Revenue of $6.21B (+5.8% Y/Y) beats by $20M.
FCF of $2.7B.
FY20 total revenues guidance reaffirmed at $25.0-$25.6B.
Shares +1.9%.
Tuesday, July 28, 2020
Moderna COVID-19 vaccine shows robust effect in preclinical study
Results from a preclinical study evaluating Moderna’s (MRNA +1.8%) COVID-19 vaccine candidate mRNA-1273 in nonhuman primates showed strong antibody and T cell responses. The data were just published in the New England Journal of Medicine.
Animals received either 10 μg or 100 μg of mRNA-1273 or no vaccine. Antibody and T cell responses were assessed before upper- and lower-airway SARS-CoV-2 challenge.
The vaccine induced antibody levels above those in human convalescent plasma with live-virus reciprocal 50% inhibitory dilution (ID50) geometric mean titers of 501 in the 10 μg dose group and 3,481 in the 100 μg dose group.
Vaccination also induced type 1 helper T cell (Th1)-biased CD4 T cell responses and low/undetectable Th2 or CD8 T cell responses.
No SARS-CoV-2 viral replication was detected in the nose of any of the eight animals in the 100 μg dose group by day 2 after challenge. Limited inflammation or detectable viral genome or antigen was noted in the lungs of animals in either vaccine group.
A large-scale in-human study should be fully enrolled in 4-6 weeks.
Pfizer ‘could earn $15B-plus in COVID-19 vaccine sales’
On the heels of Pfizer’s $1.95 billion COVID-19 vaccine deal with the U.S. government, one analyst says the drugmaker could earn many more billions in revenue on its potential vaccine—if the program succeeds.
At $1.95 billion for 100 million doses, Pfizer’s deal sets a price-per-dose of $19.50, which Bloomberg Intelligence analyst Sam Fazeli sees as a “precedent” for other groups operating on a profit model, he said in a radio interview. The deal is contingent on success in the clinic and delivery of 100 million doses.
Pending success for a one-dose regimen, Fazeli’s team calculated a potential “windfall of more than $15 billion” for the company, according to a note seen by Bloomberg. A spokeswoman told the news service that Pfizer is pursuing a two-dose regimen.
Under that two-dose regimen, the $39 price for the course would be “almost 30% less than what others charge for a seasonal flu vaccine,” she told Bloomberg. The price incorporates “public health requirements during the pandemic,” she said.
Pfizer’s deal also includes an option for another 500 million doses, RBC Capital Markets analyst Randall Stanicky pointed out, so “investors are increasingly seeing real opportunity here.”
At a virtual conference (PDF) last month, Pfizer CEO Albert Bourla said it’s not “business as usual” for the company amid the pandemic and that it would be unethical for the company to price based on “open-market principles.” Still, there’s a “huge commercial opportunity,” he said. The company never entered its research in pursuit of a return on investment, he said, and rather sought a “return on effort.”
Pfizer and partner BioNTech haven’t taken financial help from governments in developing their vaccine candidates, so their pricing considerations are likely different from companies that have received R&D support. AstraZeneca’s deal with the U.S. government comes out to $4 per dose, Fazeli said. That company has received development dollars, and it has pledged to not profit off of the vaccine under the deal.
Previously, analysts with Jefferies predicted Moderna, another COVID-19 vaccine front-runner, could earn $5 billion in revenue or more by pricing its vaccine at $50 per dose. But after Pfizer unveiled its price of less than $20 per dose, it remains to be seen how Moderna will approach pricing. The biotech on Monday received another $472 million in R&D funding from the U.S. government, taking its total to about $955 million.
Moderna and Pfizer both started late-stage testing on Monday. Also Monday, Reuters reported that Pfizer’s talks with Europe have run into complications over price.
Covid-19 relief package likely to include billions more for vaccines, testing
The latest round of Covid-19 relief could include a dramatic increase in new funding for public health initiatives, according to draft legislation released Monday by Senate Republicans.
The proposed bill includes $20 billion for BARDA, the pandemic-response agency, to advance the development of Covid-19 vaccines and therapeutics, as well as $6 billion to coordinate vaccine distribution efforts through the Centers for Disease Control and Prevention.
The bill, authored largely by the Senate’s GOP majority, also includes $16 billion for Covid-19 testing, an additional $3.4 billion for the CDC, $2 billion to supplement the Strategic National Stockpile of protective gear and medical supplies, $7.6 billion for community health centers, and a new $25 billion fund to bail out cash-strapped health providers.
While Democrats are likely to vocally resist many elements of the GOP bill, including significantly reduced unemployment benefits for millions left jobless as a result of Covid-19, it is unlikely that they would push for less funding for health programs. In a recent House bill, Democrats included $75 billion for testing and contact tracing. Earlier this month, Senate Democrats demanded $25 billion for a vaccine-distribution program, more than triple the amount the Republican plan proposes.
Congress is likely to pass a version of the bill in the next week. Supplemental unemployment benefits that millions of Americans have relied on throughout the pandemic are set to expire after July, and lawmakers have separately faced pressure to fund additional testing and vaccine-development efforts as Covid-19 continues to spread unabated in many parts of the country.
The proposed legislation includes $15.5 billion to the National Institutes of Health for biomedical research, much of which has been disrupted by the forced hiatus at many universities and research centers. It also includes $4.5 billion for substance abuse and mental health initiatives, including emergency grants to states.
More than $10 billion of the research money, according to a bill summary, is an effort to restart much of the research conducted by the NIH that the pandemic has put on pause. Another $1.24 billion is earmarked for ACTIV, a public-private partnership through which numerous pharmaceutical companies have worked with NIH on vaccine and therapeutic development.
The numbers, in many cases, are staggering: The $15.5 billion for NIH represents nearly 40% of the agency’s annual funding allocation. BARDA’s $20 billion plus-up is even more extreme: In 2020, prior to the Covid-19 pandemic, the agency received just shy of $1.4 billion in funding.
Lilly Alzheimer’s test beats MRI in study
Results from a recent study evaluating the performance of Eli Lilly’s (LLY +2.2%) P-tau217, a blood test for Alzheimer’s disease (AD), showed it to be better at distinguishing AD from other neurodegenerative diseases than other blood-based biomarkers and magnetic resonance imaging (MRI). The data, just published in JAMA, will be presented virtually at the Alzheimer’s Association International Conference.
The study involved 1402 participants across three cohorts: [#1] 81 patients in Arizona (34 with AD and 47 without), [#2] 699 in Sweden (301 with no cognitive impairment, 178 with mild cognitive impairment, 121 with AD dementia and 99 with other neurodegenerative disease) and [#3] 622 in Colombia (365 with E280A mutations and 257 noncarriers).
The test, performed on plasma samples, accurately identified AD from other neurodegenerative diseases in cohorts 1 & 2. In the third, P-tau217 was elevated in mutation carriers’ blood for 20 years before anticipated symptom onset and was associated with memory performance.
The assay did not perform significantly better that cerebrospinal fluid- or positron emission tomography (PET)-based tau biomarkers.
Nevertheless, the test has the potential, together with digital tools for checking memory performance like smartphone apps, to significantly improve the diagnostic work-up of AD patients in the clinic.
The company says it “will continue to optimize” the test and determine its potential in clinical care.
Pfizer to seek FDA emergency use nod for COVID-19 vaccine as early as October
In an interview on CNBC, Pfizer (PFE +4.0%) chief Albert Bourla said the company plans to seek regulatory review of its emergency use authorization application for COVID-19 vaccine candidate BNT162b2 as early as October.
Most of the 30K trial participants will be vaccinated by the end of August. Preliminary immunogenicity data should be available by late September of early October.
Related ticker: BioNTech (BNTX -1.6%)
Selected COVID-19 vaccine tickers: Sanofi (SNY -0.4%), Johnson & Johnson (JNJ +0.3%), Moderna (MRNA +1.3%), Novavax (NVAX +5.4%)
Kodak to get $765 million U.S. loan to make drug ingredients
Eastman Kodak Co <KODK.N> will get a $765 million loan from the U.S. government to produce pharmaceutical ingredients in the country, helping reduce dependency on other countries by strengthening domestic supply chains.
The company’s shares were trading at $8.80 after closing at $2.62 in the previous session.
The U.S. International Development Finance Corp said on Tuesday it would sign a letter of interest to provide the loan to Kodak, a company known more for its cameras and imaging business.
The Trump administration has been looking to bolster the ability to produce drugs and their raw materials in the United States after the COVID-19 pandemic exposed the industry’s dependence on China and India for its supply chain.
“This is the beginning of American independence from our pharmaceutical dependence on foreign countries,” White House trade adviser Peter Navarro said in an interview with Fox Business network.
In May, the administration awarded a contract worth up to $812 million for a new U.S. company to manufacture drugs and drug ingredients in the country.
New York-based Kodak, which was founded in 1888, has a market capitalization of $114.6 million. The loan will allow it to launch Kodak Pharmaceuticals, a new arm of the company that will produce critical pharmaceutical components.
“By the time this thing ramps up, 25% of the (active pharmaceutical ingredients) for generics we need in the United States is going to be right at that facility,” Navarro said in the interview.
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