UKRAINE – 2020/11/24: In this photo illustration a medical syringe and a vial depicting fake … [+]
Novavax stock (NASDAQ: NVAX) has gained about 12% over the last five trading days and has rallied by a solid 73% over the last month, largely recovering from the sell-off in late April and early May when the company said that it would delay seeking authorization of its Covid-19 shot to the third quarter of this year. So what are the developments driving the recent rally?
Firstly, Novavax indicated that data from its U.S. phase 3 trial was likely to be made public soon. While Novavax has already published very positive efficacy data from its U.K.-based Phase 3 trial in March, noting that its vaccine had 96.4% efficacy against the original strain of the novel Coronavirus, investors are likely eager to see U.S. data, as the Novavax shot is already six months behind leading Covid-19 shots, which started rolling out late last year.
Secondly, the company says that its experimental variant-specific Covid-19 vaccine targeting the Beta coronavirus variant that was originally identified in South Africa produced an immune response and provided protection, based on pre-clinical and clinical data. This is good news, considering that the variant of the virus is highly contagious and has apparently evaded some other Covid-19 vaccines such as the shot from AstraZeneca.
Separately, messenger RNA vaccines developed by Covid-19 vaccine leaders Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) are coming under scrutiny from the U.S. CDC after reports of several incidents of heart inflammation, particularly in young men, after receiving doses of the Covid-19 shots. This investigation comes a few months after incidents of rare blood clots from adenovirus-based shots developed by AstraZeneca and Johnson & Johnson. While these events are obviously unfortunate, investors might be viewing this as positive for Novavax’s delayed, but highly effective vaccine. Although Novavax’s vaccine hasn’t been administered at scale as yet, it is based on a differentiated protein-based vaccine technology and reported good safety results during initial trials last year.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up almost 16x since late 2019.
[5/26/2021] Don’t Count Novavax’s Covid-19 Shot Out Just YetNovavax (NASDAQ: NVAX) stock lost almost a third of its value over the past month driven by the company’s announcement that it would delay seeking Emergency Use Authorization of its Covid-19 shot in the U.S., U.K., and Europe to the end of September, falling behind its initial plan of filing by June. This means that Novavax will probably miss out on lucrative initial sales in developed markets, as about half of U.S. adults are now fully vaccinated, while the E.U. has increasingly given its Covid-19 vaccine orders to Pfizer. That being said, we still see some positives for Novavax’s Covid-19 shot and its stock.
Global vaccination drives still have a long way to go. Per the Bloomberg vaccine tracker, enough vaccine doses have been administered to fully vaccinate just 11.2% of the global population. Now Novavax’s shot seems well suited to do much of the heavy lifting in getting the global population, particularly in emerging markets, vaccinated, given that it is easier to store compared to mRNA vaccines, relatively cheap, and apparently very effective. The shot could also be preferred over vaccines from the likes of Johnson & Johnson and AstraZeneca, which have faced issues of rare but very severe side effects. Moreover, Novavax said that it was expanding its late-stage Phase 3 clinical trial study to include children ages 12 to 17 and this could also help the company cater to a largely unvaccinated population.
Many experts think that Covid is likely to become endemic with the virus continuing to mutate, potentially making Covid vaccine shots an annual occurrence, much like flu shots, and Novavax might be particularly well placed to cater to this market. Earlier this month, Novavax announced positive data from a preclinical study that evaluated a combination of its Covid-19 vaccine with NanoFlu, its experimental influenza vaccine. [1] If the company potentially combines these two shots, which have both fared well in late stage trials, it could be a gamechanger, helping to immunize people against both the flu and Covid-19.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up almost 12x since late 2019.
[4/28/2021] Whats’ Driving Novavax Stock?Novavax (NASDAQ: NVAX) stock has gained almost 50% over the last month and trades at levels of around $258. So what’s driving the surge in the stock?
Firstly, Novavax’s Covid-19 shot, which has been delayed multiple times, is likely to start being deployed commercially in the coming weeks. The shot should be approved by U.K. regulators anytime now and interim data is also expected from the company’s Phase 3 U.S. trials during the second quarter of 2021. This could be making investors buy into the stock.
Secondly, Johnson and Johnson’s single-dose Covid-19 vaccine and AstraZeneca’s Covid shot have come under increasing scrutiny for instances of extremely rare, but very severe side effects of blood clotting. It’s possible that these investigations could create some hesitancy among populations and governments globally to take the shots, potentially helping Novavax – which has a relatively affordable and highly effective Covid-19 vaccine.
Thirdly, there seems to be a possibility that Covid-19 vaccines will require booster shots within a year and possibly require an annual shot thereafter, with both Pfizer and Moderna working on booster doses of their respective vaccines. Such a scenario would be positive for Covid vaccine makers including Novavax, as they could likely see some level of recurring revenues from what initially appeared like a one-off vaccine product.
Separately, last week, the results of a clinical study on a new malaria vaccine developed by the University of Oxford leveraging Novavax’s Matrix-M adjuvant showed strong efficacy of as much as 77%. Adjuvants help to enhance the immune response of vaccines and the data from the malaria shot, as well as Novavax’s own Covid-19 and NanoFlu vaccine developments, suggest that its proprietary adjuvant appears to work very well. This indicates that Matrix-M could potentially see demand from other vaccines as well.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up almost 19x since late 2019.
[4/14/2021] Will Novovax Gain From J&J’s Vaccine Woes?Novavax (NASDAQ: NVAX) stock rallied by over 10% after the U.S. Food and Drug Administration and the U.S. Centers for Disease Control paused the rollout of Johnson & Johnson’s (NYSE:JNJ) Covid-19 vaccine in the U.S. following some rare, yet severe incidents of blood clotting. Now, will J&J’s current issues really benefit Novavax’s delayed, yet highly effective Covid-19 vaccine? While we don’t see a big upside for Novavax in the U.S., it will likely benefit in international markets.
The instances of clots with the J&J shots were rare – while close to seven million doses of the J&J shot were administered in the U.S., just six people faced issues of severe clots. The FDA itself has indicated that the pause was only due to an “abundance of caution” and that likely means that the rollout will resume in the coming days or weeks. Moreover, the J&J shot wasn’t really playing a big role in the U.S. vaccination drive in the first place. It accounted for less than 4% of shots administered in the U.S. to date, per data from Bloomberg, and the government has apparently secured 600 million doses of the vaccines from Pfizer and Moderna – likely enough to vaccinate the eligible U.S. adult population. This means that there probably isn’t much upside for Novavax in the U.S. due to J&J’s issues.
That said, J&J’s shot was expected to play a larger role in vaccinating global populations, given its ease of deployment (single-dose, easier to store and distribute). Now the recent investigations in the U.S. could create some hesitancy among populations and governments globally to take the J&J shot. The AstraZeneca shot, which is also an adenovirus-based vaccine, like Johnson & Johnson’s, has also seen multiple reports of blood clots, and governments have been apprehensive about rolling out the vaccine. For example, Australia has been limiting the use of the AstraZeneca vaccine and now says that it won’t buy the J&J shot. This could create an opportunity for Novavax as its vaccine is as easy to store and distribute as the J&J shot, is apparently more effective, and is also relatively cheap. Novavax has also lined up a lot of production capacity. Just about 5% of the global population has been vaccinated, so the addressable market also remains large.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up almost 14x since late 2019.
[4/6/2021] Has Novavax Stock Run Its Course?Novavax (NASDAQ: NVAX) stock has declined by about 20% over the last ten trading days, although it remained roughly flat over the last week. The stock currently trades at about $177 per share. There are a couple of factors driving the recent sell-off, including the postponement of a Covid-19 vaccine deal with the E.U. on account of some production issues and lower investor interest in vaccine stocks, with the end of the pandemic now in sight. Novavax’s 11x rally over the last 12 months and its relatively high valuation also make it very sensitive to any news flows.
So what’s the longer-term outlook for the stock? We think Novavax stock remains risky for long-term investors. While Covid-19 shots from Moderna, Pfizer, and AstraZeneca have been on the market for months now, Novavax’s vaccine hasn’t been approved for use yet. The shot is only likely to be cleared for use in the U.K. in the coming weeks and with the enrollment for late-stage U.S. trials completed only in late February, it could take longer for the shot to be approved and rolled out in the U.S. This means that Novavax is likely to miss out on lucrative early sales. For perspective, about a third of the U.S. population and about half the U.K population has already received at least one dose of a Covid-19 vaccine. [2] The market for Covid-19 shots will only get more competitive as time goes on. It’s likely that vaccine sales will peak this year, with supply only likely to improve going forward. For example, Pfizer intends to produce about two billion doses of its vaccine this year, noting that it should have the capacity to produce as many as three billion doses in 2022. This is likely to limit the pricing power and earnings potential of Novavax’s vaccine. Moreover, it remains to be seen if Novavax’s development pipeline, which is largely focused on vaccines for infectious diseases, can support its stock post this.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up almost 13x since late 2019.
[2/17/2021] Is Novavax Stock Too Risky At $260?Novavax (NASDAQ: NVAX) stock has had a stellar run, more than doubling since early January 2021 driven by promising efficacy data for its Covid-19 vaccine. The stock is also up about 30x over the last 12 months. After such a sizable rally, is Novavax stock looking overvalued? While it’s difficult to give a definitive answer, we think the risks are certainly looking much higher at the current valuation. Sure, the company’s Covid-19 shot is highly effective (95.6% effective against the original strain), is easier to store, and is also likely to be relatively more affordable. However, Novavax could miss out on more lucrative U.S. sales, and it’s also not clear if its pipeline can support its valuation post-Covid-19.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up almost 20x since late 2019.
The Novavax shot is somewhat late to the race. While the company has filed for approval in the U.K, it only recently completed enrollment for its phase 3 trials in the U.S. – which is likely to be one of the more lucrative markets for vaccines. While the company is asking the FDA to start evaluating its shot based on the U.K. data as it carries out late-stage U.S. trials, it should still take a couple of more months before it receives emergency approval, by when a sizable percentage of the population could already be vaccinated. Thus far about 40.2 million Americans have received at least one dose and dosing is happening at a rate of about 1.7 million per day, per the Bloomberg Vaccine Tracker. Although Novavax already has an order for 100 million doses with the U.S. government, it could miss out on the potential upside for more doses. For instance, Pfizer and Moderna – who both have approved vaccines – are now likely to supply an additional 100 million doses each to the U.S. Novavax could prove more popular in the low and middle-income markets, where vaccination drives are just starting off, although these markets will likely be far less lucrative. Per consensus estimates, Novavax sales are likely to stand at about $3.2 billion this year, compared to Moderna which is likely to sell over $10 billion worth of its Covid-19 vaccine.
Now Novavax’s $17 billion market cap implies that it is trading at a little over 5x consensus 2021 revenue – not too high for a biotech stock poised to post big growth this year. However, Coronavirus vaccine sales will likely peak in 2021 and it remains to be seen if Novavax’s development pipeline, which is focused on vaccines for infectious diseases, can support its earnings post this. The company has just one other product that’s close to the market – namely its Nanoflu vaccine, which reported positive phase 3 data last March. While this vaccine could become a source of recurring revenue for the company, it probably won’t be too profitable given that seasonal flu vaccines are typically not very high margin. This is also a reason that most big pharma companies have shown little interest in this relatively high-volume market.
[2/4/2021] Why Did Novavax Stock Double Over The Last 5 Days?Novavax (NASDAQ: NVAX) stock has had a stellar run, rising by 117% over the last five trading days. The stock is up a whopping 40x over the last 12 months. The recent gains come on the back of promising efficacy data relating to the company’s late-stage Covid-19 vaccine trials in the U.K. The shot proved 89.3% effective overall, and 95.6% effective against the original strain of the Novel Coronavirus, with no serious adverse events, putting it on track for approval in the U.K. The company is also asking the U.S. FDA to evaluate the vaccine for emergency use based on the U.K. data, as it continues phase 3 trials in the U.S.
So is Novavax stock set for further gains? It looks quite likely. Based on our machine learning model, which analyzes 5 years of stock price data, Novavax stock has a 60% chance of a rise over the next month (21 trading days). See Novavax Stock Chances of a Rise. With its efficacy and safety are now proven, we believe the Novavax vaccine will emerge very popular. It’s apparently easy to store and distribute and cheaper than rivals Moderna and Pfizer’s shots. Novavax has also lined up a lot of production capacity. (See update below) Novavax revenues are projected to jump to over $3 billion in 2021, per consensus estimates. This should give the company the cash to invest in advancing its pipeline, which is focused on vaccines for infectious diseases. Novavax has eight candidates in its pipeline apart from the Covid-19 vaccine. Its flu vaccine NanoFlu reported positive data from its phase 3 studies last year and it appears quite likely that it could go on to gain regulatory approval.
[1/29/2021]Novavax (NASDAQ: NVAX) has said that its Covid-19 shot is 89.3% effective, based on interim data from its phase 3 clinical trials conducted in the U.K. [3] The company expects to file for emergency authorization with U.K. regulators in the coming months. While the reported efficacy numbers seem to put the vaccine slightly behind Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA), who have rolled out vaccines that are roughly 95% effective, we think the Novavax shot holds more promise for a couple of reasons. Firstly, Novavax’s two-dose shot has shown efficacy against the new strains of the Coronavirus found in the U.K. and South Africa, making it the first company to prove this in clinical trials. So while the 89% figure looks slightly lower than Pfizer and Moderna’s reported results, the Novavax shot is at 95.6% effectiveness against the original virus — right in line with the two competitors. The shot should also be easier to distribute, considering that it doesn’t need to be stored in super-cold temperatures, unlike Pfizer’s mRNA based vaccine. Novavax’s vaccine is also likely to be more reasonably priced – a deal with the U.S. government saw each dose priced at about $16, versus as much as $37 per dose for Moderna’s vaccine. Crucially, the company has also lined up a lot of production capacity, collaborating with the world’s largest vaccine producer Serum Institute of India with plans to produce its vaccine at a rate of 2 billion doses a year starting from mid-2021. See our updates below for more details on the Novavax shot.
See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up about 4x over the last 2 years.
[1/27/2021] Novavax UpdatesNovavax’s (NASDAQ: NVAX) experimental Covid-19 shot is being closely watched, given some promising early-stage data and the company’s move to line up significant manufacturing capacity. Here’s a quick overview of what has been happening with Novavax stock in recent weeks. Firstly, the company is looking to raise as much as $500 million in equity, in a move that should improve its liquidity position and help fund its R&D spending. This is probably a smart move, as Novavax stock is up almost 15x over the last 12 months, with its market cap standing at about $8 billion. Novavax also has three efficacy/safety studies of its Covid-19 shot underway in the U.K, South Africa, and the U.S., with some initial efficacy data expected to come out in a few weeks. The company could be looking to hedge its position before the data readout. Separately, interest in the vaccine appears to be increasing. Novavax has finalized an agreement with the Canadian government to supply as many as 76 million doses of its Covid-19 vaccine and there have also been reports that South Korea is in talks to buy around 40 million doses of the Novavax vaccine. Novavax stock has fared relatively well year to date, rising by about 12% since the beginning of January. See our indicative theme of Covid-19 Vaccine stocks which includes U.S.-listed pharma and biotech companies. The theme is up about 4x over the last 2 years.
[1/4/2021] Why Did Novavax Stock Decline 20% In December?
Vaccine specialist Novavax (NASDAQ: NVAX) – which is seen as a key player in the Covid-19 vaccine space – saw its stock price decline by about 20% over December. Here are a few possible reasons for the decline.
Covid-19 vaccines by Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) received emergency approval from the U.S. FDA in December and inoculation drives have already begun in the U.K and the U.S. with these countries looking to get their citizens vaccinated as quickly as possible. For instance, the U.S. says that every American who wants a Covid-19 vaccine should have one by June. This likely means that demand for the Novavax vaccine – which is only likely to be available, subject to approval, in Q1 2021 or later – will be somewhat limited in the country. While Novavax has supply agreements with the U.S. and Australia, the company might not see much upside in developed markets.
Novavax announced that it was commencing phase 3 clinical trials for its novel coronavirus vaccine in the U.S. and Mexico last week. While this is good news, considering that Novavax saw multiple delays in starting late-stage U.S. studies amid manufacturing challenges, there are concerns whether the company will be able to meet its target of signing up 30k volunteers when there are two highly effective vaccines already available in the market. For example, prospective volunteers might be concerned that they are given a placebo or that Novavax’s candidate could be less protective or even if their involvement in the trial could impact their ability to take another vaccine.
See our indicative theme on Covid-19 Vaccine stocks for more details on the performance of key U.S.-based companies working on Covid-19 vaccines.
[Updated 12/23/2020] What Are The Risks For Novavax?
Vaccine specialist Novavax (NASDAQ: NVAX) has seen its stock price soar by roughly 25x year to date. While part of the gains were driven by encouraging results for phase 3 trials of the company’s NanoFlu flu vaccine back in March, a bulk of the price appreciation is due to the company’s development of a Covid-19 vaccine candidate. While we discussed some of the merits of the Novavax vaccine in our previous update (see below), in this note, we take a look at some of the key risks that it could face.
While Novavax entered the Covid vaccine race in the Spring, along with Moderna and Pfizer/BioNtech who have now started rolling out their vaccines, the company has faced delays in its timeline. The first readouts from its phase 3 trials are expected around Q1 2021 – likely one quarter behind the front runners. Only after these results are available will the company be able to file for emergency approval and rollout its vaccine. While this may not be a big deal considering that there’s enough room for multiple Covid vaccines, Novavax might miss out on relatively more lucrative orders from developed markets. For instance, the U.S. is now expected to increase its order for Pfizer’s vaccine to another 100 million doses.
Margins for the vaccine could also be a concern. Novavax’s vaccine is based on subunits – essentially using a fragment of the virus – and the manufacturing process is apparently more complex compared to the method used in messenger RNA vaccines including Moderna’s. This could potentially make the Novavax vaccine more expensive to manufacture. Based on a supply agreement with the U.S. government, the Novavax vaccine will be priced at about $16 per dose, below the $19.50 for Pfizer’s vaccine and as much as $37 per dose for Moderna’s. The potentially more complex manufacturing process and lower prices could mean that margins might be lower.
[Updated 12/2/2020] Does Novavax Covid Vaccine Still Matter?Novavax (NASDAQ: NVAX) stock saw some volatility after the company said that it had rescheduled its Phase-3 clinical trial in the US, indicating that it could begin in the coming weeks, instead of starting in November. This marks the second time that the company has delayed its U.S. trials, amid some challenges with scaling up production. While the company currently has late-stage trials underway in the U.K, with a readout expected in Q1 2021, Novavax significantly trails frontrunners Pfizer and Moderna who have shown extremely high efficacy rates of roughly 95% and have already applied for emergency approval with the U.S. FDA. Considering that the Novavax vaccine could be at least one quarter behind the frontrunners, will there be a place in the market for the Novavax vaccine even if it proves safe and effective and wins regulatory approval? We believe the answer is yes, for multiple reasons.
While the Novavax vaccine might arrive later than expected, it still holds promise. Firstly, based on data from early trials there are indicators that it might be highly effective. For example, the antibody responses for the Novavax vaccine were meaningfully stronger than other vaccines that have been reported at that time, per data from its Australian trials that were available in August. [4] The vaccine should also be easier to distribute, as it only needs to be stored at refrigerated temperatures, unlike Pfizer’s vaccine which needs to be stored at ultra-cold temperatures. Novavax’s vaccine might also be more reasonably priced. Based on a supply deal with the U.S. government, the vaccine’s price is estimated to be about $16 per dose, compared to as much as $37 per dose for Moderna’s vaccine and $19.50 for Pfizer’s. If all goes well, Novavax could also scale up production fairly quickly. In September Novavax reached an agreement with the Serum Institute of India, one of the largest vaccine manufacturers in the world, boosting the company’s capacity to as much as 2 billion doses a year starting from mid-2021. [5]
Novavax’s vaccine could also emerge popular in low and middle-income markets. While the Oxford-AstraZeneca’s vaccine – which is likely to be priced at a few dollars per dose – is seen as key to fighting the pandemic in emerging markets, it now faces questions regarding the way phase 3 trials were handled, potentially resulting in delays and apprehension among governments. This could make the Novavax vaccine – which can be produced at scale and easily distributed – popular if the pricing is suitably adjusted.
[Updated 11/4/2020] Covid-19 Vaccine stocks
Our indicative theme of Covid-19 Vaccine stocks – which includes a diverse set of U.S.-based pharma and biotech companies developing Covid vaccines – is up by about 560% year-to-date, on an equally weighted basis, compared to the S&P 500 which has gained just about 4% over the same period. While most vaccine stocks declined last week, amid a broader sell-off in the markets, they are likely to come back into the spotlight as efficacy data from late-stage trials is expected from frontrunners Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) in the coming weeks. Below is a bit more on the companies in our theme of Coronavirus Vaccine stocks and their relative performance.
Novavax (NVAX), a vaccine development company, began late-stage trials of its Covid vaccine in the U.K in September, and large-scale phase 3 trials are due to begin in the U.S. and Mexico this month. While the company doesn’t have any other products on the market yet, its flu vaccine NanoFlu could be ready for potential FDA approval. The company has received about $1.6 billion in funding from the Federal government. The stock has soared 2,000% year-to-date.
NVAX
Moderna (MRNA) , a clinical-stage biotech company, is carrying out phase 3 trials of its Covid-19 vaccine, completing enrollment of 30,000 participants. The company is likely to have data on whether its vaccine works or not by this month, and has noted that it would seek emergency approval from the FDA if the vaccine is at least 70% effective. The stock is up 253% this year.
Johnson & Johnson (JNJ): Unlike most other vaccine candidates, which are likely to require two shots, J&J is targeting a single-dose vaccine. While the company had to pause trials in mid-October after an illness was reported in a volunteer, the company is now preparing to resume trials. The stock is down by -5.1% this year.
Pfizer (PFE) is working with German partner BioNTech on a Covid-19 vaccine. The company is likely to have efficacy data from late-stage trials available shortly. The company could supply about 40 million doses in the United States in 2020 if the data is positive and regulators approve the vaccine. The stock is down by about -7.6% this year.
While Novavax stock may have moved, 2020 has created many pricing discontinuities that can offer attractive trading opportunities. For example, you’ll be surprised how the stock valuation for Lowe’s vs. D.R. Horton shows a disconnect with their relative operational growth. You can find many such discontinuous pairs here.
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