Moderna Analysts On Positive Coronavirus Vaccine Data, Revenue Potential

Moderna Inc MRNA 9.58% announced Monday positive efficacy data from the first interim analysis of the Phase 3 COVE study of its investigational coronavirus vaccine mRNA-1273.

The Moderna Analysts: SVB Leerink analyst Mani Foroohar maintained an Underperform rating on Moderna.

Needham analyst Alan Carr maintained a Buy rating and increased the price target from $94 to $110.

Analyst Says Data Matches Elevated Expectations: The 94.5% vaccine efficacy point estimate of mModerna's RNA-1272 is well above the previously specified primary endpoint of about 74.1% and is better than the over 90% efficacy reported by Pfizer Inc. PFE 3.29% and BioNTech SE – ADR BNTX 13.66% for their vaccine candidate, Foroohar said in a note. 

The interim analysis included 95 events compared to the prespecified 53 events and Pfizer-BioNTech's 94 events, the analyst said.

Of the 95 events, five occurred in the RNA-1273 group and 90 in the placebo arm, he said. 

The placebo group had 11 severe COVID-19 cases, and there were none in the control group, Foroohar said. 

The results are "robustly positive" and in line with elevated expectations following Pfizer-BioNTech's vaccine data, the analyst said. 

The data releases from Moderna and Pfizer-BioNTech have further validated the use of mRNA-based vaccines in SARS-COV-2, he said. 

Initial doses of Moderna's vaccine are likely to be available as early as December given the company's intention to submit an emergency use authorization in the coming weeks, Foroohar said.

The focus now shifts to the safety profile, according to SVB Leerink.

The sell-side firm expects upcoming detailed releases from Moderna and Pfizer-BioNTech to be scrutinized intensely.

The data release at first glance appears encouraging, with the majority of adverse events being mild or moderate in severity, and Grade 3 events after the second dose generally being short-lived, the analyst said. 

Moderna updated storage estimates, with a storage duration of 30 days at 2 to 8 degrees centigrade, up from the previous estimate of At negative 20 degrees centigrade, the vaccine can stay effective for six months, according to SVB Leerink. 

Needham On 'Impressive Results': Moderna's interim readout represents an impressive outcome, Needham analyst Carr said.

The analyst projects emergency use authorization by December, assuming an application is filed by the end of November after two months of safety data is collected.

Needham raised its sales estimate for 2021 substantially from $2 billion to $7.28 billion and from $1 billion to $2 billion in 2022. 

More upside is possible if other vaccines with different mechanisms of action aren't as effective — or if Moderna boosts production capacity beyond 500 million doses in 2021, Carr said.

Needham aalso raised its probability of success for the vaccine candidate from 80% to 90%.

https://www.benzinga.com/analyst-ratings/analyst-color/20/11/18384268/moderna-analysts-on-positive-coronavirus-vaccine-data-revenue-potential

Moderna raises the bar for Covid-19 vaccine efficacy

A basic reading of today’s hotly awaited pivotal Covid-19 vaccine results from Moderna is that they have beaten those from Biontech/Pfizer. But in a global pandemic meeting initial demand will be a huge issue, so when it comes to vaccine successes the more the merrier is a good rule of thumb.

Curiously, the markets do not see it that way, with Moderna up 8% this morning and Biontech falling 11%. Both rival vaccines use mRNA, a modality that has never been available commercially; perhaps the most important point about the two datasets, therefore, is that they show that this approach could be a goer.

Already Biontech/Pfizer’s BNT162b2 had massively beaten expectations, last week showing greater than 90% efficacy in protecting people from Covid-19 infection versus placebo (Pfizer and Biontech snatch first Covid vaccine victory, November 9, 2020). The financial community had expected around 70% efficacy.

This morning Moderna raised the stakes, claiming a 94.5% figure at the first interim analysis of the Cove trial of mRNA-1273. The US FDA had set a 50% threshold to consider any project for early approval, and both assets have clearly beaten this.

Company	Biontech/Pfizer	Moderna
Project	BNT162b2	mRNA-1273
Study	NCT04368728	Cove
Target enrolment	43,538	30,000
Cases in active cohort	8*	5
Cases in placebo cohort	86*	95
Efficacy	>90%	94.5%
Manufacturing capacity 2020	50m doses	20m doses
Manufacturing capacity 2021	1.3bn doses (250m in H1)	500m to 1bn doses
Note: *estimated. Source: company announcements & Evercore ISI.

Moderna’s interim analysis had been triggered by 53 cases of Covid-19 infection being reported in the 30,000-volunteer study, though because of rising coronavirus infection rates the actual number of cases adjudicated by the data-monitoring committee was 95.

The headline finding was that 90 of these occurred among control patients, versus just five in the mRNA-1273 cohort. Perhaps even more impressive, albeit with small numbers of patients, was the incidence of protocol-defined severe Covid-19 cases: 11 for control, and none with the investigational vaccine.

With global use being one aim of Covid-19 vaccination, safety is paramount, especially for a novel approach like mRNA. Moderna said there were no significant concerns in Cove, with severe events including injection site reactions, fatigue, myalgia, arthralgia and headache; most were short lived, though of course a long-term look is needed to give the full picture.

Like the Biontech/Pfizer study, Cove will continue until the final number of cases specified in the protocol (164 for BNT162b2 and 151 for mRNA-1273) are reported, though no doubt there will be calls for both trials to be unblinded to give placebo recipients the chance to get vaccinated.

Governments have already signed supply agreements for both of these and other Covid-19 projects, and several vaccines will likely be needed to meet initial demand.

Those T-cell responses

Scientifically minded investors will now want to see more detail about the nature of the responses that mRNA-1273 was able to elicit.

A notable difference had arisen between the two mRNA projects when they generated the first human data in phase I: both elicited strong production of neutralising antibodies, but only BNT162b2 could boast CD8+ (killer) T-cell responses to a meaningful degree (Covid-19 vaccine contest turns to T-cell responses, July 20, 2020).

Nothing is known so far about the nature of any T-cell responses in Cove, or about how these correlate with protection from infection. If mRNA-1273 has shown efficacy without a significant CD8+ T-cell response that could in itself be of interest; however, many view T cells as key to long-lasting immunity, and the durability of mRNA-1273’s protection will be closely watched.

While US emergency use authorisation is a priority to get a Covid-19 vaccine to those most at need, it should be noted that in the EU the regulator is already reviewing BNT162b2 and Astrazeneca’s AZD1222 under a special rolling procedure; today it announced that it was starting to evaluate mRNA-1273 too.

Attention now turns to the next pivotal Covid-19 vaccine readouts, from AZD1222, by the year end, and then from Johnson & Johnson’s Ad26.COV2-S. mRNA vaccines have set a high bar, and if these next two players’ more traditional approaches do not meet it expect them to play up attributes like ease of storage.

https://www.evaluate.com/vantage/articles/news/trial-results/moderna-raises-bar-covid-19-vaccine-efficacy

Recovery rally holds as cyclical stocks lead through day on vaccine data

• Late buying, including a spike at the last minute, came through again for Wall Street to complete the recovery trade 1-2-3: Dow (DJI) +1.6% first, S&P (SP500) +1.2% second, Nasdaq (COMP) +0.8% third.
• Industrial recovery plays Boeing and Honeywell led the Dow to a new all-time highs.
• The S&P was also boosted by Industrials (NYSEARCA:XLI), Energy (NYSEARCA:XLE), Financials (NYSEARCA:XLF) and Basic Materials (NYSEARCA:XLB) on enthusiasm about Moderna's vaccine.
• The Nasdaq lagged, but still gained. Mixed performances from the Fab 5 megacaps was countered by strength in chips, with Nvidia, Micron and AMD benefiting from positive commentary and Qualcomm getting permission to sell 4G chips to Huawei.
• https://seekingalpha.com/news/3636757-recovery-rally-holds-cyclical-stocks-lead-through-day-on-vaccine-data