Edgar Filing: AGIOS PHARMACEUTICALS INC

Document

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)


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

For the quarterly period ended June 30, 2018


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

Commission file number 001-36014

AGIOS PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)


Delaware			26-0662915
(State or Other Jurisdiction of Incorporation or Organization)			(I.R.S. Employer Identification No.)

88 Sidney Street, Cambridge, Massachusetts			02139
(Address of Principal Executive Offices)			(Zip Code)

(617) 649-8600

(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

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

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

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


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

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

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

Number of shares of the registrant’s Common Stock, $0.001 par value, outstanding on July 30, 2018: 57,992,576

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AGIOS PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2018

TABLE OF CONTENTS


		Page No.
PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	3
	Condensed Consolidated Balance Sheets as of June 30 , 2018 and December 31, 2017	3
	Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2018 and 2017	4
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017	5
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017	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	35
Item 4.	Controls and Procedures	35
PART II. OTHER INFORMATION		37
Item 1A.	Risk Factors	37
Item 6.	Exhibits	69
	Signatures	70

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(Unaudited)


	June 30, 2018		December 31, 2017
Assets
Current assets:
Cash and cash equivalents	$	210,323	$	102,724
Marketable securities	506,582		321,212
Collaboration receivable – related party	19,326		2,448
Collaboration receivable – other	440		—
Royalty receivable – related party	1,573		1,222
Prepaid expenses and other current assets	15,538		17,655
Total current assets	753,782		445,261
Marketable securities	219,724		143,814
Property and equipment, net	24,134		24,431
Other non-current assets	595		891
Total assets	$	998,235	$	614,397
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	17,320	$	22,767
Accrued expenses	25,793		34,031
Deferred revenue – related party	41,132		37,842
Deferred rent	625		301
Total current liabilities	84,870		94,941
Deferred revenue, net of current portion – related party	72,408		125,798
Deferred rent, net of current portion	17,815		18,155
Total liabilities	175,093		238,894
Stockholders’ equity:
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at June 30, 2018 and December 31, 2017	—		—
Common stock, $0.001 par value; 125,000,000 shares authorized; 57,932,639 and 48,826,153 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively	58		49
Additional paid-in capital	1,743,657		1,174,904
Accumulated other comprehensive loss	(2,398)		(1,389)
Accumulated deficit	(918,175)		(798,061)
Total stockholders’ equity	823,142		375,503
Total liabilities and stockholders’ equity	$	998,235	$	614,397

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See accompanying Notes to Condensed Consolidated Financial Statements.

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2018		2017		2018		2017
Collaboration revenue – related party	$	26,401	$	11,346	$	33,746	21,854
Collaboration revenue – other	12,440		—		12,440		—
Royalty revenue – related party	1,573		—		2,990		—
Total revenue	40,414		11,346		49,176		21,854
Operating expenses:
Research and development (net of $2,489 and $5,265 of cost reimbursement from related party for the three and six months ended June 30, 2017)	86,730		79,816		164,954		142,548
General and administrative	26,633		16,130		51,183		30,953
Total operating expenses	113,363		95,946		216,137		173,501
Loss from operations	(72,949)		(84,600)		(166,961)		(151,647)
Interest income	4,204		1,518		7,391		2,399
Net loss	$	(68,745)	$	(83,082)	$	(159,570)	$	(149,248)
Net loss per share – basic and diluted	$	(1.19)	$	(1.78)	$	(2.81)	$	(3.35)
Weighted-average number of common shares used in computing net loss per share – basic and diluted	57,721,786		46,745,760		56,713,795		44,525,478

See accompanying Notes to Condensed Consolidated Financial Statements.

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AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands)

(Unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,
	2018		2017		2018		2017
Net loss	$	(68,745)	$	(83,082)	$	(159,570)	$	(149,248)
Other comprehensive income (loss)
Unrealized gain (loss) on available-for-sale securities	245		(438)		(1,009)		(337)
Comprehensive loss	$	(68,500)	$	(83,520)	$	(160,579)	$	(149,585)

See accompanying Notes to Condensed Consolidated Financial Statements.

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AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)


	Six Months Ended June 30,
	2018		2017
Operating activities
Net loss	$	(159,570)	$	(149,248)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	3,464		3,164
Stock-based compensation expense	30,977		22,921
Net amortization of premium and discounts on investments	(1,291)		94
Loss on disposal of property and equipment	(20)		40
Changes in operating assets and liabilities:
Collaboration receivable – related party	(16,878)		44
Collaboration receivable – other	(440)		—
Royalty receivable – related party	(351)		—
Tenant improvement and other receivables	—		2,638
Prepaid expenses and other current and non-current assets	2,413		(2,417)
Accounts payable	(6,198)		4,930
Accrued expenses	(7,841)		(2,392)
Deferred revenue – related party	(10,644)		(11,184)
Deferred rent	(16)		(1,653)
Net cash used in operating activities	(166,395)		(133,063)
Investing activities
Purchases of marketable securities	(592,664)		(468,556)
Proceeds from maturities and sales of marketable securities	331,666		303,711
Purchases of property and equipment	(2,793)		(1,328)
Net cash used in investing activities	(263,791)		(166,173)
Financing activities
Payment of public offering costs, net of reimbursements	(391)		104
Proceeds from public offering of common stock, net of commissions	516,206		270,250
Net proceeds from stock option exercises and employee stock purchase plan	21,970		6,845
Net cash provided by financing activities	537,785		277,199
Net change in cash and cash equivalents	107,599		(22,037)
Cash and cash equivalents at beginning of the period	102,724		160,754
Cash and cash equivalents at end of the period	$	210,323	$	138,717
Supplemental disclosure of non-cash investing and financing transactions
Additions to property and equipment in accounts payable and accrued expenses	$	1,365	$	1,383
Proceeds from stock option exercises in other current assets	$	—	$	3
Public offering costs in other receivables, net of amounts in accounts payable and accrued expenses	$	—	$	125

See accompanying Notes to Condensed Consolidated Financial Statements.

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AGIOS PHARMACEUTICALS, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Overview and Basis of Presentation

References to Agios

Throughout this Quarterly Report on Form 10-Q, “we,” “us,” and “our,” and similar expressions, except where the context requires otherwise, refer to Agios Pharmaceuticals, Inc. and its consolidated subsidiaries, and “our Board of Directors” refers to the board of directors of Agios Pharmaceuticals, Inc.

Overview

We are a biopharmaceutical company committed to the fundamental transformation of patients’ lives through scientific leadership in the field of cellular metabolism, with the goal of making transformative, first- or best-in-class medicines. Our therapeutic areas of focus are cancer and rare genetic diseases, or RGDs, which are diseases that are directly caused by changes in genes or chromosomes, often passed from one generation to the next. Most RGDs are often associated with severe or life-threatening features. The incidence of a single RGD can vary widely but is generally very infrequent, usually equal to or less than one per 100,000 births. In both areas of cancer and RGDs, we are seeking to unlock the biology of cellular metabolism as a platform to create transformative therapies. We are located in Cambridge, Massachusetts.

Basis of presentation

The condensed consolidated balance sheet as of June 30, 2018, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2018 and 2017, and cash flows for the six months ended June 30, 2018 and 2017 are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of June 30, 2018, our results of operations for the three and six months ended June 30, 2018 and 2017, and cash flows for the six months ended June 30, 2018 and 2017. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and six-month period are also unaudited. The results of operations for the three and six months ended June 30, 2018 are not necessarily indicative of the results to be expected for the year ending December 31, 2018 or for any other future annual or interim period. The year-end condensed consolidated balance sheet data was derived from our audited financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles, or U.S. GAAP. Accordingly, the condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2017 that was filed with the Securities and Exchange Commission, or the SEC, on February 14, 2018.

Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries, Agios Securities Corporation, Agios International Sarl, and Agios Limited. All intercompany transactions have been eliminated in consolidation. The consolidated financial statements have been prepared in conformity with U.S. GAAP.

Liquidity

In January 2018, we completed a public offering of 8,152,986 shares of common stock at an offering price of $67.00 per share. We received net proceeds from this offering of $516.2 million, after deducting underwriting discounts and commissions paid by us.

As of June 30, 2018, we had cash, cash equivalents and marketable securities of $936.6 million. Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and marketable securities will be sufficient to fund current operations for at least the next twelve months from the issuance date of these financial statements.

2. Summary of Significant Accounting Policies and Recent Accounting Pronouncements

Significant accounting policies

Revenue from Contracts with Customers

In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers (Topic 606), which was codified as Accounting Standards Codification 606, Revenue from Contracts with Customers, or ASC 606, and amended through subsequent ASUs. We adopted ASC 606 effective January

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1, 2018 using the modified retrospective method. Under this method, we recognized the cumulative effect of the change in the opening balance of accumulated deficit in the current period condensed consolidated balance sheet.

In adopting ASC 606, we applied the practical expedient that permits aggregating the effect of all modifications that occurred prior to January 1, 2018. No other practical expedients were used.

Upon finalization of our assessment, which resulted in changes to our estimates as of December 31, 2017, the impact of the cumulative effect of the accounting changes upon the adoption of the standard (in thousands) is as follows:


	December 31, 2017		Cumulative Effect		January 1, 2018
Deferred revenue – related party, current and net of current portions	$	163,640	$	(39,456)	$	124,184
Accumulated deficit	(798,061)		39,456		(758,605)

The following tables summarize the effects of adopting ASC 606 on our unaudited condensed consolidated financial statements (in thousands, except per share data):

Condensed Consolidated Balance Sheets


	June 30, 2018
	Under Topic 606		Under Topic 605		Effect of Change
Collaboration receivable – related party	$	19,326	$	19,326	$	—
Collaboration receivable – other	440		—		440
Deferred revenue – related party	41,132		35,204		5,928
Deferred revenue, net of current portion – related party	72,408		113,516		(41,108)
Accumulated deficit	(918,175)		(953,795)		35,620

Condensed Consolidated Statements of Operations


	Three Months Ended June 30, 2018						Six Months Ended June 30, 2018
	Under Topic 606		Under Topic 605		Effect of Change		Under Topic 606		Under Topic 605		Effect of Change
Collaboration revenue – related party	$	26,401	$	25,982	$	419	$	33,746	$	35,959	$	(2,213)
Collaboration revenue – other	12,440		12,000		440		12,440		12,000		440
Research and development expense	86,730		85,078		1,652		164,954		162,891		2,063
Total operating expenses	113,363		111,711		1,652		216,137		214,074		2,063
Loss from operations	(72,949)		(72,156)		(793)		(166,961)		(163,125)		(3,836)
Net loss	(68,745)		(67,952)		(793)		(159,570)		(155,734)		(3,836)
Net loss per share – basic and diluted	(1.19)		(1.18)		(0.01)		(2.81)		(2.75)		(0.06)

Condensed Consolidated Statements of Comprehensive (Loss) Income


	Three Months Ended June 30, 2018						Six Months Ended June 30, 2018
	Under Topic 606		Under Topic 605		Effect of Change		Under Topic 606		Under Topic 605		Effect of Change
Net loss	$	(68,745)	$	(67,952)	$	(793)	$	(159,570)	$	(155,734)	$	(3,836)
Comprehensive loss	(68,500)		(67,707)		(793)		(160,579)		(156,743)		(3,836)

Condensed Consolidated Statements of Cash Flows


	Six Months Ended June 30, 2018
	Under Topic 606		Under Topic 605		Effect of Change
Net loss	$	(159,570)	$	(155,734)	$	(3,836)
Adjustments to reconcile net loss to net cash used in operating activities:
Collaboration receivable – related party	(16,878)		(16,878)		—
Collaboration receivable – other	(440)		—		(440)
Deferred revenue – related party	(10,644)		(14,920)		4,276

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Recent accounting pronouncements

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), or ASU 2016-02, which establishes principles that lessees and lessors shall apply to report useful information to users of financial statements about the amount, timing and uncertainty of cash flows arising from a lease. ASU 2016-02 was codified as ASC 842, Leases. Subsequently, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842): Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments (SEC Update), which codifies recent announcements by the SEC staff; ASU 2018-01, Leases (Topic 842): Land Easement Practical Expedient for Transition to Topic 842, which provides a transition practical expedient for existing or expired land easements; ASU 2018-10, Codification Improvements to Topic 842, Leases, which provides amendments to further clarify and improve sections of ASU 2016-02; and ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides an additional transition method. These ASUs, collectively with ASU 2016-02, are referred to as the Leases ASUs.

We will adopt ASC 842 effective January 1, 2019. We are currently in the process of evaluating the impact of the guidance on our consolidated financial statements.

Other accounting standards that have been issued by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption.

3. Fair Value Measurements

We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures, establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The hierarchy consists of three levels:

Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability.

Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of June 30, 2018 (in thousands):


	Level 1		Level 2		Level 3		Total
Cash equivalents	$	193,755	$	16,206	$	—	$	209,961
Marketable securities:
Certificates of deposit	—		1,670		—		1,670
U.S. Treasuries	—		258,117		—		258,117
Government securities	—		111,695		—		111,695
Corporate debt securities	—		354,824		—		354,824
Total cash equivalents and marketable securities	$	193,755	$	742,512	$	—	$	936,267

Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches, and observable market inputs to determine value. After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2018.

There have been no changes to the valuation methods during the six months ended June 30, 2018. We evaluate transfers between levels at the end of each reporting period. There were no transfers between Level 1 and Level 2 during the six months ended June 30, 2018. We have no financial assets or liabilities that were classified as Level 3 at any point during the six months ended June 30, 2018.

4. Marketable Securities

Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities, and are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive

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loss other comprehensive loss in stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were no realized gains or losses on marketable securities for the three and six months ended June 30, 2018 and 2017 and, as a result, there were no reclassifications of any amounts out of accumulated other comprehensive loss for those periods.

Marketable securities at June 30, 2018 consisted of the following (in thousands):


	Amortized Cost		Unrealized Gains		Unrealized Losses		Fair Value
Current:
Certificates of deposit	$	1,440	$	—	$	(6)	$	1,434
U.S Treasuries	226,668		4		(245)		226,427
Government securities	64,585		—		(148)		64,437
Corporate debt securities	214,677		—		(393)		214,284
Non-current:
Certificates of deposit	239		—		(3)		236
U.S Treasuries	31,997		—		(307)		31,690
Government securities	47,534		—		(276)		47,258
Corporate debt securities	141,564		—		(1,024)		140,540
Total marketable securities	$	728,704	$	4	$	(2,402)	$	726,306

Marketable securities at December 31, 2017 consisted of the following (in thousands):


	Amortized Cost		Unrealized Gains		Unrealized Losses		Fair Value
Current:
Certificates of deposit	$	8,081	$	—	$	(11)	$	8,070
U.S. Treasuries	113,852		—		(119)		113,733
Government securities	44,421		—		(57)		44,364
Corporate debt securities	155,222		—		(177)		155,045
Non-current:
Certificates of deposit	960		—		(8)		952
U.S. Treasuries	36,165		—		(311)		35,854
Government securities	23,992		—		(182)		23,810
Corporate debt securities	83,722		—		(524)		83,198
Total marketable securities	$	466,415	$	—	$	(1,389)	$	465,026

At June 30, 2018 and December 31, 2017, we held both current and non-current investments. Investments classified as current have maturities of less than one year. Investments classified as non-current are those that: (i) have a maturity of one year to two years, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and therefore classified as available-for-sale.

At June 30, 2018 and December 31, 2017, we held 246 and 240 debt securities that were in an unrealized loss position for less than one year, respectively. The aggregate fair value of debt securities in an unrealized loss position at June 30, 2018 and December 31, 2017 was $616.5 million and $439.4 million, respectively. There were no individual securities that were in a significant unrealized loss position as of June 30, 2018 and December 31, 2017. Given our intent and ability to hold such securities until recovery, and the lack of material of change in the credit risk of these investments, we do not consider these marketable securities to be other-than-temporarily impaired as of June 30, 2018 and December 31, 2017.

5. Collaboration and License Agreements

Celgene Corporation

To date, our revenue has primarily been generated from our collaboration agreements with Celgene, or collectively, the Collaboration Agreements. Celgene is a related party through ownership of our common stock. In April 2010, we entered into a discovery and development collaboration and license agreement focused on cancer metabolism, or the 2010 Agreement. The

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2010 Agreement was amended in October 2011 and July 2014. In April 2015, we entered into a joint worldwide development and profit share collaboration and license agreement with Celgene, and our wholly owned subsidiary, Agios International Sarl, entered into a collaboration and license agreement with Celgene International II Sarl, or collectively, the AG-881 Agreements, to establish a worldwide collaboration focused on the development and commercialization of AG-881 products. In May 2016, we entered into a master research and collaboration agreement with Celgene, or the 2016 Agreement.

2016 Agreement

In May 2016, we entered into the 2016 Agreement focused on metabolic immuno-oncology, or MIO, a developing field which aims to modulate the activity of relevant immune cells by targeting critical metabolic nodes, thereby, enhancing the immune mediated anti-tumor response. In addition to new programs identified under the 2016 Agreement, both parties also agreed that all future development and commercialization of two remaining cancer metabolism programs discovered under the 2010 Agreement, including AG-270, an inhibitor of methionine adenosyltransferase 2a, will now be governed by the 2016 Agreement.

During the research term of the 2016 Agreement, we plan to conduct research programs focused on discovering compounds that are active against metabolic targets in the immuno-oncology, or IO, field. The initial four-year research term will expire on May 17, 2020, and may be extended for up to two, or in specified cases, up to four additional one-year terms.

For each program under the 2016 Agreement, we may nominate compounds that meet specified criteria as development candidates and, in limited circumstances, Celgene may also nominate compounds as development candidates for each such program. Celgene may designate the applicable program for further development following any such nomination, after which we may conduct, at our expense, additional preclinical and clinical development for such program through the completion of an initial phase 1 dose escalation study.

At the end of the research term, Celgene may designate for continued development up to three research programs for which development candidates have yet to be nominated, which are referred to as continuation programs. We may conduct further research and preclinical and clinical development activities on any continuation program, at our expense, through the completion of an initial phase 1 dose escalation study.

We granted Celgene the right to obtain exclusive options for development and commercialization rights for each program that Celgene has designated for further development, and for each continuation program. Celgene may exercise each such option beginning on the designation of a development candidate for such program (or on the designation of such program as a continuation program) and ending on the earlier of: (i) the end of a specified period after we have furnished Celgene with specified information about the initial phase 1 dose escalation study for such program, or (ii) January 1, 2030. Research programs that have applications in the inflammation or autoimmune, or I&I, field that may result from the 2016 Agreement will also be subject to the exclusive options described above.

We will retain rights to any program that Celgene does not designate for further development or as to which it does not exercise its option.

Under the terms of the 2016 Agreement, following Celgene’s exercise of its option with respect to a program, the parties will enter into either a co-development and co-commercialization agreement if such program is in the IO field, or a license agreement if such program is in the I&I field. Under each co-development and co-commercialization agreement, the two parties will co-develop and co-commercialize licensed products worldwide. Either we or Celgene will lead development and commercialization of licensed products for the United States, and Celgene will lead development and commercialization of licensed products outside of the United States. Depending on the country, the parties will each have the right to provide a portion of field-based marketing activities. Under each license agreement, Celgene will have the sole right to develop and commercialize licensed products worldwide.

Co-development and co-commercialization agreements

Under each co-development and co-commercialization agreement entered into under the 2016 Agreement, the parties will split all post-option exercise worldwide development costs, subject to specified exceptions, as well as any profits from any net sales of, or commercialization losses related to, licensed products in the IO field. Celgene has the option to designate one program in the IO field as the 65/35 program, for which Celgene will be the lead party for the United States and will have a 65% profit or loss share. For programs in the IO field other than the 65/35 program, we and Celgene will alternate, on a program-by-program basis, being the lead party for the United States, with us having the right to be the lead party for the first such program, and each party will have a 50% profit or loss share. The lead party for the United States will book commercial sales of licensed products, if any, in the United States, and Celgene will book commercial sales of licensed products, if any, outside of the United States.

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License agreements

Under each license agreement under the 2016 Agreement, Celgene will be responsible for all post-option exercise worldwide development and associated costs, subject to specified exceptions, as well as worldwide commercialization and associated costs, for licensed products in the I&I field.

Financial terms

Under the terms of the 2016 Agreement, we received an initial upfront payment in the amount of $200.0 million. The 2016 Agreement provides specified rights to extend the research term for up to two, or in specified cases, up to four, additional years by paying a $40.0 million per-year extension fee. Celgene will pay an $8.0 million designation fee for each program that Celgene designates for further development and for each continuation program. During the three months ended March 31, 2017, we received $8.0 million from Celgene upon the designation of AG-270 as a development candidate. For each program as to which Celgene exercises its option to develop and commercialize, subject to antitrust clearance, Celgene will pay an option exercise fee of at least $30.0 million for any designated development program and at least $35.0 million for any continuation programs. In certain cases, Celgene may exercise its option to develop and commercialize two early-stage I&I programs, prior to Celgene designating the program for further development, by paying an option exercise fee of $10.0 million.

We are eligible to receive the following milestone-based payments associated with the 2016 Agreement:

Program

Milestone

Amount

65/35 program in IO field

Specified clinical development event

25 million

65/35 program in IO field

Specified regulatory milestone events

Up to $183.8 million

50/50 program in IO field

Specified clinical development event

$20.0 million

50/50 program in IO field

Specified regulatory milestone events

Up to $148.8 million

I&I field

Specified clinical development event

25.0 million

I&I field

Specified regulatory milestone events

Up to $236.3 million

I&I field

Specified commercial milestone events

Up to $125.0 million

Additionally, for each licensed program in the I&I field, we are eligible to receive royalties at tiered, low double-digit percentage rates on Celgene’s net sales, if any.

Opt-out right

Under the 2016 Agreement, we may elect to opt out of the cost and profit share under any co-development and co-commercialization agreement, subject to specified exceptions. Upon opting out, Celgene will have the sole right to develop, manufacture and commercialize the applicable licensed products throughout the world, at its cost, and we will undertake transitional activities reasonably necessary to transfer the development, manufacture and commercialization of such licensed products to Celgene, at our expense. Further, in lieu of the profit or loss sharing described above, we would be eligible to receive royalties at tiered, low double-digit percentage rates on Celgene’s net sales, if any, of the applicable licensed products. However, we would continue to be eligible to receive the developmental and regulatory milestone-based payments described above.

Term

The term of the 2016 Agreement commenced on May 17, 2016 and, if not terminated earlier, will expire upon the later of the last-to-expire of the research term and all option exercise periods, or, if an option is exercised by Celgene for one or more programs in the collaboration, upon the termination or expiration of the last-to-exist co-development and co-commercialization agreement or license agreement, as applicable, for any such program.

Termination

Subject to specified exceptions, Celgene may terminate the 2016 Agreement in its entirety for any reason by providing us with prior written notice if there are no active co-development and co-commercialization agreements or license agreements in place or on a program-by-program basis if there are no active co-development and co-commercialization agreements or license agreements in place for the terminated program(s). Either party may terminate the 2016 Agreement for the insolvency of the other party. On a program-by-program basis, prior to the exercise of an option, either party may terminate the 2016 Agreement either in its entirety or with respect to one or more programs on prior written notice to the other party in the case of an uncured material breach by the other party that frustrates the fundamental purpose of the 2016 Agreement. Following the exercise of an option for a program, either party may terminate the 2016 Agreement with respect to such program if such party terminates the co-development and co-commercialization agreement or license agreement for such program for an uncured material breach by the other party that frustrates the fundamental purpose of such agreement. Either party may terminate a co-development and co-

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commercialization agreement or a license agreement upon the bankruptcy or insolvency of the other party. Either party also has the right to terminate the co-development and co-commercialization agreement or license agreement if the other party or any of its affiliates challenges the validity, scope or enforceability of or otherwise opposes, any patent included within the intellectual property rights licensed to the other party under such agreement.

Exclusivity

While any of Celgene’s options remain available under the 2016 Agreement, subject to specified exceptions, we may not directly or indirectly develop, manufacture or commercialize, outside of the 2016 Agreement, any therapeutic modality in the IO or I&I field with specified activity against a metabolic target.

During the term of each co-development and co-commercialization agreement and license agreement, subject to specified exceptions, neither we nor Celgene may directly or indirectly develop, manufacture or commercialize outside of such agreement any therapeutic modality in any field with specified activity against the metabolic target that is the focus of the program licensed under such agreement.

TIBSOVO® Letter Agreement

In May 2016, we entered into a letter agreement with Celgene regarding TIBSOVO®, or the TIBSOVO® Letter Agreement. Under the TIBSOVO® Letter Agreement, the parties agreed to terminate the 2010 Agreement, effective as of August 15, 2016, as to the program directed to the isocitrate dehydrogenase 1, or IDH1, target, for which TIBSOVO® is the lead development candidate. Under the 2010 Agreement, Celgene had held development and commercialization rights to the IDH1 program outside of the United States, and we held such rights inside the United States. As a result of the termination, we obtained global rights to TIBSOVO® and the IDH1 program. Neither party will have any further financial obligation, including royalties or milestone payments, to the other concerning TIBSOVO® or the IDH1 program. Under the terms of the termination, the parties also agreed to conduct specified transitional activities in connection with the termination. In addition, pursuant to the TIBSOVO® Letter Agreement, the parties are released from their exclusivity obligations under the 2010 Agreement with respect to the IDH1 program. The termination does not affect the AG-881 Agreements, which are directed to both the IDH1 target and the isocitrate dehydrogenase 2, or IDH2, target.

AG-881 Agreements

In April 2015, we entered into the AG-881 Agreements. The AG-881 Agreements establish a joint worldwide collaboration focused on the development and commercialization of AG-881 products. Under the terms of the AG-881 Agreements, we received an initial upfront payment of $10.0 million in May 2015 and are eligible to receive milestone-based payments described below. The parties will split all worldwide development costs equally, subject to specified exceptions, as well as any profits from any net sales of, or commercialization losses related to, licensed AG-881 products. Either party may, at its own expense and with the other party's permission, undertake additional development activities outside of the scope of the development plan agreed upon with the other party.

We are eligible to receive up to $70.0 million in potential milestone payments under the AG-881 Agreements. The potential milestone payments are comprised of: (i) a $15.0 million milestone payment for filing of a first new drug application, or NDA, in a major market, and (ii) up to $55.0 million in milestone payments upon achievement of specified regulatory milestone events. We may also receive royalties at tiered, low-double digit to mid-teen percentage rates on net sales if we elect not to participate in the development and commercialization of AG-881.

Termination

Celgene may terminate the AG-881 Agreements in their entirety for any reason upon ninety days written notice to us. Either party may terminate the AG-881 Agreements for the insolvency of the other party. Either party may terminate the AG-881 Agreements in their entirety or with respect to one of the agreements upon prior written notice to the other party in the case of an uncured material breach by the other party that frustrates the fundamental purpose of the AG-881 Agreements. If one of the AG-881 Agreements terminates, the other will terminate automatically.

2010 Agreement

In April 2010, we entered into the 2010 Agreement, which was amended in October 2011 and July 2014. The goal of the collaboration was to discover, develop and commercialize disease-altering therapies in oncology based on our cancer metabolism research platform. We initially led discovery, preclinical and early clinical development for all cancer metabolism programs under the collaboration. The discovery phase of the 2010 Agreement expired in April 2016.

Upon agreement to terminate the 2010 Agreement, effective as of August 15, 2016, as to the program directed to the IDH1 target, for which TIBSOVO® is the lead development candidate, the sole program remaining under the 2010 Agreement is IDHIFA®, a co-commercialized licensed program for which Celgene leads and funds global development and commercialization activities. We have exercised our right to participate in a portion of commercialization activities in the

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United States for IDHIFA® in accordance with the applicable commercialization plan. On August 1, 2017, the U.S. Food and Drug Administration, or FDA, granted Celgene approval of IDHIFA® for the treatment of adult patients with relapsed or refractory acute myeloid leukemia, or R/R AML, with an IDH2 mutation as detected by an FDA-approved test.

During the three months ended June 30, 2018, Celgene submitted a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, for IDHIFA® for IDH2 mutant-positive R/R AML. As a result of the filing, we determined that a $15.0 million milestone payment for filing of a first new drug application equivalent in an ex-U.S. country is considered probable of being reached and a significant reversal of revenue would not occur in future periods. Under the remaining terms of the 2010 Agreement, we are eligible to receive up to $95.0 million in potential milestone payments for the IDHIFA® program. The potential milestone payments are comprised of: (i) up to $70.0 million in milestone payments upon achievement of specified ex-U.S. regulatory milestone events, including the aforementioned $15.0 million milestone for the MAA submission, and (ii) a $25.0 million milestone payment upon achievement of a specified ex-U.S. commercial milestone event.

Under the 2010 Agreement, we receive royalties at tiered, low-double digit to mid-teen percentage rates on net sales of IDHIFA®.

Unless terminated earlier by either party, the term of the 2010 Agreement will continue until the expiration of all royalty terms with respect to IDHIFA®. Celgene may terminate this agreement for convenience in its entirety upon ninety days written notice to us. If either party is in material breach and fails to cure such breach within the specified cure period, the other party may terminate the 2010 Agreement in its entirety. Either party may terminate the agreement in the event of specified insolvency events involving the other party.

Accounting analysis and revenue recognition – collaboration revenue

On January 1, 2018 we adopted ASC 606 under the modified retrospective method. Prior to January 1, 2018 we accounted for the Collaboration Agreements under ASC 605-25, Multiple Element Arrangements.

Accounting under ASC 606

In adopting ASC 606, we applied the practical expedient that permits aggregating the effect of all modifications that occurred prior to January 1, 2018. No other practical expedients were used. Similar to the accounting under ASC 605-25, the 2016 Agreement was determined to be a modification of the 2010 Agreement and the AG-881 Agreements. In determining the appropriate amount of revenue to be recognized under ASC 606, we performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price, including the constraint on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v) recognized revenue when (or as) we satisfied each performance obligation.

As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price, or SSP, for each performance obligation identified in the contract. We use key assumptions to determine the SSP, which include forecast of revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.

The satisfied and unsatisfied performance obligations at the time of the ASC 606 adoption, each of which are considered by us to be distinct within the context of the contract, their SSP, the method of recognizing the allocated consideration, and the period through which they are expected to be recognized are as follows:

Performance Obligations

SSP

No. of Performance Obligation(s)

Recognition Method

Fully satisfied at time of adoption

Licenses (1)

$86.7 million

Fully satisfied; recognized upon adoption of ASC 606

Research and development services (2) (3)

$350.7 million

Fully satisfied; recognized upon adoption of ASC 606

Partially satisfied at time of adoption

Research and development services (2) (3)

266.6

$266.6 million

Proportionally as services are delivered over the performance period, expected to be through September 2022 (4)

(1) The SSP was developed by probability weighting multiple cash flow scenarios using the income approach. Our management estimates within the models include the expected, probability-weighted net profits from estimated future sales, an estimate of the direct cost incurred to generate future cash flows, a discount rate and other business forecast factors. There are significant judgments and estimates inherent in the determination of the SSP of these units of accounting. These judgments and estimates include assumptions regarding future operating performance, the timelines of the clinical trials and regulatory approvals, and other factors. If different reasonable assumptions are utilized, the SSP and revenue recognized would vary.

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(2) The SSP was developed using our management’s best estimate of the cost of obtaining these services at arm’s length from a third-party provider.

(3) The SSP was developed using internal full time equivalent costs to support the development services.

(4) We determined that recognizing revenue on a proportional basis using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation best depicts the satisfaction of our obligations under the Collaboration Agreements.

During the three and six months ended June 30, 2018, we recognized the following as collaboration revenue (in thousands):


	Three Months Ended June 30, 2018						Six Months Ended June 30, 2018
Performance Obligation	Under Topic 606		Under Topic 605		Effect of Change		Under Topic 606		Under Topic 605		Effect of Change
Collaboration revenue - related party
Licenses	$	15,000	$	15,000	$	—	$	15,000	$	15,000	$	—
Research and development services	9,830		9,367		463		16,194		18,320		(2,126)
Committee participations	—		44		(44)		—		87		(87)
Reduction of research and development expenses
Development services	—		1,652		(1,652)		—		2,063		(2,063)

During the three and six months ended June 30, 2018 and 2017, we recognized as collaboration revenue the following non-contingent consideration allocated to each performance obligation (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2018		2017		2018		2017
Licenses	$	15,000	$	—	$	15,000	$	—
On-going research and development services	$	9,830	$	10,279	$	16,194	$	20,666
Committee participations	—		41		—		83

During the three and six months ended June 30, 2017, we recognized $2.5 million and $5.3 million, respectively, as a reduction of research and development expenses. During the three and six months ended June 30, 2018, we did not recognize any reductions to research and development expenses.

Consideration for development and commercialization services performed by us, that were not considered performance obligations as of the modification dates, are recognized as collaboration revenue or a reduction of research and development expenses in the period in which they are earned. There was no impact from the adoption of ASC 606 on these obligations. For the three and six months ended June 30, 2018 and 2017, we recognized the following collaboration revenue and reduction of research and development expenses related to such expenses (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2018		2017		2018		2017
Collaboration revenue - related party
Development activities	$	590	$	—	$	590	$	—
Commercialization activities	981		1,026		1,962		1,105
Reduction of research and development expenses
Research and development activities	—		—		—		14

For the three and six months ended June 30, 2018 and 2017, we recognized the following totals of collaboration revenue and reduction of research and development expenses (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2018		2017		2018		2017
Collaboration revenue - related party	$	26,401	$	11,346	$	33,746	$	21,854
Reduction of research and development expenses	—		2,489		—		5,265

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The following table presents changes in our contract assets and liabilities during the six months ended June 30, 2018 (in thousands):


	December 31, 2017		Additions		Deductions		June 30, 2018
Contract assets (1)
Collaboration receivable – related party	$	2,448	$	22,838	$	(5,960)	$	19,326
Royalty receivable – related party	1,222		$	2,990	$	(2,639)	$	1,573
Contract liabilities (2)
Deferred revenue – related party, current and net of current portions	$	163,640	5,839		(55,939)		113,540

(1) Additions to contract assets relate to amounts billed to Celgene for reimbursable costs incurred by us during the reporting period. Deductions to contract assets relate to collection of receivables during the reporting period.

(2) Additions to contract liabilities relate to consideration from Celgene during the reporting period. Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period and cumulative catch-up adjustment recognized upon adoption of ASC 606 on January 1, 2018.

During the three and six months ended June 30, 2018, we recognized the following as revenue due to changes in the contract liability balances (in thousands):


	June 30, 2018
	Three Months Ended		Six Months Ended
Amounts included in the contract liability at the beginning of the period	$	9,932	$	15,917
Performance obligations satisfied in previous periods	220		543

As of June 30, 2018, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $121.8 million.

We consider the total consideration expected to be earned in the next twelve months for services to be performed as current deferred revenue, and consideration that is expected to be earned subsequent to twelve months from the balance sheet date as non-current deferred revenue.

Accounting analysis and revenue recognition – royalty revenue

For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, we recognize royalty revenue upon the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

As the underlying performance obligation, or delivery of the license to IDHIFA®, had been satisfied as of June 2014, royalty revenue is recognized as the related sales occur. During the three and six months ended June 30, 2018, we earned $1.6 million and $3.0 million, respectively, in royalty revenue under the 2010 Agreement.

Accounting analysis and revenue recognition – milestone revenue

At each reporting period we evaluate whether milestones are considered probable of being reached and, to the extent that a significant reversal would not occur in future periods, estimate the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our control, such as regulatory approvals, are not considered probable of being achieved and are excluded from the transaction price until those approvals are received.

During the three months ended June 30, 2018, Celgene submitted an MAA to the EMA for IDHIFA® for IDH2 mutant-positive R/R AML. As a result of the filing, we determined that a $15.0 million milestone payment, which is unbilled as of June 30, 2018, for filing of a first new drug application equivalent in an ex-U.S. country is considered probable of being reached and a significant reversal of revenue would not occur in future periods. As the underlying performance obligation, or delivery of the license to IDHIFA, had been satisfied as of June 2014, the milestone payment was recognized in full as collaboration revenue during the three months ended June 30, 2018.

No other milestones were achieved during the three and six months ended June 30, 2018. The next potential milestone expected to be achieved under our collaboration agreements with Celgene is the first regulatory approval in any of China, Japan or a major European country. Achievement of this event will result in milestone payments of $35.0 million under the 2010 Agreement.

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CStone Pharmaceuticals

In June 2018, we entered into an exclusive license agreement, or the CStone Agreement, with CStone Pharmaceuticals, or CStone, to grant CStone specified intellectual property licenses to enable CStone to develop and commercialize certain products containing TIBSOVO® in mainland China, Hong Kong, Macau, and Taiwan. We retain development and commercialization rights with respect to TIBSOVO® for the rest of the world. Pursuant to the CStone Agreement, CStone will initially be responsible for the development and commercialization of TIBSOVO® in acute myeloid leukemia, or AML, cholangiocarcinoma, and, at our discretion, brain cancer indications.

Under the terms of the CStone Agreement,we received an initial upfront payment in the amount of $12.0 million and are entitled to receive up to an additional $412.0 million in milestone payments upon the achievement of certain development, regulatory and sales milestone events. Approximately half of the milestone payments are related to the development and commercialization of TIBSOVO® in AML, cholangiocarcinoma and the other half of the milestone payments are related to brain cancer indications, including glioma. We will also be entitled to receive tiered royalties, ranging from 15 to 19 percent, on annual net sales, if any, of TIBSOVO®.

CStone is responsible for all costs it incurs in developing, obtaining regulatory approval of, and commercializing TIBSOVO® in China, Hong Kong, Macau, and Taiwan, as well as certain costs incurred by us.

During the term of the CStone Agreement, each party and its affiliates are prohibited from developing or commercializing any other compound or product that inhibits IDH1 mutations at specified levels of binding, in the case of CStone, anywhere in the world, and in our case, in China, Hong Kong, Macau, and Taiwan.

Termination

Unless earlier terminated, the CStone Agreement will expire upon the expiration of the last royalty term for the last licensed product within the scope of the CStone Agreement. At any time after CStone has obtained regulatory approval in mainland China in R/R AML and the last patient has been enrolled in a specified clinical trial (or, if earlier, at any time that CStone acquires or is acquired by an entity with a competing or restricted product), CStone may terminate the CStone Agreement in its entirety by providing us with prior written notice. Either party may, subject to specified cure periods, terminate the CStone Agreement in the event of the other party’s uncured material breach. Either party may terminate the CStone Agreement under specified circumstances relating to the other party’s insolvency. We have the right to terminate the CStone Agreement immediately if CStone or its affiliates or sublicensees or subcontractors challenges the validity, patentability, or enforceability of certain patent rights that relate to TIBSOVO® and are owned by or licensed to us or our affiliates.

Accounting analysis and revenue recognition - collaboration revenue

The CStone Agreement was determined to be within the scope of ASC 606. Accordingly, in determining the appropriate amount of revenue to be recognized, we performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price, including the constraint on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v) recognized revenue when (or as) we satisfied each performance obligation.

As part of the accounting for the CStone Agreement, we developed assumptions that require judgment to determine the SSP for each performance obligation identified in the contract. We use key assumptions to determine the SSP, which include forecast of revenues, development timelines, reimbursement rates, discount rates and probabilities of technical and regulatory success.

The satisfied and unsatisfied performance obligations, each of which are considered by us to be distinct within the context of the contract, their SSP, the method of recognizing the allocated consideration, and the period through which they are expected to be recognized are as follows:


Performance Obligations	SSP		No. of Performance Obligation(s)	Recognition Method
License (1)	$	16.4	1	Fully satisfied; recognized upon execution of CStone Agreement
Development service (2)	1.7		1	Proportionally as services are delivered over the performance period, expected to be through September 2020 (3)

(2) The SSP was developed using our management’s best estimate of the cost of obtaining these services at arm’s length from a third-party provider.

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(3) We determined that recognizing revenue on a proportional basis using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation best depicts the satisfaction of our obligations under the CStone Agreement.

During the three and six months ended June 30, 2018, we recognized as collaboration revenue the following non-contingent consideration allocated to each performance obligation (in thousands):


	Under Topic 606		Under Topic 605		Effect of Change
Collaboration revenue
License	$	12,440	$	12,000	$	440

The following table presents changes in our contract assets during the six months ended June 30, 2018 (in thousands):


	December 31, 2017		Additions		Deductions		June 30, 2018
Contract assets (1)
Collaboration receivable	$	—	$	12,440	$	(12,000)	$	440

(1) Additions to contract assets relate to amounts receivable from CStone. Deductions to contract assets relate to collection of receivables during the reporting period.

As of June 30, 2018, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $1.3 million.

Accounting analysis and revenue recognition – royalty revenue

The license was determined to be the predominant item to which sales-based royalties and sales-based milestones relate. As the license was delivered in June 2018, we will recognize royalty revenue when the related sales occur. To date, no royalties have been received under the CStone Agreement.

Accounting analysis and revenue recognition - milestone revenue