Qiagen Adjusts FY21 Expectations Downward

 Qiagen on Monday reported preliminary second quarter revenues and earnings per share above prior guidance and analysts' estimates as lower COVID-19 testing sales were tempered by stronger-than-expected growth in the company's core portfolios.

However, Qiagen also adjusted its full-year outlook for revenue growth downward and said it expects full-year EPS to be at the low end of its prior guidance range as COVID-19 vaccine uptake is expected to continue to weigh on the firm's testing revenues. The company also initiated a $100 million share repurchase program.

For the three months ended June 30, Qiagen expects to report total revenues of $567.3 million, up 28 percent year over year or 24 percent at constant exchange rates (CER), besting the company's prior outlook for 20 percent CER growth and beating analysts' consensus expectation of $554.4 million.

Non-COVID-related product groups rose 52 percent at CER to $407.6 million in Q2 and represented 72 percent of total sales, Qiagen said. Meanwhile, COVID-19 product group sales declined 17 percent at CER to $159.7 million from a year ago as testing demand waned due to increased vaccination uptake.

By product type, Q2 consumables and related revenues grew 28 percent at CER to about $498 million, while instrument sales fell 3 percent at CER to $69 million. By customer class, molecular diagnostics grew 28 percent at CER to $272 million while life sciences jumped 20 percent at CER to $296 million.

Qiagen said that it expects adjusted Q2 EPS of $.65 to $.66, beating previously stated guidance of $.62 to $.64 and trumping analysts' average estimate of $.62.

Qiagen updated its full-year 2021 outlook for net sales growth of 12 percent at CER compared to prior guidance of 18 percent to 20 percent at CER, and adjusted EPS of at least $2.42 compared to prior guidance of $2.42 to $2.46. On average, analysts are expecting full-year EPS of $2.47.

For the third quarter of 2021, Qiagen expects adjusted net sales to be flat year over year at approximately $483.8 million and adjusted EPS to be in the range of $.52 to $.53 compared to $.58 in the year-ago period. On average, analysts are expecting Q3 EPS of $.58.

"We welcome the success of vaccination campaigns and their contributions to moving the world beyond the pandemic," Qiagen CEO Thierry Bernard said in a statement. "At the same time, the faster-than-expected uptake has led to a reduction in demand for COVID-19 testing. This has prompted us to update our view on COVID-19 testing trends for the second half of 2021, and update the outlook for sales and adjusted EPS growth. As we prepare Qiagen for sustained growth beyond the pandemic, and reaffirm the mid-term targets set for our five pillars of growth, we are confident in developing a stronger and more differentiated leadership position."

Qiagen's share repurchase program will see the company purchase up to $100 million of its shares, excluding transaction costs. Based on the closing price of $50.52 on July 9, this represents approximately 2 million shares, the company said.

The share repurchase program "reflects our confidence in Qiagen's growth prospects and is a reaffirmation of our commitment to increasing returns for shareholders," Qiagen CFO Roland Sackers said in a statement.

Shares of Qiagen were down more than 3 percent at $48.81 at the close market Monday on the New York Stock Exchange. The company plans to release its full Q2 earnings on July 29.

https://www.genomeweb.com/business-news/qiagen-reports-preliminary-q2-revenues-above-guidance-adjusts-fy21-expectations

J&J vaccine may pose 'small possible risk' for rare nerve condition

 Federal health officials warned Monday that Johnson & Johnson’s single-dose COVID-19 vaccine may pose a "small possible risk" of a rare, but serious side effect: Guillain-Barré syndrome, an autoimmune disorder that can cause muscle weakness and occasionally paralysis.

The Centers for Disease Control and Prevention (CDC) said in a statement that it has seen roughly 100 reports of individuals contracting the Guillain-Barré syndrome after receiving the Johnson & Johnson COVID-19 vaccine. Around 12.8 million doses of the vaccine have been administered nationwide. 

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What You Need To Know

• The CDC said in a statement that it has received roughly 100 accounts of individuals contracting the rare but dangerous autoimmune disorder Guillain-Barré syndrome after receiving the Johnson & Johnson COVID-19 vaccine
  
  
• The FDA will reportedly announce a new warning that links the Johnson & Johnson vaccine to a rare autoimmune disease later this week, according to multiple reports


• Nearly 13 million Americans have been vaccinated with the single-shot J&J vaccine


• Guillain-Barré is a rare autoimmune disorder in which a “person’s own immune system damages the nerves, causing muscle weakness and sometimes paralysis,” per the CDC

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According to multiple reports, the Food and Drug Administration (FDA) is expected to announce a new warning linking the J&J vaccine to Guillain-Barré syndrome some time this week.

The news of the expected announcement was first reported by the Washington Post on Monday, and later confirmed the New York Times. 

The reports say most of the cases appeared around two weeks after an individual was vaccinated against COVID-19, and primarily occurred in men over the age of 50. The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.

Spectrum News has reached out to the FDA and the CDC for comment. J&J didn’t immediately respond to a request for comment from The Associated Press.

Guillain-Barré is a rare autoimmune disorder in which a “person’s own immune system damages the nerves, causing muscle weakness and sometimes paralysis,” per the CDC. 

Symptoms include tingling or weakness, often in the upper body, that can lead to partial or full paralysis that typically is temporary.

Typically, anywhere from 3,000-6,000 people develop Guillain-Barré on an average year nationwide. While most people who develop Guillain-Barré make a full recovery, some are left with permanent nerve damage — and a small number of people have died after developing the autoimmune disorder. 

Several factors are linked to the onset of Guillain-Barré, with about two-thirds of those who develop the syndrome having contracted diarrhea or a respiratory illness in the two weeks prior to diagnosis. 

The CDC notes that “very rarely” have people developed Guillain-Barré after receiving certain other vaccines. While experts previously discovered an apparent link between a 1976 vaccination created specifically for the swine flu and an uptick in Guillain-Barré cases, the increased risk amounted to approximately one additional case for every 100,000 vaccines administered. 

Officials at the CDC saw only one case of Guillain-Barré in an individual who received a trial dose of the Johnson & Johnson vaccine last year, with an additional case in the group who received a placebo shot. 

While the rate of those developing Guillain-Barré after the Johnson & Johnson vaccine is markedly low, the announcement will likely serve as yet another blow to the company which has struggled to gain the public’s trust. 

In April, the FDA and CDC temporarily paused administration of the vaccine after several recipients in the U.S. developed a rare disorder involving blood clots.

That pause was lifted within days, with health officials maintaining that the benefits of the Johnson & Johnson vaccine far outweighed the risks. 

The company hasn’t been able to produce as much of the vaccine as expected because of problems at a Baltimore factory that helps make the shots.

https://spectrumlocalnews.com/nys/capital-region/news/2021/07/12/johnson-janssen-covid-coronavirus-vaccine-autoimmune-disease

Vaccine To Get WHO Approval 'At The Earliest' - Bharat Biotech

 With a review process of Covaxin, the indigenous vaccine against COVID-19, commencing at the World Health Organisation (WHO), the Hyderabad-based Bharat Biotech on Monday said it expects to receive emergency use listing (EUL) from the global body at the earliest.

"All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from the WHO at the earliest," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.

A WHO pre-qualification, or a EUL, is necessary for a vaccine company to supply vaccines for global facilities such as Covax or international procurement.

The WHO has approved vaccines Pfizer-BioNTech, AstraZeneca- SK Bio/SII, Johnson & Johnson Janssen, Moderna and Sinopharm for emergency use.

The indigenous vaccine showed 63.6 per cent efficacy against the Delta variant of Covid-19, which has spread in many other countries. Covaxin demonstrated 93.4 per cent efficacy against severe symptomatic Covid-19 and 63.6 per cent against asymptomatic Covid-19.

The trial was conducted on 25,800 subjects, and the data submitted to the Subject Expert Committee (SEC) showed the vaccine was "well-tolerated."

https://www.ndtv.com/india-news/bharat-biotech-world-health-organisation-nod-for-covaxin-covid-19-vaccine-emergency-use-listing-at-the-earliest-2485166

Sigilon hold hurts ahead of key haemophilia meeting

 Sigilon Therapeutics had claimed that its cell therapy SIG-001 could have advantages over gene therapies for haemophilia A. Now the group is contending with a hold on the project’s phase 1/2 trial after a patient developed inhibitors.

It is unclear whether SIG-001 caused the issue, and the company suggested that the problem might be patient-specific. Still, the development adds to doubts about uptake of cell and gene therapies for haemophilia, just as the annual meeting of the International Society on Thrombosis and Haemostasis (ISTH) approaches.

Gene therapy data

That meeting, being held on July 17-21, will feature data on various haemophilia A gene therapies, including the current frontrunner, Biomarin’s valoctocogene roxaparvovec (valrox), and Roche’s SPK-8011, acquired from Spark. There will also be results with a possible wild card, Bayer/Ultragenyx’s BAY 2599023, which is designed to be a more durable option.

Questions about durability have hung over haemophilia A gene therapies since Biomarin reported phase 1/2 data with valrox. ISTH will see five-year results with the 6x1013vg/kg dose, which might make things clearer; at four years the median factor VIII level was 16% of normal.

At the conference there will also be more data from the pivotal Gener8-1 study, for which initial results were released in January. Although mean factor VIII levels were 43% at one year, there were signs that this was beginning to wane over the longer term (Pivotal valrox data give Biomarin déjà vu, January 11, 2021).

Nevertheless, on this measure valrox still looks more impressive than SPK-8011. The ISTH abstract for the latter details a mean FVIII level of around 12% in 11 patients followed for over two years. It is unclear how important this metric is, or whether the FDA will be more focused on a reduction in bleeding.

Another question is how much of a priority SPK-8011 is for Roche. The group has been relatively quiet about the project since finalising its purchase of Spark in December 2019; the acquisition was scrutinised by the FTC amid worries that Roche might squash the development of SPK-8011 to benefit its haemophilia blockbuster, Hemlibra.

A phase 3 study of SPK-8011 is slated to start this year but there is no sign of it yet. As Evaluate Vantage went to press Roche had not responded to questions about the status of this trial.

More durable?

Questions over durability – which have also hit Pfizer/Sangamo’s giroctocogene fitelparvovec – could make haemophilia A patients wary about gene therapy, particularly as these therapies cannot be redosed, and patients already have other options.

Step forward Bayer, which believes that it has a longer-lasting candidate in BAY 2599023. Initial data on the project from six patients, presented at last year’s Ash meeting, suggested a dose response, although FVIII levels remained relatively low, apart from in one patient.

However, Bayer’s head of rare disease, Francesca Ferrante, previously stressed to Evaluate Vantage that this is was dose-finding study and that any efficacy would be a bonus.

ISTH will feature data on eight patients, including two new patients receiving a 2x1013vg/kg dose of BAY 2599023 plus prophylactic steroids. Bayer also has the option to increase the dose to 4x1013vg/kg.

Source: ISTH abstract

As for Sigilon, that group might take heart that other studies of haemophilia A therapies have been put on hold and then restarted again relatively quickly: Novo Nordisk’s concizumab and Alnylam/Sanofi’s fitusiran both managed to overcome non-fatal thrombotic events and get pivotal trials going again last year.

It is also worth noting that inhibitors are a common complication of FVIII therapy, a current mainstay of haemophilia A treatment.

Still, Sigilon’s stock sank 25% on Friday and, with a market cap of $218m, the group is trading not far off cash levels. Gaining an edge in a crowded market was always going to be tricky, and things have just got trickier for the company.

Selected novel projects in development for haemophilia A
Project	Company	Description	Trial details
Phase 3
Valoctocogene roxaparvovec	Biomarin Pharmaceutical	Factor VIII gene therapy	Gener8-1, initial data reported Jan 2021
Giroctocogene fitelparvovec (SB-525)	Pfizer/Sangamo	Factor VIII gene therapy	Affine
Efanesoctocog alfa (BIVV001)	Sanofi/Sobi (ex Bioverativ)	Once-weekly factor VIII replacement therapy	Xtend-1; Xtend-Kids
Concizumab	Novo Nordisk	Tissue factor pathway inhibitor antibody	Explorer 7; Explorer 8*
Marstacimab (PF-06741086)	Pfizer	Tissue factor pathway inhibitor antibody	Basis
Fitusiran	Alnylam/Sanofi	Anti-thrombin-targeting RNAi therapeutic	Atlas A/B; Atlas-PPX*
Phase 1/2
SIG-001	Sigilon Therapeutics	Encapsulated allogeneic factor VIII cell therapy	Ph1/2 on hold – pt developed inhibitors
SPK-8011 (RG6357)	Roche (ex Spark)	Factor VIII gene therapy	Ph1/2
SPK-8016 (RG6358)	Roche (ex Spark)	Factor VIII gene therapy	Ph1/2 in inhibitor pts
BAY 2599023/DTX201	Bayer/Ultragenyx (ex Dimension)	Factor VIII gene therapy	Ph1/2
ASC-618	ASC Therapeutics	Factor VIII gene therapy	Ph1/2
CD68-ET3-LV	Expression Therapeutics	Haematopoietic stem cell transplantation gene therapy	Ph1
*Previously paused but restarted; Source: Evaluate Pharma & clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/trial-results/sigilon-hold-hurts-ahead-key-haemophilia-meeting

UK health chief: England will lift all lockdown restrictions

 All remaining lockdown restrictions in England will be lifted in a week despite a sharp rise in coronavirus cases, Britain’s health secretary said Monday, adding it’s the right time to allow Britons a chance to return to normal life.

Sajid Javid told Parliament that Britain’s successful vaccine rollout means that nine out of 10 adults in the U.K. now have antibodies against the virus. The government is on track to meet its target of offering all adults a first vaccine dose by July 19, the day when all remaining lockdown restrictions, including mandatory mask-wearing, are set to be lifted.

As of Monday, 87% of the U.K.’s adult population have had their first dose, and 66% have had both doses.

Javid said while new infections could reach 100,000 a day later in the summer, driven by the more transmissible delta variant, two doses of the vaccine offer effective protection against serious illness from the virus and officials believe the surge in cases will not put “unsustainable pressure” on hospitals. Waiting any longer to lift restrictions will risk having the virus spread in the winter, when hospitals are most likely to be overwhelmed, he added.

“There will never be a perfect time to take this step, because we simply cannot eradicate this virus — whether we like it or not, coronavirus is not going away,” he said.

The U.K. as a whole has seen infections soar in recent weeks as a result of the delta variant, first found in India. Daily infection levels are running at over 30,000, their highest rates since January. Most infections have largely occurred among younger people, many of whom have yet to receive a first dose of vaccine.

The British government hopes that the vaccine rollout has severely disrupted the link between infections and those needing hospitalization. However, both the number of people requiring hospitalization and dying from COVID-19 have been edging up in recent days, though not at the same rate as infections.

Still, concerns over the rapid increase in cases has piled pressure on the government to take a more cautious approach over lifting restrictions. Authorities are expected to recommend that people continue to wear face masks in enclosed places, such as on public transport and in shops.

Public health officials and scientists have been voicing their concerns, saying ditching masks and social distancing altogether could be dangerous.

Professor Peter Openshaw, a member of a group that advises the government on new and emerging respiratory viruses, said it was vital to keep some protective measures in place, such as wearing masks.

“I really don’t see why people are reluctant to wear face coverings, it is quite clear that they do greatly reduce transmission,” he told BBC radio. “Vaccines are fantastic but you have to give them time to work. And in the meantime, keeping up all those measures which we have learned to reduce the transmission is to me really vital.”

The British government, which enforced one of the longest lockdowns in the world, has lifted restrictions for England in a series of steps that began with reopening schools in March. The fourth and final stage was delayed last month to provide time for more people to be vaccinated amid the rapid spread of the delta variant.

Other parts of the U.K. — Scotland, Wales and Northern Ireland — are following their own, broadly similar, road maps out of lockdown.

https://apnews.com/article/europe-business-health-government-and-politics-coronavirus-pandemic-3776cfdb1c180720b9ea000a2c65618b

Does Shocking CDC Statement Mean Trouble for Pfizer and Moderna?

 

Key Points

• Pfizer and Moderna vaccines are more than 90% efficacious.
• But real-world data shows immunity is declining when it comes to prevention only.
• Pfizer and Moderna count on selling booster shots to keep immunity strong.

Coronavirus vaccine leaders Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) announced earlier this year that they'd launched clinical trials of booster shot candidates -- and you could almost hear the world's collective sigh of relief. As coronavirus variants gained ground, everyone's big worry was staying ahead of them. Boosters may help because they offer the already vaccinated person's immune system an extra push.

Moderna has said it aims to bring a booster to market this fall. And Pfizer just last week said it's ready to file for regulatory approval of its third-shot booster candidate in the coming weeks. On the same day as Pfizer's news, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) delivered a startling message. One that could upset Pfizer's and Moderna's booster plans.

No need for a booster

"Americans who have been fully vaccinated do not need a booster shot at this time," the agencies said in a joint statement.

The reason? Today's vaccines are very efficacious against the original coronavirus and variants so far. And they're especially effective at protecting people from hospitalization and death.

This is true. Pfizer and Moderna both have reported six-month follow up data from their phase 3 trials. Their vaccines boast overall efficacy of 91.3% and more than 90%, respectively. And both companies have performed in vitro tests that demonstrate satisfactory vaccine efficacy against variants of concern.

So... maybe the U.S. health agencies are right? And maybe this means the companies' chances of selling boosters are getting pretty slim? Wait a minute. Let's not get ahead of ourselves.

First, let's talk about whether the CDC and FDA are right. Technically, they may be right this very moment. The Delta variant -- the strain originating in India -- is becoming more and more prevalent. But overall, coronavirus cases in the U.S. have dropped considerably since April. So, there is evidence the vaccines we have are doing their job. Without the help of boosters.

But Pfizer and Moderna themselves have warned of waning immunity several months after vaccination. In the U.S., the new number of vaccine doses administered peaked in early April. That means by October, all of those vaccinated in April and earlier probably should start thinking about getting a booster. Pfizer's CEO has said a booster likely will be needed six to 12 months after initial vaccination.

Efficacy is declining

Real world data out of Israel also indicates boosters may be needed sooner rather than later. The Pfizer vaccine -- the vaccine Israel has relied on -- showed only 64% efficacy in preventing the coronavirus last month, according to the country's health ministry. Its efficacy in avoiding hospitalization and death still remains high at 93%. That's the most important goal of the vaccine. But a decline in overall efficacy isn't a trend we want to see continuing. Thus, the need for a booster to give immunity a lift.

In my opinion, the CDC and FDA won't be right for very long. If current trends continue, the agencies may find themselves revising their statement by fall -- that's the moment Pfizer and Moderna expected to launch booster shots anyway.

And this leads us to my next point. The CDC and FDA statement today probably won't hurt eventual sales and use of booster shots. The agencies' comments pertained to what's happening right now. Many people have been freshly vaccinated and immunity is strong. But, as mentioned earlier, Pfizer, Moderna and other experts have given us a potential timeframe for immunity. That means boosters by fall or winter are pretty much inevitable. And that equals demand for these shots before the end of the year.

So, yes, the message from the CDC and FDA surprised many of us. But it doesn't represent difficulties ahead for Pfizer's and Moderna's booster candidates. Even if the coronavirus situation improves, boosters still will be needed as part of the companies' planned vaccination regimens. So, for vaccine stock investors -- and the companies themselves -- revenue expectations are still very much on track.

https://www.fool.com/investing/2021/07/12/could-this-cdc-comment-hurt-pfizer-and-moderna/

Sputnik V second dose shortage to delay India's full rollout - Dr Reddy's

 

India's full rollout of the Sputnik V COVID-19 vaccine will have to be put on hold until the Russian producer provides equal quantities of its two differing doses, Dr. Reddy's Laboratories Ltd said on Monday.

Dr. Reddy's had received about 3 million first doses by June 1 and about 360,000 doses of the second by early this month, the company and the Indian government have said.

"As a matter of responsibility, we would not like to announce a full-fledged commercial launch until we have an equivalent quantity (of the second dose)," Dr. Reddy's said in an e-mail to Reuters.

Dr. Reddy's, which originally planned a full rollout in mid-June, is currently running a pilot programme under which more than 195,000 doses have been administered at hospitals across the country.

"It is our commitment to ensure supply of component 2 in equal quantity and on time to all partner hospitals to whom we have supplied dose 1," the company said, declining to share more details ahead of its financial results.

India has approved a gap of 21 days between the two doses.

The Russian Direct Investment Fund, which markets the vaccine abroad, did not immediately respond to a request for comment.

The Indian government expects 100 million locally produced and imported Sputnik V doses to be available in the country between August and December. India is expected to be one of the biggest manufacturing hubs of the vaccine.

India has administered more than 375 million vaccine doses, the world's most after China, inoculating 32% of its estimated 944 million adults with at least one dose.

It is mainly relying on the AstraZeneca shot and one developed at home by Bharat Biotech and the state-run Indian Council of Medical Research.

Daily vaccinations hit a national record of 9.2 million doses on June 21 but have dropped to around 4 million per day.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Exclusive-Sputnik-V-second-dose-shortage-to-delay-India-s-full-rollout-Dr-Reddy-s-35836556/