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Tuesday, January 14, 2025

PacBio updates, prelims

 Business updates:

  • Expanded long-read sequencing portfolio: Launched the Vega system, an innovative benchtop sequencing platform designed to make HiFi long-reads accessible to a broader customer base.
  • Enhanced the Revio platform: Launched SPRQ chemistry, unlocking the sub-$500 HiFi long-read human genome and enabling Revio customers to sequence more samples with 4-fold lower DNA input requirements.
  • Advanced clinical market strategy: Delivered our first Vega systems to Berry Genomics as part of an early access agreement, supporting their efforts to develop targeted assays for prenatal health and carrier and newborn screening programs in China and other global markets.
  • Strengthened financial position: Enhanced our balance sheet by exchanging $459 million in aggregate principal of the 1.5% convertible senior notes due 2028 for $200 million in newly issued 1.5% convertible senior notes due August 2029, along with approximately 20.5 million shares of common stock and $50 million in cash.

Preliminary fourth quarter results:

  • Preliminary, unaudited revenue for the fourth quarter of 2024 is expected to be approximately $39.2 million compared with $58.4 million in the prior-year period.
  • Preliminary instrument revenue for the fourth quarter of 2024 is expected to be approximately $15.3 million, compared with $35.1 million for the fourth quarter of 2023. Preliminary instrument revenue in the fourth quarter of 2024 included 23 Revio sequencing systems and 7 Vega sequencing systems.
  • Preliminary consumables revenue for the fourth quarter of 2024 is expected to be approximately $18.8 million, compared with $18.9 million for the fourth quarter of 2023. Revio annualized pull through in the fourth quarter is expected to be approximately $240,000.
  • Preliminary service and other revenue for the fourth quarter of 2024 is expected to be approximately $5.1 million, compared with $4.4 million for the fourth quarter of 2023.
  • Total preliminary unrestricted cash, cash equivalents, and investments balance as of December 31, 2024, is expected to be approximately $390 million.

PacBio is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 4:30 p.m. Pacific Time. PacBio plans to make the presentation available on the Events & Presentations Section of PacBio's website at investor.pacificbiosciences.com. The information posted on or that can be accessed through PacBio's website, including PacBio's updated corporate presentation, is not incorporated by reference into this press release, and the inclusion of PacBio's website address is an inactive textual reference only.

https://www.globenewswire.com/news-release/2025/01/14/3009362/16261/en/PacBio-Announces-Preliminary-Fourth-Quarter-and-Full-Year-Revenue.html

Illumina prelims

 Illumina, Inc. (NASDAQ: ILMN) ("Illumina" or the "company") today announced unaudited preliminary financial results for the fourth quarter and fiscal year 2024 and preliminary outlook for fiscal year 2025 ahead of its presentation at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025 at 9:00 a.m. Pacific Time (12:00 p.m. Eastern Time). The webcast can be accessed through Illumina's website at investor.illumina.com.

Core Illumina

  • Revenue of approximately $1.10 billion for Q4 2024, up 1% from Q4 2023
  • Revenue of approximately $4.33 billion for 2024, down 2% from 2023 (and on a constant currency basis)
  • GAAP operating margin of approximately 16.7% for Q4 2024 and 34.2% for 2024
  • Non-GAAP operating margin of approximately 19.7% for Q4 2024 and 21.3% for 2024
  • GAAP diluted EPS of approximately $0.77 - $0.79 for Q4 2024 and $5.65 - $5.67 for 2024
  • Non-GAAP diluted EPS of approximately $0.91 - $0.93 for Q4 2024 and $4.12 - $4.14 for 2024
  • Cash flow provided by operations of approximately $1.21 billion and free cash flow (cash flow provided by operations less capital expenditures) of approximately $1.07 billion for 2024
  • For fiscal year 2025, expect constant currency revenue growth in the low single digits (reported revenue in the range of approximately $4.28 billion to $4.4 billion), non-GAAP operating margin of approximately 23%, and non-GAAP diluted EPS growth of approximately 10%

As previously announced, the company expects to report its full fourth quarter and fiscal year 2024 results following the close of market on Thursday, February 6, 2025. The unaudited results in this press release are preliminary and subject to the completion of accounting and annual audit procedures and are therefore subject to adjustment.

https://www.prnewswire.com/news-releases/illumina-announces-preliminary-unaudited-financial-results-for-fourth-quarter-and-fiscal-year-2024-and-provides-preliminary-outlook-for-fiscal-year-2025-302350044.html

Perrigo cut to Hold from Buy by Argus

 Target to $27 from $34

https://finviz.com/quote.ashx?t=PRGO&ty=c&ta=1&p=d

Hims & Hers stock up as Eli Lilly GLP-1 sales miss

 Eli Lilly (LLY) stock fell as its obesity therapy tirzepatide missed forecasts, amid focus on compounded weight loss drugmaker Hims & Hers

https://seekingalpha.com/news/4394979-hims-hers-stock-up-eli-lilly-glp-1-sales-miss

'FDA proposes putting nutrition info on the front of food packages'

 The Food and Drug Administration on Tuesday proposed a new rule for nutrition labels on packaged food and drinks that’s intended to help Americans make healthier choices at a glance. 

Under the new rule, which shoppers could see as early as 2028, food manufacturers will be required to display levels of saturated fat, sodium and added sugar on the front of the packaging, in addition to the standard nutrition labels on the back.

Packaged foods in the U.S. often come with a number of health and nutrition claims, which can make it confusing for consumers to know what’s good or bad for them, said Lindsey Smith Taillie, a nutrition epidemiologist at the University of North Carolina Gillings School of Global Public Health. 

Fruit drinks, for example, may advertise high levels of vitamin C on the front of the bottle, making them seem like a healthy choice, but at the same time, they are loaded with added sugar, Smith Taillie said. 

The idea is that by placing certain nutrition information directly in front of consumers, they’ll be more likely to make health-conscious decisions. 

"We believe that food should be a vehicle for wellness, not a contributor of chronic disease," Rebecca Buckner, the FDA's associate deputy director for human food policy, said on a call with reporters.

Nutrition Info box containing all proposed requirements.
The proposed front-of-package labels will include saturated fat, sodium and added sugar, along with whether the product contains high, medium or low amounts of the nutrients.U.S. Food & Drug Administration

The FDA's proposed front-of-package label will include the amount of saturated fat, sodium and added sugars and whether those amounts are considered "low," "medium" or "high."

FDA officials said the label it landed on was backed by science, including a body of research, consumer focus groups and an agency-led study of nearly 10,000 adults that looked at how people responded to several possible designs.

Saturated fat, sodium and added sugar were chosen as the three nutrients because research shows they're leading contributors of chronic disease, including cancer, heart disease and diabetes, Buckner said.

“I think people want to know this information to help them make good decisions,” said Dr. Yian Gu, a nutrition epidemiologist at the Columbia University Medical Center in New York City.

However, the extra information won’t do much good if people aren’t aware of how certain nutrients, such as saturated fat, can affect their health, Gu said, adding that more work needs to be done on educating people about their nutrition. 

The FDA’s proposal comes amid high rates of diet-related chronic diseases, such as Type 2 diabetes and heart disease, in the U.S. Heart disease is the leading cause of death in the U.S., accounting for 1 in every 5 deaths, according to the Centers for Disease Control and Prevention. About 1 in 10 Americans have diabetes, mostly Type 2 diabetes. And about 2 in 5 adults have obesity, the CDC says. 

“These diseases are not coming from nowhere,” Gu said. “If people are not aware of the science behind all of this nutrition, they will not pay attention to it.”

The front-of-package labels won’t go into effect immediately, according to the FDA. The proposal includes a 120-day comment period after which the agency may make additional changes to the proposal or finalize the new rule.

Large food manufacturers will have three years after the rule is finalized to make the changes to most of their products, the agency said. Smaller manufacturers will get an additional year to implement the changes.

While not the FDA's intent of the food labels, Buckner said the new rules may cause food manufactures to reformulate their products so they can move to the "low" or "medium" categories.

The Consumer Brands Association, an industry trade group, has been against the mandatory labeling, saying the FDA is considering “schemes with arbitrary scales and symbols that could cause confusion among consumers.”

Sarah Gallo, senior vice president of product policy at Consumer Brands Association, said in a statement the group has instead pushed the agency to collaborate on industry-led initiatives, including Facts Up Front, which allows food manufacturers to voluntarily summarize important nutrition information — such as calories, saturated fat, sodium and added sugars — on the front of packaging. The industry has also introduced SmartLabel, which allows consumers to access detailed nutritional information via QR codes, Gallo said.

Will the labels affect consumers’ habits?

Putting nutrition labels on the front of packages isn’t a new concept — at least outside of the U.S. Dozens of countries, including the United Kingdom, Mexico, Chile, Australia and New Zealand, have implemented similar measures. 

Cookies with labels stating their high content in sugar, calories and saturated fat
Since 2016, packaged foods in Chile had black, hexagonal labels on the front stating whether the product was high in calories, saturated fat and sugar. Martin Bernetti / AFP via Getty Images file

In 2016, Chile introduced mandatory labels on the front of packaging, alerting consumers to high levels of sugar, saturated fat and other potentially harmful ingredients. 

In 2022, Brazil also implemented mandatory front-of-package labels for products.

Colleen Tewksbury, an assistant professor of nutrition science at the University of Pennsylvania, said research has shown that the labels do influence what people buy in those countries.

However, she said, those findings may not easily translate to the U.S., where “individualism” prevails and consumers don’t “want to be told what to do.” 

Often, she said, the people who change their buying behavior were the ones who were already looking to make changes.

“Research is relatively clear that having very simplistic front of packaging labeling does catch people’s attention, but the second step to that is whether or not it changes purchasing behaviors,” Tewksbury said. “We really don’t know if it’s going to fully impact people’s purchasing habits.”

https://www.nbcnews.com/health/health-news/fda-proposes-putting-nutrition-info-front-food-packages-rcna175977

Pfizer to more than halve Haleon holding in GBP2.57 billion sale

 Pfizer Inc is selling 700 million shares in Haleon PLC, more than halving its remaining stake, according to a statement from JPMorgan Securities on Tuesday.

Weybridge-based Haleon is a consumer healthcare products manufacturer which owns brands such as Sensodyne toothpaste, Panadol and Advil painkillers, and Centrum vitamins.

According to JPMorgan, Pfizer, the New York pharmaceutical and biotechnology firm, is offloading 7.7% of Haleon's share capital, via an accelerated bookbuilding process to institutional investors. This process will determine the price at which the shares are sold.

JPMorgan and Morgan Stanley are acting as joint global coordinators and joint bookrunners.

At Haleon's closing share price on Tuesday of 367.10 pence, the share sale is worth around GBP2.57 billion. Shares in Pfizer were 1.3% lower at USD26.45 each in New York.

The sale will reduce Pfizer's interest in Haleon to around 7.3% from 15.0%.

Pfizer has undertaken not to transfer or dispose of any of its remaining equity securities in Haleon for 60 days from the date of settlement of the offering.

Haleon was formed in 2019 as a joint venture of Pfizer and GSK PLC’s consumer health assets. It was listed on the London stock market in July 2022, with Pfizer retaining a 32% stake which it has reduced it over time.

GSK sold its remaining 4.2% holding in Haleon in May 2024.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-to-more-than-halve-Haleon-holding-in-GBP2-57-billion-sale-48758255/

Biden to significantly relax Cuba sanctions in final days before Trump

 U.S. President Joe Biden will relax sanctions targeting long-time foe Cuba days before Donald Trump takes office in a broad set of steps on Tuesday that he expects to lead to release of political prisoners in Havana.

As part of the steps, Biden is reversing several hardline restrictions put in place by Trump, his predecessor and the president-elect. Those steps include notifying Congress of plans to lift the U.S. designation of Cuba as a state sponsor of terrorism and undoing a Trump order that had restricted some financial transactions with some military and government-tied Cubans, according to a senior administration official.

Biden was also set to suspend the ability of individuals to use U.S. courts to make claims for potentially confiscated property in Cuba following Fidel Castro's 1959 revolution, the official said.

The steps were connected to the expected release by Cuba of a "significant" number of political prisoners, following the communist-run government's talks with the Catholic Church.

Cuba faced sharp criticism from rights groups, the United States and the European Union following the imprisonment of hundreds of protesters after riots on July 11, 2021, the largest since Castro's revolution.

The announcements, just days before Biden leaves office, mark his first real break in policy from Trump-era sanctions that have contributed to one of Cuba's worst economic crises.

Trump may seek to revive the sanctions once in office.

But in the short term, Biden's new measures were expected to give Havana more space to maneuver as it battles a crippling economic crisis.

Trump placed Cuba on the U.S. State Sponsor of Terrorism list in 2021 in the final hours of his first term, saying Havana had repeatedly provided "support for acts of international terrorism" by harboring U.S. fugitives and Colombian rebel leaders.

Cuba denied the allegations, calling the designation a farce and seeking removal from the list, which carries a prohibition on U.S. economic aid, a ban on U.S. arms exports and enough geopolitical downside to keep even Cuba's closest allies leery of doing business with the island.

https://www.marketscreener.com/news/latest/Biden-to-significantly-relax-Cuba-sanctions-in-final-days-before-Trump-48758691/