UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM10-Q

 

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended JuneSeptember 30, 2017

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from        toto    

Commission File Number000-14656

 

 

REPLIGEN CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 04-2729386

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

41 Seyon Street, Bldg. 1, Suite 100

Waltham, MA

 02453
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code:(781) 250-0111

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of RegulationS-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer   Accelerated filer 
Non-accelerated filer ☐  (Do not check if a smaller reporting company)  Smaller reporting company 
   Emerging growth company 

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act.):    Yes  ☐    No  ☒

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule12b-2 of the Securities Exchange Act of 1934. Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    ☐

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of July 28,November 2, 2017.

 

Class

 

Number of Shares

Common Stock, par value $.01 per share 37,356,12343,565,306

 

 

 


Table of Contents

 

     PAGE 

PART I

FINANCIAL INFORMATION

  

Item 1.

 

Unaudited Condensed Consolidated Financial Statements

  
 

Condensed Consolidated Balance Sheets as of JuneSeptember  30, 2017 and December 31, 2016

   3 
 

Condensed Consolidated Statements of Comprehensive Income for the Three- andSix-Month Nine-Month Periods Ended JuneSeptember 30, 2017 and 2016

   4 
 

Condensed Consolidated Statements of Cash Flows for theSix-Month Nine-Month Periods Ended JuneSeptember 30, 2017 and 2016

   5 
 

Notes to Unaudited Condensed Consolidated Financial Statements

   6 

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   25 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

   3233 

Item 4.

 

Controls and Procedures

   3334 

PART II

OTHER INFORMATION

   3435 

Item 1.

 

Legal Proceedings

   3435 

Item 1A.

 

Risk Factors

   3435 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

   3835 

Item 3.

 

Defaults Upon Senior Securities

   3835 

Item 4.

 

Mine Safety Disclosures

   3835 

Item 5.

 

Other Information

   3835 

Item 6.

 

Exhibits

   3835 

Signatures

   3937 

REPLIGEN CORPORATION

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

(in thousands, except share data)  June 30, 2017 December 31,
2016
   September 30,
2017
 December 31,
2016
 

Assets

      

Current assets:

      

Cash and cash equivalents

  $142,207  $122,233   $159,666  $122,233 

Marketable securities

   2,744  19,547    —    19,547 

Accounts receivable, less reserve for doubtful accounts of $32 at June 30, 2017 and $23 at December 31, 2016

   22,115  15,194 

Accounts receivable, less reserve for doubtful accounts of $32 at September 30, 2017 and $23 at December 31, 2016

   29,479  15,194 

Other receivables

   534  839    598  839 

Inventories

   26,085  24,696    38,663  24,696 

Prepaid expenses and other current assets

   2,260  1,644    2,789  1,644 
  

 

  

 

   

 

  

 

 

Total current assets

   195,945  184,153    231,195  184,153 
  

 

  

 

   

 

  

 

 

Property, plant and equipment, net

   15,996  14,956    22,056  14,956 

Intangible assets, net

   29,013  29,806    147,416  29,806 

Goodwill

   60,979  59,548    326,652  59,548 

Restricted cash

   450  450    450  450 

Other assets

   6,380   —      6,467   —   
  

 

  

 

   

 

  

 

 

Total assets

  $308,763  $288,913   $734,236  $288,913 
  

 

  

 

   

 

  

 

 

Liabilities and stockholders’ equity

      

Current liabilities:

      

Accounts payable

  $6,951  $5,061   $6,423  $5,061 

Accrued liabilities

   9,568  16,014    13,793  16,014 

Convertible senior notes, current portion

   98,231   —   
  

 

  

 

   

 

  

 

 

Total current liabilities

   16,519  21,075    118,447  21,075 

Convertible senior notes

   97,228  95,272    —    95,272 

Deferred tax liabilities

   2,457  2,103    37,347  2,103 

Other long-term liabilities

   1,616  1,699    1,573  1,699 

Commitments and contingencies (Note 15)

      

Stockholders’ equity:

      

Preferred stock, $.01 par value, 5,000,000 shares authorized, no shares issued or outstanding

   —     —      —     —   

Common stock, $.01 par value, 80,000,000 shares authorized, 34,118,994 shares at June 30, 2017 and 33,844,074 shares at December 31, 2016 issued and outstanding

   341  338 

Common stock, $.01 par value, 80,000,000 shares authorized, 43,559,081 shares at September 30, 2017 and 33,844,074 shares at December 31, 2016 issued and outstanding

   436  338 

Additionalpaid-in capital

   247,628  242,036    626,766  242,036 

Accumulated other comprehensive loss

   (8,671 (13,749   (6,647 (13,749

Accumulated deficit

   (48,355 (59,861   (43,686 (59,861
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

   190,943  168,764    576,869  168,764 
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

  $308,763  $288,913   $734,236  $288,913 
  

 

  

 

   

 

  

 

 

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

REPLIGEN CORPORATION

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(Unaudited)

 

  Three months ended September 30, Nine months ended September 30, 
(in thousands, except share and per share data)  Three months ended June 30, Six months ended June 30,   2017 2016 2017 2016 
  2017 2016 2017 2016 

Revenue:

          

Product revenue

  $32,434  $29,170  $63,003  $54,265   $36,514  $24,677  $99,516  $78,942 

Royalty and other revenue

   21   —    42   —      66   —    108   —   
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total revenue

   32,455  29,170  63,045  54,265    36,580  24,677  99,624  78,942 

Operating expenses:

          

Cost of product revenue

   13,937  12,644  27,926  23,713    19,987  11,242  47,913  34,955 

Research and development

   1,860  1,890  3,602  3,430    2,001  1,886  5,603  5,316 

Selling, general and administrative

   11,185  8,140  20,367  15,159    14,998  7,127  35,365  22,286 

Contingent consideration – fair value adjustments

   —    637   —    2,642    —    675   —    3,317 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total operating expenses

   26,982  23,311  51,895  44,944    36,986  20,930  88,881  65,874 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Income from operations

   5,473  5,859  11,150  9,321 

Income (loss) from operations

   (406 3,747  10,743  13,068 

Investment income

   110  76  206  137    102  97  308  234 

Interest expense

   (1,601 (638 (3,187 (643   (1,618 (1,555 (4,804 (2,198

Other income (expense)

   (328 75  (448 (904   (100 (75 (548 (979
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Income before income taxes

   3,654  5,372  7,721  7,911 

Income (loss) before income taxes

   (2,022 2,214  5,699  10,125 

Income tax (benefit) provision

   (4,784 1,500  (3,785 2,415    (6,691 1,059  (10,476 3,474 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Net income

  $8,438  $3,872  $11,506  $5,496   $4,669  $1,155  $16,175  $6,651 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Earnings per share:

          

Basic

  $0.25  $0.12  $0.34  $0.16   $0.11  $0.03  $0.44  $0.20 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Diluted

  $0.24  $0.11  $0.33  $0.16   $0.11  $0.03  $0.43  $0.20 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Weighted average shares outstanding:

          

Basic

   34,097,805  33,649,296  33,995,323  33,336,989    41,236,554  33,779,141  36,435,591  33,485,448 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Diluted

   35,094,814  34,175,127  34,715,797  33,862,311    42,563,002  34,312,887  37,386,333  34,011,534 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Other comprehensive income:

          

Unrealized gain (loss) on investments

   —     —    5  15    —    74 5  89 

Foreign currency translation gain (loss)

   4,046  (2,514  5,073  (633   2,025  (386 7,097  (1,019
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Comprehensive income

  $12,484  $1,358  $16,584  $4,878   $6,694  $843  $23,277  $5,721 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

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

REPLIGEN CORPORATION

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

  Nine months ended September 30, 
(In thousands)  Six months ended June 30,   2017 2016 
  2017 2016 

Cash flows from operating activities:

      

Net income

  $11,506  $5,496   $16,175  $6,651 

Adjustments to reconcile net income to net cash used in operating activities:

      

Depreciation and amortization

   3,278  2,465    6,374  3,844 

Non-cash interest expense

   1,956  382    2,958  1,320 

Stock-based compensation expense

   3,027  2,059    4,845  3,341 

Deferred tax expense

   (5,384 218    (13,062 326

Loss on revaluation of contingent consideration

   —    2,642    —    3,317 

Gain on sale of fixed assets

   —    (15   —    (15

Loss on disposal of assets

   64  26    64  25 

Changes in assets and liabilities:

      

Accounts receivable

   (6,347 892    (8,472 (3,270

Other receivables

   226  (318   196  20 

Inventories

   (813 (5,093   699  (6,457

Prepaid expenses and other current assets

   (236 793    (739 820 

Other assets

   (754  —      (704  —   

Accounts payable

   1,740  511    159  (1,918

Accrued liabilities

   (4,216 (3,239   (6,089 (2,389

Long-term liabilities

   (86 (66   (171 (48
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   3,961  6,753    2,233  5,567 
  

 

  

 

   

 

  

 

 

Cash flows from investing activities:

      

Acquisition of Spectrum, Inc., net of cash received

   (112,941  —   

Acquisition of Atoll GmbH, net of cash received

   —    (8,767   —    (8,767

Purchases of marketable securities

   (42 (3,952   (48 (21,394

Redemptions of marketable securities

   16,850  14,100    19,600  19,700 

Proceeds from sale of fixed assets

   —    45    —    45 

Purchases of property, plant and equipment

   (2,676 (1,406   (3,686 (3,462
  

 

  

 

   

 

  

 

 

Net cash provided by investing activities

   14,132  20 

Net cash used in investing activities

   (97,075 (13,878
  

 

  

 

   

 

  

 

 

Cash flows from financing activities:

      

Proceeds from issuance of convertible senior notes, net of costs

   —    111,323 

Proceeds from issuance of common stock, net of issuance costs

   129,309   —   

Proceeds from issuance of convertible senior notes, net of issuance costs

   —    111,070 

Exercise of stock options

   1,505  958    2,035  1,630 

Payment of contingent considerations

   (1,677 (498   (1,702 (498
  

 

  

 

   

 

  

 

 

Net cash (used in) provided by financing activities

   (172 111,783 

Net cash provided by financing activities

   129,642  112,202 
  

 

  

 

   

 

  

 

 

Effect of exchange rate changes on cash and cash equivalents

   2,053  (26   2,633  (332
  

 

 ��

 

   

 

  

 

 

Net increase in cash and cash equivalents

   19,974  118,530    37,433  103,559 

Cash and cash equivalents, beginning of period

   122,233  54,092    122,233  54,092 
  

 

  

 

   

 

  

 

 

Cash and cash equivalents, end of period

  $142,207  $172,622   $159,666  $157,651 
  

 

  

 

   

 

  

 

 

Supplemental disclosure ofnon-cash activities:

      

Income taxes paid

  $2,150  $1,981   $3,555  $2,888 
  

 

  

 

   

 

  

 

 

Interest paid

  $1,222  $—   
  

 

  

 

 

Payment of contingent consideration in common stock

  $1,062  $875   $1,062  $875 
  

 

  

 

 

Stock tendered for acquisition of Spectrum, Inc.

  $247,575  $—   
  

 

  

 

   

 

  

 

 

Stock tendered for acquisition of Atoll GmbH

  $—    $14,135   $—    $14,135 
  

 

  

 

   

 

  

 

 

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

REPLIGEN CORPORATION

REPLIGEN CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Basis of Presentation

1.Basis of Presentation

The condensed consolidated financial statements included herein have been prepared by Repligen Corporation (the “Company,” “Repligen” or “we”) in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”), for Quarterly Reports on Form10-Q and Article 10 of RegulationS-X and do not include all of the information and footnote disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes thereto included in the Company’s Annual Report on Form10-K for the fiscal year ended December 31, 2016.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Repligen Sweden AB (“Repligen Sweden”), Repligen GmbH (acquired as Atoll GmbH as ofon April 1, 2016 and renamed on September 20, 2016), Repligen Singapore Pte. Ltd. and, our former subsidiary, TangenX Technology Corporation (acquired as of(“TangenX,” acquired on December 14, 2016 and merged into the Company as of June 30, 2017) and Spectrum LifeSciences, LLC (“Spectrum,” acquired on August 1, 2017). All significant intercompany accounts and transactions have been eliminated in consolidation.

In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of only normal, recurring adjustments necessary for a fair presentation of the financial position, results of operations and cash flows. The results of operations for the interim periods presented are not necessarily indicative of results to be expected for the entire year.

Recently Issued Accounting Pronouncements

In May 2014, the FASB issued ASUNo. 2014-09, “Revenue from Contracts with Customers (Topic 606),”which supersedes the revenue recognition requirements in Accounting Standards Codification Topic 605,Revenue Recognition, and creates a new Topic 606,Revenue from Contracts with Customers. Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. The adoption of this ASU will include updates as provided under ASU2015-14, “Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date”; ASU2016-08, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net)”; ASU2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing”; and ASU2016-12, “Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients.” The Company intends to adopt the provisions of Topic 606 using the modified retrospective method effective January 1, 2018. The Company has made substantial progress withsubstantially completed its assessment of the impact of the new revenue standard on itsthe current contracts andof all principal revenue streams. Followingstreams except those related to the closingrecently acquired business of Spectrum. The Company will complete its assessment of the acquisitionimpact of Spectrum, Inc. (“Spectrum”), the new revenue standard on Spectrum’s revenue arrangements in the fourth quarter of 2017. The Company will also need to assess the potential impact on the Spectrum revenue arrangements. Additionally, the Company will begin to updateis currently updating its revenue recognition policies and procedures and developdeveloping a framework for the newly required financial statement disclosures duringdisclosures. While the third quarter of 2017 to prepare for the adoption of this standard. The Company has not made a final determination on the impact of this new revenue standard to its consolidated financial statements.statements, it does not expect this impact to be material.

In July 2015, the FASB issued ASUNo. 2015-11, “Inventory (Topic 330): Simplifying the Measurement of Inventory” (“ASU2015-11”). ASU2015-11 requires inventory be measured at the lower of cost and net realizable value, and options that currently exist for market value be eliminated. ASU2015-11 defines net realizable value as estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The guidance is effective prospectively for reporting periods beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. The Company adopted the provisions of ASU2015-11 as of January 1, 2017, and this standard did not have a material impact on its consolidated financial statements.

In January 2016, the FASB issued ASUNo. 2016-01, “Financial Instruments - Overall (Subtopic825-10): Recognition and Measurement of Financial Assets and Financial Liabilities.” (“ASU2016-01”) This guidance changes how entities measure equity investments that do not result in consolidation and are not accounted for under the equity method. Entities will be required to measure these investments at fair value at the end of each reporting period and recognize changes in fair value in net income. A practicability

exception will be available for equity investments that do not have readily determinable fair values; however, the exception requires the Company to consider relevant transactions that can be reasonably known to identify any observable price changes that would impact the fair value. This guidance also changes certain disclosure requirements and other aspects of current U.S. GAAP. This guidance is effective for annual periods beginning after December 15, 2017, and is applicable to the Company in 2018. Upon adoption, the Company will be required to recognize unrealized gains and losses on its equity securities directly through the Company’s consolidated statements of operations, whereas these equity securities currently are designated as available for sale, and unrealized gains and losses are recognized within accumulated other comprehensive income.

In February 2016, the FASB issued ASU No.2016-02, “Leases (Topic 842)” (“ASU2016-02”). ASU2016-02 requires lessees to recognize aright-of-use asset and a lease liability for most leases. Extensive quantitative and qualitative disclosures, including significant judgments made by management, will be required to provide greater insight into the extent of revenue and expense recognized and expected to be recognized from existing contracts. The accounting applied by a lessor is largely unchanged from that applied under the current standard. The standard must be adopted using a modified retrospective transition approach and provides for certain practical expedients. This ASU is effective for public entities for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company has not yet completed its assessment ofassessed the impact of the new standard on its consolidated financial statements.statements, but does expect this new standard to have a material impact on the Company’s consolidated balance sheet.

In March 2016, the FASB issued ASU No.2016-09, “Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”, which aims to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, classification of certain items on the statement of cash flows and accounting for forfeitures. This ASU is effective for public entities for fiscal years beginning after December 15, 2016, with early adoption permitted. The Company adopted the provisions of this ASU as of January 1, 2017. As a result of this standard, the Company increased its U.S. federal and state net operating loss carryovers by approximately $5.3 million for previously unrecognized excess tax benefits outstanding as of January 1, 2017. Since the Company maintained a full valuation allowance on its net U.S. deferred tax assets as of the adoption date, the Company recorded a corresponding increase to the valuation allowance and the impact of adopting ASU2016-09 on retained earnings is zero.

In August 2016, the FASB issued ASUNo. 2016-15, “Statement of Cash Flows (Topic 203): Classification of Certain Cash Receipts and Cash Payments”. ASUNo. 2016-15 addresses eight specific cash flow issues and clarifies their presentation and classification in the Statement of Cash Flows. This ASU is effective for fiscal years beginning after December 15, 2017 and is to be applied retrospectively with early adoption permitted. The Company currently classifies payments up to the amount of its contingent consideration liability recognized at the date of its acquisition as financing activities, with additional payments classified as operating activities. As a result, the Company does not expect the adoption of ASU2016-15 to have a material impact on its consolidated financial statements.

In January 2017, the FASB issued ASU No.2017-01, “Business Combinations (Topic 805): Clarifying the Definition of a Business”, which clarifies the definition of a business to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. This ASU is effective for public entities for fiscal years beginning after December 15, 2017, with early adoption permitted. The Company does not expect the adoption of ASU2017-01 to have a material impact on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASUNo. 2017-04, “Intangibles–Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment,” eliminating the requirement to calculate the implied fair value, essentially eliminating step two from the goodwill impairment test. The new standard requires goodwill impairment to be based upon the results of step one of the impairment test, which is defined as the excess of the carrying value of a reporting unit over its fair value. The impairment charge will be limited to the amount of goodwill allocated to that reporting unit. The standard is effective for the Company on a prospective basis beginning on January 1, 2020, with early adoption permitted. This new guidance is not expected to have a material impact on the Company’s consolidated financial statements.

2. Acquisitions

2.Acquisitions

Acquisition of Spectrum LifeSciences, LLC

On August 1, 2017, the Company completed the acquisition of Spectrum pursuant to the terms of the Agreement and Plan of Merger and Reorganization, dated as of June 22, 2017 (such acquisition, the “Spectrum Acquisition”).

Spectrum is a diversified filtration company with a differentiated portfolio of hollow fiber cartridges,bench-top to commercial scale filtration and perfusion systems and a broad portfolio of disposable andsingle-use solutions. Spectrum’s products are primarily used for the filtration, isolation, purification and concentration of monoclonal antibodies, vaccines, recombinant proteins, diagnostic products and cell therapies where the company offers both standard and customized solutions to its bioprocessing customers.

Spectrum’s filtration products include its KrosFlo® line of hollow-fiber cartridges, tangential flow filtration (TFF) systems andsingle-use flow path consumables, as well as its Spectra/Por® portfolio of laboratory dialysis products and itsPro-Connex®single-use hollow fiberModule-Bag-Tubing (MBT) sets. Outside of filtration, the company sells its Spectra/Chrom® liquid chromatography products for research applications. These bioprocessing products account for the majority of Spectrum revenues. Spectrum also offers a line of operating room products.

The Spectrum Acquisition was accounted for as a purchase of a business under ASC 805, Business Combinations. The Spectrum Acquisition was funded through payment of approximately $122.9 million in cash, 6,153,995 unregistered shares of the Company’s common stock totaling $247.6 million and an estimated working capital adjustment of approximately $1.0 million for a total purchase price of $371.5 million.

Consideration Transferred

The Company accounted for the Spectrum Acquisition as a purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the assets of Spectrum were recorded as of the acquisition date, at their respective fair values, and consolidated with those of the Company. The fair value of the net assets acquired was approximately $371.5 million.

The estimated consideration and preliminary purchase price information has been prepared using a preliminary valuation. The preparation of the valuation required the use of significant assumptions and estimates. Critical estimates included, but were not limited to, future expected cash flows, including projected revenues and expenses, and the applicable discount rates. These estimates were based on assumptions that the Company believes to be reasonable; however, actual results may differ from these estimates.

The total consideration transferred follows (in thousands):

Cash consideration

  $122,932 

Equity consideration

   247,575 

Working capital adjustment

   955 
  

 

 

 

Net assets acquired

  $371,462 
  

 

 

 

Acquisition-related costs are not included as a component of consideration transferred, but are expensed in the periods in which the costs are incurred. The Company has incurred $3,378,000 and $5,761,000 in costs related to the Spectrum Acquisition for the three- and nine-month periods ended September 30, 2017, respectively. These costs are primarily included in selling, general and administrative expenses in the consolidated statements of operations.

Fair Value of Net Assets Acquired

The allocation of purchase price was based on the fair value of assets acquired and liabilities assumed as of August 1, 2017, based on the preliminary valuation. The components and allocation of the purchase price consists of the following amounts (in thousands):

Cash and cash equivalents

  $9,990 

Accounts receivable

   5,124 

Inventory

   13,774 

Prepaid expenses and other assets

   547 

Fixed assets

   6,015 

Deferred tax assets

   1,102 

Customer relationships

   78,400 

Developed technology

   38,560 

Trademark and tradename

   2,160 

Non-competition agreements

   960 

Goodwill

   265,084 

Accounts payable

   (1,142

Unrecognized tax benefit

   (576

Accrued liabilities

   (5,535

Deferred tax liabilities, net

   (43,001
  

 

 

 

Fair value of net assets acquired

  $371,462 
  

 

 

 

Of the consideration paid, $78.4 million represents the fair value of customer relationships that will be amortized over the weighted average determined useful life of 16 years, and $38.6 million represents the fair value of developed technology that will be amortized over a determined useful life of 20 years. $960,000 represents the fair value ofnon-competition agreements that will be amortized over a determined life of 3 years. $2.2 million represents the fair value of trademarks and trade names that are determined to have an indefinite useful life. The aforementioned intangible assets will be amortized on a straight-line basis.

The goodwill of $265.1 million represents future economic benefits expected to arise from synergies from combining operations and commercial organizations to increase market presence and the extension of existing customer relationships. None of the goodwill recorded is expected to be deductible for income tax purposes.

The purchase price allocation is subject to adjustment as purchase accounting is preliminary as of September 30, 2017. The final purchase price allocation will be determined upon completion of a final valuation analysis, and the fair value allocation of assets acquired and liabilities assumed could differ materially from the preliminary valuation analysis. The final allocation may include, but not be limited to, changes in the fair value of property, plant and equipment; changes in allocations to intangible assets and goodwill; changes in deferred tax assets and liabilities; and changes in the values of other assets and liabilities.

Revenue, Net Income and Pro Forma Presentation

The Company recorded revenue from Spectrum of $7,550,000 from August 1, 2017 through September 30, 2017. The Company has included the operating results of Spectrum in its consolidated statements of operations since the August 1, 2017 acquisition date. The following table presents unaudited supplemental pro forma information as if the Spectrum Acquisition had occurred as of January 1, 2016 (in thousands, except per share data):

   Nine months ended
September 30, 2017
 

Total revenue

  $121,301 

Net income

  $14,994 
  

 

 

 

Earnings per share:

  

Basic

  $0.36 
  

 

 

 

Diluted

  $0.36 
  

 

 

 

Prior to the Spectrum Acquisition, Spectrum did not generate monthly or quarterly financial statements that were prepared in accordance with U.S. GAAP. Therefore, the effort to create Spectrum interim financial information for 2016 would be administratively impracticable. As a result, the unaudited supplemental pro forma information for the nine-month period ended September 30, 2016 has been omitted.

The unaudited pro forma information for the nine-month period ended September 30, 2017 was calculated after applying the Company’s accounting policies and the impact of acquisition date fair value adjustments. The unaudited pro forma net income for the nine-month period ended September 30, 2017 was adjusted to exclude acquisition-related transaction costs, retention costs solely related to the acquisition, the impact of the fair value step-up to inventory and the release of the valuation allowance on the Company’s deferred tax assets, as these expenses would have been incurred in the prior year assuming the Spectrum Acquisition closed on January 1, 2016.

These pro forma condensed consolidated financial results include certain adjustments to reflect the pro forma results of operations as if the acquisition had occurred as of January 1, 2016. The pro forma information does not reflect the effect of costs or synergies that would have been expected to result from the integration of the acquisition. The pro forma information does not purport to be indicative of the results of operations that actually would have resulted had the combinations occurred at the beginning of the period presented, or of future results of the consolidated entities.

TangenX Technology Corporation

On December 14, 2016, the Company acquired TangenX, pursuant to the terms of the Share Purchase Agreement, dated as of December 14, 2016, by and among the Company, John Connors and Novasep Process SAS (such acquisition, the “TangenX Acquisition”). Through the TangenX Acquisition, the Company acquired all outstanding shares and the business of TangenX, including TangenX’s innovativesingle-use Sius line of tangential flow filtration (“TFF”) cassettes and hardware used in downstream biopharmaceutical manufacturing processes.

TangenX™ TFF products are used in the filtration of biological drugs, thereby expanding Repligen’s filtration portfolio and complementing the OPUS®pre-packed column product line in downstream purification. Effective June 30, 2017, TangenX was legally merged with and into the Company.

The TangenX Acquisition was accounted for as a purchase of a business under ASC 805, “Business Combinations.” The total purchase price of the TangenX Acquisition was $37.1 million in cash.

Consideration Transferred

The Company accounted for the TangenX Acquisition as a purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the assets of TangenX were recorded as of the acquisition date, at their respective fair values, and consolidated with those of the Company. The fair value of the net assets acquired was approximately $37.1 million.

The preparation of the valuation required the use of significant assumptions and estimates. Critical estimates included, but were not limited to, future expected cash flows, including projected revenues and expenses, and the applicable discount rates. These estimates were based on assumptions that the Company believes to be reasonable. However, actual results may differ from these estimates.

The total consideration transferred follows (in thousands):

Cash consideration

  $37,532 

Less: working capital adjustment

   (382
  

 

 

 

Net assets acquired

  $37,150 
  

 

 

 

Acquisition-related costs are not included as a component of consideration transferred, but are expensed in the periods in which the costs are incurred. The Company incurred $0 and $376,000 in transaction costs for the three- and nine-month periods ended September 30, 2017, respectively, and $935,000 in transaction costs for the year ended December 31, 2016 related to the TangenX Acquisition. The transaction costs are included in selling, general and administrative expenses in the consolidated statements of operations.

Fair Value of Net Assets Acquired

The allocation of purchase price was based on the fair value of assets acquired and liabilities assumed as of December 14, 2016. The components and allocation of the purchase price consists of the following amounts (in thousands):

Cash and cash equivalents

  $1,218 

Accounts receivable

   459 

Other receivables

   111 

Inventory

   936 

Other current assets

   50 

Fixed assets, net

   215 

Customer relationships

   6,192 

Developed technology

   6,044 

Non-competition agreements

   21 

Trademark and trade name

   11 

Accounts payable and other liabilities assumed

   (3,083

Deferred tax liabilities

   (4,525

Goodwill

   29,501 
  

 

 

 

Net assets acquired

  $37,150 
  

 

 

 

Of the consideration paid, $6.2 million represents the fair value of customer relationships that will be amortized over the determined useful life of 13 years and $6.0 million represents the fair value of developed technology that will be amortized over a determined useful life of 20 years. $21,000 represents the fair value ofnon-competition agreements that will be amortized over a determined life of 2 years. $11,000 represents the fair value of trademarks and trade names that will be amortized over a determined useful life of 5 years. The aforementioned intangible assets will be amortized on a straight-line basis.

The goodwill of $29.5 million represents future economic benefits expected to arise from synergies from combining operations and the extension of existing customer relationships. None of the goodwill recorded is expected to be deductible for income tax purposes.

Atoll GmbH

On April 1, 2016, the Company’s subsidiary, Repligen Sweden, acquired Atoll GmbH (“Atoll”) fromUV-Cap GmbH & Co. KG ( “UV(“UV Cap”) pursuant to a Share Purchase Agreement (the “Atoll Share Purchase Agreement”), dated as of March 31, 2016 (such acquisition, the “Atoll Acquisition”), by and among Repligen Sweden, UV Cap, and the Company, in its capacity as guarantor of the obligations of Repligen Sweden under the Atoll Share Purchase Agreement. The Atoll Acquisition was subject to certain closing conditions that did not occur until April 1, 2016. Payment for the Atoll Acquisition was denominated in Euros but is reflected here in U.S. dollars for presentation purposes.

In connection with the Atoll Acquisition, the Company issued and contributed 538,700 shares of the Company’s common stock, par value of $0.01 per share valued at $14.1 million (the “Atoll Stock Consideration”) to Repligen Sweden through a transfer by the Company on behalf of Repligen Sweden to fulfill Repligen Sweden’s obligation to deliver the Atoll Stock Consideration under the Atoll Share Purchase Agreement. The issuance of the Atoll Stock Consideration was not registered under the Securities Act of 1933, as amended (the “Securities Act”), in reliance upon the exemption from registration provided by Section 4(2) of the Securities Act. The Atoll Stock Consideration was based on the fair value of the Company’s common stock on April 1, 2016.

This acquisition strengthened Repligen’s bioprocessing business by adding a complementary extension to an existing product line while expanding its direct sales presence worldwide. On September 20, 2016, Atoll changed its name to Repligen GmbH.

The Atoll Acquisition was accounted for as a purchase of a business under ASC 805, “Business Combinations.” The total purchase price of the Atoll Acquisition was $25.3 million, consisting of an upfront cash payment of $10.2 million, less $74,000 as a result of the final determination of working capital, issuance of the Atoll Stock Consideration, and a future potential milestone payment of $1.1 million iffor achievement of specific revenue growth targets are met for 2016. The $1.1 million potential contingent consideration had an initial probability weighted fair value at the time of the closing of the Atoll Acquisition of approximately $952,000.

Consideration Transferred

The Company accounted for the Atoll Acquisition as the purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the assets of Atoll were recorded as of the acquisition date, at their respective fair values, and consolidated with those of Repligen.the Company. The fair value of the net assets acquired was approximately $25.3 million.

The preparation of the valuation required the use of significant assumptions and estimates. Critical estimates included, but were not limited to, future expected cash flows, including projected revenues and expenses, and the applicable discount rates. These estimates were based on assumptions that the Company believes to be reasonable. However, actual results may differ from these estimates.

The total consideration transferred follows (in thousands):

 

Cash consideration, less $74 of working capital adjustments

  $10,176   $10,176 

Value of common stock issued

   14,138 

Equity consideration

   14,138 

Estimated fair value of contingent consideration

   952    952 
  

 

   

 

 

Total consideration transferred

  $25,266   $25,266 
  

 

   

 

 

The fair value of contingent consideration was determined based upon a probability weighted analysis of expected future milestone and settlement payments to be made to UV Cap. Pursuant to the terms of the Atoll Share Purchase Agreement, the Company would make a contingent consideration payment of $1.1 million if specific revenue growth targets were met for 2016. Because the specified revenue growth targets were met for 2016, the Company made the contingent consideration payment in March 2017. No further measurement of this liability is required as of JuneSeptember 30, 2017.

Acquisition related costs are not included as a component of consideration transferred, but are expensed in the periods in which the costs are incurred. The Company incurred $1,307,000 in transaction costs in 2016 related to the Atoll Acquisition. The transaction costs are included in selling, general and administrative expenses in the consolidated statements of operations.

Fair Value of Net Assets Acquired

The allocation of purchase price was based on the fair value of assets acquired and liabilities assumed as of April 1, 2016. The components and allocation of the purchase price consists of the following amounts (in thousands):

 

Cash and cash equivalents

  $1,409 

Accounts receivable

   697 

Inventory

   155 

Other current assets

   169 

Fixed assets, net

   114 

Customer relationships

   5,318 

Developed technology

   2,175 

Non-competition agreements

   57 

Trademark and trade name

   11 

Deferred tax assets

   885 

Accounts payable and other liabilities assumed

   (599

Deferred tax liabilities

   (2,202

Goodwill

   17,077 
  

 

 

 

Net assets acquired

  $25,266 
  

 

 

 

Of the consideration paid, $5.3 million represents the fair value of customer relationships that will be amortized over the determined useful life of 13 years and $2.2 million represents the fair value of developed technology that will be amortized over a determined useful life of 14 years. $57,000 represents the fair value ofnon-competition agreements and $11,000 represents the fair value of trademarks and trade names that will be amortized over a determined useful life of 2 years. The aforementioned intangible assets will be amortized on a straight-line basis.

The goodwill of $17.1 million represents future economic benefits expected to arise from synergies from combining operations, utilizing the Company’s existing sales infrastructure to increase market presence and the extension of existing customer relationships.

TangenX Technology Corporation

On December 14, 2016, the Company acquired TangenX Technology Corporation (“TangenX”), pursuant to the terms None of the Share Purchase Agreement, dated as of December 14, 2016 (the “TangenX Share Purchase Agreement”), by and among the Company, John Connors and Novasep Process SAS (such acquisition, the “TangenX Acquisition”). Through the TangenX Acquisition, the Company acquired all outstanding shares and the business of TangenX, including TangenX’s innovativesingle-use Sius line of tangential flow filtration (“TFF”) cassettes and hardware used in downstream biopharmaceutical manufacturing processes.

TangenX™ TFF products are used in the filtration of biological drugs, thereby expanding Repligen’s filtration portfolio and complementing the OPUS®pre-packed column product line in downstream purification. Effective June 30, 2017, the operations of TangenX were merged with and into the Company.

The TangenX Acquisition was accounted for as a purchase of a business under ASC 805, “Business Combinations.” The total purchase price of the TangenX Acquisition was $37.1 million in cash.

Consideration Transferred

The Company accounted for the TangenX Acquisition as a purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the assets of TangenX weregoodwill recorded as of the acquisition date, at their respective fair values, and consolidated with those of Repligen. The fair value of the net assets acquired was approximately $37.1 million.

The preparation of the valuation required the use of significant assumptions and estimates. Critical estimates included, but were not limited to, futureis expected cash flows, including projected revenues and expenses, and the applicable discount rates. These estimates were based on assumptions that the Company believes to be reasonable. However, actual results may differ from these estimates.

The total consideration transferred follows (in thousands):

Cash consideration

  $37,532 

Less: working capital adjustment

   (382
  

 

 

 

Net assets acquired

  $37,150 
  

 

 

 

Acquisition related costs are not included as a component of consideration transferred, but are expensed in the periods in which the costs are incurred. The Company incurred $376,000 in transaction costsdeductible for thesix-month period ended June 30, 2017 and $935,000 in transaction costs for the year ended December 31, 2016 related to the TangenX Acquisition. The transaction costs are included in selling, general and administrative expenses in the consolidated statements of operations.

Fair Value of Net Assets Acquired

The allocation of purchase price was based on the fair value of assets acquired and liabilities assumed as of December 14, 2016. The components and allocation of the purchase price consists of the following amounts (in thousands):

Cash and cash equivalents

  $1,218 

Accounts receivable

   459 

Other receivables

   111 

Inventory

   936 

Other current assets

   50 

Fixed assets, net

   215 

Customer relationships

   6,192 

Developed technology

   6,044 

Non-competition agreements

   21 

Trademark and trade name

   11 

Accounts payable and other liabilities assumed

   (3,083

Deferred tax liabilities

   (4,525

Goodwill

   29,501 
  

 

 

 

Net assets acquired

  $37,150 
  

 

 

 

Of the consideration paid, $6.2 million represents the fair value of customer relationships that will be amortized over the determined useful life of 13 years and $6.0 million represents the fair value of developed technology that will be amortized over a determined useful life of 20 years. $21,000 represents the fair value ofnon-competition agreements that will be amortized over a determined life of 5 years. $11,000 represents the fair value of trademarks and trade names that will be amortized over a determined useful life of 2 years. The aforementioned intangible assets will be amortized on a straight-line basis.

The goodwill of $29.5 million represents future economic benefits expected to arise from synergies from combining operations and the extension of existing customer relationships.

Revenue, Net Income and Pro Forma Presentation

The Company recorded revenue from TangenX of $119,000 from December 15, 2016 through December 31, 2016 and revenue of $1,865,000 and $3,838,000 for the three- andsix-month periods ended June 30, 2017. The Company has included the operating results of TangenX in its consolidated statements of operations since the December 15, 2016 acquisition date. The following table presents unaudited supplemental pro forma information as if the TangenX Acquisition had occurred as of January 1, 2016 (in thousands, except per share data):

   Three months ended
June 30, 2016
   Six months ended
June 30, 2016
 

Total revenue

  $30,676   $57,628 

Net income

  $4,191   $9,309 
  

 

 

   

 

 

 

Earnings per share:

    

Basic

  $0.12   $0.28 
  

 

 

   

 

 

 

Diluted

  $0.12   $0.27 
  

 

 

   

 

 

 

The unaudited pro forma information for the three- andsix-month periods ended June 30, 2016 was calculated after applying the Company’s accounting policies and the impact of acquisition date fair value adjustments. The unaudited pro forma net income for the three- andsix-month periods ended June 30, 2016 was adjusted to include acquisition-related transaction costs, inventorystep-up charges, amortization of intangible assets and income tax benefits resulting from the acquisition.purposes.

These pro forma condensed consolidated financial results have been prepared for comparative purposes only and include certain adjustments to reflect the pro forma results of operations as if the acquisition had occurred as of the beginning of the periods presented, such as fair value adjustments to inventory and increased amortization for the fair value of acquired intangible assets. The pro forma information does not reflect the effect of costs or synergies that would have been expected to result from the integration of the acquisition. The pro forma information does not purport to be indicative of the results of operations that actually would have resulted had the combination occurred at the beginning of each period presented, or of future results of the consolidated entities.3. Revenue Recognition

Spectrum, Inc.

On August 1, 2017, the Company completed the acquisition of Spectrum, pursuant to the terms of the Agreement and Plan of Merger and Reorganization, dated June 22, 2017 (the “Spectrum Agreement”). See Note 17 for further information.

3.Revenue Recognition

Product Sales

The Company’s revenue recognition policy is to recognize revenues from product sales and services in accordance with ASC 605,Revenue Recognition. These standards require that revenues are recognized when persuasive evidence of an arrangement exists, product delivery, including customer acceptance when required, has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. Determination of whether these criteria have been met are based on management’s judgments primarily regarding the fixed nature of the fee charged for the product delivered and the collectability of those fees. The Company has a few longstanding customers who comprise the majority of revenue and have excellent payment histories and therefore the Company does not require collateral. The Company has had no significant write-offs of uncollectible invoices in the periods presented. When more than one element such as equipment, consumables, and services are contained in a single arrangement, the Company allocates revenue between the elements based on each element’s relative selling price, provided that each element meets the criteria for treatment as a separate unit of accounting. An item is considered a separate unit of accounting if it has value to the customer on a stand-alone basis. The selling price of the undelivered elements is determined by the price charged when the element is sold separately, or in cases when the item is not sold separately, by third-party evidence of selling price or management’s best estimate of selling price.

The Company’s product revenues are from the sale of bioprocessing products, equipment devices, and related consumables used with these equipment devices to customers in the life science and biopharmaceutical industries. On product sales to end customers, revenue is recognized, net of discounts, when both the title and risk of loss have transferred to the customer, as determined by the shipping terms provided there are no uncertainties regarding acceptance, and all obligations have been completed. Generally, our product arrangements for equipment sales are multiple element arrangements, and may include services, such as installation and training, and multiple products, such as consumables and spare parts. In accordance with ASC605-25, based on terms and conditions of the product arrangements, the Company believes that these services and undelivered products can be accounted for separately from the delivered product element, as the delivered products have value to our customers on a standalone basis. Accordingly, revenue for services not yet performed at the time of product shipment are deferred and recognized as such services are performed. The relative selling price of any undelivered products is also deferred at the time of shipment and recognized as revenue when these products are delivered. For product sales to distributors, the Company recognizes revenue for both equipment and consumables upon delivery to the distributor unless direct shipment to the end user is requested. In this case, revenue is recognized upon delivery to the end user’s location. In general, distributors are responsible for shipment to the end customer along with installation, training and acceptance of the equipment by the end customer. Sales to distributors are not contingent upon resale of the product.

At the time of sale, the Company also evaluates the need to accrue for warranty and sales returns. The supply agreements the Company has with its customers and the related purchase orders identify the terms and conditions of each sale and the price of the goods ordered. Due to the nature of the sales arrangements, inventory produced for sale is tested for quality specifications prior to shipment. Since the product is manufactured to order and in compliance with required specifications prior to shipment, the likelihood of sales return, warranty or other issues is largely diminished. Furthermore, there is no customer right of return in our sales agreements. Sales returns and warranty issues are infrequent and have not had a material impact on the Company’s financial statements historically.

Shipping and handling fees are recorded as a component of product revenue, with the associated costs recorded as a component of cost of product revenue.

Therapeutics Licensing Agreements

Activities under licensing agreements are evaluated in accordance with ASC605-25 to determine if they represent a multiple element revenue arrangement. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate units of accounting if the following two criteria are met:

 

The delivered item or items have value to the customer on a stand-alone basis; and

 

If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company’s control.

Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the licensee could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments, if any, under a license agreement will be recognized under the provisions of ASC605-28, which the Company adopted on January 1, 2011. The Company has elected to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is substantive if:

 

It can only be achieved based in whole or in part on either the Company’s performance or the occurrence of a specific outcome resulting from the Company’s performance;

 

There is substantive uncertainty at the date an arrangement is entered into that the event will be achieved; and

 

It would result in additional payments being due to the entity.

The commercial milestone payments and royalty payments received under license agreements, if any, will be recognized as revenue when they are earned.

Sale of Intellectual Property to BioMarin

In January 2014, the Company entered into an asset purchase agreement (the “BioMarin Asset Purchase Agreement”) with BioMarin Pharmaceutical Inc. (“BioMarin”) to sell Repligen’s histone deacetylase inhibitor (HDACi) portfolio. Pursuant to the terms of the

BioMarin Asset Purchase Agreement, the Company is entitled to receive up to $160 million in potential future milestone payments, comprised of:

 

Up to $60 million related to the achievement of specified clinical and regulatory milestone events; and

 

Up to $100 million related to the achievement of specified commercial sales events, specifically the first commercial sale in specific territories.

In addition, Repligen is eligible to receive royalties on sales of therapeutic products originating from the HDACi portfolio. The royalty rates are tiered and begin in themid-single-digits for the first HDACi portfolio product and for the firstnon-HDACi portfolio product with lesser amounts for any backup products developed under the BioMarin Asset Purchase Agreement. The Company’s receipt of these royalties is subject to customary offsets and deductions. There are no refund provisions in this agreement. Any milestones earned upon specified clinical development or commercial sales events or future royalty payments, under the BioMarin Asset Purchase Agreement will be recognized as revenue when they are earned.

Activities under this agreement were evaluated in accordance with ASC605-25 to determine if they represented a multiple element revenue arrangement. The Company identified the following deliverables in the BioMarin Asset Purchase Agreement:

 

The assignment by the Company to BioMarin of its intellectual property rights in the HDACi portfolio and the Scripps Agreement (the “Transferred Assets”); and

 

The transfer of certain notebooks, data, documents, biological materials (if any) and other such documents in our possession that might be useful to further development of the program (the “Technology Transfer”).

Two criteria must be met in order for a deliverable to be considered a separate unit of accounting. The first criterion requires that the delivered item or items have value to the customer on a stand-alone basis. The second criterion, which relates to evaluating a general right of return, is not applicable because such a provision does not exist in the BioMarin Asset Purchase Agreement. The deliverables outlined above were deemed to have stand-alone value and to meet the criteria to be accounted for as separate units of accounting. Factors considered in this determination included, among other things, BioMarin’s right under the agreement to assign the Transferred Assets, whether any other vendors sell the items separately and if BioMarin could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the multiple-element arrangements guidance addresses how to allocate the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative selling price.

The Company evaluated the potential milestones in accordance with ASC605-28, which allows an entity to make an accounting policy election to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. This evaluation included an assessment of the risks that must be overcome to achieve the respective milestone as well as whether the achievement of the milestone was due in part to our initial clinical work, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement. There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestones that are not considered substantive are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming all other revenue recognition criteria are met.

The Company believes that the $60 million of specified clinical and regulatory milestone payments are substantive. Therefore, any such milestones achieved will be recognized as revenue when earned.

Any milestones achieved upon specified commercial sales events or future royalty payments are considered contingent revenue under the BioMarin Asset Purchase Agreement, and will be recognized as revenue when they are earned as there are no undelivered elements remaining and no continuing performance obligations under the arrangement.

4. Accumulated Other Comprehensive Income

4.Accumulated Other Comprehensive Income

The following table summarizes the changes in accumulated other comprehensive income by component (in thousands):

 

(In thousands)

  Unrealized gain
(loss) on
investments
   Foreign currency
translation gain
(loss)
   Total   Unrealized gain
(loss) on
investments
   Foreign currency
translation gain
(loss)
   Total 

Balance at December 31, 2016

  $(5  $(13,744  $(13,749  $(5  $(13,744  $(13,749

Other comprehensive income

   5    5,073    5,078    5    7,097    7,102 
  

 

   

 

   

 

   

 

   

 

   

 

 

Balance at June 30, 2017

  $—     $(8,671  $(8,671

Balance at September 30, 2017

  $—     $(6,647  $(6,647
  

 

   

 

   

 

   

 

   

 

   

 

 

5. Earnings Per Share

5.Earnings Per Share

The Company reports earnings per share in accordance with ASC Topic 260, “Earnings Per Share,” which establishes standards for computing and presenting earnings per share. Basic earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of common shares and dilutive common share equivalents then outstanding. Potential common share equivalents consist of restricted stock awards and the incremental common shares issuable upon the exercise of stock options. Under the treasury stock method, unexercised“in-the-money”

stock options and warrants are assumed to be exercised at the beginning of the period or at issuance, if later. The assumed proceeds are then used to purchase common shares at the average market price during the period. Share-based payment awards that entitle their holders to receivenon-forfeitable dividends before vesting are considered participating securities and are considered in the calculation of basic and diluted earnings per share. There were no such participating securities outstanding during the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016.

Basic and diluted weighted average shares outstanding were as follows:

 

  Three months ended
June 30,
   Six months ended
June 30,
   Three months ended
September 30,
   Nine months ended
September 30,
 
  2017   2016   2017   2016   2017   2016   2017   2016 

Weighted average common shares

   34,097,805    33,649,296    33,995,323    33,336,989    41,236,554    33,779,141    36,435,591    33,485,448 

Dilutive common stock options and restricted stock units

   437,427    525,831    433,483    525,322    484,242    533,746    454,340    526,086 

Dilutive effect of senior convertible notes

   559,582    —      286,991    —      842,206    —      496,402    —   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Weighted average common shares, assuming dilution

   35,094,814    34,175,127    34,715,797    33,862,311    42,563,002    34,312,887    37,386,333    34,011,534 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

At JuneSeptember 30, 2017, there were outstanding options to purchase 803,532749,669 shares of the Company’s common stock at a weighted average exercise price of $20.16$20.84 per share and 393,338515,468 restricted stock units. For the three- andsix-month nine-month periods ended JuneSeptember 30, 2017, 187,072162,544 and 222,001326,572 options to purchase shares of the Company’s common stock, respectively, were excluded from the calculation of diluted earnings per share because the exercise prices of the stock options were greater than or equal to the average price of the common shares, and were therefore anti-dilutive. As provided by the terms of the indenture underlying the senior convertible notes,Company’s 2.125% Convertible Senior Notes due 2021 (the “Notes”), the Company has a choice to settle the conversion obligation for its senior convertible notesthe Notes in cash, shares or any combination of the two. The Company currently intends to settle the parface value of its senior convertible notesthe Notes in cash and any excess conversion premium in shares. During the third quarter of 2017, the closing price of the Company’s common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the Notes are convertible at the option of the holders of the Notes during the fourth quarter of 2017; however, no holders have elected to convert any of their Notes as of the date of this filing. The Company applies the provisions of ASC 260,Earnings Per Share, Subsection10-45-44, to determine the diluted weighted average shares outstanding as it relates to the conversion spread on its convertible notes.the Notes. Accordingly, the parface value of the senior convertible notesNotes is not included in the calculation of diluted income per share, but the dilutive effect of the conversion premium is considered in the calculation of diluted net income per share using the treasury stock method. The share figures in the table above represent the estimated incremental shares that would be issued related to the conversion premium, assuming conversion of all the outstanding senior convertible notesNotes as of JuneSeptember 30, 2017.

At JuneSeptember 30, 2016, there were outstanding options to purchase 1,315,7391,198,673 shares of the Company’s common stock at a weighted average exercise price of $11.70$12.03 per share. For the three- andsix-month nine-month periods ended JuneSeptember 30, 2016, 359,828253,754 and 417,279348,608 options to purchase shares of the Company’s common stock, respectively, were excluded from the calculation of diluted earnings per share because the exercise prices of the stock options were greater than or equal to the average price of the common shares, and were therefore anti-dilutive. The Company intendsapplies the provisions of ASC 260,Earnings Per Share, Subsection10-45-44, to settledetermine the par value of its senior convertible notes in cash and any excessdiluted weighted average shares outstanding as it relates to the conversion premium in shares.spread on the Notes. Accordingly, the parface value of the senior convertible notesNotes is not included in the calculation of diluted income per share. As of June 30, 2016, thereThere is no dilution related todilutive effect of the conversion premium on these notes.

the Notes for the three- and nine-month periods ended September 30, 2016, as the weighted average price of the Company’s common stock was less than the conversion price of the Notes

6. Cash, Cash Equivalents and Marketable Securities

As detailed in Note 17, in JulyAt September 30, 2017, the Company completed a public offering in which a totaldid not have any marketable securities.

As of 3,228,069 shares of its common stock were sold to the public at a price of $42.75 per share.

6.Cash, Cash Equivalents and Marketable Securities

At June 30, 2017 and December 31, 2016, the Company’s investments included money market funds and short-term marketable securities. These marketable securities arewere classified asavailable-for-sale. Marketable securities are investments with original maturities of greater than 90 days. Long-term marketable securities are securities with maturities of greater than one year. The average remaining contractual maturity of marketable securities at June 30, 2017 was approximately 2.0 months.

Management reviewed the Company’s investments as of June 30, 2017 and December 31, 2016 and concluded that there are no securities with other than temporary impairments in the investment portfolio. The Company does not intend to sell any investments in an unrealized loss position, and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.

Investments in marketable securities consisted of the following at June 30, 2017 (in thousands):

   June 30, 2017 
   Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
   Fair
Value
 

Marketable securities:

        

Corporate and other debt securities

  $2,744   $—     $—     $2,744 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $2,744   $—     $—     $2,744 
  

 

 

   

 

 

   

 

 

   

 

 

 

There were no long-term marketable securities as of June 30, 2017.

At June 30, 2017, the Company’s investments included two securities in unrealized loss positions with a total unrealized loss of less than $1,000 and a total fair market value of approximately $1,498,000. All investments with gross unrealized losses have been in unrealized loss positions for less than 12 months. The unrealized losses were caused primarily by current economic and market conditions. There was no change in the credit risk of the securities. There were no realized gains or losses on the investments for the three- andsix-month periods ended June 30, 2017 and 2016.

Investments in marketable securities consisted of the following at December 31, 2016 (in thousands):

 

   December 31, 2016 
   Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
   Fair
Value
 

Marketable securities:

        

U.S. Government and agency securities

  $807   $—     $—     $807 

Corporate and other debt securities

   18,745    2    (7   18,740 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $19,552   $2   $(7  $19,547 
  

 

 

   

 

 

   

 

 

   

 

 

 

There were no long-term marketable securities as of December 31, 2016.

The contractual maturities of all money market funds and marketable securities are less than one yearManagement reviewed the Company’s investments as of June 30, 2017.December 31, 2016 and concluded that there are no securities with other than temporary impairments in the investment portfolio. The Company did not intend to sell any investments in an unrealized loss position, and it was not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.

7. Inventories

7.Inventories

Inventories relate to the Company’s bioprocessing business. The Company values inventory at cost or, if lower, market value, using thefirst-in,first-out method. The Company reviews its inventories at least quarterly and records a provision for excess and obsolete inventory based on its estimates of expected sales volume, production capacity and expiration dates of raw materials,work-in-process and finished products. Expected sales volumes are determined based on supply forecasts provided by key customers for the next 3 to 12 months. The Company writes down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net

realizable value, and inventory in excess of expected requirements to cost of product revenue. Manufacturing of bioprocessing finished goods is done to order and tested for quality specifications prior to shipment. Reserves for excess and obsolete inventory were approximately $406,000 at JuneSeptember 30, 2017 and $435,000 at December 31, 2016.

A change in the estimated timing or amount of demand for the Company’s products could result in additional provisions for excess inventory quantities on hand. Any significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results. During all periods presented in the accompanying financial statements, there have been no material adjustments related to a revised estimate of inventory valuations.

Work-in-process and finished products inventories consist of material, labor, outside processing costs and manufacturing overhead. Inventories consist of the following (in thousands):

 

  June 30, 2017   December 31,
2016
   September 30,
2017
   December 31,
2016
 

Raw Materials

  $16,538   $14,954   $22,235   $14,954 

Work-in-process

   2,461    2,789    3,633    2,789 

Finished products

   7,086    6,953    12,795    6,953 
  

 

   

 

   

 

   

 

 

Total

  $26,085   $24,696   $38,663   $24,696 
  

 

   

 

   

 

   

 

 

8. Property, Plant and Equipment

8.Property, Plant and Equipment

Property, plant and equipment consist of the following (in thousands):

 

  June 30, 2017   December 31, 2016   September 30, 2017   December 31, 2016 

Land

  $1,021   $—   

Buildings

   768    —   

Leasehold improvements

  $15,272   $14,592    15,743    14,592 

Equipment

   16,471    15,214    19,543    15,214 

Furniture and fixtures

   3,732    3,218    4,111    3,218 

Construction in progress

   1,604    1,264    3,286    1,264 
  

 

   

 

   

 

   

 

 

Total property, plant and equipment

   37,079    34,288    44,472    34,288 

Less: accumulated depreciation

   (21,083   (19,332   (22,416   (19,332
  

 

   

 

   

 

   

 

 

Property, plant and equipment, net

  $15,996   $14,956   $22,056   $14,956 
  

 

   

 

   

 

   

 

 

Depreciation expense totaled approximately $1,858,000$2,988,000 and $1,535,000$2,360,000 for thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016, respectively.

9. Intangible Assets

9.Intangible Assets

Intangible assets are amortized over their useful lives using the straight-line method, as applicable, and the amortization expense is recorded within selling, general and administrative expense in the Company’s statements of comprehensive income.

The Company reviews its indefinite-lived intangible assets not subject to amortization to determine if adverse conditions exist or a change in circumstances exists that would indicate an impairment. Intangible assets and their related useful lives are reviewed at least annually to determine if any adverse conditions exist that would indicate the carrying value of these assets may not be recoverable. More frequent impairment assessments are conducted if certain conditions exist, including a change in the competitive landscape, any internal decisions to pursue new or different technology strategies, a loss of a significant customer, or a significant change in the marketplace, including changes in the prices paid for our products or changes in the size of the market for our products. An impairment results if the carrying value of the asset exceeds the estimated fair value of the asset. If the estimate of an intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over the revised remaining useful life. The Company continues to believe that its intangible assets are recoverable at JuneSeptember 30, 2017.

Intangible assets consisted of the following at JuneSeptember 30, 2017 (in thousands):

 

  Gross Carrying
Amount
   Accumulated
Amortization
   Weighted
Average
Useful Life
(in years)
   Gross Carrying
Amount
   Accumulated
Amortization
   Weighted
Average
Useful Life
(in years)
 

Technology – developed

  $13,119   $(1,926   17   $51,775   $(2,491   19 

Patents

   240    (223   8    240    (230   8 

Customer relationships

   23,312    (6,260   11    102,090    (7,774   15 

Trademark

   711    —      —   

Trademark – indefinite lived

   2,860    —      —   

Other intangibles

   89    (49   2    1,062    (116   3 
  

 

   

 

   

 

   

 

   

 

   

 

 

Total intangible assets

  $37,471   $(8,458   13   $158,027   $(10,611   16 
  

 

   

 

     

 

   

 

   

Intangible assets consisted of the following at December 31, 2016 (in thousands):

 

   Gross Carrying
Amount
   Accumulated
Amortization
   Weighted
Average
Useful Life
(in years)
 

Technology – developed

  $12,911   $(1,468   17 

Patents

   240    (208   8 

Customer relationships

   22,555    (4,995   11 

Trademark/ tradename

   711    —      —   

Other intangibles

   84    (24   2 
  

 

 

   

 

 

   

 

 

 

Total intangible assets

  $36,501   $(6,695   13 
  

 

 

   

 

 

   

Amortization expense for amortized intangible assets was approximately $1,484,000$3,476,000 and $932,000$1,484,000 for thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016, respectively. As of JuneSeptember 30, 2017, the Company expects to record amortization expense as follows (in thousands):

 

Years Ending

  Amortization Expense   Amortization Expense 

December 31, 2017 (six months remaining)

  $1,708 

December 31, 2017 (three months remaining)

  $2,625 

December 31, 2018

   2,904    10,308 

December 31, 2019

   2,870    10,214 

December 31, 2020

   2,388    9,619 

December 31, 2021

   2,227    9,046 

The amounts reported above do not include amortization expense related to intangible assets acquired as part of the Spectrum Acquisition, as reported in Note 17, below.10. Accrued Liabilities

10.Accrued Liabilities

Accrued liabilities consist of the following (in thousands):

 

  June 30, 2017   December 31, 2016   September 30, 2017   December 31, 2016 

Employee compensation

  $4,602   $5,586   $6,497   $5,586 

Accrued interest payable

   204    204    806    204 

Accrued purchases

   659    382    448    382 

Taxes

   539    1,692    591    1,692 

Contingent consideration

   —      6,119    —      6,119 

Royalties

   450    248    1,064    248 

Professional fees

   1,505    411    734    411 

Accrued warranty

   528    178 

Unearned revenue

   864    408    1,299    408 

Other accrued expenses

   745    964    1,826    786 
  

 

   

 

   

 

   

 

 

Total

  $9,568��  $16,014   $13,793   $16,014 
  

 

   

 

   

 

   

 

 

11. Convertible Senior Notes

11.Long Term Debt

The carrying value of the Company’s convertible senior notes is as follows:

 

  June 30, 2017   December 31, 2016   September 30, 2017   December 31, 2016 

2.125% Convertible Senior Notes due 2021:

        

Principal amount

  $115,000   $115,000   $115,000   $115,000 

Unamortized debt discount

   (15,114   (16,777   (14,261   (16,777

Unamortized debt issuance costs

   (2,658   (2,951   (2,508   (2,951
  

 

   

 

   

 

   

 

 

Total convertible senior notes

  $97,228   $95,272   $98,231   $95,272 
  

 

   

 

   

 

   

 

 

On May 24, 2016, the Company issued $115 million aggregate principal amount of its 2.125% Convertible Senior Notes due 2021 (the “Notes”). The net proceeds from the sale of the Notes, after deducting the underwriting discounts and commissions and other related offering expenses, were approximately $111.1 million. The Notes bear interest at the rate of 2.125% per annum, payable semiannually in arrears on June 1 and December 1 of each year, beginning on December 1, 2016.

The Notes will mature on June 1, 2021, unless earlier repurchased, redeemed or converted in accordance with their terms. Prior to March 1, 2021, the Notes will be convertible at the option of holders of the Notes only upon satisfaction of certain conditions and during certain periods, and thereafter, the notes will be convertible at any time until the close of business on the second scheduled trading day immediately preceding the maturity date. Upon conversion, holders of the Notes will receive shares of the Company’s common stock, cash or a combination thereof, at the Company’s election. It is the Company’s current intent and policy to settle all conversions through combination settlement, which involves satisfying the principal amount outstanding with cash and any note conversion value over the principal amount in shares of the Company’s common stock.

During the third quarter of 2017, the closing price of the Company’s common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the Notes are convertible at the option of the holders of the Notes during the fourth quarter of 2017. As a result, the Company reclassified the carrying value of the Notes to current liabilities from long term liabilities on the Company’s consolidated balance sheet as of September 30, 2017. In the event the closing price conditions are met in the fourth quarter of 2017 or a future fiscal quarter, the Notes will be convertible at a holder’s option during the immediately following fiscal quarter. As of September 30, 2017, theif-converted value of the Notes exceeded the aggregate principal amount by approximately $39.8 million. As of the date of this filing, none of the Notes have been converted by the holders of such Notes.

The conversion rate for the Notes will initially be 31.1813 shares of the Company’s common stock per $1,000 principal amount of Notes, which is equivalent to an initial conversion price of approximately $32.07 per common share, and is subject to adjustment under the terms of the Notes. Holders of the Notes may require the Company to repurchase their Notes upon the occurrence of a fundamental change prior to maturity for cash at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased plus accrued and unpaid interest, if any, to, but excluding, the repurchase date.

The Company will not have the right to redeem the Notes prior to June 5, 2019, but may redeem the Notes, at its option, in whole or in part, on any business day on or after June 5, 2019 and prior to the maturity date if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company provides written notice of redemption. The redemption price will be equal to 100% of the principal amount of the principal amount of Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date.

The Notes contain customary terms and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving the Company) occurs and is continuing, the holders of at least 25% in aggregate principal amount of the outstanding Notes may declare 100% of the principal of, and any accrued and unpaid interest on, all of the Notes to be due and payable. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving the Company, 100% of the principal of and accrued and unpaid interest, if any, on all of the Notes will become due and payable automatically. Notwithstanding the foregoing, the Notes provide that, to the extent the Company elects and for up to 270 days, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants consist exclusively of the right to receive additional interest on the Notes. The Company is not aware of any events of default, current events or market conditions that would allow holders to call or convert the Notes as of JuneSeptember 30, 2017.2017, except as noted below.

The cash conversion feature of the Notes required bifurcation from the Notes and was initially accounted for as an equity instrument classified to stockholders’ equity, as the conversion feature was determined to be clearly and closely related to the Company’s stock. Based on market data available for publicly traded, senior, unsecured corporate bonds issued by companies in the same industry and asset base and with similar maturity, the Company estimated the implied interest rate, assuming no conversion option. Assumptions used in the estimate represent what market participants would use in pricing the liability component, including market interest rates, credit standing, and yield curves, all of which are defined as Level 2 observable inputs. The estimated implied interest rate was applied to the Notes, which resulted in a fair value of the liability component of $96,289,000 upon issuance, calculated as the present value of implied future payments based on the $115 million aggregate principal amount. The equity component of the Notes was recognized as a debt discount, recorded in additionalpaid-in capital, and represents the difference between the aggregate principal of the Notes and the fair value of the Notes without conversion option on their issuance date. The debt discount is amortized to interest expense using the effective interest method over five years, or the life of the Notes. The Company assesses the equity classification of the cash conversion feature quarterly, and it is not remeasured as long as it continues to meet the conditions for equity classification.

Interest expense recognized on the Notes during the three-month period ended JuneSeptember 30, 2017 includes $611,000, $839,000$852,000 and $147,000$150,000 for the contractual coupon interest, the accretion of the debt discount and the amortization of the debt issuance costs, respectively. Interest expense recognized on the Notes during thesix-month nine-month period ended JuneSeptember 30, 2017 includes $1,222,000, $1,663,000$1,833,000, $2,516,000 and $293,000$442,000 for the contractual coupon interest, the accretion of the debt discount and the amortization of the debt issuance costs, respectively. The effective interest rate on the Notes is 6.6%, which includes the interest on the Notes, amortization of the debt discount and debt issuance costs. As of JuneSeptember 30, 2017, the carrying value of the Notes was approximately $97.2$98.2 million and the fair value of the principal was approximately $165.5$154.8 million. The fair value of the Notes was determined based on the most recent trade activity of the Notes as of JuneSeptember 30, 2017.

12. Equity and Stock-Based Compensation

12.Stock-Based Compensation

Public Offering of Common Stock

On July 3, 2017, the Company completed a public offering in which 2,807,017 shares of its common stock were sold to the public at a price of $42.75 per share. The underwriters were granted an option, which they exercised in full, to purchase an additional 421,052 shares of the Company’s common stock. The total proceeds from this offering, net of underwriting discounts, commissions and other offering expenses, totaled approximately $129.3 million.

Stock-Based Compensation

For the three-month periods ended JuneSeptember 30, 2017 and 2016, the Company recorded stock-based compensation expense of approximately $1,496,000$1,817,000 and $1,137,000,$1,282,000, respectively, for share-based awards granted under the Second Amended and Restated 2001 Repligen Corporation Stock Plan (the “2001 Plan”) and the Repligen Corporation Amended and Restated 2012 Stock Option and Incentive Plan (the “2012 Plan,” and collectively with the 2001 Plan and the 1992 Repligen Corporation Stock Option Plan, the “Plans”). The Company recorded stock-based compensation expense of approximately $3,027,000$4,845,000 and $2,059,000$3,341,000 for thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016, respectively, for share-based awards granted under the Plans.

The following table presents stock-based compensation expense included in the Company’s consolidated statements of comprehensive income (in thousands):

 

  Three months ended
June 30,
   Six months ended
June 30,
   Three months ended
September 30,
   Nine months ended
September 30,
 
  2017   2016   2017   2016   2017   2016   2017   2016 

Cost of product revenue

  $153   $84   $294   $144   $197   $116   $491   $260 

Research and development

   79    105    211    185    127    177    338    362 

Selling, general and administrative

   1,264    948    2,522    1,730    1,493    989    4,016    2,719 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $1,496   $1,137   $3,027   $2,059   $1,817   $1,282   $4,845   $3,341 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

The 2012 Plan allows for the granting of incentive and nonqualified options to purchase shares of common stock, restricted stock and other equity awards. Incentive options granted to employeesEmployee grants under the Plans generally vest over a three to five-year period, with20%-33% vesting on the first anniversary of the date of grant and the remainder vesting in equal yearly installments thereafter. Nonqualified options issued tonon-employee directors under the Plans generally vest over one year. Options granted under the Plans have a maximum term of ten years from the date of grant and generally, the exercise price of the stock options equals the fair market value of the Company’s common stock on the date of grant. At JuneSeptember 30, 2017, options to purchase 803,532749,669 shares and 393,338515,468 restricted stock units were outstanding under the Plans. At JuneSeptember 30, 2017, 1,483,3671,228,987 shares were available for future grant under the 2012 Plan.

The Company uses the Black-Scholes option pricing model to calculate the fair value of stock option awards on the grant date, and the Company uses the value of the common stock as of the grant date to value restricted stock units. The Company measures stock-based compensation cost at the grant date based on the estimated fair value of the award, andaward. The Company recognizes expense on awards with service based vesting as expense over the employee’s requisite service period on a straight-line basis. In the third quarter of 2017, the Company issued performance stock units to certain individuals related to the Spectrum Acquisition which are tied to the achievement of certain revenue and gross margin metrics and the passage of time. The Company has norecognizes expense on performance based awards over the vesting period of each tranche when it is probable that are performance-based or subject to market conditions.the performance metrics will be achieved. The Company recognizes stock-based compensation expense for options that are ultimately expected to vest, and accordingly, such compensation expense has been adjusted for estimated forfeitures.

Information regarding option activity for thesix-month nine-month period ended JuneSeptember 30, 2017 under the Plans is summarized below:

 

  Options
Outstanding
   Weighted-
Average

Exercise
Price Per
Share
   Weighted-
Average

Remaining
Contractual
Term
(in years)
   (in thousands)
Aggregate
Intrinsic
Value
   Options
Outstanding
   Weighted-
Average
Exercise
Price Per
Share
   Weighted-
Average
Remaining
Contractual
Term
(in years)
   (in thousands)
Aggregate
Intrinsic
Value
 

Options outstanding at December 31, 2016

   882,748   $16.88        882,748   $16.88     

Granted

   101,844    33.38        101,844    33.38     

Exercised

   (149,903   10.04        (201,966   10.08     

Forfeited/cancelled

   (31,157   20.27        (32,957   20.31     
  

 

         

 

       

Options outstanding at June 30, 2017

   803,532   $20.16    6.90   $17,145 

Options outstanding at September 30, 2017

   749,669   $20.84    6.72   $13,205 
  

 

         

 

       

Options exercisable at June 30, 2017

   439,980   $14.98    5.71   $11,695 

Options exercisable at September 30, 2017

   423,217   $15.86    5.53   $9,602 
  

 

         

 

       

Vested and expected to vest at June 30, 2017 (1)

   790,545   $20.04    6.87   $16,921 

Vested and expected to vest at September 30, 2017(1)

   739,381   $20.74    6.70   $13,065 
  

 

         

 

       

 

(1) Represents the number of vested options as of JuneSeptember 30, 2017 plus the number of unvested options expected to vest as of JuneSeptember 30, 2017 based on the unvested outstanding options at JuneSeptember 30, 2017 adjusted for estimated forfeiture rates of 8% for awards granted tonon-executive level employees and 3% for awards granted to executive level employees.

The aggregate intrinsic value in the table above represents the totalpre-tax intrinsic value (the difference between the closing price of the common stock on JuneSeptember 30, 2017 of $41.44$38.32 per share and the exercise price of eachin-the-money option) that would have been received by the option holders had all option holders exercised their options on JuneSeptember 30, 2017.

The weighted average grant date fair value of options granted during thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was $16.94 and $13.55, respectively. The total fair value of stock options that vested during thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was approximately $1,734,000$2,074,000 and $1,195,000,$1,590,000, respectively.

Information regarding restricted stock unit and performance stock unit activity for the three monthsnine-month period ended JuneSeptember 30, 2017 under the Plans is summarized below:

 

 Options
Outstanding
 Weighted-
Average

Exercise
Price Per
Share
 Weighted-
Average
Remaining
Contractual
Term
(in years)
 (in thousands)
Aggregate
Intrinsic
Value
   Units
Outstanding
   Weighted-
Average
Exercise
Price Per
Share
   Weighted-
Average
Remaining
Contractual
Term
(in years)
   (in thousands)
Aggregate
Intrinsic
Value
 

Restricted stock units outstanding at December 31, 2016

 353,838  $—        353,838   $—       

Granted

 146,154   —        279,054    —       

Exercised

 (94,261  —        (100,221   —       

Forfeited/cancelled

 (12,393  —        (17,203   —       
 

 

      

 

       

Restricted stock units outstanding at June 30, 2017

 393,338  $—    2.93  $16,300 

Restricted stock units outstanding at September 30, 2017

   515,468   $—      2.80   $19,753 
 

 

      

 

       

Vested and expected to vest at June 30, 2017(1)

 362,788  $—    2.82  $15,034 

Vested and expected to vest at September 30, 2017 (1)

   488,104   $—      2.66   $18,704 
 

 

      

 

       

 

(1) Represents the number of vested restricted stock units as of JuneSeptember 30, 2017 plus the number of unvested restricted stock units expected to vest as of JuneSeptember 30, 2017 based on the unvested outstanding restricted stock units at JuneSeptember 30, 2017 adjusted for estimated forfeiture rates of 8% for awards granted tonon-executive level employees and 3% for awards granted to executive level employees.

The aggregate intrinsic value in the table above represents the totalpre-tax intrinsic value (equal to the closing price of the common stock on JuneSeptember 30, 2017 of $41.44$38.32 per share) that would have been received by the restricted stock unit holders had all holders exercisedrestricted stock units vested on JuneSeptember 30, 2017. The aggregate intrinsic value of restricted stock units exercisedvested during thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was approximately $3,231,000$3,480,000 and $1,392,000,$1,479,000, respectively.

The weighted average grant date fair value of restricted stock units granted during the three monthsnine-month periods ended JuneSeptember 30, 2017 and 2016 was $33.06$36.85 and $26.07,$26.28, respectively. The total grant date fair value of restricted stock units that vested during thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was approximately $2,373,000$2,565,000 and $1,201,000,$1,315,000, respectively.

As of JuneSeptember 30, 2017, there was $14,437,000$18,114,000 of total unrecognized compensation cost related to unvested share-based awards. This cost is expected to be recognized over a weighted average remaining requisite service period of 2.742.66 years.

13.Income Taxes

13. Income Taxes

The Company’s effective tax rate for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 was (130.9%)330.9% and (49.0%(183.8%), respectively, compared to 27.9%47.8% and 30.5%34.3%, respectively, for the corresponding periods in the prior year.

In the second quarter of 2017, the Company completed a sale of intellectual property from the Repligen Corporation to Repligen Sweden AB that allowed for the Company to utilize certain of its U.S. deferred tax assets. Accordingly, the Company reduced its valuation allowance on its U.S. deferred tax assets by approximately $9,200,000 in the second quarter of 2017 and recorded a $5,625,000 tax benefit on the Company’s consolidated statement of operations as a result of the sale of the intellectual property.

In the third quarter of 2017, in conjunction with the Spectrum Acquisition, the Company determined that its U.S. deferred tax assets were more likely than not to be realized after considering deferred tax liabilities related to the acquired intangible assets. Accordingly, the Company reduced its valuation allowance on its U.S. deferred tax assets by approximately $6,611,000 in the third quarter of 2017.

For the three- andsix-month nine-month periods ended JuneSeptember 30, 2017, the effective tax rate differed from the U.S. statutory tax rate of 34% primarily due to valuation allowance releases related to the sale of intellectual property, the Spectrum Acquisition and lower statutory tax rates on foreign profits. For the three-month period ended September 30, 2016, the effective tax rate was lowerhigher than the U.S. statutory tax rate of 34% primarily due to this sale of intellectual property. Additionally, the effective tax rate is lower than the U.S. statutory tax rate due tounbenefited domestic losses, partially offset by lower statutory tax rates onin foreign profits. For the three- andsix-month periods ended June 30, 2016, the effective tax rate was lower than the U.S. statutory tax rate of 34% primarily due to increased foreign profits at lower tax rates, partially offset by unbenefited domestic losses.jurisdictions.

At December 31, 2016, the Company had net operating loss carryforwards of approximately $48,550,000 in the U.S., net operating loss carryforwards of approximately €2,287,000 (approximately $2,407,000) in Germany, federal business tax credit carryforwards of $1,745,000 and state business tax credit carryforwards of approximately $442,000 available to reduce future domestic income taxes, if any. The net operating loss and business tax credits carryforwards will continue to expire at various dates through December 2036. The net operating loss and business tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service. While an IRC Section 382 study was completed through June 30,in the second quarter of 2017, and no current limitations were identified, use of these net operating loss and business tax credit carryforwards may be limited in the future based on certain changes in the ownership interest of significant stockholders.

As of June 30, 2017, after accounting for the sale of intellectual property to Repligen Sweden AB as detailed above, the Company concluded that realization of the remainder of its deferred tax assets in the United States is not more likely than not, and as such, the Company maintained a valuation allowance against its net U.S. deferred tax assets, after considerations for deferred tax liabilities which will not be utilized as a future source of income.

ASU2016-09 states that previously unrecognized excess tax benefits related to stock based compensation should be recognized on a modified retrospective basis. As such, the Company increased its U.S. federal and state net operating loss carryovers by approximately $5.3 million as of January 1, 2017 for previously unrecognized stock based compensation excess tax benefits outstanding as of the beginning of the period. Because the Company maintained a full valuation allowance on its U.S. deferred tax assets at that date, the Company recorded a corresponding increase to the valuation allowance as of January 1, 2017, and the impact of adopting ASU2016-09 on retained earnings is zero.

In the first quarter of 2017, Repligen Germany GmbH was subject to a tax examination for the years 2012 through 2015. The examination was general in nature, covering all aspects of the subsidiary’s operations prior to the Atoll Acquisition on April 1, 2016. There were no material findings as a result of this examination, and the examination was closed by the German tax authorities.

The Company’s tax returns are subject to examination by federal, state and international taxing authorities for the following periods:

 

Jurisdiction

  Fiscal years subject
to examination

United States – federal and state

  2013-20162014-2016

Sweden

  2011-2016

Germany

  2016

14.

Netherlands

Fair Value Measurement2012-2016

14. Fair Value Measurement

In determining the fair value of its assets and liabilities, the Company uses various valuation approaches. The Company employs a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

 

Level 1  

Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access

Level 2  

Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly

Level 3  

Valuations based on inputs that are unobservable and significant to the overall fair value measurement

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement.

The Company’s fixed income investments arehave historically comprised of obligations of U.S. government agencies and corporate marketable securities. These investments have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. At least annually, the Company validates theapplicable prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. The Company did not adjust or override any fair value measurements provided by the pricing services as

As of June 30, 2017.

The following fair value hierarchy table presents information about each major category of the Company’s assets measured at fair value on a recurring basis as of JuneSeptember 30, 2017, (in thousands):

   Fair value measurement at reporting date using: 
   Quoted prices in
active markets for
identical assets
(Level 1)
   Significant
other observable
inputs
(Level 2)
   Significant
unobservable
inputs
(Level 3)
   Total 

Assets:

        

Money market funds

  $94,863   $—     $—     $94,863 

Corporate and other debt securities

   —      2,744    —      2,744 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $94,863   $2,744   $—     $97,607 
  

 

 

   

 

 

   

 

 

   

 

 

 

Thethe Company hashad no other assets or liabilities for which fair value measurement is either required or has been elected to be applied.

As of December 31, 2016, the Company had accrued liabilities with a fair value of $6,119,000 related to contingent consideration in connection with the Refine and Atoll business combinations. The contingent consideration related to Refine was based on actual 2016 revenues. The contingent consideration related to Atoll was based on meeting revenue growth targets in 2016. These valuations are Level 3 valuations, as the primary inputs are unobservable. All contingent consideration liabilities were paid in the first quarter of 2017.

The following table provides a rollforward of the fair value of contingent consideration (in thousands):

 

Balance at December 31, 2016

  $6,119   $6,119 

Payments

   (6,119   (6,119
  

 

   

 

 

Balance at June 30, 2017

  $—   

Balance at September 30, 2017

  $—   
  

 

   

 

 

In May 2016, the Company issued $115 million aggregate principal amount of the Notes due June 1, 2021. Interest is payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2016. As of JuneSeptember 30, 2017, the carrying value of the Notes was $97.2approximately $98.2 million, net of unamortized discount, and the fair value of the Notes was approximately $165.5$154.8 million. The fair value of the Notes was determined based on the most recent trade activity of the Notes as of JuneSeptember 30, 2017. These valuations are Level 1 valuations, as the valuations are based on unadjusted quoted prices in active markets that the Company has the ability to access. The Notes are discussed in more detail in Note 11, “Long Term Debt.

There were nore-measurements to fair value during the three months ended JuneSeptember 30, 2017 of financial assets and liabilities that are not measured at fair value on a recurring basis.

15. Commitments and Contingencies

15.Commitments and Contingencies

Future minimum rental commitments under the Company’s leases as of JuneSeptember 30, 2017 are as follows (in thousands):

 

  Minimum Rental
Commitments
   Minimum Rental
Commitments
 

2017 (six months remaining)

  $1,355 

2017 (three months remaining)

  $939 

2018

   2,707    3,644 

2019

   2,567    3,367 

2020

   2,567    3,060 

2021

   2,567    2,751 

Thereafter

   1,812    2,319 

16. Related Party Transactions

16.Segment Reporting

In July 2017, in conjunction with the Spectrum Acquisition, the Board of Directors engaged one of the Company’s independent directors to serve as the chairperson of the Spectrum Integration Committee. In this role, this Director will work directly with the Company’s executive team on general integration strategy and focus on the integration of Spectrum’s operations and commercial organization with the Company. As of September 30, 2017, the Company has accrued approximately $95,000 of expense related to this director’s services.

Additionally, certain facilities leased by Spectrum are owned by the former owner of Spectrum, who currently holds greater than 10% of the Company’s outstanding common stock. The lease amounts paid to this shareholder were negotiated in connection with the Spectrum Acquisition. The Company has incurred rent expense totaling $134,000 for the three-month period ended September 30, 2017 related to these leases.

17. Segment Reporting

The Company views its operations, makes decisions regarding how to allocate resources and manages its business as one operating segment. As a result, the financial information disclosed herein represents all of the material financial information related to the Company’s principal operating segment.

The following table represents the Company’s total revenue by geographic area (based on the location of the customer):

 

  Three months ended
June 30,
 Six months ended
June 30,
   Three months ended
September 30,
 Nine months ended
September 30,
 
  2017 2016 2017 2016   2017 2016 2017 2016 

United States

   38 45 38 37   45 45 40 40

Sweden

   29 29 28 31   15 23 23 29

United Kingdom and Ireland

   14 13 14 16   10 11 13 14

Other

   19 13 20 16   30 21 24 17
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total

   100 100 100 100   100 100 100 100
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Revenue from significant customers as a percentage of the Company’s total revenue is as follows:

 

  Three months ended
June 30,
 Six months ended
June 30,
   Three months ended
September 30,
 Nine months ended
September 30,
 
  2017 2016 2017 2016   2017 2016 2017 2016 

GE Healthcare

   28 28 28 31   17 23 24 29

MilliporeSigma

   19 30 20 30   14 28 18 30

Significant accounts receivable balances as a percentage of the Company’s total trade accounts receivable are as follows:

 

   June 30,
2017
  December 31,
2016
 

GE Healthcare

   20  26

MilliporeSigma

   15  8

Customer C

   14  —   

17.Subsequent Events

Acquisition of Spectrum, Inc.
   September 30,
2017
  December 31,
2016
 

GE Healthcare

   20  26

MilliporeSigma

   11  8

On August 1, 2017, the Company completed the acquisition of Spectrum pursuant to the terms of the Agreement and Plan of Merger and Reorganization, dated as of June 22, 2017, by and among the Company and Spectrum (such acquisition, the “Spectrum Acquisition”).

Spectrum is a diversified filtration company with a differentiated portfolio of hollow fiber cartridges, bench-top to commercial scale filtration and perfusion systems and a broad portfolio of disposable and single-use solutions. Spectrum’s products are primarily used for the filtration, isolation, purification and concentration of monoclonal antibodies, vaccines, recombinant proteins, diagnostic products and cell therapies where the company offers both standard and customized solutions to its bioprocessing customers.

Spectrum’s filtration products include its KrosFlo® line of hollow-fiber cartridges, tangential flow filtration (TFF) systems and single-use flow path consumables, as well as its Spectra/Por® portfolio of laboratory dialysis products and its Pro-Connex® single-use hollow fiber Module-Bag-Tubing (MBT) sets. Outside of filtration, the company sells its Spectra/Chrom® liquid chromatography products for research applications. These bioprocessing products account for the majority of Spectrum revenues. Spectrum also offers a line of operating room products.

The Spectrum Acquisition will be accounted for as a purchase of a business under ASC 805, Business Combinations. The Spectrum Acquisition was funded through payment of approximately $124.2 million in cash and 6,153,995 shares of the Company’s common stock totaling $247.6 million for a total purchase price of $371.8 million.

Consideration Transferred

The Company accounted for the Spectrum Acquisition as a purchase of a business under U.S. GAAP. Under the acquisition method of accounting, the assets of Spectrum were recorded as of the acquisition date, at their respective fair values, and consolidated with those of the Company. The fair value of the net assets acquired was approximately $371.8 million.

The estimated consideration and preliminary purchase price information has been prepared using a preliminary valuation. An updated purchase price valuation and allocation will be completed in the third quarter of 2017. The preparation of the valuation required the use of significant assumptions and estimates. Critical estimates included, but were not limited to, future expected cash flows, including projected revenues and expenses, and the applicable discount rates. These estimates were based on assumptions that Repligen believes to be reasonable. However, actual results may differ from these estimates.

The total consideration transferred follows (in thousands):

Cash consideration

  $124,686 

Equity consideration

   247,575 

Less: working capital adjustment

   (449
  

 

 

 

Net assets acquired

  $371,812 
  

 

 

 

Acquisition related costs are not included as a component of consideration transferred, but are expensed in the periods in which the costs are incurred. The Company has incurred $2,395,000 in transaction costs related to the Spectrum Acquisition for the three- andsix-month periods ended June 30, 2017. The transaction costs are included in selling, general and administrative expenses in the consolidated statements of operations.

Fair Value of Net Assets Acquired

The allocation of purchase price was based on the fair value of assets acquired and liabilities based on the preliminary valuation. The components and allocation of the purchase price consists of the following amounts (in thousands):

Cash and cash equivalents

  $7,071 

Marketable securities

   990 

Accounts receivable

   5,950 

Inventory

   11,349 

Prepaid expenses and other current assets

   891 

Fixed assets

   5,613 

Customer relationships

   73,530 

Developed technology

   37,630 

Trademark and tradename

   2,140 

Non-competition agreements

   770 

Other assets

   988 

Goodwill

   276,241 

Accounts payable

   (1,287

Accrued liabilities

   (2,248

Deferred tax liabilities, net

   (42,629

Unrecognized tax benefit

   (576

Estimated closing indebtedness

   (2,635

Estimated transaction costs

   (1,976
  

 

 

 

Fair value of net assets acquired

  $371,812 
  

 

 

 

The preliminary purchase price allocation is subject to adjustment as purchase accounting is finalized. The final purchase price allocation will be determined upon completion of a final valuation analysis, and the fair value allocation of assets acquired and liabilities assumed could differ materially from the preliminary valuation analysis. The final allocation may include, but not be limited to, changes in the fair value of property, plant and equipment and changes in allocations to intangible assets and goodwill, as well as changes in the values of other assets and liabilities.

Due to the proximity of the closing date of the Spectrum Acquisition to the filing date of these financial statements, financial information from Spectrum, as well as other financial information related to the Spectrum Acquisition, could not be reasonably obtained in order to prepare pro forma financial statement disclosures as of and for the three- andsix-month periods ended June 30, 2017.

Public Offering of Common Stock

On July 3, 2017, the Company completed a public offering in which 2,807,017 shares of its common stock were sold to the public at a price of $42.75 per share. The underwriters were granted an option, which they exercised in full, to purchase an additional 421,052 shares of the Company’s common stock. The total proceeds from this offering, net of underwriting discounts, commissions and other offering expenses, totaled approximately $129.4 million.

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We are a bioprocessing-focused, global life sciences company bringing over 30 years of expertise and innovation to our customers. Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide.

Focused on delivering cost and process efficiencies, we offer innovative technologies that help set new standards in the way that our customers manufacture biologic drugs We develop and market a broad range of high-value products and flexible solutions that address critical steps in the production of biologic drugs – principally antibody-based therapeutics, recombinant proteins and vaccines – while ensuring that the highest drug quality and safety standards are upheld.

Since our strategic decision in 2012 to focus fully on building our bioprocessing business, we have expanded and diversified our product offering beyond our core Protein A affinity ligands portfolio, and believe we are well-positioned in the bioprocessing market assingle-use and continuous processing technologies are increasingly adopted by biopharmaceutical manufacturers. This expansion has been through a combination of internal innovations and acquisitions. Our Proteins business today includes cell culture growth factors in addition to our longstanding Protein A ligands. In recent years, we have significantly expanded our Chromatography business, which includes ourbest-in-class OPUS®pre-packed columns as well as our ELISA kits and chromatography resins. In addition, we have established a Filtration business that includes our leading XCell™ ATF and TangenX™ tangential flow filtration (“TFF”) product lines, and with our acquisition of Spectrum, Inc. (“Spectrum”) on August 1, 2017 we added a diverse line of hollow fiber filtrationTFF products and systems through our acquisition of Spectrum, Inc.systems.

Our team has substantial experience in biomanufacturing and works with industry leaders and customers to develop innovative solutions that address pressure points in the bioproduction process. Our bioprocessing products drive process efficiency, cost and yield improvements for our customers. In upstream processes, our XCell™ ATF filtration devices and cell culture supplements are used in clinical and commercial-stage manufacturing to improve biologic drug yields. In downstream processes, our Protein A ligands are a critical component of Protein A resins used to purify over 70 antibody-based drugs on the market and in over 300 drugs in clinical development. Also in downstream processes, our OPUS®pre-packed chromatography columns (PPCs) are used in the purification of clinical-stage biologics, and our TangenX™ Sius™flat sheet TFF filtration cassettes are used to concentrate clinical and commercial-stage biologic drugs. Spectrum KrosFlo™ TFF systems are used downstream in ultrafiltration and diafiltration applications as well as microfiltration applications. In perfusion (continuous) processes, Spectrum KrosFlo™ TFF is upstream in cell retention applications.

We manufacture and supply our Protein products, such as Protein A ligands, through long-term agreements with major life sciences companies, such as GE Healthcare and MilliporeSigma, who in turn produce and sell Protein A resins to end users (biopharmaceuticalbiopharmaceutical companies and CMOs)contract manufacturing organizations (“CMOs”). We manufacture and supply our cell culture supplements through a distribution agreement with MilliporeSigma.

We sell our Chromatography and Filtration products directly to biopharmaceutical companies and contract manufacturing organizations (“CMOs”).CMOs. These products are manufactured or assembled internally and marketed globally through a direct commercial organization in the United States (US) and Europe, and through a combination of direct sales and distributors in Asia. Since 2014, we have steadily invested in our global commercial organization to support our growing Chromatography and Filtration businesses; we have added 32 sales, marketing, product management, service and applications personnel to form a40-person commercial team as of JuneSeptember 30, 2017. The acquisition of Spectrum further expands our commercial organization in the US and Europe, and adds a direct sales presence in Asia Pacific regions.

Our commercial and R&D teams have a track record of launching new products and building new markets for acquired technologies. For example, since acquiring the XCell™ ATF business in 2014, we have expanded its market penetration through increased customer interaction, product extensions and new applications that increase flexibility and convenience for customers, while streamlining their biomanufacturing workflows.

Our acquisitions since 2012 have bolstered ourdirect-to-customer product offering. In 2014, we acquired our XCell™ ATF line from Refine Technologies LLC. We completed two acquisitions in 2016, acquiring Atoll GmbH (“Atoll”) in April (the “Atoll Acquisition”) and TangenX Technology Corporation (“TangenX”) in December (the “TangenX Acquisition”). The Atoll Acquisition strengthened our Chromatography business by broadening our line of OPUS®pre-packed columns (to includelab- and process development-scale columns) and establishing a customer-facing center in Europe. The TangenX Acquisition strengthened our Filtration business, balancing our existing upstream XCell™ ATF line with a downstream line of TangenX™ Sius™ TFF filtration products. On August 1, 2017, we completed the acquisition ofacquired Spectrum, a leader in bioprocess filtration with expertise in hollow fiber technology based in Rancho Dominguez, California (the “Spectrum Acquisition”). We believe the addition of Spectrum will strengthen our Filtration business and support our flagship XCell™ ATF product line with an extensive consumables portfolio. We also believe the Spectrum Acquisition will help diversify our markets beyond monoclonal antibody manufacturing, into vaccine and recombinant protein production.

Our internal innovation has also driven the growth of ourdirect-to-customer product offerings. Internally, we developeddevelop and market our process-scale OPUS®pre-packed chromatography columns. Also through internal innovation, we have extended both our OPUS® and XCell™ ATF product lines, to include more size options and technology features to benefit our customers. For example in 2016 we introduced OPUS® R, a resin recovery feature on our largest OPUS® columns, and we launched asingle-use (disposable) alternative to our stainless steel XCell™ ATF Systems, XCell™ ATFSingle-use. Notably, the Spectrum Acquisition satisfies a strategic goal of owning the hollow fiber filter cartridges that can be used in our XCell™ ATF devices. Spectrum has historically been a key supplier of these filters to Repligen.us.

Many of our products are early in their adoption cycle and, together with the expansion of our commercial organization and strategic acquisitions, have contributed to product revenue expansion from $41.8 million in 2012 to $104.5 million in 2016. While all product franchises have grown, our diversification strategy has resulted in our direct product sales accounting for approximately 50% of our bioprocessing revenue in 2016, compared to approximately 20% in 2012. To meet increased demand for our products, we have increased and continue to increase the volume and scale of manufacturing at our two manufacturing facilities in the United States and Sweden and plan to expand manufacturing capacity at our newly acquired manufacturing facilities in the United States and Germany.

Customers use our products to produce initial quantities of drug for clinical studies, thenscale-up to larger volumes as the drug progresses to commercial production following regulatory approval. Detailed specifications for a drug’s manufacturing process are included in applications that must be approved by regulators, such as the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency, throughout the clinical trial process and prior to final commercial approval. As a result, products that become part of the manufacturing specifications of a late-stage clinical or commercial process can be very “sticky” due to the costs and uncertainties associated with displacing them.

Spectrum Acquisition

On June 22, 2017, the Company announced its entry into the Spectrum Merger Agreement. On August 1, 2017, the Company completed the Spectrum Acquisition for approximately $124.2$122.9 million in cash, and 6,153,995 unregistered shares of the Company’s common stock totaling $247.6 million and an estimated working capital adjustment of approximately $1.0 million for a total purchase price of $371.5 million, subject to further adjustment based on (i) cash and working capital adjustment provisions, (ii) the amount of Spectrum’s transaction expenses and indebtedness that remain unpaid as of the closing of the merger, and (iii) indemnification obligations of holders of equity securities of Spectrum receiving merger consideration.

Spectrum is a diversified filtration company with a differentiated portfolio of hollow fiber cartridges,bench-top to commercial scale filtration and perfusion systems and a broad portfolio of disposable andsingle-use solutions. Spectrum’s products are primarily used for the filtration, isolation, purification and concentration of monoclonal antibodies, vaccines, recombinant proteins, diagnostic products and cell therapies where the company offers both standard and customized solutions to its bioprocessing customers.

Spectrum’s filtration products include its KrosFlo® line of hollow-fiber cartridges, tangential flow filtration (TFF)TFF systems andsingle-use flow path consumables, as well as its Spectra/Por® portfolio of laboratory dialysis products and itsPro-Connex®single-use hollow fiberModule-Bag-Tubing (MBT) sets. Outside of filtration, the company sells its Spectra/Chrom® liquid chromatography products for research applications. These bioprocessing products account for the majority of Spectrum revenues. Spectrum also offers a line of operating room products.

Critical Accounting Policies and Estimates

A “critical accounting policy” is one which is both important to the portrayal of our financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For additional information, please see the discussion of our critical accounting policies in Management’s Discussion and Analysis of Financial Condition and Results of Operations and our significant accounting policies in Note 2 to the Financial Statements included in our Annual Report on Form10-K for the year ended December 31, 2016.

Results of Operations

Revenues

Product revenuesRevenues for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 were as follows:

 

  Three months ended
September 30,
 Nine months ended
September 30,
 
(in thousands, except percentages) Three months ended
June 30,
 Six months ended
June 30,
   2017   2016   $ Change   % Change 2017   2016   $ Change   % Change 
 2017 2016 $ Change % Change 2017 2016 $ Change % Change 

Product revenue

 $32,434  $29,170  $3,264  11.2 $63,003  $54,265  $8,738  16.1  $36,514   $24,677   $11,837    48.0 $99,516   $78,942   $20,574    26.1

Royalty and other revenue

 21   —    21  100.0 42   —    42  100.0   66    —      66    100.0 108    —      108    100.0
 

 

  

 

  

 

   

 

  

 

  

 

    

 

   

 

   

 

    

 

   

 

   

 

   

Total revenues

 $32,455  $29,170  $3,285  11.3 $63,045  $54,265  $8,780  16.2  $36,580   $24,677   $11,903    48.2 $99,624   $78,942   $20,682    26.2
 

 

  

 

  

 

   

 

  

 

  

 

    

 

   

 

   

 

    

 

   

 

   

 

   

 

 

Sales of bioprocessing productsRevenues increased 11.2%48.2% and 16.1%26.2% in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year. This increase was primarily due to increases in orders for our XCell ATF systems and OPUSpre-packed chromatography columns from our key bioprocessing customers, in addition to revenues from the Spectrum Acquisition, Atoll Acquisition and the TangenX Acquisition in 2017. Sales of our bioprocessing products are impacted by the timing of orders, development efforts at our customers orend-users and regulatory approvals for biologics that incorporate our products, which may result in significant quarterly fluctuations. Such quarterly fluctuations are expected, but they may not be predictive of future revenue or otherwise indicate a trend.

Costs and operating expenses

Total costs and operating expenses for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 were comprised of the following:

 

  Three months ended
September 30,
 Nine months ended
September 30,
 
(in thousands, except percentages) Three months ended
June 30,
 Six months ended
June 30,
   2017   2016   $ Change % Change 2017   2016   $ Change % Change 
 2017 2016 $ Change % Change 2017 2016 $ Change % Change 

Cost of product revenue

 $13,937  $12,644  $1,293  10.2 $27,926  $23,713  $4,213  17.8  $19,987   $11,242   $8,745  77.8 $47,913   $34,955   $12,958  37.1

Research and development

 1,860  1,890  (30 (1.6%)  3,602  3,430  172  5.0   2,001    1,886    115  6.1 5,603    5,316    287  5.4

Selling, general and administrative

 11,185  8,140  3,045  37.4 20,367  15,159  5,208  34.4   14,998    7,127    7,871  110.4 35,365    22,286    13,079  58.7

Contingent consideration – fair value adjustments

  —    637  (637 (100.0%)   —    2,642  (2,642 (100.0%)    —      675    (675 (100.0%)   —      3,317    (3,317 (100.0%) 
 

 

  

 

  

 

   

 

  

 

  

 

    

 

   

 

   

 

   

 

   

 

   

 

  

Total costs and operating expenses

 $26,982  $23,311  $3,671  15.7 $51,895  $44,944  $6,951  15.5  $36,986   $20,930   $16,056  76.7 $88,881   $65,874   $23,007  34.9
 

 

  

 

  

 

   

 

  

 

  

 

    

 

   

 

   

 

   

 

   

 

   

 

  

Cost of product revenue increased 10.2%77.8% and 17.8%37.1% in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year. This increase is primarily due to the increased product revenues noted aboveabove; the impact of the Spectrum Acquisition, the Atoll Acquisition and the TangenX Acquisition; and product mix. Gross margins may fluctuate in the third and fourth quarters of 2017 based on expected production volume and product mix.

Research and development expenses decreased 1.6%increased 6.1% and increased 5.0%5.4% in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year. This increase is primarily related to the timing and scale of our various bioprocessing product development projects.projects as well as costs related to continuing projects assumed as part of the Spectrum Acquisition. Expenses generally include personnel costs, external development costs, supplies and other expenses related to our new products in development.

Selling, general and administrative expenses increased 37.4%110.4% and 34.4%58.7% in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year. This increase is primarily due to additional expense resulting from our acquisitions of Spectrum, Atoll and TangenX, the continued buildout of our administrative infrastructure to support future growth, and the continued expansion of our customer-facing activities to drive sales of our bioprocessing products, additional expense resulting from our acquisitions of Atoll and TangenX and costs related to our pending acquisition of Spectrum.products.

Contingent consideration fair value adjustments were approximately $637,000$675,000 and $2,642,000$3,317,000 for the three- andsix-month nine-month periods ended JuneSeptember 30, 2016. These fair value adjustments were related to the increased probability of achieving the 2016 sales milestone under the Refine acquisition agreement. There was no such expense in 2017, as the contingent consideration periods for the Atoll Acquisition and Refine Acquisition ended in 2016.

Investment income

Investment income for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was as follows:

 

  Three months ended
September 30,
 Nine months ended
September 30,
 
(in thousands, except percentages) Three months ended
June 30,
 Six months ended
June 30,
   2017   2016   $ Change   % Change 2017   2016   $ Change   % Change 
 2017 2016 $ Change % Change 2017 2016 $ Change % Change 

Investment income

 $110  $76  $34  44.7 $206  $137  $69  50.4  $102   $97   $5    5.2 $308   $234   $74    31.6

Investment income includes income earned on invested cash balances. Increases in investment income in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year are mainly attributable to higher average interest rates and higher average invested cash balances related to the receipt of proceeds from the issuance of our 2.125% Convertible Senior Notes due 2021 (the “Notes”) in May 2016 and our issuance of convertible senior notescommon stock in MayJuly 2017.

Interest expense

Interest expense for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was as follows:

 

  Three months ended
September 30,
 Nine months ended
September 30,
 
(in thousands, except percentages) Three months ended
June 30,
 Six months ended
June 30,
   2017 2016 $ Change % Change 2017 2016 $ Change % Change 
 2017 2016 $ Change % Change 2017 2016 $ Change % Change 

Interest expense

 $(1,601 $(638 $(963 150.9 $(3,187 $(643 $(2,544 395.6  $(1,618 $(1,555 $(63 4.1 $(4,804 $(2,198 $(2,606 118.6

Increases in interest expense in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year are attributable to interest expense related to the issuance of convertible senior notesthe Notes in May 2017.2016.

Other income (expense)

Other income (expense) for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was as follows:

 

  Three months ended
September 30,
 Nine months ended
September 30,
 
(in thousands, except percentages) Three months ended
June 30,
 Six months ended
June 30,
   2017 2016 $ Change % Change 2017 2016 $ Change   % Change 
 2017 2016 $ Change % Change 2017 2016 $ Change % Change 

Other income (expense)

 $(328 $75  $(403 (537.3%)  $(448 $(904 $456  50.4  $(100 $(75 $(25 33.3 $(548 $(979 $431    44.0

Changes in other income (expense) in the current three- and six-monthnine-month periods, respectively, compared to the corresponding periods in the prior year are primarily attributable to foreign currency losses related to amounts due fromnon-Swedish kronor-based customers and cash balances denominated in U.S. dollars and British pounds held by our Sweden operations.

Income tax (benefit) provision

Income tax (benefit) provision for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 was as follows:

 

  Three months ended
September 30,
 Nine months ended
September 30,
 
(in thousands, except percentages) Three months ended
June 30,
 Six months ended
June 30,
   2017 2016   $ Change % Change 2017 2016   $ Change % Change 
 2017 2016 $ Change % Change 2017 2016 $ Change % Change 

Income tax provision

 $(4,784 $1,500  $(6,284 (418.9%)  $(3,785 $2,415  $(6,200 (256.7%)   $(6,691 $1,059   $(7,750 (731.8%)  $(10,476 $3,474   $(13,950 (401.6%) 

For the three- andsix-month nine-month periods ended JuneSeptember 30, 2017, we had losses before taxes of ($2,022,000) and income before taxes of $3,654,000 and $7,721,000,$5,699,000, respectively, and recorded a tax benefit of ($4,784,000)6,691,000) and ($3,785,000)10,476,000), respectively. The effective tax rate was (130.9%)330.9% and (49.0%(183.8%) for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017, respectively, and is based upon the estimated income for the year and the composition of the income in different jurisdictions. The effective tax rate was lower than the U.S. statutory tax rate of 34% primarily due to a benefit of approximately $6,611,000 related to the release of the valuation allowance on deferred tax assets held in the U.S. resulting from the Spectrum Acquisition in the third quarter of 2017 and a benefit of approximately $5,625,000 related to the reduction of the Company’s valuation allowance on its deferred tax assets resulting from the sale of certain intellectual property from Repligen Corporation to Repligen Sweden AB in the second quarter of 2017.

For the three- andsix-month nine-month periods ended JuneSeptember 30, 2016, we had income before taxes of $5,372,000$2,214,000 and $7,911,000,$10,125,000, respectively, and recorded a tax provision of $1,500,000$1,059,000 and $2,415,000,$3,474,000, respectively. The effective tax rate was 27.9%47.8% and 30.5%34.3% for the three- andsix-month nine-month periods ended JuneSeptember 30, 2016, respectively, and is based upon the estimated income for the year and the composition of the income in different jurisdictions. The effective tax rate differs fromin the prior year is lower than the U.S. statutory tax rate primarily due to lower statutory tax rates in foreign jurisdictions and the tax treatment of contingent consideration expense recorded in the first half of 2016.and related payments.

Non-GAAP Financial Measures

We providenon-GAAP adjusted income from operations, adjusted net income, and adjusted EBITDA as supplemental measures to GAAP measures regarding our operating performance. A detailed explanation and a reconciliation of eachnon-GAAP financial measure to its most comparable GAAP financial measure are provided below.

We include this financial information because we believe these measures provide a more accurate comparison of our financial results between periods and more accurately reflect how management reviews its financial results. We excluded the impact of certain acquisition-related items because we believe that the resulting charges do not accurately reflect the performance of our ongoing operations for the period in which such charges are incurred.

In the first quarter of 2017, we began deducting intangible amortization in our presentation ofnon-GAAP financial metrics. Thenon-GAAP financial metrics included in our Quarterly Reports on Form10-Q for the quartersquarter ended March 31, 2016 and JuneSeptember 30, 2016 do not deduct intangible amortization. However, we have included a deduction for thenon-GAAP financial metrics below for the three- andsix-month nine-month periods ended March 31, 2016 and JuneSeptember 30, 2016 for comparability. As a result, thenon-GAAP financial metrics below differ from those included in our Quarterly Reports on Form10-Q for the quartersquarter ended March 31, 2016 and JuneSeptember 30, 2016.

Adjusted Income from Operations

Adjusted income from operations is measured by taking income from operations as reported in accordance with GAAP and excluding acquisition and integration costs, inventorystep-up charges, amortization of intangible assets and contingent consideration expense booked through our consolidated statements of comprehensive income.

The following is a reconciliation of income from operations in accordance with GAAP to adjusted income from operations for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 (in thousands):

 

  Three months ended June 30,   Six months ended June 30,   Three months ended September 30,   Nine months ended September 30, 
  2017   2016   2017   2016   2017   2016   2017   2016 

GAAP income from operations

  $5,473   $5,859   $11,150   $9,321 

GAAP income (loss) from operations

  $(406  $3,747   $10,743   $13,068 

Non-GAAP adjustments to net income:

                

Acquisition costs

   2,385    725    2,787    1,118 

Acquisition and integration costs

   3,378    144    6,165    1,262 

Inventorystep-up charges

   2,720    —      2,720    —   

Intangible amortization

   769    533    1,484    932    1,993    552    3,476    1,484 

Contingent consideration – fair value adjustments

   —      637    —      2,642    —      675    —      3,317 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Non-GAAP adjusted income from operations

  $8,627   $7,754   $15,421   $14,013   $7,685   $5,118   $23,104   $19,131 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Adjusted Net Income

Adjusted net income is measured by taking net income as reported in accordance with GAAP and excluding acquisition and integration costs, inventorystep-up charges, amortization of intangible assets and related tax effects, contingent consideration expense,non-cash interest expense and the partial release of the valuation allowance on our deferred tax assets booked through our consolidated statements of comprehensive income.

The following is a reconciliation of net income in accordance with GAAP to adjusted net income for the three-month periods ended JuneSeptember 30, 2017 and 2016:

 

   Three Months Ended June 30, 
   2017   2016 
   (in thousands)
Amount
   Fully Diluted
Earnings per
Share
   (in thousands)
Amount
   Fully Diluted
Earnings per
Share
 

GAAP net income

  $8,438   $0.24   $3,872   $0.11 

Non-GAAP adjustments to net income:

        

Acquisition costs

   2,385    0.07    725    0.02 

Contingent consideration – fair value adjustments

   —      —      637    0.02 

Intangible amortization

   769    0.02    533    0.02 

Non-cash interest expense

   986    0.03    382    0.01 

Tax effect of intangible amortization

   (103   (0.00   (105   (0.00

Release of valuation allowance on deferred tax assets

   (5,625   (0.16   —      —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjusted net income

  $6,850   $0.20   $6,044   $0.18 
  

 

 

   

 

 

   

 

 

   

 

 

 

   Three Months Ended September 30, 
   2017   2016 
   (in thousands)
Amount
   Fully Diluted
Earnings per
Share
   (in thousands)
Amount
   Fully Diluted
Earnings per
Share
 

GAAP net income

  $4,669   $0.11   $1,155   $0.03 

Non-GAAP adjustments to net income:

        

Acquisition and integration costs

   3,378    0.08    144    0.00 

Inventorystep-up charges

   2,720    0.06    —      —   

Contingent consideration – fair value adjustments

   —      —      675    0.02 

Intangible amortization

   1,993    0.05    552    0.02 

Non-cash interest expense

   1,002    0.02    938    0.03 

Tax effect of intangible amortization and acquisition costs

   (577   (0.01   (104   (0.00

Release of valuation allowance on deferred tax assets

   (6,611   (0.16   —      —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP adjusted net income

  $6,574   $0.15   $3,360   $0.10 
  

 

 

   

 

 

   

 

 

   

 

 

 

The following is a reconciliation of net income in accordance with GAAP tonon-GAAP adjusted net income for thesix-month nine-month periods ended JuneSeptember 30, 2017 and 2016:

 

  Six Months Ended June 30,   Nine Months Ended September 30, 
  2017   2016   2017 2016 
  (in thousands)
Amount
   Fully Diluted
Earnings per
Share
   (in thousands)
Amount
   Fully Diluted
Earnings per
Share
   (in thousands)
Amount
 Fully Diluted
Earnings per
Share
 (in thousands)
Amount
 Fully Diluted
Earnings per
Share
 

GAAP net income

  $11,506   $0.33   $5,496   $0.16   $16,175  $0.43  $6,651  $0.20 

Non-GAAP adjustments to net income:

             

Acquisition costs

   2,787    0.08    1,118    0.03 

Acquisition and integration costs

   6,165  0.16  1,262  0.04 

Inventorystep-up charges

   2,720  0.07   —     —   

Contingent consideration – fair value adjustments

   —      —      2,642    0.08    —     —    3,317  0.10 

Intangible amortization

   1,484    0.04    932    0.03    3,476  0.09  1,484  0.04 

Non-cash interest expense

   1,956    0.06    382    0.01    2,958  0.08  1,320  0.04 

Tax effect of intangible amortization

   (204   (0.01   (209   (0.01

Tax effect of intangible amortization and acquisition costs

   (781 (0.02 (313 (0.01

Release of valuation allowance on deferred tax assets

   (5,625   (0.16   —      —      (12,236 (0.33  —     —   
  

 

   

 

   

 

   

 

   

 

  

 

  

 

  

 

 

Non-GAAP adjusted net income

  $11,904   $0.34   $10,361   $0.31   $18,477  $0.49  $13,721  $0.40 
  

 

   

 

   

 

   

 

   

 

  

 

  

 

  

 

 

Per share totals may not add due to rounding.

Adjusted EBITDA

Adjusted EBITDA is measured by taking net income as reported in accordance with GAAP, excluding investment income, interest expense, taxes, depreciation and amortization, and excluding acquisition and integration costs, inventorystep-up charges and contingent consideration expenses booked through our consolidated statements of comprehensive income.

The following is a reconciliation of net income in accordance with GAAP to adjusted EBITDA for the three- andsix-month nine-month periods ended JuneSeptember 30, 2017 and 2016 (in thousands):

 

  Three months ended June 30,   Six months ended June 30,   Three months ended September 30,   Nine months ended September 30, 
  2017   2016   2017   2016   2017   2016   2017   2016 

GAAP net income

  $8,438   $3,872   $11,506   $5,496   $4,669   $1,155   $16,175   $6,651 

Non-GAAP EBITDA adjustments to net income:

                

Investment income

   (110   (76   (206   (137   (102   (97   (308   (234

Interest expense

   1,601    638    3,187    643    1,618    1,555    4,804    2,198 

Tax provision

   (4,784   1,500    (3,785   2,415    (6,691   1,059    (10,476   3,474 

Depreciation

   929    785    1,858    1,536    1,130    824    2,988    2,360 

Amortization

   769    533    1,484    932    1,993    552    3,476    1,484 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

EBITDA

   6,843    7,252    14,044    10,885    2,617    5,048    16,659    15,933 

Othernon-GAAP adjustments:

                

Acquisition costs

   2,385    725    2,787    1,118 

Acquisition and integration costs

   3,378    144    6,165    1,262 

Inventorystep-up charges

   2,720    —      2,720    —   

Contingent consideration – fair value adjustments

   —      637    —      2,642    —      675    —      3,317 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Adjusted EBITDA

  $9,228   $8,614   $16,831   $14,645   $8,715   $5,867   $25,544   $20,512 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Liquidity and Capital Resources

We have financed our operations primarily through revenues derived from product sales, research grants, proceeds and royalties from license arrangements, a litigation settlement, sales of equity securities and issuance of convertible debt. Our revenue for the foreseeable future will primarily be limited to our bioprocessing product revenue.

At JuneSeptember 30, 2017, we had cash and cash equivalents of $159,666,000 compared to cash and marketable securities of $144,951,000 compared to $141,780,000 at December 31, 2016. A deposit for leased office space of $450,000 is classified as restricted cash and is not included in cash and marketable securities totals as of JuneSeptember 30, 2017 and December 31, 2016.

OnIn July 3, 2017, we completed a public offering in which 2,807,017 shares of our common stock were sold to the public at a price of $42.75 per share. The underwriters were granted an option, which they exercised in full, to purchase an additional 421,052 shares of our common stock. The total proceeds from this offering, net of underwriting discounts, commissions and other offering expenses, totaled approximately $129.4$129.3 million.

On August 1, 2017, we completed our acquisition of Spectrum for approximately $124.2$122.9 million in cash and 6,153,995 unregistered shares of the Company’s common stock.

During the third quarter of 2017, the closing price of the Company’s common stock exceeded 130% of the conversion price of the Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the Notes are convertible at the option of the holders of the Notes during the fourth quarter of 2017. As a result, the Notes with a face value of $115 million and a carrying value of $98.2 million are classified as current liabilities on the Company’s consolidated balance sheet as of September 30, 2017. It is the Company’s policy and intent to settle the face value of the Notes in cash and any excess conversion premium in shares of our common stock. As of the date of this filing, none of the Notes have been converted by the holders of such Notes.

Operating activities

For thesix-month nine-month period ended JuneSeptember 30, 2017, our operating activities provided cash of $3,961,000$2,233,000 reflecting net income of $11,506,000$16,175,000 andnon-cash charges totaling $2,941,000$1,115,000 primarily related to depreciation, amortization,non-cash interest expense, deferred tax expense and stock-based compensation charges. An increase in accounts receivable consumed $6,347,000$8,472,000 of cash, and was primarily due to the increase in revenues and timing of cash receipts from customers. An increase in inventories consumed $813,000 of cash to support future revenues. An increase in accounts payable provided $1,740,000 of cash, which was primarily due to the timing of purchases and payments to vendors. Payments of accrued liabilities consumed $4,216,000$6,089,000 of cash, and were mainly due to the payment of contingent consideration to Refine and Atoll related to 2016 sales milestones.milestones and the payment of certain Spectrum liabilities in the third quarter of 2017. The remaining cash flow provided by operations resulted from net unfavorable changes in various other working capital accounts.

For thesix-month nine-month period ended JuneSeptember 30, 2016, our operating activities provided cash of $6,753,000$5,567,000 reflecting net income of $5,496,000$6,651,000 andnon-cash charges totaling $7,766,000$12,148,000 including depreciation, amortization,non-cash interest expense, stock-based compensation charges, deferred tax expenses and the revaluation of contingent consideration. A decreaseAn increase in accounts receivable provided $892,000consumed $3,270,000 of cash, and was primarily due to the timing of cash receipts from customers. An increase in inventories

consumed $5,093,000$6,457,000 of cash to support future revenues. Decreases in accounts payable consumed $1,918,000 of cash, and were due primarily due to purchasing activity and timing of cash payments to vendors. Payments of accrued liabilities consumed $3,239,000$2,389,000 of cash, and was mainly due to the payment of contingent consideration to Refine related to 2015 sales milestones.

Investing activities

We place our marketable security investments in high quality credit instruments as specified in our investment policy guidelines. Our investing activities provided $14,132,000consumed $97,075,000 of cash for thesix-month nine-month period ended JuneSeptember 30, 2017, primarily due to the payment of cash consideration of $112,941,000 (net of cash received) for the Spectrum Acquisition and $3,686,000 used for fixed asset additions, partially offset by net redemptions of marketable securities of $16,808,000 offset by $2,676,000 used for fixed asset additions.$19,552,000. For thesix-month nine-month period ended JuneSeptember 30, 2016, our investing activities provided $20,000. Net redemptions of marketable debt securities provided $10,148,000 of cash.consumed $13,878,000 for the nine-month period ended September 30, 2016. On April 1, 2016 we paid $8,767,000approximately $8.8 million (net of cash received) as cash consideration for the acquisition of Atoll, Acquisition. Additionally, we$3,462,000 used $1,406,000 of cash for fixed asset additions in thesix-month period ended June 30, 2016.and net purchases of marketable securities of $1,694,000.

Financing activities

For thesix-month nine-month period ended JuneSeptember 30, 2017, our financing activities used $172,000provided $129,642,000 of cash. We madeIn July 2017, we completed a public offering in which 2,807,017 shares of our common stock were sold to the public at a price of $42.75 per share. The underwriters were granted an option, which they exercised in full, to purchase an additional 421,052 shares of our common stock. The total proceeds from this offering, net of underwriting discounts, commissions and other offering expenses, totaled approximately $129.3 million. Proceeds from stock option exercises in the nine-month period ended September 30, 2017 were $2,035,000, partially offset by contingent consideration payments of $1,677,000$1,702,000 related to the initial valuation of the likelihood that the 2016 XCell™ ATF sales milestones and Atoll revenue growth milestones would be achieved. These payments were partially offset by proceeds from stock option exercises totaling $1,505,000. For thesix-month nine-month period ended JuneSeptember 30, 2016, our financing activities provided $111,783,000$112,202,000 of cash. In May 2016, we received net proceeds of $111.3$111.1 million from the issuance of our 2.125% Convertible Senior Notes due 2021. For thesix-month period ended June 30, 2016, proceeds Notes. Proceeds from exercises of $958,000stock options totaling $1,630,000 were partially offset by contingent consideration payments of $498,000 which stemmed from the initial valuation of the likelihood that the 2015 ATF sales milestone would be achieved.

We do not currently use derivative financial instruments.

Working capital increaseddecreased by approximately $16,348,000$50,330,000 to $179,426,000$112,748,000 at JuneSeptember 30, 2017 from $163,078,000 at December 31, 2016 due to the various changes noted above.above as well as the reclassification of the Notes to current liabilities from long term liabilities, as these Notes are convertible at the option of the holders of these Notes in the fourth quarter of 2017.

Our future capital requirements will depend on many factors, including the following:

 

the expansion of our bioprocessing business;

 

the ability to sustain sales and profits of our bioprocessing products;

 

market acceptance of our new products;

 

our ability to acquire additional bioprocessing products;

 

the resources required to successfully integrate the acquisitions of Refine and Atoll and recognize expected synergies;

 

our identification and execution of strategic acquisitions or business combinations;

 

the scope of and progress made in our research and development activities;

 

the extent of any share repurchase activity;

the election of any Note holders to convert their Notes during an eligible period; and

the success of any proposed financing efforts.

Absent acquisitions of additional businesses, products, product candidates or intellectual property, we believe our current cash balances are adequate to meet our cash needs for at least twelve months from the date of this filing.filing, even if all of the Notes are converted by the holders of those Notes in the fourth quarter of 2017. We expect operating expenses in the year ending December 31, 2017 to increase as we integrate Spectrum into our business, continue to expand our bioprocessing business. We expect to incur continued spending following the closing of the Spectrum Acquisitiondevelop and otherwise related to the development and expansion ofexpand our bioprocessing product lines and expansion ofexpand our commercial capabilities for the foreseeable future. Our future capital requirements may include, but are not limited to, purchases of property, plant and equipment, the acquisition of additional bioprocessing products and technologies to complement our existing manufacturing capabilities, continued investment in our intellectual property portfolio and future repayment of convertible debt.

We plan to continue to invest in our bioprocessing business and in key research and development activities associated with the development of new bioprocessing products. We actively evaluate various strategic transactions on an ongoing basis, including monetizing existing assets and licensing or acquiring complementary products, technologies or businesses that would complement our

existing portfolio of development programs. We continue to seek to acquire such potential assets that may offer us the best opportunity to create value for our shareholders. In order to acquire such assets, we may need to seek additional financing to fund these investments. This may require the issuance or sale of additional equity or debt securities. The sale of additional equity may result in additional dilution to our stockholders. Should we need to secure additional financing to acquire a product, fund future investment in research and development, or meet our future liquidity requirements, we may not be able to secure such financing, or obtain such financing on favorable terms because of the volatile nature of the biotechnology marketplace.

Off-Balance Sheet Arrangements

We do not have any special purpose entities oroff-balance sheet financing arrangements as of JuneSeptember 30, 2017.

Cautionary Statement Regarding Forward-Looking Statements

This Quarterly Report on Form10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements in this Quarterly Report on Form10-Q do not constitute guarantees of future performance. Investors are cautioned that statements in this Quarterly Report on Form10-Q which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding current or future financial performance and position, potential impairment of future earnings, management’s strategy, plans and objectives for future operations or acquisitions, product development and sales, litigation strategy, product candidate research, development and regulatory approval, selling, general and administrative expenditures, intellectual property, development and manufacturing plans, availability of materials and product and adequacy of capital resources and financing plans constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative or supply relationships, including our agreements with BioMarin, General ElectricGE Healthcare and MilliporeSigma, our ability to successfully grow our bioprocessing business, including as a result of acquisition,acquisitions, commercialization or partnership opportunities, and our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our patent and other intellectual property rights, the risk of litigation with collaborative partners, our limited sales and marketing experience and capabilities, our limited manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers, our ability to hire and retain skilled personnel, the market acceptance of our products, reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition, our ability to compete with larger, better financed life sciences companies, our history of losses and expectation of incurring losses, our ability to generate future revenues, our ability to successfully integrate Refine, Atoll, TangenX and TangenX,Spectrum, our ability to raise additional capital to fund potential acquisitions, our volatile stock price, and the effects of our anti-takeover provisions. Further information on potential risk factors that could affect our financial results are included in the filings made by us from time to time with the Securities and Exchange Commission including under the section entitled “Risk Factors” in our Annual Report on Form10-K for the year ended December 31, 2016 and in thisour Quarterly Report on Form10-Q.10-Q for the quarter ended June 30, 2017.

 

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest rate risk

We have investmentshistorically invested funds in U.S. Government and agency securities. As a result, we arehave been exposed to potential loss from market risks that may occur as a result of changes in interest rates, changes in credit quality of the issuer or otherwise.

We generally place our marketable security investments As of September 30, 2017, we do not have any such investments; however, we may seek to invest funds in high quality credit instruments,similar investment vehicles in the future, as specified in our investment policy guidelines. A hypothetical 100 basis point increase in interest rates would result in an approximate $5,000 decrease in the fair value of our investments as of June 30, 2017. We believe, however, that the conservative nature of our investments mitigates our interest rate exposure, and ourOur investment policy limits the amount of our credit exposure to any one issuer, (with the exception of U.S. agency obligations) and type of instrument. We do not expect any material loss from our marketable security investments and therefore believe that our potential interest rate exposure is limited.

Foreign exchange risk

The reporting currency of the Company is U.S. dollars. Transactions by Repligen Sweden, a wholly-owned subsidiary, may be denominated indollars, and the functional currency of each of our foreign subsidiaries is its respective local currency. Our foreign currency exposures include the Swedish kronor, Euro, British pound, sterling, U.S. dollars, or Euros whileChinese yuan, Japanese yen, Singapore dollar, South Korean won and Indian rupee; of these, the entity’s functionalprimary foreign currency isexposures are the Swedish krona. Transactions by Repligen Germany GmbH, a wholly-owned subsidiary, may be denominated in U.S. dollars or Euros while the entity’s functional currency is the Euro. Certain sales transactions made by the U.S. entity related to XCell™ ATF system products are denominated in foreign currencies.kronor, Euro and British pound. Exchange gains or losses resulting from the translation between the transactional currency and the functional currency are included in net income. Fluctuations in exchange rates may adversely affect our results of operations, financial position and cash flows. We currently do not seek to hedge this exposure to fluctuations in exchange rates.

ITEM 4.CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

The Company’s management, with the participation of the principal executive officer and the principal financial officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules13a-15(e) or15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based on such evaluation, the principal executive officer and principal financial officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were effective in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, on a timely basis, and is accumulated and communicated to the Company’s management, including the Company’s principal executive officer and the Company’s principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control

OnWe acquired Spectrum LifeSciences, LLC (“Spectrum”) on August 1, 2017. The financial results of Spectrum are included in our unaudited condensed consolidated financial statements as of September 30, 2017 and for the quarter then ended. The Spectrum business represented approximately 57% of our total assets as of September 30, 2017 and approximately $7.6 million of revenue and ($2.0) million of net loss, respectively, for the quarter then ended. As this acquisition occurred in the third quarter of 2017, the scope of our assessment of our internal control over financial reporting does not include Spectrum. This exclusion is in accordance with the SEC’s general guidance that an assessment of a recently acquired business may be omitted from our scope in the year of acquisition.

Additionally, on December 14, 2016, we completed our acquisition of TangenX Technology Corporation (“TangenX”). On June 30, 2017 we legally merged TangenX into Repligen Corporation. As a result, we are in the process of integrating the businessWe continue to integrate TangenX into our control environment, and determining the need for additional controls in our internal control over financial reporting. process and procedures to conform to those of Repligen.

Other than the foregoing, there have been no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Securities Exchange Act Rule13a-15 or Rule15d-15 that occurred in the three months ended JuneSeptember 30, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

 

ITEM 1.LEGAL PROCEEDINGS

From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.

 

ITEM 1A.RISK FACTORS

The following information updates, and should be read in conjunction with, the factorsmatters discussed in Part I,this Quarterly Report onForm 10-Q include forward-looking statements that involve risks or uncertainties. These statements are neither promises nor guarantees, but are based on various assumptions by management regarding future circumstances, over many of which Repligen has little or no control. A number of important risks and uncertainties, including those identified under the caption “Risk Factors” in Item 1A “Risk Factors” in our Annual Report onForm 10-K for for the year ended December 31, 2016 whichand subsequent filings as well as risks and uncertainties discussed elsewhere in this Quarterly Report onForm 10-Q, could cause our actual results to differ materially affect our business, financial condition or future results. The risksfrom those in the forward-looking statements. There are no material changes to the Risk Factors described in our Annual Report onForm 10-K for as updated inthe fiscal year ended December 31, 2016 and our Quarterly Report on Form10-Q for the quarter ended March 31, 2017 and this Quarterly Report, are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or operating results.

Risks Related to the Spectrum Acquisition

Spectrum may have unknown liabilities or liabilities which exceed our estimates. Any such liabilities could adversely affect the financial position of the combined company.

Spectrum’s business activities may have associated with them various potential liabilities relating to the conduct of its business prior to the Spectrum Acquisition, including, but not limited to, product liability, historical tax matters and other potential liabilities that could adversely affect the financial position of the combined company. We have assumed these potential liabilities since August 1,June 30, 2017. While we have evaluated and continue to evaluate what we believe to be the most significant of these potential liabilities, it is possible that certain unknown liabilities could be realized and other liabilities (including those that we have fully evaluated and those that we have not fully evaluated) may exceed our estimates. Spectrum and its security holders’ obligation to indemnify us is limited to approximately $36.0 million, subject to limited exceptions. If any issues were to arise, we may not be entitled to sufficient, or any, indemnification or recourse from Spectrum and its shareholders, which could have a materially adverse impact on our business and results of operations.

The Spectrum Acquisition could possibly create numerous risks and uncertainties, which could adversely affect our financial condition and operating results.

Strategic transactions like the Spectrum Acquisition create numerous uncertainties and risks. Given that Spectrum is now our wholly-owned subsidiary, we expect that the acquisition will result in a loss per share on a GAAP basis for us in 2017. Further, the addition of Spectrum to our business will entail many changes, including the integration of Spectrum and its personnel, changes in systems and employee benefit plans and management of multiple geographic locations. These transition activities are complex and we may encounter unexpected difficulties, incur unexpected costs or experience business disruptions, including as a result of:

 

disruption of our ongoing businesses and increased commitments for the management team, including the need to divert management’s attention to integration matters, particularly if we are unable to recruit, hire and retain key personnel;

difficulties in retaining Spectrum’s key personnel and its sales force;

difficulties in integrating Spectrum’s products, systems, sales force, internal controls over financial reporting and technologies;

changes in market demand for Spectrum’s products;

risks associated with acquiring intellectual property;

difficulties in operating Spectrum profitably;

difficulties in transitioning and maintaining key manufacturer, customer, distributor and supplier relationships;

our inexperience with Spectrum’s customers and our ability to meet or exceed such customers’ service level expectations and Spectrum’s contractual obligations with respect to such customers;

difficulties realizing the revenue projections, growth prospects, financial benefits, synergies, market position and other strategic opportunities anticipated in connection with the acquisition;

risks associated with entering foreign markets in which we have no or limited prior experience;

potential disputes regarding Spectrum’s intellectual property;

potential disputes with the sellers of Spectrum; and

difficulties in the assimilation and retention of employees, including key personnel responsible for the success of Spectrum’s operations.

If any of these factors limits our ability to integrate Spectrum into our operations successfully or on a timely basis, the expectations of future results of operations, including certain synergies, might not be met. As a result, we may not be able to realize the expected benefits that we sought to achieve from the acquisition, which could result in declines in the market value of our common stock. In addition, we may be required to spend additional time or money on integration that otherwise would be spent on the development and expansion of our business, including efforts to further expand our product portfolio.

We acquired Spectrum under certain assumptions that may prove to be materially inaccurate.

Our assumptions may be inaccurate, including as the result of higher than expected transaction and integration costs as well as general economic and business conditions that could adversely affect the combined company. For example, the purchase price for Spectrum was significantly more than Spectrum’s net book value as of April 1, 2017. Accordingly, we will record a substantial amount of goodwill and other intangible assets as a result of the acquisition. In the event that industry, competitive or technological factors become unfavorable, we may incur future impairment of the value of goodwill and other intangible assets acquired through the acquisition. Under GAAP, we are not allowed to amortize goodwill or other indefinite-lived intangible assets. Instead, we are required to periodically determine if our goodwill and other indefinite-lived intangible assets have become impaired, in which case we would write down the impaired portion of our goodwill and/or other indefinite-lived intangible assets. If we were required to write down all or part of our goodwill or other indefinite-lived intangible assets, our net income (loss) and stockholders’ equity could be materially and adversely affected.

Risks Related to the Business of Spectrum

Spectrum’s operating results and financial condition may fluctuate.

Spectrum’s operating results and financial condition may fluctuate from quarter to quarter and year to year for a number of reasons. The following events or occurrences, among others, could cause fluctuations in its financial performance from period to period:

loss of revenue from Repligen as a customer;

development of new competitive products by others;

changes in the amount it spends to promote its products and develop new technologies;

changes in technology that may render its products obsolete;

increases in the cost of raw materials used to manufacture its products;

manufacturing and supply interruptions, including failure to comply with manufacturing specifications;

the impact of third party patents and other intellectual property rights which it may be found to infringe, or may be required to license, and the potential damages or other costs it may be required to pay as a result of a finding that it infringes such intellectual property rights;

the mix of products that it may sell during any time period;

lower than expected demand for its products;

its response to price competition;

expenditures as a result of legal actions;

the impairment and write-down of goodwill or other intangible assets;

general economic and industry conditions, including changes in interest rates affecting returns on cash balances and investments that affect customer demand;

impairment or write-down of investments or long-lived assets;

costs and outcomes of tax audits, including an ongoing audit by the Internal Revenue Commission;

fluctuations in foreign currency exchange rates; and

risks related to the growth of its business across numerous countries world-wide and the inherent international economic, regulatory, political and business risks.

Spectrum’s products are subject to quality control requirements.

Whether a product is produced by Spectrum or purchased from outside suppliers, it is subjected to quality control procedures, including the verification of porosity and with certain products, the complete validation for good manufacturing practices, U.S. Food and Drug Administration, CE and ISO 2001 compliance, prior to final packaging. Quality control is performed by a staff of technicians utilizing calibrated equipment. In the event Spectrum, or its manufacturers, produce batches of product that fail to comply with required quality standards, it may incur delays in fulfilling orders, write-downs, damage to its reputation and damages resulting from product liability claims.

Spectrum’s business could suffer as a result of manufacturing difficulties or delays.

Spectrum’s business could suffer if certain manufacturing or other equipment, or a portion or all of its facilities were to become inoperable for a period of time. This could occur for various reasons, including catastrophic events such as earthquake, monsoon, hurricane or explosion, unexpected equipment failures or delays in obtaining components or replacements thereof, as well as construction delays or defects and other events, both within and outside of our control. Spectrum’s largest manufacturing facility is in Rancho Dominguez, California, which is an area that is prone to earthquakes and other natural disasters. Any inability to timely manufacture its products could have a material adverse effect on Spectrum’s results of operations, financial condition and cash flows.

If Spectrum is unable to obtain or maintain its intellectual property, its operations may be adversely affected.

Spectrums endeavors to obtain and maintain the patents and trade secrets that it utilizes in its manufacturing process. Its commercial success will depend, in part, on its ability to:

obtain and maintain patent protection for its products and manufacturing processes;

preserve its trade secrets;

operate without infringing the proprietary rights of third parties; and

obtain any necessary licenses from others on acceptable terms.

We cannot be sure that any patent applications relating to Spectrum’s products that it files in the future or that any currently pending applications will issue on a timely basis, if ever. Even if patents are issued, the degree of protection afforded by such patents will depend upon the scope of the patent claims, the validity and enforceability of the claims obtained and our willingness and financial ability to enforce such patents.

The patent position of life sciences companies is often highly uncertain and usually involves complex legal and scientific questions. In some cases, litigation or other proceedings may be necessary to assert claims of infringement, to enforce patents issued to Spectrum. Such litigation could result in substantial cost to Spectrum and diversion of its resources. An adverse outcome in any such litigation or proceeding could have a material adverse effect on Spectrum’s business, financial condition and results of operations.

Spectrum’s global operations expose it to risks and challenges associated with conducting business internationally.

Spectrum operates on a global basis with offices or activities in Japan, South Korea, China, India, Europe and North America. Spectrum faces several risks inherent in conducting business internationally, including compliance with international and U.S. laws and regulations that apply to its international operations. These laws and regulations include data privacy requirements, labor relations laws, tax laws, real estate and property laws, anti-competition regulations, import and trade restrictions, export requirements, U.S. laws such as the Foreign Corrupt Practices Act, and other U.S. federal laws and regulations established by the office of Foreign Asset Control, local laws such as the UK Bribery Act 2010 or other local laws which prohibit corrupt payments to governmental officials or certain payments or remunerations to customers. Given the high level of complexity of these laws, however, there is a risk that some provisions may be inadvertently breached by Spectrum, for example through fraudulent or negligent behavior of individual employees, its failure to comply with certain formal documentation requirements, or otherwise. Violations of these laws and regulations could result in fines, criminal sanctions against Spectrum, its officers or its employees, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on Spectrum’s ability to offer its products in one or more countries and could materially damage its reputation, brand, international expansion efforts and operating results.

Foreign currency fluctuations could adversely affect Spectrum’s business and financial results.

Spectrum does business and generates sales in numerous countries outside the United States. As such, foreign currency fluctuations may affect the costs that it incurs in such international operations. Some of its operating expenses are incurred innon-U.S. dollar currencies. The appreciation ofnon-U.S. dollar currencies in those countries where it has operations against the U.S. dollar could increase our costs and could harm our results of operations and financial condition.

Spectrum’s foreign operations may become less attractive if political and diplomatic relations between the United States and any country where it conducts business operations deteriorates.

The relationship between the United States and the foreign countries where Spectrum conducts business operations may weaken over time. Changes in the state of the relations between any such country and the United States are difficult to predict and could adversely affect Spectrum’s future operations. This could lead to a decline in its profitability. Any meaningful deterioration of the political and diplomatic relations between the United States and the relevant country could have a material adverse effect on Spectrum’s operations.

Spectrum may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that it violated the Foreign Corrupt Practices Act could have a material adverse effect on our business.

Spectrum is subject to the Foreign Corrupt Practice Act, or the FCPA, and other laws that prohibit improper payments or offers of payments to foreign governments and their officials and political parties by U.S. persons and issuers as defined by the statute for the purpose of obtaining or retaining business. Spectrum has significant operations, agreements with third parties and sales in jurisdictions outside of the U.S., which may experience corruption. Spectrum’s activities in jurisdictions outside of the U.S. create the risk of unauthorized payments or offers of payments by one of our employees, consultants, sales agents or distributors, because these parties are not always subject to our control. Violations of the FCPA may result in severe criminal or civil sanctions, and Spectrum may be subject to other liabilities, which could negatively affect its business, operating results and financial condition.

Prior to the Spectrum Acquisition, Spectrum was a private company and has not previously been subject to the Sarbanes-Oxley Act of 2002, the rules and regulations of the SEC or other corporate governance requirements.

Prior to its acquisition by us, Spectrum was a private company and has not been subject to the Sarbanes-Oxley Act of 2002, the rules and regulations of the SEC, or other corporate governance requirements to which public reporting companies may be subject. As a result, we are required to implement the appropriate internal control processes and procedures over Spectrum’s financial accounting and reporting. We may incur significant legal, accounting and other expenses in efforts to meet these requirements, which may include additional staffing, infrastructure investments and improving Spectrum’s finance function systems and process. Implementing the controls and procedures at Spectrum that are required to comply with the various applicable laws and regulations may place a significant burden on our management and internal resources. The diversion of management’s attention and any difficulties encountered in such an implementation could adversely affect our business, financial condition and operating results.

Risks Related to Our Business

If we are unable to obtain or maintain our intellectual property, we may not be able to succeed commercially.

We endeavor to obtain and maintain trade secrets and, to a lesser extent, patent protection for our products and processes when available in order to protect them from unauthorized use and to produce a financial return consistent with the significant time and expense required to bring our products to market. Our success will depend, in part, on our ability to:

preserve our trade secrets andknow-how;

operate without infringing the proprietary rights of third parties;

obtain and maintain patent protection for our products and manufacturing processes; and

secure any necessary licenses from others on acceptable terms.

We consider trade secrets,know-how and other forms of market protection to be among the most important elements of our proprietary position. We also own or have exclusive rights to a number of U.S. patents and U.S. pending patent applications as well as corresponding foreign patents and patent applications. We continue to actively and selectively pursue patent protection and seek to expand our patent estate, and we cannot be sure that any patent applications relating to our products that we will file in the future or that any currently pending applications will issue on a timely basis, if ever. We cannot be certain that we were the first to make the inventions covered by each of our pending patent applications or that we were the first to file patent applications for such inventions. Even if patents are issued, the degree of protection afforded by such patents will depend upon the:

scope of the patent claims;

validity and enforceability of the claims obtained in such patents; and

our willingness and financial ability to enforce and/or defend them.

The patent position of life sciences companies is often highly uncertain and usually involves complex legal and scientific questions. Patents which may be granted to us in certain foreign countries may be subject to opposition proceedings brought by third parties or result in suits by us, which may be costly and result in adverse consequences for us.

In some cases, litigation or other proceedings may be necessary to assert claims of infringement, to enforce patents issued to us or our licensors, to protect trade secrets,know-how or other intellectual property rights we own or to determine the scope and validity of the proprietary rights of third parties. Such litigation could result in substantial cost to us and diversion of our resources. An adverse outcome in any such litigation or proceeding could have a material adverse effect on our business, financial condition and results of operations. If our competitors prepare and file patent applications in the United States that claim technology also claimed by us, we may be required to participate in interference proceedings declared by the U.S. Patent and Trademark Office to determine priority of invention, which would result in substantial costs to us.

ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.Pursuant to the Agreement and Plan of Merger and Reorganization described in Note 2 to Condensed Consolidated Financial Statements, on August 1, 2017, the Company issued 6,153,995 unregistered shares of the Company’s common stock valued at $247.6 million as part of the consideration for the Company’s acquisition of Spectrum. The issuance is not registered under the Securities Act of 1933, as amended (the “Securities Act”), in reliance upon the exemption from registration provided by Rule 506(b) of Regulation D.

 

ITEM 3.DEFAULTS UPON SENIOR SECURITIES

None.

 

ITEM 4.MINE SAFETY DISCLOSURES

Not applicable.

 

ITEM 5.OTHER INFORMATION

None.

 

ITEM 6.EXHIBITS

(a) Exhibits

 

Exhibit

Number

  

Document Description

    2.1

Agreement and Plan of Merger and Reorganization, dated June 22, 2017, by and among Repligen Corporation, Top Hat,

Inc., Swing Time, LLC, Spectrum, Inc., and Roy T. Eddleman (filed as Exhibit 2.1 to Repligen Corporation’s Current

Report on Form8-K filed on June 23, 2017 and incorporated herein by reference).

3.1  

Restated Certificate of Incorporation, dated JuneSeptember 30, 1992 and amended September  17, 1999 (filed as Exhibit 3.1 to

Repligen Corporation’s Quarterly Report on Form10-Q for the quarter ended September 30, 1999 and incorporated herein by reference).

3.2  

Certificate of Amendment to the Certificate of Incorporation of Repligen Corporation, effective as of May  16, 2014 (filed

as Exhibit 3.1 to Repligen Corporation’s Current Report on Form8-K filed on May 19, 2014 and incorporated herein by

reference).

3.3  

Second Amended and Restated Bylaws (filed as Exhibit 3.1 to Repligen Corporation’s Current Report on Form8-K filed

on May 23, 2017 and incorporated herein by reference).

Exhibit

Number

Document Description

  10.131.1 +  

Stockholder Agreement, dated June 22, 2017, by and between Repligen Corporation and Roy T. Eddleman (filed as

Exhibit 10.1 to Repligen Corporation’s Current Report on FormRule8-K13a-14(a)/15d-14(a) filed on June 23, 2017 and incorporated herein by

reference).

Certification.
  31.131.2 +  Rule13a-14(a)/15d-14(a) Certification.
  31.2 +32.1 *  Rule13a-14(a)/15d-14(a) Certification.
  32.1*Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101+  The following materials from Repligen Corporation on Form10-Q for the quarterly period ended March 31,September 30, 2017, formatted in Extensible Business Reporting Language (xBRL): (i) Condensed Consolidated Statements of Comprehensive Income (Loss), (ii) Condensed Consolidated Balance Sheets, (iii) Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Condensed Consolidated Financial Statements, tagged as blocks of text.

 

+Filed herewith.
*Furnished herewith.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  REPLIGEN CORPORATION
Date: August 3,November 9, 2017  By:  

/S/s/ TONY J. HUNT

    Tony J. Hunt
    President and Chief Executive Officer
    (Principal executive officer)
    Repligen Corporation
Date: August 3,November 9, 2017  By:  

/S/s/ JON SNODGRES

    Jon Snodgres
    Chief Financial Officer
    (Principal financial officer)
    Repligen Corporation

 

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