FDA Approval and Launch of Yeztugo for HIV Prevention
Early launch data shows over 25,000 customer calls and high engagement, with 72% unaided awareness and 95% aided awareness among providers.
The company aims for 75% access within 6 months and 90% within 12 months, with early signs of successful reimbursement and formulary inclusion, including a new J-code coming in October.
Gilead has initiated preparations for European approval and a partnership with the Global Fund to expand access to approximately 2 million people in low-income countries over three years.
Impact and Management of PAMA Legislation for 2026
The company anticipates a potential $100 million impact if PAMA is implemented next year, with ongoing efforts to delay or mitigate this through legislation and data collection improvements.
Management is working with trade organizations to seek legislative solutions, including delays and data adjustments, to offset the impact.
Base case assumption is that PAMA will come into effect in 2026, but the company is preparing for various scenarios, including offsets via initiatives like LaunchPad.
Strategic Merger of Pelthos and Channel Therapeutics
The merger involved a reverse merger process, creating a new public entity, Pelthos Therapeutics, which launched Zelsuvmi, a treatment for Molluscum contagiosum.
Pelthos's market forecast suggests capturing fewer than 100,000 patients in a 16.7 million patient market, with potential royalties of around $23 million annually in the U.S.
Ligand's strategic ownership of the nitric oxide platform and pipeline of late-stage programs offers multiple future royalty streams, emphasizing its focus on high-value assets.
FDA Label Expansion for EMPAVELI in C3G and Primary IC-MPGN
FDA approved a label expansion for EMPAVELI for patients 12 years and older with C3 myelopathy and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
This is the company's third FDA approval in 4 years, highlighting scientific strength and regulatory success.
The approval enables treatment with a C3-targeting therapy that achieves outcomes across proteinuria reduction, eGFR stabilization, and C3 deposit clearance.
Launch is underway, expanding into rare nephrology and underserved populations, including pediatric patients and post-transplant recurrence.
Strong and Sustained Revenue Growth in Core Business and New Launch Countries
Amicus reported 17th consecutive quarter of double-digit revenue growth at CER, driven by Pompe and Fabry disease.
Q2 revenue reached $154.7 million, up 22% YoY, with significant contributions from newly launched countries including Italy, Switzerland, Portugal, Czech Republic, Sweden, and the Netherlands.
The company expects continued growth in these markets and plans to launch in up to 10 new countries in 2025.
Major Capitated Contract with National Healthcare System
AdaptHealth signed a 5-year definitive agreement to become the exclusive provider for a major national healthcare system covering over 10 million members across multiple states.
The contract is projected to generate over $1 billion in revenue during its term, with adjusted EBITDA margins aligned with the company's enterprise margins.
Once fully ramped, this partnership will elevate capitated revenue to at least 10% of total revenue, significantly increasing recurring revenue.
The contract is expected to start generating revenue 2-3 months after infrastructure setup, with full ramp-up by 2027.
Management emphasized this as a historic, transformative deal that supports long-term growth and market consolidation.
Dafinchi
