Reports Q1 revenue $291.1M, consensus $295.16M. Adjusted results for the first quarter of 2018 exclude merger and other costs of $6.3 million after tax, or $0.35 per diluted share. Total organic growth in home health admissions was 6.7%. Total organic revenue growth in home health was 9.0%. Total organic growth in hospice admissions was 4.6%. Keith G. Myers, LHC Group’s chairman and CEO, said: “Our acquisition and joint venture pipeline remains robust. Based on the early success with the Almost Family integration and the ability to seamlessly integrate other acquisitions, we remain laser-focused on M&A as a key component of our overall growth strategy. The value proposition enhanced by a full spectrum of post-acute care is an important differentiator we can offer prospective partners. We also expect to generate additional organic growth and expanded capabilities through co-locating our service lines in markets we serve and capitalizing on the relatively untapped potential of our healthcare innovations segment.”
Wednesday, May 2, 2018
LivaNova selloff overdone: Piper
LivaNova selloff today ‘very much overdone,’ says Piper Jaffray. Piper Jaffray analyst Matt O’Brien tells investors to buy shares of LivaNova following today’s post-earnings pullback. The analyst views the guidance as “essentially maintained” given that the company is just baking in TandemLife. He still believes the outlook is conservative. Further, there are meaningful leverage opportunities ahead, with LivaNova’s spending likely to be more front-end loaded to support growth, O’Brien writes in a post-earnings research note titled “This Time We Really Mean It; Buy This Name on the Pullback.” The analyst calls today’s pullback “very much overdone” and he “strongly” encourages investors to start or build positions in the name. O’Brien keeps an Overweight rating on the shares with a $105 price target. LivaNova closed the trading day down 7% to $83.32.
Exelixis, Invenra enter into biologics collaboration
Exelixis announced that it has entered into a collaboration with Invenra, Inc., the Madison, Wisconsin-based biotechnology firm focused on developing next-generation biologics, to discover and develop multispecific antibodies for the treatment of cancer. The partnership pairs Exelixis’ fundamental biological insights, clinical development prowess and commercialization expertise with Invenra’s innovative platform technologies and biologics expertise to identify, optimize, and manufacture multispecific therapeutics, including immunotherapy applications. The collaboration is part of Exelixis’ ongoing strategy to build an innovative pipeline beyond its two internally discovered, commercially available compounds, cabozantinib and cobimetinib. The agreement with Invenra creates a biologics discovery capability that complements Exelixis’ in-house small molecule drug discovery efforts
Zoetis First-Quarter Profit Benefits From Tax Changes; Backs 2018 Guidance
Zoetis Inc. (ZTS) on Wednesday reported a 48% rise in first-quarter profit as it benefited from tax changes, and backed its full-year guidance.
The Parsippany, N.J.-based animal-health company posted a quarterly profit of $352 million, or 72 cents a share, compared with $238 million, or 48 cents a share, for the same period last year. Excluding items, Zoetis reported an adjusted profit of 75 cents a share for the quarter, compared with 53 cents a year earlier and analysts forecasts of 69 cents.
Sales rose to $1.37 billion, from $1.23 billion for the quarter ended March 31. This compares with analysts forecasts of $1.35 billion, according to FactSet.
Zoetis expects to report revenue for the year of $5.68 billion to $5.80 billion, compared with $5.31 billion in 2017. It forecasts profit of $2.77 to $2.93 a share, and an adjusted profit of $2.96 to $3.10 a share for 2018. This compares with a profit of $1.75 a share in 2017 and an adjusted profit of $2.40 a share.
Novo Nordisk 1Q Beat Expectations; Cautions on Competition, Pricing
Danish pharmaceutical company Novo Nordisk A/S (NOVO-B.KO) on Wednesday posted first-quarter earnings that beat forecasts, but it cautioned that despite expecting robust sales growth in the future, intensifying competition and price pressure will have an effect.
Net profit for the three months ended Mar. 31 rose to 10.75 billion Danish kroner ($1.74 billion) from DKK10.16 billion in the same period last year, beating the DKK9.87 billion forecast in a FactSet poll of analysts. Sales fell to DKK26.93 billion from DKK28.45 billion, but still beat the expected DKK26.72 billion.
Sales in the quarter found support from Novo Nordisk’s new diabetes and obesity treatments, partly offset by declining sales of long-acting insulin Levemir. However, a significant hit from the depreciation of the U.S. dollar and related currencies versus the Danish krone meant that reported sales fell.
Measured in local currencies, 2018 sales growth is now seen at 3% to 5% compared with an earlier estimate of 2% to 5%. Reported sales growth is now expected to be around six percentage points below that range, having earlier been anticipated at seven percentage points lower.
Operating-profit growth in local currencies is now seen at 2% to 5% from a previous estimate of 1% to 5%, with reported growth seen around nine percentage points lower, from a drop of 10 percentage points expected earlier.
Growth this year is expected to be underpinned by a robust performance in Novo Nordisk’s modern insulin and obesity drugs, but the company said intensifying global competition both within diabetes care and biopharmaceuticals, as well as continued pricing pressure within U.S. diabetes care, would keep a lid on growth.
Looking into next year, Novo Nordisk said new U.S. legislation will hit group sales by 1% to 2%. Funding of the Medicare Part D coverage gap will be changed from 2019, with pharmaceutical companies required to cover 70% of the coverage gap compared with a current level of 50%, it said.
Combination Therapy for Osteoporosis May Benefit High-Risk Patients
While monotherapy, generally with bisphosphonates or other antiresorptive agents, is generally standard of care for osteoporosis, significant strides have been made in combination therapy — particularly by pairing an anabolic drug with an antiresorptive agent, one researcher argued.
“In some ways, osteoporosis is very different from other chronic diseases, such as diabetes and hypertension, that use agents from more than one class,” Benjamin Z. Leder, MD, chair of the American Society for Bone and Mineral Research (ASBMR) Professional Practice Committee and an endocrinologist at Massachusetts General Hospital in Boston, told MedPage Today. “To treat osteoporosis, historically we use one drug at a time at a single dose and transition from one to the other without a lot of thought about combining the two.”
But over the past 10 years, that school of thought is beginning to change. While researchers have already studied the effects of combining antiresorptive agents with each other “20 to 30 years ago,” Leder pointed to recent interest in combining an anabolic agent with an antiresorptive agent.
In 2013, Leder’s team published a study that found that combining the anabolic agent teriparatide (Forteo) with the antiresorptive agent denosumab (Prolia) was linked with greater bone mineral density compared with using a single therapy.
But Leder added that there have been a number of barriers to wider uptake of combination therapy. The first is that there have yet to be fracture studies done for the treatment. Leder said that studies have used other surrogate endpoints, such as bone density, bone quality, bone microarchitecture and bone strength, and combination therapy improved these endpoints, but there have yet to be studies to prove that this therapy can better reduce the incidence of fracture in high-risk patients.
“Those studies are done in thousands of patients over many years, and outside of funding from a specific pharma company, they are hard to do,” Leder said.
He voiced his hope for a fracture efficacy study that would compare anabolic and antiresorptive agents with the most common antiresorptive agent. “Hopefully the study will be done either from industry or from the NIH,” he added.
In addition to combination therapy, the sequence of the therapy appears to make a difference in the outcome. Even if the drugs are used in combination, Leder said it is becoming “increasingly clear” from the research that one should start patients on an anabolic agent first, followed by an antiresorptive agent rather than giving the drugs in the opposite order.
Leder’s team published an additional article in The Lancet in 2015, which found that patients who switched from the anabolic agent teriparatide to the antiresorptive agent denosumab had an increase in bone mineral density, but if patients switched from denosumab to teriparatide, the effects of the treatment were blunted. A 2016 editorial in the Journal of Bone and Mineral Research also argued that “the order matters” in osteoporosis patients receiving this type of combination therapy.
Barriers to Adoption
But Leder cited a couple of barriers to this type of treatment being more widely adopted: First, different medical societies have different guidelines for the treatment of osteoporosis. In addition to the lack of fracture studies, Leder said, “the data is fairly recent,” on combination therapy.
In fact, the most recent guidelines from the American Association of Clinical Endocrinologists (AACE) on the diagnosis and treatment of osteoporosis in postmenopausal women explicitly state that “until the effect of combination therapy on fracture risk is demonstrated, AACE does not recommend concomitant use of these agents for prevention or treatment of postmenopausal osteoporosis.”
Moreover, the most recent guidelines from the American College of Physicians (ACP) “didn’t discuss sequence therapy or combination therapy or anabolic therapy at all,” Leder said.
“It would help a lot if it was incorporated into the guidelines,” he argued. “I would expect it, as the guidelines continue to evolve.”
The second barrier to combination therapy is the way that payers mandate that the drugs are used. Leder said that insurance will not let clinicians use an anabolic agent to treat osteoporosis patients first — that it will be allowed only if bisphosphonate therapy has not worked well.
Leder emphasized that most patients with osteoporosis can be treated with a single drug, but that those with the highest risk of fracture, such as patients with a metabolic abnormality, would benefit from combination therapy. His hope, he said, is that clinical trials will continue to examine different forms of combination therapy.
Leder reported financial relationships with Lilly, Amgen, and Radius Pharmaceuticals.
Fresenius alleges ‘blatant fraud’ at U.S. drugmaker Akorn
German healthcare group Fresenius (FREG.DE) alleged it uncovered “blatant fraud at the very top level” of U.S. generic drugmaker Akorn Inc (AKRX.O) after Fresenius agreed to acquire the company for $4.75 billion, according to a court filing made public late on Tuesday.
Fresenius abandoned the merger agreement last month, and Akorn has sued in Delaware Court of Chancery to try to hold Fresenius to the deal.
Shares of Akorn fell more than 8 percent in early trading Nasdaq on Wednesday to $13.57 per share. The stock has plummeted from more than $30 per share in February after Fresenius said it was investigating data integrity at Akorn, and warned it could end their merger agreement.
Fresenius officially abandoned the $34 per share deal for Akorn in April.
Akorn spokeswoman Jennifer Bowles said the company categorically disagreed with the allegations and intended to enforce the merger agreement.
The drugmaker will ask a Delaware judge at a hearing on Tuesday to fast-track its lawsuit and schedule a trial as soon as next month, according to court documents. Fresenius wants the trial to be held in January.
Akorn said in its lawsuit last month that Fresenius uncovered data integrity problems that are common in the generic drug industry and is seizing on them to try to back out of a deal it soured on for financial reasons.
FREG.DEXETRA
+1.82(+2.87%)
Fresenius alleged that an Akorn executive vice president for quality assurance, whose name was redacted from the court filing, knowingly directed the submission of fraudulent testing data to the U.S. Food and Drug Administration.
The fabricated data concerned Akorn’s application to market the antibiotic azithromycin, and Fresenius alleged the fraudulent scheme began in 2012.
Fresenius also alleged that “the same scheme has infected” at least five other Akorn products.
In the court filing, Fresenius said its investigation revealed “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations.”
Akorn has said in court documents it investigated the possible submission of falsified data and fired an executive who was involved.
“Critically, azithromycin and the five other drug products in question either have never been marketed or are not currently being marketed and were never forecasted to form a material portion of Akorn’s future earnings,” the company said in one of the documents.
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