Acquisition of Prolong – the world’s only FDA – Cleared medical device for premature ejaculation

InnovaDerma PLC

(“InnovaDerma”, the “Company” or the “Group”)

Acquisition of the ProlongTM  – the world’s only FDA-cleared medical device for premature ejaculation

InnovaDerma (LSE: IDP), a UK developer of life sciences, beauty, and personal care products, is pleased to announce it has acquired the entire share capital of Ergon Medical Limited, the owner of the intellectual property rights of ProlongTM, the world’s only medical device cleared by the U.S. Food & Drug Administration (“FDA”) for premature ejaculation (the “Acquisition”). 

About ProlongTM

ProlongTM is a Class II vibrating medical device as classified by the FDA and used as part of a climax control programme for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation through the use of the training sessions using the stimulating vibratory effects of the device on the penis as part of the “Start-Stop” technique. Prolong offers an affordable, pain-free, one-off, or long-term treatment option with no side effects.  The ProlongTM   prototype delivered efficacy 338% above the combination of the Start-Stop technique with behaviour therapy, which is the current gold standard treatment for premature ejaculation. In a clinical trial in Finland which featured a group of lifelong sufferers of premature ejaculation, 70% of patients who failed on all known treatments including drug treatment, improved after being treated with ProlongTM and the improvement was either sustained or bettered six months after completion of the treatment.

 ProlongTM can be sold without prescription, is patented in 72 countries and ready for mass-market distribution. 

 Strategic rationale for the Acquisition – creating value in the life sciences portfolio

 The Board believes that the Acquisition presents an excellent strategic fit as the Group seeks to diversify its income stream by growing its life sciences business division.  This is to be achieved through the development of new products and selectively acquiring complementary FDA-cleared or approved products which are ready to be marketed and distributed worldwide and will further drive the Group’s revenue and earnings.  The Group is hiring specialist health care personnel to support the Group’s future growth of its life sciences business.

 There is significant opportunity for several commercial, operational, and financial synergies, which are expected to create value for InnovaDerma’s shareholders:

 ·     There is strong existing and growing demand for highly effective and affordable treatment for premature ejaculation suffered by more than 500 million men globally.  The current market is valued at more than US$1billion (with the USA accounting for 43% of the global market) and growing at CAGR of 10% per annum.

·     ProlongTM offers an affordable, pain-free treatment for premature ejaculation with long-term benefits.

·     This acquisition is highly complementary to the Leimo Headmaster (the hair regeneration helmet) which shares similar demographics and target markets.  Both products present substantial cross-selling and cross-border sales and distribution collaboration opportunities.

·     ProlongTM will be marketed and distributed through the Company’s successful Direct to Consumer channel to eliminate the embarrassment of patients having to seek treatment at a local pharmacy.  There are multiple benefits in utilising Direct to Consumer selling including improved ownership of the client base which can be used to introduce other products, e.g. Leimo Headmaster.  It also enhances cash flow with all revenues realised within hours of ordering and creates real-time market intelligence, enabling the Group to optimise the development of promotional activities and new product portfolios.

·     ProlongTM will be launched in the first half of the financial year 2018. The Company expects to launch it firstly in North America and this will be followed by launches in Europe and Australia in 2018.

·     ProlongTM is expected to have a retail price of between £250- 300 per device.

·     The Boards expects the Acquisition to be revenue and earnings enhancing in the second half of financial year 2018. 

·     The Board does not envisage any integration costs.

·     Dr Andy Zamar, founder of the London Psychiatry Centre and inventor of ProlongTM, will remain with the Group for the first 12 months post-acquisition as a consultant to the Board, supporting marketing and distribution campaigns in North America and Europe.

 Terms of the Acquisition

The consideration for the Acquisition is £1 million satisfied by the issue of ordinary shares in the Company at a 25% discount to the average closing bid price three days prior to and three days post the announcement of the Acquisition less the number of ordinary shares in the Company which will be issued at the non-discounted average price to settle certain creditors totalling approximately £323,600. The number of ordinary shares to be issued will reduce to the extent there are net current liabilities revealed in the target company.

In addition, the Group will pay a royalty of £11 per unit to the Vendor for each ProlongTM device sold (no minimum yearly royalty commitment) for the term of ProlongTM‘s patent, due to expire in 2031. If, during any calendar year, Prolong returns a 20% EBIT of net sales then the sellers will be entitled to a £150,000 bonus payment. Dr Andy Zamar, who will act as a consultant to the Group for the first 12 months post-acquisition, will receive a fee of £4,166 per month.    

A further announcement will be made when the consideration shares are issued.

Haris Chaudhry, Executive Chairman of InnovaDerma said:

“Today’s agreed acquisition of ProlongTM an innovative device which provides a truly effective non-prescription solution with long-term benefits for premature ejaculation, a common and embarrassing problem for men all over the world, marks our entry into a substantial market place.  The acquisition underpins our strategy to grow our life sciences business and the value of our intellectual property, both of which will diversify and drive future revenue and earnings.” 

 Investor presentation

Copies of this announcement and of the investor presentation on the Acquisition will be made available on InnovaDerma’s website (www.innovaderma.com) today.

Further enquiries

 

InnovaDerma

Haris Chaudhry/Joe Bayer

 

+61 (0)3 9111 0071

Sole broker

Hybridan LLP

Claire Noyce

 

+44 (0)203 764 2341

Cardew Group

Shan Shan Willenbrock

David Roach

 

+ 44 (0)20 7930 0777

 About InnovaDerma

InnovaDerma PLC (LSE: IDP) is an emerging leader specializing in the research, manufacture and marketing of clinically proven products in life sciences, beauty, and personal care products. InnovaDerma has presence in the UK, US, Australia, New Zealand, Philippines, South Africa, Hong Kong, and South Korea.

 www.innovaderma.com

About Dr. Andy Zamar

Dr. Andy Zamar is the founder of the London Psychiatry Centre and triple qualified in medicine in Egypt (Cairo University), the UK and the USA. He is a Member of the Royal College of Psychiatrists and is on their Roll of Honour having been awarded The Gaskell Gold Medal & Prize. According to the Royal College of Psychiatrists’ publication, the Psychiatric Bulletin, “The Gaskell Gold Medal & Prize has always been considered one of the foremost academic distinctions in clinical psychiatry”.

Dr Zamar has taught psychiatry to under- and post-graduate students at Guy’s and St Thomas’ Teaching Hospitals, University College Teaching Hospital, Ain Shams University in Cairo and at Makerere University in Kampala, Uganda.

Medical devices and the FDA

 ProlongTM is a Class II medical device as classified by the FDA.  Class II medical devices require clearance from the FDA. FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories-Class I, Class II, and Class III:

·     Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as a Class I device.

·     Class II devices are higher risk devices and require greater regulatory controls to provide reasonable assurance of the devices’ safety and effectiveness.  For example, condoms are classified as Class II devices.

·     Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.

Source: https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm