FORM 10-Q (Mark One) Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Exact name of registrant as specified in its charter) Delaware 94-3248524 (State or other jurisdiction of incorporation or (I.R.S. Employer Identification No.) organization) 1180 Veterans Blvd. South San Francisco, CA 94080 (Address of principal executive offices) (Zip Code) (650) 624-1100 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY P ...

| --- | --- | --- | |----------------------------|-------------------|-------| | | | | | | | | | Q4 & YE 2021 | Financial Results | | | Presentation March 1, 2022 | | | | | | | 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1955 ("PSLRA") relating to, among other things, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; including expectations related to the potential and market opp ...

Start Time: 16:30 January 1, 0000 5:35 PM ET Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q4 2021 Earnings Conference Call March 01, 2022, 16:30 PM ET Company Participants Raul Rodriguez - President and CEO Wolfgang Dummer - EVP and CMO Dave Santos - EVP and Chief Commercial Officer Dean Schorno - EVP and CFO Dolly Vance - EVP, Corporate Affairs and General Counsel Conference Call Participants Do Kim - Piper Sandler Eun Yang - Jefferies Joe Pantginis - H.C. Wainwright Yigal Nochomovitz - Citigroup Kristen Klus ...

Revenue and Sales Performance - Total revenues for 2021 were $149.236 million, an increase of $40.615 million (37.4%) from $108.621 million in 2020[488]. - Product sales, net, reached $63.010 million in 2021, up from $61.696 million in 2020, reflecting an increase of $1.314 million (2.1%) driven by higher sales volumes and prices[488]. - Contract revenues from collaborations increased significantly to $75.726 million in 2021, a rise of $28.801 million (61.3%) compared to $46.925 million in 2020[488]. - The company reported a government contract revenue of $10.500 million in 2021, marking its first recognition in this category[488]. - Lilly accounted for 48% of total revenues in 2021, while McKesson Specialty Care Distribution Corporation and ASD Healthcare contributed 20% and 17%, respectively[488]. - License revenues from collaborations increased significantly to $70.553 million in 2021 from $40.358 million in 2020, marking a growth of 74.7%[634]. - The company generated 48% of its total net product sales from Lilly in 2021, while McKesson Specialty Care Distribution Corporation accounted for 20% and ASD Healthcare and Oncology Supply for 17%[637]. Expenses and Financial Performance - Research and development expenses increased to $65.2 million in 2021 from $60.1 million in 2020, driven by higher costs related to COVID-19 trials and IRAK 1/4 inhibitor program[497]. - Selling, general and administrative expenses rose to $91.9 million in 2021 from $76.6 million in 2020, primarily due to increased commercial activity costs[507]. - Total costs and expenses for 2021 were $161.732 million, up from $137.594 million in 2020, primarily due to increased R&D and administrative expenses[561]. - The company reported a net loss of $17.914 million for the year ended December 31, 2021, compared to a net loss of $29.744 million in 2020, indicating a reduction in losses by 39.8%[633]. - The company reported a comprehensive loss of $18.012 million for 2021, compared to $29.771 million in 2020, indicating a 39.5% improvement[564]. Cash Flow and Liquidity - As of December 31, 2021, cash, cash equivalents, and short-term investments totaled approximately $125.0 million, up from $57.3 million in 2020, an increase of $67.6 million[514]. - Net cash provided by operating activities was $5,878,000 in 2021, compared to $(52,185,000) in 2020, primarily due to cash received from Lilly[515]. - Net cash used in investing activities was $(80,036,000) in 2021, mainly due to net purchases of short-term investments of $79.4 million[518]. - Net cash provided by financing activities was $62,675,000 in 2021, primarily from cash received from Lilly amounting to $57.9 million[519]. - Cash, cash equivalents, and short-term investments totaled approximately $125.0 million as of December 31, 2021, providing sufficient liquidity for at least the next 12 months[577]. Research and Development - Fostamatinib is currently in Phase 3 trials for wAIHA and COVID-19 treatments, indicating ongoing investment in clinical development[468]. - The company has multiple product candidates in development across immunology, hematology, cancer, and rare diseases, showcasing a diverse pipeline[471]. - The company anticipates continued significant research and development expenses as it progresses with ongoing clinical studies, including wAIHA and COVID-19[498]. - Research and development expenses included costs for clinical trials and personnel, with all costs charged as incurred, reflecting the company's commitment to innovation[622]. Collaborations and Agreements - The company has ongoing collaboration agreements with multiple partners, including Grifols and Kissei, to develop and commercialize various drug candidates across different regions[638]. - The global exclusive license agreement with Lilly includes a non-refundable upfront cash payment of $125 million and potential milestone payments totaling $330 million for non-CNS disease products and $255 million for CNS disease products[645]. - The exclusive license agreement with Grifols includes an upfront payment of $30 million and potential total regulatory and commercial milestones of $297.5 million, along with tiered royalty payments that may reach 30% of net sales[651]. - The company recognized $1.8 million of revenue related to a milestone achievement under the Daiichi Collaboration Agreement during the year ended December 31, 2021[665]. Financial Position and Liabilities - As of December 31, 2021, the principal term loan outstanding with MidCap was $20.0 million, with access to an additional $40.0 million subject to certain conditions[526]. - The company has accrued research and development liabilities of $10.4 million as of December 31, 2021, up from $4.9 million in 2020[559]. - The company recorded net liabilities for product sales allowances and discounts amounting to $7.9 million as of December 31, 2021[553]. - The company has a contractual commitment related to its facilities lease amounting to $11.4 million, with $10.5 million payable within 12 months[536]. Accounting and Valuation - Stock-based compensation is recognized using the Black-Scholes model, with significant estimates involved in determining fair value[483]. - The allowance for doubtful accounts is currently not required, based on existing contractual payment terms and actual payment patterns[583]. - The carrying amounts of financial instruments approximate fair value due to their short maturities, including cash and accounts receivable[611]. - Fair value measurements are categorized based on the level of judgment associated with the inputs used, reflecting market-based measurements[613].

TAVALISSE Sales Performance and Growth - Q3 2021 net product sales reached $16 million[17] - Bottles shipped to patients and clinics increased by 5% compared to Q3 2020[17] - A total of 1,657 bottles were shipped, including 1,710 to patients and clinics, offset by a decrease of 53 bottles in distribution channels[64] - The company maintained a strong persistency rate of 56%[9] wAIHA Opportunity - Rigel is positioned to capitalize on the warm autoimmune hemolytic anemia (wAIHA) opportunity, targeting 45,000 US adult wAIHA patients[35] - In a Phase 2 clinical trial, 44% of patients responded by Week 24, with an increase in hemoglobin levels[41] - Enrollment is complete for the wAIHA Phase 3 clinical trial[9, 44] COVID-19 Program - Rigel is exploring fostamatinib in COVID-19, with ~210 patients enrolled in the Rigel-led Phase 3 clinical trial as of November 1, 2021[9] - Government contract revenue of $1 million was related to U S DOD support for Rigel's ongoing Phase 3 clinical trial of fostamatinib in hospitalized COVID-19 patients[70] Pipeline Programs - Rigel is advancing the development of its IRAK1/4 inhibitor program, with preparations for a Phase 1b/2 study in low-risk MDS underway[9] - The company is progressing both RIP1 inhibitor programs in collaboration with Lilly[9] Financial Position - Cash, cash equivalents, and short-term investment balance totaled $143.1 million as of September 30, 2021[70] - Contract revenues from collaborations reached $4.5 million, including $2.4 million from the Lilly license agreement and $1.8 million from the Daiichi milestone[69, 70]

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q3 2021 Results Conference Call November 2, 2021 4:30 PM ET Company Participants Dolly Vance - EVP, Corporate Affairs and General Counsel Raul Rodriguez - CEO Wolfgang Dummer - Chief Medical Officer Dave Santos - Chief Commercial Officer Dean Schorno - CFO Conference Call Participants Gary Nachman - BMO Capital Markets Joe Pantginis - H.C. Wainwright Kristen Kluska - Cantor Fitzgerald Operator Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Rigel Pharmaceuticals' unaudited condensed financial statements, showing increased assets and a shift to net income driven by collaboration revenue Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $30,403 | $30,373 | | Short-term investments | $112,743 | $26,954 | | Total current assets | $171,104 | $88,983 | | **Total assets** | **$186,518** | **$110,378** | | **Liabilities & Equity** | | | | Total current liabilities | $59,282 | $40,841 | | Total liabilities | $136,848 | $76,352 | | **Total stockholders' equity** | **$49,670** | **$34,026** | Condensed Statements of Operations Highlights (in thousands, except per share amounts) | Metric | Q3 2021 | Q3 2020 | 9 Months 2021 | 9 Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $21,543 | $18,389 | $128,827 | $90,171 | | Total costs and expenses | $41,328 | $32,170 | $119,905 | $100,317 | | Income (loss) from operations | $(19,785) | $(13,781) | $8,922 | $(10,146) | | **Net income (loss)** | **$(20,952)** | **$(14,174)** | **$4,727** | **$(10,507)** | | Diluted EPS | $(0.12) | $(0.08) | $0.03 | $(0.06) | Condensed Statements of Cash Flows Highlights (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $24,964 | $(36,613) | | Net cash (used in) provided by investing activities | $(86,524) | $38,755 | | Net cash provided by financing activities | $61,590 | $11,904 | | **Net increase in cash and cash equivalents** | **$30** | **$14,046** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=46&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, TAVALISSE® sales, the Eli Lilly collaboration, and clinical trial updates, noting sufficient liquidity for the next 12 months [Business Update and Product Portfolio](index=48&type=section&id=Business%20Update%20and%20Product%20Portfolio) This section details TAVALISSE® sales growth, the Eli Lilly collaboration with a **$125 million** upfront payment, and updates on fostamatinib clinical trials for wAIHA and COVID-19 - Net product sales of TAVALISSE were **$45.4 million** for the nine months ended September 30, 2021, a **3% increase** year-over-year, driven by higher quantities sold and price increases, though partially offset by higher rebates and inventory fluctuations[149](index=149&type=chunk) - In February 2021, Rigel entered into a global exclusive license and strategic collaboration with Eli Lilly for its RIP1 inhibitor, R552, receiving a **$125.0 million** upfront cash payment and eligible for up to **$835.0 million** in potential milestone payments plus tiered royalties[152](index=152&type=chunk)[154](index=154&type=chunk) - The FDA informed Rigel that data from the Phase 2 trial of fostamatinib in hospitalized COVID-19 patients was **insufficient** to support an Emergency Use Authorization (EUA), with the company continuing its larger Phase 3 trial[155](index=155&type=chunk) - Enrollment for the pivotal Phase 3 FORWARD study of fostamatinib in warm autoimmune hemolytic anemia (wAIHA) is **complete**, with topline data expected in **mid-2022**, potentially making TAVALISSE the **first approved therapy** for wAIHA[191](index=191&type=chunk) [Results of Operations](index=67&type=section&id=Results%20of%20Operations) Operations analysis reveals total revenues increased to **$128.8 million** driven by collaboration and government contracts, while R&D and SG&A expenses also rose due to clinical and commercial activities Revenues Breakdown (in thousands) | Revenue Source | 9 Months 2021 | 9 Months 2020 | Change | | :--- | :--- | :--- | :--- | | Product sales, net | $45,441 | $43,943 | $1,498 | | Contract revenues from collaborations | $73,886 | $46,228 | $27,658 | | Government contract | $9,500 | $0 | $9,500 | | **Total revenues** | **$128,827** | **$90,171** | **$38,656** | - The significant increase in contract revenues for the nine months ended Sep 30, 2021, was primarily driven by **$66.4 million** related to the license agreement with Lilly[221](index=221&type=chunk)[222](index=222&type=chunk) Operating Expenses (in thousands) | Expense Category | 9 Months 2021 | 9 Months 2020 | Change | | :--- | :--- | :--- | :--- | | Cost of product sales | $596 | $574 | $22 | | Research and development | $51,933 | $44,963 | $6,970 | | Selling, general and administrative | $67,376 | $54,780 | $12,596 | - The increase in R&D expense for the nine months of 2021 was mainly due to a **$10.2 million increase** in costs for the ongoing Phase 3 clinical trial in hospitalized COVID-19 patients[230](index=230&type=chunk) - The increase in SG&A expense for the nine months of 2021 was primarily due to higher costs for consultants and third-party services (**$4.6 million**) and commercial activities (**$3.1 million**)[243](index=243&type=chunk) [Liquidity and Capital Resources](index=77&type=section&id=Liquidity%20and%20Capital%20Resources) Rigel's liquidity significantly strengthened to **$143.1 million** by September 30, 2021, primarily due to the **$125.0 million** Lilly upfront payment, with sufficient capital for at least the next 12 months - Cash, cash equivalents, and short-term investments increased by **$85.8 million** to **$143.1 million** as of September 30, 2021, primarily due to the **$125.0 million** upfront payment from Lilly[252](index=252&type=chunk) - Net cash from financing activities for the nine months of 2021 was **$61.6 million**, which included **$57.9 million** from Lilly allocated as a financing component related to future R&D cost-sharing[257](index=257&type=chunk) - The company believes its existing capital resources are **sufficient** to support funding requirements for **at least the next 12 months** from the filing date[258](index=258&type=chunk) - Rigel has access to an additional **$40.0 million** under its term loan credit facility with MidCap, subject to the achievement of certain conditions[263](index=263&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=85&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section indicates that the company has no applicable quantitative or qualitative disclosures regarding market risk for the reporting period - This section is not applicable[275](index=275&type=chunk) [Controls and Procedures](index=85&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were deemed effective, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2021, the company's disclosure controls and procedures were **effective**[276](index=276&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter that have **materially affected**, or are reasonably likely to materially affect, internal controls[277](index=277&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=85&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the current reporting period - None[279](index=279&type=chunk) [Risk Factors](index=87&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including dependence on TAVALISSE®, COVID-19 impacts, clinical trial uncertainties, potential generic competition, and regulatory compliance challenges - The company's prospects are **highly dependent** on the **commercial success** of its first product, TAVALISSE, and any negative impact on its sales could adversely affect the business[283](index=283&type=chunk)[479](index=479&type=chunk) - The COVID-19 pandemic is **adversely affecting** the business through its impact on commercialization efforts, supply chain, regulatory processes, and clinical development activities[283](index=283&type=chunk)[507](index=507&type=chunk) - The company **may not be able to obtain** an Emergency Use Authorization (EUA) for fostamatinib for COVID-19, as the FDA has already deemed the initial Phase 2 data **insufficient**; a resubmission depends on the success of the ongoing Phase 3 trial[283](index=283&type=chunk)[426](index=426&type=chunk) - The company faces risks from potential **generic competition** for TAVALISSE, **unfavorable pricing regulations**, and **challenges in securing reimbursement** from third-party payors[283](index=283&type=chunk)[316](index=316&type=chunk)[488](index=488&type=chunk) - The company is subject to **stringent and evolving** privacy and information security laws (e.g., GDPR, CCPA), and failure to comply could result in **significant fines and penalties**[283](index=283&type=chunk)[299](index=299&type=chunk)

August 3, 2021 Q2 2021 Financial Presentation Forward-Looking Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1955 ("PSLRA") relating to, among other things, the commercial success of TAVALISSE in the U.S. and TAVLESSE in Europe; Rigel's submission of an EUA application for fostamatinib for the treatment of hospitalized COVID-19 patients the commercial availability of fostamatinib; the three ongoing clinical studies on fos ...

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q2 2021 Results Earnings Conference Call August 3, 2021 4:30 PM ET Company Participants Dolly Vance - Executive Vice President, Corporate Affairs and General Counsel Raul Rodriguez - President and Chief Executive Officer Wolfgang Dummer - Executive Vice President and Chief Medical Officer Dave Santos - Chief Commercial Officer Dean Schorno - Executive Vice President and Chief Financial Officer Conference Call Participants Yigal Nochomovitz - Citigroup Nicole Gabresk ...

Sales Performance - TAVALISSE net product sales reached $29.4 million in the first half of 2021, a 6% increase compared to the same period in 2020, driven by increased quantities sold and price per bottle [139]. - Product sales of TAVALISSE increased by 14% to $17.1 million for the three months ended June 30, 2021, compared to $15.0 million in 2020 [211]. - Total revenues for the three months ended June 30, 2021, were $26.3 million, a 64% increase from $16.0 million in the same period of 2020 [211]. - Contract revenues from collaborations reached $3.7 million for the three months ended June 30, 2021, up from $1.0 million in the same period of 2020 [212]. - Government contract revenue was $5.5 million for the three months ended June 30, 2021, related to a $16.5 million award from the U.S. Department of Defense [214]. Clinical Trials and Research - Fostamatinib is being studied in multiple Phase 3 trials, including for warm autoimmune hemolytic anemia and hospitalized high-risk patients with COVID-19, with positive topline results reported in April 2021 [137][146]. - A post-hoc analysis of TAVALISSE in adult patients with chronic immune thrombocytopenia (cITP) showed a 78% response rate when used as a second-line therapy [141]. - Fostamatinib has been selected for the NIH ACTIV-4 trial, evaluating its efficacy in hospitalized COVID-19 patients, targeting 308 participants [147]. - The ACTIV-4 Host Tissue trial is evaluating fostamatinib in hospitalized patients with COVID-19, with approximately 150 of the targeted 308 patients enrolled as of August 2021 [192]. - R835, an orally administered IRAK1/4 inhibitor, is advancing through clinical trials with positive tolerability and pharmacokinetic data established in a Phase 1 trial [201]. - The investigational AXL inhibitor BGB324 is being investigated in two Phase 2 clinical trials for hospitalized COVID-19 patients and ongoing oncology indications [204]. Financial Overview - Research and development expenses increased to $16.8 million for the three months ended June 30, 2021, compared to $14.2 million in 2020, primarily due to ongoing clinical trials [217]. - The company anticipates an increase in research and development expenses for the remainder of 2021 due to ongoing clinical trials for COVID-19 and warm AIHA [221]. - Selling, general and administrative expenses for the three months ended June 30, 2021 were $22.4 million, an increase of $3.5 million from $18.9 million in the same period of 2020 [231]. - The company expects selling, general and administrative expenses to increase for the remainder of 2021 as it expands commercial activities [233]. - As of June 30, 2021, the company had approximately $153.4 million in cash, cash equivalents, and short-term investments, an increase of approximately $96.1 million from $57.3 million as of December 31, 2020 [242]. Strategic Partnerships and Agreements - The company entered a global exclusive license agreement with Lilly in February 2021 for the development and commercialization of R552, a RIP1 inhibitor, with an upfront cash payment of $125 million and potential milestone payments totaling $585 million [145]. - The company is responsible for 20% of development costs for R552 in the U.S., Europe, and Japan, with a maximum funding commitment of $65 million [144]. - The company received an upfront cash payment of $30 million from Grifols and is eligible for up to $297.5 million in regulatory and commercial milestones for fostamatinib in Europe and Turkey [173]. - The company received an upfront payment of $5 million from Medison for commercialization rights in Canada and Israel, with potential regulatory and commercial milestones of approximately $35 million [178]. Impact of COVID-19 - The ongoing COVID-19 pandemic has impacted patient-doctor interactions, but the company has adapted by increasing virtual engagements and plans to continue both virtual and in-person initiatives [151]. - The company has observed a reduction in patient-doctor interactions due to COVID-19, which has negatively affected product sales growth [151]. - The company continues to monitor the impact of COVID-19 on its business and has implemented safety measures to protect staff and stakeholders [150]. - The ongoing COVID-19 pandemic may adversely impact the company's ability to raise additional capital due to disruptions in global financial markets [255]. - Insufficient funds may require the company to delay or eliminate commercial efforts and research or development programs [257]. Future Outlook - Future funding requirements will depend on various factors, including the ongoing costs to commercialize TAVALISSE and the progress of clinical trials [256]. - The company anticipates opportunistically financing future cash needs through public/private offerings, debt financings, and collaboration arrangements [255]. - The company expects to receive approximately $7.4 million in future sublease income through January 2023 [254]. - The company has contractual commitments totaling $39.7 million related to facilities lease and credit facility obligations, with $11.7 million due within one year [262].