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Welcome to the Eiger BioPharmaceuticals Third Quarter 2022 Financial Results 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 [Operator Instructions]. As a reminder, this call will be recorded.
I would now like to turn the call over to Sarah Mathieson, Senior Vice President, Corporate Affairs at Eiger. 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 Q3 financial results, which is also available on our Web site at eigerbio.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 Investors section of our Web site. Joining me on the call with prepared remarks are David Cory, President and CEO; Sri Ryali, Chief Financial Officer; Eldon Mayer, Chief Commercial Officer; and Dr. Ingrid Choong, Senior Vice President, Clinical Development. We also have subject matter experts on our team Dr. Colin Hislop, Senior Vice President, Clinical & Development Operations and Dr. Colleen Craig, Vice President of Metabolic Diseases available for Q&A.
Before we begin, I would 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 Eiger's control, which could cause our actual results to differ materially. A description of these risks and uncertainties is contained in Eiger's filings with the SEC, including our latest 10-K and 10-Q reports available on the Eiger Web site in the Investors Section. All forward-looking statements are based on information currently available to Eiger and we assume no obligation to update these statements.
I will now turn the call over to David.
Thanks Sarah. At Eiger, we are committed to fulfilling the promise of high potential drugs for patients with serious diseases. To that end, we built a pipeline of multiple late stage breakthrough therapy designated programs, including our hepatitis delta virus platform Lonafarnib ritonavir, and Peginterferon lambda, two first-in-class therapies that are both in Phase 3. We're just weeks away from unblinding and reporting topline data from the Phase 3 D-LIVR study of two different Lonafarnib based regimens for the treatment of HDV. With over 400 patients enrolled across 100 sites in over 20 countries, D-LIVR is the largest HDV study ever conducted. We look forward to recording data from this landmark study next month, an important milestone both for Eiger and for patients suffering from HDV. We're also making good progress advancing our second HDV therapy in development, Peginterferon lambda in the Phase 3 LIMT-2 study. We are activating 50 clinical trial sites and enrolling patients in 12 countries. Hepatitis delta is the most severe form of viral hepatitis, impacting more than 12 million people around the globe. There are currently no FDA approved HDV therapies, and effective treatment options are desperately needed for these patients. We believe that based on their mechanisms of action and convenient administration, Lonafarnib and Peginterferon lambda are highly differentiated from other therapies in development. Ingrid will provide additional details on our plans for D-LIVR topline data and Eldon will comment on the HDV commercial opportunity and our commercialization plans in just a few minutes.
Turning to our rare metabolic disease programs. We believe of Avexitide, our first-in-class GLP-1 receptor antagonist, has the potential to confer meaningful therapeutic benefit across a broad spectrum of hyperinsulinemic hypoglycemic conditions. For our lead indication, we have initiated the Phase 3 AVANT program in congenital hyperinsulinism, a rare life threatening disorder affecting neonates and children. With no approved treatments for congenital hyperinsulinism, new effective therapies are urgently needed. Avexitide has been granted FDA breakthrough therapy designation and rare pediatric disease designation, potentially making it eligible for a priority review voucher upon approval for congenital hyperinsulinism. We have agreement with FDA on the study design and endpoints, and expect to enroll over 40 neonates and children. We've been pleased by the enthusiasm and support from across both the clinical and patient advocacy communities for the AVANT program, and look forward to sharing more details as we begin activating sites and screening patients.
Regarding Peginterferon lambda for COVID-19, we're disappointed that the FDA will not consider an EUA application of Peginterferon lambda for COVID-19 based on results generated from the investigator sponsored Phase 3 TOGETHER study. However, we continue to have strong conviction in the data and in the potential of Peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections. We’re actively evaluating next steps for this program, both in the US and ex-US, as well as strategic options for continued development of Peginterferon lambda for COVID-19 and other respiratory viral infections. We plan to update as material progress warrants. And finally tuning to our commercial product. This year we've successfully expanded the global commercial reach of Zokinvy with marketing authorizations in the EU and UK, as well as a partnership with AnGes, a commercial stage biopharmaceutical company based in Japan. The approval of Zokinvy in the US and now in Europe demonstrates Eiger's ability to navigate complex global regulatory requirements and successfully commercialize medicines for patients in need. We're executing across our strategic priorities and continuing the momentum we've seen throughout 2022 to finish this year strong. 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 to prepare for growth.
I'll now hand the call over to Ingrid.
Thanks, David. I'll begin by highlighting our continued progress across our hepatitis delta virus platform. As David noted, we are excited that we are just weeks away from unblinding and reporting topline data from the landmark Phase 3 D-LIVR study of two Lonafarnib based regimens. Our clinical team is in the process of cleaning the database before it can be locked and analyzed to report top line results. This milestone is years in the making for Eiger and HDV patients. As the largest study conducted in hepatitis delta virus, D-LIVR will generate a comprehensive source of patient data from a well controlled global clinical trial to better understand and characterize this devastating progressive disease and if positive support global regulatory filings. The design of the Phase 3 D-LIVR study was informed by our Phase 2 Lonafarnib HDV platform. To recap, this broad Phase 2 program spanned five studies and explored over 50 different Lonafarnib based regimens in 129 HDV infected patients. And the regimens that were subsequently advanced into Phase 3, the composite endpoint defined as a two log decline in HDV RNA and normalization of ALT was achieved in 29% of patients receiving the all oral regimen and 63% of patients receiving the combination with Peginterferon Alpha after 24 weeks of treatment.
The Phase 3 D-LIVR study provides multiple paths to registration of two Lonafarnib based regimens, the primary endpoint is a composite of a two log decline in HDV RNA and normal rotation of ALT after 48 weeks of treatment. If either of the Lonafarnib base regimens, the all oral or the combination with Peginterferon Alpha meet the primary endpoint versus placebo, we have a path for an NDA submission. Importantly, we do not need to see response rates higher than any other investigational therapies for a successful outcome. We believe that in a chronic disease like HDV where patients maybe on treatment for many years, there will be a high patient demand for an all oral treatment option or an oral regimen combined with a weekly interferon that delivers a robust response. A key secondary endpoint of D-LIVR is histology, assessed using baseline and week 48 and the treatment paired liver biopsies. In a disease as aggressive as hepatitis delta virus, demonstrating stabilization of fibrosis in a treatment arm compared to placebo would be clinically meaningful for patients as this could potentially obviate the need for liver transplants. We expect to report both the primary endpoint and key secondary endpoints when we report topline results in December, and we’ll host an investor call to discuss the data.
Turning to our second HDV program, Peginterferon lambda. The Phase 3 LIMT-2 study continues to activate sites and enroll patients. LIMT-2 is a straightforward study of 150 patients largely enrolling from the best performing sites from the D-LIVR study. LIMT-2 is a randomized two arm study; arm one is 48 weeks of Peginterferon lambda once weekly, followed by 24 weeks off treatment; arm two is 12 weeks of no treatment. The primary endpoint is the proportion of patients with HDV RNA below the limit of quantitation at 24 weeks post treatment in arm one compared to 12 weeks of no treatment in arm two. All patients in arm two will be offered the option to move to active treatment after 12 weeks, making this an attractive study where all patients can be treated with Peginterferon lambda. This Phase 3 primary endpoint was previously demonstrated in Phase 2 where 36% of patients achieved HDV RNA below the limit of quantitation at 24 weeks post treatment, a durable virologic response or DVR. This is similar to the sustained virologic response or SVR endpoint previously used for HCV therapies. The DVR endpoint is meaningful for regulatory agencies and physicians as it demonstrates durability and response to a finite therapy and the potential for a cure for hepatitis delta virus.
Our strategic approach in HDV is to seek regulatory approvals of two Lonafarnib based regimens from the results of the D-LIVR study. We will follow with data from LIMT-2, which could lead to approval of Peginterferon lambda for HDV. We believe this approach provides the most expeditious route to approval for both Lonafarnib and Peginterferon lambda. In parallel, we will generate data through the NIH Phase 2 LIFT study, which we believe will support the future use of our proprietary combination of Lonafarnib ritonavir and Peginterferon lambda for hepatitis delta infection. We are excited about the continued advancements in the HDV space. Last month, Eiger participated in the first international Delta Cure Conference, the only medical meeting focused solely on hepatitis delta, and we look forward to attending AASOD, the liver meeting, starting tomorrow in Washington DC. With topline data from D-LIVR right around the corner and continued progress enrolling the LIMT-2 study, Eiger’s contributing to the strong momentum in this space. We believe our platform of first-in-class differentiated therapies positions as well to become a leader in HDV.
I'll now turn the call over to Eldon.
Thanks Ingrid. I'll spend the next few minutes providing an overview of our commercial planning for the anticipated launch of Lonafarnib based regimens for the treatment of HDV. As Ingrid noted, D-LIVR provides multiple potential pathways to registration of Lonafarnib based regimens. We believe that either Lonafarnib based regimens, the all oral Lonafarnib ritonavir or the combination with Peginterferon Alpha, has the potential to confer benefits to HDV patients and represents a significant commercial opportunity. These are exciting times for the commercial team at Eiger. Collectively, this team has extensive experience with product launches, specifically in the orphan disease space. Over the past 25 years, we've launched 10 FDA approved therapeutics for multiple orphan diseases across different therapeutic areas. Eiger has been developing therapies for HDV for over a decade. During that time, we've built strong relationships with HDV investigators and key opinion leaders, conducted market research and developed our launch plans, which we continue to refine. With Phase 3 D-LIVR data now imminent, we are closer to operationalizing these plans. As David noted, HDV is a significant unmet medical need, impacting more than 12 million people around the globe. In the US and Europe, HDV is a large orphan disease with an estimated prevalent patient population of 300,000. The potential of the HDV commercial opportunity has been validated by the recent entry of multiple other companies with early stage development programs into the space where there are currently no FDA approved therapies.
Both our HCV programs Lonafarnib ritonavir and Peginterferon lambda are at late stage and we believe highly differentiated from other therapies in clinical development. Lonafarnib 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 Lonafarnib, we expect increased awareness and diagnosis rates of hepatitis delta virus made possible by greater utilization of commercial HDV PCR tests and update to EASL and AASLD testing guidelines. In the future, we believe that as a first in class type three interferon, Peginterferon 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 HDV commercial launch. The same physicians who treat patients with HDV 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 US, HBV prescribers are heavily concentrated in major metropolitan areas. 70% of HBV scripts are written by 10% of HDV prescribers, a dynamic that allows for a lean targeted field force. Outside the US, we believe that D-LIVR data could provide opportunities for strategic collaborations. While we're planning for a successful US launch, we are preserving our options for partnerships in both the US and in Europe. In China, where there are an estimated to be more than 1 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 D-LIVR results, we plan to share additional details on our plans for commercialization of Lonafarnib based regimens for HDV.
Finally, a quick update on Zokinvy. We reported $4 million in net sales during the third quarter in the US. As we previously stated, 80% of identified US patients with Progeria received Zokinvy with 100% payer reimbursement coverage. In July, we announced EMA approval of Zokinvy. Demonstrated success in our reimbursement strategy, we secured reimbursement in two of the largest European markets, in France, under our reimbursed 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 in our ability to execute an efficient launch of lonafarnib based regimens for HDV. As I've noted before, the infrastructure we've established in the US and now in Europe for the launch of Zokinvy 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.
I will now hand the call over to Sri for financial update.
Thanks, Eldon. The press release we issued this afternoon include the financial update, and I'll call out a few highlights here. As Eldon noted, total revenue this quarter was $4 million, which consisted entirely of US Zokinvy 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 units shipped during the quarter. Turning to our third quarter 2022 GAAP operating expenses. Cost of sales was $1.2 million, which included a onetime write off of a nonconforming 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 $0.62 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've 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 HDV. Importantly, we have access to additional nondiluted capital under our debt facilities that we entered into earlier this year. Eiger can access up to $35 million in additional cash, contingent on positive clinical and regulatory milestones across two tranches, which can be instrumental to fund our Lonafarnib HDV 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.
[Operator Instructions] And our first question comes from the line of Maurice Raycroft of Jefferies.
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 reflective or similar these patients are to your Phase 3 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 3 results?
And I will turn that one to Ingrid Choong. Ingrid?
The Phase 3 baseline characteristics, those patient population is very similar to what we previously thought in Phase 2. Regarding the specifics of the baseline characteristics, we put out an abstract at an EASL earlier this year that did share that mean HDV RNA, for example, in D-LIVR is around five logs. And we also shared what the ALT baseline characteristics are as well and we certainly will be sharing additional information when topline results come out next month.
And so nothing additional you’d say just on how some of those baseline characteristics could potentially impact the results versus what you've already shown with the Phase 2 composite data on Slide 13?
So far, like I said, all of the -- what we've seen as the baseline characteristics from Phase 3 is very comparable to what's in Phase 2 for cirrhotic, for example, around 30% of patients are already cirrhotic. 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 Peginterferon Alpha, also was very comfortable from Phase 2 to Phase 3.
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 2 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, maybe 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 HDV RNA levels. And so we have high expectations on reduction in ALT or normalization of liver enzymes as well.
And I wanted 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 3 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?
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 Lonafarnib containing regimens over placebo. Today, we've had no impact on the Russian sites on patients. And again, we haven't -- while we were planning for potential losing all patients for 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 topline data in December helps, hopefully that gives you a straight line between today and sometime in December.
So we are on track to still having a topline data. We've been -- 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.
And your next question comes from the line of Brian Skorney of Baird.
This is Charlie on for Brian. We wanted to know how you were thinking about the CRL or Hepcludex . And if you think that will have any impact on the HDV commercial opportunity for your products?
As you can imagine, we're not aware of bulevirtide 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 D-LIVR results in December. This is a key strategy obviously and priority for Eiger.
Your next question comes from the line of Bert Hazlett of BTIG.
Apologies if this has been addressed. But could you just remind us of the potential for maybe more rapid enrollment of LIMT-2, the Peginterferon lambda. Kind of what pushes and pulls are in place in that trial that might help enrollment relative to D-LIVR?
Thanks for joining us today. And that's a great question. I'll turn that one over to Ingrid.
The Phase 3 LIMT-2 study, it's a much smaller, more straightforward study compared to D-LIVR only 150 patients planned across 12 countries across 50 sites. We've picked these 50 sites from the best performing sites from D-LIVR. So this will definitely facilitate more expeditious enrollment. Also the inclusion and exclusion criteria in LIMT-2 is much more or less compared to that of D-LIVR based on learnings. For example, in D-LIVR because we -- part of our composite endpoint is a two log decline in HDV RNA, we are requiring all patients to have at least a 2.5 log HDV RNA at study entry for D-LIVR. In the case of LIMT-2, since the primary endpoint is being below the limit of quantitation, patients only have to have unquantifiable HDV RNA at study entry. So that's just one example. Another example is all patients on both D-LIVR and LIMT-2 must have suppressed HDV DNA upon study entry, and that criteria for -- that’s finding suppressed HDV DNA is much higher in LIMT-2, so it's 20 IUs per ml in the case of D-LIVR and 100 IUs per ml in LIMT-2. And again, these are just learnings and the benefit of having, first, having one D-LIVR before LIMT-2.
We definitely learned a lot from the Phase 3 D-LIVR study across over 20 countries and 100 sites, and those learnings we've all applied in the LIMT-2 lambda study for HDV. And look forward to obviously providing more guidance after we have completed activation of all roughly 50 sites and will communicate in the future.
[Operator Instructions] Your next question comes from the line of Michael Higgins of Ladenburg.
This is Farhana on behalf of Michael. We have a question basically on the Delta Cure Meeting…
Farhana, could you repeat that again?
I was just talking to you guys. Can you hear me now?
Yes.
We wanted to know a little bit more about your participation of the Delta Cure Meeting. I guess what can you share about what you learned there and what sort of feedback did you get on Eiger’s program.
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 portend 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.
Delta Cure was held for two days, in the early part of October. There was 160 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 [Technical Difficulty] Eiger, there was Gilead, J&J, Vir and then also some diagnostics 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 therapies and then the second half day was focused on pharma, giving updates on programs. Eiger presented on Lonafarnib, as well as Peginterferon lambda. And ultimately, there's just a lot of excitement around the space now with data coming out across from Bill [Everett] as well as Lonafarnib ritonavir and Peginterferon lambda, and really discussing the need for potentially combination therapies to really be able to conquer HDV, which is a very serious and virulent viral hepatitis.
And I'll add Farhana that, I think part of the reason that the host of the delta cure meeting Dr. Heiner Wedemeyer out of Hannover, Germany and Dr. Pietro Lampertico out of Milan, Italy, two major 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 Eiger, as Ingrid mentioned, Vir is now in the HDV development space as well as Gilead, J&J, Assembly, Albireo, and I'm sure I'm leaving a few companies out. But the pipeline of programs, albeit earlier stage, Lonafarnib ritonavir 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.
Can I just ask one more quick thing, maybe we missed so if you could just clarify. So Avexitide, it looks like we're just screening patients, right? There are no patients enrolled.
Farhana, that’s correct. We had not yet enrolled patient in the Avexitide AVANT 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.
But 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 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 will do so.
And then is 2024 a fair estimate for data?
For the Avexitide AVANT program, we will complete activation of sites and begin enrolling patients and then provide more guidance, Farhana, on next steps for enrollment and obviously, then timelines for site on data.
And I'm not showing any further questions. I would now like to call back to David Cory 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 D-LIVR study is just weeks away, and we look forward to hosting an investor call when we announce the topline results. This landmark D-LIVR 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 3, 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 Eiger 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.