Arcturus Therapeutics (ARCT) 7 Nov 242024 Q3 Earnings call transcript

Good day, everyone, and welcome to today's Arcturus Therapeutics Third Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note this call may be recorded. [Operator Instructions] It is now my pleasure to turn the conference over to Ms. Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. Please go ahead.

Thank you, operator. Good afternoon, and welcome to Arcturus Therapeutics quarterly financial update and pipeline progress call. Today's call will be led by Joe Payne, our President and CEO; and Andy Sassine, our CFO. Dr. Pad Chivukula, our CSO and COO, will join them for the Q&A session.

Before we begin, I would like to remind everyone that the statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements are not guarantees of performance.

They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statement. Please see the forward-looking statement disclaimer on the company's press release issued earlier today as well as the Risk Factors section in our most recent Form 10-K and in subsequent filings with the SEC.

In addition, any forward-looking statements present our views only as of the date such statements are made. Arcturus specifically disclaims any obligation to update such statements.

And with that, I will now turn the call over to Joe.

Thank you, Neda. It's good to be with you again, everybody. We look forward to providing our updates today on our quarterly investor call. I will begin my remarks with an update on progress with our vaccine franchise, led by KOSTAIVE, our self-amplifying mRNA COVID-19 vaccine.

We're thrilled about our recent commercial launch of KOSTAIVE in Japan. Last month, members of our senior management team, including myself, have the wonderful opportunity to travel to Japan to be vaccinated with KOSTAIVE in Tokyo.

In addition to our team from Arcturus, we shared this experience with senior management from Meiji, CSL and ARCALIS.

As you can imagine, it was an experience our team will never forget.

In connection with the first sale of our COVID-19 vaccine, Arcturus received a $25 million commercial milestone.

On the regulatory front, CSL secures its partner in Japan, Meiji Seika Pharma, announced earlier this year that they submitted a partial change application for an amendment to the manufacturing and marketing approval of KOSTAIVE to include domestic manufacturing sites in Japan, including ARCALIS. And ARCALIS is Arcturus' joint venture in Japan.

When approved, this will allow for Meiji Seika Pharma to begin selling domestically produced KOSTAIVE this season. The European Medicine Agency continues to review the KOSTAIVE marketing authorization application. I've been impressed with how our team has worked diligently with the agency as they review the first potential self-amplifying mRNA product in Europe. The process is near completion with the CHMP opinion expected next month.

As we look forward to achieving marketing approval in the U.S., we plan to file a BLA for KOSTAIVE in the first half of next year, which will be supported by positive results from multiple Phase III studies.

We continue to collect meaningful clinical data for our proprietary next-generation STARR mRNA platform.

The company announced today another set of positive Phase III results wherein ARCT-2303, this is the monovalent XBB variant derivative of KOSTAIVE, met all 4 primary study objectives and key secondary objectives. The study supports co-administration of KOSTAIVE with licensed influence of vaccines.

ARCT-2303 demonstrated superior immune response versus ARCT-154 as measured by neutralizing antibodies against Omicron XBB.1.5.6 in terms of geometric mean titer or GMT ratio and a seroconversion rate or SCR difference.

Co-administration of ARCT-2303 and cell-based quadrivalent influenza vaccine showed noninferior immune response versus standalone QIV administration. Co-administration of ARCT-2303 and QIV also showed noninferior immune response versus standalone ARCT-2303 administration.

And lastly, co-administration of ARCT-2303 and adjuvanted QIV in older adults showed similar responses versus standalone administration of ARCT-2303 and adjuvanted QIV.

In September, the company, along with our partner, CSL, ARCALIS and Meiji announced new 12-month post-vaccination data for KOSTAIVE at OPTIONS XII for the Control of Influenza conference. The results of a head-to-head Phase III study demonstrated that KOSTAIVE maintained superior immunogenicity compared to the conventional mRNA vaccine, COMIRNATY, for up to 1 year against Wuhan-Hu-1 and Omicron BA.4/5 and certain other variants and at 1/6 of the dose of the comparator. These results were published in The Lancet Infectious Disease.

Additional Phase III data presented at the OPTIONS conference showed that by bivalent KOSTAIVE, also known as ARCT-2301, induced superior immunogenicity over conventional bivalent mRNA vaccine COMIRNATY that persisted against key variants up to 6 months post vaccination.

Now shifting our attention to our mRNA therapeutics franchise.

Let's begin with an update on ARCT-032. ARCT-032 is an inhaled messenger RNA therapeutic for cystic fibrosis. And it's formulated with Arcturus' LUNAR delivery technology that differentiates us from our competitors.

In September, we received clearance of an investigational new drug application to the U.S. Food and Drug Administration. The FDA clearance of the IND application enables Arcturus to initiate a Phase II multiple-ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with cystic fibrosis.

Our team is actively engaged in onboarding a substantial number of clinical sites to help us in this effort.

We are fortunate to be able to be working closely with the CF Foundation in this process.

The Phase II study is presently screening individuals with CF who do not qualify for or benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and/or drug intolerance. This study will allow us to evaluate FEV lung function improvement in individuals with CF. And I'm very pleased to report that the company is on track to share interim Phase II proof-of-concept data for our CF program in the first half of 2025.

I'll now move on to our ARCT-810 program. This is our messenger RNA therapeutic candidate for ornithine transcarbamylase or OTC deficiency. Earlier this year, Arcturus announced the expansion of the Phase II clinical program of ARCT-810 into the United States.

This open-label multiple-dose study evaluating pharmacodynamics and safety is currently enrolling adults and adolescents requiring clinical management for OTC deficiency.

Our placebo-controlled Phase II European study has completed the dosing phase.

These concurrent Phase II studies in Europe and the U.S. will allow us to evaluate meaningful biomarker changes in individuals with OTC deficiency. And I'm happy to report that the company is on track to share interim Phase II proof-of-concept data in the first half of 2025.

With that, I'll now pass the call to Andy.

Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the third quarter of 2024 and provide the summary and analysis of year-over-year and sequential financial performance. Please also reference our most recent Form 10-Q for more details on the financial performance.

We are very pleased with the launch of KOSTAIVE, our COVID-19 vaccine candidate in Japan. This represents an important milestone for Arcturus as it is the first commercial product in the company's history. We believe that this product highlights the differentiating aspect of SA mRNA technology and how it can potentially represent an improved vaccine option for patients.

I am also happy to announce that we have received a $25 million commercial milestone with the first KOSTAIVE sale in Japan. I also went to Tokyo last month to get the KOSTAIVE vaccine with 32 executives from Arcturus, ARCALIS, CSL and Meiji.

Due to the early clinical success of our cystic fibrosis program, ARCALIS has become a strategic manufacturing asset for Arcturus. And therefore, we have decided not to sell our stake in ARCALIS at this point in time. The strategic review process conducted by JPMorgan generated interest from financial and strategic participants, which will benefit Arcturus and ARCALIS in the future.

We decided to expand our manufacturing product line with ARCALIS to include respiratory mRNA therapeutics. And therefore, we are planning to transfer our cystic fibrosis manufacturing process technology to ARCALIS.

I will now provide a summary of our financial results for the third quarter of 2024.

For the 3 months ended September 30, 2024, we reported revenues of $41.7 million, a slight decrease from the $45.1 million reported in the same period in 2023. This small decrease is attributable to a decrease in CSL revenue as we achieved a milestone of $35 million during Q3 of 2023 compared to a milestone of $25 million during Q3 of 2024. This was offset by an increased revenue from the BARDA agreement.

Total operating expenses for Q3 2024 were $52.4 million compared with $64.5 million for Q3 2023. Total operating expenses for the 9 months ended September 30, 2024, were $191.8 million compared with $195.9 million for the 9 months ended September 30, 2023.

Research and development expenses were $39.1 million for Q3 2024 compared with $51.1 million for Q3 2023. The decrease was primarily due to $15.9 million in manufacturing expenses incurred in the Q3 2023 related to the Meiji supply agreement in other clinical trial manufacturing batches as well as decreased facilities and equipment expenses. The decreases were primarily offset by a $3.6 million increase in clinical trial-related expenses for the COVID and flu program.

For Q3 2024, Arcturus reported a net loss of approximately $6.9 million or $0.26 per diluted share compared with a net loss of $16.2 million or $0.61 per diluted share for Q3 2023. Cash, cash equivalents and restricted cash were $294.1 million as of September 30, 2024, and $348.9 million as of December 30, 2023.

Arcturus achieved a total of approximately $462.1 million in upfront payments and milestones from CSL as of September 30, 2024, and expect to continue to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu program and 3 additional vaccine programs by CSL. Based on the current pipeline and programs, cash runway is expected to extend into the first quarter of fiscal year 2027 and does not include any contribution from the sale of KOSTAIVE vaccines in Japan.

In summary, the company remains in a strong financial position and has the cash runway needed to achieve multiple near-term value-creating milestones for the vaccine and therapeutic programs. Furthermore, with the recent launch of KOSTAIVE in Japan, we look forward to reporting potential commercial revenues in 2025.

I will now pass the call back to Joe.

Thanks, Andy. We've continued to make exceptional progress on our mRNA vaccines and therapeutics pipeline.

We are particularly excited about the launch of KOSTAIVE, the first commercial product in company's history. And we're also pleased that both of our flagship mRNA therapeutic programs, ARCT-032 and ARCT-810, are on track for interim Phase II POC clinical data in the first half of 2025.

I will now turn the call to the operator for Q&A.

[Operator Instructions] We'll go first to Lili Nsongo with Leerink.

I guess 2 questions from my side.

So first question regarding the commercial launch of KOSTAIVE in Japan. Any chance you could give us maybe a little more granularity? So you had mentioned that 4 million doses had been delivered to Japan through partner, Meiji, that they are also upping production. I was wondering if you could give maybe a little more color on the launch trajectory in Japan and expectations for the winter season going into 2025.

Secondly, so for the OTC deficiency study.

So the European study has completed for a while now and for -- the U.S. study is ongoing. Would you mind giving maybe a little more color on the number of patients and type of data we should expect from the upcoming readout in the first half of 2025?

Thanks, Lili, for the question. Andy, with respect to the additional nuance on the commercialization process in Japan, do you want to handle that question?

Sure. Thanks, Lili. We're pretty excited about working with Meiji in Japan because, as you know, they're the #1 flu vaccine company.

And so they're in a very strong position to be able to launch the product very effectively.

And if you may have paid attention into a recent press release, they've actually articulated that they were planning to sell roughly 4.5 million vaccines during the season with the guidance. And of course, we only shipped 4 million. And of course, the remaining vaccine must have come from the opportunity to produce them in ARCALIS in Japan.

So we're all awaiting the announcement of that approval by the PMDA shortly, which should enable Meiji to have a full launch by probably December or so with a vaccine that's actually made in Japan.

So pretty exciting, I think, for not only Meiji and CSL, but the Japanese people overall.

So we're not really privy to give specific guidelines other than they've been able to articulate publicly, but I would closely pay attention to any communications coming from Meiji and CSL regarding the launch and progress of the vaccine sales in Japan.

And pertaining to the OTC question, Lili, the U.S. expansion is going to be similar in size relative to what we did in Europe.

We are enrolling younger and more advanced disease subjects. We did see some early signals that were encouraging in the European trial, but we're going to be combining this data in what we share in the first half of next year.

We'll go next to Yasmeen Rahimi with Piper Sandler.

This is Jim for Yas.

First, to the extent that you can, for the Phase II cystic fibrosis study, could you provide any color on the size and cohorts that you're thinking about? What doses are you planning to move forward with?

And then for the second question, what is needed to demonstrate proof of concept in your view?

Pad, do you want to take that question, the CF study?

Yes. I mean, obviously, if you look at -- we are going to be looking at what a lot of our competitors are doing in terms of looking at the various biomarkers. And we can't disclose a lot about the actual study design.

And our plan is to again, recruit. We finished our Phase II study. We plan to start our study in the U.S. And we'll provide more data around our CF study later on this year -- I mean, early next year.

Yes. Multiple doses are going to be evaluated in the CF study. It's an open-label study. There's no bronchoscopy included in the study. And FEV is going to be measured throughout the study.

But with respect to specific time points and additional details, there will be an appropriate time for us to share that. And that will be at a later time.

We'll move next to Whitney Ijem with Canaccord Genuity.

Firstly, I just wanted to follow up on the commentary around vaccine in Japan and the switch to ARCALIS once approved. Is the idea that when ARCALIS is approved and it's manufactured domestically in Japan, there will be kind of a step-up or an acceleration just as we think about modeling quarter-over-quarter next year?

And then just second question to follow up on OTC.

I think looking back, the -- interim Phase II data had originally been expected in the fourth quarter.

So maybe I missed it, but what drove the shift to the first half next year?

Andy, do you want to address the first question?

Sure, Whitney. No, I think you were spot on there with that assessment. And as you can tell, Meiji and ARCALIS are very proud to obviously be able to manufacture the first SA mRNA vaccine in Japan, and it was pretty evident by the response in the press that were all in attendance, they had over 30 press officials there.

So a pretty well-attended press conference.

And certainly, I think they would probably prefer to launch and articulate that this vaccine is made in Japan, and certainly adding shipments from ARCALIS in December will enable them to articulate that more clearly.

So with respect to probably a more aggressive commercial launch, you could probably anticipate it would happen in December, January time frame, in my opinion.

So if you're looking at the timing of the revenue, probably would happen in probably the first 2 quarters of next year.

And with respect to the OTC data, we did complete dosing in Europe, and there was some early evaluation of some of that data. The data is not locked, and we initiated the enrolling process in the U.S. prior to that process.

So we thought it was wise to just couple these together and provide the interim data update in the first half of next year.

We'll move next to Evan Wang with Guggenheim Securities.

Just a few for me.

Firstly, on KOSTAIVE. Anything you can share on broader vaccination trends in Japan, so not just KOSTAIVE specific? I know that the Japanese season starts later, but has this been in line with Meiji's estimates to support the dose totals for the season?

And also KOSTAIVE, you highlighted kind of recognizing revenue in 2025. Can you remind us some of the reporting here and how Arcturus recognizes some of this revenue?

And then third, on OTC and cystic fibrosis. I'm just wondering, it's great to see the timelines that proof of concept in the first half '25.

Just wondering what gives confidence in some of these timelines. Is dosing and recruitment thus far better than expected? Any additional color there would be helpful.

Sure.

Let's see there.

You had a question about revenues. Do you want to address that one first, Andy?

Sure.

As you could see when -- yes, when Meiji will sell the vaccines in Japan, they will be reporting those sales to CSL on a quarterly basis. CSL then will, in turn, determine the allocation of the profit share between CSL, Meiji and Arcturus. At that point in time, we'll be able to recognize those revenues once that allocation has contributed to Arcturus.

And keep in mind that we do have to offset the initial revenue by the 40% of the production cost that we are responsible for in development of the program.

And so that amount has not been communicated officially. But you can assume that, that would probably incur at least a few million doses before you're able to offset those initial 40% of the development and production cost for the KOSTAIVE vaccine. I hope that was helpful.

And addressing your second -- or question is about the KOSTAIVE trend and the CF timeline. I can comment that the team was in Japan, and we got a really good feel for Meiji's presence in Japan and the vaccine industry.

They have a large sales force. They have approximately 40% of the flu shot business in Japan.

So it was really good to see what kind of materials they're providing to just a large number of physicians in Japan, as you can imagine.

So clearly, there's an educational phase of the launch, teaching people about this next-generation technology. But any additional details in that, it would be more appropriate to just for them to provide with their regular updates on -- with respect to commercial guidance. But I can -- all I can say is that I was very impressed with the management team and the commercial staff there that they really knew what they were doing.

With respect to the CF timeline, the reason we're very comfortable on this is, first of all, if you notice our -- the design of our trial is, I would say, open label. It's not placebo-controlled. There's no bronchoscopy involved or lung brushing, which can deter participants from participating.

And we also have some early data that we've already shared in Phase Ib, including a Class I subject that had some early and promising data.

So I think that data collection is helping us.

We're also working with the CF Foundation. And as we're onboarding a substantial number of sites, I think it's given us encouragement with these preliminary conversations that we should be well on track to deliver some data in the first half of next year.

We'll move next to Myles Minter with William Blair.

Three quick ones, if I may.

The first one is just on the guidance that you'd get the EMA approval milestone from CSL for potential approval of KOSTAIVE in the first quarter of '25. Does that imply that you'd expect to see a CHMP opinion issued at either the November, December meeting by the end of this quarter, first one.

The second one is on the decision to keep the ARCALIS equity stake. Does that mean if Meiji does give additional manufacturing orders of KOSTAIVE to ARCALIS, that's something you could actually report on rather than just pushing back to Meiji for commercial guidance?

And the third question is moving the CF program manufacturing to ARCALIS and having a U.S.-focused Phase II clinical trial. Does that mean you have to get FDA inspection of that facility?

Andy, do you want to provide a first stab?

Sure. No. It's -- we were obviously very encouraged by the opportunity with the early progress we've had in cystic fibrosis.

So obviously, manufacturing and trying to plan strategically a global production base is quite daunting because just to address -- just to give you an idea, just to address the Class I population, you're looking at probably 17 roughly kilograms per year.

And so you need to put together a very well-orchestrated manufacturing base to be able to address all that. And of course, ARCALIS has now become very strategic because of that opportunity. And consequently, they are a very low cost and very efficient operation because, as you know, the drug substance, drug product and D&A is all made there.

And so it's [indiscernible] authorization and the fill/finish.

So having all that in one location reduces a substantial amount of transportation logistical risk, especially with transferring drug substance to Europe for the drug product completion stage.

And so there are many implications and opportunities.

And obviously, as you have just heard the amount of mRNA we're going to need to make for the CF program is quite substantial. And based on just the capacity ARCALIS has now, that's about $100 million a year just for ARCALIS in sales. And that's only considering 2 kilograms out of the 17.

So just to give you the significant impact of this opportunity is pretty substantial.

So we've had to reevaluate our global supply base and working very closely with Aldevron and Danaher, of course, and Catalent and Recipharm and Polymun.

And so this has taken on a very global concerted effort. It's exciting, but it's going to take a little bit of work. And certainly, it makes ARCALIS a much more valuable partner right now, and we need them. And we're kind of excited about working more closely with them on the CF program.

And pertain to EMA approval, we've clearly guided today that we're anticipating a CHMP decision in December. And that obviously precedes a formal approval process shortly thereafter. That takes us into Q1.

So I think your assumption is fair. Did we address all your questions, Myles?

Just a quick one on the second one.

Just with the manufacturing orders that could come to Meiji when the PMDA issue approval in December. If they do that, is that something you as Arcturus would be able to report on if they do indeed receive a bulk manufacturing order for KOSTAIVE?

Yes. The short answer is no. But Andy, yes, go ahead.

Yes. No. We really can't comment on those because that will be up to Meiji and CSL to articulate that.

Of course, we'll give you as much color as we can post quarter. And hopefully, that will enable you to have a better insight as to the ramp-up and the success of the ARCALIS production on a quarterly basis.

We'll move next to Yanan Zhu with Wells Fargo.

This is Kuan-Hung for Yanan.

So I have a question on your CF program. Can you share with us your path for success on FEV1? And also, Vertex Moderna will report their VX-522 Phase I/II data also in first half '25.

So can you remind us the differentiation of 032 versus VX-522?

Yes. It's definitely a wonderfully competitive area, and I think this is great for patients in general in the CF community. But we do have key differentiation elements to our program and our technology compared to our competitive peers.

So thank you for the question.

The first and foremost, we have a different delivery technology that we call LUNAR. But this not only has a different registered trademark, but it's a chemically different lipid nanoparticle that is biodegradable, nonaccumulating. And we believe these chemical differences have proven out to provide differentiated data preclinically.

So we have preclinical data in the [indiscernible] model that has shown that we have a very significant response that supersedes positive control after a single administration.

I think that would be representative of the differentiation I'm speaking to.

We're also sharing data more visibly. We've already provided some Phase Ib data in a Class I subject that has provided some promising early response after these 2 administrations.

And then finally, a purification IP, I think, is a differentiator. And this is a big deal in the therapeutic space when you're dosing chronically and larger amounts of mRNA. It's very important, especially in compromised lungs like the CF patient population, that these mRNA molecules are substantially pure.

And we have a potentially leadership position in this space and with intellectual property behind it that's different. How we purify our mRNAs is likely different than our competitors. But I'll stop there. I could talk for a while, but I think those are the key differentiators.

Right. Got it. And would you mind sharing your thought process on FEV1?

Did you say our expectations around FEV1? What was your question?

Right.

Because we're addressing the -- a patient population where there's substantial unmet medical need, again, these are the nonmodulator responders. It's about 15% to 18% of the CF population.

So we're going after these folks that do not really have an excellent treatment option.

So the barrier for entry, the bar that we need to establish for lung function improvement, I believe, is very small.

We haven't provided any details on that.

And with respect to our conversations with regulatory agencies, for example, we hold those cards close to our chest. But the short answer is anything measurable, I believe it'd be very significant for this patient population.

A small percentage improvement would be very meaningful in our view. But we haven't given that specific number yet. There will be an appropriate time later down the road.

Yes. And FEV quick question on 2303. Congrats on the data. Can you share with us what's the next step for the program? Are you ready to buy? Or what's your strategy?

Oh, 2303, the strategic purpose for these other Phase III trials was just to showcase the breadth of the platform, that the technology can be multi antigenic, for example, in the bivalent trials we're doing. And also in where we're conducting these trials is meaningful because we're collecting an expanded safety database and multiple ethnicities around the world with these additional Phase III trials.

Taking that all together, it helps beef up and support a really strong BLA application in the first half of next year.

So they're strategically important to support the BLA application in the U.S. I don't foresee us marketing these products. The data is used to support the platform of KOSTAIVE in the United States.

We will move next to Pete Stavropoulos with Cantor Fitzgerald.

This is Samantha on the line for Pete. Can you touch on the H5N1 pandemic flu program? If you could remind us on key details for this non-CFO partner program and what to expect?

Thank you. The short answer to that question is we remain on track to get into the clinic this year.

So thank you for the question. H5N1 is definitely important to BARDA.

We do have some BARDA references in our filing documents and our press release and probably the script as well.

You can see that we're elevating our relationship with them, but that stage of getting into the clinic is coming up here shortly.

We'll move next to Ed Arce with H.C. Wainwright.

This is Thomas [indiscernible]. Congratulations on the progress to date.

So first question, wondering what the Phase II data readout for 810 and OTC expected in the first half next year? Which efficacy measurement do you believe has the potential to support approvable endpoints or which efficacy endpoint should investors focus on?

That's actually a really good question. The data we're collecting is not only important to establish proof-of-concept for intravenously dosed mRNA and our platform. But a key part of the OTC strategy is to identify the appropriate biomarker if we choose to advance this into a pivotal trial or a Phase III trial.

So it's not just the data that's important in this first half of 2025, but understanding which of these many biomarkers that we're collecting data on many of them. And we believe we have a strategy that is going to be appropriate for a Phase III or pivotal trial, but we won't be communicating specifically what that biomarker strategy is today. That's something that we can do concurrently with the interim data sharing in the first half of next year.

Got it. And then for the other program, that is partner -- I believe that's partnered with CSL. Are there any updates with the LUNAR flu program? I believe last we heard there's Phase I [indiscernible].

Yes. Good question.

Our CSL collaboration in the flu is a very active one. I'll say that. It's multiple programs are involved. The funding for these programs has been increasing. We're meeting regularly in JSC meetings with CSL.

But with respect to the cadence of data sharing and any sort of commercial strategy on these, we've respectively agreed with CSL that we'll allow them to provide that information.

So all we can say with respect to the flu program is that it's very active.

There's multiple programs, and that funding is increasing for these programs. And it's definitely a priority for our collaboration. But again, how the data is shared and the cadence of that data and any sort of commercial strategy and what it's combined with and the bundling commercial strategies, these kind of things we can't refer to at all.

Got it. One more question from us, this one perhaps for Andy.

Just wonder what's the entire $25 million milestone from Meiji, was that entire amounts recognized in third quarter? Or it's going to be spread over several quarters?

Yes. The $25 million that is recognized, go ahead, Andy, yes.

Yes. Thank you, Joe. Yes, the $25 million is going to be reported just like all of our other development milestones at this point in time on -- and ASC 606 requires that we probably amortize around 90% to 93% of the milestone in the quarter that it was earned. And then the remaining amount is amortized over production to complete method.

And so that allow you to see the accruals on some of the CSL revenues that occur on a recurring basis in our quarter.

So hopefully, that gives you a perspective of what we've recorded here in the quarter.

We'll move now to Yale Jen with Laidlaw & Company.

Great. My first question is that given that 3 parties will be involved in terms of determining the allocations, so should we anticipate any potential royalty from revenue from Japan would be something of next year instead of the last quarter of this year?

Timing of revenue recognition? Yes, go ahead, Andy.

Yes, yes.

I think if you listen closely to what we were articulating, by the time Meiji reports the sale the CSL and then they will, in turn, determine the allocation, you're probably better off assuming that the sale will be recognized in the first half of next year rather than this year.

So hopefully, that gives you some perspective because remember, we also have the 40% of the production cost that we have to absorb before we're able to recognize any revenue.

So I think I would prefer to caution on the conservative side and probably anticipate the first half of next year is a better predicament of when we can see some of those revenues. Hopefully, that helps you.

Yes, it does. And maybe just to tag on one more question, at least on the P&L side. I noticed that this quarter's R&D expenses was lower than the sort of prior 2 quarters. I understand you have changes from the last years, but should we anticipate these a little bit lower R&D expenses will -- presumably will continue? Or how should we think about that?

That's a good question. And one of the reasons why it's so difficult to give quarterly guidance is because of the functionality of when trials are completed and when inventory is shipped.

So that's why I prefer to provide a runway guidance.

And so if you can be reassured that we had restated that our guidance is in the first quarter of '27, so that's remained consistent now for a few quarters.

You can assume that our burn is going to be somewhere around $100 million a year. And if you divide that by the cash we have, that should give you some comfort that we should be easily achieving that first quarter of '27 goal. And keep in mind that it doesn't include any revenue contributions from Japan.

So hopefully, we'll be able to update the market next year on that progress.

Great. And maybe the last question here is that in terms of 2303 combined with the QIV, how should we think about that going forward in terms of these combined vaccines? Would that be something that we should -- CSL will make a decision on the specifics?

Exactly. Yes, yes. We now have the Phase III data to show that non-inferiority or equivalents, right? So CSL will be determining anything to do with commercial strategy and especially with the flu, they provide that, whether it's combos or co-promotions or bundling, anything like that, that will all come from them.

Okay. Great. Congrats on the progress.

Yes. Thank you.

We'll move next to Yigal Nochomovitz with Citi.

I hope you can hear me okay.

Just first of all, could you just clarify $25 million milestone from Japan. Is that accounts receivable? Or is it actually your cash reported at the end of the third quarter?

Go ahead.

Good question. We give CSL about 60 days to pay the bill.

So -- and they've been a pretty good customer.

So I'm not too worried about getting that $25 million. Hopefully, that alleviates your concern about them paying us.

Okay. And then on the manufacturing, I'm just wondering, so you're saying that you're going to transfer the manufacturing of the CF over there. Capacity is left at ARCALIS after including CF on top of COVID.

And do you have -- do they have the capability there to do the fill and finish for the specialization of the CF product, given that it's going to be the nebulized product? Is there anything else that they need to incorporate into the manufacturing chain to do that piece of things?

Is your question on...

Go ahead.

We can go ahead and let Pad answer that if he has any more color on the production.

Yes. Again, the process for making our drug substance for both our CF product as well as our vaccine products are very similar.

So that's the great beauty about messenger RNA.

I think we can use a very similar process for all of the APIs and all of our programs that we're currently having internally. There's obviously nuances related to [indiscernible] product or a frozen drug product. And I think that there is some specific and the components -- exact components that are in our CF products are different than what we're currently using for our vaccines.

So because of that, there is a know-how or a tech transfer process that we have to undergo. But we're confident that, that tech transfer process is going to be fine, and they're capable of making our drug substance.

And ultimately, you asked a question a little bit about fill/finish. They are building out not just drug substance capabilities but also drug product and final fill/finish capabilities as well. And because of that, we're going to be leveraging our partners.

So the product produced for CF in Japan will be the final commercial product, correct?

Yes. That would be the vision of the -- yes.

Okay. And then as far as capacity, I guess the question is what about OTC? Is that something you would consider transferring over there? Or is there the reason you are deciding not to do that? Is it a capacity question...

Relatively small amount.

We can handle that with our current partners, so we're fine there.

Just the demand for the amount of cystic fibrosis mRNA that's going to be required is pretty substantial. I articulated early on a year-over-year basis of 17 kilogram. That's a lot of mRNA.

And as you know, ARCALIS has capacity up to 5 kilograms right now.

So -- and so certainly, there's an opportunity to potentially expand that as we are able to achieve some clinical success with the CF program.

And then last one is, so you have the 4 million doses that you're shipping over there. And then you said another 0.5 million that's going to be made locally in Japan.

So are they basically -- and then at some point, they're all going to go into the channel and then maybe some overlap or potentially. Are they all going to kind of look [indiscernible] from a labeling branding perspective?

Well, they all have the same label. The label is uniform.

And so the excitement here is that ARCALIS is now in the process of producing the KOSTAIVE vaccine. And that's important because the Japanese government has given ARCALIS $165 million to help construct that facility.

So it's a very strategic plan, not only for the Japanese people, but the government to protect the people in any future pandemic that should arise.

And so that, I think, is why the people over there are very excited about this opportunity.

And one thing to correct, Yigal, the 4 million has already been shipped. I just wanted to make sure that was clear.

And with no further questions holding at this time, I'll turn the conference back to Joe Payne for any additional or closing remarks.

Thanks, everyone, for participating on the call. If there's any remaining questions, please don't hesitate to reach out to our team, and we'll get back to you as soon as we can. Thanks, and good night.

Thank you. Ladies and gentlemen, that will conclude today's program. We thank you for your participation.

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