Photocure - Termination of coverage

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 - Buying back rights from Ipsen

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

Photocure - Firing on all cylinders

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 les

Photocure - US sales up 53% compared to last year

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 c

Photocure - US continues to be the driver

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

Photocure - A licensing deal for Cevira

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 t

Photocure - A strong quarter

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 - Rapid acceleration in the US market

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 - Strong revenue growth

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 - US growth accelerating

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 - Solid growth in the US

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 transureth

Photocure - Q4 results and a new indication

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) procedur

Photocure - The stars are aligning for fast growth in the US

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 dramat

Positive CMS draft rule change

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 pro

A strong quarter in the US

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.

FY22 in line – focus on core increasing

FY22 results are in line with revised estimates. Management continues to intensify its focus on the growing, profitable and cash generative Point-of-Care and Life Sciences activities, where confidence in the latter opportunity is increasing. We make some modest changes to our forecasts to reflect further streamlining post-period end and point to the strong growth outlook from FY24 onwards. We believe this is being overly discounted by the market and view the shares as being in deep value territo

Clean exit from ADL Health

EKF has announced a clean solution has been found for the non-core Laboratory Testing business ADL Health, selling the business back to one of its management team. Having pared back our estimates for this division in February, we expect no further material impact on earnings from this move. Strategically, we view it as positive, removing a distraction and further re-focussing activities back towards the core established Point-of-Care & Central Labs business and the growing new Life Sciences acti

SHORE CAPITAL - Destiny Pharma plc+ (DEST, House Stock at 30p)

Hybridan Small Cap Feast - 06 Mar 23

6 March 2023 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment objective

LIBERUM: Futura Medical* - Eroxon live in EU, FDA decision now Q2

Hybridan Small Cap Feast - 23 Mar 23

23 March 2023 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment objectiv

Positive momentum persists

2022 was a pivotal year for NIOX as it moved firmly into sustainable profitability and cash generation. The foundations for a scalable platform are now well-established and the group enters 2023 with strong momentum (revenues in the first two months of the year were +19%). Having upgraded our forecasts following the trading update in January, we push through further EBITDA upgrades on improved margin assumptions. NIOX is a rare asset and fully deserves a premium rating. We stay at Buy, with an i

Tissue Regenix - FY 2022 – a pivotal year to a sustainably profitable business

Tissue Regenix reported full-year results to 31 December in line with its January trading update that indicated it had reached EBITDA profitability in Q4. What was undisclosed then was that it included a $0.45m provision, without which it would have generated an adjusted EBITDA of c.$0.4m in H2, illustrating the positive underlying progression to a profitable and sustainable growth company. The outlook remains positive – new products, new geographies and additional distributors/strategic partner

Morning Note – 27 March 2023

Hybridan Small Cap Feast - 21 Mar 23

21 March 2023 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment objectiv

Hybridan Small Cap Feast - 24 Mar 23

24 March 2023 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment objectiv

Morning Note – 21 March 2023

SHORE CAPITAL - Warpaint London+ (W7L, House Stock at 198p)

Destiny Pharma - Positive Phase II data with XF-73 published in medical journal

Destiny Pharma announced the publication of Phase II data with anti-bacterial drug XF-73 nasal gel in the peer-reviewed medical journal, Infection Control & Hospital Epidemiology. The data showed that XF-73 treatment in an 83-patient study resulted in a >99% reduction in nasal Staphylococcus aureus burden (after three applications of nasal gel 24 hours prior to surgery) measured 1 hour prior to cardiac surgery, which was the primary end-point of the study. The data are consistent with previous s

Hybridan Small Cap Feast - 14 Mar 23

14 March 2023 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment objectiv