The Hats On Challenge: Biofrontera and Almirall’s Strategic Push to Combat Actinic Keratosis

In May 2025, Biofrontera Inc. and Almirall launched the Hats On Challenge, a social media initiative aimed at raising awareness for actinic keratosis (AK), a precancerous skin condition affecting millions globally. The campaign, timed to coincide with Global AK Awareness Day on May 24, encourages participants to share photos or videos of themselves wearing hats—a simple yet critical preventive measure against UV-induced skin damage. This partnership not only underscores the growing recognition of AK as a public health concern but also highlights the strategic alignment of the two companies in addressing both awareness and treatment gaps in dermatology.

The Dual Focus: Awareness and Innovation

Biofrontera and Almirall are leveraging the Hats On Challenge to amplify education about AK’s risks while reinforcing their respective roles in advancing medical solutions. For Biofrontera, the initiative complements its FDA-approved portfolio, including Ameluz® (aminolevulinic acid HCl), a topical gel used in photodynamic therapy (PDT) for AK, and the RhodoLED® XL device. These products are central to the company’s mission to provide evidence-based treatments for skin conditions. Clinical trials for Ameluz® are also underway to expand its use to superficial basal cell carcinoma (sBCC), a move that could broaden its market potential.

Almirall’s contribution centers on Klisyri® (tirbanibulin ointment 1%), a topical AK treatment lauded for its 5-day application regimen—the shortest among competitors. Data from the 2025 American Academy of Dermatology (AAD) Annual Meeting highlighted Klisyri’s high efficacy, with 63% of patients achieving complete clearance of AK lesions. Patient-reported outcomes further underscore its appeal, as manageable side effects like skin irritation or pruritus improve adherence.

Strategic Partnerships and Market Opportunities

The collaboration between Biofrontera and Almirall extends beyond the Hats On Challenge. Almirall’s partnership with Athenex since 2017 has been pivotal in advancing Klisyri® through Phase III trials and securing regulatory approvals. The drug’s projected peak sales of over €250 million by 2030 reflect its potential in a growing market. Meanwhile, Biofrontera’s expansion into sBCC treatment with Ameluz® aligns with the rising incidence of non-melanoma skin cancers, driven by aging populations and increased UV exposure awareness.

The global AK treatment market, valued at $1.2 billion in 2023, is projected to grow at a 6.8% CAGR through 2030. This expansion is fueled by innovations like Klisyri® and Ameluz®, as well as heightened awareness campaigns such as the Hats On Challenge, which reduce stigma and encourage early detection.

Investment Implications

For investors, Biofrontera and Almirall represent distinct yet complementary opportunities in dermatology. Biofrontera’s focus on PDT and expanding indications for Ameluz® positions it as a leader in AK treatment innovation, particularly if its sBCC trials succeed. Almirall’s Klisyri®, with its shorter regimen and robust clinical data, offers a near-term revenue driver, especially in markets like the U.S., where AK is the most common precancerous condition.

The Hats On Challenge also signals a strategic shift toward patient education and community engagement, which can enhance brand loyalty and product adoption. By linking preventive measures (like hat-wearing) to their treatments, both companies aim to position themselves as holistic partners in skin health, rather than just drug suppliers.

Conclusion: A Growing Market Anchored in Innovation and Advocacy

The Hats On Challenge exemplifies how pharmaceutical companies can drive awareness and commercial success simultaneously. With Klisyri®’s projected sales exceeding €250 million and Biofrontera’s pipeline advancements, both firms are well-positioned to capitalize on a market expected to surpass $2 billion by 2030.

Investors should monitor key milestones:
- Biofrontera’s FDA submissions for Ameluz® in sBCC, expected in 2026.
- Almirall’s sales growth for Klisyri® in the U.S., where AK affects over 5 million people annually.

The strategic alignment of these companies—combining advocacy with cutting-edge treatments—suggests a sustainable competitive advantage. As the dermatology space matures, those prioritizing both awareness and innovation are poised to lead. The Hats On Challenge isn’t just a campaign; it’s a blueprint for turning public health challenges into commercial opportunities.