Novavax cuts 2024 revenue forecast on lower COVID vaccine sales

 Novavax (NVAX) on Thursday cut its revenue forecast for 2024 as it anticipated lower sales of its COVID-19 vaccine, including the company's updated shot for the fall season targeting the JN.1 variant.

The vaccine maker now expects $275 million to $375 million in product sales for the year, versus its earlier forecast of between $400 million and $600 million, which also included royalties and other revenue.

Of this, the company has already recorded $100 million in the first half of the year. Novavax has sought authorization for its fall-season COVID shot from the US and European regulators.

The company has struggled to sell its protein-based COVID vaccines and, in turn, failed to make a significant dent in the market share of key players like Pfizer/BioNTech and Moderna.

Novavax had signed a licensing deal worth at least $1.2 billion with French drugmaker Sanofi for its COVID vaccine in exchange for a stake in the U.S. biotech firm.

The deal helped Novavax remove the warning notice in February last year that raised doubts about its ability to remain in business, while it boosted Sanofi's plans to co-develop a combination of its influenza and COVID vaccine.

Gaithersburg, Maryland-based Novavax also cut its full-year forecast range for total revenue to $700 million to $800 million, from between $970 million and $1.17 billion, which it gave in May following its deal with Sanofi.

The new forecast included around $425 million in upfront payment, royalty and other revenue, compared with the $570 million it was expecting under the deal in May.

Novavax recorded $415.5 million in total revenue in the second quarter, lower than the average of analyst estimate of $458.6 million, according to LSEG data.

The company's profit of 99 cents per share also missed analysts' estimates of $1.64.

https://finance.yahoo.com/news/novavax-quarterly-revenue-misses-estimate-114709149.html

Cassava Q2 update

 

• $207.3 Million in Cash and Cash Equivalents at June 30, 2024.
• Company in Advanced Discussions to Resolve SEC Investigation. $40 Million Estimated Loss Contingency Recorded in Q2 for Resolution.
• Conference Webcast Scheduled for Today at 8:30AM ET.

Webcast Details
Date: Thursday, August 8th Time: 8:30 a.m. Eastern Time
Audio Webcast: https://www.CassavaSciences.com/company-presentations
Or https://edge.media-server.com/mmc/p/zjvmjjcr

https://www.globenewswire.com/news-release/2024/08/08/2926904/8339/en/Cassava-Sciences-Reports-Q2-2024-Financial-Results-and-Operational-Updates.html

Lyell Q2 Update

 

• Reported dose-dependent antitumor clinical activity in patients with relapsed/refractory triple-negative breast cancer from the Phase 1 trial of LYL797, a ROR1-targeted Chimeric Antigen Receptor (CAR) T‑cell product candidate enhanced with proprietary anti-exhaustion technology; 40% objective response rate and 60% clinical benefit rate at the highest dose cleared at the time of the initial data report (150 x 106 CAR T cells)
• Expanded development of LYL797 into four new tumor types, including ROR1+ relapsed/refractory platinum‑resistant ovarian cancer, endometrial cancer, multiple myeloma and chronic lymphocytic leukemia
• Received FDA clearance of an IND for LYL119, a next-generation ROR1-targeted CAR T-cell product candidate incorporating four proprietary technologies designed to enhance the anti-exhaustion capability and persistence of T cells
• Cash, cash equivalents and marketable securities of $491.1 million as of June 30, 2024 supports advancing diverse pipeline through multiple clinical milestones into 2027

https://www.globenewswire.com/news-release/2024/08/07/2926322/0/en/Lyell-Immunopharma-Reports-Business-Highlights-and-Financial-Results-for-the-Second-Quarter-2024.html

Viatris ups new product revenue forecast

 

• Total Revenues of $3.8 Billion and Operational Revenue Growth of ~2% on a Divestiture-Adjusted Basis[1]
  
  
• Strong New Product Revenues in the Quarter of $210 Million Drove Growth Across Segments
  
  
• U.S. GAAP Net Loss was $326 Million; Adjusted EBITDA Grew ~2% to $1.2 Billion on a Divestiture-Adjusted Basis; U.S. GAAP Diluted EPS was a Loss of $0.27 per Share; Adjusted EPS Grew ~3% to $0.69 per Share on a Divestiture-Adjusted Basis[2]
  
  
• Completion of Divestitures Marks Inflection Point in Company's Move Towards Accelerated Growth and Shareholder Return
  
  
• Raises 2024 Full-Year New Product Revenues Range to $500 Million-$600 Million
  
  
• Expects 2024 Full-Year Total Revenues Growth of ~2% on a Divestiture-Adjusted Operational Basis[3]

https://www.prnewswire.com/news-releases/viatris-reports-second-quarter-financial-results-for-2024-302217815.html

Stocks Surge On Small Drop In Initial Jobless Claims; Continuing Claims Hits 33-Month High

 The number of Americans filing for jobless benefits for the first time fell from 12-month highs at 249k to 233k last week...

Source: Bloomberg

The non-seasonally-adjusted claims data plunged and is basically unchanged over one and two years

Source: Bloomberg

...as it appears the Texas storm impact is fading...

Source: Bloomberg

With Michigan and Texas dominating the drop in initial claims...

But, continuing jobless claims rose to 1.875mm Americans - the highest since Nov 2021...

Source: Bloomberg

...and smoothing for the week to week noise - the 4-week moving average of initial claims also reached a new cycle high.

One key thing to note that we warned about...

Is this bad news or good news?

Stocks seem to think 'good' news.

Imagine what happens next week if CPI is hotter than expected?

https://www.zerohedge.com/personal-finance/continuing-jobless-claims-surge-33-month-highs

National Guard Disputes Walz's Military Bio; CNN Calls Out 'Absolutely False' Claim Over Deployment

 The Minnesota National Guard has disputed Governor Tim Walz's military biography, saying that his claims of retiring at the rank of command sergeant major is untrue.

Minnesota National Guard spox Army Lieutenant Colonel Kristen Augé told Just the News that Walz, Kamala Harris' vice presidential running mate, was demoted and did not retire as a command sergeant major as he has claimed for years - including on his official gubernatorial biography - as he failed to complete a 750-hour course in the Army's Sergeants Major Academy, a mandatory course for E-9s, the Army's highest enlisted rank.

While Walz temporarily held the title of command sergeant major he "retired as a master sergeant in 2005 for benefit purposes because he did not complete additional coursework at the U.S. Army Sergeants Major Academy," Army Lt. Col. Kristen Augé, the Minnesota National Guard’s State Public Affairs Officer, told Just the News.

The statement reignited a controversy that began during his 2018 election for governor in which National Guardsman claimed on social media and in a paid ad that Walz declined to deploy to Iraq for combat duty in 2005 and forfeited his title of command sergeant major. Walz chose to run for Congress that year. -Just the News

The governor's biography, however, says that "Command Sergeant Major Walz" retired from the Minnesota National Guard in 2005. At the time he was serving as one of the highest ranking members of the 1-125th Field Artillery Battalion.

"He retired as a master sergeant in 2005 for benefit purposes because he did not complete additional coursework at the U.S. Army Sergeants Major Academy," said Augé.

That said, an unnamed Guard spokesperson told Task & Purpose, in direct contradiction to Augé, that Walz's demotion was a technicality.

"Soldiers who do not finish the course revert back to their prior rank," they told the outlet. "This is what we refer to as an administrative reduction and not punitive in nature."

The outlet also claims that the Guard 'confirmed' that Walz was properly promoted and served in the E-9 role, and "retired as" an E-9, despite the later reduction.

That said, Task & Purpose also framed the entire stolen valor controversy as "The 'Swift Boating' of Tim Walz" - as if his on-record lies about 'weapon of war, that I carried in war' (he never saw war), are the same as disputed allegations over John Kerry's (D) Vietnam war record.

On Wednesday we noted that Walz straight up lied about having been deployed in a combat zone.

The lies were so egregious that even CNN acknowledged they were less than ideal.

"Walz did make a comment speaking to a group, he’s done it a couple of times, where he has used language that has suggested that he carried weapons in a fighting situation," said CNN correspondent Tom Foreman in a fact check. "As you know, with your contact with the military, I know from coming from a military family, there is a difference between being in a combat area, being involved at a time of war and actually being in a position where people are shooting at you. There is no evidence that at any time Governor Walz was in a position of being shot at, and some of his language could easily be seen to suggest that he was."

"So that is absolutely false when he said that about gun rights out there. The campaign has essentially come forward to say, ‘Look, he had a long career, he would never want to purposely mislead people about this.’ It’s what campaigns tend to say," Foreman continued.

Meanwhile, in a 2006 press release issued by his campaign, Walz is described as a "veteran of Operation Enduring Freedom," the US military operation in Afghanistan. As modernity.news notes, some have charged that this is misleading given that Walz was stationed in Italy at the time, with his battalion providing base security in Europe.

Walz has also come under fire from the men he served with, who they described in a 2019 letter as 'Traitorous, fraudulent and shameful.'

Meanwhile, the Free Beacon reports that Walz knew his National Guard battalion was being eyed for a likely redeployment to Iraq when he decided to retire.

"As Command Sergeant Major, I have a responsibility not only to ready my battalion for Iraq, but also to serve if called on," Walz said in a campaign statement on March 20, 2005. Just three days prior, the National Guard Public Affairs Office announced that at least part of his battalion could be shipped overseas to the Middle East in the next two years.

Walz left the National Guard that May. Two months later, his battalion was put on notice that they would be deploying to Iraq.

When questioned about all of it, Walz decided to duck, cover, and run from a journalist before an explanation could be 'deployed.' 

https://www.zerohedge.com/political/national-guard-disputes-walzs-military-bio-even-cnn-admits-no-evidence-walz-saw-combat 

Phathom Q2

 

• Over 122,000 prescriptions for VOQUEZNA^® products written by healthcare providers, launch to date, a 184% increase since last quarterly report
  
• 
  
• Net revenues of $7.3 million reported for the second quarter 2024 compared to $1.9 million in the first quarter 2024, greater than a 280% increase
  
• 
  
• VOQUEZNA (vonoprazan) tablets 10mg now FDA-approved and available to treat heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (GERD) in adults – unlocking the entire GERD market of over 22 million diagnosed and annually treated patients
  
• 
  
• Expansion of commercial coverage for VOQUEZNA tablets now includes over 116 million U.S. lives, an estimated 77% of total U.S. commercial lives
  
• 
  
• Management to host conference call today, August 8, 2024, at 8:30 am ET

Phathom will host a conference call and webcast to discuss its second quarter financial results and business highlights today, August 8, 2024, at 8:30 am ET. A live webcast will be available on the investors page of Phathom’s website under Events & Presentations. A replay of the webcast will be available following the completion of the event and will be archived for up to 90 days.

https://www.biospace.com/phathom-pharmaceuticals-reports-second-quarter-2024-financial-results-and-provides-business-update