Q3 2022 Eiger BioPharmaceuticals Inc Earnings Call
Okay.
Come to the Iger bio pharmaceuticals third quarter 2000 financial Joe and this is a big conference call.
At this time all participants are in a listen only mode.
We'll 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'd now like to turn the call over and introduce our Mathison Senior Vice President Corporate Affairs.
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 website at <unk> Dot com.
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 <unk>, President and CEO , Sri Ali Chief Financial Officer, Eldon Ladd, Chief Commercial officer conductor, Ingrid Chung Senior Vice President clinical development.
We also have subject matter experts from our team, calling his law senior Vice president of clinical and development operations and Doctor, calling Craig Vice President 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.
Forward looking statements rely on such and assumptions and involve risks uncertainties beyond August control, which could cause our actual results to differ materially.
Scripts and of these risks and uncertainties is contained in <unk> filings with the SEC, including our latest 10-K and 10-Q reports available on the website in the investors section.
All forward looking statements are based on information currently available to I guess and we assume no obligation to update these statements I would like to turn the call over to David.
Thanks Sarah.
Either 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 low enough on a per ton of ear and peg interferon Lambda two first in class therapies that are both in phase III.
We're just weeks away from unblinded and reporting topline data from the phase III deliver study of two different <unk> based regimens for the treatment of H D. D with over 400 patients enrolled across 100 sites in over 20 countries deliver is the largest HCV studies ever conducted.
Look forward to reporting data from this landmark study next month and important milestone both for iger and for patients suffering from H D D.
We're also making good progress advancing our second HDD therapy in development Peg interferon Lambda in the phase III limit to study.
We're 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 HCV therapies and effective treatment options are desperately needed for these patients.
We believe that based on their mechanisms of action and convenient administration lawn and garden and Peg interferon Lambda are highly differentiated from other therapies in development.
Ingrid will provide additional details on our plans for deliver topline data in Eldon will comment on the HDD commercial opportunity and our commercialization plans in just a few minutes.
Turning to our rare metabolic disease programs.
We believe of Exenatide, our first in class <unk> receptor antagonist has the potential to confirm meaningful therapeutic benefit across a broad spectrum of hyperinsulinism, a hypoglycemic conditions for our lead indication we have initiated the phase III advanced program and congenital hyperinsulinism.
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 peg interferon Lambda for COVID-19.
We are disappointed that the FDA will not considering EUA application of peg interferon lander for COVID-19 based on results generated from the investigators sponsored phase III. Together study. However, we continue to have strong conviction and the data and in the potential of peg interferon lambda to confirm meaningful benefit.
For patients with COVID-19, and other respiratory viral infections.
We are actively evaluating next steps for this program both in the U S and X U S as well as strategic options for continued development of Peg interferon Lambda for COVID-19, and other respiratory viral infections, we plan to update as material progress warrants.
And finally, turning to our commercial product. This year, we successfully expanded the global commercial reach a Zoe Kennedy with marketing authorizations in the D U and U K as well as a partnership with Angelus, a commercial stage biopharmaceutical company based in Japan.
The approval as though can be in the U S and now in Europe demonstrates acres ability to navigate complex global regulatory requirements and successfully commercialized 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.
Now hand, the call over to Ingrid.
Thanks, David I'll begin by highlighting our continued progress across my hepatitis Delta virus platform.
As David noted we are excited that we are just weeks away, so unblinding and reporting top line data from the landmark phase III deliver study of to learn a foreigner based regimen.
A clinical team is in the process of cleaning the database before it can be locked and analyzed to report topline results.
This milestone is years in the making for iger and H D V patients.
As the largest study conducted in hepatitis Gotta virus delivery 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 it's positive support global regulatory filings.
The design of the face be deliver study was informed by our phase two lone upon of HD <unk> form.
To recap this broadfaced two programs spend five studies and explored over 50 different Luna foreigner based regimen and 129 H D V infected patients.
And the regiments that were subsequently advanced interface III, the composite endpoint defined as a to log decline and HPV RNA and normalization of a L. T was achieved in 29% of patients receiving the oral regimen and 63 per cent of patients receiving the combination with peg interferon alpha after.
24 weeks.
Statement.
The phase III deliver study provides multiple password registration of two loan appointment base regimen the.
The primary endpoint is a composite of a to log the client and HPV RNA and normalization of L. T. After 48 weeks of treatment.
If either of the alone upon the base regiments, the <unk> or the combination with peg interferon Alpha meet the primary endpoint versus placebo, we have a pack for an NDA submission.
Importantly, we do not need to see response rates higher than any other investigational therapies for a successful outcome we.
We believe that in a chronic disease like HDTV for 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 deliver is histology assessed using baseline in week 48, and a treatment paired liver biopsies.
And a disease as aggressive as hepatitis Delta virus, demonstrating stabilization of fibrosis, and a treatment arm compared to placebo would be clinically meaningful for patients at this could potentially obviate the need for a liver transplant.
We expect to report both the primary endpoint and key secondary endpoints. When we report hotline was off in December and will host an investor call to discuss the data.
Turning to our second HPV program Peg interferon lander the phase three limit to study continues to activate sites and enrolled patients.
Limit to as a straightforward study of 150 patients largely enrolling from the best performing sites from the deliver study.
Limit to is a randomized two one study.
One is 48 weeks, a purgative ground Lambda once weekly followed by 24 weeks off treatment.
Two is 12 weeks of no treatment.
The primary endpoint is the proportion of patients with HVV RNA below the limit of quantitation at 24 weeks post treatment and arm, one compared to 12 weeks of no treatment and arm too.
All patients and arm to 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 peg interferon landa.
This phase III primary end point was previously demonstrated in phase two where 36 per cent of patients achieved HDD RNA below the limit of quantitation at 24 weeks post treatment of durable Virologic response or D V R.
This is similar to the sustained Bureau logic response or S. B R. N. <unk> previously used for H C V therapies.
The DVR and point is meaningful for regulatory agencies and physicians as it demonstrates straights durability response to a finite therapy and the potential for a cure for hepatitis felt the virus.
Our strategic approach and HVV is to seek regulatory approvals of two loan appointment base regiments from the results of the deliver study.
We will follow up with data from limits too, which could lead to approval of Peginterferon Lambda for HDTV.
We believe this approach provides the most expeditious route to approval for both <unk> and pegging a frown landa.
In parallel we will generate data through the NIH phase two lifts study, which we believe will support the future use of our proprietary combination of loan a foreigner per ton of ear and pegging, if you're on Lambda for hepatitis Delta infection.
We are excited about the continued advancements in the Hvv's space.
Last month, either participated in the first international Delta Cure conference. The only medical meeting focused solely on hepatitis Delta and we look forward to attending a S. O D. The liver meetings, starting tomorrow in Washington D C.
With the top line data from deliver right around the corner and continued progress enrolling the limit to study I goes contributing to the strong momentum in this space.
We believe our platform a first in class differentiated therapies positions as well to became a leader in H D V.
I'll now turn the call over to Alvin.
Thanks <unk>.
I'll spend the next few minutes, providing an overview of our commercial planning for the anticipated launch a loner foreigners based regimens for the treatment of H D. J.
<unk> noted deliver provide multiple potential pathways to registration of <unk> regiments, we believe that either one of our interface regimen, you're all oral <unk> or a combination with peginterferon Alfa has the potential to confer benefits H D V patients and represents.
A significant commercial opportunities.
These are exciting times for the commercial tinge of ardor collectively this team has extensive experience with product launches specifically orphan disease space.
Over the past 25 years, we've launched 10 F D. A approved therapeutics for multiple orphan diseases across different therapeutic areas.
Either had been developing therapies for H D V for over a decade during that time, we built strong relationships of HPV investigators in key opinion leaders conduct market research and develop a lunch plans, which we continue to report.
With phase three delivered data now <unk>.
Closer to Operationalizing these plans.
Is David noted H D V as a significant unmet medical need impacting more than 12 million people around the globe and the U as in Europe , H D V as a large orphan disease.
Estimated prevalent patient population of 300000.
The potential of U H D V commercial opportunity has been validated by the recent entry of multiple other companies with early stage development programs into the space where.
Where there are currently no F D a approved therapies.
Both are HCV programs, <unk> and peg interferon Lambda are late stage and we believe highly differentiated from other therapies in clinical development.
Mona foreign over a ton of your the only oral therapy and clinical development Fridge T V.
And we expect the patient preference for a convenient all oral HDD therapy or a combination with interferon it delivers a robust response will be high.
By the time, we <unk>, we expect increased awareness and diagnosis rates of hepatitis Delta virus, maybe possible by greater utilization of commercial H D. V. P. C. R tests and updates to Eagle M. A S O V testing guidelines and.
In the future, we believe that as a first inquest type three interferon Peggy.
Peg interferon landers 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 focus and cost efficient H D V commercial launch the.
The same physicians, who treat patients with H b b treat patients with Delta virus.
Delta is only found as a co infection with HBV.
As you can see from this map and the U S. H BB prescribers are heavily concentrated in the major metropolitan areas.
70% of HBV scripts are written by 10% of HBV prescribers.
Dynamic that <unk> that allows for a lien targeted field force.
Outside the U S. We believe that deliver data could provide opportunities for strategic collaborations.
While we're planning for a successful U S launch we are preserving our options for partnerships and both of us and in Europe , and China, where there are estimated to be more than 1 million hepatitis Delta patients. We will pursue a partner in strategy to provide access to patients been as important market <unk>.
While maximizing potential for shareholder value.
Following deliver results.
Plan assure additional details on our plans for commercialization of <unk> regiments for a T V.
Finally, a quick update on that can be.
We were $44 million in net sales during the third quarter in the U S.
As we previously stated 80 per cent of identified you as patients with progeria received it can be with 100 per cent pay a reimbursement coverage and.
In July we announced DMA approval was it can be.
Demonstrated success in our reimbursement strategy, we secured reimbursement in two of the largest European markets and 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 you, including distribution and patient support services. We're engaged with health care providers were managing patients with progeria as well as the 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 confidence in our ability to execute an efficient March a loan or foreigners based regimens for H D V.
As I've noted before the infrastructure, we've established in the U S and now in Europe for the launch of that can be for progeria has been designed to scale and grow to support future launches in larger indications, including H D V. As we advance our mission to help patients with serious disease.
Now hand, the call over to Sri for financial what date.
Thanks to open the press release, we issued this afternoon includes a financial update and I'll call out a few highlights here.
Cause elven noted in total revenue this quarter was $4 million, which consisted entirely of <unk> can be net sales.
This compares to $3 million reported for third quarter of 2021 and $3.3 million for second quarter of 2022.
Higher net sales in Q3, four largely driven by additional units shipped during the quarter.
Turning to our third quarter of 2022 gap operating expenses.
Cost of sales was $1.2 million, which included a one time right off a nonconforming desert inventory and a quarter.
R&D expenses were $22.2 million, and SG&A expensive or $7 million for the quarter.
The 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 commercialized innovative therapies for underserved patients and a capital and resource efficient manner.
And we have been disciplined managing our expenses, because we've advanced multiple programs into and through <unk> through.
With approximately $121 million in cash cash equivalents and investments as of September 30th.
We are well positioned ahead, an important milestone some catalysts.
We expect this cash to fund planned operation through 2024 before potential commercialization and H D V.
Importantly would have access to additional nondilutive capital under our debt facility that we entered into earlier this year.
Either can access up to $35 million in additional cash contingent on positive clinical and regulatory milestones across two choices.
It can be instrumental to fund our <unk> commercial launch expenses.
When I opened up the call for Q&A operator, please provide the instructions for the Q&A portion of the call.
Mmm.
Tell them and if you had a question at this time. Please press. The start then one one on your Touchtone telephone.
If your question has been answered in English to remove yourself from the queue.
<unk>.
We ask that you please limit yourself to one question and one.
One moment for our questions.
And our first question comes from the line of my right calf of Jesse.
Can I ask you a question.
[noise] hi, congrats on the progress and thanks for taking my my questions I was gonna ask just about the the composite endpoint data that you have on slide 13. If you can talk about reflective are similar to these patients are to your phase III population and is there anything you can say about baseline viral.
Code or other baseline variables and how these can ended up impacting the pastry results.
Hi, Thanks for your question and I will turn that one to Ingrid Chung.
Hey, Laurie yes, the the phase III baseline characteristics. Those patient population is very similar to what we previously spot in phase two regarding the specifics of the baseline characteristics Uhm, we put out an abstract at an easel on earlier this year.
Sure that the the mean HD RNA for example, and deliver Uhm is around five blocks and we also shared with the L. T based on characteristics as well and Uhm, we certainly will be sharing additional information when topline results come out next month.
Got it.
And so nothing. Additionally, you could say just on on how some of those baseline characteristics could potentially impact the results versus what you've already shown with the phase two composite data on slide 13.
And is so far like I said all of the what we've seen us at the based on characteristics on phase three is very comparable to what's in in phase two per cent Parodic. For example, 30 around 30 per cent of <unk> per cent of patients are already cirrhotic. You know I think that's one of the important things of ensuring that your your faith.
Three entry an exclusion criteria very similar to your face too.
No.
No other other criteria. Unlike uhm patients were previously on Peg interferon Alpha I'm also was there uncomfortable uhm from face it a phase three.
Got it Uhm add I'll just I'll just add boy that is you know the composite endpoint of greater than or equal to two large decline in HDD 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 <unk>.
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 to log decline uhm. We believe this is consistent across baseline viral loads and then of course a L T.
We believe typically follows HDD RNA levels, and so we have high expectations on on production in a L T or normalization of liver enzymes as well.
Got it that's that's helpful and I wanted to ask one other follow up questions. There was some impact related to sites in the Ukraine, and Russia I believe can you say, where you're at with Phase III data collection. What final numbers will be included in your analyses and if the database is locked or if you have a line of sight to database.
<unk>.
You are angry.
Yeah. So uhm yeah early on in the Ukraine Russian conflict back in February we did some sensitivity analyses on.
And showed that uhm, even if we were to lose all the patients who are randomised to Ukraine that we would still be more than adequately powered dishes statistical significance of either of the lunar fine up containing regiments of the placebo.
Today, we've had no impact on the Russian site.
Patience and again, we haven't.
We were planning for a potential of losing all patience that you currently have only lasts a subset. So we're still more than adequately power to sell statistical significance against either arm.
We we haven't guide on on database lock yet but.
To the extent that <unk>.
Providing guidance that we plan to announce top line data in December helps hopefully that gives you a straight line between today and some time in December .
Yeah. So we are on track to to still having a cop line data. We've been this is a large study in Houston, no cleaning and and carrying the database since the early part of this year and I feel really good about having top line data by the by December .
Got it Okay look forward to the results. Thank you.
Thank you.
Thank you so much.
And your next question comes from the line of Brian scoring appeared please go ahead and ask you a question.
Particular question. This is Charlie on for Brian We wanted to know how you were thinking about the <unk> for have critics and if you think that'll have any impact on the H b.
Commercial opportunity for your products. Thank you.
Hey, Charlie Thanks, so much for joining us today and definitely appreciate the questions that we as you can imagine we were not aware of <unk> timing or the C. R. L that gilead announced related to their programs, but we do plan to provide more details on a regular.
Tori strategy and timelines following our announcement of deliver results in December .
A key strategy, obviously and priority for iron.
Alright, thank you.
How much. Your next question comes from the line of <unk>.
C. P. I T. Please go ahead and answer your question.
Yes. Thank you for taking the question apologize. If this has been addressed but could you just remind us of the your potential for it maybe more rapid enrollment of limit to the peg interferon Lambda kind of what pushes and pulls are in place and that trial.
<unk> help enrollment relative to deliver thank you.
Hi, <unk>, thanks for joining us today, and that's a great question I'll turn that one over to Ingrid.
Siebert, Yeah. The base three limit to study, it's a much smaller more straightforward study compared to deliver I'm only 150 patients uhm planned across 12 countries across 50 sites. We've picked the 50 sites from the best performing sites from deliver.
So this will definitely facilitate uhm more expeditious enrollment I'm also the inclusion and exclusion criteria unlimited too is much more or less compared to that of deliver based on learning for example, and deliver because we part of our composite and point isn't too long decline in HD.
<unk>, we are requiring all patients to have at least a two and a half like <unk> <unk> at study entry for deliver them in the case of limit to since the primary complaint is uhm being below the limit of quantitation patients only have to have unquantifiable H D V. RNA at study entry Uhm. So that's.
Just one example, another example is all patients on both deliver and limit to uhm must have suppressed HBV DNA upon study entry and that criteria for that's the finding a suppressed HBV DNA uhm is uhm much higher uhm and limits to uhm. So it's <unk>.
20, I used <unk> amount in the case of deliver and 100 I use.
<unk> unlimited and again these are just learning the benefit of having first.
First having been deliver a four minutes too.
Yeah, we we definitely learned a lot from the phase III deliver study across over 20 countries and and 100 sites and those learning we've all applied in the limit to Lambda study for HDTV and look forward to obviously, providing more guidance after we have <unk>.
Pleaded activation of all roughly 50 sites and we'll communicate in the future.
Okay. Thank you that's all from me thanks, so much.
Thank you so much.
And again, ladies and gentlemen, if you have a question for you <unk> and one one on your Touchtone Uhm.
Your next question comes from the line of Michael Higgins a sandwich. Please go ahead and ask a question.
Hi, This is put on on behalf of my shows.
We have.
We have a question basically on the does not kill me thing.
Sorry for Hanukkah could you repeat that again, yeah, sorry, sorry, I was just talk to you guys could you know what I mean, how can you hear me now.
Yes.
Okay do you wanted to know a little bit more about your father's face number does not charge anything I guess, what can you share about what you learned that in what sort of feedback that you'll get an iPhone program.
Oh of course, then 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 is in good pointed out. It's the first actually international meeting specifically focused on hepatitis Delta virus infection, which we think.
Four tons of great things to come in terms of focus and this therapeutic area in England I'll, let you comment on some of the experiences and learning is out of Delta cure.
Sure Yeah does that show was held <unk> 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 uhm medical meeting focus solely on Delta.
Most of the attendees were a key opinion leaders. There's also farmer represented <unk>.
<unk> there was gilead Uhm J&J Dear and then also some uhm diagnostic companies as well.
So it was one and a half days of presentations on the first day or oral presentations really just talking about disease space and the need for therapy and then there's the second half day. It was focused on pharma, giving updates on programs.
Uhm Iger presented on loan a foreigner as well as pegging are found Lambda and and ultimately there's just a lot of excitement around the space now with data coming out across from <unk>.
You Wanna find out for ton of ear and pegging, a frown landa and really discussing the need for you know potentially combination therapies to really be able to conquer H D V, which is a very serious and virulent uhm viral hepatitis.
Thanks fingers, just add add far out of it but I think part of the reason that the the host of the Delta Cure meeting Dr. <unk> out of Hanover, Germany, and Dr. Pietro Lancair to go out of Milan, Italy, two major key opinion leaders in the HDTV space I think the reason that they.
They wanted to advance with a program like this in part.
Because now in addition to Iger is Ingrid mentioned Veer is now in the H D V development space as well as Gilead J N J Assembly, <unk> and I'm sure I'm, leaving a few companies out that the pipeline of programs, albeit earlier stage load up on <unk> 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 H D V.
Great. Thanks can I just ask one more quick thing maybe my sister, just clarify fulfill a expedite it looks like you just screaming patience tried that a notation controlled.
Hey, Pronto, that's correct, we have not yet enrolled a patient <unk> programmer undertaking all the enabling work to be able to activate sites and scream patient and we'll be able to provide updates once we have more to say on that but I will say that the congenital hyperinsulinism the international.
<unk> recently held a benefit.
Afternoon, and evening in Montclair, New Jersey, which was attended by key opinion leaders and investigators from both shop at children's hospital of Philadelphia as well as a cook children's it was an amazing event, both for fund raising for supporting congenital hyperinsulinism the internet.
National 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.
We definitely are very motivated to provide additional updates in the near future and will do so.
Okay, great. Thanks, and then it's 2024 to set up for data.
For the <unk> program, we will complete activation of sites and begin enrolling patients and then provide more guidance for honor on on next steps for enrollment and obviously then timelines for a site on data.
Okay, great. Thank you guys for taking our questions.
Thank you.
Alright, thank you so much.
And I'm not showing any further questions I would now like to call back to David <unk>.
Certainly and thank you very much in closing I just want to make a few comments were 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 announced the top line results.
This landmark deliver study provides multiple pastor registration of <unk> based regimens, which we believe are well differentiated from other therapeutics and development, we continue to execute across our pipeline of multiple FDA designated breakthrough therapy programs in phase III, which have the potential to.
Deliver both patient and shareholder value and.
And of course, none of this would be possible without our team of dedicated people. So I'd like to thank everyone for.
For their relentless efforts across our programs not only at iger, but our investigators are patient advocacy support groups and of course. Thank all of you for joining us today on our call have a great day.
Thank you for center and this concludes today's conference call give me <unk>.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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