Desperation on Variants Paints Path for Long-Term Vaccine Thesis (DYAI, MRNA, PFE, JNJ, NVAX, BNTX, AZN, SRNE)

The future of vaccine stocks can probably best be extrapolated from recent moves out of the Biden administration to approve the concept of booster shots, and then various swirling rumors about the idea of shortening the window for third-shot administration.

First, earlier this month, we heard news that the administration had approved the idea of administering booster shots as early as 8 months after the second shot of an original vaccination from one of the mRNA vaccines or the initial shot of a non-mRNA vaccine.

Then, last week, we heard rumors that the administration was considering, first, moving this up to 6 months, and then, moving it to just 5 months. 

This increasing sense of desperation is being fueled by hospitals filling up across the US with Delta patients. Granted, most all of them are unvaccinated. But some of them aren’t. And that swing factor could start to grow for those vaccinated more than 6 months ago. 

And this is just the story for Delta. What about future variants? 

The entire story is yet another boost for the narrative that the vaccine plays are a long-term game still in its early innings. That has major implications for top plays in the space, including Moderna Inc (NASDAQ:MRNA), Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), Novavax, Inc. (NASDAQ:NVAX), BioNTech SE – ADR (NASDAQ:BNTX), AstraZeneca plc (NASDAQ:AZN), and Dyadic International, Inc. (NASDAQ:DYAI).

 

Pfizer Inc. (NYSE:PFE) engages in the discovery, development, manufacture, marketing, sales and distribution of biopharmaceutical products worldwide. The firm works across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases.

Pfizer has been in the spotlight on the vaccine stage since it took over pole position from MRNA last fall through its powerful partnership with BNTX, giving it a leading position in the race to produce the world’s first mRNA-based vaccine solution. With its recent announcement, it hasn’t given up that narrow lead.

Pfizer Inc. (NYSE:PFE) and BioNTech SE – ADR (NASDAQ:BNTX) recently announced that the U.S. Food and Drug Administration approved the Biologics License Application (BLA) for COMIRNATY, its COVID-19 Vaccine, to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.

“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60 percent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval.”

While this is a clear factor, it has been incorporated into a trading tape characterized by a pretty dominant offer, which hasn’t been the type of action PFE shareholders really want to see. In total, over the past five days, shares of the stock have dropped by roughly -6% on above average trading volume. All in all, not a particularly friendly tape, but one that may ultimately present some new opportunities. 

Pfizer Inc. (NYSE:PFE) managed to rope in revenues totaling $19B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 60.8%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($21.7B against $35.7B, respectively).

 

Dyadic International, Inc. (NASDAQ:DYAI) has become one of the most interesting emerging names in the space given its strong recent results and its new deal with Sorrento Therapeutics, Inc. (NASDAQ:SRNE) to kickstart the next stage of bringing its truly unique vaccine solution to market. As the story has progressed, investors have started to spot the name, driving shares over 60% higher in recent weeks. But that could be just the tip of the iceberg here if this is the real deal.

The company has a special edge with its fungal-based C1 technology platform, which uses a different vector for producing more vaccine volume faster and cheaper, and its vaccine solution (now starting human testing) is easier to store, produce, transport, and distribute, and cheaper to manufacture quickly, than the mRNA solutions.

Dyadic International, Inc. (NASDAQ:DYAI) recently announced, along with Sorrento Therapeutics, Inc. (NASDAQ:SRNE), the signing of a binding term sheet to enter into an exclusive license agreement to develop and commercialize vaccines, therapeutics, and diagnostics for coronaviruses, including Dyadic’s lead COVID-19 vaccine candidate, DYAI-100, produced using Dyadic’s proprietary and patented C1-cell protein production platform. The final terms of the license will be set forth in a definitive agreement to be entered into between the parties.

Sorrento Chairman and CEO, Dr. Henry Ji, commented, “We look forward to continuing our collaboration with Dyadic, which began last year, initially with a goal of developing and commercializing a protein-based COVID-19 vaccine that can be rapidly manufactured in large quantities in our existing cGMP facilities, and stored and transported at room temperature, in order to increase access and affordability to underserved populations globally.” Dr Ji. continued, “Over the past six months we have carried out several promising preclinical animal studies using the C1-produced RBD antigen in Dyadic’s lead COVID-19 vaccine candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine that will provide protection across the variants of concern, including Delta, and in addition, apply the C1 protein production platform broadly across our current and future coronavirus programs.”

Mark Emalfarb, Dyadic’s President and Chief Executive Officer noted, “We are delighted to have executed a binding term sheet with Sorrento Therapeutics to license the C1 technology for the development and commercialization of coronavirus vaccines, therapeutics, and diagnostics, including COVID-19. This marks a significant milestone in our corporate development efforts as we expect the license agreement we will enter into to enable us to monetize our internal COVID-19 development efforts with a partner that has the resources and expertise to advance vaccines, therapeutics, and diagnostics both clinically and commercially.”

Dyadic International, Inc. (NASDAQ:DYAI) generated research and development revenue of $937k in the quarter ended June 30, 2021 versus $524,000 in the second quarter of 2020, up 79% year over year. Cash and equivalents balance as of June 30, 2021 totaled $25.6 million.

 

Johnson & Johnson (NYSE:JNJ) has been one of the established first-wave vaccine leaders in the Covid space, though perhaps without the fanfare of MRNA and PFE.

The Consumer Health segment includes products used in the baby care, oral care, beauty, over-the-counter pharmaceutical, women’s health, and wound care markets. The Pharmaceutical segment focuses on therapeutic areas, such as immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, and cardiovascular & metabolic diseases. The Medical Devices segment offers products used in the orthopedic, surgery, cardiovascular & neurovascular, and eye health fields.

Johnson & Johnson (NYSE:JNJ) recently announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. According to company materials, in July, the Company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization.

“We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months. With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination.”

The stock has suffered a bit of late, with shares of JNJ taking a hit in recent action, down about -2% over the past week. 

Johnson & Johnson (NYSE:JNJ) managed to rope in revenues totaling $23.3B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 27.1%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($25.3B against $38.7B, respectively).

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Published by Brendan Byrne

While studying economics, Brendan found himself comfortably falling down the rabbit hole of restaurant work, ultimately opening a consulting business and working as a private wine buyer. On a whim, he moved to China, and in his first week following a triumphant pub quiz victory, he found himself bleeding on the floor based on his arrogance. The same man who put him there offered him a job lecturing for the University of Wales in various sister universities throughout the Middle Kingdom. While primarily lecturing in descriptive and comparative statistics, Brendan simultaneously earned an Msc in Banking and International Finance from the University of Wales-Bangor. He's presently doing something he hates, respecting French people. Well, two, his wife and her mother in the lovely town of Antigua, Guatemala. You may contact Brendan via his email (brendanbyrne@wallstreetpr.com) or his Google+ page (https://plus.google.com/u/0/116608759701551457422).