Nuvectra said last night in its earnings release, “We remain committed to the sacral neuromodulation (SNM) opportunity via the eventual FDA approval of Virtis, our SNM system for the treatment of chronic urinary retention and the symptoms of overactive bladder. As an update, the FDA has requested additional information as part of our PMA application. To satisfy their request, we will secure supplementary data on the biocompatibility of our Virtis leads and expect to submit this information around year end 2019. Accordingly, we project potential Virtis approval in the first half of 2020 and therefore no longer expect Virtis-related revenue in 2019.” Shares of Nuvectra are down 12% in premarket trading to $8.25.
https://thefly.com/landingPageNews.php?id=2901647
Thursday, May 2, 2019
Aerie: U.S. Launch of Rocklatan; Increase in Rhopressa Medicare Part D Coverage
Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced that it has launched Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% into the United States glaucoma market.
Rocklatan is now with national and regional U.S. pharmaceutical wholesalers, and patients can fill prescriptions for Rocklatan through their local pharmacies across the nation.
Rocklatan has already gained non-preferred brand coverage with payors representing 60% of commercial lives. Additionally, effective May 1, Medicare Part D preferred tier coverage for Rhopressa (netarsudil ophthalmic solution) 0.02% increased from approximately 40% to 75%. Commercial coverage for Rhopressa remains at 90% of lives, with 55% of lives in a preferred tier.
‘We are very pleased to announce the availability of Rocklatan in the United States. As the first fixed-dose combination glaucoma medication including a prostaglandin analog introduced in this country, and the first to contain a Rho kinase (ROCK) inhibitor in the world, Rocklatan adds an important new tool to the treatment paradigm – and a second way to provide the benefits of a ROCK inhibitor – for physicians and their patients with glaucoma or ocular hypertension,’ said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. ‘In fact, the approval of Rocklatan in mid-March was greeted very enthusiastically by the glaucoma treatment community. These eye care professionals are now able to prescribe Rocklatan and obtain samples of the product.’
Dr. Anido added, ‘We are also providing a single savings card to reduce out-of-pocket costs for commercially-insured patients who are prescribed either Rocklatan or Rhopressa. We are committed to maximum access for patients and we continue to meet with commercial and Medicare Part D plans to accelerate market access for Rocklatan on those formularies. Ultimately, we believe Rocklatan has the potential to become a new cornerstone of medical therapy for glaucoma and ocular hypertension. At this point, Rhopressa is covered in a preferred tier for the majority of commercial and Medicare Part D lives in the United States. We are delighted to have obtained this level of market access within one year of the Rhopressa launch and believe the increased Medicare Part D coverage to 75% of lives will bolster volume growth going forward, and Rocklatan coverage is already off to a strong start.’
Thermo Fisher: Blood Biomarker May Flag Patients with Developing Sepsis
Multi-centre analysis shows that incorporation of MR-proADM (mid-regional proadrenomedullin) into an early management of patients with suspected infection protocol may aid rapid clinical decision making in the emergency department
Results from the multi-centre study titled ‘The early identification of disease progression in patients with suspected infection presenting to the emergency department’ have been published in the February issue of Critical Care. In this study, the testing 1175 patients presenting to six European emergency departments (ED) with an initial diagnosis of infection were prospectively enrolled and validated by a secondary analysis of 896 patients with suspected infection from previously published multi-centre study1.
The inappropriate discharge of patients in the early stages of sepsis development is a serious, life-threatening consequence of the complex pathophysiological signs of infection. Indeed, all infections have the potential to manifest into life-threatening conditions, depending on the virulence of the infecting organism and the subsequent pathophysiological host response. Despite a high emphasis being placed on an early identification of patients with sepsis within the ED, failure to identify those with initially low severities, but a high potential for subsequent disease development and progression towards sepsis may lead to either a delayed therapeutic response or inappropriate discharge decisions.
Siemens Healthineers sees diagnostics drag on full-year profitability
Siemens Healthineers said measures to speed up installations of its new blood and urine testing machines were bearing fruit, but would also squeeze profit margins at its diagnostics division in the short term.
The German health technology firm is pinning its hopes on its Atellica machine to turn around its In-Vitro diagnostics business which lags market leader Roche, but lengthy installation times at large and complex laboratories have dragged down profit in the division.
Healthineers said on Thursday it had shipped over 410 Atellica Solution analyser in the three months to the end of March, and over 780 machines in the first six months of its fiscal year. It has also won approval for the device in China.
“The measures taken to ensure a successful market launch of our laboratory diagnostics platform Atellica Solution have shown an early impact in the second quarter,” said Chief Executive Bernd Montag.
Steps to reduce installation times mean the number of analysers that are operational and able to book sales of the highly profitable tests used in the machines had increased to 20-30 per week, he said.
But despite an expected acceleration in shipments in the second half, Montag told analysts the target to ship between 2,200-2,500 analysers this year remained “very challenging” and that it was likely Healthineers would fall slightly short of the range.
The company also said the ramp-up would squeeze profit margins at its diagnostics division to below last year’s levels, while comparable sales growth would lag its mid-term target range of 4-6 percent.
Berenberg analyst Scott Bardo said diagnostics was “still to stage a turnaround” and the placements of 410 for the quarter were below the implied run rate of 600 machines per quarter at the start of the year.
MARKET SHARE GAINS
Despite the costs associated with the Atellica launch, Healthineers reported a 24 percent rise in net profit for its fiscal second quarter to 381 million euros ($427 million), beating consensus forecasts for 374 million euros.
Currency-adjusted sales rose 5.8 percent to 3.5 billion euros, also ahead of analyst forecasts, helped by strong sales of molecular imaging, computed tomography and X-Ray gear as well as products in its Advanced Therapies division.
This outperformed Dutch rival Philips which on Monday reported comparable quarterly sales growth of 2.3 percent, held back by a decline in demand for hospital equipment in Europe and flat sales in the United States.
Montag said Healthineers had made market share gains in all its imaging businesses and noted healthy global demand, particularly from China.
The company confirmed its full-year guidance for a profit margin of 17.5 to 18.5 percent for its 2019 fiscal year, and comparable sales growth of 4 to 5 percent.
Chief Financial Officer Jochen Schmitz said he was more confident Healthineers would hit the upper end of its target range for revenue growth, but added it would be prudent to assume the profit margin would be at the lower end of its target.
Bayer: Roundup Ads Rise as Suits Mount
Roundup is getting an advertising boost after thousands of plaintiffs have alleged that the world’s most widely used weedkiller causes cancer.
Bayer AG, the manufacturer of Roundup, and Scotts Miracle-Gro Co., which markets it to home-and-garden retailers in the U.S., have spent millions of dollars this year on expanded marketing for the weedkiller, Scotts executives said.
“We were concerned, the retailers were concerned,” James Hagedorn, Scotts’ chief executive, said Wednesday on a call with investors. So far, he said, U.S. consumers haven’t abandoned the product.
Roundup is at the center of lawsuits brought by more than 13,000 farmers, gardeners and others who blame the herbicide for causing their cancer and seek to hold Bayer accountable. The German company acquired Monsanto, Roundup’s maker, for $63 billion in 2018.
Residential gardeners and landscapers appear to be buying more Roundup, according to Scotts. Over the first three months of the year, Scotts’s sales of Roundup increased 20% from the same quarter a year earlier, the company said. Many farmers, who make up the main market for Roundup, have stood by the weedkiller, considering it less harsh on the environment and people compared with other agricultural chemicals.
Two juries over the past year have ruled in favor of plaintiffs and awarded tens of millions of dollars in damages, sending shares of Bayer about 39% lower in that time. Bayer is challenging the verdicts, and another trial is under way in a California court.
Shares in Scotts climbed 5.4% in Wednesday’s late-afternoon trading, while Bayer settled slightly lower in European trading.
Regulators have stood by their assessments showing the herbicide to be safe. The Environmental Protection Agency this week reiterated its previous conclusions that glyphosate, Roundup’s main chemical ingredient, is safe when used as directed and doesn’t pose a cancer risk. The EPA said it is in the process of renewing glyphosate’s U.S. authorization.
Bayer on Tuesday welcomed the EPA’s assessment. “Today’s EPA announcement is just the latest instance of a global regulatory agency reaffirming that glyphosate is not carcinogenic,” the company said.
Some consumer groups criticized the EPA for overlooking research they said showed glyphosate’s risks. But regulators in the European Union and Canada have ruled similarly, in some cases after revisiting scientific research that plaintiffs’ lawyers have questioned.
Bayer recently paid $20 million to reimburse Scotts for higher costs related to Roundup, including increased ad spending, Scotts executives said. Plaintiffs’ lawyers have aired their own TV ads seeking new clients in the litigation against Bayer.
“Given the environment we thought we were in, I think we spent the money extremely well and I think you’re seeing the results,” Mr. Hagedorn said. “We’re two cases into this, and it’s the court of public opinion and consumers that matters here.”
A Bayer spokeswoman said the company routinely reimburses Scotts for expenses, including ads.
Wednesday, May 1, 2019
Teva shares reflect much of bad news, says Wells Fargo
Wells Fargo analyst David Morris kept his Market Perform rating and $18 price target on Teva (TEVA) ahead of its Q1 earnings tomorrow, saying investors have “low expectations” for the quarter after “weak-ish” Sandoz results from Novartis (NVS). The analyst also points to IQVIA (IQV) sales and prescriptions data indicating that Teva generic sales were down 12% in March, 10% in February, and 13% in January, though the decline are “much smaller” than seen in U.S. generics during 2018. Morris further expects Teva to address the risk of opioid litigation that became a concern during the quarter in its earnings call.
DexCom price target raised to $173 from $165 at Piper Jaffray
Piper Jaffray analyst JP Kim raised his price target on DexCom to $173 and kept his Overweight rating after its “solid” Q1 results. The analyst notes that while the company’s Q1 gross margin of 60% was below his expected 64.5% amid capacity expansion investments, he sees DexCom well positioned for the “inflection” in the Continuous Glucose Monitoring market as it converts away from Blood Glucose Meters. Kim also cites the management’s discussion of pharmacy contracts having a 2-3 year time span and expects the company’s G7 system tracking to launch next year to be competitive “at any price point.”
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