UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(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,
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO
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As of April 27, 2023, there were
RIGEL PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023
INDEX
2
PART I. FINANCIAL INFORMATION
Item 1.Financial Statements
RIGEL PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands)
As of | |||||||
March 31, 2023 |
| December 31, 2022 (1) | |||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | $ | | ||||
Short-term investments |
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| | ||||
Accounts receivable, net |
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Inventories | |
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Prepaid and other current assets |
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Total current assets |
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Property and equipment, net |
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Intangible asset, net | | ||||||
Operating lease right-of-use assets | | ||||||
Other assets |
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Total assets | $ | $ | |||||
Liabilities and stockholders’ deficit | |||||||
Current liabilities: | |||||||
Accounts payable | $ | $ | | ||||
Accrued compensation |
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Accrued research and development |
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Revenue reserves and refund liability | | ||||||
Other accrued liabilities |
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Lease liabilities, current portion | | | |||||
Deferred revenue | | | |||||
Other long-term liabilities, current portion | | | |||||
Total current liabilities |
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Long-term portion of lease liabilities |
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Loans payable, net of discount | | | |||||
Other long-term liabilities |
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Total liabilities | | | |||||
Commitments | |||||||
Stockholders’ deficit: | |||||||
Preferred stock |
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Common stock |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
| ( |
| ( | |||
Accumulated deficit |
| ( |
| ( | |||
Total stockholders’ deficit |
| ( |
| ( | |||
Total liabilities and stockholders’ deficit | $ | $ |
(1) | The balance sheet as of December 31, 2022 has been derived from the audited financial statements included in Rigel’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC) on March 7, 2023. |
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, | |||||||
| 2023 |
| 2022 |
| |||
Revenues: | |||||||
Product sales, net | $ | | $ | | |||
Contract revenues from collaborations | | | |||||
Total revenues | | | |||||
Costs and expenses: | |||||||
Cost of product sales | | | |||||
Research and development |
| |
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Selling, general and administrative |
| |
| | |||
Total costs and expenses |
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| |||||
Loss from operations |
| ( |
| ( | |||
Interest income |
| |
| | |||
Interest expense | ( | ( | |||||
Net loss | $ | ( | $ | ( | |||
Net loss per share, basic and diluted | ( | ( | |||||
Weighted average shares used in computing net loss per share, basic and diluted | | |
See Accompanying Notes to Condensed Financial Statements
4
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
(unaudited)
Three Months Ended March 31, | |||||||
| 2023 |
| 2022 |
| |||
Net loss | $ | ( | $ | ( | |||
Other comprehensive gain (loss): | |||||||
Net unrealized gain (loss) on short-term investments |
| |
| ( | |||
Comprehensive loss | $ | ( | $ | ( |
See Accompanying Notes to Condensed Financial Statements
5
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
(In thousands, except share amounts)
(unaudited)
Additional | Accumulated Other | Total | |||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
| Shares |
| Amount |
| Capital |
| Loss |
| Deficit |
| Deficit | ||||||
Balance as of January 1, 2023 |
| | $ | | $ | | $ | ( | $ | ( | $ | ( | |||||
Net loss |
| — | — | — | — | ( |
| ( | |||||||||
Net change in unrealized gain on short-term investments |
| — | — | — | | — |
| | |||||||||
Issuance of common stock upon exercise of options |
| | — | | — | — |
| | |||||||||
Issuance of common stock upon vesting of restricted stock units (RSUs) | | — | — | — | — | — | |||||||||||
Stock-based compensation expense |
| — | — | | — | — |
| | |||||||||
Balance as of March 31, 2023 |
| | | $ | | $ | ( | $ | ( | $ | ( |
Additional | Accumulated Other | Total | |||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
| Shares |
| Amount |
| Capital |
| Loss |
| Deficit |
| Equity | ||||||
Balance as of January 1, 2022 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
Net loss |
| — | — | — | — | ( |
| ( | |||||||||
Net unrealized loss on short-term investments |
| — | — | — | ( | — |
| ( | |||||||||
Issuance of common stock upon exercise of options |
| | — | | — | — |
| | |||||||||
Issuance of common stock upon vesting of RSUs | | — | — | — | — | — | |||||||||||
Stock-based compensation expense |
| — | — | | — | — |
| | |||||||||
Balance as of March 31, 2022 |
| | $ | | $ | | $ | ( | $ | ( | $ | |
See Accompanying Notes to Condensed Financial Statements
6
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
Three Months Ended March 31, | |||||||
2023 |
| 2022 | |||||
Operating activities | |||||||
Net loss | $ | ( | ( | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation expense |
| ||||||
Loss on sale and disposal of fixed assets | | — | |||||
Depreciation and amortization |
| ||||||
Non-cash interest expense | — | | |||||
Net amortization and accretion of discount on short-term investments and term loan | ( | ||||||
Changes in assets and liabilities: | |||||||
Accounts receivable, net |
| | | ||||
Inventories | ( | ( | |||||
Prepaid and other current assets |
| | ( | ||||
Other assets |
| | | ||||
Right-of-use assets |
| | | ||||
Accounts payable |
| ( | | ||||
Accrued compensation |
| ( | ( | ||||
Accrued research and development |
| ( | ( | ||||
Revenue reserves and refund liability | | | |||||
Other accrued liabilities |
| ( | | ||||
Lease liability | ( | ( | |||||
Deferred revenue | — | ( | |||||
Other current and long-term liabilities |
| |
| — | |||
Net cash used in operating activities |
| ( |
| ( | |||
Investing activities | |||||||
Purchases of short-term investments |
| — | ( | ||||
Maturities of short-term investments |
| ||||||
Purchases of intangible asset |
| ( | — | ||||
Proceeds from sale of property and equipment | | — | |||||
Purchases of property and equipment |
| — | ( | ||||
Net cash provided by investing activities |
|
| |||||
Financing activities | |||||||
Cost share payments to a collaboration partner | ( | ( | |||||
Net proceeds from issuances of common stock upon exercise of options |
| | | ||||
Net proceeds from term loan financing | | | |||||
Net cash provided by financing activities |
|
| |||||
Net increase in cash and cash equivalents |
| |
| ||||
Cash and cash equivalents at beginning of period |
| ||||||
Cash and cash equivalents at end of period | $ | $ | |||||
Supplemental disclosure of cash flow information | |||||||
Interest paid | $ | | $ | |
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 therapies that significantly improve the lives of patients with hematologic disorders and cancer. 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 and the United Kingdom (UK) (as TAVLESSE), and in Canada, Israel and Japan (as TAVALISSE) for the treatment of chronic ITP in adult patients.
Our second FDA approved product is REZLIDHIA® (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. We began our commercialization of REZLIDHIA in December 2022. We in-licensed olutasidenib from Forma Therapeutics, Inc. (Forma), with exclusive, worldwide rights for its development, manufacturing and commercialization.
We conducted a Phase 3 clinical trial evaluating fostamatinib for the treatment of warm autoimmune hemolytic anemia (wAIHA) and announced that we did not file a supplemental New Drug Application (sNDA) for this indication considering the top-line data results and guidance received from the FDA. We announced the completion of the FOCUS Phase 3 clinical trial of fostamatinib for the treatment of hospitalized high-risk patients with COVID-19. Fostamatinib is currently being studied in a National Institute of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) sponsored Accelerating COVID-19 Therapeutic Inventions and Vaccines Phase 2/3 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, 2022 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, 2022 filed with the SEC on March 7, 2023.
8
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, 2022. There have been no material changes to these accounting policies.
Liquidity
As of March 31, 2023, we had approximately $
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
Recently issued accounting guidance is either not applicable or did not have, or is not expected to have, a material impact to us.
2. | Net Loss Per Share |
Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing net 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, RSUs 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 using 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 potential shares of common stock that were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive are as follows (in thousands):
Three Months Ended March 31, | ||||||
2023 |
| 2022 | ||||
Outstanding stock options | ||||||
RSUs | ||||||
Purchase Plan | ||||||
Total |
9
3. | Revenues |
Revenues disaggregated by category were as follows (in thousands):
Three Months Ended March 31, | ||||||
2023 |
| 2022 | ||||
Product sales: | ||||||
Gross product sales | $ | $ | ||||
Discounts and allowances | ( | ( | ||||
Total product sales, net | | | ||||
Revenues from collaborations: | ||||||
License revenues | — | | ||||
Royalty, delivery of drug supplies and others | ||||||
Total revenues from collaborations | | | ||||
Government contract | — | — | ||||
Total revenues | $ | | $ | |
Revenue from product sales are related to sales of our commercial products, TAVALISSE and REZLIDHIA, to our specialty distributors. For detailed discussions of our revenues from collaboration and government contract, see “Note 4 – Sponsored Research and License Agreements and Government Contract”.
Our net product sales include gross product sales, 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 revenue reserves and refund liability, for each of the periods presented (in thousands):
Chargebacks, | Government | |||||||||||
Discounts and | and Other | |||||||||||
Fees | Rebates | Returns | Total | |||||||||
Balance as of January 1, 2023 |
| $ | | $ | | $ | | $ | | |||
Provision related to current period sales | | | | | ||||||||
Credit or payments made during the period | ( | ( | ( | ( | ||||||||
Balance as of March 31, 2023 |
| $ | | $ | | $ | | $ | |
Chargebacks, | Government | |||||||||||
Discounts and | and Other | |||||||||||
Fees | Rebates | Returns | Total | |||||||||
Balance as of January 1, 2022 |
| $ | | $ | | $ | | $ | | |||
Provision related to current period sales | | | | | ||||||||
Credit or payments made during the period | ( | ( | ( | ( | ||||||||
Balance as of March 31, 2022 |
| $ | | $ | | $ | | $ | |
Of the $
Of the $
10
The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more of the total net product sales and revenues from collaborations:
Three Months Ended March 31, | ||||||
2023 |
| 2022 | ||||
McKesson Specialty Care Distribution Corporation | ||||||
Cardinal Healthcare | ||||||
ASD Healthcare and Oncology Supply |
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, 2023, 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 Grifols territory which includes Europe, the UK, Turkey, the Middle East, North Africa and Russia (including Commonwealth of Independent States); with Kissei Pharmaceutical Co., Ltd. (Kissei) to develop and commercialize fostamatinib in Kissei territory which includes Japan, China, Taiwan and the Republic of Korea; 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 Medison territory which includes Canada and Israel; and with Knight Therapeutics International SA (Knight) to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Knight territory which includes Latin America, consisting of Mexico, Central and South America, and the Caribbean (Knight territory).
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 receptor tyrosine kinase (AXL) inhibitors in oncology, and with Daiichi to pursue research related to murine double minute 2 (MDM2) inhibitors, a novel class of drug targets called ligases.
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. As of March 31, 2023, total future contingent payments to us under all of above existing agreements, excluding terminated agreements, could exceed $
Global Exclusive License Agreement with Lilly
We have a global exclusive license agreement and strategic collaboration with Lilly (Lilly Agreement) entered in February 2021, which became effective on March 27, 2021, upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, to develop and commercialize R552 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 parties’ collaboration is governed through a joint governance committee and appropriate subcommittees.
11
We are responsible for
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 Lilly Agreement, we were entitled to receive a non-refundable and non-creditable upfront cash payment amounting to $
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
We allocated the net transaction price of $
12
Lilly elected its option to lead the identification and selection of CNS penetrant lead candidate. As such, we recognized the remaining outstanding deferred revenue related to delivery of the CNS penetrant IP in the second quarter of 2022. For the three months ended March 31, 2022, we recognized $
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
We have an exclusive commercialization license agreement with Grifols entered in January 2019 with exclusive rights to commercialize fostamatinib for human diseases, including chronic ITP and AIHA, and non-exclusive rights to develop fostamatinib in Grifols territory. Under the agreement, we received an upfront payment of $
In January 2020, the European Commission (EC) granted a centralized Marketing Authorization (MA) for fostamatinib valid throughout the European Union (EU) and in the UK after the departure of the UK from the EU for the treatment of chronic ITP in adult patients who are refractory to other treatments. With this approval, in February 2020, we received $
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 long-term open-label extension study on patients with ITP, and (c) performance of research services related to our Phase 3 study in AIHA. We allocated the transaction price to the distinct performance obligations in our collaboration agreement based on our best estimate of the relative standalone selling price, and recognized the corresponding revenue in the periods we satisfied the performance obligations. During the three months ended March 31, 2023 and 2022,
The remaining variable consideration 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.
13
We entered into a Commercial Supply Agreement with Grifols in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols order from us pursuant to and in accordance with the agreement. Prior to the Commercial Supply Agreement, we had a Drug Product Purchase Agreement with Grifols entered in December 2019. For the three months ended March 31, 2023, we recognized revenue of $
We began recognizing royalty revenue from Grifols beginning in the third quarter of 2022. For the three months ended March 31, 2023, we recognized $
Kissei License Agreement
We have an exclusive license and supply agreement with Kissei entered in October 2018, to develop and commercialize fostamatinib in all current and potential indications in Kissei’s territory. Kissei is responsible for performing and funding all development activities for fostamatinib in the above-mentioned territories. We received an upfront cash payment of $
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 is 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 determined that the upfront fee of $
In April 2022, Kissei announced that an NDA was submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for fostamatinib in chronic ITP. With this milestone event, we received $
The remaining variable consideration 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. For sales-based milestones and tiered, escalated net sales-based payments for the supply of fostamatinib, we determined that the license is the predominant item to which the 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 allocated costs for the tiered, escalated net sales-based payments 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.
14
Medison Commercial and License Agreements
We have
The decision to exercise the buyback option is dependent of many factors including management’s cost and benefit assessments and the success of obtaining regulatory approval for the treatment of AIHA in Canada. In June 2022, we reported the top-line results from our Phase 3 trial of fostamatinib in wAIHA which showed that the trial did not demonstrate statistical significance in the primary efficacy endpoint in the overall study population. We also announced in early October 2022 that we will not file an sNDA for wAIHA indication considering the top-line data results and the guidance received from the FDA. With these developments, we assessed our options path forward, including our buyback option right with regards to the Medison license agreement. Based on management’s assessment, the likelihood of exercising the buy-back option right was remote. As such, during the fourth quarter of 2022, we relieved the outstanding financing liability to Medison amounting to $
Knight Commercial License and Supply Agreement
We have a commercial license and supply agreements with Knight entered in May 2022 for the commercialization of fostamatinib for approved indications in Knight territory. Pursuant to such commercial license agreement, we received a $
Government Contract - US Department of Defense’s JPEO-CBRND
In January 2021, we were awarded up to $
15
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.
License and Transition Services Agreement with Forma
We have a license and transition services agreement with Forma entered in July 2022, for an exclusive license to develop, manufacture and commercialize olutasidenib, Forma’s proprietary inhibitor of mutated IDH1 (mIDH1), for any uses worldwide, including for the treatment of AML and other malignancies. Forma became a wholly owned subsidiary of Novo Nordisk A/S following the closing of the acquisition of Forma in October 2022. Pursuant to the terms of the license and transition services agreement, we paid Forma an upfront fee of $
The transaction was accounted for as an acquisition of asset under ASC 730, Research and Development. In accordance with the guidance, in a transaction accounted for as an asset acquisition, any acquired IPR&D that does not have alternative future use is charged to expense at the acquisition date. At the acquisition date, the acquired license asset was accounted for as IPR&D, and we do not anticipate any economic benefit to be derived from such acquired licensed asset other than the primary indications. As such, we accounted for the upfront fee of $
Under the accounting guidance, we account for contingent cash payments when it is probable that a liability has been incurred and the amount can be reasonably estimated. We account for milestone payment obligations incurred at development stage and prior to a regulatory approval of an indication associated with the acquired licensed asset as research and development expenses when the event requiring payment of the milestone occurs. Milestone payment obligations incurred upon and after a regulatory approval of an indication associated with the acquired licensed asset, and at the commercial stage, are recorded as intangible asset when the event requiring payment of the milestones occurs. The amount recorded as intangible asset is amortized over the estimated useful life of the acquired licensed asset. Royalty payments related to the acquired licensed asset is recorded as cost of sales when incurred. During the fourth quarter of 2022 prior to the approval of FDA on December 1, 2022, a near-term regulatory milestone was met which entitled Forma to receive a $
During the three months ended March 31, 2023, we recognized $
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5. | Stock-Based Compensation |
Stock-based compensation for the periods presented was as follows (in thousands):
Three Months Ended March 31, |
| ||||||
2023 |
| 2022 |
| ||||
Selling, general and administrative | $ | | $ | | |||
Research and development | | | |||||
Total stock-based compensation expense | $ | | $ | |
Stock-based compensation expense included within research and development in the three months ended March 31, 2023 include an incremental charge of approximately $
During the three months ended March 31, 2023, we granted stock options to purchase
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, | |||||
| 2023 |
| 2022 |
| |
Risk-free interest rate | % | % | |||
Expected term (in years) | |||||
Dividend yield | % | % | |||
Expected volatility | % | % |
During the three months ended March 31, 2023, we granted
As of March 31, 2023, there was approximately $
As of March 31, 2023, there were
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Employee Stock Purchase Plan
Our Purchase Plan provides for a -month offering period comprises
Our previous -month offering period under our Purchase Plan ended on June 30, 2022, and a new twenty-four-month offering period started on July 1, 2022. The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods. As of March 31, 2023, unrecognized stock-based compensation cost related to our Purchase Plan amounted to $
As of March 31, 2023, there were
6. | Inventories |
Inventories for the periods presented consist of the following (in thousands):
As of | ||||||
March 31, 2023 |
| December 31, 2022 | ||||
Raw materials | $ | $ | ||||
Work in process | ||||||
Finished goods | ||||||
Total | $ | $ |
Inventories as of March 31, 2023 and December 31, 2022 include inventories acquired from Forma pursuant to the license and transition agreement. As of March 31, 2023 and December 31, 2022, we have $
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):
As of | ||||||
March 31, 2023 |
| December 31, 2022 | ||||
Cash | $ | $ | | |||
Money market funds |
|
| | |||
US treasury bills |
| — |
| | ||
Government-sponsored enterprise securities |
|
| | |||
Corporate bonds and commercial paper |
|
| | |||
$ | $ | | ||||
Reported as: | ||||||
Cash and cash equivalents | $ | $ | | |||
Short-term investments |
|
| | |||
$ | $ |
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Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands):
|
| Gross |
| Gross |
|
| |||||||
Amortized | Unrealized | Unrealized |
| ||||||||||
As of March 31, 2023 | Cost | Gains | Losses | Fair Value |
| ||||||||
Government-sponsored enterprise securities | $ | | $ | | $ | ( | $ | | |||||
Corporate bonds and commercial paper |
| |
| — |
| ( |
| | |||||
Total | $ | | $ | | $ | ( | $ | |
|
| Gross |
| Gross |
|
| |||||||
Amortized | Unrealized | Unrealized |
| ||||||||||
As of December 31, 2022 | Cost | Gains | Losses | Fair Value |
| ||||||||
US treasury bills | $ | | $ | — | $ | ( | $ | | |||||
Government-sponsored enterprise securities | | | ( | | |||||||||
Corporate bonds and commercial paper |
| |
| — |
| ( |
| | |||||
Total | $ | | $ | | $ | ( | $ | |
We maintain a depository relationship with Silicon Valley Bank (SVB). On March 10, 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. On March 12, 2023, federal regulators announced that the FDIC would complete its resolution of SVB in a manner that fully protects all depositors. On March 27, 2023, First Citizens BancShares, Inc. (FCB) announced that it entered into an agreement with FDIC to purchase all of the asset and liabilities of SVB. Customers of SVB automatically become customers of FCB following the acquisition. To date and as of March 31, 2023, the amount of our cash held on deposit with SVB/FCB was not material with respect our total cash, cash equivalents and short-term investments. All of our cash deposits with SVB/FCB are accessible to us, and we do not anticipate any losses with respect to such funds.
As of March 31, 2023 and December 31, 2022, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately
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):
As of March 31, 2023 |
| Fair Value |
| Unrealized Losses |
| ||
Government-sponsored enterprise securities | $ | | $ | ( | |||
Corporate bonds and commercial paper | | ( | |||||
Total | $ | | $ | ( |
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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, 2023 | ||||||||||||
| Level 1 |
| Level 2 |
| Level 3 |
| Total | |||||
Money market funds | $ | | $ | — | $ | — | $ | | ||||
Government-sponsored enterprise securities |
| — |
| |
| — |
| | ||||
Corporate bonds and commercial paper |
| — |
| |
| — |
| | ||||
Total | $ | | $ | | $ | — | $ | |