Novavax, Inc. (NVAX)
NASDAQ: NVAX · Real-Time Price · USD
7.76
-0.16 (-2.02%)
Apr 29, 2026, 1:54 PM EDT - Market open
← View all transcripts

Bank of America Global Healthcare Conference

May 11, 2023

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Get going. Hey everyone, good afternoon and welcome to, or I guess good morning. Welcome to day three of the 2023 BofA Healthcare conference. Thanks for joining this session with Novavax. My name is Alec Stranahan. I'm Vice President and Senior Biotech Analyst covering Novavax at BofA. I'm pleased to be joined by John Jacobs, President and Chief Executive Officer of Novavax, as well as Filip Dubovsky, Executive Vice President and Chief Medical Officer. Thanks for being here, guys.

John Jacobs
President and CEO, Novavax

Our pleasure. Thanks to those of you who joined us live as well. This is one of the last sessions of the conference. I appreciate you being here. Thank you.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Saving the best for last. Yeah. Let's, let's just jump into it. We've got 30 minutes for Q&A, but if there's any questions from the audience, just feel free to raise your hand throughout, and you'll be brought a microphone, and you can, you can ask your question. So, maybe just to start, John, you know, you're new to the company. You've been, you know, you now have a quarter plus under your-

John Jacobs
President and CEO, Novavax

Yeah, about 12 weeks. Yeah.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Yeah. Under your belt. You know, how have the first few months on the job been at Novavax, and, you know, what have you guys accomplished, and, you know, what's your key focus next six months?

John Jacobs
President and CEO, Novavax

I would say exhilarating. We've accomplished a lot in 12 weeks and moved very quickly. I came to the company because I really believe in the science. I did an awful lot of homework looking at it. To me, all of the ingredients for potential success are here for a biotech. You've got a proven technology platform, Alec. You've got a fully integrated global team, a set of capabilities all the way from R&D through commercialization with a global footprint, and a proven product that's registered and authorized in over 40 countries that had over $2 billion in sales. Yet the company's... You know, coming in, I knew the company's under distress financially, right? We've got to make some bold moves and aggressive moves quickly.

Normally, when you come in as a new executive to a large global organization, you wanna take a few months to listen and learn and think and talk to everyone and then set a strategy, and then you roll it out. Here, we had to, you know, come right in immediately with Dr. Dubovsky and Jim Kelly, our CFO, and the rest of our leadership team and board, make decisive moves right away. It's been exciting, it's been thrilling, and it's reconfirmed for me the potential value that this company has. We still have a long way to go before we can claim success, but we're pleased with the progress we've made so far in the first quarter.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

That's great. Great to hear. You know, you guys reported earnings on Tuesday. Maybe we could just start with an update on execution of the, of the three priorities-

John Jacobs
President and CEO, Novavax

Sure

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

that you've laid out, to redirect the company.

John Jacobs
President and CEO, Novavax

Thank you.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Yeah.

John Jacobs
President and CEO, Novavax

You know, I like to keep things simple. Our entire team is aligned around these objectives and priorities across the global organization. Any one of our employees knows what they are. If you ask them, they could tell you what they are and what their role is in helping to achieve that. Priority one is updating our Nuvaxovid COVID vaccine in line with regulatory authority requirements for this upcoming fall season.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

Doing so on time, in the right quantity, and in a competitive product presentation with, for instance, unit dose vials, lower dose unit vials. That's our top priority. Everybody is focused on that. What we've done there, accomplishments so far, we're working differently internally over the last 12 weeks. Different levels of cross-functional teaming. Every function has a seat at the table in the planning sessions, and we're looking at every item in the timeline to see where we can save time and be more efficient and effective while not sacrificing quality.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

In addition, we've had a remarkably improved relationship with regulatory authorities, including FDA. We speak multiple times a week, and we're very aligned in the conversation. In fact, we were invited for a seat at the table on the FDA strain selection committee and have a voice in that conversation that's active and frequent right now. We like the way that's going. We feel it's a collaborative environment with global regulatory authorities. We've made much progress. We think we've put ourselves in a position to have a very good chance for success this coming fall. Obviously, the VRBPAC's coming up on June 15th, and we'll learn more. Perhaps later in the conversation, Filip can discuss a little bit more about that. Pillar two, work to really financially stabilize the company, improve our cash flow, reduce our current liabilities aggressively.

You heard some of that on the earnings call. We paid down over $500 million in Q1 of current liabilities, another $140 million, including a settlement with Par Pharmaceutical in April alone. We still have a lot of work to do, but that's good progress on removing that burden on the company financially.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

We also, and it was a really tough decision for our employees, for our executives, but we did it decisively and with courage, have a cost reduction initiative that's targeting a 40%-50% reduction in R&D and SG&A expenses versus 2022 last year by 2024. Obviously, we can't realize the full annualized benefit of that immediately now. We're kicking it off in May. By next year, we should realize that full benefit. That's a significant step in the right direction to get the right ratios, operating expense ratios, et cetera, for an organization of our kind.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

Last but not least, pillar three. We have quite a unique technology platform. We really believe we're sitting on something special here at Novavax, and that was further reinforced for me with the data we just unveiled. Dr. Dubovsky shared with the public on three different vaccines in a phase II trial showing remarkable immunogenicity and safety. We believe we can take those forward from a position of strength should we continue to execute successfully, and we succeed the way we think we may be able to by the end of this year, from that position of strength, and think through our strategy for those assets, enter 2024 with quite a future ahead of us.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Very good. It seems like a lot of progress was made in 1Q. I think there was a positive reaction after the print. Like you said, you hit the ground running. You came in with a clear mission that you've outlined for your employees. I think it also helps frame the company's plan at least for the next 12 months.

John Jacobs
President and CEO, Novavax

Yeah

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

... for investors as well. There is, you know, and not necessarily a ticking clock, but, you know, you have disclosed a going concern language.

John Jacobs
President and CEO, Novavax

That's correct.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

... last quarter. Maybe we can just address that upfront, you know, any updates on this and any additional context on your cash flow situation next 12 months.

John Jacobs
President and CEO, Novavax

Absolutely. Look, that language is still there, and it needs to be. It's never a fun thing for a company to do, but I was proud to be part of that.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm

John Jacobs
President and CEO, Novavax

... when I first came in because I think, you know, total transparency is really important for the investor community. There's a lot of operational risk still ahead of us at Novavax. Yes, we've made tremendous progress. I believe, and our executive team believes we have the right plan. We've made really good progress on that plan to date. Now that's water under the bridge, right? We're looking forward. We're focused on continued execution. If we execute successfully on the pillars, by the end of the year, the company should be in a much more stable position. Hopefully, in the future then, we would be lifting that language at the right time.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm

John Jacobs
President and CEO, Novavax

when we have enough cash on hand and much more stable organization and a position of strength to grow in our future. We're not there yet. Work to do still.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Great. You know, I think the revenue guidance you provided added some additional comfort, and clarity sort of on what we could expect from your COVID vaccine pipeline, you know, $1.4 billion-$1.6 billion revenue guidance for 2023. Could you maybe talk about what feeds into this?

John Jacobs
President and CEO, Novavax

Sure

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

the expected seasonality you've mentioned?

John Jacobs
President and CEO, Novavax

Sure. Good question. You know, Jim Kelly addressed this on our earnings call very well. I'll break it into just a few simple top-line pieces for our investor audience. You know, what gave us more confidence potentially giving that guidance now was a little bit more, it is never total certainty, but a little bit more certainty towards pieces of that revenue. Let's describe that in three pieces. The first is an $800 million committed book of business for the calendar year 2023. As the company has said all along, toward the end of last year, we have a $2.1 billion committed book of business from APAs outside the U.S. government purchases. That's a commitment that we hope to extract the full value of over the coming three years or so.

We were in the process of negotiating that. Those negotiations are completed for calendar year 2023 regarding orders of our vaccine, our old Wuhan plus our new updated vaccine in Q4, to the total of roughly $800 million calendar year 2023. We still need to produce the vaccine, ship those orders on time in order to realize that potential revenue.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

Assuming we execute, that's a committed book of business at this point right now for the calendar year. That gave us enough confidence to at least share that component of guidance. The second piece, U.S. grant revenue, $340 million-$360 million, midpoint of $350 million, out of the approximately $415 million that we entered January this year with out of the remaining Operation Warp Speed grant that was originally given to the company.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

The work, the clinical work that Dr. Dubovsky and his team are doing to pull that grant money down is underway for the vast majority or the most part, and it would be very unlikely that FDA would try to pull that back in the middle of that, though anything's possible. That gave us more certainty or more comfort at least in sharing that component of guidance in that range. The last piece, midpoint is roughly $350 million or so on a sales projection of what we think could be possible in the U.S.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

That's low single digit market share. We're not having a high bar out there. We're not looking to promise the world. We're a late follower coming in for the first time to a U.S. commercial market.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

Though we have very experienced team, the first time Novavax itself would be launching our vaccine into a commercial market. That has yet to be proven. When you look at the analogs for that, low single digit is reasonable should we continue to execute and have the vaccine produced on time.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. You've got some potential ways to ease the uptake too, in terms of the single-dose vials.

John Jacobs
President and CEO, Novavax

Correct

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

... that you're developing. I guess one question I've gotten from the bear camp is what is the risk within that $800, what is the risk within the BARDA funding, the grants? I guess how much of that money is assured, and is there a risk that, you know, there could be renegotiations similar to what you've done.

John Jacobs
President and CEO, Novavax

Look, I mean, I'll never sit here and promise anything is 100% certain. I think that would be a mistake for any executive to do. Things happen in life and business we cannot control. It's our belief and understanding that there's a strong level of confidence and a strong level of belief that that's there.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

That's why we were comfortable enough giving the guidance. We still need to execute to pull it through. There's much more risk, in my opinion, on the execution side. The ball's in our court.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm

John Jacobs
President and CEO, Novavax

to make the vaccine on time, to deliver it, to pull through those revenues. Those negotiations are done. Now, any government can change their mind at any time. We're not anticipating that. We've been in constant and recent discussions with them and just concluded this.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

It's unlikely that a week later they'll change after we just went through months of discussion on it. Anything's possible, but we're relatively confident that's there, the grant money and the $800 million. We need to execute to pull that through.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

We could fail. We could miss that. That's not our intent or our plan. The U.S. is a projection of what might be possible.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

I've received questions, I'm sure you have, on what's possible. Is there vaccine fatigue?

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

What's going on? We hear, you know, Pfizer, Moderna, others talking about roughly 100 million doses in the U.S. for COVID, et cetera. Look, we don't know exactly where that will land. Our data triangulates in that general arena as well. Even if you cut that in half or by two-thirds, we're not looking to get a massive piece of that for us to get a foothold and begin to grow our business in this market.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Right. Right. That makes sense. You know, looking to the second half of the year, the pandemic is officially set to end, you know, this month potentially. It feels like being at the conference that it's behind us, which is a good thing. Could you maybe speak to what this means for EUAs for COVID? It sounds like you'll still be able to sell commercially, as you work on the BLA, right?

John Jacobs
President and CEO, Novavax

Absolutely. We don't see that as an impediment this year. We plan on filing our BLA second half of this year for the coming years. I don't know if, Filip, you wanted to add any context there.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Yeah.

Filip Dubovsky
EVP and CMO, Novavax

Yeah. Just so the updated strain is going to be under our EUA and not under the BLA because the BLA won't be actioned yet by the FDA. You know, that's consistent with the discussions we've had with the agency.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Okay. Maybe along those same lines, Filip, you know, ahead of the June 15th VRBPAC, what's your expectation around the scope of the discussion and, you know, what have you been doing to prepare for the strain change selection?

Filip Dubovsky
EVP and CMO, Novavax

Yeah. You know, we've been interacting very closely with all the regulators, not just the FDA, but also WHO and EMA primarily. We talk to them a lot.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

Filip Dubovsky
EVP and CMO, Novavax

Just like from the influenza side of the business, you know, we share our data with them. They share their insights into where they're heading with us. That way, when the VRBPAC comes to a head, you know, it'll be recommendations for strains that the manufacturers can make.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

Filip Dubovsky
EVP and CMO, Novavax

As in influenza, they never put out strains that the manufacturers can't make.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

Filip Dubovsky
EVP and CMO, Novavax

Our expectation is that it's a complementary vote at VRBPAC. We'll be presenting our data there, and, you know, the vote will be the final starting place to where we can start, you know, really planning in a very robust way what we have pushing forward. Our approach has been to manufacture multiple strains at risk. You know, we have those different strains up through commercial manufacture, which can be either used for clinical studies or for the commercial market, depending on what's required.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Do you have any predictions what the strain's gonna be? Do you have your bases covered already with those potential strains?

Filip Dubovsky
EVP and CMO, Novavax

Yeah. I mean, we still think that. First of all, as you know, we have this concept like an influenza of like strains.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

Filip Dubovsky
EVP and CMO, Novavax

You may not need to be the exact specific strain as long as your immune responses are comparable and relevant for the strain that's selected. It really looks like it's gonna be some variant of the XBB.1.5 lineage in our opinion. One one six is coming up fast. You know, we have data on that as well, and we're making a master virus seed for that just in case. We'll see. I mean, I think that the there's a lot of public health policy which is gonna go into the precise wording that the various agencies use to put out their recommendations. I'm hoping or expecting there to be pretty broad to allow all the manufacturers to succeed.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay.

John Jacobs
President and CEO, Novavax

And Alec, Thank you, Filip. One of the things we've done differently is bring multiple strains forward in parallel to take some risk and do work at risk.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

You know, we can't change our technology. It's five to six months or so. If we sat on the bench and waited to hear, "Here's your strain. Go," you're five to six months from that point forward. That we cannot change. What we could do is work differently internally to take some of that time already and put it behind us, so when we do finally land on the final strain, we've already taken a lot of those steps, enabling us to be ready for the fall. That's what we've done internally in the company for the first time to really try to give us the best chance for success this fall season.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. That makes sense. That actually, I guess, partially answers my next question, which is on the preemptive strain selection in parallel as a strategy, to accelerate the vaccine turnaround. You know, you mentioned the turnaround time for the platform mRNA, is faster, but do you think that you can still be competitive-

John Jacobs
President and CEO, Novavax

Absolutely

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

... with the current strain?

John Jacobs
President and CEO, Novavax

As we just said, and you're right, that what I said before helps to address that. From time point zero, mRNA will be faster than a protein-based vaccine like ours. If we do some of that work up front, then you're not starting from time point zero by the time you say go.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Yeah.

John Jacobs
President and CEO, Novavax

Right? That's the goal.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay.

Filip Dubovsky
EVP and CMO, Novavax

I guess the other point is that when you think of a season which will last several months, you don't even want all your stock to be prepared up front. You need to. Because they have shelf lives, so you need to make sure it comes at the proper cadence throughout the season. In that respect, there's a automatic release valve set on the amount of stock in your product.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. One question I've received from investors is, just trying to wrap their head around the COGS of doing the parallel strategy. What's sort of the burden in terms of, I don't know, OpEx, for that strategy, assuming that at the end of the day, just one of them will probably move forward?

John Jacobs
President and CEO, Novavax

Yeah. It's a relatively light burden. It does not cost us a lot to take those particular steps, which is actually a good thing. If it cost too much, we probably couldn't have done it to the extent we have.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Yeah.

Filip Dubovsky
EVP and CMO, Novavax

I guess the other point is that we're extremely dynamic. If we're pushing forward a strain and we see that it's no longer emerging, we stop that activity, right?

John Jacobs
President and CEO, Novavax

Exactly.

Filip Dubovsky
EVP and CMO, Novavax

we take it through to drug substance. The expensive bits happen after that when you have to fill it and etcetera.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. What's next in terms of development and preparedness of a new vaccine for this fall? I guess you're waiting for the confirmation of what the strain is gonna look like, and then what are sort of the next steps between then and, you know, launching in the fall?

John Jacobs
President and CEO, Novavax

Go ahead, Filip.

Filip Dubovsky
EVP and CMO, Novavax

Yeah. I guess it assumes really what is recommended.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

Filip Dubovsky
EVP and CMO, Novavax

You know, we anticipate that the strains we have in manufacture right now, one of them will be the strains that is selected. In that case, it's quite easy. What we need to do is really pull forward the data from a strain change study. That's a study that's ongoing right now. We'll be delivering that data in the July timeframe. That's a prerequisite for the strain change. Some manufacturing data, which is mostly about stability and quality data of the product.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay.

Filip Dubovsky
EVP and CMO, Novavax

That gets delivered up to the agency, and they allow the strain change to go forward.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Okay. Great. John, maybe you could talk a little bit about the COVID market dynamics you see evolving as we emerge from the pandemic. You know, what are sort of the drivers of success in an endemic market in your view? Is it price, access? Is it durability against new variants? Is it ease of administration and logistical considerations, or is it all that sort of wrapped up?

John Jacobs
President and CEO, Novavax

I think you've laid out a great list right there. That's a good answer, Alec, to your question. I would say yes to all of those things. They're all levers, and they're all components of a good strategy at the right level and the right mix.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

What we're encouraged by is our market research that shows a reasonably healthy Preference share for protein-based vaccine like ours, and John Trizzino shared some of that on our earnings call. There's a desire. Though mRNAs are excellent vaccines, I've had them myself.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

I've had protein-based vaccines as well.

I think having diversity of choice, and I believe global regulatory authorities are aligned with us on that, is very important for global public health.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

There's a fair segment of the population, physician, pharmacist, consumer that would like an alternative.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

I think it's important. That we believe there will be healthy demand for our product. Our job is really to execute and bring that product forward in the right format on time.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Could you maybe just touch on the logistical benefits? 'Cause I think that is an important consideration for shelf life, distribution, et cetera, that might be a strength for you guys, actually.

John Jacobs
President and CEO, Novavax

It could be. There's a differentiation there. Filip, I don't know if you wanted to comment on storage, refrigeration, freezing, et cetera.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay.

Filip Dubovsky
EVP and CMO, Novavax

Yeah. I mean, this has been true of our product from the very beginning, is that we're refrigerator stable for shipping, storage, and use. In that regard, if you're thinking about a physician's office specifically, where they may not have the freezer space required for other formats, then that's just some place we can play. That's true even more so globally, where the infrastructure just isn't as solid as it is in the U.S.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

Filip Dubovsky
EVP and CMO, Novavax

You know, that's a place we think we can have a differentiation really as it's just the platform itself. People are familiar with it, and the market share data that John shared before, I think is really why, you know, we have some confidence in that respect as well. I guess the final thing that, you know, we will be talking about and sharing data about is just how people's react to the vaccine itself.

You know, we have a almost a negligible fever signal with our vaccine. The reactogenicity seems to be quite good. There may be, if you fall into annual vaccination cadence, that may be a feature that people find important.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Do you think that could help with managing inventories on your side as well? I know you had to eat some of that actual last year. Do you think you'll have better vision sort of into the demand and being able to address it in real time so you can manage that?

John Jacobs
President and CEO, Novavax

It could be a component of that. I mean, obviously, we're gonna be thoughtful and strategic about planning around our COGS and potential returns, as all companies have to manage that and be thoughtful about that as part of our planning. That could be an element of that consideration, yes.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Okay. Very good. Last question on the commercial dynamic. Have you had any interactions with payers around reimbursement for vax clinics?

John Jacobs
President and CEO, Novavax

Absolutely, ongoing for the last couple of months at least. We have a fully deployed commercial team.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm

John Jacobs
President and CEO, Novavax

...globally and in the U.S., and they're an experienced team, though Novavax itself, this will be the first time as a company we're launching into a commercial arena. The team members that we've hired have deep experience and relationships there and know how to do that type of job well.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Okay. Maybe we can turn then to cash. $650 roughly end of 1Q. How much of this is money in the bank versus money which you may need to repay? Can you discuss the additional outstanding liabilities that still need to.

John Jacobs
President and CEO, Novavax

Yeah

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

...be addressed?

John Jacobs
President and CEO, Novavax

Let's discuss that, and that's obviously one of our three pillars, is to aggressively address current liabilities and put the company in a more stable financial position with more appropriate ratios on our, what it takes to run the business.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm

John Jacobs
President and CEO, Novavax

Separately, these one-time events. I think you saw we disclosed a bit more from a non-GAAP perspective this quarter to give investors some of the pieces so they could start to do that math. As you said, it was roughly $650, so it was $637 in cash on as of March 31st. As Jim Kelly said to the investor audience, we paid down roughly another $140 million in current liabilities in April alone, including a payment to Par that was a settlement and a U.K. payment of GBP 113 in change. We're aggressively taking this on. We still have work to do. We're not there yet, but we're making progress to remove this larger liability for the company.

Jim also said then, if you do the math, you got $637, then you have that extra $140. We're expecting through Q2 and Q3 a little more than $500 million in incoming cash, and that's a combination of payments from renegotiated APAs, grant revenue that Philip and his team are pulling in through clinical research with the U.S. government, as well as vaccine sales from our Wuhan vaccine for part of APA deliveries to ensure supply until the new variant strain could be available for the fall season. That would carry us through to the end of Q3. We would have roughly $1 billion then, if you do the math, right? $637 minus about $140 is roughly $500, plus roughly $500 coming in, assuming we execute against those things.

That's business we expect to achieve if we're successful, is roughly $1 billion then to take you through Q2 and Q3. About two-thirds of the guidance we gave, two-thirds of that $1.4 billion-$1.6 billion would come late Q3 into Q4. That's reflective of the seasonality we're seeing emerge as COVID moves from a pandemic to an endemic opportunity.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

Hopefully, that's helpful to give you some of the pieces.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Yeah. No, that's very helpful. Very good. Well, maybe we can actually.

John Jacobs
President and CEO, Novavax

One other thought. I'm sorry.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Sure

John Jacobs
President and CEO, Novavax

...one of the current liabilities, I mean, obviously the matter with Gavi is ongoing. Though I can't comment, there's not much I can say about legal matters as part of company policy, I can confirm again that we are in arbitration with Gavi right now. We believe we have the better merit in the case and that we don't owe the money.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

Arbitration is inherently uncertain.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

We're not in control of that outcome, so it leads to some uncertainty, and we feel frustrated that we're still in that situation. We'd like to put it behind us as quickly as possible because we respect Gavi and we share their global vision.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

In fact, I think everyone should be familiar with the R21 malaria vaccine that was recently approved. University of Oxford, Serum Institute of India , using our Matrix-M adjuvant and technology platform.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm-hmm.

John Jacobs
President and CEO, Novavax

That should save millions of lives in Africa. You can imagine Gavi might be one of the organizations that would like to help distribute t hat vaccine as part of their mission to low-income countries. We definitely share that mission and that desire, and it would be great if both companies could see a way to the end of that.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

That being said, you know, we've been advised by our U.S. and U.K. council, who have deep experience in these matters, on relative timing, and that it would be unlikely at this point that if it did go through to final arbitration, and we didn't settle outside of that or before that, it would be unlikely that any final judgment would occur in 2023. It would be much more likely that that would go into some time in 2024. Though anything's possible, it could be resolved in 2023.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

it would be unlikely.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Okay, that's helpful in terms of framing, you know, when the resolution could happen. I know that is something people are focused on. I did wanna spend some time, you know, you recently announced top-line results for your phase II for the combo, the flu COVID combo. Filip, could you remind us, you know, of the result and sort of next steps for the program?

Filip Dubovsky
EVP and CMO, Novavax

Sure. The study is a phase II study and it was really designed to select the dosage levels to be finalized for the combination vaccine between influenza and COVID. It had two other arms in it. It had a standalone influenza arm.

Mm-hmm.

as well as a high-dose COVID arm. The comparators we chose were Fluzone High-Dose and Fluad, which are the market leaders. They're the premium-priced, highly immunogenic vaccines, and we compare immune responses against those. and for the combination product, we also compare the COVID responses to our standalone COVID vaccine. and for the flu side, we were pretty gratified because our immune responses were non-inferior to all four strains for both vaccines and were actually superior for all the A strains. Those are the for both vaccines. Those are the strains which cause the vast majority of disease.

We've essentially de-risked the flu standalone program, and to a very large extent, we feel confident that if we were to take that into a efficacy study, the results would be very good.

On the combination side, we had really comparable results to both these high-dose premium-priced flu vaccines as well as our own vaccine. Once again, a way forward, we have at least two formulations which look promising to us. On the high-dose COVID side, this is a product which we think could be beneficial for highly primed older adults in the boosting market or the annual vaccination market. We also saw increased immune response. Importantly, all the tolerability was really quite good. It was really comparable to what we saw with the flu vaccines.

That's really the hallmark of our technology. We can really load up this platform with a lot of antigen, and it doesn't cause a lot of problems to the vaccinee.

All very positive but preliminary top line. We're gonna have additional immune results reading out over the next two or three months, and that's gonna really help define the really the value of all three of these. We know the platform does quite well in generating a very broad immune response, both for flu, for drift strains, as well as for variants in COVID. Our T-cell responses are also gonna be really quite favorable compared to the standalone flus. We know this. We've done this experiment before. We're looking forward to seeing those results.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Okay. Would the plan be this coming flu season to run, maybe a registration intent study for both the mono and the combo influenza?

Filip Dubovsky
EVP and CMO, Novavax

So what we've previously announced is that we're really focused on the first pillar John is talking about. All of our resources are going to delivering the updated COVID this fall, and all the resources we're really taking away from further clinical work for any of these products. With the exception of the high-dose COVID vaccine, we have a phase II study that's planned in the third quarter. We plan to finalize the dosage levels we would use for the high-dose COVID. The pathway forward, and John can talk about this a bit more for both the influenza and the combination, is gonna require additional resources, whether it be through strategic partnerships or other means. John, you wanna touch on that?

John Jacobs
President and CEO, Novavax

Very well said, Philip. Yeah. Really well said. Our focus, and you can see everyone in our company knows the focus...

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

-from our senior leadership all the way down through every employee who has a task. I remember when President Kennedy, we were about to launch a ship to the moon, and he saw a janitor in NASA and he said, "Sir, what are you working on?" The janitor said, "I'm working on bringing a rocket to the moon." Everyone knew the mission. Everyone in Novavax knows the mission. We need to execute. We're laser-focused on getting this vaccine out in the fall. We're laser-focused on addressing our liabilities, reducing our cost footprint, and have already taken decisive action. We haven't claimed success yet at all. We have a risk ahead of us and a lot of hard work to do, but we're pleased with where we are.

Yet, here we are with this remarkable data that we just shared with the medical community. It's top line phase II. It's not conclusive yet, but it's very encouraging to us. We believe we're sitting on something special. In our opening comments, Alec, we talked about why I wanted to come here. The ingredients for success are here and further reinforced, and I was thrilled to see the results of that phase II study, which even surprised us a little bit on how strong some of those results were. We do not have in our current operating plan, like Filip eloquently stated, the budget to bring forward three entire vaccines with large programs like that.

What we want to do is put the company, should we succeed with our plan, in a much stronger position by the end of the year, and from that position of strength, to bring forward that portfolio to optimize value for our shareholders and for global health.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

That's our mission. In the next coming months, it's not years, it's months, we'll be sitting as a leadership team and reframing our long-range plan, thinking about our priorities and how we take Novavax to the next stage of growth after we potentially succeed this year with what we need to do now to stabilize the company and generate the right revenues to give us that platform to optimize value from this remarkable technology and this platform of assets. At that time then, should we succeed, from a position of strength, we should have options on how to do that, either go alone with one or more of those products, joint venture partnerships, et cetera. From a position of strength and a position of leverage.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

we will then execute on those decisions forward. We still have a long way to go before we get to that point in the coming months to show you results. I'll close this particular series of comments here by saying, you know, it's our mission to approach this with hard work and humility.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Mm.

John Jacobs
President and CEO, Novavax

And balance in how we share our risks with our investor community as well as our opportunities. These businesses are never a guarantee. It takes an entire village and a symphony and some good luck to get there. We think we're on the right track. We do believe we have the right plan. I'm here for a reason and for a mission, and it's been nothing but encouraged over the last 12 weeks. I feel better than ever before that we have a great chance for success. We're not there yet. We can't claim it yet. We appreciate everyone's patience, and with humility and gratitude, we're gonna work hard to try to not let you down.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Well, great. I think that's a great note to end on.

John Jacobs
President and CEO, Novavax

Thank you.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

Really appreciate the discussion and look forward to tracking the progress. Thanks, guys.

John Jacobs
President and CEO, Novavax

Thank you so much.

Alec Stranahan
VP and Senior Biotech Analyst, Bank of America

All right.

John Jacobs
President and CEO, Novavax

Appreciate your time. Thank you.

Powered by