Entering its third year, the CWENCH All Canadian Volleyball Games is Canada's premier girls' volleyball event. Set to take the national stage with live streaming on CBC Gem, the event features 60 of Canada's top-performing girls' volleyball players in each of the 17U and 16U age categories. As a proudly Canadian house of brands, this sponsorship is part of Cizzle Brands' ongoing initiatives to support youth sports in Canada.
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Cizzle Brands: A Sports Nutrition Company Leading the Next Wave in Health and Wellness
Cizzle Brands (CBOE:CZZL) is a sports nutrition company driving transformative change within the health and wellness industry. The company commenced trading on CBOE Canada on December 30, 2024, marking a significant milestone in its growth trajectory.
Cizzle Brands leverages deep-rooted connections in the professional sports sector by collaborating with elite athletes to trial and refine health and wellness products to ensure optimal performance, while still being appropriate for athletes of all ages. The CWENCH Hydration products underscore its commitment to premium-quality offerings.
Through Cizzle's broad-based grassroots programs, more than 12,000 youth athletes across North America are sponsored by Cizzle, featuring CWENCH logos on their helmets, jerseys and water bottles.
Company Highlights
- Cizzle is dedicated to driving transformative change in the health and wellness industry by offering premium, clean-label sports nutrition products.
- The companycollaborates with elite athletes and professional sports teams to trial and refine its product offerings, ensuring optimal performance.
- Its flagship brand - CWENCH Hydration - is one of the fastest-growing hydration products in the world, with endorsements from top athletes like Nathan MacKinnon and Andrew Wiggins, as well as up-and-coming superstars Gavin McKenna and Chloe Primerano. Wiggins is also a significant investor in the business.
- The company generated $5 million dollars in net sales in its first 6 months of operations with a gross margin of 60% and is projected to generate net sales of $13 to $15 million in its first fiscal year.
- Driven by a well-defined growth strategy, the company is expanding distribution through major retailers, international market entry, and potential strategic acquisitions to drive revenue growth and market penetration.
- Cizzle’s executive team has extensive experience in CPG, brand building and public markets, including former executives of BioSteel and DreamWater.
This Cizzle Brand Corporation profile is part of a paid investor education campaign.*
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Cizzle Brands Corporation
Investor Insight
Through its innovative line of diversified products, Cizzle Brands Corporation is well-positioned to capitalize on the global MAHA (Make America Healthy Again) movement sweeping the nation. This includes increased consumer demand for low-sugar, high-quality functional foods and beverages, nutritional supplements and sustainable packaging.
Overview
Cizzle Brands Corporation (CBOE:CZZL) is a dynamic sports nutrition company dedicated to driving transformative change within the health and wellness industry. Cizzle commenced trading on CBOE Canada on December 30, 2024, marking a significant milestone in its growth trajectory.
Leveraging deep-rooted connections in the professional sports sector, the company collaborates with elite athletes to trial and refine its health and wellness products to ensure optimal performance, while still being appropriate for athletes of all ages. Its CWENCH Hydration line of products underscores its commitment to premium-quality offerings.
Cizzle maintains a global R&D innovation team involving top nutritionists, dieticians and strength coaches to develop cutting-edge products and bring them to market. This approach ensures that each product is designed to meet the highest standards of performance and wellness.
As consumers become increasingly health-conscious, there is a significant shift toward products that offer clean ingredients and functional benefits, such as hydration, recovery and natural energy. The functional beverage market size is estimated to reach US$229.75 billion in 2025, and is expected to climb to US$329.68 billion by 2030, at a CAGR of 7.49 percent. This growth is driven by rising disposable incomes, heightened awareness of physical well-being, and the growing popularity of fitness lifestyles.
CWENCH Hydration is already recognized as one of the fastest-growing hydration products in the world. In its first 6 months of operation, it generated net sales of $5 million with gross margins of 60 percent and is on track to achieve $13 to $15 million in sales in its first fiscal year. Since its launch, CWENCH has been endorsed by elite athletes and adopted by professional sports teams across North America.
Cizzle is led by a seasoned executive team with extensive experience in consumer-packaged goods, brand building and public markets.
Market Differentiator
Cizzle differentiates itself by developing aspirational products consumed by aspirational people that drive awareness in key markets. Through its broad-based grassroots programs, over 12,000 youth athletes across North America are sponsored by Cizzle, featuring CWENCH logos on their helmets, jerseys and water bottles.
As Cizzle's products develop loyal followings in key markets, other consumer groups are pulled into engagement with its brands. With so many youth athletes making CWENCH Hydration their preferred sports drinks, pantry-loading parents who support sugar-free, all-natural alternatives for their kids become advocates - and ultimately consumers of CWENCH.
Cizzle's commitment to sustainability is another key differentiator. By adopting eco-friendly packaging solutions such as Tetra Pak, the company significantly reduces its environmental impact compared to traditional materials. It also limits the amount of plastics that touch Cizzle's products, minimizing the risk of exposure to microplastics. This move not only addresses growing consumer demand for healthy and sustainable products but also reinforces Cizzle's brand values.
Well-defined Growth Strategy
Too often emerging CPG companies grow faster than their capitalization and infrastructure can support, leading many to flame out or incur dilutive financings. Cizzle is focused on maximizing shareholder value through sustainable revenue growth, strong gross margins, profitability and strategic acquisitions.
As brand awareness grows, and velocity through current retailers accelerates, the company plans to increase sales by expanding distribution channels through major Canadian retailers to boost market penetration and drive product visibility in high-traffic retail locations.
At the same time, Cizzle is building brand awareness and driving sales in select US and European markets where it can drive velocity while maintaining gross margins.
Product innovation is a key pillar of Cizzle’s growth strategy. The company has or is preparing to launch multiple new products across various consumer channels in 2025, including CWENCH Protein and Spoken Nutrition, among others. Each product launch will be supported by targeted marketing campaigns, in-store activations, and influencer partnerships to create brand awareness and drive consumer demand. Furthermore, Cizzle is actively pursuing opportunities to acquire young, innovative companies in the health and wellness sector that align with its mission, thus accelerating portfolio expansion.
Company Highlights
- Cizzle is dedicated to driving transformative change in the health and wellness industry by offering premium, clean-label sports nutrition products.
- The companycollaborates with elite athletes and professional sports teams to trial and refine its product offerings, ensuring optimal performance.
- Its flagship brand - CWENCH Hydration - is one of the fastest-growing hydration products in the world, with endorsements from top athletes like Nathan MacKinnon and Andrew Wiggins, as well as up-and-coming superstars Gavin McKenna and Chloe Primerano. Wiggins is also a significant investor in the business.
- The company generated $5 million dollars in net sales in its first 6 months of operations with a gross margin of 60 percent and is projected to generate net sales of $13 to $15 million in its first fiscal year.
- Driven by a well-defined growth strategy, the company is expanding distribution through major retailers, international market entry, and potential strategic acquisitions to drive revenue growth and market penetration.
- Cizzle’s executive team has extensive experience in CPG, brand building and public markets, including former executives of BioSteel and DreamWater.
Key Products & Brands
CWENCH Hydration
Cizzle’s flagship product, CWENCH Hydration, is a sugar-free, all-natural sports drink formulated with 6+ essential electrolytes and only 10 calories per serving. It stands out with eco-friendly Tetra Pak packaging and no preservatives. Endorsed by high-profile athletes like Nathan MacKinnon, Andrew Wiggins, Gavin McKenna and Chloe Primerano, CWENCH has gained traction in major retail outlets across Canada and select US markets. Its rapid market adoption has solidified it as one of the fastest-growing products in its category.
CWENCH Protein
CWENCH Protein, a post-workout recovery solution, comes in both whey and vegan options. Available in chocolate and vanilla flavors, it leverages the existing CWENCH distribution network to ensure broad reach.
Spoken Nutrition
Spoken Nutrition is a premium supplement line designed to enhance athletic performance and overall wellness by unlocking the expertise behind the world's best athletes. Developed in collaboration with elite trainers and scientists to make products that work, the range includes 14 SKUs targeting various health benefits. A standout product, Sleep Builder, has received significant acclaim for its positive impact on recovery and sleep quality. Spoken Nutrition primarily targets direct-to-consumer channels, elite training facilities and partnerships with celebrity trainers.
Management Team
John Celenza – Chairman & Chief Executive Officer
John Celenza co-founded BioSteel Sports, where he played a pivotal role in scaling the business within the consumer goods sector. His expertise in brand development and market expansion is instrumental in guiding Cizzle's strategic direction.
Tucker Wright – President & Chief Revenue Officer
Tucker Wright brings a wealth of experience from leadership roles at DreamWater and BioSteel. His proficiency in revenue generation and market strategy supports Cizzle's growth initiatives and market penetration efforts.
Anthony Mila – Chief Marketing Officer
Anthony Mila, formerly CEO of HighRise Marketing and CMO of BioSteel, has a strong background in marketing within the health and wellness industry. His strategic vision drives Cizzle's brand positioning and consumer engagement.
Blane Kaufman – Chief Operating Officer
Blane Kaufman previously led operations at BioSteel, bringing extensive operational expertise to Cizzle. His focus on operational efficiency ensures the seamless execution of the company's strategic plans.
Steven Tschirhart – Chief Financial Officer
Steven Tschirhart, who spent over a decade at Kraft Heinz ultimately as Head of Coffee Canada, oversees the financial operations of Cizzle, ensuring fiscal responsibility and strategic financial planning to support the company's growth objectives.
Andy O'Brien – Chief Performance Officer & Director
Andy O’Brien is a legendary sports performance coach who has collaborated with world-class athletes and elite trainers. His expertise contributes to the development of Cizzle's performance-oriented products.
Cizzle Brands Corporation Becomes Title Sponsor of the CWENCH All Canadian Volleyball Games
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTC: CZZLF) (Frankfurt: 8YF) ( the "Company" or "Cizzle Brands") is pleased to announce that its flagship brand CWENCH Hydration™ has become the title sponsor of the CWENCH All Canadian Volleyball Games (the " Event "), Canada's premier annual girls' volleyball event, which is taking place this year at the Athlete Institute in Orangeville, Ontario on Sunday, June 8, 2025.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250206101209/en/

CWENCH Hydration has become the title sponsor for the All Canadian Volleyball Games, part of Cizzle Brands' commitment to supporting Canadian youth sports and athletes. (Graphic: Business Wire)
Started in 2023, the All Canadian Volleyball Games has become a highly recognized and exclusive event for girls' volleyball, which received over 66 million views and impressions in its first year. As an invitation-only event for Canada's most elite girls' volleyball players, many of the participants in previous All Canadian Volleyball Games have gone on to be recruited by post-secondary institutions on athletic scholarships.
The Event was founded by Gerry Dee , a Canadian actor, director, and comedian who has hosted the televised Family Feud Canada game show since 2019. Gerry Dee's objective with the Event was to bolster visibility of girls' volleyball, a sport that he became passionate about as a father of two daughters who play the sport competitively. Cizzle Brands' Founder, Chairman, and Chief Executive Officer John Celenza also played a supporting role in the Event's launch in 2023.
In September 2024, the Associated Press reported that the popularity of girls' volleyball was at an all-time high with participation increasing every year since at least 1980 (excluding the 2020-21 pandemic year).
Under the five-year sponsorship agreement, Cizzle Brands will benefit from high-visibility placement of the CWENCH Hydration™ name and logo (on the volleyball court, arena signage, player jerseys, etc.) as part of the All Canadian Volleyball Games' marketing and recruitment initiatives, preliminary events, and the annual main event which will be live-broadcasted nationally on CBC Gem. The sponsorship agreement also provides for product placement of CWENCH Hydration™ as the sports drink provided to players and coaches/trainers, in addition to Spoken Nutrition nutraceutical supplements being made available for participants to use.
A replay of the 2024 Event can be viewed on YouTube through the following link: https://www.youtube.com/watch?v=rCJq4wNTP7s
Players who have competed in previous years include the following (along with the post-secondary institution at which they have committed or currently play), many of whom will return for the 2025 CWENCH All Canadian Volleyball Games:
Sydney Bell (Buffalo) | Maëli Cormier (Oregon State) | Remy Catojo (High Point) | Aly Donoghue (Duke) |
Lauren Edlund (Northern Arizona) | Jasmine Ellison (Oklahoma) | Brooke Fermaniuk (Northern Arizona) | Alyssa Flack (Oklahoma) |
Nikola Gamlin (Sacramento State) | Ashlyn Gent (Old Dominion) | Sara Gray (North Dakota) | Brooklyn Grobb-Prins (UTSA) |
Ella Hope (Arizona State) | Logan King (Long Beach) | Calinda Kok (USC) | Elodie Lalonde (High Point) |
Arianna Lonardi (Long Beach) | Emerson Matthews (Buffalo) | Avaya Maya (Oklahoma) | Sydney McDermott (Kansas State) |
Ana Nastase (Southern Methodist) | Ofure Odigie (Stanford) | Dumebi Okoye (Colorado) | Olivia Pasternak (Connecticut) |
Ella Piskorz (Pepperdine) | Trinity Schadd Ceres (Wisconsin) | Carmen Waye (Michigan State) | Sofia Zabjek (Colorado State) |
Grace Blaskovits (St. Mary's) | Chloe Bradley (UBC) | Emma Buntic (Western) | Jasmine Cormier (Calgary) |
Paisley Dickie (Trinity Western) | Tayana Dmitruk (Trinity Western) | Sienna Driedger (Trinity Western) | Athalia Duong (Western) |
Gabi Flaman (Saskatchewan) | Makenna Gillick (Trent) | Faith Hughes (Humber) | Sol Henson (UBC) |
Delfina Henson (UBC) | Trinity Lam (York) | Eva Lin (McMaster) | Julia Liu (Toronto) |
Julia Martens (Manitoba) | Faith Obasi (Mount Royal) | Raven Ogbodu (Mount Royal) | Abby Wasutyk (UBC) |
Toni Wilson (Western) | Jennifer Wu (McMaster) |
Cizzle Brands' sponsorship of the Event is the continuation of the Company's commitment to Canada and the nation's emerging athletes. In addition to the CWENCH All Canadian Volleyball Games, Cizzle Brands is a sponsor of The Quebec International Pee-Wee Hockey Tournament, The CWENCH Next Gen Series, the BCHL, the KLEVR Network, Play Hockey, The Hockey Super League, HPL Hockey, The Brick Invitational Hockey Tournament and hundreds of youth hockey teams across the country.
Cizzle Brands Founder, Chairman, and Chief Executive Officer, John Celenza commented, "Having been personally involved in the launch of the first All Canadian Volleyball Games back in 2023, I am particularly thrilled that CWENCH Hydration™ is becoming the title sponsor of the Event. Supporting Canadian youth sports across the country is core to who we are at Cizzle Brands and is more important than ever these days. Not only is it the right thing to do as proud Canadians, the fact is that the communities that we support return the investment in spades, giving patronage to our brands with incredible loyalty. We look forward to working with Gerry and supporting the players for the next five years, during which we foresee many opportunities to make a positive impact for girls' volleyball across Canada."
Regarding Cizzle Brands' sponsorship of the All Canadian Volleyball Games, Gerry Dee commented, "It is incredible to be working with John and his team again to support Canadian sports and girls' volleyball. This is a sport that I have grown to love because of my daughters Aly and Faith, whose participation in competitive volleyball has proven to play a key role in their journey into adulthood. As the CWENCH All Canadian Volleyball Games enters its third year, we could not be more excited to be working with Cizzle Brands as a sponsor and making CWENCH Hydration™ a valued part of the Event by providing an all-natural, sugar-free hydration option to Canada's most promising emerging volleyball stars."
Tickets for the 2025 CWENCH All Canadian Volleyball Games taking place on June 8, 2025 will be available for purchase at https://www.allcanadianvolleyball.com/ .
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH Hydration, please visit: https://cwenchhydration.ca/
For more information about the CWENCH All Canadian Volleyball Games, please visit: https://www.allcanadianvolleyball.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250206101209/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
CWENCH Hydration Strengthens its Retail Footprint in Western Canada with Placement in 75 Locations of London Drugs
Founded in 1945, London Drugs is a major retail pharmacy chain with 79 locations in the Western Canadian provinces. Starting in January, three flavours of CWENCH Hydration™ will be available in 75 locations of London Drugs, as well as through its online store.
Cizzle Brands Corporation (Cboe Canada: CZZL) (OTC: CZZLF) (Frankfurt: 8YF) ( the "Company or "Cizzle Brands") , is pleased to announce that its flagship product CWENCH Hydration™ is being placed in nearly all locations of London Drugs , a retail pharmacy chain operating primarily in the province of British Columbia, in addition to Alberta, Saskatchewan, and Manitoba.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250204688567/en/

As of January 2025, CWENCH Hydration™ is now available for purchase in nearly all locations of London Drugs, a major retail pharmacy chain in Western Canada (Photo: Business Wire)
London Drugs placed an initial purchase order to stock CWENCH Hydration™ in 75 out of its 79 stores with three flavour SKUs ( Blue Raspberry , Berry Crush, and Rainbow Swirl ), which was recently fulfilled by Cizzle Brands. The product is currently being sold in stores and is also available to purchase through the London Drugs online store for home delivery or in-store pickup.
Starting in February 2025, London Drugs will be running in-store promotions for CWENCH Hydration™. Cizzle Brands' sales and marketing personnel will coordinate directly with London Drugs' merchandising and store operations teams to drive visibility/awareness in line with broader promotional efforts and campaigns for the CWENCH brand.
Cizzle Brands Founder, Chairman, and Chief Executive Officer, John Celenza commented "Since launching in May of 2024, the CWENCH Hydration™ brand has seen incredible sales velocity with its initial retail accounts, which were strategically selected to get the product into the market in a way that is conducive to driving recurring sales and brand awareness. After establishing a sustained level of demand in key markets, we hand-picked London Drugs as an additional experienced and reputable growth partner to carry CWENCH in the British Columbia market. We are excited to be working with London Drugs as part of our commercialization journey, as we begin strategically expanding the brand's footprint with larger chain retailer accounts."
Ken Li, who is a Buyer in the General Merchandise category for London Drugs, commented "With its impressive early-stage success across North America, we are thrilled to be adding CWENCH Hydration™ to London Drugs' in-store and online product selections. Consumers of all ages are displaying a sustained interest in better options for staying hydrated, and so we are pleased to have the opportunity to make CWENCH Hydration™ available to our customer base across Western Canada. This month, we will begin with in-store promotions of CWENCH Hydration™, which we expect to be a major catalyst for raising awareness and driving conversions into purchases."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250204688567/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Cizzle Brands Corporation and Van Houtte Coffee Services Announce Entry into an Agreement for Distribution of Cizzle Brands' Products Across Canada
Cizzle Brands Corporation (Cboe Canada: CZZL) (the " Company " or " Cizzle Brands ") and Van Houtte Coffee Services (" VHCS "), a subsidiary of Keurig Canada Inc., doing business as Keurig Dr Pepper Canada, are pleased to announce that they have entered into a distribution agreement (the " Agreement ") pursuant to which VHCS will distribute Cizzle Brands' product lineup across Canada. As part of its agreement, VHCS will also be taking over distributorship for many of the Cizzle Brands' existing accounts in various categories including sporting goods retailers and stadiums.
"This partnership enables us to provide additional high-quality offerings that align with the growing needs of organizations across the country. We look forward to working together to continue expanding our product range and supporting Cizzle Brands' growth," said Jon Theisen, General Manager of Van Houtte Coffee Services.
Cizzle Brands is at the forefront of athlete-inspired sports nutrition, renowned for developing functional products like CWENCH Hydration™ that cater to active, health-conscious consumers.
Cizzle Brands Founder, Chairman, and Chief Executive Officer John Celenza commented, "Partnering with Van Houtte Coffee Services marks a significant milestone for Cizzle Brands as we continue to grow and expand our presence. With VHCS's vast distribution network and deep market penetration across Canada, we are excited to introduce our products to a broader audience, further strengthening our brand and driving long-term success."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport ® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH, please visit: https://www.cwenchhydration.com
About Van Houtte Coffee Services
Van Houtte Coffee Services Inc. is the leading provider of coffee services in Canada for the commercial clientele. They offer beverage programs adapted to every industry sector, with maintenance services and hassle-free delivery, combined with a wide range of coffee, tea, and other beverages of superior quality offered in a variety of formats and with reliable, high-performance multifunction brewing systems, including Keurig ® one cup at a time coffee-makers and bean-to-cup systems. Their mission is to offer local, regional and national enterprises, as well as foodservice providers, diversified solutions that meet their needs. Their national coverage and local roots allow them to serve hotels, universities and colleges, healthcare institutions, restaurants, service stations, and convenience stores with all the advantages of a large company and the personalized service of a small provider.
With 30 service branches strategically located across the country, they serve over a million cups of coffee a day through their 30,000 corporate clients. Van Houtte Coffee Services are a subsidiary of Keurig Canada Inc., doing business under the name Keurig Dr Pepper Canada, whose head office and roasting plant are located in Montréal.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza - Founder, Chairman, and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250129057472/en/
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Cizzle Brands Unveils its Team of Ambassadors to Accelerate North American Commercialization Initiatives
Through a curated team of the world's most experienced and qualified dieticians, performance coaches, scientists, and medical professionals who are subject matter experts in their respective fields, Cizzle Brands is building a house of brands in the sports nutrition industry that serves the world's most elite athletes and leverages that knowledge to make products for everyday people looking to live healthy, active lifestyles. Cizzle Brands' ambassadors will not only assist in product development and formulation but they will also help to expand knowledge and adoption of Cizzle Brands' products around the world.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , today unveiled the lineup of subject matter experts ("SMEs") who will underpin the Company's product commercialization efforts for 2025 and drive awareness for its lineup of sports nutrition brands. The Company's roster of SMEs includes some of the world's most experienced and respected strength and performance coaches, dieticians, and medical professionals.
In its Market Introduction press release, Cizzle Brands detailed the performance of CWENCH Hydration™ following its launch in late May of 2024, following which more than one million ready-to-drink units of the beverage have been sold across North America. On January 14, 2025 , Cizzle Brands also announced the launch of Spoken Nutrition , a brand of athlete-grade supplements and nutraceuticals primarily sold through trainers and coaches.
As Cizzle Brands continues to commercialize these product offerings alongside upcoming additional brands to be launched, the Company expects its SMEs to play a key role in product innovation and generating broad-scale awareness in product categories that tend to have very nuanced and knowledge-driven exploration journeys prior to trial or purchase.
Cizzle Brands' current roster of SMEs includes:
Carl Bergstrom: Carl is the Director of Performance for Stephen Curry and former Performance Coach of the Golden State Warriors, White Caps FC, and Canada Soccer.
Dr. Matt Frakes: Dr. Matt Frakes, Assistant Athletic Director of Sports Nutrition at LSU, has prior experience at Notre Dame and the University of Louisville, and holds a PhD in Nutrition and Hospitality Management from the University of Mississippi, along with a Master's and Bachelor's in Food and Nutrition.
Todd Herman: Todd Herman, with over 28 years of experience coaching elite athletes, entrepreneurs, and business teams on inner game, strategy, and performance, is a leading expert on mental game and peak performance, authoring books, building programs, and creating tools to help ambitious individuals succeed across various fields. Todd is the renowned performance coach who helped Kobe Bryant create the Black Mamba.
Ben Prentiss: Ben Prentiss, a strength coach with over 20 years of experience, has worked with professional and Olympic hockey players, including Stanley Cup winners and NHL All-Stars, and currently serves as a Strength and Conditioning Consultant for the New York Rangers.
Carley Patterson: Carley Patterson is a Registered Holistic Nutritionist with a Bachelor of Applied Science, with an expertise in providing nutritional advice to families with young athletes living a competitive and active lifestyle.
Matt Price: Matt Price is the Director of Strength & Performance Science for the Los Angeles Kings and was formerly the lead strength and conditioning coach for Alpine Canada.
Brianne Brown: Brianne Brown, Head of Women's Basketball Strength & Conditioning at the University of Miami, has over seven years of experience, including positions at the University of Pittsburgh and Racing Louisville FC, and holds a Master's in Exercise Science and Human Performance from Utah State University.
David Lawrence: David Lawrence is a renowned strength coach who has trained NFL athletes, including six Super Bowl champions, to enhance their body composition, speed, and performance, with his work featured in Sports Illustrated, ESPN, and The Athletic.
Dr. Jordan Shallow: Dr. Jordan Shallow is a strength coach, powerlifter, chiropractor, and founder of Pre-Script.com, specializing in innovative strategies to improve human performance for elite athletes and corporations.
Mark Fitzgerald: Mark Fitzgerald has 15 years of experience working with athletes at all levels, including CWENCH's very own Gavin McKenna. Mark founded Elite Training Systems in Ontario, served as Head of Performance for the Anaheim Ducks, and is the lead training advisor for Under Armour Canada, while consulting for various health and performance organizations.
Dan Noble: Dan Noble is the Director of Hockey at Upper Canada College, the Director of Performance for the Oshawa Generals, owns and runs Noble Sport & Performance, and is a Family Coach and Speaker.
Alan Bishop: Alan Bishop, Director of Sports Performance for the University of Houston Men's Basketball program, is a highly regarded coach known for his pragmatic approach and leadership in strength and conditioning, driving impressive physical development in his teams year after year. Alan is considered a godfather in NCAA basketball, placing many of his disciples into programs across the country.
Doug Crashley: Doug Crashley trains world class athletes through Crash Conditioning, a premier training destination for elite hockey players that offers individualized training programs and intuitive coaching based on sports science research.
Dr. Sachin Patel: Dr. Sachin Patel, a functional medicine coach, international speaker, and author, founded The Living Proof Institute to transform healthcare through patient-centered practices and lifestyle changes, while mentoring practitioners globally to provide affordable, inspired care.
Derrell Levy: Derrell Levy trains world class athletes through In-Tech High Performance Training. With over 12 years of on-ice coaching experience, Derrell has developed strength and conditioning programs for elite basketball and hockey teams, as well as NBA, NHL, OHL, and AHL athletes.
Sam Davis: Sam Davis is a Fitness Business Consultant, Women's Health Advisor, and the Founder of Powerfully Fit Training. Sam if a former NCAA athlete, and provides coaching for other well-known fitness influencers and helps them develop their own programs.
Ryan Vigneau: Ryan Vigneau is an Athlete Development Coach and runs RVX Performance, an elite training facility that works with NHL athletes in Edmonton.
Cizzle Brands' Chief Performance Officer Andy O'Brien is also one of the Company's SMEs. Andy was nicknamed "The Muscle Whisperer" by Sportsnet in 2015, highlighting his work as a trainer to NHL superstar Sidney Crosby, MVP and CWENCH's very own Nathan MacKinnon, Olympic medallist figure skater Patrick Chan, women's hockey legend Hayley Wickenheiser, and Olympic swimmer Dara Torres. Andy has also held coaching and consultancy roles for the Pittsburgh Penguins and Florida Panthers.
Additionally, Don Saladino will be an ambassador specifically for CWENCH Hydration™. Earlier this week, Cizzle Brands announced that it was engaging Mr. Saladino as an advisor, which will enable the Company to leverage his insights, expertise, and professional network as a well-known personal trainer to Hollywood's A-List, professional athletes, and award-winning musicians. Mr. Saladino has a high-profile social media presence, with over 432,000 followers on his Instagram channel .
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "In an era when product competition is fierce, we believe that the best way to stand out is by working with the world's most experienced subject matter experts to develop products of unparalleled quality and performance, like we have with CWENCH Hydration™ and Spoken Nutrition. There are very few companies out there that have as much knowledge, reach, and fire power as the team of SMEs that are behind Cizzle Brands' products. Not only are they helping us to develop our amazing lineup of products, they are also our loudest evangelists. Furthermore, anyone in the sports nutrition industry will understand that when Cizzle Brands' SMEs speak, people who matter pay attention, which can drive accelerated growth for the Company."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250123730912/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Don Saladino, Personal Trainer to Hollywood's A-List, Joins Cizzle Brands as an Advisor
Hollywood actors, professional athletes, and award-winning musicians alike have all relied on Don Saladino, coach and trainer of over 20 years, to reach their full potential in physical fitness. As an advisor to Cizzle Brands, Mr. Saladino will provide his insights, expertise, and access to his vast professional network for the commercialization and promotion of Cizzle Brands' product lines at a global scale.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that Don Saladino, a renowned coach and fitness expert to many A-List celebrities, professional athletes, and award-winning musicians has been engaged as an advisor to Cizzle Brands to help guide the Company's commercialization journey in the health and wellness space. Under his agreement with Cizzle Brands, Mr. Saladino will provide sales, marketing, and promotional support for Cizzle Brands' offerings, including through his TikTok (165k followers) and Instagram (432k followers) social media channels.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250121943080/en/

Don Saladino's one-minute Intro Reel video can be viewed on YouTube: https://www.youtube.com/watch?v=5L57AYEjZF4 (Photo: Business Wire)
Mr. Saladino has developed a reputation for training several A-List Hollywood stars, including Ryan Reynolds, Blake Lively, Anne Hathaway, John Krasinski, Emily Blunt, Liev Schreiber, Hugh Jackman and Joanna Gaines. In 2020, Mr. Saladino pivoted from running a brick-and-mortar gym in New York City to operating a global online fitness business which includes workout programs and challenges, an e-commerce portal for supplements, the Don Saladino App (available on the Apple App Store and Google Play), and yearly fitness retreats. Mr. Saladino has an extensive network of celebrity personalities to whom he will be supplying Cizzle Brands' products throughout the course of their training programs.
Additionally, Mr. Saladino has received extensive media coverage. Magazines such as Men's Health , Women's Health , and Muscle & Fitness have cited Mr. Saladino as a fitness expert. Muscle & Fitness has also featured Mr. Saladino on its print magazine cover in March 2018, October 2021, and November 2023. Other publications have featured Mr. Saladino including People , US Weekly , Cosmo , and Shape . Additionally, Mr. Saladino has done live fitness demonstrations on The Golf Channel , The Today Show , Good Morning America , Page Six TV , People NOW , E News , Fox News , and WebMD .
More information about Don Saladino can be found on his website at the following link: https://donsaladino.com/
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "We are keen to be working with Don, as he is one of the most recognized names in the fitness world with a highly engaged following, a well-earned reputation for generating results, and a broad network of highly influential executives. Cizzle Brands is only getting started with building out its presence in the world of health and wellness. With Don's knowledge of what the world's most elite athletes, entrepreneurs, and actors are demanding, we expect he will prove to be extraordinarily valuable to us as an advisor."
Regarding his appointment as an advisor to Cizzle Brands, Don Saladino commented, "In today's marketplace, very few companies truly have what it takes to formulate and produce athlete-grade products for training, nutrition, hydration, and overall wellness while also being appropriate for active people of all ages. The proven team behind Cizzle Brands has already demonstrated their ability to meet this standard with the recent successful launch of CWENCH Hydration™ which has already sold more than one million ready-to-drink units in less than a year on the market, with even more exciting offerings set to hit the market soon. As someone who personally incorporates Cizzle Brands' products into nutrition regimes for myself, my wife, and our two children, I am honoured to be part of the Cizzle Brands team, and there are exciting times to be had for all of us in 2025!"
Cizzle Brands also announced the issuance of 455,645 common shares (the "Settlement Shares") of the Company at a deemed price of $0.31 in settlement of $141,250 in debt. The Settlement Shares were issued to a provider who elected to receive part of their service fee in shares as opposed to cash. The Settlement Shares will be subject to a statutory hold period expiring four months and one day after the date of issuance pursuant to National Instrument 45-102 – Resale of Securities .
Celenza added: "I've always sought to have our key partners invested in our success, so I was pleased when one of our key professional advisers opted to receive part of their fee in equity. To me, it is one of the highest endorsements we've received to date."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities; the role of Mr. Saladino with Cizzle Brands; the supply of Cizzle Brands' products through Mr. Saladino's training programs; the building of Cizzle Brands' presence in the world of health and wellness; and the value of Mr. Saladino as an advisor to Cizzle Brands. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121943080/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Clinical trial data shows RAD 101 detects Brain Metastases
AMGEN TO PRESENT AT THE 35th ANNUAL OPPENHEIMER HEALTHCARE LIFE SCIENCES CONFERENCE
Amgen (NASDAQ: AMGN) will present at the 35 th Annual Oppenheimer Healthcare Life Sciences Conference at 11:20 a.m. ET on Wednesday Feb. 12, 2025. Narimon Honarpour, senior vice president of global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads .
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
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SOURCE Amgen

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AMGEN TO PRESENT AT THE 35th ANNUAL OPPENHEIMER HEALTHCARE LIFE SCIENCES CONFERENCE
Amgen (NASDAQ: AMGN) will present at the 35 th Annual Oppenheimer Healthcare Life Sciences Conference at 11:20 a.m. ET on Wednesday Feb. 12, 2025. Narimon Honarpour, senior vice president of global development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads .
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-to-present-at-the-35th-annual-oppenheimer-healthcare-life-sciences-conference-302371476.html
SOURCE Amgen

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AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023.
"Robust growth in sales and earnings throughout 2024 reflects the momentum of our business. With strong performance globally, we are investing heavily in our rapidly advancing pipeline to deliver innovative therapies across our four therapeutic areas," said Robert A. Bradway , chairman and chief executive officer.
Key results include:
- For the fourth quarter, total revenues increased 11% to $9.1 billion in comparison to the fourth quarter of 2023.
- Product sales grew 11%, primarily driven by 14% volume growth. Excluding sales from our Horizon Therapeutics (Horizon) acquisition, product sales grew 10%, driven by volume growth of 15%.
- Ten products delivered at least double-digit sales growth in the fourth quarter, including Repatha ® (evolocumab), BLINCYTO ® (blinatumomab), TEZSPIRE ® (tezepelumab-ekko), EVENITY ® (romosozumab-aqqg) and TAVNEOS ® (avacopan).
- Our performance included $1.2 billion of sales from our rare disease products, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA ® (teprotumumab-trbw), KRYSTEXXA ® (pegloticase), UPLIZNA ® (inebilizumab-cdon) and TAVNEOS ® .
- For the full year, total revenues increased 19% to $33.4 billion in comparison to the full year of 2023.
- Product sales grew 19%, primarily driven by 23% volume growth, partially offset by 2% lower net selling price. Excluding sales from our Horizon acquisition, product sales grew 7%, driven by volume growth of 11%.
- Ten products delivered at least double-digit sales growth for the full year, including Repatha ® , TEZSPIRE ® , EVENITY ® , BLINCYTO ® and TAVNEOS ® .
- 21 products achieved record sales for the full year.
- GAAP earnings per share (EPS) decreased 18% from $1.42 to $1.16 for the fourth quarter, primarily driven by mark-to-market losses on our equity investments, partially offset by higher revenues. For the full year, GAAP EPS decreased 39% from $12.49 to $7.56 , primarily driven by higher operating expenses, including amortization expense from Horizon acquisition-related assets and incremental operating expenses from Horizon, and overall mark-to-market losses on our equity investments in 2024, partially offset by higher revenues.
- For the fourth quarter, GAAP operating income increased from $1.3 billion to $2.3 billion , and GAAP operating margin increased 10.3 percentage points to 26.5%. For the full year, GAAP operating income decreased from $7.9 billion to $7.3 billion , and GAAP operating margin decreased 6.6 percentage points to 22.7%.
- Non-GAAP EPS increased 13% from $4.71 to $5.31 for the fourth quarter, driven by higher revenues, partially offset by higher operating expenses. For the full year, non-GAAP EPS increased 6% from $18.65 to $19.84 , driven by higher revenues, partially offset by higher operating expenses, including incremental operating expenses from Horizon, and higher interest expense.
- For the fourth quarter, non-GAAP operating income increased from $3.7 billion to $4.0 billion , and non-GAAP operating margin decreased 0.4 percentage points to 46.3%. For the full year, non-GAAP operating income increased from $13.4 billion to $15.0 billion , and non-GAAP operating margin decreased 2.9 percentage points to 46.9%.
- The Company generated $10.4 billion of free cash flow for the full year versus $7.4 billion in 2023, driven by business performance and timing of working capital items, primarily collections, partially offset by higher net interest expense.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow), "EBITDA, or earnings before interest, taxes, depreciation and amortization" (computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income) and "debt leverage ratio" (calculated as the ratio of GAAP total debt to EBITDA) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
General Medicine
- Repatha ® (evolocumab) sales increased 45% year-over-year to $606 million in the fourth quarter, primarily driven by volume growth. Full year sales increased 36%, primarily driven by 43% volume growth, partially offset by 10% lower net selling price. For 2025, we expect lower declines in net selling price.
- EVENITY ® (romosozumab-aqqg) sales increased 36% year-over-year to $431 million in the fourth quarter and 35% for the full year, driven by volume growth.
- Prolia ® (denosumab) sales increased 5% year-over-year to $1.2 billion in the fourth quarter and 8% for the full year, driven by volume growth. For 2025, we expect sales erosion driven by biosimilar competition.
Rare Disease
Except for TAVNEOS ® , the products listed below were added through the acquisition of Horizon on Oct. 6, 2023 .
- TEPEZZA ® (teprotumumab-trbw) generated $460 million of sales in the fourth quarter and $1.9 billion for the full year. TEPEZZA is the first and only approved treatment for thyroid eye disease (TED) in the U.S. and Japan .
- KRYSTEXXA ® (pegloticase) generated $346 million of sales in the fourth quarter and $1.2 billion for the full year. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout.
- UPLIZNA ® (inebilizumab-cdon) generated $101 million of sales in the fourth quarter and $379 million for the full year. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD).
- TAVNEOS ® (avacopan) generated $81 million of sales in the fourth quarter. Sales increased 84% year-over-year in the fourth quarter and 111% for the full year, primarily driven by volume growth. TAVNEOS is a first-in-class treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
- Ultra-Rare products , which consist of RAVICTI ® (glycerol phenylbutyrate) , PROCYSBI ® (cysteamine bitartrate) , ACTIMMUNE ® (interferon gamma-1b) , QUINSAIR ® (levofloxacin) and BUPHENYL ® (sodium phenylbutyrate) , generated $214 million of sales in the fourth quarter and $758 million for the full year.
Inflammation
- TEZSPIRE ® (tezepelumab-ekko) sales increased 67% year-over-year to $296 million in the fourth quarter and 71% for the full year, primarily driven by volume growth.
- Otezla ® (apremilast) sales decreased 1% year-over-year to $624 million in the fourth quarter, driven by 7% lower net selling price, partially offset by 5% volume growth. Sales decreased 3% for the full year, primarily driven by 8% lower net selling price, partially offset by 3% volume growth.
- Enbrel ® (etanercept) sales were flat year-over-year at $1.0 billion in the fourth quarter as 7% favorable changes to estimated sales deductions were offset by lower net selling price. Full year sales decreased 10%, driven by lower net selling price. For 2025, we expect continued declining net selling price and relatively flat volumes.
We expect Otezla and Enbrel to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles. - AMJEVITA ® /AMGEVITA™ (adalimumab) sales increased 84% year-over-year to $294 million in the fourth quarter and 22% for the full year, driven by volume growth, partially offset by lower net selling price.
Oncology
- BLINCYTO ® (blinatumomab) sales increased 58% year-over-year to $381 million in the fourth quarter and 41% for the full year, primarily driven by volume growth.
- Vectibix ® (panitumumab) sales decreased 2% year-over-year to $246 million in the fourth quarter, driven by 5% unfavorable foreign exchange impact and 4% lower volume, partially offset by higher net selling price. Sales increased 6% for the full year, driven by 8% higher net selling price and 4% volume growth, partially offset by unfavorable foreign exchange impact.
- KYPROLIS ® (carfilzomib) sales increased 6% year-over-year to $372 million in the fourth quarter and 7% for the full year, driven by volume growth outside the U.S.
- LUMAKRAS ® /LUMYKRAS™ (sotorasib) sales increased 10% year-over-year to $85 million in the fourth quarter, primarily driven by volume growth. Sales increased 25% for the full year, driven by volume growth and favorable changes to estimated sales deductions.
- XGEVA ® (denosumab) sales increased 6% year-over-year to $561 million in the fourth quarter, driven by volume growth. Sales increased 5% for the full year, driven by higher net selling price. For 2025, we expect sales erosion driven by biosimilar competition.
- Nplate ® (romiplostim) sales decreased 13% year-over-year to $337 million in the fourth quarter. Excluding a fourth quarter 2023 U.S. government order of $62 million , Nplate sales grew 4% year-over-year in the fourth quarter, driven by volume growth. Full year sales decreased 1%. U.S. government orders were $128 million in 2024 compared to $286 million in 2023. Excluding these U.S. government orders, Nplate sales grew 12% year-over-year for the full year, driven by 8% volume growth and 6% higher net selling price.
- IMDELLTRA ® (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE ® ) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
- MVASI ® (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year.
Established Products
- Our established products, which consist of EPOGEN ® (epoetin alfa) , Aranesp ® (darbepoetin alfa) , Parsabiv ® (etelcalcetide) and Neulasta ® (pegfilgrastim) , generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages | Q4 '24 | Q4 '23 | YOY Δ | |||||||
U.S | ROW | TOTAL | TOTAL | TOTAL | ||||||
Repatha ® | $ 315 | $ 291 | $ 606 | $ 417 | 45 % | |||||
EVENITY ® | 325 | 106 | 431 | 318 | 36 % | |||||
Prolia ® | 775 | 390 | 1,165 | 1,107 | 5 % | |||||
TEPEZZA ®(1) | 456 | 4 | 460 | 448 | 3 % | |||||
KRYSTEXXA ®(1) | 346 | — | 346 | 272 | 27 % | |||||
UPLIZNA ®(1) | 93 | 8 | 101 | 65 | 55 % | |||||
TAVNEOS ® | 76 | 5 | 81 | 44 | 84 % | |||||
Ultra-Rare products (1) | 205 | 9 | 214 | 164 | 30 % | |||||
TEZSPIRE ® | 296 | — | 296 | 177 | 67 % | |||||
Otezla ® | 514 | 110 | 624 | 629 | (1 %) | |||||
Enbrel ® | 1,008 | 7 | 1,015 | 1,015 | — % | |||||
AMJEVITA ® /AMGEVITA ™ | 153 | 141 | 294 | 160 | 84 % | |||||
BLINCYTO ® | 245 | 136 | 381 | 241 | 58 % | |||||
Vectibix ® | 134 | 112 | 246 | 251 | (2 %) | |||||
KYPROLIS ® | 236 | 136 | 372 | 350 | 6 % | |||||
LUMAKRAS ® /LUMYKRAS ™ | 53 | 32 | 85 | 77 | 10 % | |||||
XGEVA ® | 369 | 192 | 561 | 527 | 6 % | |||||
Nplate ® | 221 | 116 | 337 | 386 | (13 %) | |||||
IMDELLTRA ® | 67 | — | 67 | — | N/A | |||||
MVASI ® | 108 | 65 | 173 | 188 | (8 %) | |||||
EPOGEN ® | 19 | — | 19 | 55 | (65 %) | |||||
Aranesp ® | 90 | 218 | 308 | 319 | (3 %) | |||||
Parsabiv ® | 39 | 36 | 75 | 89 | (16 %) | |||||
Neulasta ® | 72 | 26 | 98 | 239 | (59 %) | |||||
Other products (2) | 294 | 67 | 361 | 295 | 22 % | |||||
Total product sales | $ 6,509 | $ 2,207 | $ 8,716 | $ 7,833 | 11 % | |||||
N/A = not applicable | ||||||||||
(1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , | ||||||||||
(2) Consists of (i) Aimovig ® , KANJINTI ® , AVSOLA ® , RIABNI ® , PAVBLU ™ , NEUPOGEN ® , WEZLANA ™ /WEZENLA ™ , |
$Millions, except percentages | FY '24 | FY '23 | YOY Δ | |||||||
US | ROW | TOTAL | TOTAL | TOTAL | ||||||
Repatha ® | $ 1,139 | $ 1,083 | $ 2,222 | $ 1,635 | 36 % | |||||
EVENITY ® | 1,131 | 432 | 1,563 | 1,160 | 35 % | |||||
Prolia ® | 2,885 | 1,489 | 4,374 | 4,048 | 8 % | |||||
TEPEZZA ®(1) | 1,835 | 16 | 1,851 | 448 | * | |||||
KRYSTEXXA ®(1) | 1,185 | — | 1,185 | 272 | * | |||||
UPLIZNA ®(1) | 314 | 65 | 379 | 65 | * | |||||
TAVNEOS ® | 256 | 27 | 283 | 134 | * | |||||
Ultra-Rare products (1) | 726 | 32 | 758 | 164 | * | |||||
TEZSPIRE ® | 972 | — | 972 | 567 | 71 % | |||||
Otezla ® | 1,699 | 427 | 2,126 | 2,188 | (3 %) | |||||
Enbrel ® | 3,288 | 28 | 3,316 | 3,697 | (10 %) | |||||
AMJEVITA ® /AMGEVITA ™ | 202 | 559 | 761 | 626 | 22 % | |||||
BLINCYTO ® | 800 | 416 | 1,216 | 861 | 41 % | |||||
Vectibix ® | 519 | 526 | 1,045 | 984 | 6 % | |||||
KYPROLIS ® | 948 | 555 | 1,503 | 1,403 | 7 % | |||||
LUMAKRAS ® /LUMYKRAS ™ | 214 | 136 | 350 | 280 | 25 % | |||||
XGEVA ® | 1,507 | 718 | 2,225 | 2,112 | 5 % | |||||
Nplate ® | 970 | 486 | 1,456 | 1,477 | (1 %) | |||||
IMDELLTRA ® | 115 | — | 115 | — | N/A | |||||
MVASI ® | 449 | 278 | 727 | 800 | (9 %) | |||||
EPOGEN ® | 125 | — | 125 | 226 | (45 %) | |||||
Aranesp ® | 386 | 956 | 1,342 | 1,362 | (1 %) | |||||
Parsabiv ® | 203 | 153 | 356 | 362 | (2 %) | |||||
Neulasta ® | 318 | 113 | 431 | 848 | (49 %) | |||||
Other products (2) | 1,115 | 230 | 1,345 | 1,191 | 13 % | |||||
Total product sales | $ 23,301 | $ 8,725 | $ 32,026 | $ 26,910 | 19 % | |||||
* Change in excess of 100% | ||||||||||
N/A = not applicable | ||||||||||
(1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , | ||||||||||
(2) Consists of (i)Aimovig ® ,KANJINTI ® ,RIABNI ® ,AVSOLA ® ,NEUPOGEN ® ,Corlanor ® , IMLYGIC ® ,BEKEMV ™ , |
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
- Total Operating Expenses decreased 2% year-over-year for the fourth quarter and increased 29% for the full year. Cost of Sales as a percentage of product sales decreased 4.0 percentage points for the fourth quarter primarily driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon, partially offset by changes in our sales mix, and higher profit share and royalty expense. For the full year, cost of sales as a percentage of product sales increased 8.7 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. Research & Development (R&D) expenses increased 12% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower research and early pipeline spend. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses decreased 17% for the fourth quarter primarily driven by lower Horizon acquisition-related expenses. SG&A expenses increased 15% for the full year primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower Horizon acquisition-related expenses incurred in 2024. Other operating expenses for the full year primarily consisted of impairment charges associated with in-process R&D (IPR&D) intangible assets related to our Teneobio, Inc. acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024.
- Operating Margin as a percentage of product sales increased 10.3 percentage points to 26.5% for the fourth quarter and decreased 6.6 percentage points to 22.7% for the full year.
- Tax Rate increased 9.8 percentage points in the fourth quarter and decreased 3.2 percentage points for the full year. The fourth quarter tax rate increase was related to deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries and prior year favorable items, partially offset by the change in earnings mix as a result of the fourth quarter 2024 unrealized losses on our strategic equity investments (primarily BeiGene). The full year tax rate decrease was due to the change in earnings mix, including the net unrealized impacts of our strategic equity investments (primarily BeiGene), partially offset by the deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries.
On a non-GAAP basis:
- Total Operating Expenses increased 11% year-over-year for the fourth quarter and increased 24% for the full year. Cost of Sales as a percentage of product sales increased 1.3 percentage points for the fourth quarter driven by changes in our sales mix, and higher profit share and royalty expense. Cost of sales as a percentage of product sales increased 0.9 percentage points for the full year driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 14% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower spend in research and early pipeline. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. SG&A expenses increased 3% for the fourth quarter driven by higher general and administrative expenses. SG&A expenses increased 23% for the full year primarily driven by expenses from the acquired Horizon business and other marketed product expenses.
- Operating Margin as a percentage of product sales decreased 0.4 percentage points to 46.3% for the fourth quarter and decreased 2.9 percentage points to 46.9% for the full year.
- Tax Rate decreased 1.1 percentage points for the fourth quarter and decreased 2.0 percentage points for the full year. The fourth quarter tax rate decrease was primarily due to the change in earnings mix and net favorable items as compared to the prior year. The full year tax rate decrease was primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items as compared to the prior year.
$Millions, except percentages | GAAP | Non-GAAP | ||||||||||
Q4 '24 | Q4 '23 | YOY Δ | Q4 '24 | Q4 '23 | YOY Δ | |||||||
Cost of Sales | $ 3,112 | $ 3,112 | — % | $ 1,536 | $ 1,278 | 20 % | ||||||
% of product sales | 35.7 % | 39.7 % | (4.0) pts | 17.6 % | 16.3 % | 1.3 pts | ||||||
Research & Development | $ 1,724 | $ 1,534 | 12 % | $ 1,698 | $ 1,494 | 14 % | ||||||
% of product sales | 19.8 % | 19.6 % | 0.2 pts | 19.5 % | 19.1 % | 0.4 pts | ||||||
Selling, General & Administrative | $ 1,878 | $ 2,274 | (17 %) | $ 1,819 | $ 1,764 | 3 % | ||||||
% of product sales | 21.5 % | 29.0 % | (7.5) pts | 20.9 % | 22.5 % | (1.6) pts | ||||||
Other | $ 61 | $ 5 | * | $ — | $ — | N/A | ||||||
Total Operating Expenses | $ 6,775 | $ 6,925 | (2 %) | $ 5,053 | $ 4,536 | 11 % | ||||||
Operating Margin | ||||||||||||
operating income as % of product sales | 26.5 % | 16.2 % | 10.3 pts | 46.3 % | 46.7 % | (0.4) pts | ||||||
Tax Rate | 19.8 % | 10.0 % | 9.8 pts | 14.8 % | 15.9 % | (1.1) pts | ||||||
pts: percentage points | ||||||||||||
* change in excess of 100% | ||||||||||||
N/A = not applicable | ||||||||||||
$Millions, except percentages | GAAP | Non-GAAP | ||||||||||
FY '24 | FY '23 | YOY Δ | FY '24 | FY '23 | YOY Δ | |||||||
Cost of Sales | $ 12,858 | $ 8,451 | 52 % | $ 5,736 | $ 4,573 | 25 % | ||||||
% of product sales | 40.1 % | 31.4 % | 8.7 pts | 17.9 % | 17.0 % | 0.9 pts | ||||||
Research & Development | $ 5,964 | $ 4,784 | 25 % | $ 5,878 | $ 4,700 | 25 % | ||||||
% of product sales | 18.6 % | 17.8 % | 0.8 pts | 18.4 % | 17.5 % | 0.9 pts | ||||||
Selling, General & Administrative | $ 7,096 | $ 6,179 | 15 % | $ 6,782 | $ 5,518 | 23 % | ||||||
% of product sales | 22.2 % | 23.0 % | (0.8) pts | 21.2 % | 20.5 % | 0.7 pts | ||||||
Other | $ 248 | $ 879 | (72 %) | $ — | $ — | N/A | ||||||
Total Operating Expenses | $ 26,166 | $ 20,293 | 29 % | $ 18,396 | $ 14,791 | 24 % | ||||||
Operating Margin | ||||||||||||
operating income as % of product sales | 22.7 % | 29.3 % | (6.6) pts | 46.9 % | 49.8 % | (2.9) pts | ||||||
Tax Rate | 11.3 % | 14.5 % | (3.2) pts | 14.5 % | 16.5 % | (2.0) pts | ||||||
pts: percentage points | ||||||||||||
N/A = not applicable |
Cash Flow and Balance Sheet
- The Company generated a record $4.4 billion of free cash flow in the fourth quarter of 2024 versus $0.3 billion in the fourth quarter of 2023, driven by timing of tax payments, timing of working capital, primarily collections, lower transaction expenses compared to the fourth quarter of 2023, which included significant costs tied to the closing of the Horizon acquisition, and business performance. The Company generated $10.4 billion of free cash flow for the full year 2024 versus $7.4 billion in 2023.
- The Company's fourth quarter 2024 dividend of $2.25 per share was declared on October 25, 2024, and was paid on December 9, 2024, to all stockholders of record as of November 18, 2024, representing a 6% increase from the same period in 2023.
- During the fourth quarter, there were no repayments or extinguishments of debt. For the full year 2024, the Company reduced principal debt outstanding by $4 .5 billion.
- For the fourth quarter and full year, the Company repurchased 0.7 million shares of common stock at a total cost of $200 million .
- Cash and investments totaled $12.0 billion and debt outstanding totaled $60.1 billion as of December 31, 2024 . Debt leverage was approximately 4.5 times EBITDA as of December 31, 2024 .
$Billions, except shares | Q4 '24 | Q4 '23 | YOY Δ | FY '24 | FY '23 | YOY Δ | ||||||
Operating Cash Flow | $ 4.8 | $ 0.5 | $ 4.2 | $ 11.5 | $ 8.5 | $ 3.0 | ||||||
Capital Expenditures | $ 0.4 | $ 0.2 | $ 0.1 | $ 1.1 | $ 1.1 | $ 0.0 | ||||||
Free Cash Flow | $ 4.4 | $ 0.3 | $ 4.1 | $ 10.4 | $ 7.4 | $ 3.0 | ||||||
Dividends Paid | $ 1.2 | $ 1.1 | $ 0.1 | $ 4.8 | $ 4.6 | $ 0.3 | ||||||
Share Repurchases | $ 0.2 | $ — | $ 0.2 | $ 0.2 | $ — | $ 0.2 | ||||||
Average Diluted Shares (millions) | 542 | 540 | 2 | 541 | 538 | 3 | ||||||
Note: Numbers may not add due to rounding |
$Billions | 12/31/24 | 12/31/23 | YTD Δ | |||
Cash and Investments | $ 12.0 | $ 10.9 | $ 1.0 | |||
Debt Outstanding | $ 60.1 | $ 64.6 | $ (4.5) | |||
Note: Numbers may not add due to rounding |
2025 Guidance
For the full year 2025, the Company expects:
- Total revenues in the range of $34 .3 billion to $35 .7 billion.
- On a GAAP basis, EPS in the range of $10.89 to $12.14 , and a tax rate in the range of 11.0% to 12.5%.
- On a non-GAAP basis, EPS in the range of $20.00 to $21.20 , and a tax rate in the range of 15.0% to 16.0%.
- Capital expenditures to be approximately $2 .3 billion.
- Share repurchases not to exceed $500 million.
Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General Medicine
MariTide (maridebart cafraglutide, AMG 133)
- MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR).
- In November 2024 , data were presented from Part 1 of a Phase 2 chronic weight management study in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. MariTide demonstrated robust weight loss at 52 weeks without a weight loss plateau, significant improvements in cardiometabolic parameters, and is the first obesity treatment with monthly or less frequent dosing to demonstrate safe and effective weight loss in a Phase 2 study.
- Part 2 of the Phase 2 chronic weight management study is ongoing in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025.
- A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus is enrolling adults living with and without obesity. Data readout is anticipated in H2 2025.
- Planning for MARITIME, a broad Phase 3 program across multiple indications remains on track with the first studies expected to begin in H1 2025.
AMG 513
- A Phase 1 study of AMG 513 in people living with obesity was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Discussions are underway on a path forward to reopen the study.
Olpasiran (AMG 890)
- Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
- The OCEAN(a)-Outcomes trial, a Phase 3 cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
- A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a CV event is expected to be initiated in H2 2025 / H1 2026.
Repatha
- VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
- EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Rare Disease
TAVNEOS
- A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to
TEPEZZA
- Regulatory review is underway in multiple additional geographies including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025.
- A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic or low clinical activity score TED.
- A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED.
KRYSTEXXA
- Data were presented in November 2024 from the AGILE study evaluating the safety, tolerability and efficacy of KRYSTEXXA administered with a shorter infusion duration in patients with uncontrolled gout receiving methotrexate as co-administration:
- Safety and efficacy data from the 60-minute infusion duration cohort of the AGILE trial are similar to the MIRROR randomized clinical trial and current administration of KRYSTEXXA with methotrexate over at least 120 minutes.
- U.S. Regulatory filing for AGILE is underway.
UPLIZNA
- In January 2025, the FDA granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG) based upon data from the Phase 3 MINT study. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025.
- In November 2024, data were presented and simultaneously published in the New England Journal of Medicine from the Phase 3 MITIGATE study evaluating UPLIZNA compared to placebo in patients with immunoglobin G4-related disease (IgG4-RD). In this study, UPLIZNA demonstrated a statistically significant 87% reduction in IgG4-RD flares, this primary endpoint and all key secondary endpoints were met. The safety results in the placebo-controlled period were consistent with the established safety profile of UPLIZNA.
- The FDA accepted the regulatory submission for the Phase 3 MITIGATE study under priority review with a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2025.
Dazodalibep
- Dazodalibep is a fusion protein that inhibits CD40L.
- Two Phase 3 studies of dazodalibep in Sjögren's disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab
- Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
- A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
- A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
Fipaxalparant
- Fipaxalparant is a lysophosphatidic acid receptor 1 (LPAR1) antagonist.
- A Phase 2 study of fipaxalparant in patients with diffuse cutaneous systemic sclerosis is complete. The study did not meet the primary or secondary endpoints. Further development of fipaxalparant in this indication will be discontinued.
Inflammation
TEZSPIRE
- The Company is planning to initiate Phase 3 studies in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. Study initiation is anticipated in H1 2025.
- In December, the Company announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps:
- Patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
- The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine.
- Regulatory submission is anticipated in H1 2025.
- A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis.
- In severe asthma, the WAYFINDER Phase 3b study is complete and the PASSAGE Phase 4 real-world effectiveness study is ongoing. The SUNRISE Phase 3 study will be discontinued due to limited enrollment.
Rocatinlimab (AMG 451/KHK4083)
- Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor.
- The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3300 patients. Enrollment is now complete in seven studies.
- Key milestones from the ROCKET Phase 3 program:
- ROCKET SHUTTLE is a 24-week study evaluating rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
- ROCKET IGNITE is a 24-week study evaluating rocatinlimab monotherapy in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
- ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
- ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
- A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
- A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis.
Otezla
- In November 2024, we made six data presentations at the American College of Rheumatology (ACR). Notable highlights include:
- Otezla reduces axial inflammation in patients with psoriatic arthritis (PsA) as assessed by CANDEN Magnetic Resonance Imaging Scoring, results From the Phase 4 MOSAIC study.
- FOREMOST oligoarticular PsA data presentations (4 posters), including 48-week data and data at 16 weeks showing that Otezla was associated with fewer patients progressing from 4 active joints when compared to placebo suggesting that Otezla reduced the progression from oligoarticular to polyarticular PsA.
Blinatumomab
- Blinatumomab is a BiTE molecule targeting CD19.
- A Phase 2 study of blinatumomab in autoimmune disease was initiated in patients with systemic lupus erythematosus (SLE).
Inebilizumab
- Inebilizumab is a monoclonal antibody targeting CD19.
- A Phase 2 study of inebilizumab in autoimmune disease was initiated in patients with SLE.
Ordesekimab (AMG 714/PRV-015)
- Ordesekimab is a monoclonal antibody that binds interleukin-15.
- A Phase 2b study of ordesekimab, conducted by Provention Bio, a Sanofi Company, in patients with nonresponsive celiac disease was completed as planned and did not meet primary or secondary endpoints. No safety concerns were noted.
AMG 104 (AZD8630)
- AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
- A Phase 2 study is enrolling patients with asthma.
Oncology
BLINCYTO
- In December 2024 , data from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group, were presented and simultaneously published in the New England Journal of Medicine . These data demonstrated that BLINCYTO added to chemotherapy significantly improves disease-free survival in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell precursor acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
- Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Philadelphia chromosome (Ph)-negative B-ALL.
- A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Ph-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025.
IMDELLTRA
- IMDELLTRA is a first-in-class delta-like ligand 3 (DLL3) targeting BiTE molecule.
- In 2024, IMDELLTRA received accelerated approval in the U.S. for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Marketing authorizations have subsequently been granted in Japan and in additional countries, including Canada , Brazil , Israel and Great Britain .
- The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage small cell lung cancer (SCLC):
- DeLLphi-304, a Phase 3 study of IMDELLTRA in second-line ES-SCLC, is ongoing. Data readout is anticipated in H1 2025.
- DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is enrolling patients with first-line ES-SCLC in the maintenance setting.
- DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC.
- DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
- DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, was initiated.
- DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC.
Xaluritamig (AMG 509)
- Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
- A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
- A Phase 1 monotherapy dose-expansion study of xaluritamig is enrolling mCRPC patients who have not yet received taxane-based chemotherapy and to enroll patients in a fully outpatient treatment setting to further improve administration convenience.
- A Phase 1 combination of xaluritamig with enzalutamide or abiraterone is enrolling patients with mCRPC in dose-escalation and dose-expansion respectively.
- A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer.
- A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
AMG 193
- AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
- A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
- A Phase 1/ 1b /2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
- A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
- A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract, and pancreatic cancers.
- A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients with advanced MTAP-null solid tumors.
Bemarituzumab
- Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
- FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in H1 2025.
- FORTITUDE-102, a Phase 1b /3 study of bemarituzumab plus chemotherapy and nivolumab is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025.
- FORTITUDE-103, a Phase 1b /2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
- FORTITUDE-301, a Phase 1b /2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
LUMAKRAS/LUMYKRAS
- In January 2025 , the FDA approved LUMAKRAS in combination with Vectibix as a targeted, biomarker-driven combination therapy for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
- CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC.
- Regulatory review by the EMA of the CodeBreaK 200 Phase 3 study of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC concluded with the conditional status of marketing authorization maintained.
- CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
- The ongoing CB202 study is being conducted to serve as confirmatory study and to support conversion of accelerated/conditional approval to full approval, in the US, EU and other regions where applicable.
Nplate
- The primary analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. The Company continues to follow patients through a planned final analysis in H1 2025. Data presentation at a medical congress is anticipated in mid-2025.
Biosimilars
- A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO ® (nivolumab) is enrolling patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
- A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
- A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA ® (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment.
- A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer.
- A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 and OCREVUS ® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio, a Sanofi Company. For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating results for the fourth quarters and full years of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and debt leverage ratio for 2024, both of which are non-GAAP financial measures. EBITDA is computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income. Debt leverage ratio is calculated as the ratio of GAAP total debt to EBITDA.
The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company believes its debt leverage ratio provides a supplemental operating metric for the full year period as it compares the amount of cash generated by our operations for the year.
The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads .
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
Amgen Inc. | |||||||
Consolidated Statements of Income - GAAP | |||||||
(In millions, except per-share data) | |||||||
(Unaudited) | |||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Revenues: | |||||||
Product sales | $ 8,716 | $ 7,833 | $ 32,026 | $ 26,910 | |||
Other revenues | 370 | 363 | 1,398 | 1,280 | |||
Total revenues | 9,086 | 8,196 | 33,424 | 28,190 | |||
Operating expenses: | |||||||
Cost of sales | 3,112 | 3,112 | 12,858 | 8,451 | |||
Research and development | 1,724 | 1,534 | 5,964 | 4,784 | |||
Selling, general and administrative | 1,878 | 2,274 | 7,096 | 6,179 | |||
Other | 61 | 5 | 248 | 879 | |||
Total operating expenses | 6,775 | 6,925 | 26,166 | 20,293 | |||
Operating income | 2,311 | 1,271 | 7,258 | 7,897 | |||
Other income (expense): | |||||||
Interest expense, net | (747) | (821) | (3,155) | (2,875) | |||
Other (expense) income, net | (782) | 402 | 506 | 2,833 | |||
Income before income taxes | 782 | 852 | 4,609 | 7,855 | |||
Provision for income taxes | 155 | 85 | 519 | 1,138 | |||
Net income | $ 627 | $ 767 | $ 4,090 | $ 6,717 | |||
Earnings per share: | |||||||
Basic | $ 1.17 | $ 1.43 | $ 7.62 | $ 12.56 | |||
Diluted | $ 1.16 | $ 1.42 | $ 7.56 | $ 12.49 | |||
Weighted-average shares used in calculation of earnings per share: | |||||||
Basic | 537 | 535 | 537 | 535 | |||
Diluted | 542 | 540 | 541 | 538 |
Amgen Inc. | |||
Consolidated Balance Sheets - GAAP | |||
(In millions) | |||
December 31, | December 31, | ||
2024 | 2023 | ||
(Unaudited) | |||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 11,973 | $ 10,944 | |
Trade receivables, net | 6,782 | 7,268 | |
Inventories | 6,998 | 9,518 | |
Other current assets | 3,277 | 2,602 | |
Total current assets | 29,030 | 30,332 | |
Property, plant and equipment, net | 6,543 | 5,941 | |
Intangible assets, net | 27,699 | 32,641 | |
Goodwill | 18,637 | 18,629 | |
Other noncurrent assets | 9,930 | 9,611 | |
Total assets | $ 91,839 | $ 97,154 | |
Liabilities and Stockholders' Equity | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 19,549 | $ 16,949 | |
Current portion of long-term debt | 3,550 | 1,443 | |
Total current liabilities | 23,099 | 18,392 | |
Long-term debt | 56,549 | 63,170 | |
Long-term deferred tax liabilities | 1,616 | 2,354 | |
Long-term tax liabilities | 2,349 | 4,680 | |
Other noncurrent liabilities | 2,349 | 2,326 | |
Total stockholders' equity | 5,877 | 6,232 | |
Total liabilities and stockholders' equity | $ 91,839 | $ 97,154 | |
Shares outstanding | 537 | 535 |
Amgen Inc. | |||||||
GAAP to Non-GAAP Reconciliations | |||||||
(Dollars in millions) | |||||||
(Unaudited) | |||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP cost of sales | $ 3,112 | $ 3,112 | $ 12,858 | $ 8,451 | |||
Adjustments to cost of sales: | |||||||
Acquisition-related expenses (a) | (1,576) | (1,834) | (7,122) | (3,842) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | — | — | — | (36) | |||
Total adjustments to cost of sales | (1,576) | (1,834) | (7,122) | (3,878) | |||
Non-GAAP cost of sales | $ 1,536 | $ 1,278 | $ 5,736 | $ 4,573 | |||
GAAP cost of sales as a percentage of product sales | 35.7 % | 39.7 % | 40.1 % | 31.4 % | |||
Acquisition-related expenses (a) | (18.1) | (23.4) | (22.2) | (14.3) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | 0.0 | 0.0 | 0.0 | (0.1) | |||
Non-GAAP cost of sales as a percentage of product sales | 17.6 % | 16.3 % | 17.9 % | 17.0 % | |||
GAAP research and development expenses | $ 1,724 | $ 1,534 | $ 5,964 | $ 4,784 | |||
Adjustments to research and development expenses: | |||||||
Acquisition-related expenses (b) | (26) | (28) | (86) | (55) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | — | (12) | — | (29) | |||
Total adjustments to research and development expenses | (26) | (40) | (86) | (84) | |||
Non-GAAP research and development expenses | $ 1,698 | $ 1,494 | $ 5,878 | $ 4,700 | |||
GAAP research and development expenses as a percentage of product sales | 19.8 % | 19.6 % | 18.6 % | 17.8 % | |||
Acquisition-related expenses (b) | (0.3) | (0.3) | (0.2) | (0.2) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | 0.0 | (0.2) | 0.0 | (0.1) | |||
Non-GAAP research and development expenses as a percentage of product sales | 19.5 % | 19.1 % | 18.4 % | 17.5 % | |||
GAAP selling, general and administrative expenses | $ 1,878 | $ 2,274 | $ 7,096 | $ 6,179 | |||
Adjustments to selling, general and administrative expenses: | |||||||
Acquisition-related expenses (c) | (59) | (510) | (314) | (648) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | — | — | — | (13) | |||
Total adjustments to selling, general and administrative expenses | (59) | (510) | (314) | (661) | |||
Non-GAAP selling, general and administrative expenses | $ 1,819 | $ 1,764 | $ 6,782 | $ 5,518 | |||
GAAP selling, general and administrative expenses as a percentage of product sales | 21.5 % | 29.0 % | 22.2 % | 23.0 % | |||
Acquisition-related expenses (c) | (0.6) | (6.5) | (1.0) | (2.4) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | 0.0 | 0.0 | 0.0 | (0.1) | |||
Non-GAAP selling, general and administrative expenses as a percentage of product sales | 20.9 % | 22.5 % | 21.2 % | 20.5 % | |||
GAAP operating expenses | $ 6,775 | $ 6,925 | $ 26,166 | $ 20,293 | |||
Adjustments to operating expenses: | |||||||
Adjustments to cost of sales | (1,576) | (1,834) | (7,122) | (3,878) | |||
Adjustments to research and development expenses | (26) | (40) | (86) | (84) | |||
Adjustments to selling, general and administrative expenses | (59) | (510) | (314) | (661) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives (d) | (40) | (2) | (36) | (185) | |||
Certain other expenses (e) | (21) | (3) | (212) | (694) | |||
Total adjustments to operating expenses | (1,722) | (2,389) | (7,770) | (5,502) | |||
Non-GAAP operating expenses | $ 5,053 | $ 4,536 | $ 18,396 | $ 14,791 | |||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP operating income | $ 2,311 | $ 1,271 | $ 7,258 | $ 7,897 | |||
Adjustments to operating expenses | 1,722 | 2,389 | 7,770 | 5,502 | |||
Non-GAAP operating income | $ 4,033 | $ 3,660 | $ 15,028 | $ 13,399 | |||
GAAP operating income as a percentage of product sales | 26.5 % | 16.2 % | 22.7 % | 29.3 % | |||
Adjustments to cost of sales | 18.1 | 23.4 | 22.2 | 14.4 | |||
Adjustments to research and development expenses | 0.3 | 0.4 | 0.2 | 0.3 | |||
Adjustments to selling, general and administrative expenses | 0.6 | 6.5 | 1.0 | 2.6 | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives (d) | 0.5 | 0.1 | 0.1 | 0.7 | |||
Certain other expenses (e) | 0.3 | 0.1 | 0.7 | 2.5 | |||
Non-GAAP operating income as a percentage of product sales | 46.3 % | 46.7 % | 46.9 % | 49.8 % | |||
GAAP interest expense, net | $ (747) | $ (821) | $ (3,155) | $ (2,875) | |||
Adjustments to interest expense, net: | |||||||
Interest expense on acquisition-related debt (f) | — | 19 | — | 807 | |||
Non-GAAP interest expense, net | $ (747) | $ (802) | $ (3,155) | $ (2,068) | |||
GAAP other (expense) income, net | $ (782) | $ 402 | $ 506 | $ 2,833 | |||
Adjustments to other (expense) income, net | |||||||
Interest income and other expenses on acquisition-related debt (f) | — | (18) | — | (625) | |||
Net losses (gains) from equity investments (g) | 875 | (217) | 182 | (1,522) | |||
Total adjustments to other (expense) income, net | 875 | (235) | 182 | (2,147) | |||
Non-GAAP other income, net | $ 93 | $ 167 | $ 688 | $ 686 | |||
GAAP income before income taxes | $ 782 | $ 852 | $ 4,609 | $ 7,855 | |||
Adjustments to income before income taxes: | |||||||
Adjustments to operating expenses | 1,722 | 2,389 | 7,770 | 5,502 | |||
Adjustments to interest expense, net | — | 19 | — | 807 | |||
Adjustments to other income, net | 875 | (235) | 182 | (2,147) | |||
Total adjustments to income before income taxes | 2,597 | 2,173 | 7,952 | 4,162 | |||
Non-GAAP income before income taxes | $ 3,379 | $ 3,025 | $ 12,561 | $ 12,017 | |||
GAAP provision for income taxes | $ 155 | $ 85 | $ 519 | $ 1,138 | |||
Adjustments to provision for income taxes: | |||||||
Income tax effect of the above adjustments (h) | 537 | 404 | 1,544 | 846 | |||
Other income tax adjustments (i) | (192) | (7) | (236) | (1) | |||
Total adjustments to provision for income taxes | 345 | 397 | 1,308 | 845 | |||
Non-GAAP provision for income taxes | $ 500 | $ 482 | $ 1,827 | $ 1,983 | |||
GAAP tax as a percentage of income before taxes | 19.8 % | 10.0 % | 11.3 % | 14.5 % | |||
Adjustments to provision for income taxes: | |||||||
Income tax effect of the above adjustments (h) | 0.7 | 6.1 | 5.1 | 2.0 | |||
Other income tax adjustments (i) | (5.7) | (0.2) | (1.9) | 0.0 | |||
Total adjustments to provision for income taxes | (5.0) | 5.9 | 3.2 | 2.0 | |||
Non-GAAP tax as a percentage of income before taxes | 14.8 % | 15.9 % | 14.5 % | 16.5 % | |||
GAAP net income | $ 627 | $ 767 | $ 4,090 | $ 6,717 | |||
Adjustments to net income: | |||||||
Adjustments to income before income taxes, net of the income tax effect | 2,060 | 1,769 | 6,408 | 3,316 | |||
Other income tax adjustments (i) | 192 | 7 | 236 | 1 | |||
Total adjustments to net income | 2,252 | 1,776 | 6,644 | 3,317 | |||
Non-GAAP net income | $ 2,879 | $ 2,543 | $ 10,734 | $ 10,034 | |||
Note: Numbers may not add due to rounding |
Amgen Inc. | |||||||
GAAP to Non-GAAP Reconciliations | |||||||
(In millions, except per-share data) | |||||||
(Unaudited) | |||||||
The following table presents the computations for GAAP and non-GAAP diluted earnings per share: | |||||||
Three months ended December 31, 2024 | Three months ended December 31, 2023 | ||||||
GAAP | Non-GAAP | GAAP | Non-GAAP | ||||
Net income | $ 627 | $ 2,879 | $ 767 | $ 2,543 | |||
Weighted-average shares for diluted EPS | 542 | 542 | 540 | 540 | |||
Diluted EPS | $ 1.16 | $ 5.31 | $ 1.42 | $ 4.71 | |||
Twelve months ended December 31, 2024 | Twelve months ended December 31, 2023 | ||||||
GAAP | Non-GAAP | GAAP | Non-GAAP | ||||
Net income | $ 4,090 | $ 10,734 | $ 6,717 | $ 10,034 | |||
Weighted-average shares for diluted EPS | 541 | 541 | 538 | 538 | |||
Diluted EPS | $ 7.56 | $ 19.84 | $ 12.49 | $ 18.65 |
(a) | The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions. | |
(b) | For the three and twelve months ended December 31, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three months ended December 31, 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the twelve months ended December 31, 2023, the adjustments related primarily to noncash amortization of intangible assets acquired from business acquisitions. | |
(c) | For the three and twelve months ended December 31, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. | |
(d) | For the three and twelve months ended December 31, 2024 and 2023, the adjustments related to separation costs associated with our restructuring plan and other cost-savings initiatives. | |
(e) | For the twelve months ended December 31, 2024, the adjustments related primarily to impairment charges for IPR&D intangible assets related to our Teneobio, Inc. acquisition from 2021. For the twelve months ended December 31, 2023, the adjustments related primarily to a net IPR&D intangible asset impairment charge for AMG 340. | |
(f) | For the three and twelve months ended December 31, 2023, the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon. | |
(g) | For the three and twelve months ended December 31, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the twelve months ended December 31, 2023, the adjustments related primarily to our BeiGene equity fair value adjustment. | |
(h) | The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and twelve months ended December 31, 2024, was 20.7% and 19.4%, respectively, compared to 18.6% and 20.3% for the corresponding periods of the prior year. | |
(i) | The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings. |
Amgen Inc. | |||||||
Reconciliations of Cash Flows | |||||||
(In millions) | |||||||
(Unaudited) | |||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Net cash provided by operating activities | $ 4,771 | $ 538 | $ 11,490 | $ 8,471 | |||
Net cash used in investing activities | (402) | (27,089) | (1,046) | (26,204) | |||
Net cash (used in) provided by financing activities | (1,407) | 2,754 | (9,415) | 21,048 | |||
Increase (decrease) in cash and cash equivalents | 2,962 | (23,797) | 1,029 | 3,315 | |||
Cash and cash equivalents at beginning of period | 9,011 | 34,741 | 10,944 | 7,629 | |||
Cash and cash equivalents at end of period | $ 11,973 | $ 10,944 | $ 11,973 | $ 10,944 | |||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Net cash provided by operating activities | $ 4,771 | $ 538 | $ 11,490 | $ 8,471 | |||
Capital expenditures | (371) | (249) | (1,096) | (1,112) | |||
Free cash flow | $ 4,400 | $ 289 | $ 10,394 | $ 7,359 |
Amgen Inc. | |
Reconciliation of GAAP Net Income to EBITDA and Debt Leverage Ratio Calculation | |
(Dollars in millions) | |
(Unaudited) | |
Twelve months ended | |
GAAP Net Income | $ 4,090 |
Depreciation and amortization | 5,592 |
Interest expense, net | 3,155 |
Provision for income taxes | 519 |
EBITDA (a) | $ 13,356 |
As of December 31, 2024 | |
Current portion of long-term debt | $ 3,550 |
Long-term debt | 56,549 |
Total GAAP Debt | $ 60,099 |
As of December 31, 2024 | |
Total GAAP Debt | $ 60,099 |
EBITDA | $ 13,356 |
Debt leverage ratio | 4.5 |
(a) | 2024 EBITDA includes amortization of inventory step-up of $2.4 billion and net losses from equity investments of $182 million. |
Amgen Inc. | ||||
Reconciliation of GAAP EPS Guidance to Non-GAAP | ||||
EPS Guidance for the Year Ending December 31, 2025 | ||||
(Unaudited) | ||||
GAAP diluted EPS guidance | $ 10.89 | — | $ 12.14 | |
Known adjustments to arrive at non-GAAP*: | ||||
Acquisition-related expenses (a) | 9.06 | — | 9.11 | |
Non-GAAP diluted EPS guidance | $ 20.00 | — | $ 21.20 |
* The known adjustments are presented net of their related tax impact, which amount to approximately $1.54 per share. |
(a) The adjustments include noncash amortization of intangible assets and fair value step-up of inventory acquired in business acquisitions. |
Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments.
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP | ||||
Tax Rate Guidance for the Year Ending December 31, 2025 | ||||
(Unaudited) | ||||
GAAP tax rate guidance | 11.0 % | — | 12.5 % | |
Tax rate of known adjustments discussed above | 3.5 % | — | 4.0 % | |
Non-GAAP tax rate guidance | 15.0 % | — | 16.0 % |
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SOURCE Amgen

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AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023.
"Robust growth in sales and earnings throughout 2024 reflects the momentum of our business. With strong performance globally, we are investing heavily in our rapidly advancing pipeline to deliver innovative therapies across our four therapeutic areas," said Robert A. Bradway , chairman and chief executive officer.
Key results include:
- For the fourth quarter, total revenues increased 11% to $9.1 billion in comparison to the fourth quarter of 2023.
- Product sales grew 11%, primarily driven by 14% volume growth. Excluding sales from our Horizon Therapeutics (Horizon) acquisition, product sales grew 10%, driven by volume growth of 15%.
- Ten products delivered at least double-digit sales growth in the fourth quarter, including Repatha ® (evolocumab), BLINCYTO ® (blinatumomab), TEZSPIRE ® (tezepelumab-ekko), EVENITY ® (romosozumab-aqqg) and TAVNEOS ® (avacopan).
- Our performance included $1.2 billion of sales from our rare disease products, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA ® (teprotumumab-trbw), KRYSTEXXA ® (pegloticase), UPLIZNA ® (inebilizumab-cdon) and TAVNEOS ® .
- For the full year, total revenues increased 19% to $33.4 billion in comparison to the full year of 2023.
- Product sales grew 19%, primarily driven by 23% volume growth, partially offset by 2% lower net selling price. Excluding sales from our Horizon acquisition, product sales grew 7%, driven by volume growth of 11%.
- Ten products delivered at least double-digit sales growth for the full year, including Repatha ® , TEZSPIRE ® , EVENITY ® , BLINCYTO ® and TAVNEOS ® .
- 21 products achieved record sales for the full year.
- GAAP earnings per share (EPS) decreased 18% from $1.42 to $1.16 for the fourth quarter, primarily driven by mark-to-market losses on our equity investments, partially offset by higher revenues. For the full year, GAAP EPS decreased 39% from $12.49 to $7.56 , primarily driven by higher operating expenses, including amortization expense from Horizon acquisition-related assets and incremental operating expenses from Horizon, and overall mark-to-market losses on our equity investments in 2024, partially offset by higher revenues.
- For the fourth quarter, GAAP operating income increased from $1.3 billion to $2.3 billion , and GAAP operating margin increased 10.3 percentage points to 26.5%. For the full year, GAAP operating income decreased from $7.9 billion to $7.3 billion , and GAAP operating margin decreased 6.6 percentage points to 22.7%.
- Non-GAAP EPS increased 13% from $4.71 to $5.31 for the fourth quarter, driven by higher revenues, partially offset by higher operating expenses. For the full year, non-GAAP EPS increased 6% from $18.65 to $19.84 , driven by higher revenues, partially offset by higher operating expenses, including incremental operating expenses from Horizon, and higher interest expense.
- For the fourth quarter, non-GAAP operating income increased from $3.7 billion to $4.0 billion , and non-GAAP operating margin decreased 0.4 percentage points to 46.3%. For the full year, non-GAAP operating income increased from $13.4 billion to $15.0 billion , and non-GAAP operating margin decreased 2.9 percentage points to 46.9%.
- The Company generated $10.4 billion of free cash flow for the full year versus $7.4 billion in 2023, driven by business performance and timing of working capital items, primarily collections, partially offset by higher net interest expense.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow), "EBITDA, or earnings before interest, taxes, depreciation and amortization" (computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income) and "debt leverage ratio" (calculated as the ratio of GAAP total debt to EBITDA) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
General Medicine
- Repatha ® (evolocumab) sales increased 45% year-over-year to $606 million in the fourth quarter, primarily driven by volume growth. Full year sales increased 36%, primarily driven by 43% volume growth, partially offset by 10% lower net selling price. For 2025, we expect lower declines in net selling price.
- EVENITY ® (romosozumab-aqqg) sales increased 36% year-over-year to $431 million in the fourth quarter and 35% for the full year, driven by volume growth.
- Prolia ® (denosumab) sales increased 5% year-over-year to $1.2 billion in the fourth quarter and 8% for the full year, driven by volume growth. For 2025, we expect sales erosion driven by biosimilar competition.
Rare Disease
Except for TAVNEOS ® , the products listed below were added through the acquisition of Horizon on Oct. 6, 2023 .
- TEPEZZA ® (teprotumumab-trbw) generated $460 million of sales in the fourth quarter and $1.9 billion for the full year. TEPEZZA is the first and only approved treatment for thyroid eye disease (TED) in the U.S. and Japan .
- KRYSTEXXA ® (pegloticase) generated $346 million of sales in the fourth quarter and $1.2 billion for the full year. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout.
- UPLIZNA ® (inebilizumab-cdon) generated $101 million of sales in the fourth quarter and $379 million for the full year. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD).
- TAVNEOS ® (avacopan) generated $81 million of sales in the fourth quarter. Sales increased 84% year-over-year in the fourth quarter and 111% for the full year, primarily driven by volume growth. TAVNEOS is a first-in-class treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
- Ultra-Rare products , which consist of RAVICTI ® (glycerol phenylbutyrate) , PROCYSBI ® (cysteamine bitartrate) , ACTIMMUNE ® (interferon gamma-1b) , QUINSAIR ® (levofloxacin) and BUPHENYL ® (sodium phenylbutyrate) , generated $214 million of sales in the fourth quarter and $758 million for the full year.
Inflammation
- TEZSPIRE ® (tezepelumab-ekko) sales increased 67% year-over-year to $296 million in the fourth quarter and 71% for the full year, primarily driven by volume growth.
- Otezla ® (apremilast) sales decreased 1% year-over-year to $624 million in the fourth quarter, driven by 7% lower net selling price, partially offset by 5% volume growth. Sales decreased 3% for the full year, primarily driven by 8% lower net selling price, partially offset by 3% volume growth.
- Enbrel ® (etanercept) sales were flat year-over-year at $1.0 billion in the fourth quarter as 7% favorable changes to estimated sales deductions were offset by lower net selling price. Full year sales decreased 10%, driven by lower net selling price. For 2025, we expect continued declining net selling price and relatively flat volumes.
We expect Otezla and Enbrel to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles. - AMJEVITA ® /AMGEVITA™ (adalimumab) sales increased 84% year-over-year to $294 million in the fourth quarter and 22% for the full year, driven by volume growth, partially offset by lower net selling price.
Oncology
- BLINCYTO ® (blinatumomab) sales increased 58% year-over-year to $381 million in the fourth quarter and 41% for the full year, primarily driven by volume growth.
- Vectibix ® (panitumumab) sales decreased 2% year-over-year to $246 million in the fourth quarter, driven by 5% unfavorable foreign exchange impact and 4% lower volume, partially offset by higher net selling price. Sales increased 6% for the full year, driven by 8% higher net selling price and 4% volume growth, partially offset by unfavorable foreign exchange impact.
- KYPROLIS ® (carfilzomib) sales increased 6% year-over-year to $372 million in the fourth quarter and 7% for the full year, driven by volume growth outside the U.S.
- LUMAKRAS ® /LUMYKRAS™ (sotorasib) sales increased 10% year-over-year to $85 million in the fourth quarter, primarily driven by volume growth. Sales increased 25% for the full year, driven by volume growth and favorable changes to estimated sales deductions.
- XGEVA ® (denosumab) sales increased 6% year-over-year to $561 million in the fourth quarter, driven by volume growth. Sales increased 5% for the full year, driven by higher net selling price. For 2025, we expect sales erosion driven by biosimilar competition.
- Nplate ® (romiplostim) sales decreased 13% year-over-year to $337 million in the fourth quarter. Excluding a fourth quarter 2023 U.S. government order of $62 million , Nplate sales grew 4% year-over-year in the fourth quarter, driven by volume growth. Full year sales decreased 1%. U.S. government orders were $128 million in 2024 compared to $286 million in 2023. Excluding these U.S. government orders, Nplate sales grew 12% year-over-year for the full year, driven by 8% volume growth and 6% higher net selling price.
- IMDELLTRA ® (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE ® ) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
- MVASI ® (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year.
Established Products
- Our established products, which consist of EPOGEN ® (epoetin alfa) , Aranesp ® (darbepoetin alfa) , Parsabiv ® (etelcalcetide) and Neulasta ® (pegfilgrastim) , generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages | Q4 '24 | Q4 '23 | YOY Δ | |||||||
U.S | ROW | TOTAL | TOTAL | TOTAL | ||||||
Repatha ® | $ 315 | $ 291 | $ 606 | $ 417 | 45 % | |||||
EVENITY ® | 325 | 106 | 431 | 318 | 36 % | |||||
Prolia ® | 775 | 390 | 1,165 | 1,107 | 5 % | |||||
TEPEZZA ®(1) | 456 | 4 | 460 | 448 | 3 % | |||||
KRYSTEXXA ®(1) | 346 | — | 346 | 272 | 27 % | |||||
UPLIZNA ®(1) | 93 | 8 | 101 | 65 | 55 % | |||||
TAVNEOS ® | 76 | 5 | 81 | 44 | 84 % | |||||
Ultra-Rare products (1) | 205 | 9 | 214 | 164 | 30 % | |||||
TEZSPIRE ® | 296 | — | 296 | 177 | 67 % | |||||
Otezla ® | 514 | 110 | 624 | 629 | (1 %) | |||||
Enbrel ® | 1,008 | 7 | 1,015 | 1,015 | — % | |||||
AMJEVITA ® /AMGEVITA ™ | 153 | 141 | 294 | 160 | 84 % | |||||
BLINCYTO ® | 245 | 136 | 381 | 241 | 58 % | |||||
Vectibix ® | 134 | 112 | 246 | 251 | (2 %) | |||||
KYPROLIS ® | 236 | 136 | 372 | 350 | 6 % | |||||
LUMAKRAS ® /LUMYKRAS ™ | 53 | 32 | 85 | 77 | 10 % | |||||
XGEVA ® | 369 | 192 | 561 | 527 | 6 % | |||||
Nplate ® | 221 | 116 | 337 | 386 | (13 %) | |||||
IMDELLTRA ® | 67 | — | 67 | — | N/A | |||||
MVASI ® | 108 | 65 | 173 | 188 | (8 %) | |||||
EPOGEN ® | 19 | — | 19 | 55 | (65 %) | |||||
Aranesp ® | 90 | 218 | 308 | 319 | (3 %) | |||||
Parsabiv ® | 39 | 36 | 75 | 89 | (16 %) | |||||
Neulasta ® | 72 | 26 | 98 | 239 | (59 %) | |||||
Other products (2) | 294 | 67 | 361 | 295 | 22 % | |||||
Total product sales | $ 6,509 | $ 2,207 | $ 8,716 | $ 7,833 | 11 % | |||||
N/A = not applicable | ||||||||||
(1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , | ||||||||||
(2) Consists of (i) Aimovig ® , KANJINTI ® , AVSOLA ® , RIABNI ® , PAVBLU ™ , NEUPOGEN ® , WEZLANA ™ /WEZENLA ™ , |
$Millions, except percentages | FY '24 | FY '23 | YOY Δ | |||||||
US | ROW | TOTAL | TOTAL | TOTAL | ||||||
Repatha ® | $ 1,139 | $ 1,083 | $ 2,222 | $ 1,635 | 36 % | |||||
EVENITY ® | 1,131 | 432 | 1,563 | 1,160 | 35 % | |||||
Prolia ® | 2,885 | 1,489 | 4,374 | 4,048 | 8 % | |||||
TEPEZZA ®(1) | 1,835 | 16 | 1,851 | 448 | * | |||||
KRYSTEXXA ®(1) | 1,185 | — | 1,185 | 272 | * | |||||
UPLIZNA ®(1) | 314 | 65 | 379 | 65 | * | |||||
TAVNEOS ® | 256 | 27 | 283 | 134 | * | |||||
Ultra-Rare products (1) | 726 | 32 | 758 | 164 | * | |||||
TEZSPIRE ® | 972 | — | 972 | 567 | 71 % | |||||
Otezla ® | 1,699 | 427 | 2,126 | 2,188 | (3 %) | |||||
Enbrel ® | 3,288 | 28 | 3,316 | 3,697 | (10 %) | |||||
AMJEVITA ® /AMGEVITA ™ | 202 | 559 | 761 | 626 | 22 % | |||||
BLINCYTO ® | 800 | 416 | 1,216 | 861 | 41 % | |||||
Vectibix ® | 519 | 526 | 1,045 | 984 | 6 % | |||||
KYPROLIS ® | 948 | 555 | 1,503 | 1,403 | 7 % | |||||
LUMAKRAS ® /LUMYKRAS ™ | 214 | 136 | 350 | 280 | 25 % | |||||
XGEVA ® | 1,507 | 718 | 2,225 | 2,112 | 5 % | |||||
Nplate ® | 970 | 486 | 1,456 | 1,477 | (1 %) | |||||
IMDELLTRA ® | 115 | — | 115 | — | N/A | |||||
MVASI ® | 449 | 278 | 727 | 800 | (9 %) | |||||
EPOGEN ® | 125 | — | 125 | 226 | (45 %) | |||||
Aranesp ® | 386 | 956 | 1,342 | 1,362 | (1 %) | |||||
Parsabiv ® | 203 | 153 | 356 | 362 | (2 %) | |||||
Neulasta ® | 318 | 113 | 431 | 848 | (49 %) | |||||
Other products (2) | 1,115 | 230 | 1,345 | 1,191 | 13 % | |||||
Total product sales | $ 23,301 | $ 8,725 | $ 32,026 | $ 26,910 | 19 % | |||||
* Change in excess of 100% | ||||||||||
N/A = not applicable | ||||||||||
(1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , | ||||||||||
(2) Consists of (i)Aimovig ® ,KANJINTI ® ,RIABNI ® ,AVSOLA ® ,NEUPOGEN ® ,Corlanor ® , IMLYGIC ® ,BEKEMV ™ , |
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
- Total Operating Expenses decreased 2% year-over-year for the fourth quarter and increased 29% for the full year. Cost of Sales as a percentage of product sales decreased 4.0 percentage points for the fourth quarter primarily driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon, partially offset by changes in our sales mix, and higher profit share and royalty expense. For the full year, cost of sales as a percentage of product sales increased 8.7 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. Research & Development (R&D) expenses increased 12% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower research and early pipeline spend. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses decreased 17% for the fourth quarter primarily driven by lower Horizon acquisition-related expenses. SG&A expenses increased 15% for the full year primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower Horizon acquisition-related expenses incurred in 2024. Other operating expenses for the full year primarily consisted of impairment charges associated with in-process R&D (IPR&D) intangible assets related to our Teneobio, Inc. acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024.
- Operating Margin as a percentage of product sales increased 10.3 percentage points to 26.5% for the fourth quarter and decreased 6.6 percentage points to 22.7% for the full year.
- Tax Rate increased 9.8 percentage points in the fourth quarter and decreased 3.2 percentage points for the full year. The fourth quarter tax rate increase was related to deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries and prior year favorable items, partially offset by the change in earnings mix as a result of the fourth quarter 2024 unrealized losses on our strategic equity investments (primarily BeiGene). The full year tax rate decrease was due to the change in earnings mix, including the net unrealized impacts of our strategic equity investments (primarily BeiGene), partially offset by the deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries.
On a non-GAAP basis:
- Total Operating Expenses increased 11% year-over-year for the fourth quarter and increased 24% for the full year. Cost of Sales as a percentage of product sales increased 1.3 percentage points for the fourth quarter driven by changes in our sales mix, and higher profit share and royalty expense. Cost of sales as a percentage of product sales increased 0.9 percentage points for the full year driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 14% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower spend in research and early pipeline. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. SG&A expenses increased 3% for the fourth quarter driven by higher general and administrative expenses. SG&A expenses increased 23% for the full year primarily driven by expenses from the acquired Horizon business and other marketed product expenses.
- Operating Margin as a percentage of product sales decreased 0.4 percentage points to 46.3% for the fourth quarter and decreased 2.9 percentage points to 46.9% for the full year.
- Tax Rate decreased 1.1 percentage points for the fourth quarter and decreased 2.0 percentage points for the full year. The fourth quarter tax rate decrease was primarily due to the change in earnings mix and net favorable items as compared to the prior year. The full year tax rate decrease was primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items as compared to the prior year.
$Millions, except percentages | GAAP | Non-GAAP | ||||||||||
Q4 '24 | Q4 '23 | YOY Δ | Q4 '24 | Q4 '23 | YOY Δ | |||||||
Cost of Sales | $ 3,112 | $ 3,112 | — % | $ 1,536 | $ 1,278 | 20 % | ||||||
% of product sales | 35.7 % | 39.7 % | (4.0) pts | 17.6 % | 16.3 % | 1.3 pts | ||||||
Research & Development | $ 1,724 | $ 1,534 | 12 % | $ 1,698 | $ 1,494 | 14 % | ||||||
% of product sales | 19.8 % | 19.6 % | 0.2 pts | 19.5 % | 19.1 % | 0.4 pts | ||||||
Selling, General & Administrative | $ 1,878 | $ 2,274 | (17 %) | $ 1,819 | $ 1,764 | 3 % | ||||||
% of product sales | 21.5 % | 29.0 % | (7.5) pts | 20.9 % | 22.5 % | (1.6) pts | ||||||
Other | $ 61 | $ 5 | * | $ — | $ — | N/A | ||||||
Total Operating Expenses | $ 6,775 | $ 6,925 | (2 %) | $ 5,053 | $ 4,536 | 11 % | ||||||
Operating Margin | ||||||||||||
operating income as % of product sales | 26.5 % | 16.2 % | 10.3 pts | 46.3 % | 46.7 % | (0.4) pts | ||||||
Tax Rate | 19.8 % | 10.0 % | 9.8 pts | 14.8 % | 15.9 % | (1.1) pts | ||||||
pts: percentage points | ||||||||||||
* change in excess of 100% | ||||||||||||
N/A = not applicable | ||||||||||||
$Millions, except percentages | GAAP | Non-GAAP | ||||||||||
FY '24 | FY '23 | YOY Δ | FY '24 | FY '23 | YOY Δ | |||||||
Cost of Sales | $ 12,858 | $ 8,451 | 52 % | $ 5,736 | $ 4,573 | 25 % | ||||||
% of product sales | 40.1 % | 31.4 % | 8.7 pts | 17.9 % | 17.0 % | 0.9 pts | ||||||
Research & Development | $ 5,964 | $ 4,784 | 25 % | $ 5,878 | $ 4,700 | 25 % | ||||||
% of product sales | 18.6 % | 17.8 % | 0.8 pts | 18.4 % | 17.5 % | 0.9 pts | ||||||
Selling, General & Administrative | $ 7,096 | $ 6,179 | 15 % | $ 6,782 | $ 5,518 | 23 % | ||||||
% of product sales | 22.2 % | 23.0 % | (0.8) pts | 21.2 % | 20.5 % | 0.7 pts | ||||||
Other | $ 248 | $ 879 | (72 %) | $ — | $ — | N/A | ||||||
Total Operating Expenses | $ 26,166 | $ 20,293 | 29 % | $ 18,396 | $ 14,791 | 24 % | ||||||
Operating Margin | ||||||||||||
operating income as % of product sales | 22.7 % | 29.3 % | (6.6) pts | 46.9 % | 49.8 % | (2.9) pts | ||||||
Tax Rate | 11.3 % | 14.5 % | (3.2) pts | 14.5 % | 16.5 % | (2.0) pts | ||||||
pts: percentage points | ||||||||||||
N/A = not applicable |
Cash Flow and Balance Sheet
- The Company generated a record $4.4 billion of free cash flow in the fourth quarter of 2024 versus $0.3 billion in the fourth quarter of 2023, driven by timing of tax payments, timing of working capital, primarily collections, lower transaction expenses compared to the fourth quarter of 2023, which included significant costs tied to the closing of the Horizon acquisition, and business performance. The Company generated $10.4 billion of free cash flow for the full year 2024 versus $7.4 billion in 2023.
- The Company's fourth quarter 2024 dividend of $2.25 per share was declared on October 25, 2024, and was paid on December 9, 2024, to all stockholders of record as of November 18, 2024, representing a 6% increase from the same period in 2023.
- During the fourth quarter, there were no repayments or extinguishments of debt. For the full year 2024, the Company reduced principal debt outstanding by $4 .5 billion.
- For the fourth quarter and full year, the Company repurchased 0.7 million shares of common stock at a total cost of $200 million .
- Cash and investments totaled $12.0 billion and debt outstanding totaled $60.1 billion as of December 31, 2024 . Debt leverage was approximately 4.5 times EBITDA as of December 31, 2024 .
$Billions, except shares | Q4 '24 | Q4 '23 | YOY Δ | FY '24 | FY '23 | YOY Δ | ||||||
Operating Cash Flow | $ 4.8 | $ 0.5 | $ 4.2 | $ 11.5 | $ 8.5 | $ 3.0 | ||||||
Capital Expenditures | $ 0.4 | $ 0.2 | $ 0.1 | $ 1.1 | $ 1.1 | $ 0.0 | ||||||
Free Cash Flow | $ 4.4 | $ 0.3 | $ 4.1 | $ 10.4 | $ 7.4 | $ 3.0 | ||||||
Dividends Paid | $ 1.2 | $ 1.1 | $ 0.1 | $ 4.8 | $ 4.6 | $ 0.3 | ||||||
Share Repurchases | $ 0.2 | $ — | $ 0.2 | $ 0.2 | $ — | $ 0.2 | ||||||
Average Diluted Shares (millions) | 542 | 540 | 2 | 541 | 538 | 3 | ||||||
Note: Numbers may not add due to rounding |
$Billions | 12/31/24 | 12/31/23 | YTD Δ | |||
Cash and Investments | $ 12.0 | $ 10.9 | $ 1.0 | |||
Debt Outstanding | $ 60.1 | $ 64.6 | $ (4.5) | |||
Note: Numbers may not add due to rounding |
2025 Guidance
For the full year 2025, the Company expects:
- Total revenues in the range of $34 .3 billion to $35 .7 billion.
- On a GAAP basis, EPS in the range of $10.89 to $12.14 , and a tax rate in the range of 11.0% to 12.5%.
- On a non-GAAP basis, EPS in the range of $20.00 to $21.20 , and a tax rate in the range of 15.0% to 16.0%.
- Capital expenditures to be approximately $2 .3 billion.
- Share repurchases not to exceed $500 million.
Fourth Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General Medicine
MariTide (maridebart cafraglutide, AMG 133)
- MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR).
- In November 2024 , data were presented from Part 1 of a Phase 2 chronic weight management study in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. MariTide demonstrated robust weight loss at 52 weeks without a weight loss plateau, significant improvements in cardiometabolic parameters, and is the first obesity treatment with monthly or less frequent dosing to demonstrate safe and effective weight loss in a Phase 2 study.
- Part 2 of the Phase 2 chronic weight management study is ongoing in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025.
- A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus is enrolling adults living with and without obesity. Data readout is anticipated in H2 2025.
- Planning for MARITIME, a broad Phase 3 program across multiple indications remains on track with the first studies expected to begin in H1 2025.
AMG 513
- A Phase 1 study of AMG 513 in people living with obesity was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Discussions are underway on a path forward to reopen the study.
Olpasiran (AMG 890)
- Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
- The OCEAN(a)-Outcomes trial, a Phase 3 cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
- A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a CV event is expected to be initiated in H2 2025 / H1 2026.
Repatha
- VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
- EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Rare Disease
TAVNEOS
- A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to
TEPEZZA
- Regulatory review is underway in multiple additional geographies including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025.
- A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic or low clinical activity score TED.
- A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED.
KRYSTEXXA
- Data were presented in November 2024 from the AGILE study evaluating the safety, tolerability and efficacy of KRYSTEXXA administered with a shorter infusion duration in patients with uncontrolled gout receiving methotrexate as co-administration:
- Safety and efficacy data from the 60-minute infusion duration cohort of the AGILE trial are similar to the MIRROR randomized clinical trial and current administration of KRYSTEXXA with methotrexate over at least 120 minutes.
- U.S. Regulatory filing for AGILE is underway.
UPLIZNA
- In January 2025, the FDA granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG) based upon data from the Phase 3 MINT study. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025.
- In November 2024, data were presented and simultaneously published in the New England Journal of Medicine from the Phase 3 MITIGATE study evaluating UPLIZNA compared to placebo in patients with immunoglobin G4-related disease (IgG4-RD). In this study, UPLIZNA demonstrated a statistically significant 87% reduction in IgG4-RD flares, this primary endpoint and all key secondary endpoints were met. The safety results in the placebo-controlled period were consistent with the established safety profile of UPLIZNA.
- The FDA accepted the regulatory submission for the Phase 3 MITIGATE study under priority review with a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2025.
Dazodalibep
- Dazodalibep is a fusion protein that inhibits CD40L.
- Two Phase 3 studies of dazodalibep in Sjögren's disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab
- Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
- A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
- A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
Fipaxalparant
- Fipaxalparant is a lysophosphatidic acid receptor 1 (LPAR1) antagonist.
- A Phase 2 study of fipaxalparant in patients with diffuse cutaneous systemic sclerosis is complete. The study did not meet the primary or secondary endpoints. Further development of fipaxalparant in this indication will be discontinued.
Inflammation
TEZSPIRE
- The Company is planning to initiate Phase 3 studies in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. Study initiation is anticipated in H1 2025.
- In December, the Company announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps:
- Patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
- The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine.
- Regulatory submission is anticipated in H1 2025.
- A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis.
- In severe asthma, the WAYFINDER Phase 3b study is complete and the PASSAGE Phase 4 real-world effectiveness study is ongoing. The SUNRISE Phase 3 study will be discontinued due to limited enrollment.
Rocatinlimab (AMG 451/KHK4083)
- Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor.
- The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3300 patients. Enrollment is now complete in seven studies.
- Key milestones from the ROCKET Phase 3 program:
- ROCKET SHUTTLE is a 24-week study evaluating rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
- ROCKET IGNITE is a 24-week study evaluating rocatinlimab monotherapy in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
- ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
- ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
- A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
- A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis.
Otezla
- In November 2024, we made six data presentations at the American College of Rheumatology (ACR). Notable highlights include:
- Otezla reduces axial inflammation in patients with psoriatic arthritis (PsA) as assessed by CANDEN Magnetic Resonance Imaging Scoring, results From the Phase 4 MOSAIC study.
- FOREMOST oligoarticular PsA data presentations (4 posters), including 48-week data and data at 16 weeks showing that Otezla was associated with fewer patients progressing from 4 active joints when compared to placebo suggesting that Otezla reduced the progression from oligoarticular to polyarticular PsA.
Blinatumomab
- Blinatumomab is a BiTE molecule targeting CD19.
- A Phase 2 study of blinatumomab in autoimmune disease was initiated in patients with systemic lupus erythematosus (SLE).
Inebilizumab
- Inebilizumab is a monoclonal antibody targeting CD19.
- A Phase 2 study of inebilizumab in autoimmune disease was initiated in patients with SLE.
Ordesekimab (AMG 714/PRV-015)
- Ordesekimab is a monoclonal antibody that binds interleukin-15.
- A Phase 2b study of ordesekimab, conducted by Provention Bio, a Sanofi Company, in patients with nonresponsive celiac disease was completed as planned and did not meet primary or secondary endpoints. No safety concerns were noted.
AMG 104 (AZD8630)
- AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
- A Phase 2 study is enrolling patients with asthma.
Oncology
BLINCYTO
- In December 2024 , data from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group, were presented and simultaneously published in the New England Journal of Medicine . These data demonstrated that BLINCYTO added to chemotherapy significantly improves disease-free survival in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell precursor acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
- Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Philadelphia chromosome (Ph)-negative B-ALL.
- A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Ph-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025.
IMDELLTRA
- IMDELLTRA is a first-in-class delta-like ligand 3 (DLL3) targeting BiTE molecule.
- In 2024, IMDELLTRA received accelerated approval in the U.S. for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Marketing authorizations have subsequently been granted in Japan and in additional countries, including Canada , Brazil , Israel and Great Britain .
- The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage small cell lung cancer (SCLC):
- DeLLphi-304, a Phase 3 study of IMDELLTRA in second-line ES-SCLC, is ongoing. Data readout is anticipated in H1 2025.
- DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is enrolling patients with first-line ES-SCLC in the maintenance setting.
- DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC.
- DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
- DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, was initiated.
- DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC.
Xaluritamig (AMG 509)
- Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
- A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
- A Phase 1 monotherapy dose-expansion study of xaluritamig is enrolling mCRPC patients who have not yet received taxane-based chemotherapy and to enroll patients in a fully outpatient treatment setting to further improve administration convenience.
- A Phase 1 combination of xaluritamig with enzalutamide or abiraterone is enrolling patients with mCRPC in dose-escalation and dose-expansion respectively.
- A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer.
- A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
AMG 193
- AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
- A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
- A Phase 1/ 1b /2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
- A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
- A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract, and pancreatic cancers.
- A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients with advanced MTAP-null solid tumors.
Bemarituzumab
- Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
- FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in H1 2025.
- FORTITUDE-102, a Phase 1b /3 study of bemarituzumab plus chemotherapy and nivolumab is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025.
- FORTITUDE-103, a Phase 1b /2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
- FORTITUDE-301, a Phase 1b /2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
LUMAKRAS/LUMYKRAS
- In January 2025 , the FDA approved LUMAKRAS in combination with Vectibix as a targeted, biomarker-driven combination therapy for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
- CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC.
- Regulatory review by the EMA of the CodeBreaK 200 Phase 3 study of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC concluded with the conditional status of marketing authorization maintained.
- CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
- The ongoing CB202 study is being conducted to serve as confirmatory study and to support conversion of accelerated/conditional approval to full approval, in the US, EU and other regions where applicable.
Nplate
- The primary analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. The Company continues to follow patients through a planned final analysis in H1 2025. Data presentation at a medical congress is anticipated in mid-2025.
Biosimilars
- A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO ® (nivolumab) is enrolling patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
- A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
- A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA ® (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment.
- A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer.
- A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 and OCREVUS ® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio, a Sanofi Company. For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating results for the fourth quarters and full years of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and debt leverage ratio for 2024, both of which are non-GAAP financial measures. EBITDA is computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income. Debt leverage ratio is calculated as the ratio of GAAP total debt to EBITDA.
The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company believes its debt leverage ratio provides a supplemental operating metric for the full year period as it compares the amount of cash generated by our operations for the year.
The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads .
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
Amgen Inc. | |||||||
Consolidated Statements of Income - GAAP | |||||||
(In millions, except per-share data) | |||||||
(Unaudited) | |||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Revenues: | |||||||
Product sales | $ 8,716 | $ 7,833 | $ 32,026 | $ 26,910 | |||
Other revenues | 370 | 363 | 1,398 | 1,280 | |||
Total revenues | 9,086 | 8,196 | 33,424 | 28,190 | |||
Operating expenses: | |||||||
Cost of sales | 3,112 | 3,112 | 12,858 | 8,451 | |||
Research and development | 1,724 | 1,534 | 5,964 | 4,784 | |||
Selling, general and administrative | 1,878 | 2,274 | 7,096 | 6,179 | |||
Other | 61 | 5 | 248 | 879 | |||
Total operating expenses | 6,775 | 6,925 | 26,166 | 20,293 | |||
Operating income | 2,311 | 1,271 | 7,258 | 7,897 | |||
Other income (expense): | |||||||
Interest expense, net | (747) | (821) | (3,155) | (2,875) | |||
Other (expense) income, net | (782) | 402 | 506 | 2,833 | |||
Income before income taxes | 782 | 852 | 4,609 | 7,855 | |||
Provision for income taxes | 155 | 85 | 519 | 1,138 | |||
Net income | $ 627 | $ 767 | $ 4,090 | $ 6,717 | |||
Earnings per share: | |||||||
Basic | $ 1.17 | $ 1.43 | $ 7.62 | $ 12.56 | |||
Diluted | $ 1.16 | $ 1.42 | $ 7.56 | $ 12.49 | |||
Weighted-average shares used in calculation of earnings per share: | |||||||
Basic | 537 | 535 | 537 | 535 | |||
Diluted | 542 | 540 | 541 | 538 |
Amgen Inc. | |||
Consolidated Balance Sheets - GAAP | |||
(In millions) | |||
December 31, | December 31, | ||
2024 | 2023 | ||
(Unaudited) | |||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 11,973 | $ 10,944 | |
Trade receivables, net | 6,782 | 7,268 | |
Inventories | 6,998 | 9,518 | |
Other current assets | 3,277 | 2,602 | |
Total current assets | 29,030 | 30,332 | |
Property, plant and equipment, net | 6,543 | 5,941 | |
Intangible assets, net | 27,699 | 32,641 | |
Goodwill | 18,637 | 18,629 | |
Other noncurrent assets | 9,930 | 9,611 | |
Total assets | $ 91,839 | $ 97,154 | |
Liabilities and Stockholders' Equity | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 19,549 | $ 16,949 | |
Current portion of long-term debt | 3,550 | 1,443 | |
Total current liabilities | 23,099 | 18,392 | |
Long-term debt | 56,549 | 63,170 | |
Long-term deferred tax liabilities | 1,616 | 2,354 | |
Long-term tax liabilities | 2,349 | 4,680 | |
Other noncurrent liabilities | 2,349 | 2,326 | |
Total stockholders' equity | 5,877 | 6,232 | |
Total liabilities and stockholders' equity | $ 91,839 | $ 97,154 | |
Shares outstanding | 537 | 535 |
Amgen Inc. | |||||||
GAAP to Non-GAAP Reconciliations | |||||||
(Dollars in millions) | |||||||
(Unaudited) | |||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP cost of sales | $ 3,112 | $ 3,112 | $ 12,858 | $ 8,451 | |||
Adjustments to cost of sales: | |||||||
Acquisition-related expenses (a) | (1,576) | (1,834) | (7,122) | (3,842) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | — | — | — | (36) | |||
Total adjustments to cost of sales | (1,576) | (1,834) | (7,122) | (3,878) | |||
Non-GAAP cost of sales | $ 1,536 | $ 1,278 | $ 5,736 | $ 4,573 | |||
GAAP cost of sales as a percentage of product sales | 35.7 % | 39.7 % | 40.1 % | 31.4 % | |||
Acquisition-related expenses (a) | (18.1) | (23.4) | (22.2) | (14.3) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | 0.0 | 0.0 | 0.0 | (0.1) | |||
Non-GAAP cost of sales as a percentage of product sales | 17.6 % | 16.3 % | 17.9 % | 17.0 % | |||
GAAP research and development expenses | $ 1,724 | $ 1,534 | $ 5,964 | $ 4,784 | |||
Adjustments to research and development expenses: | |||||||
Acquisition-related expenses (b) | (26) | (28) | (86) | (55) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | — | (12) | — | (29) | |||
Total adjustments to research and development expenses | (26) | (40) | (86) | (84) | |||
Non-GAAP research and development expenses | $ 1,698 | $ 1,494 | $ 5,878 | $ 4,700 | |||
GAAP research and development expenses as a percentage of product sales | 19.8 % | 19.6 % | 18.6 % | 17.8 % | |||
Acquisition-related expenses (b) | (0.3) | (0.3) | (0.2) | (0.2) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | 0.0 | (0.2) | 0.0 | (0.1) | |||
Non-GAAP research and development expenses as a percentage of product sales | 19.5 % | 19.1 % | 18.4 % | 17.5 % | |||
GAAP selling, general and administrative expenses | $ 1,878 | $ 2,274 | $ 7,096 | $ 6,179 | |||
Adjustments to selling, general and administrative expenses: | |||||||
Acquisition-related expenses (c) | (59) | (510) | (314) | (648) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | — | — | — | (13) | |||
Total adjustments to selling, general and administrative expenses | (59) | (510) | (314) | (661) | |||
Non-GAAP selling, general and administrative expenses | $ 1,819 | $ 1,764 | $ 6,782 | $ 5,518 | |||
GAAP selling, general and administrative expenses as a percentage of product sales | 21.5 % | 29.0 % | 22.2 % | 23.0 % | |||
Acquisition-related expenses (c) | (0.6) | (6.5) | (1.0) | (2.4) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives | 0.0 | 0.0 | 0.0 | (0.1) | |||
Non-GAAP selling, general and administrative expenses as a percentage of product sales | 20.9 % | 22.5 % | 21.2 % | 20.5 % | |||
GAAP operating expenses | $ 6,775 | $ 6,925 | $ 26,166 | $ 20,293 | |||
Adjustments to operating expenses: | |||||||
Adjustments to cost of sales | (1,576) | (1,834) | (7,122) | (3,878) | |||
Adjustments to research and development expenses | (26) | (40) | (86) | (84) | |||
Adjustments to selling, general and administrative expenses | (59) | (510) | (314) | (661) | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives (d) | (40) | (2) | (36) | (185) | |||
Certain other expenses (e) | (21) | (3) | (212) | (694) | |||
Total adjustments to operating expenses | (1,722) | (2,389) | (7,770) | (5,502) | |||
Non-GAAP operating expenses | $ 5,053 | $ 4,536 | $ 18,396 | $ 14,791 | |||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
GAAP operating income | $ 2,311 | $ 1,271 | $ 7,258 | $ 7,897 | |||
Adjustments to operating expenses | 1,722 | 2,389 | 7,770 | 5,502 | |||
Non-GAAP operating income | $ 4,033 | $ 3,660 | $ 15,028 | $ 13,399 | |||
GAAP operating income as a percentage of product sales | 26.5 % | 16.2 % | 22.7 % | 29.3 % | |||
Adjustments to cost of sales | 18.1 | 23.4 | 22.2 | 14.4 | |||
Adjustments to research and development expenses | 0.3 | 0.4 | 0.2 | 0.3 | |||
Adjustments to selling, general and administrative expenses | 0.6 | 6.5 | 1.0 | 2.6 | |||
Certain net charges pursuant to our restructuring and cost-savings initiatives (d) | 0.5 | 0.1 | 0.1 | 0.7 | |||
Certain other expenses (e) | 0.3 | 0.1 | 0.7 | 2.5 | |||
Non-GAAP operating income as a percentage of product sales | 46.3 % | 46.7 % | 46.9 % | 49.8 % | |||
GAAP interest expense, net | $ (747) | $ (821) | $ (3,155) | $ (2,875) | |||
Adjustments to interest expense, net: | |||||||
Interest expense on acquisition-related debt (f) | — | 19 | — | 807 | |||
Non-GAAP interest expense, net | $ (747) | $ (802) | $ (3,155) | $ (2,068) | |||
GAAP other (expense) income, net | $ (782) | $ 402 | $ 506 | $ 2,833 | |||
Adjustments to other (expense) income, net | |||||||
Interest income and other expenses on acquisition-related debt (f) | — | (18) | — | (625) | |||
Net losses (gains) from equity investments (g) | 875 | (217) | 182 | (1,522) | |||
Total adjustments to other (expense) income, net | 875 | (235) | 182 | (2,147) | |||
Non-GAAP other income, net | $ 93 | $ 167 | $ 688 | $ 686 | |||
GAAP income before income taxes | $ 782 | $ 852 | $ 4,609 | $ 7,855 | |||
Adjustments to income before income taxes: | |||||||
Adjustments to operating expenses | 1,722 | 2,389 | 7,770 | 5,502 | |||
Adjustments to interest expense, net | — | 19 | — | 807 | |||
Adjustments to other income, net | 875 | (235) | 182 | (2,147) | |||
Total adjustments to income before income taxes | 2,597 | 2,173 | 7,952 | 4,162 | |||
Non-GAAP income before income taxes | $ 3,379 | $ 3,025 | $ 12,561 | $ 12,017 | |||
GAAP provision for income taxes | $ 155 | $ 85 | $ 519 | $ 1,138 | |||
Adjustments to provision for income taxes: | |||||||
Income tax effect of the above adjustments (h) | 537 | 404 | 1,544 | 846 | |||
Other income tax adjustments (i) | (192) | (7) | (236) | (1) | |||
Total adjustments to provision for income taxes | 345 | 397 | 1,308 | 845 | |||
Non-GAAP provision for income taxes | $ 500 | $ 482 | $ 1,827 | $ 1,983 | |||
GAAP tax as a percentage of income before taxes | 19.8 % | 10.0 % | 11.3 % | 14.5 % | |||
Adjustments to provision for income taxes: | |||||||
Income tax effect of the above adjustments (h) | 0.7 | 6.1 | 5.1 | 2.0 | |||
Other income tax adjustments (i) | (5.7) | (0.2) | (1.9) | 0.0 | |||
Total adjustments to provision for income taxes | (5.0) | 5.9 | 3.2 | 2.0 | |||
Non-GAAP tax as a percentage of income before taxes | 14.8 % | 15.9 % | 14.5 % | 16.5 % | |||
GAAP net income | $ 627 | $ 767 | $ 4,090 | $ 6,717 | |||
Adjustments to net income: | |||||||
Adjustments to income before income taxes, net of the income tax effect | 2,060 | 1,769 | 6,408 | 3,316 | |||
Other income tax adjustments (i) | 192 | 7 | 236 | 1 | |||
Total adjustments to net income | 2,252 | 1,776 | 6,644 | 3,317 | |||
Non-GAAP net income | $ 2,879 | $ 2,543 | $ 10,734 | $ 10,034 | |||
Note: Numbers may not add due to rounding |
Amgen Inc. | |||||||
GAAP to Non-GAAP Reconciliations | |||||||
(In millions, except per-share data) | |||||||
(Unaudited) | |||||||
The following table presents the computations for GAAP and non-GAAP diluted earnings per share: | |||||||
Three months ended December 31, 2024 | Three months ended December 31, 2023 | ||||||
GAAP | Non-GAAP | GAAP | Non-GAAP | ||||
Net income | $ 627 | $ 2,879 | $ 767 | $ 2,543 | |||
Weighted-average shares for diluted EPS | 542 | 542 | 540 | 540 | |||
Diluted EPS | $ 1.16 | $ 5.31 | $ 1.42 | $ 4.71 | |||
Twelve months ended December 31, 2024 | Twelve months ended December 31, 2023 | ||||||
GAAP | Non-GAAP | GAAP | Non-GAAP | ||||
Net income | $ 4,090 | $ 10,734 | $ 6,717 | $ 10,034 | |||
Weighted-average shares for diluted EPS | 541 | 541 | 538 | 538 | |||
Diluted EPS | $ 7.56 | $ 19.84 | $ 12.49 | $ 18.65 |
(a) | The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions. | |
(b) | For the three and twelve months ended December 31, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three months ended December 31, 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the twelve months ended December 31, 2023, the adjustments related primarily to noncash amortization of intangible assets acquired from business acquisitions. | |
(c) | For the three and twelve months ended December 31, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. | |
(d) | For the three and twelve months ended December 31, 2024 and 2023, the adjustments related to separation costs associated with our restructuring plan and other cost-savings initiatives. | |
(e) | For the twelve months ended December 31, 2024, the adjustments related primarily to impairment charges for IPR&D intangible assets related to our Teneobio, Inc. acquisition from 2021. For the twelve months ended December 31, 2023, the adjustments related primarily to a net IPR&D intangible asset impairment charge for AMG 340. | |
(f) | For the three and twelve months ended December 31, 2023, the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon. | |
(g) | For the three and twelve months ended December 31, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the twelve months ended December 31, 2023, the adjustments related primarily to our BeiGene equity fair value adjustment. | |
(h) | The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and twelve months ended December 31, 2024, was 20.7% and 19.4%, respectively, compared to 18.6% and 20.3% for the corresponding periods of the prior year. | |
(i) | The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings. |
Amgen Inc. | |||||||
Reconciliations of Cash Flows | |||||||
(In millions) | |||||||
(Unaudited) | |||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Net cash provided by operating activities | $ 4,771 | $ 538 | $ 11,490 | $ 8,471 | |||
Net cash used in investing activities | (402) | (27,089) | (1,046) | (26,204) | |||
Net cash (used in) provided by financing activities | (1,407) | 2,754 | (9,415) | 21,048 | |||
Increase (decrease) in cash and cash equivalents | 2,962 | (23,797) | 1,029 | 3,315 | |||
Cash and cash equivalents at beginning of period | 9,011 | 34,741 | 10,944 | 7,629 | |||
Cash and cash equivalents at end of period | $ 11,973 | $ 10,944 | $ 11,973 | $ 10,944 | |||
Three months ended December 31, | Twelve months ended December 31, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Net cash provided by operating activities | $ 4,771 | $ 538 | $ 11,490 | $ 8,471 | |||
Capital expenditures | (371) | (249) | (1,096) | (1,112) | |||
Free cash flow | $ 4,400 | $ 289 | $ 10,394 | $ 7,359 |
Amgen Inc. | |
Reconciliation of GAAP Net Income to EBITDA and Debt Leverage Ratio Calculation | |
(Dollars in millions) | |
(Unaudited) | |
Twelve months ended | |
GAAP Net Income | $ 4,090 |
Depreciation and amortization | 5,592 |
Interest expense, net | 3,155 |
Provision for income taxes | 519 |
EBITDA (a) | $ 13,356 |
As of December 31, 2024 | |
Current portion of long-term debt | $ 3,550 |
Long-term debt | 56,549 |
Total GAAP Debt | $ 60,099 |
As of December 31, 2024 | |
Total GAAP Debt | $ 60,099 |
EBITDA | $ 13,356 |
Debt leverage ratio | 4.5 |
(a) | 2024 EBITDA includes amortization of inventory step-up of $2.4 billion and net losses from equity investments of $182 million. |
Amgen Inc. | ||||
Reconciliation of GAAP EPS Guidance to Non-GAAP | ||||
EPS Guidance for the Year Ending December 31, 2025 | ||||
(Unaudited) | ||||
GAAP diluted EPS guidance | $ 10.89 | — | $ 12.14 | |
Known adjustments to arrive at non-GAAP*: | ||||
Acquisition-related expenses (a) | 9.06 | — | 9.11 | |
Non-GAAP diluted EPS guidance | $ 20.00 | — | $ 21.20 |
* The known adjustments are presented net of their related tax impact, which amount to approximately $1.54 per share. |
(a) The adjustments include noncash amortization of intangible assets and fair value step-up of inventory acquired in business acquisitions. |
Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments.
Reconciliation of GAAP Tax Rate Guidance to Non-GAAP | ||||
Tax Rate Guidance for the Year Ending December 31, 2025 | ||||
(Unaudited) | ||||
GAAP tax rate guidance | 11.0 % | — | 12.5 % | |
Tax rate of known adjustments discussed above | 3.5 % | — | 4.0 % | |
Non-GAAP tax rate guidance | 15.0 % | — | 16.0 % |
View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-fourth-quarter-and-full-year-2024-financial-results-302367906.html
SOURCE Amgen

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Cardiol Therapeutics to Present at Oppenheimer 35th Annual Healthcare Life Sciences Conference
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it will present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 4:00 p.m. EST.
A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Cardiol website (www.cardiolrx.com/investors/events-presentations/).
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing Phase III MAVERIC trial (NCT06708299). The ongoing ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to statements regarding the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/239537
News Provided by Newsfile via QuoteMedia
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