Biogen Raises Full-Year Guidance

 Biogen Inc. raised its full-year sales and earnings guidance Wednesday but said it expects minimal revenue from its Aduhelm drug for Alzheimer's disease through the end of the year.

The Cambridge, Mass.-based pharmaceutical company said it now expects sales of $10.8 billion to $10.9 billion this year, an upward revision from previous guidance of $10.65 billion to $10.85 billion.

Biogen said its adjusted earnings will likely be $18.85 a share to $19.35 a share. The company had previously guided for per-share adjusted earnings of $17.50 to $19.00.

The guidance assumes minimal revenue from Aduhelm this year, Biogen said. The drug gained approval from the Food and Drug Administration earlier this year.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-Raises-Full-Year-Guidance-36729416/

Abbott Raises Full-Year Earnings Guidance

 Abbott Laboratories Wednesday raised its full-year adjusted-earnings guidance, after revenue from Covid-19 testing helped lift its diagnostics business sales 48% in the third quarter.

The Abbott Park, Ill.-based medical-products company forecast adjusted earnings per share of $5.00 to $5.10 for the year. In July, Abbott was guiding for per-share adjusted earnings of $4.30 a share to $4.50 a share.

Analysts had expected full-year adjusted earnings of $4.46 a share, according to FactSet.

https://www.marketscreener.com/quote/stock/ABBOTT-LABORATORIES-11506/news/Abbott-Raises-Full-Year-Earnings-Guidance-36729783/

First Wave BioPharma Shares Rise After FDA Letter

 First Wave BioPharma Inc. shares were up 16% to $3.26 one day after the company said the U.S. Food and Drug Administration reviewed its Investigational New Drug application and provided a "Study May Proceed" letter for a Phase 2a trial.

The trial is investigating FW-ICI-AC as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors.

FW-ICI-AC is a proprietary oral immediate-release tablet formulation of niclosamide, a prescription small molecule with anti-inflammatory and anti-viral properties.

The company said the Phase 2a clinical trial is designed to determine the safety, tolerability, and preliminary efficacy of FW-ICI-AC in the treatment of immune checkpoint inhibitor-associated colitis and diarrhea in advanced cancer patients. About 60 patients will be enrolled in the trial and divided into two arms.

One arm will receive FW-ICI-AC three times daily for two weeks, while the other arm will receive placebo three times daily for two weeks. Following treatment, each patient will enter a four-week evaluation period. The primary endpoint of the trial is safety and tolerability of FW-ICI-AC. Additional endpoints will measure early signals of efficacy, including resolution of the patient's diarrhea, sparing of steroids, and prevention of disease progression.

https://www.marketscreener.com/quote/stock/FIRST-WAVE-BIOPHARMA-INC-30506551/news/First-Wave-BioPharma-Shares-Rise-16-After-FDA-Letter-36731959/

Cigna's pharmacy benefit unit to prefer cheaper insulin drug from Viatris

 Cigna Corp's pharmacy benefit unit said on Wednesday it will prefer Viatris Inc and Biocon Biologics Ltd's insulin drug Semglee, a cheaper alternative to Sanofi SA's Lantus, on the list of medicines it reimburses on behalf of health insurers.

The unit, Express Scripts, said it expects cost savings of $20 million in 2022 by preferring the Semglee injection.

Drugmakers such as Eli Lilly, Sanofi and Novo Nordisk have been under pressure to make their insulin products more affordable amid heavy criticism from lawmakers and patients in a country with a diabetes problem.

One in 10 Americans, or 34 million people, have diabetes, and researchers have found https://www.reuters.com/business/healthcare-pharmaceuticals/diabetes-surges-among-american-youth-study-shows-2021-08-24 significant increases in the disease among both sexes and across racial and ethnic groups.

Semglee won U.S. approval in July as a biosimilar that can be used instead of Lantus without a physician's intervention.

Sales of Lantus, once Sanofi's top insulin product, have declined since its U.S. patent expired in 2015.

Biosimilars, cheaper copies of high-priced drugs, can help reduce costs, both through direct savings and competition that encourages lower prices, Express Scripts said.

Pharmacy benefit managers such as Express Scripts and CVS Health Corp help health insurers negotiate better prices from drugmakers and also draw up "formularies", or lists of drugs reimbursed by the insurers they work for. 

https://www.marketscreener.com/quote/stock/BIOCON-LIMITED-9059261/news/Cigna-s-pharmacy-benefit-unit-to-prefer-cheaper-insulin-drug-from-Viatris-36727378/

Quest to Provide Covid-19 School Testing Services in Texas, Ginkgo Supporting

 Quest Diagnostics Inc. said it was in an agreement with the Texas Department of State Health Services to provide Covid-19 kindergarten through senior school testing services.

Ginkgo Bioworks, through its Concentric by Ginkgo program, would provide support services, such as online reporting and site staffing, for the program.

With thousands of schools eligible for the program throughout over 1,150 districts in Texas, Quest Diagnostics said it would offer Covid-19 testing services to participating public, private and charter K-12 schools for the duration of the 2021-2022 school year.

Quest will perform testing using polymerase chain reaction, or PCR, and other nucleic acid amplification test technologies through its clinical laboratories in the Houston and Dallas-Fort Worth metropolitan areas.

Under the state program, school administrators can elect to implement a testing program through pooled testing.

Pooled testing combines specimens, typically nasal swabs, from all consenting individuals in a classroom and runs them as a single test.

https://www.marketscreener.com/quote/stock/QUEST-DIAGNOSTICS-INCORPO-12290/news/Quest-Diagnostics-to-Provide-Covid-19-School-Testing-Services-in-Texas-36731004/

Biogen : sales face pressure from slow uptake of Alzhiemer's drug

 

Biogen Inc's Alzheimer's drug will be of little help to its third-quarter sales, Wall Street analysts said, as the drugmaker faces an uphill task of convincing hospitals and clinics to use the $56,000-a-year treatment and insurers to reimburse it.

Aduhelm in June became the first new treatment for the memory-robbing disease in nearly 20 years, boosting hopes the treatment would cushion the blow of diving sales of Biogen's mainstay multiple sclerosis drug, Tecfidera, due to rising competition.

But the acceptance of Aduhelm has been limited due to doubts about its net benefit to patients as well as uncertainty about reimbursement from Medicare, the U.S. government health plan for people over age 65.

"We expect focus will remain Aduhelm's launch, where signals around initial sales, reimbursement and prescriber sentiment have been negative, and shares have reflected this, taking a round trip nearly all the way back from pre-approval levels," said Baird analyst Brian Skorney.

Insurers and hospitals now await coverage terms from the U.S. Centers for Medicare & Medicaid Services before covering the drug, which is administered through an infusion.

Wall Street estimates for Aduhelm sales

THE CONTEXT

** The CMS will give its initial decision on whether it will cover the Adulhelm's cost in January 2022, with a final decision expected in April.

** In June, U.S. regulators approved Biogen's aducanumab as the first treatment to attack a likely cause of Alzheimer's disease despite controversy over whether the clinical evidence proves the drug works.

** Last month, U.S. lawmakers sought information from the U.S. Food and Drug Administration related to its accelerated approval of Aduhelm, ratcheting up the pressure on the agency that has come under fire for clearing the drug.

THE FUNDAMENTALS

Biogen total quarterly sales

** Biogen is expected to report revenue of $2.67 billion when it reports third-quarter results on Oct. 20, according to the mean estimate from 25 analysts, based on Refinitiv data

** The mean estimate for Aduhelm sales is $12.01 million, according to 17 analysts

** Biogen reported overall second-quarter sales of $2.78 billion

WALL STREET SENTIMENT

** The current average analyst rating on Biogen shares is "hold", with eight analysts rating it "strong buy", eight "buy" and 16 "hold"

** Wall Street's median 12-month price target is $379

** The company's shares have risen about 10.5% so far this year

QUARTER ENDING EPS ESTIMATE($) ACTUAL EPS($) BEAT, MET,

MISSED

JUNE. 30 2021 4.54 5.68 BEAT

MARCH. 31 2021 5.04 5.34 BEAT

DEC. 31 2020 4.87 4.58 MISSED

SEPT. 30 2020 8.04 8.84 BEAT

JUNE 30. 2020 8.03 10.26 BEAT

MARCH. 31 2020 7.73 9.14 BEAT

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-sales-face-pressure-from-slow-uptake-of-Alzhiemer-s-drug-36721436/

Roche expects higher 2021 sales as Delta spurs COVID-19 tests

 

Roche raised its 2021 sales forecast on Wednesday after demand for COVID-19 tests and medicines was boosted by the highly contagious Delta variant and the wider business performed well, helping the Swiss drugmaker beat revenue expectations.

The company now predicts overall 2021 sales will grow in the mid-single digit range at constant exchange rates, having previously expected them to rise in the low to mid-single digit percentage range.

"The demand for coronavirus tests remained high in the third quarter due to the Delta variant," Chief Executive Severin Schwan said.

Roche in July had flagged an expected slowdown in demand for the tests in the second half of the year, but management was more confident this time.

"(COVID-19) testing is likely to continue into the fourth quarter, and likely into next year. The question is the level of testing," said Thomas Schinecker, head of Roche's diagnostics business.

That would depend on several factors, including the pace of vaccination, Schinecker added on a media call.

Group sales in the three months to September rose 8% to 15.97 billion Swiss francs ($17.29 billion), the company said, as diagnostics division revenues jumped 18%.

Analysts on average were expecting sales of 15.48 billion francs, according to Jefferies.

"The quality of the beat is somewhat worse than we wished for - key growth drivers underperformed," Vontobel analysts said in a note, adding that the beat comes from Actemra, which profits from the pandemic, and a slower erosion of key oncology drugs.

Shares in the company were down 0.3% by 0848 GMT, compared to a near 1% rise in the wider European pharmaceuticals index.

Roche, whose medicines RoActemra/Actemra and Ronapreve have been critical to COVID-19 treatment in several countries, said supply of biological ingredients for those drugs was improving after the situation had been tight.

There have also been signs of recovery in the pharmaceuticals unit since the summer, the company said, after the pandemic hurt sales.

A plethora of new launches, including an Alzheimer's treatment if approved by U.S. authorities, are expected to bolster future sales at Roche as it faces increasing competition for older drugs.

Final data from a study of its experimental COVID-19 antiviral pill, which Roche is working on with Atea, will be submitted to a peer-reviewed publication and the partners will continue to analyse data, the company said.

The pill had failed to help patients with mild and moderate COVID-19 in a small study of mostly low-risk patients, delivering a major setback to the firms.

https://www.marketscreener.com/news/latest/Roche-expects-higher-2021-sales-as-Delta-spurs-COVID-19-tests--36724298/