Intuitive: Prelims miss consensus

 Intuitive (the “Company”) (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced certain unaudited preliminary fourth quarter and full year 2022 financial results ahead of its presentation at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023.

Financial and Operational Highlights

• Fourth quarter 2022 worldwide da Vinci procedures grew approximately 18% compared with the fourth quarter of 2021. The fourth quarter of 2022 reflected a resurgence in COVID-19 in China, which negatively impacted procedure volumes in the region. The fourth quarter of 2021 reflected COVID-19 disruptions later in the quarter in the U.S. and Europe, which also impacted the Company’s procedures. The compound annual growth rate between the fourth quarter of 2019 and the fourth quarter of 2022 was approximately 14%.

• Full year 2022 worldwide da Vinci procedures grew approximately 18% compared with 2021. The compound annual growth rate between the full year of 2019 and the full year of 2022 was approximately 15%. The Company expects worldwide da Vinci procedures to increase approximately 12% to 16% in 2023 as compared to 2022.

• The Company placed 369 da Vinci Surgical Systems in the fourth quarter of 2022, a decrease of 4% compared with 385 in the fourth quarter of 2021. The Company placed 1,264 da Vinci Surgical Systems in 2022, a decrease of 6% compared with 1,347 systems in 2021.

• Preliminary fourth quarter 2022 revenue of approximately $1.66 billion increased 7% compared with $1.55 billion in the fourth quarter of 2021. Preliminary 2022 revenue of approximately $6.22 billion increased 9% compared with $5.71 billion in 2021.

Preliminary Results

The Company expects fourth quarter 2022 revenue of approximately $1.66 billion, an increase of 7% compared with $1.55 billion in the fourth quarter of 2021. The Company expects 2022 revenue of approximately $6.22 billion, an increase of 9% compared with $5.71 billion in 2021. The unaudited results in this press release are preliminary and subject to the completion of the Company’s final closing procedures and annual independent audit and, therefore, are subject to adjustment.

https://finance.yahoo.com/news/intuitive-announces-preliminary-fourth-quarter-140500496.html

Merck to take legal action against unauthorized distributors of its COVID treatment in China

 Merck & Co said on Wednesday it would take legal action against some pharmaceutical companies after noticing that some manufacturers were supplying COVID-19 drugs to some provinces and cities saying the medicines were authorized by Merck.

It did not name the companies in the post on its official WeChat account in China.

Merck added that Sinopharm is the only legally authorized distributor of Merck's COVID-19 antiviral molnupiravir in China, which is sold under the brand name Lagevrio and was developed by Merck and partner Ridgeback Biotherapeutics.

It added it had started talks with Sinopharm on the drug's production technology licence so that Sinopharm can supply the drug in China. Merck said in September that China National Biotec Group, an affiliate of Sinopharm, would make the drug.

China's abrupt dismantling of its zero-COVID regime starting last month has caught its public off-guard, prompting a hospital scramble for beds and blood and pharmacies to sell out of drugs as a giant wave of infections hit.

The severe shortage of drugs has made many turn to underground channels to secure treatments, which has in turn prompted caution over fake remedies, according to local media reports and social media posts.

https://www.yahoo.com/lifestyle/merck-legal-action-against-unauthorized-095841865.html

Intercept JPMorgan Presentation

 Our mission

is to build a healthier tomorrow for people with progressive non-viral liver diseases

Intercept Today: Established Expertise in Liver Disease

Sustainable and growing PBC

business with Ocaliva

Strong revenue of ~$343M

non-GAAP adjusted net sales

(~$285M U.S. net sales), representing ~10% growth in FY 2022*

OCA+bezafibrate fixed- dose combination Phase

2 development program ongoing

Progressing OCA for

pre-cirrhotic liver fibrosis

due to NASH

NDA re-submitted in December 2022

NDA supported by robust NASH development program, including two positive interim analyses from the Phase 3 REGENERATE study

Advancing internal pipeline in liver diseases with high unmet need

Initiated Phase 2a FRESH study with INT-787 in severe alcohol- associated hepatitis

Evaluating and prioritizing short- and long-term internal and external opportunities aligned with our core strengths

Fully integrated organization with ~350 employees focused exclusively in liver disease

Strengthened financial position and an overall improved capital structure

https://www.marketscreener.com/quote/stock/INTERCEPT-PHARMACEUTICALS-11718561/news/Intercept-Pharmaceuticals-JP-Morgan-Corporate-Presentation-ndash-January-2023-42710916/

Solid Bio, Phlox to Collaborate on New Therapies for Rare Cardiac Diseases

 

• Research collaboration to target severe form of genetic dilated cardiomyopathy
  

• Collaboration strengthens Solid Biosciences’ scientific capabilities and commercial potential in cardiac therapy

• Collaboration allows Phlox Therapeutics to leverage Solid Biosciences’ vector biology and manufacturing capacities to deliver its RNA therapies to the heart

https://finance.yahoo.com/news/solid-biosciences-phlox-therapeutics-announce-130000669.html

Eton's stock rallies as FDA reviews treatment for alcohol poisoning

 Shares of Eton Pharmaceuticals Inc. (ETON) jumped about 11% in premarket trading on Wednesday after the company said its experimental treatment for alcohol poisoning is being reviewed by the Food and Drug Administration. The regulator is expected to make a decision whether to approve the injection on or by June 27. Eton's stock is down 25.6% over the past 12 months, while the broader S&P 500 has declined 16.1%.

https://www.morningstar.com/news/marketwatch/20230111255/etons-stock-rallies-as-fda-reviews-treatment-for-alcohol-poisoning

Dentsply Sirona stock rallies after upbeat full-year revenue outlook

 Dentsply Sirona Inc. (XRAY) climbed 1.0% in premarket trading Wednesday, after the dental products maker provided an upbeat full-year revenue outlook. The company, which is presenting at the J.P. Morgan Healthcare Conference Wednesday morning, said it expects 2022 sales to be "above the high end" of its previous guidance of $3.85 billion to $3.88 billion. That would put revenue above the FactSet consensus of $3.87 billion. The company said it expects earnings per share excluding nonrecurring items to be within previous guidance of $1.90 to $2.00, which surrounds the FactSet consensus of $1.96. The company is projected to report fourth-quarter results in late February. The stock has rallied 18.3% over the past three months through Tuesday, while the S&P 500 has gained 9.2%.

https://www.morningstar.com/news/marketwatch/20230111242/dentsply-sirona-stock-rallies-after-upbeat-full-year-revenue-outlook

Flights grounded across the country due to FAA system outage

 Flights around the country were grounded this morning due to an outage with an important Federal Aviation Administration (FAA) system for pilots.

Earlier this morning the FAA said it was grounding all flights until 9 a.m. ET this morning in order to “validate the integrity of flight and safety information,” stemming from outage with its Notice to Air Missions (NOTAM) system.

Per an update from the FAA, departures are resuming at Newark Liberty airport (EWR) and Atlanta's Hartsfield-Jackson airport (ATL). The agency expects departures at other airports to resume at 9 a.m ET.

The NOTAM system sends out flight hazards and restrictions to pilots prior to takeoff. A NOTAM bulletin can sometimes be as long as a couple hundred pages detailing issues like possible bird activity or closed runways.

Flights currently in the air are allowed to travel to their destinations, however all flights scheduled to take off have been grounded.

Per the Air Traffic Control System Command Center, the NOTAM system went down around 3:28 am ET.

ABC News reported that a senior official briefed on the matter said the software issue led to a “cascading” series of IT failures, leading to this morning’s flight groundings.

As of 7:15 a.m., more than 1,200 flights have been delayed into or out of the U.S., which was shortly before the FAA announced the pause.

Airline stocks are all trading lower in the pre-market before the opening bell on Wall Street.

https://finance.yahoo.com/news/flights-grounded-across-the-country-due-to-faa-system-outage-134128571.html