Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET
Company Participants
Sarah Mathieson – SVP, Corporate Affairs
David Cory – President & CEO
Ingrid Choong – SVP-Clinical Development
Eldon Mayer – Chief Commercial Officer
Sriram Ryali – CFO
Colleen Craig – VP-Metabolic Diseases
Conference Call Participants
Maurice Raycroft – Jefferies
Robert Hazlett – BTIG
Michael Higgins – Ladenburg Thalmann
Operator
[Starts Abruptly] and business update conference call. At this times, 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 introduce Sarah Mathieson, Senior Vice President, Corporate Affairs at Eiger. You may begin.
Sarah Mathieson
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 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 website.
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 from our team, Dr. Colin Hislop, 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 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 website 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’ll now turn the call over to David.
David Cory
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 Eiger as a highly differentiated biopharmaceutical company with a diverse pipeline with major catalysts in our development programs for peginterferon lambda, lonafarnib and Avexitide as well as on the commercial front with Zokinvy, we believe that 2022 is shaping up to be a transformational year for Eiger.
I’ll begin with progress on our peginterferon lambda program for COVID-19. Since we announced positive top line results from the Phase III 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 subvariant, 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 peginterferon 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 peginterferon lambda available to the health care community continues to be our priority. In terms of commercial readiness, we have launched quantities to support the introduction of peginterferon 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 peginterferon lambda both in Phase III. We are actively preparing for top line data from the Phase III D-LIVR study of lonafarnib-based regimens by the end of this year, a significant upcoming milestone for Eiger and for patients with HDV. With hepatitis delta virus affecting over 12 million people worldwide, the health care 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 lonafarnib and peginterferon lambda have real momentum in Phase III, 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 are advancing Avexitide into the Phase III AVANT registrational program for congenital hyperinsulinism. Avexitide 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 Eiger 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 Zokinvy 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, Zokinvy’s European approval is an important milestone for the Progeria community. As Eiger’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-U.S. regulatory requirements.
We’re also expanding global commercial access to Zokinvy through strategic partnerships in countries like Japan with our recently announced partnership with AnGes. Eldon will provide more details on our commercial progress in just a few moments. This is an exciting time for Eiger. 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 Eiger 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.
Ingrid Choong
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 are on track to report top line data from the landmark Phase III D-LIVR study of two lonafarnib-based regimens by the end of this year, a significant milestone for Eiger.
With 407 patients enrolled across 116 clinical trial sites in 22 countries, D-LIVR 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, D-LIVR data will support global regulatory filings for two different lonafarnib-based regimens. The study includes an all-oral arm of lonafarnib boosted with ritonavir and a combination arm with peginterferon 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, peginterferon lambda in the Phase III LIMT-2 study. LIMT-2 is a randomized 2-arm study. Arm 1 is 48 weeks of lambda once weekly followed by 24 weeks off treatment. Arm 2 starts with 12 weeks of no treatment followed by 48 weeks of treatment.
The primary endpoint is the proportion of patients with a durable urologic response at 24 weeks post-treatment in arm 1 compared to 12 weeks of no treatment in arm 2. This endpoint was previously demonstrated in Phase II 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. LIMT-2 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 lonafarnib-based regimens from the results of the D-LIVR study. We will quickly follow the 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 are generating data through the LIFT-2 study, which we believe will support the future use of our proprietary combination of lonafarnib and peginterferon 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. Eiger is contributing to the strong momentum with our HDV platform of multiple potential treatment options for patients. We believe Eiger 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 Avexitide in the treatments of patients with hypoglycemia after bariatric and other upper GI surgeries, further building on the role of GLP-1 and mediating hyperinsulinemic hypoglycemia.
I’ll now hand the call over to Eldon.
Eldon Mayer
Thanks, Ingrid. I’ll provide highlights of our activities to support hepatitis delta virus commercial planning as well as an overview of our current Zokinvy 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 EASL International Liver Conference, where Eiger had a major presence with multiple presentations highlighting data across our HDV platform.
Eiger 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 HDV is rapidly growing alongside the recognition that this is a serious disease in urgent need of therapies. The competitive space is also growing in HDV with companies investing in early-stage programs recognizing this global opportunity, which is estimated to be over $1 billion in the U.S. and Europe alone.
Lonafarnib and peginterferon lambda are late-stage programs, which we believe are highly differentiated from other therapies in development. Lonafarnib 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 III interferon, peginterferon 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 launched lonafarnib, we expect increased awareness and diagnosis rates of hepatitis delta virus made possible by greater utilization of commercial HDV PCR test 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 Zokinvy, 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 received Zokinvy with 100% payer reimbursement coverage. Following approval of Zokinvy 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 health care 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 Zokinvy through expanded access or clinical trials. We’re encouraged by the positive response to Zokinvy 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 Zokinvy 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 financial update.
Sriram Ryali
Thanks, Eldon. 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 Zokinvy net sales of $3.3 million, as Eldon noted, and $750,000 for a onetime upfront payment related to our partnership with AnGes for Zokinvy 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 $0.51 on a per share basis. Our operating cash burn this quarter included a onetime $5 million payment to BMS related to our Phase III LIMT-2 study of peginterferon 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 provide us with operational flexibility and has allowed us to advance another program, Avexitide for congenital hyperinsulinism into Phase III.
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 had 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 equivalents and investments as of June 30, we are well positioned to have an 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.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] And your first question comes from the line of Maurice Raycroft of Jefferies. Please go ahead.
Maurice Raycroft
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 request related to the COVID EUA application. And are there more specifics on next steps that you can share?
David Cory
Thanks, Maurice. I appreciate you joining the call and for your question. I’ll pass that to Ingrid.
Ingrid Choong
Hey, Mauri. 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 date with FDA. And since then, we’ve been in active discussion with them. The TOGETHER is an investigator-sponsored study. And as such, it’s necessitated some additional dialogue with FDA and request for information. So the time line 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 Eiger’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.
Maurice Raycroft
Got it. So it sounds like — just as a 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?
Ingrid Choong
As you know, there was a Grand Rounds on July 29 by Ed Mills and Jeffrey Glenn, and they announced that they have 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.
Maurice Raycroft
Got it. Okay. That makes sense. Okay. Thanks for taking my questions.
Operator
Thank you so much. Your next question comes from the line of Yigal Nochomovitz of Citi. Please go ahead.
Unidentified Participant
[Technical Difficulty] on for Yigal. Thanks for taking my questions. Maybe just drilling down a little bit more on the last question. What’s the latest thinking then in terms of time line 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 is that number maybe higher now? Thanks.
David Cory
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.
Ingrid Choong
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. Of course, we’ll be prepared to submit once we have final FDA feedback. We definitely understand the desire from more details on the EUA submission process and again, as was mentioned earlier, making lambda available for COVID-19 is our top priority.
David Cory
I will just add to that. We do 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 Sri to respond.
Sriram Ryali
Yes. As you know, we’re developing lambda for HDV and have completed registration batches at our CMOs in anticipation of the Phase III 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 our ongoing HDV clinical trials. And as David noted in his comments, we are planning and working on plans for manufacturing scale up.
Unidentified Participant
Okay. Great. Maybe if I could sneak in one more. Just thinking about the D-LIVR 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 and 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.
Ingrid Choong
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 D-LIVR at the end of this year. We haven’t given any more granularity beyond that, but we are on track for D-LIVR data by end of this year.
Unidentified Participant
Okay. Great. Thank you very much.
Operator
Thank you so much. Your next question comes from the line of Brian Skorney of Baird. Please go ahead and ask your question.
Unidentified Participant
[Technical Difficulty] on for Brian. Just a couple on the CHI Phase III program. We hosted a KOL a while back, and he noted the importance of reductions in two meetings actually [indiscernible] use and an improved fasting period as key benefits that would be — that you would be looking for in a therapeutic. Will any of these aspects be touched on in the study end points?
David Cory
Hey, Brian. Thanks so much for joining the call and for your questions. And we were excited to announce Avexitide 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.
Colleen Craig
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 III 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 worked very closely and collaboratively with using inhalers as well as the congenital hyperinsulinism patient efficacy organizations and with regulators to craft and align on a thoughtful and efficient program that address with the unmet medical needs, some of those that you have raised with patients with hyperinsulinism and we’re pleased with the feedback that we received from stakeholders and the progress we need to do in our start-up activity.
David Cory
Go ahead, Brian.
Unidentified Participant
No, I was just. Go ahead.
David Cory
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 Avexitide is a highly targeted mechanism of a GLP-1 antagonist and believe it’s not only best-in-class, but may be best in group for targeting this severe disease. And so we’ve been thoughtful about how much we communicate on the Phase III study design. But clearly, as we get closer to screening and enrolling our first patients, we’ll provide more guidance.
Unidentified Participant
Great. So we can expect more details this year, if I’m understanding correctly or would that potentially be a 2023 event?
David Cory
That is our plan.
Unidentified Participant
Okay. Great. Thanks.
Operator
Thank you so much. Our next question comes from the line of Robert Hazlett from BTIG. Please go ahead and ask your question.
Robert Hazlett
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 HDV-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?
David Cory
Sure. I think those are good questions for clinical and commercial, respectively, but maybe I’ll begin with Eldon who can probably address both questions, Robert, and thanks for the questions. Eldon?
Eldon Mayer
Yeah, Bret. So we’ve been monitoring the market and purchasing some data, and we have gradually seen increased levels of HDV 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 in the future. With respect to HDV pricing, of course, there are no products available in the U.S. at this time. So there are no benchmarks there.
In Europe, however, we’re monitoring that situation as well, and we know that Bulevirtide has been available for different prices and different markets that range between the $100,000 range and $150,000 range, just to give you a couple of 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.
David Cory
Thanks, Eldon. And Bert, I’ll just add to that. As Eldon 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 has 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 HDV 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 HDV-positive patients. So we don’t need to find these patients de novo. We only need to test HDV-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 in development will also fuel that and support that activity.
Robert Hazlett
That’s good to hear. Thank you for all that. Just if I could slide in one financial question. Is the — was there any use of the ATM post the quarter? Thanks.
David Cory
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.
Robert Hazlett
Okay. Thank you for that. Congratulations on the progress reported to data.
David Cory
Thank you.
Operator
Thank you. And your next question comes from the line of Michael Higgins from Ladenburg. Please go ahead.
Michael Higgins
Thanks, guys. Thanks for taking the questions. We’re certainly looking forward to the D-LIVR data around and just ahead of year-end the way it looks. A question for you, you plan to host an R&D events — R&D day events prior to that? Thanks.
David Cory
Sure. 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 and he’s been talking about such an event. Sri?
Sriram Ryali
Yes. Hey, Michael. We’re certainly looking at different ways going into D-LIVR 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 D-LIVR 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.
Michael Higgins
Okay. I appreciate that. And then turning your attention to the opportunity in treating COVID patients. Can you share with us what groups you’re talking to globally, whether they’d be in and outside the U.S. and Europe that may be buyers of your product and the groups that you’re working with? Thanks.
David Cory
Thanks, Michael. I’ll tackle that question. And we — it’s fair to say we, as discussed in our prepared remarks, are very much prioritizing and focused on an FDA allowance to submit an EUA application and subsequently, 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 reaching, as we’ve 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.
Michael Higgins
Okay. I appreciate that. And then finally turning our attention to Zokinvy in Europe. If you can remind us 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.?
David Cory
Sure. I’ll turn that one over to our Chief Commercial Officer, Eldon.
Eldon Mayer
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 U.S. 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 U.S.
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 so 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.
Michael Higgins
Appreciate it. Thanks, guys.
Operator
Thank you so much. [Operator Instructions] And I’m not showing any further questions. I would now like to turn the call back to David Cory for any further remarks.
David Cory
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 Eiger 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 peginterferon 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 Eiger 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.
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