Fitbit results beat Street as demand for wearable devices climb

Wearable device maker Fitbit Inc reported better-than expected first-quarter results and reaffirmed its full-year revenue forecast on Wednesday, as it sells more smartwatches and wearable devices that track health at affordable prices.

Shares of the company rose 1.5 percent to $5.45 in late trade.

Fitbit, which helped pioneer the wearable devices craze, posted year-over-year trackers growth for the first time in three years, getting a boost from its new Inspire line. Smartwatch sales also more than doubled in the quarter.

The San Francisco-based company said new devices launched in the past 12 months, including the Inspire brand, made up 67 percent of revenue in the quarter.

Fitbit said it sold 2.9 million devices in the quarter, 36 percent higher than a year-ago. Average selling prices fell 19 percent to $91 per device as it focused on cheaper devices to compete with tech-heavyweights Apple Inc and Samsung .

Analysts expected the company to sell 2 million devices at an average selling price of $109.33, according to data from FactSet.

To keep pace with rivals, Fitbit has focused on value prices – selling Inspire at $69.95 and the HR version, capable of heart rate monitoring, at $99.95. Apple’s smartwatches start at $279 and Samsung’s watches and trackers lead in at $200.

Fitbit’s Health Solutions business grew 70 percent in the quarter and posted revenue of $30.5 million. The unit is focused on subscription-based fitness coaching services that connect users with doctors, hospitals and lifestyle coaches.

“We think Fitbit is on the right track pushing to get its trackers and smartwatches on as many wrists as possible, and then ultimately leveraging the user-base and technology for its healthcare initiatives,” said Alicia Reese, senior associate, equity research, Wedbush Securities Inc.

The company’s net loss narrowed to $79.5 million, or 31 cents per share, in the first quarter ended March 30 from $80.9 million, or 34 cents per share, a year earlier.

Excluding items, Fitbit reported a loss of 15 cents per share, beating analysts’ average estimate of a loss of 22 cents, according to IBES data from Refinitiv.

Revenue rose to $271.9 million from $247.9 million, above Wall Street expectations of $259.7 million.

Fitbit reaffirmed its full-year revenue forecast of $1.52 billion to $1.58 billion, expecting to sell more devices at cheaper prices.

For the second quarter, Fitbit forecast revenue between $305 million and $320 million, the midpoint of which is slightly below the average analysts’ estimate of $312.8 million.

The company forecast an adjusted loss for the second quarter between 17 cents to 20 cents per share. Analysts’ estimate a loss of 16 cents.

https://www.marketscreener.com/SAMSUNG-ELECTRONICS-CO-LT-6494906/news/Fitbit-results-beat-Street-as-demand-for-wearable-devices-climb-28518036/

Biogen’s antisense ALS drug shows promise in early clinical trial

Biogen is still reeling from the pivotal failure of aducanumab in Alzheimer’s disease, but it is celebrating some positive news from another pipeline asset in neurology.

Preliminary results from a phase 1 trial showed that tofersen (BIIB067), which Biogen in licensed from Ionis Pharmaceuticals, was well tolerated in amyotrophic lateral sclerosis (ALS) patients. The results suggest the drug could slow the progression of the disease in people with a mutant SOD1 gene.

Mutations in SOD1 can cause the protein the gene expresses to misfold in ways that are toxic nerve cells in the brain and the spinal cord, leading to loss of control over muscles, then paralysis and eventually death. About 10% of all ALS cases emerge from inherited gene mutations, and among these familial cases, around 20% are caused by the SOD1 gene.

Tofersen is an antisense oligonucleotide that aims to reduce production of the toxic protein. It works by binding to and inhibiting the SOD1 mRNA, which turns off the malfunctioning gene.

During the phase 1 trial, 50 SOD1-mutated ALS patients received either 20 mg, 40 mg, 60 mg or 100 mg of tofersen or placebo via a lumbar puncture over about three months. Investigators found that the 10 people who got the highest dose of tofersen experienced a 37% reduction of the SOD1 protein in their spinal fluid when compared to 12 people who received placebo, according to a study presented at the American Academy of Neurology’s 71st annual meeting in Philadelphia.

“Lower concentrations of the protein in the spinal fluid suggest that there were also lower concentrations in the brain and spinal cord. Such reductions could lead to preservation of motor neurons and slow progression of the disease, but more study is needed to examine this further,” the study’s senior author Timothy Miller of Washington University in St. Louis said in a statement.

What’s more, patients on the 100 mg dose performed better on tests that measure clinical decline in ALS, including breathing capacity, muscle strength and other body functions. On a score of 48, patients on 100-mg tofersen experienced an average decline of 1.1 points, while those on placebo suffered an average 5.3-point drop, according to Miller’s team.

The drivers behind most ALS cases are unknown, so targeting SOD1, a known cause of the familial form of the disease, offers a clear strategy for researchers. Swiss biotech Neurimmune used healthy elderly people’s memory B cells as the basis to develop a recombinant antibody targeting SOD1. (The company had previously used the same technology to discover aducanumab before licensing it to Biogen.) Neurimmune’s drug, called α-miSOD1, recently showed promise in postmortem spinal cord samples from ALS patients and in mouse models with SOD1 mutations.

A team of scientists at the Umeå University in Sweden has been analyzing the SOD1 clumps found in ALS, providing a roadmap for researchers developing drugs that target the gene mutation.

The phase 1 trial of Biogen’s tofersen offers a proof of concept, and based on a positive analysis first disclosed last December, the company has exercised its option to obtain full control of the antisense drug from Ionis. Biogen is now advancing the drug into pivotal trials, with the goal of proving it works in larger groups of patients over longer periods of time.

https://www.fiercebiotech.com/research/biogen-s-antisense-als-drug-shows-promise-early-clinical-study

Deciphera nears its biggest test

The small-molecule oncology player zeroes in on its first commercial opportunity.

One of the amazing things about the immune checkpoint blockade revolution in oncology is the extent to which it has concealed a parallel explosion, namely the growth in targeted small-molecule kinase inhibitors.

Deciphera floated in September 2017 precisely on this promise. Since then its fortunes have waxed and waned, but now the company has a chance to prove itself, as the phase III Invictus study of its lead asset, the Kit-PDGFRα kinase inhibitor ripretinib, is set to read out mid-year; a positive hit could result in regulatory filing, Deciphera reckons.

The extent of some analysts’ bullishness is reflected in ripretinib’s consensus 2024 estimated sales forecast, which according to EvaluatePharma amounts to $700m. Deciphera itself is sufficiently confident of success to have already started building commercial infrastructure to support launch.

Project	Ripretinib (DCC-2618)
Company	Deciphera
Market cap	$906m
Product NPV	$2.1bn
NPV as % of market cap	229%
Event	Results of phase III Invictus study
Timing	Mid-2019

Still, investors need to remain cautious. Invictus tests ripretinib in all-comer fourth-line gastrointestinal stromal tumour (GIST) patients, which likely amounts to a fairly small population, and there are questions about whether the drug could have use beyond this niche.

Invictus enrolled 129 subjects, and compares ripretinib directly against placebo, with 15-month PFS set as the primary endpoint; remission rate and 15-month overall survival feature among the trial’s secondary measures.

Leerink analysts rate Deciphera “underperform” despite expecting a hit in Invictus. They reckon ripretinib might not be used beyond the 90% of GIST patients with Kit-positive disease, and have negative expectations for the project’s use in PDGFRα-positive GISTs and advanced systemic mastocytosis; the project is also being studied in gliomas and other solid tumours.

In fairness, the baseline in fourth-line GISTs is pretty low. The latest cut of an uncontrolled study of ripretinib in all-comer GIST patients was declared successful having shown overall remission of just 9% in subjects who had failed three or more prior lines of therapy, and a median progression-free survival of 24 weeks. The vast majority of the 111 subjects in this late-line cohort had Kit-driven GISTs, so it is not entirely clear why the response to the Kit-targeted therapy was not higher.

The Blueprint issue

Leerink also says ripretinib is expected to enter the market behind Blueprint’s avapritinib, a rival Kit-PDGFRα inhibitor.

Still, this is no dead cert; avapritinib’s 2020 filing, for advanced systemic mastocytosis, is subject to FDA discussions. And in GISTs, in contrast to Deciphera, Blueprint is employing a biomarker-driven strategy from the outset, focusing on Kit-positive patients.

But the rival companies make for an interesting comparison, both having been created to capitalise on the promise of next-generation kinase inhibition (Vantage point – Life for kinase inhibitors in an immuno-oncology world, January 19, 2017).

Treatment of GISTs was revolutionised by Novartis’s Bcr-Abl tyrosine kinase inhibitor Gleevec, which is approved for first-line GISTs as well as chronic myelogenous leukaemia. Pfizer’s Sutent and Bayer’s Stivarga are second and third-line GIST therapies.

Deciphera has long argued that ripretinib is no ordinary kinase inhibitor, binding to its target kinase’s “switch pocket” and preventing the enzyme from being locked in its “on” state; this could enable it to control all mutant forms of Kit-PDGFRα kinase and reduce the scope for mutation-based escape mechanisms.

A separate Deciphera pivotal trial, Intrigue, testing ripretinib in second-line GISTs, was initiated last December. In the second-line setting a remission rate of around 20% among all-comers is expected.

The low expectations for Invictus reflect the lack of options for fourth-line subjects. All Deciphera has to do with ripentinib now is beat placebo. Convincing the US FDA that a broad label is warranted could be trickier.

https://www.evaluate.com/vantage/articles/events/company-events/deciphera-nears-its-biggest-test

GSK dumps universal flu vaccine after interim data readout

GlaxoSmithKline has dumped a universal flu vaccine after getting a look at interim phase 1 data. The clinical data and other results persuaded GSK to stop development of the candidate once it finishes the ongoing study.

The influenza vaccine, GSK3816302A, combines the Icahn School of Medicine Mount Sinai’s (ISMMS) chimeric hemagglutinin (cHA) technology and GSK’s AS03 adjuvant in a bid to develop a shot that protects against all current and future circulating influenza strains, thereby eliminating the need to develop new jabs and administer them each year.

GSK moved the vaccine into a phase 1 trial in 470 healthy volunteers in 2017. The clinical trial was designed to compare the safety and tolerability of nine unadjuvanted and adjuvanted supra-seasonal universal flu vaccine formulations to placebo and GSK’s quadrivalent seasonal influenza vaccine.

The study is assessing the effects of delivering one or two primary doses, plus a booster shot one year after the initial vaccination, and will continue to do so through its previously targeted 2020 completion date. But beyond that, GSK will stop development and feed the lessons it learned from the trial back into its discovery programs.

ISMMS will continue to develop cHA “in a variety of research platforms,” a spokesperson for GSK said.

GSK revealed the termination in a first-quarter pipeline update (PDF) that also featured news of its decision to stop development of a next-generation strep pneumonia vaccine. The candidate advanced as far as phase 2 before GSK decided to call time on the project.

The pipeline changes leave GSK with 13 clinical-phase vaccine candidates. That figure has held steady over the past year, with some quarter-to-quarter variation, while the size of the oncology pipeline has mushroomed. GSK now lists 17 cancer drugs in its clinical pipeline, up from eight this time last year.

Under the scientific leadership of Hal Barron, GSK is betting that leveraging its immunology expertise will enable it to come from behind in immuno-oncology and claim a slice of the growing market.

https://www.fiercebiotech.com/biotech/gsk-dumps-universal-flu-vaccine-after-interim-data-readout

Beyond Meat prices initial public offering at $25 a share

CNBC reports

https://thefly.com/landingPageNews.php?id=2901554

Medifast ups FY19 EPS view to $6.70-$6.90 from $6.45-$6.65, consensus $6.51

Raises FY19 revenue view to $720M-$740M from $700M-$720M, consensus $710.13M.
https://thefly.com/landingPageNews.php?id=2901307

Exelixis reports Q1 adjusted EPS 27c, consensus 23c

Reports Q1 revenue $215.5M, consensus $212.2M. “The first quarter of 2019 was a very productive start to the year, with strong execution across all aspects of our business,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We continued our efforts to maximize the commercial and clinical potential of cabozantinib through the U.S. launch in advanced hepatocellular cancer in January, as well as the initiation of the COSMIC-313 study announced today.”
https://thefly.com/landingPageNews.php?id=2901299