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8-K/A - FORM 8-K AMENDMENT - Recro Pharma, Inc.d140535d8ka.htm
EX-99.2 - EX-99.2 - Recro Pharma, Inc.d140535dex992.htm

Exhibit 99.1

 

 

 

DARA

Condensed Combined Financial Statements

At March 31, 2015 and December 31, 2014, and for the Three

Months Ended March 31, 2015 and 2014

(Unaudited)


DARA

Condensed Combined Balance Sheets

March 31, 2015 and December 31, 2014

(Unaudited)

 

     March 31,      December 31,  
     2015      2014  
     (In thousands)  
ASSETS   

CURRENT ASSETS:

     

Cash and cash equvialents

   $ 24,069       $ 22,064   

Accounts receivable

     11,680         11,321   

Due from related party

     186         317   

Inventory

     10,763         10,950   

Prepaid expenses and other current assets

     2,406         2,388   
  

 

 

    

 

 

 

Total current assets

  49,104      47,040   
  

 

 

    

 

 

 

INTANGIBLE ASSETS — NET

  41,868      43,818   

PROPERTY, PLANT AND EQUIPMENT — NET

  38,275      38,607   

GOODWILL

  498      498   

DEFERRED TAX ASSETS — LONG-TERM

  6,203      6,324   
  

 

 

    

 

 

 

TOTAL ASSETS

$ 135,948    $ 136,287   
  

 

 

    

 

 

 
LIABILITIES AND PARENT EQUITY

CURRENT LIABILITIES:

Accounts payable and accrued expenses

  2,560      4,321   

Due to related party

  —        1,563   

Deferred revenue

  520      462   
  

 

 

    

 

 

 

Total current liabilities

  3,080      6,346   
  

 

 

    

 

 

 

DEFERRED TAX LIABILITIES — LONG-TERM

  3,490      3,692   

DEFERRED REVENUE — LONG-TERM

  9,548      9,252   

DUE TO RELATED PARTY — LONG-TERM

  1,610      1,296   
  

 

 

    

 

 

 

Total liabilities

  17,728      20,586   
  

 

 

    

 

 

 

COMMITMENTS AND CONTINGENCIES (Note 10)

PARENT EQUITY:

Parent investment

  118,220      115,701   
  

 

 

    

 

 

 

Total parent equity

  118,220      115,701   
  

 

 

    

 

 

 

TOTAL LIABILITIES AND PARENT EQUITY

$ 135,948    $ 136,287   
  

 

 

    

 

 

 

The accompanying notes are an integral part of these condensed combined financial statements.

 

2


DARA

Condensed Combined Statements of Operations and Comprehensive Income

For the Three Months Ended March 31, 2015 and 2014

(Unaudited)

 

     Three Months Ended March 31,  
     2015     2014  
     (In thousands)  

REVENUES:

    

Manufacturing, royalties and profit sharing revenue (includes $200 and $197 from related party in the three months ended March 31, 2015 and 2014, respectively)

   $ 18,416      $ 16,389   

Research and development revenue

     950        234   
  

 

 

   

 

 

 

Total revenues

  19,366      16,623   
  

 

 

   

 

 

 

EXPENSES:

Cost of goods manufactured (exclusive of amortization of acquired intangible assets shown below)

  9,653      8,797   

Research and development

  891      813   

Selling, general and administrative

  4,505      1,514   

Amortization of acquired intangible assets

  1,950      1,233   
  

 

 

   

 

 

 

Total expenses

  16,999      12,357   
  

 

 

   

 

 

 

INCOME FROM OPERATIONS

  2,367      4,266   

OTHER EXPENSE, NET

  (1   —     
  

 

 

   

 

 

 

INCOME BEFORE INCOME TAXES

  2,366      4,266   

PROVISION FOR INCOME TAXES

  570      764   
  

 

 

   

 

 

 

NET INCOME AND COMPREHENSIVE INCOME

$ 1,796    $ 3,502   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these condensed combined financial statements.

 

3


DARA

Condensed Combined Statements of Cash Flows

For the Three Months Ended March 31, 2015 and 2014

(Unaudited)

 

     Three Months Ended March 31,  
     2015     2014  
     (In thousands)  

Cash flows from operating activities:

    

Net income

   $ 1,796      $ 3,502   

Adjustments to reconcile net income to cash flows from operating activities:

    

Corporate allocations

     1,996        1,514   

Depreciation and amortization

     2,853        2,506   

Share-based compensation expense

     387        1,310   

Deferred income taxes

     462        (21

Excess tax benefit from share-based compensation

     (570     (244

Changes in assets and liabilities:

    

Accounts receivable

     (359     (549

Inventory

     187        (2,315

Prepaid expenses and other assets

     (63     (133

Accounts payable and accrued expenses

     (1,191     (1,674

Due to related party, net

     (1,118     (59

Deferred revenue

     (144     (42
  

 

 

   

 

 

 

Cash flows provided by operating activities

  4,236      3,795   
  

 

 

   

 

 

 

Cash flows from investing activities:

Additions to property, plant and equipment

  (571   (1,422

Notes receivable from related party

  —        (5
  

 

 

   

 

 

 

Cash flows used in investing activities

  (571   (1,427
  

 

 

   

 

 

 

Cash flows from financing activities:

Excess tax benefit from share-based compensation

  570      244   

Net distribution to parent

  (2,230   (7,417
  

 

 

   

 

 

 

Cash flows used in financing activities

  (1,660   (7,173
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

  2,005      (4,805

Cash and cash equivalents, beginning of period

  22,064      12,766   
  

 

 

   

 

 

 

Cash and cash equivalents, end of period

$ 24,069    $ 7,961   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these condensed combined financial statements.

 

4


DARA

Notes to the Condensed Combined Financial Statements – (Unaudited)

 

1. Description of Business

Alkermes plc (“Alkermes” or the “Parent”) is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. Headquartered in Dublin, Ireland, Alkermes has a research and development (“R&D”) center in Waltham, Massachusetts; R&D and manufacturing facilities in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and Wilmington, Ohio.

DARA (the “Company”) is comprised of certain components of Alkermes. These components include the manufacturing facility in Gainesville, Georgia and certain intellectual property in Ireland. The Company develops and manufactures innovative pharmaceutical products that deliver clinically meaningful benefits to patients, using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies.

The condensed combined financial statements have been prepared solely for purposes of Alkermes’ sale of the Company to demonstrate the historical results of operations, financial position and cash flows of the Company for the indicated periods under Alkermes management.

 

2. Significant Accounting Policies

Basis of Presentation

DARA has historically operated as part of Alkermes and not as a separate stand-alone entity. These condensed combined financial statements have been prepared on a “carve-out” basis from the consolidated financial statements of Alkermes to represent the financial position, results of operations and cash flows of DARA as if DARA had existed on a stand-alone basis during the three months ended March 31, 2015 and 2014, respectively, for statement of operations and cash flow statement amounts and as of March 31, 2015 and December 31, 2014, respectively, for balance sheet amounts; and as if the Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 810, “Consolidation,” had been applied throughout. The accompanying condensed combined financial statements only include assets and liabilities that are specifically identifiable with DARA and include all revenue and expense directly attributable to the Company. In addition, certain selling, general and administrative expenses that are maintained at the corporate level, which consist primarily of salaries and other employee costs, legal and professional fees and insurance costs, were allocated to DARA based on methodologies, including cost drivers, headcount and revenues, that Alkermes management believes to be a reasonable reflection of the utilization of services provided or benefit received by the Company. The condensed combined financial statements do not purport to represent what the results of operations would have been, had the entire DARA business and activities of DARA operated independently from Alkermes for each of the periods being reported on, or for future periods. Had DARA operated as an independent stand-alone entity, its results could have differed significantly from those presented in the condensed combined financial statements.

The condensed combined financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S.”) (“GAAP”), by aggregating financial information from the consolidation reporting packages of relevant subsidiaries of Alkermes focused entirely on DARA activities. Where legal entities have historically had both DARA and non-DARA activities, the statement of operations, asset and liability balances pertaining to DARA activities have been identified and included within the condensed combined financial statements. Intra-group transactions and balances between the DARA entities have been eliminated.

These financial statements should be read in conjunction with the audited combined financial statements and the accompanying notes for the years ended December 31, 2014. The accompanying condensed combined financial statements for the three months ended March 31, 2015 and 2014 are unaudited and have been prepared on a basis substantially consistent with the audited combined financial statements for the year ended December 31, 2014. The year-end condensed consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by GAAP. In the opinion of management, the condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, that are necessary to state fairly the results of operations for the reported periods. The accounting policies described in the “Notes to Combined Financial Statements” in our audited combined financial statements are updated, as necessary, in these condensed combined financial statements.

 

5


DARA

Notes to the Condensed Combined Financial Statements – (Unaudited) (Continued)

 

DARA has certain of its own management and administrative functions. However, Alkermes provides certain central services including, but not limited to:

 

    Employee benefits administration, including equity award services;

 

    Cash and treasury management; and

 

    Accounting, information technology, taxation, legal, corporate strategy, investor relations, corporate governance and other professional services.

Central services costs amounted to $2.0 million and $1.5 million for the three months ended March 31, 2015 and 2014, respectively, and were recorded within selling, general and administrative expenses in the accompanying condensed combined statements of operations and comprehensive income. These costs have been allocated to DARA based on reasonable methodologies for the purposes of preparing the condensed combined financial statements. The reasonable methodologies for determining the usage of central service resources by DARA has been determined by estimating DARA’s portion of the most appropriate cost driver of each category of central service costs including relative spend, revenue generated and headcount. Management considers that such allocations have been made on a reasonable basis, but may not necessarily be indicative of the costs that would have been incurred if DARA had been operated on a stand-alone basis. All such amounts have been deemed to have been contributed to the Company in the period in which the costs were recorded.

Certain DARA employees participate in the equity award plans of Alkermes. The share-based compensation expense recognized in these condensed combined financial statements is based on the expense attributable to DARA employees participating in the Alkermes equity award plans.

The Parent investment balance in the condensed combined financial statements of DARA constitutes Alkermes’ investment in DARA and represents the excess of total assets over total liabilities, including the netting of intercompany funding balances between DARA and Alkermes. The Parent’s investment in the Company includes amounts due to and from the Parent, including net transfers of intercompany funding, corporate allocations for central services costs and contributions in the form of share-based compensation to DARA employees.

The tax amounts in the condensed combined financial statements have been calculated as if the business were a separate taxable entity and consistent with the asset and liability method prescribed in ASC 740 “Income Taxes”, (“ASC 740”). Current tax liabilities and receivables (other than amounts actually paid by or refunded to DARA) are included in the calculation of the net funding transfer to Alkermes that is recorded in Parent equity.

Use of Estimates

The preparation of the condensed combined financial statements in accordance with GAAP requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates and judgments and methodologies, including those related to revenue recognition and related allowances, its collaborative relationships, the valuation of inventory, impairment and amortization of intangibles and long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.

New Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard-setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

In June 2014, the FASB issued guidance that clarifies the accounting for share-based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. Existing GAAP does not contain explicit guidance on how to account for these share-based payments. The new guidance requires that a performance target that

 

6


DARA

Notes to the Condensed Combined Financial Statements – (Unaudited) (Continued)

 

affects vesting and that could be achieved after the requisite service period be treated as a performance condition. Entities have the option of prospectively applying the guidance to awards granted or modified after the effective date or retrospectively applying the guidance to all awards with performance targets that are outstanding as of the beginning of the earliest annual period presented in the financial statements. The guidance becomes effective for the Company in its year ending December 31, 2016, and early adoption is permitted. The Company is currently assessing the impact that this standard will have on its consolidated financial statements.

In May 2014, the FASB issued guidance that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. The guidance is based on the principle that an entity should recognize revenue to depict the transfer of 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. The guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to fulfill a contract. Entities have the option of using either a full retrospective or a modified retrospective approach for the adoption of the new standard. The guidance becomes effective for the Company in its year ending December 31, 2018, and early adoption is permitted. The Company is currently assessing the impact that this standard will have on its consolidated financial statements.

 

3. Accounts Receivable

Accounts receivable consist of the following:

 

(In thousands)    March 31,
2015
     December 31,
2014
 

Accounts receivable

   $ 7,066       $ 4,051   

Unbilled receivable

     4,614         7,270   
  

 

 

    

 

 

 

Total accounts receivable

$ 11,680    $ 11,321   
  

 

 

    

 

 

 

 

4. Inventory

Inventory consists of the following:

 

(In thousands)    March 31,
2015
     December 31,
2014
 

Raw materials

   $ 3,205       $ 3,339   

Work in process

     3,817         5,027   

Finished goods

     3,741         2,584   
  

 

 

    

 

 

 

Total inventory

$ 10,763    $ 10,950   
  

 

 

    

 

 

 

 

7


DARA

Notes to the Condensed Combined Financial Statements – (Unaudited) (Continued)

 

5. Property, Plant and Equipment

Property, plant and equipment consist of the following:

 

     March 31,      December 31,  
(In thousands)    2015      2014  

Land

   $ 2,298       $ 2,298   

Building and improvements

     16,565         16,565   

Furniture, fixture and equipment

     36,814         36,406   

Construction in progress

     956         793   
  

 

 

    

 

 

 

Subtotal

  56,633      56,062   

Less: accumulated depreciation

  (18,358   (17,455
  

 

 

    

 

 

 

Total property, plant and equipment

$ 38,275    $ 38,607   
  

 

 

    

 

 

 

Depreciation expense was $0.9 million and $1.3 million for the three months ended March 31, 2015 and 2014, respectively.

 

6. Goodwill and Intangible Assets

Goodwill and intangible assets consists of the following:

 

     Indefinite-lived
Intangible Assets
     Finite-lived
Intangible Assets
 
(In thousands)    Goodwill      Collaboration
Agreements
     Technology      Total  

Cost:

           

Balance, December 31, 2014

   $ 498       $ 34,110       $ 23,740       $ 57,850   
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance, March 31, 2015

$ 498    $ 34,110    $ 23,740    $ 57,850   
  

 

 

    

 

 

    

 

 

    

 

 

 

Accumulated amortization:

Balance, December 31, 2014

$ —      $ 5,813    $ 8,219    $ 14,032   

Amortization expense

  —        1,290      660      1,950   
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance, March 31, 2015

$ —      $ 7,103    $ 8,879    $ 15,982   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net Book Amount:

Balance, December 31, 2014

$ 498    $ 28,297    $ 15,521    $ 43,818   
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance, March 31, 2015

$ 498    $ 27,007    $ 14,861    $ 41,868   
  

 

 

    

 

 

    

 

 

    

 

 

 

The Company’s finite-lived intangible assets consist of collaborative agreements and OCR technologies acquired as part Alkermes’ acquisition of EDT. Amortization of intangible assets included within the condensed combined balance sheet at March 31, 2015 is expected to be approximately $8.0 million, $8.0 million, $8.0 million, $8.0 million and $6.0 million in the years ending December 31, 2015 through 2019, respectively. Although the Company believes such available information and assumptions are reasonable, given the inherent risks and uncertainties underlying its expectations regarding such future revenues, there is the potential for the Company’s actual results to vary significantly from such expectations. If revenues are projected to change, the related amortization of the intangible assets may change.

 

8


DARA

Notes to the Condensed Combined Financial Statements – (Unaudited) (Continued)

 

7. Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consist of the following:

 

     March 31,      December 31,  
(In thousands)    2015      2014  

Accounts payable

   $ 781       $ 1,065   

Accrued compensation

     1,211         2,329   

Accrued other

     568         927   
  

 

 

    

 

 

 

Total accounts payable and accrued expenses

$ 2,560    $ 4,321   
  

 

 

    

 

 

 

 

8. Share-Based Compensation

The following table presents share-based compensation expense included in the Company’s condensed combined statements of operations and comprehensive income:

 

     Three Months Ended March 31,  
(In thousands)    2015      2014  

Cost of goods manufactured

   $ 354       $ 1,196   

Research and development

     33         114   
  

 

 

    

 

 

 

Total share-based compensation expense

$ 387    $ 1,310   
  

 

 

    

 

 

 

 

9. Income Taxes

The Company’s provision for income taxes $0.6 million and $0.8 million in the three months ended March 31, 2015 and 2014 consists of U.S. federal and state taxes on income earned in the U.S. and Irish taxes on income earned in Ireland.

 

10. Commitments and Contingencies

Litigation

From time to time, the Company may be subject to other legal proceedings and claims in the ordinary course of business. For example, the Company is currently involved in Paragraph IV litigations in the U.S. and other proceedings outside of the U.S. involving its patents in respect of ZOHYRDO ER. The Company is not aware of any such proceedings or claims that it believes will have, individually or in the aggregate, a material adverse effect on its business, financial condition, cash flows and results of operations.

 

11. Related Parties

All intra-group transactions within DARA have been eliminated in the condensed combined financial statements and are not disclosed.

Amounts due from related party of $0.2 and $0.3 million, recorded within current assets at March 31, 2015 and December 31, 2014, respectively, represents amounts due to DARA from another subsidiary of Alkermes for certain manufacturing services performed.

Amounts due to related parties of $1.6 million, recorded within current liabilities at December 31, 2014, primarily represent amounts between DARA and Alkermes Pharma Ireland Limited and Alkermes, Inc., for general and administrative services received.

 

9


DARA

Notes to the Condensed Combined Financial Statements – (Unaudited) (Continued)

 

Amounts due to related party — long-term of $1.6 million and $1.3 million, recorded within long-term liabilities at March 31, 2015 and December 31, 2014, respectively, represent a liability for fees received by DARA for R&D services performed on projects for which Alkermes can obtain the results of the R&D, in accordance with ASC 730, Research and Development.

Manufacturing revenue from related parties of $0.2 million in the three months ended March 31, 2015 and 2014, respectively, consists primarily of packaging services performed by DARA on behalf of other subsidiaries of Alkermes.

 

12. Subsequent Events

On March 7, 2015, Alkermes plc entered into a definitive agreement to sell DARA to Recro Pharma, Inc. (“Recro”) and Recro Pharma LLC (together with Recro, the “Purchasers”). The sale was completed on April 10, 2015 at which time the Purchasers paid Alkermes plc $50.0 million and issued warrants to purchase an aggregate of 350,000 shares of Recro common stock. Alkermes plc is also eligible to receive low double digit royalties on net sales of IV/IM and parenteral forms of Meloxicam and up to $120.0 million in milestone payments upon the achievement of certain regulatory and sales milestones related to IV/IM and parenteral forms of Meloxicam.

 

10