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 March 31, 20172018

OR

 

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

For the transition period from    to        

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, or an emerging growth 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 April 28, 2017.May 1, 2018.

 

Class

 

Number of Shares

Common Stock, par value $.01 per share

 34,080,66443,693,913

 

 

 


Table of Contents

 

     PAGE 
PART IFINANCIAL INFORMATION
Item 1.

PART I

 Unaudited Condensed Consolidated Financial Statements

FINANCIAL INFORMATION

  

Item 1.

Unaudited Condensed Consolidated Financial Statements

Condensed Consolidated Balance Sheets as of March  31, 20172018 and December 31, 20162017

   3 

Condensed Consolidated Statements of Comprehensive Income for the Three-Month Periods Ended March 31, 20172018 and 20162017

   4 

Condensed Consolidated Statements of Cash Flows for the Three-Month Periods Ended March 31, 20172018 and 20162017

   5 

Notes to Unaudited Condensed Consolidated Financial Statements

   6 

Item 2.

 

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

   2322 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

   2928 

Item 4.

 

Controls and Procedures

28

PART II

OTHER INFORMATION

   30 
PART II

Item 1.

 

OTHER INFORMATIONLegal Proceedings

   3130 

Item 1.1A.

 

Legal ProceedingsRisk Factors

   3130 

Item 1A.2.

 Risk Factors31
Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

   3130 

Item 3.

 

Defaults Upon Senior Securities

   3130 

Item 4.

 

Mine Safety Disclosures

   3130 

Item 5.

 

Other Information

   3130 

Item 6.

 

Exhibits

   3130 

Signatures

   3332 

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

(in thousands, except share data)  March 31, 2017 December 31,
2016
   March 31, 2018 December 31, 2017 

Assets

      

Current assets:

      

Cash and cash equivalents

  $129,663  $122,233   $173,876  $173,759 

Marketable securities

   12,180  19,547 

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

   17,710  15,194 

Other receivables

   669  839 

Inventories

   23,957  24,696 

Accounts receivable, less reserve for doubtful accounts of $59 at March 31, 2018 and $58 at December 31, 2017, respectively

   29,352  27,585 

Royalties and other receivables

   31  153 

Inventories, net

   40,124  39,004 

Prepaid expenses and other current assets

   1,620  1,644    4,939  2,281 
  

 

  

 

   

 

  

 

 

Total current assets

   185,799  184,153    248,322  242,782 
  

 

  

 

 

Property, plant and equipment, net

   15,373  14,956    22,674  22,417 

Intangible assets, net

   29,222  29,806    142,273  144,753 

Goodwill

   59,784  59,548    327,989  327,333 

Restricted cash

   450  450 

Other assets

   1,990  6,234 
  

 

  

 

   

 

  

 

 

Total assets

  $290,628  $288,913   $743,248  $743,519 
  

 

  

 

   

 

  

 

 

Liabilities and stockholders’ equity

      

Current liabilities:

      

Accounts payable

  $4,635  $5,061   $6,200  $7,282 

Accrued liabilities

   9,116  16,014    14,121  17,929 
  

 

  

 

   

 

  

 

 

Total current liabilities

   13,751  21,075    20,321  25,211 

Convertible senior notes

   96,242  95,272 

Convertible senior notes, net

   100,276  99,250 

Deferred tax liabilities

   2,188  2,103    20,858  25,167 

Other long-term liabilities

   1,656  1,699    4,610  2,343 

Commitments and contingencies (Note 11)

   

Commitments and contingencies (Note 14)

   

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, 34,076,544 shares at March 31, 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, 43,692,303 shares at March 31, 2018 and 43,587,079 shares at December 31, 2017 issued and outstanding

   437  436 

Additionalpaid-in capital

   245,961  242,036    631,595  628,983 

Accumulated other comprehensive loss

   (12,718 (13,749   (6,112 (6,363

Accumulated deficit

   (56,793 (59,861   (28,737 (31,508
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

   176,791  168,764    597,183  591,548 
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

  $290,628  $288,913   $743,248  $743,519 
  

 

  

 

   

 

  

 

 

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

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(Unaudited)

 

  Three months ended March 31, 
(in thousands, except share and per share data)  Three months ended March 31,   2018 2017 
  2017 2016 

Revenue:

      

Product revenue

  $30,569  $25,094   $44,799  $30,569 

Royalty and other revenue

   21   —      31  21 
  

 

  

 

   

 

  

 

 

Total revenue

   30,590  25,094    44,830  30,590 

Operating expenses:

      

Cost of product revenue

   13,990  11,069    19,668  13,990 

Research and development

   1,742  1,539    3,288  1,742 

Selling, general and administrative

   9,182  7,018    15,898  9,182 

Contingent consideration – fair value adjustments

   —    2,005 
  

 

  

 

   

 

  

 

 

Total operating expenses

   24,914  21,631    38,854  24,914 
  

 

  

 

   

 

  

 

 

Income from operations

   5,676  3,463    5,976  5,676 

Investment income

   96  61    181  96 

Interest expense

   (1,585 (5   (1,652 (1,585

Other expense

   (120 (979

Other income (expense)

   71  (120
  

 

  

 

   

 

  

 

 

Income before income taxes

   4,067  2,540    4,576  4,067 

Income tax provision

   999  915    1,128  999 
  

 

  

 

   

 

  

 

 

Net income

  $3,068  $1,625   $3,448  $3,068 
  

 

  

 

   

 

  

 

 

Earnings per share:

      

Basic

  $0.09  $0.05   $0.08  $0.09 
  

 

  

 

   

 

  

 

 

Diluted

  $0.09  $0.05   $0.08  $0.09 
  

 

  

 

   

 

  

 

 

Weighted average shares outstanding:

      

Basic

   33,891,702  33,024,681    43,621,270  33,891,702 
  

 

  

 

   

 

  

 

 

Diluted

   34,382,322  33,493,575    44,326,732  34,382,322 
  

 

  

 

   

 

  

 

 

Other comprehensive income:

      

Unrealized gain on investments

   4  15    —    4 

Foreign currency translation gain

   1,027  1,881    251  1,027 
  

 

  

 

   

 

  

 

 

Comprehensive income (loss)

  $4,099  $3,521 

Comprehensive income

  $3,699  $4,099 
  

 

  

 

   

 

  

 

 

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

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

  Three months ended March 31, 
(In thousands)  Three months ended March 31,   2018 2017 
  2017 2016 

Cash flows from operating activities:

      

Net income

  $3,068  $1,625   $3,448  $3,068 

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

   

Adjustments to reconcile net income to net cash provided by operating activities:

   

Depreciation and amortization

   1,582  1,150    3,960  1,582 

Non-cash interest expense

   970   —      1,036  970 

Stock-based compensation expense

   1,531  922    2,268  1,531 

Deferred tax expense

   10   —      449 10

Loss on revaluation of contingent consideration

   —    2,005 

Loss on conversion of senior convertible notes

   1  —   

Loss on disposal of assets

   59  3    —    59

Changes in assets and liabilities:

      

Accounts receivable

   (2,415 (1,149   (1,529 (2,415

Other receivables

   172  (249   127  172 

Inventories

   851  (3,092   (1,188 851 

Prepaid expenses and other current assets

   34  781    (1,608 34 

Accounts payable

   (452 (1,600   (1,550 (452

Accrued liabilities

   (4,220 (4,277   (3,839 (4,220

Long-term liabilities

   (43 70    (3 (43
  

 

  

 

   

 

  

 

 

Net cash provided by (used in) operating activities

   1,147  (3,811

Net cash provided by operating activities

   1,572  1,147 
  

 

  

 

   

 

  

 

 

Cash flows from investing activities:

      

Purchases of marketable securities

   (28 (3,969   —    (28

Redemptions of marketable securities

   7,400  5,600    —    7,400 

Purchases of property, plant and equipment

   (1,295 (431   (1,564 (1,295
  

 

  

 

   

 

  

 

 

Net cash provided by investing activities

   6,077  1,200 

Net cash (used in) provided by investing activities

   (1,564 6,077 
  

 

  

 

   

 

  

 

 

Cash flows from financing activities:

      

Exercise of stock options

   1,333  821    344  1,333 

Payment of contingent considerations

   (1,663 (498

Repayment of senior convertible notes

   (11  —   

Payment of contingent consideration

   —    (1,663
  

 

  

 

   

 

  

 

 

Net cash (used in) provided by financing activities

   (330 323 

Net cash provided by (used in) financing activities

   333  (330
  

 

  

 

   

 

  

 

 

Effect of exchange rate changes on cash and cash equivalents

   536  1,409    (224 536 
  

 

  

 

   

 

  

 

 

Net increase (decrease) in cash and cash equivalents

   7,430  (879   117  7,430 

Cash and cash equivalents, beginning of period

   122,233  54,092 

Cash, cash equivalents and restricted cash, beginning of period

   173,759  122,683 
  

 

  

 

   

 

  

 

 

Cash and cash equivalents, end of period

  $129,663  $53,213 

Cash, cash equivalents and restricted cash, end of period

  $173,876  $130,113 
  

 

  

 

   

 

  

 

 

Supplemental disclosure ofnon-cash activities:

      

Income taxes paid

  $1,181  $1,039   $937  $1,181 
  

 

  

 

   

 

  

 

 

Non-cash effect of adoption of ASU2016-16

  $5,609  $—   
  

 

  

 

 

Payment of contingent consideration in common stock

  $1,062  $875   $—    $1,062 
  

 

  

 

   

 

  

 

 

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

REPLIGEN CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

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, 2016.2017.

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 of April 1, 2016 and renamed on September 20, 2016)Repligen Singapore Pte. Ltd., our former subsidiary, TangenX Technology Corporation (acquired(“TangenX,” acquired on December 14, 2016 and merged into the Company as of December 14, 2016)June 30, 2017) and Repligen Singapore Pte. Ltd.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),”(“ASC 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 includeincluded 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 adoptadopted the provisions of TopicASC 606 using the modified retrospective method effective January 1, 2018. The Company has commenced work to assess the impactSee Note 3 for further discussion of the new revenueeffects of this standard on its principal revenue streams. The Company has not made a determination on the impact to itsCompany’s consolidated financial statements.

In July 2015,January 2016, the FASB issued ASUNo. 2015-11,2016-01, “Inventory (Topic 330)“Financial Instruments—Overall (Subtopic825-10): Simplifying the Recognition and Measurement of Inventory” (“ASU2015-11”). ASU2015-11 requires inventoryFinancial Assets and Financial Liabilities.” 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 measuredrequired to measure these investments at fair value at the lowerend of costeach reporting period and recognize changes in fair value in net realizable value,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 options that currently exist for market value be eliminated. ASU2015-11 defines net realizable value as estimated selling prices in the ordinary courseother aspects 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.current U.S. GAAP. The Company adopted this guidance in the provisionsfirst quarter of ASU2015-112018. Because the Company does not hold any equity securities as of January 1,December 31, 2017 and March 31, 2018, adoption of this standard did not have a materialany impact on its consolidated financial statements.

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.

In March 2016, the FASB issued ASU No.2016-09, “Compensation—Stock Compensation (Topic 718): Improvementsstatements, but does expect this new standard 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 itemshave a material impact 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 maintains a full valuation allowance on its net U.S. deferred tax assets, the Company recorded a corresponding increase to the valuation allowance and the impact of adopting ASU2016-09 on retained earnings is zero.Company’s consolidated balance sheet.

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 classifieshas historically classified 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,Because the Company does not expecthas classified its contingent consideration payments as required by this standard, the adoption of ASU2016-15 tothis standard did not have a materialany impact on its consolidated financial statements when applied on a retrospective basis.

In October 2016, the FASB issued ASU2016-16, “Intra-Entity Transfers of Assets Other Than Inventory.” ASU2016-16 requires that the income tax consequences of an intra-entity asset transfer other than inventory are recognized at the time of the transfer. An entity will continue to recognize the income tax consequences of an intercompany transfer of inventory when the inventory is sold to a third party. The Company adopted this standard on a modified-retrospective basis on January 1, 2018. See Note 12 for a discussion of the impact of this ASU on the Company’s financial statements.

In November 2016, the FASB issued ASUNo. 2016-18, “Statement of Cash Flows (Topic 230): Restricted Cash,” which requires that the statement of cash flows explain the change during the period in the total cash, which is inclusive of cash and cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning of period and end of period balances on the statement of cash flows upon adoption of this standard. The Company adopted this standard on a retrospective basis on January 1, 2018. The adoption resulted in an increase to cash, cash equivalents and restricted cash of $450,000 in the statement of cash flows at December 31, 2016 and March 31, 2017. The Company did not hold any restricted cash at December 31, 2017 or March 31, 2018.

In January 2017, the FASB issuedASU 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. ThisThe Company adopted this standard as of January 1, 2018, and the adoption of ASU2017-01 did not 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. ASUNo. 2017-04 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 public entities for fiscal yearsthe Company on a prospective basis beginning after December 15, 2017,on January 1, 2020, with early adoption permitted. The Company adopted this standard as of January 1, 2018, and the adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

2. Acquisitions

Atoll GmbHAcquisition of Spectrum LifeSciences, LLC

On AprilAugust 1, 2016,2017, the Company’s subsidiary, Repligen Sweden, acquired Atoll GmbH (“Atoll”) fromUV-Cap GmbH & Co. KG (the “Seller”)Company completed the acquisition of Spectrum pursuant to a Share Purchasethe terms of an Agreement (the “Atoll Share Purchase Agreement”),and Plan of Merger and Reorganization, dated as of March 31, 2016June 22, 2017 (such acquisition, the “Atoll“Spectrum Acquisition”), by.

Spectrum is a diversified filtration company with a differentiated portfolio of hollow fiber cartridges,bench-top to commercial scale filtration and among Repligen Sweden, the Seller,perfusion systems and the Company, in its capacity as guarantora broad portfolio 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. Paymentdisposable andsingle-use solutions. Spectrum’s products are primarily used for the Atoll Acquisition was denominated in Euros but is reflected here in U.S. dollarsfiltration, 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, Spectrum sells its Spectra/Chrom® liquid chromatography products for presentation purposes.research applications. These bioprocessing products account for the majority of Spectrum revenues. Spectrum also offers a line of operating room products.

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 “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 Stock Consideration under the Atoll Share Purchase Agreement. The issuance of the 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 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.Transferred

The Atoll Acquisition wasCompany accounted for the Spectrum Acquisition 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 a working capital adjustment of $425,000 for a 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 Stock Consideration, and a future potential milestone payment of $1.1 million if 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.$370.9 million. Under the acquisition method of accounting, the assets of AtollSpectrum 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$370.9 million.

The preparation of theestimated consideration and preliminary purchase price information has been prepared using a valuation that required the use of significant assumptions and estimates.estimates in its preparation. 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,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 

Value of common stock issued

   14,138 

Estimated fair value of contingent consideration

   952 
  

 

 

 

Total consideration transferred

  $25,266 
  

 

 

 

Cash consideration

  $122,932 

Equity consideration

   247,575 

Working capital adjustment

   425 
  

 

 

 

Net assets acquired

  $370,932 
  

 

 

 

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 the Seller. 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 March 31, 2017.

Acquisition relatedAcquisition-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 $1,262,000$655,000 in transaction costs related to the Atoll Acquisition. The transactionSpectrum Acquisition for the three-month period ended March 31, 2018 and $7,060,000 in costs for the year ended December 31, 2017. 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 AprilAugust 1, 2016.2017, based on the preliminary valuation. The components and allocation of the purchase price consists of the following amounts (in thousands):

 

Cash and cash equivalents

  $1,409   $10,137 

Accounts receivable

   697    5,075 

Inventory

   155    13,570 

Other current assets

   169 

Fixed assets, net

   114 

Prepaid expenses and other assets

   616 

Fixed assets

   6,004 

Deferred tax assets

   1,102 

Customer relationships

   5,318    78,400 

Developed technology

   2,175    38,560 

Trademark and tradename

   2,160 

Non-competition agreements

   57    960 

Trademark and trade name

   11 

Deferred tax assets

   885 

Accounts payable and other liabilities assumed

   (599

Goodwill

   265,654 

Accounts payable

   (1,335

Unrecognized tax benefit

   (576

Accrued liabilities

   (5,787

Deferred tax liabilities

   (2,202   (43,608

Goodwill

   17,077 
  

 

   

 

 

Net assets acquired

  $25,266 

Fair value of net assets acquired

  $370,932 
  

 

   

 

 

Of the consideration paid, $5.3$78.4 million represents the fair value of customer relationships that will beis amortized over the weighted average determined useful life of 1315 years, and $2.2$38.6 million represents the fair value of developed technology that will beis amortized over a determined useful life of 1420 years. $57,000$960,000 represents the fair value ofnon-competition agreements and $11,000that are amortized over a determined life of 3 years. $2.2 million represents the fair value of trademarks and trade names that will be amortized over aare determined to have an indefinite useful life of 2 years.life. The aforementioned intangible assets will beare 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 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.

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 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, 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

   (467
  

 

 

 

Net assets acquired

  $37,065 
  

 

 

 

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 $1,337,000 in transaction costs 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

   29,416 
  

 

 

 

Net assets acquired

  $37,065 
  

 

 

 

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 $29.4$265.7 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 may be subject to adjustment as purchase accounting is preliminary as of March 31, 2018 related to inventory valuation. The final allocation may include, but not be limited to, changes in allocations to inventory and goodwill.

Revenue, Net Income and Pro Forma Presentation

The Company recorded revenue from TangenXSpectrum of $119,000 from December 15, 2016 through December 31, 2016 and $1,973,000$11,719,000 for the three monthsthree-month period ended March 31, 2017.2018. The Company has included the operating results of TangenXSpectrum in its consolidated statements of operations since the December 15, 2016August 1, 2017 acquisition date. The following table presents unaudited supplemental pro forma information as if the TangenXSpectrum Acquisition had occurred as of January 1, 20162017 (in thousands, except per share data):

 

  March 31, 2017   March 31, 2016   Pro-forma
Three months ended
March 31, 2018
   Pro-forma
Three months ended
March 31, 2017
 

Total revenue

   30,590    26,952    44,830    39,875 

Net income

   3,608    5,118    3,939    3,266 

Earnings per share:

        

Basic

  $0.11   $0.15   $0.09   $0.08 
  

 

   

 

   

 

   

 

 

Diluted

  $0.10   $0.15   $0.09   $0.08 
  

 

   

 

   

 

   

 

 

The unaudited pro forma information for the three monthsthree-month period ended March 31, 2017 and 20162018 was calculated after applying the Company’s accounting policies and the impact of acquisition date fair value adjustments. Unaudited pro forma net income for three months ended March 31, 2017 was adjusted to exclude acquisition-related transaction costs and inventorystep-up charges. The unaudited pro forma net income for the three monthsthree-month period ended March 31, 20162018 was adjusted to includeexclude acquisition-related transaction costs, inventorystep-up charges, amortization of intangible assets and income tax benefits resulting fromas these expenses would have been incurred in the acquisition.prior year assuming the Spectrum Acquisition closed on January 1, 2017.

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.January 1, 2017. 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 combinationcombinations occurred at the beginning of eachthe period presented, or of future results of the consolidated entities.

3. Revenue Recognition

Product SalesAdoption of ASC Topic 606, Revenue from Contracts with Customers

The Company’s revenue recognition policy is to recognize revenues from product salesCompany adopted ASC 606 on January 1, 2018, using the modified retrospective method for all contracts not completed as of the date of adoption. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and servicesallocating transaction price in accordance with the practical expedient in paragraph ASC606-10-65-1-(f)-4, which did not have a material effect on the cumulative impact of adopting ASC 605,606. Results for reporting periods beginning January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period. The impact to the Company’s consolidated financial statements as a result of applying ASC 606 was immaterial. Deferred revenue resulting from contracts with customers is included in accrued expenses on the Company’s consolidated balance sheet.

Revenue Recognition. These standards require that revenues are

Revenue is recognized when, persuasive evidenceor as, obligations under the terms of an arrangement exists, product delivery, including customer acceptancea contract are satisfied, which occurs when required, has occurredcontrol of the promised products or services have been rendered,is transferred to customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing the expected value method or the most likely amount method, depending on the facts and circumstances relative to the contract. Variable consideration is fixed or determinableincluded in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and collectabilitydetermination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information (historical, current and forecasted) that is reasonably assured. Determinationavailable. Sales, value add, and other taxes collected on behalf of whether these criteria have been metthird parties are based on management’s judgments primarily regardingexcluded from revenue.

When determining the fixed naturetransaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying 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 thereforepractical expedient in paragraph606-10-32-18, the Company does not require collateral.assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of March 31, 2018.

Contracts with customers may contain multiple performance obligations. For such arrangements, the transaction price is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company has haddetermines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.

The Company recognizes product revenue under the terms of each customer agreement upon transfer of control to the customer, which occurs at a point in time.

Disaggregation of Revenue

Revenues for the three-month periods ended March 31, 2018 and 2017 were as follows:

   Three months ended
March 31,
 
(in thousands, except percentages)  2018   2017   $ Change   % Change 

Product revenue

  $44,799   $30,569   $14,230    47

Royalty and other revenue

   31    21    10    48
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

  $44,830   $30,590   $14,240    47

When disaggregating revenue, the Company considered all of the economic factors that may affect its revenues. Because all of its revenues are from bioprocessing customers, there are no significant write-offs of uncollectible invoicesdifferences in the periods presented. When more than one elementnature, timing and uncertainty of the Company’s revenues and cash flows from any of its product lines. However, given that the Company’s revenues are generated in different geographic regions, factors such as equipment,regulatory and geopolitical factors within those regions could impact the nature, timing and uncertainty of the Company’s revenues and cash flows. In addition, a significant portion of the Company’s revenues are generated from two customers; therefore, economic factors specific to these two customers could impact the nature, timing and uncertainty of the Company’s revenues and cash flows.

The following tables disaggregate the Company’s revenue from contracts with customers by geographic region (in thousands).

   Three months ended
March 31, 2018
 

North America

  $20,239 

Europe

   19,401 

Asia and Pacific

   4,947 

Other

   243 
  

 

 

 

Total revenue

  $44,830 
  

 

 

 

Revenue from significant customers is as follows (in thousands):

   Three months ended
March 31, 2018
 

GE Healthcare

  $7,717 

MilliporeSigma

  $6,465 

Protein Products

The Company’s protein product line generates revenue through the sale of Protein A ligands, an essential component of Protein A chromatography resins (media) used in the purification of virtually allmAb-based drugs on the market or in development. The Company manufactures multiple forms of Protein A ligands under long term supply agreements with major life sciences companies, who in turn sell their Protein A chromatography media to end users (biopharmaceutical manufacturers). Each protein product is considered distinct and therefore represents a separate performance obligation. Protein product revenue is generally recognized at a point in time upon transfer of control to the customer.

Filtration Products

The Company’s filtration product line generates revenue through the sale of KrosFlo® hollow-fiber (HF) tangential flow filtration (TFF) membranes and modules, ProConnex®single-use flow path connectors, flat sheet TFF cassettes and hardware, and XCell™ alternating tangential flow (ATF) devices and related consumables.

The Company markets the KrosFlo line of HF cartridges and TFF systems and the ProConnex line of single-use flow path connectors which were acquired as part of the acquisition of Spectrum in August 2017. These products are used in the filtration, isolation, purification and concentration of biologics and diagnostic products. Sales of large-scale systems generally include components and consumables as well as training and installation services at the request of the customer. Because the initial sale of components and consumables are contained innecessary for the operation of the system, such items are combined with the systems as a single arrangement,performance obligation. Training and installation services do not significantly modify or customize these systems and therefore represent a distinct performance obligation. Each of the Company’s other product offerings are not highly interdependent of one another and are therefore considered distinct products that represent separate performance obligations. Revenue on these products is generally recognized at a point in time upon transfer of control to the customer. The Company allocates revenue betweeninvoices the elements based on each element’s relative selling price, providedcustomer for the installation and training services in an amount that each element meetsdirectly corresponds with 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 elementsCompany’s performance to date; therefore, revenue recognized is determined bybased on the price charged whenamount billable to the elementcustomer in accordance with the practical expedient under ASC 606-10-55-18.

The Company also markets flat sheet TFF cassettes and hardware, which were acquired as part of the acquisition of TangenX Technology in December 2016. TFF is sold separately, ora rapid and efficient method for separation and purification of biomolecules that is widely used in cases whenlaboratory, process development and process scale applications in biopharmaceutical manufacturing. The Company’ssingle-use TFF (Sius™ TFF) cassettes and hardware are not highly interdependent of one another and are therefore considered distinct products that represent separate performance obligations. Sius TFF product revenue is generally recognized at a point in time upon transfer of control to the itemcustomer.

The Company also markets the XCell™ ATF System, a technologically advanced filtration device used in upstream processes to continuously remove cellular metabolic waste products during the course of a fermentation run, freeing healthy cells to continue producing the biologic drug of interest. ATF Systems typically include a filtration system and consumables (i.e., tube devices, metal stands) as well as training and installation services at the request of the customer. The filtration system and consumables are considered distinct products and therefore represent separate performance obligations. First time purchasers of the systems typically purchase a controller that is shipped with the tube device(s) and metal stand(s). The controller is not sold separately, by third-party evidenceconsidered distinct as it is a proprietary product that is highly interdependent with the filtration system; therefore, the controller is combined with the filtration system and accounted for as a single performance obligation. The training and installation services do not significantly modify or customize the ATF system and therefore represent a distinct performance obligation. ATF system product revenue related to the filtration system (including the controller if applicable) and consumables is generally recognized at a point in time upon transfer of selling price or management’s best estimatecontrol to the customer. ATF system service revenue related to training and installation services is generally recognized over time, as the customer simultaneously receives and consumes the benefits as the Company performs. The Company invoices the customer for the installation and training services in an amount that directly corresponds with the value to the customer of selling price.the Company’s performance to date; therefore, revenue recognized is based on the amount billable to the customer in accordance with the practical expedient under ASC606-10-55-18.

Chromatography Products

The Company’s chromatography product revenuesline includes a number of products used in the downstream purification and quality control of biological drugs. The majority of chromatography revenue relates to the OPUSpre-packed chromatography (PPC) column line and Protein A chromatography resins. OPUS columns typically consist of the outer hardware of the column with a resin as ordered by the customer packed inside of the column. OPUS columns may also be ordered without the packed resin. In either scenario, the OPUS column and resin are not interdependent of one another and are therefore considered distinct products that represent separate performance obligations. Chromatography product revenue is generally recognized at a point in time upon transfer of control to the customer.

Other Products

The Company’s other products include ELISA test kits used by quality control departments to detect and measure the presence of leached Protein A and/or growth factor in the final product. Each ELISA kit is considered distinct and therefore represents a separate performance obligation. Other product revenue is generally recognized at a point in time upon transfer of control to the customer.

Transaction Price Allocated to Future Performance Obligations

Remaining performance obligations represents the transaction price of contracts for which work has not been performed or has been partially performed. The Company’s future performance obligations relate primarily to the installation and training of certain of its systems sold to customers. These performance obligations are completed within one year of receipt of a purchase order from its customers. Accordingly, the Company has elected to not disclose the value of these unsatisfied performance obligations as provided under ASC606-10-50-14.

Contract Balances from Contracts with Customers

The following table provides information about receivables and deferred revenue from contracts with customers as of March 31, 2018:

   2018 

Balances from contracts with customers only:

  

Accounts receivable

  $29,352 

Deferred revenue

   1,547 

Revenue recognized in the period relating to:

  

The beginning deferred revenue balance

  $434 

Changes in pricing related to products or services satisfied in previous periods

   —   

Impairment losses on receivables

   —   

The timing of revenue recognition, billings and cash collections results in accounts receivables and deferred revenue on the Company’s consolidated balance sheets.

A contract asset is created when the Company satisfies a performance obligation by transferring a promised good to the customer. Contract assets may represent conditional or unconditional rights to consideration. The right is conditional, and recorded as a contract asset, if the Company must first satisfy another performance obligation in the contract before it is entitled to payment from the salecustomer. Contract assets are transferred to billed receivables once the right becomes unconditional. If the Company has the unconditional right to receive consideration from the customer, the contract asset is accounted for as a billed receivable and presented separately from other contract assets. A right is unconditional if nothing other than the passage of bioprocessingtime is required before payment of that consideration is due.

When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract liability is recorded. Contract liabilities are recognized as revenue after control of the 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, revenueor services 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 obligationsrevenue recognition criteria have been completed. Generally, our product arrangements for equipmentmet.

Costs to Obtain or Fulfill a Customer Contract

The Company’s 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,commission structure is based on terms and conditions ofachieving revenue targets. The commissions are driven by revenue derived from customer purchase orders which are short term in nature.

Applying 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,practical expedient in paragraph340-40-25-4, the Company recognizes revenue for both equipment and consumables upon delivery to the distributor unless direct shipment toincremental costs of obtaining contracts as an expense when incurred if 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 acceptanceamortization period of the equipment byassets that the end customer. Sales to distributorsCompany otherwise would have recognized is one year or less. These costs are not contingent upon resaleincluded in selling, general, and administrative expenses. When shipping and handling costs are incurred after a customer obtains control of the product.

Atproducts, 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 componentsthese as separate units of accounting ifcosts to fulfill the following two criteria are met:

The delivered item or items have value to the customer on a stand-alone basis;promise 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 not 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.obligation.

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 

Balance at December 31, 2016

  $(5  $(13,744  $(13,749

Other comprehensive income

   4    1,027    1,031 
  

 

 

   

 

 

   

 

 

 

Balance at March 31, 2017

  $(1  $(12,717  $(12,718
  

 

 

   

 

 

   

 

 

 

(In thousands)

  Foreign currency
translation gain
(loss)
 

Balance at December 31, 2017

  $(6,363

Foreign currency translation gain

   251 
  

 

 

 

Balance at March 31, 2018

  $(6,112
  

 

 

 

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-month periods ended March 31, 20172018 and 2016.2017.

Basic and diluted weighted average shares outstanding were as follows:

 

   Three months ended
March 31,
 
   2017   2016 

Weighted average common shares

   33,891,702    33,024,681 

Dilutive common stock options

   490,620    468,894 
  

 

 

   

 

 

 

Weighted average common shares, assuming dilution

   34,382,322    33,493,575 
  

 

 

   

 

 

 
   Three months ended
March 31,
 
   2018   2017 

Basic weighted average common shares outstanding

   43,621,270    33,891,702 

Effect of dilutive securities:

    

Stock options and restricted stock awards

   389,702    490,620 

Convertible senior notes

   315,760    —   
  

 

 

   

 

 

 

Weighted average common shares, assuming dilution

   44,326,732    34,382,322 
  

 

 

   

 

 

 

At March 31, 2017,2018, there were outstanding options to purchase 805,9031,109,353 shares of the Company’s common stock at a weighted average exercise price of $19.68$25.34 per share and 703,076 restricted stock units to acquire 404,781 shares of the Company’s common stock.units. For the three months ended March 31, 2017, 458,6852018, 593,874 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.

At March 31, 2017, there were outstanding options to purchase 805,903 shares of the Company’s common stock at a weighted average exercise price of $19.68 per share and 404,781 restricted stock units. For the three months ended March 31, 2017, 458,685 options to purchase shares of the Company’s common stock 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 the Convertible Notes in cash, shares or any combination of the two. The Company currently intends to settle the par value of the Convertible Notes in cash and any excess conversion premium in shares. 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. Accordingly, the par value of the Convertible Notes will not be included in the calculation of diluted income per share, but the dilutive effect of the conversion premium will be considered in the calculation of diluted net income per share using the treasury stock method. The dilutive impact of the Company’s convertible notes is based on the difference between the Company’s current period average stock price and the conversion price of the convertible notes, provided there is a premium. Pursuant to this accounting standard, there is no dilution from the accreted principal of the Convertible Notes as of March 31, 2017.

At March 31, 2016, there were outstanding options to purchase 1,312,508 shares of the Company’s common stock at a weighted average exercise price of $11.50 per share. For the three- month period ended March 31, 2016, 520,030 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,2018 and were therefore anti-dilutive.

6. Cash, Cash Equivalents and Marketable Securities

At March 31, 2017 and December 31, 2016, the Company’s investments included money market funds and short-term marketable securities. These marketable securities are 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 March 31, 2017 was approximately 2.3 months.

Management reviewed the Company’s investments as of March 31, 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 March 31, 2017 (in thousands):

   March 31, 2017 
   Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
   Fair
Value
 

Marketable securities:

        

U.S. Government and agency securities

  $402   $—     $—     $402 

Corporate and other debt securities

   11,779    1    (2   11,778 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $12,181   $1   $(2  $12,180 
  

 

 

   

 

 

   

 

 

   

 

 

 

There were no long-term marketable securities as of March 31, 2017.

At March 31, 2017, the Company’s investments included seven securities in unrealized loss positions with a total unrealized loss of approximately $2,000 and a total fair market value of approximately $3,946,000. 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 months ended March 31, 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 year as of March 31, 2017.

7.6. 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 $385,000 at March 31, 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):

 

   March 31, 2017   December 31,
2016
 

Raw Materials

  $15,417   $14,954 

Work-in-process

   2,769    2,789 

Finished products

   5,771    6,953 
  

 

 

   

 

 

 

Total

  $23,957   $24,696 
  

 

 

   

 

 

 

   March 31, 2018   December 31, 2017 

Raw Materials

  $21,826   $22,351 

Work-in-process

   3,828    4,083 

Finished products

   14,470    12,570 
  

 

 

   

 

 

 

Total

  $40,124   $39,004 
  

 

 

   

 

 

 

8.7. Property, Plant and Equipment

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

 

  March 31, 2017   December 31, 2016   March 31, 2018   December 31, 2017 

Land

  $1,023   $1,023 

Buildings

   764    764 

Leasehold improvements

  $15,196   $14,592    15,740    15,673 

Equipment

   15,501    15,214    22,497    21,904 

Furniture and fixtures

   3,418    3,218    4,605    4,272 

Construction in progress

   1,142    1,264    3,052    2,581 
  

 

   

 

   

 

   

 

 

Total property, plant and equipment

   35,257    34,288    47,681    46,217 

Less: accumulated depreciation

   (19,884   (19,332   (25,007   (23,800
  

 

   

 

   

 

   

 

 

Property, plant and equipment, net

  $15,373   $14,956   $22,674   $22,417 
  

 

   

 

   

 

   

 

 

Depreciation expense totaled approximately $928,000$1,284,000 and $751,000$928,000 for the three monthsthree-month periods ended March 31, 20172018 and 2016,2017, respectively.

9.8. 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 (loss).

During the third quarter of 2016, the Company launched its XCellTM ATFsingle-use product line. The Company performed an assessment of thein-process research and development assets and their estimated useful lives to determine if any circumstances exist that would result in an impairment. The Company has determined that the fair value of these intangible assets exceeds their carrying values and are therefore not impaired; accordingly, the Company reclassifiedin-process research and development intangible assets to developed technology and began to amortize these intangible assets in the third quarter of 2016.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 March 31, 2017.2018.

Intangible assets consisted of the following at March 31, 20172018 (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

  $12,949   $(1,685   17   $51,860   $(3,898   19 

Patents

   240    (215   8    240    (240   8 

Customer relationships

   22,697    (5,525   11    102,210    (11,446   14 

Trademark

   711    —      —   

Trademark – definite lived

   2,160    (75   20 

Trademark – indefinite lived

   700    —      —   

Other intangibles

   85    (35   2    1,066    (304   3 
  

 

   

 

   

 

   

 

   

 

   

 

 

Total intangible assets

  $36,682   $(7,460   13   $158,236   $(15,963   16 
  

 

   

 

     

 

   

 

   

Intangible assets consisted of the following at December 31, 20162017 (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

  $12,911   $(1,468   17   $51,801   $(3,201   19 

Patents

   240    (208   8    240    (238   8 

Customer relationships

   22,555    (4,995   11    102,120    (9,636   14 

Trademark/ tradename

   711    —      —   

Trademarks – definite lived

   2,160    (47   20 

Trademarks – indefinite lived

   700    —      —   

Other intangibles

   84    (24   2    1,063    (209   3 
  

 

   

 

   

 

   

 

   

 

   

 

 

Total intangible assets

  $36,501   $(6,695   13   $158,084   $(13,331   16 
  

 

   

 

     

 

   

 

   

Amortization expense for amortized intangible assets was approximately $715,000$2,664,000 and $399,000$715,000 for the three monthsthree-month periods ended March 31, 20172018 and 2016,2017, respectively. As of March 31, 2017,2018, the Company expects to record amortization expense as follows (in thousands):

 

Years Ending

Amortization Expense

December 31, 2017 (nine months remaining)

2,265

December 31, 2018

2,832

December 31, 2019

2,799

December 31, 2020

2,494

December 31, 2021

2,190

Years Ending

  Amortization Expense 

December 31, 2018 (nine months remaining)

  $7,978 

December 31, 2019

   10,513 

December 31, 2020

   9,910 

December 31, 2021

   9,395 

December 31, 2022

   9,395 

10.9. Accrued Liabilities

Accrued liabilities consist of the following (in thousands):

 

  March 31, 2017   December 31, 2016   March 31, 2018   December 31, 2017 

Employee compensation

  $3,439   $5,586   $5,246   $9,560 

Accrued interest payable

   815    204 

Taxes

   2,049    1,668 

Royalty and license fees

   1,243    1,383 

Accrued purchases

   566    382    521    1,191 

Taxes

   1,604    1,692 

Contingent consideration

   —      6,119 

Royalties

   857    248 

Professional fees

   494    411    827    947 

Unearned revenue

   441    408    1,547    960 

Other accrued expenses

   900    964    2,688    2,220 
  

 

   

 

   

 

   

 

 

Total

  $9,116   $16,014   $14,121   $17,929 
  

 

   

 

   

 

   

 

 

11. Long Term Debt10. Convertible Senior Notes

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

 

  March 31, 2017   December 31, 2016   March 31, 2018   December 31, 2017 

2.125% Convertible Senior Notes due 2021:

        

Principal amount

  $115,000   $115,000   $114,989   $115,000 

Unamortized debt discount

   (15,952   (16,777   (12,513   (13,395

Unamortized debt issuance costs

   (2,806   (2,951   (2,200   (2,355
  

 

   

 

   

 

   

 

 

Total convertible senior notes

  $96,242   $95,272   $100,276   $99,250 
  

 

   

 

   

 

   

 

 

On May 24, 2016, the Company issued $115 million aggregate principal amount of its 2.125% Convertible Senior Notes due 2021 (the “Notes”).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.

Notes with a par value of $11,000 were submitted for conversion in the fourth quarter of 2017, and this conversion was settled in the first quarter of 2018. The conversion resulted in the issuance of a nominal amount of shares of the Company’s common stock, and the Company recorded a loss of $1,000 on the conversion of these Notes. The Notes are not convertible as of March 31, 2018 and are classified as long term liabilities on the Company’s consolidated balance sheet as of December 31, 2017.

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 March 31, 2017.2018.

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 March 31, 20172018 includes $611,000, $825,000$881,000 and $145,000$155,000 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 March 31, 2017,2018, the carrying value of the Notes was approximately $96.2$100.3 million and the fair value of the principal was approximately $144.3$150.5 million. The fair value of the Notes was determined based on the most recent trade activity of the Notes as of March 31, 2017.2018.

12.

11. Stock-Based Compensation

For the three monthsthree-month periods ended March 31, 20172018 and 2016,2017, the Company recorded stock-based compensation expense of approximately $1,531,000$2,268,000 and $922,000,$1,531,000, 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 collectivelytogether with the 2001 Plan, and the 1992 Repligen Corporation Stock Option Plan, the “Plans”).

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

 

  Three Months Ended
March 31,
   Three Months Ended
March 31,
 
  2017   2016   2018   2017 

Cost of product revenue

  $141   $60   $266   $141 

Research and development

   132    80    170    132 

Selling, general and administrative

   1,258    782    1,832    1,258 
  

 

   

 

   

 

   

 

 

Total

  $1,531   $922   $2,268   $1,531 
  

 

   

 

   

 

   

 

 

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 threethree- 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. In the first quarter of 2018, to create a longer term retention incentive, the Company’s Compensation Committee granted long term incentive compensation awards to its chief executive officer consisting of both stock options and restricted stock units that are subject to time-based vesting over nine years. 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 March 31, 2017,2018, options to purchase 805,9031,109,353 shares and 404,781703,076 restricted stock units were outstanding under the Plans. At March 31, 2017, 1,531,0102018, 254,907 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 based on the probability 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 the three monthsthree-month period ended March 31, 20172018 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 at December 31, 2016

   882,748   $16.88     

Granted

   86,215    32.40     

Exercised

   (137,903   9.67     

Forfeited/cancelled

   (25,157   21.31     
  

 

 

       

Options outstanding at March 31, 2017

   805,903   $19.68    7.08   $12,706 
  

 

 

       

Options exercisable at March 31, 2017

   406,859   $14.18   ��5.73   $8,659 
  

 

 

       

Vested and expected to vest at March 31, 2017 (1)

   791,227   $19.57    7.05   $12,530 
  

 

 

       
   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, 2017

   734,940   $20.80     

Granted

   398,532    33.85     

Exercised

   (14,531   23.70     

Forfeited/cancelled

   (9,588   29.71     
  

 

 

       

Options outstanding at March 31, 2018

   1,109,353   $25.34    7.51   $12,176 
  

 

 

       

Options exercisable at March 31, 2018

   499,504   $17.73    5.50   $9,300 
  

 

 

       

Vested and expected to vest at March 31, 2018 (1)

   1,057,255   $24.96    7.40   $12,015 
  

 

 

       

 

(1) Represents the number of vested options as of March 31, 20172018 plus the number of unvested options expected to vest as of March 31, 20172018 based on the unvested outstanding options at March 31, 20172018 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 March 31, 20172018 of $35.20$36.18 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 March 31, 2017.2018.

The weighted average grant date fair value of options granted during the three monthsthree-month periods ended March 31, 2018 and 2017 was $18.27 and 2016 was $16.46, and $13.49, respectively. The total fair value of stock options that vested during the three monthsthree-month periods ended March 31, 20172018 and 20162017 was approximately $1,339,000 and $1,195,000, and $645,000, respectively.

Information regarding restricted stock unit and performance stock unit activity for the three monthsthree-month period ended March 31, 20172018 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
Remaining
Contractual
Term
(in years)
   (in thousands)
Aggregate
Intrinsic
Value
 

Restricted stock units outstanding at December 31, 2016

   353,838   $—       

Restricted and performance stock units outstanding at December 31, 2017

   505,235     

Granted

   125,067    —          319,701     

Exercised

   (63,811   —          (90,691    

Forfeited/cancelled

   (10,313   —          (31,169    
  

 

         

 

     

Restricted stock units outstanding at March 31, 2017

   404,781   $—      3.12   $14,248 

Restricted stock units outstanding at March 31, 2018

   703,076    4.06   $25,437 
  

 

         

 

     

Vested and expected to vest at March 31, 2017 (1)

   378,579   $—      3.01   $13,326 

Vested and expected to vest at March 31, 2018 (1)

   639,530    3.75   $23,138 
  

 

         

 

     

 

(1) Represents the number of vested restricted stock units as of March 31, 20172018 plus the number of unvested restricted stock units expected to vest as of March 31, 20172018 based on the unvested outstanding restricted stock units at March 31, 20172018 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 March 31, 20172018 of $35.20$36.18 per share) that would have been received by the restricted stock unit holders had all holders exercisedrestricted stock units vested on March 31, 2017.2018. The aggregate intrinsic value of restricted stock units exercisedvested during the three monthsthree-month periods ended March 31, 20172018 and 20162017 was approximately $2,064,000$3,224,000 and $1,009,000,$2,064,000, respectively.

The weighted average grant date fair value of restricted stock units granted during the three monthsthree-month periods ended March 31, 2018 and 2017 was $33.80 and 2016 was $32.18, and $26.05, respectively. The total grant date fair value of restricted stock units that vested during the three monthsthree-month periods ended March 31, 20172018 and 20162017 was approximately $1,616,000$2,619,000 and $742,000,$1,616,000, respectively.

As of March 31, 2017,2018, there was $14,921,000$30,762,000 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 2.944.66 years.

13.12. Income Taxes

The Company’s effective tax rate for the three monthsthree-month period ended March 31, 20172018 was 24.6%24.7% compared to 36.0%24.6% for the corresponding period in the prior year. For the current three month period, theThe effective tax rate for the three-month period ended March 31, 2018 was higher than the U.S. statutory tax rate of 21% due to state tax effects and the impact of the Global IntangibleLow-Taxed Income (“GILTI”) tax enacted as part of the Tax Cuts and Jobs Act (the “Act”) enacted in December 2017. The effective tax rate for the three-month period ended March 31, 2017 was lower than the U.S. statutory tax rate of 34% primarilymainly due to lower statutory tax rates in foreign jurisdictions. For

ASU2016-16 requires the three month period ended March 31, 2016,income tax consequences of intra-entity transfers of assets other than inventory to be recognized when the effectiveintra-entity transfer occurs rather than deferring recognition of income tax rateconsequences until the transfer was higher thanmade with an outside party. The Company adopted the U.S. statutoryprovisions of this ASU in the first quarter of 2018. The adoption resulted in a decrease of $5,609,000 to other assets, a decrease of $4,932,000 to deferred tax rate mainly dueliabilities and a decrease of $677,000 to the tax treatment of contingent consideration expense.accumulated deficit at January 1, 2018.

At December 31, 2016,2017, the Company had net operating loss carryforwards of approximately $48,550,000$19,652,000 in the U.S., net operating loss carryforwards of approximately €2,287,000€603,000 (approximately $2,407,000)$743,000) in Germany, federal business tax credit carryforwards of $1,745,000$297,000 and state business tax credit carryforwards of approximately $442,000$99,000 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 2036.2037. The net operating loss and business tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue ServiceService. While an IRC Section 382 study was completed 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 event offuture based on certain changes in the ownership interest of significant stockholders.

As

On December 22, 2017, the Act was signed into law. The Act made significant changes to federal tax law, including, but not limited to, a reduction in the federal income tax rate from 35% to 21%, taxation of certain global intangiblelow-taxed income, allowing for immediate expensing of qualified assets, stricter limits on deductions for interest and certain executive compensation, and aone-time transition tax on previously deferred earnings of certain foreign subsidiaries. Due to the complexities involved in accounting for the enactment of the Act, the SEC issued Staff Accounting Bulletin No. 118 (“SAB 118”), which allows a registrant to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. Under the SAB 118 guidance, we have determined that our accounting for the following items is incomplete where noted, we are able to make reasonable estimates for certain effects of tax reform and therefore have recorded provisional amounts.

The Act lowered the Company’s U.S. statutory federal tax rate from 35% to 21% effective January 1, 2018. The Company recorded a tax benefit of $12,812,000 in the year ended December 31, 2017 for the reduction in its US deferred tax assets and liabilities resulting from the rate change.

The Act also includes aone-time deemed repatriation transition tax whereby entities that are shareholders of a specified foreign corporation must include in gross income the undistributed and previously untaxed post-1986 earnings and profits of the specified foreign corporation. The provisional amount recorded at December 31, 2017 increased the Company’s tax provision by $3,266,000. This amount may change as the Company refines its calculations of post-1986 earnings and profits for our foreign subsidiaries, as well as the amounts held in cash.

The Company anticipates that future guidance and interpretations with the respect to the Act will cause the Company to further adjust its provisional amounts recorded as of December 31, 2016, the Company concluded that realization of deferred tax assets2017. No further adjustments have been made to these provisional amounts in the United States beyond December 31, 2016 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 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 for previously unrecognized excess tax benefits outstanding as of the beginning of the period. Since the Company maintains a full valuation allowance on its net U.S. deferred tax assets, the Company recorded a corresponding increase to the valuation allowance and the impact of adopting ASU2016-09 on retained earnings is zero.

In the first quarter of 2017, Repligen Germany GmbH was subject to2018. Any measurement period adjustments will be reported as a tax examinationcomponent of provision for income taxes in the years 2012 through 2015.reporting period the amounts are determined. The examination was general in nature, covering all aspectsfinal accounting will be completed no later than one year from the enactment 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.Act.

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

  2013-20162014-2017

Sweden

  2011-20162011-2017

Germany

  20162017

Netherlands

2012-2017

14.13. 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–  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–  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–  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 March 31, 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 March2018 and December 31, 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

  $85,292   $—     $—     $85,292 

U.S. Government and agency securities

   402    —      —      402 

Corporate and other debt securities

   —      11,778    —      11,778 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $85,694   $11,778   $—     $97,472 
  

 

 

   

 

 

   

 

 

   

 

 

 

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 

Payments

   (6,119
  

 

 

 

Balance at March 31, 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 March 31, 2017,2018, the carrying value of the Notes was $96.2approximately $100.3 million, net of unamortized discount, and the fair value of the Notes was approximately $144.3$150.5 million. The fair value of the Notes was determined based on the most recent trade activity of the Notes as of March 31, 2017.2018. 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 11,10, “Long Term Debt.

There were nore-measurements to fair value during the three months ended March 31, 20172018 of financial assets and liabilities that are not measured at fair value on a recurring basis.

15.14. Commitments and Contingencies

The Company leases its headquarters in Waltham, Massachusetts as well as certain of its office and manufacturing space around the world.

In February 2018, the Company entered into an agreement to lease 63,761 square feet of office and manufacturing space in Marlborough, Massachusetts from U.S. REIF 111 Locke Drive Massachusetts, LLC (the “Premises”).

The lease commences during the second quarter of 2018 (the “Commencement Date”) and shall continue for a period of 126 consecutive months, unless earlier terminated in accordance with the terms of the lease (the “Lease Term”). Under the lease, the Company has the option to extend the Lease Term for two additional five-year periods.

Fixed rent with respect to 40,000 square feet of the Premises only shall commence on the Commencement Date, and rent for the full 63,761 square feet of the Premises shall begin 19 months following the Commencement Date. Under the terms of the lease, the Company has provided a letter of credit of approximately $163,000 as a security deposit and is required to pay its pro rata share of any building operating expenses and real estate taxes.

Future minimum rental commitments under the Company’s leases as of March 31, 20172018 are as follows (in thousands):

 

  Minimum Rental
Commitments
   Minimum Rental
Commitments
 

2017 (nine months remaining)

  $2,028 

2018

   2,647 

2018 (nine months remaining)

  $3,191 

2019

   2,506    3,808 

2020

   2,500    3,653 

2021

   2,467    3,342 

2022

   1,968 

Thereafter

   1,705    4,401 

15. Related Party Transactions

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 $201,000 for the three-month period ended March 31, 2018 related to these leases.

16. 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 principalsole operating segment.

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

 

   Three months ended
March 31,
 
   2017  2016 

United States

   38  30

Sweden

   27  24

Ireland

   10  4

United Kingdom

   5  13

Other

   20  29
  

 

 

  

 

 

 

Total

   100  100
  

 

 

  

 

 

 

   Three months ended
March 31,
 
   2018  2017 

North America

   45  38

Europe

   43  54

Asia and Australia

   11  8

Other

   1  —   
  

 

 

  

 

 

 

Total

   100  100
  

 

 

  

 

 

 

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

 

  Three months ended
March 31,
   Three months ended
March 31,
 
  2017 2016   2018 2017 

GE Healthcare

   27 24   17 27

MilliporeSigma

   21 28   14 21

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

 

  March 31,
2017
 December 31,
2016
   March 31, 2018 December 31, 2017 

GE Healthcare

   25 26   19 11

MilliporeSigma

   15 8   20 19

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

Repligen and its subsidiaries, collectively doing business as Repligen Corporation (“Repligen”, “we”, “our”, or “the Company”) is a leading provider of advanced bioprocessing technology and solutions used in the process of manufacturing biologic drugs. Our products are made to substantially increase biopharmaceutical manufacturing efficiencies and flexibility. As the global biologics market continues to experience strong growth and expansion, our customers – primarily large biopharmaceutical companies and contract manufacturing organizations – face critical production cost, capacity, quality and time pressures that our products are made to address. Our commitment to bioprocessing is helping to set new standards for the way our customers manufacture biologic drugs – monoclonal antibodies, recombinant proteins, vaccines and gene therapies. We are a bioprocessing-focused, global life sciences company bringing over 30 years of expertise and innovationdedicated to our customers. Our mission is to inspireinspiring advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide.

FocusedPrior to 2012, the Company was focused on delivering cost and process efficiencies, Repligen offers innovative technologiesdrug development, with clinical trial costs supported by bioprocessing product sales. At 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 buildingtime our bioprocessing business we have expanded and diversified our product offering beyond our corewas largely represented by sales of Protein A affinity ligands, which we sell through long term original equipment manufacturer (OEM) supply agreements. Our 2011 acquisition of Novozymes Biopharma Sweden AB further expanded our proteins product portfolio and believeprovided impetus to set a new direction for the company. Bymid-2012, we are well-positioned in the bioprocessing market assingle-usepermanently discontinued and continuous processing technologies are increasingly adopted by biopharmaceutical manufacturers. This expansion has beenhave since divested all drug development programs. We retained our proteins OEM business and, through a combination of internal innovation and acquisition,strategic acquisitions, we have built chromatography and filtration product offerings that we sell direct to biologics manufacturers. We continue to seek out strategic opportunities to strengthen and expand our bioprocessing business.

We currently operate as one bioprocessing business, with a clear focuscomprehensive suite of products to serve both upstream and downstream processes in biologic drug manufacturing. Building on technology leadership as a path to market leadership. Our Proteins business today includes cell culture growth factors in addition to our longstanding Protein A ligands. In recentover 35 years of industry expertise, we have significantly expandeddeveloped a broad and diversified product portfolio that reflects our Chromatography business, which includes ourcommitment to build abest-in-class OPUS®pre-packed columns as well as our ELISA kitsbioprocessing technology company with a world-class direct sales and chromatography resins. In addition, we have established an exceptional Filtration business that includes our leading XCell™ ATF and TangenX™ tangential flow filtration (“TFF”) product lines.

commercial organization. Our team has substantial experience in biomanufacturing and works proactively with industry leaders and customers to develop innovative solutions that address pressure points in the bioproduction process. Our bioprocessingOEM Protein 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,represented by our Protein A ligands areand cell culture growth factor products. Ourdirect-to customer Chromatography product line includes a critical componentnumber of Protein A resinsproducts used to purify over 65 antibody-basedin the downstream purification and quality control of biological drugs, on the market and in over 300 drugs in clinical development. Also in downstream processes,including our OPUS®pre-packed chromatography columns (PPCs) arecolumn line, chromatography resins and ELISA test kits. Ourdirect-to-customer Filtration product line includes our XCell™ ATF system for use in upstream process intensification, our Sius™ TFF cassettes for use in downstream purification and formulation processes, our KrosFlo®line of hollow-fiber cartridges and TFF systems, and our ProConnex®single-use tubing sets. With the addition of Spectrum LifeSciences LLC in August 2017 (the “Spectrum Acquisition”), wenow in-house manufacture hollow-fiber filters that can be used in the purification of clinical-stage biologics,our XCell ATF system and have increased our TangenX™ Sius™ TFF filtration cassettes are used to concentrate clinical and commercial-stage biologic drugs.

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, whodirect sales presence in turn produce and sell Protein A resins to end users (biopharmaceutical companies and 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”). These products are manufactured or assembled internally and marketed globally through a direct commercial organization in the United States and Europe and through a combination of direct sales and distributors in Asia. Since 2014, we have steadily invested inAsia, while diversifying 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 a39-person commercial team as of March 31, 2017.

Our commercial and R&D teams have a track record of successfully launching new products and building newend markets for acquired technologies. For example, since acquiring the XCell™ ATF business in 2014, we have rapidly 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 market-leading XCell™ ATF line from Refine Technologies LLC. We completed two acquisitions in 2016, acquiring Atoll GmbH (“Atoll”) in April and TangenX Technology Corporation (“TangenX”) in December. 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.

Our internal innovation has also driven the growth of ourdirect-to-customer product offerings. Internally, we developed 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,beyond monoclonal antibodies to include more size optionsvaccines, recombinant protein 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.

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.gene therapies.

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, 2016.2017.

Results of Operations

Revenues

Revenues for the three-month periods ended March 31, 20172018 and 20162017 were as follows:

 

  Three months ended
March 31,
 
(in thousands, except percentages)  Three months ended March 31,   2018   2017   $ Change   % Change 
  2017   2016   $ Change   % Change 

Product revenue

  $30,569   $25,094   $5,475    22  $44,799   $30,569   $14,230    47

Royalty and other revenue

   21    —      21    100   31    21    10    48
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total revenue

  $30,590   $25,094   $5,496    22  $44,830   $30,590   $14,240    47
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Sales of bioprocessing products for the three months ended March 31, 2018 and 2017 were $44,799,000 and 2016 were $30,569,000, and $25,094,000, respectively, representing an increase of $5,475,000,$14,230,000, or 22%47%. This increase was primarily due to increases in orders forcontinued adoption of our chromatography columns fromproducts by our key bioprocessing customers in addition to revenues from the Atoll Acquisition and, TangenX Acquisition infor the first quarter of 2017.2018, the addition of revenues following the Spectrum Acquisition. 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-month periods ended March 31, 20172018 and 20162017 were comprised of the following:

 

  Three months ended
March 31,
 
(in thousands, except percentages)  Three months ended March 31,   2018   2017   $ Change   %
Change
 
  2017   2016   $ Change   % Change 

Cost of product revenue

  $13,990   $11,069   $2,921    26  $19,668   $13,990   $5,678    41

Research and development

   1,742    1,539    203    13   3,288    1,742    1,546    89

Selling, general and administrative

   9,182    7,018    2,164    31   15,898    9,182    6,716    73

Contingent consideration – fair value adjustments

   —      2,005    (2,005   (100%) 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total costs and operating expenses

  $24,914   $21,631   $3,283    15  $38,854   $24,914   $13,940    56
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Cost of product revenue was approximately $13,990,000$19,668,000 and $11,069,000$13,990,000 for the three-month periods ended March 31, 20172018 and 2016,2017, respectively, an increase of $2,921,000$5,678,000, or 26%41%. This increase is primarily due to the increased product revenue noted above. Gross margins may fluctuate over the remainder of 20172018 based on expected production volume and shipments and product mix.

Research and development expenses were approximately $1,742,000$3,288,000 and $1,539,000$1,742,000 for the three-month periods ended March 31, 20172018 and 2016,2017, respectively, an increase of $203,000$1,546,000, or 13%89%. This increase is primarily related to product development activities acquired as part of the timingSpectrum Acquisition and scale ofincreased activity on our various bioprocessing product development projects. Expenses generally include personnel costs, external development costs, supplies and other expenses related to our new products in development.

Selling, general and administrative expenses were approximately $9,182,000$15,898,000 and $7,018,000$9,182,000 for the three-month periods ended March 31, 20172018 and 2016,2017, respectively, an increase of $2,164,000,$6,716,000, or 31%73%. This increase is primarily due to selling and administrative activities incurred following the Spectrum Acquisition, as well as the continued buildout of our administrative infrastructure to support future growth and continued expansion of our customer-facing activities to drive sales of our bioprocessing products and additional expense resulting from our acquisitions of Atoll and TangenX.

Contingent consideration fair value adjustments were approximately $2,005,000 for the three-month period ended March 31, 2016. This fair value adjustment during the first quarter of 2016 was related to the increased probability of achieving the 2016 sales milestone under the Refine acquisition agreement. There was no such expense in the first quarter of 2017, as the contingent consideration periods for the Atoll Acquisition and Refine Acquisition ended in 2016.products.

Investment income

Investment income for the three-month periods ended March 31, 20172018 and 20162017 was as follows:

 

  Three months ended
March 31,
 
(in thousands, except percentages)  Three months ended March 31,   2018   2017   $ Change   % Change 
  2017   2016   $ Change   % Change 

Investment income

  $96   $61   $35    57  $181   $96   $85    89

Investment income includes income earned on invested cash balances. The increase in investment income in the current three-monthfirst quarter of 2018 over the prior year period is attributable to higher average invested cash balances related to the receipt of proceeds from our convertible senior notes in May 2016.and higher interest rates on such cash balances.

Interest expense

Interest expense for the three-month periods ended March 31, 20172018 and 20162017 was as follows:

 

  Three months ended
March 31,
 
(in thousands, except percentages)  Three months ended March 31,   2018   2017   $ Change   % Change 
  2017   2016   $ Change   % Change 

Interest expense

  $(1,585  $(5  $(1,580   (31,600%)   $(1,652  $(1,585  $(67   (4%) 

Increases in interestInterest expense in the current three-month periodperiods ended March 31, 2018 and 2017 is attributable to interest expense on our convertible senior notes issued in May 2016.

Other expenseincome (expense)

Other expense for the three-month periods ended March 31, 20172018 and 20162017 was as follows:

 

  Three months ended
March 31,
 
(in thousands, except percentages)  Three months ended March 31,   2018   2017   $ Change   % Change 
  2017   2016   $ Change   % Change 

Other expense

  $(120  $(979  $859    88  $71   $(120  $191    159

Other income was approximately $71,000 and other expense was approximately $120,000 and approximately $979,000($120,000) for the three-month periods ended March 31, 2018 and 2017, and 2016, respectively. The decreaseOther income (expense) in other expenseeach period was primarily attributable to foreign currency losses in the first quarter of 2016gains (losses) on cash balances denominated in U.S. dollars and British pounds held and subsequently converted to local currency holdings by Repligen Sweden.

Provision for income taxes

Provision for income taxes for the three-month periods ended March 31, 20172018 and 20162017 was as follows:

 

  Three months ended
March 31,
 
(in thousands, except percentages)  Three months ended March 31,   2018   2017   $ Change   % Change 
  2017   2016   $ Change   % Change 

Income tax provision

  $999   $915   $84    9  $1,128   $999   $129    13

For the three months ended March 31, 2017,2018, we had income before taxes of approximately $4,067,000$4,576,000 and recorded a tax provision of approximately $999,000$1,128,000 for an effective tax rate of approximately 24.6%24.7%. The effective income tax rate is based upon the estimated income for the year and the composition of the income in different jurisdictions. The effective tax rate is higher the U.S. statutory tax rate of 21% due to state tax effects and the impact of the Global IntangibleLow-Taxed Income (“GILTI”) tax enacted as part of the Tax Cuts and Jobs Act enacted in December 2017. For the three months ended March 31, 2017, we had income before taxes of $4,067,000 and recorded a tax provision of $999,000 for an effective tax rate of approximately 24.6%. The effective tax rate differs from the U.S. statutory tax rate primarily due to lower statutory tax rates in foreign jurisdictions. For the three months ended March 31, 2016, we had income before taxes of approximately $2,540,000 and recorded a tax provision of approximately $915,000 for an effective tax rate of approximately 36.0%. The effective income tax rate is based upon the estimated income for the year and the composition of the income in different jurisdictions. The effective tax rate differs from the U.S. statutory tax rate primarily due to the tax treatment of contingent consideration expense recorded in the first quarter of 2016.

Non-GAAP Financial Measures

We providenon-GAAP adjusted income from operations; adjusted net income; adjusted cost of product revenue; adjusted sales, general and administrative expense; and adjusted EBITDA as supplemental measures to GAAP measures regarding our operating performance. These financial measures exclude the impact of certain acquisition related items detailed below and, therefore, have not been calculated in accordance with GAAP. A detailed explanation and a reconciliation of eachnon-GAAP financial measuresmeasure to its most comparable GAAP financial measures are describedmeasure is 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 relatedacquisition-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.

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, amortization of intangible assets and contingent consideration expenseinventorystep-up charges 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-month periods ended March 31, 20172018 and 20162017 (in thousands):

 

   Three Months Ended March 31, 
   2017   2016 

GAAP income from operations

  $5,676   $3,463 

Adjustments to income from operations:

    

Acquisition costs

   402    393 

Intangible amortization

   715    399 

Contingent consideration – fair value adjustments

   —      2,005 
  

 

 

   

 

 

 

Adjusted income from operations

  $6,793   $6,260 
  

 

 

   

 

 

 

   Three Months Ended March 31, 
   2018   2017 

GAAP income from operations

  $5,976   $5,676 

Adjustments to income from operations:

    

Acquisition and integration costs

   655    402 

Intangible amortization

   2,664    715 

Inventorystep-up charges

   —      224 
  

 

 

   

 

 

 

Adjusted income from operations

  $9,295   $7,017 
  

 

 

   

 

 

 

Adjusted Net Income

Adjusted net income is measured by taking net income as reported in accordance with GAAP and excluding acquisition and integration costs and related tax effects, amortization of intangible assets and related tax effects, contingent consideration expenseinventorystep-up charges andnon-cash interest expense 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 March 31, 20172018 and 2016:2017:

 

  Three Months Ended March 31,   Three Months Ended March 31, 
  2017   2016   2018   2017 
  (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

  $3,068   $0.09   $1,625   $0.05   $3,448   $0.08   $3,068   $0.09 

Adjustments to net income:

                

Acquisition costs

   402    0.01    393    0.01 

Acquisition and integration costs

   655    0.01    402    0.01 

Intangible amortization

   715    0.02    399    0.01    2,664    0.06    715    0.02 

Contingent consideration – fair value adjustments

   —      —      2,005    0.06 

Inventorystep-up charges

   —      —      224    0.01 

Non-cash interest expense

   970    0.03    —      —      1,036    0.02    970    0.03 

Tax effect of intangible amortization

   (101   (0.00   (104   (0.00

Tax effect of intangible amortization and acquisition costs

   (271   (0.01   (101   (0.00
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Adjusted net income

  $5,054   $0.15   $4,318   $0.13   $7,532   $0.17   $5,278   $0.15 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

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 and contingent consideration expensesinventorystep-up charges 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-month periods ended March 31, 20172018 and 20162017 (in thousands):

 

  Three Months Ended March 31,   Three Months Ended March 31, 
  2017   2016   2018   2017 

GAAP net income

  $3,068   $1,625   $3,448   $3,068 

Adjustments to net income:

        

Investment income

   (96   (61   (181   (96

Interest expense

   1,585    5    1,652    1,585 

Tax provision

   999    915    1,128    999 

Depreciation

   928    751    1,284    928 

Amortization

   715    399    2,664    715 
  

 

   

 

   

 

   

 

 

EBITDA

   7,199    3,634    9,995    7,199 

Other adjustments:

        

Acquisition costs

   402    393 

Contingent consideration – fair value adjustments

   —      2,005 

Acquisition and integration costs

   655    402 

Inventorystep-up charges

   —      224 
  

 

   

 

   

 

   

 

 

Adjusted EBITDA

  $7,601   $6,032   $10,650   $7,825 
  

 

   

 

   

 

   

 

 

Liquidity and capital resourcesCapital 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 March 31, 2017,2018, we had cash and marketable securitiescash equivalents of $141,843,000$173,876,000 compared to $141,780,000cash and cash equivalents of $173,759,000 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 March 31, 2017 and December 31, 2016.2017.

Operating activities

For the three-month period ended March 31, 2018, our operating activities provided cash of $1,572,000 reflecting net income of $3,448,000 andnon-cash charges totaling $7,714,000 primarily related to depreciation, amortization,non-cash interest expense, deferred tax expense and stock-based compensation charges. An increase in accounts receivable consumed $1,529,000 of cash, and was primarily driven by the 46% quarter over quarter increase in revenues. Payments of accounts payable and accrued liabilities consumed $5,389,000 of cash, and were mainly due to the timing of payments of payables and payment of 2017 incentive compensation programs. The remaining cash flow used in operations resulted from net unfavorable changes in various other working capital accounts.

For the three-month period ended March 31, 2017, our operating activities provided cash of $1,147,000 reflecting net income of $3,068,000 andnon-cash charges totaling $4,152,000 primarily related to depreciation, amortization,non-cash interest expense and stock-based compensation charges. An increase in accounts receivable consumed $2,415,000 of cash, and was primarily due to the 22% quarter over quarter increase in revenues. A decrease in accounts payable consumed $452,000 of cash, which was primarily due to the timing of purchases and payments to vendors. Payments of accrued liabilities consumed $4,220,000 of cash, and were mainly due to the payment of contingent consideration to Refine Technology and Atoll GmbH related to 2016 sales milestones. The remaining cash flow used in operations resulted from net favorable changes in various other working capital accounts.

ForInvesting activities

Our investing activities consumed $1,564,000 of cash related to capital expenditures for the three-month period ended March 31, 2016, our operating activities consumed cash of $3,811,000 reflecting net income of $1,625,000 andnon-cash charges totaling $4,077,000 including depreciation, amortization, stock-based compensation charges and the revaluation of contingent consideration. An increase in accounts receivable consumed $1,149,000 of cash, and was primarily due to the 21% quarter over quarter increase in revenues. An increase in inventories consumed $3,092,000 of cash to support future revenues. A decrease in accounts payable consumed $1,600,000 of cash, which was primarily due to the timing of purchases and payments to vendors. Payments of accrued liabilities consumed $4,277,000 of cash, and was mainly due to the payment of contingent consideration to Refine related to 2015 sales milestones. The remaining cash flow used in operations resulted from net unfavorable changes in various other working capital accounts.

Investing activities

We place our marketable security investments in high quality credit instruments as specified in our investment policy guidelines.2018. Our investing activities provided $6,077,000 for the three-month period ended March 31, 2017, primarily due to net redemptions of marketable securities of $7,372,000 offset by $1,295,000 used for fixed asset additions.

Financing activities

For the three-month period ended March 31, 2016,2018, our investingfinancing activities provided $1,200,000, primarily due to net redemptions$333,000 of marketable debt securitiescash. We received proceeds of $1,631,000,$344,000 from stock option exercises, partially offset by $431,000 used for fixed asset additions.

Financing activities

cash outlays of $11,000 related to the conversion of certain senior convertible notes in the first quarter of 2018. For the three-month period ended March 31, 2017, our financing activities used $330,000 of cash. We made contingent consideration payments of $1,663,000 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 $1,333,000. For the three-month period ended March 31, 2016, proceeds from exercises of $821,000 were partially offset by contingent consideration payments of $498,000 related to the initial valuation of the likelihood that the 2015 XCell™ ATF sales milestone would be achieved.

We do not currently use derivative financial instruments.

Working capital increased by approximately $8,970,000$10,430,000 to $172,048,000$228,001,000 at March 31, 20172018 from $163,078,000$217,571,000 at December 31, 20162017 due to the various changes noted above.

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

 

the expansion of our bioprocessing business;

our identification and execution of strategic acquisitions or business combinations;

 

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 Atollour recently acquired businesses 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 next twelve months.date of this filing. 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 related to the developmentdevelop 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 March 31, 2017.2018.

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 and TangenX,our recently acquired businesses, 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 this Quarterly Report on Form10-Q.2017.

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest rate risk

We have investmentshistorically invested funds in commercial paper, U.S. Government and agency securities as well as corporate bonds and other debt 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 March 31, 2018, 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 $24,000 decrease in the fair value of our investments as of March 31, 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. government and agency obligations)securities) 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

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

On April 1, 2016, we completedWe acquired Spectrum LifeSciences, LLC (“Spectrum”) in August 2017. The financial results of Spectrum are included in our consolidated financial statements as of and for the three-month period ended March 31, 2018. Spectrum represented approximately $35,159,000 of our total assets as of March 31, 2018 and $11,719,000 of revenues for the three-month period ended March 31, 2018. As this acquisition occurred during the second half of Atoll GmbH, and on December 14, 2016, we completed2017, the scope of our acquisitionassessment of TangenX Technology Corporation. As a result, we are in the process of integrating the applicable internal controls for each business into our internal control over financial reporting.

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. We are actively reviewing and updating Spectrum’s internal control procedures, and management will report on Spectrum’s internal controls in its report on internal control over financial reporting as of and for the year ended December 31, 2018.

Effective January 1, 2018, we adopted the provisions of ASC 606, “Revenue from Contracts with Customers.” As part of the adoption of this standard, we reviewed our control procedures and have modified certain of our processes to ensure compliance with the new standard.

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 March 31, 20172018 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

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

ITEM 1A. RISK FACTORS

The matters discussed in this Quarterly Report onForm10-Q include 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 in our Annual Report onForm10-K for for the year ended December 31, 20162017 and subsequent filings, as well as risks and uncertainties discussed elsewhere in this Quarterly Report on Form10-Q, could cause our actual results to differ materially from those in the forward-looking statements. There are no material changes to the Risk Factors described in our Annual Report onForm10-K for for the fiscal year ended December 31, 2016.2017.

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

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

None.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4.MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5.OTHER INFORMATION

ITEM 5. OTHER INFORMATION

None.

ITEM 6.EXHIBITS

ITEM 6. EXHIBITS

(a) Exhibits

 

Exhibit

Number

  

Document Description

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  Amended and RestatedBy-Laws (filed as Exhibit 3.2 to Repligen Corporation’s Quarterly Report on Form10-Q for the quarter ended September 30, 2003 and incorporated herein by reference).
3.3Amendment No. 1 to the Amended and RestatedBy-Laws (filed as Exhibit 3.1 to Repligen Corporation’s Current Report on Form8-K filed on December 20, 2011 and incorporated herein by reference).
3.4

Amendment No. 2 to the Amended and RestatedBy-Laws (filed as Exhibit 3.1 to Repligen Corporation’s Current Report on Form8-K filed on May 25, 2012 and incorporated herein by reference).

3.5Certificate 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).
3.3Second 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).
10.1Lease Agreement, dated February  6, 2018, by and between Repligen Corporation and U.S. REIF III Locke Drive Massachusetts, LLC (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on Form8-K filed on February  8, 2018 and incorporated herein by reference).
10.2+#Amendment No. 4 to Strategic Supplier Alliance Agreement, dated February 20, 2018, by and between Repligen Sweden AB and GE HealthcareBio-Sciences AB.

Exhibit

Number

  

Document Description

10.3 +Repligen Corporation Amended and Restated Non-Employee Directors’ Deferred Compensation Plan.
31.1 +  Rule13a-14(a)/15d-14(a) Certification.
31.2 +  Rule13a-14(a)/15d-14(a) Certification.
32.1*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+101 +  The following materials from Repligen Corporation on Form10-Q for the quarterly period ended March 31, 2017,2018, 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.
#Confidential treatment has been requested for portions of the exhibit and is pending clearance with the Securities and Exchange Commission.

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: May 4, 20178, 2018  By:  

/S/ TONY J. HUNT

    Tony J. Hunt
    President and Chief Executive Officer
    (Principal executive officer)
    Repligen Corporation
Date: May 4, 20178, 2018  By:  

/S/ JON SNODGRES

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

 

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