Summit Therapeutics Q1 2025 Earnings Call May 1, 2025 4:30pm ET Forward Looking Statement Any statements in this presentation about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidates, the pot ...

Core Insights - Kymera Therapeutics reported a first-quarter 2025 loss of 82 cents per share, which is an improvement compared to the Zacks Consensus Estimate of a loss of 92 cents and a loss of 69 cents per share in the same quarter last year [1][2] - The year-over-year loss increase was attributed to higher research and development (R&D) expenses, which rose by 64.3% to $80.2 million [4][5] - Collaboration revenues reached $22.1 million, exceeding the Zacks Consensus Estimate of $10 million and up from $10.3 million in the year-ago quarter [1][2] Financial Performance - R&D expenses increased significantly due to investments in the STAT6 and TYK2 degrader programs, as well as rising occupancy costs related to the growth of the R&D organization [4] - General and administrative expenses rose by 13% year over year to $16.3 million, primarily due to increased legal and professional service fees [5] - As of March 31, 2025, Kymera had $775 million in cash and cash equivalents, providing a cash runway into the first half of 2028 [5] Pipeline Developments - Kymera completed a phase I study on KT-621, with data expected next month [8] - The company initiated dosing in the KT-621 BroADen phase Ib study for atopic dermatitis patients, with results anticipated in the fourth quarter of 2025 [9] - Plans are in place to begin two parallel phase IIb studies in atopic dermatitis and asthma patients in late 2025 and early 2026, respectively [10] Strategic Decisions - Kymera has named KT-579 as its lead development candidate, with plans to advance it into phase I testing in early 2026 [11] - The company is conducting two phase IIb dose-ranging trials for hidradenitis suppurativa and atopic dermatitis in collaboration with Sanofi, with primary completion expected in 2026 [12] - Kymera has decided not to advance KT-295 into clinical development, allowing a focus on other pipeline programs [13]

Financial Data and Key Metrics Changes - The company recognized $400,000 in revenue for Q1 2025, down from $600,000 in Q1 2024, with revenue being non-cash based on amortization of licensing payments [39] - Research and development (R&D) expenses increased by 43% to $76.2 million in Q1 2025 compared to the same period in 2024 [39] - Selling, general and administrative (SG&A) expenses rose by 71% to $35.5 million in Q1 2025 compared to Q1 2024 [40] - Cash used in operations was $88.5 million for Q1 2025, compared to $52.9 million in Q1 2024, with an anticipated cash usage of $340 million to $380 million for the full year [41][42] Business Line Data and Key Metrics Changes - The company is focused on the anticipated commercial launch of paltusotine, which is expected to significantly improve treatment for acromegaly [7][10] - The company is advancing a robust pipeline, including two late-stage candidates and three additional candidates in preclinical studies [7][8] Market Data and Key Metrics Changes - The company is preparing for the U.S. launch of paltusotine in September, with significant engagement with healthcare professionals and payers [12][19] - The company anticipates major uptake during the early launch phase as it educates healthcare providers and patient communities about paltusotine [23] Company Strategy and Development Direction - The company aims to become a fully integrated global commercial organization, with a strong focus on patient-centric therapies [6][10] - The company is actively engaging with regulatory authorities and preparing for the launch of paltusotine, which is seen as a defining milestone [10][24] - The company is also pursuing a Phase III trial for adomelna in congenital adrenal hyperplasia (CAH), aiming to redefine treatment standards [11][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory engagement with the FDA and the progress of clinical development activities [10][24] - The company remains optimistic about the potential of paltusotine to become the new standard of care in acromegaly, addressing significant unmet needs [23][24] Other Important Information - The company ended Q1 2025 with approximately $1.3 billion in cash, which is expected to fund operations into 2029 [42] - The company has received orphan drug designation for paltusotine in the EU, highlighting the unmet need in acromegaly [25] Q&A Session Summary Question: Could you talk about the powering of your very innovative primary endpoint? - The study is highly powered to detect statistically significant differences between treatment and placebo arms, and the endpoint is better described as a composite rather than a co-primary endpoint [47][49] Question: Is the CALM CAH study design fully signed off on by FDA? - The protocol was developed based on input from the FDA and other health authorities, and they are aware of the final study design [53][54] Question: What is the rationale for looking at morning dosing versus evening dosing in the fourth cohort? - Morning dosing may be more convenient for patients, and the study aims to explore this option [60][61] Question: How are you thinking about launch strategy in different geographies? - The company is preparing for the launch in Germany, where there is a significant unmet need, and is also considering expansion into Brazil [68][69] Question: Can you give an update on enrollment and follow-up for the long-term extension study? - Enrollment is proceeding, and updates will be provided once a critical mass is reached [87] Question: Is there a risk that A4 variability may lead to some non-responders? - Responder analyses are generally conducted at single points in time, and there is confidence that the compound can achieve both components of the composite primary endpoint [57][58]

Vancouver, British Columbia, May 8th, 2025 – TheNewswire - CAVA Healthcare Inc, (the “Company”) is pleased to announce the appointment of Barbara Sharp as its new Chief Executive Officer (CEO), effective immediately.  She has also been appointed to serve as a Director of the Company until next Annual General Meeting.Barbara brings a wealth of leadership experience across public, private, and nonprofit sectors, with a career spanning over three decades in executive management, labour relations, conflict res ...

Core Viewpoint - Acadia Pharmaceuticals reported strong first-quarter 2025 earnings, exceeding expectations with total revenues driven by its marketed products, Nuplazid and Daybue [1][3][4] Financial Performance - Acadia's Q1 2025 earnings were 11 cents per share, beating the Zacks Consensus Estimate of 10 cents, and up from 10 cents in the same quarter last year [1] - Total revenues reached $244.3 million, surpassing the Zacks Consensus Estimate of $241 million, marking a 19% year-over-year increase [1][3] - Nuplazid revenues increased by 23% year over year to $159.7 million, exceeding the Zacks Consensus Estimate of $153.8 million [3] - Daybue generated net product sales of $84.6 million, an 11% year-over-year increase, although it fell short of the Zacks Consensus Estimate of $89.6 million [4] Expenses - Research and development (R&D) expenses rose to $78.3 million, a 31% increase year over year, primarily due to costs from clinical-stage programs [6] - Selling, general and administrative (SG&A) expenses were $126.4 million, up 17% year over year, attributed to increased marketing costs for Nuplazid and expansion efforts for Daybue [6] Cash Position - As of March 31, 2025, Acadia had cash, cash equivalents, and investments totaling $681.6 million, down from $756 million as of December 31, 2024 [7] Financial Outlook - Acadia expects total revenues from U.S. sales of its products to be between $1.030 billion and $1.095 billion for 2025, with Nuplazid sales projected at $650 million to $690 million and Daybue sales between $380 million and $405 million [8] - R&D expenses for 2025 are now projected to be between $330 million and $350 million, up from the previous range of $310 million to $330 million, while SG&A expenses are expected to be between $535 million and $565 million [9] Product Updates - Nuplazid is approved for treating hallucinations and delusions associated with Parkinson's disease psychosis, while Daybue is the first FDA-approved treatment for Rett syndrome, launched in April 2023 [2] - A regulatory filing for Daybue in the EU is under review, with approval expected in Q1 2026 [12] - Acadia is seeing favorable enrollment trends in the phase III COMPASS PWS study for ACP-101, with top-line results expected in early Q4 2025 [13] - The company plans to complete enrollment in the phase II RADIANT study of ACP-204 for Alzheimer's disease psychosis by Q1 2026, with top-line data anticipated in mid-2026 [14] - Acadia and Saniona completed cohorts in the phase I study of ACP-711, which showed a strong safety profile, and are focusing on essential tremor as the lead indication [15][16]

Financial Performance & Targets - Zai Lab reported a 22% year-over-year increase in total revenues for 1Q'25, reaching $106.5 million[8][44] - The company is targeting profitability in 4Q'25[13][41][48][53][54][75] - Zai Lab anticipates total revenue between $560 million and $590 million[41] - As of March 31, 2025, Zai Lab's cash position was strong at $857.3 million, compared to $879.7 million as of December 31, 2024[9][10][42][76] Key Product Performance & Pipeline Updates - VYVGART/VYVGART Hytrulo sales increased by 38% year-over-year in 1Q'25, reaching $18.1 million[44] - NUZYRA sales increased by 53% year-over-year in 1Q'25, reaching $15.1 million[44] - ZEJULA maintained its position as the leading PARP inhibitor in hospital sales for ovarian cancer[47] - Two NDAs, KarXT for schizophrenia and TIVDAK for cervical cancer, are under NMPA review[7] - ZL-1310 (DLL3 ADC) is progressing rapidly, with updated data to be presented at ASCO and a pivotal trial to be initiated in 2H'25[7][35][56][70] Strategic Focus & Pipeline Expansion - The company aims to generate at least 1-2 INDs per year[40] - Zai Lab is expanding its immunology franchise with Povetacicept (APRIL/BAFF) and VRDN-003 (IGF-1R)[7] - The company is preparing for potential launches of KarXT and bemarituzumab[19][67][72] - Zai Lab is planning local manufacturing for key products like KarXT and bemarituzumab[19][28]

Cytokinetics, Incorporated (CYTK) reported a net loss of $1.36 per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.41. In the year-ago quarter, the company reported a net loss of $1.33 per share. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The year-over-year deterioration was due to higher operating expenses.Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and comme ...

Core Viewpoint - Denali Therapeutics reported a wider-than-expected loss in Q1 2025, primarily due to increased operating expenses, and did not generate collaboration revenues during the quarter [1][2]. Financial Performance - The company reported a loss of 78 cents per share, compared to the Zacks Consensus Estimate of a loss of 71 cents and a loss of 68 cents in the same quarter last year [1]. - Research and development expenses rose by 8.6% to $116.3 million, driven by increased spending on clinical and preclinical programs [5]. - General and administrative expenses increased by 16.4% to $29.4 million, attributed to activities related to the submission of a biologics license application for tividenofusp alfa [6]. - As of May 31, 2025, the company had approximately $1.05 billion in cash, cash equivalents, and marketable securities [6]. Pipeline Developments - Denali completed the submission of a biologics license application for tividenofusp alfa under the FDA's accelerated approval pathway, based on phase I/II study data for Hunter syndrome [7]. - The FDA granted Breakthrough Therapy Designation for tividenofusp alfa in January 2025 [8]. - Denali is conducting a global phase II/III COMPASS study to support regulatory approvals for tividenofusp alfa [8]. - The company is evaluating DNL126 for Sanfilippo syndrome type A and has had productive discussions with the FDA regarding its accelerated development [9]. - Denali is collaborating with Takeda on DNL593 for frontotemporal dementia and is conducting a phase I/II study [10]. - Denali and Biogen are jointly evaluating BIIB122/DNL151 for Parkinson's disease, with the LUMA study fully enrolled [11]. - The company is also conducting the phase IIa BEACON study for LRRK2-associated Parkinson's disease and evaluating DNL343 in a phase II/III study for ALS [12]. - Denali's partner Sanofi discontinued the development of SAR443820/DNL788 for ALS due to unmet primary endpoints in the phase II study [14]. Market Performance - Shares of Denali Therapeutics have declined by 31.4% year-to-date, while the industry has seen a smaller decline of 2.2% [4]. Overall Assessment - The progress in Denali's pipeline is viewed as encouraging, with potential approval of tividenofusp alfa expected to significantly benefit the company [15].

Business Highlights - BeiGene's Q1 2025 execution sets a strong foundation for the year, focusing on hematology franchise leadership, pipeline advancement, and superior financial performance[11] - Brukinsa is now the U S revenue leader among BTKis, with over 200,000 patients treated globally[17] - BeiGene has launched Brukinsa in Japan and it is now approved in 75 markets, with 11 new or expanded reimbursements including in Japan, EU, and Brazil[21] - Enrollment is complete in the Phase 3 CELESTIAL-TNCLL trial for Sonrotoclax, with global filing expected in R/R MCL in H2 2025[23] - BeiGene achieved GAAP profitability in Q1 2025, with GAAP Operating Income of $11 million compared to a loss of $261 million in Q1 2024[40] Financial Performance - Total revenue for Q1 2025 increased by 49% year-over-year, reaching $1.117 billion, compared to $752 million in Q1 2024[93, 95] - Net product revenue in Q1 2025 was $1.109 billion, a 48% increase from $747 million in Q1 2024[95, 96] - Brukinsa revenue in Q1 2025 reached $792 million, a 62% increase from $489 million in Q1 2024[95] - Tevimbra revenue in Q1 2025 was $171 million, an 18% increase from $145 million in Q1 2024[95] - GAAP earnings per ADS was $0.01 in Q1 2025, compared to a loss of $2.41 in Q1 2024[96]

Financial Data and Key Metrics Changes - Vertex Pharmaceuticals reported total revenue of $2,770 million for Q1 2025, representing a 3% growth compared to Q1 2024 [7][41] - U.S. revenue grew by 9% year-over-year, driven by ongoing patient demand and the early launch of AlifTrex [41] - Ex-U.S. revenue declined by 5% year-over-year, impacted by illegal copy products in Russia [42][43] - Non-GAAP earnings per share were $4.06, down from $4.76 in Q1 2024, primarily due to increased operating expenses [45] Business Line Data and Key Metrics Changes - The launch of AlifTrex, Vertex's fifth CF medicine, is showing positive early dynamics and feedback from physicians and patients [7][8] - Gernavix, the first oral non-opioid for moderate to severe acute pain, has been launched and is seeing early uptake [33][34] - CASJEVI generated $14 million in revenue during Q1 2025, indicating initial traction in the market [43] Market Data and Key Metrics Changes - The company is expanding its reach with the global launch of Kashyvi, a gene-edited therapy for sickle cell disease and beta thalassemia, with over 65 authorized treatment centers activated [28][30] - In the U.S., formal commercial coverage for Kashyvi is either in place or provided through single case agreements, with significant progress in Medicaid coverage [29][30] Company Strategy and Development Direction - Vertex is focused on commercialization and expanding its product portfolio, with a strong emphasis on advancing its R&D pipeline [7][8] - The company aims to bring most CF patients to normal levels of CFTR function through its next-generation CFTR regimen [12] - Vertex is also advancing multiple pivotal development programs in diabetic peripheral neuropathy, type one diabetes, and kidney diseases [8][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, raising the low end of 2025 total revenue guidance to a range of $11.85 billion to $12 billion [45][46] - The company anticipates continued growth from its CF medicines and expects to ramp up revenue from Gernavix in the second half of 2025 [46][47] Other Important Information - Vertex ended Q1 2025 with $11.4 billion in cash and investments, having repurchased approximately $425 million worth of shares [45] - The company is committed to investing in R&D, with a guidance range for combined non-GAAP R&D and SG&A expenses set at $4.9 billion to $5 billion for the full year 2025 [48] Q&A Session Summary Question: Feedback on Elephthrex launch and chronic pain indications for Gernavix - Management noted that sweat chloride is not routinely used in clinical practice, but the combination of Elephthrex's benefits, including non-inferiority to Trikafta and additional mutation coverage, is compelling [56][58] Question: Impact of tariffs and Russia issue on CF business - The impact from the Russia issue is estimated at $100 million for Q1 and $200 million for the full year, which is included in current guidance [61][62] - Tariffs currently have an immaterial impact due to a well-balanced global supply chain and minimal exposure to China [62][63] Question: Early adopters of Elephthrex and payer coverage for Gernavix - Uptake of Elephthrex is seen across all patient groups, with the fastest uptake among those newly eligible for CFTR modulators [68] - Gernavix is being used in various settings, including surgery and non-surgery, with broad uptake and positive feedback from physicians [75]