CLINUVEL bets its cash reserves on long acting injectables and a possible US listing

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CLINUVEL managing director Philippe Wolgen has rejected calls from some shareholders for a share buyback. He told the company's annual general meeting in Melbourne that the board would keep putting cash into research and a planned business transformation.

"Ten years of profitability and no equity or debt finance is unlike the expected behaviour of a biotechnology company," he said.

CLINUVEL has not raised funds since March 2016. It has paid dividends for nine consecutive years. Between 2017, when it became profitable, and 2026, cumulative expenses were $304.8 million and cash reserves rose by $238.3 million. Wolgen said this was a deliberate strategy to give the company room to reinvest and acquire further assets.

He said a declining share price had led some shareholders to keep asking for buybacks.

"It is not management's task to discuss share price in public," he said. Wolgen argued that buybacks send the wrong signal from a company whose future depends on research. "Share buy-backs by a biotechnology company are seen by international investors as an indication that the Board and management has run out of viable ideas and started returning capital to shareholders," he said. He added that buybacks were often inefficient and their effect short-lived.

The company plans to spend an average of $55 million a year, or $220 million from financial year (FY) 2027 to FY2030. It is also holding $30 million in reserve for licensing or acquiring assets. Wolgen said this was enough to turn its scientific projects into commercial products.

CLINUVEL met 222 institutions in FY2026, up from 172 the year before. Meetings with US institutions more than doubled, from 38 to 79. Wolgen said Australian investors focused on whether revenue and profit would continue, on going-concern risk and on the cost of reaching market. American investors focused more on execution, litigation, and management's track record. Both took clinical and regulatory risk seriously.

"Same Company, same facts, two sets of risks identified, and we must answer both," he said.

He compared CLINUVEL with seven Australian listed life sciences companies from the past two decades. Starpharma, which once had a peak market value of $1 billion, was now worth $222 million. Pharmaxis, now Syntara, had fallen from $800 million to $32 million, and Acrux from $750 million to $6 million. Of the seven, only Metabolic Pharmaceuticals, now PolyNovo, had grown beyond its former peak. Wolgen said CLINUVEL had committed to three protections against that fate. The first was a continuous and diversified pipeline. The second was expansion into major therapeutic areas the company calls the "Magnificent Seven". The third was enough funding to cover three years of operating and capital costs.

Wolgen said the planned second transformation began with a question management put to itself. "What, exactly, are we good at?" he said.

He described the company's growth as concentric, with each new technology built on what came before. CLINUVEL began with peptides in the melanocortin family. It then designed a controlled-release implant, moved into polymer chemistry and built a team in Singapore to develop long-acting injectables. It has also developed its first ZEROKIN administration device. The company is now in what it calls Plan B, expanding into vitiligo, paediatric erythropoietic protoporphyria and central nervous system markets through NEURACTHEL. Plan C covers long-acting injectables, from a pilot plant to a planned manufacturing facility in the United States. Plan D is a contingency for the unlikely case that every other strategy fails, with cash reserves allowing the company to change direction completely.

Wolgen pointed to 11 patent families, seven innovations and 21 years of clean audits as evidence of the approach. He also cited Kodak, Fujifilm and Blockbuster as examples of companies that either crossed or succumbed to what CLINUVEL calls the Valley of Value.

"CLINUVEL has done this once, and is confident it can do it twice," he said. "CLINUVEL strives to become a fully integrated model, more on this will follow the next few weeks."

The company expects to give an update soon on a possible listing on a US exchange, followed by an update on its restructure and repositioning.