Futura Medical : Annual Report 2022

Futura Medical plc

Annual Report and Accounts 2022

Welcome to the Futura Medical

Annual Report 2022

WHAT WE DO

Futura Medical is a pharmaceutical company developing innovative products based on our proprietary, transdermal technology DermaSys®.

Products are optimised for clinical efficacy, safety, mode of administration, patient and consumer convenience and are developed for the prescription and consumer healthcare markets as appropriate.

Current therapeutic areas are sexual health and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst seeking to minimise clinical and regulatory risk.

Futura has a proven track record in delivery and completion of Research and Development ("R&D") projects up to value inflection points at which they are suitable for commercialisation partners.

INVESTMENT CASE

1 LONG-TERM VALUE CREATION FROM OUR LEAD PRODUCT MED3000

We are prioritising the development and regulatory approval of MED3000, our treatment for erectile dysfunction ("ED"), owing to its significant medium to long-term value creation potential in a large market where there is an unmet need for new treatment options. MED3000's efficacy and safety has been shown in two Phase 3 clinical trials and MED3000 is approved in the EU, as a Class 2 medical device under the MDR EU Quality Management Certificate ("CE mark approval") making it the first clinically proven, pan-European topical treatment for adult men with ED available without a doctor's prescription ("OTC"). MED3000 has also been submitted for marketing authorisation to the US Food and Drug Administration ("FDA").

3 CLINICAL DEVELOPMENT OF TREATMENTS IN MARKETS WITH SIGNIFICANT UNMET NEEDS

Our focus is on differentiated products, addressing areas of two large markets, sexual health and pain, seeking to solve unmet needs that will help improve patients and consumers' lives. Our purpose is to enhance quality of life to enable our patients and consumers to enjoy their lives to the full whilst being ethical in all we do.

Read more about the			Read more about our
US market for erectile			Sustainable Development
dysfunction on page 18			Goals on page 27

2 ADVANCED PROPRIETARY TECHNOLOGY DERMASYS®

We are exploiting the potential of our transdermal technology DermaSys® to innovate and develop topical treatments offering a fast onset of action and low systemic side effects. Our long-term strategy is to expand the product pipeline based on DermaSys®. Our products are underpinned by strong IP, usually specific to each product.

Read more about DermaSys®

on page 4

4 DE-RISKED STRATEGY WHICH FOCUSES ON RAPID ROUTES TO MARKET

Our lead product, MED3000, is a product that is or will be available over the counter, without a doctor's prescription and has already received CE mark approval in Europe, which will provide in many non-EU countries a "fast-track" approval. MED3000 was also submitted for US FDA approval as an OTC medical device in October 2022. The USA is the largest potential market for ED over the counter and MED3000 (subject to FDA approval) could be the first OTC product available. This regulatory strategy means that there is a lower development risk and shorter regulatory pathway to monetisation in many countries, especially the USA.

Read more about our strategy on page 16

Our purpose is to enhance our patients and consumers' quality of life to enable them to enjoy their lives to the full."

JAMES BARDER

Chief Executive

5 DISTRIBUTION NETWORK BASED ON STRATEGIC PARTNERSHIPS

As a semi-virtual company we value our commercial partners and place much emphasis on selecting and establishing a network of licensing and distribution partners with brand building strength, healthcare credibility, regional infrastructure and marketing expertise for long-term distribution of MED3000 across the globe. We look for committed commercial partners who have the regulatory and commercial expertise as well as the tenacity, drive and enthusiasm to make our products a success.

Read more about our

partnerships on page 12

6 EXPERIENCEDMANAGEMENT TEAM

The management team has significant experience in researching and developing innovative products for the global consumer healthcare and prescription markets and has strengthened the Board's business and commercial expertise as Futura moves into the next phase of MED3000's commercialisation.

Read more about governance at Futura on page 36

CONTENTS

STRATEGIC REPORT

Investment case	IFC
Highlights	02
DermaSys® at a glance	04
Product pipeline	06
Chairman's Statement	07
Chief Executive's Review	08
Our business model	14
Our strategy	16
Key performance indicators	17
Product Review - MED3000	18
Product Review - Other products	22
Financial Review	23
Key risks and mitigation	24
Sustainability Review	27
Our stakeholders	28

GOVERNANCE

Board of Directors	30
Remuneration Committee Report	32
Corporate Governance Statement	36
by Non-Executive Chairman
Corporate Governance Report	36
Directors' Report	41
Audit Committee Report	44

FINANCIAL STATEMENTS

Independent Auditor's Report to the Members of	45
Futura Medical plc
Consolidated Statement of Comprehensive Income	54
Consolidated Statement of Changes in Equity	55
Consolidated Statement of Financial Position	56
Consolidated Statement of Cash Flows	57
Notes to the Consolidated Financial Statements	58
Parent Company Balance Sheet	77
Parent Company Statement of Changes in Equity	78
Notes to the Parent Company Financial Statements	79
Company information	82

STRATEGIC REPORT

Futura Medical plc Annual Report 2022

01

Highlights

MED3000 - REGULATORY

• Europe: MED3000, brand name Eroxon®, is the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription and available over the counter ("OTC").
• • In April 2022, Futura received approval for a UKCA mark for Eroxon®, supplementing the CE Mark approval received in
    April 2021.
• USA: 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.
• • 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.
  • In October 2022, Futura filed a regulatory dossier with the US Food and Drug Administration ("FDA"), for marketing authorisation for MED3000 as De Novo Medical Device - with the potential to be the first major ED treatment available OTC in the USA.
• Middle East: In December 2022, Futura announced that MED3000 had received marketing authorisation in three Middle Eastern countries including the United Arab Emirates ("UAE").

MED3000 - COMMERCIALISATION AND MANUFACTURING

• Futura signed multiple commercial agreements across key markets.
• • In March 2022, Futura 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.
  • In May 2022, Futura entered into an exclusive licensing agreement with Cooper Consumer Health ("Cooper") for the rights to commercialise Eroxon® throughout the European Economic Area, the United Kingdom and Switzerland.
  • In December 2022, Futura formally commenced the search for a US partner ahead of planned FDA approval and continues to be engaged in several ongoing discussions.
  • Futura's contract manufacturing supply chain is now ready for commercial production, with capacity for initial launch supplies of Eroxon® and beyond.

• • In September 2022, the first production order of Eroxon® was received to fulfil initial launches through Futura's European and UK distribution partner.
  • First production orders for initial launches of Eroxon® in the Middle East, which are planned for 2023, were also received from its Middle Eastern distribution partner.
• In Q2 2022, as part of its overall IP protection strategy, Futura filed national patent applications considered necessary to protect the commercial interests of MED3000 in line with normal PCT filing procedures in all key ED markets. If successful, this will provide patent protection until 2040.

MED3000 ENVIRONMENTAL AWARENESS AND EDUCATION

• In October 2022, Futura attended the joint meeting of the Sexual Medicine Society of North America and the International Society of Sexual Medicine in Miami.
• • An Advisory Panel meeting comprised of eight world-renowned experts discussed MED3000's clinical data, its unique mode of action and how it could be used as a treatment alternative for ED. This panel acknowledged MED3000 as a potential, safe, fast-acting and effective treatment for addressing the medical unmet need of many men with ED without the requirement for a doctor's prescription.

FINANCIAL HIGHLIGHTS

• Net loss of £5.85 million in period of which £4.13 million was related to R&D (2021: net loss of £4.96 million).
• Cash resources of £4.03 million.
• £1.02 million tax credit refund due mid-2023.
• Current cash runway extends beyond initial Eroxon® launches expected over the next year and expected US regulatory approval in 2023.

POST PERIOD HIGHLIGHTS

• Formal production batches of Eroxon® successfully completed and initial retail and online launches of Eroxon® in Europe have now commenced with further manufacturing orders received.
• MED3000 has been granted initial marketing authorisation in the Middle East, which now covers four Middle Eastern countries including the UAE. Further approvals are expected in 2023 alongside initial launches, where regulatory approval has been received, under the Eroxon® brand.

02

• In February 2023, Futura presented MED3000 data in a Poster presentation at the European Society for Sexual Medicine Congress in Rotterdam.
• • The Poster presented the positive FM71 Phase 3 study results, announced in August 2022.
  • There was an Eroxon® stand at the congress where good interest was received from congress attendees who welcomed the new innovation in ED.

• In March 2023, Futura announced that MED3000 was under active review with the FDA, including a recent meeting, regarding US marketing authorisation. As a regular part of its review process, the FDA asked some additional questions and requested some non-clinical confirmatory data, to which the Company has provided a full response and the requested confirmatory data to enable the FDA to complete its review. Based on the FDA's published target review period guidelines to include time to review the newly provided information, grant of the De Novo request is now expected to be achieved in
  Q2 2023.

STRATEGIC REPORT

Futura Medical plc Annual Report 2022

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