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Monday, April 5, 2021

Illumina Prelim Q1'21 Revenue; Updates Fiscal Year 2021 Revenue Guidance

 Illumina, Inc. (NASDAQ: ILMN) today announced preliminary revenue for the first quarter of fiscal year 2021 and updated its fiscal year 2021 revenue guidance. Subject to quarter-end closing adjustments, Illumina expects to report first quarter 2021 revenue of approximately $1,085 million, compared to $859 million in the first quarter of 2020. This represents year-over-year revenue growth of approximately 26% for the quarter. For fiscal year 2021, Illumina now expects year-over-year revenue growth in the range of 25%-28% compared to fiscal year 2020.

The company’s record preliminary revenue in the first quarter of 2021 was driven by:

  • Record orders of approximately $1.4 billion in the quarter and sequencing revenue growth of approximately 28% compared to the prior year period
  • Sequencing consumables growth of approximately 25% compared to the prior year period demonstrating the solid recovery from the COVID-19 pandemic and the strength of our core business. Most customers are now at or above pre-COVID activity levels. COVID-19 surveillance revenues for sequencing consumables were approximately $20 million in the quarter
  • Sequencing instrument growth of approximately 120% compared to the prior year period, reflecting strong performance across all instrument categories. The mid-throughput category achieved another record quarter in placements. Some customers built additional capacity for COVID-19 surveillance work and accelerated instrument purchases, which resulted in approximately $35 million of incremental instrument revenue in the quarter

“Our core business is exceptionally strong and growing ahead of our expectations. This is reflected in our outstanding preliminary first quarter revenue and, as a result, we are raising our 2021 revenue guidance,” said Francis deSouza, President and CEO. “We are seeing broad-based acceleration across our core clinical and research applications as more patients, physicians and researchers than ever access the benefits of next generation sequencing. In addition, we are experiencing increased demand for COVID surveillance globally due to the critical role that Illumina’s next generation sequencing technology plays in the fight against this pandemic.”

The company expects to report its full first quarter 2021 results on its upcoming quarterly conference call following the close of market on Tuesday, April 27, 2021.

https://www.businesswire.com/news/home/20210405005446/en/Illumina-Announces-Preliminary-Revenue-for-First-Quarter-Fiscal-Year-2021

Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover

 

  • Crossover allows participants to continue in trials and remain blinded
  • Ensures that all trial participants receive active vaccine
  • South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover planned

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's COVID-19 vaccine candidate. Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax' Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United Kingdom.

Under Novavax' updated clinical trial protocols[1], all participants in the UK and US Phase 3 trials will be offered the opportunity to receive an additional round of injections. Participants who elect to do so will receive an additional two-dose regimen of either vaccine (for those who originally received placebo) or placebo (for those who originally received vaccine). Participants in the South Africa Phase 2b trial will receive either active vaccine for those who initially received placebo, or a booster dose of active vaccine for those who initially received active vaccine. Participants across all three trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy in each trial, and all will be followed for up to two years to monitor the safety and durability of protection the vaccine. In the trials taking place in South Africa and the United Kingdom, half of the participants initially received the active vaccine while two-thirds of participants in PREVENT-19, the trial being conducted in the US and Mexico, initially received active vaccine.

"The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term," said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. "We are grateful to the volunteers who stepped forward to take part in our clinical trials, without whom we would be unable to develop, study and ultimately deliver what we hope will be a significant tool in the fight against COVID-19."

The company is also planning a crossover in the PREVENT-19 study, for which the company expects to read out initial clinical data during the second quarter. In addition, the company is planning to expand the trial to include pediatric and adolescent arms, which are also expected to begin in the second quarter.

https://www.prnewswire.com/news-releases/novavax-initiates-covid-19-vaccine-clinical-trial-crossover-301262318.html

'Double mutant' coronavirus variant surfaces in SF Bay Area

 The Bay Area has yet another coronavirus variant to contend with.

Through genomic sequencing, the Stanford Clinical Virology Lab has identified and confirmed one case of an emerging variant that originated in India, according to lab director Dr. Benjamin Pinsky. The lab is screening seven other presumptive cases and should have the results early this week, he said.

According to Pinsky and news reports, the confirmed case is a patient from a Stanford Health Care clinic and likely occurred in Santa Clara County. County health officials said they are not yet monitoring the new variant because it is not yet on the Centers for Disease Control and Prevention’s list of concern.

The variant is being dubbed the “double mutant” because it carries two mutations in the virus that helps it latch itself onto cells. It could possibly be responsible for the troubling new surge in cases in India. It is not yet known if the variant is more infectious or resistant to vaccine antibodies.

Peter Chin-Hong, an infectious disease expert at UCSF, said it appears the variant could be more infectious because it accounts for 20% of cases in the heavily hit state of Maharashtra. Chin-Hong said cases have increased more than 50% there in the past week.

“It also makes sense that it will be more transmissible from a biological perspective as the two mutations act at the receptor binding domain of the virus, but there have been no official transmission studies to date,” he wrote in an email.

One of the mutations, E484Q, is similar to the E484K mutation found on both of the variants first detected in Brazil and South Africa. The other mutation, L452R, is also found in a variant first detected in California. Pinsky said both mutations could possibly reduce neutralization by antibodies, therefore making vaccinations less effective against the strain.

“This Indian variant contains two mutations in the same virus for the first time, previously seen on separate variants,” Chin-Hong said. “Since we know that the domain affected is the part that the virus uses to enter the body, and that the California variant is already potentially more resistant to some vaccine antibodies, it seems to reason that there is a chance that the Indian variant may do that too.”

He said so far no studies have confirmed any of this. Still, Chin-Hong said it appears this variant may be more regional, as the B.1.1.7 variant that originated in the U.K. is the more dominant strain in India. And while it’s not certain if the variant is resistant to vaccines, he is “optimistic” that vaccinations will work given what is known about their efficacy against the variants originating from South Africa and California.

The latest discovery adds to the list of worrisome variants that have made their way to the U.S., including the widely spreading B.1.1.7. variant, which is 50% more infectious. The P.1 strain that originated in Brazil and a variant from South Africa have both been found in the Bay Area, and both are believed to be somewhat resistant to vaccines.

There are many cases statewide of the variants originating in California that are more infectious and could possibly be resistant to vaccines, and ones from New York identified in Santa Clara County that could also be potentially vaccine-resistant.

Pinsky said there is still much to be learned about the variant from India, but nobody should panic, especially because case numbers are down in California and large numbers of people are getting vaccinated.

“It’s important for us to continue to monitor the emergence of these variants,” he said. “The point is to keep getting vaccinated and to keep monitoring for the emergence of variants. I don’t think it is of significant concern yet. We just have to be vigilant.”

https://www.sfchronicle.com/local/article/Double-mutant-coronavirus-variant-surfaces-16076361.php


DeSantis spars with '60 Minutes' over vaccine rollout

 Florida Gov. Ron DeSantis (R) sharply shot down reporting by "60 Minutes" alleging he funneled the state's coronavirus vaccines to rich communities and privatized the vaccine rollout to benefit donors while many minorities in the state struggle to obtain access to an inoculation. 

CBS reporter Sharyn Alfonsi presented a far-ranging report for "60 Minutes" Sunday evening critical of Florida's vaccine rollout. Among other allegations, Alfonsi said DeSantis gave a contract to distribute coronavirus vaccines to the grocery store chain Publix after Publix made a $100,000 donation to his political action committee.

DeSantis declined a request for an interview, Alfonsi said, but she caught up with him at an event south of Orlando.

"Publix, as you know, donated $100,000 to your campaign and then you rewarded them with the exclusive rights to distribute the vaccine in Palm Beach," Alfonsi told the governor. 

"So first of all what you're saying is wrong," DeSantis replied. "That's a fake narrative. ... I met with the county mayor. I met with the administrator. I met with all the folks in Palm Beach County and I said, 'Here's some of the options. We can do more drive-thru sites. We can give more to hospitals. We can do the Publix.' And they said, 'We think that would be the easiest thing for our residents.'"

Alfonsi pressed DeSantis, saying his critics say the inequitable vaccine distribution and awarding of the contract to the grocery store to distribute the vaccine amount to a "pay for play" scheme. 

"It's wrong, it's a fake narrative," DeSantis said. "I just disabused you of the narrative and you don't care about the facts because obviously I just laid it out for you in a way that is irrefutable. So clearly it's not." 

Alfonsi attempted to chime in again, but DeSantis shouted over her: "No, no, no, you're wrong, you're wrong, you're wrong." 

Publix told "60 Minutes" there is no connection between the supermarket chain's campaign contributions and its partnership with the state to administer the vaccine.

State Rep. Omari Hardy (D) told "60 Minutes" DeSantis's decision to privatize the vaccine rollout has not worked for people of color in the state. 

She pointed to one low-income community without a Publix, meaning its residents, including elderly residents, would need to travel almost 30 miles to get a vaccine.

"Before, I could call the public health director. She would answer my calls. But now if I want to get my constituents information about how to get this vaccine, I have to call a lobbyist from Publix? That makes no sense," Hardy said. "They're not accountable to the public." 

The accusations regarding Publix come as DeSantis is already under fire for Florida's vaccine rollout. He's been accused of funneling vaccine doses to wealthy, white communities and steering pop-up vaccine sites to communities associated with political donors.

https://thehill.com/homenews/state-watch/546408-desantis-spars-with-60-minutes-over-vaccine-rollout-what-youre-saying-is

Renewed push to delay second Covid vaccine

 As Covid-19 cases spike and coronavirus variants continue to spread, the Biden administration is facing renewed calls to delay second vaccine doses and blanket more of the U.S. population with an initial shot.

Advocates of a strategy focused on first doses include Democratic and Republican senators, Trump administration surgeon general Jerome Adams, and at least four physicians or epidemiologists who advised President Biden on pandemic response issues prior to his inauguration, including the prominent surgeon and author Atul Gawande.

Despite the new advocacy, and its own warnings of “impending doom,” the Biden administration has given no indication it will budge. But the shift in opinion underscores the growing alarm at a possible fourth wave of U.S. Covid-19 cases — and frustration with the federal government’s lack of flexibility.

We need to get 50 million more people vaccinated as fast as we can,” said Zeke Emanuel, the physician who served as a key Obama administration health adviser and sat on President Biden’s pandemic advisory board during the transition. “We could get there in the next two and a half or three weeks if we focus on giving everyone one dose. I think we’re missing another opportunity.”

Gawande wrote this week that the Biden administration should delay second vaccine doses until 12 weeks following the first dose, as opposed to the current three- or four-week interval. Two other members, Emanuel and Michael Osterholm, have argued for delaying second doses since February. A fourth, CĂ©line Gounder, recently announced she was reconsidering her stance after months of vocally opposing the strategy.

The latest push comes as U.S. case rates have begun to tick upward, and as some states, including Michigan, have begun to experience a surge in hospitalizations reminiscent of July 2020 and January 2021. The U.S. has reported roughly 60,000 new cases per day for the last week, far below the country’s January peak but similar to last summer’s surge.

The Biden administration has stayed the course despite new evidence suggesting that even a single dose of the vaccines manufactured by Moderna or the Pfizer-BioNTech partnership is highly effective at reducing Covid-19 infections. Risk of infection, according to a recent study, falls by 80% two weeks after an initial shot. The figure increases to 90% two weeks after a second dose.

A growing number of public health experts have used the new data to argue that the strategy is clear-cut. In the short term, they contend, giving twice as many people 80% protection against the virus would do dramatically more to stop the spread than giving the current number 90% protection.

Other countries have already employed the delayed-dose strategy, with varying results. It has been highly successful in the United Kingdom, which has deployed the tactic with Pfizer-BioNTech’s and AstraZeneca’s vaccines, extending the interval between doses there to 12 weeks. Already, 47% of citizens have received at least one dose. Though only 7% of the population is fully vaccinated, daily case rates there have plummeted from roughly 55,000 in January to barely 5,000 today. In the U.S., by contrast, 31% of the population has received at least one shot and 18% are fully vaccinated.

“Britain is the best argument for a delayed second dose strategy,” Emanuel said. “They seem to have done it pretty successfully. Even with the B.117 variant …. their numbers are pretty remarkable.”

The vast majority of U.S. vaccinations to date have used two-dose vaccines, despite the February authorization of Johnson & Johnson’s single-dose immunization.

Last month, Canada, too, mandated a four-month gap between first and second doses of the Pfizer-BioNTech and Moderna vaccines, a move that has led to anger and frustration especially from the country’s seniors. Preliminary research, which has not yet been peer-reviewed, has shown the approach may be less effective for older people, whose immune response to the vaccines is typically weaker than in younger people.

Members of Congress who have advocated for the change include two Democratic senators, Chris Van Hollen (Md.) and Martin Heinrich (N.M), as well as a number of staunchly conservative Republican physicians, like Sen. Roger Marshall (Kan.) and Rep. Andy Harris (Md.).

“As a threat rises from new disease variants, we write to request your consideration of a new strategy to maximize the population receiving the COVID-19 vaccine in the near term,” Van Hollen and Heinrich wrote last month in a letter to Jeff Zients, the White House pandemic coordinator. “We encourage you to explore deploying existing second doses as first doses and rely on growing real-time inventory to cover future follow-on booster shots.”

In a separate letter, Republicans lawmakers urged the Biden administration to issue a new emergency authorization allowing health officials to give only a single dose of vaccines developed by Moderna and a Pfizer-BioNTech partnership “until all vulnerable and essential populations are inoculated, and more vaccine doses become available.”

Their calls, however, largely fell on deaf ears, particularly in February and early March, when U.S. case rates were sharply down from their peak of roughly 250,000 in January.

The shift would likely require a nod of approval from the Food and Drug Administration, which warned against deviating from the three- and four-week intervals in January, prior to Biden’s inauguration. In a statement, the agency’s former commissioner, Stephen Hahn, said he found proposals for delayed dosing strategies “concerning,” and that the agency continues to “strongly recommend that health care providers follow the FDA-authorized dosing schedule.”

Tony Fauci, the country’s chief infectious diseases researcher, has argued that there isn’t solid evidence to back a delayed-dose strategy. Even if an initial first dose gives good protection against Covid-19, he said at a recent White House briefing, it’s unclear how long that protection would last.

Beyond posing an unnecessary risk to individuals’ immunity, Fauci has also warned that pivoting midway through the vaccine rollout could send the message that there’s no need to return for a second shot, whether it’s three or 12 weeks after their first.

Fauci has also warned that delaying second doses could help foster the growth of “escape” variants, or strains of the SARS-CoV-2 virus that are more likely to evade existing vaccines’ protectiveness.

A paper published this week in Nature, however, argued the opposite: There is little evidence that so-called “dose-sparing” strategies help to select for escape variants. The math, its authors note, is simple.

“[If] individuals who receive half as much vaccine (one versus two doses, or half the quantity of antigen per dose) achieve more than half the protection from clinical infection of those given a full regimen, then spreading the vaccine among more individuals will produce greater reductions in the number of clinical infections,” they wrote.

https://www.statnews.com/2021/04/02/democrats-and-republicans-alike-pressure-biden-administration-to-pursue-single-dose-vaccine-strategy/

Thank private risk-taking, not public funding, for Covid-19 vaccines, therapies

 growing chorus of lawmakers and activists is calling on the Biden administration to invalidate patent protections for Covid-19 vaccines. As they see it, the federal government invested in the research that led to today’s vaccines so the private companies behind them shouldn’t benefit from intellectual property protections.

That argument is as misinformed as it is dangerous.

I’ll use the Moderna vaccine as an example. Though the National Institutes of Health and academics helped lay a scientific foundation for our understanding of messenger RNA — the relevant technology at the heart of Moderna’s shot — the vaccine itself is the result of years of privately backed research and development. That life-saving work wouldn’t have been possible without a predictable system of intellectual property protection.

It’s easy to come away with the misimpression that the recent crop of Covid-19 vaccines is mainly the product of an aggressive federally backed research effort. Operation Warp Speed, after all, was an $18 billion initiative aimed at fostering vaccine production. There’s no doubt it helped accelerate the testing and manufacturing of successful vaccines.

But the technologies behind the leading Covid-19 vaccines long predate Operation Warp Speed. They are, in fact, the product of extraordinary private sector investment.

Moderna, for example, had been working on its mRNA technology for a decade before Covid-19 emerged as a global health threat. During that period, investors risked tens of millions, year after year, in the hopes that a breakthrough method for generating stem cells from messenger RNA might be used to create a host of powerful new treatments.

This gamble ultimately paid off. The years of work on mRNA enabled Moderna to design a successful Covid-19 vaccine just 42 days after the virus was genetically sequenced.

But there was no guarantee, federal or otherwise, that Moderna’s new technology would be a success. What made investors willing to risk so much money was a system of intellectual property protection that would allow them, if successful, to recoup and profit from their investment.

Without such protection, biotech firms would have no way of preventing copycats from stealing their technology, undercutting them on price, and removing any chance for innovator firms to earn back their upfront costs. In such a no-holds-barred environment, there would be little reason to invest in medical technology at all, and breakthroughs like Moderna’s vaccine would be all but impossible. This is precisely the scenario that anti-patent crusaders risk creating.

The same can be said of those pushing for government price controls. By removing the ability of private investors to profit from successful medical advances, such policies would destroy the incentive structure that enabled Moderna and other firms to deliver vaccines at record speed.

Some misleadingly claim that a government takeover of the fruits of U.S. medical innovation is justified because the government funds basic research through the National Institutes for Health. But federally supported basic research is more akin to public infrastructure spending than to private-sector research and development efforts.

When the government invests in roads and bridges, it creates the conditions for increased economic activity, employment, and other positive outcomes — including higher tax revenue for government. It would be absurd for the government to claim ownership of a company because trucks transport its products on publicly-funded roads and bridges.

The same is true of the basic research funded by the NIH. The federal government invests in the scientific community’s understanding of cancer or heart disease or Covid-19. But it relies on the private sector to do the risky and expensive work of turning promising discoveries into practical medical treatments.

For real-world context of this dynamic, look at remdesivir, an antiviral drug, which was the first drug approved by the FDA to treat Covid-19. It is the culmination of a nearly $1.8 billion effort on the part of Gilead Sciences. Over the course of 20 years, the company synthesized, patented, and manufactured the compound to treat a range of coronaviruses.

Questions have been raised about the government’s role in the drug’s discovery and its entitlement to patent rights. But the truth is, federal agencies centered their efforts on standard testing of the drug’s existing antiviral properties. Their work did not involve modifications to remdesivir or its parent compounds, according to a new report from the Government Accountability Office. And, all told, federal contributions amounted to $162 million, which pales in comparison to Gilead’s investment.

That critical — but often misunderstood — division of labor is reflected in the research budgets of private-sector drug firms writ large. In 2019, America’s largest pharmaceutical firms spent $83 billion on R&D. That number is more than double the entire NIH budget for that year — and doesn’t include the billions spent by small startups at the forefront of innovation.

The Covid-19 vaccines and therapies that are helping to end this pandemic are proof of the enormous power of private drug innovation. Whether they realize it or not, those calling for patent waivers and price controls are jeopardizing the system that made these vaccines possible.

John Stanford is executive director of Incubate, a Washington-based coalition of life-science venture capitalists.

https://www.statnews.com/2021/04/05/thank-private-risk-taking-not-public-funding-for-covid-19-vaccines-therapies/

Chembio Diagnostics launches rapid COVID-19 test

 Shares of Chembio Diagnostics Inc. CEMI, +57.88% skyrocketed 63.8% on record volume in afternoon trading Monday, to pace all gainers listed on major U.S. exchanges, in the wake of the point-of-care diagnostics company's announcement of the commercial launch of its rapid COVID-19/flu test. The stock was on track for the biggest one-day percentage gain since it doubled, on March 12, 2004. Trading volume ballooned to 206.6 million shares, compared with the full-day average of less than 1 million shares. The company said its test has been granted emergency use authorization by the Food and Drug Administration. Chembio said after Thursday's closing bell that the product, which produces results in 15 minutes, requires no instrumentation and simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections, is immediately available for shipment. "As COVID-19 converges with the flu, it is critical for physicians to be able to quickly differentiate between these viruses at the point-of-care, which present with nearly identical symptoms, in order to take appropriate clinical actions and maximize efficient use of healthcare resources," said Charles Caso, vice president of sales and marketing at Chembio. The stock has run up 21.4% year to date, while the S&P 500 SPX, +1.40% has gained 8.6%.

https://www.marketwatch.com/story/chembio-diagnostics-stock-rockets-on-record-volume-after-commercial-launch-of-rapid-covid-19-test-2021-04-05