PresentationRyan WeispfenningVP & Head of Investor Relations Okay. Hello, everyone. Thanks for joining us today. I'm Ryan Weispfenning, Vice President and Head of Investor Relations at Medtronic. Thank you for joining call showcasing the Altaviva device, which just secured FDA approval back on September 18. I want to remind everyone that today's event is being recorded, and a replay will be available on our website shortly after the call. A few quick announcements before we begin. Please note that today's c ...

Welcome back. President Trump vowing to impose a 100% tariff on pharmaceutical companies unless the company agrees to build a manufacturing plant here in the United States. The threatened tariffs said to go into effect on October 1st.John Flavin, Portal Innovations founder and CEO joins us now. Investor in and early stage biotech companies. John, how does this affect your world.Well, I mean, if you step back, uh, before a drug becomes a drug, um, it starts in a lab, usually at a research university, um, and ...

Core Insights - KalVista Pharmaceuticals has received FDA approval for EKTERLY, the first oral on-demand treatment for hereditary angioedema (HAE), which is expected to drive significant growth for the company [1] Financial Performance - For the quarter ending September 11, 2025, KalVista reported an earnings per share (EPS) of -$1.12, missing the estimated EPS of -$0.91, resulting in a negative surprise of 23.08% [2] - The company's revenue for the quarter was approximately $1.43 million, falling short of the expected $2.09 million, indicating a shortfall of 20.91% [2] - KalVista has exceeded consensus EPS estimates only once in the past four quarters, highlighting ongoing financial challenges [2] Financial Metrics - The company has a negative price-to-earnings (P/E) ratio of approximately -3.73 and an enterprise value to operating cash flow ratio of about -3.89, indicating difficulties in achieving profitability and generating positive cash flow [3] - The earnings yield is negative at approximately -26.83%, further emphasizing the company's financial struggles [3] Debt and Stability - KalVista's debt-to-equity ratio of 0.07 suggests a relatively low level of debt compared to its equity, indicating financial stability [4] - The recent FDA approval of EKTERLY positions the company for potential future growth, although the immediate impact on stock price and future earnings expectations remains uncertain [4]

Core Points - The FDA declined approval of Vivos Inc.'s Radiogel® IDE submission after a 30-day review period [1] - The company is focused on addressing the FDA's feedback and plans to have an initial call with the FDA within 10 days [2] - Vivos intends to participate in a pre-submission meeting with the FDA review team in the coming weeks to resubmit the application [2] - Radiogel® has received FDA Breakthrough Device Designation and has shown a strong safety profile and therapeutic ratio [2] Company Actions - Vivos Inc. is committed to pursuing approval for Radiogel® in the US market despite the recent setback [2] - The company is actively engaging with the FDA to resolve the issues raised in the rejection letter [2]

Company Overview - Milestone Pharmaceuticals Inc. is a microcap biotech company founded in 2003, based in Montreal with a subsidiary in Charlotte, NC, employing over 30 staff members [1] Investment Philosophy - The investment philosophy emphasizes the importance of compounding, dividend reinvesting, and patient investing through various market conditions to achieve wealth creation [1] - The approach combines steady accumulation of high-quality assets with high-risk/high-reward opportunities, underappreciated turnaround plays, and transformative technologies [1] Academic Background - The individual has over 20 years of teaching experience at the college/university level and holds a PhD from Brunel University, indicating a strong academic foundation [1]

Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene Served on Celgene's Executive Committee and played a key leadership role in the BMS transaction, the integration of Celgene into BMS, and the divestiture of Otezla to Amgen Appointment marks a key addition as Tonix readies for the potential approval of TNX-102 SL for the management of fibromyal ...

Financial Data and Key Metrics Changes - Amphastar reported net revenues of $170.5 million for Q1 2025, reflecting a modest 1% decline compared to $171.8 million in the same period last year [7][16] - Gross margins declined to 50% in Q1 2025 from 52.4% in the previous year, primarily due to the shift in distribution of Baqsimi and pricing declines for epinephrine [18][19] - Net income decreased to $25.3 million or $0.51 per share in Q1 2025 from $43.2 million or $0.81 per share in Q1 2024 [20] Business Line Data and Key Metrics Changes - Paxini revenues grew 177% to $38.4 million compared to $13.8 million in the prior year [16] - Primatene Mist sales reached $29.1 million, a 20% increase from $24.2 million in the same period last year [18] - Glucagon injection sales declined 27% to $20.8 million from $28.5 million due to increased competition [18] - Epinephrine sales decreased 29% to $18.6 million from $26.1 million, also due to increased competition [18] Market Data and Key Metrics Changes - Vaxemia achieved sales of $38.3 million in Q1 2025, closely aligned with the combined sales of $38.7 million recorded in the same period last year [8] - The competitive landscape for critical care products such as dextrose and epinephrine has intensified, impacting demand [7][11] Company Strategy and Development Direction - Amphastar is focused on expanding its portfolio with proprietary and interchangeable biosimilar products, including insulin aspart [13][14] - The company aims to enhance its commercial position and strengthen its product pipeline within high-value therapeutic areas [14] - A strategic partnership with MannKind has been established to enhance promotional reach for Vaxmi, with expectations for benefits to materialize in the second half of 2025 [9] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the cyclical nature of drug shortages and anticipates trends observed in Q1 to continue throughout the year [7] - The company remains optimistic about the potential for new product approvals and revenue contributions from upcoming launches [30][31] - Management is closely monitoring tariff discussions, believing that their domestic manufacturing position provides a competitive advantage [13][56] Other Important Information - The company received the Drug Shortage Assistance Award from the U.S. FDA, recognizing its efforts in preventing drug shortages [5][6] - Cash flow from operations was approximately $35.1 million, with $11 million used for share buybacks [21] Q&A Session Summary Question: Expectations for new launches and impact of competition - Management expressed optimism about potential new product launches and their ability to cushion the impact of competition [25][28] Question: Commercial support initiatives for Baqsimi - Management clarified that the increase in sales force and promotional efforts are aimed at endocrinologists, addressing previous disruptions during the transition from Lilly [31][32] Question: Insulin aspart opportunity and competitive dynamics - Management highlighted the large market opportunity for insulin aspart and the goal to become the first interchangeable biosimilar [36][39] Question: Outlook for flat sales in 2025 - Management confirmed that flat revenue guidance is based on expected contributions from new product approvals later in the year [30][42] Question: Margin pressure and future expectations - Management indicated that while margin pressures are expected, growth in higher-margin products like Primatene Mist and Vaximi will help offset some of the declines [50][51] Question: Regulatory landscape and tariff impacts - Management noted that recent changes at the FDA have not significantly impacted application timelines, and their U.S. manufacturing footprint positions them well against potential tariff impacts [52][56]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash of $98.1 million, compared to $52.6 million as of December 31, 2023, indicating a significant increase in financial resources [24] - Research and development expenses were $34.4 million for the full year ended December 31, 2024, up from $31.1 million in 2023 [25] - General and administrative expenses rose to $29.9 million for the full year ended December 31, 2024, compared to $19 million in 2023, primarily due to commercial launch preparation costs [25][26] - The net loss for the full year ended December 31, 2024, was $63.7 million, or $1.55 loss per common share, compared to a net loss of $54.2 million, or $2.53 loss per common share in 2023 [26] Business Line Data and Key Metrics Changes - The company is preparing for the potential launch of PD Cell for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), with an estimated 750 RDEB patients in the U.S. who may be candidates for treatment [10][11] - The estimated cumulative revenue potential for PD Cell in the U.S. is over $2 billion, based on a conservative treatment cost of $1.5 million per patient [12] Market Data and Key Metrics Changes - The company anticipates activating treatment centers in the U.S. to begin patient biopsies approximately three months after the PDUFA date, with a gradual ramp-up in treatment capacity expected [7][16] - The payer mix indicates that 60-65% of lives are covered by commercial plans, 30-35% by Medicaid, and less than 10% by Medicare, highlighting the market access landscape [18] Company Strategy and Development Direction - The company is focused on securing FDA approval for PD Cell and launching it as a new treatment for RDEB patients, with significant growth potential anticipated in 2025 [76] - The strategy includes onboarding five treatment centers initially, with plans to gradually increase the number of centers as manufacturing capacity ramps up [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date and the potential approval of PD Cell, which is expected to transform the treatment paradigm for RDEB patients [6][8] - The company is optimistic about the interest from payers and the clinical value of PD Cell, which addresses a significant unmet medical need in the RDEB treatment landscape [18] Other Important Information - The company has received a priority review designation from the FDA for PD Cell, which may qualify it for a Priority Review Voucher (PRV) upon approval [25][59] - The company is also exploring potential markets outside the U.S., including Europe and Asia, for future deployment of PD Cell [64][66] Q&A Session Summary Question: Is the FDA satisfied with the work done on the CMC side? - Management believes they have addressed all FDA requests from the previous CRL and have had multiple touchpoints with the agency, indicating a positive outlook [30][31] Question: What percentage of patients at the treatment centers may be eligible for PD Cell? - Approximately 30% of the estimated 750 RDEB patients are located in seven centers of excellence, with discussions ongoing about patient eligibility [34] Question: What is the primary reason for patients to seek PD Cell therapy? - The key reason is the need for durable wound closure, which significantly impacts the quality of life for patients with chronic wounds [37] Question: Will there be a patient backlog upon launch? - Management anticipates a patient backlog initially due to limited manufacturing capacity, which will gradually increase as production ramps up [44] Question: What is the company's strategy for physician education and patient awareness? - The company plans to engage in physician education and leverage advocacy groups to raise awareness within the tight-knit RDEB patient community [52][53]