Search This Blog

Thursday, December 7, 2023

Edwards Lifesciences Outlines Growth Strategy at Annual Investor Conference

 Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s sharpened focus and strategy for longer-term growth, provide an update on its technology pipeline and share financial guidance1 today during its annual investor conference.

Highlights of today’s conference include:

  • Expecting early completion of enrollment in PROGRESS, studying moderate AS patients, in early 2024
  • Expecting data from EARLY TAVR, studying severe asymptomatic AS patients, at TCT 2024
  • Commercializing EVOQUE tricuspid valve in Europe; expecting U.S. approval mid-2024
  • Expecting CE Mark for SAPIEN M3 by the end of 2025
  • Reaffirming 2023 financial guidance
  • Projecting 2024 global sales of $6.3 - $6.6 billion; constant currency growth of 8% - 10%
  • Estimating 2024 adjusted earnings per share of $2.70 - $2.80
  • Projecting 2024 TAVR sales of $4.0 - $4.3 billion; constant currency growth of 8% - 10%
  • Projecting 2024 TMTT sales of $280 - $320 million
  • Announcing intent to spin-off Critical Care at the end of 2024

“We expect our sharpened focus in structural heart to drive sustainable growth in the years to come as we embark on a new era of innovation to address large unmet patient needs,” said Bernard Zovighian, Edwards’ CEO. “I’m pleased with our performance in 2023 as we have reinforced our TAVR leadership position with new clinical evidence and reached an inflection point with new approved mitral and tricuspid technologies. In 2024, we are projecting strong sales growth and look forward to launching breakthrough technologies and progressing on multiple important clinical trials.”

https://www.businesswire.com/news/home/20231207786271/en/

Blinken 'Unwavering Support' For Guyana After Maduro Gives Energy Companies 3 Mos To Exit

To recap the rapidly evolving situation in Guyana...

  • Neighboring Venezuela now considers around three-quarters of the oil-rich nation theirs - with President Nicolás Maduro presenting a map on television that shows Guyana's Esequibo region  as under the jurisdiction of Caracas.

  • Maduro vowed to create a Venezuelan state known as Guyana Esequibo, for which he will grant Venezuelan citizenship to Guyanese residents there.

  • Maduro will has granted licenses and ordered state oil company PDVSA and state metal conglomerate CVG to drill for oil in the area.

  • A special military unit will be created for the territory.

  • Energy companies in the Esequibo region such as Exxon Mobil will "have three months to withdraw."

  • Guyanese President Irfaan Ali said he would report the matter to the UN Security Council, saying in a late-night televised address "The Guyana Defense Force is on high alert," adding "Venezuela has clearly declared itself an outlaw nation."

  • The UN Security Council will hold a closed-door meeting on the issue Friday, Bloomberg reports.

And last night, a Guyana army helicopter was reported missing near the border with Venezuela.

Now, the US State Department is involved.

"Secretary of State Antony J. Blinken spoke with Guyanese President Dr. Mohamed Irfaan Ali to reaffirm the United States’ unwavering support for Guyana’s sovereignty," said the State Department in a late Wednesday news release.

Department spokesman Matthew Miller also told reporters that the Biden administration supports a peaceful resolution.

A member of the Venezuelan National Assembly holds a map showing the Esequibo region as part of Venezuela this week. (Leonardo Fernandez Viloria/Reuters)

As we noted on Friday - why would Maduro do this nowwhen Caracas has for more than 200 years claimed rights over Esequibo, a vast swath of the territory Guyana? Simple: because as we said several days ago, it was only a few months ago that Maduro realized he has leverage over the US president of the "most powerful nation in the world" and get away with anything... even invading a sovereign nation.

Venezuela has long claimed the 61,000-square-mile region. Guyana has repeatedly rejected those claims, saying an 1899 international arbitration resolved the dispute. Venezuela has in turn questioned the validity of that ruling. Just last week, the International Court of Justice urged both sides to refrain from “any action which might aggravate or extend the dispute.” -WaPo

As Austin Bay writes at The Epoch Times, the region has a legacy of overlapping claims.

Spain claimed the Essequibo region was within the borders of Venezuela, but Great Britain and the Netherlands disputed that. Guyana was a British colony. In 1899 an arbitration tribunal in Paris, with the U.S. mediating, ruled that the region belonged to Britain.

Maduro portrays himself as a warrior seeking to right great historical wrongs. Well, playing drama king is easier than fixing a broken economy.

Maduro may be toying with a replay of 1982 when another shaky dictator thought a foreign war to distract his citizens was a dandy idea. The shaky dictator was Argentina’s Gen. Leopoldo Galtieri who proceeded to invade the Falkland Islands (Las Malvinas). He bet seizing the islands from the British “imperialists”—“recovering” them Galtieri called it—would unite Argentinians.

Britain, led by Margaret Thatcher, counterattacked, Argentina lost, and Galtieri’s regime collapsed.

All bark, no bite?

Interestingly, oil is nonplussed by the recent moves. Maybe because Venezuela won't be able to occupy the "new state?"

As WaPo further notes;

For now, Maduro’s rhetoric remains largely symbolic and political bluster. But his remarks have unsettled Guyana’s leader and attracted stern statements from the United States and Brazil urging Venezuela to refrain from using military force to enforce its territorial claim.

Guyanese President Irfaan Ali said in a CNN interview this week that Maduro’s declaration was a “desperate attempt by Venezuela to seize” his country’s territories. “We are taking every precautionary measure,” he said, including appeals to the United States, Brazil and the United Nations for diplomatic and defense support to deter a Venezuelan invasion. -WaPo

Exxon Mobil CEO Darren Woods was similarly nonplussed. In a Thursday CNBC interview, he suggested that Maduro is going to have a fight on his hands.

"There's concern that Venezuela is going to invade a certain part of the country," said host David Faber.

"I'd put it in the context of what's been happening for many, many years," Woods responded. "It is a matter between nation states... I'm not sure Guyana is standing on its own, to tell you the truth. We've all seen what happens when nations' sovereignties are challenged, and uniliteral action is taken. The world and the outside community is pretty sensitive to that, so my expectation is that there is more broad support in the international community to make sure that the right processes are followed to resolve this dispute."

Neighboring Brazil, meanwhile, has reinforced its northern border in the state of Roraima, adding armored vehicles and more troops, according to Reuters. 

https://www.zerohedge.com/geopolitical/blinken-conveys-unwavering-support-guyana-after-venezuelas-maduro-proclaims-esequibo

Altimmune open to partnerships, deals with drugmakers, says CEO

Weight-loss drug developer Altimmune is open to deals and collaborations with large drugmakers as it actively looks for partners to launch and develop its experimental obesity drug, CEO Vipin Garg told Reuters on Tuesday.

Upbeat mid-stage trial data for its obesity drug and recent multi-billion dollar deals by companies such as Roche and AstraZeneca to grab a slice of the fast-growing market have fueled hopes of Big Pharma scooping up the company.

Gaithersburg, Maryland-based Altimmune last week reported mid-stage trial data for pemvidutide that showed the drug helped reduce weight by 15.6% on average and continued weight loss at the end of treatment.

That data came just hours before Pfizer said it was dropping the development of a twice-daily pill for obesity after high rates of side effects like nausea and vomiting were seen in a separate trial.

"We are going to need a partner, global partner who cannot only help us develop it in phase three, but also launch the drug. So in fact ... we would welcome any interest in discussions with large pharma as we move this program forward," Garg said.

Altimmune is one of the half dozen companies racing to grab a slice of the lucrative market for obesity treatments estimated to be worth $100 billion by the end of the decade.

When asked if the company was open to selling itself if it received any interest, Garg said "we will evaluate each one of the discussions in situation as they develop and would make the decision which is the most favorable to shareholders."

The company, with a market value of about $250 million, had cash, cash equivalents and short-term investments of $141 million on Sept. 30.

Pemvidutide belongs to the same class of injected diabetes and obesity treatments as Novo Nordisk's Wegovy and Ozempic and Eli Lilly's Mounjaro and Zepbound, known as GLP-1 agonists, that are already bringing in billions of dollars.

https://finance.yahoo.com/news/altimmune-open-partnerships-deals-drugmakers-181914982.html

Axsome Virtual Investor Event

 Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, is hosting a virtual investor event and conference call today from 8 a.m. – 10 a.m. Eastern Time to provide an update on solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) and trace amine-associated receptor 1 (TAAR1) agonist.

At the event, invited physician thought leaders will discuss current and potential future indications. The Axsome senior leadership team will provide an overview of clinical development plans. The presenters will be available to answer questions at the end of the presentations. To access the event, please click here.

https://www.biospace.com/article/releases/axsome-therapeutics-hosts-solriamfetol-virtual-investor-event-with-expert-thought-leaders-today/

Capital Markets Day 2023 - Ipsen next phase of growth, new mid-term outlook

 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today holds its Capital Markets Day in London, U.K.

“Ipsen has made significant progress since our strategic roadmap was implemented three years ago and is today in a great spot,” commented David Loew, Chief Executive Officer, Ipsen. “Our business has been transformed, with the focus on Specialty Care now supported by a stronger pipeline and momentum from our growth platforms, as well as a robust balance sheet and an external-innovation strategy yielding compelling results.

Ipsen is now ready for its next phase of growth with several launches across multiple potential indications, providing more options for patients with high unmet medical needs. Our journey will be driven by the combination of the growth platforms, our new medicines and more external-innovation transactions to come. We will also continue to deliver on our ambitious sustainability objectives and roadmap with our Generation Ipsen program, based on Environment, Patients, People, and Governance.

As a significantly more diversified business across our three therapeutic areas and a geographically well-balanced company, we now have many sustainable and attractive growth opportunities across our portfolio and pipeline to create long-term value for all of our stakeholders and investors.”

Strategic outlook 2027

  • Several current and potential near-term launches, including Onivyde® (irinotecan), Bylvay® (odevixibat), elafibranor and Sohonos® (palovarotene), complemented by many pipeline milestones over the mid term
  • A strengthened and diversified business: a combination of seven anticipated and current medicines, each with expected peak sales of at least €500m
  • A global footprint and strong portfolio opportunity in the U.S.
  • External innovation: active business-development focus providing a platform to drive sustainable pipeline growth
  • ESG roadmap: ambitious Generation Ipsen goals for positive change to achieve net-zero emissions by 2045 and foster Ipsen’s culture centered on patients and society

Financial outlook

  • Total-sales average growth of at least 7% per year for the period 2023-27 and at constant exchange rates
  • Core operating margin in 2027 of at least 32% of total sales

This outlook excludes the impact of any potential additional late-stage1 external-innovation opportunities. The priority for capital allocation remains focused on external-innovation transactions across the three therapeutic areas while maintaining net debt, including contingent liabilities, below 2.0 times EBITDA.

Agenda
Today’s event will include the following participants:

  • David Loew, Chief Executive Officer
  • Aymeric Le Chatelier, Chief Financial Officer
  • Christelle Huguet, Head of R&D
  • Bartek Bednarz, Head of Global Product ​& Portfolio Strategy
  • Stewart Campbell, President, North America
  • Mari Scheiffele, President, International

Event details
Today’s event will start at 12.30pm GMT, 1.30pm CET in London, with attendance by invitation only. The event will be webcast live; all participants will have an opportunity to ask questions and can access webcast details here. A recording will be available on ipsen.com.

https://www.biospace.com/article/releases/capital-markets-day-2023-ipsen-outlines-next-phase-of-growth-and-transformation-and-provides-new-mid-term-outlook/

Sanofi Touts 12 Potential Blockbusters in Bid to Regain Investor Confidence

 During its R&D Day on Thursday, Sanofi spotlighted 12 investigational products which it contends could each surpass $1 billion in annual sales as it tries to win back the confidence of its investors.

The French pharma said it has nine pipeline assets under innovative medicines and vaccines that could each reach peak sales of $2.15 billion to $5.4 billion. These include tolebrutinib for multiple sclerosis, lunsekimig and rilzabrutinib for asthma and itepekimab for chronic obstructive pulmonary disease (COPD), as well as its vaccine candidates for acne, respiratory syncytial virus (RSV) in older adults and extraintestinal pathogenic Escherichia coli.

In addition, Sanofi anticipates that its three “pipeline-in-a-product” assets—amlitelimab, frexalimab and SAR441566, an orally available inhibitor of soluble TNFR1—each have peak sales potential of more than $5.4 billion.

Sanofi also announced it will invest more of its energy and focus into R&D, aiming for a 50% increase in Phase III trials between 2023 and 2025 to generate strong pipeline momentum. The pharma is also eyeing 25 mid- to late-stage readouts in the next two years, as well as nearly 20 regulatory filings.

Houman Ashrafian, head of R&D at Sanofi, in a statement called the size and blockbuster potential of the company’s pipeline “unprecedented” while highlighting the strategy to prioritize its first- and best-in-class assets to cement “our leadership in immunology and neuro-inflammation.”

Besides its projected blockbusters, Sanofi during Thursday’s investor event also touted the growth of its existing assets. Products that had recently been launched, as well as future pharma assets, could bring in nearly $11 billion in sales through 2030, according to the company.

Sanofi’s vaccines business is also expected to reach a similar revenue level through 2030, taking into account its recently launched RSV vaccine Beyfortus. The pharma also projects that Dupixent (dupilumab), one of its top-selling products, will continue its strong growth through 2023, particularly as it expands into other indications such as COPD.

CEO Paul Hudson said that taken together, the promise of its pipeline and the strength of its existing products in the market, will set the company up for “sustainable growth through 2030 and beyond.”

Sanofi’s optimistic note during its R&D event comes more than a month after the company spooked investors by abandoning its previous 2025 profit target. In a strategy brief released alongside its third-quarter earnings report in late October 2023, Sanofi said that it would no longer aim to reach a 32% operating profit margin for 2025.

Sanofi’s stock dropped 15% in reaction to the announcement, losing approximately $21 billion in market value. Since then, the company’s shares have underperformed compared to industry counterparts.

https://www.biospace.com/article/sanofi-touts-12-potential-blockbusters-in-bid-to-regain-investor-confidence/

Legacy Respiratory Illnesses On The Rise Across The US, CDC Warns

 by Jack Phillips via The Epoch Times,

The U.S. Centers for Disease Control and Prevention (CDC) issued an advisory about a recent increase in respiratory illnesses across the United States.

In an update posted on Dec. 1, the federal health agency said the country is seeing "elevated" activity of RSV, or respiratory syncytial virus, in young children. It also stated that influenza cases are increasing across most of the country and that COVID-19 has seen an increase in recent days, namely in the Midwest and Mid-Atlantic regions.

"Hospital bed occupancy for all patients, including within intensive care units, remains stable nationally; however, pediatric inpatient bed occupancy has been increasing," the agency said.

It added that emergency department visits and hospitalizations continue to increase for RSV, a virus that primarily affects young children and the elderly, and that positive tests, hospitalizations, and emergency department visits are increasing for influenza. It noted that for RSV, hospital rates remain elevated for younger children and are currently on the rise for older adults.

As for COVID-19, the CDC's data show that emergency visits were up 10.6 percent in the week ending Nov. 25 and hospitalizations were up 10 percent in the same time period. Historical trends indicate that the current increase appears to be far lower than previous "surges" since the pandemic started in 2020.

Data reported by the health agency from wastewater sampling and hospital emergency rooms show that Illinois, Indiana, Ohio, Wisconsin, Michigan, and Minnesota have seen the largest increases in COVID-19 cases in recent days.

Last week, the CDC estimated that about 1 in 10 new COVID-19 cases in the United States are due to the BA.2.86 variant—about triple what the agency estimated two weeks before that.

"In previous Nowcast updates, BA.2.86 was too uncommon to be shown separately and was grouped with other BA.2 strains," the CDC said in its update. But now, the variant stands at 8.8 percent through Nov. 25, or about three times the rate that was reported on Nov. 11.

The World Health Organization also recently said that BA.2.86 is a "variant of interest" amid the recent rise in cases.

Update on Pneumonia Cases

Following a surge of pediatric pneumonia cases in China and reports of a rise in childhood pneumonia incidents in Ohio, the CDC said that it's monitoring the situation.

"These reported increases do not appear to be due to a new virus or other pathogen but to several viral or bacterial causes that we expect to see during the respiratory illness season," the CDC bulletin said. "CDC will continue to work closely with our state and local public health partners to maintain strong situational awareness and will provide updates, as needed."

The federal agency said on Dec. 1 that pneumonia “rates are roughly in line with previous years for patients aged 0–1 years and 2–4 years nationally.” For children between the ages of 5 and 17, the “percent of emergency department visits diagnosed with pneumonia among patients” is “similar to pre-pandemic years, and it remains lower than that seen among younger children,” the CDC said.

“Diagnosis of pneumonia in children, along with other respiratory illnesses, increases every year in the fall and winter months,” the CDC said.

“The weekly percent of emergency department visits with diagnosed pneumonia is largely consistent with previous years for children aged 0 to 4 years, with slight increases above typical levels for children aged 5 to 17 years, but still consistent with pre-pandemic years.”

The CDC bulletin said the agency is monitoring cases in China and Europe and that it is “working closely” with state, local, and international health officials. “Based on laboratory findings, these increases in pediatric pneumonia do not appear to be caused by a new virus or other pathogen,” it added. “Instead, these increases are likely caused by viruses and bacteria we expect to see during the respiratory illness season.”

It comes after health authorities in Ohio’s Warren County confirmed 142 cases of pediatric pneumonia since August, noting that it's above average for the county and meets Ohio's definition of an outbreak.

But the officials said they believe it's not a "novel" or "new" respiratory infection but a "large uptick in the number of pneumonia cases normally seen at one time."

Parents take their children to see a doctor at the pediatric emergency department of a hospital in Shanghai on Nov. 14, 2023. (CFOTO/Future Publishing via Getty Images)

Reports also have indicated that cases of childhood pneumonia have also risen in Massachusetts, according to local media outlets. However, few details were provided.

Chinese Communist Party officials, meanwhile, have said the rise in childhood pneumonia cases can be attributed to RSV, COVID-19, influenza, and Mycoplasma pneumoniae, a type of bacteria that can cause “walking pneumonia” or "white lung."