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Wednesday, January 8, 2020

Medtronic Acquires Spinal Cord Stimulation Therapy Company

Medtronic PLC said Wednesday it acquired Stimgenics LLC, a privately held company that has developed a spinal cord stimulation therapy to treat patients with chronic pain.
Dublin-based Medtronic said the transaction is expected to be neutral to fiscal 2020 earnings per share and meet its long-term financial metrics for acquisitions. Additional terms of the transaction weren’t disclosed.
Randomized control trial results evaluating the Bloomington, Ill.-based Stimgenics’ Differential Target Multiplexed (DTM) Spinal Cord Stimulation therapy versus conventional SCS will be presented at the North American Neuromodulation Society Annual Meeting on Jan. 23-26 in Las Vegas.

NuVasive Is ‘A Stock To Watch For In 2020,’ SunTrust Says In Bullish Initiation

Shares of medical device maker NuVasive, Inc. NUVA 1.32% represent a particularly compelling opportunity, according to SunTrust Robinson Humphrey.

The NuVasive Analyst

Kaila Krum initiated coverage of Nuvasive with a Buy rating and $93 price target.

The NuVasive Thesis

Nuvasive is the fourth-largest spine surgery company and the largest pure play spine company operating in an estimated $10-billion market worldwide, Krum said in a Tuesday initiation note. (See the analyst’s track record here.)
Nuvasive is “a stock to watch in 2020” due to SunTrust’s expectations that revenues and earnings growth will accelerate from 2019 levels, the analyst said.
NuVasive has the ability to stabilize and strengthen its top-line growth profile, and it will subsequently begin to focus on its long-term earnings potential, Krum said.
The revenue acceleration will be driven by improvement in the company’s core spine implant business, the analyst said.
SunTrust sees the rollout of the Pulse spine surgery platform paired with a growing level of focus on robotics capabilities as meaningful catalysts for the business.
Pulse should add $10 million in revenue for 2020, Krum said, adding that the potential halo effect on the core spine business is not well appreciated.
Nuvasive’s operating margin and free cash flow generation are best-in-class, the analyst said.
Following a recovery in 2019, NuVasive’s operating margin is likely to expand 60 basis points year-over-year to 15.8%, Krum said. Over the next five years, the analyst said the metric could push toward 20%.
Despite the stock’s more than 70% rally from its January 2019 lows, it still trades in-line with September 2018 levels and a discount to peers, Krum said.
“This valuation profile makes shares of NuVasive particularly compelling, as one of the few relative “value” stocks in the high-multiple MedTech, SMID-cap world.”

Globus Medical sees Q4 sales of $211M

On a preliminary basis, Globus Medical (NYSE:GMED) expects Q4 and 2019 sales to be ~$211.0M (+8%) and ~$784.7M (+10%), respectively.
2020 guidance: Sales: $850M; non-GAAP EPS: $1.82.

Where Democrats Go Wrong On Pre-existing Conditions

This week, Senate Democrats are voting on a resolution to curtail the use of the Affordable Care Act’s Section 1332 waivers, which empower states to revamp their failing individual insurance markets. These waivers are a lifeline for states whose individual markets are on the verge of a death spiral. Yet Democrats claim they would put people with pre-existing conditions in jeopardy and are an attempt to “sabotage” Obamacare.
Here’s the problem.
If you have a decent income and have a chronic health condition, things have gotten worse, not better, for you under Obamacare.
For example, if you are single and earn $50,000 a year, you get no subsidy if you have to buy your insurance in the individual market. Yet under Obamacare, premiums have doubled nationwide. In some areas they have increased fivefold. Deductibles are three times what they are in a typical employer plan.
What about access to care? Across the country there has been a race to the bottom  in the Obamacare exchanges. Narrow networks exclude the best doctors and the best hospitals almost everywhere.
Before the passage of the Affordable Care Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) required states to enact protections for people with health problems who transitioned from the group to the individual health insurance market.
Most states met this obligation by establishing risk pools. The insurance offered in these pools was typically a Blue Cross plan that allowed access to almost all doctors and facilities. The premium was often 25% higher than what healthy people paid. But never more than 50%.
Today, if you leave an employer plan and enter the individual market you will face higher premiums and less access to care than under the old system – whether you are healthy or sick.
Centene is a Medicaid contractor that now sells about one-fifth of all the Obamacare plans sold in the country. The insurance it offers looks very much like Medicaid managed care. Doctors and hospitals that are in Centene’s network must accept Medicaid fees. If a patient goes out of network, Centene doesn’t pay anything.
It has taken a few years for the market to settle down. But today almost every other insurer is following Centene’s lead. In Dallas, Texas, not a single plan offered in the individual market ill allow a patient to enter UT Southwestern Medical Center, arguably the best medical research facility in the world. MD Anderson Cancer Center in Houston also doesn’t take Obamacare patients. Ditto for many other centers of excellence across the country.
What Obamacare promised was something that looked like traditional Blue Cross insurance for an affordable price. What we got was Medicaid with a high deductible and an unaffordable price.
A lot of healthy people are going bare. In fact, most people in the individual market who don’t qualify for a subsidy are currently uninsured! But if you are sick and need medical care, that’s not an option.
Obamacare desperately needs reforming. Seven states have received Section 1332 waivers and in every case premiums came down because the states were allowed to offset expenses for the most costly enrollees. Next year, an additional five states will get waivers and premiums are expected to decrease in those states as well.
Yet Democrats in the Senate  say they want to undo those reforms.
Much more needs to be done. Health plans need to be able to specialize – say in cancer care, diabetic care or heart disease. Plans should be able to ask heath questions at the time of enrollment to make sure the right plan gets connected with the right patient. And risk pool funds are needed to make sure that plans that attract patients with expensive-to-treat problems receive fair compensation.
The healthcare framework recently released by the Job Creators Network offers such a personalized approach to healthcare by giving patients more control over their healthcare choices through reforms such as expanded personal health management accounts and increased use of direct medical care.
We also already have a model for reform. It’s called Medicare Advantage (MA). Like Obamacare, it has an exchange. It has guaranteed issue and community rating. But unlike Obamacare, Medicare Advantage for the elderly and the disabled works and works well.
Instead of fighting the Trump Administration and state-level reformers and unduly alarming people with health problems, Democrats in Congress should work with their Republican colleagues to make changes that are long overdue.

FDA accepts Nabriva’s refiled Contepo application; shares up after hours

The FDA accepts for review Nabriva Therapeutics’ (NASDAQ:NBRV) resubmitted marketing application for Contepo (fosfomycin) for the treatment of complicated urinary tract infections. The agency’s action date is June 19.
The company received a CRL last year citing deficiencies at one of its contract manufacturers.
Shares up 8% after hours.

Applied Genetic Tech up after hours ahead of key update

Applied Genetic Technologies (NASDAQ:AGTC) perks up 6% after hours ahead of tomorrow’s announcement of preliminary six-month data from the expansion group in a Phase 1/2 clinical trial evaluating its recombinant adeno-associated virus vector rAAV2tYF-GRK1-RPGR in patients with X-linked retinitis pigmentosa caused by RPGR mutations.
The conference call will start at 8:00 am ET.

Hepion Pharma up after hours ahead of CRV431 update

Hepion Pharmaceuticals (NASDAQ:HEPA) is up 5% after hours ahead of a presentation of data from four nonclinical studies demonstrating that CRV431 improved liver fibrosis in animal and human tissue models.
Chief Scientific Officer Dr. Daren Ure will be announce the results at the NASH-TAG 2020 Conference in Park City, UT this week.