Novavax, Inc. (NVAX) stock forum & discussion – Yahoo Finance (2024)

Today, Novavax got first post-earnings coverage by B. Riley!

"Today, B. Riley Financial analyst Mayank Mamtani reiterated a Buy rating on the stock with a price target of $305 (98.9% upside potential).

Mamtani said, “Importantly, earlier than anticipated WHO EUL, unlike the prolonged process for Ocugen’s (OCGN) COVAXIN, could put NVAX nicely on the path for 350M committed doses as part of the COVAX facility allocations.”

“As a result, we aren’t necessarily concerned with both the demand and supply of ‘2373 in the long-term and continue to believe in upward revision to Street’s 2022+ topline forecasts, while understandably recognizing certain near-term regulatory and supply dynamics to cause issues with 2021-22 revenue recognition,” analyst added."

The below is a repost. I have removed the links and will put them in a reply if Yahoo allows that.

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It took a bit of work to properly research the purity issue alleged by Politico. My take is that it is just about a local problem in Texas that was blown up to make it sound like a global manufacturing issue. That is wrong as explained below.

Page 28 of the below Novavax slide deck clearly stated that purity level was at least 80% for large-scale production using 2000L bioreactors. Further, the only significant impurity seen was gp64, a baculovirus spike protein.
(Link in reply, or google: "Global Comparability/Characterization Strategy for NVX-CoV2373")

That data were gathered when the North Carolina Fuji plant were brought up to manufacture antigen for the US phase-3 trial and for stockpiling toward the 110M doses owed the US Government. The purity level must have been improved to be at the level that the FDA accepted before the trial was run per their guidance: "FDA also conducts an assessment of the product, its quality and safety, and the technology to manufacture it, to determine whether it is reasonably safe for testing of the vaccine to move forward in people."
(Link in reply or google: "FDA Vaccine Development 101"

So, North Carolina has been manufacturing high quality vaccine as required. That, of course, was reflected in the efficacy and safety results of the US trial.

That said, however wrong Politico was, they must have based their allegation on something concrete. It was likely about the new Fuji Texas plant. The plant has had problems since its opening at the start of 2021. A quote from a Baltimore Sun article:
"Trizzino said Fujifilm’s site in North Carolina was up and running quickly, but Texas didn’t have as much experience so “it’s taken us a bit longer to ramp that up.” A March inspection by the Food and Drug Administration found overcrowded and unorganized storage areas, a failure to consistently follow cleaning procedures and questions about why there was a backlog of batches, according to documents obtained by KHN in response to a public records request. The backup formed because bulk drug substance was being made faster than the facility could review produced batches, Fujifilm’s Jackman said."
(Link in reply or google: "Maryland-based Novavax’s effort to vaccinate the world, from zero to not quite warp speed:")

Given Fuji experience in North Carolina and the UK, whatever problems in Texas must have been fixed by last August when Novavax and Fuji issued a joint statement that they were working together to reopen the plant.
(Link in reply or google: "Fujifilm Novavax joint statement Texas plant")

The bottom line here, I believe, is that the purity problem was in a single new Texas plant but was blown up into a global issue over all of manufacturing. Yesterday PR by Novavax cleared up the issue that they do not have that problem anywhere else in the world when they stated the expectation that ex-US EUA applications will be completed before the next quarterly CC on 11/4/2021.

The following deserves reposting!
!!GLTA

WASHINGTON (UrduPoint News / Sputnik - 27th November, 2021) The recent data from the US biotechnology company Novavax, which is developing a vaccine against the novel coronavirus, said on Friday that its shot is likely to protect against new, emerging variants.

The new variant, B.1.1.529, is reported to carry an exceptionally high number of mutations, many of them in spike proteins that are the target of the vaccines, potentially making it even more transmissible.

"Recent data from our Phase 2 clinical trial showed that wild-type neutralizing antibodies increased more than 4-fold versus Primary vaccination series and that cross-reactive functional antibodies to the Alpha (B.1.1.7), Beta (B.1.351), and Delta variant strains increased six- to ten-fold with a booster dose of NVX-CoV2373. These data lead us to believe that our vaccine is likely to provide protection against new and emerging variants," the company said in a statement.

Novavax vowed to continue to work urgently to address the latest variant of the coronavirus.

"Specifically in response to the emerging coronavirus variant tentatively called Nu, Novavax has already initiated development of a new recombinant spike protein based on the known genetic sequence of B.1.1.529 and will have it ready to begin testing and manufacturing within the next few weeks," the statement said.

Novavax also said its recombinant nanoparticle technology allows the vaccine to adapt quickly to the changes in strains.

Earlier in the day, the World Health Organization (WHO) named the new strain Omicron and said the existing PCR diagnostic tools are able to detect this variant.

Couple of things:

1) A lot of frontline healthcare workers are refusing to get vaccinated, with many citing distrust of the approval process and political meddling.

Given this. Perhaps the red-headed-step-child status NVAX has endured will end up being a blessing in disguise. There will suddenly be a vaccine available that no one has ever heard of, that wasn’t mentioned by Fauci every 5 minutes, and that has as good or better efficacy and safety as the mRNA options, from an established and proven platform.

2) To those claiming revenue from Covid will be non-recurring. I think this is totally wrong. For one thing, most experts believe COVID is here to stay, with probable boosters needed annually. If that proves correct, the ease of transport and storage will make NVAX an obvious top choice. I highly doubt Pfizer will even bother continuing to manufacture their product after the pandemic phase. For another, the current pricing is such because no company wants to be perceived as price gouging during a global catastrophe. When things settle down and we enter the chronic phase of dealing with the virus, the pricing will be set by regular market forces. If NVAX can successfully create a combo flu/COVID vaccine especially, the cost can be much higher. Their share of this market could potentially be huge as big pharma goes back to business as usual. Recurring revenues could conceivably be higher than those anticipated in 2021.

Fingers crossed for excellent UK P3 results.

Novavax Cranks It Up: A Billion More Doses, Covid Authorization And Much More
Nov. 06, 2021 4:04 AMNovavax, Inc. (NVAX)AZN
Summary
The Serum Institute is expanding its Novavax production capacity by a billion doses. Novavax is buying these on a per dose basis, so it keeps all of the profits.
Novavax achieved its goal of 100M doses per month in Q3, and is on track to achieve its goal of 150M by December. This indicates 600M doses in 2021.
9 EUA filings have been done, covering most of the world. The vaccine has been approved by the 4th largest country, Indonesia, and many more approvals are expected soon.
The UK has already inspected and certified the SII factories, indicating it will likely give approval soon. Most countries in the world accept UK approvals.
With 2.1 billion in orders and likely 2022 revenues of $22B , this is highly undervalued and one of the strongest buys I've seen in a few years.

In my last article about Novavax (NASDAQ:NVAX), I predicted the company would file more key Emergency Use Authorization (EUA) packages in the coming days, that the first approval would occur in November and that production would not only be on track, but accelerate. I also predicted that as these and other catalysts occurred, the share price would go up significantly.
I'm happy to say that all of those predictions came true: they filed EUA packages with the EU, the WHO, Canada and New Zealand, they received approval in the 4th largest country in the world, Indonesia, and the price surged 30% from when my article was published. In the last day, news of the Pfizer (NYSE:PFE) drug treatment has caused a significant pullback from that level. But as I will describe, it isn't justified because vaccinations will continue to be important; and 2022 Novavax sales alone warrant a much higher market cap than now.
As more approvals roll in, and as the vaccine is rolled out in numerous countries, I expect the share price to rise far higher. Most importantly, the production acceleration is not only accelerating, but is doing so dramatically faster than even I expected. Those things plus the 2.1 billion doses of orders for its vaccine, plus having a very high efficacy vaccine with many advantages, plus other positive new developments make Novavax an excellent buy.
A "stupendous" production increase
Last week, a new development occurred when Novavax CEO Stanley Erck told Yahoo Finance that with capacity from SII coming online, Novavax would reach an annual run rate of as much as 2.4 billion doses per year in January. He said: "that partnership has really paid off. They've built capacity such that we can have as much as 200 million doses a month produced starting in January, and we're ramping up to that level right now." That said, there was some potential that "as much as" might only mean 180 million.
This week in an interview on Bloomberg, Erck said that in the coming months, Novavax would reach monthly production of more than 200 million doses. This was important because it moved it from being a maximum of 200 million, and possibly much less, to being at least 200 million per month. This was a major step up. Then during the Question and Answer part of the earnings call, Erck noted something that I think flew under the radar, but was the most important part of the call. In response to a question, he said SII has expanded its Novavax capacity from 1 billion doses per year to 2 billion doses. This is the exact quote:

$Nvax , Do I have this right?

1. One of, if not the safest?
2. One of, if not the most effective, including Delta?
3. The easiest to handle, store.
4. Filed for EUA in Indonesia & others.
5. Filed for EUA with WHO weeks ago.
6. Filed with UK, Last week.
7. To file with EU, Canada and others in a week ( couple weeks after press release) .
8. Covovax ( Novavax) filed for local approval in India, Oct 29.
9. Has manufacturing under control.
10. Stock under valued 4 to 10 fold compared to Moderna?
11. FDA announced Friday to put Moderna booster decision on hold up to Jan ‘22?
12. Has had more negative press ( potential hit pieces) than Pfizer, and Moderna put together?
13. Has not yet had Oxford study on mix and match, yet.
14. Usa allows as approved vac for travel purposes.
15. Usa has as vac on certain Federal Service documents?

I can by this stock for around$160 and I haven’t mentioned 1B + Covid vac demand and can be filled in weeks and months?

Let alone has Covid + Flu in vac that closed stage 3 trials.

I believe stock manipulation is about to end!

The 3Q2021 SEC 10-Q filing mentioned for the first time cost of "prelaunch-inventory" and how that is accounted for as Research and Development expense:

"Prior to an emergency use authorization ("EUA") or regulatory approval of NVX-CoV2373, the Company's policy is to recognize the cost associated with acquiring raw materials and production for preclinical studies, clinical trials and pre-launch inventory, including both internal manufacturing and third-party Contract Manufacturing Organizations ("CMO"), as research and development expense in its consolidated statements of operations, in the period in which the costs are incurred. When the Company believes EUA or regulatory approval and subsequent commercialization of NVX-CoV2373 is probable, and expects future economic benefit from the sales of NVX-CoV2373 to be realized, the Company will then start capitalizing the costs of production as inventory."

408M was accounted for in 3Q2021. Costs for trial running would be minimal at that time. So, most of this money, my WAG at least 300M, was for making prelaunch inventory. At least that much must have been spent in 4Q2021 for inventory also. As such, the amounts of antigen and Matrix-M already manufactured since 3Q2021 are likely huge. However, antigen may still be locked up in plants such as BioFabri, Novavax CZ or Fuji Texas which are not yet approved. The company said that they will add plants as soon as approval is given. My guess is that production of doses will jump up non-linearly as soon as these plants are added. Using just SIIPL antigen production to project manufacturing growth is likely too conservative.

Just got some time to listen to the CC and look over the data presented earlier today. One word: Fantastic. The presentation is below:
https://ir.novavax.com/download/2021-12-22-6-month-w-Omicron-P19-FINAL.pdf

The key data for efficacy against Omicron are on slides 10, 11 and 12. A simple way to read those slides is to focus on the first and last vertical bars. See how they are always at about the same height? The first bar predicts efficacy against the wild type virus of more than 90%. Therefore, the last bar very likely predicts efficacy against Omicron of more than 90% after the third booster shot.

It was very satisfying for me to hear Dr. Glenn made the same observation that I made previously that the hACE2 inhibition titers grew to similar high levels for Alpha, Beta, Delta and, now, Omicron after boosting. We discussed yesterday that that phenomenon indicated a maturity of the immune system to be able to neutralize a broad number of features of the virus so that distinct sets of mutations in those variants did not matter. Cov2373 is the only current vaccine that has data showing that broad effectiveness against mutations.

Lastly, the data on treating adolescents were amazing with immune responses multiple times that of adults and apparently with little serious side effects. There is very little question that Cov2373 is efficacious and safe for children. The Indian trial is even testing that on children as young as 2 years old, again with little side effects so far.

It is clear now that Cov2373 is the best vaccine we have to fight COVID. NVAX has indicated that they will complete the FDA application in a few days. I am fairly certain that the data presented today will be included. That will both strengthen the efficacy case against the current threat of Omicron which will help speed up approval and also prepare for a quick approval for adolescents afterward.

One of the most rational posts by TraderT.

NVAX LONGS. While we are watching market meltdown around us, lets put on the mood music and do a LETS CHILL review:

Forget trading risks. what other risks remain?

1.PRODUCT DOES NOT WORK - More data than ANY other manufacturers say this is the best most tolerated, safest, cheapest vaccine PLATFORM for COVID and FLU. Built by scientists. CHECK.
2.MHR APPROVAL - UK Govt own booster study says we are better than AZ (oxford). They have ordered 60 million NVAX doses and same from each of MRNA and BNTX. Its made in Billingham/Fuji and Fuji yesterday announced a doubling if capacity and a $400 investment. 700 UK jobs now depend on it and UK can make COVID and FLU vaccines. Head of Australia regulatory Greg Hunt yesterday said next week approval. Approval in Australia, NZ and Canada will follow immediately. Canada has built their own NVAX plant. CHECK
3.EMA APPROVAL. EMA is expected to approve between now and Dec 15. They said so. They ordered 200 Million doses and option more. NVAX is discussing delivery logistics. NVAX is using local production in CZ, Poland and Spain. Mabion installing doubling of capacity. EU gets a better cheaper option than Pfizer for COVID and Flu. Multiple countries are promoting deals with NVAX and stopping MRNA. CHECK
4.Approval in SK. Local global drug partner SK Bioscience and SK government are stock piling tens of millions of doses and are INDEPENDENTLY doing BLA approval by Dec 25
5.Approval in Japan. Local global drug partner Takeda and Japanese Govt government are stock piling tens of millions of doses.
6.Approval and/OR export by India/Serum Institute. 2 Billion dose capacity built and stick piling. Exports to Indonesia and Philipines underway. Pediatric studies wrapping up. DGCI waiting on UK or EMA to approve. SII switching capacity to NVAX from AZ for boosters locally and export
7.WHO Approval: Ready to roll, waiting UK or EMA
8.US FDA Approval: Who cares. FDA is bought and paid for by Pfizer. US citizens want alternative to mrna. Government needs a wake up call. Call your senator if you want this vaccine.

This brings us to valuation: CHECK. No rational market cap valuation below $30-50billion
1.Market cap $12 Billion.
2.2-4 Billion dose capacity x $3-15 = $6-60 billion revenue
3.Better value proposition than mrna (cheaper, safer, easier to transport)
4.Local Distribution and manufacturing advantage (Serum Takeda SK Fuji Mabion …..)
5.Three horse race
6.Matrix M platform

Trading Risk: HIGH but we are again at the bottom of the range and the short/ling monthly pattern is clear. The price VARIES A LOT MORE THAN THE REALITY
1.Short funds
2.Captive media (eg Politico)
3.High volatility
Conclusion: Strong BUY!

UPCOMING CATALYSTS (within a short timeframe)

Emergency Use Applications
(within 1-2 months)

-European Medicines Agency (EMA)
-Uk Medicines and Healthcare products Regulatory Agency (MHRA)
-Health Canada
-Australian Therapeutic Goods Administration
-New Zealand Medsafe
-US Food and Drug Administration (FDA)

Already submitted Applications for:
-World Health Organization (WHO)
-India
-Philipines
-Indonesia

Known Dates for Trial Completions:

-SII P 1/2 study Bivalent, B.1.351, B.1.617.2 (Start Oct 4th,Primary completion Nov 10th)

-South African study on HIV and non HIV subjects (primary and study completion date Nov 2021)

-CoVast - Covid-19 safety Tracking. 10 vaccines across the world including Novavax. (Primary completion date December 31st 2021, Study completion date Jan 31st 2022.)

-UK trial Primary and study Completion date (Jan 14th 2022)

-Phase 1/2 Flu/covid mix shot (primary and study completion date March 2022)

-Heterologous Study results (expected Fall 2021)

-Phase 1/2 study's in India began for children aged 7-11 yesterday.
-Safety results for children 12-17 expected shortly.
-Covavax(Indias Novavax) expected to be approved in January/February 2022. (as stated by CEO of SII)

100 million doses of Novavax being produced monthly as of yesterday.
150 million doses of Novavax being produced monthly by December.

Potential news of Israel purchasing Novavax for countries 4th booster. No confidence in Pfizers booster.(stated on Israel military radio by the top health official of Israel)

Advanced Commitments/Purchase agreements:

-At least 1.1billion doses to Gavi/COVAX Facility for poor countries
-350 million provided by Novavax
-1.1billion Novavax doses provided by Serum Institute of India (SII)
-400 million doses to EU(European Union), UK, Canada, Australia,New Zealand and Switzerland.
-150 million doses to Japan Provided by Takeda
-110 million doses to the US

these are guaranteed sales and will start shipping this year after the first approvals.

-Novavax is working on a Malaria vaccine in Phase 3 that has produced exceptional efficacy results both in children and adults. More news should be coming out.

Novavax is the furthest along out of any vaccine maker with their Flu/covid combo vaccine. Novavax also has completed Phase 3 for their standalone flu vaccine and produced amazing results not worse than the top flu vaccine available to market.

Feel free to post this around or add catalysts that are guaranteed in the short term (within 1-6 months)
-Please do not add conspiracy theories or hopes/guesses.

thank you.

The Sanofi-GSK news was very bullish for Novavax. It shows that there's definitely a market for new competition, and that Novavax is months ahead of their most comparable competitor (in terms of technology used to make their vaccine).

The doubters who think covid is over can't deny that there isn't a gigantic market when big companies are still trying to get into the market a year later with low likelihood of gathering enough participants in p3 studies (especially considering Novavax had issues with high drop out rates as other vaccines started getting rolled out).

Either they're aiming for EUA to get in on the pandemic because they don't believe the current producers will be able to fill the world's needs in the time it takes them to run their p3 trials (in which case Novavax is guaranteed to get EUA well before then), or they believe there's a long term market after the pandemic has been brought under control by previously authorised competitors (in which case, Novavax is guaranteed to have an early advantage in terms of getting to market with an annual flu-covid combo shot).

Either way, Sanofi-GSK's news strongly implies that there's still tons of money to be made - and Novavax is next in line to make it.

$NVAX
Paradise for Novavax according to Politico

The article proves one thing very clearly. Novavax will be able to sell everything it produces. Economically, and that's what counts on the stock market, it's a paradise for Novavax. SII alone is capable of producing 2 billion doses. Not to forget the capacities in Japan and Korea that will follow in January. The European factories are not even taken into account. Politico is targeting global supply. Novavax and the stock market want to see cash in and Novavax is guaranteed to deliver that with the emergency approvals already received. Whether 2 plants in the US contribute or not doesn't matter much in the end. It is solely an emotional issue and provides fuel for the shorties. We can only hope that January will lead to a reduction in short volume so that the stock can return to normal. The news of the last weeks were outstanding and January will also have extraordinary news flow.

April it is guys!

Feb 24 (Reuters) - Novavax Inc expects data from a late-stage U.S. trial of its COVID-19 vaccine at the start of April, after which it will apply for emergency use authorization, the drug developer's R&D head Gregory Glenn said on Wednesday.
"We are expecting results right in the beginning of quarter two and shortly thereafter we will be filing for EUA (in U.S.)," he said at a Washington Post online event.
The Novavax executive said the vaccine has shown a great "safety profile" in UK trials and the company might ask the U.S. Food and Drug Administration to consider the UK data for vaccine authorization.

On Monday, Novavax completed enrolling 30,000 volunteers in the late-stage study in the United States and Mexico.
The company said last month its vaccine was 89.3% effective in preventing COVID-19 in a trial conducted in the United Kingdom.
It was nearly as effective against the more highly contagious variant first discovered in the UK.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur)

My biggest concern until last week was a possibility of insufficient efficacy and safety on the US PH3 trial. And now we have better data that demonstrates a strong protection from multiple variants, which makes Novavax place on a higher plane in comparison to other major vaccines.

The issues of delays are still giving me feel frustration but not worrying about the company's future, because we have the fantastic data fully working for all types of the Covid viruses. Some may have expectations in mind regarding targeted share prices this year. When Novavax received a funding from CEPI in April last year, we didn't expect $320 to come in 9 months from $40. Now we are about to open doors to markets in the globe to start to sell the product. Think about what would happen in the next 9 months.