BioD investors claim accelerated $26.5m earnout after ex-CEO quits Integra

Former BioD investors are looking for an accelerated $26.5 million earnout after ex-CEO Russell Olsen resigned from Integra Lifesciences (NSDQ:IART).

BioD merged with Derma Sciences for $80 million in Aug. 2016., which was later bought by Integra for $200 million. After the series of acquisition, Olsen told Integra that he believed his new job offer materially diminished his authority and that he planned to resign.

Following Olsen’s resignation, Derma Sciences received a letter on behalf of former equity owners of BioD, claiming that Olsen was terminated without cause and his departure should trigger an acceleration of the $26.5 million earnout detailed in the BioD-Derma Sciences merger agreement.

Integra has since filed an action with the superior court in New Jersey, seeking to clarify that Olsen’s resignation was for good reason and not without cause.

“If the employment agreement was terminated for good reason, then the company believes that the earn-out provision under the BioD Merger Agreement should not be acclerated,” the company wrote in its annual report.

Also this week, Integra said it topped expectations on Wall Street this week with its fourth-quarter and full-year financial results.

The company posted profits of $44.4 million, or 56¢ per share, on sales of $368.8 million for the 3 months ended Dec. 31.

Adjusted to exclude 1-time items, earnings per share were 64¢, ahead of consensus on The Street, where analysts were looking for sales of $364.9 million.

For the full year, Integra posted profits of $64.7 million, or 82¢ per share, on sales of $1.19 billion, beating analysts’ estimates of $1.17 billion.

“2017 was a transformative year for Integra. We closed the two largest acquisitions in the company’s history, expanded our regenerative portfolio with new, innovative products and successfully executed the global launch of CUSA Clarity, a significant upgrade to our tissue ablation platform,” president & CEO Peter Arduini said in prepared remarks. “We look forward to 2018 and another year of strong revenue growth, margin expansion and improving profitability.”

IART shares were trading at $52.63 apiece today in mid-morning activity, down -0.2%.

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StimGuard launches head-to-head trial against Medtronic’s InterStim

StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT).

Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve.

The new study is designed to compare that treatment with InterStim sacral nerve stimulation therapy, which involves the surgical implantation of lead at the sacral nerve and a battery unit (StimGuard’s device uses an external transmitter).

StimGuard said it plans to commercialize the technology if the study proves successful.

“An electrode implanted at the tibial nerve in an office setting, with the potential to provide the same outcomes as sacral neuromodulation, will be a game-changing option for urgency urinary incontinence associated with OAB,” StimGuard consultant Dr. Kenneth Peters, of Oakland University’s William Beaumont School of Medicine, said in prepared remarks. “StimGuard’s innovative technology has the potential to provide similar outcomes as sacral nerve stimulation in an office based procedure, which could drastically reduce the cost of care while allowing more patients to be treated, improving accessibility to a non-drug treatment option for many patients with OAB.”

Last July Medtronic touted 5-year results from the InSite study of InterStim.

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Philips launches HealthSuite Insights AI-powered healthcare app marketplace

Royal Philips (NYSE:PHG) said today it launched the artificial intelligence powered HealthSuite Insights analytics software suite designed for the curation and analysis of healthcare data.

The launch includes the Amsterdam-based company’s Insights Marketplace, which allows users access to curated AI-based assets from Philips and others through its own private ecosystem.

AI-based tools available through the newly launched HealthSuite Insights cover fields including diagnostic imaging solutions, patient monitoring solutions, oncology and genomics, Philips said.

The marketplace will initially supply only assets from Philips, with plans to add other medically validated Philips assets later this year, and assets from third parties at a later date.

“The quality of your AI is only as good as the quality of the data you feed into it. We have designed HealthSuite Insights to be used by the people who work with patient data on a daily basis and have the contextual understanding; including doctors, clinicians and hospital managers. With the HealthSuite Insights platform, we give them the ability to bring all the relevant patient information together, curate the data and use the power of AI to support precision diagnosis, personalized therapy, early intervention and greater hospital efficiency,” Philips chief innovation & strategy officer Jeroen Tas said in a prepared statement.

Last month, Philips announced plans to shutter manufacturing operations at a Cleveland plant that makes computed tomography scanners as part of a $600 million R&D initiative.

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Merit Medical’s Q4 earnings top estimates as 2017 profits surge

Merit Medical (NSDQ:MMSI) shares got a jump today from the medical device company’s fourth-quarter results, which beat expectations for both sales and earnings.

The South Jordan, Utah-based company yesterday post profits of $6.8 million, or 13¢ per share, on sales of $190.9 million for the three months ended Dec. 31, 2017, for a bottom-line slide of -9.3% on sales growth of 21.0% compared with Q4 2016.

Adjusted to exclude one-time items, earnings per share were 33¢, a penny ahead of the consensus on Wall Street, where analysts were looking for revenues of $187.6 million.

Full-year profits rose 36.8% to $27.5 million, or 55¢ per share, on sales growth of 20.5% compared with 2016, to $737.9 million. Adjusted EPS were $1.28 for the year.

“We have now closed the final year of our initial three-year plan,” founder, chairman & CEO Fred Lampropoulos said in prepared remarks, noting that Merit expects to move production ofthe biopsy assets it acquired last month from Becton Dickinson (NYSE:BDX) to its Tijuana, Mexico plant over the next several months.

“We believe the substantial investments of the past, along with a long-term vision of the future, continued discipline, and a keen eye on the present will continue to present a substantial opportunity for stakeholders and value for our shareholders,” Lampropoulos said.

Merit said it expects to report adjusted EPS of $1.57 to $1.69 on sales of $838 million to $851 million this year.

MMSI shares, which closed down -3.0% at $45.50 apiece yesterday, opened up 2.0% at $46.40 and reached a high of $49.50 before subsiding to $46.30 per share in early trading, up 1.8%.

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FDA panel to review Senseonics’ implantable CGM this month

A panel for the FDA is slated to review Senseonics‘ (NYSE:SENS) premarket approval application for its Eversense implantable continuous glucose monitoring system on March 29.

The company’s device sends glucose data every five minutes to a transmitter, which then communicates that information to a mobile app, displaying the values in the real-time. The Eversense system also includes an alarm to warn the user if they’re approaching hyper- or hypo-glycemia.

Get the full story at our sister site, Drug Delivery Business News.

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Mylan: Generic competition pushes EpiPen sales down

Mylan (NSDQ:MYL) revealed in its annual report yesterday that EpiPen sales in the U.S. were down $655.4 million last year compared to 2016.

The company, which faces continued backlash over the price of its emergency allergy treatment, cited the launch of a generic version of its device, higher governmental rebates and increased competition as reasons for EpiPen’s declining sales in North America.

Get the full story at our sister site, Drug Delivery Business News.

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Ex-Siemens Healthcare VC sues for retaliatory firing

A former venture capitalist with the healthcare operation at Siemens (NYSE:SI) sued the company last year, alleging that he was fired in retaliation for blowing the whistle on an alleged extortion attempt.

Andrew Jay’s 14-year tenure in the German industrial conglomerate’s Boston venture shop ended in November 2017, when he declined to accept a demotion he alleges was made after he told the Siemens compliance department of a contractor’s alleged attempt to strong-arm a startup company Siemens was considering for an investment.

Formerly a managing partner and VP, Jay’s team in the summer of 2016 paid a visit to molecular diagnostics company Base4 to gauge its suitability for investment, according to Jay’s Dec. 27, 2017 complaint filed in Massachusetts’ Suffolk Superior Court. But the team decided it was too early to invest in Base4 and passed that recommendation up the ladder.

The following spring, the contractor – Thomas Miller of GreyBird Investments, a former Siemens executive with a contract to provide dealflow to its VC shop – pitched Base4 as a potential investment, according to the lawsuit, which was removed to the U.S. District Court for Massachusetts last month. Miller’s contract was arranged by then-Siemens Healthcare CEO Bernd Montag and head of strategy David Stein, whose deputy Mary Amor also backed the proposed Base4 investment, according to Jay’s complaint.

Jay then sent a pair of his own deputies to take a another look at Base4’s microdroplet technology, but again recommended against investing after reaching the same conclusion, according to the complaint. But in July 2017 he allegedly received a call from Base4 CEO Cameron Frayling about Frayling’s contact with Miller.

“Mr. Frayling informed [Jay] that Miller had represented to Base4 that Siemens Healthcare would invest if Miller told them to, that Siemens Healthcare would not invest if Miller told them not to, and that he should sign the proposed term sheet with GreyBird if he wanted to see any funding from Siemens Healthcare,” the lawsuit alleges.

After discussion with his team, Jay informed Siemens Healthcare’s compliance department about Frayling’s call. Although Amor allegedly later told Jay that Miller’s contract was not renewed, despite Siemens executive’s satisfaction with its value, the lawsuit claims that Stein continued to push for a Base4 investment which Siemens allegedly eventually made; Base4 reported a $6.5 million round in November 2017.

For Jay, the lawsuit alleges, that meant a demotion based on the alleged pretext that his demeanor during presentations was a problem.

In August 2017, Stein and Montag “acted in concert to concoct a pretextual reason to demote plaintiff, remove many of his job duties, and replace him with an outside hire, all in retaliation for plaintiff’s compliance report,” the lawsuit alleges.

Jay declined the promotion and left Siemens Nov. 6, 2017, according to the complaint. He’s seeking compensatory and punitive damages; Siemens filed notice Feb. 26 of its intent to move dismissal on failure to state a claim, according to court documents.

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