Plethora Solutions Holdings plc

Plethora Solutions Holdings plc (“Plethora”) is a specialty pharmaceutical company based in the United Kingdom (“UK”). It develops and markets products for the treatment and management of urological disorders, especially in the niche segment of premature ejaculation (“PE”). Plethora is the principal investment of Regent Pacific (or the “Group”) and became a wholly-owned subsidiary of the Group following a successful all-share conditional offer in March 2016.

Product and expected sales and marketing schedule

Plethora is the foremost value driver of the Group. Managed by one of the renowned scientists behind Viagra - Dr. Michael Wyllie, the Group’s Chief Scientific Officer, together with the senior management team, Plethora developed its core product Fortacin™, the first EU-approved prescription treatment for PE that does not act on the central nervous system. It is a topical spray containing low doses of two anaesthetics - lidocaine and prilocaine – that takes effect almost immediately upon application, giving users more control without reducing pleasure.
 
The first batch of Fortacin™ has been launched for commercial sale in the UK, by prescription, from 11 November 2016. Following the launch, Fortacin™ can now be prescribed from a physician either in person or online via an online consultation, with prescriptions to be filled by Chemist 4 U: https://www.chemist-4-u.com/
 
Furthermore, Regent Pacific has out-licensed Fortacin™ to commercial partner Recordati S.p.A., who is expected to begin sales of the product in Italy, Spain, France, Germany, Portugal, Czech Republic, Slovakia, Poland, Ireland, Romania and Greece in early 2018 and thereafter roll-out in the rest of Europe, Russia, CIS and select countries of North Africa.  
 
The Group is also in discussions with potential new licensees for the distribution of Fortacin™ in other key markets including Asia Pacific, Middle East, Latin America, North America and sub-Sahara Africa. Regulatory approval in a majority of these markets should be secured relatively rapidly, as requirements for costly and time consuming clinical trials are negated by the approval from the European Medicines Agency (“EMA”). 
 
In the United States, the Group continues to push ahead the approval process with the Food and Drug Administration. Approval is expected by late 2019, with a commercial launch to follow shortly thereafter.  

Milestone and royalty payment schedule with Recordati

Regent Pacific entered into its first commercialisation agreement with Recordati in September 2014 that was subsequently amended in October 2017. The commercialisation of Fortacin™ will bring to the Group important initial stage payments and then a steady stream of recurring cash flow in the years to come. 

 
Under the terms of the Amended and Restated Licence Agreement, Regent Pacific will now receive:
 
·        a payment of €4 million on the date on which the Amended and Restated Licence Agreement becomes effective;
 
·        a payment of up to €4 million in total upon first commercial sales of the Fortacin™ product in France, Germany, Italy, Spain and Portugal
         (being payment of €800,000 for each of these 5 countries);
 
·        a possilbe payment of up to €8 million in total, dependent on the net sales achieved by Recordati in the first 3 years of sales;
 
·        up to €25 million in aggregate in sales-based milestones; and
 
·        tiered percentage royalties on net sales, ranging from the mid-teens to the mid-twenties, for 10 years from first commercial sale, and thereafter at a single 
         digit percentage royalty rate.

Premature Ejaculation Market Potential

The three major forms of male sexual dysfunction are: ejaculatory dysfunction, erectile dysfunction and decreased libido. Premature ejaculation (PE) is a form of male sexual dysfunction, characterized by ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration, or the inability to delay ejaculation on all or nearly all vaginal penetrations. 
 
PE is possibly the most prevalent sexual dysfunction affecting 1 in every 4 men globally, regardless of age, race or geography, and an estimated greater number than erectile dysfunction. Data from the National Health and Social Life Survey have revealed a prevalence of 31 per cent of men in the United States suffer from the condition, which is fairly steady through all adult age groups. A British survey estimated this number at 14 to 31 per cent. According to the Global Study of Sexual Attitudes and Behaviors survey conducted in 29 countries in men aged 40 to 80 years in 2005, the estimated worldwide prevalence of PE was about 30 per cent. 
 
Based on internal modeling, it is believed that the PE market will in due course be worth between US$500 million and US$3 billion per annum.