Eiger BioPharmaceuticals, Inc.

are late-stage and, we believe, highly differentiated from other therapies in clinical development. Lonefarnib ritonavir is the only oral therapy in clinical development for HDV, and we expect that patient preference for a convenient all-oral HDV therapy or a combination with interferon that delivers a robust response will be high. By the time we launch Lonefarnib, We expect increased awareness and diagnosis rates of hepatitis delta virus made possible by greater utilization of commercial HDB PCR tests and updates to EASL and AASLD testing guidelines. In the future, we believe that as a first in class type three interferon, PEG interferon lambda's tolerability profile has the potential to make it the interferon of choice for physicians and patients, leading to better compliance and improved outcomes. We are planning for a focused and cost-efficient HDB commercial launch. The same physicians who treat patients with HBV treat patients with Delta virus, and Delta is only found as a co-infection with HBV. As you can see from this map, in the U.S., HBV prescribers are heavily concentrated in major metropolitan areas. Seventy percent of HBV scripts are written by 10 percent of HBV prescribers, a dynamic that allows for a lean, targeted field force. Outside the U.S., we believe that delivered data could provide opportunities for strategic collaborations. While we're planning for a successful U.S. launch, we are preserving our options for partnerships in both the U.S. and in Europe. In China, where there are estimated to be more than one million hepatitis delta patients we will pursue a partnering strategy to provide access to patients in this important market while maximizing potential for shareholder value. Following delivered results, we plan to share additional details on our plans for commercialization of Lona Farna-based regimens for HDV. Finally, a quick update on Zikinbi. We reported $4 million in net sales during the third quarter in the U.S. As we previously stated, 80% of identified U.S. patients with progeria receives Akinvi with 100% payer reimbursement coverage. In July, we announced EMA approval of Akinvi. Demonstrating success in our reimbursement strategy, we secured reimbursement in two of the largest European markets. In France, under our Reimburse Early Access Program, and most importantly, in Germany. We expect our first shipment to Germany by the end of this year. We have appropriate infrastructure in place for a 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. In summary, we're pleased with our progress to date, excited about the commercial potential of our programs, and confident and our ability to execute an efficient launch of Lona Farna-based regimens for HDV. As I've noted before, the infrastructure we've established in the U.S. and now in Europe for the launches of Kinsey for Progeria has been designed to scale and grow to support future launches and larger indications, including HDV, as we advance our mission to help patients with serious diseases. We'll now hand the call over to Sri for a financial update.

Thanks, Elden. The press release we issued this afternoon includes a financial update, and I'll call out a few highlights here. As Elden noted, total revenue this quarter was $4 million, which consisted entirely of U.S. OTV net sales. This compares to $3 million reported for third quarter 2021 and $3.3 million for second quarter 2022. Higher net sales in Q3 were largely driven by additional unit shift during the quarter. Turning to our third quarter 2022 GAAP operating expenses, cost of sales was $1.2 million, which included a one-time write-off of a non-conforming batch of inventory in the quarter. R&D expenses were $22.2 million, and SG&A expenses were $7 million for the quarter. We reported a third quarter net loss of $27.1 million, or 62 cents, on a per share basis. As we've 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. To that end, we have been disciplined managing our expenses as we've advanced multiple programs into and through Phase 3. With approximately $121 million in cash, cash equivalents, and investments as of September 30th, we are well-positioned ahead of important milestones and catalysts. We expect this cash to fund planned operations through 2024 before potential commercialization in HDB. Importantly, we have access to additional non-diluted capital under our debt facility that we entered into earlier this year. Iger can access up to $35 million in additional cash contingent on positive clinical and regulatory milestones across two tranches, which could be instrumental to fund our bona farde HDB commercial launch expenses. We'll now open up the call for Q&A. Operator, please provide the instructions for the Q&A portion of the call.

Ladies and gentlemen, if you have a question at this time, please press the star, then 11 on your touchstone 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 our first question comes from the line of Moyer-Racoff of Jeffries. You may now ask your question.

Hi. Congrats on the progress, and thanks for taking my questions. I was going to ask just about the composite endpoint data that you have on slide 13. If you can talk about how reflective or similar these patients are to your Phase III population. And is there anything you can say about baseline viral load or other baseline variables and how these can end up impacting the phase three results?

Hi, Maury. Thanks for your question. And I will turn that one to Ingrid Cho. Ingrid?

Hey, Maury. Yes, the phase three baseline characteristics, those patient population is very similar to what we previously saw in phase two. Regarding the specifics of the baseline characteristics, we put out an abstract at EASL earlier this year that did share that the mean HDV RNA, for example, in DELIVER is around five logs. We also shared what the ALT baseline characteristics are as well, and we certainly will be sharing additional information when top-line results come out next month.

Got it. Nothing additional you can say just on how some of those baseline characteristics could potentially impact the results versus what you've already shown with the Phase II composite data on slide 13.

I mean, so far, like I said, all of the, what we've seen is that the baseline characteristics from Phase 3 is very comparable to what's in Phase 2. Percent cirrhotic, for example, around 30% of patients are already cirrhotic. You know, I think that's one of the important things of ensuring that your Phase 3 entry and exclusion criteria are very similar to your Phase 2. Other criteria, like patients who are previously on PEG and if they're on alpha, also was very comparable from phase two to phase three.

Got it. I'll just add, Maury, that as you know, the composite endpoint of greater than or equal to a two-log decline in HDV RNA, we believe based on the phase two data that we should see those kinds of reductions in viral load Irrespective of whether patients come in with high viral load or high baseline or lower baseline, whether or not the patient would ultimately get negative or become undetectable, obviously may be influenced by their baseline viral loads. But our ability to achieve that two-log decline, we believe, is consistent across baseline viral loads. And then, of course, ALT. we believe typically follows HDB RNA levels. And so we have, you know, high expectations on reduction in ALT or normalization of liver enzymes as well.

Got it. That's helpful. And I want to ask one other follow-up question. There was some impact related to sites in the Ukraine and Russia, I believe. Can you say where you're at with phase three data collection? What final numbers will be included in your analyses? and if the database is locked or if you have line of sight to database lock.

Ingrid?

Yeah, so early on in the Ukraine-Russian conflict back in February, we did some sensitivity analyses. and showed that even if we were to lose all the patients who were randomized to Ukraine, that we would still be more than adequately powered to show statistical significance of either of the lonofarnib containing regimens over placebo. Today, we've had no impact on the Russian sites or in patients, and again, we haven't While we were planning for a potential losing all patients to Ukraine, we've only lost a subset. So we're still more than adequately powered to show statistical significance against either arm.

We haven't guided on database lock yet, Maury, but to the extent that providing guidance that we plan to announce top line data in December helps. Hopefully that gives you a straight line between today and sometime in December.

Yeah, so we are on track to still having a top-line data. This is a large study, and we've been cleaning and querying the database since the early part of this year and feel really good about having top-line data by December.

Got it. I look forward to the results. Thank you. Thank you.

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

Thanks for taking our question. This is Charlie on for Brian. We wanted to know how you were thinking about the CRL for HEP Quidex and if you think that'll have any impact on the HGV commercial opportunity for your products. Thank you.

Hey, Charlie. Thanks so much for joining us today and definitely appreciate the question. We, as you can imagine, we're not aware of Bolvera Tide timing or the CRL that Gilead announced related to their program, but we do plan to provide more details on our regulatory strategy and timelines following our announcement of deliver results in December. This is a key strategy, obviously, and priority for IHR.

All right, thank you.

So much. Your next question comes from the line of Bruce Haslett of EBIG. Please go ahead and ask your question.

Yes, thank you for taking the question. Apologies if this has been addressed, but could you just remind us of the potential for maybe more rapid enrollment of limit to the PEG interferon lambda? Kind of what pushes and pulls are in place in that trial that might help enrollment relative to deliver? Thank you.

Hi, Bert. Thanks for joining us today. And that's a great question. I'll turn that one over to Ingrid.

Hey, Bert. Yeah, the base three limit two study, it's a much smaller, more straightforward study compared to deliver. Only 150 patients planned across 12 countries, across 50 sites. We've picked these 50 sites from the best-performing sites from DELIVER, so this will definitely facilitate more expeditious enrollment. Also, the inclusion and exclusion criteria in Limit 2 is much more lax compared to that of DELIVER based on learnings. For example, in DELIVER, because part of our composite endpoint is a two-log decline in we are requiring all patients to have at least a two and a half log HDB RNA at study entry for deliver. In the case of limit two, since the primary endpoint is being below the limit of quantitation, patients only have to have quantifiable HDB RNA at study entry. So that's just one example. Another example is all patients on both deliver and limit two must have suppressed HBV DNA upon study entry, and that criteria for defining suppressed HBV DNA is much higher in Limit 2. So it's 20 IUs per ml in the case of DELIVER and 100 IUs per ml in Limit 2. And again, these are just learnings and the benefit of having, you know, first having run DELIVER before Limit 2.

We definitely learned a lot from the phase three deliver study across, you know, over 20 countries and 100 sites. And those learnings we've all applied in the limit two lambda study for HDV and look forward to obviously providing more guidance after we've completed activation of all roughly 50 sites and we'll communicate in the future.

Okay, thank you. That's all for me. Thanks so much.

Thank you so much. And again, ladies and gentlemen, if you have a question, please press R, then 1-1 on your touch-tone phone. Your next question comes from the line of Michael Higgins. Off the side of the room, please go ahead and ask your question.

Hi, this is Farhana on behalf of Michael. We have a question basically on the Delta Q meeting.

Sorry, Farhana, could you repeat that again?

Yeah, sorry. I wasn't sure if you guys could hear me. Can you hear me now? Yeah, yes. Okay. We wanted to know a little bit more about your participation at the Delta Cure meeting. I guess, what can you share about what you learned there and what sort of feedback did you get on AIGO's program?

Oh, of course. And Farhana, thanks so much for joining us today. Ingrid actually was in attendance with the clinical team in Milan at the Delta Cure meeting. And it was an amazing event. And as Ingrid pointed out, it's the first actually international meeting specifically focused on hepatitis delta virus infection, which we think portends great things to come in terms of focus in this therapeutic area. And Ingrid, I'll let you comment on some of the experiences and learnings out of Delta Cure.

Sure. Yeah, Delta Cure was held for two days in the early part of October. There was 150 in-person attendees with 250 people participating by Zoom. And again, this was the first and only medical meeting focused solely on Delta. Most of the attendees were key opinion leaders. There was also pharma represented. In addition to Iger, there was Gilead. J&J, Veer, and then also some diagnostic companies as well. So it was one and a half days of presentations. The first day were oral presentations, really just talking about disease space and the need for therapy. And then the second half day was focused on pharma, giving updates on programs. Iger presented on lonafarnib as well as peganifreon lambda. And ultimately, there's just a lot of excitement around on the space now with data coming out across from, you know, bulevertide as well as lonafarna, bretonavir, and peganefran lambda, and really discussing the need for, you know, potentially combination therapies to really be able to, you know, conquer HDV, which is a very serious and virulent viral hepatitis.

Thanks, Ingrid. Now, I'll just add, I'll add, Farhana, that I think part of the reason that the The host of the Delta Cure meeting, Dr. Heiner Wiedemeyer out of Hanover, Germany, and Dr. Pietro Lampertico out of Milan, Italy, two major, you know, key opinion leaders in the HDV space. I think the reason that they wanted to advance with a program like this, in part, is because now in addition to Iger, as Ingrid mentioned, Veer is now in the HDV development space, as well as Gilead, J&J, Assembly, Alberio, and I'm sure I'm leaving a few companies out, but the pipeline of programs, albeit earlier stage, lonafarnib, rutonavir, and in combination with alpha-interferon is obviously very late stage, but many early stage programs, I think, which is terrific for the future and provides hope for patients with HDV.

Great, thanks. Can I just ask one more quick thing? Maybe we missed this, so if you could just clarify. So, for vexatide, it looks like you're just screening patients, right? There are no patients enrolled.

Hey, Farhana, that's correct. We have not yet enrolled a patient in the vexatide abroad program. We're undertaking all of the enabling work to be able to activate sites and screen patients and we'll be able to provide updates once we have more to say on that.

I will say that the Congenital Hyperinsulinism International Foundation recently held a benefit afternoon and evening in Montclair, New Jersey, which was attended by key opinion leaders and investigators from both CHOP, Children's Hospital of Philadelphia, as well as Cook Children's. It was an amazing event, both for fundraising for supporting congenital hyperinsulinism international, but also for multiple pharma companies in the congenital hyperinsulinism development space to interact with key opinion leaders, patients, families, and investigators. And I think this is another exciting area that we definitely are very motivated to provide additional updates in the near future, and we'll do so.

Great, thanks. And then is 2024 a fair estimate for data?

For the Avexatide Avant program, we will complete activation of sites and begin enrolling patients and then provide more guidance for HANA on next steps for enrollment and obviously then timelines for site-on data.

Okay, great. Thank you guys for taking our questions.

Thank you.

All right. Thank you so much. And I'm not showing any further questions. I would now like to turn the call back to David Corey for any further remarks.

Certainly. And thank you very much. In closing, I just want to make a few comments. We're very excited that the unblinding and reporting of top line data from the DELIVER study is just weeks away. And we look forward to hosting an investor call when we announce the top line results. This landmark deliver study provides multiple paths to registration of lonafarnib-based regimens, which we believe are well differentiated from other therapeutics in development. We continue to execute across our pipeline of multiple FDA-designated breakthrough therapy programs in phase three, which have the potential to deliver both patient and shareholder value. And of course, none of this would be possible without our team of dedicated people, so I'd like to thank everyone for their relentless efforts across our programs, not only at Iger, but our investigators, our patient and advocacy support groups, and, of course, thank all of you for joining us today on our call. Have a great day.

Thank you, presenters. And this concludes today's conference call. You may now disconnect.

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