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.
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.
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.
Successful Launch and Early Adoption of YUTREPIA in 11 Weeks
Liquidia's new inhaled prostacyclin, YUTREPIA, achieved over 900 prescriptions and 550 patient starts within just 11 weeks of launch, indicating an unprecedented market response.
The launch was executed with high precision and purpose, leading to rapid adoption across both specialty centers and community practices.
The product's ease of use, tolerability, and dose escalation capabilities have been highly praised by physicians and patients, surpassing initial expectations.
Market access strategies, including co-pay assistance and free vouchers, contributed to a 75% script-to-start conversion rate in the first six weeks.
The early momentum was achieved despite typical market entry barriers, suggesting strong unmet needs and product differentiation.
Sanofi Partnership Milestone and Future Collaboration Opportunities
Novavax received a $175 million milestone payment from Sanofi following FDA approval of Nuvaxovid in the U.S. in Q2 2025.
The partnership with Sanofi now positions Sanofi to lead commercialization of Nuvaxovid in select global markets for the 2025-2026 season.
Novavax expects to receive additional milestones related to marketing authorization transfers in the U.S. and EU later in 2025 and in late 2026.
The collaboration includes potential royalties from new combination vaccines that include Novavax's COVID vaccine, expanding long-term revenue streams.
Management highlighted the strategic value of the multifaceted Sanofi agreement, including milestones and royalties, as a key growth driver.
Sanofi's comments on the potential of COVID-flu combo vaccines are seen as encouraging for future collaboration prospects.
Adjusted EBITDA was positive $12.5 million, improving by nearly $13 million compared to the prior year.
Gross margin was 82% for the quarter, slightly below Q1 due to nonroutine expenses related to Gvoke capacity expansion.
Gvoke revenue increased 17% to $23.5 million, supported by a 5% growth in total prescriptions and favorable gross-to-net adjustments.
Keveyis revenue rose modestly to $11.5 million, with a slight increase in patient numbers and new patient starts.
R&D expenses increased by $2.2 million to $8.1 million, reflecting investments in pipeline products including XP-8121.
Recorlev revenue surged 136% year-over-year to $31.4 million, with a 122% increase in the average number of patients on therapy.
SG&A expenses rose 11% year-over-year to $44.4 million, mainly due to Recorlev commercial expansion and personnel costs.
Xeris Biopharma reported a 49% year-over-year increase in total revenue to $71.5 million in Q2 2025, driven by a 46% increase in net product revenue to $67.7 million.
G&A expenses rose to $40.6 million in Q2 2025 from $21.7 million in Q2 2024 due to increased personnel and commercial preparation activities.
Net loss for Q2 2025 was $247.8 million, up from $133.2 million in Q2 2024, mainly due to higher operating expenses.
R&D expenses increased to $224.1 million in Q2 2025 from $134.9 million in Q2 2024, driven by clinical trial and manufacturing costs, primarily for daraxonrasib.
Revolution Medicines ended Q2 2025 with $2.1 billion in cash and investments, including a $250 million royalty monetization tranche from Royalty Pharma.
The Royalty Pharma transaction was accounted for as a liability, with $900,000 noncash interest expense recognized in Q2 2025.
Updated 2025 GAAP net loss guidance is between $1.03 billion and $1.09 billion, reflecting increased expenses from global development and commercialization plans.
Strategic Focus on Phase III Readouts and Clinical Progress
The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.
Dafinchi
