Latest news with #Vyndamax
RTÉ News
29-04-2025
- Business
- RTÉ News
Pfizer misses revenue expectations, sees $1.7 billion more in cost savings
Pfizer said today it would generate $1.7 billion more in savings from cost-cutting to its manufacturing and research operations and reported lower first-quarter revenue due to declining sales of its Paxlovid Covid-19 treatment. The company reaffirmed its full-year forecast and announced measures to mitigate the impact of potential tariffs on pharmaceuticals by the Trump administration, including possibly shifting some production to the US. While the rates and timing of tariffs on the pharma sector are unclear, analysts expect that companies will have to absorb any near-term costs if they are imposed. Washington has launched an investigation into the industry, laying the groundwork for possible levies. Pfizer had an Irish workforce of about 5,000 across four locations based in Cork, Dublin and Kildare. Last month, Pfizer CEO Albert Bourla said the company has the capability to move overseas manufacturing to its existing US plants "if something happens." Pfizer has 10 manufacturing sites and two distribution centers in the US, employing nearly 10,000 people. "While we continue to engage and plan for contingencies, we're focusing day-to-day on what we can do to move our business forward," Bourla said in prepared remarks today. Potential tariffs could add to existing pressure for Pfizer. Investors have been pushing the company to bring new drugs to market that could make up for potential revenue lost from some top-selling medicines nearing the end of patent protection. Even the drugs that outperformed Wall Street expectations this quarter face headwinds. Sales of its heart disease drug, sold under the brand names Vyndaqel and Vyndamax, were $1.49 billion, above estimates of $1.29 billion. But the company said it is already seeing the impact of new competition, which it expects to continue through the year. Pfizer's vaccine business could also face greater regulatory scrutiny under the new Health Secretary Robert F Kennedy Jr, a longtime vaccine skeptic. Covid vaccine Comirnaty, which Pfizer makes with German partner BioNTech, brought in sales of $565m. Analysts were expecting sales of $331.7m for the shot. But sales of Covid antiviral Paxlovid were $491m, well short of analysts' already diminished expectations of $794.3m, according to LSEG data. Analysts had significantly cut their expectations for the two-drug treatment in recent weeks due to a relatively small winter wave of Covid-19 in the US. The company provided an update on its cost-cutting programmes, saying it now expects about $7.7 billion in savings by the end of 2027. On an adjusted basis, Pfizer earned 92 cents per share in the first quarter, compared with analysts' expectations of 66 cents per share, helped by cost cuts and a lower tax rate. Despite the earnings beat, Pfizer is still forecasting a full-year adjusted profit of $2.80 to $3 per share on revenue of $61 billion to $64 billion .
Yahoo
21-03-2025
- Health
- Yahoo
Alnylam challenges Pfizer and BridgeBio with FDA nod for ATTR-CM drug
Alnylam Pharmaceutical's has secured US Food and Drug Administration (FDA) approval for Amvuttra (vutrisiran), expanding its use to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and life-threatening heart disease. This milestone makes Amvuttra the first medication in the US approved for both ATTR-CM and hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), positioning Alnylam as a direct competitor to Pfizer and BridgeBio Pharma in the growing ATTR-CM market. In ATTR-CM, transthyretin (TTR) proteins accumulate in the heart, leading to a stiffening of the heart muscle, reduced blood flow, and an increased risk of heart failure. The ATTR-CM market is currently dominated by Pfizer's Vyndaqel/Vyndamax (tafamidis) and BridgeBio's recently approved Attruby (acoramidis). Unlike these medications, which are TTR stabilisers, Amvuttra is an RNA interference (RNAi) therapy that reduces the production of both wild-type and mutant TTR proteins. By decreasing TTR protein expression, the drug aims to prevent the buildup of amyloid deposits in the heart. The FDA's decision was supported by data from the Phase III HELIOS-B trial (NCT04153149), which evaluated Amvuttra's impact on overall survival and cardiovascular events. The study showed a statistically significant reduction in composite of all-cause mortality and recurrent cardiovascular events. In the trial, the monotherapy group demonstrated a 33% reduction in this composite endpoint, while the overall study population showed a 28% reduction. One notable addition is the drug's impact on the need for medical visits, which could provide Amvuttra a commercial advantage. The drug's label states that Amvuttra reduces the likelihood of hospitalisation, death, and urgent visits for heart contrast, Pfizer's Vyndaqel/Vyndamax and BridgeBio's Attruby do not have language specifying a reduction in urgent heart failure visits. In the announcement accompanying the approval, Alnylam's CEO Yvonne Greenstreet said: 'The FDA approval of Amvuttra for ATTR-CM marks a pivotal advancement for patients, providing a new and clinically differentiated treatment option that has been shown to improve outcomes, including cardiovascular mortality, and reduce progression for those living with this devastating disease.' The ATTRv-PN market has seen significant revenue growth in recent years. Amvuttra generated $970m in 2024, as per the company financials. Amvuttra is expected to make $4.4bn in projected sales by 2030, according to GlobalData's Pharma Intelligence Center. In the same year, BridgeBio's Attruby is forecast to pull in $1.97bn, while Pfizer's Vyndaqel/Vyndamax is linked to a similar $1.94bn revenue forecast after its last outstanding exclusivity expires in 2026. GlobalData is the parent company of Pharmaceutical Technology. "Alnylam challenges Pfizer and BridgeBio with FDA nod for ATTR-CM drug" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
21-03-2025
- Business
- Yahoo
Alnylam Heart Drug Approval Sets Up Challenge With Pfizer
(Bloomberg) -- Alnylam Pharmaceuticals Inc. won expanded US approval for a heart drug that could be the biggest boon yet for the 23-year-old biotech — if it can beat out stiff competition from the likes of Pfizer Inc. New York Subway Ditches MetroCard After 32 Years for Tap-And-Go LA Faces $1 Billion Budget Hole, Warns of Thousands of Layoffs Despite Cost-Cutting Moves, Trump Plans to Remake DC in His Style Amtrak CEO Departs Amid Threats of a Transit Funding Pullback Chicago Transit Faces 'Doomsday Scenario,' Regional Agency Says Alnylam's Amvuttra was approved to treat transthyretin amyloid cardiomyopathy, or ATTR-CM, the company said Thursday in a statement. The shares rose as much as 12% in Friday trading in New York, the most intraday since August 2024. They had gained more than two-thirds over the past year through Thursday's close as investors anticipated the clearance. Amvuttra will now be available to treat ATTR-CM, a progressive disease that occurs when a protein becomes misshapen and builds up in the heart. Some 5,000 to 7,000 people each year in the US are diagnosed with the condition, but drugmakers say it's still largely undetected, creating opportunities for multiple competitors. Some 80% of those with this condition don't even know they have it, Alnylam has said. What Bloomberg Intelligence Says: FDA approval of a second cardiomyopathy indication for Alnylam's Amvuttra, maintained at the current list price, puts the company on track to meet 2025 guidance and may lift product sales to $5 billion by 2030... Amvuttra's broad label includes mortality, hospitalizations and urgent heart failure, differentiating it from Pfizer and BridgeBio's stabilizers. — Bloomberg Intelligence analysts Ann-Hunter Van Kirk and Jack Maltby. Read the research here. The $33 billion biotech faces a big test: Pfizer's Vyndamax and Vyndaqel dominate the ATTR-CM market with sales of about $5 billion a year. BridgeBio Pharma Inc. also won approval in November for another competitor drug, Attruby. Three Drugs Alnylam, which already sells the drug to treat a related nerve condition, decided to maintain the current list of about $470,000 a year — far above rivals. Pfizer's drug is $270,000 a year and BridgeBio's is $225,000 a year, according to an analyst at BMO Capital Markets. Alnylam's label says its treatment reduces death, hospitalizations and 'urgent heart failure visits,' going further than the approved claims for the other two. 'We believe the urgent heart failure language could give Alnylam an advantage,' Ritu Baral, an analyst at TD Cowen, said, 'especially for front-line use.' Prior to Alnylam's approval, Baral had said that patients who started on Pfizer's drug could eventually get switched to Alnylam's as their heart disease worsened. The three drugs haven't been tested against one another. Both Pfizer and BridgeBio's come in pill form, while Alnylam's is a shot. That means Alnylam will need to find patients — or their caregivers — willing to drive to a health-care facility for injections every three months. At the moment, analysts don't think that will be a major impediment: Projections are for Alnylam's drug to generate $4.3 billion in sales by 2029, largely fueled by treating the heart condition, compared with $3.2 billion for Pfizer and $1.3 billion for BridgeBio. New Patients Alnylam will initially focus on the US patients who are newly diagnosed with the heart condition each year, Chief Executive Officer Yvonne Greenstreet said in an interview. She doesn't think it will take long to find new patients and that some doctors might even prescribe a combination of Pfizer and Alnylam's drugs. 'I believe we will see physicians begin to switch patients who are progressing,' she said. While doctors view Alnylam's drug as a good option for sicker patients, the growth in the market is actually coming from healthier patients who are being diagnosed earlier and may be more likely to be prescribed a pill at first. Neil Kumar, chief executive officer of BridgeBio, said his drug's launch so far — more than 1,000 prescriptions in just a few months — has come mostly from newly diagnosed patients. Nothing to Chance 'It's not so much that we're taking patients from Pfizer,' he said. 'We're collectively finding more and more patients.' For its part, Pfizer's management has expressed confidence that doctors wouldn't take patients off its drug. 'When you have a medicine that's working very well and the physicians know it, they will never switch a patient to something different,' Chief Executive Officer Albert Bourla said at a recent investor conference, before Alnylam's drug was approved. Still, Pfizer is leaving nothing to chance. In recent weeks, about 40 members of Pfizer's sales force arrived in Boston for a training session. Over two days, doctors at Harvard-affiliated Brigham and Women's Hospital, who are leaders in the field, explained the causes of the heart disease and new drugs that could challenge Pfizer's business. Mani Foroohar, an analyst at Leerink Partners, said Alnylam was likely to face more resistance from insurers than its competitors given its higher price and he expects the company will struggle to displace Pfizer. 'The expectations and challenges for Alnylam are much greater than the others,' Foroohar said in an interview. 'It is very difficult to displace an incumbent like Pfizer that has an extremely safe product that is the established standard of care.' --With assistance from Madison Muller. (Updates shares in the second paragraph and with analyst comment in final two paragraphs.) 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