Pfizer Sees Vaccine As 'Durable Revenue Stream,' Seeks Approval For Children 2 To 11

 Yesterday, Pfizer released a strong earnings report (surpassing Wall Street's elevated projections), and also revealed that it's both on the cusp of securing regulatory approval in the US for minors between the ages of 12 and 15 to receive the vaccine (setting off another wave of demand as the Biden Administration heaps pressure on states to get their vaccination numbers up).

During a call with analysts and reporters, CEO Albert Bourla revealed that Pfizer is in talks with "basically all the governments of the world" about providing shots and booster shots through 2024.

The key number is that Pfizer expects sales of its coronavirus jab to hit $26 billion by the end of this year, a milestone that would make the vaccine the company's biggest-selling pharmaceutical product, eclipsing Humira, the popular rheumatoid arhtritis drug made by Abbvie. Also, Pfizer said it intends to use its mRNA technology underpinning its COVID-19 jab for other therapies and vaccines. For example, the company is working on creating seasonal flu shots using the same RNA lipid nanoparticle technology.

Bourla has already primed the public to expect to receive at least one additional shot within a year of their second dose, while also teasing the likelihood that the world might require annual booster shots - something that would be a boon to Pfizer's bottom line as it moves to grow its COVID-19 vaccine division into a major, and permanent, line of business.

To help make its product more durable (and thus increase demand in poorer countries) the company said it is studying whether doses ould be stored at standard refrigerator temperatures.

Regardless, Bourla expects "durable demand" for vaccnes, similar to the flu vaccine.

"It is our hope that the Pfizer-BioNTech vaccine will continue to have a global impact by helping to get the devastating pandemic under control and helping economies around the world not only open, but stay open," Bourla said in prepared remarks.

That's bad news for the rag-tag band of emerging-market economies pushing a proposal at the WTO to waive IP rights when it comes to vaccine technology. If Washington were to back such a move, it would supercharge the "open vaccine" movement, and represent a major threat to Pfizer's latest profit stream. That effort is being led by India and South Africa, yet Bill Gates and Washington lobbyists have continued to insist that respecting IP and letting Big Pharma handle global distribution (as Covax dramatically lags expectations), which means the status quo is likely safe.

Even as WHO chief Tedros Adhanom Ghebreyesus decries a "shocking imbalance in the global distribution of vaccines" and calls for more efforts to fortify the WHO's Covax programs and speed up delivery to poorer nations, Pfizer appears to be more focused on building out its latest profit stream.

President Biden said Tuesday that while he had yet to make a decision on whether to support a vaccine waiver, the US was already moving "as quickly as we can" to export doses.

Pfizer's earnings were so strong, they helped lift shares of vaccine makers on the other side of the world. Shares of some Asian vaccine makers with deals to distribute Pfizer's jabs on the Continent rallied in sympathy with Pfizer. India's Pfizer Ltd., a unit of Pfizer, rallied 4.9%, on Wednesday while Dr Reddy's and Cadila Healthcare rallied as much as 2.7% and 5.9%.

Looking ahead, CNN reported Wednesday that the FDA will approve the Pfizer-BioNTech COVID jab for use in 12 to 15 year olds as early as next week. Data released by Pfizer recently purported to show that the jab is 100% effective at preventing serious symptoms. According to recent media reports, Pfizer is also seeking approval for the vaccine to be used on children as young as 2 and as old as 11 in both the US and Europe, an authorization it expects to arrive in September.

https://www.zerohedge.com/covid-19/pfizer-expects-covid-jab-will-be-durable-revenue-stream-approval-12-15-year-olds-looms

Roche Tecentriq OKd by EC as first-line monotherapy for people non-small cell lung cancer

 -- Tecentriq significantly improved overall survival in people with high

      PD-L1 expression, compared with chemotherapy in a Phase III study 
 
   -- Tecentriq approval offers an alternative to chemotherapy for all eligible 
      patients 
 
   -- This approval marks Tecentriq's fourth indication in metastatic non-small 
      cell lung cancer and fifth indication in lung cancer overall in the EU 
 

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Press-Release-nbsp-Roche-s-Tecentriq-approved-by-European-Commission-as-a-first-line-monotherapy-t-33159989/

Novo Nordisk lifts guidance after first quarter beat

 

Denmark's Novo Nordisk raised its sales and profit forecasts on Wednesday after beating first-quarter earnings expectations, lifting shares in the world's biggest maker of diabetes drugs.

Sales were still hit by the effect of patients and wholesalers stocking up on drugs last year in preparation for the COVID-19 pandemic, Novo said, but inventory changes and the timing of shipments had offset that in the first quarter.

"We are very encouraged with the sales growth in the first three months of 2021," Chief Executive Lars Fruergaard Jorgensen said.

Novo Nordisk now expects sales growth in local currencies this year to come in at between 6% and 10%, up from a previous forecast of 5% to 9%, and operating profit growth in local currencies in the range of 5% to 9%, up from an earlier estimate of 4% to 8%.

Shares in Novo Nordisk traded up 1.82% at 0753 GMT.

Sales in local currencies rose 7% in the first quarter to 33.8 billion Danish crowns ($5.46 billion), above a forecast of 32.5 billion in a Refinitiv poll, while operating profit came in at 14.98 billion Danish crowns, beating analysts' expectations for 14.6 billion.

"It's a strong start to the year," Sydbank analyst Soren Lontoft Hansen told Reuters.

By volume Novo Nordisk is the world's biggest insulin provider, but an increasingly competitive global insulin market means it aims to sell more of its newer drugs, many of which are used to treat type 2 diabetes.

Revenues were driven by a 13% rise in sales of its GLP-1 products, which imitate an intestinal hormone that stimulates insulin production, offsetting a 7% overall drop in insulin sales.

Sales of its recently launched once-daily diabetes pill Rybelsus grew 247% to 729 million crowns, which Hansen said lagged expectations as the pandemic had made it difficult for Novo to promote the drug to physicians.

"As the U.S. is gradually coming out of a lockdown... we are very optimistic that we'll stay on a very positive trajectory for Rybelsus," Chief Executive Jorgensen told a media briefing.

https://www.marketscreener.com/quote/stock/NOVO-NORDISK-A-S-1412980/news/Novo-Nordisk-A-S-nbsp-lifts-guidance-after-first-quarter-beats-expectations-33160479/

Facing chips shortage, Biden may shelve blunt tool used in COVID fight

 Some critical industries could suffer if the U.S. government uses a national security law to redirect scarce computer chips to the auto industry, a senior administration official told Reuters.

The analysis suggests the White House could opt to reject calls to invoke the Defense Production Act by automakers and a bipartisan set https://www.rubio.senate.gov/public/index.cfm/2021/2/rubio-coons-urge-biden-to-invoke-defense-production-act-to-address-semiconductor-shortage of U.S. lawmakers.

Numerous automakers have been forced to slow or pause production due to a lack of semiconductors and have spoken with the White House about possibly using the 1950 law that allows the government to force companies to produce materials for national security reasons.

Still, many auto industry officials said privately they do not think invoking the act would be feasible or likely.

Asked whether using the law was a possibility, the administration official said "the short-term outlook is challenging."

Reallocating semiconductors to automakers "would result in fewer chips for others," the official, who is involved in high-level discussions on the issue, told Reuters. Such a move could hurt makers of consumer electronics such as laptops and medical devices like pacemakers, the official added.

"This is the worst nightmare if you're a supply chain manager," said another person familiar with the White House's thinking. "As a nation, it's terrible."

No final decisions have been made, people familiar with the matter said.

The official said the administration is pushing chips users and producers to increase transparency by improving the capacity to forecast demand and generating better information on how chips are moving through supply chains to end users.

The administration plans to issue recommendations once it completes a 100-day review required under a February executive order by Biden, including ways to "incentivize and encourage production at home and surge capacity," the official said.

The review is looking at supply chains for semiconductors, high capacity batteries, critical minerals and pharmaceuticals and active pharmaceutical ingredients.

Biden used the Korean War-era law to boost vaccines and critical medical equipment supplies to fight the COVID-19 pandemic. The chips issue threatens the U.S. economy and imperils jobs in election battlegrounds from Texas to Michigan.

Last week, Ford Motor Co warned the chip shortage will slash second-quarter production by 50%. Biden has asked Congress for $50 billion to bolster the domestic chips industry and $50 billion to create a new Commerce Department office to monitor domestic industrial capacity.

U.S. Senator Chris Coons of Delaware, who had urged use of the Defense act, said he was "pleased" with the administration's actions so far.

Washington has been appealing to Taiwan and other foreign governments to boost chip production levels for U.S. buyers, said the official. The administration is considering regulatory options and possible multilateral agreements to avert future crises, the person said.

Taiwan Semiconductor Manufacturing Co Ltd (TSMC) is looking to build more U.S. chipmaking factories in Arizona beyond one already planned, Reuters reported.

Industry data show U.S. manufacturers only account for about 12% of worldwide semiconductor manufacturing capacity, down from 37% in 1990. More than 80% of chip production happens in Asia.

"There's no quick fix," said Chad Bown, a senior fellow at the Peterson Institute for International Economics. 

https://www.marketscreener.com/quote/stock/TAIWAN-SEMICONDUCTOR-MANU-6492349/news/Taiwan-Semiconductor-Manufacturing-nbsp-Facing-chips-shortage-Biden-may-shelve-blunt-tool-used-in-33162286/

Arbutus Q1 financial results and update

 AB-729, Arbutus’ proprietary subcutaneously delivered RNAi agent, continues to demonstrate robust and continuous declines in hepatitis B surface antigen (HBsAg) in subjects with chronic hepatitis B (HBV) with favorable safety and tolerability data

Additional data from the ongoing Phase 1a/1b clinical trial of AB-729, including 60 mg multi-dose data (dosing interval every 4 and 8 weeks) and 90 mg multi-dose data (dosing interval every 8 weeks), expected in 2Q/2021

A proof-of-concept Phase 2 triple combination clinical trial evaluating AB-729, and Assembly Biosciences’ core inhibitor candidate, vebicorvir (VBR), with an approved standard of care nucleoside/nucleotide reverse transcript (NRTI) initiated by Arbutus and Assembly in 1Q/2021

Phase 1a/1b clinical trial with AB-836, Arbutus’ proprietary oral capsid inhibitor, initiated with initial data expected in 2H/2021

Arbutus, X-Chem, and Proteros biostructures announced an innovative Pan-Coronavirus Discovery Research and License Agreement in April 2021

Arbutus will hold a conference call and webcast today, Wednesday, May 5, 2021 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 4445858.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 4445858.

https://finance.yahoo.com/news/arbutus-reports-first-quarter-2021-113000338.html

Clovis: First Quarter Rubraca Sales Miss Views

 

• $38.1M in Rubraca® (rucaparib) global net product revenues for Q1 2021, down 11% vs. Q1 2020, due to continued headwinds from COVID-19 in the US and Europe

• Maintained US market share as US PARP inhibitor market impacted by COVID-19

• Imaging and treatment INDs cleared by FDA for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT)

• Phase 1/2 LuMIERE study of FAP-2286 expected to open for enrollment this quarter

• Top-line data from Phase 3 ATHENA trial of Rubraca as first-line maintenance treatment for ovarian cancer monotherapy anticipated 2H 2021

• $190.9M in cash and cash equivalents and $61.4M in available funding under the ATHENA financing at March 31, 2021, anticipated to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts

• $28.1M reduction in R&D and SG&A expense and 25% reduction in net cash used in operating activities compared to Q1 2020

Clovis will hold a conference call to discuss Q1 2021 results this morning, May 5, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 3219208.

https://finance.yahoo.com/news/clovis-oncology-announces-first-quarter-120000598.html

CureVac says mass vaccine rollout thrown into doubt by U.S. restrictions

 Germany's CureVac (5CV.DE), which is gearing up to publish results of a key COVID-19 vaccine trial, said U.S. export restrictions on key materials are making it impossible to predict its short-term supply ramp-up in Europe.

"Due to the Defense Production Act we are not getting certain goods out of the USA," CureVac Chief Executive Franz-Werner Haas told weekly Der Spiegel.

The Defense Production Act is a decades old U.S. law that gives federal agencies the power to prioritize procurement orders related to national defence, but it has also widely been used in non-military crises such as natural disasters.

"We are not getting all the materials that we need," he was quoted as saying.

"At times we live from hand to mouth. That makes it hard to build up a stockpile," Haas said, when asked how much the company would be able to deliver during the summer months.

He added that items in short supply include special plastic containers and nucleotides, which are the chemical building blocks that make up the genetic code in the vaccine's active ingredient, the so-called messenger RNA.

Unlike rival German vaccine developer BioNTech (22UAy.DE), which struck a partnership with pharma giant Pfizer (PFE.N), CureVac has not teamed up with a U.S. partner. BioNTech and Pfizer continue to increase global production and have not cited the Defense Production Act as a hindrance. 

As CureVac's only major supply deals, the European Union in November last year secured up to 405 million doses of the immunisation.

The biotech firm has said it expects to file for European authorization in late May or early June. read more

Nasdaq-listed CureVac, which is backed by investors Dietmar Hopp, GlaxoSmithKline (GSK.L) as well as the German government, has said it aims to produce up to 300 million doses of the vaccine in 2021 and up to 1 billion in 2022.

https://www.reuters.com/business/healthcare-pharmaceuticals/curevac-says-mass-vaccine-rollout-thrown-into-doubt-by-us-restrictions-2021-05-04/