Novavax, Inc. (NASDAQ:NVAX) Q4 2023 Earnings Call Transcript

Brendan Smith: Great. Thanks, guys.

Operator: Thank you. And your next question comes from the line of Mayank Mamtani of B. Riley Securities. Please proceed.

Mayank Mamtani: Good morning, team. Thanks for taking our questions and appreciate the level of detail, including on the Gavi settlement. So maybe just on the current liabilities section, could you just break out beyond Gavi? What sort of components remain and how they contribute to the influence on going concern language, and maybe just the cash outlays you expect in 2024 specifically UK, et cetera, if you could just break that down that would be great? Then I have a follow-up.

John Jacobs: Yes. And Jim Kelly will take that, Mayank. And I think we’re very proud that in the past year we’ve made a lot of good progress on removing significant portion of the one-time current liabilities that were a legacy of the pandemic, many of the take or pay contracts or other matters. I’ll let Jim Kelly give you more detail on current liability breakdown. Jim?

Jim Kelly: All right. Hey, good morning, Mayank. And if I’m going to reference Slide 21 from our presentation for listeners and so, as John noted, hey, we were able to knock down current liabilities by $825 million during 2023. And as we look at the impact of the Gavi settlement, we will be in a position to reduce those liabilities by over $500 million on our balance sheet. And that’s really by spreading the remaining – any remaining liability over five years. So we are actually exceptionally pleased on what that means in terms of predictability of cash flow and marrying that up with our core operating plan. And then with respect to liabilities at 12/31/2023, I’ll reference a couple of spots. I’ll start with the other current liabilities category of 861 [ph].

So within that, it’s approximately $700 million related to Gavi. And so as just noted, over $500 million of that will move to long-term liabilities as we continue to move forward. And then the remaining components of that were there’s $112 million related to the UK. We’ve got some other small refund liabilities related to other APA related matters, small items. And then finally, there’s a facility operating lease in there as well. So those are the components of the 861 [ph]. With respect to AP and accrued, when you look at the 527 [ph], we continue to have our Fuji matter outstanding. I think folks have or heard the update. You’ll see it. We are on a track towards an arbitration hearing in May. We of course feel strongly about the merits of our case and await that outcome.

In addition to that, as we look at the remaining components of AP and accrued, they’re part and parcel primarily of just the standard business operations of the company. And this is one of the things that we’re exceptionally proud of. As the years progressed we have increasingly, I’ll call it cleared the deck of many of these legacy pandemic era manufacturing take or pace, and we’re moving much more to a traditional, streamlined balance sheet of operating entity. So hopefully that helps with the balance sheet.

Mayank Mamtani: Super helpful. And then just on monetization of non-core assets. Any update on the check manufacturing plant would be helpful? And then I have just one more follow up for Filip.

John Jacobs: Yes. Go ahead, Jim. You want to take the check plant question?

Jim Kelly: Yes, well certainly. And Mayank, as we continue to drive towards a more lean and agile organization, supply chain is of exceptional importance to us without question. And while certainly a difficult decision right to explore this sale. We recognize that it is an area of opportunity for streamlining and improving efficiencies in our supply chain. We do anticipate leveraging this Czech plant this year. It is a part of our network for delivery of doses into Europe and other; I’ll call it Europe reliant markets that rely on their regulatory authorization. And so we’re exceptionally thankful to that team and everything they’re doing to drive product sales this fall. We are at the beginnings via working with our broker to get indications of interest. It’s a great plant and I have every expectation that we will certainly have a robust interest and we’ll keep you posted on that.

Mayank Mamtani: Great. And just last question about the CIC combo program, integrating what you’ve learned from the COVID plus and flu monotherapy Phase 3 trials. Just what should we look for in these ACIP public meetings for respiratory vaccines that help sort of build on the recent FDA interactions that you’ve had? Filip, just if you could lay that out, that would be helpful. Thanks again for taking the question.

Filip Dubovsky: Yes, I think that’s kind of a tricky I mean, we don’t have any combination COVID-Influenza vaccines that have received ACIP approval to date, and we really don’t expect it to come up before ACIP for a couple of years at the earliest. So, I think we’ll have to wait and see. We know there’s a lot of interest from the public health authorities, both in the U.S. and globally, to reduce the number of jabs to get people protected, and they see it as a way to increase COVID vaccination because people are in large getting their flu vaccines. So, I think though, we will see when it happens. But I think that, as you know, us and other people in the world are pursuing this because we think it’s the right way to go forward.

Mayank Mamtani: Thank you.

Operator: Thank you. And your last question comes from the line of Alec Stranahan from Bank of America. Please go ahead.

Alec Stranahan: Hey, guys. Good morning. Can you hear me okay?

John Jacobs: We can. Good morning, Alec.

Alec Stranahan: Great. Thanks for taking my questions. Just two quick ones from me. Maybe just to put a finer point on the BLA, I guess based on the latest FDA guidance, is your go forward assumption that a formal BLA will be required to commercialize your COVID vaccine next fall in the U.S. And maybe if you could walk us through what’s going on now and remaining hurdles to get both the single dose presentation and the BLA over the finish line, that’d be great. Thanks.

John Jacobs: John Trizzino, do you want to take question?