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Developing the Clinic of the Future, Cloud DX work to be supported by Sheridan College through federal grant
News in Summary
Cloud DX (TSXV:CDX) (OTC:CDXFF), a leading Virtual Care platform, announces the issuance of a new patent for its upcoming Pulsewave 2.0 Vital Sign Monitor. The wrist-worn device stands to be the first at home clinical-grade vital signs monitor to capture diagnostic-quality blood pressure, heart rate, heartbeat irregularities, and respiration status simultaneously. This is the second patent for the Pulsewave 2.0 platform and this award arrives during the company's record-breaking quarter.
US patent 11,272,859 entitled ‘System and Method of Determining Respiratory Status From Oscillometric Data', strengthens the protection of Cloud DX's innovative and novel methods used to determine respiratory status. Building upon the device's initial US patent 11,006,843,which depicts the concept of using oscillometric data to determine respiration rate. This patent protects the methods developed to analyze data in determining respiratory status, beyond just respiratory rate. The company congratulates inventors Vesal Badee, Sara Ross-Howe, Josh Haid, Lamiaa Amzil, Cezar Morun, and Bonghun Shin, all members of the Research and Development team at Cloud DX.
Lead inventor and Cloud DX Biomedical Data Scientist, Vesal Badaee, states "There are plenty of digital health wearables in the market. Most, however, are limited in the quality of data they provide. This can frustrate doctors and healthcare professionals when users want to rely on them. In medicine, clinical-grade vitals are required for diagnostics or medical direction; Cloud DX is driving the transition in bringing clinical-grade wearables into the consumer space, from hospitals and clinics to our homes. This second patent on our next-generation Pulsewave underlines the innovation we're producing at Cloud DX. The team and I are proud to be a part of this Virtual Care transition."
"With the Medical Metaverse and the Virtual Care movements growing the need for home-based diagnostics grows ever more prominent," added Robert Kaul, CEO and Founder of Cloud DX. He continued, "Together these technologies create an all-encompassing model of care improves access to healthcare and can expedite accurate clinician decision making. The ability to accurately capture patient vitals anywhere in the world, even in most remote locations, and transfer that data directly to their doctor or care team means primary care teams can make better clinical decisions, potentially remove the need for an in-person doctor visit, or even circumvent an emergent care visit. To put it simply, the connected ecosystem means better patient outcomes, closer circles of care, and more economical for providers and payers."
How Pulsewave 2.0 breathing rate technology works
- Cloud DX's Pulsewave vital signs monitor is worn on a patient's wrist, and oscillometric pulse waveforms are obtained as the cuff deflates, obtaining pulse wave signals and artifact signals over multiple patient breaths.
- Pulsewave software analyzes these signals producing an envelope of pulse waveforms as well as a frequency modulated sequence of pulses at various time intervals containing breathing rate data.
- Pulsewave 2.0 operates autonomously but can also be connected to the internet. When connected, clinicians receiving the data can derive additional biological metrics via the Cloud Diagnostics® online platform.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
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CDX:CA
Cloud DX partners with Sheridan College on Medical Metaverse Research and Development
- Funding awarded for mobile and machine learning healthcare innovation projects
- Supports commercialization of patented Cloud DX technology for the Medical Metaverse
- Research partnership between Sheridan's CMI and Cloud DX's eXtended Reality division, Cloud XR
Cloud DX (TSXV:CDX) (OTCQB:CDXFF), leading Virtual Care platform provider, will partner with Sheridan College (the grant recipient) on a project with Cloud XR, the company's eXtended Reality division, to further develop the Clinic of the Future, an augmented reality (AR) platform. This is made possible through the support of a Natural Sciences and Engineering Research Council (NSERC) Applied Research and Technology Partnership (ARTP) non-dilutive funding grant. As a key industry partner, Cloud DX will work with Sheridan College who will conduct a portfolio of applied research projects in Mobile Health and Health and Machine Learning
Cloud XR's Clinic of the Future demonstrates how its patented Vitaliti™ continuous monitoring device displays real-time patient information in the form of 3-D holographic images. The Clinic of the Future is the Medical Metaverse in action, a fully remote, touchless, seamless method enabling healthcare professionals to interact with patients.
Dr. Sonny Kohli, Chief Medical Officer and Co-Founder at Cloud DX states: "Improving healthcare is important to everyone, we all use it throughout our lives, and advancement in healthcare and medicine is only possible through innovation. Working with partners such as Sheridan's Center for Mobile Innovation is essential to push the industry into the future. At Cloud DX working with leaders such Dr. Edward Sykes helps bring our inventions to life and supports our commercialization of new healthcare devices, such as our patented Vitaliti™. This NSERC funding not only recognizes Canadian technology leadership like our partnership, more importantly it advances the MedTech industry - one where virtual and remote care, AI, and Augmented Reality are embedded throughout; the Medical Metaverse. Think about it, a leading specialist can now examine a patient on the other side of the world, its limitless. The Medical Metaverse will improve access to healthcare, create more efficiencies, lead to better patient outcomes, and much more."
About the Sheridan Centre for Mobile Innovation
The Sheridan Centre for Mobile Innovation (CMI) creates innovative solutions to industry-relevant challenges, in close collaboration with industry, community, and academic partners. CMI uses leading technologies in its research including: mobile, Artificial Intelligent/Machine Learning/Deep Learning, wearable computing, augmented/virtual reality/mixed reality and Internet of Things. Please visit: cmi.sheridancollege.ca. For more information on research and innovation at Sheridan, please visit research.sheridancollege.ca.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and was named a "New Innovator 2022" by Canadian Business magazine. Cloud DX is an exclusive virtual care partner to Medtronic Canada and Equitable Life.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
# # #
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX Signs Contract with Paramedical Service Provider for Remote Patient Monitoring
Cloud DX chosen as Virtual Care Platform for the Ontario Paramedical Service provider, replacing existing hardware and services
Cloud DX (TSXV:CDX)(OTCQX:CDXFF) is pleased to announce a new 24-month contract with an Ontario Paramedic Service Provider enabling the client to provide Remote Patient Monitoring (RPM) across its serviceable area. Cloud DX will provide its award-winning Connected Health™ platform and support the client as it transitions from its previous remote care tools to Cloud DX's Virtual Care Platform. The client showcases how beneficial ‘Remote Care Monitoring' is for Paramedical Service providers, enabling providers to establish deeper community roots and maintain funding levels, while community members benefit from greater access to much-needed care. The client has purchased 223 Connected Health™ kits totalling ~$145,000 CAD with additional recurring fees for subscription software services. Funding for the program comes from the $82.5M Community Paramedicine for Long-Term Care program announced by the Ontario government on October 22, 2021
The Paramedical client will provide Cloud DX's biometric monitoring equipment to clients in their homes to monitor vital signs including weight, blood pressure, heart rate, oxygen level, temperature, and blood glucose. Daily monitoring allows the client and health care providers to make informed decisions and enables the Paramedic to connect with the client if a metric is out of range. The paramedical care provider seeks to keep individuals on the long-term care bed waitlist and individuals who are medically complex or isolated comfortable and safe in their homes. In turn, Remote Care Monitoring is expected to reduce 911 calls, emergency room visits, and hospital admissions.
Cloud DX COO and co-founder, Anthony Kaul, states "At-home remote monitoring is critical to improving the health of vulnerable populations, such as community members with chronic conditions or seniors who wish to live independently for as long as possible. By bringing Remote Care Monitoring directly to the community our client is forging a new path in paramedicine. This modern approach improves community health and enables significantly earlier intervention for those with deteriorating health, in turn reducing hospitalizations. Cloud DX is well known for our high user satisfaction ratings, so we are confident this initiative will be well received by the community. Of course, with our Headquarters in Ontario, we're always extremely happy to support our neighbouring communities."
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and was named a "New Innovator 2022" by Canadian Business magazine. Cloud DX is an exclusive virtual care partner to Medtronic Canada and Equitable Life.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Social Links
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Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX Signs Two Contracts with US Primary Care Clinics
Continued growth in US RPM as partner Maxwell Telecare signs two additional clinics in Illinois
News in Summary
- These RPM contracts bring the total Maxwell Telecare clinics in 2022 to five
- Addition of these two contracts brings this quarter's total number of contracts to twelve
- Reimbursed RPM programs have the potential to impact 33% of American adults1
Cloud DX (TSXV:CDX) (OTCQB:CDXFF), Cloud DX, a leading Virtual Care platform in North America, and partner Maxwell Telecare announce two additional new contracts with US based Primary Care practices in Illinois. Under the company's Patient First™ program, the clinics will deploy Connected Health™ to control exacerbations, improve quality of life, and avoid hospital admissions, and ER visits. The participating Maxwell clinics will prescribe the kits under US codes for reimbursed Remote Patient Monitoring and Chronic Care Management, paid for by public and private health insurance. This announcement contributes to a record-setting quarter for Cloud DX bringing the total signed contracts this quarter to 12
Rajani Nair, Deployment Manager at Cloud DX, states "Maxwell Telecare understands the value of RPM and how it improves not only a clinic's return on investment but more importantly improves patient care and patient outcomes. As deployments across their network scale, the Maxwell team seamlessly integrates our Connected Health™ kit as part of their patient offerings, reimbursable in the US for RPM or Chronic Care Management. Given their ease of integration, this partnership has transitioned from establishment to scaling. We look forward to continuing to work with them"
Footnotes:
1. Hajat, C., & Stein, E. (2018). The global burden of multiple chronic conditions: A narrative review. Preventive medicine reports, 12, 284-293. https://doi.org/10.1016/j.pmedr.2018.10.008
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner of Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
# # #
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX Signs New Palliative Contract with Ontario Healthcare Team
Cloud DX Signs New Palliative Contract with Ontario Healthcare Team
Healthcare team to use Connected Health™ kits to provide dignity in care for up to 85 patients
News in Summary
- Cloud DX to provide Connected Heath™ kits and supporting software services
- Program will support up to 85 patients in palliative care
- This is the 10th contract this quarter for the Virtual Care platform
Cloud DX (TSXV:CDX)(OTCQB:CDXFF), a leading Virtual Care platform, signs a contract with a healthcare team in Niagara, Ontario, Canada. The team will use Cloud DX's Connected Health™ kits and software services for up to 85 palliative patients. The 12-month contract will commence deployment this month, adding to Cloud DX's successful quarter and recently announced, industry first patent in vital-sign analysis. Connected Health™ has been deployed for palliative patients by other provinces and territories, including Yukon Health and Social Services, since 2019
"While we're known for our post-surgical and chronic care programs, it is refreshing to work with clinics who are passionate about the extended benefits and applications of RPM. This healthcare team understands RPM and recognizes its many use cases," says Head of Operations, Cara MacDonald. "Making healthcare better means encompassing all stages of life, all stages of illness or conditions. We look forward to paving the palliative healthcare delivery pathway with a clinical leader in Ontario."
Palliative Care Management is the third focus area for Cloud DX, building upon its growing Post-Surgical and Chronic Care Management programs. As the digital healthcare sector grows globally, the company continues to work with care providers to pursue new use cases for virtual care and remote patient monitoring while innovating new care pathways alongside industry-leading partners such as Medtronic Canada and Equitable Life.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Social Links
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Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
SOURCE:Cloud DX Inc.
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Cloud DX Announces Closing of Private Placement
Cloud DX (TSXV:CDX)(OTCQB:CDXFF), a leading North American provider of virtual care and Remote Patient Monitoring (RPM) solutions, is pleased to announce that it has closed a non-brokered private placement (the "Private Placement") of 260 units (the "Units") of the Corporation at a price of $1,000 per Unit, for gross proceeds of $260,000 (the "Offering"). Each Unit is comprised of (i) a C$1,000 principal amount unsecured convertible debenture (each, a "Debenture") and (ii) 1,430 common share purchase warrants of the Corporation (each, a "Warrant"). The Debentures will mature on January 27, 2025 (the "Maturity Date") and shall bear interest at a simple rate of 10% per annum. The principal amount of the Debentures may be converted at the election of the holder thereof into common shares in the capital of the Company ("Common Shares") at a conversion price of C$0.35 per Common Share (the "Conversion Price") at any time prior to the Maturity Date. Each Warrant entitles the holder thereof to acquire one common share of the Corporation (each, a "Common Share") at a price of C$0.50 per Common Share at any time prior to 4:30 p.m. (Toronto Time) on January 27, 2024
As consideration for services rendered in connection with the Offering, the Corporation paid to certain registered brokers a cash commission in the amount equal to $13,000 (5% of the gross proceeds of the Offering); and (ii) issued to certain registered brokers 37,142 non-transferable common share purchase warrants (the "Broker Warrants"). Each Broker Warrant entitles the holder thereof to acquire one Common Share at an exercise price of $0.35 per Common Share for a period of 24 months from the date of closing of the Private Placement.
The Corporation intends to use the net proceeds from the Offering for sales, marketing, research and development and working capital requirements.
In accordance with applicable Canadian securities laws, all securities issued pursuant to the Offering will be subject to a four (4) month hold period ending July 19, 2022. The Offering remains subject to final approval from the TSX Venture Exchange.
The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any State in which such offer, solicitation or sale would be unlawful.
About Cloud DX
Accelerating virtual healthcare, Cloud DX is on a mission to make healthcare better for everyone. Our Connected Health TM remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home. Our partners achieve better healthcare and patient outcomes, reduce the need for hospitalization or re-admission, and reduce healthcare delivery costs through more efficient use of resources. Cloud DX is the co-winner of the Qualcomm Tricorder XPRIZE, a 2021 Edison Award winner, a Fast Company "World Changing Idea" finalist, and one of "Canada's Ten Most Prominent Telehealth Providers." In 2021, Cloud DX became an exclusive partner to Medtronic Canada.
Cloud DX Investor Sitehttps://ir.clouddx.com/overview/default.aspx
Social Links
Twitter https://twitter.com/CloudDX
Facebook https://www.facebook.com/clouddxinc/
LinkedIn https://www.linkedin.com/company/cloud-dx/
Instagram https://www.instagram.com/cloud.dx/
For media inquiries please contact:
Janine Scott
Marketing Lead
888-543-0944
janine.scott@CloudDX.com
For investor inquiries please contact:
Jay Bedard
Cloud DX Investor Relations
647-881-8418
jay.bedard@CloudDX.com
Forward-Looking Information
This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or 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. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Corporation to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. In particular, this news release includes certain forward-looking statements concerning the Offering, including the use of the net proceeds, as well as management's objectives, strategies, beliefs and intentions.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. In making the forward-looking statements in this news release, the Corporation has applied several material assumptions, including without limitation, information concerning the receipt of approval from the TSX Venture Exchange, the use of proceeds and the Corporation's marketing and research and development strategies and the expected benefits thereof.
Although management of the Corporation has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or 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 statements 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 statements and forward-looking information.
The securities of the Corporation have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an available exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there by any sale of the securities referenced in this press release, in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE:Cloud DX Inc.
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AbbVie Reports First-Quarter 2025 Financial Results
- Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46 , an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense
- Delivers First-Quarter Net Revenues of $13.343 Billion , an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis
- First -Quarter Global Net Revenues from the Immunology Portfolio Were $6.264 Billion , an Increase of 16.6 Percent on a Reported Basis, or 18.1 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $3.425 Billion ; Global Rinvoq Net Revenues Were $1.718 Billion ; Global Humira Net Revenues Were $1.121 Billion
- First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.282 Billion , an Increase of 16.1 Percent on a Reported Basis, or 17.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $765 Million ; Global Botox Therapeutic Net Revenues Were $866 Million ; Combined Global Ubrelvy and Qulipta Net Revenues Were $433 Million
- First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.633 Billion , an Increase of 5.8 Percent on a Reported Basis, or 7.5 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $738 Million ; Global Venclexta Net Revenues Were $665 Million ; Global Elahere Net Revenues Were $179 Million
- First -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.102 Billion , a Decrease of 11.7 Percent on a Reported Basis, or 10.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $556 Million ; Global Juvederm Net Revenues Were $231 Million
- Raises 2025 Adjusted Diluted EPS Guidance Range from $11.99 - $12.19 to $12.09 - $12.29 , which Includes an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2025
- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025 .
"AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael , chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term."
First -Quarter Results
- Worldwide net revenues were $13.343 billion , an increase of 8.4 percent on a reported basis, or 9.8 percent on an operational basis.
- Global net revenues from the immunology portfolio were $6.264 billion , an increase of 16.6 percent on a reported basis, or 18.1 percent on an operational basis.
- Global Skyrizi net revenues were $3.425 billion , an increase of 70.5 percent on a reported basis, or 72.0 percent on an operational basis.
- Global Rinvoq net revenues were $1.718 billion , an increase of 57.2 percent on a reported basis, or 59.7 percent on an operational basis.
- Global Humira net revenues were $1.121 billion , a decrease of 50.6 percent on a reported basis, or 49.5 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were $2.282 billion , an increase of 16.1 percent on a reported basis, or 17.0 percent on an operational basis.
- Global Vraylar net revenues were $765 million , an increase of 10.3 percent.
- Global Botox Therapeutic net revenues were $866 million , an increase of 15.8 percent on a reported basis, or 17.0 percent on an operational basis.
- Global Ubrelvy net revenues were $240 million , an increase of 17.8 percent on a reported basis, or 18.0 percent on an operational basis.
- Global Qulipta net revenues were $193 million , an increase of 47.6 percent on a reported basis, or 48.3 percent on an operational basis.
- Global net revenues from the oncology portfolio were $1.633 billion , an increase of 5.8 percent on a reported basis, or 7.5 percent on an operational basis.
- Global Imbruvica net revenues were $738 million , a decrease of 11.9 percent.
- Global Venclexta net revenues were $665 million , an increase of 8.3 percent on a reported basis, or 12.3 percent on an operational basis.
- Global Elahere net revenues were $179 million .
- Global net revenues from the aesthetics portfolio were $1.102 billion , a decrease of 11.7 percent on a reported basis, or 10.2 percent on an operational basis.
- Global Botox Cosmetic net revenues were $556 million , a decrease of 12.3 percent on a reported basis, or 10.7 percent on an operational basis.
- Global Juvederm net revenues were $231 million , a decrease of 22.2 percent on a reported basis, or 20.0 percent on an operational basis.
- On a GAAP basis, gross margin in the first quarter was 70.0 percent. The adjusted gross margin was 84.1 percent.
- On a GAAP basis, selling, general and administrative (SG&A) expense was 24.7 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues.
- On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues.
- Acquired IPR&D and milestones expense was 1.9 percent of net revenues.
- On a GAAP basis, operating margin in the first quarter was 28.0 percent. The adjusted operating margin was 42.3 percent.
- Net interest expense was $627 million .
- On a GAAP basis, the tax rate in the quarter was 22.4 percent. The adjusted tax rate was 14.2 percent.
- Diluted EPS in the first quarter was $0.72 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46 . These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. |
Recent Events
- AbbVie announced that its board of directors unanimously elected chief executive officer (CEO) Robert A. Michael to assume the additional position of chairman of the board of directors, effective July 1, 2025 . He will succeed Richard A. Gonzalez , who formerly served as AbbVie's CEO and has been chairman since the Company's formation in 2013.
- AbbVie announced that the European Commission (EC) granted marketing authorization to Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients. The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that Rinvoq achieved the primary endpoint of sustained remission and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission. This authorization marks the eighth approved indication for Rinvoq in the European Union (EU).
- At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie announced final data analysis from the Phase 3 MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with Elahere continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy.
- AbbVie and Xilio Therapeutics, a clinical-stage biotechnology company, announced a collaboration and option-to-license agreement that will combine AbbVie's oncology expertise with Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers, for people living with cancer.
- AbbVie announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines. TrenibotulinumtoxinE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect of 2-3 weeks. If approved, trenibotulinumtoxinE will be the first neurotoxin of its kind available to patients.
- Allergan Aesthetics announced that the Allergan Medical Institute (AMI) will open three new state-of-the-art training centers in the U.S., expanding access to high-quality, tailored training for licensed aesthetics providers. The first training center is scheduled to open in Irvine, CA , with additional locations to follow in Atlanta, GA and Austin, TX.
- AbbVie and Gubra announced a license agreement to develop GUB014295 (ABBV-295), a potential best-in-class, long-acting amylin analog for the treatment of obesity. This partnership marks AbbVie's entrance into the obesity field and under the terms of the agreement, AbbVie will lead development and commercialization of GUB014295 globally. Prior to the close of the agreement, Gubra announced positive interim results from Part A of a Phase 1 multiple ascending dose (MAD) study, which showed that GUB014295 was well tolerated with body weight loss that was sustained in a manner consistent with data from a previously announced single ascending dose (SAD) study.
- AbbVie announced that the FDA approved Emblaveo (aztreonam and avibactam), as the first monobactam/β-lactamase inhibitor combination antibiotic therapy to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria. The approval of Emblaveo was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of complicated intra-abdominal infections as well as clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of Emblaveo for the treatment of serious infections due to Gram-negative bacteria.
Full-Year 2025 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.99 - $12.19 to $12.09 - $12.29 , which includes an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2025, as both cannot be reliably forecasted. This guidance does not reflect the acquired IPR&D and milestones impact related to AbbVie and Gubra's licensing agreement to develop GUB014295, as that transaction closed after the first quarter of 2025. Additionally, this guidance is based on the existing trade environment and does not reflect any trade policy shifts, including pharmaceutical sector tariffs, that could impact AbbVie's business.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X (formerly Twitter), Facebook , Instagram , YouTube or LinkedIn .
Conference Call
AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the call will be available after 11:00 a.m. Central Time .
Non-GAAP Financial Results
Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Media: | Investors: |
Gabby Tarbert | Liz Shea |
(224) 244-0111 | (847) 935-2211 |
Todd Bosse | |
(847) 936-1182 | |
Jeffrey Byrne | |
(847) 938-2923 |
Key Product Revenues Quarter Ended March 31, 2025 (Unaudited) | |||||||||||||||
% Change vs. 1Q24 | |||||||||||||||
Net Revenues (in millions) | Reported | Operational a | |||||||||||||
U.S. | Int'l. | Total | U.S. | Int'l. | Total | Int'l. | Total | ||||||||
NET REVENUES | $9,979 | $3,364 | $13,343 | 10.4 % | 2.9 % | 8.4 % | 8.3 % | 9.8 % | |||||||
Immunology | 4,883 | 1,381 | 6,264 | 17.6 | 13.4 | 16.6 | 20.1 | 18.1 | |||||||
Skyrizi | 2,919 | 506 | 3,425 | 76.2 | 43.9 | 70.5 | 52.3 | 72.0 | |||||||
Rinvoq | 1,220 | 498 | 1,718 | 68.3 | 35.3 | 57.2 | 42.8 | 59.7 | |||||||
Humira | 744 | 377 | 1,121 | (58.0) | (24.4) | (50.6) | (19.5) | (49.5) | |||||||
Neuroscience | 1,972 | 310 | 2,282 | 15.0 | 24.0 | 16.1 | 31.0 | 17.0 | |||||||
Vraylar | 763 | 2 | 765 | 10.3 | 13.1 | 10.3 | 20.2 | 10.3 | |||||||
Botox Therapeutic | 723 | 143 | 866 | 18.2 | 4.8 | 15.8 | 11.4 | 17.0 | |||||||
Ubrelvy | 233 | 7 | 240 | 17.6 | 23.3 | 17.8 | 29.3 | 18.0 | |||||||
Qulipta | 172 | 21 | 193 | 34.2 | >100.0 | 47.6 | >100.0 | 48.3 | |||||||
Vyalev | 6 | 57 | 63 | n/m | >100.0 | >100.0 | >100.0 | >100.0 | |||||||
Duodopa | 20 | 76 | 96 | (19.4) | (16.0) | (16.7) | (11.7) | (13.3) | |||||||
Other Neuroscience | 55 | 4 | 59 | (9.5) | (1.0) | (8.9) | 6.5 | (8.4) | |||||||
Oncology | 1,027 | 606 | 1,633 | 6.0 | 5.4 | 5.8 | 10.0 | 7.5 | |||||||
Imbruvica b | 529 | 209 | 738 | (13.3) | (8.2) | (11.9) | (8.2) | (11.9) | |||||||
Venclexta | 312 | 353 | 665 | 11.0 | 6.0 | 8.3 | 13.4 | 12.3 | |||||||
Elahere | 165 | 14 | 179 | >100.0 | n/m | >100.0 | n/m | >100.0 | |||||||
Epkinly c | 21 | 30 | 51 | 66.7 | >100.0 | 89.8 | >100.0 | 94.8 | |||||||
Aesthetics | 640 | 462 | 1,102 | (17.4) | (2.4) | (11.7) | 1.6 | (10.2) | |||||||
Botox Cosmetic | 295 | 261 | 556 | (24.3) | 6.9 | (12.3) | 11.1 | (10.7) | |||||||
Juvederm Collection | 75 | 156 | 231 | (29.0) | (18.5) | (22.2) | (15.0) | (20.0) | |||||||
Other Aesthetics | 270 | 45 | 315 | (3.5) | 18.1 | (0.9) | 23.2 | (0.3) | |||||||
Eye Care | 221 | 285 | 506 | (2.6) | (8.0) | (5.7) | (2.0) | (2.2) | |||||||
Ozurdex | 30 | 93 | 123 | (12.1) | (3.8) | (6.0) | 1.1 | (2.4) | |||||||
Lumigan/Ganfort | 48 | 58 | 106 | 69.2 | (6.8) | 17.0 | (0.5) | 21.4 | |||||||
Alphagan/Combigan | 26 | 34 | 60 | 68.5 | (21.4) | 1.9 | (15.4) | 6.3 | |||||||
Other Eye Care | 117 | 100 | 217 | (21.4) | (7.1) | (15.4) | (0.2) | (12.5) | |||||||
Other Key Products | 636 | 173 | 809 | (7.2) | (19.4) | (10.1) | (14.8) | (9.0) | |||||||
Mavyret | 142 | 164 | 306 | (0.7) | (20.4) | (12.3) | (15.8) | (9.6) | |||||||
Creon | 355 | — | 355 | 24.6 | n/m | 24.6 | n/m | 24.6 | |||||||
Linzess/Constella | 139 | 9 | 148 | (46.1) | 3.1 | (44.4) | 9.3 | (44.2) | |||||||
a | "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. |
b | Reflects profit sharing for Imbruvica international revenues. |
c | Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. |
n/m = not meaningful | |
Consolidated Statements of Earnings (Unaudited) | ||||
(in millions, except per share data) | First Quarter Ended March 31 | |||
2025 | 2024 | |||
Net revenues | $ 13,343 | $ 12,310 | ||
Cost of products sold | 4,002 | 4,094 | ||
Selling, general and administrative | 3,293 | 3,315 | ||
Research and development | 2,067 | 1,939 | ||
Acquired IPR&D and milestones | 248 | 164 | ||
Total operating costs and expenses | 9,610 | 9,512 | ||
Operating earnings | 3,733 | 2,798 | ||
Interest expense, net | 627 | 453 | ||
Net foreign exchange loss | 4 | 4 | ||
Other expense, net | 1,441 | 586 | ||
Earnings before income tax expense | 1,661 | 1,755 | ||
Income tax expense | 372 | 383 | ||
Net earnings | 1,289 | 1,372 | ||
Net earnings attributable to noncontrolling interest | 3 | 3 | ||
Net earnings attributable to AbbVie Inc. | $ 1,286 | $ 1,369 | ||
Diluted earnings per share attributable to AbbVie Inc. | $ 0.72 | $ 0.77 | ||
Adjusted diluted earnings per share a | $ 2.46 | $ 2.31 | ||
Weighted-average diluted shares outstanding | 1,772 | 1,773 | ||
a | Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. |
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) | |||||
1. Specified items impacted results as follows: | |||||
Quarter Ended March 31, 2025 | |||||
(in millions, except per share data) | Earnings | Diluted | |||
Pre-tax | After-tax a | EPS | |||
As reported (GAAP) | $ 1,661 | $ 1,286 | $ 0.72 | ||
Adjusted for specified items: | |||||
Intangible asset amortization | 1,858 | 1,574 | 0.89 | ||
Change in fair value of contingent consideration | 1,518 | 1,477 | 0.83 | ||
Other | 62 | 33 | 0.02 | ||
As adjusted (non-GAAP) | $ 5,099 | $ 4,370 | $ 2.46 | ||
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. |
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2025 included acquired |
2. The impact of the specified items by line item was as follows: | |||||||
Quarter Ended March 31, 2025 | |||||||
(in millions) | Cost of | SG&A | R&D | Other | |||
As reported (GAAP) | $ 4,002 | $ 3,293 | $ 2,067 | $ 1,441 | |||
Adjusted for specified items: | |||||||
Intangible asset amortization | (1,858) | — | — | — | |||
Change in fair value of contingent consideration | — | — | — | (1,518) | |||
Other | (28) | (13) | (16) | (5) | |||
As adjusted (non-GAAP) | $ 2,116 | $ 3,280 | $ 2,051 | $ (82) | |||
3. The adjusted tax rate for the first quarter of 2025 was 14.2 percent, as detailed below: | |||||
Quarter Ended March 31, 2025 | |||||
(dollars in millions) | Pre-tax | Income taxes | Tax rate | ||
As reported (GAAP) | $ 1,661 | $ 372 | 22.4 % | ||
Specified items | 3,438 | 354 | 10.3 % | ||
As adjusted (non-GAAP) | $ 5,099 | $ 726 | 14.2 % | ||
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) | |||||
1. Specified items impacted results as follows: | |||||
Quarter Ended March 31, 2024 | |||||
(in millions, except per share data) | Earnings | Diluted | |||
Pre-tax | After-tax a | EPS | |||
As reported (GAAP) | $ 1,755 | $ 1,369 | $ 0.77 | ||
Adjusted for specified items: | |||||
Intangible asset amortization | 1,891 | 1,603 | 0.90 | ||
Acquisition and integration costs | 511 | 486 | 0.27 | ||
Change in fair value of contingent consideration | 660 | 643 | 0.36 | ||
Other | 21 | 19 | 0.01 | ||
As adjusted (non-GAAP) | $ 4,838 | $ 4,120 | $ 2.31 | ||
a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. |
Acquisition and integration costs primarily reflect costs related to the ImmunoGen acquisition. |
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended March 31, 2024 included acquired |
2. The impact of the specified items by line item was as follows: | |||||||||
Quarter Ended March 31, 2024 | |||||||||
(in millions) | Cost of | SG&A | R&D | Interest | Other | ||||
As reported (GAAP) | $ 4,094 | $ 3,315 | $ 1,939 | $ 453 | $ 586 | ||||
Adjusted for specified items: | |||||||||
Intangible asset amortization | (1,891) | — | — | — | — | ||||
Acquisition and integration costs | (79) | (280) | (128) | (24) | — | ||||
Change in fair value of contingent consideration | — | — | — | — | (660) | ||||
Other | (16) | (3) | — | — | (2) | ||||
As adjusted (non-GAAP) | $ 2,108 | $ 3,032 | $ 1,811 | $ 429 | $ (76) | ||||
3. The adjusted tax rate for the first quarter of 2024 was 14.8 percent, as detailed below: | |||||
Quarter Ended March 31, 2024 | |||||
(dollars in millions) | Pre-tax | Income taxes | Tax rate | ||
As reported (GAAP) | $ 1,755 | $ 383 | 21.8 % | ||
Specified items | 3,083 | 332 | 10.8 % | ||
As adjusted (non-GAAP) | $ 4,838 | $ 715 | 14.8 % | ||
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SOURCE AbbVie
News Provided by PR Newswire via QuoteMedia
AbbVie Submits Biologics License Application to U.S. FDA for TrenibotulinumtoxinE for the Treatment of Glabellar Lines
TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks. If approved, TrenibotE will be the first neurotoxin of its kind available to patients. –Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program.
NORTH CHICAGO, Ill. , April 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trenibotulinumtoxinE (TrenibotE) for the treatment of moderate to severe glabellar lines.
"The submission provides evidence of TrenibotE's differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin," said Darin Messina , Ph.D., senior vice president, aesthetics R&D, AbbVie. "TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category."
New patients wanting to experience the aesthetic benefits of a neurotoxin cite "fear of looking unnatural" as a barrier to initiating neurotoxin use for aesthetic indications. If approved, TrenibotE will be the first serotype E neurotoxin offering patients the opportunity to experience a neurotoxin with rapid clinical effect for a shorter duration of time as a trial before getting treatment with BOTOX® Cosmetic.
The BLA submission is supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines (M21-500 and M21-508) and a Phase 3 open-label safety study (M21-509). All primary and secondary endpoints of the Phase 3 studies were met, with a rapid onset of action as early as 8 hours after drug administration (the earliest assessment time) and observed efficacy duration for 2-3 weeks. Treatment-emergent adverse events for TrenibotE were similar to placebo, both as a single treatment and up to three consecutive treatments. Topline data from the Phase 3 pivotal studies were previously shared .
"Concern about an unnatural outcome remains a significant barrier for many patients considering medical aesthetics treatment," said Cheryl Burgess , MD, FAAD, lead clinical investigator for one of the Phase 3 studies. "Treatment with a product offering rapid onset of effect and short duration of action could help address this barrier and empower confidence for patients exploring their aesthetics treatment journey with innovation from the makers of BOTOX® Cosmetic."
BOTOX ® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX ® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis activity
- Moderate to severe platysma bands associated with platysma muscle activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT |
CONTRAINDICATIONS
BOTOX ® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Equivalency Between Botulinum Toxin Products
The potency Units of BOTOX ® Cosmetic are specific to the preparation and assay method utilized. BOTOX ® Cosmetic is not equivalent to other preparations of botulinum toxin products, and therefore, Units of biological activity of BOTOX ® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX ® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX ® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX ® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX ® . The safety and effectiveness of BOTOX ® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX ® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.
Increased Risk of Clinically Significant Effects With Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions ). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.
Dysphagia and Breathing Difficulties
Treatment with BOTOX ® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning ).
Preexisting Conditions at the Injection Site
Use caution when BOTOX ® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX ® Cosmetic
There have been reports of dry eye associated with BOTOX ® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX ® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX ® Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX ® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
The safety profile of BOTOX ® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX ® Cosmetic for other indications.
DRUG INTERACTIONS
Coadministration of BOTOX ® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX ® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX ® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX ® Cosmetic in pregnant women. There are no data on the presence of BOTOX ® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
For more information on BOTOX ® Cosmetic, please see accompanying full Prescribing Information, including Boxed Warning and Medication Guide.
US-FA-01754 10/24
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) , and YouTube .
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Media: Adelle Infante | Investors: Liz Shea |
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SOURCE AbbVie
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Adicet Bio Appoints Michael Grissinger to the Board of Directors
--Mr. Grissinger brings more than four decades of leadership experience in pharmaceutical business development and strategic transactions--
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the appointment of Michael Grissinger to its Board of Directors. Mr. Grissinger brings more than four decades of experience in business development, strategy, and M&A leadership roles at global pharmaceutical companies.
"We are honored to welcome Michael to our Board of Directors," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "His extensive operational and business development experience across the global pharmaceutical industry, especially his deep expertise in immunology, brings a wealth of knowledge and invaluable strategic insight to Adicet. Michael's notable accomplishments in driving business and commercial success will be instrumental in shaping the next stage of our growth as we continue to advance our gamma delta T cell platform for the treatment of autoimmune and solid tumor indications."
Mr. Grissinger spent more than two decades at Johnson & Johnson. During his Johnson & Johnson tenure, Mr. Grissinger served in a variety of senior level management roles including Vice President and Head of Worldwide Pharmaceutical Licensing and Vice President and Head of Worldwide Pharmaceutical Corporate Development and M&A. At Johnson & Johnson, Mr. Grissinger led the Immunology Therapeutic Area Business Development and Licensing Group and was also a member of the Immunology R&D/ Commercial leadership team for Johnson & Johnson's Worldwide Immunology Franchise. Prior to Johnson & Johnson, Mr. Grissinger spent 12 years at Ciba-Geigy in finance, marketing and business development roles. Mr. Grissinger also serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and three privately-held biotechnology companies, Envisagenics, Inc., AnaCardio AB, and NephroDI Therapeutics, Inc. Mr. Grissinger holds a B.S. in Chemistry from Juniata College and an M.B.A. from Temple University-Fox School of Business.
"I am pleased to join the Board of Adicet, a company rooted in harnessing the power of the immune system by developing off-the-shelf gamma delta CAR T cell therapies to make a meaningful difference in patients' lives," said Mr. Grissinger. "I look forward to working alongside the Board and management team and contributing to the advancement of current pipeline programs focused on autoimmune and oncology indications."
Forward-Looking Statements
This press release contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: expectations related to Adicet's business development, strategic opportunities and growth; Adicet's plans and expectations for advancing its autoimmune programs across multiple autoimmune and solid tumor indications; and the anticipated contribution of the members of Adicet's Board of Directors to the Company's business.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health emergencies on Adicet's business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet's ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Adicet's most recent quarterly report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet's other filings with the SEC. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.
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Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
abowdidge@adicetbio.com
Janhavi Mohite
Precision AQ
212-362-1200
janhavi.mohite@precisionaq.com
Media:
Kerry Beth Daly
kbdaly@adicetbio.com
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New York Plastic Surgical Group and Deep Blue Med Spa Receive State and National Recognition by Allergan Aesthetics
New York Plastic Surgical Group and Deep Blue Med Spa have been named the #1 provider of Allergan products in New York State. In addition, they have been ranked in the top 25 nationally. This distinction places them in the top 1% of over 30,000 Allergan medical aesthetic practices throughout the country.
As a pioneer in the field of aesthetic medicine, Allergan develops and manufactures a portfolio of leading brands and products including Botox Cosmetic, the Juvéderm family of fillers, Coolsculpting, Cooltone, DiamondGlow, and SkinMedica. To receive a top placement from such an authority within the industry is not only an accomplishment, but also a demonstration of true mastery. To date, NYPS Group and Deep Blue Med Spa are proud to have had multiple providers chosen to serve as national AMI (Allergan Medical Institute) trainers.
What does this mean for consumers? In short, it translates to expertise and rewards. Once a year, Allergan awards aesthetics practices nationwide through its "Allergan Partner Privileges" program. This unique program awards status levels to practices based on the volume of Allergan products used. The more a practice uses equates to the frequency in which the practice provides Allergan Aesthetic products and services. Allergan rewards these practices with rebates and offers, which are then passed along to patients.
About New York Plastic Surgical Group
As the largest, longest-running private and academic plastic surgery practice in the United States, NYPS Group consists of over 20 surgeons and maintains 10+ offices throughout the Metropolitan area. In addition, NYPS Group operates Deep Blue Med Spa, a celebrated facility that offers clinically proven, non-surgical skin rejuvenation and body procedures in four New York locations. The world-class providers at New York Plastic Surgical Group and Deep Blue Med Spa are known for their expertise and dedication, which allows them to handle complex cases and consistently deliver natural-looking results. The entire team is committed to upholding the highest standards of patient care, including clear communication, patient safety, continuing education, and uncompromising professional medical ethics.
About Allergan Aesthetics
Allergan Aesthetics is an AbbVie (NYSE: ABBV) company that develops, manufactures, and markets a portfolio of leading aesthetics brands and products around the world. The Allergan Aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. With its own research and development team focused on driving innovation in aesthetics, Allergan Aesthetics is committed to providing the most comprehensive science-based product offerings available.
Attachment
Jeanine DiGennaro New York Plastic Surgical Group Director of Marketing & Communications (516) 629-3835 jdigennaro@nyplasticsurgical.com
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