Omnicell cuts guidance

 For the full year 2022, the Company now expects product bookings to be between $950 million and $1.050 billion. The Company expects full year 2022 total GAAP and non-GAAP revenues to be between $1.284 billion and $1.294 billion. Omnicell now expects full year 2022 GAAP and non-GAAP product revenues to be between $889 million and $894 million, and full year 2022 GAAP and non-GAAP service revenues to be between $395 million and $400 million. The Company now expects full year 2022 non-GAAP EBITDA to be between $177 million and $183 million. The Company expects full year 2022 non-GAAP earnings to be between $2.73 and $2.83 per share.

For the fourth quarter of 2022, the Company expects total GAAP and non-GAAP revenues to be between $285 million and $295 million. The Company expects fourth quarter 2022 GAAP and non-GAAP product revenues to be between $183 million and $188 million, and fourth quarter 2022 GAAP and non-GAAP service revenues to be between $102 million and $107 million. The Company expects fourth quarter 2022 non-GAAP EBITDA to be between $10 million and $16 million. The Company expects fourth quarter 2022 non-GAAP earnings to be between $0.05 and $0.15 per share.

The Company’s fourth quarter and full year 2022 guidance has been adjusted to include the anticipated contributions and integration costs of recent acquisitions, as well as the anticipated effects of the current inflationary environment and expected impact of current macro-economic headwinds.

https://www.businesswire.com/news/home/20221102005381/en/Omnicell-Announces-Financial-Results-for-Third-Quarter-2022

Cedars-Sinai Joins Phase I Study of ABVC Treatiment for Depression in Cancer Patients

 ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the Cedars-Sinai Medical Center (CSMC, West Hollywood CA) Institutional Review Board (IRB) has approved their institution joining the Phase I study of ABV-1601 for treating depression in cancer patients. The Principal Investigator of the CSMC study will be Dr. Scott A. Irwin, MD, PhD., an eminent Professor of Psychiatry & Behavioral Neurosciences.

The Phase I study is open label and will be conducted with 12 cancer patients with moderate to severe depressive symptoms. The main objective of the study is to evaluate the safety of PDC-1421, the primary active ingredient in ABV-1601. The second objective is to determine the most effective dosages for a randomized, double-blind, non-inferiority Phase II trial of PDC-1421 that ABVC expects to initiate in 2023. The Company then intends to compare results of the Phase II study of ABV-1601 to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression.

https://www.biospace.com/article/releases/cedars-sinai-medical-center-joins-phase-i-clinical-study-of-abvc-biopharma-s-medication-for-treating-depression-in-cancer-patients/

J.P. Morgan Launches Life Sciences Fund to Support Early-Stage Biotech

 J.P. Morgan Asset Management launched a new life sciences-focused private equity team, dubbed Life Sciences Private Capital, Tuesday to support early- and growth-stage biotech companies.  

In particular, the Life Sciences Private Capital team will focus on innovative therapies and technologies in neuropsychology, metabolic diseases, artificial intelligence, autoimmunity, genetic medicine, oncology, rare diseases and neurodegenerative diseases. 

The new team comes amid an industry-wide slowdown in funding. According to an analysis by business information firm Crunchbase, biotech start-ups in the U.S. have been raising an average of $3.2 billion per month since June. Last year, the monthly average almost reached $4 billion.

In terms of exits, Crunchbase reported only 14 initial public offerings as of June. More than 100 biotechs went public in 2021, and more than 90 did so in 2020.

However, Stephen Squinto, Ph.D., chief investment officer of the new venture team, pointed out in a statement that innovation in the field hasn't slowed down. "As advances in genomics, biomarkers and data science converge, we are seeing firsthand the transformative impact that biomedical innovation can offer to patients at all stages of life and we expect much more to come in the next decade."

This opportunity is what J.P. Morgan is looking to support, leveraging its existing presence in the healthcare space to identify the most promising young companies with transformative technologies. The Life Sciences Private Capital team will begin investments early next year, Squinto told The Wall Street Journal.

The new venture team will be situated within J.P. Morgan Private Capital, a growth equity and private credit investment platform launched last year for consumer and climate-technology sectors. 

Beyond funding, the Life Sciences Private Capital team will also be able to leverage the bank's scale, data assets and industry expertise to "act as true partners to the companies we invest in," Squinto said. The team can help these firms build strong mastheads, design sound clinical development programs, and navigate the regulatory process.

An All-Star Roster

Squinto was a co-founder of Alexion Pharmaceuticals, which was bought by pharma powerhouse AstraZeneca last year for $39 billion. Squinto also previously served as an executive partner at OrbiMed, a biopharma-focused investment firm. He brings over three decades of industry experience to the Life Sciences Private Capital team.

Joining Squinto on the executive board is Gaurav Gupta, M.D., M.S.E., who will serve as a co-managing partner in the new venture group. He was previously with OrbiMed as an investment professional before he struck out on his own to found Ascendant BioCaptial, a life sciences-focused investment firm.

Anya Schiess is also joining as a co-managing partner. She was the co-founder and a general partner at Healthy Ventures, an early-stage venture capital firm focused on health and pharma technologies.

Aside from the executive board, the Life Sciences Private Capital team will also have a group of strategic advisors, counting among its ranks some of the most decorated and experienced industry experts to help guide the team's investment strategy.

https://www.biospace.com/article/j-p-morgan-dips-toes-in-life-sciences-with-new-private-equity-team/

GSK vaccine for older adults granted FDA priority review

 GSK opened 2% higher in U.S. trading Wednesday but closed down 2%. Shares rose after the drugmaker reported financial results that beat Wall Street forecasts and announced the Food and Drug Administration had accepted a biologics license application and granted priority review to its vaccine for respiratory syncytial virus (RSV) targeted at adults aged 60 years or older.

The vaccine review marks third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan.

RSV is a common contagious virus affecting the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment available for adults. 

Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death. 

RSV causes over 420,000 hospitalizations each year and 29,000 deaths in adults in industrialized countries. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions.

"Vaccines have stolen the show in GSK’s third quarter update today as the shingles vaccine, Shingrix, saw record sales. The continued roll-out is a key driver of the upgraded guidance for 2022, as are launches for the RSV vaccine," said Derren Nathan, Head of Equity Research at Hargreaves Lansdown.

Nathan noted GSK's RSV vaccine could reach $4 billion in annual says, but will be going head-to-head with Pfizer and Johnson & Johnson to be first on the market.

After giving GSK's RSV vaccine priority status, the FDA’s final decision on the vaccine is now expected by 2 May 2023.

GSK raised its 2022 forecast for the second time this year, after third-quarter earnings and sales topped estimates, continuing its strong start as a standalone prescription medicine and vaccine business since carving out its consumer health division. 

After years of underperformance relative to its peers and missing out on the lucrative market for the first set of COVID-19 vaccines, GSK has delivered a string of strong results.

The third-quarter saw GSK’s revenue grow by 9%, to 7.8 billion pounds ($9 billion). Specialty Medicines lead revenue growth, rising 24%, with Vaccines and General Medicines up 5% and 1% respectively. 

Despite all this positive news for GSK, Nathan told Fox Business that investors have been weary to celebrate due to GSK’s ongoing lawsuits relating to the discontinued heartburn drug Zantac.

Thousands of lawsuits have been filed in the United States against a raft of drugmakers over allegations the heartburn drug contains a probable carcinogen.

GSK said it had incurred a charge of 45 million pounds in the third quarter, primarily reflecting provisions for increased legal fees related to Zantac.

Originally marketed by a forerunner of GSK, Zantac has been sold by companies including Pfizer, Boehringer Ingelheim and Sanofi, as well as a handful of generic drugmakers.

Ticker	Security	Last	Change	Change %
SNY	SANOFI	42.94	-0.05	-0.12%
MRK	MERCK & CO. INC.	99.43	-0.35	-0.35%
BAYRY	BAYER AG	13.02	-0.25	-1.88%
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Shareholders fear a worst-case scenario where costs run into billions of dollars, as happened in cases involving Merck & Co's painkiller Vioxx and Bayer's glyphosate-based weedkiller.

https://www.foxbusiness.com/healthcare/gsk-vaccine-older-adults-granted-fda-priority-review

Alkermes Plans Separating Its Oncology Unit; Lifts FY22 Earnings Guidance

 

• Alkermes plc 
  ALKS+3.48%+ Free Alerts
   is exploring separating its commercial-stage neuroscience and development-stage oncology business as part of an ongoing review of strategic alternatives for the oncology business.
• Alkermes will retain its focus on neuroscience and drive its proprietary commercial product growth. 
• The company will also focus on advancing the development of pipeline programs focused on neurological disorders, including ALKS 2680, an orexin 2 receptor agonist for narcolepsy. 
• The oncology business would continue to focus on the discovery and development of cancer therapies, including the continued development of nemvaleukin alfa (nemvaleukin). 
• Nemvaleukin is currently in potential registration enabling studies in two difficult-to-treat tumor types: platinum-resistant ovarian cancer and mucosal melanoma. 
• The separation, if consummated, is expected to be completed in the second half of 2023. The facilities, research & manufacturing operations in Wilmington, Ohio, and Athlone, Ireland, will remain with Alkermes.
• The company reported Q3 sales of $252.4 million, compared to $294.1 million a year ago, missing the consensus of $271.41 million.
• It reported an adjusted EPS of $0.02, below the consensus of $0.03.
• Alkermes tightened FY22 guidance to $1.07–$1.12 billion from $1.05–$1.12 billion versus the consensus of $1.10 billion.
• It forecasts adjusted EPS of $0.15 – $0.33, up from $0.09 – $0.27 and the consensus of $0.20.

https://www.benzinga.com/general/biotech/22/11/29526107/alkermes-plans-separating-its-oncology-unit-lifts-fy22-earnings-guidance