of credit with
a maximum borrowing capacity of €41,450, or $46,470, (the “Euticals Revolving Credit Facilities”). The Euticals
Revolving Credit Facilities support Euticals’ short-term working capital needs and are collateralized, in part, by certain
Euticals trade receivables balances. The Euticals Revolving Credit Facilities are subject to variable interest rates and the average
effective interest rate was 4.02% during the period July 12, 2016 to September 30, 2016.
As of September 30, 2016, the aggregate
outstanding balance under the Euticals Revolving Credit Facilities was $20,787 and the related trade receivables collateral was
$12,855.
Long-Term Debt
The following table summarizes long-term debt:
|
|
September 30, 2016
|
|
|
December 31,
2015
|
|
Convertible senior notes, net of unamortized debt discount
|
|
$
|
133,922
|
|
|
$
|
128,917
|
|
Term loan, net of unamortized discount
|
|
|
424,340
|
|
|
|
198,343
|
|
Revolving credit facility
|
|
|
-
|
|
|
|
30,000
|
|
Industrial development authority bonds
|
|
|
-
|
|
|
|
2,080
|
|
Various borrowings with institutions, Gadea loans
|
|
|
30,451
|
|
|
|
39,655
|
|
Euticals Seller Notes
|
|
|
45,879
|
|
|
|
-
|
|
Capital leases – equipment & other
|
|
|
478
|
|
|
|
111
|
|
|
|
|
635,070
|
|
|
|
399,106
|
|
Less deferred financing fees
|
|
|
(13,904
|
)
|
|
|
(9,823
|
)
|
Less current portion
|
|
|
(15,054
|
)
|
|
|
(15,591
|
)
|
Total long-term debt
|
|
$
|
606,112
|
|
|
$
|
373,692
|
|
The aggregate maturities of long-term debt, exclusive of unamortized
debt discount of $34,951 at September 30, 2016, are as follows:
2016 (remaining)
|
|
$
|
4,352
|
|
2017
|
|
|
14,246
|
|
2018
|
|
|
601,229
|
|
2019
|
|
|
26,555
|
|
2020
|
|
|
22,594
|
|
Thereafter
|
|
|
1,045
|
|
Total
|
|
$
|
670,021
|
|
Term Loans
In connection with the Euticals Acquisition,
on July 7, 2016, the Company entered into the Third Restated Credit Agreement, which (i) provides incremental senior secured first
lien term loans in an aggregate principal amount of $230,000 (the “Incremental Term Loans”) which increased the aggregate
principal amount of senior secured first lien term loans under the Credit Agreement to $428,500 and (ii) increased the first lien
revolving credit facility commitments by $5,000 to $35,000. The Company used the proceeds of the Incremental Term Loans primarily
to: (i) pay a portion of the cash consideration for the Euticals Acquisition; (ii) pay various fees and expenses incurred in connection
with the Euticals Acquisition and related financing activities; and (iii) repay the $30,000 outstanding under the first lien revolving
credit facility.
The Third Restated Credit Agreement requires
that the Company make quarterly repayments toward the Incremental Term Loans principal of $579 beginning on September 30, 2016,
with all remaining unpaid principal amounts of the Incremental Term Loans maturing and payable on July 16, 2021. The revolving
credit facility commitments under the Third Restated Credit Agreement terminate and all amounts then outstanding thereunder are
payable on July 16, 2020, subject, in each case, to earlier acceleration (i) to six months prior to the scheduled maturity date
of the Company’s 2.25% Cash Convertible Senior Notes issued on December 4, 2013 (the “Notes”) if on such date,
both (x) more than $25,000 of the Notes shall remain outstanding and (y) the ratio the secured debt of the Company and its subsidiaries
to the EBITDA of the Company and its subsidiaries exceeds 1.50:1.00 and (ii) to April 7, 2019, April 7, 2020 or April 7, 2021,
respectively, in each case to the extent that at any such date the Company has not (x) prepaid or otherwise satisfied the amortization
or final maturity payment amounts to next come due under each Euticals Seller Note then outstanding or (y) refinanced such amortization
or final maturity payment amount to next come due under each Euticals Seller Note then outstanding in a manner permitted by the
Third Restated Credit Agreement.
At the Company’s election, loans
made under the Third Restated Credit Agreement bear interest at (a) the one-month, three-month or six-month LIBOR rate subject
to a floor of 1.0% (the “LIBOR Rate”) or (b) a base rate determined by reference to the highest of (i) the United States
federal funds rate plus 0.50%, (ii) the rate of interest quoted by The Wall Street Journal as the “Prime Rate,” and
(iii) a daily rate equal to the one-month LIBOR Rate plus 1.0%, subject to a floor of 2.0% (the “Base Rate”), plus
an applicable margin of 4.75% per annum for LIBOR Rate loans and 3.75% per annum for Base Rate loans.
The obligations under the Third Restated
Credit Agreement are guaranteed by each material domestic subsidiary of the Company (each a “Guarantor”) and are secured
by first priority liens on, and security interests in, substantially all of the present and after-acquired assets of the Company
and each Guarantor subject to certain customary exceptions.
The components of the term loans are as
follows:
|
|
September 30,
2016
|
|
|
December 31,
2015
|
|
Principal amount – term loan
|
|
$
|
427,430
|
|
|
$
|
200,000
|
|
Unamortized debt discount
|
|
|
(3,090
|
)
|
|
|
(1,657
|
)
|
Net carrying amount of term loan
|
|
$
|
424,340
|
|
|
$
|
198,343
|
|
Euticals Seller Notes
As indicated in Note 3, in connection with
the Euticals Acquisition, on July 11, 2016, the Company issued two notes to Lauro Cinquantasette S.p.A. with a combined face value
of €55,000, that were valued at $44,342 (net of original issue discount of $16,441). The Euticals Seller Notes are unsecured
promissory notes, guaranteed by the Company, and are subject to customary representations and warranties and events of default
with repayment to be made in three equal annual installments made on the third, fourth and fifth anniversaries of the Euticals
Acquisition closing date. The repayment is subject to certain set off rights of the Company relating to the seller’s indemnification
obligations. The Euticals Seller Notes are subject to an interest rate equal to 0.25% per annum, which is due and payable in cash
on the first day of January, April, July and October during each calendar year. The Euticals Seller Notes were recognized net of
an original issue discount of $16,441.
As of September 30, 2016, the components
of the Euticals Seller Notes were as follows:
Principal amount
|
|
$
|
61,662
|
|
Unamortized debt discount
|
|
|
(15,783
|
)
|
Net carrying amount of notes
|
|
$
|
45,879
|
|
Convertible Senior Notes
On December 4, 2013, the Company completed
the private offering of $150,000 aggregate principal amount of the Notes. The Notes mature on November 15, 2018, unless earlier
repurchased or converted into cash in accordance with their terms prior to such date and interest is paid in arrears semiannually
on each May 15 and November 15 at an annual rate of 2.25% beginning on May 15, 2014. The Notes were offered and sold only to qualified
institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).
The Notes are not convertible into the
Company's common stock or any other securities under any circumstances. Holders may convert their Notes solely into cash at their
option at any time prior to the close of business on the business day immediately preceding May 15, 2018 only under the following
circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on December 31, 2013 (and only during
such calendar quarter), if the last reported sale price of the Company's common stock for at least 20 trading days (whether or
not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar
quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (2) during the five business day
period after any five consecutive trading day period in which the trading price per thousand dollars principal amount of Notes
for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company's
common stock and the conversion rate on each such trading day; or (3) upon the occurrence of specified corporate events. On or
after May 15, 2018 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders
may convert their Notes solely into cash at any time, regardless of the foregoing circumstances. Upon conversion, in lieu of receiving
shares of the Company's common stock, a holder will receive, per thousand dollars principal amount of Notes, an amount in cash
equal to the settlement amount, determined in the manner set forth in the indenture. The initial conversion rate is 63.9844 shares
of the Company's common stock per thousand dollars principal amount of Notes (equivalent to an initial conversion price of approximately
$15.63 per share of common stock). The conversion rate is subject to adjustment upon certain events as described in the indenture
but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior
to the maturity date, the Company has agreed to pay a cash make-whole premium by increasing the conversion rate for a holder who
elects to convert its Notes in connection with such a corporate event in certain circumstances as described in the indenture.
The Company may not redeem the Notes prior
to the maturity date, and no sinking fund is provided for the Notes.
The cash conversion feature of the Notes
(“Notes Conversion Derivative”) requires bifurcation from the Notes in accordance with ASC 815, “Derivatives
and Hedging,” and is accounted for as a derivative liability. The fair value of the Notes Conversion Derivative at the time
of issuance of the Notes was $33,600 and was recorded as original debt discount for purposes of accounting for the debt component
of the Notes. This discount is amortized as interest expense using the effective interest method over the term of the Notes. For
the three months ended September 30, 2016 and 2015, the Company recorded $1,697 and $1,572, respectively, and for the nine months
ended September 30, 2016 and 2015, the Company recorded $5,005 and $4,628, respectively, of amortization of the debt discount as
interest expense based upon an effective rate of 7.69%.
The components of the Notes were as follows:
|
|
September 30,
2016
|
|
|
December 31,
2015
|
|
Principal amount
|
|
$
|
150,000
|
|
|
$
|
150,000
|
|
Unamortized debt discount
|
|
|
(16,078
|
)
|
|
|
(21,083
|
)
|
Net carrying amount of Notes
|
|
$
|
133,922
|
|
|
$
|
128,917
|
|
In connection with the pricing of the Notes,
on November 19, 2013, the Company entered into cash convertible note hedge transactions (“Notes Hedges”) relating to
a notional number of shares of the Company's common stock underlying the Notes with two counterparties (the “Option Counterparties”).
The Notes Hedges, which are cash-settled, are intended to reduce the Company’s exposure to potential cash payments that it
is required to make upon conversion of the Notes in excess of the principal amount of converted Notes if the Company’s common
stock price exceeds the conversion price. The Notes Hedges are accounted for as a derivative instrument in accordance with ASC
815, “Derivatives and Hedging.” The aggregate cost of the note hedge transaction was $33,600.
At the same time, the Company also entered
into separate warrant transactions with each of the Option Counterparties initially relating, in the aggregate, to 9,598 shares
of the Company's common stock underlying the Note Hedges. The Note Hedges are intended to offset cash payments due upon any conversion
of the Notes. However, the warrant transactions could separately have a dilutive effect to the extent that the market price per
share of the Company's common stock (as measured under the terms of the warrant transactions) exceeds the applicable strike price
of the warrants. The initial strike price of the warrants is $18.9440 per share, which was 60% above the last reported sale price
of the Company's common stock of $11.84 on November 19, 2013 and proceeds of $23,100 were received from the Option Counterparties
from the sale of the warrants.
Aside from the initial payment of a
$33,600 premium to the Option Counterparties, the Company is not required to make any cash payments to the Option
Counterparties under the Note Hedges and will be entitled to receive from the Option Counterparties an amount of cash,
generally equal to the amount by which the market price per share of common stock exceeds the strike price of the Note Hedges
during the relevant valuation period. The strike price under the Note Hedges is initially equal to the conversion price of
the Notes. Additionally, if the market price per share of the Company's common stock, as measured under the warrant
transactions, exceeds the strike price of the warrants during the measurement period at the maturity of the warrants, the
Company will be obligated to issue to the Option Counterparties a number of shares of the Company's common stock in an amount
based on the excess of such market price per share of the Company's common stock over the strike price of the warrants. The
Company will not receive any proceeds if the warrants are exercised.
Neither the Notes Conversion Derivative
nor the Notes Hedges qualify for hedge accounting, thus any changes in the fair market value of the derivatives is recognized immediately
in the statement of operations. As of September 30, 2016 and December 31, 2015, the changes in fair market value of the Notes Conversion
Derivative and the Notes Hedges were equal, therefore there was no change in fair market value that was recognized in the statement
of operations.
The following table summarizes the fair
value and the presentation in the consolidated balance sheet:
|
|
Location on Balance Sheet
|
|
September 30,
2016
|
|
|
December 31,
2015
|
|
Notes Hedges
|
|
Other assets
|
|
$
|
47,436
|
|
|
$
|
76,393
|
|
Notes Conversion Derivative
|
|
Other liabilities
|
|
$
|
(47,436
|
)
|
|
$
|
(76,393
|
)
|
IDA Bonds
In May 2016, the sale of the Company’s
Syracuse, N.Y. facility, within the DDS operating segment, was completed for $675. Commensurate with the sale of the facility,
the industrial development authority (“IDA”) bonds associated with the facility were repaid in full, with a final payment
of $1,760.
Note 6 — Facilities Impairment, Restructuring and Other
Charges
In August 2016, the Company announced a
restructuring plan in connection with the Euticals Acquisition. Under the restructuring plan, the Company initiated a reduction
in workforce in certain locations in the United States and Europe and ceased operations in one location in Italy. The Company
recorded $2,698 in charges for reduction in force and termination benefits during the three months ended September 30, 2016.
The Company also assumed $101 of Euticals restructuring liabilities for a restructuring plan initiated by Euticals prior to the
Euticals Acquisition to cease operations at a separate location in Italy.
In the second quarter of 2016, the
Company recognized a change in estimate of $634, which reduced the restructuring liabilities related to the operations of
Cedarburg. Other restructuring and other charges for various sites at the three and nine months
ended September 30, 2016, were $25 and $303, respectively.
In April 2015, the Company announced a
restructuring plan with respect to certain operations in the U.K. within its API business segment. In connection with the restructuring
plan, the Company ceased all operations at its Holywell, U.K. facility in the fourth quarter of 2015. The Company recorded $228
and $1,793 in charges for reduction in force and termination benefits and other restructuring-related charges related to the U.K.
facility during the three and nine months ended September 30, 2016, respectively. In conjunction with the Company’s actions
to cease operations at its Holywell, U.K. facility, the Company also recorded property and equipment impairment charges in the
API segment of $2,550 in the first quarter of 2015. These charges are included under the caption “impairment charges”
on the consolidated statement of operations. Also in 2015, the Company made additional resource changes at its Singapore
site (within the DDS segment) to optimize the cost profile of the facility, which resulted in restructuring charges of $16 and
$1,934 during the three and nine months ended September 30, 2016. Equipment that was not transferred or recovered through sale
was subject to accelerated depreciation over the remaining operating period of the facility, which closed in the first quarter
of 2016.
Restructuring and other charges for the
three months ended September 30, 2016 and 2015 were $2,967 and $709, respectively, and for the nine months ended September 30,
2016 and 2015 were $6,094 and $3,828, respectively, consisting primarily of employee termination charges and costs associated with
the Euticals Acquisition restructuring plan, costs associated with the closure and related transfer of continuing products from
the Holywell, U.K. facility to the Company’s other manufacturing locations, and resource optimization and lease termination
charges at the Company’s Singapore facility.
The following table displays the restructuring and other charges
activity and liability balances for the nine-month period ended as of September 30, 2016:
|
|
Balance at
January 1, 2016
|
|
|
Charges/
(reversals)
(1)
|
|
|
Amounts
Paid
|
|
|
Foreign
Currency
Translation &
Other
Adjustments
(1) (2)
|
|
|
Balance at September 30, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Termination benefits and personnel realignment
|
|
$
|
539
|
|
|
$
|
3,330
|
|
|
|
(1,603
|
)
|
|
|
51
|
|
|
$
|
2,317
|
|
Lease termination and relocation charges
|
|
|
2,153
|
|
|
|
(39
|
)
|
|
|
(2,025
|
)
|
|
|
59
|
|
|
|
148
|
|
Other
|
|
|
-
|
|
|
|
2,803
|
|
|
|
(1,533
|
)
|
|
|
(1,105
|
)
|
|
|
165
|
|
Total
|
|
$
|
2,692
|
|
|
$
|
6,094
|
|
|
|
(5,161
|
)
|
|
|
(995
|
)
|
|
$
|
2,630
|
|
|
(1)
|
Included in other restructuring charges are non-cash accelerated depreciation charges of $1,145
related to our Singapore facility.
|
|
(2)
|
Included in termination benefits and personnel realignment is an adjustment for a restructuring
liability assumed in conjunction with the Euticals Acquisition in the third quarter of 2016 of $101, as described above.
|
Termination benefits and personnel realignment
costs related to severance packages, outplacement services, and career counseling for employees affected by the restructuring.
Lease termination charges related to estimated costs associated with exiting a facility, net of estimated sublease income.
Restructuring charges are included under
the caption ‘Restructuring and other charges’ in the Condensed Consolidated Statements of Operations for the three
and nine months ended September 30, 2016 and 2015 and the restructuring liabilities are included in ‘Accounts payable and
accrued expenses’ and ‘Other long-term liabilities’ on the Condensed Consolidated Balance Sheets at September
30, 2016 and December 31, 2015.
Anticipated cash outflow related to the
above restructuring liability as of September 30, 2016 for the remainder of 2016 is approximately $701.
The Company is currently marketing its
Holywell, U.K. facility for sale. The facility is an asset of the API operating segment and is classified as held for sale with
the long-lived assets segregated to a separate line on the Condensed Consolidated Balance Sheets until they are sold. Depreciation
expense on the facility has ceased. The carrying value of the facility is $1,508 at September 30, 2016.
Note 7 — Goodwill and Intangible Assets
The changes in the carrying amount of goodwill
for the nine months ended September 30, 2016 were as follows:
|
|
DDS
|
|
|
API
|
|
|
DP
|
|
|
FC
|
|
|
Total
|
|
Balance as of December 31, 2015
|
|
$
|
45,987
|
|
|
$
|
46,182
|
|
|
$
|
77,302
|
|
|
$
|
-
|
|
|
$
|
169,471
|
|
Goodwill acquired
|
|
|
1,792
|
|
|
|
60,242
|
|
|
|
-
|
|
|
|
7,468
|
|
|
|
69,502
|
|
Measurement period adjustments
|
|
|
107
|
|
|
|
1,211
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,318
|
|
Foreign exchange translation
|
|
|
24
|
|
|
|
1,602
|
|
|
|
(621
|
)
|
|
|
106
|
|
|
|
1,111
|
|
Balance as of September 30, 2016
|
|
$
|
47,910
|
|
|
$
|
109,237
|
|
|
$
|
76,681
|
|
|
$
|
7,574
|
|
|
$
|
241,402
|
|
The components of intangible assets are as follows:
|
|
Cost
|
|
|
Impairment
|
|
|
Accumulated
Amortization
|
|
|
Foreign
exchange translation
|
|
|
Net
|
|
|
Amortization
Period
|
September 30, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual
Property and Know-How
|
|
$
|
28,277
|
|
|
$
|
(2,709
|
)
|
|
$
|
(4,217
|
)
|
|
$
|
(136
|
)
|
|
$
|
21,215
|
|
|
2-18 years
|
Customer Relationships
|
|
|
93,958
|
|
|
|
-
|
|
|
|
(8,893
|
)
|
|
|
236
|
|
|
|
85,301
|
|
|
5-20 years
|
Developed Technology
|
|
|
49,179
|
|
|
|
|
|
|
|
(689
|
)
|
|
|
708
|
|
|
|
49,198
|
|
|
16 years
|
Tradename
|
|
|
4,100
|
|
|
|
-
|
|
|
|
-
|
|
|
|
74
|
|
|
|
4,174
|
|
|
indefinite
|
In-Process Research and
Development
|
|
|
18,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
325
|
|
|
|
18,325
|
|
|
indefinite
|
Trademarks
|
|
|
2,200
|
|
|
|
-
|
|
|
|
(793
|
)
|
|
|
-
|
|
|
|
1,407
|
|
|
5 years
|
Order
Backlog
|
|
|
200
|
|
|
|
-
|
|
|
|
(204
|
)
|
|
|
4
|
|
|
|
-
|
|
|
n/a
|
Total
|
|
$
|
195,914
|
|
|
$
|
(2,709
|
)
|
|
$
|
(14,796
|
)
|
|
$
|
1,211
|
|
|
$
|
179,620
|
|
|
|
|
|
Cost
|
|
|
Impairment
|
|
|
Accumulated
Amortization
|
|
|
Foreign
exchange translation
|
|
|
Net
|
|
|
Amortization
Period
|
December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual
Property and Know-How
|
|
$
|
20,352
|
|
|
$
|
(2,508
|
)
|
|
$
|
(3,004
|
)
|
|
$
|
(165
|
)
|
|
$
|
14,675
|
|
|
2-16 years
|
Customer Relationships
|
|
|
86,774
|
|
|
|
-
|
|
|
|
(4,303
|
)
|
|
|
(408
|
)
|
|
|
82,063
|
|
|
5-20 years
|
Tradename
|
|
|
4,100
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(57
|
)
|
|
|
4,043
|
|
|
indefinite
|
In-Process Research and
Development
|
|
|
18,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(250
|
)
|
|
|
17,750
|
|
|
indefinite
|
Trademarks
|
|
|
2,200
|
|
|
|
-
|
|
|
|
(727
|
)
|
|
|
-
|
|
|
|
1,473
|
|
|
5 years
|
Order
Backlog
|
|
|
200
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
200
|
|
|
n/a
|
Total
|
|
$
|
131,626
|
|
|
$
|
(2,508
|
)
|
|
$
|
(8,034
|
)
|
|
$
|
(880
|
)
|
|
$
|
120,204
|
|
|
|
Amortization expense related to intangible
assets was $2,862 and $1,275 for the three months ended September 30, 2016 and 2015, respectively, and $6,762 and $2,702 for the
nine months ended September 30, 2016 and 2015, respectively. The weighted average amortization period is 13.3 years.
The following chart represents estimated
future annual amortization expense related to intangible assets:
Year ending December 31,
|
|
|
|
2016 (remaining)
|
|
$
|
1,775
|
|
2017
|
|
|
11,794
|
|
2018
|
|
|
11,792
|
|
2019
|
|
|
11,786
|
|
2020
|
|
|
11,786
|
|
Thereafter
|
|
|
108,188
|
|
Total
|
|
$
|
157,121
|
|
Note 8 — Income Taxes
During the three
month period ended September 30, 2016, the Company recognized $4,715 of tax expense related to a deferred tax liability for the
original discount on the Euticals Seller Notes. Additionally, during the three month period ended June 30, 2016, the Company established
a full valuation allowance against its U.S. deferred tax assets in the amount of $8,467.
In assessing the
realizability of U.S. deferred tax assets, management considers whether it is more likely than not that some portion or all of
the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation
of taxable income, either in prior years available for carryback claims or in the future. Management considers all available evidence
in support of its ability to utilize its deferred tax assets, including cumulative income or loss in recent periods, future reversals
of existing temporary differences, forecasted future taxable income and tax planning strategies.
The Company will
continue to evaluate all positive and negative evidence in support of its deferred tax assets in the future, as changes in temporary
differences, tax laws and operating performance may require a change in the need for a valuation allowance. If the Company determines
the valuation allowance should be reversed in a future period, the resulting adjustment would be recorded as a tax benefit in the
Condensed Consolidated Statements of Operations, and such amount may be material.
Note 9 — Share-Based Compensation
During the three and nine months ended
September 30, 2016, the Company recognized total share based compensation cost of $1,790 and $6,420, respectively, as compared
to total share-based compensation cost for the three and nine months ended September 30, 2015 of $1,797 and $4,816, respectively.
The Company grants share-based compensation,
including restricted shares, under its 1998 Stock Option Plan, its 2008 Stock Option and Incentive Plan, as amended, as well as
its 1998 Employee Stock Purchase Plan, as amended (“ESPP”). The 1998 Stock Option Plan, the 2008 Stock Option and Incentive
Plan and ESPP are together referred to as the “Stock Option and Incentive Plans.”
Restricted Stock
A summary of unvested restricted stock activity during the nine
months ended September 30, 2016 is presented below:
|
|
Number of
Shares
|
|
|
Weighted
Average Grant Date
Fair Value Per
Share
|
|
Outstanding, January 1, 2016
|
|
|
1,020
|
|
|
$
|
13.71
|
|
Granted
|
|
|
566
|
|
|
$
|
14.68
|
|
Vested
|
|
|
(201
|
)
|
|
$
|
13.82
|
|
Forfeited
|
|
|
(76
|
)
|
|
$
|
14.76
|
|
Outstanding, September 30, 2016
|
|
|
1,309
|
|
|
$
|
14.05
|
|
As of September 30, 2016, there was $13,268
of total unrecognized compensation cost related to unvested restricted shares. That cost is expected to be recognized over a weighted-average
period of 2.67 years. 312 shares of restricted stock outstanding have market-based vesting provisions. The grant date fair value
assumptions for these shares contain a vesting probability factor to reflect the Company’s expectation that not all shares
will vest. Of the remaining 997 shares of restricted stock outstanding, the Company currently expects all shares to vest.
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 Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2015
|
|
Expected life in years
|
|
|
5
|
|
|
|
5
|
|
Risk free interest rate
|
|
|
1.26
|
%
|
|
|
1.59
|
%
|
Volatility
|
|
|
42
|
%
|
|
|
42
|
%
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
A summary of stock option activity during
the nine months ended September 30, 2016 is presented below:
|
|
Number of
Shares
|
|
|
Weighted Average
Exercise
Price Per Share
|
|
|
Weighted Average
Remaining
Contractual Term
(Years)
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding, January 1, 2016
|
|
|
1,439
|
|
|
$
|
8.20
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
295
|
|
|
$
|
15.77
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(103
|
)
|
|
$
|
4.85
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(31
|
)
|
|
$
|
2.93
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
Outstanding, September 30, 2016
|
|
|
1,600
|
|
|
$
|
9.91
|
|
|
|
5.53
|
|
|
$
|
10,656
|
|
Options exercisable, September 30, 2016
|
|
|
984
|
|
|
$
|
7.33
|
|
|
|
5.50
|
|
|
$
|
9,407
|
|
The weighted average fair value of stock
options granted for the nine months ended September 30, 2016 and 2015 was $5.98 and $6.51, respectively. As of September 30, 2016,
there was $2,433 of total unrecognized compensation cost related to unvested stock options. That cost is expected to be recognized
over a weighted-average period of 2.66 years. Of the 1,600 stock options outstanding, the Company currently expects all options
to vest.
Employee Stock Purchase Plan
During the nine months ended September
30, 2016 and 2015, 100 and 83 shares, respectively, were issued under the Company’s ESPP.
During the nine months ended September
30, 2016 and 2015, cash received from stock option exercises and employee stock purchases under the ESPP was $1,828 and $2,818,
respectively. The excess tax benefit realized for the tax deductions from share-based compensation was $0 for both the nine months
ended September 30, 2016 and 2015, respectively.
Note 10 — Operating Segment Data
In the third quarter of 2016, the Company
completed the Euticals Acquisition. With the acquisition of Euticals, financial planning and management reporting of the Company’s
operations include a new reportable segment (Fine Chemicals (“FC”)), which has been added based on the criteria set
forth in ASC 280, “Segment Reporting.” FC includes lab to commercial scale synthesis of reagents and diverse compounds.
Prior to the Euticals Acquisition, the
Company organized its operations into the DDS, API and DP segments, which remain unchanged. The DDS segment includes activities
such as drug lead discovery, optimization, drug development, analytical services and small scale commercial manufacturing. API
includes pilot to commercial scale manufacturing of active pharmaceutical ingredients and intermediates and high potency and controlled
substance manufacturing. DP (formerly referred to as Drug Product Manufacturing or “DPM”) includes pre-formulation,
formulation and process development through commercial scale production of complex liquid-filled and lyophilized injectable formulations.
Corporate activities include sales and marketing and administrative functions, as well as research and development costs that have
not been allocated to the operating segments. The Euticals business is split between DDS, API and FC. No prior period adjustments
are necessary to reflect this change in reportable segments.
The following table contains earnings data by operating segment,
reconciled to totals included in the unaudited Condensed Consolidated Financial Statements:
|
|
Contract
Revenue
|
|
|
Recurring
Royalty
Revenue
|
|
|
Income
(Loss)
from
Operations
|
|
|
Depreciation
and
Amortization
|
|
For the three months ended September 30, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
DDS
|
|
$
|
28,465
|
|
|
$
|
—
|
|
|
$
|
9,679
|
|
|
$
|
2,744
|
|
API
|
|
|
89,568
|
|
|
|
1,057
|
|
|
|
9,056
|
|
|
|
10,083
|
|
DP
|
|
|
24,547
|
|
|
|
—
|
|
|
|
3,189
|
|
|
|
1,675
|
|
FC
|
|
|
9,101
|
|
|
|
—
|
|
|
|
(281
|
)
|
|
|
509
|
|
Corporate (a)
|
|
|
—
|
|
|
|
—
|
|
|
|
(37,304
|
)
|
|
|
—
|
|
Total
|
|
$
|
151,681
|
|
|
$
|
1,057
|
|
|
$
|
(15,661
|
)
|
|
$
|
15,011
|
|
|
|
Contract
Revenue
|
|
|
Recurring
Royalty
Revenue
|
|
|
Income
(Loss)
from
Operations
|
|
|
Depreciation
and
Amortization
|
|
For the three months ended September 30, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
DDS (b)
|
|
$
|
21,521
|
|
|
$
|
(63
|
)
|
|
$
|
5,767
|
|
|
$
|
2,013
|
|
API
|
|
|
56,158
|
|
|
|
3,294
|
|
|
|
13,559
|
|
|
|
3,778
|
|
DP (b)
|
|
|
23,669
|
|
|
|
—
|
|
|
|
1,903
|
|
|
|
1,117
|
|
Corporate (a)
|
|
|
—
|
|
|
|
—
|
|
|
|
(21,219
|
)
|
|
|
—
|
|
Total
|
|
$
|
101,348
|
|
|
$
|
3,231
|
|
|
$
|
10
|
|
|
$
|
6,908
|
|
|
|
Contract
Revenue
|
|
|
Recurring
Royalty
Revenue
|
|
|
Income
(Loss)
from
Operations
|
|
|
Depreciation
and
Amortization
|
|
For the nine months ended September 30, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
DDS
|
|
$
|
77,488
|
|
|
$
|
—
|
|
|
$
|
20,765
|
|
|
$
|
8,783
|
|
API
|
|
|
209,717
|
|
|
|
8,152
|
|
|
|
43,112
|
|
|
|
16,654
|
|
DP
|
|
|
74,670
|
|
|
|
—
|
|
|
|
12,885
|
|
|
|
5,345
|
|
FC
|
|
|
9,101
|
|
|
|
—
|
|
|
|
(281
|
)
|
|
|
509
|
|
Corporate (a)
|
|
|
—
|
|
|
|
—
|
|
|
|
(89,828
|
)
|
|
|
—
|
|
Total
|
|
$
|
370,976
|
|
|
$
|
8,152
|
|
|
$
|
(13,347
|
)
|
|
$
|
31,291
|
|
|
|
Contract
Revenue
|
|
|
Recurring
Royalty
Revenue
|
|
|
Income
(Loss)
from
Operations
|
|
|
Depreciation
and
Amortization
|
|
For the nine months ended September 30, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
DDS (b)
|
|
$
|
60,733
|
|
|
$
|
5,541
|
|
|
$
|
20,081
|
|
|
$
|
5,973
|
|
API
|
|
|
134,003
|
|
|
|
8,697
|
|
|
|
33,564
|
|
|
|
8,501
|
|
DP (b)
|
|
|
66,970
|
|
|
|
—
|
|
|
|
8,973
|
|
|
|
4,196
|
|
Corporate (a)
|
|
|
—
|
|
|
|
—
|
|
|
|
(55,211
|
)
|
|
|
—
|
|
Total
|
|
$
|
261,706
|
|
|
$
|
14,238
|
|
|
$
|
7,407
|
|
|
$
|
18,670
|
|
|
(a)
|
Corporate consists primarily of the ‘Selling, general and administrative’ expense activities of the Company.
|
|
(b)
|
A portion of the 2015 amounts were reclassified from DDS to DP to better align business activities within segments. This reclassification
impacted contract revenue and income (loss) from operations for 2015.
|
The following table summarizes other information by segment
as of, and for the nine-month period ended September 30, 2016:
|
|
DDS
|
|
|
API
|
|
|
DP
|
|
|
FC
|
|
|
Total
|
|
Long-lived assets including goodwill
|
|
$
|
150,683
|
|
|
$
|
436,665
|
|
|
$
|
193,017
|
|
|
$
|
16,778
|
|
|
$
|
797,143
|
|
Total assets
|
|
|
412,589
|
|
|
|
600,299
|
|
|
|
216,805
|
|
|
|
28,390
|
|
|
|
1,258,083
|
|
Goodwill included in total assets
|
|
|
47,910
|
|
|
|
109,237
|
|
|
|
76,681
|
|
|
|
7,574
|
|
|
|
241,402
|
|
Investments in unconsolidated affiliates
|
|
|
956
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
956
|
|
Capital expenditures
|
|
|
10,278
|
|
|
|
22,981
|
|
|
|
4,693
|
|
|
|
—
|
|
|
|
37,952
|
|
The following table summarizes other information by segment
as of December 31, 2015 and capital expenditures for the nine-month period ended September 30, 2015:
|
|
DDS
|
|
|
API
|
|
|
DP
|
|
|
Total
|
|
Long-lived assets including goodwill
|
|
$
|
136,387
|
|
|
$
|
201,219
|
|
|
$
|
161,577
|
|
|
$
|
499,183
|
|
Total assets
|
|
|
174,203
|
|
|
|
523,036
|
|
|
|
168,328
|
|
|
|
865,567
|
|
Goodwill included in total assets
|
|
|
45,987
|
|
|
|
46,182
|
|
|
|
77,302
|
|
|
|
169,471
|
|
Investments in unconsolidated affiliates
|
|
|
956
|
|
|
|
—
|
|
|
|
—
|
|
|
|
956
|
|
Capital expenditures (nine months ended September 30, 2015)
|
|
|
5,419
|
|
|
|
5,819
|
|
|
|
2,421
|
|
|
|
13,659
|
|
Note 11 — Financial Information by Customer Concentration
and Geographic Area
Total percentages of contract revenues
by each segment’s three largest customers for the three and nine months ended September 30, 2016 and 2015 are indicated in
the following table:
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
DDS
|
|
8%, 5%, 4%
|
|
10%, 9%, 4%
|
|
10%, 4%, 3%
|
|
10%, 9%, 4%
|
API
|
|
11%, 5%, 4%
|
|
21%, 7%, 6%
|
|
14%, 9%, 4%
|
|
23%, 11%, 8%
|
DP
|
|
24%, 10%, 7%
|
|
19%, 13%, 3%
|
|
12%, 10%, 6%
|
|
17%, 12%, 5%
|
FC
|
|
27%, 25%, 12%
|
|
—
|
|
27%, 25%, 12%
|
|
—
|
Total contract revenue from GE Healthcare
(“GE”), the Company’s largest customer, represented 7% and 8% of total contract revenue for the three and nine
months ended September 30, 2016, respectively. Total contract revenue from GE represented 12% of total contract revenue for both
the three and nine months ended September 30, 2015, respectively.
The Company’s total contract revenue
for the three and nine months ended September 30, 2016 and 2015 was recognized from customers in the following geographic regions:
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
|
51
|
%
|
|
|
56
|
%
|
|
|
57
|
%
|
|
|
64
|
%
|
Europe
|
|
|
33
|
|
|
|
32
|
|
|
|
31
|
|
|
|
27
|
|
Asia
|
|
|
11
|
|
|
|
7
|
|
|
|
8
|
|
|
|
6
|
|
Other
|
|
|
5
|
|
|
|
5
|
|
|
|
4
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
|
|
100
|
%
|
Long-lived assets, including goodwill,
by geographic region are as follows:
|
|
September 30,
2016
|
|
|
December 31,
2015
|
|
United States
|
|
$
|
350,068
|
|
|
$
|
323,151
|
|
Asia
|
|
|
14,531
|
|
|
|
14,336
|
|
Europe
|
|
|
432,544
|
|
|
|
161,696
|
|
Total long-lived assets
|
|
$
|
797,143
|
|
|
$
|
499,183
|
|
Note 12 — Legal Proceedings and Other
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, 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.
On November 12, 2014, a purported class
action lawsuit,
John Gauquie v. Albany Molecular Research, Inc., et al.
, No. 14-cv-6637, was filed against the Company and
certain of its current and former officers in the United States District Court for the Eastern District of New York. An amended
complaint was filed on March 31, 2015. The amended complaint alleges claims under the Securities Exchange Act of 1934 arising
from the Company’s alleged failure to disclose in its August 5, 2014 announcement of its financial results for the second
quarter of 2014 that one of the manufacturing facilities experienced a power interruption in July 2014. The amended complaint alleges
that the price of the Company’s stock was artificially inflated between August 5, 2014 and November 5, 2014, and seeks unspecified
monetary damages and attorneys’ fees and costs. The defendants submitted on July 29, 2015 a motion to dismiss lead plaintiffs’
amended complaint. Lead plaintiffs submitted an opposition on October 7, 2015, and defendants submitted a reply on November 20,
2015. On July 26, 2016, the court denied the defendants motion to dismiss. The Company has filed a motion to reconsider its July
29, 2015 motion to dismiss lead plaintiff’s amended complaint.
Note 13 — Fair Value of Financial Instruments
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 Company determines the fair value of
its financial instruments using the following methods and assumptions:
Cash and cash equivalents, restricted
cash, 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.
Convertible senior notes, derivatives
and hedging instruments:
The fair value of the Company’s Notes, which differ from their carrying value, are influenced
by interest rates and the Company's stock price and stock price volatility and are determined by prices for the Notes observed
in market trading, which are level 2 inputs. The estimated fair value of the Notes at September 30, 2016 was $177,000. The Notes
Hedges and the Notes Conversion Derivative are measured at fair value using level 2 inputs. These instruments are not actively
traded and are valued using an option pricing model that uses observable market data for all inputs, such as implied volatility
of the Company's common stock, risk-free interest rate and other factors.
Interest rate swaps:
At September
30, 2016, the Company had contracted a derivative financial instrument to reduce the impact of fluctuations in variable interest
rates on a loan that a financial institution granted in February 2015. The estimated fair value of the swap at September 30, 2016
was $62. The Company hedges the interest rate risk of the initial amount of the aforementioned bank loan through an interest rate
swap. In this arrangement, the interest rates are exchanged so that the Company receives from the financial institution a variable
rate of the 3-month Euribor, in exchange for a fixed interest payment for the same nominal amount (0.3%). The variable interest
rate received for the derivative offsets the interest payment on the hedged transaction, with the end result being a fixed interest
payment on the hedged financing. At September 30, 2016, the derivative financial instrument had not been designated as a hedging
instrument in accordance with ASC 815, “Derivatives and Hedging.”
To determine the fair value of the interest
rate swap, the Company uses cash flow discounting based on the implicit rates determined by the euro interest rate curve, according
to market conditions at the valuation date, which are level 2 inputs.
Instrument
|
Nominal Amount at 9/30/2016
|
Contract
Date
|
Contract Date Expiration
|
Interest Rate Payable
|
Interest Rate Receivable
|
Interest rate swap
|
$5,416
|
2/19/2015
|
2/19/2020
|
3-month Euribor
|
Fixed rate of 0.30%
|
Euticals Acquisition hedge:
In
May 2016, the Company entered into a forward contract to hedge the foreign currency exposure related to the purchase price of the
Euticals Acquisition. In this arrangement, the Company was obligated to purchase €150,000 at a fixed price on July 8, 2016.
The forward contract did not qualify as a hedging instrument in accordance with ASC 815, “Derivatives and Hedging.”
As a result, as of June 30, 2016, an unrealized loss of $6,401 was recorded in ‘Other (expense) income, net’ on the
Condensed Consolidated Statements of Operations. In connection with the closing of the Euticals Acquisition, the forward contract
was settled on July 8, 2016, at which time the Company recognized an additional loss of approximately $90 related to this contract.
Long-term debt, other than convertible
senior notes:
The carrying value of long-term debt approximated fair value at September 30, 2016 due to the resetting
dates of the variable interest rates.
Note 14 — Accumulated Other Comprehensive Loss, Net
The activity related to accumulated other comprehensive loss,
net was as follows:
|
|
Pension and
postretirement
benefit plans
|
|
|
Foreign
currency
adjustments
|
|
|
Total
Accumulated
Other
Comprehensive
Loss
|
|
Balance at December 31, 2015, net of tax
|
|
$
|
(5,581
|
)
|
|
$
|
(12,820
|
)
|
|
$
|
(18,401
|
)
|
Net current period change, net of tax
|
|
|
350
|
|
|
|
3,996
|
|
|
|
4,346
|
|
Balance at September 30, 2016, net of tax
|
|
$
|
(5,231
|
)
|
|
|
(8,824
|
)
|
|
|
(14,055
|
)
|
The following table provides additional details of the amounts
recognized into net earnings from accumulated other comprehensive loss, net:
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30, 2016
|
|
|
September
30, 2015
|
|
|
September 30, 2016
|
|
|
September 30, 2015
|
|
Actuarial losses before tax effect (a)
|
|
$
|
185
|
|
|
$
|
190
|
|
|
$
|
539
|
|
|
$
|
664
|
|
Tax benefit on amounts reclassified into earnings
|
|
|
(65
|
)
|
|
|
(66
|
)
|
|
|
(189
|
)
|
|
|
(232
|
)
|
|
|
$
|
120
|
|
|
$
|
124
|
|
|
$
|
350
|
|
|
$
|
432
|
|
|
(a)
|
Amounts represent amortization of net actuarial loss from shareholders’ equity into postretirement benefit plan cost.
This amount was primarily recognized as cost of contract revenue in the consolidated statements of operations.
|
Note 15 —
Collaboration
Arrangements
The Company enters into collaboration arrangements
with third parties for the development and manufacture of certain products and/or product candidates. Although each of these arrangements
is unique in nature, both parties are active participants in the activities of the collaboration and are exposed to significant
risks and rewards depending on the commercial success of the activities. These arrangements typically include research and development
and manufacturing. The rights and obligations of the parties can be global or limited to geographic regions and the activities
under these collaboration agreements are performed with no guarantee of either technological or commercial success.
The Company is obligated under these arrangements
to perform the development activities and contract manufacturing of the product. Generally, the contract manufacturing component
of the arrangement commences during the development activities and continues through the commercial stage of each product, during
which time the collaboration partner is obligated to purchase the product from the Company. The collaboration partners are generally
responsible for obtaining regulatory approval and for sale and distribution of the product. The original terms of these arrangements
vary in length but generally range from 7 to 10 years in duration. In the event the arrangements are terminated prematurely, the
Company generally has the right to receive payment for all unpaid development costs incurred through the date of termination. Additionally,
in the event of termination, the Company is generally permitted to develop, manufacture and sell the product to a third party on
a contract research and manufacturing basis provided that it does not use the technology developed during the collaboration arrangements.
None of the product candidates associated with these collaboration arrangements have reached the contract manufacturing or commercial
and profit sharing stages.
These arrangements may include non-refundable,
upfront payments, milestone payments and cost sharing arrangements during the development stage, payments for manufacturing based
on a cost plus an agreed percentage, as well as profit sharing payments during the product’s commercial stage.
The Company recognizes revenue for payments
received for services performed under these arrangements as contract revenue in accordance with ASC 605, “Revenue Recognition.”
Development stage payments are recognized using the milestone method when the contractual milestones are determined to be substantive
and have been achieved. Certain contractual milestones are deemed to be achieved upon the occurrence of the contractual performance
events. Other non-performance based milestones, including the filing of an Abbreviated New Drug Application (ANDA) and approval
by the Food and Drug Administration (FDA), which are generally events that occur at the end of the development period, are recognized
upon occurrence of the related event. Contractual milestones that are deemed not substantive are recognized using proportional
performance over the remaining development period. Upfront, non-refundable payments are recognized over the term of the development
period using the proportional performance recognition model. Revenue associated with payments received for contract manufacturing
services will be recognized upon delivery of the product to the Company’s collaborative partners. Revenue associated with
payments received for profit sharing payments will be recognized when earned based on the terms of the agreements.
The Company recognizes costs as incurred
during the performance of development activities and classifies these costs as ‘Research and development’ (“R&D”)
expense. Costs incurred by the Company during the performance of the contract manufacturing activities will be classified as ‘Cost
of contract revenue’ when the related revenue is recognized.
Contract revenue and R&D expense associated
with these collaboration arrangements recognized during the three and nine months ended September 30, 2016 and 2015 was as follows:
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30, 2016
|
|
|
September 30, 2015
|
|
|
September 30, 2016
|
|
|
September 30, 2015
|
|
Contract revenue
|
|
$
|
2,547
|
|
|
$
|
341
|
|
|
$
|
6,967
|
|
|
$
|
2,791
|
|
R&D expense
|
|
$
|
2,297
|
|
|
$
|
1,007
|
(a)
|
|
$
|
6,325
|
|
|
$
|
3,046
|
(a)
|
|
(a)
|
$286 and $2,326 of these amounts were recorded in ‘Cost of contract revenue’ in the Condensed Consolidated Statements
of Operations for the three and nine month periods ended September 30, 2015, respectively.
|
Contract revenue for the nine months ended September 30, 2016
includes $2,484 of termination revenue related to the early termination of one of the Company’s collaboration arrangements.
The Company is actively negotiating to secure a new collaboration partner for this program.
Note 16 — Subsequent Events
In October 2016, the Company reached agreement with one of its
insurers (the “Paying Insurer”) with respect to the resolution of an outstanding insurance claim related to a business
interruption loss sustained by the Company’s subsidiary, Oso Bio, in 2014 (the “Loss”). In full settlement
of the claim, the Company received a total net payment of $7,300 and has further released the Paying Insurer from any further claims
regarding the Loss and has assigned to the Paying Insurer all of the Company’s rights against one other possible insurer
with respect to the Loss.