Amryt Pharma plc

Good day, ladies and gentlemen, and welcome to AMRIT Pharma third quarter 2021 results webcast and analyst call. At this time, all participants are in listen-only mode. After speaker's presentation, there will be question and answer session. To ask a question, please press star 1 on your telephone. Please be advised, today's conference is being recorded. I will now hand you over to AMRIT Pharma. Please go ahead.

Thank you, Operator. On the call today to discuss Amrit's Q3 results are Dr. Joe Wiley, CEO, and Rory Nealon, the company's CFO and COO. In addition, Dr. Mark Summary, Amrit's Chief Medical Officer, and Sheila Frame, President of Americas, will be available to answer questions during the Q&A session. Joe will provide an update on the business, and then Rory will go through the financials in detail. Before I hand you over to Joe for his formal remarks, let me remind you that this webcast and conference call contains forward-looking statements, that involve risks, uncertainties and assumptions that are difficult to predict and which may be outside of the company's control, including, among other things, the development of its business, the trends in its operating industry, changing economic, financial or other market conditions. In light of these risks, uncertainties and assumptions, the events or circumstances referred to in the forward-looking statements may differ materially from those indicated in these statements. Words that express and reflect optimism, satisfaction with current progress, Prospects or projections, as well as words such as believes, intends, estimates, expects, plans, projects, anticipates, and other similar variations, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Any forward-looking statements made speak only as of the date of today's press release and conference call. Wednesday, November 3rd, 2021, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. For more information, we would refer you to the forward-looking statement section of the full-year financial press release issued earlier today, as well as the company's filing with the SEC. At this time, I will turn the call over to Dr. Joe Wiley. Joe, please go ahead. Thank you, Simon.

I am on slide four of the presentation. We are pleased to be reporting strong operational and financial results for Q3, with positive momentum in both our commercial business and our pipeline. The closing of the Chiasma acquisition in August means that we now have three growing commercial products, MetroLepsin, MyCapsa, and Limitified. AudioGel S10, if approved, will be the fourth. Total revenues in Q3 were $56.5 million, which represents growth of 14.6% year-over-year. Excluding the impact of sporadic last-time ordering and myCAPSAT, revenues grew 26.3% year-over-year and 5.7% sequentially quarter-over-quarter. We generated EBITDA of $6.2 million, excluding non-cash items, share-based compensation expenses, and restructuring and acquisition costs. This represents the seventh consecutive quarter of positive EBITDA generation. During the quarter, we made significant progress on the regulatory pathway for our lead pipeline asset, AudioGel S10, in both the U.S. and Europe. Our commercial launch plans for this product are now well advanced. We have a strong balance sheet with cash of $123.2 million at September 30th. Today, we are reaffirming our full-year 2021 revenue guidance of between $220 million to $225 million, representing 20% to 23% growth on 2020. As a reminder, we had raised this guidance at the time of our capital markets event in September. Moving on to our commercial policy, I'm now on slide five. Beginning with Metro-Lefton, revenues in Q3 were $36.3 million compared with $29.9 million in the same period of 2020. Metro-Lefton US revenues grew 18% year over year, and the EMEA delivered a very impressive 143% revenue growth in the quarter. This strong performance in EMEA was driven by improved market access and significant numbers of patients accessing therapy. As a reminder, Metro-Lefton was approved in Europe in 2018, and is still relatively early in its growth trajectory, and also has a broader label than in the U.S., encompassing both general lipodystrophy and partial lipodystrophy. We have previously shared with you our lifecycle plan in the U.S. to seek a label expansion for metroleptin to include the treatment of partial lipodystrophy in addition to the currently approved label for the treatment of general lipodystrophy. We received feedback from the FDA on a path forward for this initiative, which will require a Phase III study, and we are on track to initiate this study by the end of 2021. Let's move to Limitified on slide six. Limitified revenues were $18.5 million in Q3, compared with $19.1 million in the same period last year, a reduction of 3% year-over-year. The relative performance in Q3 2021 was due to some pre-ordering that occurred in Q3 2020 due to the impact of the COVID pandemic. Limitified, however, delivered $56.2 million for the first nine months of 2021 versus $54.6 million for the first nine months of 2020 and is on track to deliver expected growth for the full year 2021. We are conducting a paediatric study for Limitified and HOSH and we expect to have data mid-2022. Assuming positive data, we will seek approval of Lumicipide to treat children with HSH in both the US and Europe. Now onto myCAPSA on slide seven. myCAPSA, the first and only somatostatin analogue oral capsule, is a genuinely differentiated product. Given the robust clinical data supporting it and the patient preferences for orals, we believe myCAPSA has the potential to become the new standard of pharmacological care for the maintenance treatment of patients with acromegaly. The market opportunity is compelling. In the U.S., market research suggests there are approximately 8,000 acromegaly patients on chronic SSA injectable therapy, and this translates into a market that we estimate to be worth approximately $400 million. We estimate that the global market is worth $800 million. We strongly believe there is a place in therapy for an oral product, and we are excited to have it as part of our portfolio, and our entire team is energized to execute on the launch. Amherst held a virtual capital markets event on September 13th. The participants included Dr. Maria Flechereau of Oregon Health and Science University, who is a leading KOL in acromegaly. She presented a detailed overview of the current treatment landscape in this disease. In addition, our Chief Medical Officer, Dr. Mark Summeray, provided an update on our plans to develop mycapsa in patients with carcinoid symptoms stemming from neuroendocrine tubers, where the market opportunity is estimated at approximately $1.9 billion globally. We intend to pursue a 505 regulatory pathway in the U.S. for this indication. This event is archived on our website, and I would encourage those investors who were not able to participate on the day, to watch this webcasted presentation and accompanying slides. Turning to the product's performance in the quarter. Like Capsule delivered sales of $1.45 million, this reflects sales from August 5th when we closed the Kiasma acquisition. Revenues in Q3 were impacted by pre-ordering in Q2. Normal ordering patterns were returned in September, and the product delivered $1.14 million for the month, and it delivered another strong month in October. This product was the principal asset in our acquisition of Chiasma, so I want to spend a few minutes explaining why we're excited about it and how we are currently leveraging our sales, marketing, and medical affairs infrastructure to accelerate adoption and revenue growth. Patients are familiar with mycapsa, and they're certainly aware that there is an oral option available for octreotides. We also know that there's comfort from a physician perspective in making the switch from injectables. Furthermore, the product represents a compelling value to payers. At an oral option, it addresses unmet need, and it has been priced at a level designed to facilitate broad access. In order to maximize the potential of this product, we're effectively undertaking a relaunch. Prior to the acquisition, the commercial efforts had been exclusively focused on the pituitary centers. However, these centers were mostly closed due to the pandemic. Now, by combining the sales forces and medical teams of both organizations, Amrit is now in a position to take advantage of our MetroLeptin reps in the U.S. to accelerate the adoption of myCAPSET in the broader endocrinology community. We estimate that about 50% of the market is outside the PTCs. We already have depth of experience using an inside sales force to help identify where the patients are in the community. That helps us with metrolaptin, and we know that we can do the same thing again with mycapsa. We've combined our medical affairs teams to increase our share of voice in the field and across endocrinology. And finally, we have enhanced our patient support services to better support patient transition from injection to a morning and bedtime capsule. As these initiatives are being rolled out, we are pleased to see they've started to have an impact. And if we look at ordering patterns, we're very encouraged to see that monthly Metapsa orders in October were more than three times the orders in January. Now on to our lead pipeline asset, Oluogel S10, which will be marketed under the brand's name, FiltreVest, if approved. And now on slide eight. Oluogel S10 is a potential novel treatment for the continuous manifestations of severe EB, a rare and distressing genetic skin disorder affecting young children and adults. There is currently no approved therapy for this condition, and if approved, it would be the first to market for those patients suffering from this devastating condition. We continue to progress the regulatory pathway for Oliogel S10 in the quarter, having submitted the file to both the FDA and EMA in March of this year. In the U.S., the target producer date is the 30th of November, and we've been responding to information requests received from the FDA, all of which have been submitted on time. Our NDA is being assessed under priority review, and if approved, AMA will be eligible to apply for a priority review voucher. In Europe, we have responded to questions from the EMA that are on course for a THMP opinion in late Q4. Moving to slide nine, whilst the regulatory activities are ongoing, we are moving forward with our launch plans. If approved, we have the financial flexibility, teams, systems, and global infrastructure in place to bring all your gels to market and to execute our significant growth plans. EB represents a highly concentrated market. In the US, there are three world-class leading institutions, and then an additional seven that run specialized EB clinics. In addition, there's about 21 community-based clinics that support patients across the country. We already have in place a medical affairs team working with each of these EB centers. We have recruited two sales directors and have begun recruitment of a dedicated dermatology commercial team. One of the most important support services we can provide for patients is reimbursement. We've started to already engage with payers to make sure that they understand the burden of EB and the value that Oliogel S-CAN will bring to these patients. In parallel, we have been scaling up our manufacturing and supply chain to ensure adequate drug supply to meet expected demand. We have inventory that's ready to be shipped as soon as day one. Our existing manufacturing facility should be sufficient to build enough API for launch volumes through 2023. With that, we intend to have a dual-sourcing strategy that will be executed across the supply chain and manufacturing scale-up in order to support commercial demands beyond this. We look forward to providing the next update on Audiovisual S10 once we have a decision from the FDA. Let me now turn the call over to our CFO and COO, Rory Miller, who will provide more details on the Q3 financials. Rory.