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Monday, September 17, 2018

JMP: Changing Competitive Landscape Makes Revance Less Appealing


Revance Therapeutics Inc RVNC 8.28%, a biotech company developing a botulinum toxin product, could face a competitive backlash, according to JMP Securities.

The Analyst

Analyst Donald Ellis downgraded Revance from Market Outperform to Market Perform.

The Thesis

The downgrade of Revance is based on Allergan plc AGN 2.08%‘s recently released data in Botox responders showing that 80 units of Botox 80 produced a more than 1-point improvement in 24 weeks in 39 percent of study patients, Ellis said in a Monday note. (See his track record here.)
Revance is testing RT002, daxibotulinumtoxinA injection, in a Phase 3 study for Glabellar Lines while also pursuing Phase 2 trials for cervical dystonia and plantar fasciitis.
Revance’s RT002 showed similar improvement in about 42 percent of study population, the analyst said.
“AGN’s data suggest that the longer duration of activity for RT002 may be partially or primarily due to a ‘dose’ effect,” Ellis said.
Allergan’s recent data minimizes the benefit of extended duration claims for RT002 vs. Botox, the analyst said.
The FDA requires a more than or equal to 2-point improvement, and none or mild on wrinkle severity, which both companies have not disclosed, he said.
JMP does not expect the companies to make 24-week claims.
“AGN can educate doctors on longer duration with higher doses at medical conferences, but its reps cannot legally promote longer duration directly to doctors,” Ellis said.

Hedge fund backs away from Athenahealth deal

Paul Singer’s Elliott Management has backed away from its $160-a-share bid for Athenahealth, The Post has learned.
At the same time, other suitors — including some strategic companies that had made initial inquiries — have also gone quiet, sources close to the situation said.
As a result of Singer’s retreat and the lack of robust interest from others, Athena has extended a final bid deadline by 10 days — to Sept. 27, sources said.
Singer backing off the promised bid is a stark turnaround in the battle for the health care tech company.
Elliott succeeded in a tough activist fight to get Athena to oust founder and Chief Executive Jonathan Bush, a cousin of former President George W. Bush, and to put the company up for sale.
Singer’s firm in May said it was prepared to pay $6.9 billion for Athena — contingent on due diligence.
“There has been a lot of speculation on Elliott’s motives” for saying in May it was prepared to pay $160, an industry source said.
“It feels now like they never really wanted to own it,” and were just setting a floor for the auction, the source said.
Meanwhile, Elliott might have learned upon doing diligence that there were unexpected problems at the medical records software company, sources said.
In June, weeks after Singer’s $160 offer, Athena shares topped out at $163.94. The shares on Monday closed at $142.09, down $1.07.
Speculation in health care circles is that Athena will see sub-$150-a-share bids, sources said.
The remaining suitors, including Elliott, which is teaming with Bain Capital on its bid, are likely trying to see what Athena will take in a face-saving sale, sources said.
“Without a deal, the shares could fall to $120 a share,” the industry source said.
“It would not be totally shocking” if now there is no sale, a source with direct knowledge of the situation said.
The New Yorker in its Aug. 27 cover story on Singer, the 74-year-old activist investor, portrayed Athena as the poster child for how activists force short-term changes at companies that hurt them in the long run.
Athena CEO Bush on June 6 resigned under Elliott’s pressure. Executive Chair Jeffrey Immelt, the former GE chief, has now taken a leading role at Athena.
In May, Elliott said its offer was subject to regulatory approvals and a robust review.
The hedge fund called out Athena’s underperformance relative to peers, and the parade of five chief financial officers in the span of four years.
One hedge fund that may be relishing the delayed Athena sales process is David Einhorn’s Greenlight Capital.
 
 
 
The $5.5 billion hedge fund, which was down 25 percent through Aug. 31, has been shorting Athena shares.
“Our take is that the activist has little interest in actually buying the company, but hopes someone else does,” Einhorn said in a July letter to his investors.
https://nypost.com/2018/09/17/paul-singers-hedge-fund-backs-away-from-athenahealth-deal/

Why payers are gobbling up PBMs


With the OK from the Justice Department, Cigna’s nearly-final takeover of Express Scripts moves closer to the end of an era when standalone pharmacy benefit managers dominated the industry.
Pending remaining state approvals for that $67 billion pact and the expected clearance of the CVS-Aetna megamerger, the three largest PBMs will all be hitched to health plans. UnitedHealth created its own in 1990 with OptumRx.
The crowded landscape has drastically changed from just a decade ago when PBMs were scooping up competitors and morphed the sector into one dominated by a few behemoths controlling the prescription drug benefit for millions of Americans.
Over time, PBMs went from simply processing prescription claims, largely an administrative function, in the late 1960s to now serving as the gatekeeper to prescriptions through formularies and pharmacy networks. They also play a controversial role in pricing as they negotiate directly with drug manufacturers but reveal little about how those savings are passed onto consumers.
Over the past few years, payers have become increasingly interested in bringing the function in-house, dissolving their relationships with independent PBMs to launch their own, or acquiring others to do so.
“I think it’s a natural evolution of where this industry needs to go,” Ana Gupte, an analyst for Leerink Partners, told Healthcare Dive. “At the end of the day, the pharmacy benefit is integral to management of an insured member as a whole person.”

A case for savings

By combining both the medical and pharmaceutical benefit under one umbrella, analysts say you can potentially achieve greater costs savings than may have been possible with separate entities. For example, if a patient is prescribed a particular drug the overall drug spend may increase, but it could result in savings on the medical side if it prevents a costly hospital visit.
“Now you have a better coordination of care when you have both of those under one roof,” John Boylan, an analyst with Edward Jones, told Healthcare Dive.
That’s particularly important as spending has dramatically increased for specialty drugs that treat complex diseases. Some specialty drugs need to be administered in a healthcare setting, so it may be covered under the medical benefit. But some can be covered under the pharmacy benefit or even both, according to Adam Fein, CEO of Drug Channels Institute.
Specialty drugs represent 40% of overall drug spending for Express Scripts, yet only 1% of their members use a specialty drug, according to the company.
“Total specialty drug spending is split between medical and pharmacy benefits. Patients on specialty drugs also tend to have higher medical expenses, so integrated medical-pharmacy management is crucial,” Fein wrote in April.
Plus, if covered by pharmacy but administered in a hospital or doctor office, “PBMs are not able to control that channel because they have no leverage over the provider,” Gupte said.
Combined, the companies are better poised to deal with this problem, Boylan said.

Role in drug pricing controversy

At the same time, PBMs have faced increased scrutiny over the years as drug prices continued to soar, raising questions about their effectiveness in reining in costs. The debate surrounding PBMs really caught fire when Mylan Pharmaceuticals CEO Heather Bresch in part blamed PBMs for the rise in price while she faced criticism for raising the list price of EpiPen, a lifesaving antidote for those suffering an allergic reaction.
“Drug pricing is becoming a mainstream national issue,” Brian Tanquilut, an analyst with Jefferies, told Healthcare Dive.
But as drugmakers took heat, they pointed fingers at others in the healthcare ecosystem, including hospitals and PBMs.
The Trump administration has been particularly aggressive in taking on the industry, showing an interest in curbing the rebates, as well as overhauling safe harbor protections that shield PBMs from anti-kickback lawsuits.
Tanquilut thinks the increased scrutiny has played a role in fueling these payer-PBM acquisitions.
PBMs decide which drugs they will cover each year for their members and, to get a preferred status, drug manufacturers agree to rebates or discounts. It’s unclear how much of that savings actually makes it way back to patients. PBMs also use spread pricing — pocketing the difference between what they charge the pharmacy and what they bill their client.
“The black box model is under scrutiny,” Tanquilut said. “It’s better for them to be embedded. You can kind of hide your economics.”

Piper Jaffray Upgrades Acceleron Pharma (XLRN) to Overweight


Piper Jaffray analyst Danielle Brill upgraded Acceleron Pharma (NASDAQ: XLRN) from Neutral to Overweight with a price target of $75.00 (from $52.00).
The analyst says the Luspatercept opportunity has been de-risked and likes the equity noting the royalty stream remains under-appreciated.

Activist ValueAct raises stake in Horizon Discovery


Activist hedge fund ValueAct Capital has nearly doubled its stake in Horizon Discovery Group, buying an additional 7.5 million shares from Woodford Investment Management.

ValueAct, which now holds less than 10 percent, said in a statement it was exploring the possibility of appointing a member of its team to the life science company’s board.
“Horizon Discovery is one of the leading players in its field and is highly supportive of the Company’s ongoing efforts to contribute to improved healthcare,” it said in a statement.
Horizon said in a separate statement that it has had a dialogue with ValueAct over time and believes its board is “very strong, well governed and appropriately constituted”.
In May, biotech firm Abcam walked away from a takeover offer after Cambridge-based Horizon rebuffed a 270 million pound ($355 million) deal, rejecting its rationale.
Earlier on Monday, Horizon, which mostly deals with gene editing applications, said its half-year core loss before one-off items narrowed from last year.
It also forecast full-year revenue to be slightly ahead of consensus expectations and said it expects negative EBITDA before exceptional items for the first half of the year to be offset by positive EBITDA for the second half.
Shares of Horizon Discovery closed at an 8-month high of 236 pence on Monday.

White House OKs ambulatory surgery center safety database


The White House has approved HHS’ plan to launch a patient safety database for ambulatory surgery centers, as more of the facilities pop up across the country and represent a bigger share of healthcare providers.
The ambulatory surgery center database will be similar to other HHS programs in place hospitals, nursing homes and pharmacies. The Office of Management and Budget posted an approval notice Friday for the ASC database.
HHS’ Agency for Healthcare Research and Quality wanted to launch the databasebecause ASCs are treating a growing number of patients and federal regulators want to ensure patient safety.
The database will store information from surveys of surgical center staff on patient safety culture. For instance, staffers will be asked if their management regularly develops action plans for adverse outcomes and whether all of the staff members involved in a surgery get to weigh in on post-care recovery plans.
There were 5,532 Medicare certified centers in 2016, up 3.5% from 5,344 in 2011, according to federal data. From 2011 to 2016, the number of ASCs grew at an average annual rate of 1.3%. Roughly 3.4 million Medicare enrollees receive care at ASCs annually. However, spending has grown about 27%, from $3.4 billion to $4.3 billion, over that five-year period as the facilities provide more services and see more patients.
AHRQ’s request came months after a joint investigation by Kaiser Health News and USA Today raised concerns about the quality of care and safety at ASCs. The news outlets discovered that more than 260 patients have died since 2013 after outpatient procedures at surgery centers across the country.
ASCs support creating the database, as the surveys will help ensure surgery centers are providing the best care possible, according to William Prentice, CEO of the Ambulatory Surgery Center Association.

CMS plans to stop hospitals from rejecting ASC patient transfers


The CMS issued sweeping regulation Monday meant to ease Medicare regulations. The overall goal is to reduce administrative burden on providers and ease access to care for patients. Collectively, the CMS estimates the provisions will save providers $1.12 billion every year.
The CMS wants to prevent hospitals from rejecting patients being transferred from competitive ambulatory surgical centers. Currently, surgical centers must have a written transfer agreement with a hospital or ensure all physicians performing surgery have admitting privileges in a nearby hospital. The CMS proposes removing that requirement, citing complaints from the “largest ASC trade association.”
Also under the rule, the CMS wants to allow providers that belong to a health system to avoid their own quality reporting and have a universal quality assessment and performance improvement, or QAPI, program. A similar proposal for infection control programs is also in the rulemaking.
More than half of all U.S. hospitals belong to multi-hospital health systems, and about 60% of all hospital admissions occur in system hospitals.
“While a wide range of quality improvement mechanisms can be applied in individual hospitals, there has been a lack of actionable information that leaders of multi-hospital systems can leverage to improve quality across their systems,” the agency said in the rule.
The rule also eliminates duplicate reporting for transplant programs to submit data and other information to Medicare. That policy, the CMS said, has led to transplant programs avoiding performing transplants for certain patients, causing some organs to go unused.
The CMS also wants to streamline access for X-ray services by replacing four different qualifications with a single, streamlined criterion that focuses on the skills and abilities of the technologist.
The public has until Nov. 20 to comment on this rulemaking.
Since announcing its Patients Over Paperwork initiative last year, the agency has taken action to address 55% of the 624 topics considered burdensome by the industry. Another 16% of the topics remain under consideration and 29% were either referred to another agency or did not require further action.
The CMS projects these moves have saved providers nearly $5.2 billion and reduced 53 million in paperwork hours through 2021.