Anthem (NYSE:ANTM): Q2 Non-GAAP EPS of $4.64 beats by $0.02; GAAP EPS of $4.36 in-line.
Revenue of $25.47B (+11.0% Y/Y) beats by $590M.
https://seekingalpha.com/news/3480612-anthem-eps-beats-0_02-beats-revenue
Wednesday, July 24, 2019
Integra LifeSciences Holdings EPS beats by $0.07, beats on revenue
Integra LifeSciences Holdings (NASDAQ:IART): Q2 Non-GAAP EPS of $0.73 beats by $0.07; GAAP EPS of $0.34 misses by $0.01.
Revenue of $383.65M (+4.8% Y/Y) beats by $10.36M.
https://seekingalpha.com/news/3480602-integra-lifesciences-holdings-eps-beats-0_07-beats-revenueTuesday, July 23, 2019
Danaher’s dental spin-off Envista files for a $100 million IPO
Envista Holdings, the dental equipment and services provider being spun out of Danaher, filed on Monday with the SEC to raise up to $100 million in an initial public offering.
Envista is one of the largest global dental products companies with market positions in multiple segments of the dental products industry, including implants, orthodontics and digital imaging technologies. In 2018, the company spent $172 million on research and development, accelerating product development initiatives including the DTX software suite, the N1 implant system, and Spark Aligners. Its operating companies Nobel Biocare Systems, Ormco, and KaVo Kerr serve more than 1 million dentists in over 150 countries.
The Brea, CA-based company was incorporated in 2018 and booked $2.8 billion in sales for the 12 months ended March 29, 2019. It plans to list on the NYSE under the symbol NVST. Envista Holdings filed confidentially on May 20, 2019. J.P. Morgan is the sole bookrunner on the deal. No pricing terms were disclosed.
Telemedicine provider Telemynd files for an $8 million IPO
Telemynd, which operates a telemedicine and analytics platform for mental health services, filed on Tuesday with the SEC to raise up to $8 million in an initial public offering.
Earlier this month, former parent company MYnd Analytics (formerly Nasdaq: MYND) was acquired in a reverse merger with sickle cell drug developer Emmaus Life Sciences, which now trades under the symbol EMMA. Prior to completing the merger, MYnd Analytics contributed its core telehealth and analytics assets and liabilities to its shareholders, forming Telemynd.
The Mission Viejo, CA-based company traces its roots to 2000 and booked $2 million in revenue for the 12 months ended March 31, 2019. It plans to list on the Nasdaq under the symbol PSYC. Telemynd filed confidentially on April 5, 2019. Aegis Capital Corp. is the sole bookrunner on the deal. No pricing terms were disclosed.
LEAPER: New Genetic Editing Approach May Rival CRISPR
Scientists from Peking University have recently created a gene-editing technique that has great potential in treating disease. This technique, known as LEAPER, is similar to CRISPR-Cas13 in its ability to edit RNA rather than DNA; however, the Peking researchers feel that LEAPER presents several advantages over the CRISPR-Cas13 technique. Their findings were published recently in Nature Biotechnology.
LEAPER (leveraging endogenous ADAR for programmable editing of RNA) is analogous to the Cas13 protein with its ability to target strands of RNA, but the two differ in that Cas13 relies on both a guide RNA and the Cas13 enzyme to manipulate RNA. This new technique sets itself apart by using only one component, known as arRNA, to do so. This simplicity makes LEAPER easier to deliver and less likely to cause undesirable side effects.
This novel approach uses engineered strands of RNA that recruit the ADAR enzyme to swap out different compounds in RNA, effectively editing the molecule. The research team notes that LEAPER circumvents some issues that arise from current gene-editing techniques, including immune responses and other side effects. LEAPER is an efficient and accurate tool that can be used on a variety of cell types, as per the Peking scientists.
“There are clear prospects for using this technology in disease treatment,” said study author Zhou Zhuo of Peking University’s School of Life Sciences. Zhuo explained that LEAPER was used to switch adenosine for guanosine, two nucleotide bases that function as RNA ‘building blocks,’ in their trials. He went on to say that this switching of bases could potentially treat almost half of all known hereditary disorders.
Hurler syndrome, a severe and rare genetic disorder that is associated with reduced life expectancy and various complications, is one of these diseases that was used in Zhuo and colleagues’ research. The team extracted cells from patients with the condition and found that LEAPER was effective in restoring functional enzyme activity in these cells.
This was done not by editing the faulty gene that coded for this mutated enzyme, but rather by altering the RNA that is transcribed from this gene. Genes are used to create RNA, which is the used as a template to synthesize proteins, like enzymes. LEAPER’s function is to edit this transcribed RNA before it is read to create a protein, therefore the technique promotes synthesis of the proper enzyme.
Though this technique shows promise, it still has a way to go. Ernst Wolvetang of the Australian Institute for Bioengineering and Nanotechnology noted that LEAPER’s mechanism may not be applicable to certain cell types and that undesired genetic changes may manifest. This technique will need to be proven in animal studies as well before the team can consider moving into clinical trials.
Wolvetang did, however, praise LEAPER for its simplified approach compared to other genetic-editing techniques. He claimed that using only arRNA rather than Cas and a guide RNA makes the compound much easier to deliver.
Other techniques have been developed in China that were said to rival CRISPR in editing genetic material, with the “NgAgo” technique initially showing promise but falling short in follow up studies. In more controversial news, the Chinese researcher He Jiankui announced last year that he had used CRISPR technology to genetically edit two children before they were born. He received severe backlash for doing so, however there is now a Russian biologist aspiring to follow suit.
Exponential Medicine@ExponentialMedNew technology, LEAPER, which stands for “leveraging endogenous ADAR for programmable editing of RNA May be an alternative to #CRIPRhttps://futurism.com/the-byte/chinese-scientists-crispr-alternative-leaper …Chinese Scientists Say They’ve Found a Safer Alternative to CRISPR
Chinese researchers have created a CRISPR alternative called LEAPER that they say is less likely to trigger an unwanted immune response.futurism.com
Mobile Phone App that Treats Insomnia and Depression Files for FDA Approval
Pear Therapeutics has recently filed a submission to the US Food and Drug Administration (FDA) for a prescription digital therapeutic (PDT) oriented towards insomniaand depression. The company created the first FDA-approved PDT last year when they teamed up with Novartis’s Sandoz to develop a smartphone app prescribed to treat substance abuse disorders. Now, Pear is looking to get the same approval for their latest mobile health innovation, Somryst.
“One in three adults suffer from symptoms of insomnia in a given week and more than 30 million adults have chronic insomnia,” said Charles M. Morin, PhD, Professor of Psychology, Director Sleep Research Centre at Université Laval in Quebec City. “Chronic insomnia can have an impact on quality of life – and can put people at risk long-term for depression, hypertension, and even heart attack.”
Somryst is designed to create cognitive behavioral therapy for insomnia (CBTi) and sleep restriction windows that are both made unique to each user via an algorithm. The goal of this system is to reduce the symptoms of both insomnia and depression in each user. CBTi is commonly used in treating patients with chronic insomnia, however, many patients don’t have access to this recommended treatment. In addition, there are currently no means of CBTi delivery that are approved by the FDA.
CBTi refers to several techniques that help aid those with insomnia. Popular techniques include stimulus control, which strengthens the bed as a cue for sleep by eliminating its use for other activities, and sleep restriction. The latter involves limiting the number of hours spent laying unnecessarily in bed. For example, if one were only getting five hours of sleep at night despite laying there for seven hours, their sleep restriction therapy would limit them to five hours in bed a night. Though they will likely get less than five hours of sleep a night, this will help them eventually establish a healthier sleep schedule.
“Most adults with insomnia receive medication intended for short-term use or struggle with insomnia without receiving effective, lasting treatment,” explained Morin. “Somryst could facilitate patient access to CBTi treatment with appropriate clinical oversight and management from clinicians.”
The Research Behind Somryst
Pear submitted two randomized controlled trials to the FDA that evaluate the efficacy of Somryst. These works included over 1,400 adults with chronic insomnia, with 1,100 of these participants having depression. These individuals with both conditions were randomly assigned to either receive Somryst intervention or an “attention-matched digital placebo”. These groups received therapy for nine weeks and had their results compared at baseline and nine weeks, with post treatment measurements recorded at six months, a year, and a year and a half.
After 9 weeks of treatment, those who used Somryst showed significantly reduced Insomnia Severity Index scores, dropping from an average of 15.92 to 7.27, whereas the control group dropped from 16.23 to 13.17. In addition, those who received the treatment also showed reduced depression severity based on their Patient Health Questionnaire 9 (PHQ9) scores. The treatment group’s PHQ9 scores decreased from 8.03 to 3.78, whereas the control only from 7.84 to 6.20. After 9 weeks of using Somryst, most of the participants no longer met the inclusion criteria for insomnia or depression, in these improvements were still seen at 18 months follow up. This study also found the PDT alleviated symptoms of anxiety and thoughts of suicide in the treatment group as well. These findings can be found in Lancet Psychiatry.
“Prescription digital therapeutics are a new treatment class that use software applications to directly treat serious disease,” said Corey McCann, MD, PhD, President and CEO of Pear Therapeutics. “PDTs are designed to deliver evidence-based treatment anytime, anywhere, while also providing clinicians with real-time data on patient progress. Pear Therapeutics is the leader in this emerging space. If authorized, Somryst could become our third FDA-authorized PDT, representing a new wave of innovation for patients and physicians.”
Angsana@Angsana_UKDigital therapeutic is on the rise, as Pear further pioneers in this space with Somryst, an app-based programme which uses CBT to help patients treat insomnia and depression – potentially in place of medicines.#mentalhealth#pharma#newdrugdevelopmenthttp://www.pmlive.com/pharma_news/pear_therapeutics_submits_latest_digital_therapeutic,_insomnia_and_depression_treatment_1294880 …
As ACA exchange members stay longer, Centene sees medical cost bump in Q2
- Managed care giant Centene reported a bump in its medical cost ratio, increasing to 86.7% in the second quarter of 2019 compared with 85.7% in the prior-year period.
- Shares slid more than 2% during trading Tuesday morning despite beating Wall Street earnings expectations for the quarter and reporting membership and revenue increases.
- Centene CEO Michael Neidorff said growth in the medical cost ratio was fueled by Affordable Care Act exchange members who are staying with their plans longer, and are expected to reach their out-of-pocket maximums, causing costs to go up.
Overall for the quarter, Centene reported an increase of 2.2 million members and a 29% increase in revenue to $18.4 billion compared with the prior-year period. Net income for the quarter increased to $495 million, or $1.18 per share, compared with $300 million, or 75 cents per share, during the second quarter of 2018.
Neidorff sought to assure investors during the second quarter earnings call that it was business as usual for the health insurance exchanges and that retaining more members and for longer is ultimately good for business.
But during the call analysts tried to pinpoint how well the exchanges were doing in terms of margins as the company kept providing a wide range of between 5% and 10%.
However, Neidorff acknowledged his frustration over the questions focused on the margins within the exchange business.
“It’s a little frustrating to see people concerned about a movement of margin which is doing so well within the range, is normal health insurance performance, and shows that this business is really growing and performing as we expect it to,” he said.
However, it’s important to know how the exchanges are performing because it’s a meaningful line of business in terms of contributing to overall profitability, David Windley, an analyst with Jefferies, told Healthcare Dive.
“It’s surprising that management would give a range that wide and then be irritated when analysts try to narrow in on where in a very wide range they’re landing,” Windley said.
Although the increase in medical cost ratio seems small, it’s a big deal as it eats into profitability.
It’s unclear why members are staying longer compared to previous years. When asked to give more clarity on the type of member that drops off in the middle of the year, Neidorff answered with a bit of sarcasm.
“We have 1.9 million members. You want to tell me which one you’re thinking about? I mean seriously.” he said.
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