Edison Investment Research is terminating coverage on China Water Affairs Group (855), CREALOGIX Group (CLXN), FCR Immobilien (FC9), HarbourVest Global Private Equity (HVPE), Marble Point Loan Financing (MPLF), Paion (PA8), PDL Biopharma (PDLI), Redhill Biopharma (RDHL) and Targovax (TRVX). Please note you should no longer rely on any previous research or estimates for these companies. All forecasts should now be considered redundant.
Companies: PAION AG
The Remimazolam Phase III general anaesthesia (GA) trial in Europe has released initial data. Remimazolam was as effective as propofol in maintaining anaesthesia in major surgery so met the primary endpoint. More importantly, fewer hypotensive episodes were noted on average in the remimazolam arm; these are common and may lead to post-surgical morbidity. For at risk patients (ASA Class III or IV), this safety gain could be critical in justifying remimazolam’s price premium over propofol. In the
Paion has gained approvals in the US, China and Japan for its fast-onset, short-recovery anaesthesia product remimazolam. In the US, partner Acacia is expected to launch it in Q420 for procedural sedation (PS). In Japan, Mundipharma launched it in Q320 for general anaesthesia (GA). In China, Yichang Humanwell launched it for PS in August with GA trials ongoing. Initial European PS approval is expected by H121. European marketing will be either direct or by using regional partners. Paion indicate
Remimazolam is approved in the US and China for procedural sedation (PS) and was launched in late July in Japan by partner Mundipharma for general anaesthesia (GA). In the US, launch by Acacia is expected by Q4. In China, partner Yichang Humanwell launched for PS in August with GA trials ongoing. H120 results reported revenues of €3m from the Japanese approval and the Asian Hana Pharma deal; a €15m milestone was paid in H2 after US approval. Paion indicates that it has cash until H221. Our valua
In a breakthrough achievement for Paion, the FDA has approved ByFavo (remimazolam) for US sale for procedural sedation (PS) taking under 30 minutes – mainly 25m colonoscopy and bronchoscopy procedures. A €15m milestone is due from US partner Cosmo. Cosmo has sublicensed ByFavo to Acacia in the US; launch is indicated in autumn 2020. Paion has operational funds and loan facilities until 2022. Our valuation has been updated to reflect US approval and is now €283m vs €270m previously.
As we await the FDA verdict on ByFavo (remimazolam) for procedural sedation (PS) due 5 July 2020, Paion announced in June that it will provide remimazolam for compassionate use, supplied free, to sedate five intensive care COVID-19 patients in Milan. This has no immediate commercial implications but shows how remimazolam might be further developed. This may lead to published ICU case reports and we expect remimazolam to be an alternative to midazolam and propofol. Paion announced Q1 gross cash a
By 5 July 2020, the FDA is due to announce its decision on remimazolam (ByFavo) for procedural sedation (PS). In Japan, Remimazolam (Anerem) was approved in January for general anaesthesia (GA). Paion guides to royalties of under €1m for 2020. In the EU, the possible approval for PS is due in H121. The GA European trial has closed early with 424 patients; this potentially gives launch from late 2021 with top-line data in H220. Paion is considering licensing or acquiring products to make a direct
Acacia Pharma will sell ByFavo (remimazolam) in the US after a deal with Cosmo (Paion’s Switzerland-based US partner). Cosmo estimates 24.5m endoscopy procedures per year. Acacia may launch its first US product, BARHEMSYS, from mid-2020 but has limited US infrastructure and, as yet, no salesforce. We are updating our Paion valuation (formerly €317m).
Assuming a successful FDA review of remimazolam for procedural sedation (PS), with an outcome due by 5 April 2020, Paion is set for 20–25% royalties from US sales made by Cosmo. Remimazolam is a safe ultra-short-acting sedative/anaesthetic offering both rapid onset and offset of action. This profile should drive US market uptake for short, painful procedures such as colonoscopy. A European regulatory filing for PS will now be made in H219 allowing a possible European launch in 2021, and an abbre
Assuming a successful FDA review of remimazolam for procedural sedation (PS), with an outcome due by 5 April 2020, Paion is set for 20–25% royalties from US sales made by Cosmo. Remimazolam is a safe ultra-short-acting sedative/anaesthetic offering both rapid onset and offset of action. This profile should drive US market uptake for short, painful procedures such as colonoscopy. A European regulatory filing for PS will now be made in H219 allowing a possible European launch in 2021, an abbreviat
Paion achieved a major milestone in April when partner Cosmo filed for approval of remimazolam in procedural sedation (PS) in the US. This adds to filings in Q418 by partners for general anaesthesia (GA) in Japan and for PS in China. Remimazolam is an ultra-short-acting sedative/anaesthetic that combines the best features of propofol and midazolam. We expect its rapid onset and offset of action combined with a favourable cardio-respiratory safety profile to drive market uptake, if approved. Paio
Following discussions with the EMA, Paion has added filing for procedural sedation (PS) in Europe to the list of potential near-term filings for remimazolam. Mundipharma filed for approval in general anaesthesia (GA) in Japan in December 2018, while Cosmo is expected to file for PS in the US shortly. Paion’s GA Phase III in Europe is on track to complete recruitment by the end of 2019. The filings will be an important step towards commercialising remimazolam and establishing Paion as a leader in
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Full-year results were in line with the trading update of 21 July, with revenues of £31m (-2%), reflecting the impact of COVID-19 on out-patient procedure rates, resulting in 14% and 24% declines in adjusted EBITDA and pre-tax profit, respectively. Lower than expected procedure growth rates and the decision to discontinue non-core (non-chlorine dioxide products) reduces forecast revenues by c.£3m to £33m in FY 2022. However, higher gross profit and tight control of costs (+6%) results in an unch
Companies: Tristel Plc
Recruitment resumed the Phase 2a trial of the lead programme hRPC in retinitis pigmentosa (RP) with the treatment of the first UK-patient in Oxford. The protocol gives greater infection control after the safety issue (a possible infection) in June. Five patients were treated up to mid-October and the remaining four could be treated by December 2021. By late March 2022, ReNeuron expects to give an interim update. The full data set should be available around mid-2022. This will enable regulatory d
Companies: ReNeuron Group plc
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Devolver Digital to join AIM, an award-winning digital video games publisher and developer in the indie games space. Recently awarded indie 'Publisher of the Year 2021' by GamesIndustry.biz. Offer TBA. Due early Nov.
Life Science REIT to join AIM raising up to £100m. This will be the first London listed real estate investment trust (REIT) focused on UK life science properties providing investors with exposure
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IXICO has announced that one of its clients has put an indefinite halt on a clinical trial for which the company was providing its artificial intelligence medical image analysis. The halt is the result of unexpected preclinical data. IXICO had expected the contract to deliver £0.8m of revenues in FY22E and it represented £3.3m of the £18.8m order book as of the close September 2021. While this news is disappointing, clearly the trial halt has no reflection on the capability of IXICO's technology
Companies: IXICO Plc
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Arrow Exploration Corp. (AIM: AXL ; TSXV: AXL) , the oil and gas exploration and production company, has conditionally raised approximately £8.8m and is due to complete its dual listing on AIM on 25 Oct. Market cap c£13.1m.
Devolver Digital to join AIM, an award-winning digital video games publisher and developer in the indie games space. Recently awarded indie 'Publisher of the Year 2021' by GamesIndustry.biz.
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IXICO has provided an upgraded trading statement for FY21E following its previous update in August 2021. Revenues are now expected to be £9.2m (vs £8.7m previously), broadly in line with FY20A, which we see as a strong result given the pandemic and Huntington's Disease (HD) trials de-scope. EBITDA is expected to be materially ahead of FY20A's £1.3m, supported by strong Q4/21 trading, cost control and positive one-offs. The company has ended FY21 with a strong order book (£18.8m) and cash positio
CareTech is a specialist social care and educational services provider. This morning, the group has announced an update for the year to 30 September pointing to the fact that results will be in line with market expectations. The net debt position of £259m illustrates a further reduction since the end of H1 (31 March £263.1m) and implying a reduction to 2.7x adjusted EBITDA. During the year, seven new developments have opened, with a further eight properties purchased in H2. The group's freehold
Companies: CareTech Holdings PLC
H1 EBITDA declined by 45% YoY, albeit this was slightly better than we had anticipated after the pre-close update in August. The beat was cost related (efficiencies/savings). There was a significant gross margin drag though and, while transitory in nature and diminishing in H2, this means further savings need to be realised to hit full year forecasts. This is our view and we retain a good level of confidence in next year’s forecasts. Having de-rated, valuation looks very undemanding now on just
Companies: Venture Life Group Plc
SkinBioTherapeutics has announced it will launch its lead commercial product, AxisBiotix-Ps on World Psoriasis Day, 29 October 2021. To support the launch, the company has begun to receive, and store finished product in the Netherlands (close to its manufacturing partner) ahead of initial launches in the UK and US. Clearly the launch of its first product is a significant step for SkinBioTherapeutics, marking the transition from development company to commercial operation. We are encouraged by th
Companies: SkinBioTherapeutics Plc
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Softline the global solutions and services provider in digital transformation and cybersecurity, with its headquarters in London, is considering proceeding with a potential initial public offering of global depositary receipts representing its ordinary shares. The Company is considering applying for admission of the GDRs to the standard listing segm
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Hikma’s H1 20 top-line acceleration was driven by COVID-19-related demand in Injectables and Generics and the economic recovery in Algeria propelled growth in the Branded segment. Combined with a favourable product-mix, the operating margin was up 1.5ppt. In the near term, new launches across segments should provide some respite against the ongoing pricing pressure. Given the company’s thin R&D pipeline and a robust balance sheet, M&A (probably in the biosimilars space) seems on the cards.
Companies: Hikma Pharmaceuticals Plc
The oncology consultancy using mathematical models to support the development of cancer treatment regimens and personalised medicine solutions yesterday announced it has entered into a partnership with Tabula Rasa HealthCare® (TRHC) (NASDAQ: TRHC), a healthcare technology Company advancing the field of medication safety. Through this initiative, Physiomics' personalised docetaxel model will be integrated into TRHC's market-leading precision dosing solution, DoseMeRx®. Both parties expect positiv
Companies: Physiomics Plc
Samarkand Group Limited, the cross-border eCommerce technology and retail group opening up the world's largest market for brands and retailers, intends to IPO on the Apex Segment Aquis Stock Exchange Growth Market. Admission is targeted for March 2021. Cellular Goods a UK-based provider of premium consumer products based on biosynthetic cannabinoids announced its intention to join the main market (standard) this spring. Target valuation £20m raising c. £8m “to finalise the development and launch
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Today’s prelims are in line with management’s expectations with losses before tax in the period of £30.3m (vs. £29.4m prior year). Post-merger, 4D pharma is clearly a different beast with access to the largest global capital market for Pharma/Biotech, and supported by £25.2m (net) proceeds from corporate activity. The company has cash runway until Q2 2022 and is well placed to successfully execute its clinical development strategy with multiple shots on goal. Primary focus is on MRx0518 with two
Companies: 4d Pharma PLC