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Thursday, February 9, 2023

Baxter: Results Lag Views

 

  • Fourth-quarter sales of $3.9 billion increased 11% on a reported basis, 17% on a constant currency basis and 2% on an operational basis1

  • Fourth-quarter U.S. GAAP diluted earnings per share (EPS) of $0.36 and adjusted diluted EPS of $0.88

  • Full-year sales of $15.1 billion increased 18% on a reported basis, 23% on a constant currency basis and 2% on an operational basis

  • Full-year U.S. GAAP diluted EPS (loss) of ($4.83) and adjusted diluted EPS of $3.50

  • Company provides update on previously announced actions to improve operational efficiency through streamlined operating model while positioning for proposed spinoff of Renal Care and Acute Therapies businesses

Veru: Q1 Loss, Misses Revenue Estimates

 Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies

Presented late-breaker oral presentation at IDWeek; sabizabulin treatment resulted in 81.2% relative reduction in deaths compared to the placebo in the WHO 4 subset group

Company to host conference call and webcast today at 8:00 a.m. ET

The audio webcast will be accessible under “Investor Kit” in the Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on February 9, 2023 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) passcode 9127050 for one week.

https://finance.yahoo.com/news/veru-reports-fiscal-2023-first-113000230.html

AbbVie's 2023 profit forecast misses as Humira faces heat from rivals

 AbbVie Inc on Thursday forecast 2023 profit below Wall Street expectations, in the first outlook since its blockbuster arthritis drug Humira faced competition from cheaper biosimilars in the United States early this year.

The company said it expected adjusted profit in the range of $10.70 to $11.10 per share for the full year, compared with analysts' average estimate of $11.65, according to Refinitiv IBES data.

Investors have feared the company's guidance could be below consensus estimates, and this was "not a major surprise", SVB Securities analyst David Risinger said.

Shares of the company were flat at $144.61 in choppy premarket trading.

Most analysts are expecting the stock to be driven by management's comments on Humira sales this year during the investor conference call.

AbbVie's weak forecast suggests that Humira rivals could nibble away at the blockbuster drug's market share at a faster pace this year than analysts' projections.

Amgen Inc recently launched Amjevita, the first such competition for Humira in the U.S., at a 5% and 55% discount to the drug's monthly price of $6,922.

At least seven other Humira biosimilars are expected this summer and could debut with discounted prices.

In the fourth quarter, Humira sales dropped 26.5% to $573 million in international markets such as Europe, where it already faces competition from multiple cheaper versions.

Overall, Humira sales rose 4.6% to $5.58 billion, in line with estimates, lifted by growth in the U.S. market.

The drugmaker has been hoping newer immunology drugs Skyrizi and Rinvoq can help replace the lost revenue from Humira.

Skyrizi sales of $1.58 billion beat estimates of $1.52 billion, while Rinvoq missed with $770 million in sales compared with expectations of $816.14 million.

Excluding items, AbbVie earned $3.60 per share in the fourth quarter, beating analysts' average estimates of $3.56 per share.

https://finance.yahoo.com/news/1-abbvies-2023-profit-forecast-132124083.html

Wearable Devices Gets Grant Budget to Develop Manufacturing Process for AI-based Neural Input Products

 Wearable Devices Ltd. (Nasdaq: WLDS, WLDSW) (“Wearable Devices” or the “Company”), a growth company developing a wrist-worn neural interface technology for B2B and B2C customers, today announced it has received a grant approval from the Israel Innovation Authority ("IIA”) in the amount of $900,000 (NIS 3.1 million) to finance further development of the Company’s manufacturing process of its flagship wearable neural interface, the Mudra Band.

This is the fourth grant Wearable Devices has received from the IIA, and it is the first time to receive a grant from the IIA New Product Manufacturing program. The Company previously received three research and development grants for the development of hardware and software for the Company’s Mudra technology. The IIA will finance 60% of the approved grant.

https://finance.yahoo.com/news/wearable-devices-receives-approval-900-124800668.html

Hims & Hers upped to Buy from Hold by Jefferies

 Target to $11 from $7

https://finviz.com/quote.ashx?t=HIMS&p=d

Publication Highlights geneType’s Ability to Detect Breast Cancer Earlier and Provide Data

 Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”) – a global leader in genomics-based tests in health, wellness and serious disease – is pleased to announce the publication of a new research paper in the peer-reviewed journal Breast Cancer Research and Treatment.

Highlights:

  • GeneType outperforms 5-year and remaining lifetime risk prediction compared to the commonly used clinical models Gail and IBISv7, respectively.

  • The study results provide further clinical validation for the breast cancer risk score component of recently announced Comprehensive Breast and Ovarian HBOC Risk Test.

  • The study highlighted geneType’s ability, when using United States clinical guidelines,1 to identify more women for whom chemoprevention or increased screening would improve outcomes.

  • GeneType and the more complex Rosner model had similar performance, with geneType’s data collection simplicity making its adoption in general practice easier.

  • If women with stage 2 and above breast cancer had been assessed with geneType they could have been diagnosed with earlier stage cancer, with the corresponding prognostic improvements.

  • The use of geneType could improve uptake of risk-reducing medication, potentially resulting in a significant reduction in the incidence of breast cancer.

Abbott Adds Complementary Tech To Vascular Offering Via Cardiovascular Systems Deal For $890M

 

  • Abbott Laboratories (NYSE: ABT) agrees to acquire Cardiovascular Systems Inc (NASDAQ: CSII) for $20/share for an equity value of approximately $890 million.

  • CSI offers devices for atherectomy, a minimally invasive treatment for plaque build-up in arteries that can restrict blood flow.

  • Procedural use of atherectomy can help maximize the benefits of standard balloon angioplasty or stent treatments in restoring blood flow in complex arterial disease.

  • CSI also has an early-stage pipeline of complementary vascular intervention devices in development.

  • "The acquisition of CSI will add new, complementary technologies to Abbott's leading vascular device offerings," said Lisa Earnhardt, EVP of Medical Devices of Abbott.

  • Upon close, the transaction is expected to be neutral to Abbott's recently issued 2023 ongoing earnings per share guidance.

  • Q4 Earnings: Cardiovascular Systems reported Q2 FY23 sales of $61.5 million, up 3.9% Y/Y, missing the consensus of $63.08 million, with a gross profit margin of 70.0%.

  • Second-quarter net loss of $7.9 million, or $(0.20)/share below the consensus of $(0.15). The Adjusted EBITDA loss increased to $(3.7) million from $(3.0) million in the prior year.