Intercept Pharma completes enrollment in late-stage NASH study

Intercept Pharmaceuticals (NASDAQ:ICPT) announces the completion of enrollment in a Phase 3 clinical trial, REVERSE, evaluating obeticholic acid (OCA) in NASH patients with compensated cirrhosis.

The primary endpoint is the proportion of patients achieving at least one-stage histological improvement in fibrosis with no worsening of NASH at month 18 versus placebo.

Participants who complete the double-blind phase will be eligible to enroll in an open-label extension study for up to an additional 12 months.

https://seekingalpha.com/news/3535693-intercept-pharma-completes-enrollment-in-late-stage-nash-study

Philips bids farewell to home appliances to sharpen health focus

Philips will complete its transformation to a health technology business with the sale of its domestic appliances division, which no longer fits with the company’s range of hospital equipment and personal health products.

Once a sprawling conglomerate, Amsterdam-based Philips has narrowed its focus in recent years, spinning off the lighting and consumer electronics divisions for which it was previously best known.
Philips said on Tuesday it would carve out the domestic appliances business, which produces coffee machines, vacuum cleaners and airfryers and generated 2.3 billion euros (£1.9 billion) in sales last year, in the coming 12 to 18 months.
“This business is not a strategic fit for our future as a health technology leader,” Chief Executive Officer Frans van Houten said.
He added that all options remained open for the division, which he said had a double-digit profit margin that was “slightly less” than the average for Philips.
ING analyst Marc Hesselink said a “quick and dirty” calculation valued the division at around 3 billion euros, assuming a 10% profit margin with a price tag of 12 times gross profit.
“This was a, in our view, widely expected move…to focus even more on health tech”, he said.
DISAPPOINTING RESULTS
Philips shares fell 3% in Amsterdam, with analysts pointing to fourth-quarter results that missed expectations, and disappointing sales growth in all sectors.
Comparable sales increased 3% to 6 billion euros from a year earlier, compared with an average forecast in a company poll of analysts for a 4.9% increase.
Adjusted earnings before interest, tax and amortisation (EBITA) rose 10% to 1.07 billion euros, also slightly below expectations.
Philips reaffirmed its 2020 targets for a 100 basis point improvement in adjusted EBITA margin and a 4 to 6% increase in comparable sales, but said it expected a slow start to the year with growth likely to be dented by China’s efforts to contain a coronavirus outbreak.
The company has around 8,000 employees in China, many of whom have been ordered by authorities to stay at home.
Philips fell far short of a similar 100 basis point profit margin improvement goal in 2019, having warned in October that it would miss the target as the U.S.-China trade war forced it to shift production and seek new suppliers.
The already struggling connected care business, which specialises in remote patient monitoring, was the hardest hit and Van Houten said that following a significant fall in margins, the division’s leader Carla Kriwet would leave the company and be replaced by Philips veteran Roy Jakobs.
Philips expects rising life expectancy and associated chronic diseases to increase demand for devices that allow patients to be monitored at home, but sales at the connected care unit have in recent years lagged those of bigger divisions selling large medical equipment and personal care devices.

https://www.marketscreener.com/ROYAL-PHILIPS-6289/news/Philips-bids-farewell-to-home-appliances-to-sharpen-health-focus-29899211/

Pfizer profit misses estimates as revenue falls; plans no 2020 share repurchases

Pfizer Inc on Tuesday reported quarterly profit that fell short of Wall Street expectations for the first time in at least two years, and the drugmaker said it will no longer rely on share repurchases to help drive growth.

Shares of the largest U.S. drugmaker, which also reported higher operating costs and sharply lower sales of its off-patent pain treatment Lyrica, were down 4% at $38.51.
The company, which is spinning off its Upjohn unit that sells branded drugs that have lost patent protection such as Lyrica and Viagra into a combination with generic drugmaker Mylan NV, said it expects that deal to be completed by the middle of this year as it focuses on more profitable newer growth medicines.
On a conference call with analysts, company executives said it does not plan any share repurchases this year. It bought back nearly $9 billion of its own shares in 2019.
“We will focus instead on increasing the dividend and investing in the business during this period of growth,” said Chief Financial Officer Frank D’Amelio.
Chief Executive Officer Albert Bourla said Pfizer would not need such “financial engineering” to produce growth and that share buybacks could dilute it deal making firepower.
Pfizer forecast full-year adjusted earnings of $2.25 to $2.35 per share, excluding the Upjohn unit. Analysts on average are estimating 2020 earnings of $2.11 per share.
However, UBS analyst Navin Jacob raised concerns over higher-than-expected fourth-quarter operating costs and sales of some drugs that fell short of Wall Street estimates, which contributed to the earnings miss.
“It’s very surprising,” he said, noting that Pfizer tends to be “very good at cost control.”
Excluding special items, Pfizer said it had adjusted earnings of 55 cents per share, three cents shy of Wall Street expectations, according to IBES data from Refinitiv
Sales of breast cancer drug Ibrance, an important growth driver, rose 13% to $1.28 billion in the quarter, but fell short of the consensus estimate of $1.35 billion, according to Refinitiv data.
Total revenue fell 9% to $12.69 billion in the fourth quarter, with Lyrica sales plunging 67% to $433 million in the face of generic competition.
Lower revenue also reflected the absence of the consumer health business it sold last year.

https://www.marketscreener.com/news/Pfizer-profit-misses-estimates-as-revenue-falls-plans-no-2020-share-repurchases–29900508/?countview=0

FDA accepts Alkermes application for ALKS 383

The FDA accepts for review Alkermes plc’s (NASDAQ:ALKS) marketing application seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder. The agency’s action date is November 15.

Shares up 4% premarket on light volume.

https://seekingalpha.com/news/3535046-fda-accepts-alkermes-application-for-alks-3831-shares-ahead-4-premarket

Armata Pharma inks deal with Innoviva

Armata Pharmaceuticals (NYSEMKT:ARMP) and Innoviva (NASDAQ:INVA) have entered into a securities purchase agreement pursuant to which Innoviva will purchase ~$25M in Armata common stock and warrant securities.

As per the terms of the agreement, Innoviva will purchase ~8.7M newly issued Armata’s common shares, at $2.87 per share, and warrants to purchase same number of common stock, with an exercise price of $2.87 per share.

The stock purchases are expected to occur in two tranches.

The transactions are expected to close during Q1.

Also, Armata hopes to achieve the following milestones in 2020:

Initiate a clinical trial evaluating safety and tolerability of AP-PA02 in cystic fibrosis patients chronically infected with P. aeruginosa and obtain topline data.

Obtain third party, non-dilutive funding to advance AP-SA02, into clinical trials and file an IND to initiate studies of AP-SA02.

Shares are up 22% premarket.

https://seekingalpha.com/news/3535050-armata-pharma-inks-deal-innoviva-shares-up-22-premarket

Bausch Health’s Xipere successful in late-stage uveitis study

Bausch Health Companies (NYSE:BHC) unit Bausch + Lomb and licensor Clearside Biomedical (NASDAQ:CLSD) announce positive results from a Phase 3 clinical trial, PEACHTREE, evaluating Xipere (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of uveitis-associated macular edema. The data were just published in the journal Ophthalmology.

The 160-subject study met the primary endpoint of a statistically significant proportion (47%) of treated patients achieving at least a 15-letter gain in best corrected visual acuity from baseline at week 24 compared to 16% in the control arm (p<0.001).

All key secondary endpoints were also met.

On the safety front, no treatment-related serious adverse events (AEs) were observed. Corticosteroid-related AEs occurred in 11.5% of the treatment group and 15.6% in the control group. The rates of cataract AEs were  7.3% and 6.3%, respectively.

Clearside expects to refile its U.S. marketing application this quarter. It received a CRL in 2019 citing the need for additional stability data.

CLSD is up 9% premarket on light volume.

https://seekingalpha.com/news/3535063-bausch-healths-xipere-successful-in-late-stage-uveitis-study

Cytosorbents latest entry in coronavirus rally

Thinly traded micro cap Cytosorbents (NASDAQ:CTSO) is up 17% premarket on average volume on the heels of the publication of a report in The Lancet detailing the clinical features of patients in Wuhan, China infected with the coronavirus 2019-nCoV.

The company says levels of circulating inflammatory cytokines are correlated with the severity of illness, providing the rationale for using blood purifier CytoSorb to reduce cytokine levels and ameliorate inflammation.

Selected outbreak-related premarket movers: NanoViricides (NYSEMKT:NNVC) (-28%), Allied Healthcare Products (NASDAQ:AHPI) (-22%), Novavax (NASDAQ:NVAX) (-8%), Moderna (NASDAQ:MRNA) (+3%), BioCryst Pharmaceuticals (NASDAQ:BCRX) (+5%), Aethlon Medical (NASDAQ:AEMD) (-17%), Lakeland Industries (NASDAQ:LAKE) (-3%), Alpha Pro Tech (NYSEMKT:APT) (-9%), Co-Diagnostics (NASDAQ:CODX) (-10%), Lianluo Smart (NASDAQ:LLIT) (-5%), Cleveland BioLabs (NASDAQ:CBLI) (-11%)

https://seekingalpha.com/news/3535078-cytosorbents-latest-entry-in-coronavirus-rally-shares-up-17-premarket