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 SEPTEMBER 30,
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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(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.
Large 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 November 4, 2024, there were
RIGEL PHARMACEUTICALS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024
INDEX
2
PART I. FINANCIAL INFORMATION
Item 1.Financial Statements
RIGEL PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands)
As of | ||||||
September 30, 2024 |
| December 31, 2023 (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 |
|
| | |||
Intangible assets, net | | |||||
Operating lease right-of-use assets | | |||||
Other assets |
|
| | |||
Total assets | $ | $ | ||||
Liabilities and stockholders’ deficit | ||||||
Current liabilities: | ||||||
Accounts payable | $ | $ | | |||
Accrued compensation |
|
| | |||
Accrued research and development |
|
| | |||
Acquisition-related liabilities | — | |||||
Revenue reserves and refund liability | | |||||
Loans payable, net, current portion | — | | ||||
Other accrued liabilities |
|
| | |||
Deferred revenue | | | ||||
Lease liabilities, current portion | | | ||||
Other long-term liabilities, current portion | — | | ||||
Total current liabilities |
|
| ||||
Long-term portion of lease liabilities |
| — |
| | ||
Long-term portion of loans payable, net | | | ||||
Other long-term liabilities |
| |
| | ||
Total liabilities | | | ||||
Commitments | ||||||
Stockholders’ deficit: | ||||||
Common stock (2) |
|
| | |||
Additional paid-in capital (2) |
|
| | |||
Accumulated other comprehensive income |
|
| | |||
Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ deficit |
| ( |
| ( | ||
Total liabilities and stockholders’ deficit | $ | $ |
(1) | The balance sheet as of December 31, 2023 has been derived from the audited financial statements included in Rigel’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) on March 5, 2024. |
(2) | Common stock and additional paid-in capital have been restated to reflect the reverse stock split effected on June 27, 2024 on a retroactive basis for the periods presented. |
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 September 30, | Nine Months Ended September 30, | |||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | |||||
Revenues: | ||||||||||||
Product sales, net | $ | | $ | | $ | | | |||||
Contract revenues from collaborations | | | | | ||||||||
Government contracts | — | — | — | | ||||||||
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 | ( | ( | ( | ( | ||||||||
Net income (loss) | $ | | $ | ( | $ | | $ | ( | ||||
Net income (loss) per share(1) | ||||||||||||
Basic | $ | | $ | ( | $ | | $ | ( | ||||
Diluted | $ | | $ | ( | $ | | $ | ( | ||||
Weighted average shares used in computing net income (loss) per share (1) | ||||||||||||
Basic | | | | | ||||||||
Diluted | | | | |
(1) | Share and per share amounts have been restated to reflect the reverse stock split effected on June 27, 2024 on a retroactive basis for all periods presented. |
See Accompanying Notes to Condensed Financial Statements
4
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
Other comprehensive income: | ||||||||||||
Net unrealized gain on short-term investments |
| |
| |
| | | |||||
Comprehensive income (loss) | $ | $ | ( | $ | $ | ( |
See Accompanying Notes to Condensed Financial Statements
5
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(In thousands, except share amounts)
(unaudited)
Additional | Accumulated Other | Total | |||||||||||||||
Common Stock (1) | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
| Shares |
| Amount |
| Capital (1) |
| (Loss) Income |
| Deficit |
| Deficit | ||||||
Balance as of January 1, 2024 |
| | $ | | $ | | $ | | $ | ( | $ | ( | |||||
Net loss |
| — | — | — | — | ( |
| ( | |||||||||
Net change in unrealized loss 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, 2024 |
| | | | ( | ( | ( | ||||||||||
Net loss |
| — | — | — | — | ( | ( | ||||||||||
Net change in unrealized loss on short-term investments |
| — | — | — | ( | — | ( | ||||||||||
Issuance of common stock upon exercise of options and participation in Purchase Plan |
| | — | | — | — | | ||||||||||
Issuance of common stock upon vesting of RSUs | | — | — | — | — | — | |||||||||||
Stock-based compensation expense |
| — | — | | — | — | | ||||||||||
Balance as of June 30, 2024 | | $ | | $ | | $ | ( | $ | ( | $ | ( | ||||||
Net income |
| — | — | — | — | | | ||||||||||
Net change in unrealized gain 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 September 30, 2024 |
| | $ | | $ | | $ | | $ | ( | $ | ( |
Additional | Accumulated Other | Total | |||||||||||||||
Common Stock (1) | Paid-in | Comprehensive | Accumulated | Stockholders’ | |||||||||||||
| Shares |
| Amount |
| Capital (1) |
| (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 RSUs | | — | — | — | — | — | |||||||||||
Stock-based compensation expense |
| — | — | | — | — |
| | |||||||||
Balance as of March 31, 2023 |
| | | | ( | ( | ( | ||||||||||
Net loss |
| — | — | — | — | ( | ( | ||||||||||
Net change in unrealized gain on short-term investments |
| — | — | — | | — | | ||||||||||
Issuance of common stock upon exercise of options and participation in Purchase Plan |
| | — | | — | — | | ||||||||||
Issuance of common stock upon vesting of RSUs | | — | — | — | — | — | |||||||||||
Stock-based compensation expense |
| — | — | | — | — | | ||||||||||
Balance as of June 30, 2023 | | $ | | $ | | $ | ( | $ | ( | $ | ( | ||||||
Net loss |
| — | — | — | — | ( | ( | ||||||||||
Net change in unrealized gain on short-term investments |
| — | — | — | | — | | ||||||||||
Issuance of common stock upon exercise of options |
| | — | | — | — | | ||||||||||
Stock-based compensation expense |
| — | — | | — | — | | ||||||||||
Balance as of September 30, 2023 |
| | $ | | $ | | $ | ( | $ | ( | $ | ( |
(1) | All share amounts in this column, including appropriate reclassifications between common stock and additional paid-in capital, have been restated to reflect the reverse stock split effected on June 27, 2024 on a retroactive basis for all periods presented. |
See Accompanying Notes to Condensed Financial Statements
6
RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
Nine Months Ended September 30, | ||||||
2024 |
| 2023 | ||||
Operating activities | ||||||
Net income (loss) | $ | $ | ( | |||
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||||||
Stock-based compensation expense |
| |||||
(Gain) loss on sale and disposal of fixed assets | ( | | ||||
Depreciation and amortization |
| |||||
Net amortization of discount on short-term investments and term loans | ( | ( | ||||
Changes in assets and liabilities: | ||||||
Accounts receivable, net |
| ( | ||||
Inventories | ( | ( | ||||
Prepaid and other current and non-current 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 provided by operating activities |
|
| ||||
Investing activities | ||||||
Maturities of short-term investments |
| | ||||
Purchases of short-term investments |
| ( | ( | |||
Capital expenditures | ( | — | ||||
Payments for acquisition of intangible assets |
| ( | ( | |||
Proceeds from sale of property and equipment | | | ||||
Net cash provided by investing activities |
|
| ||||
Financing activities | ||||||
Net proceeds from term loan financing | — | | ||||
Net proceeds from issuances of common stock upon exercise of options |
| | | |||
Closing purchase price payment related to asset acquisition | ( | — | ||||
Cost share payments to a collaboration partner | ( | ( | ||||
Net cash (used in) 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 | $ | | $ | | ||
Acquisition-related liabilities | $ | | $ | — |
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 developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms.
TAVALISSE® (fostamatinib disodium hexahydrate) is our first product approved by the US Food and Drug Administration (FDA). TAVALISSE is 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.
REZLIDHIA® (olutasidenib) is our second FDA-approved product. REZLIDHIA capsules are indicated 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 in-licensed REZLIDHIA from Forma Therapeutics, Inc., now Novo Nordisk (Forma), with exclusive, worldwide rights for its development, manufacturing and commercialization.
GAVRETO® (pralsetinib) is our third FDA-approved product which we began commercializing on June 27, 2024. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type rearranged during transfection (RET) and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. GAVRETO is also approved under accelerated approval based on overall response rate and duration response rate, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). We acquired the rights to research, develop, manufacture and commercialize GAVRETO in the US from Blueprint Medicines Corporation (Blueprint) pursuant to an Asset Purchase Agreement entered in February 2024.
We continue to advance the development of R289, our dual interleukin receptor-associated kinases 1 and 4 (IRAK 1/4) inhibitor program, in an open-label, Phase 1b study to determine the tolerability and preliminary efficacy of the drug in patients with lower-risk myelodysplastic syndrome (MDS) who are relapsed, refractory or resistant to prior therapies.
We have strategic development collaborations with the University of Texas MD Anderson Cancer Center (MDACC) to expand our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations, and with Collaborative Network for Neuro-Oncology Clinical Trials (CONNECT) to conduct a Phase 2 clinical trial to evaluate olutasidenib in combination with temozolomide in patients with high-grade glioma (HGG) harboring an IDH1 mutation.
We have a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor program in clinical development with our partner Eli Lilly and Company (Lilly). We also have product candidates in clinical development with partners BerGenBio ASA (BerGenBio) and Daiichi Sankyo (Daiichi).
8
Reverse Stock Split
We filed with the Secretary of State of the State of Delaware a certificate of amendment to our Amended and Restated Certificate of Incorporation, to effect a reverse stock split, effective June 27, 2024. As a result of the reverse stock split, every ten issued and outstanding shares of our common stock were automatically combined into one issued and outstanding share of common stock. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from common stock to additional paid-in capital on the condensed balance sheet and statement of changes in stockholders’ deficit. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive fractional shares of common stock were entitled to receive the cash value equal to the fraction to which the stockholder would otherwise be entitled, multiplied by the closing price of the common stock as reported by Nasdaq on the last trading day prior to the effective date of the split. As a result of the reverse stock split, proportionate adjustments were made to the number of shares underlying (and as applicable, the exercise or conversion prices of) our outstanding equity awards and to the number of shares of common stock issuable under our equity incentive plans. The reverse stock split did not change the par value of our common stock, which remains $
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, 2023 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, 2023.
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, 2023. There have been no material changes to these accounting policies except for the accounting consideration related to the Asset Purchase Agreement with Blueprint as discussed below in “Note 5 – In-licensing and Acquisition.”
Liquidity
As of September 30, 2024, 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.
9
Recently Issued Accounting Standards
In November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update expands public entities’ segment disclosures, among others, requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss; an amount and description of its composition for other segment items; and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure requirements under this update are also required for public entities with a single reportable segment. This update is effective for our Annual Report on Form 10-K for the fiscal year ending December 31, 2024, and interim periods thereafter. Early adoption is permitted. The update should be applied retrospectively to all periods presented in the financial statements. We are currently evaluating the impact of adopting this update on our financial statements and disclosures.
In December 2023, FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which enhance the annual disclosure requirements regarding the tax rate reconciliation and incomes taxes paid information. This update is effective for our fiscal year ending December 31, 2025, and maybe adopted on a prospective or retrospective basis. Early adoption is permitted. We are currently assessing the impact of adopting this guidance but do not expect it to have a significant impact to our financial statements and disclosures.
Other recently issued accounting guidance not discussed in this Quarterly Report on Form 10-Q are either not applicable or did not have, or are not expected to have, a material impact on 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, 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 following table sets forth the computation of basic and diluted earnings per share (in thousands except per share amounts):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||||
EPS Numerator: | |||||||||||||
Net income (loss) | $ | $ | ( | $ | $ | ( | |||||||
EPS Denominator—Basic: | |||||||||||||
Weighted-average common shares outstanding |
|
|
|
| |||||||||
EPS Denominator—Diluted: | |||||||||||||
Weighted-average common shares outstanding |
| ||||||||||||
Dilutive effect of stock options, RSUs and shares under Purchase Plan |
| | — | | — | ||||||||
Weighted-average shares outstanding and common stock equivalents |
|
|
|
| |||||||||
Net income (loss) per share | |||||||||||||
Basic | $ | | $ | ( | $ | | $ | ( | |||||
Diluted | $ | | $ | ( | $ | | $ | ( |
10
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 September 30, | Nine Months Ended September 30, | |||||||||||
2024 |
| 2023 | 2024 |
| 2023 | |||||||
Stock options | ||||||||||||
RSUs | ||||||||||||
Shares under Purchase Plan | ||||||||||||
Total |
3. | Revenues |
Revenues disaggregated by category were as follows (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2024 |
| 2023 | 2024 |
| 2023 | |||||||
Product sales: | ||||||||||||
Gross product sales | $ | $ | $ | $ | ||||||||
Discounts and allowances | ( | ( | ( | ( | ||||||||
Total product sales, net | | | | | ||||||||
Revenues from collaborations: | ||||||||||||
License revenue | | — | | — | ||||||||
Milestone revenue | — | | — | | ||||||||
Delivery of drug supplies, royalty and others | ||||||||||||
Total revenues from collaborations | | | | | ||||||||
Government contracts | — | — | — | | ||||||||
Total revenues | $ | | $ | | $ | | $ | |
Revenue from product sales are related to sales of our commercial products to our customers. For detailed discussions of our revenues from collaborations and government contracts, see “Note 4 – Sponsored Research, License Agreements and Government Contracts.”
Our net product sales include gross product sales, net of chargebacks, discounts and fees, government and other rebates and returns. Of the total discounts and allowances from gross product sales for the nine months ended September 30, 2024 and 2023, $
Chargebacks, | Government | |||||||||||
Discounts and | and Other | |||||||||||
Fees | Rebates |