Search This Blog

Tuesday, January 28, 2020

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.

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

Lilly to donate insulin pens to low-income Americans

Starting this month, Eli Lilly (NYSE:LLY) will donate at least 200K KwikPens to three relief organizations – Americares, Direct Relief and Dispensary of Hope – to stock ~200 free health clinics in the U.S. for lower-income diabetics who qualify for free clinic services.
Separately, the company is providing $2M to fund programs aimed at informing diabetics about available resources that can help them acquire medical care, insurance coverage, medicines and more. The relief agencies will distribute the funds to free clinics in the form of grants.
https://seekingalpha.com/news/3535096-lilly-to-donate-insulin-pens-to-low-income-americans

Seelos up on advancement of second gene therapy for Parkinson’s

Nano cap Seelos Therapeutics (SEEL +7%) is up out of the gate this morning in reaction to its update on SLS-007, its second gene therapy candidate for the potential treatment of Parkinson’s disease.
An in vivo study delivering SLS-007, a family of peptidic inhibitors designed to block the aggregation of α-synuclein in the brain, via an adeno-associated virus (AAV) is set to begin. Data to determine delivery and target engagement should be available in H2.
The company’s other PD candidate, SLS-004, is an all-in-one lentiviral gene therapy that targets the gene that encodes for the production of α-synuclein.
https://seekingalpha.com/news/3535150-seelos-up-7-on-advancement-of-second-gene-therapy-for-parkinsons