Amryt Pharma plc – Q & A

28 February 2017

Amryt Pharma plc – Q & A

28th February 2017

Amryt Pharma PLC was established as a platform to acquire, develop and commercialise a range of drugs targeted at niche, orphan diseases, thereby creating a Speciality Pharmaceutical business. Following the company’s first set of results since floatation, Shard Capital published an update Research note on 30thSeptember with the headline “Progressing to plan”. Recent announcements however suggest that the strategy has been given a boost. Shard Capital asked CEO, Joe Wiley some questions to clarify the recent positive news flow.


Q: On the 2nd December Amryt announced that it had entered into a EUR20m facility agreement with the European Investment Bank on highly attractive terms for the company. Does this mean that Amryt is fully funded now for their Phase III clinical trials with Episalvan (AP101) in patients suffering from epidermolysis bullosa (EB)?

A: Completing the €20M facility was a great result for Amryt. We were able to tap into a source of non-dilutive financing, on very favourable terms, that allows us to fund the business to data in Phase III. We believe that this will be a significant value driver for the business that will be appreciated by shareholders and potential pharma partners alike.

We therefore now have sufficient funding to get us to this value driver.  The Phase III will study Episalvan (AP101) in a 164 patient study in multiple sites in multiple countries around the world.  We are already ready to start and are currently finalising the protocol for this study with both the FDA and EMA. We hope to finalise and announce the detail of the study shortly.

Q: Are these trials still on track to start recruiting patients in Q1 2017?

A : Yes, we believe the first patient will be enrolled in late Q1, possibly in Australia where our lead investigator is based.

Q: When are the headline outcomes of these trials expected?

A : we anticipate that the trial will be an 18 month trial and will be complete in Q3 2018 at which point we will release our top-line data to the markets.

Q: More recently on 5th December you announced that Amryt had reached a licence agreement with NASDAQ-listed biopharmaceutical firm Aegerion Pharmaceuticals Inc for the rights to sell Aegerion’s rare disease drug, Lojuxta. What value can be attributed to this? What does this deal mean for Amryt?

A: We are very excited about this deal and believe it was a truly transformative deal for Amryt. Completing this deal has turned Amryt into a fully-fledged commercial pharma company with products both in development and also now marketed across Europe.  HoFH is a very rare genetic disorder which starts in utero and which causes premature cardiovascular disease due to cumulative exposure to very high levels of cholesterol.  Untreated, the mean life expectancy for these patients is approximately 18 years. We licensed the rights for Lojuxta covering Europe, the Middle East and North Africa, Israel and Turkey. The license extends to 2024, with an option to extend at our behest. This license allows us to treat adults with HoFH and we also plan to conduct a study in children that will extend the market opportunity. Most importantly, the Lojuxta licencing deal is cash-flow positive from day 1 and it therefore significantly de-risks the Amryt business, as we now have a sustainable cash generative business that will become highly profitable in the years to come.  We have also not needed to tap into our cash resources for this deal, so this was a great deal for Amryt.

The addition of Lojuxta for the treatment of HoFH to our portfolio has further allowed us to roll out our Amryt European commercial infrastructure, and  we will be able to leverage off this infrastructure once we come to commercialize our lead product Episalvan (AP101), pending approval by the EMA for the treatment of EB.

Q: Amryt has a strong management team. Is the infrastructure and management in place to maximise the benefit of having a commercial product or will their need to be additions?

A: Our CMO, Mark Sumeray, previously worked as the CMO of Aegerion and was responsible for getting Lojuxta approved by both the FDA and the EMA.  As such he is intimately familiar with the product.  We have also added various other key members of the previous Lojuxta team in Europe to Amryt. We have thereby been able to integrate the Lojuxta business seamlessly into Amryt and are confident that through this team that we can significantly grow this business in the coming years and generate significant profitability for the group.

Q: With a commercial product in your portfolio can we expect more?

A: Absolutely, we have an excellent team as you have noted and we will certainly be on the look-out for other late stage development assets or other opportunities to licence approved products in Europe.

Q: Would you now class yourself as a commercial pharmaceutical business? Who are your comparables?

A : Most definitely. We are now a fully-fledged commercial pharmaceutical company with significant cash generation ahead.  As well as our existing pre-clinical and Phase III development assets, we now have significant revenues that are growing, with the associated sales and marketing infrastructure alongside a commercial supply chain network already in place.  As previously mentioned we would expect to expand this further as more opportunities arise.

Our most obvious comparable right now would be the Scioderm business which was acquired by Amicus in August 2015 in the USA.  Amicus paid $840M for Scioderm ($240M up-front with the remainder based on hitting certain milestones) when they entered their lead product Zorblisa into Phase III. Zorblisa is also being developed for the treatment of EB and Amicus expects to read out its data from this phase III study in the coming months. We are however confident that in AP101 we have a better product than Zorblisa.

Q: With last month’s announcement of your compound, AP102, receiving orphan drug designation from the FDA when can we expect to see that in the clinic?

A : We are about to commence some further pre-clinical development work for AP102 that will be required before we can start testing the product in humans.  We anticipate the first-in-man trials to commence in early 2018.  Given this is an earlier stage asset with a higher risk profile I don’t believe it is currently dialled into the share price.  However, as we progress through clinical development it should also unlock significant value for shareholders.

Q: Since listing on AIM in April the management team has demonstrated an ability to do deals and to execute on attractive terms for Amryt. What next?

A: Our key focus right now is the commencement of our Phase III clinical trials and driving the growth of our Lojuxta business.  After that, I think this management team has shown shareholders our ability to execute compelling deals that have the ability to unlock significant value and I would be confident that we will continue to do so.



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