GRAIL (GRAL) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants None - ExecutiveBob Ragusa - CEO & Board MemberHarpal Kumar - President Biopharma Business & EuropeJoshua Ofman - PresidentAaron Freidin - Chief Financial OfficerSubbu Nambi - Managing DirectorDoug Schenkel - Managing Director Conference Call Participants Tejas Savant - Executive Director & Senior Healthcare Equity AnalystKyle Mikson - Managing Director & Senior Research Analyst Operator Good day, ladies and gentlemen, and welc ...

Gevo (GEVO) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Eric Frey - VP of Finance & StrategyPatrick Gruber - CEO & DirectorLynn Smull - Chief Financial OfficerChris Ryan - President, Chief Operating OfficerPaul Bloom - Chief Business OfficerWhitney Mutalemwa - Equity Research Senior AssociateDerrick Whitfield - Managing Director Conference Call Participants Amit Dayal - Managing Director & Senior Technology AnalystPeter Gastreich - Managing Director - Energy and Sustainability Analys ...

Genasys (GNSS) Q2 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Brian Alger - SVP, Corporate Development & IRRichard Danforth - CEODennis Klahn - CFO Conference Call Participants Scott Searle - Managing Director, Senior Research AnalystMike Latimore - Managing Director & Senior Research AnalystEdward Woo - Director of Research & Senior Analyst Operator At this time, it is my pleasure to turn the floor over to your host, Brian Alger, SVP, Investor Relations and Corporate Development. Welco ...

Fractyl Health (GUTS) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Brian Luque - Head - IR & Corporate DevelopmentHarith Rajagopalan - Co-Founder, CEO & DirectorLisa Davidson - CFO & TreasurerChi Fong - VP - Equity ResearchAvraham Novick - Biotech Equity Research AssociateMichael Difiore - Managing DirectorWhitney Ijem - Managing Director Operator Good afternoon, and welcome to Fractal Health's First Quarter twenty twenty five Financial Results and Business Updates Call. As a reminder ...

Financial Data and Key Metrics Changes - The company's first quarter revenue was $17.3 million, a 117% increase from $8 million in the first quarter of 2024 [35] - Product sales reached $14 million, up 76% from $8 million in the prior year, driven by increased sales of Alkindi Sprinkle and the addition of Incralyx [36] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [36] - Adjusted EBITDA for the first quarter was $3.7 million, compared to $500,000 in the prior year [39] - The company reported a net loss of $1.6 million for the quarter, compared to a net loss of $800,000 in the prior year [40] Business Line Data and Key Metrics Changes - Alkindi Sprinkle has shown strong growth for 17 consecutive quarters, with an increase in new patient referrals in 2025 [15] - Incralyx has seen rapid patient acquisition, reaching over 90 active patients shortly after its relaunch, with expectations to reach 100 by year-end [8][12] - Galzin, acquired for Wilson's disease treatment, is expected to generate significant revenue as the company addresses access and affordability issues [21][22] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and infrastructure to drive growth in this segment [6][15] - The market for severe primary IGF-1 deficiency is estimated to have around 200 patients in the U.S., with potential for significant growth through increased awareness and screening [6][12] - The Wilson disease market is estimated to impact approximately 10,000 people in the U.S., with only about 2,000 diagnosed and treated, indicating a substantial unmet need [19][20] Company Strategy and Development Direction - The company aims to become a leading player in the ultra-rare disease market, with a strong focus on product launches and pipeline development [30][31] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [10][12] - The company is also advancing new product candidates like ET-700 and ET-800, targeting unmet needs in rare disease treatments [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, expecting to exit 2025 with an annual revenue run rate of approximately $80 million [36] - The management team is optimistic about the upcoming product launches and the potential for significant revenue growth from the pipeline [31] - The company is not concerned about tariff impacts, as most products are produced domestically, and any European purchases represent less than 5% of forecasted revenue [33][34] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team and commercial activities for product relaunches [37][38] - The company expects to maintain adjusted gross margins of approximately 70% for the full year 2025, with long-term goals exceeding 75% by 2028 [36] Q&A Session Summary Question: Update on Incralyx FDA meeting - The meeting request has been submitted, with expectations for a follow-up in July and a submission for label change in Q3 [42] Question: Recent interactions with FDA regarding ET-400 - The company is on track for approval within two weeks, with final labeling discussions underway [44] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients, with expectations to exceed revenue goals this year [54][55] Question: Expected timing for ET-400 commercial revenue - The launch is anticipated around June, with revenue expected to ramp up in Q3 [56][57] Question: Commentary on tariff risk exposure - The company does not foresee a meaningful impact from tariff proposals, as it primarily sells domestically [60][62] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a strong patient uptake and zero copay for patients [68][70]

Financial Data and Key Metrics Changes - The company's first quarter revenue was $17.3 million, a 117% increase compared to $8 million in the first quarter of 2024 [37] - Product sales reached $14 million, up 76% from $8 million in the same quarter last year, driven by increased sales of Alkindi Sprinkle and the addition of Incralyx [38] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [39] - Adjusted EBITDA for the first quarter was $3.7 million, compared to $500,000 in the prior year [43] - The total net loss was $1.6 million, compared to a net loss of $800,000 in the prior year [43] Business Line Data and Key Metrics Changes - The acquisition and relaunch of Incralyx and Dalzan contributed to strong growth in existing products [6] - Alkindi Sprinkle has shown consistent growth for 17 consecutive quarters, with an increase in new patient referrals in 2025 [16] - The company expects to reach approximately 80,000,000 annual revenue run rate by the end of 2025 [38] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and commercial infrastructure to raise awareness of severe primary IGF-1 deficiency [8] - The market for ET400 is estimated to have around 5,000 adrenal insufficiency patients under nine years of age, presenting a compelling opportunity [18] Company Strategy and Development Direction - The company aims to become a leading player in the ultra-rare disease market, with a focus on expanding its product portfolio through acquisitions and licensing [31] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [13] - The company is also developing ET700, an extended-release version of Galzin, to address dosing challenges and improve patient outcomes [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of existing products and the potential for new product approvals in the near future [6] - The company is optimistic about the upcoming launch of ET400, expecting rapid uptake and significant revenue impact in subsequent quarters [60] - Management noted that the tariff situation is not a major concern, as most products are produced in the U.S. and the impact of European purchases is minimal [34][35] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team and commercial activities for product relaunches [41] - The company reported a cash balance of $17.4 million and generated $2.1 million in operating cash flow during the quarter [43] Q&A Session Summary Question: Update on Incralyx label expansion meeting with FDA - The meeting request has been submitted, and the company expects to have it in the coming weeks, likely in July [45] Question: Recent interactions with FDA regarding ET400 - The company is on track for approval within two weeks, with the final step being labeling discussions [47] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients and expects to meet or exceed revenue goals this year [56] Question: Expected timing for commercial revenue from ET400 - The launch is expected around the approval date, with revenue anticipated in Q3 [59] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a strong uptake and zero copay for patients, improving access significantly [70]

Clearpoint Neuro (CLPT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Joseph Burnett - President and Chief Executive OfficerDanilo D’Alessandro - CFOMathew Blackman - Managing Director Conference Call Participants Frank Takkinen - Senior Research AnalystAnderson Schock - Research Analyst Operator Please note this conference is being recorded. Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statement ...

Clearpoint Neuro (CLPT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Joseph Burnett - President and Chief Executive OfficerDanilo D’Alessandro - CFOMathew Blackman - Managing Director Conference Call Participants Frank Takkinen - Senior Research AnalystAnderson Schock - Research Analyst Operator Please note this conference is being recorded. Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statement ...

CI&T (CINT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Cesar Gon - CEOBruno Guicardi - Co-Founder of CI&T and President of North America & Europe OperationsStanley Rodrigues - Chief Financial OfficerVitor Tomita - VP - Equity ResearchGustavo Farias - Associate DirectorBryan Bergin - MD - Equity ResearchPuneet Jain - Associate - Equity ResearchBruno Guicardi - Co-Founder of CI&T and President of North America & Europe OperationsMaria Clara Infantozzi - Equity Research Associate Cesar ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $144.8 million [23] - Revenues for Q1 2025 were zero, compared to approximately $4.9 million for Q1 2024, with the previous revenue being from a $40 million distribution agreement fully recognized by the end of 2024 [23][24] - Operating expenses for Q1 2025 were approximately $16.2 million for R&D, up from $10.1 million in Q1 2024, and general and administrative expenses were approximately $3.1 million, compared to $1.8 million in Q1 2024 [24] - The net loss for Q1 2025 was approximately $24.4 million, compared to a net loss of approximately $9.8 million for Q1 2024 [25] Business Line Data and Key Metrics Changes - The company is focused on the BLA for daramycin, aimed at treating Duchenne muscular dystrophy (DMD) cardiomyopathy, with a strong emphasis on the safety and efficacy data supporting the application [5][8] - The company has been providing daramycin to all open-label extension patients for over three years, with nearly all HOPE-three patients now in open-label extension [15] Market Data and Key Metrics Changes - The company is negotiating with Nippon Shinyaku for the distribution of deramycin in Europe, with the negotiation period extended through the end of Q2 2025 [18] - The company is also exploring opportunities for its technology in other global markets [18] Company Strategy and Development Direction - The company aims to transition from a translational medicine company to a commercial stage entity, actively working with NS Pharma on launch readiness in the U.S. [12] - The company plans to have over 100 patients transition from clinical to commercial product following potential BLA approval [14] - The company is enhancing its medical leadership to guide physicians through the prescribing process for daramycin [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting the BLA and the unmet need in treating DMD cardiomyopathy, which could lead to FDA approval [5][6] - Management noted that the FDA has not indicated any substantive issues with the application, providing confidence in the ongoing review process [30] - The company has a cash balance of approximately $145 million, with a runway extending into 2027 without additional cash infusions [20] Other Important Information - The company is developing its Stealth Exosome Platform technology as part of a next-generation drug delivery platform, although this program has taken a backseat to daramycin [19] - The company is also working on a vaccine candidate for COVID-19 prevention under Project NextGen, with Phase 1 trials set to start in Q3 2025 [20] Q&A Session Summary Question: Has the site inspection in San Diego occurred? - The site inspection is scheduled for the upcoming quarter, and management feels prepared for it [28] Question: What is the status of negotiations with Nippon Shinyaku for Europe? - The company is actively negotiating and evaluating opportunities for commercialization in Europe, while also preparing to work directly with European authorities [37] Question: What are the key drivers of proof for the efficacy data? - The statistical significance of cardiac MRI data is a key driver, showing very little chance that the data is due to chance [46] Question: What is the plan if the FDA issues a CRL for efficacy? - The company would submit data from the HOPE-three trial for skeletal muscle dysfunction if a CRL is issued [55] Question: What is the plan for the PRV voucher? - The current plan is to sell the PRV voucher to strengthen the balance sheet [72]