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EX-32.2 - EX-32.2 - Clovis Oncology, Inc.clvs-20170331ex322af751a.htm
EX-32.1 - EX-32.1 - Clovis Oncology, Inc.clvs-20170331ex321b54f49.htm
EX-31.2 - EX-31.2 - Clovis Oncology, Inc.clvs-20170331ex312d11ed9.htm
EX-31.1 - EX-31.1 - Clovis Oncology, Inc.clvs-20170331ex3114163f7.htm
EX-10.39 - EX-10.39 - Clovis Oncology, Inc.clvs-20170331ex1039dd6f6.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q


 

 

 

 

 

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

 

For the quarterly period ended March 31, 2017.

 

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

 

For the transition period from            to           .

 

Commission file number: 001-35347

 


Clovis Oncology, Inc.

(Exact name of Registrant as specified in its charter)


 

(State or other jurisdiction of

 

Delaware

90-0475355

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

Identification No.)

 

 

5500 Flatiron Parkway, Suite 100

 

Boulder, Colorado

80301

(Address of principal executive offices)

(Zip Code)

 

(303) 625-5000

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)


 

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

 

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

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

 

 

 

 

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

(Do not check if a smaller reporting company)

Smaller reporting company

 

 

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 Ace. 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

 

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of April 28, 2017 was 44,772,600.

 

 


 

CLOVIS ONCOLOGY, INC.

 

FORM 10-Q

 

TABLE OF CONTENTS

 

 

 

 

 

PART I. Financial Information 

3

 

 

 

 

ITEM 1. 

 

Financial Statements (unaudited)

3

 

 

 

 

 

 

Consolidated Statements of Operations and Comprehensive Loss — for the three months ended March 31, 2017 and 2016

3

 

 

 

 

 

 

Consolidated Balance Sheets — as of March 31, 2017 and December 31, 2016

4

 

 

 

 

 

 

Consolidated Statements of Cash Flows — for the three months ended March 31, 2017 and 2016

5

 

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

6

 

 

 

 

ITEM 2. 

 

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

21

 

 

 

 

ITEM 3. 

 

Quantitative and Qualitative Disclosures About Market Risk

30

 

 

 

 

ITEM 4. 

 

Controls and Procedures

30

 

 

PART II. Other Information 

32

 

 

 

 

ITEM 1. 

 

Legal Proceedings

32

 

 

 

 

ITEM 1A. 

 

Risk Factors

35

 

 

 

 

ITEM 2. 

 

Unregistered Sales of Equity Securities and Use of Proceeds

36

 

 

 

 

ITEM 3. 

 

Defaults Upon Senior Securities

36

 

 

 

 

ITEM 4. 

 

Mine Safety Disclosures

36

 

 

 

 

ITEM 5. 

 

Other Information

36

 

 

 

 

ITEM 6.

 

Exhibits

36

 

 

SIGNATURES 

40

 

 

 

2


 

PART I. FINANCIAL INFORMATION

 

ITEM 1.FINANCIAL STATEMENTS

 

CLOVIS ONCOLOGY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31, 

 

 

    

2017

    

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

7,045

 

$

 —

 

Operating expenses:

 

 

  

 

 

  

 

Cost of sales - product

 

 

1,163

 

 

 —

 

Cost of sales - intangible asset amortization

 

 

372

 

 

 —

 

Research and development

 

 

32,447

 

 

74,608

 

Selling, general and administrative

 

 

29,224

 

 

9,827

 

Change in fair value of contingent purchase consideration

 

 

 —

 

 

516

 

Total expenses

 

 

63,206

 

 

84,951

 

Operating loss

 

 

(56,161)

 

 

(84,951)

 

Other income (expense):

 

 

  

 

 

  

 

Interest expense

 

 

(2,581)

 

 

(2,104)

 

Foreign currency losses

 

 

(159)

 

 

(551)

 

Other income

 

 

354

 

 

25

 

Other income (expense), net

 

 

(2,386)

 

 

(2,630)

 

Loss before income taxes

 

 

(58,547)

 

 

(87,581)

 

Income tax benefit

 

 

83

 

 

4,181

 

Net loss

 

$

(58,464)

 

$

(83,400)

 

Other comprehensive income:

 

 

  

  

 

  

 

Foreign currency translation adjustments, net of tax

 

 

467

  

 

3,513

 

Net unrealized (loss) gain on available-for-sale securities, net of tax

 

 

(5)

  

 

230

 

Other comprehensive income

 

 

462

  

 

3,743

 

Comprehensive loss

 

$

(58,002)

 

$

(79,657)

 

 

 

 

 

 

 

 

 

Loss per basic and diluted common share:

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(1.33)

 

$

(2.17)

 

Basic and diluted weighted average common shares outstanding

 

 

44,039

 

 

38,360

 

 

See accompanying Notes to Unaudited Consolidated Financial Statements.

3


 

CLOVIS ONCOLOGY, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except for share amounts)

 

 

 

 

 

 

 

 

 

 

 

March 31, 

 

December 31, 

 

 

    

2017

    

2016

 

 

 

 

 

 

 

 

 

ASSETS

 

 

  

 

 

  

 

Current assets:

 

 

  

 

 

  

 

Cash and cash equivalents

 

$

276,049

 

$

216,186

 

Accounts receivable, net

 

 

2,378

 

 

121

 

Inventories

 

 

6,504

 

 

 —

 

Available-for-sale securities

 

 

132,778

 

 

49,997

 

Prepaid research and development expenses

 

 

5,465

 

 

6,427

 

Other current assets

 

 

5,645

 

 

6,679

 

Total current assets

 

 

428,819

 

 

279,410

 

Property and equipment, net

 

 

4,226

 

 

4,440

 

Intangible assets, net

 

 

20,675

 

 

21,047

 

Goodwill

 

 

58,015

 

 

57,192

 

Other assets

 

 

24,879

 

 

2,468

 

Total assets

 

$

536,614

 

$

364,557

 

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

 

 

  

 

 

  

 

Current liabilities:

 

 

  

 

 

  

 

Accounts payable

 

$

23,918

 

$

10,912

 

Accrued research and development expenses

 

 

25,868

 

 

35,198

 

Other accrued expenses

 

 

9,083

 

 

19,487

 

Total current liabilities

 

 

58,869

 

 

65,597

 

Deferred income taxes, net

 

 

207

 

 

 —

 

Milestone liability

 

 

20,528

 

 

20,062

 

Convertible senior notes

 

 

281,443

 

 

281,126

 

Deferred rent, long-term

 

 

1,358

 

 

1,406

 

Total liabilities

 

 

362,405

 

 

368,191

 

Commitments and contingencies (Note 14)

 

 

  

 

 

  

 

Stockholders' equity (deficit):

 

 

  

 

 

  

 

Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2017 and December 31, 2016

 

 

 —

 

 

 —

 

Common stock, $0.001 par value per share, 100,000,000 shares authorized at March 31, 2017 and December 31, 2016; 44,769,756 and 38,724,090 shares issued and outstanding at March 31, 2017 and December 31, 2016 respectively

 

 

45

 

 

39

 

Additional paid-in capital

 

 

1,410,789

 

 

1,174,950

 

Accumulated other comprehensive loss

 

 

(47,118)

 

 

(47,580)

 

Accumulated deficit

 

 

(1,189,507)

 

 

(1,131,043)

 

Total stockholders' equity (deficit)

 

 

174,209

 

 

(3,634)

 

Total liabilities and stockholders' equity (deficit)

 

$

536,614

 

$

364,557

 

 

See accompanying Notes to Unaudited Consolidated Financial Statements.

4


 

CLOVIS ONCOLOGY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31, 

 

 

 

    

2017

    

2016

 

 

 

 

 

 

 

 

 

 

 

Operating activities

 

 

  

 

 

  

 

 

Net loss

 

$

(58,464)

 

$

(83,400)

 

 

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

 

 

  

 

 

  

 

 

Share-based compensation expense

 

 

8,947

 

 

10,965

 

 

Depreciation and amortization

 

 

639

 

 

270

 

 

Amortization of premiums and discounts on available-for-sale securities

 

 

214

 

 

80

 

 

Amortization of debt issuance costs

 

 

317

 

 

307

 

 

Change in fair value of contingent purchase consideration

 

 

 —

 

 

1,049

 

 

Loss on disposal of property and equipment

 

 

 —

 

 

169

 

 

Deferred income taxes

 

 

(60)

 

 

(4,145)

 

 

Changes in operating assets and liabilities:

 

 

  

 

 

  

 

 

Accounts receivable

 

 

(2,257)

 

 

 —

 

 

Inventory

 

 

(6,504)

 

 

 —

 

 

Prepaid and accrued research and development expenses

 

 

(10,047)

 

 

(7,601)

 

 

Other operating assets

 

 

(17,014)

 

 

(130)

 

 

Accounts payable

 

 

13,780

 

 

2,682

 

 

Other accrued expenses

 

 

(9,990)

 

 

(3,984)

 

 

Net cash used in operating activities

 

 

(80,439)

 

 

(83,738)

 

 

Investing activities

 

 

  

 

 

  

 

 

Purchases of property and equipment

 

 

(53)

 

 

(604)

 

 

Deposits for purchases of property and equipment

 

 

(2,515)

 

 

 —

 

 

Purchases of available-for-sale securities

 

 

(133,000)

 

 

 —

 

 

Maturities of available-for-sale securities

 

 

50,000

 

 

25,000

 

 

Acquired in-process research and development - milestone payment

 

 

(1,100)

 

 

 —

 

 

Net cash (used in) provided by investing activities

 

 

(86,668)

 

 

24,396

 

 

Financing activities

 

 

  

 

 

  

 

 

Proceeds from the sale of common stock, net of issuance costs

 

 

221,224

 

 

 —

 

 

Proceeds from the exercise of stock options

 

 

5,674

 

 

705

 

 

Net cash provided by financing activities

 

 

226,898

 

 

705

 

 

Effect of exchange rate changes on cash and cash equivalents

 

 

72

 

 

254

 

 

Increase (decrease) in cash and cash equivalents

 

 

59,863

 

 

(58,383)

 

 

Cash and cash equivalents at beginning of period

 

 

216,186

 

 

278,756

 

 

Cash and cash equivalents at end of period

 

$

276,049

 

$

220,373

 

 

Supplemental disclosure of cash flow information:

 

 

  

 

 

  

 

 

Cash paid for interest

 

$

3,594

 

$

3,594

 

 

Non-cash investing and financing activities:

 

 

  

 

 

  

 

 

Vesting of restricted stock units

 

$

2,534

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying Notes to Unaudited Consolidated Financial Statements.

5


 

CLOVIS ONCOLOGY, INC.

 

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Nature of Business and Basis of Presentation

 

Clovis Oncology, Inc. (together with its consolidated subsidiaries, the “Company”, “Clovis”, “we”, “our”, “us”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and other international markets. We have and intend to continue to license or acquire rights to oncology compounds in all stages of development. In exchange for the right to develop and commercialize these compounds, we generally expect to provide the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, we generally expect to assume the responsibility for future drug development and commercialization costs. We currently operate in one segment. Since inception, our operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities.

 

During the second quarter of 2016, we completed the submission of our New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for approval of rucaparib in the U.S. On December 19, 2016, the FDA approved Rubraca® (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. We began selling Rubraca in the U.S. in the fourth quarter of 2016. Also in the fourth quarter of 2016, we submitted our rucaparib E.U. regulatory application for a comparable ovarian cancer indication, which was accepted by the European Medicines Agency (“EMA”) during the fourth quarter of 2016.

 

Basis of Presentation

 

All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.

 

The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments, consisting only of normal recurring adjustments that, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented herein. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2016 (“2016 Form 10-K”) for a broader discussion of our business and the opportunities and risks inherent in such business.

 

Use of Estimates

 

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, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates, including estimates related to revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. We base our estimates on historical experience and other market-specific or other relevant assumptions that we believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.

 

Liquidity

 

We have incurred significant net losses since inception and have relied on our ability to fund our operations through debt and equity financings. We expect operating losses and negative cash flows to continue for the foreseeable future. As we continue to incur losses, transition to profitability is dependent upon achieving a level of revenues from Rubraca adequate to support our cost structure. We may never achieve profitability, and unless or until we do, we will continue to need to raise additional cash.

6


 

 

In January 2017, we sold 5,750,000 shares of our common stock in a public offering at $41.00 per share. The net proceeds from the offering were $221.2 million, after deducting underwriting discounts and commissions and offering expenses. We intend to use the net proceeds of the offering for general corporate purposes, including commercial planning and sales and marketing expenses associated with the launch of Rubraca in the United States and, if approved by the EMA, in Europe, funding of our development programs, selling, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital. Based on current estimates, we believe that our existing cash, cash equivalents and available-for-sale securities will allow us to fund our operating plan through at least the next 12 months.

 

 

2. Summary of Significant Accounting Policies

 

Revenue Recognition

 

Product revenue is derived from sales of our product, Rubraca, in the United States. We distribute our product in the U.S. principally through a limited number of specialty distributor and specialty pharmacy providers, collectively, our customers. Our customers subsequently resell our products to patients and healthcare providers. Separately, we have arrangements with certain payors and other third parties that provide for government-mandated and privately-negotiated rebates, chargebacks and other discounts.

 

Revenues from product sales are recognized when persuasive evidence of an arrangement exists, delivery has occurred and title of the product and associated risk of loss has passed to the customer, the price is fixed or determinable, collection from the customer has been reasonably assured and all performance obligations have been met and returns and allowances can be reasonably estimated. Revenue is recorded net of estimated rebates, chargebacks, discounts and other deductions as well as estimated product returns (collectively, “sales deductions”). We only recognize revenue on product sales once the product is resold to the patient or healthcare provider by the specialty distributor or specialty pharmacy provider, therefore reducing the significance of estimates made for product returns. To date, we have not had any product returns and, we currently do not have an accrual for product returns. We will continue to assess our estimate for product returns as we gain additional historical experience.

 

Cost of Sales – Product

 

Product cost of sales consists primarily of materials, third-party manufacturing costs as well as freight and royalties owed to our licensing partners for Rubraca sales. Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, certain of the manufacturing costs of Rubraca units recognized as revenue during the three months ended March 31, 2017 were expensed prior to the December 19, 2016 FDA approval, and therefore are not included in costs of sales during the current period. We expect cost of sales to increase in relation to product revenues as we deplete these inventories and we expect to use the remaining pre-commercialization inventory for product sales through the third quarter of 2017.

 

Cost of Sales – Intangible Asset Amortization

 

Cost of sales for intangible asset amortization consists of the amortization of capitalized milestone payments made to our licensing partners upon FDA approval of Rubraca. Milestone payments are amortized on a straight-line basis over the estimated remaining patent life of Rubraca. 

 

Inventory

 

Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, first-out, or FIFO, basis. We began capitalizing incurred inventory related costs upon the regulatory approval of Rubraca. Prior to the regulatory approval of Rubraca, we incurred costs for the manufacture of the drug that could potentially be available to support the commercial launch of Rubraca and all such costs were recognized as research and development expense. We periodically analyze our inventory levels, and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and/or inventory in excess of expected sales requirements as cost of product revenues. Expired inventory would be disposed of and the related costs would be written off as cost of product revenues. 

 

7


 

The active pharmaceutical ingredient (“API”) in Rubraca is currently produced by a single supplier. As the API has undergone significant manufacturing specific to its intended purpose at the point it is purchased by us, we classify the API as work-in-process inventory.       

 

Our other significant accounting policies are described in Note 2,  Summary of Significant Accounting Policies of the Notes to the Consolidated Financial Statements included in the Company’s 2016 Form 10-K.

 

From time to time, the Financial Accounting Standards Board (“FASB”) or other standards setting bodies issue new accounting pronouncements.  Updates to the FASB Accounting Standards Codification (“ASC”) are communicated through issuance of an Accounting Standards Update (“ASU”).

 

Recently Adopted Accounting Standards

 

During the first quarter of 2017, we adopted ASU No. 2016-09, “Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”, which is intended to simplify the financial reporting of the income tax impacts of share-based compensation arrangements.  The classification guidance under ASU No. 2016-09 requires the recognition of excess tax benefits from share-based compensation arrangements as a discrete item within income tax benefit rather than additional paid-in capital and the classification guidance requiring presentation of excess tax benefits from share-based compensation arrangements as an operating activity on the statement of cash flows, rather than as a financing activity. 

 

 The adoption of ASU No 2016-09 had no immediate impact on our financial statements and related disclosures because we do not currently recognize a tax benefit related to share-based compensation expense as we maintain net operating loss carryforwards and have established a valuation allowance against the entire net deferred tax asset as of March 31, 2017.  Further, we have elected to continue to estimate the number of stock-based awards expected to vest, as permitted by ASU 2016-09, rather than electing to account for forfeitures as they occur.

 

Also during the first quarter of 2017, we adopted ASU 2015-11, “Simplifying the Measurement of Inventory,” which was issued by the FASB in July 2015. ASU 2015-11 applies a simplified method to value inventory at the lower of cost or net realizable value rather than at the lower of cost or market. The adoption of ASU 2015-11 had no impact on our consolidated financial statements.

 

In January 2017, the FASB issued ASU No. 2017-04, “Simplifying the Test for Goodwill Impairment.” ASU No. 2017-04 removes the requirement to compare the implied fair value of goodwill with its carrying amount as part of step 2 of the goodwill impairment test.  As a result, under the ASU, an entity should perform its annual, or interim, goodwill impairment by comparing the fair value of a reporting unit with its carrying amounts and should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit's fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. As permitted by the ASU, we have early adopted this standard and will apply the new guidance to any interim or annual goodwill impairment testing performed after the date of adoption, March 1, 2017.

 

Recently Issued Accounting Standards

 

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers” and has subsequently issued several supplemental and/or clarifying ASUs (collectively, “ASC 606”). ASC 606 prescribes a single common revenue standard that replaces most existing U.S. GAAP revenue recognition guidance. ASC 606 is intended to provide a more consistent interpretation and application of the principles outlined in the standard across filers in multiple industries and within the same industries compared to current practices, which should improve comparability.  Adoption of ASC 606 is required for annual and interim periods beginning after December 15, 2017. Upon adoption, we must elect to adopt either retrospectively to each prior reporting period presented or use the modified retrospective transition method with the cumulative effect of initial adoption recognized at the date of initial application. We expect to apply the new standard using the modified retrospective method upon its adoption date on January 1, 2018. 

 

We have begun a comprehensive scoping process to identify and disaggregate all revenue streams that may be impacted by the adoption of ASC 606. To date, we have examined our revenue recognition policy specific to revenue streams from representative contracts governing product sales from Rubraca and have come to preliminary conclusions on the impact of the new standard using the 5-step process prescribed by ASC 606. However, a detailed analysis of

8


 

individual contracts representative of each of the revenue streams planned for the assessment phase of our implementation plan may impact these preliminary conclusions. We are continuing to assess ASC 606’s impact on its financial statements. 

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” which requires lessees to recognize assets and liabilities for the rights and obligations created by most leases on their balance sheet. The guidance is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. Early application is permitted. ASU 2016-02 requires modified retrospective adoption for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. We are currently evaluating the impact the standard may have on our consolidated financial statements and related disclosures. 

 

3. Financial Instruments and Fair Value Measurements

 

Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.

 

The three levels of inputs that may be used to measure fair value include:

 

Level 1:

Quoted prices in active markets for identical assets or liabilities. Our Level 1 assets consist of money market investments. We do not have Level 1 liabilities.

 

 

Level 2:

Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Our Level 2 assets consist of U.S. treasury securities. We do not have Level 2 liabilities.

 

 

Level 3:

Unobservable inputs that are supported by little or no market activity. We do not have Level 3 assets or liabilities that are measured at fair value on a recurring basis.

 

The following table identifies our assets and liabilities that were measured at fair value on a recurring basis (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Balance

    

Level 1

    

Level 2

    

Level 3

 

March 31, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market

 

$

123,166

 

$

123,166

 

$

 —

 

$

 —

 

U.S. treasury securities

 

 

256,278

 

 

 —

 

 

256,278

 

 

 —

 

Total assets at fair value

 

$

379,444

 

$

123,166

 

$

256,278

 

$

 —

 

December 31, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market

 

$

202,361

 

$

202,361

 

$

 —

 

$

 —

 

U.S. treasury securities

 

 

49,997

 

 

 —

 

 

49,997

 

 

 —

 

Total assets at fair value

 

$

252,358

 

$

202,361

 

$

49,997

 

$

 —

 

 

There were no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the three months ended March 31, 2017.

 

Financial instruments not recorded at fair value include our convertible senior notes. At March 31, 2017, the carrying amount of the convertible senior notes was $281.4 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $370.9 million. The fair value was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the Notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. See Note 9, Convertible Senior Notes for discussion of the convertible senior notes.

 

9


 

4. Available-for-Sale Securities

 

As of March 31, 2017, available-for-sale securities consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

    

 

    

Gross

    

Gross

    

Aggregate

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

Fair

 

 

 

Cost

 

Gains

 

Losses

 

Value

 

U.S. treasury securities

 

$

256,290

 

$

 —

 

$

(12)

 

$

256,278

 

 

As of December 31, 2016, available-for-sale securities consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

    

 

    

Gross

    

Gross

    

Aggregate

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

Fair

 

 

 

Cost

 

Gains

 

Losses

 

Value

 

U.S. treasury securities

 

$

50,004

 

$

 —

 

$

(7)

 

$

49,997

 

 

As of March 31, 2017, the fair value and gross unrealized losses of available-for-sale securities that have been in a continuous unrealized loss position for less than 12 months were as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

    

Aggregate

    

Gross

 

 

 

Fair

 

Unrealized

 

 

 

Value

 

Losses

 

U.S. treasury securities

 

$

256,278

 

$

(12)

 

 

We have concluded that decline in the market value of the available-for-sales securities is temporary.  A decline in the market value of a security below its cost that is deemed to be other than temporary is charged to earnings and results in the establishment of a new cost basis for the security. Factors evaluated to determine if an investment is other-than-temporarily impaired include significant deterioration in earnings performance, credit rating, asset quality or business prospects of the issuer; adverse changes in the general market conditions in which the issuer operates; and our intent and ability to hold the security until an anticipated recovery in value occurs.

 

As of March 31, 2017, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands):

 

 

 

 

 

 

 

 

 

 

    

Amortized

    

Fair

 

 

 

Cost

 

Value

 

Due in one year or less

 

$

256,290

 

$

256,278

 

Due in one year to two years

 

 

 —

 

 

 —

 

Total

 

$

256,290

 

$

256,278

 

 

 

5. Inventories

 

We generally have two categories of inventory: work-in-process and finished goods. As of March 31, 2017, the carrying value of all of our product inventory, which consisted only of the Rubraca API, was categorized as work-in-process. The costs related to our finished goods on-hand as of March 31, 2017 were expensed as incurred prior to the commercialization of Rubraca on December 19, 2016. The carrying value of our inventory as of December 31, 2016 was zero.

 

At March 31, 2017, other assets on the Consolidated Balance Sheets includes a cash deposit of $18.2 million made to a manufacturer for the purchase of inventory which we do not expect to be commercially consumed within the next twelve months.

10


 

6. Other Current Assets

 

Other current assets were comprised of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

March 31, 

 

December 31, 

 

 

    

2017

    

2016

 

Receivable from partners

 

$

770

 

$

2,882

 

Prepaid insurance

 

 

878

 

 

1,234

 

Prepaid expenses - other

 

 

2,975

 

 

2,109

 

Receivable - other

 

 

963

 

 

364

 

Other

 

 

59

 

 

90

 

Total

 

$

5,645

 

$

6,679

 

 

 

 

 

 

 

7. Intangible Assets and Goodwill

 

Intangible assets related to capitalized milestones under license agreements consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

March 31, 

 

December 31, 

 

 

 

2017

    

2016

 

Intangible asset - milestones

 

$

21,100

 

$

21,100

 

Accumulated amortization

 

 

(425)

 

 

(53)

 

Total intangible asset, net

 

$

20,675

 

$

21,047

 

  

The estimated useful lives of these intangible assets are based on the estimated remaining patent life of Rubraca and extend through 2031.

 

We recorded amortization expense of $0.4 million related to capitalized milestone payments during the three months ended March 31, 2017 included in cost of sales – intangible asset amortization at the Consolidated Statements of Operations and Comprehensive Loss. There was no amortization expense during the three months ended March 31, 2016.

 

Estimated future amortization expense associated with intangibles is expected to be as follows (in thousands):

 

 

 

 

 

 

 

 

 

2017 (remaining)

 

 

 

 

$

1,114

 

2018

 

 

 

 

 

1,486

 

2019

 

 

 

 

 

1,486

 

2020

 

 

 

 

 

1,486

 

2021

 

 

 

 

 

1,486

 

Thereafter

 

 

 

 

 

13,617

 

 

 

 

 

 

$

20,675

 

 

The change in goodwill established as part of the purchase accounting of EOS in November 2013 consisted of the following (in thousands):

 

 

 

 

 

 

Balance at December 31, 2016

 

$

57,192

 

Change in foreign currency gains and losses

 

 

823

 

Balance at March 31, 2017

 

$

58,015

 

 

 

11


 

8. Other Accrued Expenses

 

Other accrued expenses were comprised of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

March 31, 

 

December 31, 

 

 

    

2017

    

2016

 

Accrued personnel costs

 

$

5,808

 

$

15,850

 

Accrued interest payable

 

 

299

 

 

2,096

 

Income tax payable

 

 

629

 

 

556

 

Accrued corporate legal fees and professional services

 

 

1,467

 

 

589

 

Accrued expenses - other

 

 

880

 

 

396

 

Total

 

$

9,083

 

$

19,487

 

 

 

9. Convertible Senior Notes

 

On September 9, 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertible senior notes due 2021 (the “Notes”) resulting in net proceeds of $278.3 million after deducting offering expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets.

 

The Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on March 15 and September 15 of each year. The Notes will mature on September 15, 2021, unless earlier converted, redeemed or repurchased.

 

Holders may convert all or any portion of the Notes at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 16.1616 shares per $1,000 in principal amount of Notes, equivalent to a conversion price of approximately $61.88 per share. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the Notes in connection with such a corporate event or during the related redemption period in certain circumstances.

 

On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% 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 not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.

 

If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may require us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

 

The Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the Notes; equal in right of payment to all of our liabilities that are not so subordinated; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries.

 

In connection with the issuance of the Notes, we incurred $9.2 million of debt issuance costs. The debt issuance costs are presented as a deduction from convertible senior notes on the Consolidated Balance Sheets and are amortized as interest expense over the expected life of the Notes using the effective interest method. We determined the expected life of the debt was equal to the seven-year term of the Notes. As of March 31, 2017 and December 31, 2016, the balance of unamortized debt issuance costs was $6.1 million and $6.4 million, respectively.

 

12


 

The following table sets forth total interest expense recognized during the three months ended March 31, 2017 and 2016 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31, 

 

 

    

2017

    

2016

 

Contractual interest expense

 

$

1,797

 

$

1,797

 

Accretion of interest on milestone liability

 

 

467

 

 

 —

 

Amortization of debt issuance costs

 

 

317

 

 

307

 

Total interest expense

 

$

2,581

 

$

2,104

 

 

 

10. Stockholders’ Equity

 

Common Stock

 

In January 2017, we sold 5,750,000 shares of our common stock in a public offering at $41.00 per share. The net proceeds from the offering were $221.2 million, after deducting underwriting discounts and commissions and offering expenses.

 

The holders of common stock are entitled to one vote per share on all matters to be voted upon by our stockholders. Subject to the preferences that may be applicable to any outstanding shares of preferred stock, the holders of common stock are entitled to receive ratably such dividends, if any, as may be declared by our Board of Directors.

 

Accumulated Other Comprehensive Loss

 

Accumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which includes changes in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities.

 

The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign Currency

 

Unrealized

 

Total Accumulated

 

 

 

Translation Adjustments

 

(Losses) Gains

 

Other Comprehensive Loss

 

 

 

2017

 

2016

 

2017

 

2016

 

2017

 

2016

 

Balance at December 31, 

 

$

(47,434)

 

$

(47,077)

 

$

(146)

 

$

(383)

 

$

(47,580)

 

$

(47,460)

 

Other comprehensive income (loss)

 

 

735

 

 

5,580

 

 

(5)

 

 

365

 

 

730

 

 

5,945

 

Total before tax

 

 

(46,699)

 

 

(41,497)

 

 

(151)

 

 

(18)

 

 

(46,850)

 

 

(41,515)

 

Tax effect

 

 

(268)

 

 

(2,067)

 

 

 —

 

 

(135)

 

 

(268)

 

 

(2,202)

 

Balance at March 31, 

 

$

(46,967)

 

$

(43,564)

 

$

(151)

 

$

(153)

 

$

(47,118)

 

$

(43,717)

 

 

The period change between December 31, 2016 and March 31, 2017 was primarily due to the currency translation of the goodwill and deferred income taxes associated with the acquisition of EOS in November 2013. There were no reclassifications out of accumulated other comprehensive loss in both the three months ended March 31, 2017 and 2016.

 

11. Share-Based Compensation

 

Share-based compensation expense for all equity based programs, including stock options, restricted stock units and the employee stock purchase plan, for the three months ended March 31, 2017 and 2016 was recognized in the accompanying Consolidated Statements of Operations as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31, 

 

 

 

    

2017

    

2016

 

 

Research and development

 

$

4,167

 

$

7,309

 

 

Selling, general and administrative

 

 

4,780

 

 

3,656

 

 

Total share-based compensation expense

 

$

8,947

 

$

10,965

 

 

 

We did not recognize a tax benefit related to share-based compensation expense during the three months ended March 31, 2017 and 2016, respectively, as we maintain net operating loss carryforwards and have established a valuation allowance against the entire net deferred tax asset as of March 31, 2017.

13


 

 

Stock Options

 

The following table summarizes the activity relating to our options to purchase common stock for the three months ended March 31, 2017:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

 

    

 

 

    

Weighted

    

 

 

 

 

 

 

 

Weighted

 

Average

 

Aggregate

 

 

 

 

 

Average

 

Remaining

 

Intrinsic

 

 

 

Number of

 

Exercise

 

Contractual

 

Value

 

 

 

Options

 

Price

 

Term (Years)

 

(Thousands)

 

Outstanding at December 31, 2016

 

5,520,482

 

$

42.00

 

  

 

 

  

 

Granted

 

446,200

 

 

64.43

 

  

 

 

  

 

Exercised

 

(252,912)

 

 

22.44

 

  

 

 

  

 

Forfeited

 

(128,180)

 

 

38.10

 

  

 

 

  

 

Outstanding at March 31, 2017

 

5,585,590

 

$

44.77

 

7.6

 

$

134,859

 

Vested and expected to vest at March 31, 2017

 

5,212,054

 

$

44.76

 

7.5

 

$

126,378

 

Vested and exercisable at March 31, 2017

 

2,948,774

 

$

44.46

 

6.4

 

$

73,489

 

 

The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $63.67 as of March 31, 2017, which would have been received by the option holders had all option holders with in-the-money options exercised their options as of that date.

 

The following table summarizes information about our stock options as of and for the three months ended March 31, 2017 and 2016 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31, 

 

 

    

2017

    

2016

 

Weighted-average grant date fair value per share

 

$

47.71

 

$

15.24

 

Intrinsic value of options exercised

 

$

9,525

 

$

46

 

Cash received from stock option exercises

 

$

5,674

 

$

55

 

 

As of March 31, 2017, the unrecognized share-based compensation expense related to unvested options, adjusted for expected forfeitures, was $81.5 million and the estimated weighted-average remaining vesting period was 2.6 years.

 

Restricted Stock

 

During 2016, we issued restricted stock units (“RSUs”) to certain employees under the 2011 Stock Incentive Plan. The RSUs ratably cliff vest one year from the date of grant with the remaining RSUs vesting ratably each subsequent quarter over either a two-year or four-year vesting period, as defined in the grant agreement. Vested RSUs are payable in shares of our common stock at the end of the vesting period. RSUs are measured based on the fair value of the underlying stock on the grant date. The minimum statutory tax on the value of common stock shares issued to employees upon vesting are paid by us through the sale of registered shares of our common stock.

 

The following table summarizes the activity relating to our unvested RSUs for the three months ended March 31, 2017:

 

 

 

 

 

 

 

 

    

 

    

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Average

 

 

 

Number of

 

Grant Date

 

 

 

Units

 

Fair Value

 

Unvested at December 31, 2016

 

562,458

 

$

24.70

 

Granted

 

210,484

 

 

61.42

 

Vested

 

(42,754)

 

 

19.37

 

Forfeited

 

(20,991)

 

 

20.81

 

Unvested as of March 31, 2017

 

709,197

 

$

36.03

 

Expected to vest after March 31, 2017

 

592,152

 

$

35.53

 

 

14


 

As of March 31, 2017, the unrecognized share-based compensation expense related to unvested RSUs, adjusted for expected forfeitures, was $19.7 million and the estimated weighted-average remaining vesting period was 3.6 years.

 

12. License Agreements

 

In June 2011, we entered into a worldwide license agreement with Pfizer, Inc. to obtain exclusive global rights to develop and commercialize rucaparib, a small molecule inhibitor of poly (ADP-ribose) polymerase (“PARP”), used for the treatment of selected solid tumors. The exclusive rights are exclusive even as to Pfizer and include the right to grant sublicenses. Pursuant to the terms of the license agreement, we made a $7.0 million upfront payment to Pfizer and are required to make additional payments to Pfizer for the achievement of certain development and regulatory and sales milestones and royalties on sales as required by the license agreement.  Prior to the FDA approval of rucaparib, discussed below, we made milestone payments of $1.4 million, which were recognized as acquired in-process research and development expense.

 

On August 30, 2016, we entered into a first amendment to the worldwide license agreement with Pfizer, which amends the June 2011 existing worldwide license agreement to permit us to defer payment of the milestone payments payable upon (i) FDA approval of an NDA for 1st Indication in US and (ii) EMA approval of an MAA for 1st Indication in EU, to a date that is 18 months after the date of achievement of such milestones. In the event that we defer such milestone payments, we have agreed to certain higher payments related to the achievement of such milestones.

 

On December 19, 2016, the FDA approved Rubraca (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The FDA approval resulted in a $0.75 million milestone payment to Pfizer as required by the license agreement, which was made in the first quarter of 2017. The FDA approval also resulted in the obligation to pay a $20.0 million milestone payment, for which we have exercised the option to defer payment by agreeing to pay $23.0 million within 18 months after the date of the FDA approval. These payments were recognized as intangible assets and will be amortized over the estimated remaining useful life of Rubraca.

 

We are obligated under the license agreement to use commercially reasonable efforts to develop and commercialize rucaparib and we are responsible for all remaining development and commercialization costs for rucaparib. We are required to make regulatory milestone payments to Pfizer of up to an additional $69.75 million in aggregate if specified clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, we are obligated to make sales milestone payments to Pfizer if specified annual sales targets for rucaparib are met, the majority of which relate to annual sales targets of $500.0 million and above, which, in the aggregate, could amount to total milestone payments of $170.0 million, and tiered royalty payments at a mid-teen percentage rate on our net sales, with standard provisions for royalty offsets to the extent we need to obtain any rights from third parties to commercialize rucaparib.

 

In April 2012, we entered into a license agreement with AstraZeneca UK Limited to acquire exclusive rights associated with rucaparib under a family of patents and patent applications that claim methods of treating patients with PARP inhibitors in certain indications. The license enables the development and commercialization of rucaparib for the uses claimed by these patents.  The FDA approval of rucaparib on December 19, 2016 resulted in a $0.35 million milestone obligation to AstraZeneca as required by the license agreement, which was paid in the first quarter of 2017. This payment was recognized in intangible assets and will be amortized over the estimated remaining useful life of rucaparib. AstraZeneca will also receive royalties on any net sales of rucaparib.

 

We are party to other product license agreements for our other drug candidates, lucitanib and rociletinib (see our 2016 Form 10-K for additional details). We and Les Laboratories Servier (“Servier”) are developing lucitanib pursuant to a global development plan agreed to between the parties. Servier is responsible for all of the global development costs for lucitanib up to €80.0 million. Cumulative global development costs in excess of €80.0 million, if any, will be shared equally between us and Servier. We recorded a $0.8 million and $1.3 million receivable at March 31, 2017 and December 31, 2016, respectively, for the reimbursable development costs incurred under the global development plan, which is included in other current assets on the Consolidated Balance Sheets. For the three months ending March 31, 2017 and 2016, we incurred $0.7 million and $3.6 million, respectively, in research and development costs and recorded reductions in research and development expense of $0.8 million and $3.6 million, respectively, for reimbursable development costs due from Servier.

15


 

 

During the second quarter of 2016, we and Servier agreed to discontinue the development of lucitanib for breast cancer and lung cancer and are continuing to evaluate, what, if any, further development of lucitanib will be pursued. Based on current estimates, we expect to complete the committed on-going development activities in 2017 and expect full reimbursement of our development costs from Servier. Reimbursements are recorded as a reduction to research and development expense on the Consolidated Statements of Operations.

 

13. Net Loss Per Common Share

 

Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury-stock method for the stock options and RSUs and the if-converted method for the Notes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share.

 

The shares outstanding at the end of the respective periods presented in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in thousands):

 

 

 

 

 

 

 

 

 

Three months ended March 31, 

 

 

    

2017

    

2016

 

Common shares under option

 

3,557

 

539

 

Convertible senior notes

 

4,646

 

4,646

 

Total potential dilutive shares

 

8,203

 

5,185

 

 

 

14. Commitments and Contingencies

 

Royalty and License Fee Commitments

 

We have entered into certain license agreements, as identified in Note 12, License Agreements, with third parties that include the payment of development and regulatory milestones, as well as royalty payments, upon the achievement of pre-established development, regulatory and commercial targets. Our payment obligation related to these license agreements is contingent upon the successful development, regulatory approval and commercialization of the licensed products. Due to the nature of these arrangements, the future potential payments are inherently uncertain, and accordingly, we only recognize payment obligations which are probable and estimable as of the balance sheet date. Milestone liabilities of $20.5 million and $20.1 million are recorded on our Consolidated Balance Sheets at March 31, 2017 and December 31, 2016, respectively, and relate to milestone payments for the licensing of our rucaparib product, which was approved by the FDA on December 19, 2016.

 

Manufacture and Services Agreement Commitments

 

On October 3, 2016, we entered into a Manufacturing and Services Agreement (the “Agreement”) with a non-exclusive third-party supplier for the production of the active ingredient for Rubraca. Under the terms of the Agreement, we will provide the third-party supplier a rolling forecast for the supply of the active ingredient in Rubraca that will be updated by us on a quarterly basis. We are obligated to order material sufficient to satisfy an initial quantity specified in any forecast. In addition, the third-party supplier will construct, in its existing facility, a production train that will be exclusively dedicated to the manufacture of the Rubraca active ingredient.  We are obligated to make scheduled capital program fee payments toward capital equipment and other costs associated with the construction of the dedicated production train. Further, once the facility is operational, we are obligated to pay a fixed facility fee each quarter for the duration of the Agreement, which expires on December 31, 2025, unless extended by mutual consent of the parties. As of March 31, 2017, $174.5 million of purchase commitments exist under the Agreement. 

 

Legal Proceedings

 

We and certain of our officers were named as defendants in several lawsuits, as described below. We cannot reasonably predict the outcome of these legal proceedings, nor can we estimate the amount of loss or range of loss, if any, that may result. An adverse outcome in these proceedings could have a material adverse effect on our results of operations, cash flows or financial condition.

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On November 19, 2015, Steve Kimbro, a purported shareholder of Clovis, filed a purported class action complaint (the “Kimbro Complaint”) against Clovis and certain of its officers in the United States District Court for the District of Colorado. The Kimbro Complaint purports to be asserted on behalf of a class of persons who purchased Clovis stock between October 31, 2013 and November 15, 2015. The Kimbro Complaint generally alleges that Clovis and certain of its officers violated federal securities laws by making allegedly false and misleading statements regarding the progress toward FDA approval and the potential for market success of rociletinib. The Kimbro Complaint seeks unspecified damages.

 

Also on November 19, 2015, a second purported shareholder class action complaint was filed by Sonny P. Medina, another purported Clovis shareholder, containing similar allegations to those set forth in the Kimbro Complaint, also in the United States District Court for the District of Colorado (the “Medina Complaint”). The Medina Complaint purports to be asserted on behalf of a class of persons who purchased Clovis stock between May 20, 2014 and November 13, 2015. On November 20, 2015, a third complaint was filed by John Moran in the United States District Court for the Northern District of California (the “Moran Complaint”). The Moran Complaint contains similar allegations to those asserted in the Kimbro and Medina Complaints and purports to be asserted on behalf of a plaintiff class who purchased Clovis stock between October 31, 2013 and November 13, 2015.

 

On December 14, 2015, Ralph P. Rocco, a fourth purported shareholder of Clovis, filed a complaint in the United States District Court for the District of Colorado (the “Rocco Complaint”). The Rocco Complaint contains similar allegations to those set forth in the previous complaints and purports to be asserted on behalf of a plaintiff class who purchased Clovis stock between October 31, 2013 and November 15, 2015.

 

On January 19, 2016, a number of motions were filed in both the District of Colorado and the Northern District of California seeking to consolidate the shareholder class actions into one matter and for appointment of a lead plaintiff. All lead plaintiff movants other than M. Arkin (1999) LTD and Arkin Communications LTD (the “Arkin Plaintiffs”) subsequently filed notices of non-opposition to the Arkin Plaintiffs’ application.

 

On February 2, 2016, the Arkin Plaintiffs filed a motion to transfer the Moran Complaint to the District of Colorado (the “Motion to Transfer”). Also on February 2, 2016, the defendants filed a statement in the Northern District of California supporting the consolidation of all actions in a single court, the District of Colorado. On February 3, 2016, the Northern District of California court denied without prejudice the lead plaintiff motions filed in that court pending a decision on the Motion to Transfer.

 

On February 16, 2016, the defendants filed a memorandum in support of the Motion to Transfer, and plaintiff Moran filed a notice of non-opposition to the Motion to Transfer. On February 17, 2016, the Northern District of California court granted the Motion to Transfer.

 

On February 18, 2016, the Medina court issued an opinion and order addressing the various motions for consolidation and appointment of lead plaintiff and lead counsel in the District of Colorado actions. By this ruling, the court consolidated the Medina, Kimbro and Rocco actions into a single proceeding. The court also appointed the Arkin Plaintiffs as the lead plaintiffs and Bernstein Litowitz Berger & Grossman as lead counsel for the putative class.

 

On April 1, 2016, the Arkin Plaintiffs and the defendants filed a stipulated motion to set the schedule for the filing of a consolidated complaint in the Medina, Kimbro and Rocco actions (the “Consolidated Complaint”) and the responses thereto, including the defendants’ motion to dismiss the Consolidated Complaint (the “Motion to Dismiss”), and to stay discovery and related proceedings until the District of Colorado issues a decision on the Motion to Dismiss. The stipulated motion was entered by the District of Colorado on April 4, 2016.

 

Subject to further agreed-upon extensions by the parties, the Arkin Plaintiffs filed a Consolidated Complaint on May 6, 2016. The Consolidated Complaint names as defendants the Company and certain of its current and former officers (the “Clovis Defendants”), certain underwriters (the “Underwriter Defendants”) for a Company follow-on offering conducted in July 2015 (the “July 2015 Offering”) and certain Company venture capital investors (the “Venture Capital Defendants”). The Consolidated Complaint alleges that defendants violated particular sections of the Securities Exchange Act of 1934 (the “Exchange Act”) and the Securities Act of 1933 (the “Securities Act”). The purported misrepresentations and omissions concern allegedly misleading statements about rociletinib. The consolidated action is purportedly brought on behalf of investors who purchased the Company’s securities between May 31, 2014 and April 7,

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2016 (with respect to the Exchange Act claims) and investors who purchased the Company’s securities pursuant or traceable to the July 2015 Offering (with respect to the Securities Act claims). The Consolidated Complaint seeks unspecified compensatory and recessionary damages.

 

On May 23, 2016, the Medina, Kimbro, Rocco, and Moran actions were consolidated for all purposes in a single proceeding in the District of Colorado.