Financial Highlights: Q4 and Full Year 2024

Rigel Pharmaceuticals demonstrated robust financial performance in its latest report. For the fourth quarter,ending December 31,2024,the company reported total revenues of $57.6 million. This revenue is comprised of several key contributors:

• $31.0 million in TAVALISSE net product sales
• $7.4 million in REZLIDHIA net product sales
• $8.1 million in GAVRETO net product sales
• $11.1 million in contract revenue from collaborations

TAVALISSE net product sales saw a significant increase, rising 21% compared to the $25.7 million reported during the same period in 2023. REZLIDHIA net product sales experienced even more substantial growth, surging by 92% compared to the $3.9 million recorded in the fourth quarter of 2023. GAVRETO, commercially available from rigel since June 2024, also made a notable contribution to the revenue stream.

Contract revenue from collaborations included several key partnerships. Dr. Reddy’s contributed a $4.0 million upfront cash payment. Grifols S.A. provided $3.6 million related to drug supplies and royalties. Kissei Pharmaceutical Co., Ltd. added $2.9 million related to drug supplies, and Medison Pharma Trading AG contributed $0.3 million related to drug supplies and royalties.

Looking at the full year 2024, Rigel’s total revenues reached $179.3 million. This included:

• $104.8 million in TAVALISSE net product sales
• $23.0 million in REZLIDHIA net product sales
• $17.1 million in GAVRETO net product sales
• $34.4 million in contract revenue from collaborations

TAVALISSE net product sales grew 12% compared to $93.7 million in 2023, while REZLIDHIA net product sales soared by 118% compared to $10.6 million in the previous year.

Rigel reported a net income of $14.3 million,or $0.81 basic and $0.80 diluted per share, for the fourth quarter of 2024.This is a significant improvement compared to a net income of $0.7 million, or $0.04 basic and diluted per share, for the same period in 2023. For the full year 2024, the company reported a net income of $17.5 million, or $0.99 basic and diluted per share, compared to a net loss of $25.1 million, or $1.44 basic and diluted per share, for the same period of 2023. These figures reflect a 1-for-10 reverse stock split effected on June 27, 2024.

Clinical Advancements: Olutasidenib Studies and NCCN Guidelines

Rigel Pharmaceuticals is also making significant strides in clinical development. Enrollment has begun for four studies of olutasidenib at the Texas MD Anderson Cancer Center. These studies will investigate the drug’s potential in treating various diseases where mutated IDH1 can play a role. The targeted diseases include:

• Acute myeloid leukemia (AML)
• higher-risk myelodysplastic syndromes (MDS)
• Chronic myelomonocytic leukemia (CMML) and advanced myeloproliferative neoplasms (MPN)
• Clonal cytopenia of undetermined significance (CCUS) and lower-risk MDS/CMML
• Its use as post-transplant maintenance therapy

Further validating the recognition of olutasidenib, the National Extensive Cancer Network (NCCN) added the drug to its latest NCCN Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes in November. Olutasidenib is now a recommended option in several treatment algorithms, including management of Lower-Risk Disease, Management of Lower-Risk Disease – Evaluation of Related Anemia, and management of Higher-Risk Disease. It received an NCCN Category 2B proposal in all circumstances, either as a single agent or in combination with azacitidine.

Publication Highlights

Several significant publications have highlighted the efficacy and safety of Rigel’s products:

• A paper titled Long‑term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia, by Masataka Kuwana, M.D., Ph.D., was published in January in the International Journal of Hematology. The study reported positive 3-year data from a phase 3 trial, showing sustained platelet response and no new safety concerns.
• Jorge E. Cortes, M.D., Director, Georgia cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator, published a paper in January in the Journal of Hematology and Oncology titled olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial.
• Stéphane de Botton, M.D., Ph.D., head of translational research in hematology, Institut Gustave Roussy, France, published a paper in December in the British Journal of Haematology titled Olutasidenib demonstrates significant clinical activity in mutated IDH1 acute myeloid leukaemia arising from a prior myeloproliferative neoplasm.

2025 outlook

Rigel anticipates total revenue of approximately $200 million to $210 million in 2025, including net product sales of approximately $185 million to $192 million and contract revenues from collaborations of approximately $15 million to $18 million. The company expects to report positive net income for the full year 2025 while funding existing and new clinical development programs.

About ITP, AML, and NSCLC

Immune thrombocytopenia (ITP) is a condition where the immune system attacks and destroys blood platelets, leading to bruising and bleeding. Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow. Non-small cell lung cancer (NSCLC) accounts for 85-90% of all lung cancer diagnoses.

About TAVALISSE^® and REZLIDHIA^®

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

REZLIDHIA: A Targeted Therapy for AML

REZLIDHIA is designed to treat adult patients battling relapsed or refractory acute myeloid leukemia (AML). This therapy is specifically for those whose AML exhibits a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, which must be detected by an FDA-approved test. AML, a cancer of the blood and bone marrow, can be particularly challenging to treat when it relapses or becomes refractory, meaning it no longer responds to standard treatments.

According to the American Cancer Society, acute myeloid leukemia (AML) remains a significant health concern. The availability of targeted therapies like REZLIDHIA offers a crucial option for patients with specific genetic mutations driving their disease.Further details about REZLIDHIA, including important safety data and full prescribing information with a Boxed WARNING, can be found here.

GAVRETO: Addressing RET Fusion-Positive Cancers

GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. It is also approved for 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).

The thyroid indication for GAVRETO received accelerated approval based on overall response rate and duration of response. Continued approval for this indication might possibly be contingent upon verification and description of clinical benefit in confirmatory trial(s). The American Cancer Society notes that lung cancer is a leading cause of cancer-related deaths, highlighting the importance of therapies like GAVRETO that target specific genetic drivers of the disease.

More information about GAVRETO,including important safety information and full prescribing information,is available here.

Reporting Side Effects

It is critically important to report any side effects experienced while taking prescription drugs to the FDA. this can be done by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088 (800-332-1088).

Key Financial Highlights for Q4 2024

Arcutis Biotherapeutics experienced a notable surge in financial performance during the fourth quarter of 2024. Product sales, net, reached $46.52 million, a significant increase compared to the $29.539 million reported during the same period in 2023.The company also saw growth in contract revenues from collaborations, which climbed to $11.074 million, up from $6.153 million in the prior year. Though, government contract revenue experienced a decrease, falling from $100 in 2023 to zero in 2024. total revenues for the quarter amounted to $57.596 million, a substantial increase from the $35.792 million reported in 2023.

Full Year 2024 Financial Performance: A Detailed Overview

The full year ended December 31, 2024, showcased even more impressive financial gains for Arcutis Biotherapeutics. Product sales, net, soared to $144.902 million, marking a significant jump from the $104.294 million reported in 2023. Contract revenues from collaborations also experienced substantial growth, increasing to $34.376 million from $11.488 million in the previous year. In contrast, government contract revenue decreased from $1.100 million in 2023 to zero in 2024. Consequently, total revenues for the year reached $179.278 million, compared to $116.882 million in 2023.

Revenue Breakdown: A Closer Look at the Numbers

A detailed examination of Arcutis Biotherapeutics’ revenue streams reveals the following key figures:

• Product sales, net: $46.522 million for the three months ended December 31, 2024, compared to $29.539 million for the same period in 2023; $144.902 million for the year ended december 31,2024,compared to $104.294 million for the year ended December 31, 2023.
• contract revenues from collaborations: $11.074 million for the three months ended December 31, 2024, compared to $6.153 million for the same period in 2023; $34.376 million for the year ended December 31, 2024, compared to $11.488 million for the year ended December 31, 2023.
• Government contract: $0 for the three months ended December 31, 2024, compared to $100 for the same period in 2023; $0 for the year ended December 31, 2024, compared to $1.100 million for the year ended December 31, 2023.

Analysis of Revenue Growth Drivers

The significant increase in product sales suggests a growing market demand for Arcutis Biotherapeutics’ offerings. The rise in contract revenues from collaborations indicates successful partnerships and strategic alliances that have contributed to the company’s overall financial health. While the decrease in government contract revenue is notable, the overall financial performance remains strong, driven by the robust growth in product sales and collaborations.

Conclusion: A Positive Trajectory for Arcutis Biotherapeutics

Arcutis Biotherapeutics’ unaudited financial results for 2024 demonstrate a year of substantial growth, propelled by strong product sales and successful collaborations. The company’s increased revenues reflect its expanding market presence and the effectiveness of its strategic partnerships. While government contract revenue experienced a decline, the overall financial performance indicates a positive trajectory for Arcutis Biotherapeutics, positioning the company for continued success in the future.

Financial Highlights

The company’s financial results for the three months ended march 31 showcase a notable increase in income compared to the same period in the prior year. A detailed analysis of revenue, costs, and expenses provides insights into the factors driving this positive financial performance. The report emphasizes key areas such as cost of product sales, research and development, and selling, general, and administrative expenses.

Revenue for the three months ended March 31 reached $57,596, a significant increase from the $35,792 reported for the same period last year. This surge in revenue played a crucial role in the company’s improved financial standing. The cost of product sales also saw an increase, rising from $3,790 to $5,789. Research and development expenses increased from $3,186 to $5,632, reflecting the company’s continued investment in innovation. Selling, general, and administrative expenses also rose, from $26,850 to $29,520.

For the year-to-date figures, the company reported revenue of $179,278 compared to $157,882 in the previous year. The cost of product sales increased from $7,110 to $18,647. Research and development expenses decreased from $24,522 to $23,380. Selling, general, and administrative expenses increased from $105,741 to $113,059.

Analysis of Costs and Expenses

A closer look at the company’s costs and expenses reveals critically important trends. The total costs and expenses for the three months ended March 31 amounted to $40,941, compared to $33,826 for the same period last year. For the year-to-date, total costs and expenses were $155,086, compared to $137,373 in the previous year.

The income from operations for the three months ended March 31 was $16,655, a substantial increase from the $1,966 reported in the prior year. However, the year-to-date figures show a different picture, with an income from operations of $24,192 compared to a loss of $(20,491) in the previous year.

Interest income for the three months ended March 31 was $522,compared to $678 in the previous year. Interest expense was $(1,955), compared to $(1,907) in the previous year. For the year-to-date, interest income was $2,092, compared to $2,272 in the previous year.Interest expense was $(7,918), compared to $(6,872) in the previous year.

Income Before Income Taxes

The company’s income before income taxes for the three months ended March 31 was $15,222, a significant improvement from the $737 reported in the same period last year. The year-to-date figures also show a positive trend, with an income before income taxes of $18,366 compared to a loss of $(25,091) in the previous year.

The provision for income taxes for the three months ended March 31 was $2,441, compared to $184 in the previous year. For the year-to-date,the provision for income taxes was $2,762,compared to $1,000 in the previous year.

Net Income (Loss)

the company reported a net income of $12,781 for the three months ended March 31, a substantial increase from the $553 reported in the same period last year. The year-to-date figures also show a significant improvement, with a net income of $15,604 compared to a net loss of $(26,091) in the previous year.

Financial Highlights

The company has announced its latest financial results, showcasing a remarkable improvement in net income. The report reveals a net income of $14.341 million, a substantial increase compared to the $737,000 reported for the same period last year. This significant turnaround reflects positive shifts in the company’s financial performance.

Earnings per share also saw a considerable rise. basic net income per share reached $0.81, while diluted net income per share was $0.80.These figures represent a notable improvement over the previous year’s earnings per share.

Key Financial Figures

A detailed look at the financial data reveals the extent of the company’s progress. The net income of $14.341 million stands in stark contrast to the previous year’s $737,000. Similarly, when comparing to the $17.485 million and $(25.091) from prior periods, the current financial standing demonstrates a positive trajectory.

The basic net income per share of $0.81 is a significant jump from the $0.04 reported in the corresponding period of the previous year. Diluted net income per share shows a similar trend, with $0.80 compared to the previous $0.04.

The weighted average shares used in computing net income per share provide additional context. For basic shares, the figure is 17,647, compared to 17,437 from the previous year. Diluted shares are at 17,986, up from 17,44

Here’s a summary of the financial and clinical achievements of rigel Pharmaceuticals in 2024, based on the provided articles:

Financial Highlights (2024):

Strong Revenue Growth: Rigel reported total revenue of approximately $179.3 million for the year, a critically importent increase.The first article mentions a 39% increase in net product sales compared to 2023, reaching $144.9 million. The second article provides a more detailed breakdown:

TAVALISSE: $104.8 million (12% growth compared to 2023)

REZLIDHIA: $23.0 million (118% growth compared to 2023)

GAVRETO: $17.1 million

contract revenue from collaborations: $34.4 million (this figure is onyl in the second article)

Profitability: For the first time, Rigel achieved a full-year net income of over $17 million (the first article states over $17 million, the second specifies $17.5 million). The fourth quarter alone saw a net income of $14.3 million.

Increased Cash Reserves: Increased cash balances by over $20 million.

Fourth Quarter 2024 Performance: Total revenue was $57.6 million, with strong sales across all products:

TAVALISSE: $31.0 million (a 21% increase compared to Q4 2023 according to the second article)

REZLIDHIA: $7.4 million (a 92% increase compared to Q4 2023 according to the second article)

GAVRETO: $8.1 million

international Expansion: Successfully launched TAVALISSE in Korea and Mexico through partnerships, resulting in milestone payments. Additionally, a licensing agreement with Dr. Reddy’s Laboratories for REZLIDHIA in various markets resulted in an upfront payment and potential future milestone payments.

Clinical Growth Advancements (2024):

R289 Progress: R289, a dual IRAK1/4 inhibitor, received Fast Track and Orphan drug designations from the FDA for the treatment of lower-risk MDS. Phase 1b clinical trials are showing promising preliminary efficacy data and good tolerability in patients with relapsed/refractory lower-risk MDS.Data presented at the ASH annual meeting.

Olutasidenib Studies: Multiple studies of olutasidenib are underway, focusing on it’s potential in treating various cancers where mutated IDH1 plays a significant role (AML and high-grade glioma). Four posters were presented on olutasidenib at the ASH annual meeting detailing its benefits in patients with mIDH1 AML. The second article highlights four studies initiated at MD Anderson Cancer Center targeting acute myeloid leukemia and other IDH1 mutation-related diseases.A Phase 2 “TarGet-D” study in collaboration with CONNECT is evaluating olutasidenib in combination with temozolomide for high-grade glioma in adolescents and young adults. Another phase 1b/2 study in collaboration with MD Anderson is evaluating olutasidenib in combination with venetoclax and azacitidine for relapsed/refractory mIDH1 AML.

Overall:

Rigel Pharmaceuticals experienced a highly accomplished 2024, marked by strong financial performance and significant progress in their clinical development programs. The company’s focus on hematologic disorders and cancer, coupled with strategic partnerships and a robust pipeline, positions them for continued growth in 2025. There are some discrepancies between the two articles regarding exact figures, which might be due to rounding or different reporting methods. It’s recommended to consult Rigel’s official financial reports for the most accurate data.