Ford, Ekso Partner On New ‘Exoskeletons’ To Protect Factory Workers

In partnership with Ekso Bionics Holdings Inc EKSO 28.02%, Ford Motor Company F 0.6% is equipping many in its global workforce with exoskeleton wearable technology to assist in the performance of repetitive, overhead movements.

What Happened

The technology provides lift assistance to the arms to help reduce fatigue and injury risk.

“Building vehicles is physically a tough job,” Bruce Hettle, Ford group vice president of Manufacturing and Labor Affairs, said in a press release. “We care about our employees and are trying to help them do their jobs with the least amount of wear and tear on their bodies possible.”

Why It’s Important

The Ford partnership was, in itself, big for Ekso. Ford ordered vests for all its North American plants, as well as many others in Asia Pacific, Europe and South America.

But the investment also lends critical validation that may inspire additional manufacturers to equip its workers with Ekso technology.

“At Ekso, our mission is to augment human capability with wearable technology and robotics that help people rethink current physical limitations and achieve the remarkable,” Ekso CEO Jack Peurach said in a statement. “Advancing our collaboration with a global leader like Ford, represents a major step forward in achieving our mission as our EksoVest is deployed around the world to enhance the well-being of its workforce.”

What’s Next

Ford has not yet employed the technology in all its global plants, and it’s unclear whether it intends to do so.

https://bit.ly/2M7PNBL

4 Reasons Behind Stifel’s Neurocrine Bull Thesis

Neurocrine Biosciences, Inc. NBIX 1.21%, which already has two strong drugs in the market in the form of Ingrezza and the recently approved elagolix, has a promising pipeline ahead, according to Stifel.

The Analyst

Analyst Paul Matteis initiated coverage of Neurocrine with a Buy rating and $137 price target. The stock was added to Stifel’s “Select List.”

The Thesis

Notwithstanding the run-up in shares, Neurocrine stock has scarcity value in the midcap space due to its “blockbuster lead asset, strong patent protection, multiple shots on goal and near-term profitability,” Matteis said in the initiation note.

These factors give a positive twist to Neurocine’s long-term growth story even in the presence of very few attractive near-term clinical catalysts, the analyst said.

Stifel’s bullish stance is predicated on four factors, Matteis said:

• Ingrezza, the company’s lead asset for tardive dyskinesia, possesses blockbuster potential, the analyst said: nearly 8,000 patients who took Ingrezza in the second quarter and represent a small fraction of the total candidate pool. The analyst estimates that Ingrezza will hit the $1-billion mark in tardive dyskinesia sales in 2021.
• The belief that Ingrezza has a reasonable chance of succeeding and expanding its market in Tourette’s syndrome.
• Stifel’s projection that endometriosis-related pain treatment elagolix will generate close to $2 billion in cash flows.
• The analyst’s view that little of Neurocrine’s remaining pipeline is priced into the stock.

“We expect Neurocrine to continue to diversify its pipeline with both in-house candidates and the consideration of small acquisitions or licensing arrangements,” Matteis said.

https://bit.ly/2vLiBpC

Reaction To Weight Watcher’s Q2 Earnings

Weight Watchers International, Inc. WTW 14.9% reported an earnings beat in its second-quarter results, which may have been overshadowed by a slowdown in subscriber growth. Here’s a summary of how some Street analysts reacted to the report.

The Analysts

• D.A. Davidson’s Linda Bolton Weiser maintains a Buy rating on Weight Watchers with an unchanged $143 price target.
• KeyBanc Capital Markets’ Edward Yruma maintains at Overweight, unchanged $115 price target.
• B. Riley FBR’s Kara Anderson maintains at Buy, price target lifted from $103 to $113.

Shares of Weight Watchers were trading lower by 12 percent at $80.90 at time of publication.

Encouraging Takeaways

Weight Watchers reported a revenue miss in the quarter, but multiple other metrics support a bullish stance on the stock, Bolton Weiser said in a note. These include:

• 27.6 percent growth in subscribers to 4.5 million versus expectations of 4.4 million;
• 21 percent of subscribers opted for the six month plan compared to 14 percent last year; and
• Average retention reached a new all-time high;

Related Link: Weight Watchers CEO Talks Earnings, Celeb Collaborations After Q2 Print

Strong Tailwind Ahead

The “solid” earnings report is highlighted by the growth in online subscribers, which resulted in a 430 basis point expansion in margins, Yruma said in a note. Encouragingly, a 32-percent year-over-year increase in marketing expenses flowed to the top-line strength and the momentum seen in the quarter should be sustainable.

The company expects to end 2018 with 25 percent more subscribers than 2017 and this alone could result in a 50-cent per share tailwind for 2019 EPS due to the impressive nature of the subscription model, the analyst said. The company is likely to see incremental upside from improved retention, a rewards and loyalty program and ongoing investments in brand-building initiatives.

Weight Watchers continues to stand out within the weight loss space due to the simplicity of its app along with a database of 200 zero-point foods. This is evident in the greater number of people signing up for a six month plan compared to the same quarter a year ago and 1.3 million unique members syncing their app to a fitness device.

Progress Towards Wellness Brand

Exiting Weight Watchers’ report, it’s evident the company continues to progress towards a “holistic wellness brand” that offers its 4.5 million subscribers “freedom and livability,” Andersonsaid in a note. At the same time, the company is succeeding in another transition of becoming more of a leading technology company.

Management comments it won’t be running TV commercials in the fall season is encouraging as it reinforces the strength of its digital marketing, the analyst said. A focus on advertising in the right space is key to achieve a longer-term $2 billion revenue target by 2020.

https://bit.ly/2ORE2Od

Stifel Buys Back Into Biogen, Sees Upside In Alzheimer’s Candidate

The Street leans bullish on Biogen Inc BIIB 2.62%, and one sidelined analyst doesn’t want to miss on the profits.

The Rating

Stifel Nicolaus analyst Paul Matteis resumed coverage of Biogen with a Buy rating and $394 price target.

The Thesis

Biogen’s fate is seen to hinge on its Alzheimer’s therapy, with the odds of success being better than 50-50, Matteis said in a note.

“From a sentiment perspective, we think the stock — in a positive or negative Alzheimer’s scenario — could overshoot its fundamental value,” the analyst said.

Stifel read Phase 1b aducanumab data with more forgiveness than investors did given the treatment’s differentiated profile.

“The hardest thing to get comfort with is that the effect size — even if Aducanumab does work — is small, so, even if the drug does work, there are still exogenous variables that place the trial at risk.”

At the same time, Biogen’s multiple sclerosis candidates are expected to perform in line with or better than consensus forecasts for the next two years, although branded competition, payor pushback and generics could impede growth after that, Matteis said.

Stifel also anticipates growth in Spinraza among Type 2 and Type 3 spinal muscular atrophy patients, particularly considering the opportunity for quicker than expected international sales. Stifel said ex-U.S. sales could soon exceed U.S. sales by hundreds of millions of dollars. The spread would help buffer the drug against inevitable competition.

“Global diversification may also help with durability when gene therapy disrupts the category,” the analyst said. “When this happens we assume that Spinraza’s front-line Type 1 share will quickly approach zero percent, but we believe its ability to retain patients already on therapy who are doing well could be stronger than many expect.”

https://bit.ly/2Ohfz44

ANI Pharmaceuticals Reports Second Quarter, Year-To-Date, Updates Guidance

For the second quarter 2018:

• Net revenues of $47.3 million, an increase of 6% as compared to the same period in 2017
• GAAP net income of $2.8 million and diluted GAAP earnings per share of $0.23
• Adjusted non-GAAP EBITDA of $19.0 million
• Adjusted non-GAAP diluted earnings per share of $1.13

The following table summarizes 2018 guidance:

($ in millions except EPS figures)

                                                 2018 Guidance Range                   2017             2018
                                                                                             Guidance
                                                                                             --------

                                                      First Half          Second Half        Full Year        Full Year        Growth
                                                      ----------          -----------        ---------        ---------        ------

                                                        Actual                Low              High              Low            High          Actual               Low       High
                                                        ------                ---              ----              ---            ----          ------               ---       ----


    Net Revenues                                                    $93.8             $101.2           $111.2           $195.0        $205.0                $176.8       10%        16%


    Adjusted non-GAAP EBITDA                       40.8(c)                             41.2             47.2             82.0          88.0  74.2(e)                   11%        19%


    Adjusted non-GAAP diluted earnings per share             $    2.45(d)             $2.35            $2.92            $4.80         $5.27          $    3.91(f)      23%        35%
                                                              -----------             -----            -----            -----         -----           -----------      ---         ---

https://bit.ly/2KCF2m3

Eagle Pharmaceuticals, Inc. Reports Second Quarter 2018 Results

Business and Recent Highlights:

• EHS clinical trial for RYANODEX^® will be conducted August 20 – 24, 2018 during the Hajj pilgrimage;
• Eagle received a favorable decision by the U.S. District Court for the District of Columbia granting seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI) until December 2022 and denying the Food and Drug Administration’s (FDA’s) attempt to preemptively exclude TREANDA generics from the scope of exclusivity;
• Data from the fulvestrant clinical trial expected in the fourth quarter of 2018;
• Advancing discussions with U.S. military to formalize clinical and regulatory plans for RYANODEX in the treatment of nerve agent exposure;
• United States Patent and Trademark Office issued patent number 10,010,533 for BENDEKA. The USPTO has now issued or allowed a total of 15 U.S. patents in the BENDEKA family of patents expiring from 2021 to 2033;
• Eagle was first to file a vasopressin 1ml injection ANDA, which was accepted for filing by the FDA in April; and
• A second source manufacturing facility for Eagle’s bendamustine products has been approved by the FDA.

Financial Highlights:

Second quarter 2018

• Total revenue for the second quarter of 2018 was $59.3 million, compared to $50.1 million in the second quarter of 2017;
• Eagle launched bendamustine hydrochloride 500ml solution (“Big Bag”) on May 15, 2018 and Big Bag product sales were $8.1 million in the second quarter of 2018;
• Q2 2018 Ryanodex product sales were $7.2 million, up 38% compared to Q2 2017;
• Q2 2018 net income was $2.7 million, or $0.18 per basic and $0.17 per diluted share, compared to net income of $4.5 million, or $0.30 per basic and $0.28 per diluted share in Q2 2017;
• Q2 2018 Adjusted Non-GAAP net income was $14.7 million, or $0.99 per basic and $0.95 per diluted share, compared to Adjusted Non-GAAP net income of $7.9 million, or $0.52 per basic and $0.49 per diluted share in Q2 2017;
• During Q2 2018, Eagle purchased an additional $3.5 million of Eagle common stock as part of its share buyback program; since August 2016, Eagle has repurchased $91.3 million of Eagle common stock; and
• Cash and cash equivalents were $100.2 million, accounts receivable was $69.4 million, and debt was $47.5 million as of June 30, 2018.
• Reiterating 2018 Expense Guidance:
  • R&D expense is expected to be in the range of $46 – $50 million ($40 – $44 million on a non-GAAP basis)
  • SG&A expense is expected to be in the range of $61 – $64 million ($44 – $47 million on a non-GAAP basis)

“We believe 2018 will be another solid year of growth for Eagle, with continued near-term value creation, and strong upside potential with our advanced pipeline that could meaningfully contribute to the long-term value of the business. This includes protecting the value and longevity of our existing bendamustine franchise where we recently prevailed in litigation and received orphan drug exclusivity until December 2022 for BENDEKA, as well as having recently launched “Big Bag”, our 500 mL liquid form bendamustine solution that does not require reconstitution, filling an important need in the market for a lower-cost alternative. Our RYANODEX portfolio is advancing as we take advantage of product and label expansion opportunities for Exertional Heat Stroke and evaluate the neurological impact of nerve agent exposure in collaboration with the U.S. military,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

“As a result of the favorable court ruling requiring the FDA to grant BENDEKA orphan drug exclusivity, the FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022. The court also denied the FDA’s attempt to preemptively exclude TREANDA generics from the scope of BENDEKA’s ODE. We continue to believe that an appropriate application of ODE would first allow generic TREANDA entrants in December 2022, rather than November 2019 and intend to vigorously pursue our position with the FDA and through additional litigation, if necessary,” added Tarriff.

“We look forward to completing our clinical study for RYANODEX for EHS scheduled during the Hajj Pilgrimage, to support the data we have previously collected. We anticipate reporting results for our fulvestrant study later this year, along with progress on other products under development. We look forward to sharing our continued progress to create value for patients and shareholders,” concluded Tarriff.

https://bit.ly/2Oeb1uY

Array Gets FDA Breakthrough Tag for Colorectal Cancer Combo

Array BioPharma, Inc. (NASDAQ: ARRY) today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI™), in combination with binimetinib (MEKTOVI®) and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease. BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation, and currently there are no therapies specifically approved for this high unmet need population. [1-6] Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that they may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. “We are delighted that the FDA has recognized the potential of this combination for patients with BRAFV600E-mutant metastatic colorectal cancer,” said Victor Sandor, M.D., Chief Medical Officer. “As there are no regimens approved specifically for BRAFV600E-mutant mCRC, this designation provides us with the opportunity to work closely with the FDA to potentially accelerate our effort to bring an important treatment option to these patients in critical need.” As presented at the ESMO 20th World Congress on Gastrointestinal Cancer in June 2018, the results from the safety lead-in of the ongoing randomized Phase 3 BEACON CRC trial showed that, at the time of analysis, the overall survival (OS) data were fully mature through 12.6 months and that the median OS had not yet been reached. One-year overall survival rate for this cohort was 62%. Median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. Confirmed overall response rate (ORR) was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%. The triplet combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%). The triplet combination of BRAFTOVI, MEKTOVI and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer is investigational and not approved by the FDA. https://bit.ly/2M2hvRd