Photocure is a commercial-stage Norwegian speciality pharmaceutical company that currently markets Hexvix/Cysview, an imaging agent for diagnosing and managing bladder cancer. The franchise is currently profitable and growing at a 38% annual rate. The company is Phase III-ready for Cevira, a treatment for HPV-related diseases of the cervix. Finally, it is Phase III-ready for Visonac, potentially the first photodynamic treatment for moderate to severe inflammatory acne and addressing a large unmet need.
Hexvix/Cysview is approved globally for detecting and managing bladder cancer, and has been shown to improve detection rates and also reduce the recurrence rate, leading to improved progression-free survival. Growth is currently being driven mainly in the US, where unit sales in Q115 increased 61% quarter-on-quarter (global in-market sales +10% to NOK51m/US$6.6m in Q115). The company has initiated a Phase III trial for the purpose of label expansion into the surveillance segment, which has the potential to expand the market opportunity two- to three-fold.
Cevira is a combination of a drug with a disposable intra-vaginal device for the treatment of patients with HPV-related diseases of the cervix. It has demonstrated significant efficacy in patients with high-grade squamous intraepithelial lesions (HSIL), a condition with over one million cases diagnosed annually in the US and EU that indicates a higher risk of cancer. Photocure submitted a Phase III special protocol assessment request (SPAR) to the FDA and is waiting for protocol approval.
Visonac is potentially the first photodynamic treatment for inflammatory acne and could be used for those who fail or are unsuitable for isotretinoin and oral antibiotics, a 2 million-person market in the US and EU. It is currently Phase III-ready.
With NOK118.4m in annualised sales as of Q115, Photocure is trading at 5x sales and one could argue the current valuation is supported just by its NOK149.7m in cash and the Hexvix/Cysview franchise, with Cevira and Visonac potentially representing significant upside. Upcoming catalysts will be the initiation of Phase III for Hexvix/Cysview to expand into the surveillance market, SPA approval for Cevira in HSIL patients, and potential partnerships for both Visonac and Cevira.