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Tuesday, October 31, 2023
Investor urges Staar Surgical Asia spinoff
Investment firm Anatole Investment Management called on STAAR Surgical Company to consider spinning off its Asia or China business, arguing the standalone China business could be worth as much as $5 billion, according to its letter to the company.
Hong Kong-based Anatole, which owns roughly 4.2% of the Monrovia, California headquartered company's shares, said STAAR is undervalued and not reaching its "huge growth potential."
STAAR designs, makes and sells lenses that can be implanted during eye surgeries.
Since February, STAAR's stock price has dropped nearly 50%. It closed at $41.82 on Tuesday.
Pointing to a large market in China and research that suggests female patients are willing to pay more for brand and product quality, the investment firm wrote that management should raise prices and streamline the sales process.
Most importantly, the investment firm urged STAAR to hire investment bankers or corporate finance advisers to consider spinning off the Asia business, which it said makes up close to 80% of total sales.
"We suggest that the company consider spinning off its Asia or China business and listing it on one of the Asian exchanges," Anatole wrote in the Oct. 20 letter to STAAR's board. "STAAR’s China business alone is worth $5 billion in our estimation."
The letter has not been reported.
STAAR has a market capitalization of $2 billion.
The letter was posted on Anatole's website. Anatole did not respond to emails or calls for comment.
A STAAR spokesman said that the company has responded to Anatole's letter.
"We welcome and appreciate input from our shareholders and our management team and board regularly review opportunities to maximize value for all shareholders, so we are open-minded as to best paths to achieve this objective," the STAAR spokesperson said.
Asian investors are closer to the company's core market and would have a better understanding of the business's value, Anatole said. "The spin-off would result in a change of the investor base, thereby helping to narrow the gap between STAAR's intrinsic value and its market value," the letter said.
https://finance.yahoo.com/news/investor-urges-staar-surgical-spin-204026104.html
FDA panel says Vertex/CRISPR to assess safety risks of gene therapy in follow-up study
A panel of advisers to the U.S. health regulator said on Tuesday Vertex Pharmaceuticals and CRISPR Therapeutics could assess potential safety risks of their sickle cell disease gene therapy after approval.
If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy.
The inherited red-blood-cell disorder causes the cells to become sickle-shaped due to abnormal levels of hemoglobin in the body. A vaso-occlusive crisis occurs when sickled red blood cells block blood flow to the point that tissues become deprived of oxygen and causes pain.
The panel members said the 15-year follow up will help generate data from real-time monitoring of the therapy, which uses the new gene editing CRISPR technology.
Staff reviewers to the U.S. Food and Drug Administration said the new type of technology raised concerns about the "off target", or unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about the therapy's efficacy.
The therapy, exagamglogene autotemcel or exa-cel, met the main goal of a late-stage study. Patients who were treated with the therapy were free from severe vaso-occlusive crisis for 12 months from the infusion of exa-cel. "With regards to off target analysis we want to be careful to not let the perfect be the enemy of the good," said Dr. Scot Wolfe, professor at the department of molecular, cell and cancer biology at UMass Chan Medical School.
Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator's nod by Dec. 8.
"It was made pretty clear that any theoretical off-target editing concerns do not outweigh the benefits of drug approval," said Salim Syed, analyst at Mizuho.
https://finance.yahoo.com/news/fda-panel-says-vertex-crispr-222610620.html
Why the US offshore wind industry is in the doldrums
Energy giants BP and Norway's Equinor have booked hundreds of millions of dollars worth of impairments on their U.S. offshore wind power portfolios in recent days, the latest examples of a renewable energy industry in turmoil.
Danish energy company Orsted, the world's largest offshore wind farm developer and a big player in the U.S., said in late August it may see
$2.3 billion
in U.S. impairments due to supply delays, high interest rates and a lack of new tax credits. It will report third quarter earnings on Wednesday.
The companies are among several energy firms trying to build new offshore wind farms in the U.S., but feeling pain, raising questions about the future of fleet of projects that U.S. President Joe Biden hopes can help fight climate change.
Biden’s administration wants the U.S. to deploy 30,000 megawatts (MW) of offshore wind by 2030 from a mere 41 MW now, a key part of his plan to decarbonize the power sector and revitalize domestic manufacturing, and has passed lucrative subsidies aimed at helping companies do that.
But even with regulatory rules and subsidies in place, developers are facing a whole new set of headwinds.
Here is what they are:
INFLATION
The U.S. offshore wind industry has developed much more slowly than in Europe because it took years for the states and federal government to provide subsidies and draw up rules and regulations, slowing leasing and permitting.
However, as government policies started to line up in the industry's favor in recent years, offshore wind developers unveiled a host of new project proposals, mostly off the U.S. East Coast.
Two small projects came into operation - Orsted's five-turbine Block Island wind farm off Rhode Island and the first two test turbines of U.S. energy firm Dominion Energy's Coastal Virginia Offshore Wind off Virginia.
Then came a hitch.
The COVID-19 pandemic gummed up supply chains and increased the cost of equipment and labor, making new projects far more expensive than initially projected.
FDA targeting ‘candy-like’ drugs that risk accidental overdose in kids
The Food and Drug Administration is beginning a crackdown on drugs and supplements that often appear to be gummies, vitamins or candy as more kids are accidentally ingesting and overdosing on them because of their appearance.
From 2012 to 2021, there was a 530% increase in kids consuming melatonin — an over-the-counter sleep aid commonly sold in gummy form — according to the Centers for Disease Control and Prevention.
“Alternatives to conventional solid oral tablets are becoming more prevalent in the nonprescription drug space as manufacturers seek to make drugs more palatable for consumers,” the FDA wrote online ahead of a meeting on better identifying “candy-like” drugs.
“Many of these products are easily confused with candy and non-drug products, resulting in misuse and inadvertent overdose, particularly among young children.”
“I’ve heard of situations where babysitters didn’t know which are the gummies or which are the medications,” said Doyon, who attended the meeting, according to NBC News.
Cleveland Clinic pediatrician Dr. Gina Robinson, who was not involved with the event, also said the issue commonly stems from people thinking that herbal supplements and vitamins do not pose a risk.
“Because things are natural or because things aren’t prescription medications doesn’t mean that there can’t be some complications or dangers involved with using them,” she said.
Another expert outside of the FDA panel, Johns Hopkins pediatrician Dr. Rachel Dawkins, also put out a stern warning to parents to never call vitamins candy to children.
“When I was a kid, my brother ate all of the Flintstones vitamins because he thought they were candy,” she said. “Poison control was very helpful, and he was just fine … But why risk letting kids think they are candy?”
Another issue: as drug makers have aimed to make some substances much more palatable, it’s causing kids to treat them as if they are a snack as well.
“Children will get into anything, and children will especially get into anything that tastes or looks like candy,” added Dr. Theresa Michele, who is in charge of the FDA’s office of nonprescription drugs.
Dr. Christopher Hoyte, medical director of the Rocky Mountain Poison & Drug Center, urged the creation of a straightforward definition for candy-like medications as a uniform term does not currently exist.
Pediatric pharmacist and Rutgers professor Rachel Meyers is preaching that “we need to get rid of the idea” of medicine going down like Skittles in order to take it.
Drug makers, like Senopsys president Jeffrey Worthington, are recommending the removal of appealing colors and shapes.
“I think there are lots of things I can point to in a gummy that I would rather not see in a drug product,” he said. “Things like rings and worms, cartoon characters and a lot of the iconography that aligns with gummies and other dietary supplements.”
Multivitamins that contain iron are of noteworthy risk to children, as they can potentially cause toxic symptoms, according to the Missouri Poison Center.
“Most prenatal vitamins, some adult vitamins, and many children’s chewable tablets likely contain iron,” the agency reports.
Research from 2006 also targeted candy-like vitamins.
It found that some vitamins — notably chewables — can be tied to Vitamin A toxicity in children when too many are consumed.
https://nypost.com/2023/10/31/lifestyle/fda-targeting-candy-like-drugs-that-risk-overdose-in-kids/
US sending 300 more troops to the Middle East as Israel escalates airstrikes
Pentagon press secretary Brig. Gen. Pat Ryder announced Tuesday that the U.S. will be sending an additional 300 troops to the Middle East.
These soldiers reportedly specialize in communications and explosive ordinance disposal.
In addition, Ryder said that attacks on U.S. military bases in Syria and Iraq have risen to 27 — 16 on bases in Iraq and 11 in Syria.
The announcement comes shortly after the IDF confirmed the death of a senior Hamas commander responsible for all military operations in the northern Gaza Strip.
Ibrahim Biari and several other terrorists were killed in an airstrike with Hamas claiming 50 civilians died, the Times of Israel reports.
Surmodics Launches Med Device Coating Tech for Range of Complex Devices
SurModics, Inc., (NASDAQ: SRDX), the global leader in medical device coating technologies, announced the commercial launch of its most advanced hydrophilic medical device coating technology, Preside™ hydrophilic coatings.
Preside hydrophilic coatings complement Surmodics’ existing Serene hydrophilic coatings by providing customers with a unique low-friction and low-particulate generation coating to further enhance distal access for neurovascular applications, as well as improve crossing for challenging coronary lesions or chronic total occlusions.
Preside hydrophilic coatings are specifically formulated to meet the challenge of achieving the right balance of enhanced lubricity (reduction in friction) and excellent coating durability (resulting in low particulates) for the next-generation of Neurovascular, Coronary and Peripheral vascular devices. Surmodics’ Preside hydrophilic coatings allow customers to leverage their existing coating processes resulting in easy implementation in a manufacturing environment.
https://www.biospace.com/article/releases/surmodics-announces-launch-of-preside-medical-device-coating-technology-providing-industry-leading-lubricity-and-durability-to-a-broader-range-of-complex-device-applications/
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