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Friday, July 13, 2018

What If Nevro Loses Legal Battle to Boston Scientific?


Nevro and Boston Scientific have been clashing over intellectual property since shortly after FDA approved Nevro’s Senza spinal cord stimulation (SCS) system in May 2015. Now, Nevro is suffering a massive stock dip prompted by a surprise preliminary ruling in the case. Are investors throwing the baby out with the bathwater on this one?
“While it’s nearly impossible to make an educated call on a fluid legal dispute, which frankly could go either way, we seek to provide both a more comprehensive construction of the legal process – both past and future – to hopefully mitigate any future surprises similar to today, and a reasonable valuation framework for assessing a risk/reward at current levels,” said Jason Mills, an analyst at Canaccord Genuity, in a report he issued Wednesday.
U.S. District Judge Vince Chhabria adopted a tentative ruling in Nevro’s intellectual property suit against Boston Scientific around spinal cord stimulation patent infringement. Chhabria said he would likely remove five of the seven patents included in the suit due to ambiguity in the wording and structure of the company’s original patents. If this happens, those patents would be removed from the case.
“Conversations with third-party patent attorneys have led us to an understanding that in California district courts, decisions issued in the final ruling have historically tended to be in line with tentative rulings,” Mills noted in his report.
In May 2015, shortly after FDA approved Nevro’s Senza SCS system, Boston Scientific filed petitions with the U.S. Patent and Trademark Office that challenged the validity of Nevro’s patents. Later that year, the petitions were denied. Then, in late 2016, Nevro filed a patent infringement lawsuit against Boston Scientific.
Even if the judge throws out five of the patents in the suite, at least one claim will survive, which means Nevro could potentially win on summary judgement, or the claim could go before a jury, Mills explained.
The bad news for Nevro is that if five of the patents are tossed out of the lawsuit, they will effectively be invalidated as U.S. patents, allowing Boston Scientific to use the previously patented technology, Mills noted. However, Nevro will likely file an appeal if that happens.
“We see tailwinds outweighing headwinds,” Mills said, pointing out that in the SCS market in general, the total addressable market “remains quite large and significantly underpenetrated, at approximately 7%, in our estimation.”
The analyst estimates that the SCS market grew last year by 13%, resulting in a $1.7 billion market, and he expects the market to grow 11% by the end of 2018.
“Regardless of legal outcomes, we view a significant growth opportunity still in front of Nevro, even if the firm were ultimately to lose its IP battle with [Boston Scientific] and face another competitor in the high-frequency space,” Mills said.
Beyond Nevro’s current market opportunity, the analyst said a large determinant of the company’s future growth will be indication expansion into areas like painful diabetic neuropathy (PDN).
“The fact that the PDN study has taken longer than expected to get up and running is a bit frustrating,” Mills acknowledged in his report. “That said, the opportunity is still quite compelling in this area.”
In an earlier report from Mills, issued in May, he also pointed out that technology like Nevro’s offers an alternative to opioids, an issue that is gaining more and more attention in healthcare. He also said Nevro has been expanding its sales force to drive more share gain.
Nevro has been on another industry analyst’s radar as well. Needham & Co.’s Mike Matson included the company on his list of the 25 most attractive public medtech companies in terms of potential M&A targets.

Achaogen 30% pullback since last month overdone, says William Blair


After attending the company’s investor event, William Blair analyst Y. Katherine Xu says shares of Achaogen at current levels offer an attractive entry opportunity. While most of the Street has modeled the use of Zemdri in carbapenem-resistant enterobacteriaceae, extended-spectrum beta-lactamases-producing bacteria is also a major target and represents a much larger population, Xu tells investors in a research note. Further, she believes physicians are and will be comfortable to use Zemdri off-label in blood stream infections and pneumonia. The analyst views the 30% pullback in Achaogen shares since the complicated urinary tract infections approval last month as overdone and thinks her $23 fair value estimate could prove conservative. Xu keeps an Outperform rating on Achaogen.

Aerie target upped by Needham


Aerie Pharmaceuticals price target raised to $86 from $76 at Needham. Needham analyst Serge Belanger raised his price target on Aerie Pharmaceuticals to $86 and kept his Buy rating after hosting investor meetings with its management. The analyst says the company has provided “anecdotal feedback” of a strong initial launch of Rhopressa, with physicians reporting efficacy levels superior to those observed in the clinical trials along with lower incidences of hyperemia. Belanger notes that the management is “increasingly confident” about meeting its $20M-$30M sales guidance for 2018 and “comfortable” with consensus estimates for revenue in FY19

Novartis disputes Dem report on Cohen contract


Novartis is disputing a report from Democratic senators that said it made misleading comments about its $1.2M contract with former attorney for President Donald Trump, Michael Cohen, according to Reuters.The group of senators concluded that Novartis’ relationship with Cohen was longer and more detailed than reported

MEI started at buy by SunTrust


MEI Pharma initiated with a Buy at SunTrust. SunTrust analyst Yatin Suneja initiated MEI Pharma with a Buy rating and $12 price target.

Galmed started at buy by Stifel


Galmed initiated with a Buy at Stifel. Stifel analyst Adam Walsh initiated Galmed with a Buy rating and $35 price target, calling it a “legitimate late-stage NASH play” after Aramchol recently proved itself in a Phase 2 trial as a clearly active and “very safe” compound for treating NASH.

Catalyst started at buy by Oppco


Catalyst Pharmaceuticals initiated with an Outperform at Oppenheimer. Oppenheimer analyst Leland Gershell initiated Catalyst Pharmaceuticals with an Outperform rating and $6 price target, telling investors that he sees “smooth FDA sailing” for Firdapse following a surprise setback in 2016, and says Firdapse should start generating revenue for Catalyst by early 2019. Looking ahead, Gershell sees label expansion to congenital myasthenic syndromes in 2020, and clinical data reveals in other ultra-orphan conditions over the next 12-18 months that could catalyse upward revisions to his model.