10-Q 1 bpmc-20210930x10q.htm 10-Q
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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 September 30, 2021

OR

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

Commission file number 001-37359

_____________________________

BLUEPRINT MEDICINES CORPORATION

(Exact Name of Registrant as Specified in Its Charter)

_____________________________

Delaware

 

26-3632015

(State or Other Jurisdiction of
Incorporation or Organization)

 

(I.R.S. Employer
Identification No.)

 

 

45 Sidney Street

Cambridge, Massachusetts

 

02139

(Address of Principal Executive Offices)

 

(Zip Code)

(617374-7580

(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 every Interactive Data File required to be submitted 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 such files).    Yes       No  

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

Large accelerated filer

Non-accelerated filer  

Accelerated filer

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

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common stock, par value $0.001 per share

BPMC

Nasdaq Global Select Market

Number of shares of the registrant’s common stock, $0.001 par value, outstanding on October 25, 2021: 58,838,034

TABLE OF CONTENTS

Page

Part I – FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

4

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020

4

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2021 and 2020

5

Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2021 and 2020

6

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020

7

Notes to Condensed Consolidated Financial Statements

8

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

26

Item 3. Quantitative and Qualitative Disclosures About Market Risk

44

Item 4. Controls and Procedures

45

Part II – OTHER INFORMATION

Item 1. Legal Proceedings

46

Item 1A. Risk Factors

46

Item 6. Exhibits

93

Signatures

94

1

Unless otherwise stated, all references to “us,” “our,” “Blueprint,” “Blueprint Medicines,” “we,” the “Company” and similar designations in this Quarterly Report on Form 10-Q refer to Blueprint Medicines Corporation and its consolidated subsidiaries. Blueprint Medicines, AYVAKIT, AYVAKYT®, GAVRETO® and associated logos are trademarks of Blueprint Medicines Corporation. Other brands, names and trademarks contained in this Quarterly Report on Form 10-Q are the property of their respective owners.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative of these words or other comparable terminology, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

the timing or likelihood of regulatory actions, filings and approvals for our current and future drug candidates, including our ability to obtain marketing approval for avapritinib and pralsetinib for additional indications or in additional geographies;
our ability and plans in continuing to expand out our commercial infrastructure and successfully launching, marketing and selling AYVAKIT™ (avapritinib) (marketed in Europe under the brand name AYVAKYT®), GAVRETO® (pralsetinib) and any current and future drug candidates for which we receive marketing approval;
the rate and degree of market acceptance of AYVAKIT/AYVAKYT, GAVRETO and any current and future drug candidates for which we receive marketing approval;
the pricing and reimbursement of AYVAKIT/AYVAKYT, GAVRETO and any current and future drug candidates for which we receive marketing approval;
the initiation, timing, progress and results of our pre-clinical studies and clinical trials, including our ongoing clinical trials and any planned clinical trials for our current and future drug candidates and research and development programs;
our ability to advance drug candidates into, and successfully complete, clinical trials;
our ability to successfully develop manufacturing processes for any of our current and future drugs or drug candidates and to secure manufacturing, packaging and labeling arrangements for development activities and commercial production;
the implementation of our business model and strategic plans for our business, drugs, drug candidates, platform and technology;
the scope of protection we are able to establish and maintain for intellectual property rights covering our current and future drugs, drug candidates and technology;
the potential benefits of our collaboration with F. Hoffmann-La Roche Ltd and Genentech, Inc. to develop and commercialize pralsetinib globally (excluding Greater China), our cancer immunotherapy collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., and our collaboration with CStone Pharmaceuticals to develop and commercialize avapritinib, pralsetinib and fisogatinib in Greater China, as well as our ability to maintain these collaborations and establish additional strategic collaborations;
the potential benefits of our exclusive license agreement with Clementia Pharmaceuticals, Inc. to develop and commercialize BLU-782 for fibrodysplasia ossificans progressiva;

2

the development of companion diagnostic tests for our current or future drugs or drug candidates;
our financial performance, estimates of our revenues, expenses and capital requirements and our needs for future financing, including our ability to achieve a self-sustainable financial profile;
developments relating to our competitors and our industry;
the actual or potential benefits of designations granted by the U.S. Food and Drug Administration, or FDA, such as orphan drug, fast track and breakthrough therapy designation or priority review; and
the impact and scope of the ongoing COVID-19 pandemic on our business, operations, strategy, goals and anticipated milestones, including our ongoing and planned research and discovery activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, and the launch, marketing, sale and commercial supply of AYVAKIT/AYVAKYT, GAVRETO and any current or future drug candidates for which we receive marketing approval.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” section, that could cause actual results or events to differ materially from the forward-looking statements that we make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make or enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results, performance or achievements may be materially different from what we expect. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.

For purposes of this Quarterly Report on Form 10-Q, including the footnotes to our condensed consolidated financial statements, (i) with respect to our collaboration for pralsetinib, Roche means F. Hoffmann-La Roche Ltd and Genentech, Inc., and (ii) with respect to our cancer immunotherapy collaboration, Roche means F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc.

3

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

Blueprint Medicines Corporation

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(Unaudited)

September 30, 

December 31, 

    

2021

    

2020

 

Assets

Current assets:

Cash and cash equivalents

$

553,593

$

684,636

Marketable securities

148,285

187,213

Accounts receivable, net

18,400

7,096

Unbilled accounts receivable

11,324

18,213

Inventory

16,570

8,581

Prepaid expenses and other current assets

 

23,676

 

22,020

Total current assets

 

771,848

 

927,759

Marketable securities

 

591,920

677,873

Property and equipment, net

31,204

 

34,129

Operating lease right-of-use assets, net

62,986

67,539

Restricted cash

 

5,171

 

5,168

Other assets

 

14,193

 

5,925

Total assets

$

1,477,322

$

1,718,393

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

9,549

4,370

Accrued expenses

 

94,540

 

105,938

Current portion of operating lease liabilities

8,810

7,935

Current portion of deferred revenue

6,792

12,559

Total current liabilities

 

119,691

 

130,802

Operating lease liabilities, net of current portion

75,054

81,669

Deferred revenue, net of current portion

28,605

28,599

Other long-term liabilities

6,885

7,235

Total liabilities

230,235

248,305

Commitments (Note 15)

Stockholders’ equity:

Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding

Common stock, $0.001 par value; 120,000,000 shares authorized; 58,814,666 and 57,793,533 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

59

 

58

Additional paid-in capital

 

2,209,456

 

2,106,600

Accumulated other comprehensive loss

(5,673)

(5,214)

Accumulated deficit

 

(956,755)

 

(631,356)

Total stockholders’ equity

 

1,247,087

 

1,470,088

Total liabilities and stockholders’ equity

$

1,477,322

$

1,718,393

4

Blueprint Medicines Corporation

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except per share data)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

2021

    

2020

    

2021

    

2020

Revenues:

Product revenue, net

$

17,270

$

6,308

$

37,658

$

15,446

Collaboration revenue

6,918

738,810

35,401

744,183

Total revenues

24,188

745,118

73,059

759,629

Cost and operating expenses:

Cost of sales

3,790

146

10,385

297

Collaboration loss sharing

3,269

3,269

Research and development

84,419

74,230

244,157

249,456

Selling, general and administrative

 

49,806

 

37,375

 

141,093

115,203

Total cost and operating expenses

 

141,284

 

111,751

 

398,904

 

364,956

Other income (expense):

Interest income, net

 

552

 

1,173

 

1,923

5,663

Other expense, net

 

(522)

 

(192)

 

(1,109)

(416)

Total other income

 

30

 

981

 

814

 

5,247

Income (loss) before income taxes

(117,066)

634,348

(325,031)

399,920

Income tax expense

175

370

368

370

Net income (loss)

$

(117,241)

$

633,978

$

(325,399)

$

399,550

Other comprehensive income (loss):

Unrealized gain (losses) on available-for-sale investments

(12)

(777)

(1,035)

658

Currency translation adjustments

174

(43)

577

(64)

Comprehensive income (loss)

$

(117,079)

$

633,158

$

(325,857)

$

400,144

Net income (loss) per share - basic

$

(2.00)

$

11.49

$

(5.58)

$

7.40

Net income (loss) per share - diluted

(2.00)

11.16

(5.58)

7.20

Weighted-average number of common shares used in net income (loss) per share - basic

58,647

55,169

58,361

54,018

Weighted-average number of common shares used in net income (loss) per share - diluted

 

58,647

 

56,786

 

58,361

55,492

5

Blueprint Medicines Corporation

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share data)

(Unaudited)

Accumulated

 

Additional

Other

 

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders’

 

    

Shares

    

Amount

    

Capital

    

Loss

Deficit

Equity

 

Balance at December 31, 2020

57,793,533

$

58

$

2,106,600

$

(5,214)

$

(631,356)

$

1,470,088

Issuance of common stock under stock plan

483,879

8,318

 

8,318

Stock-based compensation expense

21,212

 

21,212

Other comprehensive income

117

117

Net loss

(99,714)

 

(99,714)

Balance at March 31, 2021

58,277,412

$

58

$

2,136,130

$

(5,097)

$

(731,070)

$

1,400,021

Issuance of common stock under stock plan

254,823

$

1

$

11,709

$

$

$

11,710

Purchase of common stock under ESPP

22,324

1,733

1,733

Stock-based compensation expense

24,522

24,522

Other comprehensive income

(738)

(738)

Net loss

(108,444)

(108,444)

Balance at June 30, 2021

58,554,559

$

59

$

2,174,094

$

(5,835)

$

(839,514)

$

1,328,804

Issuance of common stock under stock plan

260,107

$

$

11,038

$

$

$

11,038

Stock-based compensation expense

24,324

24,324

Other comprehensive income

162

162

Net loss

(117,241)

(117,241)

Balance at September 30, 2021

58,814,666

$

59

$

2,209,456

$

(5,673)

$

(956,755)

$

1,247,087

Balance at December 31, 2019

 

49,272,223

$

49

$

1,412,083

$

(2,534)

$

(945,239)

$

464,359

Issuance of common stock under stock plan

186,166

1

1,612

 

1,613

Stock-based compensation expense

17,026

 

17,026

Follow-on offering, net of issuance costs

4,710,144

4

308,419

308,423

Other comprehensive income

2,465

2,465

Net loss

(110,953)

 

(110,953)

Balance at March 31, 2020

54,168,533

$

54

$

1,739,140

$

(69)

$

(1,056,192)

$

682,933

Issuance of common stock under stock plan

98,950

2,335

2,335

Purchase of common stock under ESPP

17,018

942

942

Stock-based compensation expense

19,675

19,675

Other comprehensive income

(1,051)

(1,051)

Net loss

(123,474)

(123,474)

Other

7

7

Balance at June 30, 2020

54,284,501

$

54

$

1,762,099

$

(1,120)

$

(1,179,666)

$

581,367

Issuance of common stock under stock plan

194,375

1

6,279

6,280

Stock-based compensation expense

19,889

19,889

Issuance of common stock related to collaboration agreement

1,035,519

1

79,305

79,306

Other comprehensive income

(820)

(820)

Net income (loss)

633,978

633,978

Balance at September 30, 2020

55,514,395

$

56

$

1,867,572

$

(1,940)

$

(545,688)

$

1,320,000

6

Blueprint Medicines Corporation

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

Nine Months Ended

September 30, 

    

2021

    

2020

Cash flows from operating activities

Net income (loss)

$

(325,399)

$

399,550

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

Depreciation and amortization

 

4,816

4,887

Noncash lease expense

 

4,668

4,289

Stock-based compensation

68,949

56,022

Other

2,677

573

Changes in assets and liabilities:

 

Accounts receivable

(11,375)

(43,705)

Unbilled accounts receivable

6,891

5,862

Inventory

(11,812)

(4,491)

Prepaid expenses and other current assets

(1,795)

(7,266)

Other assets

 

(2,842)

1,796

Accounts payable

 

5,144

(1,978)

Accrued expenses

(12,844)

1,573

Deferred revenue

 

(5,761)

(666)

Operating lease liabilities

(5,856)

(4,612)

Net cash provided by (used in) operating activities

 

(284,539)

411,834

Cash flows from investing activities

 

Purchases of property and equipment

(1,831)

(2,472)

Purchases of investments

(514,906)

(796,980)

Maturities of investments

637,831

440,735

Net cash provided by (used in) investing activities

 

121,094

(358,717)

Cash flows from financing activities

 

Proceeds from public offerings of common stock, net of issuance cost

308,750

Net proceeds from stock option exercises and employee stock purchase plan

 

32,787

9,921

Issuance of common stock related to collaboration agreement

79,305

Payment of offering costs

(310)

Net cash provided by financing activities

 

32,787

397,666

Net increase (decrease) in cash, cash equivalents, and restricted cash

(130,658)

450,783

Cash, cash equivalents and restricted cash at beginning of period

689,804

119,604

Effect of exchange rate changes on cash, cash equivalents and restricted cash

(382)

2

Cash, cash equivalents and restricted cash at end of period

$

558,764

$

570,389

Supplemental cash flow information

Property and equipment purchases unpaid at period end

$

206

$

209

Cash paid for taxes, net

$

674

$

68

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands).

September 30, 

September 30, 

2021

2020

Cash and cash equivalents

$

553,593

$

565,221

Restricted cash

5,171

5,168

Total cash, cash equivalents, and restricted cash shown in condensed consolidated statements of cash flows

$

558,764

$

570,389

7

Blueprint Medicines Corporation

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Nature of Business

Blueprint Medicines Corporation (the Company), a Delaware corporation incorporated on October 14, 2008, is a precision therapy company focused on genomically defined cancers and hematologic disorders. The Company’s approach is to leverage its novel target discovery engine to systematically and reproducibly identify kinases that are drivers of diseases and to craft highly selective and potent drugs and drug candidates that may provide significant and durable clinical responses for patients without adequate treatment options.

The Company has two approved precision therapies and is globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy. The Company is devoting substantially all of its efforts to research and development for current and future drug candidates and commercialization of AYVAKIT/AYVAKYT, GAVRETO and any current or future drug candidates that obtain marketing approval.

As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $1,293.8 million. Based on the Company’s current operating plans, the Company anticipates that its existing cash, cash equivalents and marketable securities will be sufficient to enable it to fund its current operations for at least the next twelve months from the issuance of the financial statements.

2. Summary of Significant Accounting Policies and Recent Accounting Pronouncements

Basis of Presentation

The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) as found in the Accounting Standards Codification (ASC), Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB) and the rules and regulations of the Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these financial statements should be read in conjunction with the financial statements as of and for the year ended December 31, 2020 and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 17, 2021 (the 2020 Annual Report on Form 10-K).

The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements, and updated, as necessary, in this report. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments that are necessary to present fairly the Company’s financial position as of September 30, 2021, the results of its operations for the three and nine months ended September 30, 2021 and 2020, stockholder’s equity for the three and nine months ended September 30, 2021 and 2020 and cash flows for nine months ended September 30, 2021 and 2020. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results for the year ending December 31, 2021 or for any future period.

The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Blueprint Medicines Security Corporation, which is a Massachusetts subsidiary created to buy, sell and hold securities, Blueprint Medicines (Switzerland) GmbH, Blueprint Medicines (Netherlands) B.V., Blueprint Medicines (UK) Ltd, Blueprint Medicines (Germany) GmbH, Blueprint Medicines Spain, S.L., Blueprint Medicines (France) SAS and Blueprint Medicines (Italy) S.r.L. All intercompany transactions and balances have been eliminated.

8

Use of Estimates

The preparation of financial statements in conformity with GAAP requires the Company’s 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. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: revenue recognition, inventory, operating lease right-of-use assets, operating lease liabilities, stock-based compensation expense, accrued expenses, and income taxes. The length of time and full extent to which the ongoing COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including revenues, expenses, reserves and allowances, manufacturing, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, subject to change and difficult to predict, including as a result of new information that may emerge concerning COVID-19, including the identification and spread of new variants, and the actions taken to contain or treat COVID-19, as well as the economic impact thereof on local, regional, national and international customers and markets. The Company considers the impact of COVID-19 while making the estimates within its consolidated financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates.

Significant Accounting Policies

The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2021 are consistent with those discussed in Note 2 to the consolidated financial statements in the 2020 Annual Report on Form 10-K.

New Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed consolidated financial statements and disclosures.

Reclassification

Certain items in the prior year’s condensed consolidated financial statements have been reclassified to conform to the current presentation.

3. Marketable securities

Marketable securities consisted of the following at September 30, 2021 and December 31, 2020 (in thousands):

Amortized

Unrealized

Unrealized

Fair

September 30, 2021

Cost

 

Gain

Losses

Value

Marketable securities, available-for-sale:

U.S. government agency securities 

$

483,281

$

100

(175)

$

483,206

U.S. treasury obligations

256,998

68

(67)

256,999

Total

$

740,279

$

168

$

(242)

$

740,205

Amortized

Unrealized

Unrealized

Fair

December 31, 2020

Cost

 

Gain

Losses

Value

Marketable securities, available-for-sale:

U.S. government agency securities

$

746,770

$

513

$

(14)

$

747,269

U.S. treasury obligations

117,368

449

117,817

Total

$

864,138

$

962

$

(14)

$

865,086

9

As of September 30, 2021, the Company held 38 debt securities that were in an unrealized loss position with an aggregate fair value of $407.2 million. As of December 31, 2020, the Company held 8 debt securities that were in an unrealized loss position with an aggregate fair value of $125.7 million. As of September 30, 2021 and December 31, 2020, there were no securities held by the Company in an unrealized loss position for more than twelve months. The Company has the intent and ability to hold such securities until recovery. As a result, the Company did not record any charges for credit-related impairments for its marketable debt securities for the three and nine months ended September 30, 2021.

As of September 30, 2021, 53 securities with an aggregate fair value of $591.9 million had remaining maturities between one year and five years. As of December 31, 2020, 65 securities with an aggregate fair value of $677.9 million had remaining maturities between one year and five years.

The Company received proceeds of $237.3 million and $637.8 million from maturities of debt securities for the three and nine months ended September 30, 2021, respectively, and proceeds of $134.7 million and $440.7 million from maturities of debt securities for the three and nine months ended September 30, 2020, respectively. The Company did not realize any gains or losses from maturities of debt securities for the three and nine months ended September 30, 2021 and 2020.

4. Fair Value of Financial Instruments

The following table summarizes cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2021 (in thousands):

    

    

Active

    

Observable

    

Unobservable

September 30, 

Markets

Inputs

Inputs

Description

2021

(Level 1)

(Level 2)

(Level 3)

Cash equivalents:

Money market funds

$

509,616

$

509,616

$

$

Marketable securities, available-for-sale:

U.S. government agency securities 

483,206

483,206

U.S. treasury obligations

256,999

256,999

Total

$

1,249,821

$

766,615

$

483,206

$

The following table summarizes cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2020 (in thousands):

    

    

Active

    

Observable

    

Unobservable

December 31, 

Markets

Inputs

Inputs

Description

2020

(Level 1)

(Level 2)

(Level 3)

Cash equivalents:

Money market funds

$

420,567

$

420,567

$

$

Marketable securities, available-for-sale:

U.S. government agency securities 

747,269

747,269

U.S. treasury obligations

117,817

117,817

Total

$

1,285,653

$

538,384

$

747,269

$

5. Product Revenue Reserves and Allowances

In January 2020, the U.S. Food and Drug Administration (FDA) approved AYVAKIT for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. In June 2021, the FDA granted a subsequent approval for AYVAKIT, expanding the labeled indications to include adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL). In September 2020, the FDA granted accelerated approval of GAVRETO for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test, and the European Commission granted conditional marketing authorization to AYVAKYT as a monotherapy for the treatment of adult patients with unresectable or metastatic GIST harboring the PDGFRA D842V mutation. In December 2020, the FDA

10

granted a subsequent accelerated approval for GAVRETO, expanding the labeled indications to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

On July 1, 2021, the Company transferred certain responsibilities associated with product sales to customers, pricing and distribution matters related to U.S. product sales of GAVRETO to its collaboration partner and did not record any net product revenue from product sales of GAVRETO during the three months ended September 30, 2021. Products sales of GAVRETO were reflected as part of collaboration loss sharing in the unaudited condensed consolidated statements of operations and comprehensive income (loss). For additional information, see Note 9, Collaboration a