Financial Data and Key Metrics Changes - The company reported a net income of $737,000 for Q4 2023, attributed to increased net product sales and disciplined operating expense management [8][12][84] - Total net product sales reached nearly $104 million for the full year 2023, representing a 36% growth over 2022 [19][68] - The company ended Q4 2023 with cash, cash equivalents, and short-term investments of $56.9 million [11] Business Line Data and Key Metrics Changes - TAVALISSE generated approximately $94 million in net sales for 2023, a 24% increase over the prior year [68] - REZLIDHIA contributed $10.6 million in net product sales for 2023, with expectations for continued strength in 2024 [84] - GAVRETO generated $28 million in U.S. net product sales in 2023, with a 21% increase from 2022 [30] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in the non-small cell lung cancer market, with approximately 235,000 lung cancer patients expected to be diagnosed in 2024 [35] - The incidence of RET fusion-positive non-small cell lung cancer is estimated at around 3,000 patients annually in the U.S. [35][71] Company Strategy and Development Direction - The company aims to leverage its existing commercial and medical affairs infrastructure to drive growth, particularly with the acquisition of GAVRETO [20][21] - Strategic alliances with MD Anderson and CONNECT are expected to enhance the evaluation of REZLIDHIA in various cancers [22][87] - The company is actively pursuing additional in-licensed deals and acquisitions to expand its product portfolio [90] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of TAVALISSE and REZLIDHIA, anticipating continued momentum in 2024 [88] - The company is focused on transitioning GAVRETO into its commercial operations and expects to recognize revenue from it in Q3 2024 [82][84] - Management highlighted the importance of maintaining a disciplined financial approach to achieve financial breakeven [90] Other Important Information - The company plans to complete the transition of the GAVRETO asset to Rigel and expects to incur certain costs associated with this new product [11] - The company reported a decrease in total costs and expenses to $33.8 million in Q4 2023, down from $49.2 million in the same period in 2022 [12][83] Q&A Session Summary Question: Update on GAVRETO's post-marketing requirements and studies - Management confirmed that the AcceleRET study was not necessary for U.S. approval, and discussions with the FDA regarding the thyroid cancer indication are ongoing [100] Question: Synergies with existing sales infrastructure for GAVRETO - Management noted that over half of the sales team has lung cancer experience, which will be leveraged to efficiently promote GAVRETO alongside existing products [102][106] Question: Barriers to adoption and strategies for switching patients to GAVRETO - Management acknowledged the challenge of familiarity with other drugs but expressed confidence in raising awareness and promoting GAVRETO's efficacy to drive adoption [114]

Revenue Performance - Total revenues for 2023 were $116.9 million, a decrease of $3.4 million or 2.8% from $120.2 million in 2022[584]. - Total revenues decreased to $116.882 million in 2023 from $120.242 million in 2022, primarily due to a decline in contract revenues from collaborations[657]. - The company incurred a net loss of $25.091 million in 2023, a significant improvement from a net loss of $58.573 million in 2022[657]. - The company reported a net loss of $25,091,000 for the year ended December 31, 2023, compared to a net loss of $58,573,000 in 2022, indicating a 57.3% improvement in losses year-over-year[666]. Product Sales - Product sales, net for 2023 were $104.3 million, an increase of $27.6 million or 36% compared to $76.7 million in 2022[584]. - TAVALISSE net product sales in 2023 were $93.7 million, up by $17.9 million or 24% from $75.8 million in 2022[584]. - REZLIDHIA net product sales in 2023 were $10.6 million, an increase of $9.7 million compared to $0.9 million in 2022[584]. - The company reported net product sales of $104.294 million for the year ended December 31, 2023, an increase of 36% compared to $76.718 million in 2022[657]. Collaboration and Contract Revenues - Contract revenues from collaborations in 2023 were $11.5 million, a decrease of $27.5 million or 70.6% from $39.0 million in 2022[585]. - Revenue from Grifols in 2023 was $8.8 million, primarily related to drug supplies and earned royalty[585]. - The company has potential future contingent payments exceeding $1.3 billion under existing collaboration agreements, with $279.5 million related to development events and $796.0 million to commercial events[743]. - The global exclusive license agreement with Lilly includes up to $330 million in milestone payments for non-CNS disease products and up to $255 million for CNS disease products[746]. Expenses and Costs - Cost of product sales increased to $7.1 million in 2023 from $1.7 million in 2022, primarily due to higher amortization and royalty expenses related to REZLIDHIA[590][591]. - Research and development expense decreased to $24.5 million in 2023 from $60.3 million in 2022, driven by reduced clinical trial expenses and personnel-related costs[592][593]. - Selling, general and administrative expenses were $105.7 million in 2023, a decrease from $112.5 million in 2022, attributed to lower stock-based compensation and various operational cost reductions[603][604]. - Stock-based compensation expense for 2023 was $8,806,000, a decrease from $12,385,000 in 2022, reflecting a 28.5% reduction[666]. Cash Flow and Investments - As of December 31, 2023, the company had approximately $56.9 million in cash, cash equivalents, and short-term investments, a slight decrease from $58.2 million in 2022[610]. - Net cash used in operating activities for 2023 was $(5,743) thousand, a significant improvement from $(73,758) thousand in 2022[611]. - The company received a $20.0 million regulatory milestone payment from Kissei in January 2023, contributing to cash flow from operating activities[612]. - Cash and cash equivalents increased to $32.786 million as of December 31, 2023, compared to $24.459 million in 2022[655]. Liabilities and Financial Commitments - The total liabilities decreased slightly to $145.869 million in 2023 from $147.895 million in 2022[655]. - The company has a credit facility with MidCap, with an outstanding principal amount of $60.0 million as of December 31, 2023, maturing on September 1, 2026[620]. - The company is responsible for funding development costs for R552 up to $22.6 million through April 1, 2024, with $18.6 million billed by Lilly as of December 31, 2023[628]. - Future interest payments associated with the credit facility are estimated at $9.4 million, with approximately $4.4 million payable within 12 months[634]. Clinical Development and Strategic Initiatives - The company is advancing its IRAK1/4 inhibitor program in a Phase 1b trial for patients with lower-risk MDS[566]. - Strategic collaborations with MD Anderson and CONNECT are ongoing to evaluate REZLIDHIA in AML and pediatric patients with HGG[568]. - The company has a RIPK1 inhibitor program in clinical development with partner Lilly[569]. - The company entered into an Asset Purchase Agreement with Blueprint in February 2024 to acquire rights to GAVRETO for development and commercialization in the US[567]. Revenue Recognition and Accounting Policies - Revenue from product sales is recognized when specialty distributors obtain control of the product, with provisions for government-mandated rebates and chargebacks[681]. - The company recognizes revenues from upfront license fees when the license is transferred to the licensee and the licensee can use and benefit from the license[691]. - Future variable consideration related to regulatory and commercial milestones is fully constrained due to uncertainty of success, impacting revenue recognition[759]. - The company will recognize revenue from sales-based milestones and royalties when related sales occur or when performance obligations are satisfied[760].

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q3 2023 Earnings Conference Call November 7, 2023 4:30 PM ET Company Participants Ray Furey - Executive Vice President, General Counsel & Corporate Secretary Raul Rodriguez - President & Chief Executive Officer Dean Schorno - Chief Financial Officer Dave Santos - EVP & Chief Commercial Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Operator Greetings, and welcome to Rigel Pharmaceuticals Financial Conference Call for the Third Quarter of 2023. ...

Please visit www.TAVALISSE.com for Full Prescribing Information. Please visit www.REZLIDHIA.com for Full Prescribing Information, including Boxed WARNING. Ray Furey, J.D. Dean Schorno Commercial Execution Development & Expansion • Evaluating additional olutasidenib and fostamatinib opportunities Partnered Programs 5 rigel. Select Important Safety Information 6 Please see Important Safety Information on slide 27. Please visit www.TAVALISSE.com for Full Prescribing Information. $24.5M 500 1000 1500 2000 2500 ...

Financial Performance - For the nine months ended September 30, 2023, net product sales of TAVALISSE were $68.1 million, a 26% increase compared to the same period in 2022[105]. - Net product sales for the nine months ended September 30, 2023, rose by 39% to $74,755,000 from $53,935,000 in the prior year[186]. - Product sales for the three months ended September 30, 2023, increased by 41% to $27,129,000 compared to $19,188,000 in the same period of 2022[186]. - TAVALISSE net product sales increased by $5.3 million or 27% in Q3 2023 and $14.1 million or 26% in the nine months of 2023 compared to the same periods in 2022[186]. - REZLIDHIA generated net product sales of $2.7 million and $6.7 million for the three and nine months ended September 30, 2023, respectively[186]. - Interest income increased to $1.6 million for the nine months ended September 30, 2023, compared to $0.3 million in the same period of 2022, reflecting a rise of approximately 533%[214]. - Interest expense rose to $5.0 million for the nine months ended September 30, 2023, from $2.6 million in the same period of 2022, an increase of approximately 92%[215]. Research and Development - The Phase 1b trial of R289 is expected to enroll approximately 22 patients, with preliminary results anticipated by mid-year 2024[109]. - Lilly has initiated a Phase 2a trial for R552, which plans to enroll 100 patients globally, focusing on moderately to severely active rheumatoid arthritis[110]. - The primary endpoint of the FOCUS Phase 3 clinical trial for fostamatinib in hospitalized COVID-19 patients was met after correcting a statistical error, showing lower mean days on oxygen compared to placebo (4.8 vs. 7.6 days, p=0.0136)[112]. - The NIH/NHLBI recommended ceasing enrollment in the fostamatinib study arm of the ACTIV-4 Host Tissue Trial due to low likelihood of benefit for primary outcomes[115]. - The Phase 2 trial of olutasidenib showed an overall response rate (ORR) of 46% and a median overall survival of 10.5 months for patients with CR/CRh[143]. - The Phase 2 trial data for fostamatinib in wAIHA was published in the American Journal of Hematology, highlighting its potential to increase hemoglobin levels in nearly half of the patients[170]. - The FORWARD Phase 3 clinical trial for wAIHA did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population[174]. Product Development and Commercialization - The company paid an upfront fee of $2.0 million for the in-licensing of olutasidenib, with potential additional payments of up to $67.5 million upon achieving specified development and regulatory milestones[107]. - The commercialization agreement with Grifols includes an upfront cash payment of $30 million and potential regulatory and commercial milestones of up to $297.5 million[131]. - The agreement with Medison for Canada and Israel includes an upfront payment of $5 million and potential milestones of approximately $35 million[135]. - REZLIDHIA demonstrated a complete remission (CR) plus complete remission with partial hematologic recovery (CRh) rate of 35% in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with mIDH1 mutations[140]. - The FDA approved REZLIDHIA for R/R AML with IDH1 mutation on December 1, 2022, and commercialization began on December 22, 2022[141]. - Commercial activities for REZLIDHIA will focus on healthcare providers managing R/R AML patients, with plans for collaborations outside the US[153]. Financial Position and Cash Flow - Cash and cash equivalents as of September 30, 2023, were approximately $62.4 million, up from $58.2 million as of December 31, 2022[221]. - Net cash provided by operating activities for the nine months ended September 30, 2023, was $0.5 million, a significant recovery from a net cash used of $51.8 million in the same period of 2022[222]. - Net cash provided by investing activities for the nine months ended September 30, 2023 was $17.4 million, a decrease from $54.0 million in the same period of 2022[223]. - Net cash provided by financing activities for the nine months ended September 30, 2023 was $20.0 million from term loan financing, compared to $19.5 million in the same period of 2022[224]. - The company expects to incur significant selling, general, and administrative expenses as it expands its commercial activities[213]. - The company may need to raise additional funds through public or private offerings, which could lead to substantial dilution of shareholders' ownership interests[233]. Regulatory and Market Considerations - The competitive landscape for TAVALISSE includes existing therapies and potential generic versions that could impact revenue[127]. - The competitive landscape includes TIBSOVO® (ivosidenib), which is also approved for patients with IDH1 mutation, highlighting the need for effective differentiation in marketing strategies[152]. - The company retains global rights to fostamatinib outside of specific territories under various license agreements[129]. - The company has not sold any shares of common stock under the Open Market Sale Agreement, which allows for sales up to $250.0 million[229].

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q2 2023 Earnings Conference Call August 1, 2023 4:30 PM ET Company Participants Ray Furey - EVP, General Counsel and Corporate Secretary. Raul Rodriguez - President and CEO Dave Santos - EVP and Chief Commercial Officer Dean Schorno - EVP and Chief Financial Officer Conference Call Participants Yigal Nochomovitz - Citigroup, Inc. Kristen Kluska - Cantor Fitzgerald & Co. Joseph Pantginis - H.C. Wainwright & Co. Eun Yang - Jefferies & Company Allison Bratzel - Piper S ...

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 potential and market opportunity of olutasidenib as therapeutics for R/R AML and other conditions; the potential and market opportunity for fostamatinib as therapeutics for chronic ITP, COVID-19 and other conditions; the regulatory approval and commercialization of fostamatinib or olutasidenib in the U.S. an ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (650) 624-1100 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: | Title of each class: | Trading Symbol | Na ...

Financial Data and Key Metrics Changes - The company reported net sales of TAVALISSE at $22.3 million for Q1 2023, representing a 38% year-over-year increase compared to the same quarter last year [31][41] - REZLIDHIA generated net sales of $1.5 million in Q1 2023, with total product sales since launch reaching $2.3 million [15][42] - Total cost and expenses decreased to $38.8 million from $43 million in the same period for 2022, primarily due to reduced research and development costs [46] Business Line Data and Key Metrics Changes - TAVALISSE achieved a record shipment of 2,256 bottles in Q1 2023, marking a 23% growth over Q1 2022 [29] - REZLIDHIA shipped 109 bottles to patients in clinics during Q1, with a total of 111 bottles shipped since its launch [13][41] - The company shipped 113 bottles of REZLIDHIA to its distribution network, resulting in gross product sales of $1.8 million [41] Market Data and Key Metrics Changes - The American Cancer Society estimates over 20,000 patients will be diagnosed with AML in 2023, with 6% to 9% having the IDH1 mutation, representing a near-term opportunity for REZLIDHIA [11][12] - Approximately 90% of Medicare lives have confirmed published coverage for REZLIDHIA, indicating strong market access [22] Company Strategy and Development Direction - The company is focused on expanding its hematology-oncology business through internal development programs and in-licensing opportunities [8][35] - The launch of REZLIDHIA is being supported by a specialized institutional team targeting key leukemia treaters and academic accounts [76] - The company aims to continue growing TAVALISSE sales while executing the launch of REZLIDHIA [50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong start to 2023, highlighting the continued momentum for TAVALISSE and the successful launch of REZLIDHIA [5][49] - The company is optimistic about achieving cash flow breakeven and is focused on revenue growth [57][58] Other Important Information - The company ended the quarter with cash, cash equivalents, and short-term investments of $58.7 million, having accessed an additional $20 million term loan [48] - The gross to net adjustment for TAVALISSE and REZLIDHIA was approximately 29% and 20% of gross product sales, respectively [42][44] Q&A Session Summary Question: Changes in partnered program with Eli Lilly regarding RIPK1 inhibitor - Management clarified that Eli Lilly has always been interested in multiple indications for the RIPK1 inhibitor, with a current focus on rheumatoid arthritis due to market opportunities [52][53] Question: Future cash burn expectations - The company ended Q1 with $58.7 million in cash and is focused on achieving cash flow breakeven, with a path towards that goal [56][58] Question: Progress on REZLIDHIA prescriber base and expectations - Management reported approximately 29 prescribers for REZLIDHIA and expressed optimism about increasing prescriber breadth as awareness grows [71][73] Question: Key factors for sustaining momentum in TAVALISSE - Management highlighted the importance of ongoing awareness efforts among clinicians and the potential for continued growth as patients fail other therapies [80][81]

Q1 2023 Financial Results Presentation 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 potential and market opportunity of olutasidenib as therapeutics for R/R AML and other conditions; the potential and market opportunity for fostamatinib as therapeutics for chronic ITP, COVID-19 and other conditions; the regulatory approval and commercialization of fostamatinib in the U.S. and in ...