Futura Medical Interim Results 2022

RNS Number : 1661Z

Futura Medical PLC

13 September 2022

 

13 September 2022

  Futura Medical plc

("Futura" or the "Company")

Interim Results for the Six Months ended 30 June 2022

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, is pleased to announce its unaudited interim results for the six months ended 30 June 2022.

Operational Highlights

MED3000 - Regulatory

·       Europe: MED3000 will be the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription ("OTC").

o  In April 2022, Futura received approval for a UKCA mark for MED3000, supplementing the CE Mark approval received in April 2021.

· US: In August 2022, Futura received highly positive results from the confirmatory Phase 3 clinical study, ("FM71") for MED3000 for the treatment of ED meeting all primary and secondary endpoints.

o Results demonstrated that MED3000 presents an effective clinically proven treatment for ED with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for OTC classification.

o  Futura expects to file a regulatory dossier with the US Food and Drug Administration ("FDA") by the end of September 2022, targeting marketing authorisation for MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.

MED3000 - Commercialisation & Manufacturing

· Futura has signed multiple commercial agreements to date across key markets, as it continues to build a strong network of licensing and distribution partners with strength in brand building, pharmaceutical credibility and marketing expertise for long-term distribution of MED3000 across the globe.

o  In March 2022, Futura announced that it had entered into a licensing agreement with Menarini Korea, a wholly owned subsidiary of Menarini Group, for the exclusive rights to commercialise MED3000 in South Korea.

o  In May 2022, Futura announced an exclusive licensing agreement with Cooper Consumer Health for the rights to commercialise MED3000 throughout the European Economic Area, the United Kingdom and Switzerland. Plans are at an advanced stage for initial launches in first half of 2023.

o  Following successful completion of FM71, Futura's specialist corporate advisors have now formally commenced the search for a US partner.

· Through its commercial partners, Futura aims to launch MED3000 and build a respected, high quality, and trusted global brand. Futura's contract manufacturing supply chain is now ready for commercial production, with capacity for initial launch supplies of Eroxon™ and beyond. Eroxon™ has an approved shelf-life of 42 months which will provide at least 3 years shelf-life at point of sale. First manufacturing orders have been received from our European partner.

· Regulatory approvals for a number of non-EU markets through Futura's commercial partners are progressing well other than in China where the regulatory approval for MED3000 remains a number of years away.

· Futura has recently completed additional national patent applications in line with normal PCT filing procedure in all key ED markets in order to protect the commercial interests of MED3000. If national patents applications are successful, this will provide patent protection until 2040.

Board updates

· Futura strengthened the Board with the appointment of Andrew Unitt, who was previously Finance director of Boots Healthcare International, as a non-executive director as of 1 January 2022.

Financial Highlights

· £2.50 million net losses in the period (30 June 2021: net total loss 1.59 million).

· Cash resources of £6.68 million at 30 June 2022 (excluding tax credit due of £0.91 million).

· Current cash runway extends well beyond expected initial MED3000 launches in the coming months and expected US regulatory approval in Q1 2023.

James Barder, Chief Executive Officer , Futura Medical said: "I am delighted with the significant progress we have made during the first half of the year as we continue to deliver on the Company's strategic objectives. The whole team at Futura looks forward with growing excitement to the launch of Eroxon™ in the coming months as we, in close alignment with our commercial partners, work hard to build Eroxon™ into a long term, profitable and trusted brand."

Webcast

The Executive Team will host a webcast of the presentation which will be available within the Investor Centre section of the Futura company website at www.futuramedical.com from 10 am BST on Tuesday 13^th September 2022. The Company will provide an update on the regulatory pathway of MED3000 in the US, manufacturing and commercialisation progress.

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: [e-mail]

Tel: [phone]

www.futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings

Tel: [phone]

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt

Email: [e-mail]

Tel: [phone]

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys®technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration and patient convenience. The products are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.

MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction ("ED") through a unique evaporative mode of action. Futura has previously conducted a Phase 3 study using MED3000 in ED, referred to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED.

MED3000 is CE marked in Europe and CA marked in the UK as a clinically proven topical treatment for adult men with erectile dysfunction under the brand Eroxon™ with a key claim of "Helps you get an erection within 10 minutes".

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.  www.futuramedical.com

Operational Review

DermaSys^® - Our proprietary patented transdermal technology platform

Futura's unique patented technology DermaSys^® is designed to deliver clinically proven effective medical treatments via the skin.

DermaSys^® is a versatile and bespoke technology. Each product gel is uniquely formulated using the DermaSys^® platform with volatile solvent component formulations tailored for each product to suit the specific therapeutic indication and desired speed of onset and duration of action. Such targeted delivery offers an optimised profile in terms of dose, onset time and duration of effect as well as an improved safety profile reducing the risk of side effects. Each product is formulated to maximise its benefits for patients and consumers. Each new unique formulation offers the opportunity for additional patent applications and potential patent protection.

MED3000 - breakthrough, fast acting topical gel formulation for the treatment of Erectile Dysfunction ("ED")

MED3000 is CE marked in Europe and CA marked in the UK, as a clinically proven topical treatment for adult men with ED that helps men get an erection within 10 minutes.

Studies have shown MED3000 to be an effective treatment for ED with an excellent safety profile. MED3000 has a unique evaporative mode of action which the Company believes stimulates nerve endings in the glans penis to cause an erection.

MED3000 helps men get an erection within 10 minutes, faster than on-demand oral tablet phosphodiesterase-5 inhibitors ("PDE5is" - oral treatments for the treatment of ED such as Viagra® Levitra ® and Cialis ® and their generic equivalents), with significant benefits for spontaneous rather than pre-planned sexual intercourse.

The prevalence of ED disrupts the lives of at least 1 in 5 men globally with around 23 million men suffering ED in the US and 20 million men in the UK, France, Italy, Spain and Germany¹. There has been little innovation in ED treatments for nearly two decades and many patients continue to suffer dissatisfaction with existing treatments. The US market, in particular, continues to evolve following the expiry of the PDE5i's patent protection with the advent of subscription services such as For Hims and Go Roman which offer a branded concierge service for ED prescription medicines online. This increased affordability of generic PDE5is is driving volumes especially in the US which have increased by 85% between 2018 and 2020².

Recent US market research conducted by IPSOS and commissioned by Futura has confirmed that even with increasing volumes the requirement of a doctor's prescription remains both an economic and emotional barrier to use: US patients spend between US$600 and US$3,500 per annum on ED treatments, when taking into account both prescription costs and doctors' visits not covered by insurance³. This reconfirms the significant opportunity that MED3000 represents with OTC availability at a likely retail price in the region of US$5 per dose in the USA.

MED3000 - approved as the first pan-European topical treatment for ED available with OTC status

Futura's breakthrough, fast-acting topical gel formulation MED3000, is the first clinically proven, pan-European topical treatment for adult men with ED available without a doctor's prescription.

In April 2021, the Company received its MDR EU Quality Management Certificate for the placing on the market of a Class 2B medical device known as MED3000 ("CE mark approval").

The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in Latin America, the Middle East, Africa and the Far East regions, with many countries considering "fast-track" review based on recognition of the EU CE mark.

Due to post-Brexit arrangements, the EU CE mark can be used to market the product in Great Britain until 30 June 2023 by which time a specific UKCA mark has to be obtained. In anticipation of this Futura filed for a UKCA mark for MED3000 as a Class 2A medical device and received approval in April 2022.

US - the largest potential OTC ED market globally

In 2020, the FDA agreed that an application may be made for MED3000 as a medical device for ED treatment, with a De Novo classification. This was followed by a number of productive and positive pre-submission meetings with the FDA during 2020 and 2021 to discuss existing Phase 3 clinical data, pathway to OTC status and any additional clinical and non-clinical requirements.

In 2021 Futura received official minutes from the FDA agreeing the design for a confirmatory, Phase 3 clinical trial, ("FM71"), designed to provide supplementary efficacy data to the previously reported Phase 3 clinical study ("FM57") study.

FM71 - Highly positive results with all primary and secondary endpoints achieved

In August 2022, Futura announced positive results from FM71, broadly comparable with data generated in both FM57 and a recent "real world", home use study.

FM71 was a multi-centre, randomised, open-label, home use, parallel group, clinical investigation of MED3000 compared to oral tadalafil (5mg) tablets. The trial design and clinical endpoints were agreed with the FDA and the trial used gold standard, internationally accepted clinical trial endpoints in ED.

FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients (recruited from the United States (African Americans), Poland, Georgia and Bulgaria) clinically diagnosed with a mix of mild, moderate and severe ED against baseline (pre-treatment).

FM71 results demonstrated that MED3000 presents an effective clinically proven treatment for ED with a 10-minute onset of action and a favourable benefit versus risk profile ideally suited for OTC classification.   

Futura is on track to file a full regulatory dossier with the FDA by the end of September 2022, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.

MED3000 - Commercialisation & Manufacturing

Futura is establishing a network of licensing and distribution partners with strength in brand building, pharmaceutical credibility and regional infrastructure and marketing expertise for long-term distribution of MED3000 (Eroxon™) across the globe.

With multiple commercial agreements in key markets, Futura now has a strong and expanding distribution platform in place for regions outside the key US market.

Menarini Korea Limited ("Menarini Korea") - South Korea

In March 2022, Futura announced that it had entered into a licensing agreement with Menarini Korea, a wholly owned subsidiary of Menarini Group, for the exclusive rights to commercialise MED3000 in South Korea.

Under the terms of the agreement, Menarini will be responsible for all costs related to the regulatory approval and marketing of the product in the region, including a clinical bridging study if necessary. Futura will provide reasonable technical support for product development and commercialisation and will receive an upfront payment and provide manufactured product from Futura's 3rd party contract manufacturers.

Cooper Consumer Health ("Cooper") - European Economic Area, United Kingdom and Switzerland

In May 2022, Futura announced an exclusive licensing agreement with Cooper, a leading European independent self-care organisation, for the rights to commercialise MED3000 throughout the European Economic Area ("EEA"), the United Kingdom and Switzerland.

Under the terms of the agreement, Futura will receive an initial upfront payment, as well as undisclosed cumulative sales milestone payments and will manufacture and supply the product (through its 3rd party contract manufacturers) for the EEA, the United Kingdom and Switzerland to Cooper. The agreement is for an initial term of five years complying with EU competition law. Futura will remain Legal Manufacturer⁴ and be responsible for the supply of MED3000 through its 3rd party contract manufacturers.

US commercialisation strategy

Following positive FM71 results announced in August 2022, Futura is on track to file a dossier with the FDA by the end of September 2022, targeting marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.

In line with the Board's US commercialisation strategy following the successful completion of FM71 and expected imminent FDA dossier submission, Futura has recently commenced the search for a US commercial partner through its specialist corporate advisors. Futura has already received a number of inquiries regarding commercialisation opportunities for MED3000 for the key US market and the Board along with its advisors are focussed on securing the best options in order to maximise long-term value and sustainable revenues whilst minimising risk for Futura's shareholders.

China and Southeast Asia

The current political environment and restrictive "Zero-Covid" policy in China has resulted in Co-High Investment Management Limited not being able to deliver to-date on the key development and regulatory milestones as set out in the agreement entered into between the companies in March 2021. Futura is exploring options to remedy this situation in line with the contractual terms of the agreement as Southeast Asia including China remains a significant commercial opportunity, although further Phase 3 trials, taking several years, will be required, as previously disclosed.

Manufacturing

The Company engaged a US FDA, EMA and UK approved contract manufacturer in 2021. Manufacturing scale up has now been completed and confirms we have sufficient production capacity to meet projected initial demand and beyond. This manufacturer is now ready for commercial production and first manufacturing orders have been received from Futura's European partner. Options for the addition of further manufacturing sites to increase supply chain robustness continue to progress. MED3000 supply is ISO 13485 accredited with a competitive cost of goods and now has an approved 42-month shelf-life giving significant distribution flexibility mindful of transport times between the country of manufacture and final country of sale.

Intellectual Property: Patents, Trademarks and exclusively supplied, Critical Ingredients

Futura's corporate strategy is to develop layers of protection around its products and in particular MED3000, and the Company continues to work with specialist patent and trademark advisors to further refine and optimise this strategy:

1.  In line with normal PCT filing procedures MED3000 patents are now filed in all major ED markets considered necessary to protect the commercial interests of MED3000. A request to the European Patent Office was made in August 2021 for examination of the MED3000 patent application and in Q2 2022 it confirmed the novel and inventive nature of the application, which is required before a patent can be granted, although further review continues .

2.  A key excipient in the MED3000 formulation is made by only one known manufacturer who has entered into an exclusivity agreement for the supply of that ingredient (within the sexual health field) for MED3000 manufacturing, providing further competitive protection around MED3000.

3.  A high-quality dossier that will shortly be submitted to the FDA will contain substantial safety and effectiveness data. This will be enshrined in Special Controls⁵ which would have to be replicated in full by any potential competitors hoping to follow the 510K medical device route using MED3000 as the predicate device to gain FDA marketing authorisation. These controls will present a formidable barrier to competitor entry to the US market.

4.  Futura aims to work with commercial partners such that MED3000 is launched, wherever possible, under the Eroxon™ trademark to help establish global awareness, consumer trust and build worldwide brand integrity. In consumer health and over-the-counter markets an established brand name is paramount in providing product price and sales volume stability for many years.

Research and Development

Futura is committed to delivering long-term and sustainable value to the Company allowing a long-lasting growth franchise to be built around MED3000 and other DermaSys^® formulated products.

Whereas Futura's priority remains the approval and subsequent successful launch of MED3000 (Eroxon™) in major markets throughout the world, Futura aims to build a significant MED3000 franchise across sexual health by leveraging and expanding its unique knowledge and expertise in underserved and new categories in sexual health, building upon market research already undertaken to identify product extensions and potentially new market segments for an OTC product treating ED. Futura intends, in due course, to commission further in-market research, especially for the US, to identify commercially attractive product line extension opportunities.

Board Changes

Futura continues to bring new skills and experience to its already highly skilled Board.

In January 2022, Andrew Unitt joined the Company as Non-Executive Director. Andrew brings strong financial experience having spent eleven years at Boots plc, where he was Finance Director for four years of Boots Healthcare International, its over-the-counter medicines business. Andrew's OTC market expertise and exceptional skills in strategic development and business management will further enhance Futura's ambition and focus on building a global brand and distribution network to accelerate Company growth.

Andrew chairs the Audit Committee as Jonathan Freeman's successor, following Jonathan stepping down at the end of 2021.

Financial Review

Research and development costs

Research and development costs for the six months ended 30 June 2022 were £1.91 million, compared to £1.19 million for the six months ended 30 June 2021 with the increase being predominantly due to increased activity related to the FM71 study cost.

Administrative costs

Administrative costs were £0.94 million for the six months ended 30 June 2022 compared to £0.71 million for the six months ended 30 June 2021. The slight increase mainly relates to legal and professional costs associated with concluding MED3000 commercial agreements and supply chain set-up costs.

Going concern

At the period end the Group held £6.68 million of cash with a further £0.91 of R&D tax credits relating to 2021 which is expected to be received in the second half of 2022. The Directors believe that it remains appropriate to prepare the financial statements on a going concern basis.

Cash runway

The Company continues to have sufficient cash resources beyond initial MED3000 launches and expected US regulatory approval. The current runway does not include any additional revenues from commercial upfront milestones, royalties or other income generated from MED3000 sales.

Outlook

Futura is well advanced in its strategic objective of creating a global network of licensing and distribution partners with strength in brand building, pharmaceutical credibility, infrastructure and marketing expertise for long-term profitable distribution of MED3000 across the world.

We are looking forward to launching MED3000 as a priority under the Eroxon ™ brand with multiple commercial agreements in place in key markets and where regulatory approval allows.  We are also firmly focussed on gaining marketing authorisation in the key market of the USA and finalising commercial arrangements to enable the marketing of MED3000 as a clinically proven topical treatment for ED with a rapid speed of onset. We look forward to updating shareholders further on regulatory and commercial progress on MED3000.

Financial Statements -  see below to view Futura Medical Financial Statements

http://www.rns-pdf.londonstockexchange.com/rns/1661Z_1-2022-9-12.pdf

1.  EMA, Withdrawal assessment report for Viagra, 2008

2.  Manufacturers' Selling Prices, IQVIA 2020 market data

3.  Ipsos research commissioned by Futura

4.  Legal Manufacture means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device

5.  www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents

 

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