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Edison Investment Research is terminating coverage on Augean (AUG), Deinove (ALDEI), Photocure (PHO), RADA Electronic Industries (RADA) and Ryvu Therapeutics (RVU). Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.
Photocure ASA Photocure ASA
Photocure has announced that it is in the process of re-acquiring the rights to Hexvix/Cysview in territories where Ipsen is currently marketing the product (primarily the EU). Key terms have been agreed upon and the transition is expected to occur in Q420. The key terms include a payment of €15m (NOK166m at the current exchange rate) from Photocure to Ipsen as well as royalty payments. Photocure expects the re-acquisition to be EBITDA accretive in 2021 and beyond. To fund the payment, Photocure has raised NOK143m in equity through a private placement.
Photocure ASA
Photocure announced very strong Q419 results, with 27% revenue growth for the Hexvix/Cysview franchise (vs Q418) to NOK58.8m, an acceleration from the 18% growth seen last quarter. The United States continued to be the main sales driver with revenues of NOK27.8m in Q419, which were up 51% compared to the same quarter last year. Importantly, the company has now indicated that it is targeting US revenues of $70m (NOK658m at current exchange rates) in 2023. While ambitious, this would equate to less than 5% penetration of its addressable market.
Photocure announced Q319 results, with 18% revenue growth for the Hexvix/Cysview franchise (vs Q318) to NOK51.1m. US sales of NOK25.2m were up 53% as the region continues to be the growth driver for the company while both Nordic and partner revenue fell (by 7% and 2% respectively) compared to the same period a year ago. Sales in the US continue to be driven mainly by improved reimbursement, added sales resources and a higher installed base of blue light cystoscopes. There are now 211 installed cystoscopes in the US, indicating 12% growth in the installed base over the quarter and up 34% since the beginning of 2019.
Photocure announced results for Q219, with 23% revenue growth for the Hexvix/Cysview franchise (vs Q218) to NOK52.1m. Sequentially, however, Hexvix/Cysview sales only grew 2% due to lower Nordic and partner region revenues, which offset strong US sales. In the US, sales increased 52% over the same quarter in the previous year and 16% sequentially. This was driven mainly by improved reimbursement and a higher installed base of blue light cystoscopes. There are now 188 installed cystoscopes in the US, indicating 10% growth in the installed base over the quarter.
Photocure announced a global licensing deal for Cevira with Asieris, a China-based specialty pharmaceutical company. Cevira is a non-invasive photodynamic therapy for HPV-related (cervical) diseases and has an SPA in place with the FDA. As part of the agreement, Photocure will receive up to $250m (NOK2.1bn) in potential milestones, including $5m (NOK43m) within six months. Royalties will be tiered and range between 10% and 20%. Asieris is expected to launch a Phase III in China initially, with that study expected to complete in 2022. US and EU development will depend on the results of that study.
Photocure has announced results for Q119, with 26% revenue growth compared to Q118. Revenues grew strongly in the US, where Hexvix/Cysview sales increased 66% over the same quarter in the previous year and 15% sequentially. This was driven mainly by improved reimbursement and a higher installed base of blue light cystoscopes. There are now 171 installed cystoscopes in the US, 14 more than at the end of 2018 and 67 more than at the beginning of 2018.
Photocure is a commercial-stage Norwegian specialty pharmaceutical company that currently markets Hexvix/Cysview for diagnosing and managing bladder cancer. The company recently announced Q418 results, including 27% revenue growth globally and 81% growth in the US, making it the largest and fastest growing region for the company. This growth has been driven by the approval and launch of Hexvix/Cysview in the surveillance setting and improved reimbursement.
Photocure has announced results for Q318, with 25% revenue growth compared to Q317. Revenues grew strongly in the US, where Hexvix/Cysview sales increased 46% over Q317. This was driven mainly by improved reimbursement and a higher installed base of blue light cystoscopes. Importantly, the company has received new medicare coding, which will increase reimbursement for the use of Hexvix/Cysview starting in 2019.
Photocure announced results for Q218 with 16% revenue growth compared to Q217. Revenue growth accelerated in the US, where Hexvix/Cysview sales increased 47% (up 56% on a constant currency basis) over Q217 compared to 27% (up 36% on a constant-currency basis) growth last quarter. This was driven mainly by improved reimbursement and a higher installed base of blue light cystoscopes (BLCs).
Photocure has announced results for Q118 with 14% revenue growth compared to Q117. Revenue growth was particularly strong in the US market where Hexvix/Cysview sales increased 27% (up 36% on a constant-currency basis). Importantly, the company also announced that it has initiated the commercial launch of Hexvix/Cysview in the surveillance setting, which greatly expands the addressable market. There are an estimated 1.2–1.4m surveillance-related procedures per year, compared to 325,000 transurethral resection of bladder tumour (TURBT) procedures, where the company has historically been focused.
Photocure announced results for Q417 with 25% growth for the Hexvix/Cysview franchise compared to Q416. For the year, Hexvix/Cysview revenues grew by 14% with the US being a major driver, up 39% for the year. Additionally, the company recently received approval by the FDA for Hexvix/Cysview in the surveillance setting which greatly expands the addressable market. There are 1.4m surveillance-related procedures per year, compared to 300,000 transurethral resection of bladder tumor (TURBT) procedures, where the company has historically been focused.
Photocure is a commercial-stage Norwegian specialty pharmaceutical company that currently markets Hexvix/Cysview for diagnosing and managing bladder cancer. Recently, the company announced that the US Centers for Medicare & Medicaid Services (CMS) issued a final rule that would improve reimbursement for a large number of procedures. Also, following positive Phase III results in the surveillance setting, the company filed a supplemental New Drug Application (sNDA) which, if approved, would dramatically increase the addressable market for Hexvix/Cysview.
Photocure announced results for Q217 with 10% growth for the Hexvix/Cysview franchise compared to Q216. The US was a major driver, up 55% to NOK10.9m, though partner sales fell by 9% to NOK15m due to lost reimbursement in France. The company also announced that the US Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would create a new set of codes to cover Blue Light Cystoscopy (BLC) with Hexvix/Cysview. These new codes should help improve the penetration of the product into the US market.
Photocure announced results for Q117 with 9% growth for the Hexvix/Cysview franchise compared to Q116. The US was a major driver, up 32% to NOK10m, though the Nordics fell by 4% to NOK9.7m due to currency and weakness in Denmark. Importantly, the company also recently announced that its Phase III trial in the bladder cancer surveillance market was successful, which should enable it to receive marketing authorisation in that market.
Photocure presented the findings of from its Phase III clinical trial of Hexvix/Cysview for bladder cancer surveillance at the American Urological Association annual meeting. These results showed that the product increased the detection of patients with recurrence by 21.5% (p<0.0001). In particular, detection of carcinoma in situ was improved by 34.6% (p<0.0001). We believe these data are supportive of marketing authorisation for the bladder cancer surveillance market.
Photocure recently announced that after seeking partners for Cevira and Visonac for the last few years, it is expanding the search to include outright sale of those products, possible spinoffs or other strategic alternatives. While partnership discussions are continuing, the chances that these will be successful appear diminished. As such, we have removed all partnership related milestones from our model and reduced the probability of success for Cevira from 50% to 20% and for Visonac from 60% to 20% as it is unclear how successful the broadened strategic search will be.
Photocure announced results for 2016 showing strong growth for the Hexvix/Cysview franchise. Total sales for the product were up 13% to NOK131m, driven by growth in both US sales (up 32% to NOK30.5m) and partner sales (up 14% to NOK61.5m). Total revenue for the period was NOK144m and there was NOK152m in operational spending. The company expects expenses in the US to increase significantly in preparation for the Hexvix/Cysview launch in the surveillance market. We now forecast profitability in 2019 instead of 2018.
Photocure announced Q3 sales of Hexvix/Cysview of NOK31.6m, which although a 17% increase year-on-year (13% in constant currency) represents a 7% sequential reduction in sales. This is largely attributable to seasonality although unit sales in Nordic countries were 14% lower as a result of salesforce staffing issues. US sales continue to be a growth driver with 10% sequential growth and 46% growth year-on-year.
Photocure is a commercial-stage Norwegian specialty pharmaceutical company that currently markets Hexvix/Cysview, an optical imaging agent for diagnosing and managing bladder cancer. The franchise is currently profitable and sales are growing at a 22% rate so far this year. The company is Phase III-ready for Cevira, a treatment for HPV-related diseases of the cervix, and for Visonac, for moderate to severe inflammatory acne. We value Photocure at NOK1,455m or NOK68/share.
Photocure announced the second quarter of record sales, NOK33.5m or 18% growth year-on-year and 26% growth in Hexvix/Cysview sales. The growth was on the back of an increase of 20% in unit sales and 23% in revenue from the Nordic region, which marks a return to growth in the region following a slow (5% unit loss) Q415. Sales were further supported by a continued increase in US market share with a 37% increase in unit sales and a 66% increase in revenue.
Hexvix/Cysview sales grew 34% year-on-year for Q415, showing marked improvement over Q315 growth rates of 17%. The year closed with NOK115.8m in sales of Hexvix/Cysview, a 26% improvement over 2014, driven primarily by increased unit volume in the US but bolstered by a favourable currency exchange. Revenue growth for the quarter was in the double digits across all reported markets and the company ended the year with cash of NOK134m, which we see as more than sufficient to bring the company to profitability in 2018.
Photocure is a commercial-stage Norwegian speciality pharmaceutical company that currently markets Hexvix/Cysview, an optical imaging agent for diagnosing and managing bladder cancer. The franchise is currently profitable and sales are growing at an annualised rate of 38%. The company is Phase III-ready for Cevira, a treatment for HPV-related diseases of the cervix, and for Visonac, for moderate to severe inflammatory acne. We value Photocure at NOK1,523m or NOK71/share.
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.