Novo Nordisk cuts some US supply of obesity drug Wegovy to cope with demand

 Danish drug developer Novo Nordisk said it would have to halve the supply of starter doses of its popular Wegovy weight-loss drug in the United States to cope with high demand after reporting forecast-beating results on Thursday.

Shares in Novo Nordisk traded down 4.7% at 0731 GMT, putting a small dent in a rise of more than 140% since the firm launched Wegovy in the U.S. in June 2021. The company's stock is the best performing in Europe.

"To safeguard continuity of care, the supply of the lower Wegovy dose strengths in the US will be reduced temporarily," Novo said in a statement.

Novo has faced supply constraints for its hugely popular Wegovy drug as a result of overwhelming demand, and has invested massively in increasing supply.

Sales of Novo's obesity care products, including Wegovy, rose 124% in the first quarter.

"We cannot supply an uptake that just continues growing, so it's important for us that we secure continuity of supply for those patients who have started treatment," Chief Executive Lars Fruergaard Jorgensen told journalists on Thursday.

Supply of starter doses in the U.S. would be cut by around 50% for "some months," Jorgensen added.

Credit Suisse analysts said they were not surprised by the move, given the level of demand for the drug.

Last month the company said a second contract manufacturer would commence production of Wegovy and on Thursday Jorgensen said a third manufacturer would begin production later this year.

Jorgensen said he could not give a date for when Wegovy would be launched in the UK, where in March the country's cost effectiveness watchdog recommended it for use for certain obese people.

"We will gradually roll out in International Operations, and UK is a part of that. We are not commenting on specific launch dates," he said.

Novo on Thursday reported earnings before interest and taxes (EBIT) of 25 billion Danish crowns ($3.72 billion), above an average analyst forecast of 22.4 billion, according to a Refinitiv poll.

Earlier this month, Novo, the second-most valuable company in Europe by market capitalisation behind French luxury goods group LVMH, significantly raised its full-year operating profit and sales expectations on the back of strong demand for Wegovy.

Novo on Thursday maintained full-year growth guidance in local currencies, but said due to the strength of the Danish crown sales and operating profit growth reported in Danish crowns are now expected to be 6 and 9 percentage points lower, respectively.

https://finance.yahoo.com/news/novo-nordisk-cuts-wegovy-starter-053914580.html

Sandoz to exclusively commercialize 6 products in the US, reinforcing lead in off-patent medicines

 

• Agreement offers exclusive rights to commercialize six products in key areas of anti-infectives and oncology.

• Products from Adalvo slated for near- to mid-term launches, with four out of six anticipated to be first-to-market

• Sandoz continues to expand patient access to much-needed medications, drive patient savings, and ensure the sustainability of healthcare systems worldwide

https://uk.finance.yahoo.com/news/sandoz-exclusively-commercialize-six-products-051500529.html

Planet Fitness misses profit and revenue expectations

 Planet Fitness Inc. (PLNT) reported Thursday first-quarter profit and revenue that rose less than expected, but provided an in-line full-year growth outlook, with "all generational groups back to pre-pandemic population penetration levels." The fitness center operator's stock was still inactive in premarket trading. Net income increased to $22.7 million, or 27 cents a share, from $16.5 million, or 19 cents a share, in the year-ago period. Excluding nonrecurring items, adjusted earnings per share of 41 cents missed the FactSet consensus of 46 cents. Revenue grew 19.0% to $222.23 million, but was below the FactSet consensus of $238.3 million. "Our business continues to rebound from the impact of COVID-19 shutdowns with more than 50 percent of our U.S. stores opened prior to 2019 back to or above pre-pandemic membership levels, with member growth driving our 9.9 percent increase in system-wide same stores sales," said Chief Executive Officer Chris Rondeau. Same-store sales beat expectations of a 9.5% rise. For 2023, the company expects adjusted EPS growth of 33% to 36%, while the FactSet EPS consensus of $2.21 implies 34.8% growth. The company also expects 2023 revenue to rise 13% to 14%, while the FactSet revenue consensus of $1.07 billion implies 13.8% growth. The stock has gained 3.5% year to date, while the S&P 500 has tacked on 6.5%.

https://www.morningstar.com/news/marketwatch/20230504293/planet-fitness-misses-profit-and-revenue-expectations-but-provides-in-line-full-year-outlook

Cardinal ups guidance

 

• Revenue increased 13% to $50.5 billion

• GAAP1 operating earnings were $572 million; GAAP diluted EPS was $1.34

• Non-GAAP operating earnings increased 11% to $606 million; non-GAAP diluted EPS increased 20% to $1.74

• Fiscal year 2023 non-GAAP EPS guidance raised and narrowed to $5.60 to $5.80, from $5.20 to $5.50

• Fiscal year 2023 adjusted free cash flow guidance raised and narrowed to $2.0 to $2.3 billion, from $1.5 to $2.0 billion

https://finance.yahoo.com/news/cardinal-health-reports-third-quarter-105500047.html

Agios Q1, upcoming milestones, call

 On Track for PYRUKYND® (mitapivat) Data Readouts of the Phase 2 Portion of the RISE UP Study in Sickle Cell Disease in Mid-2023 and the Phase 3 ENERGIZE and ENERGIZE-T Studies in Thalassemia in 2024

– U.S. PYRUKYND® Net Revenue of $5.6 Million in Q1; $1.0 Billion of Cash, Cash Equivalents and Marketable Securities as of March 31, 2023

Agios expects to execute on the following additional key milestones and priorities by the end of 2023:

• Thalassemia: Complete enrollment of the Phase 3 ENERGIZE and ENERGIZE-T studies of PYRUKYND® in not regularly transfused and regularly transfused adults with thalassemia, respectively, by mid-year.

• Sickle Cell Disease: Announce data readout from the Phase 2 portion of the RISE UP study of PYRUKYND® and go/no-go to Phase 3 decision by mid-year.

• Pediatric PK Deficiency: Enroll more than half of patients in the Phase 3 ACTIVATE-kids and ACTIVATE-kidsT studies of PYRUKYND® by year-end.

• Lower-risk Myelodysplastic Syndromes (LR-MDS): Complete enrollment of the Phase 2a study of novel PK activator AG-946 by year-end.

• Pipeline: File investigational new drug (IND) application for phenylalanine hydroxylase (PAH) stabilizer for the treatment of phenylketonuria (PKU) by year-end.

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss first quarter 2023 financial results and recent business activities. The live webcast can be accessed under “Events & Presentations” in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company's website beginning approximately two hours after the event.

https://finance.yahoo.com/news/agios-reports-business-highlights-first-110000675.html

Moderna's surprise profit powered by deferred COVID orders

 Moderna Inc on Thursday reported a surprise profit and stronger-than-expected sales for its COVID-19 vaccine in the first quarter, as it received payments for orders that were deferred last year.

The vaccine maker posted a profit of 19 cents per share, compared with analysts' expectations for a loss of $1.77 per share, in part because sales were higher than expected.

The $1.83 billion of sales for its COVID vaccine Spikevax represents most of the $2 billion expected in the first half of the year for advanced purchase agreements and double the average analyst estimate of $998 million, according to Refinitiv IBES data.

Moderna expects an additional $3 billion in deferred vaccine revenue in the second half of 2023.

The company said it continued to expect COVID vaccine sales of $5 billion for the year based on advance purchase agreements. It added it was having discussions about new contracts with customers in Europe, Japan, and in the U.S.

The company expects to sign commercial contracts for updated COVID vaccine boosters over the next few weeks and into the third quarter, Chief Commercial Officer Arpa Garay said in an investor call.Moderna continues to expect the U.S. annual COVID-19 market to be 100 million doses, she added.

"Today's beat and 2023 reiteration of guidance along with ongoing negotiations in 3 regions should support some confidence on the 2023 base business of $5 billion to $7 billion," said Jefferies analyst Michael Yee.

Moderna's shares were up 2% in morning trade in a broadly weaker market.

The results came two days after rival Pfizer Inc reported better-than-expected COVID vaccine sales for the first quarter and maintained its expectations for full-year sales.

Moderna trails Pfizer in share of the global COVID vaccine market, with the latter holding nearly two-thirds, said TD Cowen analyst Tyler Van Buren, ahead of the shot moving into the commercial market from government procurement in the U.S.

https://finance.yahoo.com/news/moderna-beats-covid-vaccine-sales-103714034.html

Ironwood Maintains Full Year 2023 Financial Guidance After Q1

 LINZESS (Iinaclotide) EUTRx prescription demand growth increased 10% year-over-year; LINZESS U.S. net sales of $250 million, an increase of 8% year-over-year –

– GAAP net income of $46 million and adjusted EBITDA of $60 million; ended Q1 2023 with $740 million in cash and cash equivalents –

• Ironwood 2023 Financial Guidance. In 2023, Ironwood continues to expect:

	2023 Guidance
U.S. LINZESS Net Sales Growth	3% to 5%
Total Revenue	$420 to $435 million
Adjusted EBITDA1	>$250 million

1 Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization from GAAP net income. For purposes of this guidance, Ironwood has assumed that it will not incur material expenses related to business development activities in 2023.

Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time on Thursday, May, 4 2023 to discuss its first quarter 2023 results and recent business activities. Individuals interested in participating in the call should dial (888) 330-2384 (U.S. and Canada) or (240) 789-2701 (international) using conference ID number and event passcode 4671230. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time on May 4, 2023, running through 11:59 p.m. Eastern Time on May 18, 2023. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (647) 362-9199 (international) using conference ID number 4671230. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.

https://finance.yahoo.com/news/ironwood-pharmaceuticals-reports-first-quarter-110000298.html