The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.

开始日期2026-11-01

申办/合作机构

The University of California, San Francisco

NCT04650841

/ Not yet recruiting早期临床1期IIT

The Role of the Opioid System in Placebo Effects on Pain and Social Rejection

The current study probes the involvement of the opioid system in placebo effects on social pain, using the opioid antagonist naloxone. 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning. Participants will be randomized to receive either a naloxone or saline nasal spray, and be informed that the spray is either saline, or an effective pain and negative emotion reducing agent.

开始日期2026-09-01

申办/合作机构

Trustees of Dartmouth College

CTIS2024-517838-17-00

/ Not yet recruiting临床1期

Bioavailability study with naloxone hydrochloride in healthy volunteers

开始日期2026-02-16

申办/合作机构-

100 项与盐酸纳洛酮相关的临床结果

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100 项与盐酸纳洛酮相关的转化医学

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100 项与盐酸纳洛酮相关的专利（医药）

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25,505

项与盐酸纳洛酮相关的文献（医药）

2026-12-01·JOURNAL OF CONTINUING EDUCATION IN THE HEALTH PROFESSIONS

Enhancing Naloxone Reach Through Innovative Training Strategies at an Academic Medical Center in Arkansas

Article

作者: Williams, Adrian J ; Breckling, Meghan ; Tobey-Moore, Leah

Abstract::

The Arkansas Naloxone Education and Training (ANET) program, based at the University of Arkansas for Medical Sciences, was developed to address the urgent need for opioid-overdose prevention across the state. Funded by the Substance Abuse and Mental Health Administration (SAMHSA), ANET uses a train-the-trainer model to equip health care professionals with the knowledge and tools necessary to deliver naloxone education in their local settings. In its first year, the program launched a three-module curriculum, accredited for continuing education, of health care professionals and delivered using an academic detailing teaching strategy, prioritized recruitment from counties through a needs assessment including the highest rates of opioids dispensed and of overdose deaths, and implemented a comprehensive evaluation plan that is grounded in an evidence-based framework that facilitates continuous evaluation and improvement (ie, RE-AIM framework—Reach, Effectiveness, Adoption, Implementation, and Maintenance). Knowledge and attitudes were assessed before and after health care professionals completed the training program. All trainers received technical support and outreach materials. The program also fostered strategic statewide partnerships to support recruitment, implementation, and community engagement. ANET is embedded within an academic medical center and aligned with continuing professional development infrastructure, offering a replicable model for community-centered overdose prevention. Lessons learned during the program's implementation underscore its potential to inform future design, delivery, and sustainability of similar interventions.

2026-06-01·Addictive behaviors reports

Substance use treatment and overdose patterns in high and low social vulnerability counties: a trends analysis in New Jersey from 2014–2022

Article

作者: Fougnies, Lara V ; Hilton, Katie ; Juntilla, Alyssa M ; Lister, Jamey J ; Cooper, Sarah E ; Lister, Holly H

Introduction:

This study investigates trends in substance use treatment admissions and overdose patterns across New Jersey counties from 2014 to 2022. Using the Social Vulnerability Index (SVI), we examined how county-level vulnerability differentiates treatment utilization and overdose outcomes.

Materials and Methods:

We created a novel, longitudinal data set using data from multiple public sources. Data were obtained and analyzed for all 21 New Jersey counties. Outcome measures included substance use treatment admissions, opioid-specific treatment admissions, overdose deaths, and naloxone administration. Using the SVI, counties were categorized as either high (n = 10) or low (n = 11) social vulnerability. Data analyses were conducted using joinpoint analysis to identify trends over time and variation by social vulnerability status.

Results:

Significant trends were identified regardless of social vulnerability status for all outcome measures, appearing as upward trends in initial segments and flat or declining trends in latter segments. High vulnerability (compared to low vulnerability) counties demonstrated greater Annual Percentage Change (APC) magnitudes for all outcome measures in the initial segment, similar APCs in the latter segment, and had higher baseline rates and peak rates.

Conclusions:

Findings demonstrate that county-level social vulnerability status is associated with substance use treatment admissions and overdose patterns. Specifically, high vulnerability counties exhibit consistently higher rates of substance use treatment admissions, naloxone administrations, and overdose deaths. This pattern highlights a need for expanded substance use services along the continuum of care for vulnerable areas and the viability of SVI status as a useful and simple tool for targeting service expansion efforts.

2026-06-01·Toxicology reports

Investigation of serum concentration and the type of opioid used in patients with opium poisoning

Article

作者: Almasi, Afshin ; Veisi, Mohammad Mehdi ; Jouybari, Toraj Ahmadi ; Shaahmadi, Zahra ; Fattahi, Nazir ; Sarabbadieh, Armin Mansouri

Opioid poisoning constitutes a major public health issue in Iran and worldwide, with increasing rates attributed to both traditional opiates and synthetic derivatives such as methadone. Reliable assessment of serum opioid concentrations is essential for clinical management and prognosis. Quantitative measurement of serum opioid concentrations determines local epidemiological patterns and identifies risk factors that guide future prevention and treatment strategies. This descriptive cross-sectional study was conducted at Imam Khomeini Hospital in Kermanshah, Iran, from March to June 2023. Fifty adult patients with confirmed opioid poisoning were clinically diagnosed based on the classic opioid toxidrome (decreased consciousness, miotic pupils, and respiratory depression) documented at emergency department admission. Clinical diagnosis was confirmed by positive response to naloxone administration. Demographic and clinical data, type and route of opioid use, clinical features, laboratory results, and patient outcomes were recorded. Serum concentrations of opioids were measured using gas chromatography-mass spectrometry (GC-MS) after administration of antidotes. Statistical analysis was performed with SPSS 26, using a significance threshold of p < 0.05. Among 50 patients (86 % male, mean age 33.5 ± 9.8 years), methadone was the most common cause of poisoning (72 %), followed by opium and heroin. The principal clinical findings included apnea (44 %), miosis (44 %), and weakness/lethargy (38 %), with severe symptoms observed primarily in methadone cases. Serum methadone concentrations were significantly higher in men than women (p = 0.007), and in rural residents compared to urban (p = 0.005). Higher opioid serum levels were associated with more severe clinical presentations and increased need for intensive care. Most patients recovered with medical management; no in-hospital deaths occurred. Methadone has become the leading cause of opioid poisoning in this region, with high serum concentrations predicting increased clinical severity. Measurement of serum opioid levels is a valuable tool for risk stratification and should be integrated into standard management protocols. Attention must be given to both preventive education and tighter regulation of methadone distribution, particularly among high-risk groups.

732

项与盐酸纳洛酮相关的新闻（医药）

2026-02-26

·BioSpace

Amphastar Pharmaceuticals Reports Financial Results for the Three Months and Full Year Ended December 31, 2025

Net revenues of $183.1 million and $719.9 million, respectively, for the three months and fiscal year ended December 31, 2025 GAAP net income of $24.4 million, or $0.51 per share and $98.1 million, or $2.03 per share, respectively, for the fourth quarter and fiscal year Adjusted non-GAAP net income of $34.2 million, or $0.73 per share and $156.6 million, or $3.25 per share, respectively, for the fourth quarter and fiscal year Company to hold a conference call today at 2:00 p.m. Pacific Time RANCHO CUCAMONGA, CA / ACCESS Newswire / February 26, 2026 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company"), a biopharmaceutical company focused on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, today reported results for the three months and full year ended December 31, 2025. "2025 underscored Amphastar's evolution into a company focused on both commercial strength and scientific innovation." said Dr. Jack Zhang, Amphastar's President and Chief Executive Officer. "On the commercial side, BAQSIMI ® maintained its momentum as a top revenue driver with sustained double-digit growth, while the FDA approvals of our iron sucrose injection and our teriparatide injection demonstrate the depth of our technical capabilities in complex generics and ability to leverage our in‑house manufacturing expertise to deliver high‑quality, affordable therapies to patients. We also furthered our long-term strategic vision by adding three novel peptides and a fully synthetic corticotropin compound to expand our presence in oncology, ophthalmology, and immunology. As we look ahead to 2026, we remain committed to advancing these programs, securing upcoming approvals, and scaling our U.S. based manufacturing to support the next phase of our growth." Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 (in thousands, except per share data) Net revenues $ 183,105 $ 186,523 $ 719,887 $ 731,967 GAAP net income $ 24,429 $ 37,964 $ 98,094 $ 159,519 Adjusted non-GAAP net income* $ 34,158 $ 47,237 $ 156,618 $ 200,806 GAAP diluted EPS $ 0.51 $ 0.74 $ 2.03 $ 3.06 Adjusted non-GAAP diluted EPS* $ 0.73 $ 0.92 $ 3.25 $ 3.86 _____________________________ * Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release. Fourth Quarter Results Three Months Ended December 31, Change 2025 2024 Dollars % (in thousands) Product revenues, net: BAQSIMI ® $ 46,708 $ 41,792 $ 4,916 12 % Primatene MIST ® 27,930 28,935 (1,005 ) (3 )% Epinephrine 17,087 18,698 (1,611 ) (9 )% Lidocaine 14,904 14,397 507 4 % Glucagon 14,081 25,619 (11,538 ) (45 )% Other products 62,395 57,537 4,858 8 % Total product revenues, net $ 183,105 $ 186,978 $ (3,873 ) (2 )% Other revenues - (455 ) 455 100 % Total net revenues $ 183,105 $ 186,523 $ (3,418 ) (2 )% Changes in product revenues, net as compared to the fourth quarter of the prior year were primarily driven by: BAQSIMI ® sales increased primarily due to an increase in unit volumes, as a result of our continued marketing efforts in the United States Primatene MIST ® sales decreased due to lower unit volumes Epinephrine sales decreased due to lower unit volumes, as well as a lower average selling price of the multi-dose vial product, impacting sales by $2.8 million and $1.5 million, respectively, as a result of increased competition. This trend was partially offset by an increase in unit volumes for our epinephrine pre-filled syringe, as a result of an increase in demand caused by shortages from other suppliers during the quarter Glucagon sales decreased primarily due to a lower average selling price, impacting sales by $10.2 million, as well as a decrease in unit volumes, impacting sales by $1.3 million, as a result of competition and the continued shift to ready to use glucagon products such as BAQSIMI ® Other pharmaceutical product sales changes were primarily due to an increase in sales of albuterol of $4.2 million and iron sucrose sales of $2.0 million, which we launched in August 2024 and August 2025, respectively. This increase was partially offset by a decrease in unit volumes of dextrose, primarily due to increased competition Other revenues were zero in the fourth quarter of 2025, as we completed the assumption of distribution responsibilities globally for BAQSIMI ® at the beginning of 2025, with all of BAQSIMI ® related revenues in the current period being recognized in product revenues, net Three Months Ended December 31, Change 2025 2024 Dollars % (in thousands) Net revenues $ 183,105 $ 186,523 $ (3,418 ) (2 )% Cost of revenues 97,435 99,875 (2,440 ) (2 )% Gross profit $ 85,670 $ 86,648 $ (978 ) (1 )% as % of net revenues 46.8 % 46.5 % Changes in the cost of revenues and gross margin were primarily driven by: Increase in sales of BAQSIMI ® and sales of iron sucrose, which we launched in August 2025, as well as cost control efforts across the business This was partially offset by a decrease in pricing of glucagon and our epinephrine multi-dose vial product Three Months Ended December 31, Change 2025 2024 Dollars % (in thousands) Selling, distribution, and marketing $ 10,279 $ 10,424 $ (145 ) (1 )% General and administrative 16,471 12,938 3,533 27 % Research and development 23,314 18,142 5,172 29 % General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, legal expenses and expenses related to the implementation of a new ERP system Research and development expenses increased primarily due to an increase in clinical trial expense, primarily related to our insulin and inhalation pipeline products, as well as an increase in material and supplies for our insulin pipeline product Three Months Ended December 31, Change 2025 2024 Dollars % (in thousands) Non-operating expenses: Interest income $ 2,423 $ 2,292 $ 131 6 % Interest expense (6,630 ) (6,425 ) (205 ) 3 % Other income, net 515 2,951 (2,436 ) (83 )% Total non-operating expenses, net $ (3,692 ) $ (1,182 ) $ (2,510 ) 212 % The change in non-operating expenses, net, is primarily due to a change in other income, net, as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts during the three months ended December 31, 2025. Year-End Results Year Ended December 31, Change 2025 2024 Dollars % (in thousands) Product revenues, net: BAQSIMI ® $ 185,358 $ 126,898 $ 58,460 46 % Primatene MIST ® 108,669 102,012 6,657 7 % Epinephrine 70,643 94,090 (23,447 ) (25 )% Glucagon 69,084 108,319 (39,235 ) (36 )% Lidocaine 56,479 55,854 625 1 % Other products 229,654 225,641 4,013 2 % Total product revenues, net $ 719,887 $ 712,814 $ 7,073 1 % Other revenues - 19,153 (19,153 ) (100 )% Total net revenues $ 719,887 $ 731,967 $ (12,080 ) (2 )% Changes in product revenues, net as compared to the prior fiscal year were primarily driven by: BAQSIMI ® sales increased primarily due to an increase in unit volumes, as a result of an expanded marketing effort in the United States; total sales of BAQSIMI ® grew 12% from the prior year including prior year sales by Eli Lilly and Company, or Lilly, which was accounted for in Other revenues Primatene MIST ® sales increased due to an increase in unit volumes driven by our continued marketing efforts Epinephrine sales decreased due to a decrease in unit volumes, impacting sales of $13.4 million, as well as a lower average selling price, which impacted sales of $10.0 million, primarily as a result of increased competition for our multi-dose vial product Glucagon sales decreased primarily due to a lower average selling price, impacting sales by $24.3 million, as well as a decrease in unit volumes, impacting sales by $14.9 million, as a result of competition and the continued shift to ready to use glucagon products such as BAQSIMI ® Other pharmaceutical product sales changes were primarily due to an increase in sales of albuterol of $14.7 million and iron sucrose sales of $4.4 million, which were launched in August 2024 and August 2025, respectively, as well as an increase in sales of sodium bicarbonate and atropine due to an increase in demand caused by other supplier shortages. This increase was partially offset by a decrease in sales of enoxaparin of $9.9 million and dextrose of $9.6 million due to increased competition Other revenues were zero in the year ended December 31, 2025 as we completed the assumption of distribution responsibilities globally for BAQSIMI ® at the beginning of 2025, with all of BAQSIMI ® related revenues in the current period being recognized in Product revenues, net. The other revenues in the year ended December 31, 2024 consisted of $19.2 million in BAQSIMI ® sales made by Lilly on our behalf under the Transition Service Agreement ("TSA"), and was net of $18.4 million in cost of sales and other expenses Year Ended December 31, Change 2025 2024 Dollars % (in thousands) Net revenues $ 719,887 $ 731,967 $ (12,080 ) (2 )% Cost of revenues 363,830 358,112 5,718 2 % Gross profit $ 356,057 $ 373,855 $ (17,798 ) (5 )% as % of net revenues 49.5 % 51.1 % Changes in the cost of revenues and gross margin were primarily driven by: Decrease in other revenues related to Lilly's sales of BAQSIMI ® under the TSA, which were recorded net of cost of sales and other expenses; as we assumed distribution of BAQSIMI ® to all of our customers by the beginning of 2025. We recorded those sales in product revenues and cost of sales separately Lower pricing of glucagon and our epinephrine multi-dose vial product, both of which are higher-margin products Cost control efforts across the business partially offset the impact of pricing declines Year Ended December 31, Change 2025 2024 Dollars % (in thousands) Selling, distribution, and marketing $ 43,885 $ 37,802 $ 6,083 16 % General and administrative 85,925 56,720 29,205 51 % Research and development 85,844 73,914 11,930 16 % Selling, distribution, and marketing expenses increased primarily due to the expansion of our sales and marketing efforts related to BAQSIMI ® , including expenses related to our co-promotion contract with MannKind, and sales efforts related to Primatene MIST ® General and administrative expenses increased primarily due to a legal settlement, which increased expenses by $23.1 million Research and development expenses increased primarily due to the $6.0 million upfront payment for the licensing agreement that we entered into with Nanjing Anji Biotechnology Co., Ltd. ("Anji"), during the year. Additionally, we had an increase in clinical trial expense, primarily related to our insulin and inhalation pipeline products, as well as an increase in depreciation expense. This was partially offset by a decrease in materials and supply expenses Year Ended December 31, Change 2025 2024 Dollars % (in thousands) Non-operating expenses: Interest income $ 8,679 $ 10,612 $ (1,933 ) (18 )% Interest expense (25,481 ) (30,343 ) 4,862 (16 )% Other income, net 23 4,076 (4,053 ) (99 )% Total non-operating expenses, net $ (16,779 ) $ (15,655 ) $ (1,124 ) 7 % The change in non-operating expenses, net is primarily a result of: A decrease in interest income resulting from a decrease in interest rates on our cash and investments accounts A decrease in interest expense as a result of the repayment of the mortgage loan with East West Bank, as well as the accretion of the interest on the deferred payment for BAQSIMI ® , both of which were paid in full in June 2024 A change to other income, net, primarily as a result of foreign currency fluctuation, as well as mark-to-market adjustments relating to our interest rate swap contracts during the year ended December 31, 2025 Cash flow provided by operating activities for the year ended December 31, 2025, was $156.1 million. Pipeline Information The Company currently has one abbreviated new drug application ("ANDA") and one biosimilar insulin candidate filed with the FDA targeting products with a combined market size exceeding $1.7 billion, along with two biosimilar products in development targeting products with a market size exceeding $3.7 billion, and two generic products in development targeting products with a market size of over $1 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2025. The Company is developing multiple proprietary products with injectable, topical and intranasal dosage forms. The Company's proprietary pipeline also includes four recently in-licensed products including three proprietary peptides targeting oncology and ophthalmology indications, and a fully synthetic corticotropin compound designed to address inflammatory and autoimmune conditions. Conference Call Information The Company will hold a conference call to discuss its financial results today, February 26, 2026, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, ten minutes before the conference. The call can also be accessed on the Investors page on the Company's website at . Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which generally excludes amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI ® , certain debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Market Data This press release contains market data that we obtained from industry sources. These sources do not guarantee the accuracy or completeness of the information. Although we believe that our industry sources are reliable, we do not independently verify the information. The market data may include projections that are based on a number of other projections. While we believe these assumptions to be reasonable and sound as of the date of this press release, actual results may differ from the projections. About Amphastar Pharmaceuticals, Inc. Amphastar is a biopharmaceutical company that focuses on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells active pharmaceutical ingredient, or API products. Most of the Company's finished products are contracted and distributed through group purchasing organizations, drug wholesalers, and drug retailers. More information and resources are available at . Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar ® , BAQSIMI ® , Primatene MIST ® , REXTOVY ® , Amphadase ® , and Cortrosyn ® , are the property of Amphastar. Forward-Looking Statements All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth and our ability to continue to scale, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the impact of our products, including their potential for continued revenue growth, the strategic trajectory of and market for our product pipeline, our long-term strategic vision, our ability to leverage our existing expertise and technology, the impacts of any licensing agreements and ability to commercialize additional therapies, our in-house manufacturing expertise, our ability to deliver high-quality, affordable therapies to patients, our commercial momentum and position in the market. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission ("SEC"), including in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 8, 2025, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025, and our other filings or reports that we may the SEC. In particular, there can be no guarantee that our sales strategies will be successful, or that we will continue to experience significant sales of BAQSIMI ® . You can locate these reports through our website at and on the SEC's website at . The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. Contact Information: Amphastar Pharmaceuticals, Inc. Bill Peters Chief Financial Officer (909) 476-3416 Table I Amphastar Pharmaceuticals, Inc. Consolidated Statement of Operations (in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 Net revenues: Product revenues, net $ 183,105 $ 186,978 $ 719,887 $ 712,814 Other revenues - (455 ) - 19,153 Total net revenues 183,105 186,523 719,887 731,967 Cost of revenues 97,435 99,875 363,830 358,112 Gross profit 85,670 86,648 356,057 373,855 Operating expenses: Selling, distribution, and marketing 10,279 10,424 43,885 37,802 General and administrative 16,471 12,938 85,925 56,720 Research and development 23,314 18,142 85,844 73,914 Total operating expenses 50,064 41,504 215,654 168,436 Income from operations 35,606 45,144 140,403 205,419 Non-operating expenses: Interest income 2,423 2,292 8,679 10,612 Interest expense (6,630 ) (6,425 ) (25,481 ) (30,343 ) Other income, net 515 2,951 23 4,076 Total non-operating expenses, net (3,692 ) (1,182 ) (16,779 ) (15,655 ) Income before income taxes 31,914 43,962 123,624 189,764 Income tax provision 7,485 5,998 25,530 29,672 Income before equity in losses of unconsolidated affiliate 24,429 37,964 98,094 160,092 Equity in losses of unconsolidated affiliate - - - (573 ) Net income $ 24,429 $ 37,964 $ 98,094 $ 159,519 Net income per share: Basic $ 0.53 $ 0.79 $ 2.10 $ 3.29 Diluted $ 0.51 $ 0.74 $ 2.03 $ 3.06 Weighted-average shares used to compute net income per share: Basic 45,907 47,975 46,743 48,429 Diluted 47,164 51,310 48,215 52,058 Table II Amphastar Pharmaceuticals, Inc. Consolidated Balance Sheets (in thousands, except share data) December 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 170,177 $ 151,609 Restricted cash 235 235 Short-term investments 112,635 70,036 Restricted short-term investments 2,200 2,200 Accounts receivable, net 143,560 136,289 Inventories 176,890 153,741 Income tax refunds and deposits 17,167 1,747 Prepaid expenses and other assets 13,152 18,214 Total current assets 636,016 534,071 Property, plant, and equipment, net 310,567 297,345 Finance lease right-of-use assets 221 383 Operating lease right-of-use assets 42,931 46,899 Goodwill and intangible assets, net 565,965 590,660 Long-term investments - 10,996 Other assets 31,135 25,992 Deferred tax assets 42,464 71,124 Total assets $ 1,629,299 $ 1,577,470 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 148,348 $ 157,057 Income taxes payable 239 9,664 Current portion of long-term debt 1,641 234 Current portion of operating lease liabilities 7,928 6,804 Total current liabilities 158,156 173,759 Long-term reserve for income tax liabilities 5,926 6,957 Long-term debt, net of current portion and unamortized debt issuance costs 608,749 601,630 Long-term operating lease liabilities, net of current portion 37,684 41,881 Other long-term liabilities 29,979 20,945 Total liabilities 840,494 845,172 Commitments and contingencies Stockholders' equity: Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding - - Common stock: par value $0.0001; 300,000,000 shares authorized; 61,779,883 and 45,645,497 shares issued and outstanding, respectively, as of December 31, 2025 and 60,847,124 and 47,617,691 shares issued and outstanding, respectively, as of December 31, 2024 6 6 Additional paid-in capital 535,380 505,400 Retained earnings 666,881 568,787 Accumulated other comprehensive loss (5,314 ) (9,181 ) Treasury stock (408,148 ) (332,714 ) Total stockholders' equity 788,805 732,298 Total liabilities and stockholders' equity $ 1,629,299 $ 1,577,470 Table III Amphastar Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures (in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2025 2024 2025 2024 GAAP net income $ 24,429 $ 37,964 $ 98,094 $ 159,519 Adjusted for: Intangible asset amortization 6,270 6,179 25,048 24,718 Share-based compensation 6,205 5,632 27,277 24,368 Expenses related to BAQSIMI ® acquisition - - - 3,651 Litigation provision - - 23,147 - Income tax provision on pre-tax adjustments (2,746 ) (2,538 ) (16,948 ) (11,450 ) Adjusted non-GAAP net income $ 34,158 $ 47,237 $ 156,618 $ 200,806 Adjusted non-GAAP net income per share: Basic $ 0.75 $ 0.99 $ 3.35 $ 4.15 Diluted $ 0.73 $ 0.92 $ 3.25 $ 3.86 Weighted-average shares used to compute adjusted non-GAAP net income per share: Basic 45,907 47,975 46,743 48,429 Diluted 47,164 51,310 48,215 52,058 Three Months Ended December 31, 2025 Selling, General Research Non-operating Cost of distribution and and (expenses) Income revenue and marketing administrative development income, net tax provision GAAP $ 97,435 $ 10,279 $ 16,471 $ 23,314 $ (3,692 ) $ 7,485 Intangible asset amortization (6,250 ) - (1 ) (19 ) - - Share-based compensation (1,193 ) (290 ) (4,142 ) (580 ) - - Income tax provision on pre-tax adjustments - - - - - 2,746 Non-GAAP $ 89,992 $ 9,989 $ 12,328 $ 22,715 $ (3,692 ) $ 10,231 Three Months Ended December 31, 2024 Selling, General Research Non-operating Cost of distribution and and (expenses) Income revenue and marketing administrative development income, net tax provision GAAP $ 99,875 $ 10,424 $ 12,938 $ 18,142 $ (1,182 ) $ 5,998 Intangible asset amortization (6,160 ) - - (19 ) - - Share-based compensation (1,159 ) (286 ) (3,682 ) (505 ) - - Income tax provision on pre-tax adjustments - - - - - 2,538 Non-GAAP $ 92,556 $ 10,138 $ 9,256 $ 17,618 $ (1,182 ) $ 8,536 Year Ended December 31, 2025 Selling, General Research Non-operating Cost of distribution and and (expenses) Income revenue and marketing administrative development income, net tax provision GAAP $ 363,830 $ 43,885 $ 85,925 $ 85,844 $ (16,779 ) $ 25,530 Intangible asset amortization (24,968 ) - (3 ) (77 ) - - Share-based compensation (6,205 ) (1,215 ) (16,919 ) (2,938 ) - - Litigation provision - - (23,147 ) - - - Income tax provision on pre-tax adjustments - - - - - 16,948 Non-GAAP $ 332,657 $ 42,670 $ 45,856 $ 82,829 $ (16,779 ) $ 42,478 Year Ended December 31, 2024 Selling, General Research Non-operating Cost of distribution and and (expenses) Income revenue and marketing administrative development income, net tax provision GAAP $ 358,112 $ 37,802 $ 56,720 $ 73,914 $ (15,655 ) $ 29,672 Intangible asset amortization (24,639 ) - (4 ) (75 ) - - Share-based compensation (5,742 ) (1,063 ) (14,921 ) (2,642 ) - - Expenses related to BAQSIMI ® acquisition - - - - 3,651 - Income tax provision on pre-tax adjustments - - - - - 11,450 Non-GAAP $ 327,731 $ 36,739 $ 41,795 $ 71,197 $ (12,004 ) $ 41,122 SOURCE: Amphastar Pharmaceuticals, Inc. View the original press release on ACCESS Newswire

财报引进/卖出生物类似药

2026-02-26

·BioSpace

Emergent BioSolutions Reports Fourth Quarter and Full Year 2025 Financial Results

Fourth Quarter 2025 Total Revenues of $148.7 million; Full Year 2025 Total Revenues of $742.9 million Fourth Quarter 2025 Net Loss of $54.6 million and Net Loss Margin of 37% Full Year 2025 Net Income of $52.6 million versus a Net Loss of $190.6 million in the prior year Full Year 2025 Net Income per diluted share of $0.93 versus a Net Loss per diluted share of $3.60 in the prior year Full Year 2025 Adjusted Net Income of $86.8 million versus an Adjusted Net Loss of $12.1 million in the prior year Full Year 2025 Adjusted Net Income per diluted share of $1.53 versus an Adjusted Net Loss per diluted share of $0.23 in the prior year Full Year 2025 Gross Margin % of 45% and Adjusted Gross Margin % of 54%, an expansion of 1,900 bps and 900 bps, respectively, versus prior year Full Year 2025 Adjusted EBITDA of $205.0 million, compares favorably to $183.1 million in 2024 GAITHERSBURG, Md., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today reported financial results for the quarter and year ended December 31, 2025. “Emergent’s 2025 results demonstrate significant progress executing our multi-year turnaround strategy, delivering improved operating margins, strong adjusted EBITDA of $205 million, increased cash flow and lower leverage,” said Joe Papa, president and CEO of Emergent. “In 2026 we look to expand penetration of international markets with our MCM biodefense business, maintain market leadership across the naloxone category and offer new innovative solutions, pursue organic and inorganic growth opportunities that align with our internal capabilities, and remain disciplined on operational efficiencies. We are committed to our mission to protect and save lives as we support patients and customers with our critical medical countermeasures and naloxone products. We do this while investing in future growth and aiming to continue to improve our balance sheet and return capital to shareholders. Our team remains focused on long-term sustainable value and achieving our vision of enabling several durable and profitable verticals in the Company over time.” FINANCIAL HIGHLIGHTS (1) Q4 2025 vs. Q4 2024 ($ in millions, except per share amounts) Q4 2025 Q4 2024 % Change Total Revenues $ 148.7 $ 194.7 (24 )% Net Loss $ (54.6 ) $ (31.3 ) (74 )% Net Loss per Diluted Share $ (1.04 ) $ (0.58 ) (79 )% Adjusted Net Income (Loss) (2) $ (22.7 ) $ 2.6 (973 )% Adjusted Net Income (Loss) per Diluted Share (2) $ (0.43 ) $ 0.05 (960 )% Adjusted EBITDA (2) $ 11.2 $ 21.0 (47 )% Net Loss Margin (37 )% (16 )% Adjusted EBITDA Margin (2) 8 % 11 % Gross Margin % 30 % 29 % Adjusted Gross Margin % (2) 43 % 40 % Full Year 2025 vs. Full Year 2024 ($ in millions, except per share amounts) FY 2025 FY 2024 % Change Total Revenues $ 742.9 $ 1,043.6 (29 )% Net Income (Loss) $ 52.6 $ (190.6 ) 128 % Net Income (Loss) per Diluted Share $ 0.93 $ (3.60 ) 126 % Adjusted Net Income (Loss) (2) $ 86.8 $ (12.1 ) 817 % Adjusted Net Income (Loss) per Diluted Share (2) $ 1.53 $ (0.23 ) 765 % Adjusted EBITDA (2) $ 205.0 $ 183.1 12 % Net Income (Loss) Margin 7 % (18 )% Adjusted EBITDA Margin (2) 28 % 18 % Gross Margin % (2) 45 % 26 % Adjusted Gross Margin % (2) 54 % 45 % SELECT 2025 FULL YEAR BUSINESS UPDATES In 2025, the Board of Directors authorized the repurchase of up to $50.0 million of the Company’s common stock and repurchased $24.8 million of shares during the year A new plan was authorized by the Board of Directors for up to $50.0 million in repurchases from February 25, 2026 through March 31, 2027 Made voluntary debt payment of $100.0 million toward Term Loan Principal Secured key contract awards, exercised options and product orders across Medical Countermeasures business totaling more than $450.0 million in revenue; highlights from 2025 include: $62.4 million contract award for BAT ® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] $56.0 million contract award for ACAM2000 ® (Smallpox and Mpox (Vaccinia) Vaccine, Live) $51.9 million contract award for CNJ-016 ® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) $30.0 million contract award for CYFENDUS ® (Anthrax Vaccine Adsorbed, Adjuvanted) $29.0 million in MCM product orders from international government partner Approximately $27.0 million in international orders targeted for delivery in 2025 associated with medical countermeasures ("MCM") portfolio $20.0 million exercised contract option and modification to supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of War $17.0 million contract award for Oral Suspension TEMBEXA ® (brincidofovir) $16.7 million contract award to continue development collaboration with BARDA on Ebanga™ (ansuvimab-zykl) treatment for Ebola Maintained our market leadership position in the naloxone business and generated more than $226.0 million in revenue; highlights from 2025 include: Continued U.S. public interest, retail, business-to-business and Canada distribution A three-year agreement valued at approximately $65.0 million to supply the Ontario Ministry of Health with NARCAN ® Nasal Spray Expansion of NARCANDirect ® to offer KLOXXADO ® (naloxone HCl) Nasal Spray and Convenience Kits Recognized multiple naloxone awareness days throughout the year, and applauded the over-the-counter availability of naloxone in U.S. House of Representatives buildings Earned $50.0 million in development milestone payments from Bavarian Nordic as part of the sale of the Travel Health Business Completed the sale of our Baltimore-Bayview facility for $36.5 million Gained exclusive commercial rights to KLOXXADO ® (naloxone HCI) Nasal Spray in U.S. and Canada from Hikma Pharmaceuticals; Hikma received Health Canada approval for the product Announced investment agreement with Swiss Rockets Ltd and pursued strategic collaboration Announced Emergent’s addition to the Russell 3000 ® Index, which includes the Russell 2000, Russell 2000 Value and Russell Microcap Indices Progressed R&D strategy, pipeline and key organic and inorganic growth initiatives FOURTH QUARTER 2025 FINANCIAL PERFORMANCE (1) Revenues The Company uses the following categories in discussing product/service level revenues: Naloxone — comprises contributions from NARCAN ® Nasal Spray and KLOXXADO ® Nasal Spray Anthrax MCM — comprises contributions from CYFENDUS ® , BioThrax ® , ANTHRASIL ® and Raxibacumab Smallpox MCM — comprises contributions from ACAM2000 ® , CNJ-016 ® (VIGIV) and TEMBEXA ® Other Products — comprises contributions from BAT ® and RSDL ®(3) All Other Revenues — comprises revenues from the Services operating segment and Contracts and grants revenues ($ in millions) Q4 2025 Q4 2024 $ Change % Change Product sales, net: (3) Naloxone $ 38.4 $ 65.1 $ (26.7 ) (41 )% Anthrax MCM 53.4 32.5 20.9 64 % Smallpox MCM 35.5 76.5 (41.0 ) (54 )% Other Products 10.3 7.8 2.5 32 % Total Product sales, net $ 137.6 $ 181.9 $ (44.3 ) (24 )% All other revenues $ 11.1 $ 12.8 $ (1.7 ) (13 )% Total revenues $ 148.7 $ 194.7 $ (46.0 ) (24 )% Product Sales, net (4) Naloxone For Q4 2025, revenues from Naloxone products decreased $26.7 million, or 41%, as compared with Q4 2024. The decrease was primarily due to lower sales of OTC NARCAN ® and lower Canadian sales of branded NARCAN ® , driven primarily by increased competition due to generics impacting price and unit sales, partially offset by an increase in KLOXXADO ® sales. Anthrax MCM For Q4 2025, revenues from Anthrax MCM products increased $20.9 million, or 64%, as compared with Q4 2024. The increase primarily reflects the impact of timing on U.S. government (the "USG") and foreign sales of BioThrax ® and ANTHRASIL ® (AIG), partially offset by a decrease in CYFENDUS ® product sales. Anthrax vaccine product sales are primarily made under annual purchase options exercised by the USG. Fluctuations in revenues result from the timing of the exercise of annual purchase options, the timing of USG purchases, the availability of governmental funding and the Company’s delivery of orders that follow. Smallpox MCM For Q4 2025, revenues from Smallpox MCM products decreased $41.0 million, or 54%, as compared with Q4 2024. The decrease was primarily due to the impact of timing on USG sales of ACAM2000 ® and both USG and international sales of CNJ-016 ® (VIGIV), partially offset by an increase in USG sales of TEMBEXA ® . Fluctuations in revenues result from the timing of the exercise of annual purchase options in existing procurement contracts, the timing of USG purchases, the availability of governmental funding and Company delivery of orders that follow. Other Products For Q4 2025, revenues from Other Product sales increased $2.5 million, or 32%, as compared with Q4 2024. The increase was primarily due to higher international BAT ® sales, partially offset by a decrease in USG sales orders due to timing. All Other Revenues Services For Q4 2025, revenues from Services decreased $1.2 million, or 16%, as compared with Q4 2024. The decrease was primarily due to lower production at the Company’s Winnipeg facility. Contracts and Grants For Q4 2025, revenues from contracts and grants decreased $0.5 million, or 9%, as compared with Q4 2024. The decrease was primarily attributable to the decline in overall funded research and development ("R&D") projects, partially offset by an increase in development work in connection with Ebanga TM . Operating Expenses ($ in millions) Q4 2025 Q4 2024 $ Change % Change Cost of product and services sales, net $ 84.9 $ 118.0 $ (33.1 ) (28 )% R&D 12.1 9.1 3.0 33 % Selling, general and administrative (“SG&A”) 51.1 60.8 (9.7 ) (16 )% Amortization of intangible assets 16.3 16.3 — — % Impairment of long-lived assets 12.2 — 12.2 NM Total operating expenses $ 176.6 $ 204.2 $ (27.6 ) (14 )% NM - Not Meaningful Cost of Product and Services Sales, Net For Q4 2025, cost of product and services sales, net decreased $33.1 million, or 28%, as compared with Q4 2024. The decrease was driven by decreases in cost of MCM Product sales of $23.1 million, cost of Commercial Product sales of $6.6 million and cost of Bioservices of $3.4 million. R&D Expenses For Q4 2025, R&D expenses increased $3.0 million, or 33%, as compared with Q4 2024. The increase was primarily driven by an increase in Ebanga™ related development work. Selling, General and Administrative ("SG&A") Expenses For Q4 2025, SG&A expenses decreased $9.7 million, or 16%, as compared with Q4 2024. The decrease was primarily due to lower marketing, professional services and legal expenses, combined with a decrease in compensation and other employee related expenses as a result of the restructuring initiatives that took place from January of 2023 through September 2025. ADDITIONAL FINANCIAL INFORMATION (1) Capital Expenditures ($ in millions) Q4 2025 Q4 2024 % Change Capital expenditures $ 3.9 $ 1.7 129 % Capital expenditures as a % of total revenues 3 % 1 % For Q4 2025, capital expenditures increased primarily due to increased development activities across the Company’s facilities. REPORTABLE SEGMENT INFORMATION The Company manages the business with a focus on three operating segments: (1) a Commercial Products segment consisting of NARCAN ® Nasal Spray and KLOXXADO ® Nasal Spray; (2) a MCM Products segment consisting of Anthrax - MCM, Smallpox - MCM and Other products and (3) a services segment consisting of our Bioservices offerings (“Services”). Commercial Products and MCM Products are our two reportable segments. In the first quarter of 2025, the Company’s determined that its Services operating segment no longer met the quantitative thresholds of a reportable segment and did not meet the aggregation criteria set forth in Accounting Standards Codification 280, Segment Reporting, and as such is categorized within “All other revenues” along with “Contracts and Grants.” The Company evaluates the performance of these reportable segments based on revenues and segment adjusted gross margin, which is a non-GAAP financial measure. Segment revenue includes external customer sales, but does not include inter-segment services. The Company does not allocate contracts and grants revenue, R&D, SG&A, amortization of intangible assets, interest and other income (expense) or taxes to its evaluation of the performance of these segments. FOURTH QUARTER 2025 REPORTABLE SEGMENT RESULTS ($ in millions) Commercial Products Quarter Ended December 31, 2025 2024 $ Change % Change Revenues $ 38.4 $ 65.1 $ (26.7 ) (41 )% Cost of sales 26.6 33.2 (6.6 ) (20 )% Intangible asset amortization 9.5 9.5 — — % Gross margin ** $ 2.3 $ 22.4 $ (20.1 ) (90 )% Gross margin % ** 6 % 34 % Add back: Intangible asset amortization $ 9.5 $ 9.5 $ — — % Segment adjusted gross margin (2) $ 11.8 $ 31.9 $ (20.1 ) (63 )% Segment adjusted gross margin % (2) 31 % 49 % ** Gross margin is calculated as revenues less cost of sales and intangible asset amortization. Gross margin % is calculated as gross margin divided by revenues. Cost of Commercial Products sales decreased $6.6 million, or 20%, to $26.6 million for the quarter ended December 31, 2025. The decrease was primarily due to lower sales of OTC NARCAN ® and lower Canadian sales of branded NARCAN ® , partially offset by an increase in KLOXXADO ® sales. Commercial Products gross margin decreased $20.1 million, or 90%, to $2.3 million for the quarter ended December 31, 2025. Commercial Products gross margin percentage decreased 28 percentage points to 6% for the quarter ended December 31, 2025. The decrease was largely due to an unfavorable price and volume mix in 2025 for NARCAN ® products. Commercial Products segment adjusted gross margin in the current year period excludes the impact of intangible asset amortization of $9.5 million. ($ in millions) MCM Products Quarter Ended December 31, 2025 2024 $ Change % Change Revenues $ 99.2 $ 116.8 $ (17.6 ) (15 )% Cost of sales 49.0 72.1 (23.1 ) (32 )% Intangible asset amortization 6.8 6.8 — — % Gross margin ** $ 43.4 $ 37.9 $ 5.5 15 % Gross margin % ** 44 % 32 % Add back: Intangible asset amortization $ 6.8 $ 6.8 $ — — % Restructuring costs (benefits) — (0.3 ) 0.3 100 % Inventory step-up provision 3.6 5.0 (1.4 ) (28 )% Segment adjusted gross margin (2) $ 53.8 $ 49.4 $ 4.4 9 % Segment adjusted gross margin % (2) 54 % 42 % ** Gross margin is calculated as revenues less cost of sales and intangible asset amortization. Gross margin % is calculated as gross margin divided by revenues. Cost of MCM product sales decreased $23.1 million, or 32%, to $49.0 million for the quarter ended December 31, 2025. The decrease was primarily due to lower production costs for ACAM2000 ® , CYFENDUS ® and CNJ-016 ® (VIGIV) due to sales volumes, combined with favorable manufacturing variances due to lower inventory reserves and shut-down costs, partially offset by an increase in costs related to higher sales volume of TEMBEXA ® , ANTHRASIL ® and BioThrax ® . MCM Products gross margin increased $5.5 million, or 15%, to $43.4 million for the quarter ended December 31, 2025. MCM Products gross margin percentage increased 12 percentage points to 44% for the quarter ended December 31, 2025. The increase was largely due to a favorable product price and volume mix weighted more heavily to higher margin products and the favorable manufacturing variance impacts described above. MCM Product segment adjusted gross margin in the current year period excludes the impact of intangible asset amortization of $6.8 million and inventory step-up provision of $3.6 million. YTD 2025 REPORTABLE SEGMENT RESULTS ($ in millions) Commercial Products Year Ended December 31, 2025 2024 $ Change % Change Revenues $ 226.1 $ 398.9 $ (172.8 ) (43 )% Cost of sales 130.1 185.9 (55.8 ) (30 )% Intangible asset amortization 37.8 37.8 — — % Gross margin ** $ 58.2 $ 175.2 $ (117.0 ) (67 )% Gross margin % ** 26 % 44 % Add back: Intangible asset amortization $ 37.8 $ 37.8 $ — — % Restructuring costs 0.2 — 0.2 NM Segment adjusted gross margin (2) $ 96.2 $ 213.0 $ (116.8 ) (55 )% Segment adjusted gross margin % (2) 43 % 53 % ** Gross margin is calculated as revenues less cost of sales and intangible asset amortization. Gross margin % is calculated as gross margin divided by revenues. NM - Not Meaningful Cost of Commercial Products sales decreased $55.8 million, or 30%, to $130.1 million for the year ended December 31, 2025. The decrease was primarily due to lower sales of OTC NARCAN ® and lower Canadian sales of branded NARCAN ® , partially offset by an increase in KLOXXADO ® sales. Commercial Products gross margin decreased $117.0 million, or 67%, to $58.2 million for the year ended December 31, 2025. Commercial Products gross margin percentage decreased 18 percentage points to 26% for the year ended December 31, 2025. The decrease was primarily due to an unfavorable price and volume mix of OTC NARCAN ® and lower Canadian sales of branded NARCAN ® , partially offset by an increase in KLOXXADO ® sales. Commercial Product segment adjusted gross margin in the current year excludes the impact of intangible asset amortization of $37.8 million and restructuring costs of $0.2 million. ($ in millions) MCM Products Year Ended December 31, 2025 2024 $ Change % Change Revenues $ 456.7 $ 509.8 $ (53.1 ) (10 )% Cost of sales 163.1 219.4 (56.3 ) (26 )% Intangible asset amortization 27.3 27.3 — — % Gross margin ** $ 266.3 $ 263.1 $ 3.2 1 % Gross margin % ** 58 % 52 % Add back: Intangible asset amortization $ 27.3 $ 27.3 $ — — % Changes in fair value of financial instruments — 0.6 (0.6 ) (100 )% Inventory step-up provision 5.4 6.2 (0.8 ) (13 )% Restructuring costs (benefits) (1.0 ) 7.2 (8.2 ) (114 )% Segment adjusted gross margin (2) $ 298.0 $ 304.4 $ (6.4 ) (2 )% Segment adjusted gross margin % (2) 65 % 60 % ** Gross margin is calculated as revenues less cost of sales and intangible asset amortization. Gross margin % is calculated as gross margin divided by revenues. Cost of MCM product sales decreased $56.3 million, or 26%, to $163.1 million for the year ended December 31, 2025. The decrease was primarily due to favorable manufacturing variances, mostly due to lower shut-down and severance costs and lower inventory reserves, as well as lower production costs reflecting reduced volumes on ACAM2000 ® and CYFENDUS ® , and no RSDL ® related costs in 2025 due to the sale of RSDL ® to SERB in the third quarter of 2024. These decreases were partially offset by higher costs for ANTHRASIL ® and TEMBEXA ® due to higher unit volume. MCM Products gross margin increased $3.2 million, or 1%, to $266.3 million for the year ended December 31, 2025. MCM Products gross margin percentage increased 6 percentage points to 58% for the year ended December 31, 2025. The increase in gross margin percentage was primarily due to a favorable product sales mix which was weighted more heavily to higher margin products and a decrease in shut-down and severance costs and inventory reserves compared with the prior year period. MCM Product segment adjusted gross margin for the year ended December 31, 2025, excludes the impacts of intangible asset amortization of $27.3 million, inventory step-up provision of $5.4 million, and restructuring benefits of $1.0 million. 2026 FINANCIAL FORECAST The Company provides the following financial forecast for full year 2026 and Q1 2026, reflecting management's expectations based on the most current information available. METRIC ($ in millions ) Full Year 2025 Actual Full Year 2026 Forecast Total revenues $742.9 $720 - $760 Net income (loss) $52.6 $(30) - $(10) Adjusted net income (2) $86.8 $25 - $45 Adjusted EBITDA (2) $205.0 $135 - $155 Total adjusted gross margin % (2) 54% 45% - 47% Key Assumptions ($ and shares in millions) Interest expense ~$40 R&D ~6% to 7% of Revenues SG&A ~26% to 28% of Revenues Weighted avg. fully diluted share count ~52 Capex ~$17 Depreciation & amortization ~$90 Q1 2026 METRIC ($ in millions ) Q1 2026 Forecast Total revenues $135M - $155M FOOTNOTES (1) All financial information included in this release is unaudited. (2) See “ Non-GAAP Financial Measures” and the “ Reconciliation of Non-GAAP Financial Measures ” tables for the definitions and reconciliations of Company-wide non-GAAP financial measures to the most closely related GAAP financial measures. Reconciliations of segment non-GAAP financial measures are included within the reportable segment tables. (3) Our MCM Products revenue in 2025 excludes revenues related to RSDL ® , which was sold during the third quarter of 2024. (4) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts in accordance with GAAP. CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION Company management will host a conference call at 5:00 pm eastern time today, February 26, 2026, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company's website or through the following: By phone Advanced registration is required. Visit to register and receive an email with the dial-in number, passcode and registrant ID By webcast Visit A replay of the call can be accessed from the Emergent website. ABOUT EMERGENT BIOSOLUTIONS INC. At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. NON-GAAP FINANCIAL MEASURES In the accompanying analysis of financial information, we sometimes use information derived from consolidated and segment financial information that may not be presented in our financial statements or prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Certain of these financial measures are considered not in conformity with GAAP (“non-GAAP financial measures”) under the United States Securities and Exchange Commission (“SEC”) rules. Specifically, we have referred to the following non-GAAP financial measures: Adjusted Net Income (Loss) Adjusted Net Income (Loss) per Diluted Share Adjusted EBITDA Adjusted EBITDA Margin Adjusted Gross Margin Adjusted Gross Margin % Segment Adjusted Gross Margin Segment Adjusted Gross Margin % We define Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share, which are non-GAAP financial measures, as net income (loss) and net income (loss) per diluted share, respectively, excluding the impact of non-cash amortization charges, impairments, severance and restructuring costs (benefits), inventory step-up provision, acquisition and divestiture costs, exit and disposal costs, gain on sale of business, settlement charges, net, contingent consideration milestones, changes in fair value of financial instruments, loss (gain) on debt extinguishment, other expense (income) items and tax effects. We use Adjusted Net Income (Loss) for the purpose of calculating Adjusted Net Income (Loss) per Diluted Share. Management uses Adjusted Net Income (Loss) per Diluted Share to assess total Company operating performance on a consistent basis. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results and GAAP financial measures, provide management and investors with an additional understanding of our business operating results, including underlying trends. We define Adjusted EBITDA, which is a non-GAAP financial measure, as net income (loss) before depreciation and amortization, income taxes, interest expense, net, and excluding impairments, inventory step-up provision, changes in fair value of financial instruments, severance and restructuring costs (benefits), exit and disposal costs, acquisition and divestiture costs, gain on sale of business, settlement charges, net, contingent consideration milestone, loss (gain) on debt extinguishment, and other expense (income) items. We define Adjusted EBITDA Margin, which is a non-GAAP financial measure, as Adjusted EBITDA divided by Total Revenues. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results and GAAP financial measures, provide management and investors with a more complete understanding of our operating results, including underlying trends. In addition, EBITDA is a common alternative measure of operating performance used by many of our competitors. It is used by investors, financial analysts, rating agencies and others to value and compare the financial performance of companies in our industry, although it may be defined differently by different companies. Therefore, we also believe that this non-GAAP financial measure, considered along with corresponding GAAP financial measures, provides management and investors with additional information for comparison of our operating results with the operating results of other companies. We define Adjusted Gross Margin, which is a non-GAAP financial measure, as Gross Margin, excluding the impact of intangible asset amortization, inventory step-up provision, settlement charges, net, restructuring costs (benefits), and changes in the fair value of financial instruments. We define Adjusted Gross Margin %, which is a non-GAAP financial measure, as Adjusted Gross Margin as a percentage of Products and services sales, net. We define Segment Adjusted Gross Margin, which is a non-GAAP financial measure, as a segment's Gross Margin excluding the respective impact of intangible asset amortization, changes in the fair value of financial instruments, inventory step-up provision, and restructuring costs (benefits). We define Segment Adjusted Gross Margin %, which is a non-GAAP financial measure, as Segment Adjusted Gross Margin as a percentage of a segment's revenues. Non-GAAP financial measures are not defined in the same manner by all companies and may not be comparable with other similarly titled measures of other companies. The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Non-GAAP financial measures should be considered in addition to, but not as a substitute for or superior to, the information contained in our Consolidated Statements of Operations and Consolidated Statements of Cash Flows. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial tables accompanying this press release. SAFE HARBOR STATEMENT This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements, other than statements of historical fact, including statements regarding the future performance of the Company or any of our businesses, our business strategy, future operations, future financial position, future revenues and earnings, our ability to achieve the objectives of our restructuring initiatives, acquisitions and divestitures, including our future results, projected costs, prospects, plans and objectives of management, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “confident,” “commit,” “forecast,” “future,” “outlook,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. These forward-looking statements are based on our current intentions, beliefs, assumptions and expectations regarding future events based on information that is currently available. You should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement contained herein. Any such forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including, among others, the availability of USG funding for contracts related to procurement of our medical countermeasures (“MCM”) products, including CYFENDUS ® (Anthrax Vaccine Adsorbed (AVA) Adjuvanted), previously known as AV7909, ACAM2000 ® (Smallpox (Vaccinia) Vaccine, Live), CNJ-016 ® (Vaccinia Immune Globulin Intravenous (Human) (VIGIV)), BAT ® (Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)), BioThrax ® (Anthrax Vaccine Adsorbed) Ebanga TM (ansuvimab-zykl) and/or TEMBEXA ® (brincidofovir) among others, as well as contracts related to development of medical countermeasures; our ability to meet our commitments to quality and compliance in all of our manufacturing operations; our ability to negotiate additional USG procurement or follow-on contracts for our MCM products that have expired or will be expiring; the commercial availability and impact of a generic and competitive marketplace on future sales of NARCAN ® (naloxone HCL) Nasal Spray, over-the-counter NARCAN ® Nasal Spray and KLOXXADO ® Nasal Spray; our ability to perform under our contracts with the USG, including the timing of and specifications relating to deliveries; the ability of our contractors and suppliers to maintain compliance with current good manufacturing practices and other regulatory obligations; our ability to collect reimbursement for raw materials and payment of service fees from our Bioservices customers; the results of pending government investigations and their potential impact on our business; our ability to satisfy the conditions of our litigation settlement agreements, and the potential impact of such agreements, including the funds to resolve related litigation, on our business; our ability to comply with the operating and financial covenants required by (i) our term loan facility under a credit agreement, dated August 30, 2024, among the Company, the lenders from time to time party thereto and OHA Agency LLC, as administrative agent, (ii) our revolving credit facility under a credit agreement, dated September 30, 2024, among the Company, certain subsidiary borrowers, the lenders from time to time party thereto and Wells Fargo, National Association, as Agent, and (iii) our 3.875% Senior Unsecured Notes due 2028; our ability to maintain adequate internal control over financial reporting and to prepare accurate financial statements in a timely manner; our ability to maintain sufficient cash flow from our operations to pay our substantial debt, both now and in the future; our ability to invest in our business operations as a result of our current indebtedness; the impact of our share and debt repurchase programs; the procurement of our product candidates by USG entities under regulatory authorities that permit government procurement of certain medical products prior to FDA marketing authorization, and corresponding procurement by government entities outside the United States; the success of our commercialization, marketing and manufacturing capabilities and strategy; our ability to identify and acquire companies, businesses, products or product candidates that satisfy our selection criteria; our ability to attract and retain qualified personnel; our ability to adequately secure and protect our intellectual property rights; the impact of cybersecurity incidents, including the risks from the unauthorized access, interruption, failure or compromise of our information systems or those of our business partners, collaborators or other third parties; and the accuracy of our estimates regarding future revenues, expenses, capital requirements and need for additional financing. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ materially from our expectations in any forward-looking statement. In addition, other risks and uncertainties not presently known to us or that we currently believe to be immaterial could affect the accuracy of any forward-looking statements. Readers should consider this cautionary statement, as well as the risks identified in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements. Trademarks Emergent ® , BioThrax ® , BaciThrax ® , BAT ® , Trobigard ® , ANTHRASIL ® , CNJ-016 ® , ACAM2000 ® , NARCAN ® , CYFENDUS ® , TEMBEXA ® and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All other brands, products, services and feature names or trademarks are the property of their respective owners, including KLOXXADO ® , which is a registered trademark of Hikma Pharmaceuticals USA Inc. Investor Contact Rich Lindahl Executive Vice President, Chief Financial Officer lindahlr@ebsi.com Media Contact Assal Hellmer Vice President, Communications mediarelations@ebsi.com Emergent BioSolutions Inc. Consolidated Balance Sheets (unaudited, in millions, except per share data) December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 205.4 $ 99.5 Restricted cash 3.7 6.1 Accounts receivable, net 84.2 154.5 Inventories, net 343.4 311.7 Prepaid expenses and other current assets 25.8 26.9 Total current assets 662.5 598.7 Property, plant and equipment, net 205.4 270.6 Intangible assets, net 436.5 501.5 Other assets 14.2 18.9 Total assets $ 1,318.6 $ 1,389.7 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 55.6 $ 60.9 Accrued expenses 12.2 17.7 Accrued compensation 41.8 56.1 Current tax liability 6.8 5.8 Other current liabilities 15.8 21.9 Total current liabilities 132.2 162.4 Debt 572.1 663.7 Deferred tax liability 37.8 41.7 Other liabilities 53.9 39.1 Total liabilities $ 796.0 $ 906.9 Stockholders’ equity: Preferred stock, $0.001 par value per share; 15.0 shares authorized, no shares issued and outstanding — — Common stock, $0.001 par value per share; 200.0 shares authorized, 60.9 and 59.9 shares issued; 52.1 and 54.3 shares outstanding, respectively. 0.1 0.1 Treasury stock, at cost, 8.7 and 5.6 common shares, respectively (252.6 ) (227.7 ) Additional paid-in capital 942.4 928.0 Accumulated other comprehensive loss, net (7.5 ) (5.2 ) Accumulated deficit (159.8 ) (212.4 ) Total stockholders’ equity $ 522.6 $ 482.8 Total liabilities and stockholders’ equity $ 1,318.6 $ 1,389.7 Emergent BioSolutions Inc. Consolidated Statements of Operations (unaudited, in millions, except per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Revenues: Product and services sales, net $ 143.8 $ 189.3 $ 705.2 $ 1,013.6 Contracts and grants 4.9 5.4 37.7 30.0 Total revenues 148.7 194.7 742.9 1,043.6 Operating expenses: Cost of product and services sales, net (1) 84.9 118.0 326.2 681.3 Research and development 12.1 9.1 53.2 70.7 Selling, general and administrative 51.1 60.8 186.1 308.0 Amortization of intangible assets 16.3 16.3 65.1 65.1 Impairment of long-lived assets 12.2 — 12.2 27.2 Total operating expenses 176.6 204.2 642.8 1,152.3 Income (loss) from operations (27.9 ) (9.5 ) 100.1 (108.7 ) Other income (expense): Interest expense (14.7 ) (14.8 ) (59.3 ) (71.0 ) Gain on sale of business — — — 24.3 Gain (loss) on debt extinguishment (13.3 ) — (12.2 ) 0.6 Other, net 5.2 (3.3 ) 54.2 11.9 Total other income (expense), net (22.8 ) (18.1 ) (17.3 ) (34.2 ) Income (loss) before income taxes (50.7 ) (27.6 ) 82.8 (142.9 ) Income tax provision 3.9 3.7 30.2 47.7 Net income (loss) $ (54.6 ) $ (31.3 ) $ 52.6 $ (190.6 ) Earnings (loss) per common share Basic $ (1.04 ) $ (0.58 ) $ 0.98 $ (3.60 ) Diluted $ (1.04 ) $ (0.58 ) $ 0.93 $ (3.60 ) Weighted average shares outstanding Basic 52.4 54.2 53.5 53.0 Diluted 52.4 54.2 56.7 53.0 (1) Excludes intangible assets amortization Emergent BioSolutions Inc. Consolidated Statements of Cash Flows (unaudited, in millions) Year Ended December 31, 2025 2024 Operating Activities Net income (loss) $ 52.6 $ (190.6 ) Adjustments to reconcile net income (loss) to net cash provided by operating activities: Share-based compensation expense 16.2 18.0 Depreciation and amortization 95.8 108.8 Change in fair value of contingent obligations, net — 0.6 Amortization of deferred financing costs 9.8 7.4 Deferred income taxes (4.0 ) (5.5 ) Noncash gain on sale of business — (32.2 ) Change in fair value of warrant liability 5.5 1.1 Impairment of long-lived assets 12.2 27.2 Loss on disposal of assets 4.5 28.7 Other 0.4 6.5 Changes in operating assets and liabilities: Accounts receivable 25.5 (24.4 ) Inventories (30.3 ) (24.5 ) Prepaid expenses and other assets 11.7 169.9 Accounts payable (8.4 ) (33.0 ) Accrued expenses and other liabilities (10.2 ) 12.3 Long-term incentive plan accrual 3.1 3.6 Accrued compensation (17.3 ) (18.2 ) Income taxes receivable and payable, net (1.7 ) 23.3 Contract liabilities 5.2 (20.3 ) Net cash provided by operating activities 170.6 58.7 Investing Activities Purchases of property, plant and equipment (13.8 ) (22.9 ) Proceeds from sale of property, plant and equipment 38.2 7.9 Milestone payments from prior asset divestiture 50.0 30.0 Proceeds from sale of business — 110.2 Purchase of convertible note receivable (5.0 ) — Net cash provided by investing activities 69.4 125.2 Financing Activities Proceeds from the issuance of debt, net of lender fees — 219.0 Proceeds allocated to warrants issued in conjunction with debt — 13.4 Proceeds allocated to common stock issued in conjunction with debt — 9.3 Principal payments on term loan facility (100.0 ) (198.2 ) Proceeds from revolving credit facility — 65.0 Principal payments on revolving credit facility — (284.2 ) Debt issuance costs — (14.6 ) Proceeds from issuance of common stock upon exercise of stock options 2.2 — Repurchase of debt (8.7 ) — Prepayment premium on debt principal payment (3.8 ) — Purchases of treasury stock (24.9 ) — Proceeds from share-based compensation activity — 1.5 Taxes paid for share-based compensation activity (1.4 ) (1.2 ) Net cash used in financing activities: (136.6 ) (190.0 ) Effect of exchange rate changes on cash, cash equivalents and restricted cash 0.1 — Net change in cash, cash equivalents and restricted cash 103.5 (6.1 ) Cash, cash equivalents and restricted cash, beginning of period 105.6 111.7 Cash, cash equivalents and restricted cash, end of period $ 209.1 $ 105.6 Supplemental cash flow disclosures: Cash paid for interest $ 49.7 $ 64.0 Cash paid for income taxes, net of refunds $ 40.0 $ 26.5 Non-cash investing and financing activities: Purchases of property, plant and equipment unpaid at period end $ 1.6 $ 1.9 Gain (loss) on extinguishments of debt $ (12.2 ) $ 0.6 Issuance of common stock in conjunction with debt $ — $ 7.7 Excise tax liability accrued for common stock repurchases $ 0.3 $ — Reconciliation of cash and cash equivalents and restricted cash: Cash and cash equivalents $ 205.4 $ 99.5 Restricted cash 3.7 6.1 Total $ 209.1 $ 105.6 Emergent BioSolutions, Inc. Reconciliation of Non-GAAP Financial Measures Reconciliation of Net Income (Loss) and Net Income (Loss) per Diluted Share to Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per Diluted Share (1) ($ in millions, except per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Source Net income (loss) $ (54.6 ) $ (31.3 ) $ 52.6 $ (190.6 ) Adjustments: Non-cash amortization charges $ 18.8 $ 18.5 $ 74.8 $ 72.5 Amortization of intangible assets ("IA"), Other Income Impairments — — 12.2 27.2 Impairment of long-lived assets and goodwill Severance and restructuring costs (benefits) — (0.4 ) (0.8 ) 22.5 Cost of product and services sales, net, SG&A and R&D Inventory step-up provision 3.6 5.0 5.4 6.2 Cost of product and services sales, net Acquisition and divestiture costs — — 0.2 — SG&A Exit and disposal costs — — — 13.3 R&D Gain on sale of business — — — (24.3 ) Other Income (Expense) Settlement charges, net 0.9 1.5 (9.6 ) 121.7 Cost of product and services sales, net Contingent consideration milestones — — (50.0 ) (30.0 ) Other Income (Expense) Changes in fair value of financial instruments 7.4 2.3 5.4 1.8 Cost of product and services sales, net and Other Income Loss (gain) on debt extinguishment 13.3 — 12.2 (0.6 ) Gain (loss) on debt extinguishment Other expense (income), net items — — (2.9 ) 10.4 Other Income (Expense) Tax effect (12.1 ) 7.0 (12.7 ) (42.2 ) Total adjustments: $ 31.9 $ 33.9 $ 34.2 $ 178.5 Adjusted net income (loss) $ (22.7 ) $ 2.6 $ 86.8 $ (12.1 ) Net income (loss) per diluted share $ (1.04 ) $ (0.58 ) $ 0.93 $ (3.60 ) Adjustments: Non-cash amortization charges $ 0.36 $ 0.34 $ 1.32 $ 1.37 Amortization of intangible assets ("IA"), Other Income Impairments — — 0.22 0.51 Impairment of long-lived assets and goodwill Severance and restructuring costs (benefits) — (0.01 ) (0.01 ) 0.42 Cost of product and services sales, net, SG&A and R&D Inventory step-up provision 0.07 0.09 0.10 0.12 Cost of product and services sales, net Acquisition and divestiture costs — — — — SG&A Exit and disposal costs — — — 0.25 R&D Gain on sale of business — — — (0.46 ) Other Income (Expense) Settlement charges, net 0.02 0.03 (0.17 ) 2.30 Cost of product and services sales, net Contingent consideration milestones — — (0.88 ) (0.57 ) Other Income (Expense) Changes in fair value of financial instruments 0.14 0.04 0.09 0.03 Cost of product and services sales, net and Other Income Loss (gain) on debt extinguishment 0.25 — 0.22 (0.01 ) Gain (loss) on debt extinguishment Other expense (income), net items — — (0.05 ) 0.20 Other Income (Expense) Tax effect (0.23 ) 0.14 (0.24 ) (0.79 ) Total adjustments: $ 0.61 $ 0.63 $ 0.60 $ 3.37 Adjusted net income (loss) per diluted share $ (0.43 ) $ 0.05 $ 1.53 $ (0.23 ) Diluted shares used in computing Adjusted net income (loss) per diluted share 52.4 54.2 56.7 53.0 Emergent BioSolutions, Inc. Reconciliation of Net Income (loss) and Net Income (loss) Margin to Adjusted EBITDA and Adjusted EBITDA Margin (1) ($ in millions) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Net income (loss) $ (54.6 ) $ (31.3 ) $ 52.6 $ (190.6 ) Adjustments: Depreciation & amortization $ 23.5 $ 26.0 $ 95.7 $ 108.8 Income taxes 3.9 3.7 30.2 47.7 Total interest expense, net 13.2 14.2 54.4 69.0 Impairments — — 12.2 27.2 Inventory step-up provision 3.6 5.0 5.4 6.2 Changes in fair value of financial instruments 7.4 2.3 5.4 1.8 Severance and restructuring costs (benefits) — (0.4 ) (0.8 ) 22.5 Exit and disposal costs — — — 13.3 Acquisition and divestiture costs — — 0.2 — Gain on sale of business — — — (24.3 ) Settlement charges, net 0.9 1.5 (9.6 ) 121.7 Contingent consideration milestones — — (50.0 ) (30.0 ) Loss (gain) on debt extinguishment 13.3 — 12.2 (0.6 ) Other expense (income), net items — — (2.9 ) 10.4 Total adjustments $ 65.8 $ 52.3 $ 152.4 $ 373.7 Adjusted EBITDA $ 11.2 $ 21.0 $ 205.0 $ 183.1 Total revenues $ 148.7 $ 194.7 $ 742.9 $ 1043.6 Net income (loss) margin (37) % (16) % 7 % (18) % Adjusted EBITDA margin 8 % 11 % 28 % 18 % Emergent BioSolutions, Inc. Reconciliations of Total Revenues to Product and Services Sales, Net and of Gross Margin and Gross Margin % to Adjusted Gross Margin and Adjusted Gross Margin % (1) Three Months Ended December 31, Year Ended December 31, ($ in millions) 2025 2024 2025 2024 Total revenues $ 148.7 $ 194.7 $ 742.9 $ 1,043.6 Contracts and grants 4.9 5.4 37.7 30.0 Product and services sales, net $ 143.8 $ 189.3 $ 705.2 $ 1,013.6 Cost of product and services sales, net 84.9 118.0 326.2 681.3 Intangible asset amortization 16.3 16.3 65.1 65.1 Gross margin $ 42.6 $ 55.0 $ 313.9 $ 267.2 Gross margin % 30 % 29 % 45 % 26 % Add back: Intangible asset amortization $ 16.3 $ 16.3 $ 65.1 $ 65.1 Inventory step-up provision 3.6 5.0 5.4 6.2 Settlement charges, net — — — 110.2 Restructuring costs (benefits) — (0.4 ) (0.8 ) 7.4 Changes in fair value of financial instruments — — — 0.6 Adjusted gross margin $ 62.5 $ 75.9 $ 383.6 $ 456.7 Adjusted gross margin % 43 % 40 % 54 % 45 % Emergent BioSolutions, Inc. Reconciliation of Net Loss Forecast to Adjusted Net Income Forecast ($ in millions) 2026 Full Year Forecast Source Net loss $(30) - $(10) Adjustments: Non-cash amortization charges $73 Amortization of IA and Other Income (Expense) Inventory step-up provision 4 Cost of products and services, net Contingent consideration milestones (5) Other Income (Expense) Tax effect (17) Total adjustments: $55 Adjusted net income $25 - $45 Reconciliation of Net Loss Forecast to Adjusted EBITDA Forecast ($ in millions) 2026 Full Year Forecast Net loss $(30) - $(10) Adjustments: Depreciation & amortization $90 Income taxes 36 Total interest expense, net 40 Inventory step-up provision 4 Contingent consideration milestones (5) Total adjustments $165 Adjusted EBITDA $135 - $155 Emergent BioSolutions, Inc. Reconciliations of Forecasted Total Revenues to Forecasted Product and Services Sales, Net and of Forecasted Gross Margin and Gross Margin % to Forecasted Adjusted Gross Margin and Adjusted Gross Margin % (1) ($ in millions) 2026 Full Year Forecast Total revenues $720 - $760 Contracts & Grants (35) Product and services sales, net $685 - $725 Cost of product and services sales, net $381- $388 Intangible asset amortization 64 Gross margin $240 - $273 Gross margin % 35% - 38% Add back: Intangible asset amortization $64 Inventory step-up provision 4 Adjusted gross margin $308 - $341 Adjusted gross margin % 45% - 47%

上市批准疫苗引进/卖出财报

2026-02-24

·PRNewswire

Consegna Pharma Highlights Innovative Modeling and Simulation Strategy as FDA Concurs with Regulatory Pathway for CP217 to Prevent Fentanyl Epidemic Deaths

Prevention of Renarcotization after Rescue from Opioid Overdose is a New Indication and Planned Clinical Studies will be Supported by Pioneering a First-of-Its-Kind, Capital Efficient, Modeling and Simulation-Driven 505(b)(2) Pathway PITTSBURGH, Feb. 24, 2026 /PRNewswire/ -- Consegna Pharma, Inc. ("Consegna" or the "Company") today announced that it has received written responses from the U.S. Food and Drug Administration (FDA) regarding its Type C meeting for CP217, the Company's investigational long‑acting naloxone product being developed for the prevention of renarcotization following rescue from opioid overdose. In its feedback, the FDA concurred that the proprietary modeling and simulation (M&S) framework proposed by Consegna is appropriate to guide the clinical development program for CP217. The Agency recognized the proposed labeling indication, prevention of renarcotization when residual opioid effects extend beyond the duration of initial naloxone rescue, as a distinct and clinically relevant labeling objective. This guidance also concurred that substantial evidence of effectiveness for this new indication can be supported by the combined M&S, bioavailability, and clinical safety package. "The Agency's written responses recognize the scientific rigor and innovation of our modeling‑driven strategy," said Larry Zana, President and CEO of Consegna Pharma. "This approach expands and improves proven in silico mechanistic models of opioid overdose, respiratory depression, and renarcotization to generate evidence of CP217's effect in vast, virtual patient populations, reducing reliance on large, expensive, and time-consuming clinical efficacy trials. With the FDA's guidance, we now have a clearly defined, capital‑efficient path to NDA filing and we look forward to exploring strategic partnerships to maximize its impact against the synthetic opioid epidemic." "Our streamlined development program for CP217 systematically addresses key questions of dose, extended exposure profile, safety, drug pharmacokinetics, and renarcotization simulation", said Darren Wolfe, Chief Scientific Officer. "A single, clinical bioavailability and safety study will be central to our accelerated 505(b)(2)approval strategy." Consegna's approach aligns with the FDA's Model‑Informed Drug Development (MIDD) and Quantitative Medicine initiatives that promote advanced modeling to streamline development, reduce or replace selected animal studies and human clinical trials, and accelerate regulatory decision‑making. The Agency has identified M&S‑driven strategies as important tools for optimizing dose selection and demonstrating therapeutic effect when traditional trials are impractical or duplicative. In its responses, the FDA confirmed that the 505(b)(2) regulatory pathway appears appropriate for CP217 and outlined expectations for establishing a robust scientific bridge to the listed naloxone drug using comparative pharmacokinetic data collected under standard dosing conditions. This represents a novel and highly innovative application of modeling‑driven, long‑acting drug delivery to pursue 505(b)(2) approval, using an integrated package of advanced M&S, comparative pharmacokinetics, and targeted clinical safety data to support prevention of the new indication of renarcotization. This work was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number 2R43DA059056. The content of this press release is solely the responsibility of the company and does not necessarily represent the official views of the National Institutes of Health. About CP217 CP217 is a microencapsulated, long‑acting injectable formulation of naloxone hydrochloride engineered to provide 12-24 hours of sustained opioid receptor antagonism following a single dose. It is being developed for the prevention of renarcotization when residual opioid effects extend beyond the duration of initial naloxone rescue in overdose patients with acute opioid toxicity. About Consegna Pharma Consegna Pharma, Inc. is a privately held biopharmaceutical company focused on applying advanced long‑acting drug delivery and quantitative clinical pharmacology to develop differentiated therapeutics in addiction medicine, non-opioid pain, and emergency response. The company's pipeline includes long‑acting formulations such as CP217 for overdose reversal, CP110 to treat substance use disorder, FP111 for post-surgical pain and several pre-lead drug candidates as long‑acting, non‑opioid pain therapeutics designed to address unmet needs in the prevention and management of acute and chronic pain. Media Contact: Larry Zana, President and CEO Phone: +1-412-213-8788 Email: [email protected] SOURCE Consegna Pharma Inc. 21% more press release views with Request a Demo

100 项与盐酸纳洛酮相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D01340	盐酸纳洛酮	A06AH04 V03AB15	DB01183

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急性淋巴细胞白血病	加拿大	Hikma Pharmaceuticals LLC	2025-02-01
阿片类药物过量	美国	Emergent Devices, Inc.	1971-04-13

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适应症	最高研发状态	国家/地区	公司	日期
阿片滥用	临床前	美国	Consegna Pharma, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03608163 (CTgov)	临床4期	1型糖尿病 \| 低血糖 \| 单纯自主神经功能衰竭 ... 更多	4	Naloxone (Naloxone)	願築鹹積衊選鬱積網壓(鑰鹹衊築範積鏇襯壓鹹) = 鹽觸淵窪鏇夢鹹鬱鹹鏇簾鹹積鹹襯膚遞夢壓艱 (鹹鏇選艱憲積簾齋積醖, 134) 更多	-	2025-09-11
				Placebo (for Naloxone) (Placebo (for Naloxone))	願築鹹積衊選鬱積網壓(鑰鹹衊築範積鏇襯壓鹹) = 襯夢淵遞鹽齋網觸構鑰簾鹹積鹹襯膚遞夢壓艱 (鹹鏇選艱憲積簾齋積醖, 195) 更多
NCT03751111 (CTgov)	临床1/2期	瘙痒 \| 肛门瘙痒	126	Naloxone (Naloxone)	窪顧衊積獵繭願簾鹹構(築鏇顧壓觸餘壓艱蓋製) = 艱鏇獵餘願衊獵築夢構蓋遞衊簾齋壓選願範壓 (餘築襯鹽餘膚淵鏇範願, 2.15) 更多	-	2025-04-20
				Placebo (Placebo)	窪顧衊積獵繭願簾鹹構(築鏇顧壓觸餘壓艱蓋製) = 鑰鹹築鹹衊繭壓製鏇憲蓋遞衊簾齋壓選願範壓 (餘築襯鹽餘膚淵鏇範願, 1.99) 更多
NCT04473950 (CTgov)	临床1期	阿片相关性障碍 \| 慢性疼痛	10	Placebo+Naloxone Hydrochloride (Pain Group)	構憲選簾獵鬱襯願蓋網(襯艱廠壓醖醖簾願壓廠) = 鬱遞積顧艱鏇築衊範壓壓鏇範襯範憲餘夢顧糧 (鹽淵鏇衊鏇鬱繭積鏇選, 1.17) 更多	-	2025-03-26
				Placebo+Naloxone Hydrochloride (No Pain Group)	構憲選簾獵鬱襯願蓋網(襯艱廠壓醖醖簾願壓廠) = 艱遞鹹艱齋鹹鬱鬱餘窪壓鏇範襯範憲餘夢顧糧 (鹽淵鏇衊鏇鬱繭積鏇選, 0.92) 更多
NCT03176316 (FusionIleus, CTgov)	临床4期	肠阻塞	53	Naloxone	窪鹹糧繭網選壓鹽蓋廠 = 簾遞積窪鬱選範製顧鑰顧繭製鹽窪糧艱衊糧衊 (蓋築鬱襯簾糧襯鹽餘餘, 選繭艱鑰網積顧糧壓鹽 ~ 鏇蓋顧鹽鏇艱獵鹽壓餘) 更多	-	2024-07-01
NCT03149770 (CTgov)	临床2期	低血糖 \| 1型糖尿病	30	Naloxone (Naloxone)	廠築壓簾淵壓窪鬱範積(繭構壓餘遞鑰鹽範淵鑰) = 觸衊艱齋觸簾糧顧齋鏇構願鬱繭鬱製鬱簾襯構 (鏇範醖繭齋艱蓋獵夢觸, 12) 更多	-	2024-04-16
				placebo (Placebo)	廠築壓簾淵壓窪鬱範積(繭構壓餘遞鑰鹽範淵鑰) = 簾鏇簾獵艱簾觸廠繭蓋構願鬱繭鬱製鬱簾襯構 (鏇範醖繭齋艱蓋獵夢觸, 13) 更多
NCT04764630 (Pubmed \| JAMA Netw Open)	临床1期	阿片类药物过量	21	1 dose at 0, 2.5, 5, and 7.5 minutes	遞範積顧網窪壓構窪艱(憲簾鏇製願鏇餘鬱淵積) = 積鬱憲製齋範衊蓋選遞遞獵窪鹹選願糧築鹹糧 (膚構壓觸醖範夢繭糧廠 )	-	2024-01-23
				2 doses at 0 and 2.5 minutes	遞範積顧網窪壓構窪艱(憲簾鏇製願鏇餘鬱淵積) = 積遞蓋餘廠糧夢廠鏇鏇遞獵窪鹹選願糧築鹹糧 (膚構壓觸醖範夢繭糧廠 )
NCT03570099 (Pubmed \| BMJ Open)	N/A	阿片类药物过量	-	Take-home naloxone distribution	膚衊簾繭齋顧艱簾膚築(窪襯繭積積範獵鏇壓醖) = 衊憲範願構範齋淵憲衊範觸夢顧獵選廠醖遞遞 (顧築遞獵願顧夢願壓觸 )	-	2024-01-01
				intranasal naloxone (Control period (2013-2017))	膚衊簾繭齋顧艱簾膚築(窪襯繭積積範獵鏇壓醖) = 餘鏇簾網鑰壓餘積鹽築範觸夢顧獵選廠醖遞遞 (顧築遞獵願顧夢願壓觸 )
NCT04303000 (CTgov)	临床4期	阿片类药物过量	111	Opioid Overdose Education with Naloxone Distribution (Opioid Overdose Education and Naloxone Distribution)	蓋壓繭選鬱蓋鏇選鹽醖 = 簾窪構觸糧鑰糧淵觸淵繭蓋壓廠醖遞製醖選窪 (築窪衊夢憲範廠觸簾夢, 鹽簾廠遞鏇繭築膚憲襯 ~ 願夢鏇鹽夢憲積糧鬱鏇) 更多	-	2023-10-30
				Opioid Overdose Education (Opioid Overdose Education)	蓋壓繭選鬱蓋鏇選鹽醖 = 壓鹹繭鹹簾蓋襯鹽積鑰繭蓋壓廠醖遞製醖選窪 (築窪衊夢憲範廠觸簾夢, 鹹製醖鏇製糧築餘衊蓋 ~ 構築鑰顧鬱壓鹽鹹積選) 更多
NCT02700048 (CTgov)	临床1/2期	1型糖尿病 \| 低血糖 \| 意识丧失	11	Intra-nasal saline (Placebo)	積淵遞範衊衊築蓋憲憲(廠膚夢顧顧壓築鹽餘鑰) = 糧繭鑰構積鏇艱鑰觸衊鹹製製蓋觸蓋積製壓繭 (願鏇餘艱鹽鹹淵醖顧繭, 願鹽憲醖選繭積糧鹹選 ~ 壓衊顧廠鏇獵獵觸積顧) 更多	-	2023-03-27
				intra-nasal naloxone (Treatment With Intra-nasal Naloxone)	積淵遞範衊衊築蓋憲憲(廠膚夢顧顧壓築鹽餘鑰) = 顧糧廠獵醖齋齋製獵鑰鹹製製蓋觸蓋積製壓繭 (願鏇餘艱鹽鹹淵醖顧繭, 鏇壓糧觸簾鏇衊製構鏇 ~ 膚鹹夢淵餘繭壓簾製淵) 更多
NCT04713709 (Corporate Publications) 人工标引	临床1期	阿片类药物过量	56	FMXIN001	夢夢糧艱廠憲憲網簾淵(廠範夢鏇鑰膚膚網構鏇) = 齋壓積觸鬱構構衊鹹膚獵鬱壓鏇壓獵觸淵鏇構 (鹹繭鬱鑰鏇鏇鏇鹹簾獵 ) 更多	相似	2022-07-28
				NARCAN	夢夢糧艱廠憲憲網簾淵(廠範夢鏇鑰膚膚網構鏇) = 憲醖網繭鏇觸餘窪鹹顧獵鬱壓鏇壓獵觸淵鏇構 (鹹繭鬱鑰鏇鏇鏇鹹簾獵 ) 更多