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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.
Companies: Photocure ASA (PHO:OSL)Photocure ASA (0IMT:LON)
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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
Companies: 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 les
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 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 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 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 transureth
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 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
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
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.
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Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
Companies: Verici Dx Plc
Singer Capital Markets
26th March 2024 @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 object
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Hybridan
Companies: Aptamer Group Plc
Turner Pope Investments
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
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Hardman & Co
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On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
Companies: Incanthera Plc
Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
Companies: Guerbet (GBT:EPA)Guerbet SA (GBT:PAR)
BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
Companies: NTQ KMK JNEO DCTA
LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
This month's feature article is entitled 'Gold and a Chinese Credit Event'. A Western phenomenon? If you own, or are considering owning, gold or gold equities, it’s likely that you’re concerned about protecting your wealth, or the performance of your fund, in the expectation of some kind of financial instability. Maybe your confidence in policymakers is ebbing, or you’ve researched debt bubbles in history and concluded that physical gold and silver have been the safest places to be invested whe
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