Arcutis reported $81.5 million in net product revenues for ZORYVE in Q2 2025, representing 28% quarter-on-quarter growth and 164% year-over-year growth.
The company received FDA approval for ZORYVE foam 0.3% for scalp and body plaque psoriasis in May, expanding the treatment options for patients with scalp involvement.
Management emphasized the importance of converting topical steroid prescriptions to ZORYVE, with over 69% of prescriptions last year being steroids, highlighting a significant shift in treatment paradigms.
The company sees a substantial long-term opportunity through label expansion for pediatric atopic dermatitis and other indications, leveraging ZORYVE's anti-inflammatory and antipruritic properties.
Sales from new indications and label expansions contributed over two-thirds of Q2 sales, demonstrating successful lifecycle management and market penetration.
ZORYVE's broad applicability across multiple inflammatory skin conditions positions it as a foundational long-term therapy, with potential to reach over $1 billion in market share if it captures 10% of the topical market.
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.
Adjusted non-GAAP EBITDA was $54.1 million, a 63% increase from the prior year period, and adjusted non-GAAP EPS was $1.80, up from $1.02.
ANI Pharmaceuticals reported record Q2 2025 results with net revenues of $211.4 million, up 53% year-over-year on an as-reported basis and 37% organically.
Cash flow from operations was $110.8 million in the first half of 2025, with unrestricted cash increasing to $217.8 million at quarter-end.
Generics revenues increased 22% to $90.3 million, supported by new product launches including prucalopride tablets with 180-day exclusivity.
Non-GAAP gross margin improved to 64.9%, up over 6 points from the prior year, due to favorable product mix and strong generics performance.
Operating expenses increased, with R&D up 130% to $16 million and SG&A up 66% to $67.1 million, reflecting investments in sales teams and clinical studies.
Rare Disease revenues doubled year-over-year to $104 million, driven by Cortrophin Gel revenues of $81.6 million, up 66% year-over-year.
Jornay prescriptions increased by 23% year-over-year in Q2 2025, indicating strong growth momentum.
Market share of Jornay in the long-acting branded methylphenidate market grew to 23%, up 7.6 percentage points from the previous year.
The prescriber base for Jornay reached over 26,000, a 23% increase compared to Q2 2024, with efforts focused on expanding awareness and adoption.
The company expanded its ADHD sales force by approximately 55 representatives, now totaling around 180, targeting 21,000 prescribers, up from 17,000.
Market research shows over 60% of healthcare professionals intend to increase Jornay prescriptions, and unaided awareness is just over 50%, ranking it second after Vyvanse and Concerta.
The company is investing in targeted marketing campaigns and digital outreach to capitalize on the back-to-school season, aiming to boost awareness and prescriptions.
Management emphasizes the importance of adult ADHD market growth, with Jornay already generating 20% of its business from adult patients, and expects this to increase.
Adjusted EBITDA margin improved by 500 basis points to 8.4%, compared to 3.4% in Q2 2024, reflecting operational efficiencies and volume leverage.
Adjusted net loss improved to $10.2 million or $0.32 per share from $18.8 million or $0.61 per share in Q2 2024.
Adjusted operating expenses increased 16% year-over-year to $145.2 million due to remediation activities, global volume growth support, and investments in innovation and commercial initiatives.
Expanded access to Zio services as an in-network benefit to over 10 million additional patients in the U.S.
Gross margin was 71.2%, ahead of expectations, benefiting from volume leverage and operational efficiencies despite higher costs from increased Zio AT mix.
iRhythm reported Q2 2025 revenue of $186.7 million, up 26.1% year-over-year, driven by growth in core long-term continuous monitoring and Zio AT product lines.
New store growth accounted for approximately 68% of year-over-year volume growth, with home enrollment for Zio Services at about 23% of volume in the U.S.
Launch and Early Market Reception of SYMBRAVO for Migraine
SYMBRAVO was launched on June 10, 2025, as Axsome's third approved product and second developed in-house.
Early feedback from the migraine community has been very encouraging, highlighting the product's differentiated profile as an effective, safe, and tolerable acute treatment.
Within 6 weeks of launch, initial patient experiences validate rapid onset of action and durability of response.
Coverage for SYMBRAVO is approximately 38% of lives across all channels, with plans for expansion and evolution throughout the year.
The company has secured a commercial contract with a major GPO, enabling formulary coverage and potential for broader access.
Dafinchi
