Q1 2024 Viridian Therapeutics Inc Earnings Call

Participants

Louisa Stone; Manager, Investor Relations; Viridian Therapeutics Inc

Scott Myers; Chief Executive Officer, President; Viridian Therapeutics Inc

Thomas Ciulla; Chief Medical Officer; Viridian Therapeutics Inc

Laura Chico; Analyst; Wedbush Securities.

Alex Thompson; Analyst; Stifel

Michael Yee; Analyst; Jefferies

Gavin Clark-Gartner; Analyst; Evercore ISI

Sam Slutsky; Analyst; LifeSci Capital

Gregory Renza; Analyst; RBC

Julian Harrison; Analyst; BTIG

Trevor Ohlinger; Analyst; Oppenheime

Presentation

Operator

Welcome to the Veridian Therapeutics First Quarter 2024 a conference call. (Operator Instructions). As a reminder, this conference call is being recorded. I would now like to hand the call over to Ms. Louisa Stone Manager of Investor Relations at. Viridian, Please go ahead.

Louisa Stone

Thank you, and welcome, everyone to our fourth first quarter 2024 earnings conference call. The press release reporting our financial results and corporate updates as available on the Investors page of our corporate website at www.veridian therapeutics.com.
Joining me on the call this morning are Steve Mahoney, our President and CEO, Thomas Ciulla, our Chief Medical Officer, and Shan Wu, our Chief Business Officer.
Before we begin, I would like to remind everyone that this conference call and webcast will contain forward looking statements regarding our financial outlook in addition to regulatory product development and commercialization plans and research activities. These statements are subject to risks and uncertainties that could cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-Q and 10-K on file with the SEC.
I'd now like to turn the call over to Steve Mahoney, our President and CEO.

Scott Myers

Thanks, Louisa, and welcome, everyone, to our first quarter earnings call. I'll start by giving a brief overview of Viridian, and then we'll get into more detail about our programs and recent progress. For those of you who are new to the Veridian story, our strategy is to identify market opportunities where there's a clear unmet need and where there's potential for us to develop differentiated products.
We then aim to engineer the best possible therapeutics and then move rapidly to advance our programs to patients turning to Slide 4. Slide 4 shows our pipeline, which includes both the thyroid eye disease or TED portfolio as well as an FcRn targeting autoimmune portfolio.
We have several exciting updates to provide across our pipeline today, which we'll get into next. We're really excited to highlight for you today, the significant progress that we've made across the business. So far this year, beginning with our oh one IV program, we are pleased to announce that thrive our Phase three trial evaluating oh one in patients with active TED completed enrollment in March.
And in fact, not only did THRIVE reach the target enrollment of 90 patients in March in mid-March, but we exceeded enrollment for a total of 113 patients due to strong patient demand at our clinical trial sites. We expect to share top line results for thrive in September 2024.
Stride two, our Phase three trial initiating oh one IV in patients with chronic TED continues enrolling. And as you know, trial is on track for line data at the end of this year.
Lastly, for OVA1, we are announcing that we anticipate filing a BLA for the oh one program in the second half of 2025 for our subcutaneous O. three program, which we believe has the potential to be best in class. We recently completed a positive Type C meeting with the FDA, and we are moving forward with our preparations for our pivotal program in line with our previous guidance,
We will provide additional updates for the oh three program before we start that pivotal program, which remains on track for midyear. We are also progressing our FcRn portfolio as planned we are aiming to file an IND for oh six by the end of this year, and we plan to share oh eight nonhuman primate data in the second half of 2021.
Lastly, we ended the quarter with $613 million in cash, cash equivalents and short-term investments, and we maintain our cash runway into the second half of 2026 also as previously guided.
Now I'd like to turn to our TED portfolio and talk more about the programs and our progress in that more detail. As a reminder, TED is an autoimmune condition characterized by inflammation and damage to the tissues around and behind the eyes.
This leads to symptoms, including proptosis or bulging of the eyes, redness, swelling, double vision and retraction to the islands. In severe cases, TED can be site threatening with those symptoms. As a backdrop, there is already a large market opportunity in TED that comes with global growth potential and an expansion that can come with better options for patients.
There is an estimated 190,000 people in the US, alone who are living with moderate to severe TED. These patients are only served by one marketed IGF-1R IV therapy currently, which generated approximately $1.8 billion in sales in just the US alone. In 2023.
This approved therapy requires eight infusion every three weeks, which can be a significant burden for patients. We see opportunity for us to provide differentiated options for TED patients with both our IV and subcu programs because TED is an autoimmune disease characterized by flaring symptoms, patients with moderate to severe symptoms, struggle with quality-of-life issues that make it hard for them to drive work and even sleep.
Because it is a flare-based disease, it is considered a new start market, which means that it doesn't matter when a patient was diagnosed because you need to treat the flare or the onset of those symptoms. This new start market also means that all patients experienced symptoms, we'll have the opportunity to choose what available treatment options with no chronic treatment to displace once have flares treated patients do not remain on any anti IGF-1R therapy.
So, when a subsequent flare rises, physicians will have the opportunity to choose from available treatment options, including potential new options to manage these flares in their patients this is a great position for our IV and subcu program content because we believe that we are developing potential best-in-class therapies in a drug class that that has shown to be highly effective in inhibiting IGF1R and in treating TED.
Turning to the specifics of our product candidates. Veridian is developing two anti-TNF anti IGF-1R antibodies for 1001, which is delivered intravenously in oh three, which is delivered subcutaneously with the potential for self-administration.
As you can see here, oh three and oh one have the same binding domain and we expect them to bind IGF-1R. Similarly, they differ because although three is engineered to have an extended half-life, which we have shown to be 40 to 50 days in healthy volunteers, which is four to five times that of oh one. It's parent molecule with only one we hope to have it a fast-to-market differentiated IV therapy for patients with fewer doses in a shorter infusion time than the current standard of care with over three, we hope to have we hope to develop it convenient, less frequent, low volume therapy, the patients can self-administer at home.
Let's review the oh one program, our progress and what makes us excited about the Phase three readout readout that we expect in September.
On slide 11, this is a reminder that we've already shown robust clinical activity with oh one after just two infusions in a Phase 2 clinical trial in active TED. This robust activity is across all key areas of the disease, proptosis or bulging of the eyes, Clinical Activity Score and diplopia or double vision we have added we have added data from the kinds of clinical trials after two doses on this slide to show the data side by side, while cross-trial comparisons are difficult we are encouraged by the clinical responses observed after just two doses of oh one.
On Slide 12, you can see that oh one was well tolerated in active TED patients with no serious adverse events, no infusion reactions and no discontinuations. Similarly, active to active TED in patients with chronic TED just after just two infusions over one, meaningfully reduced disease burden across each disease point as well.
On slide 14, oh one was also well tolerated in chronic TED patients. Based on this Phase 2 data, we believe that the clinical regimen of OVA1 with fewer infusions, shorter infusion time and lower cumulative drug exposure has the potential to be a better choice for moderate to severe patients with TED.
Now turning to our Phase 3 trial for oh one. I would like to take a moment to thank all of the patient clinical trial site teams who have participated in our THRIVE trial. We're not done yet and our achievements so far would not be possible without them.
As we announced today, we completed enrollment for THRIVE in March with 113 patients, which exceeded our enrollment target of 90 patients due to strong demand and interest at our clinical sites. About half of Triade patients were from the US, and the other half came from Europe. We expect to provide top-line results for this study in September of this year, tried to our second pivotal study in TED is ongoing and on track for top line readout at the end of this year.
In addition to thrive and tried to we have news, we recently initiated STRIVE, which is a planned safety study. Strive is a study of over one in 10 patients to complete a sufficient safety database for BLA submission alongside the patient numbers from Dr. interactive.
In conclusion, with oh one, we are developing a potentially differentiated IV therapy for patients with fewer doses and shorter infusion time than the current standard of care while inhibiting the same IGF-1R target, which has been shown clinically and commercially to be effective in treating tests we are very excited about bringing forward all one as a potential option for patients which could mean significantly less drug for patients, fewer visits in the infusion center, lower volumes and less infusion chair time.
Our next program, subcutaneous oh three will take this differentiation even further with the possibility of lower frequency subcu, lower frequency, lower frequency, subcutaneous administration and potential for at-home self-administration using autoinjectors.
We know from market examples that a later entrant subcu therapy can convert meaningful portions of an existing IV market. We've included two of those examples here in each of the cases on this slide, sub-Q offerings grew the overall market size of the class in addition to quickly commanding a significant share of the IV market and keep in mind that these are two examples have the same or more frequent dosing than their IV counterparts.
This would not be the case with oh three, which is designed to add to a potentially at best-in-class dosing program. Also, it is important to point out in both examples that neither of these are a new start market. Again, the TED market is a new start market where we need to treat flaring disease or onset of symptoms as opposed to trying to convert patients from a long-term chronic therapy with oh three, we hope to provide patients with an anti IGF-1R therapy that has a better option with respect to less overall drug exposure in more convenience.
On slide 19, we show the complete data set from our Phase one healthy volunteer study of oh three to assess PK and PD. The update here is the inclusion of the last cohort. Cohort five were participants received two doses of all three 28 days apart data confirms the differentiated PK, differentiated PK and PD for oh three seen in the first folk four cohorts with an extended half-life of 40 to 50 days and sustained increased levels of the PD biomarker IGF-1.
On slide 20, you can see that the subcutaneous oh three was well tolerated in the Phase 1 study, including in the latest Cohort five with no serious adverse events or discontinuations related to treatment and observed adverse events were generally Grade one and mine.
As we shared previously, our pharmacokinetic modeling for oh three that showed that our predicts that three potential dosing regimens are available to us all three every three, eight weeks, every four weeks and every two weeks could achieve or exceed the exposure levels of oh one that we saw in the active and chronic studies that were correlated to robust clinical activity for our Phase 2 clinical trials
And tests this gives us a lot of optionality as we move forward, move towards our pivotal studies for oh three and importantly gives us the potential to develop for patients at best in class low volume subcu delivery option. We are pleased to announce today that we have completed our Type C meeting with the FDA, and we are on track to initiate pivotal clinical trials for the oh three program. We will share more details on the pivotal trial design before we start those studies.
Now turning to our FcRn portfolio on Slide 24. In addition to Ted and consistent with our development strategy, we are developing exciting portfolio of potential best-in-class FcRn inhibitors to address the unmet needs of patients living with auto antibody mediated autoimmune disease. Fcrn inhibitors represent a large market opportunity. First, SCR, FcRn inhibitor, Asgard or discard, is approved for myasthenia gravis and in and is in registration for CIPD.
It's already annualizing over to over $1 billion in annual sales. Myasthenia Gravis alone is a large market with projected sales of over $4 billion annually by 2028 in addition to myasthenia gravis. As you can see from the slide, there are additional sizable autoimmune indications that would meaningfully add to the FcRn opportunities.
Our FcRn franchise includes two assets 006 and 008 with 006 . We are excited to have the only other FcRn targeting Fc fragment in development other than efgartigimod organic is our genetics has shown that its Fc fragment achieves substantial efficacy while sparing an effect on albumin or LDL and shows better tolerability than the full-length antibodies. We are on track to submit an IND for oh six by the end of this year and look forward to sharing more about the program in the future.
Next on the right is 008, our protein engineering efforts identified a molecule adenosine derived from Fc fragments that both extended the half-life and generated meaningfully deeper IgG reductions in animal models. We believe oh eight is a potential best-in-class extended half-life molecule targeting FcRn with the potential to more durably suppress IgG.
We are on track to provide oh eight nonhuman primate data in second half of this year as guided, and we are excited to bring forward this portfolio of next-generation FCRN.s to potentially offer patients a more convenient dosing profile compared to current weekly IV or subcu infusions.
In addition, by aiming to improve the duration and depth of IgG suppression with 008, we hope to offer a best-in-class option for patients. Our team is executing. We have made excellent progress across the company in the first quarter of the year, and we look forward to continuing that momentum through the rest of the year to deliver on our multiple upcoming catalysts.
As I mentioned, previously, we plan to report drive top line in September and thrive to top line is on track for the end of the year. The FcRn programs are also proceeding as expected it has been my pleasure today to provide these exciting updates across our portfolio and in particular for oh one and oh two oh three, reflecting the work that we've completed the core in during this quarter. This progress and our recent achievements reflect our team's ability to execute, and we are well positioned to continue to work and deliver on our exciting upcoming catalysts.
Last but not least, we remain well capitalized ending the quarter with $613 million and the runway is into the second half of 2026. So, with that, I'll ask the operator to open the call for questions. Operator?

Question and Answer Session

Operator

(Operator Instructions)
Laura Chico from Wedbush Securities.

Laura Chico

Good morning and thanks very much. For taking my question and congrats on the progress here. I guess I have two questions for you. First, with respect to the THRIVE data that's coming in September, I'm wondering if you can help kind of help us frame what success looks like on the efficacy side. But then also with respect to reduced drug exposure, how would you think this might impact the rate of hearing impairment events that you might see in trials?
And then secondarily, just related to strive, I'm wondering if you could talk a little bit more about the inclusion of the active control? Thanks.

Scott Myers

Yes, sure. Thanks for the question. In terms of what is a good look like for Thrive efficacy on when as we've as we've stated previously, we think a profile that looks like capacity is similar to capacity would be a really good place for us demand.
So, with respect to hearing, yes, certainly I think what we're looking for in the same vein on efficacy for safety, getting a similar profile on safety because the safety profile for capacity is good, it's benign, and you referenced hearing in particular to the extent the lower exposures improve upon that, that would be great to the extent it C-MAC driven. We obviously have a lower C-max just by virtue of the volume that we deliver versus the pizza. So that could possibly be helpful.
We'll have to see. But I think in terms of what good looks like, we'd love to see a similar profile with respect to your question on stride.
Yeah, I mean, look, this drive is simply to complete the safety database, which is just normal blocking and tackling for a BLA submission. So, nothing there unusual on the active control arm. It's just you've got to run a well-controlled study. And so we have the option of a of an active control arm of three makes the K it randomized three to one. So the numbers will be heavily weighted towards the 10 migs per kg. Again, it's all for the safety side of it.
So, I hope that answers the question.

Laura Chico

That does. Thank you.

Operator

Alex Thompson with Stifel.

Alex Thompson

Thanks for taking our questions. I guess I wanted to drill in a little bit more on safety in particular. I guess when you when you look back at the past, the safety profile from the Phase 3 versus the more recent chronic TED study, is it do you feel like the chronic TED study might represent a better if you ran it, as I say today with more focused hearing measuring that's more of a bar for safety? Or how are you thinking about like what to passive safety actually looks like today versus when those Phase 3 were started? And then for the top line for oh one in Phase 3, do you expect to be able to share any data beyond 15-weeks as part of that, either for safety or efficacy? Thanks.

Scott Myers

Well, you take the second first, Alex. No top line is top-line. So, it will be it will be a readout at the 52-week endpoint with respect to your question on what would it sounds like you're asking what is supposed to post the clinical trials and what those real-world experiences.
Yeah, that is all part. Like we're trying to understand that as well. I mean, I know I am just trying to understand that of the physician community, the patient community, they're all trying to understand that and maybe talk to what do you want to just explain how we're approaching our reporting of a of a ease in the same way. That depends one Sure.

Thomas Ciulla

So, Alex, as you know, the field is evolving that, as you alluded to, the updated guidance from the FDA, which led to a label change for a temporal, as you know, and in current clinical practice, physicians are assessing patients hearing at baseline during and after treatment.
So, we are recording adverse events using better returns. And as you know, this is just a standard way of recording patient reported changes in their health, including hearing. And this is standard for any clinical trial, including Teva.
And there have been their pivotal trials. And we're also assessing audio Symmetry as is done in clinical practice on that baseline in pre-specified points. So we're essentially doing what's done currently in the evolving clinical practice.

Alex Thompson

Great.

Operator

Michael Yee with Jefferies.

Michael Yee

Hello, okay, great. I guess we can you I showed two questions. First was on the ongoing THRIVE study. Can you talk a little bit about and how you can control for the hearing impairment and hearing loss. And then I know that if you actually go look back at some of the competitive push marketing studies that there's some commentary and analysis around how patients have some of this hearing loss already, and there's factors already going on with somebody's TED patients in the background. And so just trying to think about how you can screen or protect for that and think about that as you go through your Phase 3.
And then on the subcu plans for Phase 3, I think you said that you met with the FDA and are planning to start Phase three. Can you just talk a little bit about how that meeting went? And I know there were some uncertainties about going directly into Phase three. So just talk a little bit about your confidence there or anything else that you need to do in order to start the Phase 3 for subcu?

Scott Myers

Yeah, great. Thanks, Mike. Let me let me take the second first and then I'll and then I'll ask Tom to weigh in on the baseline hearing question that you had first. So, with respect to the oh three program, excuse me, we did have a positive meeting.
We have not received the minutes yet. So, but we had a positive meeting, and we are reiterating our guidance that we are going to start a mid a pivotal program midyear 20 this year or so. We will provide a lot more detail once we get once we get on the other side of minutes, but before we start the study, so more to come. But to answer your question, positive meeting, we feel good about our reiterating our guidance on starting that pivotal program. So, we're pretty excited there.
With respect to the Thrive and the baseline hearing, I'll ask Tom to jump in there please.

Thomas Ciulla

Thanks, Michael. So, that we said in the previous answer, adverse events in the studies reported via the measure of terms with standard methodology for reporting patient changes in their health including hearing, and this was done in the trials. As I mentioned, we're also using audio commentary from monitoring, and that's consistent with the current clinical practice and FDA guidance. We do have an exclusion criteria for on hearing loss at baseline. You can see that exclusion on clinicaltrials.gov.

Michael Yee

Okay, thank you.

Operator

Gavin Clark-Gartner from Evercore ISI

Gavin Clark-Gartner

Good morning and thanks for taking my questions. On Study first on the Type C meeting for oh three, does the FDA want to see any dose-ranging work in TED patients as part of that pivotal? Or do you believe you can start dosing immediately and like blinded pivotal portion of the trial?

Scott Myers

So, Thanks, Gavin, and like I said, give us give us a little bit more time. We'd like to see the minutes, but just but just take comfort from the fact that we are we feel positive coming out of that meeting and that we are starting our pivotal program, which is what we've been what we were guiding to previously, but we've now had that meeting. So we feel good about where we're going, but give us a little bit more time and we'll be able to break down those details for you on that.
That's kind of where we are and we feel good sounds good and we'll await more details.

Gavin Clark-Gartner

And are you able to provide on any details on how the THRIVE baseline characteristics compared to Tesma's Phase 3?

Scott Myers

Yes, that's another one, Gavin. I mean, it's a great question and I totally appreciate it. It's just that we're just not there yet. We don't have all that information for baseline thrive. There's we just completed enrollment. And so it's going to take us a bit to just get all that together. So more to come on that one, as well, makes them.

Operator

[Sam Slutsky] from LifeSci Capital

Sam Slutsky

Hey guys, Thanks for taking my questions as well. You touched on the significant ex-US market opportunity in TED. I guess are you planning to file for approval of zero zero one in the US and Europe in parallel once all the data is in hand and how large it has been community could ultimately represents?

Scott Myers

Yeah, I think the epidemiology in Europe is very similar. So we know that to be the case similar to the U.S. That is with respect to our ex U.S. plans. Again, that's something we'll probably talk a bit more about later on.
We are as you can imagine, we are absolutely thinking about all of them, the best approaches in these different geographies, even beyond Europe. So that's all in the works. It will have more to say at a later time.
Got it.
Sounds good.

Operator

Your next question comes from the line of Derek Archila with Wells Fargo.

Hey, this is Adam on for Derek, thanks for taking our questions today. I guess just a couple of questions on the time line really on. So given the drive is still reading out by mid 2024 ish and drive to reading out end of year.
What factors are driving a second half 25 BLA submission in TAD is this related to the STRIVE study been and and in that sense, is an interim cut. Would that be sufficient from strive for a BLA submission or does it hold drive trial need to be completed to support the BLA submission?

Scott Myers

Great. Thanks, Adam. Appreciate that question. Yes. So what's driving the timeline is that remember So, we've talked about thrive to that a top-line readout at the end of the year. So by definition, it's not the completed study, right? So we have to let that we have a follow-up period if there's a there's a total of 52 week follow-up period, but only 37 weeks post the last dose.
So there's a follow-up period that is have to be taken into account and it's primarily thrive to that's driving the time line. It really doesn't. We're not expecting strive to have an impact there that strives should fit squarely within that timeline. And so, we feel and that's probably the driver and we don't need all of STRIVE.
What you see there is this on CT. dot CAVC. 212 patients. That's the maximum number that we'll need a we can do a data cut as soon as we reach the requisite number for the safety database. And there's a little there's some moving parts that go with that in terms of you can have dropout rates in your Thrive we thrive to. So, we kind of over time we over engineer are over set up the STRIVE study, but we can do we could do a data cut when we hit that threshold. And again, all of this is really typical.
You have to have a safety database that accompanies your BLA submission. So it all kind of is normal blocking and tackling from our perspective and just kind of take into account that that drive to different top line readout. So there's more to do after top line readout, which drives the second half 25 fiber.

Okay. That makes sense. And I guess, can you provide any numbers on what that threshold is? And then just kind of following up on the STRIVE study to this, the safety database you expect to leverage then with any potential regulatory, sir, for D. and zero three?

Scott Myers

Yeah. So those three, as we've talked about previously, is a is a different molecular entity, so it will have its own path. So the answer to that question is now on the phone. On the first question, the threshold is that the threshold again, like I said, 212 is the max number. We're not we'll see where we end up the total number is 300, but that includes thrive and thrive to active patients on 10 migs per gig. So we're not anticipating needing the entire STRIVE study. And again, most importantly, STRIVE is not expected to drive the time line for BLA submission.
It's more the drive to do that.

Thank you.

Operator

Your next question comes from the line of Gregory Renza with RBC.

Gregory Renza

Steve, congrats on the progress. Thanks for taking my question. Maybe, Steve, for you and perhaps than Tom, just wanted to get your latest views on the competition for patients, clinical trials, certainly as your trials are heating up and appreciate all of the products you have made and there are others out there as well to grow with the subcutaneous, what's the latest on driving demand?
And what levers are you pulling to really accelerate enrollment as well as the trial?

Scott Myers

So, I'll turn it over to Tom in a second. But yes, I think if you could, you could see that we enrolled not only did we enroll thrive on time. We exceeded enrollments. We had really strong patient demand to drive that all within the month of it were all within the month of March.
And I think that's a I think that should be a clear sign to the world that there are lots of there are lots of patients out there with TED that want to access IGF-1R therapy. So, that's a really good sign for US.
Don't forget also that we had roughly half of the patients were enrolled in the US. I know that was a question mark for people. I think we've definitively answered that the US, is a very we've got the opportunity within the US, and then the other half in Europe where they have to be, as I mentioned, the epidemiology is the same. So I think that might be just a general answer.
Tom, to do you want to talk about how competition for trials is shaking out?

Thomas Ciulla

Yeah, Thanks for your question, Gregory on I'm out in the field a lot talking to investigators, investigators and KOLs, both in the US,. and ex US, And I can tell you there's a lot of excitement about our portfolio. As you know, our Phase two trial showed really promising results, and that's driven a lot of interest, hence the overall enrollment that Steve referenced. Some also I can tell you that with respect to strive.
We have an active control. There is no placebo, and we think that's going to drive enrollment there. So I think overall, just lots of positivity around our TED portfolio in our trials on, I really can't comment. I really can't comment on our competitors, but what I can say is just lots of excitement and enthusiasm around our portfolio.

Gregory Renza

Great. Thanks.

Operator

Julian Harrison with BTIG.

Julian Harrison

Good morning and thank you for taking my question. I understand FcRn is kind of in the background this year, but I'm wondering if there's maybe an IGF-1R to FCR and sequencing, Ted, that could be worthwhile to study in the future? Or are you mainly interested in FcRn opportunities beyond that at this point?

Scott Myers

Yes, it's the latter, Julian, we're we would we just don't take it for for TED patients. We firmly believe that IGF-1R is the key to that disease at the heart of that disease. That's where the cell signaling taking place. You've got to hit that receptor in order to disrupt that. And so with FcRn, the IL-6 is the other modalities or not or other mechanisms we don't feel are on target for moderate to severe TED patients. So for us, the IGF-1R is the key to pad so FcRn will take that in different places as we alluded to in the deck.

Julian Harrison

Thank you.

Operator

Trevor Ohlinger with Oppenheimer.

Trevor Ohlinger

Good morning. Thanks for taking the question. So, it depends on sales trending down slightly. Can you give us some perspective on why you think the newsstand market there appears to be somewhat stagnant and how you see it, but potential opportunity for you?

Scott Myers

I mean, listen, I think it's hard for us to comment on Amgen sales. I think they are they did report on their call last week, they did report year-over-year growth, which is the first time they've done that since the announcement of the merger.
So we see that as a really good sign. And Amgen was also really confident on their call that they believe that the market continues to be underpenetrated, which we agree with and they have they believe that it's going to continue to grow on growth areas. Don't forget the growth areas also include the other geographies, the introduction of subcu.
And so they've now they filed in Japan in Europe, which is good as they're continuing to kind of Blaze that trail for us. And don't forget, even in the backdrop of all this, they did close to $1.8 billion or close to $2 billion in sales in 2023 in the backdrop of all of this as a first entrant.
So again, we feel we feel that there's plenty of room to run in PAD, not only in the US but elsewhere as well. And then we think subcu, particularly our subcu, which we think is potentially going to be best in class where we can have patients that can access it just good delivery at home and they could self-administer at home.
We think that's a game changer for 10 patients, and I think the physician community agrees with us on that. So yes, we're not we're not particularly worried about IGF-1R being the right place for TED patients. And I think Amgen is going to prove that as well.

Trevor Ohlinger

That's great. That's super helpful. And I guess, could you give us some perspective on when we might back to the initial FDA or in data with it with the I&D coming in the year, maybe second half midyear 2025?

Scott Myers

Yes. In our deck, you can see that we've got some we've got some healthy volunteer data that's pegged to the second half of 25 for that oh six program. It's a little ways out, but so we'll look to see if we can pull that timeline in. But we feel we're on track for that IND. and then we'll get the healthy volunteer study going. And so we'll get some data there. I think don't forget the oh, a nonhuman primate data and that has in other FcRn that has proven to be pretty translatable. So we're pretty excited to see that we saw great humanized mice data for oh eight, but obviously, that's mice data. We want to see that HP.s, we'll get that in the second half of this year. So, we think that's actually a relatively important thing for us to get. So we're looking forward to FcRn moving forward. We've got a lot to do there.

Trevor Ohlinger

Okay. Great. Thanks.

Operator

I'm sorry, at this time, we have reached the conclusion of the question-and-answer session. I would now like to turn the call back to Varian's President and CEO, Steve Mahoney, for closing remarks.

Scott Myers

Great. Thank you, operator, and thanks, everyone, for joining the call this morning and we've made a lot of progress, and we are executing. We're delivering on what we've what we've said, and that's important. We know that's important to use well. So thank you for your participation today, and we look forward to talking to you in the future.

Operator

This concludes today's conference call. You may disconnect your lines. Thank you for participating.