.png)
We've had Eyes On some of the recent deals, results, and investor actions. Check out the happenings at Sanofi/Opella, Pfizer, Regeneron, and Novo Nordisk. What did you have Eyes On This week?
Sanofi is currently in exclusive negotiations to sell a 50% controlling stake in its consumer health company, Opella, to Clayton, Dubilier & Rice, a U.S. private equity firm.
One possible obstacle to the sale seems to have been removed, as the French government stated that it has received guarantees from Clayton, Dubilier & Rice (located in New York City) that it will maintain Opella's manufacturing facilities in France and that the country's supply of medications will not be interrupted. The deal could close as early as the second quarter of next year.
Sanofi stated that CD&R's offer to purchase the 50% stake is legally binding and fully funded, and that the proposed sale values Opella at 16 billion euros. Sanofi would focus more on its cutting-edge medications and vaccines. By doing this, they join other Big Pharma companies like Johnson & Johnson, Pfizer, and GSK, that have taken similar actions. Sanofi may now also concentrate more on providing patients with life-threatening or crippling illnesses or viruses, such Multiple Sclerosis, COPD, or RSV, with novel therapies.
Opella runs four research and innovation centres in addition to 13 production facilities. The company’s 2023 sales accounted for 5.2 billion euros (11% of Sanofi’s revenue).
For more details see the articles below:
Regeneron may have failed its most recent attempt to stop Amgen's Eylea biosimilar Pavblu from being released, but the New York-based pharmaceutical company is not giving up yet.
Amgen, however, seems to be accelerating its rollout, which may end up being the biggest loss of exclusivity in the pharmaceutical sector in the United States this year.
As Regeneron appeals a related ruling from last month, their request for an injunction to prevent Amgen's Eylea biosimilar launch was denied by three U.S. Circuit Judges. However, Regeneron's plea to expedite the appeals process was granted by the court. Prior to the anticipated oral arguments in January, Regeneron must now submit its brief on the subject by November 13, 2024, and Amgen by November 4.
Amgen is keen to enter the market and introduce Pavblu in light of the most recent ruling. In doing so, they expose themselves to possible damages if Regeneron proves that patent infringement actually happened after Eylea entered the market.
Previously, Regeneron's demands for preliminary injunctions to prevent the sale of Samsung Bioepis and Biogen’s biosim Opuviz and Biocon's Yesafili until 2027 were granted by the court in June. The judgement concluded that Regeneron's patents had indeed been infringed by the biosimilars. The Eylea biosim prospects from Sandoz, Celltrion, and Formycon have also been sued by Regeneron.
Last year, Eylea's total sales in the United States came to $5.72 billion, or 44% of Regeneron's $13.12 billion total revenue. Regeneron would suffer if Amgen's Eylea biosimilar were to be introduced, but the company's high-dose of Eylea would not be impacted.
For more details see the articles below:
Starboard Value, an activist investor, is publicly attacking Pfizer management and specifically targeting CEO Albert Bourla's position.
In a recent presentation for the 13D Monitor Active-Passive Investor Summit in New York, Starboard urged Pfizer's board to hold management responsible for what the hedgefund characterised as low revenue returns on expenditures in R&D and M&A.
In an effort to encourage improvements at the Big Pharma company, Starboard recently built a $1 billion stake in Pfizer. The fund claims that Pfizer failed to capitalize on their COVID-19 Vaccine profits, therefore losing tens of billions of dollars in market value.
According to Starboard, Pfizer's market value has dropped by over $20 billion since 2019, even though the company's COVID-19 franchise contributed $40 billion during the pandemic. Future growth may be further constrained by Pfizer's inability to make new acquisitions due to its low valuation and leveraged balance sheet.
Pfizer's poor market performance was attributed by Starboard to a lack of internal innovation and a failure to fulfil its promises. The investment shop cited a number of trial failures and suggested that Pfizer might have approved up to 15 potential blockbusters by 2022. When Bourla became CEO in early 2019, the company made that strategy public.
According to Starboard's calculation, Pfizer's anticipated revenue return on R&D and M&A investments between 2023 and 2030 is only 15%, which is significantly less than the industry peer median of 38%. In order to reach that 38% median, Pfizer needs to generate an extra $29 billion in sales in 2030 on top of the existing consensus projection of $50 billion. Starboard stated that this goal is probably unachievable.
For more details see the articles below:
More news on GLP-1 effects outside of diabetes and weight loss.
In a late-stage study the oral form of semaglutide, Rybelsus, decreased the risk of a set of cardiovascular events by 14% when compared to a placebo in certain Type 2 diabetic patients. The SOUL trial evaluated the oral GLP-1 medication in 9,650 patients with Type 2 diabetes and established cardiovascular disease, either with or without chronic renal disease.
Rybelsus was assessed using a set of cardiovascular events known as MACE, which comprised storkes, nonfatal myocardial infractions, and cardiovascular-related deaths. According to Novo, all three kinds of events helped to lower overall risk. According to the corporation, the SOUL experiment has achieved its main objective, and the 14% improvement was statistically significant.
Novo plans to submit Rybelsus for cardiovascular outcomes approvals in the United States and Europe at the beginning of the coming year, equipped with the favourable phase 3 readout.
Rybelsus, the first oral GLP-1 medication to receive FDA approval in 2019, brought in 10.9 billion Danish kroner ($1.6 billion) in sales in the first half of 2024. In comparison, 21 billion kroner ($3.05 billion) was brought in by Wegovy's and 56.7 billion kroner ($8.25 billion) by Ozempic's over the same time period.
For more details see the articles below:
PharmaTell Studio Hints
We cover quarterly earnings news too. Use the search terms similar to: "3Q24 Results", "3Q24 Earnings" or "Earnings Call Transcript" to see the analyses, feedback, and highlights from the quarterly reports.
If you are a PharmaTell client and can’t access the PharmaTell-specific links, please contact us at helpdesk@pharmatell.com.
If you are not a client and would like to learn more about PharmaTell and a free trial, please email us at info@pharmatell.com, and we will be happy to assist you.