Target to $12 from $16
Wednesday, August 2, 2023
Seagen Second Quarter 2023 Financial Results Demonstrate Exceptional Commercial Performance
-Record Net Product Sales of $544 Million in 2Q23, an Increase of 26% Over 2Q22, Contributing to Total Revenues of $604 Million in 2Q23-
-Strong PADCEV® Growth Driven By Combination First-Line Advanced Urothelial Cancer Launch; Record ADCETRIS® Performance with Overall Survival Benefit Demonstrated in the ECHELON-1 Trial Added to Label-
-Three Registrational Trial Readouts for PADCEV, TUKYSA® and TIVDAK® Anticipated in 2H23-
-Initiated Phase 3 Trial for Disitamab Vedotin and Expect to Initiate Phase 3 Trial of SGN-B6A by Year End-
-Proposed Acquisition by Pfizer Progressing Towards Close in Late 2023 or Early 2024-
Cancer Drug Manufacturer Intas Slapped with FDA Warning Letter
The FDA on Friday issued a warning letter to India-based generics manufacturer Intas Pharmaceuticals citing several quality control issues at its Sanand plant, including “significant violations” of current good manufacturing practice as well as destroyed and discarded data.
The letter revealed that in November 2022 an Intas analyst was seen pouring acetic acid into a trash bin that was containing current good manufacturing practice (CGMP) records. A quality control officer had also witnessed the same analyst destroy data sheets including balance printouts and titration curves. The employee reported these incidents to company management but Intas did not launch an investigation until a week later, according to the FDA’s letter.
Another Intas analyst, after weighing out amitriptyline hydrochloride tablets multiple times, told FDA investigators that he did not report all of the results. In other instances, the analyst said, he would throw away balance printouts.
FDA investigators also found plastic bags full of discarded CGMP documents across the manufacturing facilities, suggesting that Intas had gotten rid of Environmental Monitoring Systems engineering checklists, several analytical test reports, titration curves and balance weight slips for drug products.
Intas had been made aware of these infractions, among several others, in a 36-page document issued last December 2022. The FDA detailed these issues again in Friday’s warning letter, adding that while Intas had previously promised to work with consultants to evaluate its data governance protocols, its efforts had so far still not met the FDA’s requirements.
“Your response is inadequate in that it did not fully evaluate the scope of this deficiency and the impact to product quality,” the FDA said in the warning letter. “You did not adequately address the major failure of laboratory, operations, and quality assurance management to conduct proper oversight over documentation and prevent data integrity lapses.”
As of June 1, Intas is on the FDA’s Import Alert list, which allows the regulator’s field staff to detain products from the company even without physical examination, given repeated evidence of its CGMP violations. The alert covers several cancer drugs, including carboplatin and cisplatin, which are currently in critical short supply in the U.S.
In an interview with BioSpace last month, Erin Fox of the American Society of Health-System Pharmacists said that Intas had been responsible for approximately half of the supply of these two drugs, and that the closure of its Gujarat facility could have contributed greatly to the current shortage crisis.
Currently, the FDA has resorted to importing these drugs from other manufacturers in other countries, announcing in May that it would source cisplatin from Chinese drugmaker Qilu Pharmaceuticals. This is only a temporary fix, however, as strong legislative incentives are needed to produce these medicines domestically.
Last week, House Republicans released a draft bill designed specifically to address the drug shortage and prevent a similar crisis from happening in the future. One of the draft’s provisions is to launch a pilot program to accelerate the licensing of domestic manufacturing facilities.
https://www.biospace.com/article/generics-manufacturer-intas-slapped-with-fda-warning-letter/
Humana's stock up premarket after health insurer says claims activity stabilizing after June spike
Humana Inc.'s stock (HUM) rose 2.6% in premarket trade Wednesday, after the health insurance company topped earnings estimates for the second quarter and said the Medicare Advantage utilization environment was improving based on recent claims activity. Louisville, Ky.-based Humana had per-share earnings of $7.66 for the quarter, up from $5.48 a year ago. Adjusted per-share earnings came to $8.94, ahead of the $8.76 FactSet consensus. Revenue rose to $26.747 billion from $23.662 billion a year ago, also ahead of the $25.825 billion FactSet consensus. The company said its benefits expense ratio rose to 86.3% from 85.8% a year ago, but was within the previously provided guidance range of 86.3% to 87.3% for 2023. For insurers, a higher expense ratio means higher costs to provide insurance. Humana and rivals saw their stocks smacked in June amid reports of pent-up demand from senior citizens for hip and knee surgeries that were delayed by the COVID-19 pandemic were boosting costs, sparking a steep selloff in the sector. Humana said it now expects full-year adjusted EPS of at least $28.25, which compares with a FactSet consensus of $28.29. The stock has fallen 11% in the year to date, while the S&P 500 has gained 19%.
CVS Health beats profit estimates, starts restructuring to cut costs
CVS Health Corp reported upbeat second-quarter earnings on Wednesday, and said it had begun implementing a restructuring program to cut costs after a recent spree of acquisitions, sending its shares up over 2% in premarket trading.
The company has been expanding beyond health insurance and pharmacies with its buyouts of primary-care provider Oak Street Health and home healthcare services firm Signify Health.
CVS Health, which completed the acquisitions earlier this year, has flagged higher-than-expected transaction and integration costs related to the deals.
As part of the restructuring program it started during the quarter to rein in costs, CVS said it would reduce its workforce and stop providing services related to clinical trials.
It recorded a $496 million restructuring charge, of which $344 million were severance and employee-related costs.
CVS, which said most of the restructuring was expected to be completed by year-end, trimmed its earnings per share outlook to between $6.53 and $6.75, from $6.90 to $7.12 forecast earlier.
It maintained its annual adjusted profit forecast at $8.50 to $8.70 per share.
CVS, which has a large retail pharmacy chain, a health insurance business and a pharmacy benefit management (PBM) unit, has said it would pause acquisitions in the near term but may look at "additional opportunities" over a longer timeframe.
Excluding items, the company reported a profit of $2.21 per share, above analysts' average estimate of $2.11 per share, boosted by strength in its PBM unit, which negotiates drug prices with manufacturers.
Sales at CVS' health services segment, which contains its PBM unit, rose 7.6% to $46.22 billion in the reported quarter compared with a year earlier.
https://finance.yahoo.com/news/cvs-health-beats-quarterly-profit-103500459.html
Haleon boosts annual guidance after solid first half
Haleon PLC on Wednesday upped its annual organic revenue growth guidance following a solid revenue performance in the first half of 2023.
Haleon is a Surrey, England-based consumer healthcare products company that spun off from pharmaceutical company GSK PLC in July 2022.
In the first half of 2023, Haleon posted a pretax profit of GBP960 million, up 11% from GBP864 million the year prior.
Revenue in the half totalled GBP5.74 billion, up 11% from GBP5.19 billion the previous year. On an organic basis, revenue growth in the half was 10%.
As a result of the solid half-year results, Haleon said it was "well-placed" for future growth and raised its annual guidance. It now expects organic revenue growth between 7% and 8% in 2023. Previously, the company had expected organic revenue growth "towards the upper end of a 4% to 6% range".
"One year from listing, we are very pleased with Haleon's first half results. We delivered double digit organic revenue growth, with both price and positive volume mix. Encouragingly this trend was consistent across the first and second quarters," said Chief Executive Brian McNamara.
"Looking ahead, whilst we continue to expect a challenging environment given further pressure on consumer spending and global geopolitical and macroeconomic uncertainties, we remain confident in the resilience of Haleon's incredible portfolio of category leading brands. Our strategy is delivering, demonstrated with the strength of our results, and we remain confident that Haleon is well positioned for the rest of the year, as well as over the longer term," the CEO continued.
Haleon declared an interim dividend of 1.8 pence per share. In March, the company announced an inaugural final dividend of 2.4p per share for the trading period since its demerger from GSK.
Beijing’s Deadly Storms Brought Heaviest Rainfall on Record
- Parts of capital faced most intense deluge since 1883
- Extreme rains follow record-beating heat wave in June
The deluge of rain that triggered floods and killed at least 20 people in northern China this week was the heaviest to hit Beijing since record-keeping began in the 19th century.
The worst-affected spot of the capital recorded 29.3 inches (74.4 centimeters) of rain from Saturday through Wednesday, the Beijing Meteorological Bureau said in a social media post. That’s the most ever in data going back to 1883 — nearly three decades before the fall of the Qing dynasty.
Subscribe to:
Posts (Atom)