Q1 2021 Eiger BioPharmaceuticals Inc Earnings Call
[music].
Good afternoon, ladies and gentlemen, and welcome to the <unk> first quarter 2021 financial results and business update conference call.
At this time all participants are in a listen only mode.
We will conduct a question and answer session and instructions will follow at that time, Inc.
Anyone should require operator assistance. Please press Star then zero on your Touchtone telephone.
As a reminder, this call will be recorded I would now like to introduce your host for today's conference.
Mr. Surely reality, Chief financial Officer of Iger, Sir you may begin.
Great. Good afternoon, and thank you for joining us today welcome to our inaugural quarterly earnings call. We issued a press release. This afternoon with our Q1 financial results, which is available on our website at <unk> Dot com.
Joining me on today's call are David Cory President and CEO, Eldon Mayer Chief Commercial officer, Dr. Ingrid Chung Senior Vice President clinical development, Dr. Calling his senior Vice President clinical and development operations.
For today's call, we will have prepared remarks from the management team followed by Q&A.
We will be using slides for the webcast and we'll have a replay available on the investors section of our website.
I would 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 of 1995, 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 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 on the forward looking statements as well as the risks related 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 uncertainties, including many that are beyond your 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. Thank you for joining US today, we're making great progress across our pipeline this year advancing multiple potential catalysts for value creation in 2021 and beyond and we look forward to updating you today on our progress to date and our future plans and either.
We are developing and now commercializing first in class well characterized therapies for life, threatening rare and ultra rare diseases with high unmet medical needs are.
Our late stage clinical development pipeline includes three promising FDA breakthrough designated therapies low on a foreigner pegylated interferon Lambda and have extra time.
FTA approval of our first new drug application late last year for us, though can be to treat progeria and processing deficient perjury Atlanta on apathy is a victory for patients with these ultra rare conditions and demonstrates our ability to take a program from IND submission to NDA filing FDA approval.
<unk> and commercialization I.
<unk> is well positioned to make significant progress across our late stage pipeline. This year towards additional product approvals, we continue to grow our clinical development capabilities and with the Zoe can be launch we've established commercial and medical affairs functions that can scale and grow as we advanced two additional commercial launch.
Across larger orphan disease indications in the future for.
For our call today I'll spend a few moments highlighting each of our programs recent progress and anticipated milestones Eldon will provide more details on the U S. Though can be launch Ingrid will provide a clinical update including an update on Lambda for COVID-19, and Sri will review our financials.
Our lead clinical programs target hepatitis Delta virus or HBV. The most deadly form of viral hepatitis we are developing two well characterized promising late stage candidates in low on the Barnett and Lambda both of which had been granted FDA breakthrough therapy designation.
Low enough R&M as a first in class crenellation inhibitor and the only oral treatments in development for HDD and is currently in phase III the.
To deliver study is the largest and only global phase III study to be conducted in HDD.
Including over 100 sites across 20 countries around the world.
Deliver is enrolling and dosing and includes two <unk> based regimens and all oral arm of loan the final <unk> in a combination arm of <unk> and Pegylated interferon alpha with each arm.
Compared to placebo.
This study creates two opportunities for regulatory approval of a <unk> based regimen.
We are pleased to announce that deliver is 75% enrolled including patients randomized to date and patients currently in screening that are expected to be randomized. We are on track to complete full enrollment of 400 patients by the end of 2021 under current conditions.
Pegylated interferon Lambda or Lambda a first in class type three well tolerated interferon will begin phase III for HBV. Later this year, we have concurrence with FDA and EMA for a single pivotal study of just 150 patients aggregate now positioned to be a leader in.
Future HBV treatment paradigm with loan <unk> and Lambda both first in class therapies that will provide convenient dosing and optionality for HDD patients.
I'd also like to provide an update on lambda as a potential outpatient treatment for newly diagnosed COVID-19 patients we've previously.
We reported promising results from the Toronto Phase II <unk> study and we now have an open IND for Lambda in COVID-19, which includes a phase III three registration, enabling study protocol with clinical endpoints and targeting mild to moderate non hospitalized COVID-19 patients.
In parallel we are pleased to announce earlier this week that <unk> entered into a clinical trial agreement to include Lambda as an arm in an ongoing phase III multicenter placebo controlled platform study called together.
But together study is investigating multiple therapeutics in newly diagnosed COVID-19, outpatient at 11 clinical trial sites in Brazil, and potentially another site in Toronto, Canada.
As you know, Brazil is experiencing another wave of the COVID-19 pandemic with record numbers of hospitalizations and deaths and an urgent unmet medical need exists there today.
Together platform study design aligns well with the phase III protocol in our IND.
And we believe together could be registration, enabling Ingrid who will provide more details on the study design in just a few moments.
Finally, I'd like to update on <unk>, our pipeline program, which presents an opportunity in the metabolic disease space to advance a novel first in class targeted mechanism for patients with two very different orphan metabolic disorders post bariatric hypoglycemia, or PVH, which has been granted FDA breakthrough.
Therapy designation, and congenital hyperinsulinism or CACI, which has been granted FDA rare pediatric disease designation.
We have initiated and planned to complete manufacturing and device development as well as regulatory activities necessary to support registration, enabling clinical trials as early as 2022 for both PVH and CACI and.
<unk> represents a significant commercial opportunity in both of these indications and we will provide guidance in the future on how we plan to advance this program.
Certainly we have the financial resources to deliver on all of these commitments. We began 2021 with a strong cash position and ended Q1 with $165 million. This cash provides eiger with runway to fund our planned operations into Q4 2023 and critically low.
Able us to complete the HPV phase III deliver study and the HDD phase III limit to study.
Before turning the call over to Eldon for a commercial update.
I'd like to congratulate our team for a very successful U S. Zoe can be launch and acknowledge their relentless efforts as well as the patients and their families who are at the core of our mission Eldon.
Thanks, David let me begin by sharing our team's continued excitement in bringing this important therapy to children and young adults with progeria and processing efficient progeria monopolies.
About 180 children and young adults identified with progeria and progeria monopolies around the world. Our initial commercial efforts are focused on the approximately 20 identified patients from the U S where we launched in January and then the 'twenty three identified patients in Europe, where we expect approval later this year either as provided uninterrupted supply.
It can be to children and young adults in over 40 countries through clinical trials and through our expanded access program and we'll continue to do so in countries, where regulatory approval and commercialization may be impractical is it.
Shared on our call following FDA approval or is it can be with our prelaunch planning and the ultra rare nature of these diseases, we've been able to execute successfully launched with a focused and efficient effort, that's providing access to the approximately 20 identified children and young adults from the U S who are eligible for the kingdom.
And with that in mind, our goal continues to be that every patient diagnosed with progeria and processing deficient for Jared monopolies will have access to the kinsey.
It's important to note that 2017 U S patients were already taking that can be through either <unk> expanded access program or clinical studies, which with a distribution and support systems. We designed a enabled an efficient transition to commercial supply following launch.
We reported net sales in Q1 of $3 6 million first quarter retail shipments of the Kinsey to our dedicated specialty pharmacy totaled 165 bottles.
Of which 53 bottles were shipped to patients we expect six to eight weeks of inventory or 80 to 100 bottles in the distribution channel looking forward. Therefore, approximately 10% to 30 bottles of channel inventory burn should occur during Q2.
The payer mix is shaping up to be approximately 60% government, including Medicaid and 40% commercial.
<unk> been very pleased with payer coverage as payers have recognized a clear value propositions that can be and what it means to patients and their families.
We've also created a patient and practice support center known as either one care that delivers that can be directly to a patient's home along with supportive materials for them and their caregivers.
Primary goal of either one care is to ensure that patients who may be uninsured lack adequate insurance coverage or meet financial systems do not have any barriers treatment as a result of cost and we are pleased to report that the programs. We've implemented have enabled us to provide continuous access to as it can be with zero out of pocket costs for <unk>.
All patients an important demonstration of our commitment to the Virginia community and with that I'll hand, the call over to Ingrid to provide a clinical development update.
Thanks, Adam.
You had mentioned, we're making great progress across our clinical development portfolio. Our MAA for <unk> is currently under review by the EMA and we're expecting approval on the fourth quarter of 2021.
Our phase III HPV deliver study, which is 75% on volte is on track for completion of enrollment of 400 patients. This year and assuming current conditions hold this will put us on track to announce top line data in 2022.
To deliver primary endpoint is a composite of a two log decline in HCV RNA plus alk normalization, but deliver study includes killed on apartment based regimens and all on <unk> and the combination arm of Luna final per ton of ear and peg interferon alpha with each being compared to placebo.
This study design creates two opportunities for regulatory approval of a loan a final based regimen.
In parallel we are preparing a phase III study of Lambda for HDD complement Q for initiation in the second half from here.
In phase two we previously demonstrated one study that 36% of patients who receive Lambda for 48 weeks, we're able to achieve a durable virologic response on HDD army below limit of quantification on the.
Comfortable at 24 weeks post treatment.
We're excited about these results was formed the basis for our discussions with FDA on EMEA regarding registration.
We have agreement with both agencies on limit Q as a single pivotal study of Lambda for H D D.
<unk> is a randomized two arm study go from 48 weeks of Lambda treatment, followed by 24 weeks of treatment.
Primary endpoint is the proportion of patients with HBV RNA below the limit of quantitation at 24 weeks post treatment and on one compared to 12 weeks of low treatment and on Q.
This is a very straightforward study of 150 patients, but we anticipate will enroll across 40 to 50 global sites.
Two sites will be primarily selected from the best performing sites and the deliver study, which should allow us to enroll quickly and efficiently.
Turning now to Atlanta for COVID-19.
Interferon Lambda receptors are collectively located not only in the epithelium on the liver, but also on the epithelium lining of the respiratory tract side.
<unk> koby to suppresses the expression of Lambda interferon, which the immune system normally produces as a first line defense against viral infections.
Provided the rationale for the study Lambda as a potential therapeutic or early COVID-19 infection.
We reported that the phase III <unk> study conducted in Toronto demonstrated that a single dose of Lambda accelerated clearance of Sars COVID-19, two and newly diagnosed non hospitalized patients.
<unk> clearance of <unk> has potential to improve clinical outcomes and curb community spread, particularly in those with high viral levels as those cases associated with more severe disease on the higher risk of transmission to others.
As David mentioned, we now have an open IND from Lambda for COVID-19, including the phase III protocol targeting enrollment of high risk patients with a clinical endpoint.
Finding an efficient pathway to advance Lambda for COVID-19 has been a priority in recent months. We were excited to announce this week that we entered into a clinical trial agreement to include a lambda on the ongoing phase III together study.
Together as a platform study exploring promising treatments for COVID-19, outpatient across 11 sites in Brazil with plans to include a site in Toronto, Canada.
Up to 800 newly diagnosed high risk non hospitalized patients with mild or moderate COVID-19 are planned to be randomized one to one to receive a single dose of Lambda 180, micrograms or placebo as an outpatient treatment.
Primary endpoint of day clinical outcome, comparing the proportion of patients with COVID-19 related emergency room visits.
Amortization on debt by day 28 in patients treated with Lambda versus placebo.
The protocol includes an interim analysis that determined futility at approximately 25% enrollment.
The phase III together study is separate and distinct from the phase two three study included in our IMT. However, both studies aligned with FDA guidance on target patient population on clinical and.
We believe the phase II together could be registration enabling study.
Currently there is no convenient outpatient treatment for COVID-19.
<unk> monoclonal antibodies require intravenous infusion and have demonstrated limited used in clinical practice, where acute treatment is needed.
In addition resistance due to variance on new screens of Sars COVID-19 two is an ongoing concern with monoclonal antibodies and vaccines.
Rambus stimulate immune responses that are critical for the development of host protection during viral infection and may be ideal for addressing variance of Sars COVID-19 two.
Based on land that's convenient administration on mechanism of action that is agnostic to rifle variance. We believe lambda is ideally suited for outpatients with COVID-19.
We look forward to adding lambda to put together a platform study and investigating a utility in the treatment of newly diagnosed COVID-19, outpatient we will provide appropriate updates as they are available on this exciting program opportunity.
I'll now turn the call over to Shane to review our financials.
Thanks Kindred the press release, we issued this afternoon included a financial update which I will summarize as Albert noted, we reported $3 $6 million and there can be net sales in Q1 from launching commercially in the U S. In January.
Turning to our GAAP operating expenses cost of goods sold was $53000 in the quarter.
We had previously expense there can be supply costs incurred prior to FDA approval from R&D.
We expect low Cogs of the previously expense inventory is consumed.
For first quarter R&D expenses were $13 8 million and SG&A expenses totaled $5 6 million. We did report GAAP earnings this quarter of $29 2 million or <unk> 85 on a fully diluted per share basis.
As a result of the onetime gain from the sale of ours can be priority review voucher, which closed on January <unk>.
<unk> from $95 million and retained half of the net proceeds which was recorded to other income on our income statement this quarter.
Finally, we began the year with a strong cash position and ended the quarter with $165 million in cash cash equivalents and investments. This provides us with runway into Q4 2023, and importantly allows us to complete our phase III <unk> studies deliver and limit to on that.
Ill hand, the call back over to David.
Thanks Sri.
As you heard in our prepared remarks today <unk> has a diverse and very promising late stage pipeline targeting rare and ultra rare diseases with high unmet medical need.
We have multiple shots on goal across these programs with potential to deliver a number of value, creating catalysts in 2021 and beyond this year, we plan to complete enrollment of 400 patients in our HDD phase III deliver study, which is currently 75% enrolled setting the stage for week 48 in the treatment rich.
<unk> in 2022.
We plan to initiate the phase III limit to study to advance Lambda as our second therapy toward potential approval for HBV. We will continue the successful U S. Commercial launch of low can be and prepare for EMEA approval and so can be for progeria and processing deficient perjury lamina <unk>.
Advanced regulatory manufacturing and device development activities for <unk> and preserve options to advance clinical development for PVH and CACI.
We will advance Lambda for COVID-19, and the ongoing phase III together platform study and.
And importantly, we have the cash needed to support the execution and achievement of all of these milestones at this point I'd like to thank everyone for joining us today on our first of many quarterly financial results and business update calls and turn it over to the operator to please provide instructions for the Q&A portion of the call.
Thank you Sir.
Ladies and gentlemen, if you have a question at this time please press <unk>.
Star then the number one on your Touchtone telephone.
Your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
We ask that you limit yourself to one question and one follow up.
One moment for our questions.
Okay.
And speakers. Our first question is from Maury Raycroft of Jefferies.
Your line is open.
Hi, This is Kevin Chen on for Maury Raycroft for the Phase III delivered trial can you provide some patient background on the enrollment.
Yes. So good question and thanks for joining us via deliver study as we mentioned is the largest and only global study of HDD active in over 20 countries now across 100 sites and as we communicated today in our prepared remarks that the study is current.
75% enrolled.
Including patients enrolled and randomized to date as well as patients in screening that are expected to randomize.
We haven't provided additional detailed guidance. However, we expect full enrollment of 400 patients by the end of this year 2021, assuming current conditions hold.
Yeah.
Thanks.
And speakers. Our next question is from Yigal Yokohama Vince.
Citigroup.
Sir your line is open.
Hi, Tim This is <unk> on for Yigal. Thanks for taking my question on congrats on your first earnings call.
I guess can you briefly give US a reminder on.
On the choice of primary endpoints between the deliver study and limit too and maybe on deliver.
Why you chose the two log decline versus some other some other metric.
And then maybe how youre thinking about.
The rate of decline.
With patients, especially with the ALC normalization. Thanks.
Yes, sure all and thanks for joining us and for your question I'll provide some preliminary comments and then ask.
Ingrid and also calling to add any additional color.
Fortunately, we spent significant time with regulators negotiating endpoints for both the phase III deliver study and the phase III limit two study for <unk> based regimens and from Lambda, respectively. We believe that the endpoints line.
Well or align quite well with delivering patient benefit in terms of reducing viral load and normalizing a L. T.
A liver enzyme related to liver inflammation.
And Thats, a 48 week end of treatment endpoint, which we've been able to demonstrate successfully in our phase II program for loan of foreign net.
With Lambda, we actually demonstrated in our phase II program, a 24 week post treatment endpoint that is a bit more traditional and something more aligned with previous HCV studies, where an off treatment endpoint by regulators was desired and so we were actually.
Very pleased to offer this phase III study design to FDA and EMA and gain concurrence relatively quickly for a 48 week treatment course, with a 24 week post treatment endpoint of a DVR or durable Virologic response.
Defined as patients being below limit of quantitation at 24 weeks post treatment.
And feel very confident that that as well.
We will convert to improved patient outcomes.
And I'll make sure I check with Ingrid.
Ensure that I've covered the call David Ingrid, Yes, and I'll just add debt to limit to study will investigate 48 weeks of weekly lands attainment as a finite therapy with a 24 week post treatment follow up.
Okay, Okay, great and well also be measuring.
Surface antigen I don't know if I saw that on the slides.
Yes on both studies, both the deliver setting a limit to study we'll be looking at HBV surface antigen.
I'll, just add and importantly that debt.
These endpoints.
Green upon by regulators.
<unk> are a part of the draft guidance for the development of Therapeutics for HBV. So we feel very very good about the next steps on both the deliver and limit two studies.
Okay awesome. Thank you very much.
And speakers our next question from Robert Hazlett of <unk>, Sir Your line is open.
Yes. Thanks.
And then maybe another one on the second topic I'll jump in there could you just be a little bit more clear I think I got the.
Understanding of the.
Stocking through <unk>.
Bottles.
Could you just be a little bit more clearer.
The exact number.
Or amount of stocking that you think actually occurred in the quarter.
Okay.
Would be helpful. And then I have a follow up.
Yes, Barry good to hear your voice and thanks for calling in and for your question I'll turn that directly over to Eldon Mayer, our chief commercial officer, Alan Yes, Hi.
So I gave an approximate number of a 110, but let me walk you through we shipped.
165 bottles to from our three PL to our dedicated specialty pharmacy.
53 of those bottles were patient demand.
So that leaves 112 bottles exactly that that resided in the channel and I've rounded that after 110 as I mentioned earlier.
So those are the exact numbers, we expect as I mentioned roughly six to eight weeks going forward, which translates to approximately 80 to 100 bottles going forward hope that answer your question.
Okay. Thanks.
Just a quick one on <unk> could you just describe briefly about how the condition presents and when the patients are actually identified just a little more on the disease itself. Thanks.
Sure and thanks for your question congenital hyperinsulinism as you're referring to is a disorder of <unk>.
New borns neonates and children.
Debt presents with patients who are hypoglycemic and.
This is due to hyper insulin EMEA and we strongly believe based on the phase II data generated at chop the children's hospital of Philadelphia debt of exit tide represents a targeted mechanism.
On a potential.
Therapy for Neonates and also children with this devastating.
<unk> disease importantly, FDA has granted of exit tied in congenital hyperinsulinism rare pediatric disease designation and we look forward to making additional announcements in the future as we advance.
Okay. Thank you congratulations on the quarter. Thanks.
Yeah.
And speakers our next question from Michael Higgins of Madden very founding Sir Your line is open.
Thank you. Thanks, guys. Good to hear your voices again, congrats on the continued execution despite COVID-19 challenges.
Hoping to get an update from you.
On the on the.
Enrollment for HCV to deliver.
On the some some updates on the patient counts if you could give us some update on the site's locations et cetera.
It's interesting to hear.
A follow up on the on those extra tide.
Let's touch on a bit on the Q&A here.
But just trying to get a better understanding of the gating factors before starting.
The pivotal study is it.
As mentioned in the press release, a more of a manufacturing hurdle.
Or what.
What's next with that and I guess kind of a quick.
Quick follow up with.
Youre partnering plans there it looks like you're set to run this by yourself, but.
Curious to see or hear your feedback on a potential partner for that one price.
Sure Yeah no. Thank you for that question so as we.
Guidance publicly at the beginning of 2020, we announced that we would seek potential strategic partnering options for the excess tightened during the course of that process, we've developed greater conviction around the opportunity for <unk> in two different.
Metabolic indications and post very accurate hypoglycemia and congenital hyperinsulinism.
Importantly, we plan this year to complete manufacturing as well as device development and additional regulatory activities that will put us in a position.
Both programs PVH and CACI could move into registration as early as 2022 and so that's our plan for 2021 and certainly at that point, we will be able to provide more guidance on the strategic direction for these programs and look forward to it.
One quick follow up on that if I could on I'll jump back on the Q would be.
Can you give.
Give us for a potential framework.
Cost for something like this.
This strikes me as a relatively small study, but obviously a pretty intensive with the sites from the patients.
Sure I'll, let <unk> speak to the financials.
Importantly, manufacturing and device development activities that we have initiated our within our cash runway guidance on the funding from Q4.
Any additional studies that would need to be conducted for ehi or PVH would be smaller studies and we haven't provided financial guidance yet in terms of what the cost would be on Hollywood proceed with that program.
So after a good balance.
Gating items that David talked about.
I appreciate that thanks, guys.
Thank you.
Yeah.
And speakers we have our next question from she's.
She is EBITDA.
The key of Wedbush Securities. Your line is open.
Hi, This is from I thought on <unk> on them.
Thank you for taking my question can you provide some color on the European launch on Florida can be given that EMEA approval and anticipate that by year end and how are you thinking about rest of the world given that about more than 100 patients are in the rest of the line.
Sure and thank you for joining us today and for your question and I'll begin and then turn it over to Eldon.
We as announced plan for approval of <unk> in EMA later this year, obviously the approval in November of 'twenty 'twenty four is though can be here in the U S for progeria and perjury lamina empathy.
On allowed us to begin to build infrastructure that will be scalable and we are looking forward to EMA approval and with that I'll ask Ellen to comment a bit on next steps.
Hi, there so.
As stated our MAA is under review and we're.
With approval expected by year and of course, we have not provided guidance on that yet but it is.
And typically negotiated on a country by country basis following approval.
And.
The one example, although not in Europe for outside the U S is where we have a partnership with Neil farm in Israel.
And we submitted a regulatory application, which has been accepted and could come approval could come as early as Q4 this year.
But setting that aside we would expect in Europe that in some countries like Germany reimbursement could be secured upon EMA approval and we're preparing.
For that.
And in other countries, though it could take as you may know, sometimes up to one to two years from reimbursement. However, we are exploring opportunities for reimbursement on a country by country basis debt, where there is potential to generate revenues earlier.
Then full reimbursement approval through the various programs that are available.
And we've taken a number of steps to prepare for that conducted payer research, we're establishing our distribution and patient support services engaging with key doctors.
And.
Identified other infrastructure, such as marketing agency and working with consultants as needed. So.
That would be a quick summary, anything gentlemen, you want to add.
Yeah, I'll just add.
Add to <unk> comments to make sure that we address your question about.
Territories and regions beyond the U S and Western Europe.
There are obviously as we've.
Guided over 180 patients identified in over 30 countries around the world and many of these patients lie outside of the Western World and so we have announced a partnership with <unk> to distribute in Israel and will update on on that in the near future and.
As well many other countries that we are exploring appropriate pathways to ensure availability and also commercial revenue opportunities and we will guide on those region by region.
As those become publicly announce simple hopefully that helps.
Great. Thank you.
Yeah.
And again, if you have a question. Please press Star then the number one on your telephone keypad.
That is again star one on your Intel Sally to keep that.
Your next question speakers from Robert Tas net of <unk> E.
Sir Please go ahead.
Yeah.
Yeah.
Hi, Barry are you still with us.
It's not from us to reprocess for Q&A and if there are no more questions. We can move to closing remarks.
Okay sure Sir.
A reminder, if you would like again to ask a question. Please press Star then the number one on you touched on telephone.
Once again Star then the number one on you touched on telephone.
Yeah.
And Sir we have again, Robert <unk> net of V. P. I G. Jerry Your line is open.
Let me try this and see if it works can you hear me.
Yes, very good to hear your voice [laughter] My apologies.
Just going back to Todd a quick brief follow up maybe you touched on this maybe it didn't but with regard to PVH or.
B C.
Jai.
Is there a priority in terms of indications how should we think about the urgency with which youre going to consider either or both indications there.
Yes, thanks, Barry so with regard to the <unk> program. Our primary focus this year is to ensure that we manufactured drug product sufficient for <unk>.
Phase III.
Enabling studies as well as device work for both PVH and CACI indications as well as any continued regulatory discussions that needs to take place to enable AR.
Registration studies as early as 2022 importantly, we view, both post bariatric hypoglycemia and congenital hyperinsulinism.
Yes.
Major unmet medical needs and we believe that <unk> represents a targeted therapeutic for both of these indications and so we view them is as equally.
Commercially valuable and importantly, the.
On the unmet need within the patient populations is high and so we look forward to finding the most appropriate pathway to move of exited forward and we'll continue to provide guidance on updates as we have them.
Terrific, we look forward to those thank you.
And speakers I'm not showing any further questions I would now like to turn the call over to back to the necessary Sheree rally for any further remarks.
Great. Thank you Catherine This concludes our call free of any additional questions you can contact myself or needing toward high growth via email address to reach out to remember the management team were around thank.
Thank you everyone for joining us today I appreciate your time.
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