Alvotech - Q1 2023

Transcript

Operator (participant)

Welcome to the first quarter 2023 earnings call for Alvotech. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to introduce and hand over the call to Benedikt Stefansson, Director of Investor Relations and Global Communications at Alvotech. Please proceed.

Benedikt Stefansson (Director of Investor Relations and Global Communications)

Thank you, good morning or afternoon to everyone joining us on this call today. The company has issued a press release that can be found on our website, www.Alvotech.com. The release reports financial results for the first quarter of 2023 and provides a business update. Additionally, presentation slides that cover our call today have been posted on our investor website. You'll find all materials posted for the Q1 2023 earnings call under News and Events in the Events and Presentation section on investors.Alvotech.com. Our presentation materials and some of our statements that we make today may include forward-looking statements. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in company filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made.

With me on today's call are Róbert Wessman, Chairman and Chief Executive Officer of Alvotech, Anil Okay, Chief Commercial Officer, Joel Morales, Chief Financial Officer, and Ming Li, Chief Strategy Officer. With that, I would like to turn the call over to Róbert Wessman.

Róbert Wessman (Founder, Chairman, and CEO)

Thank you, Benedikt. Greetings to everyone joining us on the call today. 2023 marks an important year for Alvotech as we celebrate the company's 10 years anniversary. A significant amount of investment over the last decade has allowed us to build a company that includes a vertically integrated biosimilar platform, a vast commercial network, and a portfolio of attractive biosimilars and biosimilar candidates that is targeted for global markets. The company is committed to the promise of biosimilars, which we believe will provide a long-term benefit to healthcare systems and patients globally by providing low cost access to important biologic medicines. In addition to celebrating our 10 years as a company, we are also approaching our first-year anniversary as a publicly listed entity. We are listed on NASDAQ in both the U.S. and in our domestic market of Iceland.

Since that time, and as laid out on page four of our presentation, we have continued to drive towards our goal to advance the cause of global biosimilars by progressing a global portfolio of biosimilars candidates through the development process, expanding our commercial footprint and partnerships, and by driving a number of corporate initiatives that have allowed us to continue to invest into platform and the pipeline. Alvotech stands as one of the few large pure-play biosimilar companies. Before we discuss the status of AVT02, our proposed high concentration and interchangeable biosimilar to Humira sold in the U.S. market, I'd like to briefly touch upon sustainability of Alvotech. Our ESG program, which is led by our board, is crucial component of our company. We firmly believe that biosimilars are an essential element of global healthcare sustainability.

Biosimilars not only widen access to biologic medicines, but also stimulate innovation in the life science sector by introducing more cost-effective competition to medicines that accounts now over 40% of pharmaceutical spending in the U.S. and Europe. Further, in any markets, the introduction of biosimilars can expand access to many patients that would otherwise not receive biologic treatment, which have become the standard of care across numerous therapies. In alignment with our commitment to sustainability, we have recently disclosed a number of ESG indicators for 2022 that align with well-recognized frameworks such as NASDAQ and GRI. The updated disclosure are made available on our website through our sustainability portal. Now I would like to spend some time providing the status of our ongoing efforts to gain approval for AVT02 in the U.S. market.

AVT02 is seeking to be the first interchangeable and high concentration biosimilar to Humira. The high concentration form of adalimumab currently constitute over 85% of the U.S. market today. As many of you know, we have two separate applications for the same biosimilar candidate. The first BLA has data supporting biosimilarity ofAVT02 to Humira. The second BLA has the data supporting biosimilarity as well as additional data seeking interchangeability. Both BLAs have been reviewed and are deemed approvable, with the only outstanding requirement being a satisfactory site inspection. Alvotech hosted an inspection that concluded on March 17 of this year. The company provided substantive response to the 483s on April 3. The biosimilar BLA received a complete response letter from FDA on April 13 of this year, noting only that the efficiency from the recent inspection needed to be resolved.

The interchangeable BLA has a goal date of June 28th of this year. Meanwhile, as we continue to pursue further clarity on potential approval ofAVT02 in the U.S., we continue to supply other markets. We have launched AVT02 into 70 markets, including Canada and across Europe, without any negative safety signal to date. However, before we can provide specific guidance around our potential U.S. launch timing, we need additional clarity around our application. The first is to understand the status of deficiencies noted in the recently issued FDA 483s, and whether our responses satisfactorily addresses the observations. The second point of clarification needed, and it is related to the first, is whether a re-inspection would be required to gain approval of AVT02, and if such inspection would be virtual or on-site.

Looking forward, in addition to continuing to implement a culture of continuous improvement at our manufacturing sites, we have some tangible next step that we would be undertaking that we believe will allow us to gain further clarity and move forward our goal of bringing AVT02 to the U.S. market. The first is a request to FDA Office of Pharmaceutical Manufacturing Assessment to seek further clarity regarding the status of our deficiencies and clarity regarding our responses which are intended to address the deficiencies. Further, our responses to the 483s included certain commitments, and we agreed to provide FDA with monthly updates on the progress of these commitments. This was done May first of this year, and we intend to provide another one on June first, which in our view will complete outstanding corrective and preventive actions that we were committed to.

Subsequent to that, the company intends, as a matter of procedure, to resubmit the biosimilar BLA, which would trigger a six-month review period that would be needed in case approval is not granted on June 28th, which again, is the goal date for the interchangeable BLA. The company remains committed to bringing AVT02 to patients in the U.S. as soon as possible, and we believe that our product profile matches the current needs of the market. We believe that high concentration combined with interchangeability for a Humira biosimilar is necessary to convert the market effectively, especially during a time where the originator remains on formulary. I would like to pass the presentation over to Anil Okay, our Chief Commercial Officer, to cover our pipeline and provide commercial updates. Over to you, Anil.

Anil Okay (Chief Commercial Officer)

Thank you, Róbert. I will start by providing a broader update on our disclosed pipeline. Of course, as a company that develops products from scratch, we do maintain an active list of early development targets within R&D. We do expect to add more products over time as our disclosed pipeline continues to progress. Firstly, we are pleased to announce that we have initiated patient studies for AVT05, a biosimilar candidate to Simponi and Simponi Aria. AVT05 was developed using a murine cell line and utilizes a perfusion production process. This is similar to AVT04, our proposed biosimilar to Stelara. For AVT05, we are currently aware of only one other company that has a clinical-stage asset for a biosimilar to Simponi, and we are the only company with a clinical-stage asset for golimumab that has launched biosimilars in multiple global markets.

Worldwide revenues of Simponi and Simponi Aria exceeded $2 billion in 2022. Initiation of patient studies for AVT05 represents the fifth product to reach this stage in our portfolio, which demonstrates the development capabilities of our biosimilar platform. Included in this group of products is of course AVT02, which has begun commercialization in a number of markets, including Canada and Europe. AVT04, a biosimilar candidate to Stelara, which is filed in major markets globally, including Japan, U.S., Europe and Canada. On this call, we would also like to provide updates and unveil two previously undisclosed pipeline opportunities. The first of which is AVT16, a biosimilar candidate to Entyvio, which is a leading immunology product with over $5 billion in global sales in 2022, and has shown significant growth since the product's launch.

Current analyst estimates view the growth potential for the brand to exceed $8 billion. We have developed our biosimilar to the stage of at-scale manufacturing and hope to provide further updates as the development program progresses. The next previously undisclosed biosimilar candidate is AVT33, which is a proposed biosimilar to Keytruda, a leading oncology product. With worldwide sales in 2022 of over $20 billion, Keytruda is in the top five products globally in terms of revenue. AVT33 is our first disclosed product in the oncology space, which is an area we intend to expand further into as we continue to build our pipeline. The program has completed our clone selection phase, and again, we look forward to providing updates on this exciting opportunity going forward.

As mentioned in our press release yesterday evening, and in accordance with our contractual rights, we have provided Biosana Pharma a notice of termination for the global licensing agreement between the two companies covering AVT23, our proposed biosimilar to Xolair. We are currently evaluating alternative options for the program and intend to provide further updates as we finalize this strategy. AVT23 was our first proposed biosimilar that was not developed in-house, and it is also important to note that based on the timing of the licensing agreement, potential revenues from AVT23 were not included in the long-term forecasts provided during Alvotech's first Analyst Day as part of the company's SPAC process. On the commercial front, Alvotech continues to make strides in our partnership network and our launches.

As a reminder, Alvotech is a B2B model that generates revenues through substantial milestone payments from our commercial partners, as well as revenue sharing after launch that provides us with approximately 40% of net sales in any particular region. Since the start of the year, we have expanded or added partnerships in various markets around the world, including Japan and Turkey, and we continue to maintain a robust pipeline of business development opportunities similar to our existing arrangements for unlicensed pipeline candidates that are both disclosed and undisclosed. We truly believe in this model for the long term as the best way to leverage our platform and to create value and growth going forward. As of today, we have 18 distinct partners covering over 90 markets for our portfolio and pipeline.

We continue to work with our partners to progress launches for AVT02, our biosimilar to Humira, in Canada and in Europe, where we have launched in 17 markets to date. In 2023, we are planning for an additional 7 launches in various markets for AVT02, where we are already in the pricing and reimbursement stage in various geographies. This number at the moment excludes U.S. market until we have further clarity on regulatory timing. Additionally, we are already making commercial preparations and have received purchase orders for AVT04, our biosimilar candidate for Stelara for various markets. We believe we were the first to submit this product in a number of key markets and anticipate being in a strong position to compete globally in ustekinumab, which has an addressable market approaching $10 billion.

We are working with our partners to launch our proposed biosimilar at the earliest possible date. With that, I would like to hand the presentation over to our CFO, Joel Morales.

Joel Morales (CFO)

Thanks, Anil. I'll now provide some brief financial highlights for the period ending March 31, 2023. In our previous earnings call in March, we reported that during the first quarter, we had closed on a private placement with Icelandic investors of approximately $137 million in gross proceeds. In addition, during the quarter, we collected the remaining proceeds of approximately $14 million from our convertible bond issuance, which we initiated last December. With this financing activity now completed, we ended the first quarter with approximately $116 million cash on hand as of March 31, excluding restricted cash of $25 million. In terms of our operating performance, the company recorded $16 million in total revenue for the first quarter of 2023 versus $1 million during the same period in the prior year.

This sharp increase is driven by our first launch in the prior year, which meaningfully commenced in the second quarter of 2022. There were no milestone revenues recognized in the period given the timing of our performance-based licensing and R&D milestones. We expect to recognize most of our milestone and licensing revenue in the second half of 2023. A point worthwhile noting is that cost of product revenue for the quarter is disproportionate relative to product revenue due to the timing of new launches and elevated production-related charges, resulting in higher costs than revenues recognized for the period. We do expect this to normalize as we increase scale of manufacturing and expand our launches. We anticipate that this increase in volumes will have a favorable impact on cost of product revenues, particularly as we increase absorption of our fixed costs.

As a reminder, at this juncture, we are planning to wait to provide our 2023 financial guidance until after we have further clarity from the FDA on the potential approval of AVT02 and the impact on the timing of commercial contracting. In terms of near-term liquidity, given the lack of clarity regarding the exact timing of the potential approval of AVT02, we have begun to explore options to raise further capital so that we can continue advancing our pipeline over the near term with the goal of obtaining approval for and launching all of our programs in the U.S. and rest of world over time. While we remain focused on driving towards a positive outcome with the FDA, we are preparing for potential scenarios that may impact our previously communicated timelines.We will keep you updated on any developments at the appropriate time.

Until then, you can expect that we will continue to expand our launch of AVT02 into more markets and expect shipments to our commercial partners to increase in the second half of the year. As highlighted to you in the past, we are currently increasing scale for our AVT02 manufacturing process to support these launches, as well as new launches that we are anticipating later this year, including in the U.S. Our pre-launch preparations will result in a build of inventory, which we expect to continue through the first half of this year. Finally, we closed the period with 263.5 million shares outstanding, including unvested earn-out shares. With that, I'd like to turn the call back over to the operator for Q&A.

Operator (participant)

Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A roster. This will take a few moments. We will take our first question. The question comes from the line of Andrew Baum from Citigroup. Please go ahead. Your line is open.

Andrew Baum (Managing Director and Global Head of Healthcare Research)

Thank you. Couple of questions. First, in light of the FDA's inspection and the measures you've put in place to address their concerns, I'm assuming Stelara is manufactured at the same site. Is there any need to amend your filing or put in place additional remediation measures to ensure the U.S. approval? Second, I'd be curious if you have any thoughts on the impact for your future developments, given the denial of Teva's petition to the Supreme Court in relation to Coreg versus GSK. It would seem the skinny labels are gonna be somewhat more problematic in future, and I can envisage cases with your existing portfolio that may make prosecution of these in the U.S. more complex. Thank you.

Joel Morales (CFO)

Thank you, Andrew. Róbert Wessman here. We have a PDUFA date in 11th of October for our AVT04. We have, as we said, even though it's produced at the same manufacturing facility, we still believe we have a pretty good and sufficient time to resolve that. Coming to AVT02, there is not a clarity yet, and that has been confirmed by FDA that they have not taken a decision whether a re-inspection is needed or not.

That's why, as I said in my intro, we are seeking a meeting for with OPMA, which basically is by a recommendation from FDA to seek clarity if they have finalized to review our responses, if they are adequate and if inspection or re-inspection is needed and in which kind of a form that would be. The second question to Ali.

Anil Okay (Chief Commercial Officer)

Hi, Andrew. I can take the second question. We are aware of the Supreme Court decision. We do not believe that this impacts neither our portfolio or launch decisions in the U.S. market.

Operator (participant)

Thank you. We will take our next question. Your next question comes from the line of Thibault Boutherin from Morgan Stanley. Please go ahead. Your line is open.

Thibault Boutherin (Executive Director of Equity Research)

Yes. Thank you for taking my questions. A couple on Humira biosimilar. First, do you have any can you give any indication on your expected timing for the meeting with the FDA? Second, question, just to clarify, if you have to actually resubmit a BLA after the 28 of June, will it necessarily be a resubmission of the original BLA? Or could you potentially at that time already resubmit a BLA with interchangeability?

Róbert Wessman (Founder, Chairman, and CEO)

Thank you. Robert Wessman here. Basically, we would assume, as we have done in the past, that we will resubmit the aBLA a similar BLA. We will do that once we have completed the commitments towards FDA, which towards the manufacturing and supply deficiencies. We assume to close them all first of June. We would then resubmit, and we would then go for a 6 months clock. Which most likely would then give us or would give us a PDUFA date 6 months later. Within that timeframe, of course, FDA would then decide if re-inspection is needed or not, if that is not already clear at that time. That's the framework. The second part of the question?

Ming Li (Chief Strategy Officer)

Well, the first part of the question I think was Thibault, was about the potential meeting timing. I think unlike a type one, there's no defined process, but we are engaging and already working on the scheduling process for that. We don't have a defined date, but we believe it'll be, you know, 30 days or less. That's our assumption.

Róbert Wessman (Founder, Chairman, and CEO)

Yeah.

Thibault Boutherin (Executive Director of Equity Research)

Thank you.

Operator (participant)

Thank you. Once again, if you wish to ask a question, please press star one and one on your telephone. We will take our next question. The question comes from the line of Ashwani Verma from UBS. Please go ahead. Your line is open.

Ashwani Verma (Executive Director of SMID Biotech and Biopharma)

Hi. Good morning. Thank you for taking my questions. I have a few. First one, just on biosimilar Humira. I wanted to understand a little bit like what is the nature of observations that you receive from the FDA this time? Are the previous observations, I think you mentioned in previous conversations that there were no repeat observations. Are the previous observations completely resolved? Second one, on Stelara, do you have freedom to operate in this market, or does it still need to go through litigation with J&J? Just curious, I think, from the perspective of interchangeability, do you think this matters for Stelara, and your reason for not pursuing it at this stage?

Finally, a third one that I had was on Keytruda biosimilar. This can be a huge market. I think what I wanted to understand was that is there anything unique or fundamentally unique to the PD-1 design of the pembro molecule that may not lend itself well to a biosimilar market? Like we've seen competing PD-1 Opdivo not able to show the same level of clinical results as Keytruda. Is there something unique about Keytruda that a biosimilar even in studies might not be able to replicate the same level of clinical efficacy? Thanks.

Ming Li (Chief Strategy Officer)

Hey, Ash, this is Ming. Thank you, thank you for the question. Maybe I'll answer in a different order, then I'll pass it over to Anil. From the previous inspection, which of course was in March of 2022, there were no repeat observations. I think that's an important, good question and an important thing to note. The observations that were provided in the 2023, March 2023 inspection, you asked about the nature of them. I would say that most of them were around the quality system and the quality units. The nature of the observations I would describe as more pointing to upstream, call them upstream observations rather than downstream problems. I think the 483s is public.

We have, but the responses to those are not public. The way we approached them, was to try to address those specifically, but also do it at a macro level, in changes in our overall organization and things of that nature.As well as where applicable to do retrospective analysis, to ensure that these downstream problems, didn't, you know, exist historically. As you know, we currently manufacture commercially, of course, not for the U.S., but for other places. There is a history there. On the AVT04 questions, let me pass that to Anil.

Róbert Wessman (Founder, Chairman, and CEO)

Thanks, Ming. Hi, Ash. Good to hear from you. When it comes to your AVT04 question, of course, we cannot comment on that. We cannot give guidance on that. I will pass that question. When it comes to interchangeability, we have not made a final decision on pursuing interchangeability for AVT04 as of yet. The reason of that is actually related with the product profile. The product does not have the same retail profile as Humira, and it is dosed infrequently, compared to Humira. The level of competition in comparison is much more low. Because of those reasons, we have not initiated yet, but we also still potentially can consider if we want to. On your third question regarding Keytruda and, let me start with the efficacy part.

Of course, this is no different than rituximab or trastuzumab biosimilars, which has seen over 70% penetration across the world. We expect the same with the Keytruda biosimilars when it comes to efficacy. These biosimilars are efficacious products. That's point one. When it comes to study design, we are working with the authorities globally, both in the U.S., Europe, Japan, with the global authorities. In the design phase of our studies, of course, we get their advice and consult with them and jointly design our clinical trials. Thank you.

Operator (participant)

Thank you. We will take our next question.Your next question comes from the line of Carl Byrnes from Northland Capital Markets. Please go ahead. Your line is open.

Carl Byrnes (Managing Director and Senior Equity Research Analyst)

Thanks for the question, apologies if I miss this. If the FDA does not require re-inspection of the facility, when would be the earliest that you'd be made aware of that? Conversely, if they do require re-inspection, when would be the earliest that you'd be made aware of that? Thanks so much.

Róbert Wessman (Founder, Chairman, and CEO)

Yeah, thank you for that question, Róbert Wessman here. We are working, of course, with the FDA. They have said that they are not gonna take any earlier action, which means that the 28th is the day which, we would either understand that we got approval, potentially would be the day we understand then, that the inspection is needed. We would then still wanna highlight that we are still hopeful with the meeting with OPMA, which we are scheduling as Ming mentioned earlier, and we are in interaction with FDA on specific questions we have. We hope to get the clarity out of that meeting, if you will. I would say in the worst case, we would learn this 28th.

Of course, we are still hopeful that we can understand this sooner than that.

Carl Byrnes (Managing Director and Senior Equity Research Analyst)

Great. Thanks so much.

Róbert Wessman (Founder, Chairman, and CEO)

Yeah.

Operator (participant)

Thank you. There seems to be no further questions. I would like to hand back to Róbert Wessman for closing remarks.

Benedikt Stefansson (Director of Investor Relations and Global Communications)

Actually, it's Benedikt Stefansson here. Thank you, Heidi. On behalf of the Alvotech team, I would like to thank everybody who participated today. We wish you a good rest of the day and look forward to speaking to you all again. Thanks.

Operator (participant)

This concludes today's conference call. Thank you for participating. You may now disconnect.