Market Dynamics and Competitive Landscape in Hypert cortisolism and Diabetes
Management discussed the expanding hypercortisolism market, with more players increasing noise and market activity, which they view positively.
The potential launch of a competitor's drug later this year could increase market awareness and demand for cortisol testing and treatment.
In the diabetes space, there are approximately 15 million patients who should have rescue glucagon, but only about 1 million currently do, indicating significant growth opportunities.
Gvoke's collaboration with American Regent for VialDx is expected to enhance market penetration in the coming years.
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.
FIRDAPSE generated $84.8 million in net product revenue in Q2 2025, up $7.5 million from Q2 2024, with a reaffirmed full-year guidance of $355-$360 million.
The growth was impacted in 2024 by the Change Healthcare cybersecurity breach, which shifted volume from Q1 to Q2, but the impact was fully resolved by June 2024.
Year-to-date, FIRDAPSE revenue increased 16.9% over the first half of 2024, indicating strong underlying demand and market durability.
Management emphasizes high prescription approval rates above 90% and low discontinuation rates below 20%, supporting sustained performance.
The company is actively expanding education efforts supported by updated NCCN guidelines, targeting undiagnosed cancer-associated LEMS patients, with an opportunity to reach a high-potential underserved population.
Operating loss for Q2 2025 was $13.3 million, nearly half of the $23.8 million loss in Q2 2024.
Product gross margin improved significantly to 72% in Q2 2025 from 45% in Q2 2024 due to sales shifts to more profitable products.
Q2 2025 revenue was $15.3 million, up from $8 million in Q2 2024, driven by Pharma Biocatalysis customer manufacturing schedules and clinical trial progression.
Research and development expenses increased to $13.8 million from $11.4 million, mainly due to higher headcount and reclassification of employees.
Revenue variability expected to continue short term due to lumpiness in Pharma Biocatalysis orders but will be mitigated as ECO revenues grow.
Selling, general and administrative expenses decreased to $12.39 million from $15.7 million, driven by lower stock-based compensation, legal expenses, and outside services.
Strong cash position with $66.3 million in cash, cash equivalents, and investments, expected to fund operations through Q1 2027.
Reported Q2 revenues of $720 million and adjusted EBITDA of $184 million, with confidence in raising 2025 guidance.
Emphasized diversified portfolio and multiple growth drivers including new product launches, complex medicines, biosimilars, and strategic partnerships.
Projected continued growth with a focus on innovative and affordable medicines, aiming to be America's #1 affordable medicines company.
Dafinchi
