Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated data related to vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is a novel investigational PROTAC ® estrogen receptor (ER) protein degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positivehuman epidermal growth factor receptor 2 (HER2) negative (ER+HER2-) breast cancer. Four posters will be presented during the poster session at the annual congress, which will be held from May 11-13, 2023, in Berlin, Germany.
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Pfizer and Beam Enter Exclusive Multi-Target Research Collaboration to Advance Novel In Vivo Base Editing Programs for a Range of Rare Diseases
- Four-year research collaboration combines Pfizer's deep experience in global drug development, including programs utilizing messenger RNA (mRNA), lipid nanoparticles (LNP), and gene therapy, with Beam's leadership in base editing and mRNA/LNP delivery technologies
- Beam will receive an upfront payment of $300 million, be eligible to receive future milestone payments of up to $1.05 billion for a potential total consideration of up to $1.35 billion
- Beam may opt into a global co-development and co-commercialization agreement for one program
- Research and development activities aim to advance potentially transformative therapies for patients living with rare genetic diseases
Pfizer Inc. (NYSE: PFE) and Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced an exclusive four-year research collaboration focused on in vivo base editing programs for three targets for rare genetic diseases of the liver, muscle and central nervous system.
The base editing programs to be evaluated as part of the collaboration will leverage Beam's proprietary in vivo delivery technologies, which use messenger RNA (mRNA) and lipid nanoparticles (LNP) to deliver base editors to target organs. Combining these technologies with Pfizer's proven experience in developing and manufacturing medicines and vaccines, this collaboration seeks to advance potentially transformative therapies for patients living with rare diseases.
Beam's proprietary base editing technologies are designed to enable a new class of precision genetic medicines that target a single base in the genome without making a double-stranded break in the DNA. This approach aims to create a more precise and efficient edit compared to traditional gene editing methods, which operate by creating targeted double-stranded breaks in the DNA, resulting in potential challenges associated with unwanted DNA modifications.
"At Pfizer, we believe in the powerful potential of mRNA and LNP technologies to address the greatest unmet needs for patients, as evidenced by the beneficial impact our mRNA/LNP-based COVID-19 vaccine is having on the pandemic," said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. "We have a strong history in developing gene replacement therapies for rare diseases, and we see this collaboration with Beam as an opportunity to advance the next generation of gene editing therapies – an exciting scientific frontier – potentially leading to transformation for people living with rare genetic diseases."
"We are thrilled to partner with Pfizer, a global leader in the design, development, and commercialization of novel medicines," said John Evans, Chief Executive Officer of Beam. "Our leading platform for precision genetic medicine has greatly evolved over the last few years, and we are committed to ensuring the broadest reach of these potentially life-changing technologies. This collaboration will provide a unique opportunity to create potentially transformative base editing programs for indications with critical unmet needs, leveraging our proprietary base editing technology and expanding delivery capabilities. We look forward to working together with Pfizer to advance these technologies and potentially expand our impact for people suffering from serious diseases."
Under the terms of the collaboration agreement, Beam will conduct all research activities through development candidate selection for three undisclosed targets, which are not included in Beam's existing programs. Pfizer may opt in to exclusive, worldwide licenses to each development candidate, after which it will be responsible for all development activities, as well as potential regulatory approvals and commercialization, for each such candidate. Beam has a right to opt in, at the end of Phase 1/2 studies, upon the payment of an option exercise fee, to a global co-development and co-commercialization agreement with respect to one program licensed under the collaboration pursuant to which Pfizer and Beam would share net profits as well as development and commercialization costs in a 65%/35% ratio (Pfizer/Beam).
Beam will receive an upfront payment of $300 million and, assuming Pfizer exercises its opt-in license rights for all three targets, is eligible for development, regulatory and commercial milestone payments for potential total deal consideration of up to $1.35 billion. Beam is also eligible to receive royalties on global net sales for each licensed program. The collaboration has an initial term of four years and may be extended up to one additional year.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Pfizer Disclosure Notice
The information contained in this release is as of January 10, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about the potential of mRNA and LNP technology and a research collaboration between Pfizer and Beam focused on in vivo base editing programs for three targets for rare genetic diseases of the liver, muscle, and central nervous system, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; whether the collaboration between Pfizer and Beam will be successful; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
About Beam Therapeutics
Beam Therapeutics (Nasdaq: BEAM) is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that enables precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This enables a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Beam Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, statements related to the potential benefits of our collaboration with Pfizer, any future payments we may receive under our research collaboration agreement with Pfizer, the therapeutic applications and potential of our technology, including our ability to deliver base editors to target organs in and beyond the liver and our ability to develop life-long, curative, precision genetic medicines for patients through base editing. Each forward-looking statement is subject to important risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including, without limitation, risks and uncertainties related to: our ability to develop, obtain regulatory approval for, and commercialize our product candidates, which may take longer or cost more than planned; our ability to raise additional funding, which may not be available; our ability to obtain, maintain and enforce patent and other intellectual property protection for our product candidates; the potential impact of the COVID-19 pandemic; that preclinical testing of our product candidates and preliminary or interim data from preclinical studies and clinical trials may not be predictive of the results or success of ongoing or later clinical trials; that enrollment of our clinical trials may take longer than expected; that our product candidates may experience manufacturing or supply interruptions or failures; risks related to competitive products; and the other risks and uncertainties identified under the headings "Risk Factors Summary" and "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and in any subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.
Contacts:
Pfizer:
Media Relations
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848
IR@pfizer.com
Beam:
Investors:
Chelcie Lister
THRUST Strategic Communications
chelcie@thrustsc.com
Media:
Dan Budwick
1AB
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Arvinas and Pfizer Announce Upcoming Vepdegestrant Poster Presentations at the 2023 European Society for Medical Oncology Breast Cancer Annual Congress
Poster session details are as follows:
Date: Friday, May 12, 2023
Time: 12:15 – 1:00 p.m. CET/ 6:15 – 7:00 a.m. ET
- VERITAC update: phase 2 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer (Poster 205P)
- VERITAC-2: a global, randomized phase 3 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, vs fulvestrant in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer (Poster 257TiP)
- TACTIVE-N: open-label, randomized, noncomparative neoadjuvant phase 2 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal women with ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (Poster 154TiP)
- TACTIVE-E: phase 1b study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with everolimus in ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer (Poster 256TiP)
For more information, visit the official ESMO Breast Cancer Annual Congress website here .
About vepdegestrant ( ARV-471)
Vepdegestrant is an investigational, orally bioavailable PROTAC ® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.
In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.
About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC ® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC ® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC ® protein degraders against validated and "undruggable" targets, the company has three investigational clinical-stage programs in development: bavdegalutamide and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. For more information, visit www.arvinas.com .
Arvinas Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential benefits of our arrangements with our collaborative partnership with Pfizer, the development and regulatory status of our product candidates, such as statements with respect to our lead product candidates, ARV-110, ARV-471 and ARV-766 and other candidates in our pipeline, and the timing of clinical trials and data from those trials and plans for registration for our product candidates, and our discovery programs that may lead to our development of additional product candidates, the potential utility of our technology and therapeutic potential of our product candidates, the potential commercialization of any of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we and Pfizer will be able to successfully conduct and complete clinical development for ARV-471, whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-766, initiate and complete other clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all and other important factors discussed in the "Risk Factors" sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice:
The information contained in this release is as of May 8, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about vepdegestrant (ARV-471) and a global collaboration between Pfizer and Arvinas to develop and commercialize ARV-471, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed for ARV-471 for any potential indications in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for ARV-471 in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ARV-471 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ARV-471; whether the collaboration between Pfizer and Arvinas will be successful; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.Pfizer.com.
Arvinas Media Contacts
Investor Contact:
Jeff Boyle, Arvinas Investor Relations
347-247-5089
Jeff.Boyle@arvinas.com
Media Contact:
Kirsten Owens, Arvinas Communications
203-584-0307
Kirsten.Owens@arvinas.com
Pfizer Media Contacts
Investor Contact:
+1 (212) 733-4848
IR@pfizer.com
Media Contact:
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
News Provided by GlobeNewswire via QuoteMedia
Pfizer Reports First-Quarter 2023 Results
- First-Quarter 2023 Revenues of $18.3 Billion
- Expected Decline in Comirnaty (1) Revenue Drove 26% Operational Decrease in First-Quarter 2023 Revenues
- First-Quarter 2023 Revenues from Comirnaty (1) and Paxlovid of $7.1 Billion
- Excluding Contributions from Comirnaty (1) and Paxlovid, Revenues Grew 5% Operationally
- First-Quarter 2023 Reported Diluted EPS (2) of $0.97, a Year-Over-Year Decline of 29%, and Adjusted Diluted EPS (3) of $1.23, a Year-Over-Year Decline of 24%
- Pfizer Reaffirms Full-Year 2023 Financial Guidance (4)
- Pfizer Continued to Make Significant Progress Toward an Unprecedented Number of Anticipated New Product and Indication Launches; Milestones Include FDA Approvals for Zavzpret, Cibinqo for Adolescents and Prevnar 20 in Pediatric Patients
Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance.
The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "This is an exciting time for Pfizer as we are already executing on and rigorously planning for an unprecedented number of anticipated new product and indication launches, most of which are expected to occur in the second half of 2023. We have made excellent progress toward this goal already this year with the U.S. approvals for Zavzpret, Cibinqo for adolescents and Prevnar 20 in pediatric patients, and regulatory filing acceptances for a Braftovi + Mektovi sNDA, sNDA for the Talzenna and Xtandi combination, elranatamab BLA and our RSV maternal vaccine candidate — which, if approved, would be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth up to six months of age.
During the first quarter, we announced plans to advance the battle against cancer with a definitive agreement to acquire Seagen, a global biotechnology company that discovers, develops and commercializes transformative oncology medicines. By combining Seagen's category-leading antibody-drug conjugate (ADC) technology with Pfizer's scale, expertise and capabilities, we believe we can accelerate breakthroughs in cancer medicines and introduce new solutions to patients around the world. Oncology remains a core therapeutic area for Pfizer, and we believe the proposed acquisition will enhance our position in this important space.
We believe the strength of our in-line products and expected near-term launches and revenue contribution from business development activities, including the proposed acquisition of Seagen, will position Pfizer to deliver robust operational growth through 2025 and beyond."
David Denton, Chief Financial Officer and Executive Vice President, stated: "Our first-quarter results were in line with our expectations, underlining our continued confidence in achieving 7% to 9% operational revenue growth for fiscal-year 2023, excluding our COVID-19 products and anticipated foreign exchange impacts. We expect the majority of this growth to occur in the second half of 2023, given the timing of our expected near-term launches. Integration planning for our proposed acquisition of Seagen is underway, and we continue to expect the transaction to close in late 2023 or early 2024, subject to the satisfaction of customary closing conditions. As we de-lever our capital structure after the close, we expect our strong balance sheet will continue to provide the flexibility for future dividend increases and share repurchase activity, as well as additional business development activity."
Results for the first quarter of 2023 and 2022 (5) are summarized below.
OVERALL RESULTS
($ in millions, except per share amounts) | First-Quarter | |||||
2023 | 2022 | Change | ||||
Revenues | $ 18,282 | $ 25,661 | (29%) | |||
Reported Net Income (2) | 5,543 | 7,864 | (30%) | |||
Reported Diluted EPS (2) | 0.97 | 1.37 | (29%) | |||
Adjusted (3) Income | 7,036 | 9,338 | (25%) | |||
Adjusted (3) Diluted EPS | 1.23 | 1.62 | (24%) | |||
REVENUES
($ in millions) | First-Quarter | |||||||
2023 | 2022 | % Change | ||||||
Total | Oper. | |||||||
Global Biopharmaceuticals Business (Biopharma) (6) | $ 17,971 | $ 25,323 | (29%) | (26%) | ||||
Primary Care (6) | 11,505 | 18,851 | (39%) | (37%) | ||||
Specialty Care (6) | 3,612 | 3,505 | 3% | 8% | ||||
Oncology (6) | 2,855 | 2,967 | (4%) | (1%) | ||||
Business Innovation | $ 310 | $ 338 | (8%) | (5%) | ||||
TOTAL REVENUES | $ 18,282 | $ 25,661 | (29%) | (26%) | ||||
Beginning in the third quarter of 2022, Pfizer made several organizational changes to further transform its operations to better leverage its expertise in certain areas and in anticipation of potential future new product and indication launches. These changes included establishing a new commercial structure within Biopharma focused on three broad customer groups (primary care, specialty care and oncology) (6) , optimizing Pfizer's end-to-end R&D operations and further prioritizing its internal R&D portfolio, as well as realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure.
In addition, in the first quarter of 2023, Pfizer established an operating segment named Business Innovation that includes Pfizer CentreOne (PC1), the company's global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients; and Pfizer Ignite, a recently launched offering that provides strategic guidance and end-to-end R&D services to select innovative biotech companies that align with Pfizer's R&D focus areas.
Prior period amounts have been revised to conform to the current period presentation for all changes discussed above.
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates (7) .
CAPITAL ALLOCATION
During the first three months of 2023, Pfizer deployed its capital in a variety of ways, which primarily include the following two categories:
- Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including $2.5 billion invested in internal research and development projects, and
- Returning capital directly to shareholders through $2.3 billion of cash dividends, or $0.41 per share of common stock.
No share repurchases have been completed to date in 2023. As of May 2, 2023, Pfizer's remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2023.
First-quarter 2023 diluted weighted-average shares outstanding used to calculate Reported (2) and Adjusted (3) diluted EPS were 5,727 million shares, a decrease of 31 million shares compared to the prior-year quarter, primarily due to shares repurchased in the first quarter of 2022, partially offset by shares issued for employee compensation programs.
2023 FINANCIAL GUIDANCE (4)
Pfizer reaffirms all components of its full-year 2023 financial guidance, which is presented below. This guidance includes management's expectations for contributions from the entire company, including Comirnaty (1) and Paxlovid.
2023 Financial Guidance | ||
Revenues* | $67.0 to $71.0 billion | |
Operational (7) Growth/(Decline) vs. Prior Year | (33%) to (29%) | |
Growth/(Decline) vs. Prior Year | (33%) to (29%) | |
Adjusted (3) Diluted EPS* | $3.25 to $3.45 | |
Operational (7) Growth/(Decline) vs. Prior Year | (50%) to (47%) | |
Growth/(Decline) vs. Prior Year | (51%) to (48%) | |
*Changes in foreign exchange rates have had a minimal incremental impact since full-year 2023 guidance was issued. Please refer to Press Release Footnote (4) for additional information.
The midpoint of the guidance range for revenues reflects a 31% operational decrease compared to 2022 revenues. Company revenues are anticipated to be lower in 2023 than in 2022 due entirely to expected revenue declines for Pfizer's COVID-19 products.
Excluding COVID-19 products, the Company continues to expect 7% to 9% operational revenue growth in 2023.
Revenue guidance for Pfizer's COVID-19 products is as follows:
- Comirnaty (1) revenues of approximately $13.5 billion, down 64% from 2022 results.
- Paxlovid revenues of approximately $8 billion, down 58% from 2022 results.
- In contrast to previous years, guidance for both products is no longer based primarily on expected deliveries under existing signed or committed supply contracts, but now also includes, among other things, anticipated sales through traditional commercial markets in the U.S. in the second half of 2023.
The midpoint of the guidance range for Adjusted (3) diluted EPS reflects a 49% operational decrease compared to 2022, primarily driven by anticipated lower revenues from COVID-19 products, higher spending to support anticipated near-term launches and greater investment in certain late-stage pipeline projects.
Financial guidance for Adjusted (3) diluted EPS is calculated using approximately 5.75 billion weighted average shares outstanding, and assumes no share repurchases in 2023.
Other components of Pfizer's 2023 financial guidance are presented below.
Adjusted (3) Cost of Sales as a Percentage of Revenues | 28.0% to 30.0% |
Adjusted (3) SI&A Expenses | $13.8 to $14.8 billion |
Adjusted (3) R&D Expenses | $12.4 to $13.4 billion |
Acquired IPR&D Expenses (4) | Approximately $0.1 billion |
Adjusted (3) Other (Income)/Deductions | Approximately $1.5 billion of income |
Effective Tax Rate on Adjusted (3) Income | Approximately 15.0% |
Pfizer's 2023 financial guidance is based on estimates and assumptions that are subject to significant uncertainties, particularly with regard to the anticipated performance of Comirnaty (1) and Paxlovid. See the Overview of Our Performance, Operating Environment, Strategy and Outlook — The Global Economic Environment section of Management's Discussion and Analysis of Financial Condition and Results of Operations in Pfizer's 2022 Annual Report on Form 10-K and Pfizer's fourth-quarter 2022 earnings press release (available at www.pfizer.com ) for additional information.
QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2023 vs. First-Quarter 2022)
First-quarter 2023 revenues totaled $18.3 billion, a decrease of $7.4 billion, or 29%, compared to the prior-year quarter, reflecting an operational decline of $6.6 billion, or 26%, primarily due to a decrease in Comirnaty (1) revenues globally, as well as an unfavorable impact of foreign exchange of $730 million, or 3%. First-quarter 2023 revenues from Comirnaty (1) and Paxlovid were $7.1 billion. Excluding contributions from Comirnaty (1) and Paxlovid, company revenues grew $563 million, or 5%, operationally.
Compared to the prior-year quarter, first-quarter 2023 revenue growth was unfavorably impacted by approximately 1% as a result of having one fewer selling day in international markets. This unfavorable impact is expected to reverse in the fourth quarter of 2023.
First-quarter 2023 Comirnaty (1) revenues declined $10 billion, or 75%, operationally compared with the prior-year quarter, largely driven by lower contracted deliveries and demand in international markets, as well as lower U.S. government contracted deliveries with anticipated transition to traditional commercial market sales in the second half of 2023.
First-quarter Paxlovid revenues increased $2.8 billion compared with the prior-year quarter, primarily driven by favorable timing of final delivery associated with the U.S. government contract before anticipated transition to traditional commercial markets in the second half of 2023; strong demand in China due to increased COVID-19 infections; and launch in certain international markets.
Excluding contributions from Comirnaty (1) and Paxlovid, first-quarter 2023 operational growth was primarily driven by:
- Recently acquired products, Nurtec ODT/Vydura and Oxbryta, which contributed $167 million and $71 million in global revenues, respectively;
- Sulperazon internationally, up 64% operationally, largely driven by demand in China, which is not expected to be sustained;
- Eliquis globally, up 7% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of exclusivity and generic competition in certain international markets; and
- Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 16% operationally, largely driven by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe, partially offset by a planned price decrease that went into effect in Japan in the second quarter of 2022,
partially offset primarily by lower revenues for:
- Xeljanz globally, down 33% operationally, driven primarily by lower net price in the U.S. due to unfavorable changes in channel mix, as well as decreased prescription volumes worldwide resulting from ongoing shifts in prescribing patterns related to label changes.
GAAP Reported (2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES (2)
($ in millions) | First-Quarter | |||||||||
2023 | 2022 | % Change | ||||||||
Total | Oper. | |||||||||
Cost of Sales (2) | $ 4,886 | $ 9,984 | (51%) | (50%) | ||||||
Percent of Revenues | 26.7 | % | 38.9 | % | N/A | N/A | ||||
SI&A Expenses (2) | 3,418 | 2,593 | 32% | 35% | ||||||
R&D Expenses (2) | 2,505 | 2,301 | 9% | 10% | ||||||
Acquired IPR&D Expenses (2) | 21 | 355 | (94%) | (94%) | ||||||
Other (Income)/Deductions––net (2) | 70 | 350 | (80%) | (71%) | ||||||
Effective Tax Rate on Reported Income (2) | 11.4 | % | 12.9 | % | ||||||
First-quarter 2023 Cost of Sales (2) as a percentage of revenues decreased by 12.2 percentage points compared with the prior-year quarter, primarily driven by changes in sales mix, including lower sales of Comirnaty (1) and higher sales of Paxlovid.
First-quarter 2023 SI&A Expenses (2) increased 35% operationally compared with the prior-year quarter, primarily reflecting increased investments to support Paxlovid, recently acquired and launched products, and products across multiple customer groups.
First-quarter 2023 R&D Expenses (2) increased 10% operationally compared with the prior-year quarter, primarily driven by increased investments to develop recently acquired assets and certain vaccine programs, as well as activities to support upcoming product launches, partially offset by lower spending on programs to prevent and treat COVID-19 and certain other late-stage clinical programs.
First-quarter 2023 acquired IPR&D Expenses (2) decreased 94% operationally compared to the prior-year quarter, primarily driven by the non-recurrence of an upfront payment to Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) and a premium paid on Pfizer's equity investment in Biohaven, as well as a premium paid on Pfizer's equity investment in BioNTech SE (BioNTech) to develop a potential mRNA vaccine against shingles — both recorded in the first quarter of 2022.
Other deductions––net (2) decreased 71% operationally in the first quarter of 2023 compared with the first quarter of 2022, primarily driven by lower net losses on equity securities, higher dividend income and lower net interest expense, partially offset by asset impairment charges in the first quarter of 2023, and lower net periodic benefit credits associated with pension and postretirement plans.
Pfizer's effective tax rate on Reported income (2) for the first quarter of 2023 decreased compared to the prior-year quarter primarily due to a favorable change in the jurisdictional mix of earnings.
Adjusted (3) Income Statement Highlights
SELECTED ADJUSTED (3) COSTS AND EXPENSES
($ in millions) | First-Quarter | |||||||||
2023 | 2022 | % Change | ||||||||
Total | Oper. | |||||||||
Adjusted (3) Cost of Sales | $ 4,746 | $ 9,958 | (52%) | (51%) | ||||||
Percent of Revenues | 26.0 | % | 38.8 | % | N/A | N/A | ||||
Adjusted (3) SI&A Expenses | 3,350 | 2,496 | 34% | 37% | ||||||
Adjusted (3) R&D Expenses | 2,491 | 2,295 | 9% | 10% | ||||||
Adjusted (3) Other (Income)/Deductions––net | (528 | ) | (406 | ) | 30% | 23% | ||||
Effective Tax Rate on Adjusted (3) Income | 14.0 | % | 14.8 | % | ||||||
Reconciliations of certain Reported (2) to non-GAAP Adjusted (3) financial measures and associated footnotes can be found in the financial tables section of the press release located at the hyperlink below.
RECENT NOTABLE DEVELOPMENTS (Since January 31, 2023)
Product Developments
- Braftovi (encorafenib) and Mektovi (binimetinib) – In April 2023, Pfizer announced the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Applications (sNDAs) for Braftovi + Mektovi for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in the fourth quarter of 2023 for the sNDAs.
- Cibinqo (abrocitinib) – In February 2023, Pfizer announced the FDA approved an sNDA for Cibinqo, expanding its indication to include adolescents (12 to
- Comirnaty (COVID-19 vaccine, mRNA) (8)
- Regulatory Developments
- In April 2023, the FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine to simplify the vaccination schedule for most individuals. This action included authorizing the bivalent vaccine to be used for all doses administered to individuals six months of age and older, including for an additional dose or doses for certain populations such as older adults and the immunocompromised. The monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized for emergency use in the U.S.
- In March 2023, Pfizer and BioNTech announced the FDA granted EUA to provide a single 3-µg booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children six months through four years of age (also referred to as under five years of age) at least two months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Vaccine [Original]. Simultaneously, the FDA authorized the bivalent vaccine in this age group as the third dose of a three-dose primary series. The companies have submitted an application to the European Medicines Agency (EMA) to extend the Omicron BA.4/BA.5-adapted bivalent vaccine's marketing authorization (MA) to include use in children six months through four years of age as both primary series (all three doses) and booster vaccination (fourth dose).
- In February 2023, Pfizer and BioNTech announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for approval of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)) as a primary series and booster dose(s) for individuals 12 years of age and older. The companies have also submitted an application to the EMA for a variation of the MA to include the bivalent vaccine as a primary course of vaccination in individuals five years of age and older. In the European Union, the bivalent vaccine was previously granted full MA for administration as a booster dose in individuals five years of age and older.
- Regulatory Developments
- Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) (8) – In March 2023, Pfizer announced the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted that available data support the safety and effectiveness of Paxlovid for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. The AMDAC's vote, while not binding, will be considered by the FDA when making its decision regarding the potential approval of Paxlovid. If approved by the FDA, Paxlovid could be the first U.S. FDA-approved oral treatment for COVID-19. The target PDUFA action date for a decision by the FDA is in May 2023.
- Prevnar 20 (20-valent pneumococcal conjugate vaccine) – In April 2023, Pfizer announced the FDA approved Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in Prevnar. Prevnar 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine.
- Talzenna (talazoparib) – In February 2023, Pfizer announced positive results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to placebo plus Xtandi in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. Additionally, the FDA granted priority review for Pfizer's sNDA for Talzenna in combination with Xtandi for the treatment of men with mCRPC. The FDA's decision on the sNDA is expected in 2023. In addition, the marketing authorization application (MAA) for this same indication has also been accepted for review by the EMA.
- Xtandi (enzalutamide) – In April 2023, Astellas Pharma and Pfizer announced that Xtandi plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide, as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). These data from the Phase 3 EMBARK trial were presented as a plenary session during the 2023 American Urological Association Annual Meeting, and detailed results from the trial will be submitted for peer-reviewed publication. Additionally, the EMBARK data will be discussed with regulatory authorities, including the FDA, to support a potential regulatory submission for Xtandi in this indication in 2023.
- Zavzpret (zavegepant) – In March 2023, Pfizer announced the FDA approved Zavzpret, the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In the pivotal Phase 3 study, published in The Lancet Neurology , Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo. In clinical trials, Zavzpret was well tolerated. Zavzpret is anticipated to be available in pharmacies in July 2023.
Pipeline Developments
A comprehensive update of Pfizer's development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline . It includes an overview of Pfizer's research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
- Elranatamab (PF-06863135) – In February 2023, Pfizer announced the FDA granted priority review for the company's Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). The FDA's decision on the application is expected in 2023. The EMA also accepted elranatamab's MAA.
- RSVpreF (Respiratory Syncytial Virus (RSV) Bivalent Vaccine Candidate)
- Pfizer today reports positive top-line results from the Phase 3 study evaluating the safety and immunogenicity of its RSV bivalent vaccine candidate, PF-06928316 or RSVpreF, coadministered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older. The study met its primary endpoint, demonstrating non-inferiority for all four flu strains and both RSV groups. These results show that RSVpreF, if approved, can be administered concomitantly with SIIV.
- In February 2023, Pfizer announced the FDA accepted for priority review a BLA for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. If approved, RSVpreF would be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months. The PDUFA goal date for a decision by the FDA is in August 2023. Pfizer also announced that the EMA accepted Pfizer's MAA under accelerated assessment for its RSV vaccine candidate for both older adults and maternal immunization to help protect infants. A decision is expected in the second half of 2023.
- In February 2023, Pfizer announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data are adequate to support the safety and effectiveness of its RSV bivalent vaccine candidate, PF-06928316 or RSVpreF. The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older. The FDA's decision in older adults is expected by the PDUFA goal date in May 2023.
- Shingles (Varicella-zoster Virus, or VZV) mRNA Candidates – In February 2023, Pfizer and BioNTech announced the start of a Phase 1/2 trial exploring the safety, tolerability and immunogenicity of the companies' mRNA vaccine candidates against shingles (also known as herpes zoster, or HZ). The study is aiming to enroll up to 900 healthy volunteers 50 through 69 years of age and is being conducted in the U.S. Phase 1 will help select the optimal mRNA vaccine candidate, dose level, dosing schedule and formulation for advancement to Phase 2. Participants in the study will be followed to determine how long protection may last.
- VLA15 (Lyme Disease Vaccine Candidate) – In February 2023, Pfizer and Valneva SE announced that Pfizer, as the study sponsor, decided to discontinue a significant percentage of participants in the U.S. who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator. The discontinuation of these participants was not due to any safety concerns with the investigational vaccine and was not prompted by a participant-reported adverse event. The clinical trial remains ongoing at other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites.
Corporate Developments
- In March 2023, Pfizer announced it entered into a definitive merger agreement under which Pfizer will acquire Seagen Inc., a global biotechnology company that discovers, develops and commercializes transformative cancer medicines, for $229 in cash per Seagen share for a total enterprise value of approximately $43 billion. Pfizer expects to finance the transaction substantially through $31 billion of new, long-term debt, and the balance from a combination of short-term financing and existing cash. The companies expect to complete the transaction in late 2023 or early 2024, subject to fulfillment of customary closing conditions, including approval of Seagen's stockholders and receipt of required regulatory approvals. When combining the expected strong growth trajectories for Seagen's in-line medicines with candidates that could emerge from Seagen's pipeline, subject to clinical and regulatory success, Pfizer believes Seagen could contribute more than $10 billion in risk-adjusted revenues in 2030, with potential significant growth beyond 2030.
- In March 2023, it was announced that the Alliance between Merck KGaA, Darmstadt, Germany, (Merck KGaA) and Pfizer to co-develop and co-commercialize Bavencio (avelumab) will terminate. Effective June 30, 2023, Merck KGaA will take full control of the global commercialization of Bavencio. The current profit share will be replaced by a 15% royalty to Pfizer on net sales of Bavencio. Merck KGaA and Pfizer will continue to operationalize their respective ongoing clinical trials for Bavencio; and Merck KGaA will control all future research and development activities.
Please find Pfizer's press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:
https://investors.pfizer.com/Q1-2023-PFE-Earnings-Release
(Note: If clicking on the above link does not open a new webpage, you may need to cut and paste the above URL into your browser's address bar.)
For additional details, see the financial schedules and product revenue tables attached to the press release located at the hyperlink referred to above, and the attached disclosure notice.
(1) As used in this document, "Comirnaty" refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine. In the U.S., monovalent mRNA COVID-19 vaccines are no longer emergency use authorized or CDC-recommended, although Comirnaty remains a licensed vaccine. "Comirnaty" includes direct sales and alliance revenues related to sales of the above-mentioned vaccines, which are recorded within Pfizer's Primary Care customer group. It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the Pfizer CentreOne contract development and manufacturing organization. Revenues related to these manufacturing activities totaled $5 million for the first quarter of 2023 and $47 million for the first quarter of 2022.
(2) Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(3) Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and Reported diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the first quarter of 2023 and 2022. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS (2) . See the Non-GAAP Financial Measure: Adjusted Income section of Management's Discussion and Analysis of Financial Condition and Results of Operations in Pfizer's 2022 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of the press release located at the hyperlink above for a definition of each component of Adjusted income as well as other relevant information.
(4) Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues and acquired in-process R&D (IPR&D) expenses) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
Financial guidance for full-year 2023 reflects the following:
- Does not assume the completion of any business development transactions not completed as of April 2, 2023, except for signed transactions, if any, through mid-April 2023, which are expected to give rise to acquired IPR&D expenses during fiscal 2023.
- Reflects an anticipated negative revenue impact of $0.2 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent protection or that are anticipated to lose patent protection during fiscal-year 2023.
- Exchange rates assumed are a blend of actual rates in effect through the first quarter of 2023 and mid-April 2023 rates for the remainder of the year. Financial guidance reflects the anticipated unfavorable impact of approximately $0.4 billion on revenues and approximately $0.13 on Adjusted (3) diluted EPS as a result of changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2022.
- Guidance for Adjusted (3) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.75 billion shares, and assumes no share repurchases in 2023.
(5) Pfizer's fiscal year-end for international subsidiaries is November 30 while Pfizer's fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer's first quarter for U.S. subsidiaries reflects the three months ended on April 2, 2023 and April 3, 2022, while Pfizer's first quarter for subsidiaries operating outside the U.S. reflects the three months ended on February 26, 2023 and February 27, 2022.
(6) Beginning in the third quarter of 2022, Pfizer made several organizational changes to further transform its operations to better leverage its expertise in certain areas and in anticipation of potential future new product and indication launches. Biopharma, Pfizer's innovative science-based biopharmaceutical business, is operating under a new commercial structure designed to better support and optimize performance across three broad customer groups:
- Primary Care, consisting of the former Internal Medicine and Vaccines product portfolios, products for COVID-19 prevention and treatment, and potential future mRNA and antiviral products.
- Specialty Care, consisting of the former Inflammation & Immunology, Rare Disease and Hospital (excluding Paxlovid) product portfolios.
- Oncology, consisting of the former Oncology product portfolio.
(7) References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although exchange rate changes are part of Pfizer's business, they are not within Pfizer's control, and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer's results.
(8) Paxlovid and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) have not been approved or licensed by the FDA. Paxlovid has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1) of the FFDCA unless the declaration is terminated or authorization revoked sooner. Please see the EUA Fact Sheets at www.covid19oralrx.com and www.cvdvaccine-us.com .
DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 2, 2023. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.
This earnings release and the related attachments contain forward-looking statements about, among other topics, our anticipated operating and financial performance; reorganizations; business plans, strategy and prospects; our Environmental, Social and Governance (ESG) priorities, strategy and goals; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data, revenue contribution and projections, potential pricing and reimbursement, potential market dynamics and size, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our proposed acquisition of Seagen, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our ongoing efforts to respond to COVID-19, including Comirnaty (as defined in this earnings release) and our oral COVID-19 treatment (Paxlovid); and our expectations regarding the impact of COVID-19 on our business, operations and financial results that involve substantial risks and uncertainties. You can identify these statements by the fact that they use future dates or use words such as "will," "may," "could," "likely," "ongoing," "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "assume," "target," "forecast," "guidance," "goal," "objective," "aim," "seek," "potential," "hope" and other words and terms of similar meaning.
Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:
Risks Related to Our Business, Industry and Operations, and Business Development:
- the outcome of research and development (R&D) activities, including, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; and whether and when additional data from our pipeline programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations;
- our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all; regulatory decisions impacting labeling, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; the impact of, or uncertainties regarding the ability to obtain, recommendations by technical or advisory committees; and the timing of pricing approvals and product launches;
- claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the outcome of post-approval clinical trials, which could impact marketing approval, product labeling, and/or availability or commercial potential, including uncertainties regarding the commercial or other impact of the results of the Xeljanz ORAL Surveillance (A3921133) study or actions by regulatory authorities based on analysis of ORAL Surveillance or other data, including on other Janus kinase (JAK) inhibitors in our portfolio;
- the success and impact of external business development activities, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which could result in increased leverage and/or a downgrade of our credit ratings; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired products; significant transaction costs; and unknown liabilities;
- risks and uncertainties related to Pfizer's proposed acquisition of Seagen, including, among other things, risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals and failure to obtain the requisite vote by Seagen stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of the announcement or the consummation of the proposed acquisition on the market price of Pfizer's common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Seagen's business; risks related to the financing of the transaction; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; the impact of the proposed acquisition on future business combinations or disposals; uncertainties regarding the commercial success of Pfizer's and Seagen's commercialized and pipeline products; the uncertainties inherent in R&D; whether and when drug applications may be filed in any jurisdictions for Pfizer's or Seagen's pipeline products; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such products will be commercially successful; and competitive developments;
- competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
- the ability to successfully market both new and existing products, including biosimilars;
- difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
- the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
- risks and uncertainties related to our efforts to develop and commercialize our COVID-19 products, as well as challenges related to their manufacturing, supply and distribution, including, among others, uncertainties inherent in R&D, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program or Paxlovid or any future COVID-19 treatment) in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection; the ability to produce comparable clinical or other results for Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program, including the rate of effectiveness and/or efficacy, safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial for any such products and additional studies, in real-world data studies or in larger, more diverse populations following commercialization; the ability of Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent, or Paxlovid or any future COVID-19 treatment to be effective against, COVID-19 caused by emerging virus variants; the risk that demand for any products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on-hand and/or in the channel or reduced revenues; challenges related to a transition to the commercial market for any of our products; uncertainties related to the public's adherence to vaccines, boosters and treatments; the risk that use of Comirnaty or Paxlovid will lead to new information about efficacy, safety or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program, Paxlovid or other COVID-19 programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from existing or future pre-clinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for Comirnaty or any future vaccines in additional populations, for a potential booster dose for Comirnaty, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or biologics license and/or EUA applications or amendments to any such applications may be filed in particular jurisdictions for Comirnaty, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine or any other potential vaccines, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; whether and when submissions to request emergency use or conditional marketing authorizations for Paxlovid or any future COVID-19 treatment and/or any drug applications and/or EUA applications or amendments to any such applications for any indication for Paxlovid or any future COVID-19 treatment may be filed in particular jurisdictions, and if obtained, whether or when such EUA or licenses, or existing EUAs, will expire or terminate; whether and when any application that may be pending or filed for Comirnaty, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may result from the BNT162 program, Paxlovid or any future COVID-19 treatment or any other COVID-19 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's or drug's benefits outweigh its known risks and determination of the vaccine's or drug's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine or drug, including the authorization or approval of products or therapies developed by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test any such products; challenges related to our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; challenges and risks related to medication errors such as prescribing or dispensing the wrong strength, improper dosing and self-administration errors; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines, potential combination respiratory vaccines or next generation COVID-19 treatments; the risk that we may not be able to recoup costs associated with our R&D and manufacturing efforts; risks associated with any changes in the way we approach or provide research funding for the BNT162 program, Paxlovid or any other COVID-19 program; challenges and risks associated with the pace of our development programs; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our COVID-19 products, which would negatively impact our ability to supply our COVID-19 products within the projected time periods; risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments; whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine or treatment advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; pricing and access challenges for such products; challenges related to public confidence in, or awareness of Comirnaty or Paxlovid, including challenges driven by misinformation or disinformation, access, concerns about clinical data integrity, or prescriber and pharmacy education; uncertainties around future changes to applicable healthcare policies and guidelines issued by the U.S. federal government in connection with the declared termination of the federal government's COVID-19 public health emergency as of May 11, 2023; trade restrictions; potential third-party royalties or other claims related to Comirnaty or Paxlovid; and competitive developments;
- trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
- interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations and monetary policy actions in countries experiencing high inflation rates;
- any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
- the impact of the increased presence of counterfeit medicines or vaccines in the pharmaceutical supply chain;
- any significant issues related to the outsourcing of certain operational and staff functions to third parties; and any significant issues related to our JVs and other third-party business arrangements;
- uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation, and recent and possible future changes in global financial markets;
- any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, civil unrest or military action;
- the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, including our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines;
- trade buying patterns;
- the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
- the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs or organizational disruption;
- the ability to successfully achieve our climate goals and progress our environmental sustainability priorities;
Risks Related to Government Regulation and Legal Proceedings:
- the impact of any U.S. healthcare reform or legislation or any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022, or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
- U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive insurance markets;
- legislation or regulatory action in markets outside of the U.S., such as China and Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, regulatory data protection, environmental impact of medicines, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
- the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, the impact of political or civil unrest or military action, including the ongoing conflict between Russia and Ukraine and its economic consequences, unstable governments and legal systems, inter-governmental disputes and natural disasters or disruptions related to climate change;
- legal defense costs, insurance expenses, settlement costs and contingencies, including those related to actual or alleged environmental contamination;
- the risk and impact of an adverse decision or settlement and the risk related to adequacy of reserves related to legal proceedings;
- the risk and impact of tax related litigation and investigations;
- governmental laws and regulations affecting our operations, including, without limitation, the recently enacted Inflation Reduction Act of 2022, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. and potential changes to existing tax law by the current U.S. Presidential administration and Congress;
Risks Related to Intellectual Property, Technology and Security:
- any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services);
- any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack or other malfeasance by, but not limited to, nation states, employees, business partners or others;
- the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; and
- risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in loss of exclusivity; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid.
We cannot guarantee that any forward-looking statement will be realized. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in our subsequent report on Form 10-Q, in each case including in the sections thereof captioned "Forward-Looking Information and Factors That May Affect Future Results" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K.
This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
The information contained on our website or any third-party website is not incorporated by reference into this earnings release. All trademarks mentioned are the property of their owners.
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XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide
Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting
Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that XTANDI ® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P
The overall safety profile was consistent with the known safety profile of each of the medicines. The most common adverse events in those treated with XTANDI plus leuprolide were fatigue, hot flush, and arthralgia and in those treated with XTANDI monotherapy were fatigue, gynecomastia, and arthralgia.
"There are patients with localized prostate cancer who undergo prostatectomy or radiation therapy in an attempt to cure their disease, but, unfortunately, some patients will develop BCR," said Neal Shore , M.D., F.A.C.S., U.S. Chief Medical Officer of Urology and Surgical Oncology, GenesisCare, Director, Carolina Urologic Research Center, and Primary Investigator for the EMBARK study. "Importantly, some patients with BCR are at very high risk for developing metastatic disease, which can lead to a cascade of therapeutic interventions. The clinical goal of BCR therapy is to delay cancer progression and avoid metastatic disease. The MFS results from the EMBARK study demonstrate that this intervention with XTANDI plus leuprolide was statistically significant for patients with high-risk BCR."
"The EMBARK study is a Phase 3 trial exploring the potential of enzalutamide in patients with non-metastatic hormone-sensitive prostate cancer with high-risk BCR," said Stephen J. Freedland , M.D., Director of the Center for Integrated Research in Cancer and Lifestyle and the Warschaw Robertson Law Families Chair in Prostate Cancer at Cedars-Sinai Cancer and Co-Principal Investigator of the Clinical Trial. "If approved, we hope to bring a new option to men earlier in the course of their disease."
Consistent with the study's primary endpoint, statistically significant and clinically meaningful improvements were also observed in the trial's key secondary endpoints in both the XTANDI combination and monotherapy arms. Specifically, the XTANDI monotherapy arm demonstrated that treatment with XTANDI reduced the risk of metastasis or death by 37% versus leuprolide plus placebo (HR: 0.63; 95% CI, 0.46–0.87; P=0.0049), meeting its MFS endpoint. Treatment with XTANDI plus leuprolide and XTANDI monotherapy reduced the risk of PSA progression by 93% (HR: 0.07; 95% CI, 0.03–0.14; P
A positive trend in the key secondary endpoint of overall survival (OS) was also observed in the XTANDI combination arm at the time of the analysis, but these data were not yet mature. Patients in the trial will be followed for a subsequent final OS analysis.
Detailed results from the trial will be submitted for peer-reviewed publication. Additionally, the EMBARK data will be discussed with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to support a potential regulatory submission for XTANDI in this indication in 2023.
About EMBARK
The Astellas- and Pfizer-led Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States , Canada , Europe , South America and the Asia-Pacific region. Patients who were considered to experience high-risk BCR had a prostate-specific antigen doubling time (PSA-DT) ≤ 9 months; serum testosterone ≥ 150 ng/dL (5.2 nmol/L); and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer, or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide (n=355), enzalutamide 160 mg as a monotherapy (n=355), or placebo plus leuprolide (n=358). Leuprolide 22.5 mg was administered every 12 weeks.
The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide versus placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death. For more information on the EMBARK trial ( NCT02319837 ) go to www.clinicaltrials.gov .
XTANDI, either in combination with leuprolide or as a monotherapy, has not been approved by any regulatory agency for the treatment of patients with nmHSPC with high-risk BCR.
About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
In non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC), no evidence of the cancer spreading to distant parts of the body (metastases) is detectable with conventional radiological methods (CT/MRI), and the cancer still responds to medical or surgical treatment designed to lower testosterone levels. 1,2 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years. 3 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence. 4 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC and high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a prostate-specific antigen doubling time (PSA-DT) ≤ 9 months. High-risk BCR patients with a PSA-DT of ≤ 9 months have a higher risk of metastases and death. 5
About XTANDI ® (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), and non-metastatic castration-resistant prostate cancer (nmCRPC). XTANDI is currently approved for one or more of these indications in more than 100 countries, including in the United States , European Union and Japan . One million patients have been treated with XTANDI globally. 6
U.S. Important Safety Information
XTANDI (enzalutamide) is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).
Warnings and Precautions
Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer's disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space-occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES): There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.
Hypersensitivity: Reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in seven randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.
Ischemic Heart Disease: In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.
Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo.
Embryo-Fetal Toxicity: The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.
Adverse Reactions (ARs): In the data from the four randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.
In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3- 4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to AEs were reported for 6% of XTANDI treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3- 4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.
In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.
In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.
Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia.
Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% of placebo patients. Hypertension led to study discontinuation in
Drug Interactions
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If coadministration is necessary, increase the dose of XTANDI. Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.
Please see Full Prescribing Information for additional safety information.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ ® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en .
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.
About the Pfizer/Astellas Collaboration
In October 2009 , Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI ® (enzalutamide) in the United States , while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States . Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.
Astellas Forward-Looking Statement
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.
Pfizer Disclosure Notice
The information contained in this release is as of April 29, 2023 . Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about XTANDI ® (enzalutamide) and a potential new indication being evaluated for the treatment of men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence (BCR), including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the EMBARK trial will meet the secondary endpoint of overall survival; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for the potential new indication for XTANDI or any other potential indications for XTANDI may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on a myriad of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether XTANDI for any potential indication will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of XTANDI, including for the potential new indication; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
1 Cancer.net. Prostate Cancer: Types of Treatment (12-2022). https://www.cancer.net/cancer-types/prostate-cancer/types-treatment . Accessed March 16, 2023 .
2 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2021). https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf . Accessed March 16, 2023 .
3 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760.
4 Antonarakis, Emmanuel S et al. "The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up." BJU international vol. 109,1 (2012): 32-9. doi:10.1111/j.1464-410X.2011.10422.
5 Paller, Channing J et al. "Management of patients with biochemical recurrence after local therapy for prostate cancer." Hematology/oncology clinics of North America vol. 27,6 (2013): 1205-19, viii. doi:10.1016/j.hoc.2013.08.005
6 Data on file. Northbrook, IL : Astellas Inc.
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U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children
- PREVNAR 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine
- PREVNAR 20 builds on PREVNAR 13 ® and includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 1
- The vaccine further advances Pfizer's pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership, legacy and innovation in developing pneumococcal conjugate vaccines
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR ® .
"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," 1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine."
In the United States, there remains a considerable burden of disease attributed to serotypes not included in currently approved pneumococcal conjugate vaccines (PCVs). 1 PREVNAR 20 builds on Pfizer's approved PREVNAR 13 vaccine, and includes seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 1 Moreover, data show that the additional seven serotypes included in PREVNAR 20 are among some of the most common serotypes causing pediatric IPD in countries, like the U.S., with existing pneumococcal vaccination programs. 1 A study found that the seven additional serotypes alone accounted for an estimated 37% of IPD in U.S. children under five years of age. 1
"With the approval of PREVNAR 20 for the pediatric indication, we now have an expanded vaccine to help provide infants and children with the broadest serotype protection in a PCV, helping to protect against the 20 serotypes in the vaccine, which includes the specific serotypes responsible for significant burden of disease in children under five," said Dr. Sheldon Kaplan, Chief, Division of Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and Chief, Infectious Disease Service, Texas Children's Hospital. "We are thrilled with this approval as it signifies a new chapter in pediatric pneumococcal conjugate vaccination. Based on the real-world results we've observed with PREVNAR 13, PREVNAR 20 has the potential to greatly reduce the substantial remaining burden of pneumococcal disease among U.S. infants and children and help protect them against this potentially serious disease."
The FDA's decision is based on results from the Phase 2 and Phase 3 clinical trial programs for the pediatric indication for PREVNAR 20. Three core Phase 3 pediatric studies contributed to data on the safety, tolerability, and immunogenicity of PREVNAR 20, including previously announced positive, top-line results of the pivotal U.S. Phase 3 study (NCT04382326). Further positive data from a Proof-of-Concept Phase 2 study (NCT03512288) that assessed the safety and immunogenicity of PREVNAR 20 also supported the FDA's decision.
The U.S. Center for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is committed to taking action as soon as possible on new vaccines after FDA approval. The next regularly scheduled ACIP meeting is June 21-22, 2023.
About 20-Valent Pneumococcal Conjugate (PREVNAR 20) Vaccine Regulatory Review
The FDA granted PREVNAR 20 Breakthrough Therapy Designation in August 2020 for the pediatric indication for invasive pneumococcal disease (IPD). Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). 3 Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA's Fast Track designation, which may include more frequent communication with the FDA about the drug's development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. 4
In August 2022, Pfizer announced positive top-line results from its pivotal Phase 3 study in U.S. infants (NCT04382326) and, in January 2023, the U.S. FDA accepted for priority review a supplemental Biologics License Application (sBLA) for PREVNAR 20 for the prevention of IPD for the pediatric indication.
Additional positive top-line results from Pfizer's Phase 3 study (NCT04546425) in infants in the European Union were announced in September 2022. In November 2022, Pfizer submitted the 20-valent pneumococcal conjugate vaccine candidate pediatric indication to the European Medicines Agency (EMA).
INDICATIONS FOR PREVNAR 20
PREVNAR 20 is a vaccine approved for:
- the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older.
- the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.
IMPORTANT SAFETY INFORMATION FOR PREVNAR 20
- PREVNAR 20 should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria–toxoid-containing vaccine.
- Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.
- A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20.
- In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever.
- In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever.
- Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for your child.
View the full Prescribing Information . There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.
INDICATIONS FOR PREVNAR 13
- PREVNAR 13 is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains.
- PREVNAR 13 is not 100% effective and will only help protect against the 13 strains included in the vaccine.
IMPORTANT SAFETY INFORMATION
- PREVNAR 13 should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 13 or any diphtheria toxoid–containing vaccine
- Children with weakened immune systems (e.g., HIV infection, leukemia) may have a reduced immune response
- A temporary pause of breathing following vaccination has been observed in some infants born prematurely
- The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
- In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
- Ask your healthcare provider about the risks and benefits of PREVNAR 13. Only a healthcare provider can decide if PREVNAR 13 is right for your child
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer .
DISCLOSURE NOTICE:
The information contained in this release is as of April 27, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer's PREVNAR 20 ® , including its potential benefits, an approval in the U.S. for a pediatric indication, and an application submitted to the EMA for a pediatric indication, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PREVNAR 20; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any biologics license applications may be filed in any other jurisdictions for PREVNAR 20 for the prevention of invasive disease and pneumonia in infants and children six weeks through seventeen years of age and in any jurisdictions for any other potential indications; whether and when the pending in the EU may be approved and whether and when any such other applications that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether PREVNAR 20 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PREVNAR 20; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PREVNAR 20 and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.Pfizer.com .
_____________________________________ |
1 Senders, S., et al. (2021, October 1). Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants in the United States. The Pediatric infectious disease journal. Retrieved March 3, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8443440/ |
2 Gierke, R. (2022, February 24). Current Epidemiology of Pneumococcal Disease and Pneumococcal Vaccine Coverage among Children, United States. Centers for Disease Control and Prevention. Retrieved March 3, 2023, from https://stacks.cdc.gov/view/cdc/114840 |
3 U.S. Food and Drug Administration. Breakthrough Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm |
4 U.S. Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm |
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Pfizer Declares Second-Quarter 2023 Dividend
Board of Directors approves quarterly cash dividend of $0.41 per share
Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 second-quarter 2023 dividend on the company's common stock, payable June 9, 2023, to holders of the Common Stock of record at the close of business on May 12, 2023. The second-quarter 2023 cash dividend will be the 338th consecutive quarterly dividend paid by Pfizer.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Category: Finance
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Jamieson Wellness Inc. Reports Strong Fourth Quarter and Full Year 2023 Results
Profitable revenue growth of 23.5% in 2023 demonstrates successful execution of global strategy;
Canadian consumer consumption reaches record levels in Q4
Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its fourth quarter and full year results for the period ended December 31, 2023. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.
"2023 was a reflection of success on our strategic journey to become a global vitamin, mineral, and supplement leader," said Mike Pilato, President and CEO of Jamieson Wellness. "We drove growth across all our major markets and business units while successfully completing our 2022 U.S. acquisition integration and taking ownership of the full value chain in China.
"Today, over 40% of our branded revenue is derived outside of Canada, more than double the percentage it was just three years ago. While we continue to expand our leadership position in our domestic market, the success of this diversification strategy positions us as a very different company, with key growth strategies and investment choices tailored for the unique attributes of key markets, globally.
�We are entering 2024 from a position of strength strategically, operationally, and financially. To harness the full potential of the evolving needs of engaged consumers and significant industry growth tailwinds, we will continue to prioritize investment in demand generation, innovation, and distribution in all our major markets, while investing aggressively to grow our brands in the U.S. and China, building on the momentum we have coming out of 2023. Looking forward, we are confident in our ability to deliver superior organic growth across all key markets in 2024, while expanding margins within each distinctive business unit and delivering accretive earnings per share in the years ahead."
Fiscal 2023 Performance Highlights
- Expanded leadership position in Canada driven by strong dollar and unit consumption growth outpacing the market, despite some customer level inventory burn; consumers continued to interact with the Company's immune products and increase their purchases across foundational health categories including, sleep, stress and energy
- Successful implementation of the Company's growth strategy in the U.S. delivered approximately 17.4% pro forma revenue growth, driven by innovation and category growth, e-commerce expansion, and increased distribution
- Delivered 45.1% pro forma RMB revenue growth in China as a result of the completion of the Company's acquisition of its former distributor's assets and strategic partnership with DCP Capital; established Jamieson's Chinese headquarters in Shanghai, with a team of more than 45 employees
- Growth across International markets despite global volatility; consumer consumption trends began a return to historical levels in Eastern Europe
- Finalized the Company's annual ESG reporting strategy and implemented a new environmental policy
Fourth Quarter Performance Highlights
- Record-high consumer consumption and shipments drove increased market share in Canada despite retailer level inventory burn beyond expectation
- Growth of the youtheory brand in the U.S led by strong demand for existing products, innovation and progress in e-commerce
- Demand in China was further strengthened in cross border e-commerce with a strong 11/11 promotion window and expanded distribution in brick and mortar retail
- Revenue growth in International was partially offset by volatility in the Middle East
- Exited the quarter with a leverage ratio of approximately 2.1x net debt to Adjusted EBITDA with cash and available borrowings of over $200.0 million
- Completed the Company's 2023 greenhouse gas inventory report for disclosure in the Company's first formal Impact Report in Q1 2024
Fourth Quarter Financial Performance Highlights (year-over year, unless otherwise noted)
- Consolidated revenue increased by 14.3% to $220.4 million driven by 16.0% growth in Jamieson Brands and 7.0% growth in Strategic Partners
- Gross profit increased $7.8 million to $79.0 million on higher revenues partially offset by the fair value amortization impact of acquisition-related inventories
- Normalized gross profit margin was 37.1%, or 20 bps lower than last year largely due to sales mix; Gross profit margin 3 was 35.9% or 100 bps lower
- Adjusted EBITDA 1 increased by $1.8 million or 3.6% to $50.6 million, reflecting higher gross profit and higher marketing and infrastructure investments to expand the Company's footprint in China and to support youtheory innovation and channel growth; EBITDA 1 increased $5.3 million or 12.9% to $46.5 million
- Adjusted net earnings 1 increased 6.9% to $28.6 million which included the impact of lower interest on reduced average borrowings; Net earnings increased to $24.0 million
- Adjusted diluted earnings per share 2 was $0.67; Diluted earnings per share was $0.56
- Cash from operating activities before working capital considerations of $20.4 million decreased by $8.7 million compared to Q4 2022 mainly due to investments in marketing, IT infrastructure costs and acquisition related costs
- Cash generated in working capital of $5.7 million was $6.0 million lower than prior year, cash generated was impacted by the timing of vendor and income tax payments made
- Net debt 1 at the end of the quarter was $288.1 million, or 22.9% lower than Q4 2022
- As at December 31, 2023, the Company had approximately $211.9 million in cash and available borrowings
Fourth Quarter Segment Highlights (year-over-year, unless otherwise noted)
Jamieson Brands
- Revenue increased 16.0% or $25.0 million to $181.0 million
- Jamieson Canada increased 5.8% to $94.3 million, reflecting record consumption levels which outpaced shipments as retailers reduced inventories below typical levels
- U.S. business (youtheory) was $55.0 million, increasing by 8.7% with growth across all channels driven by continued demand for existing products and successful innovations launched throughout the year
- Jamieson China was $20.7 million, increasing 151.1% which reflects the seasonal impact of direct sales to consumers under the owned-distribution model beginning April 2023, while pro-forma growth on a local currency basis grew 91.6% driven by strong fourth quarter promotional plans and the successful launch with certain social media platforms through cross border e-commerce
- Jamieson International was $11.1 million, increasing by 37.0% on a constant U.S. dollar basis, driven largely by growth in Europe
- Gross profit increased $7.7 million to $73.1 million; normalized gross profit increased by $9.6 million
- Gross profit margin 3 decreased by 150 bps; normalized gross profit margin decreased by 60 bps to 41.8% largely driven by sales mix as the Company continued to invest in accelerated growth in China and the U.S.
- Adjusted EBITDA 1 increased $1.6 million to $45.4 million reflecting direct investments in brand growth; Adjusted EBITDA margin 2 decreased by 300 bps to 25.1% due to lower gross profit margin as a result of the business unit mix as noted above, and higher SG&A as a percentage of revenue
Strategic Partners
- Revenue grew 7.0% to $39.4 million, reflecting timing of shipments and remaining orders on the close-out of a customer account
- Gross profit increased $0.1 million to $5.9 million; gross profit margin 3 decreased by 80 basis points to 15.1%, with production efficiencies and pricing being offset by customer mix
- Adjusted EBITDA 1 was $5.2 million representing an Adjusted EBITDA margin 2 of 13.3%, lower by 40 bps
Fiscal 2023 Financial Performance Highlights (year-over-year, unless otherwise noted)
- Consolidated revenue increased 23.5% to $676.2 million driven by 25.5% growth in Jamieson Brands and 15.5% growth in Strategic Partners
- Adjusted EBITDA 1 increased by $14.3 million or 11.6% to $138.1 million
- Net earnings were $46.0 million; Adjusted net earnings increased 1.4% to $66.1 million
- Adjusted diluted earnings per share 2 was $1.55; Diluted earnings per share was $1.08
1 This is a non-IFRS financial measure. See the "Non-IFRS and Other Financial Measures" section of this press release for more information on each non-IFRS financial measure.
2 This is a non-IFRS ratio. See the "Non-IFRS and Other Financial Measures" section of this press release for more information on each non-IFRS ratio.
3 This is a supplementary financial measure. See the "Non-IFRS and Other Financial Measures" section of this press release for more information on each supplementary financial measure.
Fiscal 2024 Outlook (year-over-year, unless otherwise noted)
The Company is introducing its outlook for fiscal 2024 and anticipates the following:
- Consolidated revenue of between $720.0 to $760.0 million, representing growth of 6.5% to 12.5% on another strong year of growth in Jamieson Brands, partially offset by a temporary decline in Strategic Partners
- Jamieson Brands revenue of $615.0 to $650.0 million, or growth of between 12% and 18%, with approximately 47% coming from outside of Canada
- Canada: Growth of 4.0% to 7.5%, including consumption growth, lower customer inventories and pricing;
- U.S. business (youtheory): Growth of between 13% and 20%, building innovation and distribution on strong 2023 double digit growth momentum;
- China: Growth of between 60% and 80%, building on strong double digit 2023 growth and a strategic decision to rapidly accelerate demand generating and branding building investment behind exceptional recent growth;
- International: Growth of between 5% and 15% including consumption and expansion to new markets
- Strategic Partners revenue of between $100.0 and $113.0 million, or 10% to 20% lower, driven by the impact of a 2023 customer transition partially offset by onboarding new opportunities
- Adjusted EBITDA of between $138.0 to $144.0 million, or growth of up to ~4.5% with Jamieson Brands growth partially offset by a decline in Strategic Partners
- Adjusted EBITDA margins to decline between 120 and 170 basis points due to increased investment in China and the U.S. to drive accelerated scale and the impact of segment mix
- Adjusted diluted earnings per share of $1.55 to $1.65, or growth of up to ~6.5%
Fiscal 2025 Outlook (year-over-year, unless otherwise noted)
In fiscal 2025, the Company anticipates a return to low double-digit growth with Adjusted EBITDA of between $155.0 and 165.0 million. Profitability in 2025 is expected to be driven by growth in Jamieson Brands and Strategic Partners volumes, manufacturing efficiencies, along with SG&A and marketing investments consistent with Jamieson Brands revenue growth rates.
For additional details on the Company's fiscal 2024 and 2025 outlook including guidance for the first quarter of 2024, refer to the "Outlook" section in the management's discussion and analysis of financial condition and results of operations ("2023 MD&A") for the three and twelve months ended December 31, 2023.
Fourth Quarter Dividend
On February 22, 2024, the Company announced that the board of directors declared a cash dividend for the fourth quarter of 2023:
- $0.19 per common share (+11.8% vs Q4 2022), or approximately $8.0 million in the aggregate
- Paid on March 15, 2024 to all common shareholders of record at the close of business on March 1, 2024
- The Company has designated this dividend as an "eligible dividend" for the purposes of the Income Tax Act (Canada)
Consolidated Financial Statements and Management's Discussion and Analysis
The Company's audited consolidated annual financial statements and accompanying notes as at and for the three and twelve months ended December 31, 2023 and related 2023 MD&A are available under the Company's profile on SEDAR+ at www.sedarplus.com and on the Investor Relations section of the Company's website at https://investors.jamiesonwellness.com .
Conference Call
Management will host a conference call to discuss the Company's fourth quarter and full year 2023 results at 5:00 p.m. ET today, March 13, 2024. To access:
- By phone: 1-888-886-7786 from Canada and the U.S. or 1-416-764-8658 from international locations
- Online: https://investors.jamiesonwellness.com or https://viavid.webcasts.com/starthere.jsp?ei=1652695&tp_key=adfa7983af
About Jamieson Wellness
Jamieson Wellness is dedicated to improving the world's health and wellness with its portfolio of innovative natural health brands. Established in 1922, the Jamieson brand is Canada's #1 consumer health brand. The Company's youtheory brand, acquired in 2022, is an established and growing lifestyle brand in the U.S. Combined, these global brands are available in more than 50 countries worldwide. The Company also offers a variety of innovative vitamins, minerals and supplements ("VMS") as well as sports nutrition products to consumers in Canada with its Progressive, Smart Solutions, Iron Vegan and Precision brands. The Company is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. For more information please visit www.jamiesonwellness.com .
Forward-Looking Information
This press release may contain forward-looking information within the meaning of applicable securities legislation. Such information includes, but is not limited to, statements related to the Company's anticipated results and its outlook for its 2024 revenue, Adjusted EBITDA and Adjusted diluted earnings per share. Words such as "expect", "anticipate", "intend", "may", "will", "estimate" and variations of such words and similar expressions are intended to identify such forward-looking information. This information reflects the Company's current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company's control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. Such risks and uncertainties include, but are not limited to, the factors discussed under "Risk Factors" in the Company's Annual Information Form dated March 30, 2023 and under the "Risk Factors" section in the 2023 MD&A filed today, March 13, 2024. This information is based on the Company's reasonable assumptions and beliefs in light of the information currently available to it and the statements are made as of the date of this press release. The Company does not undertake any obligation to update such forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable law or regulatory authority.
The Company cautions that the list of risk factors and uncertainties is not exhaustive and other factors could also adversely affect the Company's results. Readers are urged to consider the risks, uncertainties and assumptions associated with these statements carefully in evaluating the forward-looking information and are cautioned not to place undue reliance on such information. See "Forward-looking Information" and "Risk Factors" within the 2023 MD&A for a discussion of the uncertainties, risks and assumptions associated with these statements.
Jamieson Wellness Inc. Selected Consolidated Financial Information In thousands of Canadian dollars, except share and per share amounts | |||||||||||
Three months ended | Twelve months ended | ||||||||||
December 31 | December 31 | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Revenue | 220,365 | 192,775 | 676,172 | 547,369 | |||||||
Cost of sales | 141,338 | 121,586 | 442,613 | 349,031 | |||||||
Gross profit | 79,027 | 71,189 | 233,559 | 198,338 | |||||||
Gross profit margin | 35.9 | % | 36.9 | % | 34.5 | % | 36.2 | % | |||
Selling, general and administrative expenses | 42,300 | 32,768 | 140,304 | 110,239 | |||||||
Acquisition related adjustments | (7,863 | ) | - | (7,863 | ) | - | |||||
Share-based compensation | 1,534 | 1,317 | 5,868 | 4,910 | |||||||
Earnings from operations | 43,056 | 37,104 | 95,250 | 83,189 | |||||||
Operating margin | 19.5 | % | 19.2 | % | 14.1 | % | 15.2 | % | |||
Foreign exchange loss | 1,676 | 978 | 1,962 | 269 | |||||||
Interest expense and other financing costs | 4,885 | 5,757 | 22,784 | 12,417 | |||||||
Accretion on preferred shares | 1,965 | - | 4,833 | - | |||||||
Earnings before income taxes | 34,530 | 30,369 | 65,671 | 70,503 | |||||||
Provision for income taxes | 10,530 | 8,278 | 19,631 | 17,695 | |||||||
Net earnings | 24,000 | 22,091 | 46,040 | 52,808 | |||||||
Net earnings attributable to: | |||||||||||
Shareholders | 24,407 | 22,091 | 47,882 | 52,808 | |||||||
Non-controlling interests | (407 | ) | - | (1,842 | ) | - | |||||
24,000 | 22,091 | 46,040 | 52,808 | ||||||||
Adjusted net earnings | 28,615 | 26,759 | 66,084 | 65,149 | |||||||
EBITDA | 46,516 | 41,201 | 113,611 | 100,168 | |||||||
Adjusted EBITDA | 50,628 | 48,871 | 138,063 | 123,761 | |||||||
Adjusted EBITDA margin | 23.0 | % | 25.4 | % | 20.4 | % | 22.6 | % | |||
Weighted average number of shares | |||||||||||
Basic | 42,062,117 | 41,683,753 | 41,960,516 | 40,998,065 | |||||||
Diluted | 42,766,299 | 42,817,044 | 42,650,501 | 42,116,350 | |||||||
Earnings per share attributable to common shareholders: | |||||||||||
Basic, earnings per share | 0.57 | 0.53 | 1.10 | 1.29 | |||||||
Diluted, earnings per share | 0.56 | 0.52 | 1.08 | 1.25 | |||||||
Adjusted diluted, earnings per share | 0.67 | 0.62 | 1.55 | 1.55 |
Jamieson Wellness Inc. Consolidated Statements of Financial Position In thousands of Canadian dollars | |||
December 31, | December 31, | ||
Assets | |||
Current assets | |||
Cash | 36,863 | 26,240 | |
Accounts receivable | 164,499 | 160,798 | |
Inventories | 182,456 | 154,488 | |
Derivatives | 3,707 | 6,580 | |
Prepaid expenses and other current assets | 5,335 | 4,298 | |
392,860 | 352,404 | ||
Non-current assets | |||
Property, plant and equipment | 106,903 | 111,709 | |
Goodwill | 274,411 | 272,916 | |
Intangible assets | 366,521 | 367,205 | |
Deferred income tax | 2,879 | 3,029 | |
Total assets | 1,143,574 | 1,107,263 | |
Liabilities | |||
Current liabilities | |||
Accounts payable and accrued liabilities | 135,520 | 142,566 | |
Income taxes payable | 2,263 | 7,387 | |
Current portion of other long-term liabilities | 7,546 | 4,852 | |
145,329 | 154,805 | ||
Long-term liabilities | |||
Long-term debt | 325,000 | 400,000 | |
Post-retirement benefits | 1,078 | 929 | |
Deferred income tax | 60,532 | 58,007 | |
Redeemable preferred shares | 89,409 | - | |
Other long-term liabilities | 41,031 | 61,931 | |
Total liabilities | 662,379 | 675,672 | |
Equity | |||
Share capital | 312,593 | 307,200 | |
Warrants | 14,705 | - | |
Contributed surplus | 19,089 | 17,115 | |
Retained earnings | 80,654 | 85,483 | |
Accumulated other comprehensive income | 11,892 | 21,793 | |
Total shareholders' equity | 438,933 | 431,591 | |
Non-controlling interests | 42,262 | - | |
Total equity | 481,195 | 431,591 | |
Total liabilities and equity | 1,143,574 | 1,107,263 |
Non-IFRS and Other Financial Measures
This press release makes reference to certain financial measures, including non-IFRS financial measures that are historical, non-IFRS measures that are forward-looking, non-GAAP ratios and supplementary financial measures. Management uses these financial measures for purposes of comparison to prior periods and development of future projections and earnings growth prospects. This information is also used by management to measure the profitability of ongoing operations and in analyzing the Company's business performance and trends. These measures are not recognized measures under IFRS, do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of the Company's results of operations from management's perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of the Company's financial information reported under IFRS. The Company uses the following non‑IFRS financial measures: "EBITDA", "Adjusted EBITDA" and "Adjusted net earnings", the most directly comparable financial measure for each that is disclosed in its financial statements being "net earnings", "normalized gross profit", "normalized SG&A", "normalized earnings from operations", "cash from operating activities before working capital considerations" and "net debt", the most directly comparable financial measures for each that is disclosed in its financial statements being "gross profit", "SG&A", "earnings from operations", "cash flows from operating activities", and "long-term debt", respectively, the following non-IFRS ratios: "Adjusted EBITDA margin", "Adjusted diluted earnings per share", "normalized gross profit margin", "normalized operating margin", and the following supplementary financial measures: "gross profit margin" and "operating margin" to provide supplemental measures of the Company's operating performance and thus highlight trends in the Company's core business that may not otherwise be apparent when relying solely on IFRS financial measures. Management also uses non‑IFRS and supplementary financial measures in order to prepare annual operating budgets and to determine components of management compensation. For an explanation of the composition of each such measure and the usefulness and additional uses of each by management, see the " How we Assess the Performance of our Business " section of the 2023 MD&A, which is incorporated by reference. See below for a quantitative reconciliation of each non-IFRS financial measure to its most directly comparable financial measure disclosed in the Company's financial statements to which the measure relates.
The following tables provide a quantitative reconciliation of net earnings to EBITDA, Adjusted EBITDA, and Adjusted net earnings, as well as gross profit to normalized gross profit, SG&A to normalized SG&A, earnings from operations to normalized earnings from operations, and net debt, each of which are non-IFRS financial measures (see the " Non-IFRS and Other Financial Measures " of this press release for further information on each non-IFRS financial measure) for the three and twelve months ended December 31, 2023.
Jamieson Wellness Inc. Segment Information In thousands of Canadian dollars, except as otherwise noted | ||||||||||||
Jamieson Brands | ||||||||||||
Three months ended December 31 | ||||||||||||
2023 | 2022 | $ Change | % Change | |||||||||
Revenue | 181,007 | 155,996 | 25,011 | 16.0 | % | |||||||
Gross profit | 73,082 | 65,345 | 7,737 | 11.8 | % | |||||||
Amortization of fair value adjustments | 2,621 | 793 | 1,828 | 230.5 | % | |||||||
Normalized gross profit | 75,703 | 66,138 | 9,565 | 14.5 | % | |||||||
Gross profit margin | 40.4 | % | 41.9 | % | - | (1.5 | %) | |||||
Normalized gross profit margin | 41.8 | % | 42.4 | % | - | (0.6 | %) | |||||
Share-based compensation (1) | 1,534 | 1,317 | 217 | 16.5 | % | |||||||
Selling, general and administrative expenses | 40,751 | 31,165 | 9,586 | 30.8 | % | |||||||
Acquisition and divestiture related costs (2) | (2,846 | ) | (3,165 | ) | 319 | 10.1 | % | |||||
IT system implementation (3) | (3,274 | ) | (1,417 | ) | (1,857 | ) | (131.1 | %) | ||||
Normalized selling, general and administrative expenses | 34,631 | 26,583 | 8,048 | 30.3 | % | |||||||
Earnings from operations | 38,660 | 32,863 | 5,797 | 17.6 | % | |||||||
Acquisition and divestiture related costs (2) | 2,846 | 3,165 | (319 | ) | (10.1 | %) | ||||||
IT system implementation (3) | 3,274 | 1,417 | 1,857 | 131.1 | % | |||||||
Amortization of fair value adjustments (4) | 2,621 | 793 | 1,828 | 230.5 | % | |||||||
Acquisition related purchase consideration and post-closing adjustments (5) | (7,863 | ) | - | (7,863 | ) | (100.0 | %) | |||||
Normalized earnings from operations | 39,538 | 38,238 | 1,300 | 3.4 | % | |||||||
Operating margin | 21.4 | % | 21.1 | % | - | 0.3 | % | |||||
Normalized operating margin | 21.8 | % | 24.5 | % | - | (2.7 | %) | |||||
Adjusted EBITDA | 45,404 | 43,832 | 1,572 | 3.6 | % | |||||||
Adjusted EBITDA margin | 25.1 | % | 28.1 | % | - | (3.0 | %) | |||||
Strategic Partners | ||||||||||||
Three months ended December 31 | ||||||||||||
2023 | 2022 | $ Change | % Change | |||||||||
Revenue | 39,358 | 36,779 | 2,579 | 7.0 | % | |||||||
Gross profit | 5,945 | 5,844 | 101 | 1.7 | % | |||||||
Gross profit margin | 15.1 | % | 15.9 | % | - | (0.8 | %) | |||||
Selling, general and administrative expenses | 1,549 | 1,603 | (54 | ) | (3.4 | %) | ||||||
Other | (24 | ) | - | (24 | ) | - | ||||||
Normalized selling, general and administrative expenses | 1,525 | 1,603 | (78 | ) | (4.9 | %) | ||||||
Earnings from operations | 4,396 | 4,241 | 155 | 3.7 | % | |||||||
Other | 24 | - | 24 | - | ||||||||
Normalized earnings from operations | 4,420 | 4,241 | 179 | 4.2 | % | |||||||
Operating margin | 11.2 | % | 11.5 | % | - | (0.3 | %) | |||||
Normalized operating margin | 11.2 | % | 11.5 | % | - | (0.3 | %) | |||||
Adjusted EBITDA | 5,224 | 5,039 | 185 | 3.7 | % | |||||||
Adjusted EBITDA margin | 13.3 | % | 13.7 | % | - | (0.4 | %) |
Jamieson Wellness Inc. Segment Information (continued) In thousands of Canadian dollars, except as otherwise noted | ||||||||||||
Jamieson Brands | ||||||||||||
Twelve months ended December 31 | ||||||||||||
2023 | 2022 | $ Change | % Change | |||||||||
Revenue | 551,171 | 439,147 | 112,024 | 25.5 | % | |||||||
Gross profit | 214,293 | 184,039 | 30,254 | 16.4 | % | |||||||
Amortization of fair value adjustments (4) | 8,440 | 793 | 7,647 | 964.3 | % | |||||||
Normalized gross profit | 222,733 | 184,832 | 37,901 | 20.5 | % | |||||||
Gross profit margin | 38.9 | % | 41.9 | % | - | (3.0 | %) | |||||
Normalized gross profit margin | 40.4 | % | 42.1 | % | - | (1.7 | %) | |||||
Share-based compensation (1) | 5,868 | 4,910 | 958 | 19.5 | % | |||||||
Selling, general and administrative expenses | 133,951 | 103,996 | 29,955 | 28.8 | % | |||||||
Acquisition and divestiture related costs (2) | (8,385 | ) | (12,919 | ) | 4,534 | 35.1 | % | |||||
IT system implementation (3) | (7,743 | ) | (4,527 | ) | (3,216 | ) | (71.0 | %) | ||||
Other | 179 | (127 | ) | 306 | 240.9 | % | ||||||
Normalized selling, general and administrative expenses | 118,002 | 86,423 | 31,579 | 36.5 | % | |||||||
Earnings from operations | 82,337 | 75,133 | 7,204 | 9.6 | % | |||||||
Acquisition and divestiture related costs (2) | 8,385 | 12,919 | (4,534 | ) | (35.1 | %) | ||||||
IT system implementation (3) | 7,743 | 4,527 | 3,216 | 71.0 | % | |||||||
Amortization of fair value adjustments (4) | 8,440 | 793 | 7,647 | 964.3 | % | |||||||
Acquisition related purchase consideration and post-closing adjustments (5) | (7,863 | ) | - | (7,863 | ) | (100.0 | %) | |||||
Other | (179 | ) | 127 | (306 | ) | (240.9 | %) | |||||
Normalized earnings from operations | 98,863 | 93,499 | 5,364 | 5.7 | % | |||||||
Operating margin | 14.9 | % | 17.1 | % | - | (2.2 | %) | |||||
Normalized operating margin | 17.9 | % | 21.3 | % | - | (3.4 | %) | |||||
Adjusted EBITDA | 121,836 | 113,088 | 8,748 | 7.7 | % | |||||||
Adjusted EBITDA margin | 22.1 | % | 25.8 | % | - | (3.7 | %) | |||||
Strategic Partners | ||||||||||||
Twelve months ended December 31 | ||||||||||||
2023 | 2022 | $ Change | % Change | |||||||||
Revenue | 125,001 | 108,222 | 16,779 | 15.5 | % | |||||||
Gross profit | 19,266 | 14,299 | 4,967 | 34.7 | % | |||||||
Gross profit margin | 15.4 | % | 13.2 | % | - | 2.2 | % | |||||
Selling, general and administrative expenses | 6,353 | 6,243 | 110 | 1.8 | % | |||||||
Other | (96 | ) | (48 | ) | (48 | ) | (100.0 | %) | ||||
Normalized selling, general and administrative expenses | 6,257 | 6,195 | 62 | 1.0 | % | |||||||
Earnings from operations | 12,913 | 8,056 | 4,857 | 60.3 | % | |||||||
Other | 96 | 48 | 48 | 100.0 | % | |||||||
Normalized earnings from operations | 13,009 | 8,104 | 4,905 | 60.5 | % | |||||||
Operating margin | 10.3 | % | 7.4 | % | - | 2.9 | % | |||||
Normalized operating margin | 10.4 | % | 7.5 | % | - | 2.9 | % | |||||
Adjusted EBITDA | 16,227 | 10,673 | 5,554 | 52.0 | % | |||||||
Adjusted EBITDA margin | 13.0 | % | 9.9 | % | - | 3.1 | % |
Reconciliation of Non-IFRS Financial Measures In thousands of Canadian dollars | |||||||||||
Three months ended | Twelve months ended | ||||||||||
December 31 | December 31 | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Net earnings: | 24,000 | 22,091 | 46,040 | 52,808 | |||||||
Add: | |||||||||||
Provision for income taxes | 10,530 | 8,278 | 19,631 | 17,695 | |||||||
Interest expense and other financing costs | 4,885 | 5,757 | 22,784 | 12,417 | |||||||
Accretion on preferred shares | 1,965 | - | 4,833 | - | |||||||
Depreciation of property, plant, and equipment | 3,589 | 3,579 | 14,410 | 12,153 | |||||||
Amortization of intangible assets | 1,547 | 1,496 | 5,913 | 5,095 | |||||||
Earnings before interest, taxes, depreciation, and amortization (EBITDA) | 46,516 | 41,201 | 113,611 | 100,168 | |||||||
Share-based compensation (1) | 1,534 | 1,317 | 5,868 | 4,910 | |||||||
Foreign exchange loss | 1,676 | 978 | 1,962 | 269 | |||||||
Acquisition and divestiture related costs (2) | 2,846 | 3,165 | 8,385 | 12,919 | |||||||
IT system implementation (3) | 3,274 | 1,417 | 7,743 | 4,527 | |||||||
Amortization of fair value adjustments (4) | 2,621 | 793 | 8,440 | 793 | |||||||
Acquisition related purchase consideration and post-closing adjustments (5) | (7,863 | ) | - | (7,863 | ) | - | |||||
Other | 24 | - | (83 | ) | 175 | ||||||
Adjusted EBITDA | 50,628 | 48,871 | 138,063 | 123,761 | |||||||
Provision for income taxes | (10,530 | ) | (8,278 | ) | (19,631 | ) | (17,695 | ) | |||
Interest expense and other financing costs | (4,885 | ) | (5,757 | ) | (22,784 | ) | (12,417 | ) | |||
Depreciation of property, plant, and equipment | (3,589 | ) | (3,579 | ) | (14,410 | ) | (12,153 | ) | |||
Amortization of intangible assets | (1,547 | ) | (1,496 | ) | (5,913 | ) | (5,095 | ) | |||
Share-based compensation (6) | (1,411 | ) | (1,317 | ) | (5,458 | ) | (4,910 | ) | |||
Tax deduction from vesting of certain share-based awards (7) | - | - | (1,022 | ) | (1,399 | ) | |||||
Tax effect of normalization adjustments | (51 | ) | (1,685 | ) | (2,761 | ) | (4,943 | ) | |||
Adjusted net earnings | 28,615 | 26,759 | 66,084 | 65,149 | |||||||
Three months ended | Twelve months ended | ||||||||||
December 31 | December 31 | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Gross profit | 79,027 | 71,189 | 233,559 | 198,338 | |||||||
Amortization of fair value adjustments | 2,621 | 793 | 8,440 | 793 | |||||||
Normalized gross profit | 81,648 | 71,982 | 241,999 | 199,131 | |||||||
Normalized gross profit margin | 37.1 | % | 37.3 | % | 35.8 | % | 36.4 | % | |||
Selling, general and administrative expenses | 42,300 | 32,768 | 140,304 | 110,239 | |||||||
Acquisition and divestiture related costs | (2,846 | ) | (3,165 | ) | (8,385 | ) | (12,919 | ) | |||
IT system implementation | (3,274 | ) | (1,417 | ) | (7,743 | ) | (4,527 | ) | |||
Other | (24 | ) | - | 83 | (175 | ) | |||||
Normalized selling, general and administrative expenses | 36,156 | 28,186 | 124,259 | 92,618 | |||||||
Earnings from operations | 43,056 | 37,104 | 95,250 | 83,189 | |||||||
Acquisition and divestiture related cost | 2,846 | 3,165 | 8,385 | 12,919 | |||||||
IT system implementation | 3,274 | 1,417 | 7,743 | 4,527 | |||||||
Amortization of fair value adjustments | 2,621 | 793 | 8,440 | 793 | |||||||
Acquisition related purchase consideration and post-closing adjustments (5) | (7,863 | ) | - | (7,863 | ) | - | |||||
Other | 24 | - | (83 | ) | 175 | ||||||
Normalized earnings from operations | 43,958 | 42,479 | 111,872 | 101,603 | |||||||
Normalized operating margin | 19.9 | % | 22.0 | % | 16.5 | % | 18.6 | % |
(1) | The Company's share-based compensation expense pertains to its long-term incentive plan ("LTIP" (refer to " Share-based compensation" ), with stock options, performance-based share unit ("PSU"), time-based restricted share unit ("RSU"), and deferred share unit ("DSU") expenses, along with associated payroll taxes. | |
(2) | Current period expense mainly pertains to legal, consulting and integration costs associated with the acquisition and integration of a former distributor partner in China on April 28, 2023, and the acquisition of youtheory in the U.S. on July 19, 2022. | |
(3) | Current period expense mainly pertains to development costs associated with IT system implementation to augment the Company's system infrastructure. Unlike other system improvement projects with costs capitalized, due to its cloud-based nature, these system implementation costs are expensed accordingly. | |
(4) | This cost represents the post-closing amortization of the fair value increase of acquired inventories related to the April 28, 2023 transaction with a former distribution partner in China. | |
(5) | To adjust for the fair value of purchase consideration accounted for as compensation on the 2022 youtheory acquisition, net of post-acquisition working capital adjustments to reflect acquired liabilities. | |
(6) | Costs pertaining to LTIP, excluding PSUs granted to certain employees relating to business combinations. | |
(7) | The vesting of share-based compensation provides a tax benefit during the period in which the awards are settled. |
Reconciliation of Net Debt In thousands of Canadian dollars | |||||
($ in 000's) | As at December 31, | As at December 31, | |||
2023 | 2022 | ||||
Long-term debt | 325,000 | 400,000 | |||
Cash | (36,863 | ) | (26,240 | ) | |
Net debt | 288,137 | 373,760 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240313204099/en/
Investor Relations and Media Contact Information:
Jamieson Wellness
Ruth Winker
416-960-0052
rwinker@jamiesonlabs.com
News Provided by Business Wire via QuoteMedia
Jamieson Wellness Inc. Announces Date of Fourth Quarter and Full Year 2023 Financial Results and Conference Call
Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX:JWEL) announced today that the Company will release its fourth quarter and full year 2023 financial results after the market close on Wednesday, March 13, 2024. The Company will host a conference call for investors at 5:00 p.m. Eastern Time to discuss the fourth quarter and full year 2023 results.
The call can be accessed live over the telephone by dialing 1-888-886-7786 from Canada and the U.S. or 1-416-764-8658 from international locations. A replay will be available shortly after the call and can be accessed by dialing 1-844-512-2921 from Canada and the U.S. or 1-412-317-6671 from international locations. The passcode for the replay is 82012546 and it will be available until Thursday, March 27, 2024.
Interested parties may listen to a simultaneous webcast of the conference call by logging on via the Investor Relations section of the Company's website at https://investors.jamiesonwellness.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1660353&tp_key=78dfc76e5b . A replay of the webcast will be available for approximately 12 months following the call.
About Jamieson Wellness Inc.
Jamieson Wellness is dedicated to improving the world's health and wellness with its portfolio of innovative natural health brands. Established in 1922, the Jamieson brand is Canada's #1 consumer health brand. The Company's youtheory brand, acquired in 2022, is an established and growing lifestyle brand in the United States. Combined, these global brands are available in more than 50 countries worldwide. The Company also offers a variety of innovative vitamins, minerals and supplements ("VMS") as well as sports nutrition products to consumers in Canada with its Progressive, Smart Solutions, Iron Vegan and Precision brands. The Company is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. For more information please visit www.jamiesonwellness.com .
Source: Jamieson Wellness Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240306813236/en/
Investor and Media:
Ruth Winker
Jamieson Wellness
416-960-0052
rwinker@jamiesonlabs.com
News Provided by Business Wire via QuoteMedia
Jamieson Wellness Inc. Declares Fourth Quarter 2023 Dividend
Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX:JWEL) announced today that the board of directors of the Company has declared a cash dividend for the fourth quarter of 2023 of $0.19 per common share, or approximately $8.0 million in the aggregate. The dividend will be paid on March 15, 2024 to all common shareholders of record at the close of business on March 1, 2024. The Company has designated this dividend as an "eligible dividend" for the purposes of the Income Tax Act (Canada).
About Jamieson Wellness Inc.
Jamieson Wellness is dedicated to improving the world's health and wellness with its portfolio of innovative natural health brands. Established in 1922, the Jamieson brand is Canada's #1 consumer health brand. The Company's youtheory brand, acquired in 2022, is an established and growing lifestyle brand in the United States. Combined, these global brands are available in more than 50 countries worldwide. The Company also offers a variety of innovative vitamins, minerals and supplements ("VMS") as well as sports nutrition products to consumers in Canada with its Progressive, Smart Solutions, Iron Vegan and Precision brands. The Company is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. For more information please visit www.jamiesonwellness.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20240222179572/en/
Investors and Media:
Ruth Winker
Jamieson Wellness
416-705-5437
rwinker@jamiesonlabs.com
News Provided by Business Wire via QuoteMedia
Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx for Recurrent Pericarditis
Topline Results Expected in Q2 2024
This is a Designated News Release.
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, today announced completion of patient enrollment in its Phase II open-label pilot study ("MAvERIC-Pilot") investigating the safety, tolerability, and efficacy of CardiolRxâ„¢ in patients with recurrent pericarditis. In addition, the Company announced that it expects to report topline results from MAvERIC-Pilot in Q2 2024.
"Having achieved full patient enrollment, we are now positioned to announce high-level MAvERIC-Pilot clinical trial data in the second quarter of this year. These results are expected to inform the design of a pivotal Phase III clinical trial in recurrent pericarditis to underpin the potential regulatory approval of CardiolRxâ„¢, which has recently been granted Orphan Drug Designation by the United States FDA," said Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "We thank our clinical collaborators and participating patients and families for their continued interest and commitment. Their support is contributing to our understanding of the therapeutic profile of CardiolRxâ„¢ in this debilitating inflammatory heart disease associated with symptoms that adversely affect quality of life and physical activity."
MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRxâ„¢ administered to patients with recurrent pericarditis. The study has completed enrollment of the planned target of 25 patients in the United States, and subject to fulfilling eligibility criteria, any patient currently in the screening process who agrees to participate in the study will also be enrolled and included in the final cohort. In addition to standard safety assessments, MAvERIC-Pilot is designed to evaluate improvement in objective measures of this rare disease. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Importantly, the study will also assess freedom from pericarditis recurrence.
Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
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, CardiolRxâ„¢ (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 CardiolRxâ„¢ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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 CardiolRxâ„¢ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol 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 relating to 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 for primary efficacy endpoint and secondary endpoints, the Company's plan to advance the development of a novel subcutaneous formulation of CardiolRxâ„¢ for use in heart failure, and the Company's expectation to report topline results from MAvERIC-Pilot in Q2 2024 and that these results will inform the design of a pivotal Phase III clinical trial in recurrent pericarditis to underpin the potential regulatory approval of CardiolRxâ„¢. 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 dated March 28, 2023, 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.
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/198691
News Provided by Newsfile via QuoteMedia
Principal Technologies
Overview
The healthcare sector has experienced considerable disruption in recent years, from emerging telehealth innovations to new tools for treatment and diagnosis. Each new technology has the potential to change — or even save — countless lives. Yet distributing these technologies to the global market is often far easier said than done, thanks to regulatory challenges and a lack of investment capital.
Principal Technologies (TSXV:PTEC,FRA:J07) intends to tear those barriers down. Based in Vancouver, British Columbia, Principal Technologies focuses on investing in life-saving and life-improving healthcare technologies and innovations. Working through a wholly owned European subsidiary, the company intends to invest in private healthcare technology companies in Europe, and expose them to the North American marketplace where they can benefit from the region's higher valuation of med-tech companies.Principal increases shareholder value by steadily growing the company’s financial performance, and paying off debt with improved cash flows and new equity when capital markets are advantageous.
This process is repeated as new acquisition targets come into play.
Principal's risk management strategy revolves around its acquisition targets. It exclusively pursues companies with a proven competitive advantage; stable cash flow; disruptive technology portfolio with IP capable of significantly improving patient outcomes or quality of life; significant growth potential; and a qualified management team with a strong vested interest in success.
The company leverages exclusive access to key opinion leaders and medical advisory boards and has a highly experienced leadership team.
Notable individuals in its management roster include Jerry Trent, a highly accomplished international investment banker and portfolio manager; Prince Alfred of Liechtenstein, a senior member of the Liechtenstein family; Dr. Gerald Rainer, former CEO of Switzerland’s largest and most prestigious asset management company; and Dr. Ivo Ivanovski, former European IT Minister and currently CEO of Telekom Austria Group’s Tower Co.
Principal's directors, advisors and major shareholders all maintain significant connections throughout Europe's healthcare technology space, ensuring ongoing introductions to potential investments. The company also owns a clinical research organization which maintains a database of emerging technologies, allowing it to assess prospective acquisitions on an ongoing basis.
Company Highlights
- Principal Technologies invests in leading and proven European healthcare technologies.
- Principal drives value in its investments by purchasing them at a discount in the EU and exposing them to the North American market, which offers significantly higher valuations for healthcare technology companies.
- The company is managed, directed and advised by a group of incredibly experienced entrepreneurs and investors, all of whom maintain close industry connections in the EU.
- When acquiring a new target, Principal's first step is to ensure an equity control position. It will typically finance the acquisition through a combination of debt and equity, accessing major EU funds when financing leveraged buyouts.
- Principal has implemented multiple checks, balances and strategies to reduce and manage risk, including:
- Maintaining profit-oriented compensation plans to incentivize performance.
- Maintaining strict capital allocation at the corporate level.
- Ensuring a margin of safety compared to intrinsic value in negotiating its acquisition prices.
- Principal exclusively seeks managers and advisors who will allow it to broaden its competitive advantage, expand its operations and support international expansion.
Key Investments
Principal Technologies’ previous acquisitions demonstrate a successful track record of increasing shareholder value and providing growth capital, marketing expertise and access to an international network to expand its acquisitions’ global operations and revenue.
Vivostat
Vivostat is Principal Technologies’ most recent acquisition and the result of an extensive due diligence process and evaluation of numerous European healthcare technology companies. Vivostat’s technology is a unique and best-in-class system worldwide for on-site preparation and application of autologous (i.e. based on the patient’s own blood) concentrated fibrin and platelet enriched fibrin sealants for post-surgical use.
The technology has been used in more than 200,000 post-surgical procedures, with peer-reviewed evidence of zero rejection and infection rates, which is unparalleled.
Vivostat has been profitable for the last three years with a seven-figure net profit while serving less than 5 percent of its potential market.
Principal will roll out this best-in-class technology on a global scale.
E&E CRO
An 80-percent-owned clinical research organization, E&E facilitates the international distribution permits process for healthcare technology companies. This strategic investment will allow Principal Technologies to build a unique database which it will leverage to improve patient outcomes, serve the industry (hospitals, insurers and other stakeholders seeking medical information), as well as find new acquisition targets for its international rollout process. Based in the European Union, E&E is a cash-flow-positive company with stable revenue and a highly experienced in-house technical due diligence team.
Vision Surgery AI
A minor equity investment with the capacity for expanded ownership as operations increase, Vision Surgery AI uses advanced computer vision and artificial intelligence technology for real-time monitoring of surgical teams and operating room equipment.
Its technology detects and sends alerts about any anomaly or deviation from typical surgical procedures, significantly reducing complications and fatalities. Vision's technology also leverages collected observations to build a database of medical information for machine learning purposes. Given that roughly 80 percent of surgical fatalities stem from human error, Vision Surgery has the potential to considerably improve surgical outcomes.
Management Team
Jerry Trent - President and Group CEO / Member, Board of Directors
Jerry Trent is the founder of Trent Investments, a multi-family direct investment agency for European ultra-high-net-worth individuals and asset management funds. In Europe, he served as the head of global markets and investment banking at SberBank, as well as the head of M&A and member of the Global Deals Origination Group at PricewaterhouseCoopers. His experience also includes being a highly successful Wall Street investor and portfolio manager.
Prince Alfred von Liechtenstein - Chairman, Board of Directors
His Serene Highness Prince Alfred von Liechtenstein has served on numerous boards and in several supervisory positions, including at LGT Group (largest family-owned asset management group globally). He holds a master's degree in economics and informatics and has authored numerous books and articles on a wide range of topics. Prince Alfred von Liechtenstein is also the chairman of the advisory board of the International Peace Foundation - of which 19 advisors are Nobel Prize Laureates, including four in the medical field. His Serene Highness has also received multiple awards and prizes for his healthcare initiatives and humanitarian activity.
Dr. Leopold Specht - Member, Board of Directors
Dr. Leopold Specht is a veteran attorney with extensive investment experience. He is the owner of international corporate law firm Specht & Partner. In addition to serving on numerous boards, he is a member of the Economic Council at Harvard Institute for Global Law at Harvard Law School. Widely renowned for his expertise, Specht regularly serves as a guest lecturer at institutions such as Harvard University, Brown University, the University of Turin and the University of Sapienza Rome.
Peter McKeown - CFO
A seasoned finance and business professional, Peter McKeown has founded and served in executive positions at multiple successful listed companies. Armed with decades of experience, McKeown is a serial entrepreneur focused on the technology and resource sectors. He is also a chartered accountant with a Bachelor of Commerce in Accounting from Carleton University.
Dr. Gerald Rainer - Chairman, Board of Advisors
Dr. Gerald Rainer is the former CEO of Julius Baer, a US$400-billion asset management company in Switzerland. He has also served in multiple board and trustee positions at multi-billion dollar entities and trusts. His impressive business acumen and extensive international network have allowed him to also thrive as a serial entrepreneur.
Rick Geoffrion - Member, Board of Advisors
Rick Geoffrion has been president and CEO of multiple healthcare technology companies that have developed proprietary systems to significantly improve patient outcomes. Throughout his 35-year career, Geoffrion has also served in board positions at numerous healthcare technology companies. Currently, he is vice-chairman of the Mullings Group, a leading career development firm in the healthcare sector.
Dr. Ivo Ivanovski - Member, Board of Advisors
Dr. Ivo Ivanovski served as the IT Minister of the Republic of Macedonia from 2006 to 2015. He then entered the private sector as head of mergers and acquisitions, international affairs and regulations at A1 Telekom Austria Group, where he now serves as the CEO of the exchange-listed Tower Co. Ivanovski has received multiple awards in his career, including the International Telecommunication Union's Distinguished Silver Star Award and an Honorary Doctorate for Technology Leadership.
Joe Mullings - Member, Board of Advisors
Joe Mullings is the chairman and CEO of The Mullings Group Companies, including TMG Search and Dragonfly. The search firm, with over three decades in the industry, is responsible for more than 8,000 successful searches in medtech/healthtech/life sciences with clients ranging from multi-billion-dollar companies to emerging high-tech organizations worldwide. TMG's international presence and work with over 800 companies allow them to provide solutions to the clients they partner with across the globe. As the first search firm to integrate media and talent access, Dragonfly was launched as a media production company, complete with a state-of-the-art studio, for use by clients and partners for attention and awareness. Dragonfly is the media machine behind the eight-time award-winning video docuseries, "TrueFuture," hosted by Mullings.
Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis
Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study
This is a Designated News Release.
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, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis. CardiolRxâ„¢ is currently in Phase II clinical trials for recurrent pericarditis and acute myocarditis.
"The FDA's decision was based on pre-clinical data combined with initial clinical data from the Company's MAvERIC-Pilot Phase II study," commented Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "This designation reinforces the potential of CardiolRxâ„¢ to improve the lives of patients suffering with recurrent pericarditis, a debilitating heart disease associated with symptoms that adversely affect quality of life and physical activity."
The FDA grants ODD to a drug or biological product to prevent, diagnose, or treat a rare disease or conditions that affect fewer than 200,000 people in the United States. ODD provides benefits to sponsors including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Products with ODD may also qualify for accelerated regulatory review via Fast Track, Breakthrough Therapy, or Priority Review designations.
MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRxâ„¢ administered to patients with recurrent pericarditis. In addition to standard safety assessments, MAvERIC-Pilot is designed to evaluate improvement in objective measures of this rare disease. The primary efficacy endpoint is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale ("NRS"). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Importantly, the study will assess freedom from pericarditis recurrence.
Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than 2 years, and one third are still impacted at 5 years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
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, CardiolRxâ„¢ (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 FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRxâ„¢ in two diseases affecting the heart: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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.
Cardiol is also developing a novel subcutaneously administered drug formulation of cannabidiol 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 relating to 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 for primary efficacy endpoint and secondary endpoints, the Company's plan to advance the development of a novel subcutaneous formulation of CardiolRxâ„¢ for use in heart failure, and the ODD reinforcing the potential of CardiolRxâ„¢ to improve the lives of patients suffering with recurrent pericarditis. 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 dated March 28, 2023, 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.
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/198021
News Provided by Newsfile via QuoteMedia
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