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Wednesday, October 23, 2019

Align Technology EPS beats by $0.08, beats on revenue

Align Technology (NASDAQ:ALGN): Q3 Non-GAAP EPS of $1.22 beats by $0.08; GAAP EPS of $1.28 beats by $0.14.
Revenue of $607.3M (+20.2% Y/Y) beats by $12.01M.
Shares +10.8%.
https://seekingalpha.com/news/3508609-align-technology-eps-beats-0_08-beats-revenue

Varian Medical Systems EPS in-line, beats on revenue

Varian Medical Systems (NYSE:VAR): Q4 Non-GAAP EPS of $1.21 in-line; GAAP EPS of $0.97 misses by $0.12.
Revenue of $878.9M (+9.6% Y/Y) beats by $20.43M.
https://seekingalpha.com/news/3508613-varian-medical-systems-eps-line-beats-revenue

BioMarin Q3 top line up 18%, non-GAAP earnings up 29%

BioMarin Pharmaceutical (NASDAQ:BMRN) Q3 results:
Revenues: $461.1M (+17.7%); product sales: $450.9M (+16.7%).
Key product sales: Vimizim: $163.5M (+32.6%); PKU franchise: $144.7M (+23.4%); Naglazyme: $94.4M (-8.4%).
Net income: $55.0M (+536.5%); non-GAAP net income: $78.1M (+28.7%); EPS: $0.30 (+528.6%).
2019 guidance: Revenues: $1,680M – 1,750M from $1,690M – 1,720M; Vimizim: $530M – 570M from $540M – 570M; Kuvan: $420M – 460M from $455M – 475M; Naglazyme: $350M – 380M from $360M – 380M; net loss: ($85M – 45M); non-GAAP net income: $130M – 170M from $150M – 170M.
https://seekingalpha.com/news/3508689-biomarin-q3-top-line-18-percent-non-gaap-earnings-29-percent

Edwards Life Sciences up 4% after hours on strong Q3, guidance raise

Edwards Lifesciences (NYSE:EW) Q3 results:
Sales: $1,094.0M (+20.7%), TAVR: $700.0M (+25.7%); Surgical Structural Heart: $204.1M (+10.6%); Critical Care ex. CASMED: $174.7M (+6.4%).
Net income: $274.7M (+21.6%); non-GAAP net income: $299.2M (+31.2%); EPS: $1.30 (+22.6%); non-GAAP EPS: $1.41 (+31.8%).
2019 guidance: Sales: top end of previous range of $4.0B – 4.3B; non-GAAP EPS: $5.50 – 5.65 from $5.20 – 5.40.
https://seekingalpha.com/news/3508729-edwards-life-sciences-4-percent-hours-strong-q3-guidance-raise

Gilead Sciences Q3 2019 Earnings Preview

Gilead Sciences (NASDAQ:GILD) is scheduled to announce Q3 earnings results on Thursday, October 24th, after market close.
The consensus EPS Estimate is $1.73 (-6.0% Y/Y) and the consensus Revenue Estimate is $5.61B (+0.2% Y/Y).
Over the last 2 years, GILD has beaten EPS estimates 75% of the time and has beaten revenue estimates 75% of the time.
Over the last 3 months, EPS estimates have seen 12 upward revisions and 8 downward. Revenue estimates have seen 13 upward revisions and 8 downward.
https://seekingalpha.com/news/3508507-gilead-sciences-q3-2019-earnings-preview

5 biggest risks ambulatory care needs to address – ECRI


Errors in diagnostic tests and medication safety events pose the biggest risk to patients in ambulatory care settings, according to a new analysis.
Those two errors are the most frequent safety risks in ambulatory care, a report (PDF) from the ECRI Institute, an independent nonprofit organization, found.

The analysis was based on 4,355 adverse events reported to the institute by physician practices, ambulatory care centers and community health centers between December 2017 and November 2018. Nearly half of the events involved diagnostic testing errors; a quarter involved medication safety, and the rest involved falls, security and safety and privacy-related risks, the institute reported.
Approximately half of all events reported occurred in physician practices.
“As healthcare delivery shifts from hospitals to ambulatory care settings, it can be challenging to coordinate care among various clinicians, systems and facilities, raising the potential for errors that put patients at risk,” Marcus Schabacker, M.D, president and CEO of the ECRI Institute, said in a statement.

“Reducing and eliminating adverse events in an outpatient environment will require an unprecedented commitment to collaboration and coordination,” he said.
Here are the five key types of safety problems occurring in ambulatory care settings, the largest and most widely used segment of the healthcare system:
Diagnostic testing errors. Errors that occur during diagnostic testing can have potentially devastating consequences for patients, the report noted. The majority of this kind of error involved laboratory tests. Other tests where problems occurred included imaging tests, pathology and cardiology. Diagnostic errors are the leading cause of liability claims against primary care doctors and account for the highest proportion of payouts, according to a Coverys report released earlier this year. Practices and health centers can improve by providing decision support tools to help providers order the proper tests and monitoring processes for test tracking and follow-up.

Medication safety events. Two-thirds of the analyzed medication safety events were classified as wrong drug, wrong patient or wrong time, the analysis found. Medication errors are a leading cause of malpractice claims in ambulatory care and can occur during any stage of the medication process. They are often the result of a series of failures within a system, the report said. Practices and centers should implement standardized medication management procedures and create a policy directing how to report and manage safety events.
Falls. Approximately 800,000 people will be hospitalized each year with a fall-related injury. Half of the falls in ambulatory settings that ECRI analyzed occurred in the exam room or waiting room. Practices and health centers should screen patients for fall risk at every visit, when a change in condition occurs and after a fall and should proactively identify patients at high risk.

HIPAA violations. Misunderstandings concerning HIPAA privacy and security rules prompted more than 350 HIPAA-related events to be reported to the ECRI Institute. The majority of these pertained to inadvertent disclosure of patients’ protected health information.
Security and safety incidents. The vast majority of events involved verbal threats or disruptive behavior by patients or visitors. Practices need to educate staff on what to do in the event of a violent incident and conduct monthly security and safety surveillance rounds, the report recommended.
https://www.fiercehealthcare.com/practices/5-biggest-risks-ambulatory-care-needs-to-address-according-to-ecri-institute-analysis

Perrigo Issues Voluntary Ranitidine Recall Due to Possible Impurity

As a precautionary measure, Perrigo Company plc (NYSE; TASE: PRGO) announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranitidine is an over-the-counter (OTC) and prescription product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.
After regulatory bodies announced that ranitidine may potentially contain NDMA, Perrigo promptly began testing of its externally sourced ranitidine API (active pharmaceutical ingredient) and ranitidine-based products. On October 8, 2019, Perrigo halted shipments of the product based upon preliminary results. Based on the totality of data gathered to date, Perrigo has made the decision to conduct this voluntary recall.
https://www.biospace.com/article/releases/perrigo-company-plc-issues-voluntary-worldwide-recall-of-ranitidine-due-to-possible-presence-of-impurity-n-nitrosodimethylamine-ndma-impurity-in-the-product/