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Monday, January 10, 2022

Cardinal lowers outlook on inflation, supply chain issues

 Cardinal Health (NYSE: CAH) today provided a fiscal year 2022 financial update for the Medical segment. The company now expects additional inflationary impacts and lower volumes resulting primarily from global supply chain constraints, and a lower-than-expected offset from pricing actions. The company estimates this incremental impact will be approximately $150 million to $175 million to fiscal year 2022 Medical segment profit and approximately $0.40 to $0.45 per share to non-GAAP diluted EPS. Excluding this impact to the Medical segment and non-GAAP diluted EPS, the company's other financial expectations1 for fiscal year 2022 remain unchanged.

https://finance.yahoo.com/news/cardinal-health-provides-medical-segment-115500375.html

Akoya Prelim Results Beat VIews

 Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2021.

Akoya reported the following preliminary financial results for the fourth quarter and full year 2021, which remain subject to quarter end closing adjustments:

  • Revenue for the fourth quarter of 2021 is expected to be between $16.0 million and $16.2 million, as compared to $12.9 million for the corresponding quarter of last year

  • For the fiscal year of 2021, revenue is expected to be between $54.8 million and $55.0 million, as compared to $42.4 million for fiscal year 2020

“The fourth quarter of 2021 was a record revenue quarter for Akoya and it demonstrates continued momentum in our business,” said Brian McKelligon, Chief Executive Officer. “We made significant progress in 2021 on a number of major initiatives, including our IPO in April, approximately 30% growth in revenues, nearly doubling the company’s headcount with specific emphasis on the commercial and R&D organizations, and announcement of our new 2022 product offerings at our inaugural Spatial Day on December 15, 2021. We enter 2022 with tremendous confidence in our strategy as we drive adoption of our spatial biology platforms to our research, translational and clinical customers.”

A link to a webcast replay of Akoya’s inaugural Spatial Day, which took place virtually on December 15, 2021, can be found below:

Akoya Spatial Day 2021 | Akoya (akoyabio.com)

https://finance.yahoo.com/news/akoya-announces-preliminary-financial-results-130000706.html

Novavax, Serum Institute File for Emergency Use of Novavax' COVID-19 Vax in S.Africa

 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. If authorized, the vaccine (known as NVX-CoV2373) will be manufactured by and commercialized by SII in South Africa under the brand name Covovax™.

"Novavax' is thankful for our long-standing history of partnership in South Africa to advance much-needed vaccines. This is exemplified by the country's vital role in the Phase 2b clinical trial and booster study of our protein-based COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Novavax and Serum Institute remain focused on delivering the COVID-19 vaccine - built on well-understood technology - where it is needed most. We look forward to SAHPRA's review and, if authorized, delivering the vaccine to help South Africa control the pandemic."

The submission for the regulatory evaluation by SAHPRA of NVX-CoV2373 includes data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated high efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

ATEC: Prelim 2021 Revenue Results and 2022 Guidance

 

  • Full-year 2021 U.S. organic revenue growth of 50% to 51% driven primarily by accelerated PTP™ adoption

  • Fourth quarter 2021 U.S. organic revenue growth of 41% to 42%

  • Full-year 2022 total revenue expected to grow approximately 26% to $305 million

Preliminary, Unaudited Q4 and Full-Year 2021 Revenue Ranges

Fourth Quarter Ended
December 31, 2021(1)

Full Year Ended
December 31, 2021(1)

U.S. Organic Revenue

$60.8M - $61.3M

$211.8M - $212.3M

EOS-Related Revenue

$12.5M - $12.8M

$29.7M - $30.0M

Revenue from Products & Services

$73.2M - $74.0M

$241.5M - $242.3M

International Supply Agreement

--

$0.9M

Total Revenue

$73.2M - $74.0M

$242.5 - $243.3M

(1)May not foot due to rounding

The Company expects to announce its fourth quarter and full-year 2021 financial and operating results on Tuesday, March 1st, 2022, after the market close.

Financial Outlook for the Full-Year 2022

The Company anticipates full-year 2022 total revenue of $305 million, reflecting growth of approximately 26% compared to the full year 2021. This includes organic revenue growth of between 22% and 23% and approximately $45 million of revenue related to EOS imaging. Further detail will be provided when the Company reports fourth quarter and full-year 2021 financial results.

https://finance.yahoo.com/news/atec-announces-preliminary-2021-revenue-140000475.html

Becerra orders Medicare to reassess premium hike on new Alzheimer's drug

 U.S. health secretary Xavier Becerra on Monday ordered Medicare to reassess a big premium increase facing millions of seniors this year, attributed in large part to a pricey new Alzheimer's drug with questionable benefits. 

Becerra's directive came days after drugmaker Biogen slashed the price of its $56,000-a-year medication, Aduhelm, to $28,200 a year — a cut of about half. 

"With the 50% price drop of Aduhelm on Jan. 1, there is a compelling basis ... to reexamine the previous recommendation," Becerra said in a statement about his directive to the Centers for Medicare and Medicaid Services. The statement was provided to The Associated Press. 

More than 50 million Medicare recipients who pay the $170.10 monthly "Part B" premium for outpatient care will see no immediate change to their costs, but Monday's move could open the way for a reduction later in the year. The Department of Health and Human Services says it is reaching out to the Social Security Administration, which collects the premium, to examine options. 

The standard Part B premium is rising by about $22 this year, up from $148.50 in 2021 and one of the biggest annual increases ever. About half of that, $11, was attributed to the potential costs of having to cover Aduhelm at its original $56,000 price. 

Becerra's move came after prominent Democratic senators urged the Biden administration to take immediate steps to cut rising drug costs for seniors. Bigger curbs on drug prices promised by Democrats are hung up in Congress along with the rest of President Biden's massive social agenda legislation. 

In announcing the price cut just days before the Christmas holidays, Biogen acknowledged the high cost had become a stumbling block to uptake for its medication. 

"Too many patients are not being offered the choice of Aduhelm due to financial considerations and are thus progressing beyond the point of benefitting from the first treatment to address an underlying pathology of Alzheimer’s disease," CEO Michel Vounatsos said at the time. "We recognize that this challenge must be addressed in a way that is perceived to be sustainable for the U.S. healthcare system." 

Medicare is currently covering Aduhelm on a case-by-case basis. Later this week, the agency is expected to issue an initial coverage decision, but the process of finalizing it can take months. 

Usually the financial impact of high-cost drugs falls most directly on patients with serious diseases such as cancer, rheumatoid arthritis or multiple sclerosis. But with Aduhelm, the pain would be spread among Medicare recipients generally, not just Alzheimer’s patients needing the drug. 

That's turned the drug into a case study of how one pricey treatment can swing the needle on government spending and impact household budgets. People who don’t have Alzheimer’s would not be shielded from the cost of Aduhelm, since it’s big enough to affect their premiums.  

Secretary of Health and Human Services Xavier Becerra answers questions at a Senate Health, Education, Labor, and Pensions Committee hearing to discuss reopening schools during COVUD-19 at Capitol Hill on Sept. 30, 2021, in Washington, D.C. 

Secretary of Health and Human Services Xavier Becerra answers questions at a Senate Health, Education, Labor, and Pensions Committee hearing to discuss reopening schools during COVUD-19 at Capitol Hill on Sept. 30, 2021, in Washington, D.C.  (Greg Nash- Pool/Getty Images)

Alzheimer’s is a progressive neurological disease with no known cure, affecting about 6 million Americans, the vast majority old enough to qualify for Medicare. 

Aduhelm is the first Alzheimer’s medication in nearly 20 years. It doesn’t cure the life-sapping condition, but the Food and Drug Administration determined that its ability to reduce clumps of plaque in the brain is likely to slow dementia in its earlier stages. However, many experts say that benefit has not been clearly demonstrated. 

https://www.foxnews.com/us/secretary-becerra-medicare-reassess-premium-hike-new-alzheimers-drug

Amicus Therapeutics Prelim Results, Outlook Disappoint

 Full-Year 2021 Galafold® Revenue of ~$306M, Representing 17% YoY Growth

Expect Double-Digit Growth (15-20%) of 2022 Galafold Revenue with $350M-$365M in Global Sales

U.S. and EU Regulatory Reviews Underway for AT-GAA in Pompe Disease

AT-GAA Global Launch Preparations Accelerating

Cash Flow and Balance Sheet Sufficient to Achieve Self-Sustainability and Profitability by 2023

Amicus is focused on the following five key strategic priorities in 2022:

  • Continued double-digit Galafold growth (15-20%) with revenue of $350M to $365M

  • Secure FDA approval and positive CHMP opinion for AT-GAA

  • Initiate successful, rapid launch in the U.S. for AT-GAA

  • Advance best-in-class next generation genetic medicines and capabilities

  • Maintain strong financial position on path to profitability

Mr. Crowley and Mr. Campbell will discuss the Amicus corporate objectives and key milestones in a presentation at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022, at 3:45 p.m. ET. A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate website at http://ir.amicusrx.com/events.cfm, and will be archived for 90 days.

https://finance.yahoo.com/news/amicus-therapeutics-reports-preliminary-2021-120000501.html

Karyopharm: Prelim Revenue, 2022 Objectives

 - Unaudited Net Product Revenues of Approximately $29.7 Million for Fourth Quarter 2021 and Approximately $98.3 Million for the Full Year 2021-

- Company on Track to Announce Top-Line Phase 3 Data from SIENDO Study Evaluating XPOVIO® (selinexor) in Patients with Endometrial Cancer in First Quarter 2022 -

Listen to the Webcast

These achievements and updates will be discussed during a webcast presentation at the 40th Annual J.P. Morgan Healthcare Conference to be held on Tuesday, January 11, 2022, at 3:45 p.m. ET, followed by a question-and-answer breakout session at 4:05 p.m. ET. A live webcast of the presentation and breakout session, along with accompanying slides, can be accessed under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. An archived replay will be available for 30 days following the event. The presentation slides will also be available on the Company's website following the event.

https://finance.yahoo.com/news/karyopharm-announces-preliminary-unaudited-fourth-120000971.html