Novavax expects COVID vaccine targeting Omicron in fourth quarter

 Novavax Inc said on Friday it expects to provide a COVID-19 vaccine targeting Omicron in the fourth quarter as it accelerates development of shots to protect against the BA.4 and BA.5 subvariants.

The U.S. FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants.

Novavax expects additional preclinical data on shots tailored against the fast-spreading Omicron subvariants in late summer or fall.

The company's vaccine, based on an earlier strain of the virus, has not yet been authorized in the United States and is currently under U.S. Food and Drug Administration review.

https://finance.yahoo.com/news/novavax-expects-covid-vaccine-targeting-183223757.html

Opana® ER Antitrust Trial Concludes With Jury Verdict in Endo's Favor

 Endo International plc (NASDAQ: ENDP) announced today that a federal jury in Chicago, Illinois, has returned a verdict in favor of the Company's subsidiaries Endo Pharmaceuticals Inc. and Endo Health Solutions Inc. (collectively Endo), in an antitrust trial.

As Endo previously disclosed, it has been involved since 2014 in various legal proceedings filed by multiple plaintiffs, including classes of direct and indirect purchasers, which have been consolidated in the United States District Court for the Northern District of Illinois under the caption In re Opana® ER Antitrust Litigation.  Plaintiffs in the cases alleged, among other things, that the terms of a 2010 patent settlement agreement between Endo and Impax Laboratories, Inc. (now Amneal Pharmaceuticals, Inc.) (Impax) violated the antitrust laws.  A trial of all plaintiffs' claims began in June and concluded today with a verdict in favor of Endo on all counts.

"Endo is very pleased with the jury's verdict and is grateful for its careful deliberation," said Matthew J. Maletta, Endo's Executive Vice President, Chief Legal Officer and Company Secretary. "Today's verdict confirms that the 2010 settlement agreement between Endo and Impax was procompetitive and enabled Impax to come to market with its generic version of Opana® ER years earlier than otherwise would have been permitted."

https://finance.yahoo.com/news/opana-er-antitrust-trial-concludes-173200437.html

Belite started at Buy by Benchmark

 Target $57

https://finviz.com/quote.ashx?t=BLTE&ty=c&ta=1&p=d

Celldex Skids As It Takes On Blockbuster Roche, Novartis Drug

 Celldex Therapeutics (CLDX) took aim at Roche (RHHBY) and Novartis' (NVS) blockbuster hives treatment on Friday with a small, early-stage study that showed promise — but CLDX stock tumbled.

The company tested its drug, barzolvolimab, in 26 patients with chronic spontaneous urticaria, a condition in which hives appear for up to six weeks or longer. At 12 weeks, the hives completely disappeared for 57.1% of patients who took a low dose of barzolvolimab. Another group took a higher dose and 44.4% saw completely clear skin at eight weeks.

Importantly, Celldex studied its treatment in patients who didn't respond to antihistamines. The other treatment option for them would be Roche and Novartis' Xolair. But in Xolair's pivotal test, just 36% of patients saw complete hive clearance by week 12.

Still, in morning trading on today's stock market, CLDX stock skidded 15.3% near 22.80. It was unclear why shares toppled. Novartis stock also fell 1.4% near 83.40 and shares of Roche dipped a fraction near 41.70.

CLDX Stock: Resolving Itching, Hives

Barzolvolimab works by binding to and blocking a receptor that appears on mast cells. Mast cells play a key role in inflammatory responses, particularly hypersensitivity and allergic reactions.

In Celldex's test, 66.6% of patients in the low-dose group saw improvements in subsiding their itching and hives after 12 weeks. More than three-quarters of patients in the high-dose group, 75.1%, experienced the same improvements after eight weeks.

The results stem just one dose of barzolvolimab, a bullish point for CLDX stock.

"We are excited by these interim multiple dose data which demonstrate strong clinical activity, rapid onset and sustained durability with a well-tolerated safety profile, including in patients with prior (Xolair) experience," Celldex Chief Executive Anthony Marucci said in a written statement.

Rivaling Novartis, Roche Drug

Novartis lists Xolair as one of the top 20 innovative medicine products. In 2021, the self-injected drug brought in $1.43 billion in sales, growing 12% in constant currency.

Celldex's barzolvolimab was also easily tolerated. Most side effects were mild or moderate and none led patients to stop treatment. They included urinary tract infections, headache, lower white blood cell count and back pain.

CLDX stock had run up through June 24, but then began sliding. Shares gapped down Friday on the news and now have a low Relative Strength Rating of 28 out of a best-possible 99, according to IBD Digital. This means the stock's 12-month performance ranks in the bottom 28% of all stocks.

https://www.investors.com/news/technology/cldx-stock-skids-as-it-takes-on-novartis-roche-blockbuster-drug/

Tyra Biosciences started at Buy by Wainwright

 Target $12

https://finviz.com/quote.ashx?t=TYRA

U.S. FDA to use existing Omicron booster data to review shots targeting new subvariants

 U.S. health regulators will not require companies to submit new clinical trial data on COVID-19 vaccines that target the now dominant BA.4 and BA.5 Omicron subvariants to authorize those shots, but will instead rely on studies showing the efficacy of targeting the earlier BA.1 subvariant, a top official said on Thursday.

Dr. Peter Marks, a senior official overseeing vaccines at the U.S. Food and Drug Administration, told Reuters the agency would also consider manufacturing data specific to a BA.4 and BA.5 vaccine, and that preclinical data from animal studies and safety data for those shots could also be available.

The FDA on Thursday recommended COVID-19 vaccine manufacturers Pfizer Inc/BioNTech SE and Moderna Inc change the design of their booster shots beginning this fall to include components tailored to combat BA.4 and BA.5. It plans to review them for emergency use authorization.

"It's very similar to what we do with influenza strain changes where there will be a couple of amino acids difference, but we don't expect any difference in the safety that we're going to see," Marks said.

He said he expects the immune response to the BA.4/5 booster shot to be similar to that seen with BA.1.

"We're very comfortable doing this, because it will help us get ahead of things," Marks said.

The FDA has directed manufacturers to launch human clinical trials to study the BA.4/5 vaccines, but said that data will be used to gauge the continued effectiveness of the boosters against new variants that may arise.

Marks said he believes regulators from other countries are seriously considering using BA.1-based vaccines, which some drugmakers have already been producing and may be available sooner.

"I will tell you that globally - just so you understand - different regulators feel different levels of comfort with this," Marks said.

He said the United States should run a wider vaccination campaign this fall than the one in the spring, when the focus was on older and other high-risk people.

"I actually think that this fall we have to go all out on our booster campaign," Marks said.

"It's going to be really critical as we move into this fall where we've seen this evolution into BA4/5, where we could see further evolution, to try to get as many people boosted as we can."

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/U-S-FDA-to-use-existing-Omicron-booster-data-to-review-shots-targeting-new-subvariants-official-40871393/

Pharmaceutical companies still have the upper hand

 

This old stock still has a lot of potential. Eli Lilly and Co. is one of the oldest companies in the United States and one of the global leader in the pharmaceutical industry. After facing more than 50 wars, the company remains among the most innovative and influential in its industry.

The company is structured around five business segments:
- Endocrinology with products to treat osteoporosis, diabetes and growth problems. 
- Oncology
- Veterinary medicine
- Cardiovascular diseases
- Neurology with drugs to treat depression and schizophrenia.

Since 1876 - when the company was founded - Eli Lilly has been developing its business and distributing products in 125 countries with offices in 18 countries. With a dozen blockbuster products such as the world's first insulin, the first polio vaccine and a pill to treat depression, Eli Lilly has continued to expand its product line, resulting in a 443.13% increase in market capitalization between 2013 and 2022.  

MarketScreener : Static chart – Share price evolution between June 2012 & June 2022

The company has a diverse portfolio of products including Zyprexa (for schizophrenia and bipolar disorder), Gemzar (pancreatic cancer), Evista (osteoporosis), Cymbalta (depression), Cialis (erectile dysfunction), Strattera (attention deficit hyperactivity disorder), Erbitux (cancer) and Alimta (chemotherapy). 

A real focus on R&D

With globalization and excessive population growth, awareness of health needs is increasingly necessary. The world's population is getting older, pushing laboratories to develop new drugs. To illustrate this point, only 9% of the world's population is 65 years or older, but this is expected to rise to 16% by 2050, according to Statista. The aging population will influence the group's sales, and the massive investments in research and development (R&D) suggest that the group will gain market share in the years to come.. The group is growing faster than its eight main competitors - Sanofi, Johnson & Johnson, AstraZeneca, Merck, Roche Holding,  Bristol-Myers Squibb, GSK and Pfizer - who are also major players and leaders in certain areas of the pharmaceutical sector. You can see from the table below that Eli Lilly is the company with the highest proportion R&D investments since 2019. Moreover, in 2021, these investments represented 25% of Eli Lilly's sales, almost twice as much as Pfizer’s - whose growth model is oriented on the acquisition of external companies, generally used by "big pharma" to ensure sustainable growth -. R&D investments were $83 billion in 2019 which is ten times what the industry spent per year in the 1980s. Today, these investments represent a very significant portion of pharmaceutical companies' revenue and are driven by three distinct factors: anticipated lifetime global revenues from a new drug, expected costs to develop a new drug, and policies and programs that influence the supply of and demand for prescription drugs.

A solid balance sheet and good growth momentum

Despite the covid-19 pandemic, Eli Lilly's EBITDA – perhaps the best indicator to gage the level of profitability of the operating process and to identify the wealth creation produced by a company – is set to continue to grow in 2022 to $10,206 million. Especially since with net cash expected to be up 30.25% and net debt down 26.73% this year, there is no doubt that the company will be able to use these resources to further position itself. The pandemic has not disrupted either the cash inflow or the dynamics of the company, which has remained at the same growth rate. Despite the current macroeconomic turmoil and rising interest rates, the company's balance sheet policy is to reduce its debt and leverage. It is also interesting to look at the change in operating and net margin. Between 2012 and 2021, Eli Lilly's operating margin increased by 68.6%, slightly below Johnson & Johnson (71.7%), which is the industry leader. Net margin grew 36.5% over the same period for Eli Lilly, almost 2.5 times that of Merck (13.7%).

Source: MarketScreener – Income Statement Evolution (Annual data)

At the same time, Eli Lilly's turnover is lower than its peers, but its compound annual growth rate (CAGR) is good and in line with its industry average. However, we can highlight the fact that the three companies with the highest increase since 2017 are those that most benefited from the covid pandemic. Indeed, Pfizer and AstraZeneca were among the first to provide a vaccine, and Bristol-Myers Squibb developed many treatments. But in the coming years, their growth rate is likely to decline in favor of other companies like Eli Lilly. Despite this potential downfall, these companies have gained a lot of trust from people with the implementation of vaccines, care, or personal assistance. This quick reaction at the beginning of the pandemic was beneficial for some but "destructive" for others such as Sanofi, which was unable to find a vaccine in time, thus losing consumer confidence.

The company's results and very strong balance sheet make it easy for investors to understand its results. With its large capitalization, the company offers significant visibility on its future results. Analysts are numerous and offer important coverage to investors. It can therefore be interesting to position yourself for a long-term investment, but it is essential to invest with full knowledge of the facts and to make rational decisions.

Source: MarketScreener - Ratings chart - Superformance

Eli Lilly is positioned as one of the leaders in its sector with a complete range of services thanks to a century of know-how and a strong history, which convinces investors and creditors that the business model is proven. Since its IPO, the group has been able to finance numerous acquisitions, including Promoter Technologies in 2O21. It has maintained operating margins and is trying to improve cash flow to allow the integration of new businesses. Eli Lilly sells products through wholesalers and distributors such as hospitals, pharmacies and healthcare professionals allows - maintain a high level of activity during economic shocks – in more than 125 countries, with more than 8,300 employees engaged in research and development. 

Nevertheless, the group faces several types of competitors: small, more agile players and large groups that also have a multi-service branch. Its balance sheet and revenue growth are mainly due to external acquisitions and the development of new drugs, treatments, etc. These two strategies presuppose that the company can find suitable targets to acquire under acceptable conditions without opposition from competition authorities, and that it has sufficient resources to carry out the development of new products, which may require nearly 10 years of research.  

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Pharmaceutical-companies-still-have-the-upper-hand-40873463/