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]

Core Viewpoint - The appointment of Joseph Hand as General Counsel and Executive Vice President of Operations at Tonix Pharmaceuticals is a strategic move as the company prepares for the potential approval of TNX-102 SL for fibromyalgia management next quarter [1][2]. Company Overview - Tonix Pharmaceuticals is a fully-integrated biopharmaceutical company focused on developing therapies for pain management and vaccines for public health challenges, with a particular emphasis on central nervous system (CNS) disorders [3]. - The company is advancing TNX-102 SL, a product candidate for fibromyalgia management, for which a New Drug Application (NDA) has been submitted based on two statistically significant Phase 3 studies [3]. - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL, which has also received Fast Track designation [3]. Leadership Experience - Joseph Hand brings over 20 years of strategic legal and business leadership experience in the biopharmaceutical industry, including nearly a decade at Celgene Corporation, where he held senior executive positions [1][2]. - At Celgene, Mr. Hand was involved in significant transactions, including the $74 billion acquisition by Bristol Myers Squibb and the $13.4 billion divestiture of Otezla to Amgen [2]. Strategic Importance - The addition of Mr. Hand is seen as crucial for driving company growth and operational excellence at a pivotal time in Tonix's history, particularly as it prepares for the launch of TNX-102 SL [2]. - The company aims to position itself for long-term growth while delivering meaningful therapies to patients [3]. Development Portfolio - Tonix's development portfolio includes biologics targeting organ transplant rejection, autoimmunity, and cancer, such as TNX-1500, an Fc-modified humanized monoclonal antibody [3]. - The company is also developing a vaccine for mpox, TNX-801, and has secured a contract with the U.S. Department of Defense for up to $34 million over five years to develop TNX-4200, a broad-spectrum antiviral agent [3].

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]