: Moderna calls the "complexity" of the provision chain as COVID-19 vaccine gross sales fall under $ 1 billion

It appears that Pfizer has taken the lead in the tug-of-war for market share among the leading COVID-19 vaccine manufacturers, and Moderna investors aren't happy about that.

Moderna Inc.
This week had two disappointing news to announce: the COVID-19 vaccine won't be approved for teenagers or children in the US before the end of the year, and delivery problems with admission to different countries have severely reduced sales as a result.

Moderna shares fell 18.9% in trading Thursday to close at $ 284.02, the lowest price since July 16.

"Earlier this year it was primarily shipped to CDC in the US and Europe, and that was it," Moderna CEO Stéphane Bancel said Thursday during the company's third quarter earnings conference call, according to a FactSet transcript. "But since we are now increasing the number of countries to many dozen, the complexity only increases."

Moderna said Thursday that third-quarter sales of its COVID-19 shot were $ 4.8 billion, far less than what Wall Street analysts expected to see $ 5.8 billion, according to a FactSet consensus.

Executives cited “scale-up challenges” in the third quarter as the company boosted shipments around the world.

Moderna also had to adjust its sales guidance for the year, saying it now expects between $ 15 billion and $ 18 billion in COVID-19 vaccine sales, compared to an earlier estimate of $ 20 billion in product sales for 2022. (The Vaccine is the only vaccine approved or approved by Moderna.)

The tug-of-war for market share between Moderna and Pfizer

Moderna is a major player in the pandemic and is launching the second approved COVID-19 vaccine in the United States within a few weeks of BioNTech SE
and Pfizer Inc.
+ 10.86%
COVID-19 shot, Comirnaty.

Both vaccines developed by Moderna and BioNTech / Pfizer use mRNA technology, require two doses, and had similar rates of effectiveness in last year's clinical trials.

Pfizer has long had the first mover advantage and received its first broad approval in the US last December. Comirnaty later became the only shooter to receive full US approval in those aged 16 and older and in teenagers between the ages of 12 and 16 and children between the ages of 5 and 11.

Moderna's shot is approved for adults in the United States.

However, there may be some clinical differentiators. Preliminary research has shown that the Moderna shot can produce a stronger, and possibly more permanent, immune response than the BioNTech and Pfizer shot.

The latest data comes from a federal “mix-and-match” clinical study that showed that a booster dose of Moderna produced the best immune response compared to additional doses of the Pfizer or Johnson & Johnson vaccines.

However, Moderna's struggle to keep up with the regulatory and commercial pace set by Pfizer became apparent this week.

On Sunday, the company announced to investors that the Food and Drug Administration is taking additional time to assess the risk of developing myocarditis, a type of inflammation of the heart, in those who received their vaccinations. (Myocarditis is a known but rare risk associated with the mRNA vaccines. It occurs primarily in teenagers and young men.) Then came the disappointing sales figures on Thursday.

"We see the significant loss in vaccine sales as an expression of the continued loss of shares in PFE," said Mani Foroohar of SVB Leerink on Thursday to investors, referring to the global oversupply of vaccines, the loss of sales among the adolescent and pediatric population and the revision of the Consensus expectations.

The extended review period is expected to delay the regulator's decision on approving the vaccine for adolescents until January. Moderna also said Sunday that it will put on hold plans to file its application for young children while the FDA's safety clearance is ongoing.

Executives attributed the FDA's review to timing, saying Pfizer's juvenile application was completed before "a major discussion about myocarditis".

"What we see here, with the difference, is a function of timing," Moderna President Stephen Hoge told investors during the conference call. "The other vaccine was approved prior to this concern."

Wall Street also has concerns about Comirnaty

Millions of pediatric doses of the Pfizer vaccine are now being shipped to locations in the United States.

The US bought enough doses of Comirnaty to immunize all 28 million children between the ages of 5 and 11, effectively excluding Moderna's vaccine from this phase of the country's vaccine campaign. The BioNTech / Pfizer vaccine will likely be the only vaccine for children and adolescents in the US until at least January.

The introduction of COVID-19 vaccinations for children is similar to the introduction of vaccines to the general public last spring, with some parents keen to have their children vaccinated to check for appointments and call pediatrician offices online.

Retail chains like CVS Health Corp.
Curriculum vitae,
Walgreens Boots Alliance Inc.
and Walmart Inc.
are already promoting the availability of pediatric COVID-19 vaccines in their stores.

Pfizer is also confronted with questions from investors.

Pfizer, which shares Comirnaty profits with BioNTech, said the vaccine had third-quarter sales of $ 12.9 billion.

As the US and some countries shift their populations beyond the first and second dose phases into the booster phase of the pandemic, this will reduce the strong sales that all COVID-19 vaccine manufacturers are currently generating.

Moderna executives believe the virus will become seasonal and endemic sometime in 2022.

"Most of Pfizer's other core products were in line or below expectations for the quarter," Mizuho Americas analyst Vamil Divan told investors this week, "and we continue to have questions about the longevity of Comirnaty's revenue stream."

Moderna stock is still up 168.4% so far this year, while the broader S&P 500
+ 0.37%
has increased by 24.1%.

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