10-Q 1 rigl-20220331x10q.htm 10-Q
0P24MRIGEL PHARMACEUTICALS INC2022Large Accelerated 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 MARCH 31, 2022

OR

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

FOR THE TRANSITION PERIOD FROM        TO        

Commission File Number 0-29889

Rigel Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware

94-3248524

(State or other jurisdiction of incorporation or

(I.R.S. Employer Identification No.)

organization)

1180 Veterans Blvd.

South San Francisco, CA

94080

(Address of principal executive offices)

(Zip Code)

(650) 624-1100

(Registrant’s telephone number, including area code)

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

Title of each class:

    

Trading Symbol

    

Name of each exchange on which registered:

Common Stock, par value $0.001 per share

RIGL

The Nasdaq Stock Market LLC

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, 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.

Large accelerated filer

Accelerated filer

Non-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 

As of April 29, 2022, there were 172,052,224 shares of the registrant’s Common Stock outstanding.

RIGEL PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022

INDEX

Page

PART I

FINANCIAL INFORMATION

3

Item 1.

Financial Statements

3

Condensed Balance Sheets (Unaudited) — March 31, 2022 and December 31, 2021

3

Condensed Statements of Operations (Unaudited) — three months ended March 31, 2022 and 2021

4

Condensed Statements of Comprehensive Income (Loss) (Unaudited) — three months ended March 31, 2022 and 2021

5

Condensed Statements of Stockholders’ Equity (Unaudited) — three months ended March 31, 2022 and 2021

6

Condensed Statements of Cash Flows (Unaudited) — three months ended March 31, 2022 and 2021

7

Notes to Condensed Financial Statements (Unaudited)

8

Item 2.

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

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

41

Item 4.

Controls and Procedures

41

PART II

OTHER INFORMATION

41

Item 1.

Legal Proceedings

41

Item 1A.

Risk Factors

42

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

86

Item 3.

Defaults Upon Senior Securities

86

Item 4.

Mine Safety Disclosures

86

Item 5.

Other Information

86

Item 6.

Exhibits

87

Signatures

89

2

PART I. FINANCIAL INFORMATION

Item 1.Financial Statements

RIGEL PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

(In thousands)

March 31, 

December 31,

2022

    

2021(1)

(unaudited)

Assets

Current assets:

Cash and cash equivalents

$

24,679

$

18,890

Short-term investments

 

82,840

 

106,077

Accounts receivable, net

 

15,240

 

15,472

Inventories

6,764

 

6,616

Prepaid and other current assets

 

9,415

 

7,412

Total current assets

 

138,938

 

154,467

Property and equipment, net

 

2,140

 

2,184

Operating lease right-of-use asset

7,532

9,703

Other assets

 

464

 

974

$

149,074

$

167,328

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

4,614

$

3,795

Accrued compensation

 

6,628

 

10,690

Accrued research and development

 

9,492

 

10,384

Other accrued liabilities

 

16,505

 

12,691

Lease liabilities, current portion

8,296

9,892

Deferred revenue

2,097

2,596

Other long-term liabilities, current portion

11,593

13,506

Total current liabilities

 

59,225

 

63,554

Long-term portion of lease liabilities

 

 

759

Loans payable, net of discount

29,847

19,914

Other long-term liabilities

 

53,204

 

52,727

Commitments

Stockholders’ equity:

Preferred stock

 

 

Common stock

 

172

 

172

Additional paid-in capital

 

1,358,373

 

1,354,190

Accumulated other comprehensive loss

 

(416)

 

(102)

Accumulated deficit

 

(1,351,331)

 

(1,323,886)

Total stockholders’ equity

 

6,798

 

30,374

$

149,074

$

167,328

(1)The balance sheet as of December 31, 2021 has been derived from the audited financial statements included in Rigel’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (SEC) on March 1, 2022.

See Accompanying Notes to Condensed Financial Statements

3

RIGEL PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(unaudited)

Three Months Ended March 31, 

    

2022

    

2021

Revenues:

Product sales, net

$

16,197

$

12,376

Contract revenues from collaborations

538

65,642

Government contract

3,000

Total revenues

16,735

81,018

Costs and expenses:

Cost of product sales

121

316

Research and development

 

15,474

 

16,826

Selling, general and administrative

 

27,401

 

22,121

Total costs and expenses

 

42,996

 

39,263

Income (loss) from operations

 

(26,261)

 

41,755

Interest income

 

21

 

1

Interest expense

(1,205)

(485)

Income (loss) before income taxes

(27,445)

41,271

Provision for income taxes

1,771

Net income (loss)

$

(27,445)

$

39,500

Net income (loss) per share

Basic

$

(0.16)

$

0.23

Diluted

$

(0.16)

$

0.22

Weighted average shares used in computing net income (loss) per share

Basic

171,774

169,800

Diluted

171,774

176,069

See Accompanying Notes to Condensed Financial Statements

4

RIGEL PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

(unaudited)

Three Months Ended March 31, 

    

2022

    

2021

Net income (loss)

$

(27,445)

$

39,500

Other comprehensive income (loss):

Net unrealized gain (loss) on short-term investments

 

(314)

 

3

Comprehensive income (loss)

$

(27,759)

$

39,503

See Accompanying Notes to Condensed Financial Statements

5

RIGEL PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

(unaudited)

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders’

    

Shares

    

Amount

    

Capital

    

Loss

    

Deficit

    

Equity

Balance as of January 1, 2022

 

171,602,226

$

172

$

1,354,190

$

(102)

$

(1,323,886)

$

30,374

Net loss

 

(27,445)

 

(27,445)

Net unrealized loss on short-term investments

 

(314)

 

(314)

Issuance of common stock upon exercise of options

 

420,521

940

 

940

Issuance of common stock upon vesting of restricted stock units

22,500

Stock-based compensation expense

 

3,243

 

3,243

Balance as of March 31, 2022

 

172,045,247

$

172

$

1,358,373

$

(416)

$

(1,351,331)

$

6,798

Accumulated

Additional

Other

Total

Common Stock

Paid-in

Comprehensive

Accumulated

Stockholders’

    

Shares

    

Amount

    

Capital

    

Loss

    

Deficit

    

Equity

Balance as of January 1, 2021

    

169,316,782

$

169

$

1,339,833

$

(4)

$

(1,305,972)

$

34,026

Net income

 

39,500

 

39,500

Net unrealized gain on short-term investments

 

3

 

3

Issuance of common stock upon exercise of options

 

813,854

1

2,096

 

2,097

Stock-based compensation expense

 

2,672

 

2,672

Balance as of March 31, 2021

 

170,130,636

$

170

$

1,344,601

$

(1)

$

(1,266,472)

$

78,298

See Accompanying Notes to Condensed Financial Statements

6

RIGEL PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(In thousands)

(unaudited)

Three Months Ended March 31, 

2022

    

2021

Operating activities

Net income (loss)

$

(27,445)

39,500

Adjustments to reconcile net income (loss) to net cash used in operating activities:

Stock-based compensation expense

 

3,207

2,639

Depreciation and amortization

 

237

239

Non-cash interest expense

682

60

Net amortization and accretion of discount on short-term investments and term loan

28

85

Changes in assets and liabilities:

Accounts receivable, net

 

232

(126,222)

Inventories

(112)

(5,272)

Prepaid and other current assets

 

(2,003)

5,774

Other assets

 

510

6

Right-of-use assets

 

2,171

1,976

Accounts payable

 

850

1,394

Accrued compensation

 

(4,062)

(2,997)

Accrued research and development

 

(892)

479

Other accrued liabilities

 

3,814

61

Lease liability

(2,355)

(2,059)

Deferred revenue

(499)

6,482

Other current and long-term liabilities

 

 

57,900

Net cash used in operating activities

 

(25,637)

 

(19,955)

Investing activities

Purchases of short-term investments

 

(6,997)

(4,297)

Maturities of short-term investments

 

29,850

11,900

Capital expenditures

 

(224)

(71)

Net cash provided by investing activities

 

22,629

 

7,532

Financing activities

Cost share payment to a collaboration partner

(2,118)

Net proceeds from issuances of common stock upon exercise of options

 

940

2,097

Net proceeds from term loan financing

9,975

Net cash provided by financing activities

 

8,797

 

2,097

Net increase (decrease) in cash and cash equivalents

 

5,789

 

(10,326)

Cash and cash equivalents at beginning of period

 

18,890

30,373

Cash and cash equivalents at end of period

$

24,679

$

20,047

Supplemental disclosure of cash flow information

Interest paid

$

393

$

358

See Accompanying Notes to Condensed Financial Statements

7

Rigel Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

In this report, “Rigel,” “we,” “us” and “our” refer to Rigel Pharmaceuticals, Inc.

1.

Organization and Summary of Significant Accounting Policies

Description of Business

We are a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Our pioneering research focuses on signaling pathways that are critical to disease mechanisms. Our first product approved by the US Food and Drug Administration (FDA) is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only approved oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The product is also commercially available in Europe, United Kingdom (UK) (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic ITP in adult patients.

Fostamatinib is currently being studied in a Phase 3 trial for the treatment of warm autoimmune hemolytic anemia (wAIHA); a Phase 3 clinical trial for the treatment of hospitalized high-risk patients with COVID-19; and a National Institute of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) sponsored Phase 3 trial (ACTIV-4 Host Tissue Trial) for the treatment of COVID-19 in hospitalized patients.

Our other clinical programs include our interleukin receptor-associated kinase (IRAK) inhibitor program and a receptor-interacting serine/threonine-protein kinase (RIPK1) inhibitor program in clinical development with partner Eli Lilly and Company (Lilly). In addition, we have product candidates in clinical development with partners BerGenBio ASA (BerGenBio) and Daiichi Sankyo (Daiichi).

Basis of Presentation

Our accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (US GAAP), for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Act of 1933, as amended (Securities Act). Accordingly, they do not include all the information and notes required by US GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments that we believe are necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year or any subsequent interim period. The balance sheet as of December 31, 2021 has been derived from audited financial statements at that date but does not include all disclosures required by US GAAP for complete financial statements. Because certain disclosures required by US GAAP for complete financial statements are not included herein, these interim unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 1, 2022.

Use of Estimates

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates.

Significant Accounting Policies

Our significant accounting policies are described in “Note 1 – Description of Business and Summary of Significant Accounting Policies” to our “Notes to Financial Statements” contained in “Part II, Item 8, Financial Statements and Supplementary Data” of our Annual Report on Form 10-K for the year ended December 31, 2021. There have been no material changes to these accounting policies.

8

Liquidity

As of March 31, 2022, we had approximately $107.5 million in cash, cash equivalents and short-term investments. Since inception, we have financed our operations primarily through sales of equity securities, debt financing arrangement, contract payments under our collaboration agreements and from product sales. Based on our current operating plan, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Form 10-Q.

Recently Issued Accounting Standards

No new accounting guidance adopted during the period. Recently issued accounting guidance is not applicable or did not have, or is not expected to have, a material impact to us.

2.

Net Income (Loss) Per Share

Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period and the number of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued. Potentially dilutive securities include stock options, restricted stock units and shares issuable under our Employee Stock Purchase Plan (Purchase Plan). The dilutive effect of these potentially dilutive securities is reflected in diluted earnings per share by application of the treasury stock method. Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities.

The following table sets forth the computation of basic and diluted earnings per share (in thousands except per share amounts):

Three Months Ended March 31, 

    

2022

    

2021

EPS Numerator:

Net income (loss)

$

(27,445)

$

39,500

EPS Denominator—Basic and Diluted:

Weighted-average common shares outstanding

 

171,774

 

169,800

EPS Denominator—Diluted:

Weighted-average common shares outstanding

 

171,774

169,800

Dilutive effect of stock options, restricted stock units and shares under Purchase Plan

 

6,269

Weighted-average shares outstanding and common stock equivalents

 

171,774

 

176,069

Net income (loss) per share

Basic

$

(0.16)

$

0.23

Diluted

$

(0.16)

$

0.22

The potential shares of common stock that were excluded from the computation of diluted net income (loss) per share for the periods presented because including them would have been antidilutive are as follows (in thousands):

Three Months Ended March 31, 

2022

    

2021

Outstanding stock options

32,639

8,183

Restricted stock units

1,206

2

Purchase Plan

312

Total

34,157

8,185

9

3.

Revenues

Revenues disaggregated by category were as follows (in thousands):

Three Months Ended March 31, 

2022

    

2021

Product sales:

Gross product sales

$

22,618

$

16,109

Discounts and allowances

(6,421)

(3,733)

Total product sales, net

16,197

12,376

Revenues from collaborations:

License revenues

208

64,618

Research and development services and others

330

1,024

Total revenues from collaborations

538

65,642

Government contract

3,000

Total revenues

$

16,735

$

81,018

Our net product sales include sales of TAVALISSE in the US, net of chargebacks, discounts and fees, government and other rebates and returns. The following tables summarize the activities in chargebacks, discounts and fees, government and other rebates and returns that were accounted for within other accrued liabilities, for each of the periods presented (in thousands):

Chargebacks,

Government

Discounts and

and Other

Fees

Rebates

Returns

Total

Balance as of January 1, 2022

    

$

3,404

$

2,494

$

2,017

$

7,915

Provision related to current period sales

4,345

1,397

378

6,120

Credit or payments made during the period

(3,322)

(1,227)

(31)

(4,580)

Balance as of March 31, 2022

 

$

4,427

$

2,664

$

2,364

$

9,455

Chargebacks,

Government

Discounts and

and Other

Fees

Rebates

Returns

Total

Balance as of January 1, 2021

    

$

2,461

 

$

2,115

$

1,489

$

6,065

Provision related to current period sales

1,952

1,146

201

3,299

Credit or payments made during the period

(2,727)

(988)

(243)

(3,958)

Balance as of March 31, 2021

 

$

1,686

$

2,273

$

1,447

$

5,406

Of the $6.4 million discounts and allowances from gross product sales for the three months ended March 31, 2022, $6.1 million was accounted for as additions to other accrued liabilities and $0.3 million as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fess that were prepaid) in the condensed balance sheet.

Of the $3.7 million discounts and allowances from gross product sales for the three months ended March 31, 2021, $3.3 million was accounted for as additions to other accrued liabilities and $0.4 million as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fess that were prepaid) in the condensed balance sheet.

For detailed discussions of our revenues from collaboration and government contract, see “Note 4 – Sponsored Research and License Agreements and Government Contract” below.

10

The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more (wherein * denotes less than 10%) of the total net product sales and revenues from collaborations:

Three Months Ended March 31, 

2022

    

2021

McKesson Specialty Care Distribution Corporation

38%

*

ASD Healthcare and Oncology Supply

31%

*

Cardinal Healthcare

28%

*

Lilly

*

78%

4.

Sponsored Research and License Agreements and Government Contract

Sponsored Research and License Agreements

We conduct research and development programs independently and in connection with our corporate collaborators. As of March 31, 2022, we are a party to collaboration agreements with Lilly to develop and commercialize R552, a RIPK1 inhibitor, for the treatment of non-central nervous system (non-CNS) diseases and collaboration aimed at developing additional RIPK1 inhibitors for the treatment of central nervous system (CNS) diseases; with Grifols S.A. (Grifols) to commercialize fostamatinib for human diseases in all indications, including chronic ITP and autoimmune hemolytic anemia (AIHA), in Europe and Turkey; with Kissei Pharmaceutical Co., Ltd. (Kissei) to develop and commercialize fostamatinib in Japan, China, Taiwan and the Republic of Korea; and with Medison Pharma Trading AG (Medison Canada) and Medison Pharma Ltd. (Medison Israel and, together with Medison Canada, Medison) to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Canada and Israel, respectively.

Further, we are also a party to collaboration agreements, but do not have ongoing performance obligations with BerGenBio for the development and commercialization of AXL inhibitors in oncology, and with Daiichi to pursue research related to MDM2 inhibitors, a novel class of drug targets called ligases. We have an agreement with AstraZeneca AB (AZ) for the development and commercialization of R256, an inhaled JAK inhibitor. In December 2021, AZ provided a notice to terminate the agreement effective April 19, 2022 and returned to us the full rights to our propriety JAK inhibitor.

Under the above existing agreements that we entered into in the ordinary course of business, we received or may be entitled to receive upfront cash payments, payments contingent upon specified events achieved by such partners and royalties on any net sales of products sold by such partners under the agreements. Total future contingent payments to us under all of above existing agreements, excluding terminated or terminating agreements, could exceed $1.3 billion if all potential product candidates achieved all of the payment triggering events under all of our current agreements (based on a single product candidate under each agreement). Of this amount, $279.5 million relates to the achievement of development events, $285.6 million relates to the achievement of regulatory events and $778.5 million relates to the achievement of certain commercial or launch events. This estimated future contingent amount does not include any estimated royalties that could be due to us if the partners successfully commercialize any of the licensed products. Future events that may trigger payments to us under the agreements are based solely on our partners’ future efforts and achievements of specified development, regulatory and/or commercial events.

Global Exclusive License Agreement with Lilly

On February 18, 2021, we entered into a global exclusive license agreement and strategic collaboration with Lilly (Lilly Agreement), which became effective on March 27, 2021, to develop and commercialize R552, a RIPK1 inhibitor, for the treatment of non-CNS diseases. In addition, the collaboration is aimed at developing additional RIPK1 inhibitors for the treatment of CNS diseases. Pursuant to the terms of the license agreement, we granted to Lilly exclusive rights to develop and commercialize R552 and related RIPK1 inhibitors in all indications worldwide. The agreement became effective in March 2021 upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The parties’ collaboration is governed through a joint governance committee and appropriate subcommittees.

11

We are responsible for 20% of development costs for R552 in the US, Europe, and Japan, up to a specified cap. Lilly is responsible for funding the remainder of all development activities for R552 and other non-CNS disease development candidates. We have the right to opt-out of co-funding the R552 development activities in the US, Europe and Japan at two different specified times. If we exercise our first opt-out right (no later than September 30, 2023), under the Lilly Agreement, we are required to fund our share of the R552 development activities in the US, Europe, and Japan up to a maximum funding commitment of $65.0 million through April 1, 2024. If we decide not to exercise our opt-out rights, we will be required to share in global development costs of up to certain amounts at a specified cap, as provided for in the Lilly Agreement.

We are responsible for performing and funding initial discovery and identification of CNS disease development candidates. Following candidate selection, Lilly will be responsible for performing and funding all future development and commercialization of the CNS disease development candidates.

Under the terms of the license agreement, we were entitled to receive a non-refundable and non-creditable upfront cash payment amounting to $125.0 million, which we received in April 2021, and a potential for an additional $330.0 million in milestone payments upon the achievement of specified development and regulatory milestones by non-CNS disease products and $255.0 million in milestone payments upon the achievement of specified development and regulatory milestones by CNS disease products. We are also eligible to receive up to $100.0 million in sales milestone payments on a product-by-product basis for non-CNS disease products and up to $150.0 million in sales milestone payments on a product-by-product basis for CNS disease products. In addition, depending on the extent of our co-funding of R552 development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets. We would be entitled to receive tiered royalty payments on net sales of CNS disease products up to low-double digits, subject to certain standard reductions and offsets.

We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license rights over the non-CNS penetrant intellectual property (IP), and (b) granting of the license rights over the CNS penetrant IP which will be delivered to Lilly upon completion of the additional research and development efforts specified in the agreement. We concluded each of these performance obligations is distinct. We based our assessment on the assumption that Lilly can benefit from each of the licenses on its own by developing and commercializing the underlying product using its own resources.

Under the Lilly Agreement, we are required to share 20% of the development costs for R552 in the US, Europe and Japan up to a specified cap. Given our rights to opt-out from the development of R552, we believe at the minimum, we have a commitment to fund the development costs up to $65.0 million as discussed above. We considered this commitment to fund the development costs as a significant financing component of the contract, which we accounted for as a reduction of the upfront fee to derive the transaction price. This financing component was recorded as a liability at its net present value of approximately $57.9 million using a 6.4% discount rate. Interest expense is being accreted on such liability over the expected commitment period. Interest expense accreted during the three months ended March 31, 2022 and 2021 was $0.7 million and $0.1 million, respectively. As of March 31, 2022 and December 31, 2021, the outstanding financing liability to Lilly was $59.2 million and $60.7 million, respectively, and included within other long-term liabilities, current portion, and other long-term liabilities in the condensed balance sheet. Through March 31, 2022, Lilly billed us $4.9 million for our share of development costs under this agreement, of which, $2.1 million was paid as of March 31, 2022.

We allocated the net transaction price of $67.1 million to each performance obligation based on our best estimate of its relative standalone selling price using the adjusted market assessment approach. We concluded that the license rights over the non-CNS penetrant IP represents functional IP that is not expected to change over time, and we have no ongoing or undelivered obligations relative to such IP that Lilly will benefit from the use of such IP on the delivery date. As such, the transaction price allocated to the non-CNS penetrant IP of $60.4 million was recognized as revenue during the three months ended March 31, 2021 upon delivery of the non-CNS penetrant IP to Lilly in March 2021. For the delivery of license rights over the CNS penetrant IP, we are obligated to perform additional research and development efforts before Lilly can accept the license. The allocated transaction price to the CNS penetrant IP of $6.7 million was recognized as revenue from the effective date of the Lilly Agreement through the eventual acceptance by Lilly using the input method. During the three months ended March 31, 2022 and 2021, we recognized $0.2 million of

12

revenue for both periods for activities related to the delivery of CNS penetrant IP. As of March 31, 2022, there was $0.3 million of deferred revenue related to delivery of the CNS penetrant IP.

The remaining future variable consideration related to future milestone payments as discussed above were fully constrained because we cannot conclude that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate. Accordingly, we will recognize revenue at 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). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

Grifols License Agreement

In January 2019, we entered into an exclusive license agreement with Grifols to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Europe and Turkey. Under the agreement, we received an upfront payment of $30.0 million, with the potential for $297.5 million in total regulatory and commercial milestones. We will also receive stepped double-digit royalty payments based on tiered net sales which may reach 30% of net sales. In return, Grifols received exclusive rights to commercialize fostamatinib for human diseases, including chronic ITP, AIHA, and IgAN, in Europe and Turkey. Grifols also received an exclusive option to expand the territory under its exclusive and non-exclusive licenses to include the Middle East, North Africa and Russia (including Commonwealth of Independent States). In November 2020, Grifols exercised its option to include these territories as part of the licensed territories under the agreement. The agreement also required us to continue to conduct our long-term open-label extension study on patients with ITP through European Medicines Agency (EMA) approval of ITP in Europe or until the study ends as well as conduct the Phase 3 trial of fostamatinib in AIHA.

In December 2019, we entered into a Drug Product Purchase Agreement with Grifols wherein we agreed to supply and sell to Grifols at 30% mark up the drug product requested under an anticipated first and only purchase order until Grifols enters into a supply agreement directly with a third-party drug product manufacturer. In October 2020, we entered into a Commercial Supply Agreement with Grifols.

In January 2020, the European Commission granted a centralized Marketing Authorization (MA) for fostamatinib valid throughout the European Union and in the UK after the departure of the UK from the European Union for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. With this approval, we received in February 2020 a $20.0 million non-refundable payment, comprised of a $17.5 million payment due upon Marketing Authorization Application (MAA) approval by the EMA of fostamatinib for the first indication and a $2.5 million creditable advance royalty payment, based on the terms of our collaboration agreement with Grifols. The above milestone payment was allocated to the distinct performance obligations in the collaboration agreement with Grifols.

We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license, (b) performance of research and regulatory services related to our ongoing long-term open-label extension study on patients with ITP, and (c) performance of research services related to our Phase 3 study in AIHA. In October 2020, we entered into a commercial supply agreement for the licensed territories. We concluded each of these performance obligations is distinct. We based our assessment on the following: (i) our assessment that Grifols can benefit from the license on its own by developing and commercializing the underlying product using its own resources, and (ii) the fact that the manufacturing services are not highly specialized in nature and can be performed by other vendors. Upon execution of our agreement with Grifols, we determined that the upfront fee of $5.0 million, which is the non-refundable portion of the $30.0 million upfront fee, represented the transaction price. In the first quarter of 2020, we revised the transaction price to include the $25.0 million of the upfront payment that is no longer refundable under our agreement and the $20.0 million payment received that is no longer constrained. We allocated the updated transaction price to the distinct performance obligations in our collaboration agreement based on our best estimate of the relative standalone selling price as follows: (a) for the license, we estimated the standalone selling price using the adjusted market assessment approach to estimate its standalone selling price in the licensed territories; (b) for the research and regulatory services, we estimated the standalone selling price using the cost plus expected margin approach. As a result of the adjusted transaction price, adjustments are recorded on a cumulative catch-

13

up basis, and recorded as part of contract revenues from collaborations in the first quarter of 2020.

As of March 31, 2022 and December 31, 2021, the remaining deferred revenue was $0.4 million and $0.7 million, respectively, related to the performance of research services. During the three months ended March 31, 2022 and 2021, we recognized $0.3 million and none, respectively, in revenue related to the research and development services. During the three months ended March 31, 2022 and 2021, we recognized none and $1.0 million, respectively, in revenues for the delivery of drug supplies to Grifols for its commercialization.

The remaining future variable consideration of $277.5 million related to future regulatory and commercial milestones were fully constrained because we cannot conclude that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. We are recognizing revenues related to the research and regulatory services throughout the term of the respective clinical programs using the input method. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate. Accordingly, we will recognize revenue at 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). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

Kissei License Agreement

In October 2018, we entered into an exclusive license and supply agreement with Kissei to develop and commercialize fostamatinib in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. Kissei is responsible for performing and funding all development activities for fostamatinib in the above-mentioned territories. We received an upfront cash payment of $33.0 million, with the potential for up to an additional $147.0 million in development, regulatory and commercial milestone payments, and will receive mid- to upper twenty percent, tiered, escalated net sales-based payments for the supply of fostamatinib. Under the agreement, we granted Kissei the license rights to fostamatinib in the territories above and are obligated to supply Kissei with drug product for use in clinical trials and pre-commercialization activities. We are also responsible for the manufacture and supply of fostamatinib for all future development and commercialization activities under the agreement.

We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement: (a) granting of the license, (b) supply of fostamatinib for clinical use and (c) material right associated with discounted fostamatinib that are supplied for use other than clinical or commercial. In addition, we will provide commercial product supply if the product is approved in the licensed territory. We concluded that each of these performance obligations is distinct. We based our assessment on the following: (i) our assessment that Kissei can benefit from the license on its own by developing and commercializing the underlying product using its own resources and (ii) the fact that the manufacturing services are not highly specialized in nature and can be performed by other vendors. Moreover, we determined that the upfront fee of $33.0 million represented the transaction price and was allocated to the performance obligations based on our best estimate of the relative standalone selling price as follows: (a) for the license, we estimated the standalone selling price using the adjusted market assessment approach to estimate its standalone selling price in the licensed territories; (b) for the supply of fostamatinib and the material right associated with discounted fostamatinib, we estimated the standalone selling price using the cost plus expected margin approach. Variable consideration of $147.0 million related to future development and regulatory milestones was fully constrained because we cannot conclude that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones. We will recognize revenues related to the supply of fostamatinib and material right upon delivery of fostamatinib to Kissei. For sales-based milestones and royalties, we determined that the license is the predominant item to which the royalties or sales-based milestones relate to. Accordingly, we will recognize revenue at 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). We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the three months ended March 31, 2022 and 2021, we recognized an immaterial amount of revenue and no revenue, respectively, related to the supply of fostamatinib and material right upon delivery of fostamatinib to Kissei. As of March 31, 2022 and December 31, 2021, the remaining deferred revenue was $1.4 million.

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Medison Commercial and License Agreements

In October 2019, we entered into two exclusive commercial and license agreements with Medison for the commercialization of fostamatinib for chronic ITP in Israel and in Canada, pursuant to which we received a $5.0 million upfront payment with respect to the agreement in Canada. We accounted for the agreement made with an upfront payment under ASC 606 and identified the following combined performance obligations at inception of the agreement: (a) granting of the license and (b) obtaining regulatory approval in Canada of fostamatinib in ITP. We determined that the non-refundable upfront fee of $5.0 million represented the transaction price. However, under the agreement, we have the option to buy back all rights to the product in Canada within six months from obtaining regulatory approval for the treatment of AIHA in Canada. The buyback option precludes us from transferring control of the license to Medison under ASC 606. We believe that the buyback provision, if exercised, will require us to repurchase the license at an amount equal to or more than the upfront $5.0 million. As such, this arrangement was accounted for as a financing arrangement. As of March 31, 2022 and December 31, 2021, the outstanding financing liability to Medison of $5.6 million was included within other long-term liabilities in the condensed balance sheet.

Other license agreements

In February 2021, we entered into a non-exclusive license agreement with an unrelated third party whereby we granted such unrelated third party rights to a certain patent. In consideration for the license rights granted, we received a one-time fee of $4.0 million. All the deliverables under the agreement had been delivered and the one-time fee was recognized as revenue during the three months ended March 31, 2021.

Government Contract - US Department of Defense’s JPEO-CBRND

In January 2021, we were awarded up to $16.5 million by the US Department of Defense to support our ongoing Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib for the treatment of hospitalized high-risk patients with COVID-19. The amount of award we will receive from the US Department of Defense is subject to submission of proper documentation as evidence of completion of certain clinical trial events or milestones as specified in the agreement, and approval by the US Department of Defense that such events or milestones have been met. We determined that this government award should be accounted for under IAS 2, Accounting for Government Grants and Disclosure of Government Assistance, which is outside of the scope of Topic 606, as the US Department of Defense is not receiving reciprocal value for their contributions. We record government contract revenue in the statement of operations in the period when it is probable that we will receive the award, which is when we comply with the conditions associated with the award and obtain approval from the US Department of Defense that such conditions have been met. For the three months ended March 31, 2022 and 2021, we recognized no revenue and $3.0 million of revenue, respectively, related to this grant. Through March 31, 2022, we recognized $10.5 million revenue and we expect to receive the remaining award of $6.0 million throughout the period we conduct our clinical trial, subject to us meeting certain clinical trial events or milestones and approval by the US Department of Defense as specified in the agreement.

5.

Stock-Based Compensation

Stock-based compensation for the periods presented was as follows (in thousands):

Three Months Ended March 31, 

2022

    

2021

Selling, general and administrative

$

2,739

$

2,053

Research and development

468

586

Total stock-based compensation expense

$

3,207

$

2,639

In March 2022, our Board of Directors approved to extend the exercise period of the stock option grants made to two members of our Board of Directors whose terms will expire in the next stockholders’ meeting in May 2022. As a result of this modification, we recorded an incremental stock-based compensation expense of approximately $0.8 million during the three months ended March 31, 2022. The amount was included within selling, general and administrative expense in the condensed statement of operations.

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During the three months ended March 31, 2022, we granted stock options to purchase 4,470,747 shares of common stock with weighted-average grant-date fair value of $1.58 per share, and 420,521 stock options were exercised. As of March 31, 2022, there were 32,639,145 stock options outstanding, of which, 2,410,000 are outstanding performance-based stock options wherein the achievement of the corresponding corporate-based milestones were not considered probable as of March 31, 2022. Accordingly, none of the $4.7 million grant date fair value for these awards has been recognized as stock-based compensation expense through March 31, 2022.

The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model. The following table summarizes the weighted-average assumptions relating to options granted pursuant to our Equity Incentive Plans (2018 Equity Incentive Plan and Inducement Plan) for the periods presented:

Three Months Ended March 31, 

    

2022

    

2021

    

Risk-free interest rate

1.7

%  

1.0

%  

Expected term (in years)

6.4

6.5

Dividend yield

0.0

%  

0.0

%  

Expected volatility

70.0

%  

70.6

%  

During the three months ended March 31, 2022, we granted 1,012,612 restricted stock units (RSUs) with a grant-date weighted-average fair value of $2.42 per share, and 22,500 RSUs were released. The RSUs granted generally vest over 4 years. As of March 31, 2022, there were 1,206,182 RSUs outstanding.

As of March 31, 2022, there was approximately $19.4 million of unrecognized stock-based compensation which is expected to be recognized over a remaining weighted-average period of 3.04 years related to time-based stock options, RSUs and performance-based stock options where achievement of the corresponding corporate-based milestones was considered probable as of March 31, 2022.

In September 2021 and January 2022, our Board of Directors approved increases of 469,000 shares and 610,000 shares, respectively, in common stock reserved for issuance under the Inducement Plan which became effective following the filing of a Registration Statement to register the additional shares available for issuance on March 1, 2022. As of March 31, 2022, there were 7,130,256 shares of common stock available for future grant under our Equity Incentive Plans.

In April 2022, our Board of Directors approved the increase of 626,000 shares of common stock reserved for issuance under the Inducement Plan.

Employee Stock Purchase Plan

Our Purchase Plan permits our eligible employees to purchase common stock at a discount through payroll deductions during the offering period. Our Purchase Plan provides for a twenty-four-month offering period comprised of four six-month purchase periods with a look-back option. A look-back option is a provision in our Purchase Plan under which eligible employees can purchase shares of our common stock at a price per share equal to the lesser of 85% of the fair market value on the first day of the offering period or 85% of the fair market value on the purchase date. Our Purchase Plan also includes a feature that provides for a new offering period to begin when the fair market value of our common stock on any purchase date during an offering period falls below the fair market value of our common stock on the first day of such offering period. This feature is called a “reset.” Participants are automatically enrolled in the new offering period.

Our existing twenty-four-month offering period under our Purchase Plan is from July 1, 2020 to June 30, 2022. As of March 31, 2022, the unrecognized stock-based compensation cost related to our Purchase Plan was $0.05 million, which is expected to be recognized over the remaining weighted average period of 0.24 years.

As of March 31, 2022, there were 4,584,484 shares reserved for future issuance under the Purchase Plan.

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6.

Inventories

Inventories for the periods presented consist of the following (in thousands):

March 31, 

December 31,

2022

    

2021

Raw materials

$

4,555

$

5,142

Work in process

1,040

162

Finished goods

1,169

1,312

Total

$

6,764

$

6,616

As of March 31, 2022, we have $0.7 million in advance payments to the manufacturer of our raw materials, which was included within prepaid and other current assets in the condensed balance sheet.

7.Cash, Cash Equivalents and Short-Term Investments

Cash, cash equivalents and short-term investments for the periods presented consist of the following (in thousands):

March 31, 

December 31,

2022

    

2021

Cash

$

4,070

$

6,249

Money market funds

 

12,363

 

6,842

US treasury bills

 

35,170

 

35,366

Government-sponsored enterprise securities

 

15,559

 

14,678

Corporate bonds and commercial paper

 

40,357

 

61,832

$

107,519

$

124,967

Reported as:

Cash and cash equivalents

$

24,679

$

18,890

Short-term investments

 

82,840

 

106,077

$

107,519

$

124,967

Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands):

    

    

Gross

    

Gross

    

 

Amortized

Unrealized

Unrealized

 

March 31, 2022

Cost

Gains

Losses

Fair Value

 

US treasury bills

$

35,353

$

$

(183)

$

35,170

Government-sponsored enterprise securities

15,677

(118)

15,559

Corporate bonds and commercial paper

 

40,472

 

 

(115)

 

40,357

Total

$

91,502

$

$

(416)

$

91,086

    

    

Gross

    

Gross

    

 

Amortized

Unrealized

Unrealized

 

December 31, 2021

Cost

Gains

Losses

Fair Value

 

US treasury bills

$

35,416

$

$

(50)

$

35,366

Government-sponsored enterprise securities

14,705

(27)

14,678

Corporate bonds and commercial paper

 

61,857

 

2

 

(27)

 

61,832

Total

$

111,978

$

2

$

(104)

$

111,876

As of March 31, 2022 and December 31, 2021, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 166 days and 196 days, respectively. Our short-term investments are classified as available-for-sale securities. Accordingly, we have classified certain securities as short-term investments on our condensed balance sheets as they are available for use in the current operations. As of March 31, 2022, we had no

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investments that had been in a continuous unrealized loss position for more than 12 months. As of March 31, 2022, a total of 44 individual securities had been in an unrealized loss position for 12 months or less, and the losses were determined to be temporary. The gross unrealized losses above were caused by interest rate increases. No significant facts or circumstances have arisen to indicate that there has been any significant deterioration in the creditworthiness of the issuers of the securities held by us. Based on our review of these securities, including our assessment of the duration and severity of unrealized losses, there were no other-than-temporary impairments for these securities as of March 31, 2022.

The following table shows the fair value and gross unrealized losses of our investments in individual securities that are in an unrealized loss position, aggregated by investment category (in thousands):

March 31, 2022

    

Fair Value

    

Unrealized Losses

 

US treasury bills

$

35,170

$

(183)

Government-sponsored enterprise securities

15,559

(118)

Corporate bonds and commercial paper

39,607

(115)

Total

$

90,336

$

(416)

8.

Fair Value

The table below summarizes the fair value of our cash equivalents and short-term investments measured at fair value on a recurring basis, and are categorized based upon the lowest level of significant input to the valuations (in thousands):

Assets at Fair Value as of March 31, 2022

    

Level 1

    

Level 2

    

Level 3

    

Total

Money market funds

$

12,363

$

$

$

12,363

US treasury bills

35,170

35,170

Government-sponsored enterprise securities

 

 

15,559

 

 

15,559

Corporate bonds and commercial paper

 

 

40,357