Formycon - Termination of coverage

Edison Investment Research is terminating coverage on: • 2G Energy (2GB) • Apontis Pharma (APPH) • Artec technologies (A6T) • Beta Systems (BSSA) • Blue Cap (B7E) • Cyan (CYR) • Consus Real Estate (CC1) • Daldrup & Soehne (4DS) • DATAGROUP (D6H) • Datron (DAR) • Delignit (DLX) • Deutsche Börse (DB1) • Deutsche Grundstücksauktionen (DGR) • Deutsche Rohstoff (DR0) • DVS Technology (DIS) • Edel (EDL) • Ernst Russ (HXCK) • Exasol (EXL) • expert.ai (EXAI/EXSY) • Fashionette (FSNT) • Formycon (FYB)

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,

Strong growth in core underpins FY expectations

EKF has reported a strong H1, with revenues of £37.5m and double-digit growth in underlying non-Covid related business. Management reports it is trading in line with expectations for the full year and we make no change to our profit forecasts at this stage. New growth initiatives are proceeding to plan and should lead to accelerated core growth from FY23 onwards. We continue to see substantial upside on successful execution with the shares trading on an FY23 P/E of 13.1x and an EV/EBITDA of just

Hybridan Small Cap Feast 09/08/22

Dish of the day Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports

Morning Note – 3 August 2022

Hybridan Small Cap Feast 16/08/22

Joiners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a supplier of laminated steel tapes to the fibre optic cable industry in the US. Thixotropic gels and laminated steel tapes are essential components to the rapidly growing global fibre optic cable market. The Group exports to over 40 count

Hybridan Small Cap Feast 05/08/22

Dish of the day Joiners: Inteliqo Limited has joined the Access Segment of AQSE Growth Market. Inteliqo Limited provides sales, marketing and distribution services to technology product owners. Leavers: Menzies (John) plc and Sanne Group have left the Premium Segment of the Main Market. What’s cooking in the IPO kitchen?** Unigel Group, intends to join the Aquis Growth Market. Unigel Group is a pioneer in the field of thixotropic gels for the fibre optic cable industry. The Company is also a sup

WHI First Light: Spectra Systems, ARC Minerals, KEFI Gold & Copper, Dekel Agri-vision, NetScientific & LifeSafe Holdings

Spectra, a leader in machine-readable high speed banknote authentication, brand protection technologies and gaming security software, has announced its first commercial sale of a Banknote Disinfection System (BDS) to an Asian central bank. The BDS system, utilising Spectra's patented technology, contributes to the safety of central bank staff who handle banknotes incoming from circulation, which may carry bacterial and viral pathogens. The system is a plug and play technology as it does not req

The Hardman & Co Monthly: August 2022

Feature article: Utility regulation – Changes afoot - Patching up a tainted model While the gas supply crisis – and its price implications – have dominated the UK price regulated sectors in recent months, other issues have arisen that have seriously tainted the price regulation system itself. Indeed, it is fair to ask whether it is ‘’fit for purpose’’. Back in 1984, price regulation, via an unsophisticated RPI-x formula, was introduced to prevent the privatised British Telecom (BT) from abusin

Hybridan Small Cap Feast 16/06/2022

*A corporate client of Hybridan LLP Dish of the day Joiners: No Joiners Today. Leavers: No Leavers Today. What’s cooking in the IPO kitchen? LifeSafe Holdings, a fire safety technology business with innovative fire safety products, intends to join AIM. LifeSafe has developed what the Directors believe to be market disrupting, eco-friendly fire safety protection products to both protect (via fire extinguishers) and detect (via carbon monoxide, smoke and heat alarms) fires. At the cent

WH Ireland: NetScientific (NSCI) - Portfolio company PDS Biotechnology provides a business update and Q2 2022 financial results

NetScientific is an active transatlantic life sciences, sustainability and technology investment and commercialisation group. Portfolio company, NASDAQ-listed PDS Biotechnology (PDSB), in which NSCI holds a 4.72% equity stake, announced on 8 August 2022, a business update along with Q2 2022 results to the end of June 2022.

Growth on an accelerating path

Smith & Nephew’s growth acceleration and margin expansion in Q2 should continue in H215, more reflecting internal changes than improvements in market fundamentals. Its c 13% premium on 2015 P/E to its global ortho peers is supported by its brisker growth and strategic value.

LIBERUM: Medica Group PLC* - Strong update with all divisions growing

Hybridan Small Cap Feast 11/07/22

iners: No joiners today. Leavers: No leavers today. What’s cooking in the IPO kitchen? Georgina Energy, an early-stage resource company with a strategy of actively pursuing the exploration, commercial development and monetisation of helium, hydrogen and hydrocarbon interests located in the Amadeus and Officer Basins in Northern and Western Australia intends to join AIM. Georgina Energy has two principal onshore interests. The first, the Mount Winter Prospect is located in the Amadeus Basin in No

Hybridan Small Cap Feast 12-07-2022

*A corporate client of Hybridan LLP Dish of the day Joiners: Warehouse REIT (WHR.L) has transferred to AIM from the Main Market. Leavers: No leavers today. What’s cooking in the IPO kitchen? Georgina Energy, an early-stage resource company with a strategy of actively pursuing the exploration, commercial development and monetisation of helium, hydrogen and hydrocarbon interests located in the Amadeus and Officer Basins in Northern and Western Australia intends to join AIM. Georgina

Wegovy’s supply + brewing competition concerns overshadow a decent Q2

In Q2, Novo continued its strong run, driven by strong growth momentum seen in both Obesity and GLP-1 Diabetes franchise. However, emerging and potential competition from Eli Lilly’s Mounjaro in Diabetes and Obesity, respectively, and Wegovy’s run of supply scars made investors jittery. Moreover, the group’s ever-expensive valuations and lack of sizable progress beyond diabetes are some of the other key reasons for a cautious stance on the Danish pharma giant.

Pfizer Inc.: The Biohaven Acquisition, Financial Forecasts, DCF & Comparables Valuation, ESG & Other Risks (05/22)

Pfizer had a phenomenal 2021 given the upside of the Covid-19 vaccine and medication. An estimated 1.4 billion patients have been reached by the company with its vaccines and medicines. Pfizer’s position has been upgraded from fourth to second over big bio-pharmacy companies. In R&D, its investments have been increased, and it has started 13 pivotal clinical studies. The company is increasing its investments in Covid-19 medication, Paxlovid and widening its distribution. The strength of the comp