Regeneron Misses Q1 Earnings on Lower-Than-Expected Eylea Sales

 Regeneron Pharmaceuticals reported first-quarter 2024 financial results Thursday that missed consensus Wall Street expectations for earnings and revenue. 

Analysts expected Regeneron to earn $10.18 per share and report $3.23 billion in sales in the quarter. However, the company’s Q1 adjusted earnings came in at $9.55 per share with $3.15 billion in sales. 

Soft sales of its blockbuster eye drug—developed with Bayer—also missed expectations, which Regeneron said was caused by a $40 million cut in inventory and changing market dynamics. In Q1, the company posted $1.4 billion in Eylea sales, a 2% drop compared to the $1.43 billion generated in the same period in 2023 and falling short of Wall Street estimates of $1.86 billion. 

A new, higher dose (HD) version contributed $200 million to total sales. Analysts forecast that Eylea HD will gain market share over standard dose in the next year. 

With its exclusivity originally set to expire this year, Regeneron fended off Eylea biosimilars with a court ruling that extended its patent to June 2027. However, Roche’s Vabysmo has been growing market share since its 2022 FDA approval. The competitor’s eye drug brought in sales of $927 million in the first quarter of 2024. 

“We are well positioned to continue our leadership in retinal diseases,” Regeneron CEO Leonard Schleifer said in a statement. 

Regeneron reported Q1 sales of its Sanofi-partnered asthma drug Dupixent of $3.08 billion, short of analyst expectations of $3.19 billion. However, it still represented a 24% growth rate versus the same period in 2023.  

Regeneron’s oncology portfolio is steadily gaining ground with its skin cancer drug. Global sales of Libtayo grew 49% in Q1 to $264 million compared to the same quarter last year with $177 million. The company’s cholesterol injection Praluent saw 75% growth to $70 million in the most recent quarter.  

Total net product sales came in at $1.76 billion, growing 6% compared to Q1 2023 sales of $1.67 billion. 

Regeneron’s board has approved a $3 billion share buyback program, on top of a $1.2 billion buyback program announced in March 2024. 

The repurchase program provides Regeneron with “additional flexibility to continue returning capital to shareholders over time,” CFO Christopher Fenimore said in a statement. 

https://www.biospace.com/article/regeneron-misses-q1-earnings-on-lower-than-expected-eylea-sales-/

Novartis Buys Mariana Oncology in $1B Acquisition, Bolsters Radiopharma Assets

Novartis pushed deeper into radioligand therapy Thursday, announcing a $1 billion buyout that will give it control of Mariana Oncology’s preclinical cancer pipeline and clinical supply capabilities.

The Swiss drugmaker is paying $1 billion and committing up to $750 million in milestones to add Mariana to its stable of radiopharmaceutical assets. Mariana quickly emerged as a well-financed player in the hot radioligand space, exiting stealth with $75 million in 2021 and following up with a $175 million Series B financing round in 2023.

Massachusetts-based Mariana has used the money to establish a pipeline led by MC-339. The candidate consists of a peptidic small molecule engineered to carry a radioactive actinium payload. By using a small molecule to deliver the payload to an undisclosed target, Mariana could administer a dose of actinium that is fatal to small cell lung cancer cells without causing unbearable harm to healthy tissue.

Mariana was aiming to move MC-339 into the clinic in 2024 when it raised the Series B round last year. To support its move into human testing, the biotech has established radiopharmaceutical manufacturing capabilities. Novartis noted the acquired clinical supply capabilities among the positives of Thursday’s deal.

Radiopharmaceuticals pose distinct manufacturing challenges. Radioisotopes have short half-lives and a relatively small number of facilities are equipped to produce and handle the molecules. Novartis ran into problems last year, delaying access to its approved radioligand therapy Pluvicto. However, CEO Vas Narasimhan said on an earnings call in April 2024 that “supply performance is now consistently at a very high level with over 99.5% of injections administered on the planned day.”

Mariana is not set up for commercial supply but has invested to support its clinical trials. The biotech also has research infrastructure that will add to the capabilities that Novartis has created and picked up through deals in recent years.

Novartis was ahead of the radiopharmaceutical trend. In 2018, the company closed acquisitions of Advanced Accelerator Applications and Endocyte, paying a total of $6 billion to add Lutathera and the candidate now sold as Pluvicto to its portfolio.

Rival drugmakers followed Novartis into the radiopharma space, with AstraZeneca, Bristol Myers Squibb and Eli Lilly paying between $1.4 billion and $4.1 billion to acquire biotechs that specialize in the modality in recent months. Novartis has continued to seek out technologies as well, leading to deals with 3B Pharmaceuticals, Bicycle Therapeutics and PeptiDream over the past year or so.

Novartis has added to its radioligand capabilities while buying treatments that kill cancer cells via different mechanisms. This year, the company has struck deals to buy MorphoSys for 2.7 billion euros ($2.9 billion) and license Arvinas’ Phase III-ready protein degrader for $150 million.

https://www.biospace.com/article/novartis-buys-mariana-oncology-in-1b-acquisition-bolsters-radiopharma-assets/

Unit Labor Costs Soar In Q1 As 'AI Productivity Boom' Fails To Show Up

 Remember how AI was going to save the world, give us all more leisure time because of its massive boost to productivity?

Well, in Q1 in the US... it failed to show up as non-farm productivity - or nonfarm employee output per hour - rose at a measly 0.3% annualized rate after an upwardly revised 3.5% gain in the prior period (well below expectations)...

On the flip-side of that - and echoing the market-worrying ECI data earlier this week - Unit Labor Costs soared 4.7% in Q1 (well above the 4.0% expected and the 0.4% rise in Q4)...

Source: Bloomberg

So wage inflation is confirmed - rising at the fastest pace in a year - as all the gains we have been told to expect from AI just aren't there in the data.

While quarterly productivity figures are quite volatile, a sustained slowdown represents another hurdle for the Federal Reserve’s inflation fight. With interest rates expected to stay at a two-decade high for awhile longer, business investment in equipment will likely continue to be a weak factor in overall economic growth.

Today's data corroborates other data that showed gross domestic product cooled in the first quarter while employment costs rose by the most in a year. As a result, inflation is proving stubborn, supporting the Fed’s pivot to a more hawkish stance that will keep interest rates higher for longer than anticipated.

Of course, Fed Chair Powell told us yesterday that he "doesn't see the stag or the flation" in US data...

https://www.zerohedge.com/markets/unit-labor-costs-soar-q1-ai-productivity-boom-fails-show

Context IND Application for Phase 1 OKd

 CTIM-76 Phase 1 clinical trial to focus on CLDN6-positive gynecologic and testicular cancers

Company expects to enroll first patient in mid-2024

https://www.globenewswire.com/news-release/2024/05/02/2874098/0/en/Context-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-a-Phase-1-Clinical-Trial-of-CTIM-76.html

Allarity Stenoparib Clinical Benefit, Milestone with Early Conclusion of Ovarian Cancer Phase 2

 Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced the early discontinuation of its Phase 2 clinical trial of stenoparib, a novel PARP inhibitor, for the treatment of advanced recurrent ovarian cancer. The patients enrolled in the trial had been pre-screened by Allarity’s unique Drug Response predictor (DRP®) companion diagnostic (CDx) in order to treat only patients with the highest likelihood of deriving clinical benefit.

The trial, evaluating stenoparib given twice daily, has shown clear clinical benefit, including tumor shrinkage and long-term disease stability, in heavily pre-treated ovarian cancer patients who otherwise have limited life expectancy. These results have provided sufficient clinical proof of concept for stenoparib as monotherapy, prompting Allarity to halt further enrollment in this trial to enable and accelerate the development of a follow-on trial with FDA regulatory intent.

"Based on the substantial clinical benefit observed in the early stages of the trial, we have achieved proof of concept results that surpassed our initial expectations and provided the critical insights we were seeking," stated Thomas Jensen, CEO of Allarity Therapeutics. "Concluding the trial now is the most effective way to re-allocate our financial resources to develop a follow-on trial with the fastest route to regulatory submission for stenoparib. The patients enrolled in this trial are heavily pretreated, having undergone multiple prior treatments, often including PARP inhibitors. It is highly noteworthy that stenoparib, used in patients selected with the DRP® CDx, has delivered sustained clinical benefit for such very heavily pre-treated patients in the trial.”

This Company’s decision will not affect the ongoing treatment of current patients, as described in greater detail in Allarity’s March 27, 2024, press release.

https://www.globenewswire.com/news-release/2024/05/02/2874113/0/en/Allarity-Therapeutics-Stenoparib-Shows-Clear-Clinical-Benefit-and-Achieves-Significant-Milestone-with-Early-Conclusion-of-Phase-2-Trial-in-Advanced-Ovarian-Cancer.html

Why Is Emergent BioSolutions (EBS) Stock Up

 Emergent BioSolutions (NYSE:EBS) stock is taking off on Thursday after surprising investors with strong first quarter 2024 earnings results.

The life sciences company reported adjusted earnings per share of 59 cents for the quarter. That’s a massive beat compared to Wall Street’s estimate of -86 cents per share. It’s also a major improvement over the -$3.26 reported in the same period of the year prior.

Adding to that success is Emergent BioSolutions’ revenue of $300.4 million. Yet again, that blows past analysts’ estimate of $220.25 million for the quarter. It’s also an 83% increase year-over-year from $164.3 million.

Emergent BioSolutions’ outlook for Q2 2024 gives investors some ideas of what to expect from the company. This has it predicting revenue ranging from $160 million to $210 million. For comparison, Wall Street’s Q1 revenue estimate is sitting at $244.5 million.

Emergent BioSolutions also increased its 2024 revenue guidance to between $1 billion and $1.1 billion. Before this, that range was $900 million to $1.1 billion. Wall Street is looking for $1.02 billion in 2024.

https://investorplace.com/2024/05/why-is-emergent-biosolutions-ebs-stock-up-57-today/

Elevation Oncology Results, Recent Business Achievements

 Enrollment ongoing in Phase 1 clinical trial of EO-3021 in the U.S. and Japan; expect to announce initial safety and efficacy data by mid-3Q 2024, with additional data in 1H 2025 --

-- Presented preclinical proof-of-concept data for HER3-ADC program at AACR Annual Meeting; on-track to nominate development candidate in 2H 2024 --

-- Raised $44.2 million year-to-date through ATM facility, extending cash runway into 2026 --

https://www.biospace.com/article/releases/elevation-oncology-reports-first-quarter-2024-financial-results-and-highlights-recent-business-achievements/