Q2 2021 Eiger BioPharmaceuticals Inc Earnings Call

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Good day, ladies and gentlemen, and welcome to the other Biopharmaceuticals second quarter 2021 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.

If anyone should require operator assistance. Please press Star then zero on your telephone.

For the reminder of this call will be recorded I would now like to introduce your host for today's conference. Mr. Sharif reality, Chief Financial Officer of Iger, you may begin.

Good afternoon, 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 available on our website at <unk> Dot com for today's call. We will have prepared remarks from the management team followed by Q&A, we will be using slack.

For the webcast, we will have a replay available on the investors section of our website.

Joining me on the call are David Cory, our President and CEO Eldon Mayer, our Chief commercial officer and Dr. Ingrid Chung Senior Vice President of clinical development, Dr. Colin Hislop Senior Vice President of clinical and development operations will be available for the Q&A portion of the call.

I'd like to remind investors that this call will include forward looking statements within the meaning of the safe Harbor provisions of the private Securities Litigation Reform Act, I've mentioned 95, including but not limited to the types of statements identified as forward looking in our 2020 annual report on form 10-K, our quarterly reports on form 10-Q, and our subsequent periodic.

Our reports filed with the SEC, which will all be available on our website in the investors section.

For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward looking statements as well as risks relating to our business. Please see our periodic reports filed with the SEC. These forward looking statements represent our views only as of the date of this call and involve substantial risks and I am.

Certainties, including many that are beyond our control and should not be relied upon as representing our views as of any subsequent date.

Specifically disclaim any obligation to update such statements I will now turn the call over to David.

Thanks, Sri and good afternoon, everyone and thank you for joining US today, we are making great progress across our pipeline, which includes multiple late stage therapies for rare diseases. We are very proud of Tiger that every 1 of our rare disease programs now has FDA breakthrough therapy designation and these include loan are funded.

And peg interferon Lambda for hepatitis Delta virus infection <unk> for post bariatric hypoglycemia, and now congenital hyperinsulinism Enzo can be for progeria, which is now commercially approved.

<unk> is well positioned to advance several catalysts for value creation in 2021 and beyond we look forward to updating you today on our progress and future plans.

Our lead clinical development programs are focused on hepatitis Delta virus, the most severe form of human viral hepatitis.

Hepatitis Delta virus is always a co infection with HBV and has found an approximately 6% of HBV infected patients. However, hepatitis delta virus causes a much more rapid progression of liver disease in HBV alone Sadly, 60% of HBV patients die within 10 years after diet.

Gnosis. This is a large orphan disease in the U S and Europe with an urgent unmet medical need.

There is no FDA approved therapy for hepatitis Delta virus Eiger is pioneering the development of treatments in this space. We are often asked what would a win look like for HBV patients.

<unk> is a devastating rapidly progressive disease. The first goal of therapy is reduction in HBV viral load and reduction in liver inflammation to slow progression of disease, which has been shown to lead to improved outcomes.

Importantly, this is consistent with FDA guidance for development of HCV therapies.

Additionally.

HDD therapies will require chronic dosing.

Convenient administration for long term treatment could improve compliance and outcomes, which are critical to both patients and physicians, we believe that loan a <unk> Ah.

Daily oral medications and peg interferon Lambda a weekly subcutaneous injection offer the most convenient dosing compared to other late stage HDD programs in development.

At Eiger, we are advancing an HDD platform strategy that provides multiple paths to win for patients.

<unk> 2 well characterized promising late stage product candidates in <unk> and peg interferon Lambda.

<unk> have different mechanisms of action are conveniently administered and should benefit HBV patients alone and in combinations.

For <unk>, the only oral treatment in development for HDD is currently dosing in the phase III <unk> III deliver study.

Deliver is the largest global phase III study to be conducted in HBV with over 100 sites across 20 countries.

The deliver study design opens the door to deliver a win for HDD patients with the all oral alone our foreign net based regimen and in combination with peg interferon Alpha.

We are pleased to see continued momentum and deliver which is now over 90% enrolled this includes patients randomized to date and patients in screening that are expected to be randomized. We are on track to complete enrollment before end of 2021 setting up for pivotal topline data release in late 2022.

2.

Our second therapy in development for HDD as Peg interferon Lambda.

Well tolerated interferon, which is beginning phase III.

We have concurrence with FDA and EMA for a single pivotal study called limit too and we expect to enroll our first patient in this study before the end of the year.

Limit 2 represents an efficient pathway for peg interferon Lambda approval in HBV and we are excited to begin this study.

For over a decade Eiger has been engaged and the clinical development of therapies for viral hepatitis.

We have gained a deep understanding of the needs of HBV patients and our physicians who care for them.

We believe that <unk> and peg interferon Lambda will become foundational therapies to be used alone and in combination for the treatment of HDD Eiger is well positioned to be a leader in HDD $8 billion plus commercial market opportunity.

Beyond HDD, we continued to advance the rest of our rare disease pipeline of Exenatide is a novel first in class targeted therapy for 2 very different orphan metabolic disorders post bariatric hypoglycemia, which has been granted FDA breakthrough therapy designation and congenital hyperinsulinism.

Which has been granted FDA breakthrough therapy designation and rare pediatric disease designation, we plan to complete manufacturing and device development as well as regulatory activities. This year to support registration, enabling clinical trials as early as 2022 for both indications of Exenatide represents.

A significant commercial opportunity and we will provide guidance in the future on how we plan to advance this program.

While we remain focused on our mission to develop and commercialize targeted therapies for serious rare and ultra rare diseases, we have opportunistically and in a capital efficient manner explore the potential of peg interferon lambda as a convenient outpatient treatment for COVID-19, the placebo controlled phase III together study.

Is enrolling and dosing patients across multiple clinical sites in Brazil positive results from this study could support a submission for emergency use authorization, we look forward to reporting interim futility data analysis potentially by year end.

Turning to our first approved product we were pleased that Zoe can be was the recipient of the 2021 National organization of rare disorders industry Innovation Award and is now a nominee for the 2021 pre galleon USA best Pharmaceutical agent Award the U S launch of Zoe can be continue.

As to progress very well and we expect DNA approval later this year as though can be has demonstrated our ability to go from IND.

To NDA to approval and launch and to successfully navigate complex global regulatory landscapes.

Importantly, we have established infrastructure, along with commercial and medical affairs functions that can scale and grow for additional commercial launches across larger orphan disease indications in the future.

Before turning the call over to Ingrid to discuss our clinical development programs in more detail I'd like to note that we ended the quarter with approximately $140 million in cash and investments enough to fund our planned phase III <unk> studies and sufficient runway to fund planned operations into Q4, 2023 and <unk>.

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Thanks, David we're making great progress across our clinical development program. We have deliberately designed and are executing an HDD platform strategy with potential to generate approvals for multiple HCV treatment regimens.

Taking a moment to dive deeper into our HDD strategy as David mentioned, we believe a win for HDD patients are approved therapies that suppressed HBV virus, which has been shown to lead to improved hepatic function improved liver histology and improved survival.

We also believe that for chronic HCV therapies convenient administration as well as antiviral activity are important considerations for patients and their physicians.

On a final then peg interferon lambda potentially offer both.

And phase 2 the all oral regimen of <unk> hundred 50 milligrams PID.

With <unk> achieved a composite endpoint of a 2 log decline in HCV, RNA and normalization of liver enzyme or <unk> and 29% of patients at week 24 of treatment.

When <unk> is combined with peg interferon alpha the response rate more than doubled to 63%.

Importantly, the combination of <unk> and peg interferon alpha with synergistic on the composite endpoint improving both reduction in HBV viral load as well as <unk> normalization.

These data were the basis for our phase III deliver study design.

The liver as a foundational global phase III trial that we believe positions either it could be a leader in HBV.

To deliver primary endpoint is a composite of a 2 log decline in HCV RNA plus alk normalization as was demonstrated in phase II.

But deliver study design creates 2 opportunities for regulatory approval of <unk> based regimens and all oral in a combination with peg interferon alpha.

In addition, deliver as the only HDD steady requiring baseline and end of treatment biopsies, which will support key secondary endpoints examining histologic improvement.

Biopsies have been shown to be significantly more reliable and fiber scans in assessing liver inflammation.

As David mentioned, the phase B deliver steady it's now over 90% enrolled this puts us on track to report top line data in late 2022.

When complete deliver will provide the largest global safety database from a single <unk> study and a wealth of data to inform and drive <unk> HDD platform strategy.

We are equally excited to advance our second therapy in development for HDD Peg interferon Lambda is a first in class type III well tolerated interferon now in phase III and limits to study.

In phase II Peg interferon Lambda was dosed once weekly in HBV infected patients for 48 weeks with 24 week follow up.

36% of patients who received peg interferon Lambda achieved a durable gear logic response, or DVR, which is HBV RNA below limit of quantitation or undetectable at 24 weeks post treatment.

This post treatment DVR endpoint is most meaningful for both regulatory agencies and physicians at the demonstrates durability of response to treatment for HCV patients.

Limit 2 is a randomized 2 arm study arm..1 is 48 weeks of peg interferon Lambda once weekly treatment, followed by 24 weeks of treatment.

<unk> 2 is 12 weeks of no 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 and arm to.

This is a very straightforward study of 150 patients that we anticipate will enroll across 40% to 50 global sites limb.

<unk> 2 sites will be primarily selected from the best performing sites under deliver study, which should allow us to enroll quickly and efficiently.

We have agreement with EMEA and FDA unlimited 2 as a single pivotal study of peg interferon Lambda for HDD and on track for roll our first patient by end of year.

We believe limit 2 is the most expeditious pathway for purgative from Lambda approval in HDD.

A successful outcome and limit 2 could lead to approval of peg interferon Lambda as a monotherapy for HDD and opened the door for it to become the interferon of choice and combination therapies for the treatment of HDD.

We believe that peg interferon Lambda tolerability profile will be preferred by physicians and patients leading to better compliance and improve outcomes.

Bona fide other on peg interferon lambda have distinct and complementary mechanism that can be used alone or in combination with each other and in combination with other HCV regiments to suppress virus reduced liver inflammation and improve outcomes.

Ultimately our goal will be complete suppression of HBV virus, and HDD cure to that and the combination of peg interferon Lambda and bona Fide up with Ritonavir achieved the most robust antiviral effect further demonstrating the opportunity for this combination in the future.

Ill now turn the call over to Eldon for a commercial update.

Thanks, Ingrid I'm pleased to provide an update on our commercial progress and the kenzie launch.

Our initial efforts have been focused on the approximately 20 identified patients in the U S where we launched in January.

In anticipation of EMA approval later this year, we're actively preparing for launch in Europe, where there are also approximately 20 identified patients as David noted the U S. It can be launched continues to progress very well, we reported $2.1 million and that can be net sales in Q2, bringing our year to date net sales for $5.7.

Million importantly, we've converted the vast majority of the 20 identified U S patients to commercial supply.

For the patient support center, we established known as Iger wound care has facilitated inefficient U S launch the primary goal of <unk> unencumbered patient access to <unk> and this program has delivered continuous access for zero out of pocket costs for all patients.

Our commitment is to provide that can be accessed for every child and young adult with progeria and processing deficient procured limit optics ultimately our goal is to deliver a global commercial launches across our late stage rare disease programs.

Our execution of this it can be launched has enabled us to serve the progeria community, while establishing a commercial distribution network patient support services and payer engagement there'll be scalable for future HEB and other larger orphan indications.

And with that I'll hand, the call over to <unk> for a financial update.

Thanks, Bill from the press release, we issued this afternoon and create a financial update I'll call out a few of the highlights.

As Albert noted Q2s or community net sales were $2.1 million.

Paris for $3.6 million reported in the first quarter, which included initial channel inventory at our specialty pharmacy. After we commercially launched <unk> from January of this year. The contribution from <unk> will help offset expenses as we advance the rest of our pipeline.

Turning to our GAAP operating expenses cost of goods sold was approximately <unk> $3 million in the quarter for second quarter R&D expenses were $14.3 million and SG&A expenses totaled $5.9 million rich.

Reported net loss of $19.2 million or <unk> 57.

Per share basis.

Finally, we continue to operate with a strong cash position and ended the quarter with $139.8 million in cash cash equivalents and investments.

This provides us with runway into Q4.2023 fully funds our ongoing phase III <unk> studies as well as the activities required to enable phase III <unk> studies as early as 2022.

I'll now hand, the call back to David for closing comments. Thank you Sri.

As you've heard in our prepared remarks today, either continues to successfully execute on our strategy and deliver on our pipeline commitments across the board. Our HDD platform is advancing with multiple opportunities to win for patients chronically infected with hepatitis Delta virus infection. The phase III deliver study is over.

90% enrolled full enrollment is expected before the end of 2021 and release of top line data is expected in late 2022, the phase III limit to study is on track for first patient enrolled by year end, we are planning for <unk> to be phase III ready for post bariatric hypoglycemia and congenital.

For insulin ism as early as 2022, we expect DMA approval and so can be before the end of the year building on a successful U S. Commercial launch importantly, we have the cash necessary to support the execution and achievement of these milestones with our pipeline of multiple breakthrough therapy designation programs rapid.

Lee advancing we look forward to several investor update this year, including participation in 6 upcoming banking and investor conferences attendance at <unk> in November including a planned iger sponsored HDD focused KOL investor event future earnings calls and continuous.

<unk> efforts on our progress at this point I'd like to acknowledge the IR team for their relentless efforts across our programs and thank all of you for joining us on our Q2 financial results and business update call. Operator at this time, please provide instructions for the Q&A portion of the call.

Thank you ladies and gentlemen, if you have a question at this time. Please press. The Star then the 1 key on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Ask that you please limit yourself to 1 question and 1 follow up 1 moment for our questions.

Our first question comes from the line of Maury Raycroft from Jefferies. Your line is now open you may ask your question.

Alright and Jamaica.

Hi, This is Kevin Chen on for Mary craft. So I have 1 question regarding the HBV program. What are your thoughts on <unk> 301 data from <unk> and how does that compared to learn to mono therapy in terms of HGTV and the composite HGTV plus Iot normalization endpoints and are there any <unk>.

Vacations for our Beauvais Aerotech combo therapy. Thanks.

Sure. Thanks very much for your question I'll ask Ingrid Chung to address those thanks Kenny.

Yes, our phase II <unk> on a per ton of your all oral achieved a 30% composite endpoint. After 24 weeks of therapy at 24 weeks <unk> monotherapy, which is a daily subcutaneous injection achieved a 30% composite endpoint as well.

When <unk> was combined with peg interferon alpha 60% of patients achieved the composite endpoint. After 24 weeks of therapy. They will be retired combined with peg interferon Alpha should a composite response rates of 30%. So we believe that our phase II data suggests that Luna find out with <unk> in combination with peg interferon alpha.

Has a synergistic impact on the FDA guide a composite endpoint of the reduction in both the viral load and liver inflammation and we look forward to deliver topline 48 week data in late 2022.

<unk> add to answer the second part of your question given the fact that <unk> and Pegylated interferon Lambda work by different mechanisms to fight HBV viral infection. We believe that there is an opportunity for combination therapies in the future as Ingrid outlined in her.

Prepared remarks to answer your question with regard to potential combinations with other agents with different mechanisms investigators and key opinion leaders are already talking about cocktail options for the future to drive toward a cure and we look forward to providing more updates as those studies.

Actually are initiated and data readout.

Thanks.

Thank you we have the next question comes from the from the line of V. Go nuts from all gets from Citigroup. Your line is now open you may ask your question.

Hi, Craig This is Oscar Mubarak on for Yigal. Thanks for taking my question.

I guess for personal 1 will be on the deliver readout next year.

Can you talk a little bit about how.

To what extent you will release the data.

Want to confirm there isn't going to be an interim look.

Those sort of in.

48 week data point.

And maybe 1 point after the deliver studies over will you start engaging with the FDA about a potential filing.

Sure ill turn that 1 over to Ingrid as well and grid sure. So as we said in our prepared remarks or the timing of the delivery readout is at 48 weeks. After the last patient has received last us for the planned for the end of 2022, we are not planning for any interim readouts.

Top line data will be at the end of next year and with that once we've cleaned unlock the data.

Reported out the data we will.

Discuss next steps as to when we would go to FDA.

Okay got it.

Maybe a quick 1 on of exercise.

Sounds like <unk> been engaging with the FDA.

Both postpaid Patrick hypoglycemia.

And.

Congenital hyperinsulinism I guess.

When can we expect some details on what those studies might look like.

Maybe how long they will take to run et cetera.

Sure. So I'll I'll provide thoughts and then if she would like to add any additional thoughts I'll turn it over to him.

We believe that the post bariatric hypoglycemia.

Indication as well as congenital hyperinsulinism are both significant unmet medical needs and more and more we view of exit tied as a significant commercial opportunity at eiger for both of these indications. We were obviously very pleased to announce that congenital hyperinsulinism as an indication for <unk> has been <unk>.

<unk> breakthrough therapy designation.

And that pairs with the <unk> post bariatric hypoglycemia indication already having obtained breakthrough therapy designation. This year. We are focused on completing manufacturing doing all device modification and.

Per the BTT, our breakthrough announcement today.

Our inactive discussions with regulators about next steps for phase III study.

Designed for both PVH and congenital hyperinsulinism, and we'll definitely provide additional guidance as it becomes available.

Okay. Thank you very much.

Next question, we have from the line of Bryan Caronia from Baird. Your line is now open you may ask your question.

Hi. Thank you this is Jack Allen dialing in for Brian Congrats.

Congrats on all the progress this quarter and thank you for taking our questions or question is mainly focused on it back for the tightest wellbeing, so timing with the breakthrough breakthrough therapy designation granted this morning.

We were hoping that you can provide a little bit more context around the congenital hyperinsulinism.

Order in the current treatment landscape in this space and then I know you just touched on this but any other additional color you can provide with respect for the timing of development here would be great I appreciate it. Thank you.

Sure Ingrid would you like to comment.

Yes, so congenital hyperinsulinism is a ultra rare disease.

1 in 5000 patients.

It's a disorder that if left untreated results in <unk>.

Brain damage and 50% of patients and so what <unk> offers is a top targeted.

Therapy to a blocker <unk> 1.

As a <unk> antagonist to alleviate these hyper install anemic episodes.

I'd just add to that that as you are probably aware the congenital hyperinsulinism space.

In terms of therapeutics targeting this indication.

Has grown in the last 12 to 24 months heightening.

Not only our awareness of this disorder and the unmet medical need, but I think of the medical community at large which makes us even more excited today to announce breakthrough therapy designation, having been granted from FDA.

And as you probably know again there are now multiple therapeutics.

In clinical phases of development importantly, but none of them have the targeted mechanism of blocking GOP, 1, which we believe is a necessary approach and mechanism towards treating this very very difficult disorder.

And so we will provide updates as we move forward, obviously with regulatory announcements in terms of opportunities moving forward.

Thank you so much for other color.

Thank you next question comes from the line of Michael Higgins with Ladenburg Thalmann. Your line is now open you may ask your question.

Thanks, operator, and congrats guys on the continued development successes, including a breakthrough drug Desi and <unk>.

Couple of questions, if I could start off here with HGTV or really your primary programs.

If you can confirm for us any material changes in the design and execution of those sites globally.

Including any differences in the pretreatment or prior treatment differences across the globe.

And then as you're getting ready to get through the startup limit to any potential to be cannibalizing deliver with the enrollment of the of the 2 trials. Thanks.

Charles I'll turn that 1 over to Ingrid and Michael Thanks for your question for you.

First question regarding the study design for deliver there has been no material changes from what we've discussed in the past it's been very consistent.

As far as I think for a second the follow on to your first question was about 80 patient demographics across all sites and so.

So far our understanding is that patient demographics as balanced pretty evenly across all sites.

And I'll just add to the third part of your question, Michael which was are we concerned about limit to patients cannibalizing deliver patients.

The reality is we have staged the nature of the deliver study completing enrollment and the ramp up of the limit to study.

Really well such that we plan to complete enrollment of 400 patients.

Within 2021 literally as targeted sites are ramping up to begin enrolling patients in the Lambda limit to study and so we do not see cannibalism of patients out of deliver by the limit to study.

Quite the opposite we are opportunistically able to select the best performing deliver sites.

It will be a part of the limit to study, which we think will allow us to quickly and efficiently enroll 150 patients in the lambda limit to trial.

To get that study completed as quickly as possible.

Thanks, David that's really helpful. Just a follow up to that then typically there is a hockey stick pattern with trial enrollment.

Is there a way for that too.

Bleed over into limit twos enrollment such that the sites are up and going of identified patients and where they're designed to be different such that it's kind of a restart for let me too.

Yes that is a great question and I will.

Bond in the group can add color if they like.

The good news with hepatitis Delta virus infection is that there are multiple treatments now in the clinic and awareness is growing day by day and with that interest in presenting studies to patients who are diagnosed.

Is increasing and that is allowing for increased opportunities to enroll patients in clinical trials, which as you. Appreciate are critical for us to move both <unk> and lambda towards registration and so.

We're very excited actually to report that awareness of hepatitis Delta is growing and this is good for patients because more of being identified and diagnosed that ultimately we believe we will get into clinical trials that we can then treat with commercial product in the future and I'll just add to that Michael that physicians and patients alike are very excited about a while Tom.

The weighted interferon for the treatment of HCV and so theres a lot of excitement and enthusiasm on ahead of us starting to enroll at the limit to study.

It makes sense just 1 last follow up on that are you comfortable with roughly a year and a half to enroll in that to considering.

What you just said about patients coming in and kind of having that base available any comments on timing to enrollment would be super helpful. Thanks.

Yeah, Hi, Hi, there. So we have not standard anything about the label that we expect at this point and I think for that question. It's really uncertain until we have the final labels. So I think we'd like to provide an update when we do get that later on later this year.

But we are as as mentioned in the prepared comments, we are tracking we believe toward approval for us, though can be in Europe by ear and and so we're obviously anxiously anticipating and looking forward to providing an update as soon as.

Possible.

Okay terrific and then with regard to general Hyperinsulinism.

Could you provide a little bit more color as to what really.

What types of the data.

That you accrued and face to the drove the breakthrough designation.

Was it a particular patient group.

The neonates or others, just a little more color on your interaction that really drove the breakthrough designation for.

That program.

Sure I'll I'll, let Ingrid provide some commentary and then maybe add color after yeah.

So for the breakthrough designation, we shared with the agency all available data that have been generated in congenital hyper and that's expedite and that included at 3 studies 1 in neonate when in children and 1 in adolescence for total is 39 patients desk with a extra tight.

<unk> them for other therapeutics have been in the range of 40% to 50 patients.

So a very focused program with especially with an active and effective therapy. We believe may lead in a similar direction, but obviously, we will provide guidance as we have that from FDA.

Okay.

Thank you I'll get back in the queue. Thanks.

Thank you.

Thank you again, if you have a question. Please press star and then 1 key on your Touchtone telephone.

I'm not showing any further questions I would now like to turn the call over to Sri rally for any further remarks.

Well. Thank you ma'am. This concludes our call. If you have any additional questions. Please contact us at <unk> at Eiger bio dot com or you can reach out to a member of the management team and thanks to everyone for joining us today.

Thank you ladies and gentlemen. This concludes today's conference call. Thank you all for participating you may now disconnect.

Okay.

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True.

David.

Revenue.

David.

Thank you for.

Gross margin.

Okay.

Yes.

Okay.

Thank you.

Okay.

Other revenue.

Thanks for your question.

Yes.

Yes.

<unk>.

<unk> revenue.

Okay.

Okay.

For users.

David.

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