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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
Edison
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
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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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Companies: BILN IGP RBN SBTX
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
Companies: BIRD MBH CHRT INSE KMK FNTL HDD JNEO CCS
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 (
Companies: TXG NDVA TSVT BCOW Z29 TXG NCYT GNS SUN AMS OMG APH EKF EAH IMM AGL DEMG AGY TSTL IPO GDR ETX TRX HVO CTEC AVO OXB DEST VLG IXI VAL INDV AGR AVCT BAI 123F IMCR BCOW
Hardman & Co
Companies: CLBS GHH NANO TRX SAVE TMT GELN
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
Companies: NBPE ICGT ARBB CSN RECI CLIG HAT AVO STX VTA APAX
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