Managing Director’s Letter

Turning Regulatory Challenges into Therapeutic Breakthroughs.

At CLINUVEL, we view each regulatory hurdle not as a barrier, but as a catalyst to innovate – pushing us to develop smarter strategies and uncover new pathways to deliver life-changing therapies. This is not an empty slogan, but actually how we live our professional lives.

A European Paediatric Journey with SCENESSE®

When the EMA declined to approve SCENESSE® for children in 2025, despite impeccable safety data, our teams refused to accept “no” as the final answer based on data and science. Instead, we:

• pioneered compassionate access programs that have already transformed lives;
• treated our first 9-year-old EPP patient, enabling her to leave her homebound existence and attend school; and
• completed a comprehensive adolescent study (12+ years) with plans to resubmit a revised dossier to the EMA to seek a full approval.

A Medical Community is Speaking – Loudly

European insurers are already reimbursing SCENESSE® for paediatric EPP cases based on physician demand – a powerful endorsement of both medical necessity and our persistent advocacy.

Our team embodies what it takes to succeed in this complex landscape, based on relentless execution, and the difference we have made:

• disproportionate persistence – we outlast the challenges;
• strategic creativity – we find alternative pathways when doors close; and
• resource commitment – we fund multiple approaches simultaneously.

Where others see dead ends, we find detours that ultimately become alleys to approval.

Vitiligo Program: Clinical Momentum Translates to Commercial Opportunity

The past year marked a pivotal inflection point for our vitiligo program, as we successfully completed enrolment of 210 patients in the CUV105 Phase III trial – a milestone that validates both our clinical execution capabilities and the growing recognition of SCENESSE® among global dermatologists.

Why This Matters: Beyond the Trial Data?

1. Operational Excellence
   • Teng and Rodenburger demonstrated world-class trial management, coordinating multi-centre studies across three continents with precision. There are rich learnings from the CUV105 clinical study and its recruitment strategy, which will bear fruit for years to come.
   • this infrastructure now serves as the foundation for our pivotal CUV107 study – accelerating timelines and reducing costs.
2. Pre-Commercial Success
   • 104 centers have been trained and accredited in North America, targeting 120 by the end of 2025, creates a ready prescriber network for future launches.
   • our presence at the American Academy of Dermatology Meeting (in Orlando) drew unprecedented engagement, with a disruptive exhibit strategy that will be replicated in Denver in 2026.
3. Brand Building with Targeted Precision
   • started the runway to “household brand” status in photomedicine among key opinion leaders, despite a lean sub-10% marketing budget.
   • converted clinical credibility into real-world demand through:
     • peer-to-peer physician education;
     • digital engagement amplifying trial results; and
     • strategic presence at tier-1 dermatology forums.

Why Investors Should Be Energised?

1. Multiple shots on goal – our multi-pronged approach de-risks the regulatory process.
2. Market demand outpacing approvals – insurers are voting with their feet.
3. Proven ability to navigate complexity – each challenge makes our teams smarter.
4. Ability to finance research, development & innovation.
5. Reserves to absorb and face unexpected set-backs.

The coming year will see us take our hard-won paediatric data back to regulators – armed with even more evidence, even more compelling physicians’ experiences, and even greater determination to make SCENESSE® available to every EPP patient and parent who demands it.

A Letter to Shareholders: Strength Through Unity

As we close this chapter and look to the horizon, I am filled with profound conviction – not just in our strategy, but in the coherent and driven team executing it.

The newly formed Board stands united in a vital truth: strategic vision and shareholder returns are partners, not opponents. While all biotechs are seeking to climb to their respective mountain summits, our debt-free resilience, consistent profitability, and vertically integrated model have positioned us not merely to endure—but to acquire, innovate, and lead the ascendance where others withdraw.

Leadership Forged in Opportunity

This year marked an important evolution in our corporate stewardship:

• Mr Lachlan Hay has embraced his role with strategic clarity—and as he completes his legal studies in FY2027, we gain yet another lens through which to sharpen our governance.
• CFO, Mr Peter Vaughan mastered his first full year guiding our financial helm, ensuring growth and discipline remained inseparable.
• Dr Dennis Wright led the advancements in research & development in melanocortins and formulations.
• Dr Linda Teng led us to a new chapter of seeding a North-American market in vitiligo, overseeing training & accreditation of 104 centres.
• Dr Emile Rodenburger reinstated herself as clinical executive putting all wheels in motion to deliver a first advanced study in vitiligo.
• Mr Malcolm Bull, Head of IR, expanded our sell-side coverage to 10 analysts, bridging the gap between our results and market recognition.
• Dr Azza Hamila led global inspections and audits, and managed manufacturing and regulatory queries.
• Dr David Solomon joined as head of regulatory affairs, building on the expertise of Dr Rose Quadbeck-Diel.
• Mrs Antonella Colucci continued to lead the expansion of SCENESSE® in Europe and Latin America.
• Our Board, enriched by three new voices, has turned rigorous debate into wiser decisions—proving that diversity of thought fortifies, not fractures, progress.
• Mr Lilian Bougy stepped in seamlessly to become European General Manager.
• The mexi of new and incumbent managers and staff worked tirelessly to achieve current results.

To You, Our Shareholders

Most of you are not passive investors – you are owners of an enterprise built to last. My gratitude runs deep, as does my alignment: like you, I am a major shareholder, with personal capital tethered to our long-term success.

The years ahead will reward those who combine:

• patience to ignore short-term noise;
• precision in allocating every dollar; and the
• courage to scale the mountain peaks ahead for the benefit of patients and stakeholders, alike.

We have chosen the harder path – a meaningful one. And together, we will prove its worth.

Philippe Wolgen
Managing Director
CLINUVEL Group