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This week marked the start of earnings season for the pharma and biotech sector with J
J Profits & Sales
Its Innovative Medicines unit (formerly the Pharmaceuticals segment) exceeded expectations, with sales of several key drugs such as Stelara, Tremfya and Imbruvica beating estimates. Sales in the Innovative Medicines segment increased by 5. 1% year-on-year. Sales in the Medical Technology segment are up more than 10% year-on-year. J
Roche’s nine-month 2023 sales decline: Roche’s third-quarter earnings increased 7% in consistent currencies (“CER”). However, in the first nine months of 2023, sales fell 6% due to an expected drop in sales of its COVID-19 product tests. Excluding COVID products, group sales were up 1% in CER. Pharmaceutical sales increased 9% in CER in the first nine months due to higher demand for medicines. Sales in the Diagnostics department fell by 18%. Excluding similar COVID-19 In sales, the core Diagnostics business grew by 7%.
Roche maintained its expectation of a single-digit sales decline in CER in 2023 due to a drop in sales of COVID-19 products. Core earnings consistent with the percentage are expected to be broadly in line with sales expectations.
Pfizer cuts its sales guidance for 2023 due to COVID-related sales decline: Pfizer said it is cutting its previously published earnings guidance for 2023 due to weaker-than-expected demand for its COVID products, the COVID-19 vaccine, Comirnaty and the oral vaccine. antiviral tablet for COVID, Paxlovid.
Revenue guidance is reduced from $67 billion to $70 billion, to $58 billion and $61 billion, adding a $7 billion relief to Paxlovid earnings and a $2 billion relief to Comirnaty’s earnings.
While demand for COVID products is lower than expected, Pfizer has announced rate reductions, adding layoffs, which are expected to generate targeted savings of at least $3. 5 billion. Of this amount, approximately $1. 0 billion is expected to be raised in 2023 and at least $2. 5 billion is expected to be raised in 2024. In the third quarter, Pfizer will post a $5. 5 billion non-cash rate due to stock write-offs related to COVID. de goods sold. Due to lower-than-expected COVID earnings and stock write-downs, adjusted EPS is expected to be in the range of $1. 45 to $1. 65, down from the $3. 25 to $3. 45 previously expected.
The FDA has granted approval to Pfizer’s once-daily etrasimod oral tablet to treat moderately to severely active ulcerative colitis, which will be advertised under the logo called Velsipity (2 mg dose). The approval of etrasimod was based on knowledge of two fundamental phases. III, ELEVATE UC 52 and ELEVATE 12. An application for approval of etrasimod is also under review in the EU, and a resolution from the European Medicines Agency is expected by the first part of 2024. Velsipity (etrasimod) adds to Pfizer’s inflammation and immunology portfolio with the acquisition of Arena Pharmaceuticals in March 2022.
NVO Raises 2023 Sales and Profit Growth Outlook: Novo Nordisk raised its previously reported sales and earnings outlook at CER for 2023. While the diversity of sales expansion has been increasing from a diversity of 27-33% to 32-38%, the benefit of diversity has been increasing from 31-37% to 40-46%. Higher-than-expected sales at Ozempic and Wegovy led to an increase in forecasts.
Novo Nordisk also announced initial sales and operating profit expansion rates for the first nine months of 2023, Novo Nordisk’s sales increased up to 33% and the operating source of revenue up to 37%, either in CER in the first nine months of this year.
Novo Nordisk announced an agreement to acquire oceparerenone for the treatment of out-of-control high blood pressure from Singapore-based biotechnology company KBP Biosciences for up to $1. 3 billion. The candidate is being developed in a Phase III study, called CLARION-CKD, for out-of-control high blood pressure and complex chronic kidney disease (CKD). In a phase IIb study, cedurenone demonstrated a clinically and statistically significant improvement in systolic blood pressure from baseline to day 84 in patients with level IIIb/IV and out-of-control CKD. High blood pressure. Novo Nordisk believes that the drug can evolve for the treatment of cardiovascular and kidney diseases and plans to conduct phase studies in this direction in the future.
Merck’s new $22 billion deal with Daiichi Sankyo: Merck has signed an agreement with Daiichi Sankyo to jointly develop and market the latter’s 3 DXd ADCs: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan worldwide, Japan. In Japan, Daiichi Sankyo retained the exclusive rights for the progression of the applicants. The 3 applicants are being evolved for multiple tumors falsified into other targets, either as monotherapy and/or in mix with other cancer drugs. They are in the early or intermediate stages of progression and have shown promising effects in clinical studies.
For the deal, Merck will make an upfront payment of $4 billion to Daiichi, while it will be allowed to make $1. 5 billion in ongoing invoices over the next 24 months. The deal also includes potential sales-based milestone bills of up to $16. 5 billion.
The FDA and the European Commission have approved Merck’s blockbuster cancer drug, Keytruda, for expanded use in the early stages of the NSCLC indication.
The FDA approved Keytruda in combination with chemotherapy as neoadjuvant therapy followed by surgery and continuation of adjuvant treatment with Keytruda monotherapy for patients with resectable NSCLC level II, IIIA, or IIIB (N2). The approval, as learned by the KEYNOTE-671 study, marks NSCLC’s sixth indication for Keytruda in the U. S. In the U. S. , either at metastatic or early levels of the disease.
The European Commission has approved Keytruda as an adjuvant cure for patients with NSCLC who are at increased risk of recurrence after complete resection and platinum-based chemocure. The approval was based on disease-free survival insights from the Phase III KEYNOTE-091 study. This resolution marks Keytruda’s fifth approval for the treatment of NSCLC in the EU. Keytruda was approved for similar use in the U. S. in the U. S. in January.
The NYSE ARCA Pharma Index is down 3. 1% in recent trading sessions.
Large-Cap Pharmaceuticals, 5-Year Return
Here are the results of the top 8 stocks over the past few trading sessions.
Image source: Zacks Investment Research
In the last few trading sessions, all stocks have fallen, with AstraZeneca being the biggest loser (5. 4%).
In the last six months, Lilly has risen to the high (53. 4%), while Pfizer has lowered the high (22. 4%).
(See Pharmaceutical Inventory Summary Here: LLY Achieves IBD Study Goal, PFE and MRK Provide Updates on Cancer Development)
Keep an eye on the third-quarter effects of MRK, ABBV, SNY, and NVS as the usual regulatory and portfolio updates next week.
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