Eiger BioPharmaceuticals, Inc.

and Business Update conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require operator assistance, please press star, then zero on your telephone. As a reminder, this call will be recorded. I would now like to introduce Sarah Matheson, Senior Vice President, Corporate Affairs at Iger. You may begin.

Thank you. Good afternoon, everyone, and thank you for joining us today. Welcome to our quarterly financial results and business update call. We issued a press release earlier this afternoon with our Q2 financial results, which is also available on our website at igobio.com. For today's call, we will have prepared remarks from the management team, followed by Q&A. We will use slides for the webcast, and a replay will be available on the investor section of our website. Joining me on the call with prepared remarks are David Corey, President and CEO, Sri Riali, Chief Financial Officer, Eldon Mayer, Chief Commercial Officer, and Dr. Ingrid Chung, Senior Vice President, Clinical Development. We also have subject matter experts on our team, Dr. Colin Hyslop, Senior Vice President, Clinical and Development Operations, and Dr. Colleen Craig, Vice President, Metabolic Diseases, available for Q&A. Before we begin, I'd like to remind investors that this call will include forward-looking statements, including expectations concerning financial performance, commercial products, and potential future products in different therapeutic areas and stages of development. The forward-looking statements rely on certain assumptions and involve risks and uncertainties beyond eyes of control, which could cause or impact your results to differ materially. A description of these risks and uncertainties is contained in IGA's filings with the SEC, including our latest 10-K and 10-Q reports available on the IGA website in the investor section. All forward-looking statements are based on information currently available to IGA, and we assume no obligation to update these statements. I'll now turn the call over to David.

Thanks, Sarah. As we enter the second half of 2022, Momentum continues to build across all of our programs, with multiple upcoming value-creating milestones. These clearly position Iger as a highly differentiated biopharmaceutical company with a diverse pipeline. With major catalysts in our development programs for PEG-interferon lambda, lonafarnib, and avexatide, as well as on the commercial front with Zokinbi, we believe that 2022 is shaping up to be a transformational year for Iger. I'll begin with progress on our PEG Interferon Lambda program for COVID-19. Since we announced positive top line results from the phase three investigator-sponsored TOGETHER study in March, our team has been actively engaged with the FDA on a potential emergency use authorization application and have provided responses to all of the agency's information requests during this time. As we continue to see the rise of new variants, including the new BA.5 sub-variant, it is clear that while the COVID-19 threat is evolving, it continues to be a burden to the public health system and the need for more effective medicines persists. The TOGETHER study demonstrated that despite widespread vaccination, there remains significant risk of morbidity and mortality from COVID-19, especially for vulnerable patient populations. We believe PEG interferon-Lambda represents an effective one and done therapeutic that is potentially agnostic to the shifting variant landscape, and that if authorized, could play a meaningful role in the COVID-19 response. Given the ongoing need, making PEG interferon lambda available to the healthcare community continues to be our priority. In terms of commercial readiness, we have launch quantities to support the introduction of PEG interferon lambda should the FDA grant emergency use authorization. And as previously communicated, we are actively planning for expanded production capacity. Turning now to our hepatitis delta virus program, we continue to advance our HDV platform with lonafarnib and PEG interferon lambda, both in phase three. We are actively preparing for top-line data from the phase three deliver study of lonafarnib-based regimens by the end of this year, a significant upcoming milestone for Iger and for patients with HDV. With hepatitis delta virus affecting over 12 million people worldwide, the healthcare and economic burden is enormous. We're developing first-in-class therapies to treat this devastating disease. The commercial opportunity in the U.S. and Europe alone is estimated to be more than $1 billion, and we believe both Lonefarnib and PEG interferon lambda have real momentum in phase three, providing opportunities for significant long-term value creation. Ingrid will provide more details on the continued progress in both of these Phase III programs shortly. Now turning to our rare metabolic disease programs, we're advancing Avexatide into the Phase III Avant Registrational Program for congenital hyperinsulinism. Avexatide has been granted FDA breakthrough therapy designation and rare pediatric disease designation, making it eligible for a priority review voucher upon approval. Avexitide is an exciting opportunity for Iger, and most importantly, has the potential to transform the lives of children born with this life-threatening condition. Now finally, turning to our commercial product. We were delighted recently to announce European approval of Zokenvi to treat children and young adults with Hutchinson-Gilford Progeria Syndrome and processing-deficient progeroid laminopathies, collectively known as Progeria. As the world's first and only treatment for Progeria, Zokendi's European approval is an important milestone to the Progeria community. As Iger's first approval in Europe, this is also a significant achievement for our company, establishing our footprint in Europe and demonstrating our ability to navigate ex-US regulatory requirements. We're also expanding global commercial access to Zokendi through strategic partnerships in countries like Japan, with our recently announced partnership with Anges. Elden will provide more details on our commercial progress in just a few moments. This is an exciting time for Iger. 2022 has already been successful as we've achieved key milestones, which further reinforces our confidence in our ability to execute. And we're making great progress as we prepare for critical catalysts during the remaining half of this year. We remain focused on our operational plan to drive growth by advancing our pipeline, leveraging our commercial capabilities to expand our reach, and strengthening the foundation of our business. The progress we have seen this year is reflected across all of these objectives. Going forward, we will continue to leverage our internal capabilities and capitalize on our strengths in a cost-efficient manner to position Iger for sustained growth. I believe this will create value for our shareholders and fulfill unmet needs for patients with serious diseases in need of treatment options. And now I'll hand the call over to Ingrid to review our clinical development progress.

Thanks, David. I'll begin by highlighting our progress across our HDV platform. Hepatitis Delta virus is the most severe form of viral hepatitis with the most rapid disease progression. Over half of patients are already cirrhotic at diagnosis. We're on track to report top-line data from the landmark Phase III deliver study of two Lona Farna-based regiments by the end of this year, a significant milestone for Iger. With 407 patients enrolled across 116 clinical trial sites in 22 countries, the liver will generate the single largest source of HDV patient data from a well-controlled clinical trial to better understand and characterize this devastating disease. If positive, the liver data will support global regulatory filings for two different lonofarna-based regimens. The study includes an all-oral arm of lonofarna boosted with ritonavir and a combination arm with PEG interferon-alpha. Each arm will be separately compared to placebo with a primary endpoint of a two-log decline in HDV RNA plus normalization of ALT after 48 weeks of treatment. Key secondary endpoints include histology, Additionally, we are continuing to advance development of our second therapy for HDV, PEG-interground lambda, in the phase three limit two study. Limit two is a randomized two-arm study. Arm one is 48 weeks of lambda once weekly, followed by 24 weeks off treatment. Arm two starts with 12 weeks of no treatment, followed by 48 weeks of treatment. The primary endpoint is the proportion of patients with a durable virologic response at 24 weeks post-treatment in arm one, compared to 12 weeks of no treatment in arm two. This endpoint was previously demonstrated in phase two and is most meaningful for regulatory agencies and physicians as it demonstrates durability of response to a finite therapy and a potential for an HDV cure. Limit two is a straightforward study of 150 patients where all patients will receive treatment. We're activating sites and enrolling patients in over 10 countries. Our strategic approach in HDV is to seek regulatory approvals of two Lona Farna-based regiments from the results of the DELIVER study. We will quickly follow the data from Limit 2, which could lead to approval of PEG Interferon Lambda for HDV. We believe this approach provides the most expeditious route to approval for both Lona Farna and PEG Interferon Lambda. In parallel, we are generating data through the List 2 study, which we believe will support the future use of our proprietary combination of lonafarnib and peganifera lambda for hepatitis delta infection. We are excited about the advancements that are being made in the HDV space. The first international Delta Cure Conference, the only medical meeting focused solely on HDV epidemiology, diagnosis, and recent advancements in antiviral treatments, is coming up in early October in Milan, Italy. AASLD will immediately follow in early November in Washington, D.C. Iger is contributing to the strong momentum with our HDV platform of multiple potential treatment options for patients. We believe Iger is well-positioned to become a leader in this space. Finally, turning to Avexitide, a first-in-class GLP-1 antagonist that we are developing as a targeted therapy for rare metabolic diseases. We are excited to initiate the Phase III AVANT program for our lead indication, congenital hyperinsulinism. a rare, life-threatening genetic disease with a devastating impact on newborns and children. Our team has obtained alignment with the FDA on what we believe will be an efficient Phase III clinical program, and we look forward to sharing more details on the program as we begin screening patients later this year. Additionally, we were encouraged by the positive response to Phase II data recently presented at the ENDO conference in June. These data support the broader potential of Avexatide in the treatment of patients with hypoglycemia after bariatric and other upper GI surgeries, further building on the role of GLP-1 in mediating hyperinsulinemic hypoglycemia. I'll now hand the call over to Eldon.

Thanks, Ingrid. I'll provide highlights of our activities to support hepatitis delta virus commercial planning. as well as an overview of our current Kinby business in the U.S. and our plans for expanding global access, including in Europe, where we just received marketing authorization from the European Commission. In June, we attended the EGLE International Liver Conference, where Iger had a major presence, with multiple presentations highlighting data across our HDV platform. Iger has been developing treatments for HDV and attending these conferences for over a decade, and we're encouraged to see hepatitis delta featured more prominently than ever before at a major liver conference. The awareness of HTV is rapidly growing alongside the recognition that this is a serious disease in urgent need of therapies. The competitive space is also growing in HTV with companies investing in early stage programs recognizing this global opportunity, which is estimated to be over $1 billion in the US and Europe alone. Lonifarnib and PEG interferon lambda are late-stage programs which we believe are highly differentiated from other therapies in development. Lonifarnib is the only oral therapy in clinical development for HDV, and we expect that patient preference for a convenient all-oral HDV therapy will be high. We also believe that as a first-in-class type 3 interferon, PEG interferon lambda's tolerability profile will make it the interferon of choice for physicians and patients leading to better compliance and improved outcomes. By the time we launch Launafarnam, we expect increased awareness and diagnosis rates of hepatitis Delta virus, made possible by greater utilization of commercial HDV PCR tests and updates to EASL and AASLD testing guidelines. We look forward to attending additional conferences, including the AASLD liver meeting in November, where we're planning to have a major presence. Moving on to Zakindy. We reported $3.3 million in net sales during the second quarter in the U.S. As we previously stated, 80% of identified U.S. patients with progeria receives AKINDI with 100% payer reimbursement coverage. Following approval of AKINDI in Europe, we're moving at pace with our launch plans. We have appropriate infrastructure in place for successful commercialization across the EU, including distribution and patient support services. We're engaged with healthcare providers who are managing patients with progeria, as well as reimbursement authorities, ministries of health, and local payers to obtain reimbursement in each country. There are approximately 20 identified patients across Europe, and half of those are already receiving Zikindi through expanded access or clinical trials. We're encouraged by the positive response to Zikindi from physicians across Europe. Marketing authorization in Europe is an important milestone, both for Eiger, and the Progeria community, and we now look forward to bringing Zikindi to market to further support patients in need. To summarize, we're pleased with our commercial progress. The infrastructure we've established in the U.S. and now in Europe can scale and grow to support future launches and larger indications as we advance our mission to help patients with serious diseases. I'll now hand the call over to Sri for a financial update.

Thanks, Elvin. The press release we issued this afternoon includes a financial update, and I'll call out a few highlights here that demonstrate continued progress against our strategic and operational priorities. Total revenue this quarter was $4.1 million, which included Zokinbi net sales of $3.3 million, as Elvin noted, and $750,000 for a one-time upfront payment related to our partnership with Angus for Zokinbi in Japan. Turning to our second quarter 2022 GAAP operating expenses, cost of sales was approximately $0.2 million. R&D expenses were $17 million, and SG&A expenses were $7 million for the quarter. We reported a second quarter net loss of $21.9 million, or 51 cents, on a per share basis. Our operating cash burden this quarter included a one-time $5 million payment to BMS related to our phase three limit two study of Peganer-Furong Lambda for HDV. We accrued this as R&D expense in the first quarter and made the cash payment in the second quarter. As we have discussed before, a key part of our growth strategy is to develop and commercialize innovative therapies for underserved patients in a capital and resource efficient manner Our continued expense discipline and strong balance sheet provided us with operational flexibility and has allowed us to advance another program, Avexatide for congenital hyperinsulinism, into phase three. In June, we announced that we entered into a term loan agreement with Innovatus Capital Partners. This transaction allowed us to retire our previous debt facility and extend interest only for five years. We netted approximately $11 million at closing, And importantly, we have access up to an additional $35 million in non-diluted capital based on specific clinical and regulatory milestones. With approximately $142 million in cash, cash equivalent and investments as of June 30th, we are well positioned ahead of important milestones this year. We expect this cash to fund planned operations through 2024. We'll now open up the call for Q&A. Operator, please provide the instructions for the Q&A portion of the call.

Thank you. Ladies and gentlemen, if you have a question at this time, please press the star 11 key on your touch phone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We ask that you please limit yourself to one question and one follow-up. One moment for our questions.

And your first question comes from the line of Maureen Raycroft of Jefferies. Please go ahead. Congrats on the progress.

For COVID, I was wondering if you can provide more perspective at this point into the nature of FDA's information requests related to the COVID EUA application. And are there more specifics on next steps that you can share?

Thanks, Maury. I appreciate you joining the call. And for your question, I'll pass that to Ingrid.

Hey, Maury. So as you know, concurrent with the top-line data that we announced in mid-March, that was when we also shared this top-line data with FDA. And since then, we've been in active discussion with them. The TOGETHER is an investigator-sponsor study, and as such, it's necessitated some additional dialogue with FDA and requests for information. So the timeline isn't entirely within our control. However, we are pleased that we've responded to all of the information requests from FDA Submitting the EUA, as you know, is IHR's top priority, and as such, we've been preparing our EUA application in parallel with our FDA dialogue, and we're prepared to submit once we have final FDA feedback.

Got it. So it sounds like, just as follow-up, it sounds like next step is waiting for FDA feedback. And then, as far as the publication for the data goes, is there a status update on where that stands?

As you know, there was a Grand Rounds on July 29th by Ed Mills and Jeffrey Glenn, and they announced that they had submitted the manuscript for peer review. Our plan is still to have an investor call at the time of EUA submission such that we can review data with investors.

Got it. Okay. That makes sense. Okay. Thanks for taking my questions.

Thank you so much. And your next question comes from the line of Igor Noshimovitz of Citi. Please go ahead.

Hi, I'm for Igor. Thanks for taking my questions. Maybe just drilling down a little more on the last question. What's the latest thinking then in terms of timeline for actually filing? And based on your earlier comments in terms of ramping up production, is it your expectation that you'll have about 300,000 doses available by the end of the year for COVID, or that number may be higher now. Thanks.

Thanks very much for joining us and for your questions. And I'll turn, since it's a two-part question, I'll turn the first question regarding EUA timelines to Ingrid.

Yes. Again, I'll just reiterate, I mean, the EUA submission is our top priority. And in an effort to expedite that, we've been working in parallel to prepare this EUA application as we continue our dialogue with FDA, such that we'll be prepared to submit once we have final FDA feedback. We definitely understand the desire for more details on the EUA submission process. And again, as was mentioned earlier, making Lambda available for COVID-19 is our top priority.

I will just add to that. We believe that Together data are robust and compelling and represent a real-world population that is highly generalizable to the U.S. population. While we're unable at this point to provide specific details on the ongoing discussions with FDA, we very much look forward to providing near-term updates on the program. And secondly, with regard to manufacturing and procurement and quantities, I'll turn that one to Cherie to respond.

Yeah, so as you know, we're developing Lambda for HDV and have completed registration batches at our CMOs in anticipation of the Phase 3 program, which is ongoing in HDV. We do expect to have up to 300,000 doses available for potential launch. And importantly, that is separate from the supply required for ongoing HDV clinical trials. And as David noted in his comments, we are planning and working on plans for manufacturing scale-up.

Okay, great. Maybe if I could think in one more. As you're thinking about the delivery readout towards the end of the year, are you able to maybe give a little more color on the timelines involved, maybe when the last patient visit will be, database lock and so on? Are you thinking that the readout might just be in December, or is there a possibility it might be a little earlier? Thanks very much.

Thanks. Yeah, so we announced that we had completed enrollment of 407 patients back in November of last year. Top line data is 48 weeks post that last patient reaching week 48. So we've guided that we will release top line data for deliver at the end of this year. We haven't given any more granularity beyond that, but we are on track for deliver data by end of this year.

Okay, great. Thank you very much.

Thank you so much. Your next question comes from the line of Brian Scorney. Please go ahead and ask your question.

Thanks for taking our questions. Just a couple on the CHI Phase III program. We hosted a KOL a while back, and he noted the importance of reductions in tube feedings, octreotide use, and an improved fasting period as key benefits that he would be looking for in a therapeutic. Will any of these aspects be touched on in the study endpoints?

Hey, Brian, thanks so much for joining the call and for your questions. And we were excited to announce Avexatide beginning registration in congenital hyperinsulinism this year. And Dr. Colleen Craig actually is not only one of the inventors on the program, but also running the clinical program for us and has joined us for this call. So I'll turn those questions to Colleen.

Thanks, David. Yes, so as Ingrid and David described, we're very pleased with the progress that we've made to date in initiating the phase three program. And we do plan to disclose further details on the program and endpoints as we begin to screen patients later this year. What I can say at this point is that we've worked very closely and collaboratively with key opinion leaders as well as the congenital hyperinsulinism patient advocacy organizations and with regulators to craft and align on a thoughtful and efficient program that addresses the unmet medical needs, some of those that you have raised with patients with hyper-insulinism, and we're pleased with the feedback that we've received from stakeholders and the progress we've made to date with our startup activities.

Yeah, I'll just add, we... Oh, go ahead, Brian.

Oh, no, I was just... Go ahead, go ahead.

I was just going to say, we're pleased to initiate the program this year, and We believe it's a good thing for patients that this has become a fairly competitive environment for agents in development or therapeutics in development. We think of Exetide as a highly targeted mechanism as a GLP-1 antagonist and believe it's not only best in class but maybe best in group for targeting this severe disease. We've been thoughtful about how much we communicate on the Phase 3 study design, but clearly, as we get closer to screening and enrolling our first patients, we'll provide more guidance.

Great. So, we can expect more details this year, if I'm understanding correctly, or would that potentially be a 2023 event?

That is our plan.

Okay. Great. Thanks.

Thank you so much. Our next question comes from the line of Robert Hazlett from BDIG. Please go ahead and ask your question.

Yes, thanks for taking the question. One or two on HDV, kind of big picture questions, actually. With regard to HDV, is it your sense that testing maybe of HBV positive patients is increasing? And then could you just give us maybe parameters with regard to how you're thinking about pricing of therapeutics in the category?

Sure. I think those are good questions for clinical and commercial, respectively. But maybe I'll begin with Elden, who can probably address both questions, Bert. And thanks for the questions. Elden?

Yeah. Hi, Bert. So we've been monitoring the market and purchasing some data, and we have gradually seen increased levels of HPV testing. Of course, We do expect that to continue to increase as products approach commercialization and the educational efforts and awareness efforts do increase. So we'll continue to monitor that, and we'll probably have more information for you on that in the future. With respect to HDB pricing, of course, there are no products available in the U.S. at this time. So there are no benchmarks there. In Europe, however, you know, we're monitoring that situation as well. And we know that Bolveritide has been available for different prices in different markets that range between the $100,000 range and the $150,000 range, just to give you a couple benchmarks there. But, of course, as we get a closer look at our data and we're able to evaluate it and conduct some market research, we'll be able to understand the value proposition that our products will hold, which we think will be very strong with what our products have to offer. And we'll be able to determine the appropriate price to achieve the right access and the right value for shareholders in the company. Thanks, Elvin.

And Bert, I'll just add to that, you know, as Elvin mentioned in his prepared remarks, we attended the EASL International Liver Conference in London just a few months ago. And I can tell you after being in this space now for 14 years, this liver conference had the greatest exposure for hepatitis delta virus infection in my experience. And we view that as very positive to directly answer your question. There's more attention being placed on HDB today than ever. It's forcing interest in guideline discussions by both EASL and AASLD. And we believe that that will lead to more testing of HBV positive patients. So we don't need to find these patients de novo. We only need to test HBV-positive patients to find those patients who are co-infected with Delta. And we believe that we're well on our way. And we believe that the competitive environment with multiple programs and development will also fuel that and support that activity.

That's good to hear. Thank you for all that. Just if I could slide in one financial question. Was there any use of the ATM post a quarter? Thanks.

Yeah, we announced in our Q1 call a pro forma cash number that included ATM sales in April. There hasn't been any additional sales from the ATM other than what we announced back in our call in May.

Okay. Thank you for that. Congratulations on the progress. Look forward to the data. Thank you.

Thank you. And your next question comes from the line of Michael Higgins from Allenburg, Please go ahead.

Thanks, Emperor. Thanks, guys. Thanks for taking the questions. We're certainly looking forward to the deliver data around and just ahead of year end, the way it looks. Question for you, do you plan to host any R&D events, R&D day events prior to that? Thanks.

Sure. Hey, Michael, thanks so much for joining the call and for the thoughtful question, which is a good one. I'll pass that one to Sri, who's been talking about such an event. Sri?

Hey, Michael. Yes, we're certainly looking at different ways going into deliver data to spend some more time talking about our programs, talking about HDV generally. We mentioned we'll be at upcoming conferences. And certainly around deliver data, we would plan to host a call and talk through the details of that data. But stay tuned. More to come as we finalize details.

Okay. I appreciate that. And then turning our attention to the opportunity in treating COVID patients. Can you share with us what groups you're talking to globally, whether they be in and outside the U.S. and Europe that may be buyers of your product and then the groups that you're working with? Thanks.

Thanks, Michael. I'll tackle that question. And it's fair to say, you know, we, as discussed in our prepared remarks, are very much prioritizing and focused on an FDA allowance to submit an EUA application. And subsequently, you know, our plan is for an EUA authorization. We think that FDA stamp of approval is very important. That being said, we know that this is a global pandemic, and we definitely had reach in, as we communicated previously, from other regulators in other regions of the world. And we have plans to, in next steps, follow up and begin discussions with those other regulatory agencies. And likewise, it's fair to say that we have been in discussions with potential collaborators and partners who have keen interest and have not communicated beyond that, but believe that our first step in obtaining an emergency use authorization will catalyze many, if not most, of those discussions, such that we'll be able to communicate progress in the future.

Okay, I appreciate that. And then finally, turning our attention to Zirconia in Europe, if you could remind us of the number of patients that you've identified there and your thoughts on the pace of adoption, obviously, as you noted, roughly half or just over half already on drug, but also on what the pricing may look like in Europe versus the U.S. Thanks.

Sure.

I'll turn that one over to our Chief Commercial Officer, Eldon. Sure. So, we have identified approximately 20 patients across Europe. As you mentioned, roughly approximately half of those are already on drug. either on a clinical trial or on our managed access program. The percentage of patients that were on these programs in the US was higher, so based on that and that reimbursement, as you probably know, can be more of a lengthy process in Europe than in the US. We would expect to get patients on commercial supply over a longer time period, but in a steady fashion over the second half of this year and the first half of 2023. And we're looking to convert them over that time period as we're able to achieve reimbursement in various countries, which is done on a country by country basis. With respect to pricing, reimbursement is negotiated country by country, as I mentioned. And so we're engaged with the European authorities to file all the required dossiers that support access to drug, which includes pricing. And that will take some time, but we will share those details in the future as that more specific information becomes available.

Appreciate it. Thanks, Guy.

Thank you so much. And again, if you have a question, please press bar 1-1 on your touchstone telephone.

And I'm not showing any further questions.

I would now like to turn the call back to David Corey for any further remarks.

Sure. Thank you so much. I'd just like to close by reiterating the fact that it's been a quarter of successful delivery here at Iger against our objectives. and we're very excited to be driving forward to what we believe are multiple value-creating milestones very soon, in the second half of this year, and that we anticipate we will deliver both patient and shareholder impact by continuing the execution that we've reported today. I look forward to providing future updates on our progress across all of our programs, including what we believe will be near-term updates on our PEG Interferon Lambda COVID-19 EUA submission plans, And of course, none of this is possible without our dedicated people. And so I'd like to take this opportunity to thank the IHR team for their relentless efforts across all of our programs. And equally important, thank all of you for taking the time and joining us today on our call. Thank you very much and have a great day.