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Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended June 30, 2015

 

or

 

o         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: 0-27488

 

INCYTE CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware

 

94-3136539

(State or other jurisdiction of
incorporation or organization)

 

(IRS Employer
Identification No.)

 

 

 

1801 Augustine Cut-Off
Wilmington, DE 19803

 

19803

(Address of principal executive offices)

 

(Zip Code)

 

(302) 498-6700

(Registrant’s telephone number, including area code)

 

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.  x Yes  o 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).  x Yes  o 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

 

Smaller reporting company o

(Do not check if a smaller reporting company)

 

 

 

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

 

The number of outstanding shares of the registrant’s Common Stock, $0.001 par value, was 180,482,542 as of July 29, 2015.

 

 

 



Table of Contents

 

INCYTE CORPORATION

 

INDEX

 

PART I: FINANCIAL INFORMATION

3

 

 

 

Item 1.

Financial Statements

3

 

 

 

 

Condensed Consolidated Balance Sheets

3

 

 

 

 

Condensed Consolidated Statements of Operations

4

 

 

 

 

Condensed Consolidated Statements of Comprehensive Income (Loss)

5

 

 

 

 

Condensed Consolidated Statements of Cash Flows

6

 

 

 

 

Notes to Condensed Consolidated Financial Statements

7

 

 

 

Item 2.

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

22

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

38

 

 

 

Item 4.

Controls and Procedures

39

 

 

 

PART II: OTHER INFORMATION

40

 

 

 

Item 1A.

Risk Factors

40

 

 

 

Item 5.

Other Information

56

 

 

 

Item 6.

Exhibits

58

 

 

 

 

Signatures

59

 

 

 

 

Exhibit Index

60

 

2



Table of Contents

 

PART I:    FINANCIAL INFORMATION

Item 1.    Financial Statements

 

INCYTE CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except number of shares and par value)

 

 

 

June 30,
2015

 

December 31,
2014*

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

439,681

 

$

452,297

 

Marketable securities—available-for-sale

 

187,788

 

147,966

 

Restricted investments

 

517

 

500

 

Accounts receivable

 

75,122

 

57,933

 

Inventory

 

1,897

 

358

 

Deferred income taxes

 

7,725

 

19,641

 

Prepaid expenses and other current assets

 

20,260

 

20,519

 

 

 

 

 

 

 

Total current assets

 

732,990

 

699,214

 

 

 

 

 

 

 

Restricted investments

 

14,256

 

14,000

 

Long term investment

 

67,003

 

 

Inventory

 

18,548

 

19,078

 

Property and equipment, net

 

81,602

 

81,790

 

Other assets, net

 

15,938

 

15,987

 

 

 

 

 

 

 

Total assets

 

$

930,337

 

$

830,069

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

29,162

 

$

24,462

 

Accrued compensation

 

25,794

 

34,422

 

Interest payable

 

1,282

 

1,841

 

Accrued and other current liabilities

 

80,437

 

62,270

 

Deferred revenue—collaborative agreements

 

12,857

 

12,880

 

Convertible senior notes

 

42,940

 

85,640

 

 

 

 

 

 

 

Total current liabilities

 

192,472

 

221,515

 

 

 

 

 

 

 

Convertible senior notes

 

617,025

 

603,478

 

Other liabilities

 

51,858

 

54,552

 

Deferred income taxes

 

7,725

 

19,641

 

Deferred revenue—collaborative agreements

 

6,083

 

12,511

 

 

 

 

 

 

 

Total liabilities

 

875,163

 

911,697

 

 

 

 

 

 

 

Stockholders’equity (deficit):

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized; none issued or outstanding as of June 30, 2015 and December 31, 2014

 

 

 

Common stock, $0.001 par value; 400,000,000 shares authorized; 180,191,498 and 170,876,619 shares issued and outstanding as of June 30, 2015 and December 31, 2014, respectively

 

180

 

171

 

Additional paid-in capital

 

1,847,626

 

1,701,904

 

Accumulated other comprehensive income

 

1,949

 

1,815

 

Accumulated deficit

 

(1,794,581

)

(1,785,518

)

Total stockholders’ equity (deficit)

 

55,174

 

(81,628

)

 

 

 

 

 

 

Total liabilities and stockholders’equity (deficit)

 

$

930,337

 

$

830,069

 

 


*   The condensed consolidated balance sheet at December 31, 2014 has been derived from the audited financial statements at that date.

 

See accompanying notes.

 

3



Table of Contents

 

INCYTE CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited, in thousands, except per share amounts)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Revenues:

 

 

 

 

 

 

 

 

 

Product revenues, net

 

$

142,406

 

$

84,025

 

$

257,736

 

$

153,676

 

Product royalty revenues

 

17,364

 

12,340

 

33,037

 

22,166

 

Contract revenues

 

3,214

 

3,214

 

31,429

 

13,429

 

Other revenues

 

 

3

 

58

 

103

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

162,984

 

99,582

 

322,260

 

189,374

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

6,254

 

187

 

9,229

 

355

 

Research and development

 

112,445

 

84,683

 

230,809

 

160,269

 

Selling, general and administrative

 

51,679

 

40,899

 

96,548

 

77,873

 

 

 

 

 

 

 

 

 

 

 

Total costs and expenses

 

170,378

 

125,769

 

336,586

 

238,497

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(7,394

)

(26,187

)

(14,326

)

(49,123

)

Interest and other income, net

 

1,144

 

790

 

2,773

 

1,526

 

Interest expense

 

(11,494

)

(11,406

)

(24,181

)

(22,849

)

Unrealized gain on long term investment

 

27,174

 

 

27,174

 

 

Debt exchange expense on senior note conversions

 

 

 

 

(265

)

 

 

 

 

 

 

 

 

 

 

Income (loss) before provision for income taxes

 

$

9,430

 

$

(36,803

)

$

(8,560

)

$

(70,711

)

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

136

 

70

 

503

 

119

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

9,294

 

$

(36,873

)

$

(9,063

)

$

(70,830

)

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.05

 

$

(0.22

)

$

(0.05

)

$

(0.43

)

Diluted

 

$

0.05

 

$

(0.22

)

$

(0.05

)

$

(0.43

)

 

 

 

 

 

 

 

 

 

 

Shares used in computing net income (loss) per share:

 

 

 

 

 

 

 

 

 

Basic

 

178,676

 

167,914

 

175,373

 

166,636

 

Diluted

 

186,493

 

167,914

 

175,373

 

166,636

 

 

See accompanying notes.

 

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Table of Contents

 

INCYTE CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)

(unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

9,294

 

$

(36,873

)

$

(9,063

)

$

(70,830

)

 

 

 

 

 

 

 

 

 

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on restricted investments and marketable securities, net of tax

 

(309

)

40

 

134

 

87

 

Other comprehensive (loss) income

 

(309

)

40

 

134

 

87

 

 

 

 

 

 

 

 

 

 

 

Comprehensive income (loss)

 

$

8,985

 

$

(36,833

)

$

(8,929

)

$

(70,743

)

 

See accompanying notes.

 

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Table of Contents

 

INCYTE CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

 

 

Six Months Ended
June 30,

 

 

 

2015

 

2014

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(9,063

)

$

(70,830

)

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

 

 

 

 

 

Depreciation and amortization of debt discounts

 

23,101

 

19,321

 

Stock-based compensation

 

35,150

 

30,825

 

Debt exchange expense on senior note conversions

 

 

265

 

Unrealized gain on long term investment

 

(27,174

)

 

Excess tax provision (benefit) from stock based compensation

 

(2,073

)

31

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(17,189

)

(11,831

)

Prepaid expenses and other assets

 

946

 

(10,494

)

Inventory

 

(1,009

)

(517

)

Accounts payable

 

4,700

 

8,149

 

Accrued and other liabilities

 

7,866

 

(4,736

)

Deferred revenue — collaborative agreements

 

(6,451

)

(6,434

)

Net cash provided by (used in) operating activities

 

8,804

 

(46,251

)

Cash flows from investing activities:

 

 

 

 

 

Long term investment

 

(39,829

)

 

Capital expenditures

 

(5,749

)

(11,362

)

Purchases of marketable securities

 

(80,212

)

(65,115

)

Maturities of marketable securities

 

40,524

 

247

 

Net cash used in investing activities

 

(85,266

)

(76,230

)

Cash flows from financing activities:

 

 

 

 

 

Restricted investments, net

 

(273

)

 

Proceeds from issuance of common stock under stock plans

 

62,958

 

57,612

 

Direct financing arrangement repayments

 

(912

)

 

Excess tax provision (benefit) from stock based compensation

 

2,073

 

(31

)

Cash paid in connection with exchange of 4.75% convertible senior notes due 2015

 

 

(265

)

Net cash provided by financing activities

 

63,846

 

57,316

 

Net decrease in cash and cash equivalents

 

(12,616

)

(65,165

)

Cash and cash equivalents at beginning of period

 

452,297

 

471,429

 

Cash and cash equivalents at end of period

 

$

439,681

 

$

406,264

 

 

 

 

 

 

 

Supplemental Schedule of Cash Flow Information

 

 

 

 

 

Interest paid

 

$

1,670

 

$

5,241

 

Incomes taxes paid

 

$

83

 

$

 

Reclassification to additional paid in capital in connection with conversions or exchanges of 4.75% convertible senior notes due 2015

 

$

45,327

 

$

4,446

 

 

See accompanying notes.

 

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Table of Contents

 

INCYTE CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2015

(Unaudited)

 

1.              Organization and business

 

Incyte Corporation (“Incyte,” “we,” “us,” or “our”) is a biopharmaceutical company focused on developing and commercializing proprietary therapeutics, primarily for oncology. Our pipeline includes compounds in various stages, ranging from preclinical to late stage development, and a commercialized product, JAKAFI® (ruxolitinib). Our operations are treated as one operating segment.

 

2.              Summary of significant accounting policies

 

Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  The condensed consolidated balance sheet as of June 30, 2015 and the condensed consolidated statements of operations, comprehensive loss and cash flows for the three and six months ended June 30, 2015 and 2014, are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented.  The condensed consolidated balance sheet at December 31, 2014 has been derived from audited financial statements.

 

Although we believe that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote information normally included in 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 Securities and Exchange Commission.

 

Results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

Principles of Consolidation.  The condensed consolidated financial statements include the accounts of Incyte Corporation and our wholly owned subsidiaries, including Incyte Holdings Corporation, Incyte International Holdings Sarl, and Incyte Europe Sarl. All inter-company accounts, transactions, and profits have been eliminated in consolidation.

 

Foreign Currency Translation. Operations in non-U.S. entities are recorded in the functional currency of each entity. For financial reporting purposes, the functional currency of an entity is determined by a review of the source of an entity’s most predominant cash flows. The results of operations for any non-U.S. dollar functional currency entities are translated from functional currencies into U.S. dollars using the average currency rate during each month, which approximates the results that would be obtained using actual currency rates on the dates of individual transactions. Assets and liabilities are translated using currency rates at the end of the period. Adjustments resulting from translating the financial statements of our foreign entities that use their local currency as the functional currency into the U.S. dollars are reflected as a component of other comprehensive income (loss). Transaction gains and losses are recorded in interest and other income, net in the condensed consolidated statements of operations. To date, both the translation gains or losses in other comprehensive income and the transaction gains or losses in interest and other income, net have been immaterial.

 

Use of Estimates.  The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

 

Concentrations of Credit Risk.  Cash, cash equivalents, marketable securities, trade receivables and restricted investments are financial instruments which potentially subject us to concentrations of credit risk. The estimated fair value of financial instruments approximates the carrying value based on available market information. We primarily invest our excess available funds in notes and bills issued by the U.S. government and its agencies and corporate debt securities and, by policy, limit the amount of credit exposure to any one issuer and to any one type of investment, other than securities issued or guaranteed by the U.S. government. Our receivables mainly relate to our product sales of JAKAFI and collaborative agreements with pharmaceutical companies. We have not

 

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experienced any significant credit losses on cash, cash equivalents, marketable securities, trade receivables or restricted investments to date and do not require collateral on receivables.

 

Cash and Cash Equivalents.  Cash and cash equivalents are held in U.S. banks or in custodial accounts with banks. Cash equivalents are defined as all liquid investments and money market funds with maturity from date of purchase of 90 days or less that are readily convertible into cash.

 

Marketable Securities—Available-for-Sale.  All marketable securities are classified as available-for-sale. Available-for-sale securities are carried at fair value, based on quoted market prices and observable inputs, with unrealized gains and losses, net of tax, reported as a separate component of stockholders’ equity (deficit). We classify marketable securities that are available for use in current operations as current assets on the condensed consolidated balance sheets. Realized gains and losses and declines in value judged to be other than temporary for available-for-sale securities are included in “Interest and other income, net.” The cost of securities sold is based on the specific identification method.

 

Accounts Receivable.  As of June 30, 2015 and December 31, 2014, we had no allowance for doubtful accounts. We provide an allowance for doubtful accounts based on experience and specifically identified risks. Accounts receivable are carried at fair value and charged off against the allowance for doubtful accounts when we determine that recovery is unlikely and we cease collection efforts.

 

Inventory.  Inventories are determined at the lower of cost or market value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. We began capitalizing inventory in mid-November 2011 once the U.S. Food and Drug Administration (“FDA”) approved JAKAFI as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to approval of JAKAFI have been recorded as research and development expense in our statements of operations. As a result, cost of product revenues for the next 15 to 18 months will reflect a lower average per unit cost of materials.

 

The raw materials and work-in-process inventory is not subject to expiration and the shelf life for finished goods inventory is 36 months from the start of manufacturing of the finished goods. We evaluate for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. We classify inventory as current on the condensed consolidated balance sheets when we expect inventory to be consumed for commercial use within the next twelve months.

 

Variable Interest Entities. We perform an initial and on-going evaluation of the entities with which we have variable interests, such as equity ownership, in order to identify entities (i) that do not have sufficient equity investment at risk to permit the entity to finance its activities without additional subordinated financial support or (ii) in which the equity investors lack an essential characteristic of a controlling financial interest as variable interest entities (“VIE” or “VIEs”). If an entity is identified as a VIE, we perform an assessment to determine whether we have both (i) the power to direct activities that most significantly impact the VIE’s economic performance and (ii) have the obligation to absorb losses from or the right to receive benefits of the VIE that could potentially be significant to the VIE. If both of these criteria are satisfied, we are identified as the primary beneficiary of the VIE.  As of June 30, 2015, there were no entities in which we held a variable interest which we determined to be VIEs.

 

Equity Method Investments.  In circumstances where we have the ability to exercise significant influence over the operating and financial policies of a company in which we have an investment, the investment is accounted for either (i) under the equity method of accounting or (ii) at fair value by electing the fair value option under U.S. GAAP.  In assessing whether we exercise significant influence, we consider the nature and magnitude of our investment, any voting and protective rights we hold, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationship. Under the equity method of accounting, we record within our results of operations our share of income or loss of the investee company.  Under the fair value option, our investment is carried at fair value on our condensed consolidated balance sheets as a long term investment and all changes in fair value are reported in our condensed consolidated statements of operations as an unrealized gain (loss) on long term investment.

 

Property and Equipment.  Property and equipment is stated at cost, less accumulated depreciation and amortization. Depreciation is recorded using the straight-line method over the estimated useful lives of the respective assets (generally three to five years). Leasehold improvements are amortized over the shorter of the estimated useful life of the assets or lease term.

 

Management continually reviews the estimated useful lives of technologically sensitive equipment and believes that those estimates appropriately reflect the current useful life of our assets. In the event that a currently unknown significantly advanced technology became commercially available, we would re-evaluate the value and estimated useful lives of our existing equipment, possibly having a material impact on the financial statements.

 

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Lease Accounting.  We account for operating leases by recording rent expense on a straight-line basis over the expected life of the lease, commencing on the date we gain possession of leased property. We include tenant improvement allowances and rent holidays received from landlords and the effect of any rent escalation clauses as adjustments to straight-line rent expense over the expected life of the lease.

 

Capital leases are reflected as a liability at the inception of the lease based on the present value of the minimum lease payments or, if lower, the fair value of the property. Assets under capital leases are recorded in property and equipment, net on the condensed consolidated balance sheets and depreciated in a manner similar to other property and equipment.

 

Certain construction projects may be accounted for as direct financing arrangements, whereby we record, over the construction period, the full cost of the asset in property and equipment, net on the condensed consolidated balance sheets. A corresponding liability is also recorded, net of leasehold improvements paid for by us, and is amortized over the expected lease term through monthly rental payments using the effective interest method.

 

Income Taxes.  We account for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes. In addition, we follow the guidance related to accounting for uncertainty in income taxes. This guidance creates a single model to address uncertainty in tax positions and clarifies the accounting for income taxes by prescribing the minimum recognition threshold a tax position is required to meet before it is recognized in the financial statements.

 

Financing Costs Related to Long-term Debt.  Costs associated with obtaining long-term debt are deferred and amortized over the term of the related debt using the effective interest method. Such costs are included in other assets, net on the condensed consolidated balance sheets.

 

Grant Accounting.  Grant amounts received from government agencies for operations are deferred and are amortized into income over the service period of the grant. Grant amounts received for purchases of capital assets are deferred and amortized into interest and other income, net over the useful life of the related capital assets. Such amounts are recorded in other liabilities on the condensed consolidated balance sheets.

 

Net Income (Loss) Per Share.  Our basic and diluted income (losses) per share are calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during all periods presented. Options to purchase stock and shares issuable upon the conversion of convertible debt are included in diluted earnings per share calculations, unless the effects are anti-dilutive.

 

Accumulated Other Comprehensive Income (Loss).  Accumulated other comprehensive income (loss) consists of unrealized gains or losses on marketable securities and restricted cash and investments.

 

Revenue Recognition.  Revenues are recognized when (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable and (4) collectability is reasonably assured. Revenues are deferred for fees received before earned or until no further obligations exist. We exercise judgment in determining that collectability is reasonably assured or that services have been delivered in accordance with the arrangement. We assess whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. We assess collectability based primarily on the customer’s payment history and on the creditworthiness of the customer.

 

Product Revenues

 

Our product revenues consist of U.S. sales of JAKAFI and are recognized once we meet all four revenue recognition criteria described above. In November 2011, we began shipping JAKAFI to our specialty pharmacy customers, which in turn dispense JAKAFI to patients in fulfillment of prescriptions.

 

We recognize revenues for product received by our specialty pharmacy customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and Medicare Part D coverage gap reimbursements. Product shipping and handling costs are included in cost of product revenues.

 

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Customer Credits:  Our specialty pharmacy customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. We expect our specialty pharmacy customers will earn prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. Service fees are also deducted from total product sales as they are earned.

 

Rebates:  Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector benefit providers. The accrual for rebates is based on statutory discount rates and expected utilization as well as historical data we have accumulated since product launch. Our estimates for expected utilization of rebates are based on data received from our specialty pharmacy customers. Rebates are generally invoiced and paid 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 prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

 

Chargebacks:  Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy, or an intermediary distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy or distributor, in turn, charges back to us the difference between the price initially paid by the specialty pharmacy or distributor and the discounted price paid to the specialty pharmacy or distributor by the customer. The accrual for chargebacks is based on the estimated contractual discounts on the inventory levels on hand in our distribution channel. If actual future chargebacks vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

 

Medicare Part D Coverage Gap:  Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for the expected Medicare Part D coverage gap are based on historical invoices received and in part from data received from our specialty pharmacy customers. Funding of the coverage gap is generally invoiced and paid 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 prior quarters. If actual future funding varies from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

 

Co-payment Assistance:  Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators.

 

Product Royalty Revenues

 

Royalty revenues on commercial sales for ruxolitinib (marketed as JAKAVI® outside the United States) by Novartis Pharmaceutical International Ltd. (“Novartis”) are based on net sales of licensed products in licensed territories as provided by Novartis. We recognize royalty revenues in the period the sales occur.

 

Cost of Product Revenues

 

Cost of product revenues includes all JAKAFI related costs that are recoverable through the commercialization of the product. Beginning in October 2014, we became obligated to pay tiered, low single digit royalties under our collaboration and license agreement to Novartis on all future sales of JAKAFI in the United States which are included in cost of product revenues.

 

Contract and License Revenues

 

Under agreements involving multiple deliverables, services and/or rights to use assets that we entered into prior to January 1, 2011, the multiple elements are divided into separate units of accounting when certain criteria are met, including whether the delivered items have stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. When separate units of accounting exist, consideration is allocated among the separate elements based on their respective fair values. The determination of fair value of each element is based on objective evidence from historical sales of the individual elements by us to other customers. If such evidence of fair value for each undelivered element of the arrangement does not exist, all revenue from the arrangement is deferred until such time that evidence of fair value for each undelivered element does exist or until all elements of the arrangement are delivered. When elements are specifically tied to a separate earnings process, revenue is recognized when the specific performance obligation tied to the element is completed. When revenues for an element are not specifically tied to a separate earnings process, they are recognized ratably over the term of the agreement. We assess whether a substantive milestone

 

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exists at the inception of our agreements. For all milestones within our arrangements that are considered substantive, we recognize revenue upon the achievement of the associated milestone. If a milestone is not considered substantive, we would recognize the applicable milestone payment over the remaining period of performance under the arrangement. As of June 30, 2015, all remaining potential milestones under our collaborative arrangements are considered substantive.

 

On January 1, 2011, updated guidance on the recognition of revenues for agreements with multiple deliverables became effective and applies to any agreements we may enter into on or after January 1, 2011. This updated guidance (i) relates to whether multiple deliverables exist, how the deliverables in a revenue arrangement should be separated and how the consideration should be allocated; (ii) requires companies to allocate revenues in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; and (iii) eliminates the use of the residual method and requires companies to allocate revenues using the relative selling price method. During the three and six months ended June 30, 2015 and 2014, we did not enter into any agreements that are subject to this updated guidance. If we enter into an agreement with multiple deliverables after January 1, 2011 or amend existing agreements, this updated guidance could have a material effect on our financial statements.

 

Our collaborations often include contractual milestones, which typically relate to the achievement of pre-specified development, regulatory and commercialization events. These three categories of milestone events reflect the three stages of the life-cycle of our drugs, which we describe in more detail in the following paragraphs.

 

The regulatory review and approval process, which includes preclinical testing and clinical trials of each drug candidate, is lengthy, expensive and uncertain. Securing approval by the FDA requires the submission of extensive preclinical and clinical data and supporting information to the FDA for each indication to establish a drug candidate’s safety and efficacy. The approval process takes many years, requires the expenditure of substantial resources, involves post-marketing surveillance and may involve ongoing requirements for post-marketing studies. Before commencing clinical investigations of a drug candidate in humans, we must submit an Investigational New Drug application (“IND”), which must be reviewed by the FDA.

 

The steps generally required before a drug may be marketed in the United States include preclinical laboratory tests, animal studies and formulation studies, submission to the FDA of an IND for human clinical testing, performance of adequate and well-controlled clinical trials in three phases, as described below, to establish the safety and efficacy of the drug for each indication, submission of a new drug application (“NDA”) or biologics license application (“BLA”) to the FDA for review and FDA approval of the NDA or BLA.

 

Similar requirements exist within foreign regulatory agencies as well. The time required satisfying the FDA requirements or similar requirements of foreign regulatory agencies may vary substantially based on the type, complexity and novelty of the product or the targeted disease.

 

Preclinical testing includes laboratory evaluation of product pharmacology, drug metabolism, and toxicity, which includes animal studies, to assess potential safety and efficacy as well as product chemistry, stability, formulation, development, and testing. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND. The FDA may raise safety concerns or questions about the conduct of the clinical trials included in the IND, and any of these concerns or questions must be resolved before clinical trials can proceed. We cannot be sure that submission of an IND will result in the FDA allowing clinical trials to commence. Clinical trials involve the administration of the investigational drug or the marketed drug to human subjects under the supervision of qualified investigators and in accordance with good clinical practices regulations covering the protection of human subjects. Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Phase I usually involves the initial introduction of the investigational drug into healthy volunteers to evaluate its safety, dosage tolerance, absorption, metabolism, distribution and excretion. Phase II usually involves clinical trials in a limited patient population to evaluate dosage tolerance and optimal dosage, identify possible adverse effects and safety risks, and evaluate and gain preliminary evidence of the efficacy of the drug for specific indications. Phase III clinical trials usually further evaluate clinical efficacy and safety by testing the drug in its final form in an expanded patient population, providing statistical evidence of efficacy and safety, and providing an adequate basis for labeling. We cannot guarantee that Phase I, Phase II or Phase III testing will be completed successfully within any specified period of time, if at all. Furthermore, we, the institutional review board for a trial, or the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

 

Generally, the milestone events contained in our collaboration agreements coincide with the progression of our drugs from development, to regulatory approval and then to commercialization. The process of successfully discovering a new development candidate, having it approved and successfully commercialized is highly uncertain. As such, the milestone payments we may earn from our partners involve a significant degree of risk to achieve. Therefore, as a drug candidate progresses through the stages of its life-cycle, the value of the drug candidate generally increases.

 

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Research and Development Costs.  Our policy is to expense research and development costs as incurred. We often contract with clinical research organizations (“CROs”) to facilitate, coordinate and perform agreed upon research and development of a new drug. To ensure that research and development costs are expensed as incurred, we record monthly accruals for clinical trials and preclinical testing costs based on the work performed under the contract.

 

These CRO contracts typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain clinical trial milestones. In the event that we prepay CRO fees, we record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Most professional fees, including project and clinical management, data management, monitoring, and medical writing fees are incurred throughout the contract period. These professional fees are expensed based on their percentage of completion at a particular date. Our CRO contracts generally include pass through fees. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, travel costs, and other miscellaneous costs, including shipping and printing fees. We expense the costs of pass through fees under our CRO contracts as they are incurred, based on the best information available to us at the time. The estimates of the pass through fees incurred are based on the amount of work completed for the clinical trial and are monitored through correspondence with the CROs, internal reviews and a review of contractual terms. The factors utilized to derive the estimates include the number of patients enrolled, duration of the clinical trial, estimated patient attrition, screening rate and length of the dosing regimen. CRO fees incurred to set up the clinical trial are expensed during the setup period. Under our clinical trial collaboration agreements and clinical trial agreements, we may be reimbursed for certain development costs incurred. Such costs are recorded as a reduction of research and development expense in the period in which the related expense is incurred.

 

Stock Compensation.  Share-based payment transactions with employees, which include stock options, restricted stock units (“RSUs”) and performance shares (“PSUs”), are recognized as compensation expense over the requisite service period based on their estimated fair values as well as expected forfeiture rates.  The stock compensation process requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected forfeiture rates and the probability of PSUs vesting.  The fair value of stock options, which are subject to graded vesting, are recognized as compensation expense over the requisite service period using the accelerated attribution method.  The fair value of RSUs, which are generally subject to cliff vesting, are recognized as compensation expense over the requisite service period using the straight line attribution method.  The fair value of PSUs are recognized as compensation expense beginning at the time in which the performance conditions are deemed probable of achievement, over the remaining requisite service period. We recorded $17.6 million and $35.2 million of stock compensation expense on our condensed consolidated statements of operations for the three and six months ended June 30, 2015, respectively. We recorded $15.5 million and $30.8 million of stock compensation expense on our condensed consolidated statements of operations for the three and six months ended June 30, 2014, respectively.

 

Recent Accounting Pronouncements

 

In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-15, “Presentation of Financial Statements—Going Concern,” to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. This guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. We do not believe the pending adoption of ASU No. 2014-15 will have a material impact on our condensed consolidated financial statements.

 

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers,” which provides a five step approach to be applied to all contracts with customers. ASU No. 2014-09 also requires expanded disclosures about revenue recognition. This guidance is effective for annual reporting periods beginning after December 15, 2017 and interim periods therein.  Early adoption is permitted for reporting periods beginning after December 15, 2016.  We are currently analyzing the impact of ASU No. 2014-09 on our results of operations and, at this time, we are unable to determine the impact on the new standard, if any, on our condensed consolidated financial statements.

 

In February 2015, the FASB issued ASU No. 2015-02, “Amendments to the Consolidation Analysis,” which affects reporting entities that are required to evaluate whether they should consolidate certain legal entities.  The amendments place more emphasis in the consolidation evaluation on variable interests other than fee arrangements such as principal investment risk (including debt or equity interests), guarantees of the value of the assets or liabilities of the VIE, written put options on the assets of the VIE, or similar obligations. Additionally, the amendments reduce the extent to which related party arrangements cause an entity to be considered a primary beneficiary. This guidance is to be applied using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the fiscal year of adoption. The amendments are effective for fiscal years beginning

 

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after December 15, 2015, and interim periods therein. We are currently analyzing the impact of ASU No. 2015-03, if any, on our condensed consolidated financial statements.

 

In April 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs,” which requires debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs is not affected by the amendments in this update.  This guidance is to be applied retrospectively and is effective for fiscal years beginning after December 15, 2015 and interim periods therein.  Early adoption is permitted. We are currently analyzing the impact of ASU No. 2015-03 on our condensed consolidated financial statements.

 

3.              Fair value of financial instruments

 

FASB accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (“the exit price”) in an orderly transaction between market participants at the measurement date. The standard outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value we use quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of us. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

 

Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

 

Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.

 

Level 3—Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement.

 

Our marketable securities consist of investments in U.S. government agencies, corporate debt securities and non-agency mortgage-backed securities that are classified as available-for-sale.

 

At June 30, 2015 and December 31, 2014, our Level 2 corporate debt securities and mortgage-backed securities are valued using readily available pricing sources which utilize market observable inputs, including the current interest rate and other characteristics for similar types of instruments.

 

The following fair value hierarchy table presents information about each major category of our financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2015 (in thousands):

 

 

 

Fair Value Measurement at Reporting Date Using:

 

 

 

 

 

Quoted Prices in
Active Markets for
Identical Assets
(Level 1)

 

Significant Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Balance as of
June 30, 2015

 

Cash and cash equivalents

 

$

439,681

 

$

 

$

 

$

439,681

 

Corporate debt securities

 

 

184,521

 

 

184,521

 

Long term investment (Note 7)

 

67,003

 

 

 

67,003

 

Mortgage-backed securities

 

 

3,267

 

 

3,267

 

Total assets

 

$

506,684

 

$

187,788

 

$

 

$

694,472

 

 

The following fair value hierarchy table presents information about each major category of our financial assets measured at fair value on a recurring basis as of December 31, 2014 (in thousands):

 

 

 

Fair Value Measurement at Reporting Date Using:

 

 

 

 

 

Quoted Prices in
Active Markets for
Identical Assets
(Level 1)

 

Significant Other
Observable
Inputs
(Level 2)

 

Significant
Unobservable
Inputs
(Level 3)

 

Balance as of
December 31, 2014

 

Cash and cash equivalents

 

$

452,297

 

$

 

$

 

$

452,297

 

Corporate debt securities

 

 

144,402

 

 

144,402

 

Mortgage-backed securities

 

 

3,564

 

 

3,564

 

Total assets

 

$

452,297

 

$

147,966

 

$

 

$

600,263

 

 

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The following is a summary of our marketable security portfolio as of June 30, 2015 and December 31, 2014, respectively.

 

 

 

Amortized
Cost

 

Net
Unrealized
Gains

 

Net
Unrealized
Losses

 

Estimated
Fair Value

 

 

 

(in thousands)

 

June 30, 2015

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

184,670

 

$

 

$

(149

)

$

184,521

 

Mortgage backed securities

 

1,169

 

2,098

 

 

3,267

 

 

 

$

185,839

 

$

2,098

 

$

(149

)

$

187,788

 

December 31, 2014

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

144,684

 

$

 

$

(282

)

$

144,402

 

Mortgage backed securities

 

1,461

 

2,103

 

 

3,564

 

 

 

$

146,145

 

$

2,103

 

$

(282

)

$

147,966

 

 

Our corporate debt securities generally have contractual maturity dates of between 12 to 18 months. Because of the potential for prepayment on mortgage-backed securities, they are not categorized by contractual maturity.

 

4.              Concentration of Credit Risk

 

In December 2009, we entered into a license, development and commercialization agreement with Eli Lilly and Company (“Lilly”). In November 2009, we entered into a collaboration and license agreement with Novartis. The concentration of credit risk related to our collaborative partners is as follows:

 

 

 

Percentage of Total
Contract Revenues for the
Three Months Ended June 30,

 

Percentage of Total
Contract Revenues for the
Six Months Ended June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Collaboration Partner A

 

0

%

0

%

80

%

52

%

Collaboration Partner B

 

100

%

100

%

20

%

48

%

 

Collaboration Partner A and Collaboration Partner B comprised in the aggregate 24% and 26% of the accounts receivable balance as of June 30, 2015 and December 31, 2014, respectively.

 

In November 2011, we began commercialization and distribution of JAKAFI to a number of specialty pharmacies. Our product revenues are concentrated in a number of specialty pharmacy customers. The concentration of credit risk related to our specialty pharmacy customers is as follows:

 

 

 

Percentage of Total Net
Product Revenues for the
Three Months Ended June 30,

 

Percentage of Total Net
Product Revenues for the
Six Months Ended June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Customer A

 

27

%

29

%

28

%

29

%

Customer B

 

19

%

23

%

20

%

22

%

Customer C

 

13

%

11

%

13

%

11

%

Customer D

 

9

%

10

%

9

%

10

%

 

We are exposed to risks associated with extending credit to specialty pharmacy customers related to the sale of products. Customer A, Customer B, Customer C and Customer D comprised in the aggregate 53% and 54% of the accounts receivable balance as of June 30, 2015 and December 31, 2014, respectively.

 

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5.              Inventory

 

Our inventory balance consists of the following:

 

 

 

June 30,
2015

 

December 31,
2014

 

 

 

(in thousands)

 

Raw materials

 

$

289

 

$

591

 

Work-in-process

 

18,259

 

18,487

 

Finished goods

 

1,897

 

358

 

 

 

20,445

 

19,436

 

Inventories—current

 

1,897

 

358

 

Inventories—non-current

 

$

18,548

 

$

19,078

 

 

Inventories, stated at the lower of cost or market, consist of raw materials, work in process and finished goods. At June 30, 2015, $1.9 million of inventory was classified as current on the condensed consolidated balance sheet as we expect this inventory to be consumed for commercial use within the next twelve months. At June 30, 2015, $18.5 million of inventory was classified as non-current on the condensed consolidated balance sheet as we did not expect this inventory to be consumed for commercial use within the next twelve months. We obtain a number of inventory components from single source suppliers due to technology, availability, price, quality or other considerations. The loss of a single source supplier, the deterioration of its relationship with a single source supplier, or any unilateral violation of the contractual terms under which we are supplied components by a single source supplier could adversely affect our total revenues and gross margins.

 

The raw materials and work-in-process inventory is not subject to expiration and the shelf life for finished goods inventory is 36 months from the start of manufacturing of the finished goods. We evaluate for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage.

 

6.              Property and Equipment

 

Property and equipment consists of the following:

 

 

 

June 30,
2015

 

December 31,
2014

 

 

 

(in thousands)

 

Office equipment

 

$

6,279

 

$

6,090

 

Laboratory equipment

 

28,702

 

26,800

 

Computer equipment

 

20,746

 

18,648

 

Building and leasehold improvements

 

65,606

 

64,926

 

 

 

121,333

 

116,464

 

Less accumulated depreciation and amortization

 

(39,731

)

(34,674

)

 

 

$

81,602

 

$

81,790

 

 

In 2013, we entered into a lease agreement for a new corporate headquarters, which consists of approximately 190,000 square feet of laboratory and office space located in Wilmington, Delaware. The term of this lease is 15 years from the date of commencement. The construction of the facility was completed and the lease commenced on October 1, 2014 with a monthly lease rate of $0.5 million for the first 10 years of the lease and with the monthly lease rate increasing annually during the last five years of lease.

 

We are accounting for the lease as a direct financing arrangement whereby over the construction period, we recorded the value of the facility (consisting of the estimated fair value of the existing shell, plus construction costs incurred) as a capital asset, with a corresponding lease liability, net of build out costs paid for by us during the construction period. The lease liability will be amortized over the term of the lease using the effective interest method. In addition, we have posted a $15.0 million letter of credit for the facility lease for the benefit of the landlord, which is collateralized by a restricted investments account for the same amount. This amount was recorded as restricted investments on the condensed consolidated balance sheets and will be reduced over a period of time during the duration of the lease. The letter of credit could be subject to accelerated reductions if we meet certain pre-defined financial targets. Restricted investments related to this direct financing lease on the condensed consolidated balance sheets at June 30, 2015 and December 31, 2014 were $14.3 million and $14.5 million, respectively.

 

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7.              License agreements

 

Novartis

 

In November 2009, we entered into a Collaboration and License Agreement with Novartis. Under the terms of the agreement, Novartis received exclusive development and commercialization rights outside of the United States to our JAK inhibitor ruxolitinib and certain back-up compounds for hematologic and oncology indications, including all hematological malignancies, solid tumors and myeloproliferative diseases. We retained exclusive development and commercialization rights to JAKAFI (ruxolitinib) in the United States and in certain other indications. Novartis also received worldwide exclusive development and commercialization rights to our c-MET inhibitor compound capmatinib and certain back-up compounds in all indications. We retained options to co-develop and to co-promote capmatinib in the United States.

 

Under this agreement, we received an upfront payment and immediate milestone payment totaling $210.0 million and were initially eligible to receive up to $1.2 billion in milestone payments across multiple indications upon the achievement of pre-specified events, including up to $174.0 million for the achievement of development milestones, up to $495.0 million for the achievement of regulatory milestones and up to $500.0 million for the achievement of commercialization milestones.  As of June 30, 2015, we have recognized in the aggregate $97.0 million for the achievement of development milestones and $160.0 million for the achievement of regulatory milestones.

 

During the six months ended June 30, 2015, under this agreement, we recognized and received a $25.0 million regulatory milestone triggered by the Committee for Medicinal Products for Human Use of the European Medicines Agency adopting a positive opinion for JAKAVI (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. In 2014, we recognized and received a $60.0 million regulatory milestone related to reimbursement of JAKAVI (ruxolitinib) in Europe, a $25.0 million regulatory milestone for the approval of JAKAVI in Japan for the treatment of patients with myelofibrosis and a $7.0 million development milestone based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib in non-small cell lung cancer.  In 2013, we recognized and received a $25.0 million development milestone payment under this agreement based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib. In 2012, we recognized and received a $40.0 million regulatory milestone payment under this agreement for the achievement of a predefined milestone for the European Union regulatory approval of JAKAVI. In 2011, we recognized and received a $15.0 million development milestone payment under this agreement for the achievement of a predefined milestone in the Phase I dose-escalation trial for capmatinib in patients with solid tumors and a $10.0 million regulatory milestone payment for the approval of JAKAFI in the United States. We determined the 2015, 2014, 2013, 2012 and 2011 milestones to be substantive as their achievement required substantive efforts by us and was at risk until the milestones were ultimately achieved. We also are eligible to receive tiered, double-digit royalties ranging from the upper-teens to the mid-twenties on future JAKAVI net sales outside of the United States. Since the achievement of the $60.0 million regulatory milestone related to reimbursement of JAKAVI in Europe, we are obligated to pay to Novartis tiered royalties in the low single digits on future JAKAFI net sales within the United States. During the three and six months ended June 30, 2015, such royalties payable to Novartis on net sales within the United States totaled $5.6 million and $8.1 million, respectively, and are reflected in cost of product revenues on the condensed consolidated statement of operations.  Each company is responsible for costs relating to the development and commercialization of ruxolitinib in its respective territories, with costs of collaborative studies shared equally. Novartis is now responsible for all costs relating to the development and commercialization of capmatinib.

 

The Novartis agreement will continue on a program-by-program basis until Novartis has no royalty payment obligations with respect to such program or, if earlier, the termination of the agreement or any program in accordance with the terms of the agreement. Royalties are payable by Novartis on a product-by-product and country-by-country basis until the latest to occur of (1) the expiration of the last valid claim of the licensed patent rights covering the licensed product in the relevant country, (2) the expiration of regulatory exclusivity for the licensed product in such country and (3) a specified period from first commercial sale in such country of the licensed product by Novartis or its affiliates or sublicensees. The agreement may be terminated in its entirety or on a program-by-program basis by Novartis for convenience. The agreement may also be terminated by either party under certain other circumstances, including material breach.

 

At December 31, 2009, we recorded $10.9 million of reimbursable costs incurred prior to the effective date of the agreement as deferred revenue on the consolidated balance sheet. These costs were recognized on a straight line basis through December 2013 consistent with the aforementioned upfront and milestone payments. Future reimbursable costs incurred after the effective date of the agreement with Novartis will be recorded net against the related research and development expenses. At June 30, 2015 and December 31, 2014, $0.5 million and $0.3 million, respectively, of reimbursable costs were included in accounts receivable on the condensed consolidated balance sheets. Research and development expenses for the three and six months ended June 30, 2015 were net of $0.5 million and $1.0 million, respectively, of costs reimbursed by Novartis. Research and development expenses for the three and six months ended June 30, 2014 were net of $1.1 million and $2.2 million, respectively, of costs reimbursed by Novartis.

 

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Contract revenue under the Novartis agreement was $0.0 million and $25.0 million for the three and six months ended June 30, 2015, respectively. Contract revenue under the Novartis agreement was $0.0 million and $7.0 million for the three and six months ended June 30, 2014, respectively. Product royalty revenue related to Novartis net sales of JAKAVI outside of the United States was $17.4 million and $33.0 million for the three and six months ended June 30, 2015, respectively. Product royalty revenue related to Novartis net sales of JAKAVI outside of the United States was $12.3 million and $22.2 million for the three and six months ended June 30, 2014, respectively. At June 30, 2015 and December 31, 2014, $17.3 million and $14.8 million, respectively, of product royalties were included in accounts receivable on the condensed consolidated balance sheets.

 

Lilly

 

In December 2009, we entered into a License, Development and Commercialization Agreement with Lilly. Under the terms of the agreement, Lilly received exclusive worldwide development and commercialization rights to our JAK inhibitor baricitinib, and certain back-up compounds for inflammatory and autoimmune diseases. We received an upfront payment of $90.0 million, and were initially eligible to receive up to $665.0 million in substantive milestone payments across multiple indications upon the achievement of pre-specified events, including up to $150.0 million for the achievement of development milestones, up to $365.0 million for the achievement of regulatory milestones and up to $150.0 million for the achievement of commercialization milestones. As of June 30, 2015, we have recognized and received in the aggregate $99.0 million for the achievement of development milestones.

 

In 2012, we recognized and received a $50.0 million development milestone under this agreement for the achievement of a predefined milestone for the initiation of the rheumatoid arthritis Phase III program for baricitinib. In 2010, we recognized and received a $30.0 million development milestone payment based upon the initial three month data in the Phase IIa clinical trial of baricitinib for the treatment of rheumatoid arthritis and a $19.0 million development milestone payment for the Phase IIb clinical trial initiation of baricitinib for the treatment of rheumatoid arthritis. We determined the 2012 and 2010 milestones to be substantive as their achievement required substantive efforts by us and was at risk until the milestones were ultimately achieved. We also could receive tiered, double-digit royalty payments on future global net sales with rates ranging up to 20% if the product is successfully commercialized.

 

We retained options to co-develop our JAK inhibitors with Lilly on a compound-by-compound and indication-by-indication basis. Lilly is responsible for all costs relating to the development and commercialization of the compounds unless we elect to co-develop any compounds or indications. If we elect to co-develop any compounds and/or indications, we would be responsible for funding 30% of the associated future global development costs from the initiation of a Phase IIb trial through regulatory approval. We would receive an incremental royalty rate increase across all tiers resulting in effective royalty rates ranging up to the high twenties on potential future global net sales for compounds and/or indications that we elect to co-develop. We also retained an option to co-promote products in the United States. In July 2010, we elected to co-develop baricitinib with Lilly in rheumatoid arthritis and we are responsible for funding 30% of the associated future global development costs for this indication from the initiation of the Phase IIb trial through regulatory approval. Research and development expenses recorded under the Lilly agreement representing 30% of the global development costs for baricitinib for the treatment of rheumatoid arthritis were $10.3 million and $21.9 million for the three and six months ended June 30, 2015, respectively. Research and development expenses recorded under the Lilly agreement representing 30% of the global development costs for baricitinib for the treatment of rheumatoid arthritis were $12.7 million and $26.7 million for the three and six months ended June 30, 2014, respectively. We have retained certain mechanisms to give us cost protection as baricitinib advances in clinical development. We can defer our portion of co-development study costs by indication if they exceed a predetermined level. This deferment would be credited against future milestones or royalties and we would still be eligible for the full incremental royalties related to the co-development option. In addition, even if we have started co-development funding for any indication, we can at any time opt out and stop future co-development cost sharing. If we elect to do this we would still be eligible for our base royalties plus an incremental pro-rated royalty commensurate with our contribution to the total co-development cost for those indications for which we co-funded. The Lilly agreement will continue until Lilly no longer has any royalty payment obligations or, if earlier, the termination of the agreement in accordance with its terms. Royalties are payable by Lilly on a product-by-product and country- by-country basis until the latest to occur of (1) the expiration of the last valid claim of the licensed patent rights covering the licensed product in the relevant country, (2) the expiration of regulatory exclusivity for the licensed product in such country and (3) a specified period from first commercial sale in such country of the licensed product by Lilly or its affiliates or sublicensees. The agreement may be terminated by Lilly for convenience, and may also be terminated under certain other circumstances, including material breach.

 

We determined that there were two deliverables under the agreement: (i) the worldwide license and (ii) our obligations in connection with a co-development option. We concluded that these deliverables should be accounted for as a single unit of accounting and the $90.0 million upfront payment should be recognized on a straight line basis as revenue through December 2016, our estimated performance period under the agreement.

 

Contract revenue under the Lilly agreement was $3.2 million and $6.4 million, respectively, for each of the three and six months ended June 30, 2015 and 2014.

 

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Agenus

 

In January 2015, we entered into a License, Development and Commercialization Agreement with Agenus Inc. and its wholly owned subsidiary, 4 Antibody AG, which we collectively refer to as Agenus. Under this agreement, the parties have agreed to collaborate on the discovery of novel immuno therapeutics using Agenus’ proprietary Retrocyte Display antibody discovery platform. The agreement became effective on February 18, 2015, upon the expiration of the waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 (“HSR Act”).

 

Under the terms of this agreement, we received exclusive worldwide development and commercialization rights to four checkpoint modulators directed against GITR, OX40, LAG-3 and TIM-3. In addition to the initial four program targets, we and Agenus have the option to jointly nominate and pursue additional targets within the framework of the collaboration. These targets may be designated profit share programs, where all costs and profits are shared equally by us and Agenus, or royalty bearing programs, where we will be responsible for all costs associated with discovery, preclinical activities, clinical development and commercialization activities. The programs relating to GITR and OX40 are profit share programs and the programs relating to LAG-3 and TIM-3 are royalty bearing programs. For each royalty bearing product, Agenus will be eligible to receive up to $155 million in future contingent development, regulatory and commercialization milestones as well as tiered royalties on global net sales ranging from 6% to 12%. For each profit share product, Agenus will be eligible to receive up to $20 million in future contingent development milestones. Additionally, Agenus retains co-promotion participation rights in the United States on any profit share product. For each royalty bearing product, Agenus has reserved the right to elect to co fund 30% of development costs for a commensurate increase in royalties. The agreement may be terminated by us for convenience and may also be terminated under certain other circumstances, including material breach.

 

In January 2015, we also entered into a Stock Purchase Agreement with Agenus Inc. pursuant to which we agreed to purchase approximately 7.76 million shares of Agenus Inc. common stock for an aggregate purchase price of $35.0 million in cash, or approximately $4.51 per share. We completed the purchase of the shares on February 18, 2015. On February 18, 2015 the closing price of Agenus Inc. common shares on The NASDAQ Stock Market was $5.13 per share and, therefore, the value of the 7.76 million shares acquired by us was $39.8 million. We have agreed not to dispose of any of the shares of common stock for a period of 12 months and Agenus Inc. has agreed to certain registration rights with respect to the shares of common stock.

 

Upon closing of the Agenus transaction on February 18, 2015, we paid total consideration of $60.0 million to Agenus Inc.  Of the $60.0 million, $39.8 million was allocated to our stock purchase in Agenus Inc. and was recorded as a long term investment on the condensed consolidated balance sheets and $20.2 million was allocated to research and development expense on the condensed consolidated statement of operations.

 

We have concluded Agenus Inc. is not a VIE because it has sufficient equity to finance its activities without additional subordinated financial support and its at-risk equity holders have the characteristics of a controlling financial interest. We own approximately 9% of the outstanding shares of Agenus Inc. common stock and conclude that we have the ability to exercise significant influence, but not control, over Agenus Inc. based primarily on our ownership interest, the level of intra-entity transactions between us and Agenus related to development expenses, as well as other qualitative factors. We have elected the fair value option to account for our long term investment in Agenus Inc. whereby the investment is marked to market through earnings in each reporting period. We believe the fair value option to be the most appropriate accounting method to account for securities in publicly held collaborators for which we have significant influence. For the six months ended June 30, 2015, we recorded an unrealized gain of $27.2 million based on the increase in the market price of Agenus Inc.’s common stock at June 30, 2015 to $8.63 per share. For the three months ended March 31, 2015, Agenus Inc. reported total revenues of $4.0 million and a net loss of $18.7 million within their consolidated financial statements.

 

Research and development expenses for the three and six months ended June 30, 2015, also included $3.8 million and $5.6 million, respectively, of development costs incurred pursuant to the Agenus arrangement. At June 30, 2015, a total of $3.8 million of such costs were included in accrued and other liabilities on the condensed consolidated balance sheet.

 

8.              Stock compensation

 

We recorded $17.6 million and $35.2 million of stock compensation expense on our condensed consolidated statements of operations for the three and six months ended June 30, 2015, respectively. We recorded $15.5 million and $30.8 million of stock compensation expense on our condensed consolidated statements of operations for the three and six months ended June 30, 2014, respectively.

 

Stock compensation expense included within our condensed consolidated statements of operations included research and development expense of $10.2 million, $20.4 million, $8.5 million and $16.8 million for the three and six months ended June 30, 2015

 

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and 2014, respectively. Stock compensation expense included within our condensed consolidated statements of operations also included selling, general and administrative expense of $7.4 million, $14.7 million, $7.0 million and $14.0 million for the three and six months ended June 30, 2015 and 2014, respectively.

 

We utilized the Black-Scholes valuation model for estimating the fair value of the stock compensation granted, with the following weighted-average assumptions:

 

 

 

Employee Stock Options

 

Employee Stock Purchase Plan

 

 

 

For the Three
Months Ended

 

For the Six
Months Ended

 

For the Three
Months Ended

 

For the Six
Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

2015

 

2014

 

2015

 

2014

 

Average risk-free interest rates

 

1.38

%

1.32

%

1.35

%

1.20

%

0.64

%

0.47

%

0.60

%

0.52

%

Average expected life (in years)

 

5.20

 

5.01

 

5.06

 

4.55

 

0.50

 

0.50

 

0.50

 

0.50

 

Volatility

 

49

%

52

%

50

%

50

%

27

%

42

%

36

%

52

%

Weighted-average fair value (in dollars)

 

45.56

 

22.69

 

33.80

 

25.95

 

9.24

 

7.87

 

9.90

 

9.13

 

 

The risk-free interest rate is derived from the U.S. Federal Reserve rate in effect at the time of grant. The expected life calculation is based on the observed and expected time to the exercise of options by our employees based on historical exercise patterns for similar type options. Expected volatility is based on the historical volatility of our common stock over the period commensurate with the expected life of the options. A dividend yield of zero is assumed based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends.

 

Option activity under the 2010 Stock Plan was as follows:

 

 

 

 

 

Shares Subject to
Outstanding Options

 

 

 

Shares Available
for Grant

 

Shares

 

Weighted Average
Exercise Price

 

Balance at December 31, 2014

 

5,399,816

 

14,655,043

 

$

21.96

 

Options granted

 

(1,789,638

)

1,789,638

 

$

76.79

 

Options exercised

 

 

(3,801,201

)

$

16.18

 

Options cancelled

 

278,099

 

(278,099

)

$

42.92

 

Balance at June 30, 2015

 

3,888,277

 

12,365,381

 

$

31.20

 

 

RSU and PSU award activity under the 2010 Stock Plan was as follows:

 

 

 

 

 

Shares Subject to

 

 

 

Shares Available

 

Outstanding Awards

 

 

 

for Grant

 

Shares

 

Grant Date Value

 

Balance at December 31, 2014

 

1,001,523

 

398,477

 

 

RSUs granted

 

(188,095

)

188,095

 

$

75.88

 

PSUs granted

 

 

 

 

RSUs cancelled

 

25,278

 

(25,278

)

$

61.40

 

PSUs cancelled

 

4,958

 

(4,958

)

$

64.55

 

Balance at June 30, 2015

 

843,664

 

556,336

 

 

 

In January 2014, we began granting RSUs and PSUs to our employees at the share price on the date of grant. Each RSU represents the right to acquire one share of our common stock. We granted a total of 188,095 RSUs during the six months ended June 30, 2015 which will cliff vest in three years and will be recognized as stock compensation expense over this period.  Also, in January 2014, Hervé Hoppenot, our President and Chief Executive Officer, was granted a one-time grant of 400,000 RSUs outside of our 2010 Stock Incentive Plan. Vesting of the RSUs will be subject to Mr. Hoppenot’s continued employment on the applicable vesting dates, with one-sixth of the RSUs vesting at the end of each of the calendar years 2014 through 2019, subject to earlier acceleration of vesting upon the occurrence of certain events in accordance with the terms of his employment agreement.  As of June 30, 2015, a total of 66,666 RSUs granted to Mr. Hoppenot vested and were released leaving 333,334 RSUs outstanding.

 

At June 30, 2015, we have only recognized stock compensation expense relating to performance conditions of the outstanding PSUs that are deemed probable of achievement at that date. For PSUs containing performance conditions which have not been deemed probable of achievement at June 30, 2015, no stock compensation expense has been recognized for these awards. The actual number of shares of our common stock into which each PSU may convert are subject to a multiplier of up to 125% based on the level at which the performance conditions are achieved.

 

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Based on our historical experience of employee turnover, we have assumed an annualized forfeiture rate of 5% for our options, PSUs and RSUs.  Under the true-up provisions of the stock compensation guidance, we will record additional expense if the actual forfeiture rate is lower than we estimated, and will record a recovery of prior expense if the actual forfeiture is higher than we estimated.

 

Total compensation cost of options granted but not yet vested, as of June 30, 2015, was $51.9 million, which is expected to be recognized over the weighted average period of 3.0 years. Total compensation cost of RSUs granted but not yet vested, as of June 30, 2015, was $29.3 million, which is expected to be recognized over the weighted average period of 3.0 years. Total compensation cost of PSUs granted but not yet vested, as of June 30, 2015, was $0.6 million, which is expected to be recognized over the weighted average period of 3.0 years, should the underlying performance conditions be deemed probable of achievement.

 

9.              Debt

 

The components of the convertible notes are as follows (in thousands):

 

 

 

 

 

 

 

Carrying Amount

 

Debt

 

Interest Rates
June 30, 2015

 

Maturities

 

June 30,
2015

 

December 31,
2014

 

4.75% Convertible Senior Notes due 2015

 

4.75

%

2015

 

$

42,940

 

$

85,640

 

0.375% Convertible Senior Notes due 2018

 

0.375

%

2018

 

321,876

 

314,752

 

1.25% Convertible Senior Notes due 2020

 

1.25

%

2020

 

295,149

 

288,726

 

 

 

 

 

 

 

659,965

 

689,118

 

Less current portion

 

 

 

 

 

42,940

 

85,640

 

 

 

 

 

 

 

$

617,025

 

$

603,478

 

 

The carrying amount and fair value of our convertible notes are as follows (in thousands):

 

 

 

June 30, 2015

 

December 31, 2014

 

 

 

Carrying
Amount

 

Fair Value

 

Carrying
Amount

 

Fair Value

 

4.75% Convertible Senior Notes due 2015

 

$

42,940

 

$

519,217

 

$

85,640

 

$

755,143

 

0.375% Convertible Senior Notes due 2018

 

321,876

 

766,875

 

314,752

 

560,156

 

1.25% Convertible Senior Notes due 2020

 

295,149

 

773,205

 

288,726

 

577,736

 

 

 

$

659,965

 

$

2,059,297

 

$

689,118

 

$

1,893,035

 

 

The fair values of the 4.75% Convertible Senior Notes due 2015 (the “2015 Notes”), the 0.375% Convertible Senior Notes due 2018 (the “2018 Notes”) and the 1.25% Convertible Senior Notes due 2020 (the “2020 Notes”) are based on data from readily available pricing sources which utilize market observable inputs and other characteristics for similar types of instruments, and, therefore, these convertible senior notes are classified within Level 2 in the fair value hierarchy.

 

Prior to May 14, 2014, the 2018 and 2020 Notes were not convertible except in connection with a make whole fundamental change, as defined in the respective indentures. Beginning on, and including, May 15, 2014, the 2018 and 2020 Notes are convertible prior to the close of business on the business day immediately preceding May 15, 2018, in the case of the 2018 Notes, and May 15, 2020, in the case of the 2020 Notes, only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2014 (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the 2018 Notes or 2020 Notes, as applicable, on each applicable trading day; (2) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of 2018 Notes or 2020 Notes, as applicable, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate for the 2018 Notes or 2020 Notes, as applicable, on each such trading day; or (3) upon the occurrence of specified corporate events. On or after May 15, 2018, in the case of the 2018 Notes, and May 15, 2020, in the case of the 2020 Notes, until the close of business on the second scheduled trading day immediately preceding the relevant maturity date, the Notes are convertible at any time, regardless of the foregoing circumstances. Upon conversion we will pay or deliver, as the case may be, cash, shares of common stock or a combination of cash and shares of common stock, at our election.

 

On July 1, 2015, the 2018 Notes and 2020 Notes became convertible through at least September 30, 2015, based on meeting the conversion criteria related to the sale price of our common stock during the calendar quarter ended June 30, 2015 as described in (1) above. Management’s intent is to settle any conversions of 2018 Notes or 2020 Notes during this period in shares of our common

 

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stock and, therefore, the 2018 Notes and 2020 Notes are reflected in long term liabilities on the condensed consolidated balance sheet at June 30, 2015.

 

During 2015, certain holders of the 2015 Notes converted a total of $47.1 million in aggregate principal amount of the 2015 Notes for the shares of our common stock into which the 2015 Notes were convertible, aggregating 5.4 million shares.

 

10.       Income taxes

 

In January 2015, we licensed certain intellectual property rights related to our non-partnered clinical programs to our wholly-owned subsidiary in Switzerland. Although the license of intellectual property rights did not result in any gain or loss in the condensed consolidated statements of operations, the transaction generated a taxable gain in the U.S, and we are utilizing available federal and state net operating loss carryforwards to offset the majority of this gain. Any taxes incurred related to intercompany transactions are treated as prepaid tax in our condensed consolidated balance sheets and amortized to income tax expense over the life of the intellectual property. Any cash taxes anticipated to be paid related to this intercompany transaction are immaterial.

 

11.       Net income (loss) per share

 

Net income (loss) per share was calculated as follows for the periods indicated:

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

(in thousands except per share data)

 

2015

 

2014

 

2015

 

2014

 

Basic Net Income (Loss) Per Share

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

9,294

 

$

(36,873

)

$

(9,063

)

$

(70,830

)

Weighted average common shares outstanding

 

178,676

 

167,914

 

175,373

 

166,636

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per share

 

$

0.05

 

$

(0.22

)

$

(0.05

)

$

(0.43

)

 

 

 

 

 

 

 

 

 

 

Diluted Net Income (Loss) Per Share

 

 

 

 

 

 

 

 

 

Diluted net income (loss)

 

$

9,294

 

$

(36,873

)

$

(9,063

)

$

(70,830

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding

 

178,676

 

167,914

 

175,373

 

166,636

 

Dilutive stock options and RSU’s

 

7,817

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares used to compute diluted net income (loss) per share

 

186,493

 

167,914

 

175,373

 

166,636

 

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per share

 

$

0.05

 

$

(0.22

)

$

(0.05

)

$

(0.43

)

 

The following potential common shares were excluded from the calculations as their effect would be anti-dilutive:

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Stock options and awards

 

137,012

 

17,684,266

 

13,255,051

 

17,684,266

 

Common shares issuable upon conversion of the 2015 Notes

 

4,990,916

 

10,441,728

 

4,990,916

 

10,441,728

 

Common shares issuable upon conversion of the 2018 Notes

 

7,245,263

 

7,245,263

 

7,245,263

 

7,245,263

 

Common shares issuable upon conversion of the 2020 Notes

 

7,245,263

 

7,245,263

 

7,245,263

 

7,245,263

 

Total potential common shares excluded from diluted net income (loss) per share computation

 

19,618,454

 

42,616,520

 

32,736,493

 

42,616,520

 

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion of our financial condition and results of operations as of and for the three and six months ended June 30, 2015 should be read in conjunction with the unaudited condensed consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements as of and for the year ended December 31, 2014 included in our Annual Report on Form 10-K for the year ended December 31, 2014 previously filed with the SEC.

 

This report contains forward-looking statements that involve risks and uncertainties. These statements relate to future periods, future events or our future operating or financial plans or performance. Often, these statements include the words “believe,” “expect,” “target,” “anticipate,” “intend,” “plan,” “seek,” “estimate,” “potential,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” or “may,” or the negative of these terms, and other similar expressions. These forward-looking statements include statements as to:

 

·                  the discovery, development, formulation, manufacturing and commercialization of our compounds, our drug candidates and JAKAFI®/JAKAVI® (ruxolitinib);

 

·                  conducting clinical trials internally, with collaborators, or with clinical research organizations;

 

·                  our collaboration and strategic relationship strategy; anticipated benefits and disadvantages of entering into collaboration agreements;

 

·                  our licensing, investment and commercialization strategies, including our plans to commercialize JAKAFI;

 

·                  the regulatory approval process, including obtaining U.S. Food and Drug Administration and other international health authorities approval for our products in the United States and abroad;

 

·                  the safety, effectiveness and potential benefits and indications of our drug candidates and other compounds under development;

 

·                  the timing and size of our clinical trials; the compounds expected to enter clinical trials; timing of clinical trial results;

 

·                  our ability to manage expansion of our drug discovery and development operations;

 

·                  future required expertise relating to clinical trials, manufacturing, sales and marketing;

 

·                  obtaining and terminating licenses to products, drug candidates or technology, or other intellectual property rights;

 

·                  the receipt from or payments pursuant to collaboration or license agreements resulting from milestones or royalties;

 

·                  plans to develop and commercialize products on our own;

 

·                  plans to use third party manufacturers;

 

·                  expected expenses and expenditure levels; expected uses of cash; expected revenues and sources of revenues;

 

·                  expected losses; fluctuation of losses; currency translation impact associated with collaboration royalties;

 

·                  our profitability; the adequacy of our capital resources to continue operations;

 

·                  the need to raise additional capital;

 

·                  the costs associated with resolving matters in litigation;

 

·                  our expectations regarding competition;

 

·                  our investments, including anticipated expenditures, losses and expenses;

 

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·                  our patent prosecution and maintenance efforts; and

 

·                  our indebtedness, and debt service obligations.

 

These forward-looking statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. These risks and uncertainties could cause actual results to differ materially from those projected and include, but are not limited to:

 

·                  our ability to successfully commercialize JAKAFI;

 

·                  our ability to maintain at anticipated levels, reimbursement for JAKAFI from government health administration authorities, private health insurers and other organizations;

 

·                  our ability to establish and maintain effective sales, marketing and distribution capabilities;

 

·                  the risk of reliance on other parties to manufacture JAKAFI, which could result in a short supply of JAKAFI, increased costs, and withdrawal of regulatory approval;

 

·                  our ability to maintain regulatory approvals to market JAKAFI;

 

·                  our ability to achieve a significant market share in order to achieve or maintain profitability;

 

·                  the risk of civil or criminal penalties if we market JAKAFI in a manner that violates health care fraud and abuse and other applicable laws, rules and regulations;

 

·                  our ability to discover, develop, formulate, manufacture and commercialize our drug candidates;

 

·                  the risk of unanticipated delays in research and development efforts;

 

·                  the risk that previous preclinical testing or clinical trial results are not necessarily indicative of future clinical trial results;

 

·                  risks relating to the conduct of our clinical trials;

 

·                  changing regulatory requirements;

 

·                  the risk of adverse safety findings;

 

·                  the risk that results of our clinical trials do not support submission of a marketing approval application for our drug candidates;

 

·                  the risk of significant delays or costs in obtaining regulatory approvals;

 

·                  risks relating to our reliance on third party manufacturers, collaborators, and clinical research organizations;

 

·                  risks relating to the development of new products and their use by us and our current and potential collaborators;

 

·                  risks relating to our inability to control the development of out-licensed compounds or drug candidates;

 

·                  risks relating to our collaborators’ ability to develop and commercialize drug candidates;

 

·                  costs associated with prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights;

 

·                  our ability to maintain or obtain adequate product liability and other insurance coverage;

 

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·                  the risk that our drug candidates may not obtain or maintain regulatory approval;

 

·                  the impact of technological advances and competition;

 

·                  our ability to compete against third parties with greater resources than ours;

 

·                  risks relating to changes in pricing and reimbursements in the markets in which we may compete;

 

·                  competition to develop and commercialize similar drug products;

 

·                  our ability to obtain patent protection and freedom to operate for our discoveries and to continue to be effective in expanding our patent coverage;

 

·                  the impact of changing laws on our patent portfolio;

 

·                  developments in and expenses relating to litigation;

 

·                  our ability to in-license drug candidates or other technology;

 

·                  our substantial leverage;

 

·                  our ability to obtain additional capital when needed;

 

·                  fluctuations in net cash provided and used by operating, financing and investing activities;

 

·                  our history of operating losses; and

 

·                  the risks set forth under “Risk Factors.”

 

Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by federal securities laws, we undertake no obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.

 

In this report all references to “Incyte,” “we,” “us,” “our” or the “Company” mean Incyte Corporation and our subsidiaries, except where it is made clear that the term means only the parent company.

 

Incyte and JAKAFI are our registered trademarks. We also refer to trademarks of other corporations and organizations in this Quarterly Report on Form 10-Q.

 

Overview

 

Incyte is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics to treat serious unmet medical needs, primarily in oncology. JAKAFI (ruxolitinib) is our first product to be approved for sale in the United States. It was approved by the U.S. Food and Drug Administration (FDA) in November 2011 for the treatment of patients with intermediate or high-risk myelofibrosis, and in December 2014 for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Myelofibrosis and polycythemia vera are both rare blood cancers.

 

In April 2015, we announced our intention to establish the new headquarters of Incyte Europe Sarl (Incyte Europe) in Geneva, Switzerland. We intend to use Incyte Europe as the base from which we will conduct our European clinical development operations.

 

JAKAFI is marketed in the United States through our own specialty sales force and commercial team. Under our collaboration agreement with Novartis International Pharmaceutical Ltd., Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications and sells ruxolitinib outside of the United States under the name JAKAVI.

 

In 2003, we initiated a research and development program to explore the inhibition of enzymes called janus associated kinases (JAK). The JAK family is composed of four tyrosine kinases—JAK1, JAK2, JAK3 and Tyk2—that are involved in the

 

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signaling of a number of cytokines and growth factors. JAKs are central to a number of biologic processes, including the formation and development of blood cells and the regulation of immune functions. Dysregulation of the JAK-STAT signaling pathway has been associated with a number of diseases, including myeloproliferative neoplasms, other hematological malignancies, solid tumors, rheumatoid arthritis, psoriasis and other chronic inflammatory diseases. Myeloproliferative neoplasms are a closely related group of blood diseases in which blood cells, specifically platelets, white blood cells, and red blood cells, grow or act abnormally in the bone marrow. These diseases include myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia.

 

We have discovered multiple potent, selective and orally bioavailable JAK inhibitors that are selective for JAK1 or JAK1 and JAK2. JAKAFI is the most advanced compound in our JAK program. It is an oral JAK1 and JAK2 inhibitor and was approved by the FDA in November 2011 as a treatment for patients with intermediate or high-risk MF, which includes primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. We estimate there are between 16,000 and 18,500 patients with MF in the United States. Based on the modern prognostic scoring systems referred to as International Prognostic Scoring System and Dynamic International Prognostic Scoring System, we believe intermediate and high-risk patients represent 80 percent to 90 percent of all patients with MF in the United States and encompass patients over the age of 65, or patients who have or have ever had any of the following: anemia, constitutional symptoms, elevated white blood cell or blast counts, or platelet counts less than 100,000 per microliter of blood.

 

In December 2014, the FDA approved JAKAFI for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea. Current standard treatment for PV is phlebotomy (the removal of blood from the body) plus aspirin. When phlebotomy can no longer control PV, chemotherapy such as hydroxyurea, or interferon, is utilized. Approximately 25,000 patients with PV in the United States are considered uncontrolled because they have an inadequate response to or are intolerant of hydroxyurea, the most commonly used chemotherapeutic agent for the treatment of PV.

 

JAKAFI was the first FDA-approved JAK inhibitor for any indication and was the first and remains the only product approved by the FDA for use in MF, and also now in PV. The FDA has granted JAKAFI orphan drug status for MF, PV and essential thrombocythemia.

 

In August 2012, the European Commission approved ruxolitinib as JAKAVI for the treatment of disease-related splenomegaly or symptoms in adult patients with primary MF (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF. In January 2015, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for JAKAVI for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea, and approval was granted by the European Commission in March 2015.

 

We have retained all development and commercialization rights to JAKAFI in the United States and are eligible to receive development and commercial milestones as well as royalties from product sales outside the United States. We hold patents that cover the composition of matter and use of ruxolitinib through late 2027, excluding additional potential patent term extensions. We believe ruxolitinib may have potential as a treatment for other cancers.

 

Full results from the Phase II proof-of-concept RECAP trial of ruxolitinib in patients with refractory metastatic pancreatic cancer were presented in June 2014 and suggest a demonstrable survival benefit in a pre-specified subgroup of patients with elevated C-reactive protein (CRP). The Company and the FDA have agreed on a Special Protocol Assessment (SPA) for a registration trial for advanced or metastatic pancreatic cancer. Under the SPA, the Phase III JANUS 1 trial can be limited to patients with elevated CRP and there is no requirement to develop a companion diagnostic. The global Phase III program includes a second nearly identical Phase III trial, JANUS 2, and both trials are ongoing. The FDA has granted orphan drug status for ruxolitinib for the treatment of pancreatic cancer.

 

Elevated CRP has negative prognostic significance in many tumor types, and we believe that JAK inhibition may represent a new treatment approach for other solid tumors. To test this hypothesis, we have initiated three blinded proof-of-concept Phase II trials evaluating ruxolitinib in non-small cell lung cancer (NSCLC), breast cancer and colorectal cancer. The primary endpoint for each trial will be overall survival.

 

We have a second oral JAK1 and JAK2 inhibitor, baricitinib, which is subject to a collaboration agreement with Eli Lilly and Company in which Lilly received exclusive worldwide development and commercialization rights for the compound for inflammatory and autoimmune diseases. We could receive tiered, double-digit royalty payments on future global sales of products subject to the agreement with rates ranging up to 20 percent if the products are successfully commercialized. This collaboration also contains an option for us to co-develop compounds for any inflammatory and autoimmune disease, whereby we fund 30 percent of development costs from Phase IIb through regulatory approval for that indication in exchange for tiered royalties ranging up to the high twenties on potential future sales. We exercised our co-development option for the development of baricitinib in rheumatoid arthritis in 2010. The Phase III program of baricitinib in patients with rheumatoid arthritis is ongoing, and in December 2014, we announced with Lilly that

 

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the first of the Phase III trials met the primary endpoint. In February 2015, we announced with Lilly that the second of the Phase III trials also met the primary endpoint. Baricitinib has also completed Phase II trials for patients with moderate-to-severe psoriasis and patients with diabetic nephropathy. We have decided not to exercise our co-development option for psoriasis, and the timeframe for exercising our co-development option for diabetic nephropathy has not yet occurred.

 

We have a portfolio of wholly-owned JAK1 inhibitors. Our lead JAK1 inhibitor, INCB39110, has completed proof-of-concept studies in patients with psoriasis, rheumatoid arthritis and myelofibrosis. While the results of the psoriasis and rheumatoid arthritis studies were positive, for strategic reasons, we are pursuing oncologic indications with INCB39110. We believe that selective JAK1 inhibition has the potential to minimize the myelosuppression associated with JAK2 inhibition, thus potentially enabling the combination of JAK1 selective inhibitors with myelosuppressive chemotherapy. The clinical program to evaluate INCB39110 in solid tumors includes an ongoing open-label safety study in combination with gemcitabine and nab-paclitaxel. We have completed the Phase I dose-escalation portion of the trial, and additional first-line pancreatic cancer patients are being recruited into the dose-expansion cohort. INCB39110 is also being studied in a blinded proof-of-concept Phase II trial in NSCLC, in combination with erlotinib, with overall survival as the primary endpoint. The Phase II trial of INCB39110 in combination with docetaxel in patients with NSCLC has been stopped in the second quarter of 2015 because of slow rates of recruitment. We have another JAK1 inhibitor, INCB52793, which is in a Phase I/II trial in advanced malignancies.

 

We have an oral IDO1 inhibitor, epacadostat (previously INCB24360) which belongs to a new class of agents known as immuno-oncology agents. IDO1 is an enzyme whose increased levels in multiple solid tumor types are associated with decreased survival. IDO1 inhibition shifts the immune system from an immunosuppressive state to an activated state, allowing the body to mount a more effective anti-tumor immune response. While preclinical data suggest that IDO1 inhibition can provide anti-tumor effects as monotherapy, based on the significant synergy exhibited in combination with checkpoint inhibitors as well as emerging clinical data, we believe that the optimal development strategy for our IDO1 inhibitor is in combination with other immuno-oncology therapies. During 2014 we signed clinical trial agreements with Merck, Roche / Genentech, AstraZeneca / MedImmune and Bristol-Myers Squibb to evaluate epacadostat with their respective PD-1 and PD-L1 agents in Phase I/II trials, and all four of these trials are now in progress. The tumor types under investigation under these agreements include non-small cell lung cancer, metastatic melanoma, head and neck cancer, colorectal cancer, ovarian cancer, diffuse large B-cell lymphoma and pancreatic cancer. Epacadostat is also in a proof-of-concept trial in combination with Bristol-Myers Squibb’s CTLA-4 inhibitor, Yervoy (ipilimumab), in patients with metastatic melanoma.

 

We have two PI3K-delta inhibitors in clinical development, INCB40093 and INCB50465. The PI3K-delta pathway mediates oncogenic signaling in B cell malignancies. INCB40093 is being studied as both monotherapy and in combination with our JAK1 inhibitor, INCB39110, in patients with B-lymphoid malignancies, including classical Hodgkin lymphoma. An open-label, dose-escalation study of INCB50465 in subjects with previously treated B-cell malignancies has also been initiated.

 

We have a c-MET inhibitor, capmatinib, which is licensed to Novartis. c-MET is a clinically validated receptor kinase cancer target. Abnormal c-MET activation in cancer correlates with poor prognosis. Dysregulation of the c-MET pathway triggers tumor growth, formation of new blood vessels that supply the tumor with nutrients, and causes cancer to spread to other organs. Dysregulation of the c-MET pathway is seen in many types of cancers, including kidney, liver, stomach, breast and brain. Several small molecule c-MET kinase inhibitors have demonstrated clinical efficacy in a number of cancers; however, these molecules have limited potency and are relatively non-selective, which could lead to off-target toxicities. We believe that capmatinib has the requisite properties to overcome these limitations, including greater selectivity, improved potency and more effective inhibition of c-MET. Under our agreement, Novartis received worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications. Capmatinib is being evaluated in hepatocellular carcinoma, non-small cell lung cancer, and other solid tumors and may have potential utility as a combination agent.

 

We have recently added two new compounds to our clinical development portfolio. INCB54828 is a selective inhibitor of the FGFR1, FGFR2 and FGFR3 kinases that has demonstrated potency and selectivity in preclinical studies across multiple solid tumor types. The FGFR family of receptor tyrosine kinases can act as oncogenic drivers in several solid and liquid tumor types. INCB54329 is a bromodomain (BRD) inhibitor. BRDs are a family of proteins which play important roles in mediating gene transcription, most notably by facilitating the expression of oncogenes such as MYC, one of the most frequently dysregulated genes in all of human cancer. INCB54329 has shown broad single agent activity in preclinical models of leukemia, lymphoma, multiple myeloma and in some solid tumor settings; INCB54329 can synergize with inhibitors of JAK/STAT signaling, PI3K/AKT signaling and PIM signaling.  Clinical trials of both INCB54828 and INCB54329 are now underway.

 

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We have a number of programs in preclinical development, and we intend to continue our investment in drug discovery to expand our pipeline.

 

Our current pipeline includes the following compounds:

 

Target/Drug Compound

 

Indication

 

Collaborator (1)

 

Status

ONCOLOGY

 

 

 

 

 

 

JAK1 and JAK2

 

 

 

 

 

 

JAKAFI

 

Myelofibrosis(2)

 

Novartis

 

FDA Approved—Marketed

JAKAFI

 

Polycythemia Vera(3)

 

Novartis

 

FDA Approved—Marketed

ruxolitinib

 

Pancreatic Cancer

 

Novartis (opt-in option)

 

Phase III

ruxolitinib

 

Breast Cancer

 

Novartis (opt-in option)

 

Phase II

ruxolitinib

 

Non-Small Cell Lung Cancer

 

Novartis (opt-in option)

 

Phase II

ruxolitinib

 

Colorectal Cancer

 

Novartis (opt-in option)

 

Phase II

JAK1

 

 

 

 

 

 

INCB39110

 

Pancreatic Cancer

 

None

 

Phase II

INCB39110

 

Non-Small Cell Lung Cancer

 

None

 

Phase II

INCB52793

 

Advanced malignancies

 

None

 

Phase I/II

PI3K-delta

 

 

 

 

 

 

INCB40093

 

B-lymphoid Malignancies

 

None

 

Phase I/II

INCB50465

 

B-lymphoid Malignancies

 

None

 

Phase I/II

JAK1+PI3K-delta

 

 

 

 

 

 

INCB39110+INCB40093

 

B-lymphoid Malignancies

 

None

 

Phase I/II

IDO1

 

 

 

 

 

 

epacadostat

 

Metastatic Melanoma

 

None

 

Phase II

epacadostat

 

Non-Small Cell Lung Cancer

 

Merck

 

Phase I/II

epacadostat

 

Non-Small Cell Lung Cancer

 

Roche / Genentech

 

Phase I/II

epacadostat

 

Multiple tumor types

 

AstraZeneca / MedImmune

 

Phase I/II

epacadostat

 

Multiple tumor types

 

Bristol-Myers Squibb

 

Phase I/II

c-MET

 

 

 

 

 

 

capmatinib

 

Solid Tumors

 

Novartis

 

Phase I/II

capmatinib

 

Hepatocellular Carcinoma

 

Novartis

 

Phase II

capmatinib

 

Non-Small Cell Lung Cancer

 

Novartis

 

Phase II

FGFR

 

 

 

 

 

 

INCB54828

 

Solid Tumors

 

None

 

Phase I/II

BRD

 

 

 

 

 

 

INCB54329

 

Hematology / Oncology

 

None

 

Phase I/II

 

 

 

 

 

 

 

INFLAMMATION

 

 

 

 

 

 

JAK1 and JAK2

 

 

 

 

 

 

baricitinib

 

Rheumatoid Arthritis

 

Lilly

 

Phase III

baricitinib

 

Psoriasis

 

Lilly

 

Phase IIb

baricitinib

 

Diabetic Nephropathy

 

Lilly

 

Phase II

 


(1)                                 For information about certain of our agreements with collaborators and other third parties, please see “Business Relationships” below and Note 7, License Agreements to our condensed consolidated financial statements included in this report.

 

(2)                                JAKAFI is approved for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post—polycythemia vera MF, and post—essential thrombocythemia MF.

 

(3)                                 JAKAFI is approved for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

 

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Business Relationships

 

As part of our business strategy, we establish business relationships, including collaborative arrangements with other companies and medical research institutions to assist in the clinical development and/or commercialization of certain of our drugs and drug candidates and to provide support for our research programs. We also evaluate opportunities for acquiring products or rights to products and technologies that are complementary to our business from other companies and medical research institutions.

 

Below is a brief description of our significant relationships and collaborations that expand our pipeline and provide us with certain rights to existing and potential new products and technologies. For more information regarding certain of these relationships, including their ongoing financial and accounting impact on our business, please read Note 7, License Agreements to our condensed consolidated financial statements included in this report.

 

·                  Novartis - In November 2009, we entered into a Collaboration and License Agreement with Novartis. Under the terms of the agreement, Novartis received exclusive development and commercialization rights outside of the United States to our JAK inhibitor ruxolitinib and certain back-up compounds for hematologic and oncology indications, including all hematological malignancies, solid tumors and myeloproliferative diseases. We retained exclusive development and commercialization rights to JAKAFI (ruxolitinib) in the United States and in certain other indications including pancreatic cancer, breast cancer, non-small cell lung cancer, and colorectal cancer. Novartis also received worldwide exclusive development and commercialization rights to our c-MET inhibitor compound capmatinib and certain back-up compounds in all indications. We retained options to co-develop and to co-promote capmatinib in the United States. Several JAKAFI clinical trials in patients with myelofibrosis are ongoing, including long-term extension studies, alternative dosing studies, joint global trials with Novartis and trials in patients with low platelet counts.

 

·                  Lilly - In December 2009, we entered into a License, Development and Commercialization Agreement with Lilly. Under the terms of the agreement, Lilly received exclusive worldwide development and commercialization rights to our JAK inhibitor baricitinib, and certain back-up compounds for inflammatory and autoimmune diseases. We retained options to co-develop and co-promote our JAK inhibitors for the treatment of Diabetic Nephropathy, we retained options to co-promote our JAK inhibitors for the treatment of Psoriasis, and we elected to co-develop our JAK inhibitors for the treatment of Rheumatoid Arthritis and retained co-promotion options.

 

·                  Merck & Co. - In 2014, we entered into a clinical trial agreement with Merck to evaluate epacadostat with their anti-PD-1immunotherapy, Keytruda (pembrolizumab), for the treatment of previously treated metastatic and recurrent non-small cell lung cancer and other advanced or metastatic cancers. The trial is in progress and is currently in Phase I/II.

 

·                  Roche / Genentech - In 2014, we entered into a clinical trial agreement with Roche / Genentech to evaluate epacadostat with their anti-PD-L1 immunotherapy, ateolizumab (MPDL3280A), for the treatment of non-small cell lung cancer. The trial is in progress and is currently in Phase I/II.

 

·                  AstraZeneca / MedImmune - In 2014, we entered into a clinical trial agreement with AstraZeneca / MedImmune to evaluate epacadostat with their anti-PD-L1 immunotherapy, MEDI4736, for the treatment of multiple solid tumors, including non-small cell lung cancer, metastatic melanoma, squamous cell carcinoma of the head and neck and pancreatic cancer.  The trial is in progress and is currently in Phase I/II.

 

·                  Bristol-Myers Squibb - In 2014, we entered into a clinical trial agreement with Bristol-Myers Squibb to evaluate epacadostat with their anti-PD-1 immunotherapy, Opdivo (nivolumab), for the treatment of tumors which could potentially include non-small cell lung cancer, melanoma, squamous cell carcinoma of the head and neck, colorectal and ovarian cancer, and diffuse large B-cell lymphoma.  The trial is in progress and is currently in Phase I/II.

 

·                  Agenus - In 2015, we announced a global license, development and commercialization agreement with Agenus Inc. focused on novel immuno-therapeutics using Agenus’ proprietary Retrocyte Display antibody discovery platform. The alliance will initially focus on the development of checkpoint modulator antibodies directed against GITR, OX40, LAG-3 and TIM-3.

 

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Critical Accounting Policies and Significant Estimates

 

The preparation of financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent assets and liabilities. On an on-going basis, we evaluate our estimates. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances, the results of which form our 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 those estimates under different assumptions or conditions.

 

We believe the following critical accounting policies affect the more significant judgments and estimates used in the preparation of our condensed consolidated financial statements:

 

·                  Revenue recognition;

 

·                  Research and development costs;

 

·                  Stock compensation;

 

·                  Investments;

 

·                  Inventory; and

 

·                  Convertible debt accounting

 

Revenue Recognition. Revenues are recognized when (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services have been rendered, (3) the price is fixed or determinable and (4) collectability is reasonably assured. Revenues are deferred for fees received before earned or until no further obligations exist. We exercise judgment in determining that collectability is reasonably assured or that services have been delivered in accordance with the arrangement. We assess whether the fee is fixed or determinable based on the payment terms associated with the transaction and whether the sales price is subject to refund or adjustment. We assess collectability based primarily on the customer’s payment history and on the creditworthiness of the customer.

 

Product Revenues

 

Our product revenues consist of U.S. sales of JAKAFI and are recognized once we meet all four revenue recognition criteria described above. In November 2011, we began shipping JAKAFI to our specialty pharmacy customers, which in turn dispense JAKAFI to patients in fulfillment of prescriptions.

 

We recognize revenues for product received by our specialty pharmacy customers net of allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, patient assistance programs, and Medicare Part D coverage gap reimbursements. Product shipping and handling costs are included in cost of product revenues.

 

Customer Credits:  Our specialty pharmacy customers are offered various forms of consideration, including allowances, service fees and prompt payment discounts. We expect our specialty pharmacy customers will earn prompt payment discounts and, therefore, we deduct the full amount of these discounts from total product sales when revenues are recognized. Service fees are also deducted from total product sales as they are earned.

 

Rebates:  Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector benefit providers. The accrual for rebates is based on statutory discount rates and expected utilization as well as historical data we have accumulated since product launch. Our estimates for expected utilization of rebates are based on data received from our specialty pharmacy customers. Rebates are generally invoiced and paid 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 prior quarters’ unpaid rebates. If actual future rebates vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

 

Chargebacks:  Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy, or an intermediary distributor. Contracted customers, which currently consist primarily of Public Health Service institutions, non-

 

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profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy or distributor, in turn, charges back to us the difference between the price initially paid by the specialty pharmacy or distributor and the discounted price paid to the specialty pharmacy or distributor by the customer. The accrual for chargebacks is based on the estimated contractual discounts on the inventory levels on hand in our distribution channel. If actual future chargebacks vary from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

 

Medicare Part D Coverage Gap:  Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Our estimates for the expected Medicare Part D coverage gap are based on historical invoices received and in part from data received from our specialty pharmacy customers. Funding of the coverage gap is generally invoiced and paid 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 prior quarters. If actual future funding varies from estimates, we may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

 

Co-payment Assistance:  Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. We accrue a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators.

 

Product Royalty Revenues

 

Royalty revenues on commercial sales for JAKAVI by Novartis are estimated based on information provided by Novartis. We exercise judgment in determining whether the information provided is sufficiently reliable for us to base our royalty revenue recognition thereon. If actual royalties vary from estimates, we may need to adjust prior period which would affect royalty revenue in the period of adjustment.

 

Cost of Product Revenues

 

Cost of product revenues includes all JAKAFI related costs that are recoverable through the commercialization of the product. Beginning in October 2014, we became obligated to pay tiered, low single digit royalties to Novartis on all future sales of JAKAFI in the United States, which are included in cost of product revenues.

 

Contract and License Revenues

 

Under agreements involving multiple deliverables, services and/or rights to use assets that we entered into prior to January 1, 2011, the multiple elements are divided into separate units of accounting when certain criteria are met, including whether the delivered items have stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. When separate units of accounting exist, consideration is allocated among the separate elements based on their respective fair values. The determination of fair value of each element is based on objective evidence from historical sales of the individual elements by us to other customers. If such evidence of fair value for each undelivered element of the arrangement does not exist, all revenue from the arrangement is deferred until such time that evidence of fair value for each undelivered element does exist or until all elements of the arrangement are delivered. When elements are specifically tied to a separate earnings process, revenue is recognized when the specific performance obligation tied to the element is completed. When revenues for an element are not specifically tied to a separate earnings process, they are recognized ratably over the term of the agreement. We assess whether a substantive milestone exists at the inception of our agreements. For all milestones within our arrangements that are considered substantive, we recognize revenue upon the achievement of the associated milestone. If a milestone is not considered substantive, we would recognize the applicable milestone payment over the remaining period of performance under the arrangement. As of June 30, 2015, all remaining potential milestones under our collaborative arrangements are considered substantive.

 

On January 1, 2011, updated guidance on the recognition of revenues for agreements with multiple deliverables became effective and applies to any agreements we may enter into on or after January 1, 2011. This updated guidance (i) relates to whether multiple deliverables exist, how the deliverables in a revenue arrangement should be separated and how the consideration should be allocated; (ii) requires companies to allocate revenues in an arrangement using estimated selling prices of deliverables if a vendor does not have vendor-specific objective evidence or third-party evidence of selling price; and (iii) eliminates the use of the residual method and requires companies to allocate revenues using the relative selling price method. During the three and six months ended June 30, 2015 and 2014, we did not enter into any agreements that are subject to this updated guidance. If we enter into an agreement with multiple deliverables after January 1, 2011 or amend existing agreements, this updated guidance could have a material effect on our financial statements.

 

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Our collaborations often include contractual milestones, which typically relate to the achievement of pre-specified development, regulatory and commercialization events. These three categories of milestone events reflect the three stages of the life-cycle of our drugs, which we describe in more detail in the following paragraphs.

 

The regulatory review and approval process, which includes preclinical testing and clinical trials of each drug candidate, is lengthy, expensive and uncertain. Securing approval by the U.S. Food and Drug Administration (FDA) requires the submission of extensive preclinical and clinical data and supporting information to the FDA for each indication to establish a drug candidate’s safety and efficacy. The approval process takes many years, requires the expenditure of substantial resources, involves post-marketing surveillance and may involve ongoing requirements for post-marketing studies. Before commencing clinical investigations of a drug candidate in humans, we must submit an Investigational New Drug application (IND), which must be reviewed by the FDA.

 

The steps generally required before a drug may be marketed in the United States include preclinical laboratory tests, animal studies and formulation studies, submission to the FDA of an IND for human clinical testing, performance of adequate and well-controlled clinical trials in three phases, as described below, to establish the safety and efficacy of the drug for each indication, submission of a new drug application (NDA) or biologics license application (BLA) to the FDA for review and FDA approval of the NDA or BLA.

 

Similar requirements exist within foreign regulatory agencies as well. The time required satisfying the FDA requirements or similar requirements of foreign regulatory agencies may vary substantially based on the type, complexity and novelty of the product or the targeted disease.

 

Preclinical testing includes laboratory evaluation of product pharmacology, drug metabolism, and toxicity, which includes animal studies, to assess potential safety and efficacy as well as product chemistry, stability, formulation, development, and testing. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND. The FDA may raise safety concerns or questions about the conduct of the clinical trials included in the IND, and any of these concerns or questions must be resolved before clinical trials can proceed. We cannot be sure that submission of an IND will result in the FDA allowing clinical trials to commence. Clinical trials involve the administration of the investigational drug or the marketed drug to human subjects under the supervision of qualified investigators and in accordance with good clinical practices regulations covering the protection of human subjects. Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Phase I usually involves the initial introduction of the investigational drug into healthy volunteers to evaluate its safety, dosage tolerance, absorption, metabolism, distribution and excretion. Phase II usually involves clinical trials in a limited patient population to evaluate dosage tolerance and optimal dosage, identify possible adverse effects and safety risks, and evaluate and gain preliminary evidence of the efficacy of the drug for specific indications. Phase III clinical trials usually further evaluate clinical efficacy and safety by testing the drug in its final form in an expanded patient population, providing statistical evidence of efficacy and safety, and providing an adequate basis for labeling. We cannot guarantee that Phase I, Phase II or Phase III testing will be completed successfully within any specified period of time, if at all. Furthermore, we, the institutional review board for a trial, or the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

 

Generally, the milestone events contained in our collaboration agreements coincide with the progression of our drugs from development, to regulatory approval and then to commercialization. The process of successfully discovering a new development candidate, having it approved and successfully commercialized is highly uncertain. As such, the milestone payments we may earn from our partners involve a significant degree of risk to achieve. Therefore, as a drug candidate progresses through the stages of its life-cycle, the value of the drug candidate generally increases.

 

Research and Development Costs.  Our policy is to expense research and development costs as incurred. We often contract with clinical research organizations (CROs) to facilitate, coordinate and perform agreed upon research and development of a new drug. To ensure that research and development costs are expensed as incurred, we record monthly accruals for clinical trials and preclinical testing costs based on the work performed under the contract.

 

These CRO contracts typically call for the payment of fees for services at the initiation of the contract and/or upon the achievement of certain clinical trial milestones. In the event that we prepay CRO fees, we record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Most professional fees, including project and clinical management, data management, monitoring, and medical writing fees are incurred throughout the contract period. These professional fees are expensed based on their percentage of completion at a particular date. Our CRO contracts generally include pass through fees. Pass through fees include, but are not limited to, regulatory expenses, investigator fees, travel costs, and other miscellaneous costs, including shipping and printing fees. We expense the costs of pass through fees under our CRO contracts as they are incurred, based on the best information available to us at the time. The estimates of the pass through fees incurred are based on the amount of work completed for the clinical trial and are

 

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monitored through correspondence with the CROs, internal reviews and a review of contractual terms. The factors utilized to derive the estimates include the number of patients enrolled, duration of the clinical trial, estimated patient attrition, screening rate and length of the dosing regimen. CRO fees incurred to set up the clinical trial are expensed during the setup period.

 

Under our clinical trial collaboration agreements, we may be reimbursed for certain development costs incurred.  Such costs are recorded as a reduction of research and development expense in the period in which the related expense is incurred.

 

Stock Compensation.  Share-based payment transactions with employees, which include stock options, restricted stock units (RSUs) and performance shares (PSUs), are recognized as compensation expense over the requisite service period based on their estimated fair values on the dates of grant.  The stock compensation process requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected forfeiture rates and the probability of PSUs vesting.  The fair value of stock options, which are subject to graded vesting, are recognized as compensation expense over the requisite service period using the accelerated attribution method.  The fair value of RSUs, which are generally subject to cliff vesting, are recognized as compensation expense over the requisite service period using the straight line attribution method.  The fair value of PSUs are recognized as compensation expense beginning at the time in which the performance conditions are deemed probable of achievement, over the remaining requisite service period. We recorded $17.6 million and $35.2 million of stock compensation expense for the three and six months ended June 30, 2015, respectively. We recorded $15.5 million and $30.8 million of stock compensation expense for the three and six months ended June 30, 2014, respectively.

 

Investments.  We carry our investments at their respective fair values. We periodically evaluate the fair values of our investments to determine whether any declines in the fair value of investments represent an other-than-temporary impairment. This evaluation consists of a review of several factors, including the length of time and extent that a security has been in an unrealized loss position, the existence of an event that would impair the issuer’s future repayment potential, the near term prospects for recovery of the market value of a security and if we intend to sell or if it is more likely than not that we will be required to sell the security before recovery of its amortized cost basis. If management determines that such an impairment exists, we would recognize an impairment charge. Because we may determine that market or business conditions may lead us to sell our marketable securities prior to maturity, we classify our marketable securities as “available-for-sale.” Investments in securities that are classified as available-for-sale and have readily determinable fair values are measured at fair market value in the balance sheets, and unrealized holding gains and losses for these investments are reported as a separate component of stockholders’ equity until realized. We classify marketable securities that are available for use in current operations as current assets on the condensed consolidated balance sheets.

 

We carry our long term investment in Agenus at fair value on the condensed consolidated balance sheets.  Fair value of the long term investment is based on the quoted market price of Agenus as of the balance sheet date.   All changes in fair value are reported in our condensed consolidated statements of operations as an unrealized gain (loss) on long term investment.

 

Inventory.  Inventories are determined at the lower of cost or market value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. We began capitalizing inventory in mid-November 2011 once the FDA approved JAKAFI as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to approval of JAKAFI have been recorded as research and development expense in our statements of operations. As a result, cost of product revenues for the next 15 to 18 months will reflect a lower average per unit cost of materials.

 

The raw materials and work-in-process inventory is not subject to expiration and the shelf life for finished goods inventory is 36 months from the start of manufacturing of the finished goods. We evaluate for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. We classify inventory as current on the condensed consolidated balance sheets when we expect inventory to be consumed for commercial use within the next twelve months.

 

Convertible Debt Accounting.  We perform an assessment of all embedded features of a debt instrument to determine if (1) such features should be bifurcated and separately accounted for, and (2) if bifurcation requirements are met, whether such features should be classified and accounted for as equity or liability instruments. If the embedded feature meets the requirements to be bifurcated and accounted for as a liability, the fair value of the embedded feature is measured initially, included as a liability on the condensed consolidated balance sheets, and re-measured to fair value at each reporting period. Any changes in fair value are recorded in the condensed consolidated statement of operations. We monitor, on an ongoing basis, whether events or circumstances could give rise to a change in our classification of embedded features.

 

We determined the embedded conversion options in the 0.375% convertible senior notes due 2018 (the 2018 Notes) and the 1.25% convertible senior notes due 2020 (the 2020 Notes) are not required to be separately accounted for as derivatives. However,

 

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since the 2018 Notes and the 2020 Notes can be settled in cash or common shares or a combination of cash and common shares at our option, we are required to separate the 2018 Notes and 2020 Notes into a liability and equity component. The carrying amount of the liability component is calculated by measuring the fair value of a similar liability that does not have an associated equity component. The carrying amount of the equity component representing the embedded conversion option is determined by deducting the fair value of the liability component from the initial proceeds. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense over the expected life of the 2018 Notes and 2020 Notes using the effective interest method. The equity component is not re-measured as long as it continues to meet the conditions for equity classification for contracts in an entity’s own equity.

 

The fair value of the liability component of the 2018 Notes was estimated at $299.4 million at issuance. Therefore, the difference between the $375.0 million face value of the 2018 Notes and the $299.4 million estimated fair value of the liability component will be amortized to interest expense over the term of the 2018 Notes through November 15, 2018 using the effective interest method.

 

The fair value of the liability component of the 2020 Notes was estimated at $274.8 million at issuance. Therefore, the difference between the $375.0 million face value of the 2020 Notes and the $274.8 million estimated fair value of the liability component will be amortized to interest expense over the term of the 2020 Notes through November 15, 2020 using the effective interest method.

 

The estimated fair value of the liability components at the date of issuance for the 2018 Notes and 2020 Notes were determined using valuation models and are complex and subject to judgment. Significant assumptions within the valuation models included an implied credit spread, the expected volatility and dividend yield of our common stock and the risk free interest rate for notes with a similar term.

 

Prior to May 14, 2014, the 2018 Notes and 2020 Notes were not convertible except in connection with a make whole fundamental change, as defined in the respective indentures. Beginning on, and including, May 15, 2014, the 2018 Notes and 2020 Notes are convertible prior to the close of business on the business day immediately preceding May 15, 2018, in the case of the 2018 Notes, and May 15, 2020, in the case of the 2020 Notes, only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2014 (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the 2018 Notes or 2020 Notes, as applicable, on each applicable trading day; (2) during the five business day period after any five consecutive trading day period (the measurement period) in which the trading price per $1,000 principal amount of 2018 Notes or 2020 Notes, as applicable, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate for the 2018 Notes or 2020 Notes, as applicable, on each such trading day; or (3) upon the occurrence of specified corporate events. On or after May 15, 2018, in the case of the 2018 Notes, and May 15, 2020, in the case of the 2020 Notes, until the close of business on the second scheduled trading day immediately preceding the relevant maturity date, the Notes are convertible at any time, regardless of the foregoing circumstances. Upon conversion we will pay or deliver, as the case may be, cash, shares of common stock or a combination of cash and shares of common stock, at our election.

 

On a quarterly basis, we perform an assessment in order to determine whether the 2018 Notes or 2020 Notes have become convertible at the option of the holder, based on meeting any of the conversion criteria described above. Should either the 2018 Notes or the 2020 Notes become convertible, we then assess our intent and ability to settle the 2018 Notes or the 2020 Notes in cash, shares of common stock, or a combination of cash and shares of common stock, in order to determine the appropriate classification of the 2018 Notes and the 2020 Notes at the balance sheet date. On July 1, 2015, the 2018 Notes and 2020 Notes became convertible through at least September 30, 2015, based on meeting the conversion criteria related to the sale price of our common stock during the calendar quarter ended June 30, 2015 as described above. Management’s intent is to settle any conversions of 2018 Notes or 2020 Notes in common shares and, therefore, the 2018 and 2020 Notes are reflected in long term liabilities on the condensed consolidated balance sheet as of June 30, 2015.

 

Recent Accounting Pronouncements

 

In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, “Presentation of Financial Statements—Going Concern,” to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. This guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter.

 

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Early application is permitted. We do not believe the pending adoption of ASU No. 2014-15 will have a material impact on our condensed consolidated financial statements.

 

In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers,” which provides a five step approach to be applied to all contracts with customers. ASU No. 2014-09 also requires expanded disclosures about revenue recognition. This guidance is effective for annual reporting periods beginning after December 15, 2017 and interim periods therein.  Early adoption is permitted for reporting periods beginning after December 15, 2016. We are currently analyzing the impact of ASU No. 2014-09 on our results of operations and, at this time, we are unable to determine the impact on the new standard, if any, on our condensed consolidated financial statements.

 

In February 2015, the FASB issued ASU No. 2015-02, “Amendments to the Consolidation Analysis,” which affects reporting entities that are required to evaluate whether they should consolidate certain legal entities.  The amendments place more emphasis in the consolidation evaluation on variable interests other than fee arrangements such as principal investment risk (including debt or equity interests), guarantees of the value of the assets or liabilities of the variable interest entity (VIE), written put options on the assets of the VIE, or similar obligations. Additionally, the amendments reduce the extent to which related party arrangements cause an entity to be considered a primary beneficiary. This guidance is to be applied using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the fiscal year of adoption. The amendments are effective for fiscal years beginning after December 15, 2015, and interim periods therein. We are currently analyzing the impact of ASU No. 2015-03, if any, on our condensed consolidated financial statements.

 

In April 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs,” which requires debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs is not affected by the amendments in this update.  This guidance is to be applied retrospectively and is effective for fiscal years beginning after December 15, 2015 and interim periods therein.  Early adoption is permitted. We are currently analyzing the impact of ASU No. 2015-03 on our condensed consolidated financial statements.

 

Results of Operations

 

We recorded net income of $9.3 million and basic and diluted net income per share of $0.05 for the three months ended June 30, 2015, as compared to a net loss of $36.9 million and basic and diluted net loss per share of $0.22 in the corresponding period in 2014. We recorded a net loss of $9.1 million and basic and diluted net loss per share of $0.05 for the six months ended June 30, 2015, as compared to a net loss of $70.8 million and basic and diluted net loss per share of $0.43 in the corresponding period in 2014.

 

Revenues.

 

 

 

For the Three Months Ended,
June 30,

 

For the Six Months Ended,
June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

(in millions)

 

(in millions)

 

Product revenues, net

 

$

142.4

 

$

84.0

 

$

257.7

 

$

153.7

 

Product royalty revenues

 

17.4

 

12.3

 

33.0

 

22.2

 

Contract revenues

 

3.2

 

3.2

 

31.4

 

13.4

 

Other revenues

 

 

0.1

 

0.2

 

0.1

 

Total revenues

 

$

163.0

 

$

99.6

 

$

322.3

 

$

189.4

 

 

Our product revenues, net from JAKAFI for the three and six months ended June 30, 2015, were $142.4 million and $257.7 million, respectively. Our product revenues, net from JAKAFI for the three and six months ended June 30, 2014, were $84.0 million and $153.7 million, respectively. The increase in product revenues for the six months ended June 30, 2015 as compared to the corresponding period in 2014 was comprised of a volume increase of $80.8 million and a price increase of $23.2 million.  Product revenues from the sale of JAKAFI are recorded net of estimated product returns, pricing discounts including rebates offered pursuant to mandatory federal and state government programs and chargebacks, prompt pay discounts and distribution fees and co-pay assistance. Our revenue recognition policies require estimates of the aforementioned sales allowances each period.

 

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The following table provides a summary of activity with respect to our sales allowances and accruals for the six months ended June 30, 2015:

 

Six Months Ended June 30, 2015

 

Discounts and
Distribution
Fees

 

Government
Rebates and
Chargebacks

 

Co-Pay
Assistance
and Other
Discounts

 

Product
Returns

 

Total

 

Balance at January 1, 2015

 

$

2,057

 

$

7,906

 

$

119

 

$

399

 

$

10,481

 

Allowances for current period sales

 

7,755

 

24,322

 

1,036

 

741

 

33,854

 

Allowances for prior period sales

 

(156

)

(358

)

 

 

(514

)

Credits/payments for current period sales

 

(5,644

)

(14,624

)

(928

)

(348

)

(21,544

)

Credits/payments for prior period sales

 

(1,694

)

(5,109

)

(61

)

(72

)

(6,936

)

Balance at June 30, 2015

 

$

2,318

 

$

12,137

 

$

166

 

$

720

 

$

15,341

 

 

Government rebates and chargebacks are the most significant component of our sales allowances. Increases in certain government reimbursement rates are limited to a measure of inflation, and when the price of a drug increases faster than this measure of inflation it will result in a penalty adjustment factor that causes a larger sales allowance to those government related entities. We expect government rebates and chargebacks as a percentage of our gross product sales will continue to increase in connection with any future JAKAFI price increases greater than the rate of inflation, and any such increase in these government rebates and chargebacks will have a negative impact on our reported product revenues, net.

 

We expect our sales allowances to fluctuate from quarter to quarter as a result of the Medicare Part D Coverage Gap, the volume of purchases eligible for government mandated discounts and rebates as well as changes in discount percentages which are impacted by potential future price increases, rate of inflation, and other factors.

 

Product royalty revenues on commercial sales of JAKAVI by Novartis are based on net sales of licensed products in licensed territories as provided by Novartis. Our net product royalty revenues for the three and six months ended June 30, 2015, were $17.4 million and $33.0 million, respectively. Our net product royalty revenues for the three and six months ended June 30, 2014, were $12.3 million and $22.2 million, respectively.

 

Our contract revenues were $3.2 million and $31.4 million for the three and six months ended June 30, 2015, respectively. Our contract revenues were $3.2 million and $13.4 million for the three and six months ended June 30, 2014, respectively. For the three and six months ended June 30, 2015 and 2014, contract revenues were derived from the straight line recognition of revenue associated with the Lilly upfront fees over the estimated performance period as well as milestone payments from Novartis earned during the periods. The upfront fees related to the Lilly agreement consisted of a $90.0 million upfront payment received in 2010.  During the six months ended June 30, 2015, under the Novartis agreement, we recognized a $25.0 million regulatory milestone triggered by the Committee for Medicinal Products for Human Use of the European Medicines Agency adopting a positive opinion for JAKAVI (ruxolitinib) for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. During the six months ended June 30, 2014, under the Novartis agreement, we recognized a $7.0 million development milestone based on the formal initiation by Novartis of a Phase II clinical trial evaluating capmatinib in non-small cell lung cancer.

 

Cost of Product Revenues.

 

We began capitalizing inventory in mid-November 2011 once the FDA approved JAKAFI as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to FDA approval of $9.6 million were recorded as research and development expenses in our statements of operations prior to commercialization of JAKAFI. At June 30, 2015, inventory with $1.8 million of product costs incurred prior to FDA approval had not yet been sold. We expect to sell the pre- commercialization inventory over the next 15 to 18 months; however, the time period over which this inventory is consumed will depend on a number of factors, including the amount of future JAKAFI sales, and the ability to utilize inventory prior to its expiration date. As a result, cost of product revenues for the next 15 to 18 months will reflect a lower average per unit cost of materials. Commencing in October 2014, we became obligated to pay tiered, low single digit royalties to Novartis on all sales of JAKAFI in the United States, which is included in cost of product revenues.

 

Cost of product revenues was $6.3 million and $9.2 million for the three and six months ended June 30, 2015, respectively. Cost of product revenues was $0.2 million and $0.4 million for the three and six months ended June 30, 2014, respectively. The increase in cost of product revenues for the three and six months ended June 30, 2015 as compared to the same periods in 2014 is due to increased JAKAFI sales and our obligation that commenced in October 2014 to pay royalties to Novartis on all JAKAFI sales in the United States. We expect future cost of product revenues to range in the mid-single digits as a percentage of net product sales subsequent to the utilization of all of the remaining pre-launch inventory.

 

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Operating Expenses.

 

Research and development expenses.

 

 

 

For the Three Months Ended,
June 30,

 

For the Six Months Ended,
June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

(in millions)

 

(in millions)

 

Salary and benefits related

 

$

25.4

 

$

21.0

 

$

51.6

 

$

42.2

 

Stock compensation

 

10.2

 

8.5

 

20.4

 

16.8

 

Clinical research and outside services

 

66.5

 

46.9

 

138.3

 

85.4

 

Occupancy and all other costs

 

10.3

 

8.3

 

20.5

 

15.9

 

 

 

 

 

 

 

 

 

 

 

Total research and development expenses

 

$

112.4

 

$

84.7

 

$

230.8

 

$

160.3

 

 

We currently account for research and development costs by natural expense line and not costs by project. Salary and benefits related expense increased from the three and six months ended June 30, 2014 to the three and six months ended June 30, 2015 due primarily to increased development headcount to sustain our development pipeline. Stock compensation expense may fluctuate from period to period based on the number of awards granted, stock price volatility and expected award lives, as well as expected award forfeiture rates which are used to value equity-based compensation. The increase in clinical research and outside services expense from the three and six months ended June 30, 2014 to the three and six months ended June 30, 2015 was primarily the result of increased development costs to advance our clinical pipeline and the $20.2 million charge related to the upfront payment made to Agenus pursuant to our license, development and commercialization agreement, as well as an additional $5.6 million of research and development costs incurred under the arrangement through June 30, 2015.  Research and development expenses for the three and six months ended June 30, 2015 and 2014 were net of $1.2 million, $2.4 million, $1.3 million and $2.4 million, respectively, of costs reimbursed by our collaborative partners. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of pre-clinical and clinical trial related activities. Many factors can affect the cost and timing of our clinical trials, including requests by regulatory agencies for more information, inconclusive results requiring additional clinical trials, slow patient enrollment, adverse side effects among patients, insufficient supplies for our clinical trials and real or perceived lack of effectiveness or safety of our investigational drugs in our clinical trials. In addition, the development of all of our products will be subject to extensive governmental regulation. These factors make it difficult for us to predict the timing and costs of the further development and approval of our products.

 

In July 2010, we elected to co-develop baricitinib with Lilly in rheumatoid arthritis and we are responsible for funding 30% of the associated future global development costs for this indication from the initiation of the Phase IIb trial through regulatory approval. Research and development expenses recorded under the Lilly agreement representing 30% of the global development costs for baricitinib for the treatment of rheumatoid arthritis were $10.3 million and $21.9 million for the three and six months ended June 30, 2015, respectively. Research and development expenses recorded under the Lilly agreement representing 30% of the global development costs for baricitinib for the treatment of rheumatoid arthritis were $12.7 million and $26.7 million for the three and six months ended June 30, 2014, respectively. We expect our share of the global development costs for baricitinib for the treatment of rheumatoid arthritis to decline upon submission of the NDA filing by Lilly in late 2015 or early 2016. We have retained certain mechanisms to give us cost protection as baricitinib advances in clinical development. We can defer our portion of co-development study costs by indication if they exceed a predetermined level. This deferment would be credited against future milestones or royalties and we would still be eligible for the full incremental royalties related to the co-development option. In addition, even if we have started co-development funding for any indication, we can at any time opt out, which will stop future co-development cost sharing. If we elect to do this we would still be eligible for our base royalties plus an incremental pro-rated royalty commensurate with our contribution to the total co-development cost for those indications for which we contributed funding.

 

Selling, general and administrative expenses.

 

 

 

For the Three Months Ended,
June 30,

 

For the Six Months Ended,
June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

(in millions)

 

(in millions)

 

Salary and benefits related

 

$

16.1

 

$

12.0

 

$

30.3

 

$

24.7

 

Stock compensation

 

7.4

 

7.0

 

14.7

 

14.0

 

Other contract services and outside costs

 

28.2

 

21.9

 

51.5

 

39.2

 

 

 

 

 

 

 

 

 

 

 

Total selling, general and administrative expenses

 

$

51.7

 

$

40.9

 

$

96.5

 

$

77.9

 

 

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Salary and benefits related expense increased from the three and six months ended June 30, 2014 to the three and six months ended June 30, 2015 due to increased headcount. This increased headcount was due primarily to the ongoing commercialization efforts related to JAKAFI for intermediate or high-risk myelofibrosis and for the commercial launch in uncontrolled polycythemia vera which occurred in December 2014. Stock compensation expense may fluctuate from period to period based on the number of awards granted, stock price volatility and expected award lives, as well as expected award forfeiture rates which are used to value equity-based compensation. The increase in other contract services and outside costs was primarily the result of marketing activities for JAKAFI for intermediate or high-risk myelofibrosis and uncontrolled polycythemia vera.

 

Other income (expense).

 

Interest and other income, net. Interest and other income, net, for the three and six months ended June 30, 2015 was $1.1 million and $2.8 million, respectively. Interest and other income, net, for the three and six months ended June 30, 2014 was $0.8 million and $1.5 million, respectively.

 

Interest Expense.  Interest expense for the three and six months ended June 30, 2015 was $11.5 million and $24.2 million, respectively as compared to $11.4 million and $22.8 million, respectively, for the same periods in 2014. Included in interest expense for the three and six months ended June 30, 2015, were $8.5 million and $17.8 million, respectively, of non-cash charges to amortize the discounts on our 4.75% convertible senior notes due 2015 (the 2015 Notes), the 2018 Notes and the 2020 Notes as compared to $8.9 million and $17.7 million, respectively, for the same periods in 2014.

 

Unrealized gain on long term investment. The unrealized gain on our long term investment in Agenus for the three and six months ended June 30, 2015 was $27.2 million, based on the change in fair value of Agenus’ common stock during the period.

 

Debt exchange expense on senior note conversions.  Debt exchange expense on senior note conversions for the three and six months ended June 30, 2014 was $0.0 million and $0.3 million, respectively, and was related to the exchange of $4.9 million in aggregate principal amount of our 2015 Notes for the underlying shares of common stock and cash.

 

Liquidity and Capital Resources

 

We had net losses from inception in 1991 through 1996 and in 1999 through June 30, 2015. Because of those losses, we had an accumulated deficit of $1.8 billion as of June 30, 2015. We have funded our research and development operations through sales of equity securities, the issuance of convertible notes, cash received from customers, and collaborative arrangements. At June 30, 2015, we had available cash, cash equivalents and marketable securities of $627.5 million. Our cash and marketable securities balances are held in a variety of interest-bearing instruments, including money market accounts, corporate debt securities and U.S. government agency and non-agency mortgage-backed securities. Available cash is invested in accordance with our investment policy’s primary objectives of liquidity, safety of principal and diversity of investments.

 

Net cash provided by operating activities was $8.8 million for the six months ended June 30, 2015, compared to $46.3 million used in operating activities for the six months ended June 30, 2014.  The $55.1 million increase in cash provided by operating activities was due primarily to our lower net loss during the 2015 period.

 

Our investing activities, other than purchases, sales and maturities of marketable securities, have consisted predominantly of capital expenditures and purchases of long term investments.  Net cash used in investing activities was $85.3 million for the six months ended June 30, 2015, which represented purchases of marketable securities of $80.2 million, capital expenditures of $5.7 million, and our long term investment in Agenus of $39.8 million offset in part by maturities of marketable securities of $40.5 million.  Net cash used in investing activities was $76.2 million for the six months ended June 30, 2014, which represented purchases of marketable securities of $65.1 million and capital expenditures of $11.4 million offset in part by maturities of marketable securities of $0.2 million.  In the future, net cash used by investing activities may fluctuate significantly from period to period due to the timing of strategic equity investments, acquisitions and capital expenditures and maturities/sales and purchases of marketable securities.

 

Net cash provided by financing activities was $63.8 million and $57.3 million for the six months ended June 30, 2015 and 2014, respectively, primarily representing proceeds from the issuance of common stock under our stock plans and employee stock purchase plan.

 

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Table of Contents

 

The following summarizes our significant contractual obligations as of June 30, 2015 and the effect those obligations are expected to have on our liquidity and cash flow in future periods (in millions):

 

 

 

Total

 

Less Than
1 Year

 

Years
2 - 3

 

Years
4 - 5

 

Over
5 Years

 

Contractual Obligations: