Alvotech SA

NASDAQ:ALVO

Earnings Call Transcript 2022-Q4

[Benedikt Stefansson, Director of Investor Relations]

Thank you, and good morning or afternoon to everyone joining this call today.

Yesterday evening, the company issued a press release that can be found on our website, investors.alvotech.com, under News and Events in the Events and Presentations section. The press release reports financial results for fiscal year 2022 and provides a business update.

Additionally, presentation slides that cover our call today will be posted on our website at investors.alvotech.com. Please look under News and Events for the Events and Presentations section.

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, including in our Annual Report on Form 20-F for the fiscal year ending December 31, 2022. 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 Robert Wessman, Chairman and CEO of Alvotech; Hafrun Fridriksdottir, Chief Operating Officer; Joel Morales, Chief Financial Officer; Anil Okay, Chief Commercial Officer; and Ming Li, Chief Strategy Officer.

With that, I would like to turn the call over to Robert Wessman.

[Robert Wessman, Chairman and CEO]

Thank you, Benedikt, and welcome, everyone, to our fourth quarter and full year 2022 update call.

As you know, I have recently been appointed as a Chief Executive Officer for Alvotech. I see this as a seamless extension of my role as Executive Chairman. I'm excited to take on this new challenge, and continue to drive Alvotech's growth and success in the global biosimilar markets.

I'm also thrilled to welcome Hafrun Fridriksdottir to Alvotech as our Chief Operating Officer. Hafrun brings a wealth of experience in the pharmaceutical industry, most recently at Teva Pharmaceuticals.

Before we move to our business update, I want again to reinforce Alvotech core competence. Alvotech is a pure-play biosimilar platform. I believe that we have the infrastructure, the personnel, the processes and the dedication it takes to be successful in the biosimilar space.

Alvotech also takes a multiproduct approach with the portfolio and pipeline that currently

includes 8 biosimilar and biosimilar candidates. We plan to expand our offering in this area by leveraging our platform's capacity as we progress candidates through the approval process.

And finally, Alvotech has commercial partnership with top-tier partners covering over 90 markets. We have started to commercialize our first biosimilar in 17 markets, including Canada and markets across Europe. We believe that Alvotech's global approach will further enhance our top line growth going forward. At the same time, it will provide scale and flexibility to Alvotech by marketing the same products worldwide.

And with that, let us go through some of the highlights of 2022, which was a very meaningful year in our journey.

Firstly, we were able to meet the lower end of our top line guidance that we presented in our

first Analyst Day as a part of our [ back ] process. It's also important to note that the revenue growth was achieved while investing in the future through the growth of our pipeline. Alvotech have been able to secure July 1 launch date in the U.S. for our biosimilar candidate to HUMIRA. We expect that the AVT02 can be the first and only high-concentration interchangeable biosimilar adalimumab on the market for at least 12 months.

Of course, this requires approval, but if satisfactory, the inspection of our manufacturing facility remains the only outstanding item. FDA is expected to begin on March 6 their inspection of our facility in Iceland.

This past January, the team hosted the EMA inspection that resulted in EU GMP recertification. Collectively, we equally anticipate the forthcoming FDA inspection and are grateful for the agency's commitment to a timely reinspection.

We also have submitted marketing applications for our proposed biosimilar to STELARA in our major markets, including U.S. and EU. Both applications have now been accepted by the respective regulatory authorities.

Further, we have moved 3 proposed biosimilar into clinical stage development. These are the biosimilar candidates for EYLEA, Prolia and XGEVA and SIMPONI.

From a capital market perspective, 2022 was truly transformational as we moved from being a private company into a public one. We are now listed on NASDAQ both in U.S. and Iceland. We have been able to access the capital markets in order to secure necessary financing to allow us to continue to invest into our programs and the infrastructure.

Finally, we have implemented an ESG framework at the company that includes Board level oversights and transparency through our ESG Portal available on our website.

As we look back on 2022, we can confidently say that Alvotech has advanced greatly as a global biosimilar company. I'm very proud of the accomplishments of the team and believe strongly that we have put ourselves in a position to drive growth in 2023 and beyond.

And with that, I would like to pass the call over to Anil Okay, our Chief Commercial Officer. Over to you, Anil.

[Anil Okay, Chief Commercial Officer]

Thanks, Robert. Let me provide a brief overview of AVT02, our biosimilar to HUMIRA.

As you know, we have developed from the beginning a high-concentration citrate-free biosimilar that comes with a proprietary autoinjector. And as Robert mentioned earlier, this product is now launched in 17 markets, including Canada and a number of retail markets in Europe.

In the U.S., we are working closely with our commercial partner, Teva, to prepare for launch, which is expected is on July 1, 2023, subject to regulatory approval.

As a reminder, the U.S. originator sales for HUMIRA was $18.6 billion based on 2022 data, which, of course, didn't include the 8% price increase taken in the beginning of 2023. And we have the opportunity to be the first interchangeable high-concentration biosimilar on the U.S. market for adalimumab.

As we move to the next slide, I would like to provide more clarity on why we firmly believe that our approach for AVT02 in the U.S. market is the optimum strategy.

Given the magnitude of this loss of exclusivity, there has been a great deal of discourse around this launch. We consider it to be the first of its kind, featuring a payer-driven biosimilar market formation and a truly retail model. I will outline our strategy using 4 key pillars.

The first is to develop the right product, and the high concentration currently reflects around 85% of the total volume in the U.S. Currently, there is only 1 approved high-concentration biosimilar, and we are aware of 2 other companies that have announced submissions supporting the high-concentration form.

The second is to combine the right product with interchangeability, which is an important construct for the U.S. market. Interchangeability, we believe, will make it easier to transition patients to the biosimilar. According to a recent report by Cardinal Health, which surveyed HCPs across various therapeutic areas, over 60% of respondents expressed their willingness to prescribe the biosimilar whilst it has obtained the interchangeable designation. And if we are approved, we have the potential to be the first interchangeable high-concentration biosimilar to HUMIRA on the U.S. market for a period of at least 1 year post our launch, based on our interpretation of the exclusivity provisions.

The next pillar of our strategy is the autoinjector. As predominantly self-administered products taken relatively frequently, the autoinjector is an important part of the patient experience and physician confidence level. As a result, we chose to invest in a proprietary autoinjector to help support the product rollout. Thus far, we have had very positive reception to our device in the retail markets where we have launched the product outside the U.S.

And finally, we needed to establish commercial presence and have supply reliability. This is why we have partnered with Teva, a well-known, reputable company in both specialty and generics. Teva has demonstrated its ability to commercialize biosimilars in the U.S., and, just as importantly, Teva has a long-term commitment to biosimilars going forward.

Further, as a private company, we were able to invest into building out our infrastructure so we could have in-house capacity. This capacity is dedicated to our portfolio and pipeline, and we had the opportunity to host many of the larger payers in the U.S. market at our facility this last summer.

The adalimumab market will be a competitive model, and this is why we believe it's important to have a differentiated strategy that can be successful in this market.

With that, I would like to turn the call over to Hafrun, our new Chief Operating Officer, to go over our second candidate and overall pipeline of products. Thank you.

[Hafrun Fridriksdottir, Chief Operating Officer]

Thank you, Anil. And also thank you, Robert for your kind introduction earlier. I am very excited to be joining Alvotech. Of course, coming from Teva, I did know the company quite well already, and I am a strong believer in Alvotech and in the future, and promises of biosimilars globally.

It's my pleasure to walk everyone through the rest of our pipeline, starting with our second most advanced biosimilar candidate, which is a proposed biosimilar to STELARA.

The originated product approaches $10 billion in global sales based on 2022 figures, and like HUMIRA, it is also in immunology. Alvotech, in my view, was very wise to build out capability using murine cell line, also known as SP2/0. Along with this capability, Alvotech invested into a future manufacturing technology that is required to manufacture these types of biotics. I do believe that this setup has facilitated the AVT04 program, with the marketing application has now been submitted and assessed in major markets, including the U.S. and Europe, with regulatory approval decisions expected in the second half of this year.

AVT04, we think, is quite an attractive asset for a couple of reasons. The first is that STELARA is at high price point today relative to some of the other products in the space, allowing biosimilar entrants to potentially drive significant cost reduction for patients and for the health care systems.

The second is that there were a number of companies that were and remain active in biosimilar space that have not participated thus far in the clinical development of STELARA biosimilars. As far as companies that have announced submissions on acceptance for filing in major markets, we believe it is currently limited to Alvotech, although we are aware of another filing on others that have introduced the positive top line results on Phase III.

We expect to be in the first wave for STELARA biosimilars in U.S. and in Europe, and we are very pleased with our progress to date. We currently anticipate that our inspection, expected later this month from FDA, will also serve as a pre-approval inspection for AVT04.

Moving to the next slide, let us shift our focus to the broader pipeline. We continue to receive regulatory approvals for AVT02 in additional markets and work with our supply chain and commercial partners on pricing, reimbursement and launch timing for each market.

For AVT04, as noted, we have 5 in major markets, and we look to continue filings in other jurisdictions around the world. Please note that number of markets require either a U.S. or European certification or approval as pre-filing, or, in some cases, as pre-launch requirement.

Over time, and subject regulatory approval, we expect to commercialize our portfolio in over 90 markets around the world.

Beyond 02 and 04, in the past year, we have successfully initiated clinical development for 3 biosimilar candidates, AVT06, AVT03 and AVT05, which are all currently in active clinical development.

AVT06 is a proposed biosimilar to EYLEA and is currently in a confirmatory clinical study.

AVT03 is a proposed biosimilar to Prolia and XGEVA and is currently in a patient trial as well as in our bioequivalent study.

AVT05 is a biosimilar candidate to SIMPONI and SIMPONI ARIA. And SIMPONI, like STELARA, is a product developed using SP2/0 cell line and manufacturing using perfusion technology. AVT05 is currently in an active bioequivalent study.

As Robert mentioned earlier, Alvotech is a biosimilar platform. Our pipeline progress is a testament to the platform capabilities. I am excited to keep our stakeholders updated as our pipeline continues to advance and potentially expand in the future.

And with that, I would like to turn the presentation over to Joel Morales, our Chief Financial Officer, to provide a financial update for the company. Thank you.

[Joel Morales, Chief Financial Officer]

Thanks, Hafrun. I'll now provide some brief financial highlights for the period ending December 31, 2022.

On our third quarter business update in November, we reported that we had executed financing agreements with existing lenders and shareholders to secure $136 million of gross proceeds. As part of the commitments we had made to our lenders, we also reported that we intended to raise up to $150 million of additional capital over the near to midterm, and that we were evaluating a variety of different capital instruments including convertible debt, common equity and preferred equity.

I'm pleased to report that since then, we have fulfilled this commitment to our lenders and have subsequently finalized a convertible bond issuance of $70 million, of which $56 million was collected in December and the balance of $14 million in Q1 of 2023. $50 million of these proceeds were used to replace the Alvogen shareholder loan facility from our November financing, which allowed us to avoid the issuance of 4% penny warrants attached to the facility.

Additionally, in early February, we announced that we successfully raised $137 million in gross proceeds in a private placement with Icelandic investors. Altogether, we were able to raise $157 million of gross proceeds incremental to our November financing and net of the replacement of the Alvogen shareholder loan facility of $50 million.

As a result of this additional capital, we also avoided the issuance of an additional 1% of penny warrants to our first lien lenders under the terms of the November agreement.

We ended the year with approximately $66 million of cash on hand as of December 31. Giving effect to the financing now in place, our pro forma cash balance as of December 31 would have been approximately $209 million, excluding restricted cash of $25 million. We are proud to have raised this significant capital and to have avoided the potentially higher cost in terms of dilution from warrants, which we believe is a significant accomplishment given the backdrop of the challenging capital market conditions.

We're also pleased to have garnered considerable interest from investors in our company and its prospects. With the funds raised, we plan to continue investing in our platform, our pipeline and our ongoing commercial launches.

In terms of our operating performance, the company recorded $85 million in total revenue for 2022, which represented an increase of 114% versus the prior year. This included $25 million of product revenues in our first year of launch from Canada and certain European markets, as well as $60 million in license, milestone and other revenues.

A point worthwhile noting is that we believe that our year-to-date cost of product revenues are disproportionate relative to our revenues in the period. We do expect this to normalize as we increase scale and expand on our launches. We anticipate that this increase in volumes will have a favorable impact on cost of product revenues, particularly when we increase absorption of our fixed costs.

Now transitioning to 2023, at this juncture, we are planning to wait to provide our 2023 financial guidance until after the potential U.S. approval and launch of AVT02. Accordingly, we intend to provide more details regarding our operating outlook during our Q2 earnings call.

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're anticipating later this year, including in the U.S.

Our pre-launch preparations have resulted in a build of inventory of approximately $32 million through December 31, and we expect that to continue in the first half of the year, leading up to our anticipated launch in the U.S. on July 1.

Also, given the timing of our performance-based licensing and R&D milestones, we expect to recognize most of our milestone and licensing revenue for the year in the second half of 2023.

And finally, we closed the period with 248.6 million shares outstanding, including the earnout shares which had not yet vested.

And with that, I'd like to turn the call back over to the operator for Q&A.

[Operator]

[Operator Instructions] We will now take the first question. It comes from the line of Thibault Boutherin from Morgan Stanley.

[Thibault Boutherin, Morgan Stanley]

Thibault calling. First one on STELARA. Just to know if you could -- if you have clarity in terms of the launch timing, in particular with regards to the IP and any potential IP of [indiscernible] and if you can share this with us? In particular, any theories in terms of filing and approval time lines? It looks like you could launch STELARA as well approved in the U.S., so just you could comment on that.

And then second question, if you could just give some high-level comments on what you're seeing on the market with the performance of the first biosimilar for HUMIRA and how you see this evolving through the year as obviously, we go through the second wave of biosimilars being approved from July? So yes, some maybe very general comments on the state of the market and the first data you have on the first biosimilar.

[Robert Wessman, Chairman and CEO]

Thank you so much. Robert Wessman here. So first of all, we filed ustekinumab fourth quarter last year. Generally, we have not said publicly when we believe we would be able to launch. What I can say, though, is that we believe that we are in a very good position on this opportunity, if you will.

We have approval decision coming up, we believe, both in U.S. and EU in the second half of this year. And as we have discussed, there seems to be less biosimilar competition when it comes to ustekinumab. So all in all, we are quite excited about the opportunity.

Then I will hand it over to Anil Okay to take the second half.

[Anil Okay, Chief Commercial Officer]

Thank you, Robert. Thibault, nice to hear from you. Thanks for your question. First of all, regarding Amgen launch, which is, of course, very recent event, so we do not have enough facts about it yet, however, I would like to remind that it was a low concentration formulation launch without interchangeability. I prefer not to comment on what other companies are saying.

However, from a vantage point of view, we view our product in the U.S. as a differentiated offering. And also, we believe that particularly because AbbVie will remain on formulary for the near term, that we believe interchangeability is very important differentiation, especially for the companies that will be entering into the market by 1st of July.

[Operator]

We will now take the next question. It comes from the line of Niall Alexander from Deutsche Bank.

[Niall Alexander, Deutsche Bank]

It's Niall Alexander from Deutsche Bank. Just 2 questions. It would be good to get your views on what the country-by-country rollout will look like in 2023 for AVT02, and where do you see the biosimilar share overall reaching in the EU?

And then the second question, if you can just give any color and thoughts as to potential hurdles or sort of questions that FDA are pushing on the ongoing inspection of facilities to get the AVT02 U.S. approval finalized?

[Anil Okay, Chief Commercial Officer]

Niall, thanks for your question. Let me take the first one, and I will hand over the second question to my colleagues. So regarding our rollout, just to remind that our European launch has happened in June 2022. And since then, we have a track record of doubling our sales, so we have really good projections in Europe. And our commercial partner, STADA, is doing a very good job in the key retail markets.

So we are very satisfied with the progress and the performance.

Additionally, as Hafrun mentioned, in 2023, on top of U.S., we have lined up several other regulatory approvals, and we will be rolling out AVT02 into many more markets in 2023, which will, of course, help us to have additional sales revenues in 2023. Thank you.

[Robert Wessman, Chairman and CEO]

Yes. And Robert Wessman here, I will take the second half part of the question. So I would say, first of all, there has been a significant communication with FDA post the 483s which we received end of March 2022.

It has been an interactive process, if you will, where we have submitted responses to FDA. That includes number of productive and preventative actions, if you will, based on quality piece and we have, of course, received feedback from FDA. At this stage, we feel as we have addressed the issues that have been raised in the 483s. However, from our preparation, we looked at this as a reinspection as general GMP inspection, and we have been preparing accordingly.

So overall, we are very optimistic, and we believe that the company is well prepared for the upcoming visit which starts on Monday.

[Operator]

We will now take the next question. It comes from the line of Andrew Baum from Citi.

[Andrew Baum, Citi]

A couple of questions. First, since we last heard from you, AbbVie has given a point estimate for anticipated declines for U.S. HUMIRA in 2023 of 37%. I'm curious whether that number was above or below your expectations for the overall market, and how that fits with your own internal modeling?

And then second, could you talk to your expectation of AbbVie's contracting to multiyear contracts, and therefore, we should think about concessions which are going to secure positioning on formularies for 2024 as well as 2023?

[Anil Okay, Chief Commercial Officer]

Thank you, Andrew, for your question. Of course, we are not leading those contracting discussions but support our partner, Teva, where we can. The discussions we understand are very collaborative and supportive, and reinforces the product profile attributes very well. We are approved on April 13, as we communicated. We believe we will have broad formulary access and that our product profile will be differentiated from other biosimilars on the market.

As I also highlighted in the previous question, we believe, particularly because AbbVie will remain on formulary for the near term as they have communicated to the market, that interchangeability is critically important, and I really would like to remind again that Alvotech is the only candidate that can still have an interchangeable high-concentration biosimilar for adalimumab in the U.S. market by 1st of July 2023.

[Operator]

[Operator Instructions] There are no further questions at this time. I would like to hand back over to Benedikt Stefansson for final remarks.

[Benedikt Stefansson, Director of Investor Relations]

Thank you, Sandra. So on behalf of the Alvotech team, I would like to thank all the participants on our webcast today, and we wish you a good rest of the day and look forward to speaking with you all again. Thank you.