Monday, September 10, 2018
MyoKardia initiated with an Overweight at Morgan Stanley
MyoKardia initiated with an Overweight at Morgan Stanley. Morgan Stanley analyst Jeffrey Hung initiated (MYOK) at Overweight with a $72 price target, stating that the obstructive hypertrophic cardiomyopathy Phase 2 data for its lead program, mavacamten, were “robust” and the fact that the company is partnered with Sanofi (SNY) gives him incremental confidence. He expects a mavacamten launch in oHCM in early 2022 and peak U.S. sales for the drug of greater than $1.3B.
https://thefly.com/landingPageNews.php?id=2787817
MacroGenics initiated at BTIG
MacroGenics assumed with a Buy at BTIG. BTIG analyst Thomas Shrader assumed MacroGenics with a Buy rating and a price target if $30, saying he is positive on its DART and TRIDENT multi-functional antibodies programs and its Fc Optimization technology that “allows antibodies to interact more strongly with immune effector cells that resolve antibody-antigen complexes”. The analyst contends that while the company’s monoclonal antibodies, or mAb, development space is “crowded”, MacroGenics offers “nearly two decades of tough won experience” and over two years of cash runway to give its “deep pipeline” multiple opportunities to “turn heads”.
https://thefly.com/landingPageNews.php?id=2787819
Sunday, September 9, 2018
NY Presbyterian reports lower net income, higher expenses in H1
- New York-Presbyterian’s net income for the first half of 2018 dropped nearly 47% from a year ago to $170.6 million.
- The system’s operating income also decreased by about 16% to $140 million in the first half, while total operating revenue increased almost 8% to $3.1 billion.
- NYP also saw total operating expenses jump 8.3% compared to a year ago to $3 billion.
The New York City-based nonprofit health system has six main facilities. That includes NYP Hospital, which U.S. News and World Report named the metro area’s top-ranked hospital for 18 consecutive years.
The system, which recently joined Walgreens’ Find Care Now self-service telehealth kiosk initiative, said the lower income came mostly from decreased investments. Higher expenses were associated with salary and benefits and supply costs. Investments dropped from $154 million a year ago down to $30.6 million this year.
For the second quarter, NYP had $78.5 million in operating income, a 9% drop from a year ago. Total revenue increased 8.7% and total expenses increased 9.9% in the quarter compared to last year.
Operating income also fell 18.1% in the quarter to $125.9 million, which was connected to lower investment returns. On the plus side, net patient service revenue increased nearly 9% to $124.7 million. That increase came from higher inpatient and outpatient volume, higher acuity and higher payment rates compared to a year ago.
Salaries increased in Q2 by 7.3% compared to a year ago. That increase was connected to investments in bedside nursing, care coordination and population, information technology and innovation, expanded emergency services and new clinical initiatives that were mostly connected to opening a new ambulatory care facility at the Weill Cornell campus.
NYP is the latest provider to release financial information this quarter. The second quarter and first half have been a mixed bag for providers. Overall, reports show that admissions didn’t drop and volume trends varied by system. Consolidation also remained a hot trend for the quarter.
In recent interviews with Healthcare Dive, analysts said hospitals can’t rely on the graying of American to swell admissions and volume numbers.
“We need to deal with the fact that a lot of these hospitals will face the problem of slowing organic volume growth, other than those who can spend money to drive market share,” Brian Tanquilut, senior vice president of healthcare services equity research at Jefferies, said.
Gottlieb: UnitedHealth, CareFirst in FDA pilot aiming to speed device coverage
UnitedHealthcare and CareFirst have signed onto an FDA pilot allowing device manufacturers to get feedback from regulators and payers during pre-submission meetings, Commissioner Scott Gottlieb said Wednesday.
The announcement was just one of several made in a wide-ranging speech on FDA’s oversight of medical devices to a room full of industry executives, high-ranking government officials and trade association leaders.
The goal of the payer pilot, Gottlieb said at the Medical Device Innovation Consortium’s annual public forum, is to encourage manufacturers to “develop a more efficient evidence-generation strategy” during the meetings and facilitate a shorter period of time between FDA approval of devices and coverage decisions “particularly for new and innovative devices.”
Other members of the program, which currently receives one product inquiry per week, include the BlueCross BlueShield Association, Duke Evidence Synthesis Group, the ECRI Institute, Humana, Kaiser Permanente and the National Institute for Health and Care Excellence in the U.K.
Gottlieb said that while FDA’s medical device regulatory paradigm has advanced at a healthy pace, delays by private payers in coverage decisions are reducing incentives for device companies to innovate.
“Insurers have every right to demand good data to support their coverage decisions. And they have an obligation to be good stewards of the healthcare needs of their beneficiaries,” Gottlieb said. “But if there are steps that the FDA can take to make that coverage process more efficient, and to make sure payers have the data they need to enable efficient access to beneficial new technologies, we want to do our part to make these opportunities available. Access is a matter of public health.”
FDA will also be launching what it is deeming a new “QUiK Review” pilot that Gottlieb says will lower review time for well understood low-risk 510(k) submissions “by as much as 30%.” The program will use a more streamlined, electronic submission that offers a more structured format that in theory will allow reviewers to cut down the maximum review time from 90 to 60 days.
In another bid to facilitate medical device premarket review, FDA also issued a new draft guidance Wednesday. The document aims to bring bring clarity to how the agency considers the risk-benefit balance during approval decision making.
“By providing a more systematic review to how we evaluate and address uncertainty — and how we define an acceptable extent of uncertainty — we believe that this sort of transparency can help improve device development programs, especially when it comes to innovation in treatment options for small patient populations, such as medical devices targeted to rare conditions or pediatric patients,” Gottlieb said in a statement.
The draft guide notes the agency’s obligation under the 21st Century Cures Act to “consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.” Gottlieb noted that overly complex clinical trial requirements risk pushing companies to conduct research overseas, putting “the U.S. at risk of losing its leadership in this fast-moving sector.”
The commissioner emphasized that product safety remains FDA’s principal obligation, but argued that no “reasonably-sized premarket trial” can provide “absolute certainty about all aspects of how a new product will perform” for PMAs. But in the draft guide, FDA pointed to its risk classification for medical devices, noting that “as a general matter, high-risk and innovative moderate-risk devices will typically need clinical evidence to show reasonable assurance of safety and effectiveness.”
FDA lists several considerations for a premarket approval decision in the draft guidance including:
- The probable benefits of a device.
- The extent of probable risks, such as the severity, rate and duration of such risks.
- Uncertainty of the benefit-risk profile of other treatments or diagnostics.
- Patient input on appropriate levels of uncertainty.
- The feasibility of generating “extensive clinical evidence premarket based on appropriate considerations.”
- The potential benefit of earlier patient access to a device.
Device cybersecurity is also on Gottlieb’s mind. he said that FDA will issue an update to its cybersecurity pre-market guidance to equip device makers with recommendations to protect moderate and major risks such as ransomware campaigns or remote multi-patient attacks.
BlueCross BlueShield Tenn. drops Oxycontin for Collegium’s competitor
In a statement, BlueCross BlueShield pushed back on Purdue Pharma’s suggestion that the insurance change “appears to be more about pharmaceutical rebates.”
“This has nothing to do with rebates,” a spokesperson for the health plan said. “At no point have we considered cost in our efforts to address the opioid epidemic — our changes are designed to promote safety and appropriate use.”
- Tennessee’s largest health insurer will stop covering Oxycontin beginning in 2019 and recommend two other opioids with abuse-deterrent labels for coverage instead, BlueCross BlueShield of Tennessee announced Thursday.
- Collegium Pharmaceutical’s Xtampza and Japanese pharma Daiichi Sankyo’s MorphaBond will both be picked up for coverage, mounting a small but momentous challenge to the roughly $2 billion per year OxyContin franchise.
- The embattled OxyContin maker Purdue Pharma said “this decision appears to be more about pharmaceutical rebates,” in an emailed statement to BioPharma Dive, while BlueCross BlueShield touted it as the insurer’s next move in fighting painkiller abuse.
Purdue Pharma, which has suffered through a summer of lawsuits against its opioid marketing, criticized the insurer’s stated rationale for the decision, noting Oxycontin was the first opioid to receive an abuse-deterrent label in April 2013.
Furthermore, Purdue highlighted that Xtampza (oxycodone) carries a risk warning similar to Oxycontin (oxycodone).
“This decision limits prescribers’ options to help address the opioid crisis,” a Purdue spokesperson wrote in the email to BioPharma Dive. “Further, while both products are formulated with properties designed to deter center routes of abuse, neither is abuse proof or less addictive. Unfortunately, this decision appears to be more about pharmaceutical rebates.”
By contrast, a BlueCross BlueShield of Tennessee spokesperson said the decision was “the right to do for our members and for the state” by making “a meaningful difference in addressing the dangers of opioids,” in an emailed statement.
The insurer also mentioned it has been working with a panel of Tennessee physicians to help reduce opioid abuse. A spokesperson said the panel agreed with its “clinical leaders” on the change.
Jefferies analyst David Steinberg called the decision meaningful for Collegium with roughly 8,000 yearly prescriptions on the line. And he sees more “managed care wins” as “increasingly likely” for the Massachusetts-based company with the upcoming annual enrollment period.
“More importantly, it could mark the beginning of other state plans to follow, many of whom are significantly larger than Tennessee in terms of annual [prescriptions],” he wrote in a Sept. 6 analyst note.
Florida’s largest insurer and insuring giant Cigna both dropped Oxycontin this year from their coverage plans, replacing it with Collegium’s offering.
Xtampza extended release was previously rejected 100% of the time by BlueCross BlueShield of Tennessee, Steinberg added.
Collegium has had a tough summer on the Nasdaq, nearly halving in value from a June peak of about $28 to closing at roughly $15 yesterday as prescription growth began to slow. Share price was up roughly 5% in opening trading hours Friday.
Xtampza commercially launched in June 2016 as the company’s first product. For the first half of 2018, the drug posted net sales of $33.9 million compared to $5.7 million a year ago. By contrast, Oxycontin posted $1.7 billion in sales in 2017.
CEO Joe Ciaffoni said on an Aug. 8 earnings call that Xtampza prescription grew 23% from the first quarter, up to 80,364, and the opioid is expected to have a gross-to-net discount of roughly 60%.
SEC halts trading in two cryptocurrency products, citing market confusion
The U.S. Securities and Exchange Commission said on Sunday it was immediately suspending trading in two investment products that track cryptocurrencies, citing confusion in the markets over whether the products are exchange-traded funds (ETFs).
The SEC said in a statement that trading in Bitcoin Tracker One and Ether Tracker One would be halted in the United States until at least Sept. 20.
The products promise to track the price of the cryptocurrencies, less fees. They are both listed on a Nasdaq Inc exchange in Stockholm, but trade “over the counter” in transactions that occur off exchanges within the United States.
“It appears … that there is a lack of current, consistent and accurate information,” the SEC said in a notice posted on its website. “Application materials submitted to enable the offer and sale of these financial products in the United States, as well as certain trading websites, characterize them as ‘Exchange Traded Funds.'”
The issuer of Bitcoin Tracker One and Ether Tracker One, XBT Provider AB <SE0010296574.ST> and its parent company, did not immediately respond to emailed requests for comment. Nasdaq declined to comment.
The SEC has taken a strict stance against letting ETFs tracking bitcoin and other cryptocurrencies come to market.
But investment firms have been pushing other types of investments that attempt to make it as easy to trade cryptocurrencies as a regular stock.
Those products are sometimes called ETFs, but that term generally refers to a different and often more stringently regulated product. Some industry experts, including the largest ETF provider BlackRock Inc, have called for regulators to standardize the terms used to describe ETFs and other kinds of investment products.
Virtual currency, including bitcoin and ether, can be used to move money around the world quickly and with relative anonymity, without the need for a central authority, such as a bank or government. A fund holding the currency could attract more investors and push its price higher.
Coca-Cola Plans to Bid for Glaxo’s Horlicks
The Coca-Cola Co. is moving forward with its interest in GlaxoSmithKline Plc’s Indian malted milk drink company Horlicks Ltd, according to the Sunday Telegraph.
The company is making preparations ahead of a deadline for first round bids, said the newspaper, which didn’t say where it got the information. The newspaper has previously reported that the transaction may be valued at 3 billion pounds ($3.9 billion).
Coca-Cola’s interest in Horlicks comes just weeks after its acquisition of U.K. coffee chain Costa for 3.9 billion pounds, reflecting the company’s strategy to diversify away from soft drinks. Coca Cola, its adviser Citigroup and GSK declined to comment to the Sunday Telegraph.
GSK announced a strategic review of Horlicks and other nutrition-focused products in March to potentially help fund its $13-billion buyout of Novartis AG’s stake in their consumer healthcare joint venture.
Other large consumer retail companies such as Kellogg Co., Unilever Plc, Reckitt Benckiser Group Plc, The Kraft Heinz Co. and Nestle SA have also registered interest in Horlicks, according to the Sunday Telegraph, as well as private equity firm KKR & Co Inc.
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