Key Takeaways Iovance's Amtagvi sales jumped 183% in the first nine months of 2025, driving growth.IOVA cut its 2025 revenue guidance and withdrew its EU filing for Amtagvi, hurting shares.Rigel's 2025 sales rose 60% to $232M, led by Tavalisse, with 2026 growth projected.Both Iovance Biotherapeutics (IOVA) and Rigel Pharmaceuticals (RIGL) are small-cap companies focused on the successful commercialization of their marketed products.While Iovance is a cancer biotech concentrated on developing immunotherapies ...

Key Takeaways Rigel Pharmaceuticals expects 2025 sales to rise 60% to $232M, topping prior guidance.Tavalisse drove $158.9M in 2025 sales, up 52%, while Gavreto and Rezlidhia added momentum.RIGL guides 2026 product sales of $255-$265M but faces competition from Sanofi and Eli Lilly drugs.Rigel Pharmaceuticals (RIGL) had an encouraging year in 2025. The company is yet to report its fourth-quarter and full-year 2025 results, but preliminary figures released last month point to another strong finish — driven p ...

Core Insights - Rigel Pharmaceuticals (RIGL) shares have increased by 59% over the past year, significantly outperforming the industry growth of 2% [1][8] - The company's financial performance is primarily driven by its product Tavalisse, which treats adults with low platelet counts due to chronic immune thrombocytopenia (ITP) [4][6] Financial Performance - Preliminary figures indicate that Rigel expects total revenues of $69.4 million for Q4 2025, representing a 21% year-over-year growth [5] - Tavalisse generated $45.6 million in Q4 sales, reflecting a 47% year-over-year increase and accounting for approximately two-thirds of total revenues [6] - Full-year 2025 product sales are projected to rise by 60% year-over-year to $232 million, exceeding previous guidance [9] - For 2026, Rigel anticipates net product sales of $255–$265 million and expects to achieve positive net income [10] Product Portfolio and Pipeline - Rigel's oncology assets, including Gavreto and Rezlidhia, contributed $10.2 million and $9.6 million in quarterly sales, respectively, diversifying the revenue base [7] - The company is advancing its pipeline with a lead candidate, R289, currently in a phase Ib study for lower-risk myelodysplastic syndrome (MDS) [11] - Rigel is exploring label expansion for Rezlidhia in collaboration with major cancer research institutions [12] - A partnership with Eli Lilly for the development of ocadusertib is also in place, with potential milestone payments and royalties [13] Competitive Landscape - Competition is intensifying, particularly with the FDA approval of Sanofi's Wayrilz for a similar indication in ITP, which could threaten Tavalisse's market position [14] - Gavreto faces competition from Eli Lilly's Retevmo in the RET fusion-positive non-small cell lung cancer (NSCLC) market [15] Valuation and Analyst Outlook - Rigel's stock is trading at a slight premium with a price/sales (P/S) ratio of 2.33 compared to the industry average of 2.28 [16] - Recent estimates for Rigel's 2025 and 2026 EPS have increased, indicating a positive analyst outlook [18] - Despite competitive risks, the company's financial guidance for 2026 reflects confidence in sustaining growth and profitability [19]

Core Viewpoint - Amicus Therapeutics (FOLD) and Rigel Pharmaceuticals (RIGL) are appealing to growth-focused investors due to their focus on rare diseases, which can support strong revenue growth despite small patient populations [2] Company Overview - Amicus is a mid-cap stock, while Rigel is classified as a small biotech [2] - Both companies are developing treatments for rare medical conditions with limited existing therapies [2] Product Highlights - Amicus' lead product, Galafold, is the first oral precision medicine for Fabry disease, generating significant revenue [3][6] - Rigel's lead drug, Tavalisse, is an oral spleen tyrosine kinase inhibitor for chronic immune thrombocytopenia (ITP), also showing strong sales growth [3][9] Acquisition Potential - Amicus is set to be acquired by BioMarin Pharmaceutical for $14.50 per share, totaling $4.8 billion, expected to close in Q2 2026 [5][10] - This acquisition could enhance Amicus' value realization beyond organic sales growth [4] Financial Performance - Galafold generated $371.5 million in sales in the first nine months of 2025, a 12% year-over-year increase, contributing over 80% of Amicus' net product sales [6] - Pombiliti + Opfolda, a new therapy for late-onset Pompe disease, generated $77.5 million in sales, up 61% year-over-year [7] - Rigel's Tavalisse sales reached $113.3 million in the first nine months of 2025, a 54% increase year-over-year [9] Future Outlook - Rigel expects total revenues of $294.3 million for 2025, with net product sales of $232 million [12] - The company anticipates fourth-quarter revenues of $69.8 million, a 21.2% increase year-over-year [13] Competitive Landscape - Rigel faces increasing competition in the ITP market, particularly from Sanofi's Wayrilz, which poses a threat to Tavalisse [15][16] - Amicus' reliance on Galafold makes it vulnerable to regulatory setbacks, while Rigel's dependence on Tavalisse highlights its exposure to competitive risks [8][26] Valuation and Performance - In the past six months, FOLD shares have increased by 133.1%, while RIGL shares have risen by 87.2%, compared to the industry return of 21.7% [21] - Amicus has a higher price-to-sales (P/S) ratio of 7.41 compared to Rigel's 2.53, indicating a more expensive valuation [23] Investment Recommendation - Amicus is viewed as a better investment opportunity due to its acquisition by BioMarin and strong sales performance, while Rigel's strategy is seen as riskier due to its dependence on Tavalisse [24][27]

Summary of Rigel Pharmaceuticals FY Conference Call Company Overview - **Company**: Rigel Pharmaceuticals (NasdaqGS:RIGL) - **Date of Conference**: January 14, 2026 - **Speaker**: Raul Rodriguez, CEO and President Key Industry and Company Insights Strategic Objectives - Rigel's strategic plan includes four objectives: 1. Grow the commercial business 2. In-license and add products to the commercial portfolio 3. Advance the product pipeline in the clinic 4. Maintain financial discipline [2][4][41] Historical Growth - In 2020, Rigel was a one-product company with Tavalisse for adult chronic ITP. - By 2025, the company expanded to three commercial products: Tavalisse, Rezlidhia, and Gavreto, with four different indications [3][4]. Financial Performance - Rigel became profitable in Q3 2024, generating $100 million in cash since then [4]. - The company reported a 35% sales growth from 2022, projecting total revenue of $275-$290 million for the year, with product revenue between $255-$265 million [6][42]. Product Performance Tavalisse - Tavalisse sales grew by 47%, reaching $45 million, with a significant patient population of approximately 24,000 in the U.S. [7][9]. - The product is used primarily in patients who have failed first-line steroid treatments [10][11]. - The Inflation Reduction Act positively impacted patient retention on Tavalisse, reducing dropout rates due to affordability issues [12][13]. Rezlidhia - Rezlidhia targets adult patients with relapsed or refractory AML with an IDH1 mutation, addressing a significant unmet need [14][15]. - The product achieved a CR/CRH rate of 35% with a durability of response lasting 25 months [16]. Gavreto - Gavreto is indicated for non-small cell lung cancer and thyroid cancer with RET fusion-positive mutations, showing good sales growth from $7 million to over $10 million per quarter [17][18]. Pipeline Development R289 (IRAK1 and 4 Inhibitor) - R289 is being studied in low-risk MDS, with potential for significant market opportunities estimated in the multi-hundred million to billion-dollar range [6][29]. - The product has received fast track and orphan designation from the FDA, with ongoing studies to evaluate its efficacy in treating low-risk MDS [25][39]. Future Plans - Rigel aims to launch additional products in the Heme-Onc space by 2026-2028, focusing on late-stage assets with registrational data [20][21]. - The company is exploring other indications for R289, leveraging its unique mechanism of action in inflammatory modulation [43][44]. Financial Discipline - Rigel has maintained a strong cash position, doubling its cash reserves to $154 million in 2025, allowing for further investment in pipeline development [41]. - The company emphasizes maintaining low operational expenses while growing revenue, achieving a balance that supports profitability [40]. Conclusion - Rigel Pharmaceuticals is positioned for continued growth with a diversified product portfolio and a promising pipeline. The company is focused on expanding its commercial business, advancing its development pipeline, and maintaining financial discipline to support future initiatives [41][42].

Industry Overview - The drug and biotech sector has shown recovery after a sluggish first half, supported by drug pricing agreements with the Trump administration and renewed M&A activity [1][4] - Innovation in areas such as obesity treatments, gene therapy, inflammation, and neuroscience continues to drive growth, despite challenges like pipeline setbacks and regulatory uncertainty [2][3] Market Performance - The Zacks Medical-Drugs industry has underperformed compared to the Zacks Medical sector and the S&P 500 over the past year, with a collective rise of 1.2% compared to 3.4% and 18.9% respectively [13] - The industry currently holds a Zacks Industry Rank of 90, placing it in the top 37% of 244 Zacks industries, indicating potential for outperformance [12] Valuation Metrics - The industry is trading at a trailing 12-month price-to-sales (P/S) ratio of 2.25, lower than the S&P 500's 6.03 and the Zacks Medical sector's 2.61 [16] Key Companies and Their Prospects - **Ironwood Pharmaceuticals**: Developing apraglutide for short bowel syndrome, with a significant rise in stock price by 178.9% in the past three months and a consensus estimate for 2026 earnings increasing from $0.40 to $0.47 [20][22] - **Rigel Pharmaceuticals**: Sales of Tavalisse rose by approximately 54% in the first nine months of 2025, with a stock increase of 46.7% and a consensus estimate for 2026 earnings rising from $3.70 to $4.30 [24][27] - **Soleno Therapeutics**: Launched Vykat XR for Prader-Willi syndrome, generating around $99 million in sales since April, with a stock decline of 25.7% but a rising consensus estimate for 2026 earnings from $3.10 to $3.59 [29][30] - **Marker Therapeutics**: Focused on next-generation T cell therapies, with a stock increase of 75.5% and a narrowing consensus estimate for 2026 loss per share from $4.92 to $1.86 [33][34] - **Nektar Therapeutics**: Developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with a stock decline of 26.0% but a narrowing consensus estimate for 2026 loss per share from $12.17 to $10.81 [36][38]

Summary of Rigel Pharmaceuticals FY Conference Call Company Overview - **Company**: Rigel Pharmaceuticals (NasdaqGS:RIGL) - **Industry**: Biotechnology, specifically focusing on hematology and oncology Key Points and Arguments 1. **Business Growth**: Rigel has experienced significant growth in its hematology and oncology business, with a 65% year-over-year increase in U.S. net product sales, reaching $64.1 million in Q4 and totaling $166 million through Q3 [3][17] 2. **Product Performance**: - **Tavalisse (ITP Product)**: Generated $44.7 million, reflecting a 70% year-over-year growth. It is primarily used for adult chronic ITP patients who have not responded adequately to previous treatments [3][4] - **Gavreto**: Acquired from Blueprint Medicines, it has grown from $7 million per quarter to over $11 million, indicating strong commercial execution [3][4] - **Rezlidhia**: Indicated for IDH1 positive AML patients, showing a 50% year-over-year growth [4][5] 3. **Market Opportunity**: - **Chronic ITP**: Approximately 81,000 patients in the U.S. suffer from chronic ITP, with Rigel's products increasingly being utilized in second and third-line therapies, where there are larger patient populations [4][5] - **AML**: About 22,000 patients diagnosed annually in the U.S., with a significant portion having IDH1 mutations, presenting a targeted market for Rezlidhia [5][6] 4. **Clinical Development**: Rigel is focused on in-licensing differentiated assets in hematology and oncology, with ongoing clinical trials for IRAK1/4 inhibitors and other products [10][12] 5. **Strategic Collaborations**: Partnerships with organizations like Grifols, Kissei, and MD Anderson to enhance product reach and development [9][14] 6. **Financial Performance**: - **Net Income**: Approximately $28 million through Q3, with profitability in each quarter [17] - **Cash Balance**: Increased to $137 million, providing a strong financial foundation for future growth [17] - **Revenue Guidance**: Increased guidance to $285-$290 million total revenue, with net product sales projected at $225-$230 million [17][18] Additional Important Information - **Regulatory Support**: The IRAK1/4 program has received fast-track and orphan designations from the FDA, indicating a supportive regulatory environment [12] - **Market Dynamics**: Rigel faces competition in the RET fusion-positive therapeutic market but sees opportunities due to recent changes in practice guidelines favoring their products [8][9] - **Future Goals**: Rigel aims to continue expanding its product sales, advancing its development pipeline, and seeking in-license opportunities [18]

Core Insights - Rigel Pharmaceuticals has experienced substantial growth, with an average increase of 30% over the past four years and approximately 50% growth this year [1] - The company's stock has surged about 50% in the last three months, making it one of the top-performing stocks in San Francisco [1][2] Financial Performance - In the second quarter, Rigel reported earnings of $3.28 per share, exceeding analyst expectations of $2.58 per share [3] - Revenue for the quarter was $101.7 million, significantly higher than the consensus estimate of $88.9 million [3] - The company raised its full-year revenue guidance to a range of $270 million to $280 million, up from the previous forecast of $200 million to $210 million [3] Product Portfolio - Rigel has three drugs currently on the market: Tavalisse for chronic immune thrombocytopenia, Gavreto for lung cancer, and Rezlidhia for acute myeloid leukemia with IDH1 mutation [4] - The company is advancing two clinical programs, one in partnership with Eli Lilly for Ocadusertib and another for R835, targeting lower-risk myelodysplastic syndrome [5] Clinical Trials and Future Outlook - Rigel is expanding its clinical trials to include a larger patient population, with more definitive data expected by the end of next year [6] - The company plans to present data on R835 at the American Society of Hematology meeting in December [5][6] - The next quarterly results are anticipated to be announced on November 4 [6]

Core Insights - Rigel Pharmaceuticals (RIGL) is advancing its hematology and oncology pipeline, with Tavalisse being the primary revenue driver [1][2] Product Performance - Tavalisse, an oral spleen tyrosine kinase inhibitor, generated sales of $68.5 million in the first half of 2025, reflecting a 44% year-over-year increase [2][10] - Rezlidhia, the second FDA-approved product, reported sales of $13.1 million in the same period, up 31% year over year [3][10] - Gavreto was added to Rigel's portfolio in 2024, contributing incremental sales starting June 2024, which positively impacted the company's revenue in the first half of 2025 [5][10] Future Outlook - Rigel expects steady sales growth as it expands its commercial presence and enhances marketing efforts, projecting total revenues of $270-$280 million for 2025, up from a previous estimate of $200-$210 million [6] Pipeline Development - Rigel is conducting a phase Ib study for R289, a dual IRAK1 and IRAK4 inhibitor, in patients with lower-risk myelodysplastic syndrome (MDS), with plans to initiate the dose expansion phase in the second half of 2025 [8] - The company is also exploring Rezlidhia's application in other cancers with IDH1 mutations, which could serve as a significant growth catalyst [9] Competitive Landscape - The recent FDA approval of Sanofi's Wayrilz (rilzabrutinib) for chronic ITP poses a competitive threat to Tavalisse, despite differing mechanisms of action [11] - Other companies are also developing treatments that may compete with Rigel's marketed products, including Eli Lilly's Retevmo (selpercatinib) for cancer indications [12] Stock Performance and Valuation - Rigel's shares have increased by 70.2% year to date, outperforming the industry and the S&P 500 [13] - The company is trading at a price-to-sales (P/S) ratio of 1.94, below the industry average of 2.47 and its five-year mean of 2.21 [14] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen from $2.68 to $5.10 over the past 60 days, with 2026 EPS estimates increasing from $1.61 to $3.07 [17]

Core Insights - Rigel Pharmaceuticals (RIGL) and Amicus Therapeutics (FOLD) are focused on developing treatments for rare medical conditions, aiming to establish leadership in their respective fields [1][2] Rigel Pharmaceuticals (RIGL) - Rigel's lead drug, Tavalisse, is an oral spleen tyrosine kinase inhibitor approved for chronic immune thrombocytopenia (ITP), generating $68.5 million in sales in the first half of 2025, a 44% increase year over year [3][6] - The company is also progressing with Rezlidhia, approved for relapsed/refractory acute myeloid leukemia (AML), with sales increasing 31% year over year in the first half of 2025 [4] - Rigel added Gavreto to its portfolio in 2024, contributing to revenue growth in the first half of 2025 [5] - The company raised its total revenue guidance for 2025 to $270-$280 million, up from a previous estimate of $200-$210 million, due to strong sales performance [6] - Rigel has a pipeline product, R289, in early-stage studies for myelodysplastic syndrome (MDS) and is exploring Rezlidhia's use in other cancers [7] Amicus Therapeutics (FOLD) - Amicus' lead product, Galafold, generated $233.1 million in sales in the first half of 2025, an 11% year-over-year increase, with patent protection extending to 2038 [8][9] - The company’s two-component therapy, Pombiliti + Opfolda, approved for late-onset Pompe disease, generated $46.8 million in sales in the first half of 2025, a 74% increase year over year [10] - Amicus is experiencing a shift of patients from Sanofi's Pompe disease drugs to Pombiliti and Opfolda, with expectations for increased patient starts in new markets in the second half of 2025 [11] - Despite the growth of Galafold and Pombiliti + Opfolda, FOLD remains heavily reliant on Galafold for revenue, posing a risk to the company's overall growth [12] Financial Estimates and Performance - The Zacks Consensus Estimate for Rigel's 2025 sales and EPS indicates a year-over-year increase of approximately 57% and 415%, respectively [13] - In contrast, Amicus' 2025 sales and EPS estimates imply a year-over-year increase of around 18% and 29%, respectively, with EPS estimates for 2025 trending downward [17] - Year-to-date, RIGL shares have increased by 80.1%, while FOLD shares have decreased by 11.3%, compared to an industry return of 11.7% [19] - Amicus is valued higher than Rigel based on the price-to-sales (P/S) ratio, with FOLD trading at 4.51 times trailing sales compared to RIGL's 2.05 [20] Comparative Analysis - Rigel holds a Zacks Rank 1 (Strong Buy), indicating a more favorable investment outlook compared to Amicus, which has a Zacks Rank 3 (Hold) [24] - Rigel's strong performance and optimistic guidance for 2025, driven by Tavalisse and other products, suggest significant upside potential [25] - Amicus' reliance on Galafold and competition from established players like Sanofi present challenges for sustained growth [26] - Rigel's expanding portfolio, improving earnings estimates, and lower valuation position it as a more attractive investment compared to Amicus [27]