American Shared Hospital Services Won’t Stay Cheap For Long?

American Shared Hospital Services leases radiosurgery and radiotherapy equipment to cancer centers.

It’s a very predictable, high margin business that will likely see significant growth in the coming years.

At under 10x EV/EBIT, the stock offers a very attractive risk/reward opportunity with 60+% upside potential over the next 12-24 months.

With the market hitting new highs almost weekly, finding cheap stocks is like looking for a shrinking needle in a large haystack. You have to sort through hundreds of stocks just to maybe find a couple worth investing in. One of these increasingly rare finds is a little company called American Shared Hospital Services (AMS).

Business

AMS provides state-of-the-art radiosurgery and radiotherapy equipment to medical centers. It does so by financing the equipment and then entering into 10-year contractual agreements with each medical center. The medical center operates the equipment and pays AMS a fee, either on a fixed per use or revenue sharing basis.

The Gamma Knife, a precise, noninvasive tool that applies radiation beams for tumor treatment, accounts for just over 70% of revenue. Most of the remaining revenue comes from Proton Beam Radiation Therapy, or PBRT for short, which is similar to the Gamma Knife except that it uses proton rather than photon radiation.

The Gamma Knife business is well-established with minimal growth potential. The PBRT business, on the other hand, has only been around since early 2016 and is growing rapidly. AMS currently has one PBRT system in operation. Management plans to launch two more systems within the next couple of years, which have the potential to be significant growth drivers.

Growth

AMS’ revenue has been hovering in the $15 million to $20 million range for over a decade. Despite being very profitable during these years, this lack of growth is likely a big reason why the company’s stock has stayed off of most investors’ radars. However, I expect this to change going forward, and the PBRT system will be the catalyst.

https://seekingalpha.com/article/4208326-american-shared-hospital-services-stay-cheap-long-shares-offer-60-plus-percent-upside

60% of pharma companies using or trying blockchain – survey

Six out of ten pharma companies are using or experimenting with blockchain, according to a new study.

According to the not-for-profit organisation The Pistoia Alliance, 60% of pharmaceutical and life science professionals are either using or experimenting with blockchain today, compared to 22% when asked in 2017.

However, 40% are not currently looking at implementing, or have no plans to implement blockchain, according to the survey of 170 senior pharma and life science professionals this year.

The biggest barriers identified to adoption are access to skilled blockchain personnel (55%), and that blockchain is too difficult to understand (16%).

These factors underline why The Pistoia Alliance is calling for the life science and pharmaceutical industries to collaborate over the development and implementation of blockchain.

Blockchain is an open, distributed ledger of information that is saved across several different servers, and is constantly growing as computers cryptographically discover the next “block” of information in the chain.

Data is protected in any given block as they cannot be altered retroactively without alteration of blocks, requiring consensus of the majority of the network.

Famously employed to administer the bitcoin cryptocurrency, blockchain can be used to create a secure repository for sensitive healthcare information such as clinical trial data.

The survey showed life science and pharmaceutical professionals are becoming more aware of the capabilities of blockchain.

Respondents believed the greatest opportunities for using blockchain lie in the medical supply chain (30%), electronic medical records (25%), clinical trials management (20%), and scientific data sharing (15%).

Of the benefits of blockchain, life science and pharmaceutical professionals believe the most significant is the immutability of data (73%). Significantly, for an industry with tight regulations, 39% also believe the transparency of the blockchain system is its best feature.

However, almost a fifth (18%) of professionals believe using blockchain adds no value beyond a traditional database, showing there is some reluctance in the industry to use the technology.

The Pistoia Alliance said that some of the misconceptions about blockchain can be overcome with greater education of those in industry.

Richard Shute, consultant for The Pistoia Alliance, said “We are currently focusing on educating scientists and researchers about the potential uses of blockchain technologies outside of the supply chain, particularly in R&D. At The Pistoia Alliance, we want to support our members’ initiatives in blockchain, as well as provide a secure global forum for partnerships and collaboration.”

• The Pistoia Alliance is holding a Blockchain Bootcamp on 8^th – 9^th October in Boston as part of its drive to educate the life science industry about the technology. For more information on the event and to register, see here.

https://pharmaphorum.com/news/60-of-pharma-companies-using-or-trying-blockchain-survey/

Alnylam rare disease drug may be delayed

Alnylam may have to put hold off plans for an early FDA approval for its gene-silencing drug givosiran – because recruitment to a rare disease trial is going better than expected.

Rare disease trials are notoriously difficult to conduct because of a paucity of available patients, but Alnylam said that the trial of givosiran in acute hepatic porphyria has attracted more participants than expected.

The firm had hoped to seek an accelerated approval from the FDA on early data before the trial completes – but because of the fast pace of enrolment, Alnylam said the regulator may choose to wait for full results.

Citing a company conference call, Reuters reported that this would push a filing back by four to six months.

“It is possible the FDA could ask [the] company to wait another 6 months until the full data is released,” an unnamed executive said.

Another concern could be safety – there were no deaths on the trial, but 22% of those on the drug reported serious side effects, compared with 10% of patients given a placebo.

There are no approved treatments for acute hepatic porphyria and the Cambridge, Massachusetts-based biotech reckons about 1,000 patients have a severe form of the disease, without around 5,000 suffering less frequent attacks.

Interim data revealed this week showed patients with the condition that were given givosiran had a significant reduction in aminolevulinic acid (ALA) protein in their urine.

High levels of ALA are considered to trigger an increase in the “attacks” experienced by patients.

There were no other details about efficacy, or further data on the drug’s safety, according to Reuters.

In August, Alnylam’s Onpattro (patisiran) became the first ever RNA interference drug approved by the FDA to treat the nerve damage caused by the rare disease hereditary transthyretin-mediated amyloidosis (hATTR) in adults.

The drug’s $450,000 per year price tag is expected to be mitigated by discounts and “value-based” deals with insurers.

Alnylam beat competition from biotech Ionis to get the approval, which is developing a rival hATTR drug, Tegsedi (inotersen).

https://pharmaphorum.com/news/alnylam-rare-disease-drug-may-be-delayed/

SEC charges Stryker for second time for FCPA violations

The Securities and Exchange Commission charged Stryker Corp. with violating the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act, or FCPA, with the regulator stating that this is the second time the SEC has brought an FCPA action against the medical device company. Stryker agreed to settle the charges and pay a $7.8M penalty. The SEC’s order found that Stryker’s internal accounting controls were not sufficient to detect the risk of improper payments in sales of Stryker products in India, China, and Kuwait, and that Stryker’s India subsidiary failed to maintain complete and accurate books and records.

https://thefly.com/landingPageNews.php?id=2797201

Eisai Reports FDA OK of Seizure Med in Pediatric Patients as Young as 4

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both FYCOMPA tablet and oral suspension formulations.

“Eisai is working tirelessly to provide treatment options for patients of all ages to help better control seizures and achieve the ultimate goal of seizure freedom,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “We are excited about the potential of FYCOMPA as an important tool to reduce the incidence of seizures among pediatric patients living with epilepsy. This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need.”

Today, an estimated 470,000 children in the U.S. are living with epilepsy. Up to 40 percent will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures.

https://www.streetinsider.com/FDA/Eisai+Reports+FDA+Approval+of+FYCOMPA+in+Pediatric+Patients+as+Young+as+4+Years+Old+for+the+Treatment+of+Partial-Onset+Seizures/14655756.html

FDA halts imports from China’s Huahai after heart drug recall

The U.S. Food and Drug Administration said on Friday it will no longer allow imports of drug ingredients or medicines made with ingredients produced by China’s Zhejiang Huahai Pharmaceuticals, after a recall of one of its drugs that contained a probable carcinogen.

The Chinese bulk manufacturer of the high blood pressure treatment valsartan recalled the product from consumers in the United States in July because an impurity linked to cancer had been detected.

European authorities also said on Friday that they had found that Huahai did not comply with good manufacturing practices and that the company’s factory in Linhai, China, was no longer authorized to produce valsartan.

The European Medicines Agency said it was considering further action for other substances produced at the site.

The FDA said it was halting imports after it found major manufacturing process issues during its inspection of Huahai’s plant. The agency said the freeze on the imports would remain in place until the Chinese manufacturer determines how the impurities were introduced and improves its quality control systems.

Huahai’s English-language website suggests that the company makes more than 50 drugs, active pharmaceutical ingredients and intermediate products used in a variety of medicines to treat high blood pressure, depression and other conditions. It was not immediately clear how many were exported to the United States.

FDA spokesman Jeremy Kahn said the agency had no concern about additional drug shortages due to the import ban at this time.

In a heavily-redacted inspection report to Huahai posted on the FDA’s website on Sept. 20, the health regulator pointed out a range of serious problems, including with the company’s quality management system, how it evaluates the impact of changes to its manufacturing process, and its handling of products with impurities.

In all, the Aug. 3 report listed 11 problems based on an inspection by two investigators sent to the factory for about two weeks in late July and early August.

Huahai’s public relations department could not be reached for comment.

The company, which is based in eastern China’s Zhejiang province and makes bulk ingredients for drugmakers, told customers in late June that it had found N-nitrosodimethylamine, or NDMA, which is classified as a probable human carcinogen, in its valsartan.

In September, after a global recall of valsartan products, the FDA and the European Medicines Agency announced that another known carcinogen called N-Nitrosodiethylamine, or NDEA, had also been found in valsartan made by Huahai and by India’s Torrent Pharmaceuticals, another manufacturer.

The FDA often redacts product-specific information in inspection reports, and the report released last week did not mention valsartan, NDMA or NDEA. However, the FDA wrote that Huahai’s “change control system to evaluate all changes that may affect the production and control of intermediates or Active Pharmaceutical Ingredients (APIs) is not adequate.”

Regulators and industry consultants say the NDMA was most likely introduced when Huahai changed the way it made valsartan in 2012. The FDA’s Kahn told Reuters in an email in August that the change in valsartan manufacturing that was believed to have led to the introduction of NDMA occurred around December 2013.

https://www.reuters.com/article/us-huahai-pharm-imports/fda-halts-imports-from-chinas-huahai-after-heart-drug-recall-idUSKCN1M821U

‘GenScript Strongly Denies Allegations Made in Obscure Research Report’

 GenScript®, the world leader in the biotechnology reagent service industry, strongly denies allegations made in a research report by short seller Flaming Research.

“The allegations made against our subsidiary Nanjing Legend Biotechnology Co. are inaccurate and misleading, as well as groundless and irresponsible,” said Eric Wang, GenScript’s vice president of marketing. “We are very proud of the significant breakthroughs in CAR-T research made by Legend’s scientific team, led by Dr. Frank Fan, and have and will continue to conduct our research and business to the highest standards of integrity with patient safety our paramount priority.”

Johnson &Johnson, Nanjing Legend’s partner, also confirmed to the Wall Street Journal that the company “conducted careful and detailed reviews” of Legend’s data and is “optimistic about the potential of this investigative therapy.”

GenScript has no information on the identity of Flaming Research and was never contacted by the entity. At this time, GenScript is consulting with its legal counsel and considering legal actions against Flaming.

A full response to the allegations may be found here.

https://www.tullahomanews.com/news/business/genscript-strongly-denies-allegations-made-in-obscure-research-report/article_60647eb1-f719-5560-943e-04f601c5336f.html