Amryt Pharma plc

Hello, everyone, and thank you for joining us for the call to discuss the proposed acquisition of Chiasma by Amish. Before we begin formal remarks, let me remind you that some of the information in today's news release and on this conference call contain forward-looking statements related to, among other things, the anticipated benefits of the proposed transaction, the anticipated impact of the proposed transaction on the combined company's business, and future financial and operating results. the expected amount and timing of synergies from the proposed transaction, the anticipated closing date for the proposed transaction and other aspects of our operations or operating results. These forward-looking statements involve risks, uncertainties and assumptions that are difficult to predict and which may be outside of the party's control, including, among other things, risks that the merger disrupts current plans and operations of the businesses, the outcome of any legal proceedings related to the merger, the ability of the parties to consummate the proposed transaction on a timely basis or at all, the satisfaction of the conditions preceding the consummation of the proposed transaction, the development of amnesty and chiasmus businesses, trends in their 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 statement may differ materially from those indicated in these statements. Words of expression 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 the 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, May 5th, 2021 and the companies undertake no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. I want to draw your attention to two press releases that we used earlier today. Earlier today, Amherst and Chiasma published a joint press release announcing the proposed acquisition of Chiasma by Amherst, copies of which can be found on the respective Amherst and Chiasma corporate website. Separately, Amrit issued a press release this morning announcing financial results for Q1 2021. Today's call will happen in two segments. To begin with, Dr. Joe Wiley and Raj Kannan will present the details of the proposed transaction and then will be joined by senior management from both companies for a Q&A session regarding the transaction at the conclusion of their formal remarks. We will then turn the call back to Joe Wiley and Rory Nealon, Amrit's CFO and COO, to discuss Amrit's Q1 2021 results. This will be followed by a second Q&A session specifically focused on questions around AMRIS Q1. There are slides accompanying today's call. You can access these through AMRIS and Kiasma's corporate website. At this time, I will turn the call over to Dr. Joe Wiley. Joe, please go ahead.

Thank you, Simon. I am now at slide five. Good afternoon, everyone, and good morning to those joining from the U.S. Today is an important day for AMRIS. we are very excited to be announcing that we've entered into a definitive agreement to acquire Kiasma in an all-stock transaction. I'm pleased to be joined on the call by Raj Pranan, CEO of Kiasma, along with other members of the Kiasma management team. Before getting into the details of the transaction, along with the deal rationale and more, Let me first say thank you to the teams from both companies for working very hard over these last few weeks to get to this point. This is a deal which further strengthens Armour's position as a global leader in treating wear and orphan conditions. The combined company will have three on-market commercial products, Lumicipide, Metroleptin and Mycafta, as well as a significant development pipeline. This portfolio will be supported by a global commercial and operational footprint. Mycapsa is the first and only approved oral somatostatin analogue for appropriate patients with acromegaly. We see significant revenue growth opportunities for Mycapsa in acromegaly, where we estimate the global market is worth $800 million. We are also very excited to further develop the potential for mycapsa in patients with carcinoid symptoms stemming from neuroendocrine tumors or NET, where the total market opportunity is even larger, estimated at $1.9 billion. This transaction is expected to accelerate and diversify AMET's growing revenues, and we believe this combined portfolio of products offers a pathway to a potential $1 billion in peak revenue. Moving on to slide six. For Amerslea's development candidate, Oleogel S10, we have made regulatory submissions in both the US and EU. If approved, this will bring the combined company's portfolio of commercial products to four. Very importantly, this transaction will leverage our track record of successful integration. Amrit already has in place the infrastructure, expertise, and the financial flexibility to realize the full potential of myCAPSA. We intend to deploy this infrastructure to further accelerate the launch of myCAPSA in the US and also leverage our regulatory affairs experience and global commercial infrastructure to seek myCAPSA approval and launch internationally. The acquisition is expected to deliver annual cost synergies of approximately $50 million and we expect that it will be revenue and EBITDA accreted and cash generated in the first full calendar year of combined operations and substantially accreted thereafter. Fiatma's existing Royalty Interest Financing Agreement is expected to be fully repaid upon closing of this transaction, allowing us to add a high margin unencumbered asset to our portfolio. This is an all-stock transaction with Amris shareholders to own approximately 60% of the combined company and Chiasma shareholders to own approximately 40%. The deal has been unanimously approved and recommended by the board of both Amris and Chiasma. We also have boating agreements with the shareholders of both businesses, Ethereum Capital Management, Highbridge Capital Management and MTM Capital. Slide seven. should help explain exactly why we're so excited about this transaction and how we can leverage our combined infrastructure to really get the most out of our assets and create shareholder value. The addition of my capture to Amrit's existing commercial products means the combined company will have a total of three products on the market with strong IP protection. Amrit already has existing global infrastructure. In addition to our commercial and medical teams, We also have strong capabilities in R&D and regulatory, and the addition of Chiasma will further strengthen our existing footprint in the U.S. MyCAPSA has recently been launched in the U.S., and given the significant degree of customer call point overlap, we believe the combined business will potentially accelerate the adoption of MyCAPSA with endocrinologists. Given our strong existing relationships with endocrinologists, and by combining and scaling sales forces, We believe that this will both drive more cancer adoption and also potentially enable further metraleptin revenue growth. On the R&D front, our lead development pipeline product, Oleogel S10, is under regulatory review in the US and EU. And we intend to advance our gene therapy asset, AP103, into the clinic in 2022. With this transaction, we are also excited by the opportunity for Mercasa in NEP. And post-FDA discussion, it is our intention to start a Phase 3 study on this indication in the first half of 2022. We believe there is also a potential to leverage GASMA's technology delivery platform with our other products. I already mentioned the financial benefits, but just to reiterate, the transaction will be revenue-accretive immediately, We expect approximately $50 million in annual cost synergy and expect to be EBITDA positive and cash generative in the first full calendar year. Turning to slide 8. This is an overview of Amherst, and I'm presenting this mainly for the benefit of Chiasma shareholders and others who might be a bit less familiar with us. Amherst is a growing commercial business with two commercial products, MetroLeptin and Memitified, and a significant development pipeline. Our business is EBITDA positive and cash generative. Our global HQ is in Dublin, Ireland. Our US HQ is in Boston. The company was founded in 2015. On the right, you can see financial metrics, including some highlights from our Q1 2021 numbers that we reported this morning. Slide nine presents a financial snapshot of Amrit and should give you a sense of how well the business is currently performing. What you are seeing here are the 2020 versus 2019 numbers, as well as some highlights from our Q1 2021 financial results. What I want to emphasise here is that these numbers are, to a large extent, testament to the success of the Agerian acquisition. We acquired Agerian in September 2019 and it was successfully integrated, turning the combined business EBITDA positive in Q1 2020. Acquiring businesses and products is an integral part of Amrit's growth strategy and success to date. We have a proven track record of doing it successfully and I am fully confident that we can repeat this success with Chiasma. Today we announced Q1 2021 revenues of $48.4 million. That's up 8.7% over the same period last year and up 13.9% sequentially over Q4 2020. Metro-Lefton revenues in Q1 increased by 11.3% year-over-year to $30 million, and limited product revenues increased 4.4% year-over-year to $18.2 million. EBITDA in Q1 was $9.9 million, and that compares with $4.6 million in Q1 2020. We have a strong balance sheet with cash of $118.6 million as of March 31st. Today, we have announced that we are raising our full year 2021 revenue guidance from a previous range of $200 million to $205 million to now $205 million to $210 million. This, of course, reflects the strength of Armlet's existing business and excludes the expected uplift from my capital revenues post-transaction growth. Moving on to Armlet's approved products, I am now in slide 10. I will start with metraleptin, which is our product for the treatment of lipodystrophy. This is a chronic condition that results in leptin deficiency, which in turn causes metabolic abnormalities, including severe insulin resistance, diabetes, hypertriglyceridemia, and fatty liver. Metraleptin is an analogue of the hormone leptin and has been shown to improve these metabolic parameters, resulting in lower triglyceride levels, lower blood sugar levels, and lower HbA1c. The size of the opportunity in the major markets is summarized here. We estimate that the global market for metrolapsin is worth $530 million. We believe the product still has significant potential for further market penetration. On to slide 11. Our other product, Lumitify, is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal treatments for adults with a rare cholesterol disorder known as homozygous familial hypercholesterolemia, or HOFH. HOFH is a potentially life-threatening disorder that impairs the body's ability to remove LDL or bad cholesterol from the blood. The result is extremely high blood LDL cholesterol levels that, left unfeated, can lead to blocking of arterial blood vessels. HOFH patients are at risk of experiencing life-threatening cardiovascular events and untreated have a substantially reduced life expectancy. We estimate that the global market for the misplaced in HOFH is approximately $250 million. On slide 12, AMIT's most advanced development stage candidate and potentially a very significant growth driver is Oleogel F10. If approved, this product will be known under the brand name Silt-A-Bed. The successful completion of our Phase 3 trial in EB was one of AMRIT's major accomplishments last year. The trial, known as EASE, met its primary endpoint with 41.3% of patients in the Audiogel S10 group achieving first complete closure of EB target rooms within 45 days of treatment versus 28.9% in the control group. The results were statistically significant, the p-value was 0.013. EASE was the largest phase III trial ever conducted in EB and also the first to show a positive readout. Our plans to seek approval for Oliogel S10 are already far advanced and we have made regulatory submissions in both the US and EU. Our NDA submission to the FDA includes a request for priority review which could potentially expedite the review process to six months following acceptance of the NDA submission. If this is granted, we could potentially be looking at a U.S. approval in the fourth quarter this year. Previously, Oligogel S10 has been granted orphan, fast track, and pediatric rare disease designation by the FDA. It means that if an NDA is approved under priority review, we will be eligible to apply for a priority review voucher, which can be used sold or transferred. Turning to slide 13. As you can see, the combined portfolio of products and pipeline post-transaction flows will be significant. For the two commercial AMRAC products, Limitified and Metroleptin, you can see the approved indications on the upper section of the chart. Mycapsa in acromegaly will be our third market for products, and as I mentioned, this also has the potential to be developed for neuroendocrine tumours. I've already discussed Oliogel S10 and would like to highlight our exciting gene therapy asset AP103, which is expected to enter the clinic next year. The important thing to note here is both the breadth of our portfolio and also that these products will generate meaningful news flows this year into 2022 and beyond. Slide 14 shows the extent of AMRET's global infrastructure. For the US and major markets in the EU, we have our own direct sales teams. In the Middle East, we operate a hybrid model with our own teams working together with local distributors, and we have a similar model in Latin America. Beyond that, we have distributors in Canada, Central and Eastern Europe, and in Russia. We plan to leverage this infrastructure to drive the launch of myCAPTA internationally. At this point, I will hand over to Raj Kanan to talk about Kiasma, the opportunity for myCAPTA and the potential for this transaction to deliver significant value for shareholders. Raj.

Thank you, Joe. And good morning and good afternoon, everyone, depending on where you are. Let me start by saying I'm equally excited about the combination and the potential for the combined company to deliver value for both the patients we serve and for our shareholders. For the AMOLED shareholders and for those of you who may be less familiar with Chiasma, we're a commercial stage company that is focused on developing and commercializing oral formulations for patients who face significant challenges with their infectables. We were pleased to see MyCapsa, as the first and only oral somatostatin analog approved for patients with acromegaly in June of 2020. The U.S. adult acromegaly market is a commercially attractive space in which we estimate approximately 8,000 patients to be on chronic somatostatin injectable therapy. We believe, given the robust clinical data that we have generated for Mitasa and the patient preference for orals, Mycapsa has the potential to become the new standard of pharmacological care for the maintenance treatment of patients with acromegaly. We believe we have strong patent protection for Mycapsa in the US and in the EU through 2029, with method of use coverage in the US through 2036, and with the EU patent pending. And lastly, our company is genesis with the technology platform we call TPE, or transient permeability enhancer. And with the approval of MICAXA, we believe we now have a validated platform to explore other development opportunities in the conversion of burdensome injectables in therapeutic areas of high unmet need for an oral option. Moving on to slide 16, acromegaly, as many of you may know, is a rare disease most often caused by a benign pituitary tumor and characterized by an excessive growth hormone and insulin-like growth factor 1, also called IGF-1. It is a serious life-altering and life-threatening disease. The first-line treatment choice is surgery. However, we estimate that 4 out of 10 patients are either ineligible for surgery or are not cured and will need lifelong pharmacological treatment. The somatostatin analog or SSA class is the preferred dominant first-line therapeutic choice for these patients. Prior to the introduction of mycapsa, the current SSA injectables, while offering a life-altering treatment option for patients with acromegaly, brought with them significant challenges. These injectables are administered via large board needles, 18 to 19-gauge injections, Many patients experience considerable pain even days after administration, and a significant percentage of patients experience modest to severe injection site reactions. Importantly, more than half experience breakthrough symptoms towards the end of the monthly dosing cycle when the level of the monthly depot injections begins to taper off. Patients may also miss working days in scheduling visits with their doctors, as these injections often have to be administered by a healthcare provider. Given the significant challenges patients with acromegaly face, we believe Mycasa offers an attractive alternative in providing consistent biochemical control and a positive patient experience with a simple daily dose regimen of an oral pill. Turning to slide 17. We launched MyCAPSA in September of 2020, and given the launch was during a pandemic, we adopted a hybrid and a phased approach in our go-to-market launch plan with MyCAPSA. We're pleased with our launch progress to date. We've significantly increased the number of covered lives with access to MyCAPSA, now over 185 million lives, and also significantly increased our reach into pituitary centers and high-volume endocrinologists who are most likely to be early adopters of the potential paradigm shift. Importantly, based on our market research, the leading indicators on physicians' intent to prescribe, the patient's willingness to try an oral option, and the increasing care coverage who recognize and accept the value proposition of a needed oral option for patients with acromegaly support our belief that Mitasa is well-positioned to become the new standard of pharmacological care in the maintenance treatment of patients with acromegaly. Moving on to slide 18, net sales of somatostatin analogs in 2019 were estimated at $2.8 billion globally, of which acromegaly represents approximately 800 million. In addition to this opportunity, the dominant utilization of SSAs is in NET. Potentially expanding the benefits of mycapsa to patients with neuroendocrine tumors, or NET, is a logical next step. NETs represent the single largest segment of the U.S. SSA market, accounting for approximately $1.3 billion. This could represent a significant market opportunity for mycasa. Moving on to slide 19, NETs or neuroendocrine tumors are abnormal growths of neuroendocrine cells occurring throughout the body, most commonly found in the gastrointestinal tract. NETs can metastasize and produce hormones that cause significant symptoms termed as carcinoid syndrome, which includes diarrhea and flushing episodes. Treatments include surgery and somatostatin analogs to limit tumor progression and address carcinoid symptoms. Octreotide LAR and landreotide DEPO injections are broadly used as first-line pharmacological treatments, and the potential addressable market with somatostatin analogs in any T is estimated at approximately 24,000 patients in the U.S. We believe there is a high unmet need for an oral option in neuroendocrine tumors similar to the acromegaly market. As we noted in the joint press release today, following feedback from the FDA, we believe we have a modified 505 regulatory pathway for marketing approval that could potentially enable mycapsa to become the first approved oral somatostatin analog indicated for the treatment of carcinoid symptoms in patients with NET. Moving on to slide 20. Finally, myCAPSA emerged from our proprietary oral technology platform, which we call TPE. This is now a validated platform that allows us to further explore additional new development opportunities in therapeutic areas dominated by burdensome injectables with high unmet needs. I'm now on slide 21. I hope that gives you a good overview of Chiasma and why we are confident in establishing a successful commercial company with a meaningful pipeline. I now want to articulate why we want to join with Amherst and why this is the right time in Chiasma's evolution to enter into this transaction. As you heard from Joe, Amrit is an established successful company focused on rare and orphan diseases with a consistent track record of commercial success. Amrit's global presence is a key factor for us in joining forces with them. Chiasma is a US-focused organization today so there will be clear benefits to leveraging AMRIT's global commercial presence and success in key markets outside the United States. This will be critical, we believe, to the continued growth of MICAPSAR globally. Importantly, we believe this combination allows us to accelerate the commercialization of MICAPSAR in the United States while extracting significant operational synergies of approximately $50 million in annual savings. We believe the combination allows our business to get to profitability and positive cash flows faster than doing this alone. Lastly, capitalizing on AMET's financial strength and cash flows, we expect the combined company to further expand the development opportunities for MyCapsa beyond Acromegaly and by leveraging our technology delivery platform. Importantly, I believe that Amrit and Chiasma have shared values in that both companies are passionate about delivering innovative new treatments that can help improve the lives of patients with rare and orphan diseases. In meeting with Joe and many members of his management team, I believe there's a good cultural fit, and this is going to be a key factor in making this combination a success. Finally, I can say that I'm impressed by the management team at Amrit. They have a clear vision for the company, and I'm confident that they have the passion, the drive, and the resources to maximize the value of myCAPSA and the TPE to create long-term value, both for our patients and for our shareholders. I will now turn the call back over to Joe for closing remarks.

Thank you, Raj. Starting with slide 22, let me conclude by reiterating why we think this transaction makes sense strategically and why we have strong conviction of the value that this combination will bring to our patients and our shareholders. This transaction strengthens our position as a leading global commercial stage orphan disease company. The combined business will have three marketed products, each of them growing and addressing large attractive markets. In addition, we have an insightful pipeline of development stage assets with the potential to drive near and long-term growth. Overall, the combination represents a compelling operational and strategic fit supported by global commercial, medical and regulatory rare disease infrastructure. And very importantly, we believe we will have the financial strength to deliver on our future growth plans. That concludes our prepared remarks. I will now hand over to our operator and we will open the call to questions. In the interest of time, I would ask that everyone limit themselves to a maximum of two questions each fee. Operator.

Thank you. As a reminder, ladies and gentlemen, if you wish to ask a question, please press star 1 on your telephone keypad. As a reminder, we have a second number of attendees online today, and we will be limiting questions to a maximum of two per analyst. Our first question today is from Brandon Fuchs from Cantor Fitzgerald. Please go ahead.

Hi. Thanks for taking my questions, and congratulations to both teams on this. All right, lots of questions, but I think it's very good. But the two I'm going to ask is maybe just on OleoGel S10. I'd love to get Amrit's updated thoughts on gene therapy. We've obviously seen some safety concerns in general around gene therapy. And how do you think about what we've seen and how this could play out for AP103, just given an even more, you know, Could this make it more compelling versus perhaps a viral vector? And then any implication do you think for Oleagel S10 in that meantime? And then you covered a lot on Chiesa, but maybe if I can ask one, just maybe for Raj. Any color on your access to physicians at the moment? You know, the number of patients on therapy, just sort of even if it's just qualitatively And within that for sort of the broader team, how should we think about the synergies? Are they going to be reinvested back into the combined business or drop to the bottom line? Thank you.

I think you spoke a third question in there, Brandon. Thank you for your question. Let me address the question. the question on the gene therapies first. I might hand that over. We have a number of both management teams on the call today. So our chief medical officer, Mark Summers, I'll ask him to speak as well. So I think you're right. Our AP103 product, we didn't get a chance to speak about it in our former remarks, but it is a topical gene therapy delivering the gene called 7A1 in patients with dystrophic EB. So we're also focused on EB. However, the delivery vector is not a virus. It is a polymer-based delivery vector based on a platform technology, HPAE. And in our preclinical work, it's giving the same degree of collagen production in our models that you see with viral vector. So we're very excited by that because in a situation where you have the likely need for chronic therapy with a gene therapy with the skin turning over, having a gene therapy that does not have a viral vector, we believe could confer some significant benefits. Mark, maybe I'll hand it over to you and you could give us a little bit more colour.

Yeah, thanks, Joe. So just very quickly to add to what you said, more specifically with a viral vector, one is always going to be concerned about the risk of an immune response from the patient. And that could potentially have consequences in terms of anti-vector antibodies, which would interfere with efficacy over time, as well as potential safety concerns as well with adverse immune responses and inflammation causing symptoms which are unpleasant for the patient and potentially even dangerous. So avoiding a virus, even a virus that might have been modified to try to mitigate those potential adverse effects, is always going to be an attractive potential. So we believe that the platform behind AP103 is attractive for those reasons. In addition, of course, it's also attractive because the manufacturing process is simpler. It doesn't involve biological material. The supply chain isn't frozen. And the application of the product is more straightforward. And it doesn't have the potential to be limited to a situation where a healthcare provider might be applying the product. As Joe has already mentioned, there's plenty of non-clinical data so far that suggests it's feasible to deliver the gene using the polymer technology as the vector instead of the virus, and we think that's a very appealing potential. You did ask briefly about how it fits in with Oleagel S10. We think that there's some attractive complementarity to these two approaches. Oleagel S10, as you know, is a product that's also applied topically, but which accelerates the healing process. And we've seen evidence of clinical benefits in terms of number of endpoints that we've measured in our phase three program, which are associated with that acceleration of healing process. But there are definitely wounds, in particular chronic wounds, that are very difficult to heal. One would envisage that actually the most likely opportunity to benefit the patient by treating those chronic non-healing wounds would be to apply a gene therapy approach. So in conversations with KOLs, we're certainly of the view that we see and they see an opportunity for these products to be used alongside each other.

Thanks, Mark. Raj, I'll hand over to you on the access to KOS question, and then maybe Rory can speak about synergies.

Sure. So, Brandon, great question. I would say that our access to customers continues to improve as COVID-19 restrictions have begun to ease in many of the states around the country. And we continue to believe that that access will improve further in the months to come. As we stated in our 1Q earnings release this morning, Brandon, you clearly saw an increased momentum with our launch where we doubled our net sales in the first quarter. And as I noted before, I think I'm waiting for at least a couple of normal quarters without COVID-19 to be able to start talking about, you know, where we are netting out and what the future guidance is. But at this time, I will say that I remain confident that we are on our way in our belief and our intent to make my CAPSA the new standard of pharmacological care. I'll ask Anand before Rory jumps on if to add any other color from his perspective on the launch.

Thanks, Raj. I appreciate it. So, Brandon, in addition to what Raj said, what we are seeing is that the accounts that are open to calls are more productive in terms of prescription generation than those that aren't. So that's another positive leading indicator for ongoing momentum because obviously our expectation is that these accounts will continue to reopen to face-to-face sales calls as the the pandemic recedes, more people are vaccinated, and then there's more general reopening. And we have seen that in the pockets of the country, where there is a greater level of reopening as well, that those accounts are more productive in terms of prescriptions. So, that's, I think, for us, a positive leading indicator.

Thanks, Anand. Actually, before we go to Rory and answer that synergy question, we also have our President of the Americas, Sheila Frame, on this call. Sheila, maybe you could give some color as to why we're so excited about the opportunity for my cancer.

Sure. Thanks, Joe. And I think the combination of the two sales organizations as it relates to endocrinologists, especially now as the country starts to open up, is really an opportunity for us. So we've seen significant momentum in Q1 with respect to MyLept. And I think that that combined with the open access and the value that MyCapsa can bring to patients, I think is really what will demonstrate the value of these two companies and these two teams in particular coming together. So I think having the product upon close, of course, the two products together in the case of endocrinology really enhances the value that we can bring to the marketplace. And then as well, I think payers are demonstrating that they are certainly supportive of what these two products can continue to bring to patients overall. So we're certainly very optimistic about what we can do together.

Thanks, Sheila. Rory, I'll hand over to you on the sneaky third question in there.

I think Brandon's getting lots of value for money with his two questions. But anyway, I draw your attention, folks, to slide, I think it was 13, which is the pipeline slide. I believe your question was, to what extent are we reinvesting the synergies back into the business, Brandon? And if you look through that slide, you'll note that we are investing, and in our models and our plans, is in NET, in the partial lipodystrophy, opportunity for MetroLept in the United States, which could potentially double the market opportunity in the States. We're also doing a paediatric study in Limitapide. We're also, as you all, as Joe alluded to, pushing through, hopefully to conclusion, the Oliogel S10 study in EB, and as was spoken of a short while ago, AP103. So we are investing back into the business, to answer your question, and we're also planning to pull out the 50 million of synergies that we alluded to in the press release.

I think you mean the other 10 regulatory approval process, a lot of them. Thanks for it.

Thank you very much, everyone. I appreciate that. That's great.

Thanks, Pauline.

Our next question is from the line of Michelle Gilson from Haniford. Please go ahead.

Hi. Thank you so much for taking my question. I was hoping you could get a little bit more into the specifics here in terms of what the AMA team, I guess, you know, what are some of the efforts that you think that you need to execute on to accelerate the launch of myCAPSA? And maybe you can point to your experience in a little bit more, I guess, specifics that gives you confidence that, you know, you can execute on those parameters and, you know, the value that the, I guess, AMRIT team and experience adds to the MyCapsule launch. And then I do have a follow-up.

Absolutely, Michelle. Maybe I'll hand that one to you, Sheila. You can give a little bit of color on your background as well for Michelle.

Sure. I think, Michelle, the most important thing to look at is the quarter-over-quarter success that Emirates has demonstrated with respect to endocrinology in particular, but certainly on both products in the U.S. since the integration of Agerion. And so we have been able to demonstrate sort of this notion of bringing the companies together and leveraging the synergies that came available from the Adgerion acquisition. And I think what really excites us now is that with the access and relationships that we have, in particular in the endocrinology space, instead of starting from scratch, we actually have those relationships and have had pretty consistent access throughout. I think where... you know, myCAPSA, I think, has an opportunity to enhance our value proposition with respect to what we bring to the endocrinology total office call will really accelerate that. I think trying to launch a product in endocrinology, which I think was very hard hit by the pandemic, I think just made the launch that much more difficult for for the team at Chiasma, although from what we've seen, every one of the fundamentals have been in place in order to do that. So as the marketplace opens up, combining the deep relationships and experience that we have with my left in particular, with the value that my CAPSA brings to patients, and I think Raj spoke a little while ago about stable patients, you're launching into a marketplace where you're asking physicians to switch. And that in the context of this pandemic in particular is a big hurdle. So as the marketplace opens up, we have a value proposition that will provide sustained control for patients at the same time as we're leveraging the relationships that we have and a track record from a business perspective that of sustained quarter-over-quarter growth.

Sheila, I would also say I think we have invested quite heavily to that question in a digital and virtual platform during the pandemic. And I think increasing our focus, as Sheila just said, right, between two companies, really in serving our endocrinologists better with the continued strength of relationships that we have with our KOLs and the increasing payer coverage that we're getting from ICASA and our patient support services system that is in place, we remain confident to your question that this combined company can further accelerate the adoption and utilization of mycapsa in a much more efficient way than we've been able to do on our own.

Thanks, Raj. Before you go to your second question, Michelle, the other thing that we shouldn't forget here is that there's a huge opportunity internationally, and Amrit brings the the infrastructure to the table we're already a global commercial business as as you saw in on the slides where we showed our our our infrastructure including our own folks on the ground our own teams on the ground medical and and commercial and our distributor network we do have our chief business officer dave almond on the line as well so dave maybe you can give a little bit of color as to how we see the opportunity for my capstone beyond the us yeah thanks joe um so

I mean, pending the work that the Chiasma team are doing in Europe from a clinical and regulatory perspective, which is ongoing, we are in the midst of assessing market by market where the opportunity lies for mycapsa to serve patients across the Europe, Middle East, Africa region, and that would be on two levels. One is at the formal reimbursement approach for you know, full launch in a given market where we see attractive opportunity. Under the number of those markets, we've done a full bunch of research now as to where those markets must be. Countries like Germany, for example, would be one to consider as an example. We've also done our research in Japan. So we're considering each market around the world for that formal full approach. And, of course, as we see in rare diseases, because patients frankly don't choose where they're born and they can access these therapies perhaps where physicians are seeking treatments for them. We expect also some named patient demand, which is unsolicited, but we see that in the Middle East. We see that in Latin America and beyond. And where patients are dissatisfied with current standards of care, and physicians are seeking alternatives of their own volition will be ready and able to support those requests in addition to those sort of formal reimbursement approaches once we've done our full market assessments.

Thanks, Dave. Michelle, I think you said you had a second question.

Yes, I do. Thank you so much for the comprehensive answer. Also, I wanted to ask, you know, You mentioned in the slides that the TPE technology could be expanded into more of a pipeline. You know, I just was wondering about metraleptin more specifically, if the size of metraleptin fits within the constraints of the TPE technology. From my memory, I think that size was the constraint. It's been a while. But then the other question that I had is, just in terms of, I guess, the altered PK profile that a daily oral could sort of provide for metraleptin in terms of, I guess, CMAX more specifically, you know, could that also have an effect on neutralizing antibodies?

Thanks, Michelle. Yeah, I'm not the expert in TPE, so I'm certainly going to hand that over to Raj in his team. But in terms of the overall strategy, we believe that we can invest in the TPE technology and leverage that for other products. You alluded to metraleptin. Metraleptin is an obvious choice. There's a lot of work left to do, though, before we could understand that better. Raj, maybe you want to take a little bit, talk a little bit about TPA, and then Mark, you might answer the question on the . Yeah, sure.

Look, I think it's important to kind of focus on, you know, the comments that Joe and I made during our call today. We've got three very strong commercially growing marketed products. We have an exciting product in registration in OleoGel S10. We've got a midterm opportunity with MET. And certainly we're starting to explore how we can leverage our PPE. So there's quite a lot of exciting things to do within the company. We certainly have our eyes on certain therapeutic areas where there's a high unmet need. But as we progress, right, we certainly feel there are opportunities to potentially explore and leveraging TPE to start further supporting the robust pipeline that Joe pointed out during this presentation. I think, Joe, you wanted Mark to take over from there, or I wanted to see if Bill also had any comments to make for my team. Okay.

No, Raj, I completely agree with that. We've got a lot of very exciting opportunities that we're going to be looking at carefully as we move ahead. But this merger together really opens up a lot of new possibilities for us.

The only thing I've got to add to that before Mark jumps in is that because we believe that this will be EBITDA positive and cash generative accretive in the first full calendar year, we have the financial strength not only to invest in that energy opportunity as we stand, but also to invest in TPE, which we would definitely want to do and will do. Mark?

Yeah, thanks, Joe. So just like everybody else, I'm also excited about the possibilities for TPE. And it probably wouldn't surprise you, Michelle, to know that I've already looked at the size of MetroLeptin It's a 16 kilodalton molecular weight molecule. So, of course, it's important to caveat we have not looked in any detail whatsoever into the feasibility of combining metroleptin with the TPE technology approach. However, I can say that at least on the face of it, the size of the molecule does not appear to be a barrier based on how TPE is able to facilitate entry of molecules of that size across the small intestine. So, at least in that sense, it doesn't fall at the first hurdle. And regarding your question about the potential to have an impact on the incidence of neutralizing antibodies and how that might relate to the PK profile, it's a very good point. And maybe it would have a beneficial impact in terms of avoidance of those neutralizing antibodies. We don't fully understand the mechanism behind neutralizing antibody formation with injected metrolaptin. However, I think it's actually quite likely, rather than it being a TK issue, it may well be a route of administration issue, by which I mean when you inject it, it may well be that the molecule or the, The metraleptin drug substance comes out of solution and precipitates under the skin, and that's something that can cause an immune response because it gets taken up by antigen-presenting cells, and then that triggers a series of events that lead to antibody production. So it could be that administering this differently would avoid that, but we just don't know. Certainly very excited to explore it, though.

Thank you so much for taking my questions and congratulations on the merger.

Thanks, Michelle. Thank you.

Our next question is from Max Herman from Stifel. Please go ahead.

Great. Thanks for taking my question and congratulations on the deal. Amrit was looking at acromegaly from its very early days, so it's interesting to see you moving into there now. In terms of my caps, I have one question, which is in terms of what you expect in terms of the market penetration, do you see it really being an alternative for patients with acromegaly or do you see it potentially for the larger market, in other words, patients who are also perhaps on somatuline as well or other treatments for acromegaly?

Raj, I'll hand the question over to you given that it's your product.

Yeah, absolutely. Thanks for asking that question. you know, consistently stated that our intent is to make my CAPSA the new standard of care. And, you know, what I presented during the call with Joe is that if you look at all of the leading indicators and the feedback that we've had from patients, physicians, opinion leaders, patient advocacy organizations, and payers, We continue to see a clear unmet need for an oral option. And for all the problems that I stated during my call that the monthly injectables bring with them, clearly patients have a very good preference, clear preference for oral options. One of the most tangible points that I can point to you is our optimal study where in the open-label extension, you saw 90% of the patients who stayed on mycapsa. Remember, these were patients who were well stabilized on injectables. And in the open-label extension, 90% of them chose to stay on the oral therapy. And we continue to see the same kind of feedback every time we do market surveys and what we hear from patients. So, we continue to remain very confident that this could become the new standard of pharmacological care. I don't know if I can give you a specific share what a standard of care means, but usually in our estimation, that means it's the preferred agent for physicians to go to versus the current standard of care.

So just as a follow-up in terms – I know it's early days. Are patients that you're seeing now switch or move to mycapsa? Are they – new patients, are they patients that have previously been on Sandostatin, or are they a combination of patients who've been on Sandostatin and somatolene?

Yeah, great question. Remember, our label right now and our clinical trials were done in patients who were controlled on somatostatin injectables. So this is also, by the way, the largest market opportunity that we have. As we stated, 8,000 patients are at any given point in time on any given day, they are on chronic SSA injectables. So that's the market to go after. That's our label. The new patient flows, per se, is not as attractive if you think about the incidence and prevalence of the new diagnosis for acromegaly. So going after the patients who are on FSA injectables and who face the challenges on an everyday basis is the right target to go after to be able to realize the intent of making this as the new standard of care.

Great. Thank you.

Our next question is from the line of Douglas Stow from HC Wainwright. Please go ahead.

Hi, good morning. Thanks for taking the questions and congratulations on the deal. Obviously, you highlighted the opportunity in NETS for MyCASA. Just curious, how quickly can we start to see development in that indication? Thank you. Sorry, you didn't get that last part of that question. Sorry. Oh, sorry. I'm just curious how quickly... in terms of the next opportunity, do you think you can start to see some actual clinical development work?

So, Joe, if I could answer that question. Yeah, please go ahead. Thanks, Joe. As we noted in our press release, right, and in our joint presentation as well, we have an IND submitted for a phase one healthy volunteer PK study. followed by a single phase three study, and we stated expected to be initiated in the first half of 2022. Obviously, this needs final alignment with the FDA, which we hope to do in the middle of this year. And once we have that final alignment, the expectation is to kick off that study in the first half of 2022. And so all of this is designed to support a modified travel 5B2 pathway. So our intent is to get to the market as efficiently as possible to be able to expand the benefits of mycapsa to patients in NET, Doug.

Okay. And again, just in terms of sort of a very accelerated path, how do you feel your comfort level in terms of not needing sort of a dose-ranging study, or do you feel that given what you've done in acromegaly, you have a sufficient understanding? Okay.

I think if you look at the MICAPSA submission on acromegaly, right, a lot of the preclinical CNC talks and the dose characterization has been well substantiated. So I think, you know, that's what gave us the impetus to sit with the FDA and really work with them to be able to what I call a modified 505BQ pathway. Again, I think there is a final alignment still pending. Post that, we'll be able to update you, Doug, in what that timeline looks like and what the feasibility of that study looks like.

Okay, great. Thanks.

Our next question is from Tara Ravindra from SureCap. Please go ahead.

Hi. Morning, guys. Congratulations on the acquisition. So two questions for me, please. I guess firstly for Joe and Raj. How have you arrived at your $1 billion peak sales for the combined entity? So if I look at consensus on Bloomberg for Kayapna, I see revenues of $240 million by 2024. So are you comfortable with this, and how is this made up? Is it Akamai Kiliomi or U.S. and EU? And then secondly, if you could just give us a bit more color on the pivotal net trial that you're thinking of doing. just in terms of design and timeline. Thank you.

Hey, Cara. Thanks for your questions. Yeah, so on the announced potential pathway to a billion dollars in revenues, we haven't given any specifics on that, but when you looked at it, so we have, We have three marketed products. We have the opportunity for Metro-Lefton. We've stated that the market for that product is $530 million. We have Limitify for the market opportunities, $250 million. You then look at Acromegaly. You've given some numbers there. The addressable market is $800 million. But NET, the addressable market is $1.9 billion. and the addressable market for NEB is north of a billion dollars. So, you know, when you look at that, you can see, and that's before we start thinking about AP103 coming to market as well, you can see that there is a significant opportunity here for the combined group. Raj, I'll hand over to you on the NET question.

Yeah. Thanks, Joe. As I've stated before, we still have a type C meeting scheduled with the FDA. Our intent is to conduct a phase one healthy volunteer study followed by a single phase three study. I think as soon as we have that alignment, we should be able to provide you details at an appropriate time in the second half of this year in terms of what that phase three study design looks like and potentially the timeline and the cost for that.

Okay, great. Thanks, and congratulations again, guys.

Thanks, guys.

And our next question is from Naz Rahman from Maxim Group. Please go ahead.

Hi, guys. Congrats on the deal. I have a question on my CAPSA and international markets. What are your thoughts on timelines for regulatory submissions, potential approvals, and potential launches?

My apologies, I agree to catch your first name. Naz. Naz, apologies, Naz. Yeah, so I'll pass the question on the regulatory timelines in the EU to Mark, and then maybe, Dave, you could speak a little bit more, give a little bit more colour on the international markets that we're looking at. There are a number of those where I'll leave it to you, Dave, to give some comments.

Mark? Yeah, thanks, Joe. So let me start the answer, but I'm going to ask Bill, who has been obviously much more involved with the implementation of the European filing for MICAPSA, to comment. But based on the information and the exchange between the two companies so far, My understanding is that Chiasma have progressed discussions with the European Medicines Agency and the rapporteur and co-rapporteur countries over the last few months and are expecting fairly soon to be in a position to file a marketing authorization application in the EU. But I'll ask Bill perhaps to comment with a little bit more specificity.

Thanks, Mark. Yeah, that's what you said is exactly right. We started our initial interactions, we've had a rapid tour meetings. And as Raj said earlier, we'll be submitting our MAA mid this year. So we are well on our way to that application process.

Thanks. I have another question on phase one study NET. I know that you said the phase one study is mostly a healthy volunteer safety study, but are there any biomarkers you're going to be looking at or any, like, specific endpoints you want to look at on top of safety?

Bill, do you want to answer that question? Sure. Yeah. So, as you point out, this is a small healthy volunteer study. In acromegaly, our dosing went up to 80 milligrams total a day. In neuroendocrine tumors, there's often higher doses used in those patients as compared to patients with acromegaly. So, we'll be looking at some higher doses for that safety and get a sense of PK analysis in that study, enabling us to launch into our phase three study. That's the primary purpose of that phase one study.

Thank you.

And there are no further questions at this time. We're going to hand back to Amrit Farmer for the second part of today's call.

Now to discuss the AMRIT Q1 results are Dr. Joe Wiley and Rory Nealon, the company's CFO and COO. In addition, Dr. Mark Summary, Amish Chief Medical Officer, 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 turn it back to Joe for his formal remarks, let me remind you that this 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 of expression 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, May 5th, 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, I would refer you to the forward-looking statement section of the quarterly press release issued earlier today, as well as the company's filings with the SEC. At this time, I will turn the call back to Dr. Joe Wiley. Joe, please go ahead.

Thank you, Simon. I will now go to our earnings for the quarter ended March 31, 2021, and recent business highlights. I will begin on slide 28 of the presentation. The financial results we released this morning demonstrate the continued positive momentum and growth in our commercial business. We generated overall double digit organic revenue growth and are raising our guidance for 2021. More on this later. We made progress on our label expansion plans for both of our commercial products. On the regulatory front, we have made submissions to both the FDA and EMA for our lead pipeline asset, AudioGel S10, and if we are successful, we could potentially be looking at an approval in the US before year-end 2021. Overall, a busy and exciting quarter for AMRIT and a really fantastic start to the year. Let me now run you through some more specific highlights for Q1. I am now on slide 29. First quarter, total revenues grew by 8.7% year-over-year to $48.4 million. If we exclude periodic LATAM orders, the underlying year-over-year revenue growth was 16.5%. On a sequential basis, revenues increased 13.9% quarter-on-quarter. We generated $9.9 million of EBITDA in the quarter. This represents the fifth consecutive quarter of positive EBITDA generation. Token cash as of March 31, 2021 was $118.6 million, which is about flat versus year-end 2020. Today, we are raising guidance for 2021. Given the strong performance of the business year to date, we are now increasing our revenue guidance for 2021 from a previous range of $200 million to $205 million to a new guidance today of between $205 million to $210 million, which represents growth of between 12% to 15% on 2020. For clarity, the new guidance excludes any potential revenue contribution from the Kiasma acquisition. Moving now to our two commercial products. I am now on slide 30. Global sales of Metro-Lefton in the first quarter were $30 million, up 11% year-over-year. Underlying sales, which excludes periodic LATAM orders, increased by 25%. A significant order has now been received and will be booked in Q2 2021 from LATAM. The US accounted for 54% of Metro-Lefton sales and EMEA accounted for 43%. EMEA methaleptin sales growth was 50% in the quarter. This was driven by the ongoing rollout of methaleptin in the EMEA and previously announced positive reimbursement decisions. In Q1, we announced a new multi-region distribution partnership with Medecin Pharma. Medecin will work with Amherst to distribute methaleptin and LimitPi in Canada and Israel. Medicine has a significant presence in each of these geographies, and we are pleased to leverage the distribution strengths to expand our commercial access. We have previously shared our lifecycle plan in the U.S. to seek a label expansion for metraleptin to include the treatment of partial lipodystrophy in addition to the currently approved label for the treatment of generalized lipodystrophy. We received feedback from the FDA on the path forward for this initiative, which will require a Phase III study. Based on our discussion with the FDA, we are planning a global 80 patients, 12-month randomized placebo-controlled Phase III trial to evaluate the safety and efficacy of daily subcutaneous metholeptin treatment in patients with PL. Our goal is to initiate the study by the end of 2021. As we have discussed on prior calls, we estimate the market opportunity in the U.S., with the current GL label to be approximately $140 million. And if we are successful in adding PL, we believe it will be approximately double the size of the investment market to $280 million. Let's move to limited price on slide 31. First quarter sales were $18.2 million, a 4% year-over-year increase. The US made up 46% of sales and EMEA sales were 41%. EMEA sales increased by 42% year over year. We are conducting a pediatric study in HOFH and we expect to have data in early 2022. Assuming positive data, we will seek license variation in both Europe and the US to include the treatment of children with HOFH. We are also testing the use of Lumetipide in familial collimacronemia syndrome, or FCS. This is a severe, rare genetic lipid disease characterized by extremely elevated levels of triglycerides or hypertriglyceridemia. We recently announced positive clinical results from an investigator-led proof-of-concept study in Italy. In the open-label study, patients were administered escalating doses of Lumetabide for 26 weeks. The median fasting triglyceride levels at 26 weeks were 672 milligrams per deciliter, representing a 70.5% median reduction versus baseline. Fourteen of the 18 enrolled adult patients achieved a reduction in triglycerides to less than 1,000 milligrams per deciliter. and 13 of these achieved triglycerides of 750 mg per deciliter or below at 26 weeks. The reduction in triglyceride levels is consistent with Lomitopite mechanism of action in the small intestine, where it inhibits the assembly of chylomicrons. Reduction in triglycerides to these levels or below is generally considered adequate to substantially reduce the risk of acute pancreatitis. We are encouraged by these data, and we plan to discuss the potential development path forward with the FDA and EMA. We will provide further updates in the coming quarters. Finally, let me provide an update on Oliogel S10. I'm now on slide 32. We completed the rolling submission of an NDA to the FDA for the potential treatment of the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa. The NDA submission includes a request for a priority review, which, if granted, can expedite the review process to six months following acceptance of the NDA submission. Previously, Oliogel S10 has been granted orphan, fast-track, and pediatric rare disease designation by the FDA. The rolling submission of the NDA began on June 29, 2020. Based on FDA timelines, AMRIT expects to receive notification if priority review has been granted and if the NDA has been accepted for filing sometime this quarter. We also announced the validation of the marketing authorization application for Oliogel S10 by the European Medicines Agency for EB. The EMA validation confirms that the application is sufficiently complete to begin the formal review process. The standard timeline for an opinion of the Committee for Medicinal Products for Human Use is within 210 active days. We look forward to working with the respective agencies as they review our applications and we prepare for potential launch. If approved, we have the commercial and medical teams, systems and infrastructure in place to launch AudioGel S10. Let me now turn the call over to our CFO and COO, Rory Nealon, who will provide more details on the Q1 financials.

Thanks, Joe. I will keep my comments relatively short today as it's been a long call already. So let's just briefly start with our revenues. Joe has already covered the revenue performance by product and by geography. Just to remind you of the headline numbers, we've seen an overall 8.7% improvement in our year-on-year revenues. which represents a 16.5% increase if the impact of that 3 million periodic Metroleptin LATAM order from Q1 2020 is removed. And as Joe noted, there were no such periodic orders in Q1, and a significant order for Metroleptin and LATAM was received and will be booked in Q2. Finally, before concluding on the revenues, as noted in the press release and reiterating what Joe has said, We're issuing revenue guidance for the full year of 2021 from 205 to 210 million. And please note that this guidance excludes the impact of the incremental revenues from the Chiasma deal if that deal concludes as planned in Q3. Our annual revenues have grown from 136 million in 2018 to 154 million in 2019, with both 2018 and 2019 being pro forma combined numbers, as if Amherst and Algerian were merged from January 2018. to 182.6 million for 2020, and finally to that guidance of 205 to 210 million for 2021. The next item I would like to touch on is our gross margin performance, excluding the impact of the non-cash items, which is at 75.8% for the quarter. This compares to 73.5% for the year as a whole in 2021. At this stage, a lot of the heavy lifting and improving our gross margin has been done. In particular, we've affected the savings we sought in inventory storage costs, a reduction in the number of SKUs or stock-keeping units with an associated reduction in regulatory fees. We've renegotiated our minimum annual purchase commitments with a number of suppliers, which has reduced the potential for inventory obsolescence. And finally, we've brought in-house the limit applied logistics coordinating function for EMEA, which was completed in late Q4. Moving on to our SG&A and R&D spend. Our R&D spend increased to $8.9 million for the quarter from the average for last year of $6.9 million per quarter. This is in part due to the timing of spend associated with the recent submissions to the FDA and EMA for Alliogel S10 and EB, and also the ongoing spend on the paediatric study for Limitabyte and our development efforts in AP103, our gene therapy assets focused on EB. Our SG&A spend before the impact of the non-cash depreciation and amortization has been very consistent for the last two quarters. During the quarter, we spent $17.9 million, which is also, in fact, the average for quarters three and four. It's also marginally lower than the average quarterly spend for the year as a whole last year of $18.8 million. We're particularly happy to have managed to contain this spend while our underlying revenues have been increasing. As we move later into the year, in 2021, I will remind you that this spend will increase as we start to incur pre-launch costs in anticipation of the potential approval of AlioGel S10 for EV. The next key metric I would like to focus on is EBITDA before I come back and touch on some of its constituent components. EBITDA is a key metric for us, given it was a good proxy for our cash from operations in 2020. I draw your attention to slide 33 where we adjusted our Q1 operating loss for non-cash items and get to adjusted EBITDA of $9.9 million for the quarter. This compares to $4.6 million for the same quarter won in 2020 or a 115% increase year-on-year and represents our fifth successive quarter of positive EBITDA. I remind you that when we closed the Ethereum acquisition in September 2019, we stated that our objective was to turn the business into an EBITDA-positive business through a significant reduction in the pro forma combined operating cost base of both Legacy Algerian and Legacy Amherst. In particular, we transitioned a sizable number of non-customer-facing functions and roles from Boston to Dublin, which resulted in significant economies of scale. We also leveraged off the significant previous experience that the management team of Amherst has from acquisitions, integrating processes, and extracting synergies. The outcome of the Algerian integration was that we not only achieved but exceeded our objectives and expectations. We converted the combined business into an EBITDA positive business in quarter one 2020, a quarter ahead of schedule, which was just six months after the deal concluded. When it comes to the proposed Chiasma transaction, we believe we can leverage off this experience and our expertise when seeking to extract the expected synergies from the Chiasma integration. Before moving off EBITDA, I would just like to note that the $10.7 million in tangible amortization in the EBITDA calculation is consistent with previous quarters, and also that the adjustment for amortization of inventory fair values step-up associated with the Algerian acquisition inventory is almost finished. We booked approximately $1 million in quarter one, and the final amount of approximately $250,000 will be released in quarter two. Beneath the operating loss line in our income statement, you will note that the non-cash change in the fair value of the contingent consideration and the non-cash contingent value rights expense are broadly consistent with the same quarter in 2020. And finally, in that section of our income statement, you will note a $7.9 million charge for net finance expense, of which $4.8 million is non-cash and $3.1 million is the cash interest payable in the quarter on our convertible bonds and term debt. Before concluding, I'd like to summarize our current net debt position. Excluding the convertible, we have net cash of $29.8 million at the end of March, being cash of $118.6 million and term debt of $88.8 million. On top of this, we do have a convertible loan with a principal value of $125 million, albeit the conversion price on this is $12.95 per ABS or $2.59 per ordinary share, which is in the money currently. Given the strong operational performance of the business and the recent Phase 3 data in EB, we believe it is likely that this will get converted to equity before it is otherwise due for a payment in April 2025. As a result, we view this as more akin to equity in debt. Finally, I'd like to discuss the impact of the payments we made to the Department of Justice in the U.S. during the period. We paid $3.9 million in legacy fines during the quarter, which were fines that we inherited when we acquired Agerian. Without these payments, our operating cash flows would have been $3.9 million higher and our cash balances would have increased accordingly. The good news is that this payment of $3.9 million in Q1 was the final payment, and as of today, we have no other amounts due to the DOJ. That is the end of my remarks. I'll now hand you back to Joe.

Thank you, Rory. I am now on slide 34. In conclusion, I am very pleased with today's very strong results for Q1, which demonstrates the continued positive momentum and growth we are experiencing in our business across our two commercial products globally. Q1 was extremely busy and we delivered a number of commercial and regulatory successes during the quarter. Our two commercial products, Metroleptin and Limitify, continue to deliver solid growth across a host of metrics, including revenue, EBITDA growth, cash generation, and market expansion. This performance year-to-date gives us confidence to increase our previous revenue guidance for the full year. The announcement earlier today of a proposed acquisition of Chiasma, we believe will pave a path to a combined potential $1 billion peak revenue for Amarisk. I will now hand over to our operator for Q&A. And given that the Chiasma team have dropped off the call, I would ask that you limit your questions, please, at this time to our Q1 results only.

Thank you very much, sir. Ladies and gentlemen, as a reminder, if you wish to ask a question, please press star 1 on your telephone keypad. Thank you for waiting. Our first question is from Tara Ravindran from SureCap. Please go ahead.

Hi again, guys. I didn't think I'd get to squeeze in my extra questions, so I'm glad for the opportunity, so thank you. So the first question is for Joe. So I know it's early days, but I was wondering if you could give us any color on what's going on in the HOFH market in the U.S., particularly with the February approval of Kiva as an adjunctive therapy. Yes. And then, secondly, for Roy, please, in the press release related to the acquisition, there was a line about financial obligations related to the chiasma royalty financing agreement. So, can you just remind us how much is due to be repaid by then? Thank you.

Thanks. Thanks, Sarah. Sheila, are you still on the line?

I am.

Okay. Look at you. I'm going to pass Sarah's question to you.

Sure, and thanks for the question. We've obviously been working with anticipation and anticipating the launch of Avkiza in the U.S. Certainly, we expect that they may actually expand the market and help us find additional patients. As you know, it's a pretty rare disease, and being able to identify and find those patients and then secure access to treatment is a significant challenge in this marketplace. So we haven't seen a specific impact yet in the U.S. on our business and expect that we will continue to see additional activity in the marketplace overall. But the patients that we have are well-controlled and certainly have tend to be quite sustainable. And so I think what we expect to see is really that the market may grow in terms of the total number of patients that are treated in the U.S.

Thanks, Sheila. Rory, do you want to take Cara's other question?

Sure, Tara. So it's like a quasi-debt facility. It's a royalty arrangement from healthcare royalty partners. And on a change of controls, that accelerates and will result in a payment to healthcare royalty partners of a little over $116 million. And obviously, at that point in time, all royalties stop.

Okay, great. Thank you.

Thanks, Sarah.

Our next question is from Naz Rahman from Maxim Group. Please go ahead.

Hey, guys. Thanks for taking this question too. Now that your NDA is filed for OIGEL, Have you guys had a manufacturing plant inspection that produces the product, or are you guys expecting one in the near term?

Thanks. Roy, do you want to say something?

Sure. So bear in mind this product was approved back in 2016 to treat partial thickness wounds in adults by the EMA. Now, obviously, EB is a partial thickness wound, but obviously since that point in time, we amateurs have gone on and done Phase 3 study specifically in EB. So that facility has been inspected on a number of occasions within Europe by the EMA or the people who do so on their behalf. So the facility has been inspected. In relation to the FDA, it has not been inspected at this point in time. We watch with interest what the FDA are doing in terms of new submissions for new products and facilities that haven't been inspected. I read that on occasions they rely on local inspections that have been done heretofore. So, this point is a little bit early to say now, but that, I believe, may be the direction that we'll see them go, but we just need to wait and see.

Just to add a little bit more colour on that, we have actually had that query from the FDA and have provided them with the local inspection findings.

All right. Thank you.

Thank you very much. There are no further questions at this time. I'll now hand the call back to Dr. Joe Wiley.

Thank you. So thank you all for joining us today. Hopefully we will speak with you and hopefully see you again soon. Thanks, everybody.