Formycon - Termination of coverage

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Formycon - H121 update: Future markets take shape

Formycon progressed all key projects in H121. FYB201 (partnered with Bioeq) is a Lucentis biosimilar to treat neovascular age-related macular degeneration (nAMD). The US FDA is reviewing the BLA with an August 2022 decision due; the European EMA review should complete in mid-2021. FYB201 will be marketed by Teva in Europe and by Coherus in the US. FYB202 (a Stelara biosimilar in a joint venture with Aristo Pharma) is waiting for its Phase III readout in psoriasis. FYB203 (an Eylea biosimilar par

Formycon - FY20 results – core progress on key projects

Formycon progressed all key projects in 2020. FYB201 (partnered with Bioeq) is a Lucentis biosimilar to treat neovascular age-related macular degeneration (nAMD). After scaling up manufacturing in 2020, Bioeq aims to resubmit a BLA to the FDA in H121 with a subsequent EMA filing. FYB202 (a Stelara biosimilar) in a joint venture with Aristo Pharma started its Phase III for psoriasis. FYB203 (an Eylea biosimilar partnered with Klinge) is in Phase III. FYB207 is a novel COVID-19 therapy that neutra

Formycon - Two submissions and two Phase III trials in 2021

Formycon continues to progress three core biosimilar projects. In H220, it is preparing the FYB201 (Lucentis biosimilar) EMA approval submission and helping in the resubmission of FYB201 to the FDA. FYB203 (Eylea biosimilar) entered Phase III in August. FYB202 (Stelara biosimilar, autoimmunity) is due to enter Phase III imminently. Development income from partners was €16.5m in H120, giving a loss of €1.4m and a cash outflow of €2.1m. Cash was €20.3m on 30 June.

Formycon - FY19 results – strong position, new projects

Formycon ended 2019 with a strong €22.4m cash position and three main projects. A new project to manufacture antibodies against SARS-CoV-2 is underway to treat COVID-19. Formycon’s lead project, Lucentis biosimilar FYB201, treats neovascular age-related macular degeneration (nAMD) and is partnered with Bioeq AG (Bioeq). Bioeq aims to resubmit the BLA to the FDA in H220. FYB202 (a Stelara biosimilar) is in a joint venture with Aristo Pharma and is slated to enter Phase III in Q320. FYB203 (an Eyl

Formycon - FYB201 FDA filing imminent

Formycon's partner Bioeq IP plans to file FYB201, a Lucentis biosimilar candidate, to treat neovascular age-related macular degeneration (nAMD) with the FDA imminently in Q419. The US launch could be in 2021 and the EU in 2022. H119 revenues were €17.2m from partners for product development services. There are three main projects. Bioeq is the partner on FYB201, Santo on FYB203 (an Eylea biosimilar candidate) and there isa a joint venture with Aristo Pharma on FYB202 (a Stelara biosimilar candid

Formycon - H119 results – FYB201 FDA filing imminent

Formycon's partner Bioeq IP (Bioeq) plans to file FYB201, a Lucentis biosimilar candidate, to treat neovascular age-related macular degeneration (nAMD) with the FDA imminently in Q419. The US launch could be in 2021 and the EU in 2022. H119 revenues were €17.2m from partners for product development services. There are three main projects. Bioeq is the partner on FYB201, Santo on FYB203 (an Eylea biosimilar candidate) and a joint venture with Aristo Pharma on FYB202 (a Stelara biosimilar candidat

Formycon - FY18 results: FYB201 launch on track for 2021

Formycon's partner Bioeq IP AG (Bioeq) plans to file FYB201, its Lucentis biosimilar, to treat neovascular age-related macular degeneration (nAMD) with the FDA in early Q419. The Phase III met its key primary endpoint. The US launch could be in 2021 and the EU in 2022. FY18 revenues were €43m, which includes €34.5m in payments from partnered projects. Bioeq is the partner on FYB201, Santo on FYB203 (an Eylea biosimilar) and there is a joint venture with Aristo Pharma on FYB202 (a Stelara biosimi

Formycon - H118 results: FYB201 registration closer

Formycon has reported record H118 revenues, boosted by the one-off transfer of FYB202 into a joint venture with Aristo Pharma and payments stemming from the out-licensed assets FYB201 and FYB203. We believe that Formycon biosimilars FYB201 (Lucentis) and FYB203 (Eylea) are set to enter neovascular age-related macular degeneration (nAMD) market post-2020. Cash and equivalents at end-H118 were €11.8m and should give a cash runaway until 2020 based on H118 cash burn. Formycon guides for FY18 revenu

Formycon - Lucentis biosimilar scores Phase III success

Formycon has announced that its Lucentis biosimilar FYB201 showed comparable efficacy with branded Lucentis in a global Phase III study in nAMD. With positive data in hand, the launch of FYB201 remains on track for 2020 (US) and 2022 (EU), ahead of most competitors. Formycon has also signed a JV (24.9% stake) with Aristo to develop its Stelara biosimilar FYB202 for approval. Lastly, Eylea biosimilar FYB203 and undisclosed FYB205 are advancing in preclinical studies. End-2017 cash was €15.5m.

- H117 results show further business progress

In H117 Formycon disclosed that FYB202 is a proposed biosimilar of Stelara and it recently announced that it is in the process of entering into a co-investment agreement with Santo Holding to advance FYB202 through regulatory approval. The global Phase III study of Lucentis biosimilar FYB201 for neovascular age-related macular degeneration (nAMD) is progressing according to plan with US and EU launches slated for 2020 and 2022. Lastly, FYB203 (Eylea biosimilar) and FYB205 (undisclosed) are advan

Building a pipeline of third-wave biosimilars

Formycon has reported FY16 financial results that highlight the progress of its biosimilars pipeline. During 2016 partner Bioeq IP AG started a global Phase III study of Lucentis biosimilar FYB201 for neovascular age-related macular degeneration (nAMD); US and EU launches are planned for 2020 and 2022. Formycon disclosed that FYB203 is a proposed biosimilar of Eylea in preclinical studies. It targets all biologics in the nAMD market, which had revenues of $8.2bn in 2016. The company recently dis

Surfing the next wave of biosimilars

Formycon is a pure-play biosimilar company focused on third-wave biosimilars (those coming off patent after 2020), an overlooked opportunity for most biosimilar developers. The company has four compounds, two of which are partnered. FYB201 is a biosimilar of Lucentis for neovascular age-related macular degeneration (nAMD) undergoing a global Phase III study; the company is aiming for US and EU launch in 2020 and 2022, respectively, upon patent expiries. FYB203 is a proposed biosimilar of Eylea,

Warpaint London+ (W7L, House Stock at 470p) - Outstanding FY23A - Upgrades!

Shield Therapeutics - Termination of coverage

Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web

Cambridge Nutritional Sciences - Operational efficiencies; adjusted EBITDA profi

Cambridge Nutritional Sciences (CNS) has provided a trading update for the 12 months to 31 March 2024, noting that a combination of strong sales growth and significant margin improvements, driven by operational efficiencies, have played key factors in the group’s expectation of being adjusted EBITDA positive in FY 2024. Revenues are expected to be £9.8m (30% YoY growth), ahead of our £9.0m forecast, with gross profits expected to exceed £6m, which is again ahead of our year-end forecast of £5.6m

Futura Medical: Eroxon poised for launch in key US market

Futura Medical’s investment case has shifted firmly onto commercial execution. The highly successful initial launches of Eroxon, its novel topical gel for ED (erectile dysfunction), by partner Cooper Consumer Health in the UK and Belgium are now being followed by roll-outs across the major European markets. The much-anticipated launch in the commercially important US market by consumer healthcare giant Haleon is expected before February 2025. Launches in Other Regions are anticipated throughout

Creo Medical Group - Speedboat savings validated

An official NHS Supply Chain case study has quantified the savings made by an NHS Trust from adopting Creo Medical’s Speedboat device to perform Speedboat Submucosal Dissection (SSD) in comparison to surgical alternatives. In total, the net cash saving from 130 SSD procedures for the NHS Trust was calculated at £687k, including savings from reduced length of hospital stay and reduced theatre costs. Notably, these savings did not include the patient and financial benefits associated with reduced

Morning Note – 24 April 2024

Destiny Pharma plc+ (DEST, House Stock at 22p) - All eyes on XF-73

Creo Medical - NHS data validates Speedboat’s economic merit

Creo Medical has presented real-world evidence of the economic utility of its minimally invasive electrosurgical devices, based on NHS data from 130 submucosal dissection procedures using Creo’s flagship Speedboat Inject device. The data demonstrated net cash savings of £687k for the NHS trust, driven by a significant reduction in both hospitalisation and critical care costs. We believe this provides external validation to Creo’s pursuit of improving patients’ outcomes through its novel suite of

Hybridan Small Cap Feast - 24 April 24

24th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi

Warpaint London+ (W7L, House Stock at 375p) - Trading ahead of expectations - +10% upgrade implied

Hybridan Small Cap Feast - 22 April 2024

22nd April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi

Cambridge Nutritional Sciences - H1 2024 interims: Executing a newly focussed st

Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We

e-therapeutics - Termination of coverage

Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web

Hybridan Small Cap Feast - 25 April 2024

25th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: Smart Metering Systems (SMS.L) has delisted from the AIM market What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar

Venture Life Group - Strong organic growth; focus on EBITDA

Venture Life has reported FY23 results to December 2023, following the February trading update. Revenues grew 17% in the year to £51.4m (our est. £50.7m) and adjusted EBITDA was £11.6m (our est. £11.6m). Cash conversion was 85%, generating £9.8m of cash from operations. Cash generation and no M&A in 2023 allowed the company to de-lever, closing FY23 with net debt to adjusted EBITDA at 1.3x. Management have focused on growth with three therapy areas generating double-digit revenue growth and onli