Moderna Q4 2024 Earnings Call Transcript

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Provided by Quartr
February 14, 2025

Key Takeaways

  • 2024 financials: Revenue fell 53% to $3.2 B, resulting in a $3.6 B net loss, while cash and investments rose to $9.5 B by year-end.
  • Cost discipline: Operating expenses were cut by $2.6 B (27%), targeting cash cost break-even by 2028, with 2025 cash costs guided at $5.5 B.
  • 2025 outlook: Total revenue is forecast at $1.5–$2.5 B, GAAP expenses at $6.4 B (capex $400 M), and year-end cash near $6 B, excluding all new product revenues.
  • Respiratory vaccine progress: Moderna now has two commercial mRNA vaccines, reported positive Phase III data in four respiratory programs, and filed next-gen COVID (PDUFA May 31), RSV 18-59 (PDUFA June 12), and flu+COVID combo.
  • Late-stage pipeline: Seasonal flu Phase III efficacy readout expected this season, oncology adjuvant melanoma Phase III fully enrolled, propionic acidemia study shows reduced metabolic decompensations, and MMA pivotal trial starts in 2025.
AI Generated. May Contain Errors.
Earnings Conference Call
Moderna Q4 2024
00:00 / 00:00

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Operator

Good day and thank you for standing by. Welcome to the Moderna Fourth Quarter twenty twenty four Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised, today's conference is being recorded.

Operator

I would now like to hand the conference over to your speaker today, Lavinia Tulipdar. Please go ahead.

Lavina Talukdar
Lavina Talukdar
Senior VP & Head of Investor Relations at Moderna

Thank you, Kevin. Good morning, everyone, and thank you for joining today's call to discuss Moderna's fourth quarter and full year twenty twenty four financial results and business updates. You can access the press release issued this morning as well as the slides that we'll be reviewing by going to the Investors section of our website. On today's call are Stephane Bancel, Chief Executive Officer Jamie Mach, Chief Financial Officer and Stephen Hogue, President. Before we begin, please note that this conference call will include forward looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Lavina Talukdar
Lavina Talukdar
Senior VP & Head of Investor Relations at Moderna

Please see Slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward looking statements. I will now turn the call over to Stephane.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Thank you, Lavina. Good morning or good afternoon, everyone. Thank you for joining us. I will start with a review of 2024. Jamie will present our financial results and outlook.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Steven will review our clinical programs. I will then come back and share key priorities for 2025 before we take your questions. In 2019, we recorded revenue of $3,200,000,000 The team has worked hard to generate cost savings of $2,600,000,000 or 27% down from 2023. We reported a loss of $3,600,000,000 While we are anticipated to end the year with $9,000,000,000 in cash, thanks to the team's work on OpEx, CapEx and also working capital, we ended the year with $9,500,000 of cash and investments at the end. In September 2024, we are now focused on 10 high volume programs for which we expect potential approvals over the next three years, driving sales growth and diversification from our top line from COVID.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

These programs include the respiratory vaccine, next gen COVID, combination flu plus COVID, RAG eighteen to 59 at high risk adults, seasonal flu in late Santenovirus, CMV and norovirus in rare disease, PA, LMMA and in pathology, ILC for adjuvant melanoma. In addition to growing sales growth, the prioritization of these programs will allow us to reduce our R and D expenses in this time frame. From a pipeline standpoint, it was a year of strong progress. In 2024, we became a multiproduct company who we are proud of MOSBIA. Along with Spirox, we now have two commercial products on the market.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

We reported positive Phase III results in four of our respiratory vaccine programs and we filed for FDA approval on vaccine COVID, our combination of two plus COVID and the RAV vaccine for RASK eighteen through twenty nine. And our seasonal vaccine is currently in the Phase three efficacy trial. We also reported additional progress across our programs for this Phase onetwo vaccine against NovoRis, EBV and BV. In oncology, we presented data at major medical meetings in 2024. For IND program in June, we reported positive three year data in adjuvant melanoma for the Phase two trial.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

In addition, for checkpoint program vaccine, mRNA four thousand three hundred and fifty nine, we presented positive Phase I data in September. In rare diseases, we showed positive early safety and clinical data from PMMA. With that, I will hand over to Jamie.

Jamey Mock
Jamey Mock
CFO at Moderna

Thanks, Stefan, and hello, everyone. Today, I'll walk through our financial results for the fourth quarter and full year 2024, providing insights into the key drivers behind our performance. I'll also outline our 2025 financial framework as we continue to optimize our operations and position the company for long term success. Let's begin by reviewing our commercial performance on Slide eight. For the fourth quarter of twenty twenty four, net product sales were $900,000,000 with $200,000,000 in The United States and $700,000,000 outside The United States.

Jamey Mock
Jamey Mock
CFO at Moderna

For the full year, net product sales were $3,100,000,000 at the lower end of our revised guidance. U. S. Sales were $1,700,000,000 for the year, benefiting from a $200,000,000 favorable adjustment related to a prior period return reserve reversal. Excluding this adjustment, sales volume saw a decline compared to last year, primarily due to lower vaccination rates, lower market share and increased competition.

Jamey Mock
Jamey Mock
CFO at Moderna

However, we observe signs of stabilization and believe the COVID market will remain durable over time. Outside The U. S, product sales were $1,400,000,000 aligning with the midpoint of our guidance. This includes approximately $400,000,000 from advanced purchase agreements that will not recur in 2025. The vast majority of our sales were from Spikevax.

Jamey Mock
Jamey Mock
CFO at Moderna

While we launched our second product, EMERESTIA, in the third quarter, sales were only $25,000,000 for the full year. While early RSV sales were limited, we see long term opportunity to expand our presence in this market, both in The U. S. And internationally. Moving on to Slide nine, I will now walk through our financial results for the fourth quarter of twenty twenty four.

Jamey Mock
Jamey Mock
CFO at Moderna

Total revenue for the fourth quarter was $966,000,000 down 66% from the same period last year. As expected, sales were impacted by the earlier launch of our updated COVID vaccine in The U. S. With FDA approval granted three weeks earlier than the prior year. This allowed us to meet demand sooner, shifting a portion of sales into the third quarter.

Jamey Mock
Jamey Mock
CFO at Moderna

International sales were also lower year over year reflecting the ongoing phase out of advanced purchase agreements. Cost of sales for the quarter was $739,000,000 including $45,000,000 in third party royalties, 193,000,000 in inventory write downs and a non cash charge of $238,000,000 from the termination of a contract manufacturing agreement. The contract termination is part of our continued effort to optimize our manufacturing footprint following the strategic resizing initiative launched in 2023 to align with the transition to a seasonal endemic market. While cost of sales declined by $190,000,000 compared to the prior year, lower product sales volume drove cost of sales to 79% of product sales. Excluding the resizing charge, this would have been 53%. R and D expenses in Q4 were $1,100,000,000 reflecting a 20% year over year decline. The decrease was primarily driven by lower clinical development and manufacturing costs across our COVID, RSV, flu and combination vaccine programs. This was partially offset by increased investment in our norovirus and INT programs.

Jamey Mock
Jamey Mock
CFO at Moderna

Additionally, last year's R and D expenses included $120,000,000 upfront payment related to our collaboration with Imadix, which did not recur this year. SG and A expenses for the fourth quarter were $351,000,000 down 25% year over year. The decrease was primarily driven by reductions in purchase services and external consultants as we continue to focus on cost management and operational efficiencies. We recognized an income tax benefit of $64,000,000 in the fourth quarter. Similar to the prior year, the benefit was not material due to the global valuation allowance maintained against most of our deferred tax assets.

Jamey Mock
Jamey Mock
CFO at Moderna

Net loss for the quarter was $1,100,000,000 compared to net income of $217,000,000 in Q4 twenty twenty three. Loss per share was $2.91 compared to earnings per share of $0.55 in the prior period. We ended the quarter with cash, cash equivalents and investments totaling $9,500,000,000 up from $9,200,000,000 at the end of the third quarter. The increase was primarily due to accounts receivable collections. Now let's turn to our full year 2024 financial results on Slide 10.

Jamey Mock
Jamey Mock
CFO at Moderna

Total revenue for the year was $3,200,000,000 a 53% decline from 2023, primarily driven by lower product sales, which I discussed on the prior page. Other revenue contributed $127,000,000 for the year, reflecting grant revenue, collaboration, licensing and royalty revenue. Cost of sales for the full year 2024 was $1,500,000,000 or 47% of net product sales. Excluding the $200,000,000 non cash resizing charge, this would have been 39% and below our previous guidance of 40% to 45%. This represents a $3,200,000,000 decrease from 2023 due to lower manufacturing resizing charges as well as lower inventory write downs and reduced unutilized manufacturing capacity costs, all of which reflect improved efficiency.

Jamey Mock
Jamey Mock
CFO at Moderna

R and D expenses for the year were $4,500,000,000 down 6% from 2023. The decrease was largely due to lower clinical trial and manufacturing costs as well as fewer upfront payments for collaboration agreements. We did, however, purchase two priority review vouchers during the year, which offset some of those savings. For the full year, SG and A expenses totaled $1,200,000,000 a 24% decrease compared to twenty twenty three. The decrease reflects disciplined cost management across the organizations.

Jamey Mock
Jamey Mock
CFO at Moderna

We have continued to build capabilities and bring more functions in house, allowing us to reduce reliance on external consultants while improving operational efficiency. Additionally, these savings were supported by better leveraging digital technology and artificial intelligence to streamline operations. We recorded an income tax benefit of $46,000,000 for the full year compared to an income tax expense of $772,000,000 in 2023. The shift is mainly due to the global valuation allowance we established last year on most of our deferred tax assets, which continues to impact our tax position. Net loss for the year was $3,600,000,000 compared to $4,700,000,000 in 2023 with a loss per share of $9.28 compared to $12.33 in the prior period.

Jamey Mock
Jamey Mock
CFO at Moderna

Moving to Slide 11, we want to highlight the significant reduction in our operating expenses in 2024. On a GAAP basis, cost declined $3,900,000,000 from $11,100,000,000 to $7,200,000,000 Excluding resizing charges of $1,600,000,000 and $200,000,000 for 2023 and 2024 respectively, We reduced operating expenses by $2,600,000,000 compared to 2023, driven by manufacturing footprint resizing, pricing renegotiations, R and D prioritization, volume reductions and a greater use of digital tools to improve efficiency. Additionally, both 2023 and 2024 operating expenses included non cash costs of $900,000,000 and $600,000,000 respectively, related to stock based compensation and depreciation and amortization. If we exclude the manufacturing footprint resizing charges, stock based compensation and depreciation, our defined cash costs were $8,900,000,000 in 2023 and $6,300,000,000 in 2024, representing a year over year decline of $2,600,000,000 To avoid double counting, please note that in 2023, there was approximately $300,000,000 of depreciation and amortization included in the $1,600,000,000 of resizing charges. We are committed to drive additional cost efficiencies in 2025 and beyond by prioritizing investments to support the 10 product launches over the next three years.

Jamey Mock
Jamey Mock
CFO at Moderna

Our 2025 GAAP expenses are projected at $6,400,000,000 in 2025, which includes $900,000,000 of non cash charges from stock based compensation, depreciation and amortization. Excluding those items, we project a cash cost of $5,500,000,000 This represents an approximately $1,000,000,000 year over year reduction from our prior 2024 projection of $6,500,000,000 We are also planning for an additional $500,000,000 of expense reduction in 2026 as we continue to drive efficiencies across all areas of the business. Now let's turn to our financial framework for 2025. We expect total revenue in 2025 to be in the range of $1,500,000,000 to $2,500,000,000 with first half sales of approximately $200,000,000 reflecting the seasonality of our respiratory vaccine business. As discussed with investors in January, our wider guidance reflects the uncertainties in vaccination rates, the competitive market environment, the size of the RSV market and timing of licensure of our factories and product approvals in Australia, Canada and The UK.

Jamey Mock
Jamey Mock
CFO at Moderna

As a reminder, we filed three products to the FDA in 2024 and we are not including any new product revenue in our guidance range. Also, we expect the revenue and R and D expense from our recently announced Pandemic Influenza program to be relatively immaterial in 2025 and is embedded in our guidance.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Positive sales is projected to

Jamey Mock
Jamey Mock
CFO at Moderna

be approximately $1,200,000,000 reflecting continued improvements in manufacturing efficiency and lower expected inventory write offs offset by increased costs associated with the go live of our new manufacturing sites in Australia, Canada and The UK. R and D expenses are anticipated to be approximately $4,100,000,000 as we continue to invest in our late stage pipeline, while maintaining financial discipline. SG and A expenses are expected to be approximately $1,100,000,000 reflecting a continued focus on efficiency while supporting our commercial execution. We expect taxes to be negligible in 2025. Capital expenditures are projected to be approximately $400,000,000 This increase from our prior guidance of $300,000,000 is primarily due to the timing of spend between 2024 and 2025.

Jamey Mock
Jamey Mock
CFO at Moderna

'20 '20 '4 actual capital expenditures was approximately $150,000,000 below our prior guidance. Some of that reduction was attributable to prioritization changes, but the majority of the impact was timing of spend between 2024 and 2025. We expect to end 2025 with approximately $6,000,000,000 in cash and investments. In summary, 2024 was a year of financial discipline and we are well positioned as we enter 2025. We remain committed to managing costs, optimizing our operations and investing in our future growth.

Jamey Mock
Jamey Mock
CFO at Moderna

With that, I will now turn the call over to Steve.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Thank you, Jamie, and

Stephen Hoge
Stephen Hoge
President at Moderna

good morning or good afternoon, everyone. Slide 15 shows the prioritized programs we highlighted at our R and D Day in September. As Stefan mentioned earlier, we are focused on pursuing these 10 approvals over the next three years to drive growth. We've now filed for approval for three respiratory vaccines, our next gen COVID vaccine, our RSV vaccine for high risk adults ages 18 to 59, and our flu COVID combination vaccine for people age 50 and older. Most of the other seven prioritized programs are in pivotal studies and the remainder are expected to begin their pivotal studies in the near future.

Stephen Hoge
Stephen Hoge
President at Moderna

Slide 16 highlights the most recent updates from our late stage portfolio. As a reminder, in September, we presented positive efficacy and immunogenicity data from our next gen COVID vaccine mRNA twelve eighty three. We have since filed for approval in multiple jurisdictions and have a PDUFA date of May 31 in The United States. Also in September, we shared positive Phase three data for RSV vaccine in high risk adults ages 18 to 59. This vaccine has also been filed for approval in multiple countries with a PDUFA date of June 12 in The United States.

Stephen Hoge
Stephen Hoge
President at Moderna

For our combination flu COVID vaccine, we previously shared positive Phase three immunogenicity and safety data, and on the basis of that data, we filed for approval at the end of last year in The United States and other countries. We've previously demonstrated efficacy for the flu for the COVID component of the vaccine. Demonstration of efficacy for the flu component may ultimately be required for approval. To that end, our standalone flu vaccine mRNA ten ten is currently in a Phase three efficacy study that is accruing cases rapidly. Based on the current case of case accrual, we are optimistic that we will be able to conduct the first analysis of efficacy for our flu vaccine at the end of the current season.

Stephen Hoge
Stephen Hoge
President at Moderna

Now turning to our non respiratory portfolio, starting with our latent and other virus vaccines. For our CMV vaccines, we announced last month that the Data and Safety Monitoring Board informed us that the early efficacy criteria was not met and recommended that the study continue to its final analysis. We remain blinded to the study and continue to expect the results for the final analysis later this year. Our norovirus vaccine Phase three study is fully enrolled in the Northern Hemisphere and we are preparing to enroll participants for the upcoming Southern Hemisphere season. The trial is currently on FDA clinical hold in The U.

Stephen Hoge
Stephen Hoge
President at Moderna

S. Following a single case of Guillain Barre syndrome, which remains under investigation. Given that enrollment had already completed for this season, we do not currently expect any impact on timelines while we complete the investigation and update trial documents with this information. In oncology, we and our partner Merck have multiple late stage studies underway evaluating INT or mRNA-four thousand one hundred and fifty seven in combination with KEYTRUDA. The first of which, adjuvant melanoma is part of our 10 prioritized program.

Stephen Hoge
Stephen Hoge
President at Moderna

The Phase III for this is now fully enrolled. Two additional Phase III studies are underway in non small cell lung cancer and there are two randomized Phase II trials ongoing in high risk muscle invasive bladder cancer and adjuvant renal cell carcinoma. In rare diseases, propionic acidemia or PA is in its registrational study and methylmalonic acidemia or MMA, we have with MMA, we have agreed with FDA on our pivotal study design and expect to start that study in 2025. With that, I'll now hand it back to Stefani.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Thank you, Stephen and Jamie. For 2025, we have three priorities. Priority one is to wrap sales of approved products. Priority two is to focus on our late stage pipeline, where we believe we have up to 10 product approvals over the next four years, which will drive sales growth and diversification. Priority three is to deliver cost efficiency across the business.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Let me take you through each of these. Our first priority is to drive you the SPACVAX mRNA vaccines. Importantly, we entered 2025 with two approved products, which gives us a better competitive positioning than when we entered 2024. We are closely on RMB contracting in The U. S.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

We expect to better compete in the respiratory vaccine market. In addition, upcoming MResVIA approval outside The U. S. Should also add to sales in 2025. Priority two, we are focused on delivering up to 10 products a per row over the next four years, which we believe will drive sales growth.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Together, these 10 anticipated products target a total addressable market of over $30,000,000,000 Priority three, there is a cost efficiency across the business. We've demonstrated our commitment to cost savings by the $2,600,000,000 cost reduction we made in 2024. We will continue to focus on improving efficiency by reducing costs across the entire company, across manufacturing, across R and also D and across SG and A in 2025 but also in 2026. For efficiency program, we're reducing cash costs to an estimated 5,500,000,000 in 2025 and $5,000,000,000 in 2026. This brings our total cash cost reduction towards a well over $1,000,000,000 over these two years from from a $6,200,000,000 in 2024.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

We will continue to adjust our cost structure to ensure we breakeven on a cash cost basis no later than 2028. In November, to be very clear, if needed, we will reduce our cost structure further than the $5,000,000,000 cash cost level if our sales objectives are not met. For last of the same product products, we expect important milestones. We filed three deals of CME to look forward to having the final result of Phase three study in 2025. Fluentorovar vaccine line Phase three studies and the timing of data with that will be suggested to KVACROL.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

For the ITC pacificatement, we will also be subject to KVACROL. For PA, we're already joining data from our registration study and we expect to start registration study for MMA this year. We will continue to focus on delivering the greatest possible impact to people pre mRNA medicine. Our portfolio of products and pipeline are progressing well. To approve products, pre PS5 and six Phase three, our pivotal study is ongoing.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

So our money platform is working. We've demonstrated progress in our cost reduction program. We have shown that with the financial discipline to achieve our goals and fulfill our mission. With this operator, we'll be happy to take questions.

Operator

Thank you. Our first question comes from Ellie Murrell with UBS. Your line is open.

Ellie Merle
Ellie Merle
ED - Biotech Equity Research at UBS Group

Hey, guys. Thank you for taking the question. Can you help us understand the breakdown of the R and D spend across your program? So if you needed to or wanted to reduce R and D spend further, how much flexibility is there on the expense structure there for say further cuts in the 2026 timeframe? And then just a second question on the clinical hold on norovirus, can you give any more detail around sort of this, why one case of GBS prompted the clinical hold? And yes, any more color surrounding the situation there would be helpful. Thanks.

Jamey Mock
Jamey Mock
CFO at Moderna

Yes. Thanks, Ali, for the questions. Maybe I'll address the first one on R and D. So we still think there's a lot of room to be reduced and a lot of flexibility. So as a reminder, we're guiding $4,100,000,000 for 2025.

Jamey Mock
Jamey Mock
CFO at Moderna

And in R and D, we said we would take it down by $1,100,000,000 from the $4,800,000,000 level by 2027. So that suggests a number of about $3,600,000,000 3 point 7 billion dollars To answer your question on what we're spending on, that's still backed primarily over 50% of our trial spend and therefore overhead is related to respiratory trials, which as you know, we expect to roll off over this year and the following year. And then the only other Phase III trials that we've started are in latent disease and oncology for norovirus and CMV and INT and we expect those to be reduced over the coming years as well. So, we expect that there will be some flexibility beyond the $3,600,000,000 that we've already indicated. But right now, we're still monitoring the sales line, but that is an area that we could continue to reduce if need be.

Stephen Hoge
Stephen Hoge
President at Moderna

And thank you for the second question.

Stephen Hoge
Stephen Hoge
President at Moderna

I'll take it. So just a little bit of context, as you alluded to, GBS does happen obviously in the background population. It's usually seen in older adults about one to two per one hundred thousand participants per year or people per year. And given we've enrolled well over 250,000 participants in studies over the last couple of years, it wouldn't be surprising to see cases in our clinical trial as you suggested. And although that hasn't been associated as a risk factor with our approved vaccines, this is something that does happen.

Stephen Hoge
Stephen Hoge
President at Moderna

As it relates to this case, when we identified it, we proactively decided to pause our activities and update our study documents because we prioritized patient safety and obviously transparency first and foremost, and we wanted to make sure that all that information was shared as soon as the case emerged. We submitted those for review with regulators globally, and the FDA has placed us on a clinical hold while they review that information in those documents. Perhaps most importantly for study conduct, because we had enrolled and dosed everybody prior to the emergence of this case in the current season study, we really don't expect there to be any impact on the conduct of the study or its timelines for readout on efficacy which will ultimately be case driven. So from our side, this is just about being prudent and transparent and making sure that we're prioritizing patient safety.

Ellie Merle
Ellie Merle
ED - Biotech Equity Research at UBS Group

Understood. Thank you.

Operator

Our next question comes from Gina Wang with Barclays. Your line is open.

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

Thank you. Maybe I just follow-up on the norovirus. What would it take for the FDA to remove the clinical hold? What kind of outcome that would deem to be okay? And then relate another question regarding the CMV.

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

Now we should see more events accrue. Will it still happen in the first half twenty twenty five? Should we see the final readout?

Stephen Hoge
Stephen Hoge
President at Moderna

So, Gina, it broke for just a second. Could you repeat the CMV portion of the question?

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

Sure. CMV, since now we've seen additional months of events accruing, should we still be able to see the final redial in the first half twenty twenty five?

Stephen Hoge
Stephen Hoge
President at Moderna

Thank you. So I think so I'm going to deal with that first. So yes, we continue to accrue cases in the CMV trial. As I said, we remain blinded to the interim analysis. We still do expect that result in 2025.

Stephen Hoge
Stephen Hoge
President at Moderna

I don't know that we've got into the specific timing, but we still do expect the result in 2025. As it relates to the norovirus clinical hold, obviously, I think the FDA needs time to review the materials we've submitted. They may come back with some questions. If they do, we'll answer those. But as has been suggested, even in the question, a case of GBS is not necessarily unexpected. And because we've updated the documents, we really do expect there to be minimal impact on trial conduct at this point.

Stephen Hoge
Stephen Hoge
President at Moderna

But it will be ultimately up to the agency what they need to see before we move forward with further enrollment.

Gena Wang
Gena Wang
MD - Biotech Equity Research at Barclays

Thank you.

Operator

The next question comes from Michael Yoo with Jefferies. Your line is open.

Michael Yee
Managing Director at Jefferies LLC

Hi, thanks. Good morning. We had two timing questions for you guys. First on the INT cancer vaccine, which of course is a really exciting product. I think previously if you've done some math on the Phase two, it's certainly possible on the event rates that were seen in Phase two that the data could come by end of year or first half of twenty twenty six and the company has not totally dissuaded us or others from that type of timing.

Michael Yee
Managing Director at Jefferies LLC

Do you generally agree with that timing? And can you shed some light on how to think about the powering for the INT cancer vaccine primary endpoint? And then similarly with the norovirus, I think you mentioned that you're enrolling the Southern Hemisphere, but completed the Northern. Do you need both to hit the primary or to hit the event rate? And just help us understand the timing of that despite the fact that it's on hold, the Northern which already completed enrollment? Thank you.

Stephen Hoge
Stephen Hoge
President at Moderna

Thanks for the question. So first on INT, there are some differences between the study population between the Phase II and the Phase III. And so we will want to be guided by the actual event accrual, a case accrual rate, the relapse rate in the Phase III study before we feel confident that we could offer a timing on that. And so as we have started to accrue cases, the study, as you know, is fully enrolled, so there are going to be events that start to happen. We'll have a better sense of that.

Stephen Hoge
Stephen Hoge
President at Moderna

Certainly, 2026 seems plausible, but whether or not it could be on the early side of that or the late side of that, we just don't know at this point it is event driven. And so more as we have information in the future. On the question of Norovirus, so we have we fully enrolled and fully dosed the Northern Hemisphere study, which is the majority of the study, but given epidemiology, we also wanted to enroll some participants in Southern Hemisphere geographies. At the end of the day, we will also be case driven. So you ultimately need cases of norovirus towards that efficacy endpoint because the majority is the sizable majority of the studies is completely enrolled now.

Stephen Hoge
Stephen Hoge
President at Moderna

But the Northern Hemisphere is completely enrolled, which is the majority of the participants we intended. It's possible that we won't need Southern Hemisphere participants, but we do intend to enroll Southern Hemisphere because we want broader epidemiology towards that final endpoint. So again, we don't know when that will happen. We do currently hope that we're sufficiently powered in this season to CFC. But if more participants are needed, then of course we will enroll them to accrue more cases towards that efficacy endpoint.

Michael Yee
Managing Director at Jefferies LLC

Got it. Thank you guys.

Operator

Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Salveen Richter
Salveen Richter
Biotechnolgy Equity Research at Goldman Sachs

Good morning. Thanks for taking my questions. Could you help us understand what the clinical bar is for the norovirus program? And then on the INT portfolio, will we get any data or just enrollment updates for the programs beyond melanoma? Thank you.

Stephen Hoge
Stephen Hoge
President at Moderna

So the on the clinical bar for norovirus, obviously, there are other vaccines out there for gastrointestinal infections, rotavirus and others, where we will want to show a meaningful decrease in the rate of moderate to severe gastrointestinal symptoms. Those are really where the burden of disease happens, particularly in higher risk populations like older adults or the immunocompromised. We'll look at a pretty broad range of endpoints as secondary and exploratory endpoints as well, things like hospitalization, utilization of healthcare services. We have not disclosed our target product profile for that yet or the powering assumptions we have in those interim analyses. And so I won't do that here, but we will perhaps in the future provide an update on that.

Stephen Hoge
Stephen Hoge
President at Moderna

But we will be looking for a meaningful reduction in the rate of moderate to severe acute gastroenteritis. As for INT, obviously, we're all looking forward to the melanoma adjuvant melanoma Phase three readout. As you know and as I mentioned, there are additional Phase IIIs as well as two randomized Phase IIIs, including bladder cancer and renal cell carcinoma, which depending on the rate of approval of events, could have readouts that we would be updating on as well in the coming years.

Operator

Thank you. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Hi, thanks for taking the question. Maybe a two part for me. Just wondering if you can confirm if you still have not seen any cases of GBS with your RSV vaccine. And then I know you filed for approval for the COVID flu combo vaccine and it sounds like now you're waiting for some vaccine efficacy data. Can you tell us anything more there about what the bar is?

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Is it only on the flu side or do you need vaccine efficacy for both COVID as well? And kind of what level of protection you need to see? Thank you.

Stephen Hoge
Stephen Hoge
President at Moderna

Thanks for both questions. So first I can confirm that GBS has not yet or has not been identified as a risk factor for RSV vaccine or our COVID vaccine spike vax to date. And so obviously, we'll continue to track that closely, but that's encouraging. On the COMLA study, so we have demonstrated efficacy for the COVID component. As you may remember, mRNA twelve eighty three had a successful efficacy study that we announced last year, and that is the COVID component of the combination vaccine, and so it does satisfy that requirement. As for the flu vaccine, we have had multiple Phase three readouts in our flu vaccines as well as for the combo vaccine demonstrating non inferior or superior immunogenicity and good safety profile for those I think, but we have not yet demonstrated efficacy for the flu component of that vaccine. That trial, as I mentioned, is actually ongoing right now.

Stephen Hoge
Stephen Hoge
President at Moderna

And given that it is a robust flu season in the Northern Hemisphere, as many folks know. And given the case accrual rate we see there, we do expect that we'll we're actually quite optimistic we'll be able to conduct the first in immunosupp efficacy at the end of this current season. And so that would then be the demonstration of efficacy for the flu component of the COMBOVEX.

Operator

Thank you. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Tyler Van Buren
Managing Director, Senior Biotech Equity Research Analyst at TD Cowen

Hey, Hey guys, thanks for the update and for taking the question. Regarding CMV, just to confirm, even though the criterion for early efficacy was not met at the interim, is it still possible that a higher vaccine efficacy threshold from the first interim could still be reached with the final analysis due to a wide confidence interval with fewer patients at the time of DSMB review or do you think that's less likely?

Stephen Hoge
Stephen Hoge
President at Moderna

Thanks, Scott. Good question. So, what we if you look at the power that we had at that first interim analysis, it actually was intended as an early look, but not sufficiently power that you would have high compounds if it was in between efficacy.

Stephen Hoge
Stephen Hoge
President at Moderna

And for that reason, it is still very much possible that at the final analysis with many more cases, the confidence interval narrow and what we see is a point estimate for efficacy that is favorable from our perspective meets or exceeds our expectations for the target practical trial. The most important thing to say though is that we remain completely blind to this. All we know is that the confidence interval did not exclude the lower bound target and given the powering of the study for that interim analysis that's not necessarily surprising, stopping for early efficacy, early criteria and would have been an upside scenario in our view. So we remain blinded. We will accrue the full number of cases. We continue doing those in that study and then we'll look to that final analysis, which is actually the fully powered analysis for assessing against our target product profile.

Operator

Thank you. Our next question comes from Luca Issey with RBC Capital. Your line is open.

Luca Issi
Luca Issi
Senior Biotechnology Analyst at RBC Capital Markets

Great. Thanks so much for taking my question. Maybe Stefan, big picture, we all know that you have worked very closely with the Trump administration during the pandemic. But have you talked to either the President, RFK or any of their representatives this time around? If so, what has been the message that you have been hearing from them?

Luca Issi
Luca Issi
Senior Biotechnology Analyst at RBC Capital Markets

I think any color there would be much appreciated. And then maybe second, Stephen, on norovirus, can you just talk about the timing of the GBS case? Is that something that occurs soon after the individual received the vaccine or maybe many months after that? I'm just trying to understand the correlation versus causation here. So again, any color much appreciated. Thanks so much.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Thank you for the question. So as you know, we work productively with the Trump administration in President Trump's first mandate. And we look forward to working with a new team as they get confirmed by the Senate and the different members. Vaccines are a very important piece of keeping people healthy and we look forward to having those discussions as people get confirmed. Stephen?

Stephen Hoge
Stephen Hoge
President at Moderna

Yes. And as on the Novartis cases, as you probably will note, we've enrolled about 20,000 participants in that study in just the last couple of months. It's all been relatively rapid enrollment for the current norovirus season. For that reason, you can imagine that it's relatively proximal, which is why we're being cautious in communicating around it, first and foremost with participants, investigators and regulators, just so they have that information. Now to the point of correlation versus causation, it's important to note that in this case there are these extremely rare events that do happen. It's very hard often to finally determine causal relationship. And so other than reporting it that it happened around this time and investigating it thoroughly and communicating about it, we may never have an answer beyond that. But, yes, out of respect for the confidentiality for that participant and more generally, I don't think I would offer any more information about it other than we continue to investigate it and see if what the potential causes would be.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Got it. Thanks so much.

Operator

Our next question comes from Corey Koslov of Evercore ISI. Your line is open.

Analyst

Hi, this is Adi on for Cory. I wanted to ask on what possible changes have you seen in the past month that has caused the bump to expense guidance already?

Jamey Mock
Jamey Mock
CFO at Moderna

To expense guidance, Adi?

Analyst

The increase in R and D and SG and A spend?

Jamey Mock
Jamey Mock
CFO at Moderna

I think so I don't know if it's a bit confusing. So we've been basically talking about two different sets of numbers, neither have changed. One is our GAAP cost, Sadi, and one which includes stock based compensation and depreciation and amortization. So maybe that's what you're referring to versus what we define as cash costs, which excludes those two numbers, which have not changed. And as a reminder, those numbers were close to $9,000,000,000 in 2023.

Jamey Mock
Jamey Mock
CFO at Moderna

We had $6,300,000,000 in 2024. We're guiding to $5,500,000,000 in 2025 and $5,000,000,000 in 2026. So perhaps you're looking at the GAAP inclusion, but we have not changed any estimates from our cost.

Analyst

Got it. And I had just one more follow-up. If you can provide any more color on the language of the PA program, the PR at JPM and today's PR suggests potential decrease in MDE frequency, wanted just some additional color on it?

Stephen Hoge
Stephen Hoge
President at Moderna

Yes. Thank you for that. So on the as we had previously disclosed from our ongoing clinical trial there, we have seen a significant a substantial decrease in the rate of metabolic decompensation events in that, propionic acidemia PA study. And we believe and ultimately have agreed with regulators that that is the endpoint that we will assess for the pivotal part of that study. We've moved forward into that pivotal phase.

Stephen Hoge
Stephen Hoge
President at Moderna

So what we'll be looking at is the rates of metabolic decompensations or MDEs for participants prior to being on drug versus once they start treatment with that medicine. That rate and the reduction in it will ultimately be, we believe, the pivotal endpoint that would support registration for the drug for PA. And so as we move forward with new participants, as well as some older other participants who are already on the study, we'll be looking at that comparison on reduction in the rates of MDEs.

Operator

Thank you. Our next question comes from Courtney Breen with Bernstein. Your line is open.

Courtney Breen
Senior Research Analyst at Bernstein

Fantastic. Thank you so much for taking the call today or taking the question today. I want to kind of pivot a little bit to some of the costs as well and specifically the inventory write downs. I think they continue to be an issue for kind of seasonal vaccines. We have to produce in advance and then see the season play out.

Courtney Breen
Senior Research Analyst at Bernstein

I would love to understand a little bit more about what the future looks like in this space. You're going to continue to be in a seasonal market kind of both with COVID, now with flu and with RSV. And so as we think about kind of projecting and manufacturing appropriately to minimize those write downs, but maximize the opportunity. What does good look like? Number one, kind of what is the goal in terms of limited inventory write downs?

Courtney Breen
Senior Research Analyst at Bernstein

And number two, kind of what are the things that you're changing to kind of continue to improve your ability to make to the right amount?

Jamey Mock
Jamey Mock
CFO at Moderna

Yes. Thanks for the question, Courtney. It's a great one. So as you know, maybe just a step back, twenty twenty three, I forget what the numbers are, but we reduced this dramatically already. But nonetheless, we did have $500,000,000 of inventory write downs in 2024 and about $100,000,000 of unutilized manufacturing capacity.

Jamey Mock
Jamey Mock
CFO at Moderna

And so at $600,000,000 on March of sales, that is obviously not what good looks like yet. What I will say is much of this is related to our raw materials where we take a inventory reserve based on future demand. And if you look at our inventory levels now, Courtney, we are under $300,000,000 I think $270,000,000 So the go forward should look much better as we project moving forward on the raw material side. On the excess capacity side, you're right. We still have a fair amount of either write offs of good product that we produce because we produced last year, for example, we assumed $4,000,000,000 in sales and we came in at $3,000,000,000 so we obviously overproduced.

Jamey Mock
Jamey Mock
CFO at Moderna

And we are still going to produce to the higher end of our guidance range of $1,500,000,000 to $2,500,000,000 which is why you see a cost of sales in the neighborhood of 50%. But as we get better, what we're working on is matching what does that future demand look like and what is the supply that we should account for. And as an example, as we've continued to adjust for that, that's simply the example of the termination of a contract manufacturing agreement that we had in the fourth quarter. So we continue to be proactive about what is that future demand, what is the capacity we require and you should see that come down. And certainly $600,000,000 on $3,000,000,000 is not what we expect.

Jamey Mock
Jamey Mock
CFO at Moderna

We want that to be less than 10%, let's say, over time. But I'm not saying that that will happen in the year 2025, but it will get better also because our inventory balance is down dramatically.

Courtney Breen
Senior Research Analyst at Bernstein

Thank you.

Operator

Our next question comes from Edward Jenoff with Piper Sandler. Your line is open.

Edward Tenthoff
Edward Tenthoff
Sr. Research Analyst at Piper Sandler Companies

Great. Thank you very much. Most of my questions have been answered, but I think I saw some news maybe on the Vertex CF program. And I was wondering if you could just kind of give us an update on what's going on there with that rare disease program. Thanks.

Stephen Hoge
Stephen Hoge
President at Moderna

Yes. So thank you for the question, Ted. So we continue with our partner, Vertex, who is conducting that clinical trial. So they're the sponsors for the study and have the most information on it. But we continue down the path of we've completed the single ascending dose portion of that trial and are now in the multiple ascending dose portion of that trial.

Stephen Hoge
Stephen Hoge
President at Moderna

That is patients receiving treatment regularly to ultimately measure whether or not we're having an effect on respiratory measures and hopefully overall addressing the burden of CF in those patients that can't take the small molecule correctors. We do expect a readout from that multiple ascending dose trial. I think Vertex previously guided that we expect that this year and we will look for them to provide further updates on that timing if they happen.

Edward Tenthoff
Edward Tenthoff
Sr. Research Analyst at Piper Sandler Companies

Great. Thanks, Steven.

Operator

Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Hey, guys. Good morning. Thanks for taking my questions. I had a few follow ups for Steven just from prior questions I was hoping to clarify the response on. On norovirus, how confident are you that the trial will not go on some equivalent of clinical hold in the Southern Hemisphere?

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Have other global regulators confirmed they do not need a pause to review the information or is there a chance of stoppage there? For CMV, just following up on Gina's question, I think in the past you had said the final CMV analysis could come near months after the interim, which we heard about in January. So should we still think of that as the first half of twenty twenty five or can you clarify the prior answer? And then on the October COVID flu filing, I think the press release states that approval may require vaccine efficacy data from the Phase three flu trial. Why is that a point of uncertainty that the FDA may require it?

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Has it been up and clear with you in your pre submission meeting? And then lastly for Jamie, can you recap what variables in the COVID vaccine and RSV markets would land you at the low end or the high end of your 2025 guidance like price vaccination rates, market share, stuff like that? Thank you.

Stephen Hoge
Stephen Hoge
President at Moderna

So last there for me. So I'll go first and then kick it to Jamie. So first on the Northern Hemisphere and this norovirus study, as we said, we will look to enroll a second season in Southern Hemisphere. At present, we do not expect any delays in doing that. Given that we have enrolled over 20,000 participants in that study already in Northern Hemisphere, If there were any delays, we're not sure that it would have an impact to study timeline.

Stephen Hoge
Stephen Hoge
President at Moderna

But at this point, we're as confident as we can be that there won't be any delays in Southern Hemisphere. As it relates to CMD on case accrual, the second half we have previously said that case accrual was moving relatively quickly. It continues to accrue steadily in the study. Ultimately, it's an event driven analysis, so we can't necessarily predict the time line, but we previously indicated that we expected it perhaps mid-twenty twenty five. We're not changing that here.

Stephen Hoge
Stephen Hoge
President at Moderna

We continue to believe that that's possible. And ultimately, again, it will depend upon the rate of case approvals, which we don't control. As it relates to ten eighty three, and so for the flu COVID product, When we submitted the package, as part of our initial exchange with regulators, we are identifying review questions that they have or issues. And as we said in our press release, in some cases, the proximity of the flu efficacy readout really does loom large on the overall review for the combination product. And we will be we do expect that that may be necessary in some cases now that flu efficacy readout is expected shortly.

Stephen Hoge
Stephen Hoge
President at Moderna

As it relates to individual conversation with individual regulators, I'll say we're working through their review questions in that submission and I won't otherwise comment on those specific back and forths. And with that, I guess, I'll turn it over

Jamey Mock
Jamey Mock
CFO at Moderna

to you, James. Okay. Thanks. So thanks, Jeff. Yes, as a reminder on the high end, the $2,500,000,000 if you exclude the unusual as we saw in 2024, we call that essentially flat.

Jamey Mock
Jamey Mock
CFO at Moderna

So in my prepared remarks, The U. S. Came in at $1,700,000,000 It had a $200,000,000 return reversal adjustment from the prior year, which would take that to about a $1,500,000,000 number. And then outside The United States, we were at $1,400,000,000 and we said that there was about $400,000,000 of advanced purchase agreements that the demand level we do not anticipate repeating. So the high end is essentially flat, yes.

Jamey Mock
Jamey Mock
CFO at Moderna

So you can anticipate both inside U. S. And outside U. S. Similar market share, vaccination rates.

Jamey Mock
Jamey Mock
CFO at Moderna

We do have a little bit of uptick in RSV in the high end, but it's altogether rather minimal in general. On the low end, it basically assumes not no increase in RSV. On in The U. S, you would have to expect it to go down substantially. So you'd have to expect it to go down 5% to 10% from a market share perspective.

Jamey Mock
Jamey Mock
CFO at Moderna

Vaccination rates would have to go down again seven percent

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

to ten percent. Both of those things would have to happen

Jamey Mock
Jamey Mock
CFO at Moderna

to go down, let's say $500,000,000 And then really the biggest factor outside The United States are the licensure timing of our plants in The UK, Canada and Australia. So should those be licensed and registered on time, we will be on the upper end, but if they are delayed, we've factored that into the lower end of our guidance.

Jessica Fye
Jessica Fye
Managing Director & Equity Research Analyst - Biotechnology at JP Morgan

Very helpful. Thanks.

Operator

Our next question comes from Simon Baker with Redbird and Lyth. Your line is open.

Simon Baker
Partner at Redburn Atlantic

Thank you for taking my question. There's also a clarification. Jamie, you mentioned the spend on respiratory trials being 50%. Was that 50% of your total trial spend or 50% of your R and D spend? And then just another question on the flu COVID combo following off from Jessica's question.

Simon Baker
Partner at Redburn Atlantic

I just interested to know what the mechanism is and the timing at which point the regulators could ask for that extra data. Is this something that could come at any time? If it happens sooner rather than later, do you think it would have an impact on the approval timeline? And is there any risks in The U. S.

Simon Baker
Partner at Redburn Atlantic

That the initial filing gets a complete response and then you have to refile with that COVID data? Any color on the machinations of that would be very handy. Thank you.

Jamey Mock
Jamey Mock
CFO at Moderna

Yes, thanks Simon. On the first one, I was referencing 50% of the trial expense, which is what we break out in our 10 ks. There are other line items that hit RMB in terms of the overhead that supports it, people, the sites, etcetera, our manufacturing facilities, as well as research. But the 50% that I was referencing is really trial related, but you could imagine many of those other costs are also related, therefore, to the respiratory trials as well.

Stephen Hoge
Stephen Hoge
President at Moderna

Yes. Thank you. And so for the clarifying question, again, we have filed in multiple geographies and I won't comment on individual regulatory exchanges. But generally speaking, we as a part of the initial round of questions and feedback that we're receiving, there are instances where we think we will be dependent upon that efficacy data from the 10/10 study, which we do expect in the coming months, the current season, to be available. The timing of that readout and the impact on the review process for regulators is not something I can predict at this point, but we're in active discussion with regulators about it.

Stephen Hoge
Stephen Hoge
President at Moderna

Certainly, it is possible that if that is substantially delayed or if it is not a favorable efficacy readout that it could for sure delay or impact the timeline to approval for the combination product. If we are able to complete that submission, get that data to regulators and they're able to conduct that review, it's possible that we continue with that review without substantial delay. Ultimately, we don't know at this point, because it will depend upon those submissions and discussions with regulators that we're having right now. But we did want to flag that we do think based on some of the initial conversations that we may be dependent upon that data ultimately for approval with some in some geographies.

Simon Baker
Partner at Redburn Atlantic

Right. That's very helpful. Thank you.

Operator

Our next question comes from Myles Winter with William Blair. Your line is open.

Myles Minter
Research Analyst - Healthcare at William Blair

Hi. Thanks for taking the question. Just one on potential ACIP recommendation review for RSV vaccines. Do you expect that here in February or the June meeting? And is there anything built into the top end of that $2,500,000,000 revenue guidance for Resvir that would require a widening of that recommendation that it currently stands? Thanks very much.

Stephen Hoge
Stephen Hoge
President at Moderna

So I'll take the first question on timing. We are obviously working closely with public health officials on the widening. We filed for approval for the eighteen to fifty nine high risk population. At this point, we are not yet approved. And so from a broader sort of engagement with ACIP perspective, we'll wait for approval before we do that too broadly.

Stephen Hoge
Stephen Hoge
President at Moderna

We do expect that the benefit risk is favorable for RSV vaccines including MRZVF and so do look forward to expansion of the recommendation to cover high risk populations, both the fifty to fifty nine, which have previously been discussed, but ultimately, hopefully, 18 plus high risk populations.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

And Jamie, I don't know if you'll take the time.

Jamey Mock
Jamey Mock
CFO at Moderna

Yes, sure. Yes. So Miles, as I mentioned in Jess' question, we have a little bit of growth in RSD. But I also mentioned that we have nothing related to new product approvals in our guidance for 2025. So that doesn't include the next gen COVID vaccine or what Stephen just talked about, about the expanded indication related to RSV or anything from a combination approval should it happen.

Myles Minter
Research Analyst - Healthcare at William Blair

Right. Thanks.

Operator

Our next question comes from Tim Anderson with Bank of America. Your line is open.

Tim Anderson
Tim Anderson
Managing Director, Senior Equity Research Analyst at Bank of America

Thank you. So if I could just go back to that very last point on your 2022 revenue guidance, you're not including any new products, makes sense for RSV because that would be tiny, makes sense for the combo product because of the reasons that you've outlined. But why wouldn't the next gen COVID product be included in guidance at this point given that the PDUFA date is not very far away May. It's a well characterized paradigm having COVID vaccines out there. I'm just wondering if that lack of inclusion guidance anticipates some uncertainty about approval, given the new administration coming in and this common thread of kind of an anti COVID stance across lots of people from the Trump administration?

Tim Anderson
Tim Anderson
Managing Director, Senior Equity Research Analyst at Bank of America

And then second question on norovirus, if you're fully enrolled, what does FDA gain by putting the program on clinical hold? Is that just a forced disclosure of that adverse event to the clinical and patient community? Or is there some other reason why they would do this?

Jamey Mock
Jamey Mock
CFO at Moderna

Yes, Tim, thanks for the question. Maybe I'll take the first one. So I don't think there's much to read into here. I think we've learned our lesson coming into 2024 in terms of guiding with a product that has yet to be approved. So moving forward, we have eliminated any products.

Jamey Mock
Jamey Mock
CFO at Moderna

Of course, there could be upside, but I think we approach our guidance understanding that there is variability and therefore we will not put the any revenue related to the next gen COVID or any of the other two products as well. And again, I don't think there's anything else to read into as a result of that.

Stephen Hoge
Stephen Hoge
President at Moderna

Yes. So, another question of norovirus. So importantly, we have already proactively communicated around this to all the investigators and IRBs and regulators around the world. So that communication has happened. And actually we've updated all the documents that would be necessary to sort of broadly identify this.

Stephen Hoge
Stephen Hoge
President at Moderna

So the purpose for the clinical hold, ultimately, we'd have to anticipate or ask the FDA that question. I mean, at this point, they're appropriately and we think prudently and conservatively reviewing the documents and making sure that all of their questions are answered around this. It does not impact from our perspective right now in the Northern Hemisphere study conduct. And so, we'll look forward to engaging with them answering those questions, hopefully completing that review, removing that whole. But as we said, we will not then reinitiate any enrollment because we now have 20,000 participants in the Northern Hemisphere, which is more than we feel like we need.

Stephen Hoge
Stephen Hoge
President at Moderna

And so, we'll just answer those questions and move forward. But I really couldn't offer any other insight around it, but it certainly isn't around transparency communication because that all happened proactively. We did that before, as we submitted all the information to them and others.

Operator

Thank you. Ladies and gentlemen, this does conclude the Q and A portion of today's conference. I'd like to turn the call back to Stefan for any closing remarks.

Stéphane Bancel
Stéphane Bancel
CEO at Moderna

Thank you very much everybody for joining us and for your good questions. Have a great day and we look forward to speaking to some of you in the next hours and in the next years. Bye.

Operator

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

Executives
    • Lavina Talukdar
      Lavina Talukdar
      Senior VP & Head of Investor Relations
    • Stéphane Bancel
      Stéphane Bancel
      CEO
    • Jamey Mock
      Jamey Mock
      CFO
    • Stephen Hoge
      Stephen Hoge
      President
Analysts
    • Ellie Merle
      ED - Biotech Equity Research at UBS Group
    • Gena Wang
      MD - Biotech Equity Research at Barclays
    • Michael Yee
      Managing Director at Jefferies LLC
    • Salveen Richter
      Biotechnolgy Equity Research at Goldman Sachs
    • Terence Flynn
      Equity Research Analyst at Morgan Stanley
    • Tyler Van Buren
      Managing Director, Senior Biotech Equity Research Analyst at TD Cowen
    • Luca Issi
      Senior Biotechnology Analyst at RBC Capital Markets
    • Analyst
    • Courtney Breen
      Senior Research Analyst at Bernstein
    • Edward Tenthoff
      Sr. Research Analyst at Piper Sandler Companies
    • Jessica Fye
      Managing Director & Equity Research Analyst - Biotechnology at JP Morgan
    • Simon Baker
      Partner at Redburn Atlantic
    • Myles Minter
      Research Analyst - Healthcare at William Blair
    • Tim Anderson
      Managing Director, Senior Equity Research Analyst at Bank of America
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