Clinuvel Pharmaceuticals (ASX:CUV) used its half-year results webinar to outline what Chief Financial Officer Peter Vaughan described as “another set of very consistent results,” while management emphasized that a deliberate lift in spending is designed to support a multi-year expansion across clinical development, regulatory filings and manufacturing capability.
Financial performance and cash position
Vaughan reported that revenue rose 4% year over year for the six months ended Dec. 31, 2025, while expenses increased 22% as the company accelerated previously flagged expansion initiatives. Despite the higher cost base, he said Clinuvel maintained profitability and generated strong net operating cash flow, lifting cash reserves by AUD 9 million over the half to AUD 233 million.
Interest income rose to $5.3 million, up 14% on the prior year, which Vaughan attributed to larger cash reserves and term deposit management. He said the company has been extending deposit maturities to capture higher yields, with an average term deposit of about 300 days and an average yield of about 4.5% across the portfolio.
Vaughan also addressed a swing in “other income,” describing it as an unrealized foreign currency translation impact at the reporting date, characterized as a non-cash accounting movement rather than an operational loss.
On the balance sheet, Vaughan said net assets increased by $8.2 million to just under $250 million. He highlighted that Clinuvel remains debt-free for the 21st consecutive year and has had no equity dilution since March 2016, positioning the company to fund clinical programs and facility expansion without raising capital.
SCENESSE demand and regional dynamics
Management attributed sales growth to continued demand for SCENESSE across regions. In Europe, Vaughan pointed to stronger volume growth following an EMA approval announced in September 2025 that increased the maximum number of implants per year from four to six, saying some patients had already begun taking up additional treatment and others were expected to follow.
In North America, Vaughan said the company reached its target of 120 sites by December to meet demand. Director of North American Operations Dr. Linda Teng explained that reimbursement has remained highly successful, describing prior authorization as a cost-control tool used by insurers to confirm medical necessity. Teng said the company has not seen prior authorization denials for EPP patients and credited an in-house team that works closely with physicians to streamline submissions and renewals, which are typically annual.
Teng also said Clinuvel deliberately avoids pharmacy benefit managers (PBMs), calling it a “smart move” as government scrutiny of the sector increases. She cited provisions aimed at the PBM industry included in the 2026 Consolidated Appropriations Act signed into law recently.
During analyst Q&A, management discussed the split between U.S. and non-U.S. sales. Vaughan said the current revenue mix is about 53% U.S. and 47% rest of world. Addressing a question on the decline in U.S. sales versus stronger growth outside the U.S., he pointed to U.S. government shutdown effects that delayed Medicare processing and reimbursements, which he said created headwinds at some smaller centers. He also said a CPI price increase in 2025 contributed to reimbursement pressure at certain centers, while emphasizing that demand remained stable and the company continued to bring new centers online.
Investment phase drives expense growth
Vaughan said spending increases were focused on targeted priorities, including R&D programs such as ACTH/NEURACTHEL, the vitiligo study CUV105, and a peptide drug platform developed at the company’s Singapore research, development and innovation center, which Clinuvel has announced will undergo a large expansion.
Personnel expenses rose 16%, which Vaughan framed as a strategic move to build in-house capability and expertise. He contrasted Clinuvel’s regulatory track record—saying the company has not had a market authorization “knockback” in more than 20 years—with challenges seen among peers, arguing that regulatory setbacks can delay commercialization and reduce market confidence.
Other expense drivers discussed included:
- Clinical and non-clinical costs: Higher CUV105 spending was partly offset by an “orderly wind down” of some earlier-phase programs, with resources reallocated to later-stage and strategically significant initiatives. Vaughan said preparation for CUV107 has begun, with related expenses expected in the second half.
- Commercial distribution: Up 42%, largely tied to increased shipment volumes in Europe, plus temporary one-off supply chain transition costs and higher regulatory fees as the company is no longer eligible for certain SME discounts.
- Finance, corporate and legal: Up 47%, which Vaughan attributed primarily to work supporting the company’s ADR uplift from Level 1 to Level 2 and the process to list on Nasdaq, including a three-year re-audit and conversion of financials to U.S. GAAP for SEC review.
- Other expenses: Up 191%, driven largely by consumables used in expanded R&D programs.
Director of Clinical Affairs Dr. Emilie Rodenburger said the company has chosen to avoid CRO-heavy models and instead expand in-house talent and infrastructure. She described investments in operations, data science, medical affairs, clinical quality, and systems to manage large data sets from vitiligo studies, calling the approach akin to “building a CRO in-house.”
Vitiligo, regulatory sequencing, and upcoming catalysts
Rodenburger discussed the regulatory path for SCENESSE in vitiligo, emphasizing that the product is already marketed for EPP and supported by decades of safety data and ongoing pharmacovigilance reporting. She said vitiligo treatment effects are visible through repigmentation and that trial analysis includes centrally assessed photographs.
Asked whether Clinuvel would need both CUV105 and CUV107 results before filing for approval, Rodenburger said the company intends to complete both studies before approaching the EMA and FDA, adding that the FDA’s recent comments about single-trial approvals did not change this strategy. She said Clinuvel plans to file with the EMA first and then the FDA, citing supportive interactions in Europe and the company’s focus on patients with darker skin color as resonating with European regulators.
Managing Director Philippe Wolgen summarized near-term milestones, including top-line CUV105 vitiligo results expected in the second half of 2026, the start of the CUV107 study, preclinical results on a peptide formulation later this year, and progress on the Nasdaq ADR listing pending SEC responses.
Nasdaq ADR update and policy notes
On the Nasdaq process, Vaughan said Clinuvel lodged its initial Form 2-F filing with the SEC on Dec. 18 and has been corresponding with the regulator, with a refiling of responses underway. He said the company hopes to receive clearance “in the very near future” and then move quickly to implement the ADR program uplift.
Responding to a question about reporting changes after a Nasdaq listing, Vaughan said Clinuvel expects to continue reporting half-year and full-year financials, but in the U.S. the company would report in U.S. dollars and under U.S. GAAP as a foreign private issuer, with no change to reporting frequency.
Separately, Teng told analysts that less than 5% of U.S. EPP patients are covered under Medicaid and said the company does not currently expect a noticeable impact from potential Medicaid cuts. She also referenced changes she said broaden the orphan drug exclusion related to Medicare price negotiations, while noting the company’s U.S. patient base is primarily commercially insured.
In closing remarks, webinar host Malcolm Bull noted Clinuvel has a stated dividend policy available on its website and said the board intends to pay dividends subject to available funds and business investment needs.
About Clinuvel Pharmaceuticals (ASX:CUV)
Clinuvel Pharmaceuticals Limited, a biopharmaceutical company, focuses on developing and commercializing treatments for patients with genetic, metabolic, and life-threatening disorders in Australia, Europe, the United States, Switzerland, and internationally. Its lead drug candidate is SCENESSE, a systemic photoprotective drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The company's pipeline products include CUV9900, an alpha-melanocyte stimulating hormone analogue; Parvysmelanotide (VLRX001), which provoke prolonged cellular activity; and PRÉNUMBRA, a liquid injectable formulation of afamelanotide.
