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
Commission File Number
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or | (I.R.S. Employer Identification No.) | |
organization) |
(Address of principal executive offices) | (Zip Code) |
(
(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: |
The 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.
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).
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.
☒ | 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
As of April 29, 2022, there were
RIGEL PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022
INDEX
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 | $ | $ | | |||
Short-term investments |
|
| | |||
Accounts receivable, net |
| |
| | ||
Inventories | |
| | |||
Prepaid and other current assets |
|
| | |||
Total current assets |
|
| ||||
Property and equipment, net |
|
| | |||
Operating lease right-of-use asset | | |||||
Other assets |
|
| | |||
$ | $ | |||||
Liabilities and stockholders’ equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | $ | | |||
Accrued compensation |
|
| | |||
Accrued research and development |
|
| | |||
Other accrued liabilities |
|
| | |||
Lease liabilities, current portion | | | ||||
Deferred revenue | | | ||||
Other long-term liabilities, current portion | | | ||||
Total current liabilities |
|
| ||||
Long-term portion of lease liabilities |
| — |
| | ||
Loans payable, net of discount | | | ||||
Other long-term liabilities |
| |
| | ||
Commitments | ||||||
Stockholders’ equity: | ||||||
Preferred stock |
|
| ||||
Common stock |
|
| | |||
Additional paid-in capital |
|
| | |||
Accumulated other comprehensive loss |
| ( |
| ( | ||
Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ equity |
|
| ||||
$ | $ |
(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 | $ | | $ | | ||
Contract revenues from collaborations | | | ||||
Government contract | — | | ||||
Total revenues | | | ||||
Costs and expenses: | ||||||
Cost of product sales | | | ||||
Research and development |
| |
| | ||
Selling, general and administrative |
| |
| | ||
Total costs and expenses |
|
| ||||
Income (loss) from operations |
| ( |
| |||
Interest income |
| |
| | ||
Interest expense | ( | ( | ||||
Income (loss) before income taxes | ( | |||||
Provision for income taxes | — | | ||||
Net income (loss) | $ | ( | $ | |||
Net income (loss) per share | ||||||
Basic | $ | ( | $ | | ||
Diluted | $ | ( | $ | | ||
Weighted average shares used in computing net income (loss) per share | ||||||
Basic | | | ||||
Diluted | | |
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) | $ | ( | $ | |||
Other comprehensive income (loss): | ||||||
Net unrealized gain (loss) on short-term investments |
| ( |
| | ||
Comprehensive income (loss) | $ | ( | $ |
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 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
Net loss |
| — | — | — | — | ( |
| ( | |||||||||
Net unrealized loss on short-term investments |
| — | — | — | ( | — |
| ( | |||||||||
Issuance of common stock upon exercise of options |
| | — | | — | — |
| | |||||||||
Issuance of common stock upon vesting of restricted stock units | | — | — | — | — | — | |||||||||||
Stock-based compensation expense |
| — | — | | — | — |
| | |||||||||
Balance as of March 31, 2022 |
| | $ | | $ | | $ | ( | $ | ( | $ | |
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
| Shares |
| Amount |
| Capital |
| Loss |
| Deficit |
| Equity | ||||||
Balance as of January 1, 2021 |
| | $ | | $ | | $ | ( | $ | ( | $ | | |||||
Net income |
| — | — | — | — | |
| | |||||||||
Net unrealized gain on short-term investments |
| — | — | — | | — |
| | |||||||||
Issuance of common stock upon exercise of options |
| | | | — | — |
| | |||||||||
Stock-based compensation expense |
| — | — | | — | — |
| | |||||||||
Balance as of March 31, 2021 |
| | $ | | $ | | $ | ( | $ | ( | $ | |
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) | $ | ( | ||||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||
Stock-based compensation expense |
| |||||
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 |
| ( | ||||
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 |
| | ||||
Capital expenditures |
| ( | ( | |||
Net cash provided by investing activities |
|
| | |||
Financing activities | ||||||
Cost share payment 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 (decrease) 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 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 $
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) | $ | ( | $ | |||
EPS Denominator—Basic and Diluted: | ||||||
Weighted-average common shares outstanding |
|
| ||||
EPS Denominator—Diluted: | ||||||
Weighted-average common shares outstanding |
| |||||
Dilutive effect of stock options, restricted stock units and shares under Purchase Plan |
| — | | |||
Weighted-average shares outstanding and common stock equivalents |
|
| ||||
Net income (loss) per share | ||||||
Basic | $ | ( | $ | | ||
Diluted | $ | ( | $ | |
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 | ||||||
Restricted stock units | | | ||||
Purchase Plan | | — | ||||
Total |
9
3. | Revenues |
Revenues disaggregated by category were as follows (in thousands):
Three Months Ended March 31, | |||||||
2022 |
| 2021 | |||||
Product sales: | |||||||
Gross product sales | $ | $ | |||||
Discounts and allowances | ( | ( | |||||
Total product sales, net | | | |||||
Revenues from collaborations: | |||||||
License revenues | |||||||
Research and development services and others | |||||||
Total revenues from collaborations | | | |||||
Government contract | — | ||||||
Total revenues | $ | | $ | |
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 |
| $ | | $ | | $ | | $ | | |||
Provision related to current period sales | | | | | ||||||||
Credit or payments made during the period | ( | ( | ( | ( | ||||||||
Balance as of March 31, 2022 |
| $ | | $ | | $ | | $ | |
Chargebacks, | Government | |||||||||||
Discounts and | and Other | |||||||||||
Fees | Rebates | Returns | Total | |||||||||
Balance as of January 1, 2021 |
| $ | |
| $ | | $ | | $ | | ||
Provision related to current period sales | | | | | ||||||||
Credit or payments made during the period | ( | ( | ( | ( | ||||||||
Balance as of March 31, 2021 |
| $ | | $ | | $ | | $ | |
Of the $
Of the $
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 | * | |||||
ASD Healthcare and Oncology Supply | * | |||||
Cardinal Healthcare | * | |||||
Lilly | * |
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 $
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
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 $
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
revenue for both periods for activities related to the delivery of CNS penetrant IP. As of March 31, 2022, there was $
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 $
In December 2019, we entered into a Drug Product Purchase Agreement with Grifols wherein we agreed to supply and sell to Grifols at
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 $
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 $
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 $
The remaining future variable consideration of $
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 $
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 $
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 $
14
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 $
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 $
Government Contract - US Department of Defense’s JPEO-CBRND
In January 2021, we were awarded up to $
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 | $ | | $ | | ||
Research and development | | | ||||
Total stock-based compensation expense | $ | | $ | |
In March 2022, our Board of Directors approved to extend the exercise period of the stock option grants made to
15
During the three months ended March 31, 2022, 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, | |||||
| 2022 |
| 2021 |
| |
Risk-free interest rate | % | % | |||
Expected term (in years) | |||||
Dividend yield | % | % | |||
Expected volatility | % | % |
During the three months ended March 31, 2022, we granted
As of March 31, 2022, there was approximately $
In September 2021 and January 2022, our Board of Directors approved increases of
In April 2022, our Board of Directors approved the increase of
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 -month offering period comprised of
Our existing -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 $
As of March 31, 2022, there were
16
6. | Inventories |
Inventories for the periods presented consist of the following (in thousands):
March 31, | December 31, | |||||
2022 |
| 2021 | ||||
Raw materials | $ | $ | | |||
Work in process | | |||||
Finished goods | ||||||
Total | $ | $ |
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 | $ | $ | | |||
Money market funds |
|
| | |||
US treasury bills |
| |
| | ||
Government-sponsored enterprise securities |
|
| | |||
Corporate bonds and commercial paper |
|
| | |||
$ | $ | | ||||
Reported as: | ||||||
Cash and cash equivalents | $ | $ | | |||
Short-term investments |
|
| | |||
$ | $ |
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 | $ | | $ | — | $ | ( | $ | | |||||
Government-sponsored enterprise securities | | — | ( | | |||||||||
Corporate bonds and commercial paper |
| |
| — |
| ( |
| | |||||
Total | $ | | $ | — | $ | ( | $ | |
|
| Gross |
| Gross |
|
| |||||||
Amortized | Unrealized | Unrealized |
| ||||||||||
December 31, 2021 | Cost | Gains | Losses | Fair Value |
| ||||||||
US treasury bills | $ | | $ | — | $ | ( | $ | | |||||
Government-sponsored enterprise securities | | — | ( | | |||||||||
Corporate bonds and commercial paper |
| |
| |
| ( |
| | |||||
Total | $ | | $ | | $ | ( | $ | |
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
17
investments that had been in a continuous unrealized loss position for more than 12 months. As of March 31, 2022, a total of
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 | $ | | $ | ( | |||
Government-sponsored enterprise securities | | ( | |||||
Corporate bonds and commercial paper | | ( | |||||
Total | $ | | $ | ( |
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 | $ | | $ | — | $ | — | $ | | ||||
US treasury bills | — | | — | | ||||||||
Government-sponsored enterprise securities |
| — |
| |
| — |
| | ||||
Corporate bonds and commercial paper |
| — |
| |
| — |
| | ||||
Total | $ | | $ | | $ | — | $ | |
Assets at Fair Value as of December 31, 2021 | ||||||||||||
| Level 1 |
| Level 2 |
| Level 3 |
| Total | |||||
Money market funds | $ | | $ | — | $ | — | $ | | ||||
US treasury bills | — | |