Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-Q


 

x

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

For the quarterly period ended June 30, 2016.

¨

For the quarterly period ended June 30, 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)


 

Delaware

 

Delaware

90-0475355

(State or other jurisdiction of

(I.R.S. Employer

incorporation or organization)

(I.R.S. Employer

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  x    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  x    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

x

 

Accelerated filer

o

Non-accelerated filer

o

(Do not check if a smaller reporting company)

Smaller reporting company

o

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

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of July 29, 201628, 2017 was 38,501,077.48,879,354.

 

 


Table of Contents

CLOVIS ONCOLOGY, INC.

 


FORM 10-Q

 

CLOVIS ONCOLOGY, INC.

FORM 10-Q

TABLE OF CONTENTS

 

PART I. Financial Information

3

 

 

 

 

PART I. Financial Information

3

ITEM 1.

 

Financial Statements (unaudited)

3

 

 

 

 

 

 

Consolidated Statements of Operations — for the three and six months ended June 30, 2016 and 2015

3

Consolidated Statements of Comprehensive Loss — for the three and six months ended June 30, 20162017 and 20152016

4

3

 

 

 

 

 

 

Consolidated Balance Sheets — as of June 30, 20162017 and December 31, 20152016

5

4

 

 

 

 

 

 

Consolidated Statements of Cash Flows — for the six months ended June 30, 20162017 and 20152016

6

5

 

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

7

6

 

 

 

 

ITEM 2.

 

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

20

21

 

 

 

 

ITEM 3.

 

Quantitative and Qualitative Disclosures About Market Risk

30

33

ITEM 4.

Controls and Procedures

30

 

 

 

 

PART II. Other InformationITEM 4.

 

Controls and Procedures

31

33

 

 

PART II. Other Information 

35

 

 

 

 

ITEM 1.

 

Legal Proceedings

31

35

 

 

 

 

ITEM 1A.

 

Risk Factors

33

37

 

 

 

 

ITEM 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

33

38

ITEM 3.

Defaults Upon Senior Securities

33

ITEM 4.

Mine Safety Disclosures

33

ITEM 5.

Other Information

33

ITEM 6.

Exhibits

33

 

 

 

 

SIGNATURESITEM 3.

Defaults Upon Senior Securities

38

 

 

36

ITEM 4.

 

Mine Safety Disclosures

38

ITEM 5.

Other Information

38

ITEM 6.

Exhibits

38

SIGNATURES

42

 

 

 


2


Table of Contents

PART I. FINANCIALFINANCIAL INFORMATION

ITEM 1.

ITEM 1.FINANCIAL STATEMENTS

FINANCIAL STATEMENTS

CLOVIS ONCOLOGY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except per share amounts)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

Three months ended June 30, 

 

Six months ended June 30, 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone revenue

 

$

 

 

$

 

 

$

 

 

$

 

    

2017

    

2016

    

2017

    

2016

 

 

(in thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

14,620

 

$

 —

 

$

21,665

 

$

 —

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

  

 

 

  

 

 

  

 

Cost of sales - product

 

 

2,730

 

 

 —

 

 

3,893

 

 

 —

 

Cost of sales - intangible asset amortization

 

 

372

 

 

 —

 

 

743

 

 

 —

 

Research and development

 

 

67,729

 

 

 

60,368

 

 

 

142,337

 

 

 

117,118

 

 

 

33,108

 

 

67,729

 

 

65,555

 

 

142,337

 

General and administrative

 

 

9,552

 

 

 

7,204

 

 

 

19,379

 

 

 

13,955

 

Selling, general and administrative

 

 

36,149

 

 

9,552

 

 

65,373

 

 

19,379

 

Acquired in-process research and development

 

 

300

 

 

 

 

 

 

300

 

 

 

 

 

 

 —

 

 

300

 

 

 —

 

 

300

 

Impairment of intangible asset

 

 

104,517

 

 

 

 

 

 

104,517

 

 

 

 

 

 

 —

 

 

104,517

 

 

 —

 

 

104,517

 

Change in fair value of contingent purchase consideration

 

 

(25,452

)

 

 

764

 

 

 

(24,936

)

 

 

1,488

 

 

 

 —

 

 

(25,452)

 

 

 —

 

 

(24,936)

 

Total expenses

 

 

156,646

 

 

 

68,336

 

 

 

241,597

 

 

 

132,561

 

 

 

72,359

 

 

156,646

 

 

135,564

 

 

241,597

 

Operating loss

 

 

(156,646

)

 

 

(68,336

)

 

 

(241,597

)

 

 

(132,561

)

 

 

(57,739)

 

 

(156,646)

 

 

(113,899)

 

 

(241,597)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

  

 

 

  

 

 

  

 

Interest expense

 

 

(2,106

)

 

 

(2,097

)

 

 

(4,210

)

 

 

(4,172

)

 

 

(2,598)

 

 

(2,106)

 

 

(5,178)

 

 

(4,210)

 

Foreign currency gains (losses)

 

 

183

 

 

 

(1,142

)

 

 

(368

)

 

 

2,105

 

Foreign currency gain (loss)

 

 

76

 

 

183

 

 

(83)

 

 

(368)

 

Legal settlement loss, net of insurance receivable

 

 

(117,000)

 

 

 —

 

 

(117,000)

 

 

 —

 

Other income

 

 

196

 

 

 

62

 

 

 

221

 

 

 

73

 

 

 

594

 

 

196

 

 

946

 

 

221

 

Other expense, net

 

 

(1,727

)

 

 

(3,177

)

 

 

(4,357

)

 

 

(1,994

)

Other income (expense), net

 

 

(118,928)

 

 

(1,727)

 

 

(121,315)

 

 

(4,357)

 

Loss before income taxes

 

 

(158,373

)

 

 

(71,513

)

 

 

(245,954

)

 

 

(134,555

)

 

 

(176,667)

 

 

(158,373)

 

 

(235,214)

 

 

(245,954)

 

Income tax benefit (expense)

 

 

29,059

 

 

 

(18

)

 

 

33,240

 

 

 

(120

)

Income tax benefit

 

 

1,281

 

 

29,059

 

 

1,365

 

 

33,240

 

Net loss

 

$

(129,314

)

 

$

(71,531

)

 

$

(212,714

)

 

$

(134,675

)

 

$

(175,386)

 

$

(129,314)

 

$

(233,849)

 

$

(212,714)

 

Other comprehensive income:

 

 

  

  

 

  

 

 

  

  

 

  

 

Foreign currency translation adjustments, net of tax

 

 

2,812

  

 

(1,381)

 

 

3,279

  

 

2,132

 

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

 

 

 —

  

 

48

 

 

(5)

  

 

278

 

Other comprehensive income (loss)

 

 

2,812

  

 

(1,333)

 

 

3,274

  

 

2,410

 

Comprehensive loss

 

$

(172,574)

 

$

(130,647)

 

$

(230,575)

 

$

(210,304)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss per basic and diluted common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(3.37

)

 

$

(2.10

)

 

$

(5.54

)

 

$

(3.96

)

 

$

(3.88)

 

$

(3.37)

 

$

(5.24)

 

$

(5.54)

 

Basic and diluted weighted-average common shares outstanding

 

 

38,389

 

 

 

34,088

 

 

 

38,375

 

 

 

34,049

 

Basic and diluted weighted average common shares outstanding

 

 

45,176

 

 

38,389

 

 

44,610

 

 

38,375

 

 

See accompanying Notes to Unaudited Consolidated Financial Statements.

3


 


Table of Contents


CLOVIS ONCOLOGY, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSSBALANCE SHEETS

(Unaudited)

(In thousands)thousands, except for share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Net loss

 

$

(129,314

)

 

$

(71,531

)

 

$

(212,714

)

 

$

(134,675

)

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments, net of tax

 

 

(1,381

)

 

 

8,313

 

 

 

2,132

 

 

 

(17,602

)

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

 

 

48

 

 

 

53

 

 

 

278

 

 

 

141

 

Other comprehensive income (loss)

 

 

(1,333

)

 

 

8,366

 

 

 

2,410

 

 

 

(17,461

)

Comprehensive loss

 

$

(130,647

)

 

$

(63,165

)

 

$

(210,304

)

 

$

(152,136

)

 

 

 

 

 

 

 

 

 

 

June 30, 

 

December 31, 

 

 

    

2017

    

2016

 

 

 

 

 

 

 

 

 

ASSETS

 

 

  

 

 

  

 

Current assets:

 

 

  

 

 

  

 

Cash and cash equivalents

 

$

491,786

 

$

216,186

 

Accounts receivable, net

 

 

1,143

 

 

121

 

Insurance receivable

 

 

25,000

 

 

 —

 

Inventories

 

 

6,478

 

 

 —

 

Available-for-sale securities

 

 

179,744

 

 

49,997

 

Prepaid research and development expenses

 

 

4,854

 

 

6,427

 

Other current assets

 

 

6,766

 

 

6,679

 

Total current assets

 

 

715,771

 

 

279,410

 

Property and equipment, net

 

 

4,155

 

 

4,440

 

Intangible assets, net

 

 

20,304

 

 

21,047

 

Goodwill

 

 

62,018

 

 

57,192

 

Other assets

 

 

47,648

 

 

2,468

 

Total assets

 

$

849,896

 

$

364,557

 

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

 

 

  

 

 

  

 

Current liabilities:

 

 

  

 

 

  

 

Accounts payable

 

$

13,360

 

$

10,912

 

Accrued research and development expenses

 

 

21,158

 

 

35,198

 

Milestone liability

 

 

21,011

 

 

20,062

 

Accrued liability for legal settlement

 

 

142,000

 

 

 —

 

Other accrued expenses

 

 

21,848

 

 

19,487

 

Total current liabilities

 

 

219,377

 

 

85,659

 

Deferred income taxes, net

 

 

632

 

 

 ��

 

Convertible senior notes

 

 

281,761

 

 

281,126

 

Deferred rent, long-term

 

 

4,333

 

 

1,406

 

Total liabilities

 

 

506,103

 

 

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 June 30, 2017 and December 31, 2016

 

 

 —

 

 

 —

 

Common stock, $0.001 par value per share, 100,000,000 shares authorized at June 30, 2017 and December 31, 2016; 48,843,131 and 38,724,090 shares issued and outstanding at June 30, 2017 and December 31, 2016 respectively

 

 

49

 

 

39

 

Additional paid-in capital

 

 

1,752,943

 

 

1,174,950

 

Accumulated other comprehensive loss

 

 

(44,306)

 

 

(47,580)

 

Accumulated deficit

 

 

(1,364,893)

 

 

(1,131,043)

 

Total stockholders' equity (deficit)

 

 

343,793

 

 

(3,634)

 

Total liabilities and stockholders' equity (deficit)

 

$

849,896

 

$

364,557

 

 

See accompanying Notes to Unaudited Consolidated Financial Statements.

4


 


Table of ContentsCLOVIS

CLOVIS ONCOLOGY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWSCONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands, except for share amounts)thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

228,379

 

 

$

278,756

 

Available-for-sale securities

 

 

150,122

 

 

 

249,832

 

Prepaid research and development expenses

 

 

14,477

 

 

 

3,377

 

Other current assets

 

 

6,559

 

 

 

7,736

 

Total current assets

 

 

399,537

 

 

 

539,701

 

Property and equipment, net

 

 

4,974

 

 

 

4,946

 

Intangible assets

 

 

 

 

 

101,500

 

Goodwill

 

 

60,606

 

 

 

59,327

 

Other assets

 

 

2,868

 

 

 

7,912

 

Total assets

 

$

467,985

 

 

$

713,386

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

15,008

 

 

$

11,260

 

Accrued research and development expenses

 

 

46,337

 

 

 

53,011

 

Other accrued expenses

 

 

11,511

 

 

 

11,305

 

Total current liabilities

 

 

72,856

 

 

 

75,576

 

Contingent purchase consideration

 

 

 

 

 

24,661

 

Deferred income taxes, net

 

 

333

 

 

 

31,133

 

Convertible senior notes

 

 

280,501

 

 

 

279,885

 

Deferred rent, long-term

 

 

1,463

 

 

 

1,481

 

Total liabilities

 

 

355,153

 

 

 

412,736

 

Commitments and contingencies (Note 14)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued

  and outstanding at June 30, 2016 and December 31, 2015

 

 

 

 

 

 

Common stock, $0.001 par value per share, 100,000,000 shares authorized at

   June 30, 2016 and December 31, 2015; 38,500,588 and 38,359,454 shares issued

   and outstanding at June 30, 2016 and December 31, 2015, respectively

 

 

39

 

 

 

38

 

Additional paid-in capital

 

 

1,152,463

 

 

 

1,129,978

 

Accumulated other comprehensive loss

 

 

(45,050

)

 

 

(47,460

)

Accumulated deficit

 

 

(994,620

)

 

 

(781,906

)

Total stockholders' equity

 

 

112,832

 

 

 

300,650

 

Total liabilities and stockholders' equity

 

$

467,985

 

 

$

713,386

 

 

 

 

 

 

 

 

 

 

 

 

Six months ended June 30, 

 

 

 

    

2017

    

2016

 

 

 

 

 

 

 

 

 

 

 

Operating activities

 

 

  

 

 

  

 

 

Net loss

 

$

(233,849)

 

$

(212,714)

 

 

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

 

 

  

 

 

  

 

 

Share-based compensation expense

 

 

19,563

 

 

20,542

 

 

Depreciation and amortization

 

 

1,281

 

 

550

 

 

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

 

 

245

 

 

151

 

 

Amortization of debt issuance costs

 

 

635

 

 

616

 

 

Legal settlement loss, net of insurance receivable

 

 

117,000

 

 

 —

 

 

Impairment of intangible asset

 

 

 —

 

 

104,517

 

 

Change in fair value of contingent purchase consideration

 

 

 —

 

 

(24,661)

 

 

Loss on disposal of property and equipment

 

 

 —

 

 

170

 

 

Deferred income taxes

 

 

(1,266)

 

 

(33,207)

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

  

 

 

Accounts receivable

 

 

(1,023)

 

 

 —

 

 

Inventory

 

 

(6,478)

 

 

 —

 

 

Prepaid and accrued research and development expenses

 

 

(15,162)

 

 

(12,772)

 

 

Other operating assets

 

 

(36,855)

 

 

1,260

 

 

Accounts payable

 

 

3,202

 

 

3,608

 

 

Other accrued expenses

 

 

3,166

 

 

270

 

 

Net cash used in operating activities

 

 

(149,541)

 

 

(151,670)

 

 

Investing activities

 

 

  

 

 

  

 

 

Purchases of property and equipment

 

 

(249)

 

 

(756)

 

 

Deposits for purchases of property and equipment

 

 

(2,515)

 

 

 —

 

 

Purchases of available-for-sale securities

 

 

(180,000)

 

 

 —

 

 

Maturities of available-for-sale securities

 

 

50,000

 

 

100,000

 

 

Acquired in-process research and development - milestone payment

 

 

(1,100)

 

 

 —

 

 

Net cash (used in) provided by investing activities

 

 

(133,864)

 

 

99,244

 

 

Financing activities

 

 

  

 

 

  

 

 

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

 

 

546,170

 

 

 —

 

 

Proceeds from the exercise of stock options and employee stock purchases

 

 

12,270

 

 

1,943

 

 

Net cash provided by financing activities

 

 

558,440

 

 

1,943

 

 

Effect of exchange rate changes on cash and cash equivalents

 

 

565

 

 

106

 

 

Increase (decrease) in cash and cash equivalents

 

 

275,600

 

 

(50,377)

 

 

Cash and cash equivalents at beginning of period

 

 

216,186

 

 

278,756

 

 

Cash and cash equivalents at end of period

 

$

491,786

 

$

228,379

 

 

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

 

$

2,627

 

$

34

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying Notes to Unaudited Consolidated Financial Statements.

5


Table of Contents

CLOVIS ONCOLOGY, INC.

 


CLOVIS ONCOLOGY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(212,714

)

 

$

(134,675

)

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

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

20,542

 

 

 

17,052

 

Depreciation and amortization

 

 

550

 

 

 

351

 

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

 

 

151

 

 

 

975

 

Amortization of debt issuance costs

 

 

616

 

 

 

598

 

Impairment of intangible asset

 

 

104,517

 

 

 

 

Change in fair value of contingent purchase consideration

 

 

(24,661

)

 

 

(878

)

Loss on disposal of property and equipment

 

 

170

 

 

 

 

Deferred income taxes

 

 

(33,207

)

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid and accrued research and development expenses

 

 

(12,772

)

 

 

10,029

 

Other operating assets

 

 

1,260

 

 

 

(2,758

)

Accounts payable

 

 

3,608

 

 

 

2,338

 

Other accrued expenses

 

 

270

 

 

 

1,337

 

Net cash used in operating activities

 

 

(151,670

)

 

 

(105,631

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(756

)

 

 

(1,006

)

Purchases of available-for-sale securities

 

 

 

 

 

(142,216

)

Maturities of available-for-sale securities

 

 

100,000

 

 

 

 

Net cash provided by (used in) investing activities

 

 

99,244

 

 

 

(143,222

)

Financing activities

 

 

 

 

 

 

 

 

Proceeds from the exercise of stock options and employee stock purchases

 

 

1,943

 

 

 

3,073

 

Net cash provided by financing activities

 

 

1,943

 

 

 

3,073

 

Effect of exchange rate changes on cash and cash equivalents

 

 

106

 

 

 

(636

)

Decrease in cash and cash equivalents

 

 

(50,377

)

 

 

(246,416

)

Cash and cash equivalents at beginning of period

 

 

278,756

 

 

 

482,677

 

Cash and cash equivalents at end of period

 

$

228,379

 

 

$

236,261

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

3,594

 

 

$

3,714

 

See accompanying Notes to Unaudited Consolidated Financial Statements.


CLOVIS ONCOLOGY, INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Nature of Business and Basis of Presentation

Clovis Oncology, Inc. (the(together with its consolidated subsidiaries, the “Company”, “Clovis”, “we”, “our”, “us”) is a biopharmaceutical company focused on acquiring, developing and commercializing cancer treatmentsinnovative anti-cancer agents in the United States, Europe and other international markets. The Company hasWe have and intendsintend 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, the Companywe generally expectsexpect to provide the licensor with a combination of upfront payments, milestone payments and royalties on future sales. In addition, the Companywe generally expectsexpect to assume the responsibility for future drug development and commercialization costs. The CompanyWe currently operatesoperate in one segment. Since inception, the Company’sour 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. Our Marketing Authorization Application (MAA) for rucaparib that was submitted to the European Medicines Agency (“EMA”) for an ovarian cancer treatment indication comparable to what was approved by the FDA is currently under review. We anticipate an opinion from the Committee for Medicinal Products for Human Use (CHMP) in late 2017, and, pending a favorable opinion from the CHMP, a potential approval would follow during the first quarter of 2018.  Following a potential approval for the treatment indication, we intend to submit a supplemental application for the second-line or later maintenance treatment indication, for which we anticipate a potential approval during the third quarter of 2018.

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 except for those discussed in the following footnotes, whichthat, in the opinion of management, are necessary to fairly state our financial position, results of operations and cash flows for the periods presented.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, 20152016 (“2016 Form 10-K”) for a broader discussion of our business and the opportunities and risks inherent in such business.

Reclassifications

Certain reclassifications have been made to prior year amounts to conform to the current year presentation. These reclassifications had no effect on the Company’s previously reported results of operations, financial position or cash flows.

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, management evaluates itswe evaluate our estimates, including estimates related to contingent purchase consideration, the allocation of purchase consideration,revenue deductions, intangible asset impairment, clinical trial accruals and share-based compensation expense. The Company bases itsWe base our estimates on historical experience and other market-specific or other relevant assumptions that it believeswe believe to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.

6


Table of Contents

Liquidity

The Company has

We have incurred significant net losses since inception and hashave relied on itsour ability to fund itsour operations through debt and equity financings. Management expectsWe expect operating losses and negative cash flows to continue for the foreseeable future. As the Company continueswe continue to incur losses, transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues from Rubraca adequate to support the Company’sour cost structure. The CompanyWe may never achieve profitability, and unless or until it does, the Companywe do, we will continue to need to raise additional cash.

Management intends

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. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceeds from the offering were $324.9 million, after deducting underwriting discounts and commissions and offering expenses. We intend to fund future operations throughuse the net proceeds of the offerings for general corporate purposes, including sales and marketing expenses associated with 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 privateproduct candidates or public debt or equity offeringsbusinesses and may seek additional capital through arrangements with strategic partners or from other sources.working capital. Based on current estimates, management believeswe believe that our existing working capital at June 30, 2016 is sufficient to meet the cash, requirementscash equivalents and available-for-sale securities will allow us to fund planned operationsour operating plan through at least the next 12 months, although there can be no assurance that this can, in fact, be accomplished.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 and six months ended June 30, 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. 

7


Table of Contents

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. 

The Company’sactive 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 Annual Report onour 2016 Form 10-K for the year ended December 31, 2015.10-K.

Recently Issued Accounting Standards

In March 2016,From time to time, the Financial Accounting Standards Board (“FASB”) issuedor 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”) No. 2016-09, “Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting.”.

Recently Issued Accounting Standards

In May 2014, the FASB issued ASU No. 2016-09 requires all income tax effects2014-09, “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 awards to be recognizedthe principles outlined in the income statement whenstandard across filers in multiple industries and within the awards vest or are settled. The guidance also requires the presentationsame industries compared to current practices, which should improve comparability.  Adoption of excess tax benefits as an operating activity on the statement of cash flows rather than as a financing activity. This updateASC 606 is effectiverequired 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 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 our 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 annual periods.fiscal years. Early adoptionapplication is permitted. Amendments related to the timing of when excess tax benefits are recognized should be applied using aASU 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 method. An entity may elect to apply the amendments related to the presentation of excess tax benefits on the statement of cash flows using either a prospective transition method or a retrospective transition method. The Company isrelief. We are currently evaluating its planned method of adoption and the impact the standard may have on itsour consolidated financial statements and related disclosures.

 

3. EOS AcquisitionIn January 2017, the FASB issued ASU No. 2017-01, “Clarifying the Definition of a Business,” which clarifies the definition of a business in ASC 805. The guidance is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early application is permitted. Currently, there is no impact to our consolidated financial statements and related disclosures, but we will adopt on January 1, 2018 for any business combinations and will consider adopting early for any acquisitions prior to January 1, 2018.

On November 19, 2013,

In May 2017, the Company acquired allFASB issued ASU 2017-09, “Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting”, which amends the outstanding common and preferred stockscope of Ethical Oncology Science, S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.). modification accounting for share-based payment arrangements.

8


Table of Contents

The Company paid $11.8 million in cash and issued $173.7 millionASU provides guidance on the types of common stock atchanges to the acquisition date and is obligatedterms or conditions of share-based payment awards to pay additional future cash paymentswhich we would be required to apply modification accounting under ASC 718. Specifically, we would not apply modification accounting if certain lucitanib regulatory and sales milestones are achieved. The potential contingent milestone payments range from a zero payment, which assumes lucitanib fails to achieve any of the regulatory milestones, to approximately $193.2 million ($65.0 million and €115.0 million) if all regulatory and sales milestones are met, utilizing the translation rate at June 30, 2016.

During the second quarter of 2016, the Company recorded a $25.5 million reduction in the fair value, vesting conditions, and classification of the contingent purchase consideration liability dueawards are the same immediately before and after the modification. The guidance is effective for annual reporting periods, including interim period within those annual periods, beginning after December 15, 2017. Early adoption is permitted, including adoption in any interim period. We are currently evaluating the impact the standard may have on our consolidated financial statements and related disclosures should we have a modification to our share-based payment awards in the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer (see Note 4). At June 30, 2016, the contingent purchase consideration liability recorded on the Consolidated Balance Sheets was zero due to the uncertainty of achieving any of the lucitanib regulatory milestones. At December 31, 2015, the liability for the estimated fair value of the payments recorded on the Consolidated Balance Sheets was $24.7 million.future.

 

4.3. Financial Instruments and Fair Value Measurements

Cash, Cash Equivalents and Available-for-Sale Securities

The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations.

Marketable securities are considered to be available-for-sale securities and consist of U.S. Treasury securities. Available-for-sale securities are reported at fair value on the Consolidated Balance Sheets and unrealized gains and losses are included in accumulated other comprehensive income (loss) on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense) on the Consolidated Statements of Operations. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on management’s intent to fund current operations with these securities or to make them available for current operations.

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 the Company’s intent and ability to hold the security until an anticipated recovery in value occurs.

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. The Company’sOur Level 1 assets consist of money market investments. The Company doesWe 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. The Company’sOur Level 2 assets consist of U.S. treasury securities. The Company doesWe do not have Level 2 liabilities.

 

 

Level 3:

Unobservable inputs that are supported by little or no market activity. The Company doesWe do not have Level 3 assets or liabilities that are measured at fair value on a recurring basis. The contingent purchase consideration related to the undeveloped lucitanib product rights acquired with the purchase of EOS is a Level 3 liability. The fair value of this liability is based on unobservable inputs and includes valuations for which there is little, if any, market activity. See Note 3 of the Company’s 2015 Form 10-K for further discussion of the unobservable inputs and valuation techniques related to the contingent purchase consideration liability.

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

 

Balance

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Balance

    

Level 1

    

Level 2

    

Level 3

 

June 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market

 

$

201,711

 

 

$

201,711

 

 

$

 

 

$

 

 

$

450,588

 

$

450,588

 

$

 —

 

$

 —

 

U.S. treasury securities

 

 

150,122

 

 

 

 

 

 

150,122

 

 

 

 

 

 

179,744

 

 

 —

 

 

179,744

 

 

 —

 

Total assets at fair value

 

$

351,833

 

 

$

201,711

 

 

$

150,122

 

 

$

 

 

$

630,332

 

$

450,588

 

$

179,744

 

$

 —

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent purchase consideration

 

$

 

 

$

 

 

$

 

 

$

 

Total liabilities at fair value

 

$

 

 

$

 

 

$

 

 

$

 

December 31, 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market

 

$

251,037

 

 

$

251,037

 

 

$

 

 

$

 

 

$

202,361

 

$

202,361

 

$

 —

 

$

 —

 

U.S. treasury securities

 

 

249,832

 

 

 

 

 

 

249,832

 

 

 

 

 

 

49,997

 

 

 —

 

 

49,997

 

 

 —

 

Total assets at fair value

 

$

500,869

 

 

$

251,037

 

 

$

249,832

 

 

$

 

 

$

252,358

 

$

202,361

 

$

49,997

 

$

 —

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent purchase consideration

 

$

24,661

 

 

$

 

 

$

 

 

$

24,661

 

Total liabilities at fair value

 

$

24,661

 

 

$

 

 

$

 

 

$

24,661

 

 

There were no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the three and six months ended June 30, 2016.2017.

 

The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) (in thousands):

 

 

For the Six

 

 

 

Months Ended

 

 

 

June 30, 2016

 

Liabilities:

 

 

 

 

Balance at beginning of period

 

$

24,661

 

Change in fair value (a)

 

 

(24,936

)

Change in foreign currency gains and losses

 

 

275

 

Balance at end of period

 

$

 

(a)

During the second quarter of 2016, the Company recorded a $25.5 million reduction in the fair value of the contingent purchase consideration due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer. At June 30, 2016, the contingent purchase consideration liability recorded on the Consolidated Balance Sheets was zero due to the uncertainty of achieving any of the lucitanib regulatory milestones.


The change in the fair value of Level 3 instruments is included in change in fair value of contingent purchase consideration and foreign currency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations.

Assets measured at fair value on a nonrecurring basis include the Company’s in-process research and development (“IPR&D”) intangible assets, which were recorded as part of the acquisition of EOS (see Note 3 and Note 7). The fair value of the IPR&D intangible assets was established based upon discounted cash flow models using assumptions related to the timing of development, probability of development and regulatory success, sales and commercialization factors and estimated product life. As the valuation is based on significant unobservable inputs, the fair value measurement is classified as Level 3. IPR&D assets are evaluated for impairment at least annually or more frequently if impairment indicators exist.

During the second quarter of 2016, the Company recorded a $104.5 million impairment charge due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer. At June 30, 2016, the IPR&D intangible asset recorded on the Consolidated Balance Sheets was zero.

Financial instruments not recorded at fair value include the Company’sour convertible senior notes. At June 30, 2016,2017, the carrying amount of the convertible senior notes was $287.5$281.8 million, which represents the aggregate principal amount net of remaining debt issuance costs, and the fair value was $207.7$487.0 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 Notesfor discussion of the convertible senior notes.

5.

9


Table of Contents

4. Available-for-Sale Securities

As of June 30, 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

 

$

179,758

 

$

 —

 

$

(14)

 

$

179,744

 

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

 

$

150,064

 

 

$

60

 

 

$

(2

)

 

$

150,122

 

As of December 31, 2015, 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

 

$

250,215

 

 

$

 

 

$

(383

)

 

$

249,832

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

    

 

    

Gross

    

Gross

    

Aggregate

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

Fair

 

 

 

Cost

 

Gains

 

Losses

 

Value

 

U.S. treasury securities

 

$

50,004

 

$

 —

 

$

(7)

 

$

49,997

 

 

As of June 30, 2016,2017, 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

 

$

25,001

 

 

$

(2

)

 

 

 

 

 

 

 

 

 

    

Aggregate

    

Gross

 

 

 

Fair

 

Unrealized

 

 

 

Value

 

Losses

 

U.S. treasury securities

 

$

179,744

 

$

(14)

 

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 June 30, 2016, one of the Company’s investments has been in an unrealized loss position for two months. Based upon our evaluation of all relevant factors, we believe that the decline in fair value of securities held at June 30, 2016 below cost is temporary, and we intend to retain our investment in these securities for a sufficient period of time to allow for recovery of the fair value.

As of December 31, 2015, 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

 

$

249,832

 

 

$

(383

)


As of June 30, 2016,2017, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands):

 

 

 

 

 

 

 

 

Amortized

 

 

Fair

 

    

Amortized

    

Fair

 

 

Cost

 

 

Value

 

 

Cost

 

Value

 

Due in one year or less

 

$

150,064

 

 

$

150,122

 

 

$

179,758

 

$

179,744

 

Due in one year to two years

 

 

 —

 

 

 —

 

Total

 

$

150,064

 

 

$

150,122

 

 

$

179,758

 

$

179,744

 

5. Inventories

We generally have two categories of inventory: work-in-process and finished goods. As of June 30, 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 June 30, 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 June 30, 2017, other assets on the Consolidated Balance Sheets includes a cash deposit of $31.8 million made to a manufacturer for the purchase of inventory which we do not expect to be commercially consumed within the next twelve months.

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6. Other Current Assets

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

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

June 30, 

 

December 31, 

 

 

2016

 

 

2015

 

    

2017

    

2016

 

Receivable from partners

 

$

2,749

 

 

$

3,241

 

 

$

52

 

$

2,882

 

Prepaid expenses- other

 

 

1,779

 

 

 

1,023

 

Prepaid insurance

 

 

817

 

 

1,234

 

Prepaid expenses - other

 

 

3,012

 

 

2,109

 

Receivable - other

 

 

1,035

 

 

 

889

 

 

 

2,750

 

 

364

 

Prepaid insurance

 

 

764

 

 

 

1,231

 

Receivable from landlord

 

 

122

 

 

 

1,153

 

Other

 

 

110

 

 

 

199

 

 

 

135

 

 

90

 

Total

 

$

6,559

 

 

$

7,736

 

 

$

6,766

 

$

6,679

 

 

7. Intangible Assets and Goodwill

IPR&D

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

 

 

 

 

 

 

 

 

 

 

June 30, 

 

December 31, 

 

 

 

2017

    

2016

 

Intangible asset - milestones

 

$

21,100

 

$

21,100

 

Accumulated amortization

 

 

(796)

 

 

(53)

 

Total intangible asset, net

 

$

20,304

 

$

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 and $0.8 million related to capitalized milestone payments during the three and six months ended June 30, 2017, respectively, 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 and six months ended June 30, 2016.

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

 

 

 

 

 

 

 

 

2017 (remaining)

 

 

 

 

$

743

 

2018

 

 

 

 

 

1,486

 

2019

 

 

 

 

 

1,486

 

2020

 

 

 

 

 

1,486

 

2021

 

 

 

 

 

1,486

 

Thereafter

 

 

 

 

 

13,617

 

 

 

 

 

 

$

20,304

 

The change in goodwill were established as part of the purchase accounting of EOS (see Note 3) andin November 2013 consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

IPR&D intangible assets:

 

 

 

 

 

 

 

 

Balance at beginning of period

 

$

101,500

 

 

$

212,900

 

Impairment of intangible asset (a)

 

 

(104,517

)

 

 

(89,557

)

Change in foreign currency gains (losses)

 

 

3,017

 

 

 

(21,843

)

Balance at end of period

 

$

 

 

$

101,500

 

 

 

 

 

 

 

 

 

 

Goodwill:

 

 

 

 

 

 

 

 

Balance at beginning of period

 

$

59,327

 

 

$

66,055

 

Change in foreign currency gains (losses)

 

 

1,279

 

 

 

(6,728

)

Balance at end of period

 

$

60,606

 

 

$

59,327

 

 

 

 

 

 

Balance at December 31, 2016

 

$

57,192

 

Change in foreign currency gains and losses

 

 

4,826

 

Balance at June 30, 2017

 

$

62,018

 

(a)

During the second quarter of 2016, the Company recorded a $104.5 million impairment charge due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer. At June 30, 2016, the IPR&D intangible asset recorded on the Consolidated Balance Sheets was zero.

During the fourth quarter of 2015, the Company recorded an $89.6 million impairment charge due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for lung cancer, as well as updates to the probability-weighted discounted cash flow assumptions for the breast cancer indication.

IPR&D intangible assets are evaluated for impairment at least annually in the fourth quarter or more frequently if impairment indicators exist and any reduction in fair value is recorded as impairment of intangible asset on the Consolidated Statements of Operations.

As part of the acquisition of EOS, the Company recorded a deferred tax liability to recognize the difference between the book and tax basis of the assets and liabilities acquired. During the first quarter of 2016, the Company updated the annual effective tax rate to reflect a reduction in the statutory rate of the foreign jurisdiction, resulting in the recognition of a $3.6 million income tax benefit.

During the second quarter of 2016, the Company recognized a $29.2 million deferred tax benefit associated with the impairment of the IPR&D intangible asset.

 

 


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8. Other Accrued Expenses

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

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

June 30, 

 

December 31, 

 

 

2016

 

 

2015

 

    

2017

    

2016

 

Accrued personnel costs

 

$

8,081

 

 

$

8,250

 

 

$

11,928

 

$

15,850

 

Accrued interest payable

 

 

2,096

 

 

 

2,096

 

 

 

2,097

 

 

2,096

 

Income tax payable

 

 

662

 

 

556

 

Accrued corporate legal fees and professional services

 

 

1,072

 

 

589

 

Accrued royalties

 

 

2,551

 

 

 —

 

Accrued sales deductions

 

 

1,003

 

 

 —

 

Accrued expenses - other

 

 

1,334

 

 

 

959

 

 

 

2,535

 

 

396

 

Total

 

$

11,511

 

 

$

11,305

 

 

$

21,848

 

$

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 to the Company 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, the Companywe 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. The CompanyWe determined the expected

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life of the debt was equal to the seven-year term of the Notes. As of June 30, 20162017 and December 31, 2015,2016, the balance of unamortized debt issuance costs was $7.0$5.7 million and $7.6$6.4 million, respectively.

 


The following table sets forth total interest expense recognized related to the Notes during the three and six months ended June 30, 20162017 and 20152016 (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three months ended June 30, 

 

Six months ended June 30, 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

    

2017

    

2016

    

2017

    

2016

 

Contractual interest expense

 

$

1,797

 

 

$

1,797

 

 

$

3,594

 

 

$

3,574

 

 

$

1,797

 

$

1,797

 

$

3,594

 

$

3,594

 

Accretion of interest on milestone liability

 

 

483

 

 

 —

 

 

949

 

 

 —

 

Amortization of debt issuance costs

 

 

309

 

 

 

300

 

 

 

616

 

 

 

598

 

 

 

318

 

 

309

 

 

635

 

 

616

 

Total interest expense

 

$

2,106

 

 

$

2,097

 

 

$

4,210

 

 

$

4,172

 

 

$

2,598

 

$

2,106

 

$

5,178

 

$

4,210

 

 

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. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceeds from the offering were $324.9 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 Income (Loss)Loss

Accumulated other comprehensive income (loss)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 changes in accumulated balances related to each component of other comprehensive income (loss) are summarized for the three months ended June 30, 2017 and 2016 as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

Foreign

 

 

 

 

 

 

Accumulated

 

 

 

Currency

 

 

Unrealized

 

 

Other

 

 

 

Translation

 

 

Gains

 

 

Comprehensive

 

 

 

Adjustments

 

 

(Losses)

 

 

Income (Loss)

 

Balance December 31, 2014

 

$

(24,448

)

 

$

 

 

$

(24,448

)

Period change

 

 

(22,629

)

 

 

(383

)

 

 

(23,012

)

Balance December 31, 2015

 

 

(47,077

)

 

 

(383

)

 

 

(47,460

)

Period change

 

 

3,410

 

 

 

441

 

 

 

3,851

 

Income tax expense

 

 

(1,278

)

 

 

(163

)

 

 

(1,441

)

Balance June 30, 2016

 

$

(44,945

)

 

$

(105

)

 

$

(45,050

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign Currency

 

Unrealized

 

Total Accumulated

 

 

 

Translation Adjustments

 

(Losses) Gains

 

Other Comprehensive Loss

 

 

 

2017

 

2016

 

2017

 

2016

 

2017

 

2016

 

Balance at April 1,

 

$

(46,967)

 

$

(43,564)

 

$

(151)

 

$

(153)

 

$

(47,118)

 

$

(43,717)

 

Other comprehensive income (loss)

 

 

4,451

 

 

(2,170)

 

 

(3)

 

 

76

 

 

4,448

 

 

(2,094)

 

Total before tax

 

 

(42,516)

 

 

(45,734)

 

 

(154)

 

 

(77)

 

 

(42,670)

 

 

(45,811)

 

Tax effect

 

 

(1,639)

 

 

789

 

 

 3

 

 

(28)

 

 

(1,636)

 

 

761

 

Balance at June 30, 

 

$

(44,155)

 

$

(44,945)

 

$

(151)

 

$

(105)

 

$

(44,306)

 

$

(45,050)

 

The changes in accumulated balances related to each component of other comprehensive income (loss) are summarized for the six months ended June 30, 2017 and 2016 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)

 

 

5,186

 

 

3,410

 

 

(8)

 

 

441

 

 

5,178

 

 

3,851

 

Total before tax

 

 

(42,248)

 

 

(43,667)

 

 

(154)

 

 

58

 

 

(42,402)

 

 

(43,609)

 

Tax effect

 

 

(1,907)

 

 

(1,278)

 

 

 3

 

 

(163)

 

 

(1,904)

 

 

(1,441)

 

Balance at June 30, 

 

$

(44,155)

 

$

(44,945)

 

$

(151)

 

$

(105)

 

$

(44,306)

 

$

(45,050)

 

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The period change between June 30, 2016 and December 31, 2015in each of the periods presented was primarily due to the currency translation of the IPR&D intangible assets, goodwill and deferred income taxes associated with the acquisition of EOS (see Note 3in November 2013. There were no reclassifications out of accumulated other comprehensive loss in each of the three and Note 7).six months ended June 30, 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 and six months ended June 30, 20162017 and 20152016 was recognized in the accompanying Consolidated Statements of Operations as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three months ended June 30, 

 

Six months ended June 30, 

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

    

2017

    

2016

    

2017

    

2016

 

 

Research and development

 

$

6,615

 

 

$

5,355

 

 

$

13,924

 

 

$

10,759

 

 

$

4,825

 

$

6,615

 

$

8,991

 

$

13,924

 

General and administrative

 

 

2,962

 

 

 

3,015

 

 

 

6,618

 

 

 

6,293

 

Selling, general and administrative

 

 

5,792

 

 

2,962

 

 

10,572

 

 

6,618

 

Total share-based compensation expense

 

$

9,577

 

 

$

8,370

 

 

$

20,542

 

 

$

17,052

 

 

$

10,617

 

$

9,577

 

$

19,563

 

$

20,542

 

 

The CompanyWe did not recognize a tax benefit related to share-based compensation expense during the three and six months ended June 30, 20162017 and 2015,2016, respectively, as the Company maintainswe maintain net operating loss carryforwards and hashave established a valuation allowance against the entire net deferred tax asset as of June 30, 2016.2017.

 


Stock Options

The following table summarizes the activity relating to the Company’sour options to purchase common stock for the six months ended June 30, 2016:2017:

 

 

 

Number of Options

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual

Term (Years)

 

 

Aggregate

Intrinsic

Value (Thousands)

 

Outstanding at December 31, 2015

 

 

5,360,257

 

 

$

51.53

 

 

 

 

 

 

 

 

 

Granted

 

 

768,265

 

 

 

20.61

 

 

 

 

 

 

 

 

 

Exercised

 

 

(62,710

)

 

 

6.50

 

 

 

 

 

 

 

 

 

Forfeited

 

 

(840,077

)

 

 

59.50

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 2016 (a)

 

 

5,225,735

 

 

$

46.25

 

 

 

7.2

 

 

$

4,177

 

Vested and expected to vest at June 30, 2016

 

 

4,958,823

 

 

$

45.84

 

 

 

7.1

 

 

$

4,177

 

Exercisable at June 30, 2016

 

 

2,874,047

 

 

$

39.26

 

 

 

5.9

 

 

$

4,177

 

(a)

Includes 42,500 performance-based stock options granted to executives of the Company in the first quarter of 2015, which vest contingent on approval by the U.S. Food and Drug Administration (“FDA”) to commercially distribute, sell or market rucaparib. Stock compensation expense will be recognized when the condition for vesting is probable of being met.

 

 

 

 

 

 

 

 

 

 

 

 

 

    

 

    

 

 

    

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

 

778,700

 

 

 

 

  

 

 

  

 

Exercised

 

(372,464)

 

 

 

 

  

 

 

  

 

Forfeited

 

(199,985)

 

 

 

 

  

 

 

  

 

Outstanding at June 30, 2017

 

5,726,733

 

$

45.43

 

7.6

 

$

276,451

 

Vested and expected to vest at June 30, 2017

 

5,364,276

 

$

45.30

 

7.4

 

$

259,650

 

Vested and exercisable at June 30, 2017

 

2,935,211

 

$

44.63

 

6.2

 

$

143,983

 

 

The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $13.72$93.63 as of June 30, 2016,2017, 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 and six months ended June 30, 2017 and 2016 and 2015:(in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three months ended June 30, 

 

Six months ended June 30, 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

   

2017

   

2016

   

2017

   

2016

 

Weighted-average grant date fair value per share

 

$

11.01

 

 

$

55.35

 

 

$

14.65

 

 

$

51.49

 

 

$

44.94

 

$

11.01

 

$

46.53

 

$

14.65

 

Intrinsic value of options exercised

 

$

578,525

 

 

$

4,966,707

 

 

$

624,925

 

 

$

10,053,841

 

 

$

4,759

 

$

578,525

 

$

14,284

 

$

624,925

 

Cash received from stock option exercises

 

$

352,423

 

 

$

1,387,060

 

 

$

407,523

 

 

$

2,580,350

 

 

$

5,439

 

$

352,423

 

$

11,113

 

$

407,523

 

 

As of June 30, 2016,2017, the unrecognized share-based compensation expense related to unvested options, adjusted for expected forfeitures, was $82.2$83.4 million and the estimated weighted-average remaining vesting period was 2.32.6 years.

 

14


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Restricted Stock

During the first quarter of 2016, the Companywe issued restricted stock units (“RSUs”) to certain employees under the 2011 Stock Incentive Plan. The RSUs vest either (i) over either a two-year periodtwo years, with 50% vesting one year from the date of grant and the remaining 50% vesting two years from the date of grant or (ii) 25% vest one year from the date of grant with the remaining RSUs vesting ratably each subsequent quarter over a four-year period andthe following three years, as defined in the grant agreement. Vested RSUs are payable in shares of the Company’sour 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. Shares issued on the vesting dates are net of theThe minimum statutory tax on the value of common stock shares issued to beemployees upon vesting are paid by us through the Company on behalfsale of its employees. As a result, the actual numberregistered shares of shares issued will be lower than the actual number of RSUs vested.our common stock.

 

The following table summarizes the activity relating to the Company’sour unvested RSUs for the six months ended June 30, 2016:

2017:

 

 

Number of Units

 

 

Weighted-

Average

Grant Date

Fair Value

 

Unvested as of December 31, 2015

 

 

 

 

$

 

Granted

 

 

146,503

 

 

 

19.37

 

Vested (a)

 

 

(2,625

)

 

 

19.37

 

Forfeited

 

 

(18,080

)

 

 

19.37

 

Unvested as of June 30, 2016

 

 

125,798

 

 

$

19.37

 

Expected to vest after June 30, 2016

 

 

109,009

 

 

$

19.37

 

(a)

During the second quarter of 2016, the Company accelerated the vesting of RSUs for certain employees.

 

 

 

 

 

 

 

 

    

 

    

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Average

 

 

 

Number of

 

Grant Date

 

 

 

Units

 

Fair Value

 

Unvested at December 31, 2016

 

562,458

 

$

24.70

 

Granted

 

214,984

 

 

61.67

 

Vested

 

(44,443)

 

 

19.37

 

Forfeited

 

(27,177)

 

 

24.08

 

Unvested as of June 30, 2017

 

705,822

 

$

36.32

 

Expected to vest after June 30, 2017

 

604,394

 

$

35.81

 

 


As of June 30, 2016,2017, the unrecognized share-based compensation expense related to unvested RSUs, adjusted for expected forfeitures, was $2.0$18.5 million and the estimated weighted-average remaining vesting period was 2.33.4 years.

 

12. License Agreements

Rucaparib

In June 2011, the Companywe entered into a worldwide license agreement with Pfizer, Inc. to acquireobtain exclusive development and commercializationglobal rights to rucaparib. This drug candidate isdevelop and commercialize rucaparib, a small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)(“PARP”), which the Company is developingused for the treatment of selected solid tumors. UnderThe exclusive rights are exclusive even as to Pfizer and include the right to grant sublicenses. Pursuant to the terms of the license agreement, the Companywe made a $7.0 million upfront payment to Pfizer.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 April 2014, the Company initiated a pivotal registration studyevent 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 rucaparib, whichthe 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 $0.4$0.75 million milestone payment to Pfizer as required by the license agreement. Thisagreement, 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, wasfor 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 acquired in-process researchintangible assets and development expense.will be amortized over the estimated remaining useful life of Rubraca.

The Company is

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 offor rucaparib. When and if commercial salesWe are required to make regulatory milestone payments to Pfizer of rucaparib begin, we will pay Pfizer tiered royalties on our net sales. In addition, Pfizer is eligible to receive up to $258.5an additional $69.75 million of further payments, in aggregate if certain development,specified clinical study objectives and regulatory filings, acceptances and sales milestonesapprovals are achieved, including $21.25 million associated with the first filing and approval of a New Drug Application (“NDA”) by the FDA. During the second quarter of 2016, we completed the submission of our NDA with the FDA for potential accelerated approval of rucaparib in the U.S.

Lucitanib

In connection with its acquisition of EOS (see Note 3), the Company gained rights to develop and commercialize lucitanib, an oral, selective tyrosine kinase inhibitor. As further described below, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”). Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Les Laboratoires Servier (“Servier”) in exchange for upfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development funding commitments.

In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excluding China. The Company is obligated to pay Advenchen royalties on net sales of lucitanib based on the volume of annual net sales achieved. In addition, the Company iswe are obligated to pay to Advenchen 25% of any consideration, excluding royalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. In the first quarter of 2014, the Company recognized acquired in-process research and development expense of $3.4 million, which represents 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office.

In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an upfront payment of €45.0 million and is entitled to receive additional payments upon achievement of specified development, regulatory and commercial milestones up to €90.0 million in the aggregate. In addition, the Company is entitled to receivemake sales milestone payments to Pfizer if specified annual sales targets for lucitanibrucaparib are

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met, the majority of which relate to annual sales targets of $500.0 million and above, which, in the aggregate, could amount to total €250.0 million.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 Company islicense 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 entitled to receive royalties on any net sales of rucaparib.

We are party to other product license agreements for our other drug candidates, lucitanib by Servier.

The development, regulatory and commercial milestones represent non-refundable amounts that would be paid byrociletinib (see our 2016 Form 10-K for additional details). We and Les Laboratories Servier to the Company if certain milestones are achieved in the future. These milestones, if achieved, are substantive as they relate solely to past performance, are commensurate with estimated enhancement of value associated with the achievement of each milestone as a result of the Company's performance, which are reasonable relative to the other deliverables and terms of the arrangement, and are unrelated to the delivery of any further elements under the arrangement.

The Company and Servier(“Servier”) are developing lucitanib pursuant to a global development plan agreed to between the parties.parties. Servier is responsible for all of the initial global development costs under the agreed upon planfor lucitanib up to €80.0 million. Cumulative global development costs if any, in excess of €80.0 million, if any, will be shared equally between the Companyus and Servier. Based on current estimates, we expect that Servier’s €80.0 million funding commitment will be fulfilled in early 2017, and thereafter, we will share with Servier in future development costs pursuant to a mutually agreed upon global development plan. Reimbursements are recorded as a reduction to research and development expense on the Consolidated Statements of Operations.


The CompanyWe recorded a $2.7$0.1 million and $3.2$1.3 million receivable at June 30, 20162017 and December 31, 2015,2016, 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 June 30, 20162017 and 2015,2016, we incurred $2.6$0.0 million and $4.2$2.6 million, respectively, in research and development costs and recorded reductions in research and development expense of $2.8$0.1 million and $3.9$2.8 million, respectively, for reimbursable development costs due from Servier. For the six months ending June 30, 20162017 and 2015, respectively,2016, we incurred $6.2$0.9 million and $7.8$6.2 million, respectively, in research and development costs and recorded reductions in research and development expense of $6.4$1.0 million and $6.6$6.4 million, respectively, for reimbursable development costs due from Servier.

Rociletinib

In May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene Avilomics Research, Inc., part of Celgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent inhibitor of mutant forms of the epidermal growth factor receptor gene product. Rociletinib was identified as the lead inhibitor candidate under the license agreement. We are responsible for all non-clinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib.

We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone payment in the first quarter of 2012 upon acceptance by the FDA of our Investigational New Drug application for rociletinib and a $5.0 million milestone payment in the first quarter of 2014 upon initiation of the Phase II study for rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDA and Marketing Authorization Application (“MAA”) for rociletinib by the FDA and European Medicines Agency (“EMA”), respectively. We recognized all payments as acquired in-process research and development expense.

During the second quarter of 2016, we and Servier agreed to discontinue the Company receiveddevelopment 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 Complete Response Letter (“CRL”) from the FDA for the rociletinib NDA. The FDA issues a CRLreduction to indicate that their review of an application is completeresearch and that the application is not ready for approval. In anticipation of receiving the CRL, the Company terminated enrollment in all ongoing sponsored clinical studies, although it continues to provide drug to patients whose clinicians recommend continuing rociletinib therapy. In addition, the Company withdrew its MAA for rociletinib on file with the EMA. The Company is continuing analyses of rociletinib data to determine whether certain populations of patients may represent an opportunity for a partner committed to investing in further clinical development.

We are obligated to pay royalties on net sales of rociletinib baseddevelopment expense on the volumeConsolidated Statements of annual net sales achieved. The Company is required to pay up to an additional aggregate of $98.0 million in development and regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, the Company is required to pay up to an aggregate of $120.0 million in sales milestone payments if certain annual sales targets are achieved.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 and Six Months Ended June 30,

 

 

 

 

 

 

 

2016

 

 

2015

 

 

Three and Six months ended June 30, 

 

    

2017

    

2016

 

Common shares under option

 

6,373

 

455

 

Convertible senior notes

 

 

4,646

 

 

 

4,646

 

 

4,646

 

4,646

 

Common shares under option

 

 

455

 

 

 

4,898

 

Total potential dilutive shares

 

 

5,101

 

 

 

9,544

 

 

11,019

 

5,101

 

 

 


14. Commitments and Contingencies

Royalty and License Fee Commitments

The Company has

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. The Company’sOur payment obligation related to these license

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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, no amounts have beenwe only recognize payment obligations which are probable and estimable as of the balance sheet date. Milestone liabilities of $21.0 million and $20.1 million are recorded on the Company’sour Consolidated Balance Sheets at June 30, 20162017 and December 31, 2015.2016, respectively, and relate to milestone payments for the licensing of our rucaparib product, which was approved by the FDA on December 19, 2016.

Development

Manufacture and ManufacturingServices Agreement Commitments

In February 2013, the Company

On October 3, 2016, we entered into a developmentManufacturing and manufacturing agreementServices Agreement (the “Agreement”) with a non-exclusive third-party supplier for the production of the active ingredient for rucaparib.Rubraca. Under the Development and Manufacturingterms of the Agreement, the Companywe will provide the third-party supplier a rolling 24-month forecast for the supply of the active ingredient in Rubraca that will be updated by the Companyus on a quarterly basis. The Company isWe are obligated to order thematerial sufficient to satisfy an initial quantity specified in the first 12 months of 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 June 30, 2016, $16.52017, $183.6  million of purchase commitments exist under this agreement.the Agreement. 

Legal Proceedings

The Company

We and certain of itsour officers and directors 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.

On November 19, 2015, Steve Kimbro,Sonny P. Medina, a purported Clovis shareholder, filed 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.Colorado (the “Medina Complaint”). The KimbroMedina Complaint purportspurported to be asserted on behalf of a class of persons who purchased Clovis stock between October 31, 2013May 20, 2014 and November 15, 2015. The Kimbro Complaint13, 2015, and it generally allegesalleged 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

Throughout November 19,and December 2015, a secondthree other purported shareholdershareholders filed similar purported 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.

actions concerning alleged misstatements about rociletinib. 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 thanOn February 18, 2016, the Medina Court consolidated the various actions into a single proceeding and appointed 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 & GrossmanGrossmann LLP 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 Complaintconsolidated complaint on May 6, 2016.

2016 (the “Consolidated Complaint”). The Consolidated Complaint namesnamed 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 allegesalleged 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 concernconcerned allegedly misleading statements about rociletinib. The putative classconsolidated action iswas purportedly brought on behalf of investors who purchased the Company’s securities between May 31, 2014 and April 7, 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 seekssought 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.

The Clovis Defendants, along with the Underwriter Defendants and the Venture Capital Defendants filed a Motionmotions to Dismissdismiss on July 27, 2016;2016. On February 9, 2017, the Medina Court issued an opinion and order granting in part and denying in part the Clovis Defendants’ motion to dismiss, granting in part and denying in part the Underwriter Defendants’ motion to dismiss, and granting the Venture Capital Defendants’ motion to dismiss. On February 22, 2017, the Arkin Plaintiff’s opposition is due on September 23, 2016;Plaintiffs

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filed an amended consolidated class action complaint, directed solely at repleading its Section 12(a) claims against the Underwriter Defendants.

On March 14, 2017, the Clovis Defendants and the defendants’ replies are due on October 14, 2016.Arkin Plaintiffs participated in a mediation, which did not result in a settlement.

The

On June 18, 2017, the Clovis Defendants intendentered into a stipulation and agreement of settlement with the Arkin Plaintiffs whereby Clovis will issue to vigorously defend against the allegations containedplaintiffs and participating class members  a total consideration comprised of $25.0 million in cash and the issuance of a to be determined number of shares of Clovis common stock (the “Settlement Shares”) equal to $117.0 million divided by the volume weighted average price of Clovis common stock over the 10 trading days immediately preceding the date of the hearing set by the Medina Court to consider the final approval of the settlement. The cash portion of the consideration is expected to be funded by Clovis’ insurance carriers. At June 30, 2017, the liability for the issuance of the shares and cash, including the amount to be reimbursed through insurance proceeds, was recorded to accrued liability for legal settlement on the Consolidated Balance Sheets in the Kimbro,amount of approximately $142.0 million and a receivable of approximately $25.0 million from the insurance carriers on the Consolidated Balance Sheets. Clovis will issue the Settlement Shares no later than 5 business days after the date the judgment is entered by the Medina MoranCourt approving the settlement whereby the issuance of the shares will be recorded in common stock and Rocco Complaints, but there canadditional paid-in capital and the accrued liability for legal settlement will be no assurancecleared.

As the settlement agreement is in response to the alleged violation of securities laws by certain of our officers, we have determined that the defense willresulting loss does not relate to activities that are in the normal course of our operations and therefore, should not be successful.recognized in operating losses for the period. Accordingly, we have recognized the entire expense associated to the settlement agreement in legal settlement loss within the other income (expense), net of insurance receivable on the Consolidated Statements of Operations and Comprehensive Loss.

On December 30, 2015, Jamie McCall, a purported shareholder of Clovis, filed a shareholder derivative complaint (the “McCall Complaint”) against certain officers and directors of Clovis inJuly 14, 2017, the Colorado DistrictMedina Court County of Boulder. The McCall Complaint generally alleged thatissued an order preliminarily approving the defendants breached their fiduciary duties owedsettlement. A final hearing to Clovis by participating in misrepresentation ofdetermine whether the Company’s business operations and prospects. The McCall Complaint also alleged claimssettlement should be approved is scheduled for abuse of control, gross mismanagement and unjust enrichment. The McCall Complaint sought, among other things, an award of money damages, declaratory and injunctive relief concerning the alleged fiduciary breaches and other forms of equitable relief. On March 17, 2016, the plaintiff filed a notice of voluntary dismissal of the McCall Complaint and the action was terminated by the Court.October 26, 2017.

On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported shareholder of Clovis, filed a purported class action complaint (the “Electrical Workers Complaint”) against Clovis and certain of its officers, directors, investors and underwriters in the Superior Court of the State of California, County of San Mateo. The Electrical Workers Complaint purports to be asserted on behalf of a class of persons who purchased stock in Clovis’the July 8, 2015 follow-on offering.Offering. The Electrical Workers Complaint generally alleges that the defendants violated the Securities Act because the offering documents for the July 8, 2015 follow-on offeringOffering contained allegedly false and misleading statements regarding the progress toward FDA approval and the potential for market success of rociletinib. The Electrical Workers Complaint seeks unspecified damages.

On February 25, 2016, the defendants removed the case to the United States District Court for the Northern District of California and thereafter moved to transfer the case to the District of Colorado (“Motion to Transfer”). On March 2, 2016, the plaintiff filed a motion to remand the case to San Mateo County Superior Court (“Motion to Remand”). Following briefing on the Motion to Transfer and the Motion to Remand, the Northern District of California held a hearing on April 18, 2016 concerning the Motion to Remand, at the conclusion of which the court granted to the Motion to Remand. On May 5, 2016, the Northern District of California issued a written decision and order granting the Motion to Remand the case to the Superior Court, County of San Mateo and denying the Motion to Transfer as moot.


While the case was pending in the United States District Court for the Northern District of California, the parties entered into a stipulation extending the defendants’ time to respond to the Electrical Workers Complaint for 30 days following the filing of an amended complaint by plaintiff or the designation by plaintiff of the Electrical Workers Complaint as the operative complaint.  Following remand, Superior Court of the State of California, County of San Mateo so-ordered the stipulation on June 22, 2016.

On June 30, 2016, the Electrical Workers Plaintiffs filed an amended Complaintcomplaint asserting substantially similar claims (the “Amended“Electrical Workers Amended Complaint”). The Amended Complaint names as defendants the Company and certain of its current and former officers and directors, certain underwriters for the July 2015 Offering and certain Company venture capital investors. The Amended Complaint purports to assert claims under the Securities Act based upon alleged misstatements in Clovis’ offering documents for the July 2015 Offering. The Amended Complaint includes new allegations about the Company’s rociletinib disclosures. The Amended Complaint seeks unspecified damages.

On July 28,September 23, 2016, the court ordered the following briefing schedule:and after hearing oral argument, the Electrical Workers Court granted defendants’ motion to stay the Electrical Workers actionproceedings pending resolution of the Medina Kimbro, Moran and Rocco actions inaction. Per the District of Colorado (“Motionorder to Stay”) and demurrerstay proceedings, the parties’ first status report as to the Amended Complaint are dueprogress of the Medina action was filed on August 15, 2016; plaintiff’s oppositions are due on August 31, 2016; and the defendants’ reply briefs areMarch 23, 2017. The parties’ second status report is due on September 15, 2016. A hearing on both motions is scheduled for September 23, 2016. 21, 2017.

The Company intends to vigorously defend against the allegations contained in the Electrical Workers Amended Complaint, but there can be no assurance that the defense will be successful.

On November 10, 2016, Antipodean Domestic Partners (“Antipodean”) filed a complaint (the “Antipodean Complaint”) against Clovis and certain of its officers, directors and underwriters in New York Supreme Court, County of New York. The Antipodean Complaint alleges that the defendants violated certain sections of the Securities Act by making allegedly false statements to Antipodean and in the Offering Materials for the July 2015 Offering relating to the efficacy of rociletinib, its safety profile, and its prospects for market success. In addition to the Securities Act claims, the Antipodean Complaint also asserts Colorado state law claims and common law claims. Both the state law and common law claims are based on allegedly false and misleading statements regarding rociletinib’s progress toward FDA approval. The Antipodean Complaint seeks compensatory, recessionary, and punitive damages.

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On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (the “Antipodean Amended Complaint”) asserting substantially the same claims against the same defendants and purporting to correct certain details in the original Antipodean Complaint.

On January 31, 2017, Defendants filed a motion to stay the Antipodean action pending resolution of the Medina action in the District of Colorado. Defendants also filed a motion to dismiss the Antipodean Amended Complaint on March 29, 2017. A hearing on both motions is scheduled for August 8, 2017.

On March 14, 2017, the Clovis Defendants and Antipodean participated in a mediation, which did not result in a settlement. The Company intends to vigorously defend against the allegations in the Antipodean Amended Complaint.  However, there can be no assurance that the defense will be successful.

Clovis received a letter dated May 31, 2016 from an alleged owner of its common stock, which purports to set forth a demand for inspection of certain of our books and records pursuant to 8 Del. C. § 220 (the “Macalinao Demand Letter”). Clovis also received a letter dated December 15, 2016 from a second alleged owner of Clovis common stock, which purports to set forth a similar demand for inspection of the Company’s books and records pursuant to 8 Del. C. § 220 (the “McKenry Demand Letter”). Both the Macalinao and McKenry Demand Letters were purportedly made for the purposes of investigating alleged misconduct at the Company relating to rociletinib. Clovis submitted a response to the Macalinao Demand Letter on June 24, 2016, and likewise submitted a response to the McKenry Demand Letter on January 4, 2017. The Company produced certain books and records in response to the Macalinao and McKenry Demand Letters in January and February 19, 2016, Maris Sanchez,2017, respectively.

In March 2017, Macalinao and McKenry (the “Derivative Plaintiffs”) filed shareholder derivative complaints against certain directors and officers of the Company in the Court of Chancery of the State of Delaware. On May 4, 2017, the Macalinao and McKenry actions were consolidated for all purposes in a single proceeding under the caption In re Clovis Oncology, Inc. Derivative Litigation, Case No, 2017-0222 (the “Consolidated Derivative Action”).

On May 18, 2017, the Derivative Plaintiffs filed the Consolidated Verified Shareholder Derivative Complaint (the “Consolidated Derivative Complaint”). The Consolidated Derivative Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company by allegedly causing or allowing misrepresentations of the Company’s business operations and prospects, failing to ensure that the TIGER-X clinical trial was being conducted in accordance with applicable rules, regulations and protocols, and engaging in insider trading. The Consolidated Derivative Complaint purported to rely on documents produced by the Company in response to the Macalinao and McKenry Demand Letters. The Consolidated Derivative Complaint sought, among other things, an award of money damages.

On July 13, 2017, the court ordered the following briefing schedule with respect to the defendants’ forthcoming motion to dismiss the Consolidated Derivative Complaint: Defendants’ motion to dismiss was due, and was filed, on July 31, 2017; Plaintiffs’ opposition is due on August 30, 2017; and Defendants’ reply is due on September 14, 2017.

The Company intends to vigorously defend against the allegations in the Consolidated Derivative Complaint, but there can be no assurance that the defense will be successful.

On May 10, 2017, John Solak, a purported shareholder of Clovis,the Company, filed a shareholder derivative complaint in the Court of Chancery of the State of Delaware (the “Solak Complaint”) against certain directors and an officer of the Company. The Solak Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company by adopting a compensation plan that overcompensated the non-employee director defendants, in relation to companies of comparable market capitalization and size. The Solak Complaint also alleged claims of waste of corporate assets and unjust enrichment due to this allegedly wrongful compensation plan. The Solak Complaint sought, among other things, an award of money damages and the imposition of corporate governance reforms.

On June 12, 2017, the parties in the Solak action entered into a stipulation extending the defendants’ time to respond to the Solak Complaint until August 11, 2017, which was entered by the Court on June 20, 2017.  

The Company intends to vigorously defend against the allegations in the Solak Complaint, but there can be no assurance that the defense will be successful.

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On March 20, 2017, a purported shareholder of the Company, filed a shareholder derivative complaint (the “Sanchez“Guo Complaint”) against certain officers and directors of Clovisthe Company in the United States District Court for the District of Colorado. The SanchezGuo Complaint generally alleged that the defendants breached their fiduciary duties owed to Clovisthe Company by participating in misrepresentationeither recklessly or with gross negligence approving or permitting misrepresentations of the Company’s business operations and prospects. The SanchezGuo Complaint also alleged claims for abusewaste of controlcorporate assets and gross mismanagement.unjust enrichment. Finally, the Guo Complaint alleged that certain of the individual defendants violated Section 14(a) of the Securities Exchange Act, by allegedly negligently issuing, causing to be issued, and participating in the issuance of materially misleading statements to stockholders in the Company’s Proxy Statement on Schedule DEF 14A in connection with the 2015 Annual Meeting of Stockholders, held on June 11, 2015. The SanchezGuo Complaint sought, among other things, an award of money damages.

On March 11, 2016,June 19, 2017, the plaintiffparties filed a notice of voluntary dismissaljoint motion to stay the Guo action pending resolution of the Sanchez Complaint without prejudice.motion to dismiss the Consolidated Derivative Complaint. On March 14, 2016,June 20, 2017, the Sanchez action was terminated bycourt granted the District of Colorado.motion to stay.

The Company intends to vigorously defend against the allegations in the Guo Complaint, but there can be no assurance that the defense will be successful.

In addition, the Company has received inquiries and requests for information from governmental agencies, including the U.S. Securities and Exchange Commission and the U.S. Department of Justice, relating to the Company’s regulatory update announcement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of rociletinib. The Company is cooperatingcontinuing to cooperate with the inquiries.

these agencies with respect to their investigations. The Company received a letter dated May 31, 2016 from an alleged ownerproposed settlement of the Company’s common stock, which purports to set forth a demand for inspection of certain of the Company’s booksMedina action does not resolve these inquiries and records pursuant to 8 Del. C. § 220 (the “Demand Letter”). The Demand Letter was purportedly made for the purpose of investigating alleged misconduct at the Company relating to rociletinib. On June 24, 2016, the Company submitted a response to the Demand Letter. The Company believes that the Demand Letter fails to establish an entitlement to anycannot predict their timing or outcome.

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Table of the requested documents, but there can be no assurance about the likelihood of an adverse outcome.Contents

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

 

15. Subsequent Events

The Company evaluated events up to the filing date of these interim financial statements and determined that no subsequent activity required disclosure.Forward-Looking Information

 


ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Information

This Quarterly Report on Form 10-Q and the information incorporated herein by reference includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this Quarterly Report on Form 10-Q and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned non-clinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, the degree of clinical utility of our products, particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity and the development of the industry in which we operate may differ materially from the forward-looking statements contained herein.

Any forward-looking statements that we make in this Quarterly Report on Form 10-Q speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated events.

You should also read carefully the factors described in the “Risk Factors” section of this Quarterlyin  Part I, Item 1A in our most recent Annual Report on Form 10-Q10-K filed with the U.S. Securities and Exchange Commission (“SEC”), as updated from time to time in our subsequent SEC filings, to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. You are advised, however, to consult any further disclosures we make on related subjects in our other reports filed with the SEC and on our website.

Overview

We are a biopharmaceutical company focused on acquiring, developing and commercializing cancer treatmentsinnovative anti-cancer agents in the United States, Europe and otheradditional international markets. Our productWe target our development programs generally targetfor the treatment of specific subsets of cancer populations, and we seek to simultaneously develop, with partners, companion diagnostics thatdiagnostic tools intended to direct our product candidatesa compound in development to the patientspopulation that is most likely to benefit from its use.

Our commercial product Rubraca® (rucaparib) is the first and only oral, small molecule poly ADP-ribose polymerase, or PARP, inhibitor of PARP1, PARP2 and PARP3 approved in the United States by the FDA as monotherapy for the treatment of patients with deleterious BRCA (human genes associated with the repair of damaged DNA) 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.

Our MAA for rucaparib that was submitted to the EMA for an ovarian cancer treatment indication comparable to what was approved by the FDA is currently under review. We anticipate an opinion from the CHMP in late 2017, and, pending a favorable opinion from the CHMP, a potential approval would follow during the first quarter of 2018.  Following a potential approval for the treatment indication, we intend to submit a supplemental application for the second-line or later maintenance treatment indication, for which we anticipate a potential approval during the third quarter of 2018. Additionally, rucaparib is being studied as a potential maintenance therapy for ovarian cancer patients in the ARIEL3 trial. On June 19, 2017, we announced that the ARIEL3 trial successfully achieved the primary endpoint of improved progression-free survival (PFS) by investigator review in each of the three populations studied. PFS was also improved in the rucaparib group compared with placebo by blinded independent central review (BICR), a key secondary endpoint. Based on these findings, we plan to submit a supplemental New Drug Application (sNDA) before the end of

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October 2017 for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their use. We are currently developing two product candidates:most recent platinum therapy. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies.  Studies open for enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers.

 

·

Rucaparib, an oral inhibitor of poly (ADP-ribose) polymerase (PARP) currently in advanced clinical development for the treatment of ovarian cancer. 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 potential accelerated approval of rucaparib in the U.S. We intend to submit our first E.U. regulatory application in the fourth quarter of 2016.

·

Lucitanib, an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors (VEGFR) 1-3, platelet-derived growth factor receptors (PDGFR) alpha and beta and fibroblast growth factor receptors (FGFR) 1-3.

We hold globalworldwide rights for rucaparib. In June 2011, we obtained an exclusive, worldwide license from Pfizer to develop and commercialize rucaparib. U.S. Patent 6,495,541, and its equivalent counterparts issued in dozens of countries, directed to the rucaparib composition of matter, expire in 2020 and are potentially eligible for up to five years patent term extension in various jurisdictions. We believe that patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act, could be available to extend our patent exclusivity for rucaparib to the fourth quarter of 2023 in the United States. In Europe, we believe that patent term extension under a supplementary protection certificate could be available for an additional five years to at least 2025. In April 2012, we obtained an exclusive license from AstraZeneca under a family of patents and patent applications to permit the development and commercialization rightsof rucaparib for rucaparib. For lucitanib, we hold developmentcertain methods of treating patients with PARP inhibitors. Additionally, other patents and commercialization rightspatent applications are directed to methods of making, methods of using, dosing regimens, various salt and polymorphic forms and formulations and have expiration dates ranging from 2020 through potentially 2035, including the camsylate salt/polymorph patent family licensed from Pfizer, which expires in 2031 and a patent application directed to high dosage strength rucaparib tablets that, if issued, will expire in 2035. We are aware of a number of cases where salt and polymorph patents have been challenged. Two oppositions were filed in the U.S.granted European counterpart of the rucaparib camsylate salt/polymorph patent on June 20, 2017. European oppositions are commonly filed against patents related to pharmaceutical products. The grounds of opposition related to Rubraca were lack of novelty and Japanlack of inventive step. The novelty and have sublicensed rightsinventive step challenges are based on prior art references (or closely related disclosures) that were previously raised by the European patent examiner during prosecution of the application.  The claims of the granted patent were found to Europebe patentable over this prior art. While the ultimate results of patent challenges can be difficult to predict, we believe a number of factors, including a constellation of unexpected properties, support the novelty and restnon-obviousness of world markets, excluding China, to Les Laboratoires Servier (“Servier”).our rucaparib camsylate salt/polymorph composition of matter patent. Based on these factors, we believe a successful challenge of that patent would be difficult.

In addition, we have a thirdtwo other product candidate,candidates: lucitanib, an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors (VEGFR) 1-3, platelet-derived growth factor receptors (PDGFR) alpha and beta and fibroblast growth factor receptors (FGFR) 1-3, and rociletinib, an oral mutant-selective inhibitor of epidermal growth factor receptor (“EGFR”)(EGFR). During the second quarter of 2016, the Company received a Complete Response Letter (“CRL”) from the FDA for the rociletinib NDA, which was submitted during the third quarter of 2015. The FDA issues a CRL to indicate that their review of an application is complete and that the application is not ready for approval. In anticipation of receiving the CRL, the Company terminatedWhile we have stopped enrollment in all ongoing sponsored clinical studies, although it continuestrials for each of these candidates, we continue to provide drugdrugs to patients whose clinicians recommend continuing rociletinib therapy. In addition, the Company withdrew its Marketing Authorization Application (“MAA”)We maintain certain development and commercialization rights for rociletinib on file with the European Medicines Agency (“EMA”). The Company is continuing analyses of rociletinib data to determine whether certain populations of patients may represent an opportunity for a partner committed to investing in further clinical development. We holdlucitanib and global development and commercialization rights for rociletinib.

 


We commenced operations in April 2009. To date, we have devoted substantially all of our resources to identifying and in-licensing product candidates, performing development activities with respect to those product candidates and the general and administrative support of these operations. To date,Through June 30, 2017, we have generated $13.6 million in license and milestone revenue butrelated to our collaboration and license agreement with Servier and have generated no$21.7 million net product revenues.revenue related to sales of Rubraca, which we began to commercialize on December 19, 2016. We have principally funded our operations using the net proceeds from the sale of convertible preferred stock, the issuance of convertible promissory notes, public offerings of our common stock and our convertible senior notes offering.

We have never been profitable and, as of June 30, 2016,2017, we had an accumulated deficit of $994.6$1,364.9 million. We incurred net losses of $233.8 million and $212.7 million for the six months ended June 30, 2017 and 2016, respectively. The net loss for the six months ended June 30, 2017 included a charge of $117.0 million related to a legal settlement. The net loss for the six months ended June 30, 2016 included a charge of $104.5 million for the impairment of intangible asset and a gain of $24.9 million from a reduction in fair value of contingent purchase consideration. We had cash, cash equivalents and available-for-sale securities totaling $671.5 million at June 30, 2017.

We expect to incur significant losses for the foreseeable future, as we advanceincur costs related to commercial activities associated with Rubraca. In January 2017, we sold 5,750,000 shares of our product candidates through clinical developmentcommon 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. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceeds from the offering were $324.9 million, after deducting underwriting discounts and

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commissions and offering expenses. We intend to seek regulatory approvaluse the net proceeds of the offerings for general corporate purposes, including sales and marketing expenses associated with Rubraca in the United States and, if approved commercialize suchby the EMA, in Europe, funding of our development programs, selling, general and administrative expenses, acquisition or licensing of additional product candidates.candidates or businesses and working capital. Based on our current estimates, we believe that our cash, cash equivalents and available-for-sale securities as of June 30, 2016 will allow us to fund activities through at least the next 12 months. WeUntil we can generate a sufficient amount of revenue from Rubraca, we expect to finance future cash needsour operations in part through a combination ofadditional public or private equity or debt offerings collaborations,and may seek additional capital through arrangements with strategic alliancespartners or from other similar licensing arrangements.sources.  Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenues to achieve profitability, and we may never do so.

Product License Agreements

Rucaparib

In June 2011, we entered into a worldwide license agreement with Pfizer, Inc. to acquireobtain exclusive global development and commercialization rights to rucaparib.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.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 April 2014, the Company initiated a pivotal registration studyevent 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 rucaparib, whichthe 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 $0.4$0.75 million milestone payment to Pfizer as required by the license agreement. This paymentagreement, which was recognized as acquired in-process research and development expense.

We are responsible for all development and commercialization costs of rucaparib. When and if commercial sales of rucaparib begin, we will pay Pfizer tiered royalties on our net sales. In addition, Pfizer is eligible to receive up to $258.5 million of further payments, in aggregate, if certain development, regulatory and sales milestones are achieved, including $21.25 million associated with the first filing and approval of an NDA by the FDA.

Lucitanib

On November 19, 2013, the Company acquired all of the issued and outstanding capital stock of Ethical Oncology Science, S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.) and gained rights to develop and commercialize lucitanib, an oral, selective tyrosine kinase inhibitor. As further described below, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”). Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Servier in exchange for upfront milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development funding commitments.

In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excluding China. The Company is obligated to pay Advenchen royalties on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, the Company is obligated to pay to Advenchen 25% of any consideration, excluding royalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. In the first quarter of 2014, the Company recognized acquired in-process research and development expense of $3.4 million, which represents 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office.

In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an upfront payment of €45.0 million. We are entitled to receive additional payments upon achievement of specified development, regulatory and commercial milestones up to an additional €90.0 million in the aggregate. In addition, the Company is entitled to receive sales milestone payments if specified annual sales targets for lucitanib are met, which, in the aggregate, could total €250.0 million. The Company is also entitled to receive royalties on net sales of lucitanib by Servier.


The Company and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is responsible for the initial €80.0 million in global development costs under the agreed upon plan. Cumulative global development costs in excess of €80.0 million, if any, will be shared equally between the Company and Servier. Based on current estimates, we expect that Servier’s €80.0 million funding commitment will be fulfilled in early 2017, and thereafter, we will share with Servier in future development costs pursuant to a mutually agreed upon global development plan. During the second quarter of 2016, the Company and Servier agreed to discontinue the development of lucitanib for breast cancer. The Company and Servier are continuing to evaluate what, if any, further development of lucitanib will be pursued.

Rociletinib

In May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene Avilomics Research, Inc., part of Celgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent inhibitor of mutant forms of the EGFR gene product. Rociletinib was identified as the lead inhibitor candidate under the license agreement. We are responsible for all non-clinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib.

We made an upfront payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone payment in the first quarter of 2012 upon acceptance by2017. The FDA approval also resulted in the FDA of our Investigational New Drug application for rociletinib andobligation to pay a $5.0$20.0 million milestone payment, infor which we have exercised the first quarter of 2014 uponoption to defer payment by agreeing to pay $23.0 million within 18 months after the initiationdate of the Phase II study for rociletinib. InFDA approval. These payments were recognized as intangible assets and will be amortized over the third quarterestimated remaining useful life of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments as acquired in-process research and development expense.Rubraca.

We are obligated under the license agreement to pay royalties on net sales of rociletinib based on the volume of annual net sales achieved. The Company isuse 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 paymake regulatory milestone payments to Pfizer of up to an additional aggregate of $98.0$69.75 million in development and regulatory milestone paymentsaggregate if certainspecified clinical study objectives and regulatory filings, acceptances and approvals are achieved. In addition, the Company is requiredwe are obligated to pay up to an aggregate of $120.0 million inmake sales milestone payments to Pfizer if certainspecified annual sales targets for rucaparib are achieved.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.

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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).

Financial Operations Overview

Revenue

To date,

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 generated $13.6 million in licensearrangements with certain payors and milestone revenue related to our collaborationother third parties that provide for government-mandated and license agreement with Servier. In the future, we may generate revenue from the salesprivately-negotiated rebates, chargebacks and other discounts. Revenue is recorded net of product candidates that are under development by the Company,estimated rebates, chargebacks, discounts and other deductions as well as from milestone paymentsestimated product returns (collectively, “sales deductions”). We only recognize revenue on product sales once the product is resold to the patient or royalties pursuanthealthcare provider by the specialty distributor or specialty pharmacy provider, therefore reducing the significance of estimates made for product returns. 

Sales Deductions

Estimating sales deductions requires significant judgments about future events and uncertainties, and requires us to our sublicense agreement with Servier.rely heavily on assumptions, as well as historical experience. Estimated sales deductions are provided for the following:

·

Rebates. Rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare coverage gap program. Rebates are amounts owed after the final dispensing of products to a benefit plan participant and are based upon contractual agreements or legal requirements with the public sector benefit providers. The accrual for rebates is based on statutory discount rates and known sales to specialty pharmacy patients, or expected utilization for specialty distributor sales to healthcare providers. As we gain more historical experience, the accrual will be based solely on the expected utilization from historical data we have accumulated since Rubraca product launch. Rebates are generally invoiced and paid quarterly in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known or estimated prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust balances of such rebates to reflect our actual expenditures with respect to these programs, which would affect revenue in the period of adjustment.

·

Chargebacks. Chargebacks are discounts that occur when contracted customers, which currently consist primarily of group purchasing organizations, Public Health Service organizations and federal government entities purchasing via the Federal Supply Schedule, purchase directly from our specialty distributors at a discounted price. The specialty distributor, in turn, charges back the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by the healthcare provider. The accrual for specialty distributor chargebacks is estimated based on known chargeback rates and known sales to specialty distributors adjusted for the estimated utilization by healthcare providers.

·

Discounts. Specialty distributors and specialty pharmacies are offered various forms of consideration, including service fees and prompt pay discounts for payment within a specified period. We expect these customers will earn prompt pay discounts and therefore, we deduct the full amount of these discounts from product sales when revenue is recognized. Service fees are recorded as a selling expense when product sales occur.

·

Co-pay assistance. Patients who have commercial insurance and meet certain eligibility requirements may receive co-pay assistance. The intent of this program is to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are based on actual program participation and estimates of program redemption using data provided by third-party administrators.

·

Returns. Sales of our products are not subject to a general right of return at the point we recognize revenue, which is the point the product is sold to the patient or healthcare provider. 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.

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In the three and six months ended June 30, 2017, we failrecorded net product revenue of $14.6 million and $21.7 million, respectively, related to successfully complete the regulatory reviewsales of Rubraca, which we began to commercialize on December 19, 2016. Our ability to generate revenue and development of our product candidates and, together with our partners, companion diagnostics or obtain regulatory approval for them,become profitable depends upon our ability to successfully commercialize products. Any inability on our part to successfully commercialize Rubraca in the United States and any foreign territories where it may be approved, or any significant delay in such approvals, could have a material adverse impact on our ability to execute upon our business strategy and, ultimately, to generate futuresufficient revenues from Rubraca to reach or maintain profitability or sustain our anticipated levels of operations.

Cost of Sales – Product

We recorded product cost of sales from sales of Rubraca in the three and six months ended June 30, 2017.  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 and six months ended June 30, 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 resultslicensing partners upon FDA approval of operations and financial position will be adversely affected.Rubraca. Milestone payments are amortized on a straight-line basis over the estimated remaining patent life of Rubraca.     

Research and Development Expenses

Research and development expenses consist of costs incurred for the development of our product candidates and companion diagnostics, which include:

·

license fees and milestone payments related to the acquisition of in-licensed products, which are reported on our Consolidated Statements of Operations as acquired in-process research and development;

·

employee-related expenses, including salaries, benefits, travel and share-based compensation expense;

·

expenses incurred under agreements with contract research organizations and investigative sites that conduct our clinical trials;

·

the cost of acquiring, developing and manufacturing clinical trial materials;

·

costs associated with non-clinical activities and regulatory operations;

·

market research, disease education and other commercial product planning activities, including the hiring of a U.S. sales and marketing and medical affairs organization in preparation for potentialthe commercial launch of rucaparib; and

·

activities associated with the development of companion diagnostics for our product candidates.

 


Research and development costs are expensed as incurred. License fees and milestone payments related to in-licensed products and technology are expensed if it is determined that they have no alternative future use. Costs for certain development activities, such as clinical trials and manufacturing of clinical supply, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors.

Product candidatesAs a result of the FDA approval of Rubraca and the discontinuation of enrollment in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later stage clinical trials. We expectrociletinib, our research and development expenses decreased in 2016both the three and six months ended June 30, 2017 compared to increase over 2015.the same periods in the prior year and are expected to decrease for the remainder of 2017 compared to prior year as we continue to commercialize Rubraca and commercialization related expenses are classified as selling, general and administrative expenses and not research and development costs.

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The following table identifies research and development and acquired in-process research and development costs on a program-specific basis for our products under development. Personnel-related costs, depreciation and share-based compensation are not allocated to specific programs, as they are deployed across multiple projects under development and, as such, are separately classified as personnel and other expenses in the table below.below (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Three months ended June 30, 

 

Six months ended June 30, 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

    

2017

     

2016

    

2017

    

2016

 

 

(in thousands)

 

 

(in thousands)

 

Rucaparib Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

24,379

 

 

$

11,527

 

 

$

48,936

 

 

$

23,823

 

 

$

16,980

 

$

24,379

 

$

31,490

 

$

48,936

 

Acquired in-process research and development

 

 

300

 

 

 

 

 

 

300

 

 

 

 

 

 

 

 

 

300

 

 

 —

 

 

300

 

Rucaparib Total

 

 

24,679

 

 

 

11,527

 

 

 

49,236

 

 

 

23,823

 

 

 

16,980

 

 

24,679

 

 

31,490

 

 

49,236

 

Lucitanib Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (a)

 

 

(194

)

 

 

308

 

 

 

(214

)

 

 

1,243

 

 

 

(13)

 

 

(194)

 

 

(99)

 

 

(214)

 

Lucitanib Total

 

 

(194

)

 

 

308

 

 

 

(214

)

 

 

1,243

 

 

 

(13)

 

 

(194)

 

 

(99)

 

 

(214)

 

Rociletinib Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

16,821

 

 

 

31,149

 

 

 

37,415

 

 

 

59,994

 

 

$

1,528

 

$

16,821

 

 

4,719

 

 

37,415

 

Rociletinib Total

 

 

16,821

 

 

 

31,149

 

 

 

37,415

 

 

 

59,994

 

 

 

1,528

 

 

16,821

 

 

4,719

 

 

37,415

 

Personnel and other expenses

 

 

26,723

 

 

 

17,384

 

 

 

56,200

 

 

 

32,058

 

 

 

14,613

 

 

26,723

 

 

29,445

 

 

56,200

 

Total

 

$

68,029

 

 

$

60,368

 

 

$

142,637

 

 

$

117,118

 

 

$

33,108

 

$

68,029

 

$

65,555

 

$

142,637

 

 

(a)

This amount reflects actual costs incurred less amounts due from Servier for reimbursable development expenses pursuant to the collaboration and license agreement described in Note 12 to our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q.

(a)This amount reflects actual costs incurred less amounts due from Servier for reimbursable development expenses pursuant to the collaboration and license agreement described in Note 12, License Agreements to our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q.

Selling, General and Administrative Expenses

General

Selling, general and administrative expenses consist principally of salaries and related costs for personnel in executive, commercial, finance, legal, investor relations, human resources, and information technology functions. Other selling, general and administrative expenses include facilities expenses, communication expenses, information technology costs, corporate insurance and professional fees for legal, consulting and accounting services.

Effective May 9, With the FDA approval of Rubraca on December 19, 2016, at Mr. Mahaffy’s request,all sales and marketing expenses associated with Rubraca are included in selling, general and administrative expenses. We anticipate that our selling, general and administrative expenses will continue to increase in the Compensation Committeefuture in support of the Board of Directors approved his waiver of any annual base salary in excess of $1.00, plus the cost of the employee portion of any premiums to be paid pursuant to any health and welfare benefit plans maintained by the Company and any tax withholdingsour commercial activities related to health and welfare benefits. Such waiver shall continue in effect until the earliest to occur of (i) the Company entering into a definitive agreement with respect to a transaction that if consummated would constitute a Change in Control (as defined in his Employment Agreement) or the public announcement of a proposal or transaction that if consummated would constitute a Change of Control, (ii) approval by the FDA to commercially distribute, sell or market rucaparib, and (iii) termination of his employment by the Company without Just Cause or by Mr. Mahaffy for Good Reason (each as defined in his Employment Agreement).Rubraca.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development expenses consist of upfront payments to acquire a new drug compound, as well as subsequent milestone payments. Acquired in-process research and development payments are immediately expensed provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use.


Impairment Once regulatory approval is received, payments to acquire rights, and the related milestone payments, are capitalized and the amortization of Intangible Asset

In connection with the acquisition of EOS, wesuch assets recorded intangible assets to reflect the fair value of acquired in-process research and development (“IPR&D”) as of the acquisition date. The fair value was established based upon discounted cash flow models using assumptions related to the timing of development, probability of development and regulatory success, sales and commercialization factors and estimated product life. During the second quarter of 2016, the Company recorded a $104.5 million impairment charge due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer. At June 30, 2016, the IPR&D intangible asset recorded on the Consolidated Balance Sheets was zero.amortization cost of sales.

The IPR&D intangible assets are treated as indefinite-lived intangible assets and are not amortized. IPR&D intangible assets are evaluated for impairment at least annually or more frequently if impairment indicators exist and any reduction in fair value is recorded as impairment of intangible asset on the Consolidated Statements of Operations.

Change in Fair Value of Contingent Purchase Consideration

In connection with the acquisition of EOS in November 2013, we also recorded a purchase consideration liability equal to the estimated fair value of future payments that are contingent upon the achievement of various regulatory and sales milestones. Subsequent to the acquisition date, we re-measure contingent consideration arrangements at fair value each reporting period and record changes in fair value to change in fair value of contingent purchase consideration and foreign currency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations. Changes in fair value are primarily attributed to new information about the likelihood of achieving such milestones and the passage of time. In the absence of new information, changes toin fair value reflect only the passage of time as we progress towards the achievement of future milestones. During the second quarter of 2016, the Companywe recorded a $25.5 million reduction in the fair value of the contingent purchase consideration liability due to the Company’sour and itsour development partner’s decision to discontinue the development of lucitanib for breast cancer. At June 30, 2016,2017, the contingent purchase consideration

26


Table of Contents

liability recorded on the Consolidated Balance Sheets was zero due to the uncertainty of achieving any of the lucitanib regulatory milestones.

Other Income and Expense

Other income and expense is primarily comprised of foreign currency gains and losses resulting from transactions with contract research organizations (“CROs”), investigational sites and contract manufacturers where payments are made in currencies other than the U.S. dollar. In addition, a significant portion of the contingent purchase consideration liability will be settled in Euro-denominated payments if certain future milestones are achieved and is subject to fluctuations in foreign currency rates. Other expense also includes interest expense recognized related to the Company’sour convertible senior notes.

Critical Accounting Policies and Significant Judgments and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses and revenue and related disclosures. On an ongoing basis, we evaluate our estimates and judgments, including those related to contingent purchase consideration, the allocation of purchase consideration, intangible asset impairment, clinical trial accruals and share-based compensation. We base our estimates on historical experience, known trends and events and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

For a description of our critical accounting policies, please see Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015.2016. There have not been any material changes to our critical accounting policies since December 31, 2015.2016.

 


Recently IssuedNew Accounting Standards

In March 2016,

From time to time, the Financial Accounting Standards Board issued(“FASB”) or other standards-setting bodies issue new accounting pronouncements. Updates to the FASB Accounting Standards Update (“ASU”) No. 2016-09, “Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting.” ASU No. 2016-09 requires all income tax effectsCodification are communicated through the issuance of awardsan Accounting Standards Update. Unless otherwise discussed, we believe that the impact of recently issued guidance, whether adopted or to be recognizedadopted in the income statement whenfuture, is not expected to have a material impact on our Consolidated Financial Statements upon adoption.

To understand the awards vestimpact of recently issued guidance, whether adopted or are settled. The guidance also requiresto be adopted, please review the presentationinformation provided in Note 2, Summary of excess tax benefits as an operating activity onSignificant Accounting Policies, in the statement of cash flows rather than as a financing activity. This update is effective for annual periods beginning after December 15, 2016, including interim periods within those annual periods. Early adoption is permitted. Amendments relatedNotes to the timingUnaudited Consolidated Financial Statements included in Part I, Item 1 of when excess tax benefits are recognized should be applied using a modified retrospective transition method. An entity may elect to apply the amendments related to the presentationthis Form 10-Q.

27


Table of excess tax benefits on the statement of cash flows using either a prospective transition method or a retrospective transition method. The Company is currently evaluating its planned method of adoption and the impact the standard may have on its consolidated financial statements and related disclosures.Contents

Results of Operations

Comparison of Three Months Ended June 30, 20162017 and 2015:2016:

The following table summarizes the results of our operations for the three months ended June 31,30, 2017 and 2016 and 2015 (in thousands):

 

 

Three Months Ended June 30,

 

 

Change 2016 vs. 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2016

 

 

2015

 

 

$

 

 

%

 

 

 

 

 

 

 

 

Change

 

 

Three months ended June 30, 

 

Favorable/(Unfavorable)

 

    

2017

    

2016

    

$

    

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

14,620

 

$

 —

 

$

14,620

 

 

n/a

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

 

2,730

 

 

 —

 

 

(2,730)

 

 

n/a

 

Cost of sales - intangible asset amortization

 

 

372

 

 

 —

 

 

(372)

 

 

n/a

 

Research and development

 

$

67,729

 

 

$

60,368

 

 

$

7,361

 

 

 

12

%

 

 

33,108

 

 

67,729

 

 

34,621

 

 

51

%

General and administrative

 

 

9,552

 

 

 

7,204

 

 

 

2,348

 

 

 

33

%

Selling, general and administrative

 

 

36,149

 

 

9,552

 

 

(26,597)

 

 

(278)

%

Acquired in-process research and development

 

 

300

 

 

 

 

 

 

300

 

 

n/a

 

 

 

 —

 

 

300

 

 

300

 

 

n/a

 

Impairment of intangible asset

 

 

104,517

 

 

 

 

 

 

104,517

 

 

n/a

 

 

 

 —

 

 

104,517

 

 

104,517

 

 

n/a

 

Change in fair value of contingent purchase consideration

 

 

(25,452

)

 

 

764

 

 

 

(26,216

)

 

 

(3,431

%)

 

 

 —

 

 

(25,452)

 

 

(25,452)

 

 

n/a

 

Total expenses

 

 

156,646

 

 

 

68,336

 

 

 

88,310

 

 

 

129

%

 

 

72,359

 

 

156,646

 

 

84,287

 

 

54

%

Operating loss

 

 

(156,646

)

 

 

(68,336

)

 

 

(88,310

)

 

 

129

%

 

 

(57,739)

 

 

(156,646)

 

 

98,907

 

 

63

%

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,106

)

 

 

(2,097

)

 

 

(9

)

 

 

0

%

 

 

(2,598)

 

 

(2,106)

 

 

(492)

 

 

(23)

%

Foreign currency gains (losses)

 

 

183

 

 

 

(1,142

)

 

 

1,325

 

 

 

(116

%)

Foreign currencygains (losses)

 

 

76

 

 

183

 

 

(107)

 

 

58

%

Legal settlement loss

 

 

(117,000)

 

 

 —

 

 

(117,000)

 

 

n/a

 

Other income

 

 

196

 

 

 

62

 

 

 

134

 

 

 

216

%

 

 

594

 

 

196

 

 

398

 

 

(203)

%

Other income (expense), net

 

 

(1,727

)

 

 

(3,177

)

 

 

1,450

 

 

 

(46

%)

 

 

(118,928)

 

 

(1,727)

 

 

(117,201)

 

 

(6,786)

%

Loss before income taxes

 

 

(158,373

)

 

 

(71,513

)

 

 

(86,860

)

 

 

121

%

 

 

(176,667)

 

 

(158,373)

 

 

(18,294)

 

 

(12)

%

Income tax benefit (expense)

 

 

29,059

 

 

 

(18

)

 

 

29,077

 

 

 

(161,539

%)

Income tax benefit

 

 

1,281

 

 

29,059

 

 

(27,778)

 

 

96

%

Net loss

 

$

(129,314

)

 

$

(71,531

)

 

$

(57,783

)

 

 

81

%

 

$

(175,386)

 

$

(129,314)

 

$

(46,072)

 

 

(36)

%

 

Product Revenue, Net. Product revenue for the three months endedJune 30, 2017 was due to the recognition of $14.6 million of net product revenue from the sale of our first commercial product, Rubraca, which was approved for sale in the United States markets and we began shipping on December 19, 2016. Revenue is recorded net of sales deductions comprised of rebates, chargebacks and other discounts. Sales deductions represented approximately 7.9% of the gross product revenue recognized in the three months ended June 30, 2017 and are summarized as follows:

 

 

 

 

 

 

 

 

 

 

Three months ended

 

 

    

June 30, 2017

 

 

 

$

    

% of Gross Sales

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Gross product revenue

 

$

15,876

 

 

100.0%

 

Sales deductions:

 

 

 

 

 

 

 

Government rebates and chargebacks

 

 

635

 

 

4.0%

 

Discounts and fees

 

 

621

 

 

3.9%

 

Total sales deductions

 

 

1,256

 

 

7.9%

 

Product revenue, net

 

$

14,620

 

 

92.1%

 

Cost of Sales – Product. Product cost of sales for the three months ended June 30, 2017 of $2.7 million relate to freight and royalties costs associated with Rubraca sales in the period. Manufacturing costs associated with sales in the quarter were expensed as incurred based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, and therefore, were not included in product cost of sales for the three months ended June

28


Table of Contents

30, 2017. We expect cost of sales to increase in relation to product revenues once we deplete these inventories in the third quarter 2017.  

Cost of Sales – Intangible Asset Amortization. In the three months ended June 30, 2017, we recognized cost of sales of $0.4 million associated with the amortization of capitalized milestone payments related to the FDA approval of Rubraca. Prior to the FDA approval on December 16, 2016, all acquired license and milestone payments were expensed as incurred.

Research and Development Expenses. Research and development expenses increaseddecreased during the three months ended June 30, 20162017 compared to the same period in the prior year primarily due to increasedlower research and development activitiescosts for rucaparib and rociletinib and classification of commercialization related expenses associated with Rubraca in selling, general and administrative expenses rather than research and development expenses. In the rucaparib programthree months ended June 30, 2017, Rubraca commercialization costs included in selling, general and higher salaries, share-based compensation and other personnel-related costs, partially offset by loweradministrative expenses related to the rociletinib program.were $26.9 million.

 

Clinical trial costs for rucaparib were $5.2 million higher thanrelatively flat compared to the same quarter in the priora year primarily due toago as higher costs from enrollment in ARIEL4, our confirmatory ovarian cancer trials, and enrollment in our TRITON2 and TRITON3 studies for prostate cancer were largely offset by lower costs for the ARIEL2 and ARIEL3 studies, in ovarian cancer. Market research, disease education and other commercial product planning activities were $4.2 million higher than the same quarter in the prior year due to the preparation for the potential regulatory approval and commercial launch of rucaparib. In addition, clinicalwhich have completed enrollment. Clinical supply and related manufacturing development costs were $2.1$3.5 million higherlower than the second quarter of 2015, as we increased production2016 due to support the expanded clinical studies.capitalization of these costs subsequent to the FDA approval of rucaparib.    

 

Salaries, share-based compensation expense and other personnel-related costs were $9.3 million higher in the second quarter of 2016 driven by increased headcount to support our expanded development and commercial planning activities. During the third quarter of 2015, we completed the hiring of our U.S. sales and marketing and medical affairs organizations in preparation for the potential regulatory approval and commercial launch of rucaparib.


Clinical trial costs for rociletinib were $9.8$8.2 million lower than the second quarter in 2015of 2016 primarily due to the completion of patient enrollment for all of the TIGER-1, TIGER-2 and TIGER-XTIGER studies in non-small cell lung cancer. This decrease was partially offset by higher clinical trial costs for the TIGER-3 study, which began enrolling patients during the second quarter of 2015. Market research, disease education and other commercial product planning activities were $3.7 million lower than the same quarter in the prior year. The Company incurred higher costs during the second quarter of 2015 due to the preparation for the potential regulatory approval and commercial launch of rociletinib.In addition, clinicalClinical supply and related manufacturing development costs were $1.2$4.3 million lower than the second quarter in 2015of 2016 driven by timing of production to support our clinical studies.

Selling, General and Administrative Expenses. GeneralSelling, general and administrative expenses increased during the three months ended June 30, 20162017 compared to the same period in the prior year primarily due to $1.7 million higher legal expense and $0.3 million higher personnel costs.

Impairmentclassification of Intangible Asset.During the second quarter of 2016, the Company recorded a $104.5 million impairment chargeto the IPR&D intangible asset relating to our lucitanib product candidate.This reduction in the estimated fair value of lucitanib was the result of the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer.

Change in Fair Value of Contingent Purchase Consideration.Change in fair value of contingent purchase consideration totaled ($25.5) million for the three months ended June 30, 2016 compared to $0.8 million for the same period in the prior year. During the second quarter of 2016, the Company recorded a $25.5 million reduction in the fair value of the contingent purchase consideration liability due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer.

Other Income (Expense), net. Other expense decreased during the three months ended June 30, 2016 compared to the same period in the prior year. During the second quarter of 2016, the Company recognized $0.2 million of foreign currency gains compared with $1.1 million of foreign currency losses during the same period in 2015. The change in the foreign currency gains and losses was driven by fluctuations in the foreign currency rate utilized to translate our Euro-denominated contingent purchase consideration liability into U.S. dollars.

Income Tax Benefit (Expense). During the second quarter of 2016, the Company recognized a $29.2 million deferred tax benefitcommercialization related expenses associated with the impairmentRubraca in selling, general and administrative expenses rather than research and development expenses.

29


Table of the IPR&D intangible asset.Contents

Comparison of Six Months Ended June 30, 20162017 and 2015:2016:

The following table summarizes the results of our operations for the six months ended June 31,30, 2017 and 2016 and 2015 (in thousands):

 

 

Six Months Ended June 30,

 

 

Change 2016 vs. 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2016

 

 

2015

 

 

$

 

 

%

 

 

 

 

 

 

 

 

Change

 

 

Six months ended June 30, 

 

Favorable/(Unfavorable)

 

    

2017

    

2016

    

$

    

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

21,665

 

$

 —

 

$

21,665

 

 

n/a

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales - product

 

 

3,893

 

 

 —

 

 

(3,893)

 

 

n/a

 

Cost of sales - intangible asset amortization

 

 

743

 

 

 —

 

 

(743)

 

 

n/a

%

Research and development

 

$

142,337

 

 

$

117,118

 

 

$

25,219

 

 

 

22

%

 

 

65,555

 

 

142,337

 

 

76,782

 

 

54

%

General and administrative

 

 

19,379

 

 

 

13,955

 

 

 

5,424

 

 

 

39

%

Selling, general and administrative

 

 

65,373

 

 

19,379

 

 

(45,994)

 

 

(237)

%

Acquired in-process research and development

 

 

300

 

 

 

 

 

 

300

 

 

n/a

 

 

 

 —

 

 

300

 

 

300

 

 

n/a

 

Impairment of intangible asset

 

 

104,517

 

 

 

 

 

 

104,517

 

 

n/a

 

 

 

 —

 

 

104,517

 

 

104,517

 

 

n/a

 

Change in fair value of contingent purchase consideration

 

 

(24,936

)

 

 

1,488

 

 

 

(26,424

)

 

 

(1,776

%)

 

 

 —

 

 

(24,936)

 

 

(24,936)

 

 

n/a

 

Total expenses

 

 

241,597

 

 

 

132,561

 

 

 

109,036

 

 

 

82

%

 

 

135,564

 

 

241,597

 

 

106,033

 

 

44

%

Operating loss

 

 

(241,597

)

 

 

(132,561

)

 

 

(109,036

)

 

 

82

%

 

 

(113,899)

 

 

(241,597)

 

 

127,698

 

 

52.86

%

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(4,210

)

 

 

(4,172

)

 

 

(38

)

 

 

1

%

 

 

(5,178)

 

 

(4,210)

 

 

(968)

 

 

(22.99)

%

Foreign currency gains (losses)

 

 

(368

)

 

 

2,105

 

 

 

(2,473

)

 

 

(117

%)

 

 

(83)

 

 

(368)

 

 

285

 

 

77.45

%

Legal settlement loss

 

 

(117,000)

 

 

 —

 

 

(117,000)

 

 

n/a

 

Other income

 

 

221

 

 

 

73

 

 

 

148

 

 

 

203

%

 

 

946

 

 

221

 

 

725

 

 

328

%

Other expense, net

 

 

(4,357

)

 

 

(1,994

)

 

 

(2,363

)

 

 

119

%

Other income (expense), net

 

 

(121,315)

 

 

(4,357)

 

 

(116,958)

 

 

(2,684.37)

%

Loss before income taxes

 

 

(245,954

)

 

 

(134,555

)

 

 

(111,399

)

 

 

83

%

 

 

(235,214)

 

 

(245,954)

 

 

10,740

 

 

4.37

%

Income tax benefit (expense)

 

 

33,240

 

 

 

(120

)

 

 

33,360

 

 

 

(27,800

%)

Income tax benefit

 

 

1,365

 

 

33,240

 

 

(31,875)

 

 

(96)

%

Net loss

 

$

(212,714

)

 

$

(134,675

)

 

$

(78,039

)

 

 

58

%

 

$

(233,849)

 

$

(212,714)

 

$

(21,135)

 

 

(10)

%

 

Product Revenue, Net. Product revenue for the six months endedJune 30, 2017 was due to the recognition of $21.7 million of net product revenue from the sale of our first commercial product, Rubraca, which was approved for sale in the United States markets and we began shipping on December 19, 2016. Revenue is recorded net of sales deductions comprised of rebates, chargebacks and other discounts. Sales deductions represented approximately 8.9% of the gross product revenue recognized in the six months ended June 30, 2017 and are summarized as follows:

 


 

 

 

 

 

 

 

 

 

 

Six months ended

 

 

    

June 30, 2017

 

 

    

$

    

% of Gross Sales

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Gross product revenue

 

$

23,778

 

 

100.0%

 

Sales deductions:

 

 

 

 

 

 

 

Government rebates and chargebacks

 

 

1,072

 

 

4.5%

 

Discounts and fees

 

 

1,041

 

 

4.4%

 

Total sales deductions

 

 

2,113

 

 

8.9%

 

Product revenue, net

 

$

21,665

 

 

91.1%

 

Cost of Sales – Product. Product cost of sales for the six months ended June 30, 2017 of $3.9 million relate to freight and royalties costs associated with Rubraca sales in the period. Manufacturing costs associated with sales in the quarter were expensed as incurred based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, and therefore, were not included in product cost of sales for the six months ended June 30, 2017. We expect cost of sales to increase in relation to product revenues once we deplete these inventories in the third quarter of 2017.  

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Cost of Sales – Intangible Asset Amortization. In the six months ended June 30, 2017, we recognized cost of sales of $0.7 million associated with the amortization of capitalized milestone payments related to the FDA approval of Rubraca. Prior to the FDA approval on December 19, 2016, all acquired license and milestone payments were expensed as incurred.

Research and Development Expenses. Research and development expenses increaseddecreased during the six months ended June 30, 20162017 compared to the same period in the prior year primarily due to increasedlower research and development activitiescosts for rucaparib and rociletinib and classification of commercialization related expenses associated with Rubraca in selling, general and administrative expenses rather than research and development expenses. In the rucaparib programsix months ended June 30, 2017, Rubraca commercialization costs included in selling, general and higher salaries, share-based compensation and other personnel-related costs, partially offset by loweradministrative expenses related to the rociletinib program.were $47.0 million.

 

Clinical trial costs for rucaparib were $10.5 million higher thanrelatively flat compared to the same period in the priora year primarily due toago as higher costs from enrollment in ARIEL4, our confirmatory ovarian cancer trials, and enrollment in our TRITON2 and TRITON3 studies for prostate cancer were largely offset by lower costs for the ARIEL2 and ARIEL3 studies, in ovarian cancer. Market research, disease education and other commercial product planning activitieswhich have completed enrollment. Diagnostic development costs were $7.0$6.1 million higher than the same period inlower compared to the prior year due toas the preparation forprior year included the potential regulatory approval and commercial launch of rucaparib. Diagnostic development costs for rucaparib were $3.5 million higher than 2015 due to the advancement ofassociated with our collaboration with Foundation Medicine, Inc. to develop a novel companion diagnostic test to identify patients most likely to respond to rucaparib. In addition,Finally, clinical supply and related manufacturing development costs were $2.9$7.0 million higherlower than 2015, as we increased production2016 due to support the expanded clinical studies.capitalization of these costs subsequent to the FDA approval of rucaparib.    

 

Salaries, share-based compensation expense and other personnel-related costs were $23.8 million higher in 2016 driven by increased headcount to support our expanded development and commercial planning activities. During the third quarter of 2015, we completed the hiring of our U.S. sales and marketing and medical affairs organizations in preparation for the potential regulatory approval and commercial launch of rucaparib.

Clinical trial costs for rociletinib were $13.6$18.5 million lower than 20152016 primarily due to the completion of patient enrollment infor all of the TIGER-1, TIGER-2 and TIGER-XTIGER studies in non-small cell lung cancer. This decrease was partially offset by higher clinical trial costs for the TIGER-3 study, which began enrolling patients during the second quarter of 2015. Clinical supply and related manufacturing development costs were $6.3$7.2 million lower than 20152016 driven by timing of production to support our clinical studies. In addition, market research, disease education and other commercial product planning activities were $4.6 million lower than the prior year. The Company incurred higher costs during 2015 due to the preparation for the potential regulatory approval and commercial launch of rociletinib.

Selling, General and Administrative Expenses. GeneralSelling, general and administrative expenses increased during the six months ended June 30, 20162017 compared to the same period in the prior year primarily due mainly to $3.2 million higher legal expense, $0.7 million higher personnel costs and $0.5 million higher consulting fees.

Impairmentclassification of Intangible Asset.During the second quarter of 2016, the Company recorded a $104.5 million impairment chargeto the IPR&D intangible asset relating to our lucitanib product candidate.This reduction in the estimated fair value of lucitanib was the result of the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer.

Change in Fair Value of Contingent Purchase Consideration.Change in fair value of contingent purchase consideration totaled ($24.9) million for the six months ended June 30, 2016 compared to $1.5 million for the same period in the prior year. During the second quarter of 2016, the Company recorded a $25.5 million reduction in the fair value of the contingent purchase consideration liability due to the Company’s and its development partner’s decision to discontinue the development of lucitanib for breast cancer.

Other Income (Expense), net. Other expense increased during the six months ended June 30, 2016 compared to the same period in the prior year. During the first half of 2016, the Company recognized $0.4 million of foreign currency losses compared with $2.1 million of foreign currency gains during the same period in 2015. The change in the foreign currency gains and losses was driven by fluctuations in the foreign currency rate utilized to translate our Euro-denominated contingent purchase consideration liability into U.S. dollars.

Income Tax Benefit (Expense). During the six months ended June 30, 2016, the Company recognized a $29.2 million deferred tax benefitcommercialization related expenses associated with the impairment of the IPR&D intangible asset recordedRubraca in the second quarter of 2016. In addition, during the first quarter of 2016, the Company recognized a $3.6 million deferred tax benefit due to a reduction in the enacted corporate tax rate of a foreign jurisdiction in which the Company operates.selling, general and administrative expenses rather than research and development expenses.

Liquidity and Capital Resources

To date, we have funded our operations through the public offering of our common stock and the private placement of convertible debt securities and preferred 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. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceeds from the offering were $324.9 million, after deducting underwriting discounts and commissions and offering expenses. At June 30, 2016,2017, we had cash, cash equivalents and available-for-sale securities totaling $378.5$671.5 million.

 


The following table sets forth the primary sources and uses of cash for the six months ended June 30,March 31, 2017 and 2016 and 2015:(in thousands):

 

 

 

 

 

 

 

 

 

Six Months Ended June 30,

 

 

Six months ended June 30, 

 

 

2016

 

 

2015

 

    

2017

    

2016

 

 

(in thousands)

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

$

(151,670

)

 

$

(105,631

)

 

$

(149,541)

 

$

(151,670)

 

Net cash provided by (used in) investing activities

 

 

99,244

 

 

 

(143,222

)

Net cash (used in) provided by investing activities

 

 

(133,864)

 

 

99,244

 

Net cash provided by financing activities

 

 

1,943

 

 

 

3,073

 

 

 

558,440

 

 

1,943

 

Effect of exchange rate changes on cash and cash equivalents

 

 

106

 

 

 

(636

)

 

 

565

 

 

106

 

Net decrease in cash and cash equivalents

 

$

(50,377

)

 

$

(246,416

)

Net increase (decrease) in cash and cash equivalents

 

$

275,600

 

$

(50,377)

 

Operating Activities

Net cash used in operating activities for all periods resulted primarily from our net losses adjusted for non-cash chargesitems and changes in components of working capital. Net cash used in operating activities increased $46.0 millionwas lower during the six months ended June 30, 20162017 compared to the same period in the prior year drivendue to a lower net loss as adjusted for non-

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cash items, partially offset by higher rucaparib research and development costs associated withincreases in the expansion of the clinical trials and the preparation for the potential commercial launch and higher salaries, benefits and personnel-related costs resulting from higher headcountoperating assets needed to support the expanded development activities and commercial planning. These costs were partially offset by lower expenditurescommercialization of Rubraca, most notably related to development activities for rociletinib.inventory.

Investing Activities

Net cash provided by investing activities for the six months ended June 30, 2016 includes $100.0 million in maturities of available-for-sale securities.

Net cash used in investing activities for the six months ended June 30, 20152017 includes $142.2 million in purchases of available-for-sale securities.securities of $180.0 million offset by cash from maturities of available-for-sale securities of $50.0 million. Net cash provided by investing activities in the same period in the prior year was mainly the result of maturities of available-for-sale securities of $100.0 million in that period. 

Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2017 and 2016 and 2015 includes $1.9$12.3 million and $3.1$1.9 million, respectively, received from employee stock option exercises andexercises. In addition, we completed the sale of $546.2 million of common stock, purchases undernet of issuance costs, during the employee stock purchase plan.six months ended June 30, 2017. 

Operating Capital Requirements

Assuming we successfully complete clinical trials and obtain requisite regulatory approvals, we do not anticipate commercializing any of our product candidates until at least the fourth quarter of 2016. As such, we anticipate that we will continue

We expect to generateincur significant losses for the foreseeable future, as we incur expenses to complete our development activities for our programs, prepare for the potential commercial launch of our productscommercialize Rubraca and expand our selling, general and administrative functions to support the growth in our researchcommercial organization. Additionally, our operating plan for the next 12 months includes a significant investment in inventory to meet the projected commercial requirements for Rubraca. We receive the active pharmaceutical ingredient in Rubraca from one supplier and developmentwe experience long lead times associated with its production. Accordingly, we expect to experience a decrease in our liquidity at the beginning of a production cycle and commercial organizations.an increase as the inventory produced is sold through. 

As of June 30, 2016,2017, we had cash, cash equivalents and available-for-sale securities totaling $378.5$671.5 million and total current liabilities of $72.9$219.4 million. 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. In June 2017, we sold 3,920,454 shares of our common stock in a public offering at $88.00 per share. The net proceeds from the offering were $324.9 million, after deducting underwriting discounts and commissions and offering expenses. We intend to use the net proceeds of the offerings 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 as of June 30, 2016 will allow us to fund our operating plan through at least the next 12 months. We expect to finance future cash flow needs through the public or private sale of equity or debt securities, collaborations, strategic alliances or other similar licensing arrangements. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates. The sale of additional equity and debt securities may result in additional dilution to our shareholders.

In addition, if we raise additional funds through the issuance of debt securities or preferred stock, these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations. Furthermore, any such required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned development and commercialization activities, which could harm our business.

 


Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amounts of our working capital requirements. Our future funding requirements will depend on many factors, including but not limited to:

·

the number and characteristics of the product candidates, companion diagnostics and indications we pursue;

·

the achievement of various development, regulatory and commercial milestones resulting in required payments to partners pursuant to the terms of our license agreements;

·

the scope, progress, results and costs of researching and developing our product candidates and related companion diagnostics and conducting clinical and non-clinical trials;

·

the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates and companion diagnostics;

·

the cost of commercialization activities, if any, assuming our product candidates are approved for sale, including marketing and distribution costs;

·

the cost of manufacturing any of our product candidates we successfully commercialize;

·

the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; and

·

the timing, receipt and amount of sales, if any, of our product candidates.

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Contractual Obligations and Commitments

For a discussion of our contractual obligations, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 20152016 Annual Report on Form 10-K. There have not been any material changes to such contractual obligations or potential milestone payments since December 31, 2015.2016. For further information regarding the Company’sour contractual obligations and commitments, see Note 14,Commitments and Contingencies to our unaudited consolidated financial statements included elsewhere in this report.

   

ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK


ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to market risk related to changes in interest rates. As of June 30, 2016,2017, we had cash, cash equivalents and available-for-sale securities of $378.5$671.5 million, consisting of bank demand deposits, money market funds and U.S. treasury securities. The primary objectives of our investment policy are to preserve principal and maintain proper liquidity to meet operating needs. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are in short-term securities. Our available-for-sale securities are subject to interest rate risk and will decline in value if market interest rates increase. Due to the short-term duration of our investment portfolio and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair value of our portfolio.

We contract with contract research organizations, investigational sites and contract manufacturers globally where payments are made in currencies other than the U.S. dollar. In addition, on October 3, 2016, we entered into a significant portionManufacturing and Services Agreement with a Swiss company for the production and supply of the contingent purchase consideration liabilityactive ingredient for Rubraca. Under the terms of this agreement, payments for the supply of the active ingredient in Rubraca as well as scheduled capital program fee payment toward capital equipment and other costs associated with the construction of a dedicated production train will be settled with Euro-denominated paymentsmade in Swiss francs. Once the production 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.

As of June 30, 2017, $183.6 million of purchase commitments exist under the Swiss Manufacturing and Services Agreement and we are required to remit amounts due in Swiss francs. Due to other variables that may exist, it is difficult to quantify the impact of a particular change in exchange rates. However, we estimate that if certain future milestones are achieved. We may be subjectthe value of the US dollar was to fluctuations in foreign currency rates in connection with these agreementsstrengthen by 10% compared to the value of Swiss franc as of June 30, 2017, it would decrease the total US dollar purchase commitment under the Swiss Manufacturing and future contingent payments. Services Agreement by approximately $16.7 million. Similarly, a 10% weakening of the US dollar compared to the Swiss franc would increase the total US dollar purchase commitment by approximately $20.4 million.

While we periodically hold foreign currencies, primarily Euro and pounds sterling,Pound Sterling, we do not use other financial instruments to hedge our foreign exchange risk. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise. As of both June 30, 20162017 and December 31, 2015,2016, approximately 2% and 3%, respectively,1% of our total liabilities were denominated in currencies other than the functional currency.

ITEM 4.

ITEM 4.CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended (“Exchange Act”) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Principal Financial and Accounting Officer, to allow timely decisions regarding required disclosures. Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective. With the participation of our Chief Executive Officer and Principal Financial and Accounting Officer, management performed an evaluation as of June 30, 20162017 of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Based on this evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer

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concluded that, as of June 30, 2016,2017, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended June 30, 20162017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHEROTHER INFORMATION

ITEM 1.

LEGAL PROCEEDINGS

ITEM 1.LEGAL PROCEEDINGS

On November 19, 2015, Steve Kimbro,Sonny P. Medina, a purported Clovis shareholder, filed 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.Colorado (the “Medina Complaint”). The KimbroMedina Complaint purportspurported to be asserted on behalf of a class of persons who purchased Clovis stock between October 31, 2013May 20, 2014 and November 15, 2015. The Kimbro Complaint13, 2015, and it generally allegesalleged 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.  

Throughout November and December 2015, three other purported shareholders filed similar purported class actions concerning alleged misstatements about 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 thanOn February 18, 2016, the Medina Court consolidated the various actions into a single proceeding and appointed 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 & GrossmanGrossmann LLP 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 Complaintconsolidated complaint on May 6, 2016.


2016 (the “Consolidated Complaint”). The Consolidated Complaint namesnamed 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 allegesalleged 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 concernconcerned allegedly misleading statements about rociletinib. The consolidated action iswas purportedly brought on behalf of investors who purchased the Company’s securities between May 31, 2014 and April 7, 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 seekssought 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.

The Clovis Defendants, the Underwriter Defendants and the Venture Capital Defendants each filed a Motionmotions to Dismissdismiss on July 27, 2016;2016. On February 9, 2017, the Medina Court issued an opinion and order granting in part and denying in part the Clovis Defendants’ motion to dismiss, granting in part and denying in part the Underwriter Defendants’ motion to dismiss, and granting the Venture Capital Defendants’ motion to dismiss. On February 22, 2017, the Arkin Plaintiff’s opposition is due on September 23, 2016;Plaintiffs filed an amended consolidated class action complaint, directed solely at repleading its Section 12(a) claims against the Underwriter Defendants.

On March 14, 2017, the Clovis Defendants and the defendants’ replies are due on October 14, 2016.Arkin Plaintiffs participated in a mediation, which did not result in a settlement.

The

On June 18, 2017, the Clovis Defendants intendentered into a stipulation and agreement of settlement with the Arkin Plaintiffs whereby Clovis will issue to vigorously defend against the allegations containedplaintiffs and participating class members total consideration comprised of $25.0 million in cash and the issuance of a to be determined number of shares of Clovis common stock (the “Settlement Shares”) equal to $117.0 million divided by the volume weighted average price of Clovis common stock over the 10 trading days immediately preceding the date of the hearing set by the Medina Court to consider the final approval of the settlement. The cash portion of the consideration is expected to be funded by Clovis’ insurance carriers. At June 30, 2017, the liability for the issuance of the shares and cash, including the amount to be reimbursed through insurance proceeds, was recorded to accrued liability for legal settlement on the Consolidated Balance Sheets in the Kimbro,amount of approximately $142.0 million and a receivable of approximately $25.0 million from the insurance carriers on the Consolidated Balance Sheets. Clovis will issue the Settlement Shares no later than 5 business days after the date the judgment is entered by the Medina Moran and Rocco Complaints, but there can be no assurance thatCourt approving the defensesettlement whereby the issuance of the shares will be successful.recorded in common stock and additional paid-in capital and the accrued liability for legal settlement will be cleared.

On December 30, 2015, Jamie McCall, a purported shareholderJuly 14, 2017, the Medina Court issued an order preliminarily approving the settlement. A final hearing to determine whether the settlement should be approved is scheduled for October 26, 2017.

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Table of Clovis, filed a shareholder derivative complaint (the “McCall Complaint”) against certain officers and directors of Clovis in the Colorado District Court, County of Boulder. The McCall Complaint generally alleged that the defendants breached their fiduciary duties owed to Clovis by participating in misrepresentation of the Company’s business operations and prospects. The McCall Complaint also alleged claims for abuse of control, gross mismanagement and unjust enrichment. The McCall Complaint sought, among other things, an award of money damages, declaratory and injunctive relief concerning the alleged fiduciary breaches and other forms of equitable relief. On March 17, 2016, the plaintiff filed a notice of voluntary dismissal of the McCall Complaint and the action was terminated by the Court.Contents

On January 22, 2016, the Electrical Workers Local #357 Pension and Health & Welfare Trusts, a purported shareholder of Clovis, filed a purported class action complaint (the “Electrical Workers Complaint”) against Clovis and certain of its officers, directors, investors and underwriters in the Superior Court of the State of California, County of San Mateo. The Electrical Workers Complaint purports to be asserted on behalf of a class of persons who purchased stock in Clovis’the July 8, 2015 follow-on offering.Offering. The Electrical Workers Complaint generally alleges that the defendants violated the Securities Act because the offering documents for the July 8, 2015 follow-on offeringOffering contained allegedly false and misleading statements regarding the progress toward FDA approval and the potential for market success of rociletinib. The Electrical Workers Complaint seeks unspecified damages.

On February 25, 2016, the defendants removed the case to the United States District Court for the Northern District of California and thereafter moved to transfer the case to the District of Colorado (“Motion to Transfer”). On March 2, 2016, the plaintiff filed a motion to remand the case to San Mateo County Superior Court (“Motion to Remand”). Following briefing on the Motion to Transfer and the Motion to Remand, the Northern District of California held a hearing on April 18, 2016 concerning the Motion to Remand, at the conclusion of which the court granted to the Motion to Remand. On May 5, 2016, the Northern District of California issued a written decision and order granting the Motion to Remand the case to the Superior Court, County of San Mateo and denying the Motion to Transfer as moot.

While the case was pending in the United States District Court for the Northern District of California, the parties entered into a stipulation extending the defendants’ time to respond to the Electrical Workers Complaint for 30 days following the filing of an amended complaint by plaintiff or the designation by plaintiff of the Electrical Workers Complaint as the operative complaint.  Following remand, Superior Court of the State of California, County of San Mateo so-ordered the stipulation on June 22, 2016.

On June 30, 2016, the Electrical Workers Plaintiffs filed an amended Complaintcomplaint asserting substantially similar claims (the “Amended“Electrical Workers Amended Complaint”). The Amended Complaint names as defendants the Company and certain of its current and former officers and directors, certain underwriters for the July 2015 Offering and certain Company venture capital investors. The Amended Complaint purports to assert claims under the Securities Act based upon alleged misstatements in Clovis’ offering documents for the July 2015 Offering. The Amended Complaint includes new allegations about the Company’s rociletinib disclosures.  The Amended Complaint seeks unspecified damages.

 


On July 28,September 23, 2016, the court ordered the following briefing schedule:and after hearing oral argument, the Electrical Workers Court granted defendants’ motion to stay the Electrical Workers actionproceedings pending resolution of the Medina Kimbro, Moran and Rocco actions inaction. Per the District of Colorado (“Motionorder to Stay”) and demurrerstay proceedings, the parties’ first status report as to the Amended Complaint are dueprogress of the Medina action was filed on August 15, 2016; plaintiff’s oppositions are due on August 31, 2016; and the defendants’ reply briefs areMarch 23, 2017. The parties’ second status report is due on September 15, 2016. A hearing on both motions is scheduled for September 23, 2016. 21, 2017.

The Company intends to vigorously defend against the allegations contained in the Electrical Workers Amended Complaint, but there can be no assurance that the defense will be successful.

On November 10, 2016, Antipodean Domestic Partners (“Antipodean”) filed a complaint (the “Antipodean Complaint”) against Clovis and certain of its officers, directors and underwriters in New York Supreme Court, County of New York. The Antipodean Complaint alleges that the defendants violated certain sections of the Securities Act by making allegedly false statements to Antipodean and in the Offering Materials for the July 2015 Offering relating to the efficacy of rociletinib, its safety profile, and its prospects for market success. In addition to the Securities Act claims, the Antipodean Complaint also asserts Colorado state law claims and common law claims. Both the state law and common law claims are based on allegedly false and misleading statements regarding rociletinib’s progress toward FDA approval. The Antipodean Complaint seeks compensatory, recessionary, and punitive damages.

On December 15, 2016, the Antipodean Plaintiffs filed an amended complaint (the “Antipodean Amended Complaint”) asserting substantially the same claims against the same defendants and purporting to correct certain details in the original Antipodean Complaint.

On January 31, 2017, Defendants filed a motion to stay the Antipodean action pending resolution of the Medina action in the District of Colorado. Defendants also filed a motion to dismiss the Antipodean Amended Complaint on March 29, 2017. A hearing on both motions is scheduled for August 8, 2017.

On March 14, 2017, the Clovis Defendants and Antipodean participated in a mediation, which did not result in a settlement. The Company intends to vigorously defend against the allegations in the Antipodean Amended Complaint.  However, there can be no assurance that the defense will be successful.

Clovis received a letter dated May 31, 2016 from an alleged owner of its common stock, which purports to set forth a demand for inspection of certain of our books and records pursuant to 8 Del. C. § 220 (the “Macalinao Demand Letter”). Clovis also received a letter dated December 15, 2016 from a second alleged owner of Clovis common stock, which purports to set forth a similar demand for inspection of the Company’s books and records pursuant to 8 Del. C. § 220 (the “McKenry Demand Letter”). Both the Macalinao and McKenry Demand Letters were purportedly made for the purposes of investigating alleged misconduct at the Company relating to rociletinib. Clovis submitted a response to the Macalinao Demand Letter on June 24, 2016, and likewise submitted a response to the McKenry Demand Letter on January 4, 2017. The Company produced certain books and records in response to the Macalinao and McKenry Demand Letters in January and February 19, 2016, Maris Sanchez,2017, respectively.

In March 2017, Macalinao and McKenry (the “Derivative Plaintiffs”) filed shareholder derivative complaints against certain directors and officers of the Company in the Court of Chancery of the State of Delaware. On May 4, 2017, the Macalinao and McKenry actions were consolidated for all purposes in a single proceeding under the caption In re Clovis Oncology, Inc. Derivative Litigation, Case No, 2017-0222 (the “Consolidated Derivative Action”).

On May 18, 2017, the Derivative Plaintiffs filed the Consolidated Verified Shareholder Derivative Complaint (the “Consolidated Derivative Complaint”). The Consolidated Derivative Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company by allegedly causing or allowing misrepresentations of the

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Company’s business operations and prospects, failing to ensure that the TIGER-X clinical trial was being conducted in accordance with applicable rules, regulations and protocols, and engaging in insider trading. The Consolidated Derivative Complaint purported to rely on documents produced by the Company in response to the Macalinao and McKenry Demand Letters. The Consolidated Derivative Complaint sought, among other things, an award of money damages.

On July 13, 2017, the court ordered the following briefing schedule with respect to the defendants’ forthcoming motion to dismiss the Consolidated Derivative Complaint: Defendants’ motion to dismiss was due, and was filed, on July 31, 2017; Plaintiffs’ opposition is due on August 30, 2017; and Defendants’ reply is due on September 14, 2017.

The Company intends to vigorously defend against the allegations in the Consolidated Derivative Complaint, but there can be no assurance that the defense will be successful.

On May 10, 2017, John Solak, a purported shareholder of Clovis,the Company, filed a shareholder derivative complaint in the Court of Chancery of the State of Delaware (the “Solak Complaint”) against certain directors and an officer of the Company. The Solak Complaint generally alleged that the defendants breached their fiduciary duties owed to the Company by adopting a compensation plan that overcompensated the non-employee director defendants, in relation to companies of comparable market capitalization and size. The Solak Complaint also alleged claims of waste of corporate assets and unjust enrichment due to this allegedly wrongful compensation plan. The Solak Complaint sought, among other things, an award of money damages and the imposition of corporate governance reforms.

On June 12, 2017, the parties in the Solak action entered into a stipulation extending the defendants’ time to respond to the Solak Complaint until August 11, 2017, which was entered by the Court on June 20, 2017.

The Company intends to vigorously defend against the allegations in the Solak Complaint, but there can be no assurance that the defense will be successful.

On March 20, 2017, a purported shareholder of the Company, filed a shareholder derivative complaint (the “Sanchez“Guo Complaint”) against certain officers and directors of Clovisthe Company in the United States District Court for the District of Colorado. The SanchezGuo Complaint generally alleged that the defendants breached their fiduciary duties owed to Clovisthe Company by participating in misrepresentationeither recklessly or with gross negligence approving or permitting misrepresentations of the Company’s business operations and prospects. The SanchezGuo Complaint also alleged claims for abusewaste of controlcorporate assets and gross mismanagement.unjust enrichment. Finally, the Guo Complaint alleged that certain of the individual defendants violated Section 14(a) of the Securities Exchange Act, by allegedly negligently issuing, causing to be issued, and participating in the issuance of materially misleading statements to stockholders in the Company’s Proxy Statement on Schedule DEF 14A in connection with the 2015 Annual Meeting of Stockholders, held on June 11, 2015. The SanchezGuo Complaint sought, among other things, an award of money damages.

On March 11, 2016,June 19, 2017, the plaintiffparties filed a notice of voluntary dismissaljoint motion to stay the Guo action pending resolution of the Sanchez Complaint without prejudice.motion to dismiss the Consolidated Derivative Complaint. On March 14, 2016,June 20, 2017, the Sanchez action was terminated bycourt granted the District of Colorado.motion to stay.

The Company intends to vigorously defend against the allegations in the Guo Complaint, but there can be no assurance that the defense will be successful.

In addition, the Company has received inquiries and requests for information from governmental agencies, including the U.S. Securities and Exchange Commission and the U.S. Department of Justice, relating to the Company’s regulatory update announcement in November 2015 that the FDA requested additional clinical data on the efficacy and safety of rociletinib. The Company is cooperatingcontinuing to cooperate with the inquiries.

these agencies with respect to their investigations. The Company received a letter dated May 31, 2016 from an alleged ownerproposed settlement of the Company’s common stock, which purports to set forth a demand for inspection of certain of the Company’s booksMedina action does not resolve these inquiries and records pursuant to 8 Del. C. § 220 (the “Demand Letter”). The Demand Letter was purportedly made for the purposes of investigating alleged misconduct at the Company relating to rociletinib. On June 24, 2016, the Company submitted a response to the Demand Letter. The Company believes that the Demand Letter fails to establish an entitlement to any of the requested documents, but there can be no assurance about the likelihood of an adversecannot predict their timing or outcome.

ITEM 1A.

ITEM 1A.RISK FACTORS

RISK FACTORS

Our business faces significant risks and uncertainties. Certain factors may have a material adverse effect on our business prospects, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business, we encourage you to consider the risk factors described under the heading “Risk Factors” in Part I, Item 1A of our Quarterlymost recent Annual Report on Form 10-Q for the quarter ended March 31, 2016,10-K, in addition to other information contained in or

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incorporated by reference into this Quarterly Report on Form 10-Q and our other public filings with the SEC. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations.

There have been no material changes to the risk factors included in our previously filed QuarterlyAnnual Report on Form 10-Q10-K for the quarteryear ended MarchDecember 31, 2016. Additional risks and uncertainties not presently known to us or that we currently believe are immaterial also may negatively impact our business.

ITEM 2.

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

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3.

ITEM 3.DEFAULTS UPON SENIOR SECURITIES

DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4.

ITEM 4.MINE SAFETY DISCLOSURES

MINE SAFETY DISCLOSURES

Not Applicable.

ITEM 5.

OTHER INFORMATION

None.

ITEM 5.OTHER INFORMATION

 

None.

ITEM 6.

EXHIBITS

 


ITEM 6.EXHIBITS

INDEX TO EXHIBITS

 

Exhibit

Numbero

 

Exhibit

Number

Exhibit Description

 

 

3.1(5)

Amended and Restated Certificate of Incorporation of Clovis Oncology, Inc.

 

 

3.2(5)

Amended and Restated Bylaws of Clovis Oncology, Inc.

 

 

4.1(3)

Form of Common Stock Certificate of Clovis Oncology, Inc.

 

 

4.2(8)

Indenture dated as of September 9, 2014, by and between Clovis Oncology, Inc. and The Bank of New York Mellon Trust Company, N.A.

 

 

10.1*(4)

Amended and Restated Strategic License Agreement, dated as of June 16, 2011, by and between Clovis Oncology, Inc. and Avila Therapeutics, Inc.

 

 

10.2*(4)

License Agreement, dated as of June 2, 2011, by and between Clovis Oncology, Inc. and Pfizer Inc.

 

 

10.3+(1)

Clovis Oncology, Inc. 2009 Equity Incentive Plan.

 

 

10.4+(4)

Clovis Oncology, Inc. 2011 Stock Incentive Plan.

 

 

10.5+(1)

Form of Clovis Oncology, Inc. 2009 Equity Incentive Plan Stock Option Agreement.

 

 

10.6+(4)

Form of Clovis Oncology, Inc. 2011 Stock Incentive Plan Stock Option Agreement.

 

 

10.7+(3)

Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Patrick J. Mahaffy.

 

 

10.8+(3)

Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Erle T. Mast.

 

 

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10.9+(3)

Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Gillian C. Ivers-Read.

 

 

10.10+(3)

Employment Agreement, dated as of August 24, 2011, between Clovis Oncology, Inc. and Andrew R. Allen.

10.11+(1)

Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Paul Klingenstein.

 

 

10.12+10.11+(1)

Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and James C. Blair.

 

 

10.13+10.12+(1)

Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Edward J. McKinley.

 

 

10.14+10.13+(1)

Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Thorlef Spickschen.

 

 

10.15+10.14+(1)

Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and M. James Barrett.

 

 

10.16+10.15+(1)

Indemnification Agreement, dated as of May 15, 2009, between Clovis Oncology, Inc. and Brian G. Atwood.

 

 

10.17+10.16+(1)

Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Patrick J. Mahaffy.

 

 

10.18+10.17+(1)

Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Erle T. Mast.

 

 

10.19+10.18+(1)

Indemnification Agreement, dated as of May 12, 2009, between Clovis Oncology, Inc. and Gillian C. Ivers-Read.

 

 

10.20+10.19+(1)

Indemnification Agreement, dated as of May 13,12, 2009, between Clovis Oncology, Inc. and Andrew R. Allen.

 

 

10.21+10.20+(4)

Clovis Oncology, Inc. 2011 Employee Stock Purchase Plan.

 

 

10.22+10.21+(4)

Clovis Oncology, Inc. 2011 Cash Bonus Plan.

 

 

10.23+10.22+(6)

EmploymentIndemnification Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven L. Hoerter.

 

 

10.24+(6)

Indemnification Agreement, dated as of March 22, 2012, by and between Clovis Oncology, Inc. and Steven L. Hoerter.

10.25+10.23+(2)

Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Ginger L. Graham.

 

 

10.26+10.24+(2)

Indemnification Agreement, dated as of June 13, 2013, between Clovis Oncology, Inc. and Keith Flaherty.

 

 

10.27(7)

10.25(7)

Stock Purchase Agreement, dated as of November 19, 2013, by and among the Company, EOS, the Sellers listed on Exhibit A thereto and Sofinnova Capital V FCPR, acting in its capacity as the Sellers’ Representative.

 

 


10.28*10.26*(7)

Development and Commercialization Agreement, dated as of October 24, 2008, by and between Advenchen Laboratories LLC and Ethical Oncology Science S.p.A., as amended by the First Amendment, dated as of April 13, 2010 and the Second Amendment, dated as of July 30, 2012.

 

 

10.29*10.27*(7)

Collaboration and License Agreement, dated as of September 28, 2012, by and between Ethical Oncology Science S.p.A. and Les Laboratoires Servier and Institut de Recherches Internationales Servier.

 

 

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10.30(9)

Consulting Agreement, dated August 6, 2015, by and between Andrew Allen and Clovis Oncology, Inc.

10.31+(10)

10.28+(12)

Indemnification Agreement, dated as of January 29, 2016, by and between Clovis Oncology, Inc. and Lindsey Rolfe.

 

 

10.32+(10)

10.29+(12)

Employment Agreement, dated as of February 25, 2016, by and between Clovis Oncology, Inc. and Lindsey Rolfe.

 

 

10.33+(10)

10.30+(12)

Indemnification Agreement, dated as of January 26, 2016, by and between Clovis Oncology, Inc. and Dale Hooks.

 

 

10.34+(10)

10.31+(12)

Employment Agreement, dated as of January 26, 2016, by and between Clovis Oncology, Inc. and Dale Hooks.

 

 

10.35+(11)

10.32+(9)

Indemnification Agreement, dated as of February 17, 2016, by and between Clovis Oncology, Inc. and Daniel W. Muehl.

 

 

10.36+(12)10.33+(15)

Offer Letter,Employment Agreement, dated as of May 27, 2015,July 6, 2017, by and between Clovis Oncology, Inc. and Daniel W. Muehl.

 

 

10.37+(12)

10.34+(10)

Salary Waiver Letter, dated as of May 9, 2016, by and between Clovis Oncology, Inc. and Patrick J. Mahaffy.

 

 

10.35*(11)

First Amendment to License Agreement, by and between Clovis Oncology, Inc. and Pfizer Inc., dated as of August 30, 2016.

10.36+(13)

Form of Clovis Oncology, Inc. 2011 Stock Incentive Plan RSU Agreement.

10.37*(13)

Manufacturing Services Agreement, by and between Clovis Oncology, Inc. and Lonza Ltd, dated as of October 3, 2016.

10.38*(14)

Strata Trial Collaboration Agreement, by and between Clovis Oncology, Inc. and Strata Oncology, Inc., dated as of January 30, 2017

21.1

List of Subsidiaries of Clovis Oncology, Inc.

 

31.1

Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended.

 

 

31.2

Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended.

 

 

32.1

Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

32.2

Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

101

The following materials from Clovis Oncology, Inc.’s Quarterly Report on Form 10-Q for the period ended June 30, 2016,2017, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Statements of Operations (ii) the Consolidated Statements ofand Comprehensive Loss, (iii)(ii) the Consolidated Balance Sheets, (iv)(iii) the Consolidated Statements of Cash Flows and (v)(iv) Notes to Unaudited Consolidated Financial Statements.

 

(1)

Filed as an exhibit with the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on June 23, 2011.

(2)

Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on June 14, 2013.

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(3)

Filed as an exhibit with Amendment No. 2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on August 31, 2011.

(4)

Filed as an exhibit with Amendment No. 3 to the Registrant’s Registration Statement on Form S-1 (File No. 333-175080) on October 31, 2011.

(5)

Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on March 15, 2012.

(6)

Filed as an exhibit with the Registrant’s Registration Statement on Form S-1 (File No. 333-180293) on March 23, 2012.

(7)

Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on November 19, 2013.

(8)

Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on September 9, 2014.

(9)

Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on August 12, 2015.

(10)

Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on February 29, 2016.

(11)

Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on April 1, 2016.

(12)

(10)

Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on May 9, 2016.

+

Indicates management contract or compensatory plan.(11)

Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on November 4, 2016.

*

Confidential treatment has been granted with respect to portions of this(12)

Filed as an exhibit which portions have been omitted and filed separately with the Securities and Exchange Commission.Registrant’s Annual Report on Form 10-K on February 29, 2016.

(13)

Filed as an exhibit with the Registrant’s Annual Report on Form 10-K on February 23, 2017.

(14)

Filed as an exhibit with the Registrant’s Quarterly Report on Form 10-Q on May 4, 2017.

(15)

Filed as an exhibit with the Registrant’s Current Report on Form 8-K (File No. 001-35347) on July 7, 2017.

+     Indicates management contract or compensatory plan.

*     Confidential treatment has been granted with respect to portions of this exhibit, which portions have been omitted and filed separately with the Securities and Exchange Commission.

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SIGNATURES

 


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.

 

Date: August 9, 20163, 2017

CLOVIS ONCOLOGY, INC.

 

 

 

 

 

By:

  

/s/ PATRICK J. MAHAFFY

 

 

 

Patrick J. Mahaffy

 

 

 

President and Chief Executive Officer; Director

 

 

 

 

 

By:

  

/s/ DANIEL W. MUEHL

 

 

 

Daniel W. Muehl

 

 

 

Senior Vice President of Finance and Principal Financial and Accounting Officer

 

 

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