Cutera (CUTR) Lowers FY Revenue Guidance

Cutera, Inc. (CUTR) (“Cutera” or the “Company”), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, today pre-announced that the Company expects its revenues in the third quarter of 2018 to be approximately $40 million, or mid-single digit percentage growth over the third quarter of 2017. Based on this, the Company is revising full year 2018 revenue guidance to $165 million to $170 million, from $178 million to $181 million.

(Street sees FY revenue of $178.56 million)

“A few key factors that negatively impacted our third quarter results are expected to continue into fourth quarter. Given this, we are reducing our 2018 revenue guidance,” commented James Reinstein, President and CEO of Cutera, Inc. “Among the factors are headwinds faced by Juliet, our distributed women’s health system. We believe there was a clear impact on the overall market following the recent FDAcommunication to multiple manufacturers. While Cutera did not receive a notification from the agency, we believe our third quarter Juliet sales were negatively affected. Additionally, our hiring goals for US-based capital equipment sales personnel remain unmet. The result is an overburdened sales team, which we also believe will impact the fourth quarter as we hire and train new sales personnel. The newly revised 2018 revenue guidance incorporates these challenges with plans to remediate the latter in preparation for 2019.” Reinstein continued, “While the Q3 result did not meet our expectations, it should not overshadow an exceptional launch of our next generation body sculpting offering, truSculpt® iD, which delivered a record number of systems in the quarter. We continue to be excited about our prospects in the fast-growing body sculpting segment.”

Analyst Event Scheduled for October 9, 2018 The Company confirms it will host an analyst event as scheduled on October 9 at the Company’s headquarters in Brisbane, California. The event will begin at 4:00 p.m. Eastern Time and will be webcast. Additional details regarding the webcast will be posted on the investor relations section of the Company website before the event.

Third Quarter 2018 Earnings Release Scheduled for November 6, 2018 The Company plans to report results for the third quarter ended September 30, 2018 after market close on November 6, 2018. The Company will host a conference call to discuss these results with additional comments and details on that date, at 4:30 p.m. Eastern Time. Additional details regarding the webcast and conference call dial-in information will follow.

https://www.streetinsider.com/Corporate+News/Cutera+%28CUTR%29+Lowers+FY+Revenue+Guidance/14676676.html

Amarin price target raised to $35 from $15 at Cantor Fitzgerald

https://thefly.com/landingPageNews.php?id=2800009

Wells Fargo: OK for Bausch’s Bryhali expected by tomorrow’s PDUFA date

Wells Fargo says approval for Bausch’s Bryhali expected by tomorrow’s PDUFA date. Wells Fargo analyst David Maris noted that the PDUFA date for Health’s Bryhali for psoriasis is tomorrow, October 5, and it is expected that the company will receive FDA approval. He reads the fact that the company has already gone live with a Bryhali webpage promoting the message “Coming Soon” as a sign of Bausch’s confidence in the approval, Maris added. He maintains an Underperform rating on Bausch Health shares.
https://thefly.com/landingPageNews.php?id=2800025

New way to possibly eliminate clogged arteries

Researchers have proposed a unique study in humans to reduce the early onset of atherosclerosis, the buildup of the artery-clogging plaque that can lead to heart attacks and strokes.

The report, published Oct. 4 in the Journal of the American Heart Association, reviews a host of previous research and proposes a new clinical trial to reduce apolipoprotein B, also called apo B lipoproteins, in young and middle-age adults. Over the past few decades, research has pointed to this group of blood proteins, which includes LDL, or “bad cholesterol,” as the main culprit in the beginnings of atherosclerosis.

“Lowering them may have a big impact on making atherosclerosis go away,” said study lead author Dr. Jennifer Robinson, a professor of epidemiology and director of the Prevention Intervention Center at the University of Iowa. “If this works, you could completely eliminate heart attacks and strokes within a generation, because you can’t have a heart attack or stroke unless you have atherosclerosis.”

The proposed trial, CURing Early ATHEROsclerosis, or CURE ATHERO, would set out to determine if atherosclerosis in high-risk adults aged 25 to 55 might be reversed by using medicines called statins and PCSK9 inhibitors over the course of three years.

“The idea is to get the cholesterol very low for a short period of time, let all the early cholesterol buildup dissolve, and let the arteries heal,” Robinson said, adding that this approach has worked well in animal studies. “Then patients might need to be retreated every decade or two if the atherosclerosis begins to develop again.”

Lipoproteins are tiny, complex particles that transport fat and cholesterol through the blood. “There are a lot of different types of lipoproteins, but the ones that have apolipoprotein B on them are the ones that cause atherosclerosis,” said Dr. John Wilkins, a cardiologist and assistant professor at Northwestern University Feinberg School of Medicine.

Wilkins, who wasn’t involved in the report, called the proposal a “very compelling idea” that might show whether older adults can avoid heart attacks and strokes by making sure they have low LDL and apo B levels earlier in their lives.

“It’s a very important question that we really need to answer, because we have therapies now to lower apo B lipoproteins and LDL cholesterol,” said Wilkins, who has conducted research on apo B lipoproteins.

“We know that people who have low LDL cholesterol for genetic reasons have a very low risk of having cardiovascular events, so if we can replicate one of these genetic states and get people’s LDL cholesterol really low in early adulthood, perhaps these people won’t have downstream complications like heart attack and stroke,” Wilkins added.

The proposed trial would face certain challenges, including reluctance among young, seemingly healthy adults to take medication, Wilkins said. Another possible obstacle is the length of the study.

“Atherosclerosis develops over decades. It’s going to be very difficult to conclusively link a treatment strategy in people in their 30s or 40s to a reduction in risk 20 or 30 years later,” Wilkins said. “You would have to treat people and then follow them for 20 to 30 years, and that type of study design just isn’t practical.”

Doctors aren’t currently advised to test patients’ apo B levels, Robinson said, because routine LDL cholesterol tests and other measures already give doctors information to assess cardiovascular risk.

But she said she hopes the proposed trial will show that lowering apo B levels early in life will help people who are genetically inclined to have high cholesterol, as well as those with health problems caused by a poor diet, obesity and lack of exercise.

“People should do as much as they can with lifestyle, but it’s really hard to have a healthy lifestyle in modern society,” Robinson said.

A clinical trial could pave the way for a new generation of therapies to fight heart attacks and strokes, she said.

“Once you know what causes something, you can come up with a hammer for it and eliminate it. We’re not the first ones to think of this idea. This would be the culminating study of decades of research by thousands of people. But I’m excited about this, and I think it’s really time to pursue this hypothesis.”

 Explore further: Statins save lives of people with high levels of LDL cholesterol

https://medicalxpress.com/news/2018-10-possibly-clogged-arteries.html

Blackstone bags Clarus, gains growing Phase 3 niche in fast changing biopharma

Blackstone likes life sciences. And now it’s diving in deep.

The private equity giant has completed a deal to buy Clarus, a busy life sciences investor with an extensive history of gambling on late-stage drug development.

With $2.6 billion under management, Clarus is a peanut on Blackstone’s $440 billion plate. But with $19 billion in healthcare deals completed and a vast portfolio of biotech facility space on its books, Blackstone has the resources to go much bigger in a field that has been exploding with new activity over the last few years.
Clarus managing director and co-founder Nick Galakatos will now become head of Blackstone Life Sciences, bringing his portfolio of 50 life sciences companies with him.

Clarus has been a keen player in late-stage rounds, a highly competitive field where investors like to scale down risk as much as possible. That strategy was on display just days ago, when Clarus spearheaded a $150 million raise for Galera so it could complete a pivotal Phase III study on GC4419, which targets the toxic effect of radiation therapy as superoxide swiftly builds up in patients, afflicting the sensitive tissue in their mouths.

The big opportunity for Blackstone, though, is to do more of the specialty Phase III deals that Clarus has been inking with Big Pharma and Big Biotech, funding Phase III studies that can’t fit into their budgets or the bandwidth of their R&D groups — taking the risk and getting a payback through a mix of cash milestones and royalty streams.

These are deals you rarely hear about in detail.

“We think there’s a significant unmet need on the part of Big Pharma… to develop more of their R&D pipeline,” says Joe Baratta, head of private equity at Blackstone.

Clarus raised a $910 million fund for this niche last fall, and Blackstone has the assets necessary to go deeper.

“For the most part the R&D budget of the major pharma companies is constrained,” Galakatos told me last fall. “They have a very exciting pipeline and frankly they cannot fund their existing budget.”

In a call with reporters today, Galakatos says they’ve done a string of a dozen deals like this ranging from $50 million to $300 million, noting that late-stage development costs have doubled in the past 10 years.

Their arrival comes as the industry is undergoing a transformation. Instead of being picked off one by one by Big Pharma, more companies — like Alnylam or Agios — are pursuing a future in which they remain independent companies with commercial operations. As these companies grow into mid-cap companies, they’ll need significant amounts of money to make the changeover, more likely to see an advantage in doing development deals the new Blackstone operation has in mind.

Blackstone evidently plans to be ready to work for that business.

“This is a unique moment where rapid advancements in science and technology are creating unprecedented innovation and unparalleled impact on human health,” noted Jon Gray, Blackstone’s CEO. “Private capital can play an important role in accelerating the lengthy clinical development process to help bring vital, but underfunded, drugs to market. Building on the foundation of the world-class Clarus team, Blackstone Life Sciences is uniquely suited to provide much needed capital and expertise to this sector.”

https://endpts.com/blackstone-bags-biotech-backer-clarus-and-stakes-out-a-leading-place-for-itself-in-a-rapidly-changing-biopharma-industry/

JPMorgan sees opportunity to buy Constellation Brands shares after earnings

JPMorgan sees opportunity to buy Constellation Brands shares after earnings. JPMorgan analyst Andrea said that Constellation Brands’ (STZ) better than expected Q2 EPS was driven by stronger top-line growth, better operating profit growth and a favorable tax rate. The company’s updated FY19 EPS view of $9.60-$9.75, when adjusted for 25c-30c dilution from its increased investment in Canopy Growth (CGC), compares to Teixeira’s $9.26 estimate heading into the quarter and the consensus forecast of $9.30, she noted. The analyst, who sees an opportunity to buy Constellation shares following the report, keeps an Overweight rating on the stock, which is up nearly 5% to $220.65 in afternoon trading.
https://thefly.com/landingPageNews.php?id=2799997

Lilly’s breast cancer drug Verzenio approved in EU

Eli Lilly’s Verzenio breast cancer drug has been approved in Europe, as the pharma prepares to compete with established rivals from Pfizer and Novartis.

Verzenio (abemaciclib) is a CDK4 and 6 inhibitor, and has been approved by the European Commission in women living with HR+, HER2- advanced breast cancer, in combination with an aromatase inhibitor or fulvestrant.

The drug can be used in women who have not received endocrine therapy, or women who have received this form of therapy.

Already approved in the US since last year, Verzenio will compete with Pfizer’s Ibrance (palbociclib), and Novartis’ Kisqali (ribociclib), which are in the same class of drugs, which work by interrupting the cycle of cell growth in tumours.

Ibrance is now Pfizer’s biggest selling cancer drug, with sales approaching $2 billion in the first six months of this year, although sales of Novartis’ Kisqali are far behind as the drug was second to the market.

Whether Eli Lilly’s drug will make any inroads remains to be seen, and there was no word from US pharma about pricing in Europe.

However in the US it has a list price before any discounts or rebates of about $10,948 per month.

Dr Arash Tahbaz, Senior Medical Director, Eli Lilly and Company UK and Northern Europe, said: “Despite advancements in medicine, metastatic or advanced breast cancer remains a difficult-to-treat, diverse disease with a range of characteristics that can present differently in each individual.

“This marketing authorisation recognises the potential clinical benefit abemaciclib offers and represents continued progress towards helping more people living with this devastating disease.”

The approval is based on the efficacy and safety demonstrated in the global MONARCH 2 and MONARCH 3 clinical trials. MONARCH 2 was a Phase 3, randomised, double blind, placebo-controlled trial evaluating abemaciclib in combination with fulvestrant that enrolled 669 patients with HR+, HER2- metastatic breast cancer who progressed while on endocrine therapy.

The most commonly occurring adverse reactions observed with abemaciclib are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite.

https://pharmaphorum.com/news/lillys-breast-cancer-drug-verzenio-approved-in-eu/