TIXiMED Inc. Announces Successful Dosing of First Cohort in the Phase 1 Clinical Trial of TIX100, its Investigational Disease-Modifying Treatment for Type 1 Diabetes




TIXiMED Inc. Announces Successful Dosing of First Cohort in the Phase 1 Clinical Trial of TIX100, its Investigational Disease-Modifying Treatment for Type 1 Diabetes

• No drug associated adverse effects were reported
• Oral drug was well tolerated, and no clinically significant findings or safety concerns were noted
• Escalation to the second dose cohort of this single ascending dose study continues per protocol

BIRMINGHAM, Ala.–(BUSINESS WIRE)–TIXiMED Inc. (www.tiximed.com), a clinical-stage pharmaceutical company based on the breakthrough discovery that TXNIP plays an important role in the development and progression of diabetes, today announced successful dosing of the first dose cohort in the Phase 1 Single Ascending Dose (SAD) trial of TIX100, its investigational novel oral therapy targeting beta cell health and islet cell function. Additionally, based on the safety review meeting, it was recommended that the randomized, placebo-controlled quadruple-blind clinical trial continue with no modifications and the next cohort escalate to the pre-specified dose level.

“We are pleased to achieve this significant milestone in the development of TIX100 with this first-in-human trial,” said Dr. Anath Shalev, TIXiMED Founder and Chief Scientific Officer. “We look forward to evaluating the findings of the next, higher dose cohorts in the coming months and to a successful completion of the SAD trial later this year,” Dr. Shalev added.

“We have seen increasing recognition of the promise of TIX100 to one day improve the lives of people with type 1 diabetes,” said TIXiMED President and Board Chair Mike Goodrich. “This first-in-human trial is the cornerstone of the clinical work we’ve planned to advance this novel therapy. We are very thankful to our investors and partners, including The Helmsley Charitable Trust, who made a program-related investment in the form of a loan to TIXiMED,” Mr. Goodrich concluded.

About TIXiMED Inc.

TIXiMED is a clinical stage pharmaceutical company dedicated to developing and commercializing a first-of-its kind oral therapy for type 1 diabetes based on TXNIP inhibition. TIXiMED is the exclusive license holder for the patent surrounding TIX100, a novel, small molecule TXNIP inhibitor, and its derivatives, that has been shown to protect against models of type 1 and type 2 diabetes as well as metabolic dysfunction–associated steatotic liver disease. Visit www.tiximed.com for more information.

Contacts

Emma Bolden

info@tiximed.com
+1.205.578.1005

Quanterix Highlights Compelling Benefits of Akoya Biosciences Acquisition




Quanterix Highlights Compelling Benefits of Akoya Biosciences Acquisition

Comments on Director Nominations Received from Kent Lake

BILLERICA, Mass.–(BUSINESS WIRE)–Quanterix Corporation (NASDAQ: QTRX) (“Quanterix” or the “Company”), a company fueling scientific discovery through ultra-sensitive biomarker detection, today reiterated the strategic and financial benefits of its proposed acquisition of Akoya Biosciences, which will create the first integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers. Quanterix issued the following statement:

Quanterix’s proposed acquisition of Akoya is the result of a rigorous and thorough Board evaluation consistent with its commitment to position the Company for long-term growth. With enhanced scale and a strengthened financial foundation, Quanterix will accelerate the execution of its strategic plan and deliver significant value to shareholders:

• Expanded Addressable Market. The addition of Akoya’s cutting-edge spatial biology capabilities will unlock a high-growth $5 billion serviceable addressable market across neurology, immunology and oncology, with an additional $10 billion market opportunity in Alzheimer’s Disease diagnostics. By combining Quanterix’s leading position in ultrasensitive detection of proteins in blood and Akoya’s leading position in biomarker detection in tissue, Quanterix will be uniquely positioned to speed up development of new liquid biopsy tests, a market which it believes will surpass that of all other diagnostic tests combined.

• Synergy Generation: With extensive diligence and deep familiarity with Akoya’s platform, Quanterix has clear line of sight to capture approximately $40 million in annual run-rate cost synergies by the end of 2026, $20 million of which is expected to be realized within the first year following close.

• Enhanced Scale and Profitability: With expected positive free cash flow in 2026 and continued strong double-digit organic revenue growth, Quanterix expects the transaction will allow it to multiply its revenue to approximately $1 billion with EBIT margins of approximately 15% within five years following close.

Kent Lake Nominations

Quanterix confirmed that Kent Lake PR LLC (“Kent Lake”) has submitted notice nominating three candidates to stand for election to the Quanterix Board of Directors at the Company’s 2025 Annual Meeting of Shareholders.

The Company welcomes engagement with its shareholders and has attempted to engage constructively with Kent Lake and will continue to do so. Kent Lake’s recent statements, however, contain significantly flawed financial assumptions, factually inaccurate information and fail to recognize the compelling and strategically necessary rationale of the transaction. Kent Lake’s director nominations are a clear attempt to obfuscate the long-term value creation opportunity the acquisition of Akoya presents.

The Quanterix Board has been built thoughtfully to ensure that it is composed of directors with outstanding track records and the right mix of skillsets to successfully oversee the Company’s strategic plan, which includes deep expertise across the life sciences industry with a particular focus on diagnostics, as well as commercial strategy, strategic planning, corporate governance and capital markets experience.

The Quanterix Board will evaluate Kent Lake’s nomination notice and present its recommendation with respect to the election of directors in the Company’s proxy statement, which will be filed with the Securities and Exchange Commission (“SEC”) and mailed to all shareholders eligible to vote at the 2025 Annual Meeting. The date of the 2025 Annual Meeting has not yet been announced. Quanterix shareholders are not required to take any action with respect to the election of directors at this time.

Quanterix and Akoya are progressing toward closing. On February 13, 2025, Quanterix filed a registration statement on Form S-4, which contains a preliminary joint proxy statement of Quanterix and Akoya and a preliminary prospectus of Quanterix, with the SEC. The transaction is expected to close in the second quarter of 2025, subject to applicable approvals by both companies’ shareholders and satisfaction of other customary closing conditions.

Goldman Sachs & Co. LLC is serving as financial advisor to Quanterix and Covington & Burling LLP is serving as its legal counsel in Quanterix’s acquisition of Akoya.

About Quanterix

From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Quanterix’s Simoa^® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 3,100 peer-reviewed journals.

IMPORTANT ADDITIONAL INFORMATION

In connection with the proposed acquisition of Akoya Biosciences, Inc. (“Akoya”) by Quanterix (the “Merger”), Quanterix filed with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, dated February 13, 2025 (the “Registration Statement”), which contains a preliminary joint proxy statement of Quanterix and Akoya and a preliminary prospectus of Quanterix (the “Joint Proxy Statement/Prospectus”), and each of Quanterix and Akoya may file with the SEC other relevant documents regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT AND THE JOINT PROXY STATEMENT/PROSPECTUS CAREFULLY AND IN THEIR ENTIRETY AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC BY QUANTERIX AND AKOYA, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT QUANTERIX, AKOYA AND THE PROPOSED TRANSACTION. A definitive copy of the Joint Proxy Statement/Prospectus will be mailed to Quanterix and Akoya stockholders when that document is final. Investors and security holders will be able to obtain the Registration Statement and the Joint Proxy Statement/Prospectus, as well as other filings containing information about Quanterix and Akoya, free of charge from Quanterix or Akoya or from the SEC’s website when they are filed. The documents filed by Quanterix with the SEC may be obtained free of charge at Quanterix’s website, at www.quanterix.com, or by requesting them by mail at Quanterix Investor Relations, 900 Middlesex Turnpike, Billerica, MA 01821. The documents filed by Akoya with the SEC may be obtained free of charge at Akoya’s website, at www.akoyabio.com, or by requesting them by mail at Akoya Biosciences, Inc., 100 Campus Drive, 6th Floor, Marlborough, MA 01752 ATTN: Chief Legal Officer.

PARTICIPANTS IN THE SOLICITATION

Quanterix and Akoya and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Quanterix or Akoya in respect of the proposed transaction. Information about Quanterix’s directors and executive officers is available in the Joint Proxy Statement/Prospectus, and other documents filed by Quanterix with the SEC. Information about Akoya’s directors and executive officers is available in the Joint Proxy Statement/Prospectus and Akoya’s proxy statement dated April 23, 2024, for its 2024 Annual Meeting of Stockholders, and other documents filed by Akoya with the SEC. Other information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, is contained in the Joint Proxy Statement/Prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. Investors should read the definitive Joint Proxy Statement/Prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Quanterix or Akoya as indicated above.

NO OFFER OR SOLICITATION

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the Merger, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Statements included in this press release which are not historical in nature or do not relate to current facts are intended to be, and are hereby identified as, forward-looking statements for purposes of the safe harbor provided by Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are based on, among other things, projections as to the anticipated benefits of the Merger as well as statements regarding the impact of the Merger on Quanterix’s and Akoya’s business and future financial and operating results, the amount and timing of synergies from the Merger and the closing date for the Merger. Words and phrases such as “may,” “approximately,” “continue,” “should,” “expects,” “projects,” “anticipates,” “is likely,” “look ahead,” “look forward,” “believes,” “will,” “intends,” “estimates,” “strategy,” “plan,” “could,” “potential,” “possible” and variations of such words and similar expressions are intended to identify such forward-looking statements. Quanterix and Akoya caution readers that forward-looking statements are subject to certain risks and uncertainties that are difficult to predict with regard to, among other things, timing, extent, likelihood and degree of occurrence, which could cause actual results to differ materially from anticipated results. Such risks and uncertainties include, among others, the following possibilities: the occurrence of any event, change or other circumstances that could give rise to the right of one or both of the parties to terminate the Merger Agreement; the outcome of any legal proceedings that may be instituted against Quanterix or Akoya; the failure to obtain necessary regulatory approvals (and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the Merger) and stockholder approvals or to satisfy any of the other conditions to the Merger on a timely basis or at all; the possibility that the anticipated benefits and synergies of the Merger are not realized when expected or at all, including as a result of the impact of, or problems arising from, the integration of the two companies or as a result of the strength of the economy and competitive factors in the areas where Quanterix and Akoya do business; the possibility that the Merger may be more expensive to complete than anticipated; diversion of management’s attention from ongoing business operations and opportunities; potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger; changes in Quanterix’s share price before the closing of the Merger; risks relating to the potential dilutive effect of shares of Quanterix common stock to be issued in the Merger; and other factors that may affect future results of Quanterix, Akoya and the combined company. Additional factors that could cause results to differ materially from those described above can be found in the Joint Proxy Statement Prospectus, and in other documents Quanterix and Akoya file with the SEC, which are available on the SEC’s website at www.sec.gov.

All forward-looking statements, expressed or implied, included in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to herein. If one or more events related to these or other risks or uncertainties materialize, or if Quanterix’s or Akoya’s underlying assumptions prove to be incorrect, actual results may differ materially from what Quanterix and Akoya anticipate. Quanterix and Akoya caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made and are based on information available at that time. Neither Quanterix nor Akoya assumes any obligation to update or otherwise revise any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements were made or to reflect the occurrence of unanticipated events except as required by federal securities laws.

Contacts

Media

Marissa Klaassen
media@quanterix.com

Or

Jim Golden / Tali Epstein

Collected Strategies

QTRX-CS@collectedstrategies.com

Investor Relations

Joshua Young

ir@quanterix.com

Or

Geoffrey Weinberg / Michael Verrechia / Bill Dooley

Sodali & Co

QTRX@info.sodali.com

Guardian Pharmacy Services, Inc. Announces Preliminary Fourth Quarter and Full Year 2024 Results; Provides 2025 Financial Guidance and Earnings Conference Call Date




Guardian Pharmacy Services, Inc. Announces Preliminary Fourth Quarter and Full Year 2024 Results; Provides 2025 Financial Guidance and Earnings Conference Call Date

ATLANTA–(BUSINESS WIRE)–Guardian Pharmacy Services, Inc. (“Guardian” or the “Company”) (NYSE: GRDN), one of the nation’s largest long-term care (LTC) pharmacy services companies, today announced certain preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2024.

Guardian will discuss these preliminary unaudited financial results and guidance during a presentation today at 9:50 a.m. ET at the Raymond James & Associates 46th Annual Institutional Investors Conference, being held in Orlando, Florida. The live audio webcast of the presentation will be available online at https://investors.guardianpharmacy.com. A replay will also be available at such location for 30 days.

“We’re proud to report that we ended the year on a strong note, exceeding our expectations for the fourth quarter and year ended December 31, 2024. The outperformance was driven by strong organic growth, acquisitions, and the new benefit of the seasonal trend related to conducting vaccine clinics in certain long-term care facilities we serve. Looking ahead, we enter 2025 well-positioned for success and we remain committed to meeting the needs of all of the residents we serve,” said Fred Burke, President & CEO of Guardian.

The selected unaudited results in this press release are preliminary and subject to the Company’s normal quarter and year-end accounting procedures and external audit by the Company’s independent registered public accounting firm. Therefore, these preliminary unaudited results are subject to adjustment. In addition, these preliminary unaudited results are not a comprehensive statement of the Company’s financial results for the year ended December 31, 2024 and should not be viewed as a substitute for full, audited financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”).

Fourth Quarter and Full Year Selected Preliminary Unaudited Financial Information

Three Months Ended December 31, 2024

• Revenue is expected to be approximately $338.6 million, an expected increase of approximately 20.5% year-over-year, driven by organic growth of the business and the previously announced acquisitions of Heartland Pharmacy and Freedom Pharmacy, completed on April 1, 2024 and November 1, 2024, respectively. Revenue was also positively impacted by an increase in flu and COVID-19 vaccinations administered through clinics in certain long-term care facilities we serve.
• Resident Count is expected to be approximately 186,000 at the end of the quarter, an expected increase of approximately 14.1% year-over-year, which can be attributed to organic growth of the business and acquisitions of Heartland Pharmacy and Freedom Pharmacy.
• Net Income is expected to be between $10.1 million and $11.1 million, an expected decrease between $3.5 million and $4.5 million year-over-year, primarily attributable to expected income tax provision expense between $5.0 million and $6.0 million.
• Adjusted EBITDA is expected to be approximately $25.9 million, an expected increase of approximately 30.3% year-over-year. See reconciliation of adjusted EBITDA to net income, the most directly comparable GAAP financial measure, below.

Year Ended December 31, 2024

• Revenue is expected to be approximately $1.228 billion, an expected increase of approximately 17.4% year-over-year, driven by organic growth of the business and the previously announced acquisitions of Heartland Pharmacy and Freedom Pharmacy, completed on April 1, 2024, and November 1, 2024, respectively. Revenue was also positively impacted by an increase in flu and COVID-19 vaccinations administered through clinics in certain long-term care facilities we serve.
• Net Income (loss) is expected to be between ($71.8) million and ($72.8) million, an expected decrease between $109.5 million and $110.5 million year-over-year, primarily attributable to approximately $131.5 million of share-based compensation expense, the majority of which is associated with our Corporate Reorganization and initial public offering (“IPO”). This also resulted in a net loss per share for the year.
• Adjusted EBITDA is expected to be approximately $90.8 million, an expected increase of approximately 19.2% year-over-year. See reconciliation of adjusted EBITDA to net income, the most directly comparable GAAP financial measure, below.

Initial 2025 Full Year Guidance

For the full year ending December 31, 2025, Guardian is providing the following guidance:

• Revenue of $1.330 billion to $1.350 billion
• Adjusted EBITDA of $97.0 million to $101.0 million

Guardian has not provided a quantitative reconciliation of forecasted Adjusted EBITDA, a non-GAAP financial measure to forecasted net income within this communication because Guardian is unable, without making unreasonable efforts, to calculate certain reconciling items with confidence due to the variability and complexity of such items. These items include, but are not limited to, income taxes and share-based compensation. These items, which could materially affect the computation of forecasted net income, are inherently uncertain and depend on various factors.

Earnings Conference Call Information

Guardian will announce complete fourth quarter and full year 2024 financial results and host a conference call to discuss such results on Wednesday, March 26, 2025, at 4:30 p.m. ET.

The conference call can also be accessed by dialing +1 (646) 564-2877 for U.S. participants, or +1 (800) 549 8228 for international participants, and referencing conference ID “69868.” A replay will be available online at https://investors.guardianpharmacy.com shortly after the call’s completion and will remain available for approximately 60 days.

About Guardian Pharmacy Services

Guardian Pharmacy Services is a leading long-term care pharmacy services company that provides an extensive suite of technology-enabled services designed to help residents of long-term health care facilities (“LTCFs”) adhere to their appropriate drug regimen, which in turn helps reduce the cost of care and improve clinical outcomes. As of December 31, 2024, our 51 pharmacies served approximately 186,000 residents in approximately 7,000 LTCFs across 38 states.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements are all statements other than those of historical fact. Any statements about our expectations, beliefs, plans, predictions, forecasts, objectives, assumptions, or future events or performance are forward-looking. These statements are often, but not always, made through the use of words such as “aims,” “anticipates,” “believes,” “continue,” “estimates,” “expects,” “intends,” “may,” “outlook,” “plans,” “projects,” “seeks,” “should,” “will,” “would,” and similar expressions. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements are not guarantees of future performance and involve risks and uncertainties which are subject to change based on various important factors, many of which are beyond our control. Such risks and uncertainties include: our ability to effectively execute our business strategies, implement new initiatives and improve efficiency; our ability to effectively market and sell, customer acceptance of, and competition for, our pharmaceutical services in new and existing markets; our relationships with pharmaceutical wholesalers and key manufacturers, LTCFs and health plan payors; our ability to maintain and expand relationships with LTCF operators on favorable terms; the impact of a national emergency, public health crisis, global pandemic or outbreak of infectious disease on our employees and business and on our supply chain and the LTCFs we serve; continuing government and private efforts to lower pharmaceutical costs, including by limiting pharmacy reimbursements; changes in, and our ability to comply with, healthcare and other applicable laws, regulations or interpretations; further consolidation of managed care organizations and other health plan payors and changes in the terms of our agreements with these parties; our ability to retain members of our senior management team, our local pharmacy management teams and our pharmacy professionals; our exposure to, and the results of, claims, legal proceedings and governmental inquiries; our ability to maintain the security and integrity of our operating and information technology systems and infrastructure (e.g., against cyber-attacks); product liability, product recall, personal injury or other health and safety issues related to the pharmaceuticals we dispense; the impact of supply chain and other manufacturing disruptions or trade policies related to the pharmaceuticals we dispense; the sufficiency of our sources of liquidity and financial resources to fund our future operating expenses and capital expenditure requirements, and our ability to raise additional capital, if needed; the misuse or off-label use, or errors in the dispensing or administration, of the pharmaceuticals we dispense; and volatility of our stock price. We are subject to additional risks and uncertainties described in our periodic reports filed with the Securities and Exchange Commission from time to time, including in the “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections contained in our most recent Quarterly Report on Form 10-Q, which reports are made publicly available at www.sec.gov and via our website, investors.guardianpharmacy.com Any forward-looking statements in this press release should be evaluated in light of these important risk factors. This press release reflects management’s views as of the date hereof. Except to the extent required by applicable law, Guardian undertakes no obligation to update or revise any information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise.

Preliminary Unaudited Financial Results

The Company is presenting certain preliminary unaudited financial results as of and for the three months and year ended December 31, 2024, based upon the information available to the Company as of the date of this press release. These preliminary unaudited results are not a comprehensive statement of the Company’s results for such periods, and the Company’s actual results may differ materially from these preliminary unaudited results. These preliminary unaudited results are inherently uncertain and subject to change as the Company completes the preparation of its consolidated financial statements and related notes and its financial close procedures for the year ended December 31, 2024. Therefore, you should not place undue reliance upon this information. The Company’s independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to the preliminary unaudited financial information included herein and, accordingly, does not express any opinion or any other form of assurance with respect thereto.

The Company currently intends to release its finalized fourth quarter and full year earnings results on March 26, 2025, and management will hold a conference call to discuss the results at 4:30 p.m. ET on March 26, 2025. You should carefully review the Company’s consolidated financial statements for the year ended December 31, 2024, when they become available.

Use of Non-GAAP Financial Measures

To supplement our results prepared in accordance with GAAP, we also present Adjusted EBITDA, which is a non-GAAP financial measure. We define Adjusted EBITDA as net income (loss) before interest expense, income taxes, depreciation and amortization, as adjusted to exclude the impact of items and amounts that we view as not indicative of our core operating performance, including share-based compensation, acquisition accounting adjustments, certain legal and regulatory items, and IPO-related costs. Adjusted EBITDA does not have a definition under GAAP, and our definition of Adjusted EBITDA may not be the same as, or comparable to, similarly titled measures used by other companies.

We use Adjusted EBITDA to better understand and evaluate our core operating performance and trends. We believe that presenting Adjusted EBITDA provides useful information to investors in understanding and evaluating our operating results, as it permits investors to view our core business performance using the same metrics that management uses to evaluate our performance.

There are a number of limitations related to the use of Adjusted EBITDA rather than the most directly comparable GAAP financial measure, including:

• Adjusted EBITDA does not reflect interest and income tax payments that represent a reduction in cash available to us;
• Depreciation and amortization are non-cash charges and the assets being depreciated may have to be replaced in the future, and Adjusted EBITDA does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements;
• Adjusted EBITDA does not reflect changes in, or cash requirements for, our working capital needs;
• Adjusted EBITDA does not consider the impact of share-based compensation; and
• Adjusted EBITDA excludes the impact of certain legal and regulatory items, which can affect our current and future cash requirements.

Because of these limitations, Adjusted EBITDA should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. You should consider Adjusted EBITDA alongside other financial measures, including net income and our other financial results presented in accordance with GAAP. For a reconciliation of Adjusted EBITDA to net income for the historical periods presented herein, please see the reconciliation tables below.

A reconciliation of Adjusted EBITDA to net income, the most directly comparable GAAP financial measure, are set forth below.

Contacts

GuardianPharmacyIR@westwicke.com

QIAGEN takes legal action to defend QuantiFERON intellectual property and protect innovations in latent tuberculosis testing




QIAGEN takes legal action to defend QuantiFERON intellectual property and protect innovations in latent tuberculosis testing

• QIAGEN files lawsuit against bioMérieux with German Unified Patent Court to protect key innovations in its QuantiFERON technology

• QuantiFERON-TB Gold Plus plays a critical role in fighting the spread of TB worldwide

VENLO, The Netherlands–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has filed a complaint against bioMérieux S.A. (EPA: BIM) for patent infringement, reinforcing its commitment to protecting the scientific advancements behind its proprietary QuantiFERON technology.

The complaint, filed in the Local Division of the Court of First Instance of the Unified Patent Court (UPC) in Duesseldorf, Germany, concerns European Patent EP 2 276 883 B2. This patent, which is one of many held by QIAGEN protecting the QuantiFERON technology, covers important innovations in QuantiFERON-TB Gold Plus that is used worldwide for TB detection.

“Protecting our intellectual property is essential to ensuring continued innovation in infectious disease diagnostics,” said Thierry Bernard, CEO of QIAGEN. “QuantiFERON has transformed latent tuberculosis testing, and we will always take the necessary legal steps to defend our proprietary technologies against infringement.”

This legal action follows QIAGEN’s recent success in defending another QuantiFERON-related patent against an invalidity challenge by SD Biosensor in Germany, further demonstrating the strength of QIAGEN’s patent portfolio.

As a leader in molecular diagnostics, QIAGEN continues to defend its intellectual property to ensure that investments in innovation remain secure and that customers worldwide have access to trusted, high-quality testing solutions.

QuantiFERON-TB Gold Plus (QFT-Plus) is widely recommended by leading health organizations, including the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC), for identifying individuals at risk of developing active TB. Unlike traditional skin tests, QFT-Plus provides more reliable and objective results, supporting global TB control efforts.

Latent TB infection occurs when the Mycobacterium tuberculosis bacteria remains dormant in the body without causing symptoms. While not contagious, latent TB can progress to active TB, which is a major public health concern. Effective screening and treatment of latent TB are critical for preventing the spread of tuberculosis worldwide.

For more information about QuantiFERON technology and QIAGEN’s commitment to TB diagnostics, visit https://www.qiagen.com/us/applications/tb-management.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. QIAGEN serves over 500,000 customers globally in Life Sciences (academia, pharma R&D and industrial applications, primarily forensics) and Molecular Diagnostics for clinical healthcare. As of December 31, 2024, QIAGEN employed more than 5,700 people in over 35 locations worldwide. For more information, visit www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s products, development timelines, marketing and / or regulatory approvals, financial and operational outlook, growth strategies, collaborations and operating results – such as expected adjusted net sales and adjusted diluted earnings – are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to, challenges in managing growth and international operations (including the effects of currency fluctuations, regulatory processes and logistical dependencies), variability in operating results and allocations between customer classes, commercial development for our products to customers in the Life Sciences and clinical healthcare, changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancements; fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN’s products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other “force majeure” events. There is also no guarantee that anticipated benefits from acquisitions will materialize as expected. For a comprehensive overview of risks, please refer to the “Risk Factors” contained in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Corporate

Contacts

Contacts QIAGEN:
Investor Relations
John Gilardi, +49 2103 29 11711

Domenica Martorana, +49 2103 29 11244

e-mail: ir@QIAGEN.com

Public Relations
Thomas Theuringer, +49 2103 29 11826

Lisa Specht, +49 2103 29 14181

e-mail: pr@QIAGEN.com

AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum




AAD 2025: Galderma to Present Extensive Updates From Across Its Dermatology Portfolio, Demonstrating Its Category Leadership and Strong Momentum

• New data on Nemluvio^® (nemolizumab), including an oral e-poster presentation characterizing the impact of Nemluvio in different pruriginous lesion types in prurigo nodularis from the phase III OLYMPIA program, and post-hoc analyses exploring the continuous response of Nemluvio up to 56 weeks in atopic dermatitis patients from the ARCADIA 1&2 trials and long-term extension study who had partial or no disease response at week 16
• The latest data from the phase III READY-4 and phase IIIb RELAX studies of ready-to-use liquid neuromodulator Relfydess^® (RelabotulinumtoxinA), which has previously demonstrated a six-month clinical effect and rapid onset from day one for frown lines and crow’s feet, in the phase III READY clinical trial program^1-3
• Updates on Restylane^® and Sculptra^®, including data from a study exploring the benefits of Restylane Lyft™ or Contour™ with Sculptra in patients with medication-driven weight loss with associated facial volume loss, as well as new data from Galderma’s acne and sensitive skin product portfolio
• With 22 presentations in total, the extent and range of data to be shared underscore the pace of Galderma’s growth journey, which AAD attendees can further explore at booth #2021

ZUG, Switzerland–(BUSINESS WIRE)–Galderma will present updates from across its broad dermatology portfolio at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place from March 7-11, 2025 in Orlando, Florida. The company will present 22 e-posters – including two oral presentations – with updates on a number of its innovative products, including Nemluvio, Sculptra, Restylane and Relfydess. These presentations combined reinforce the strength of Galderma’s growth journey, its status as the pure-play category leader in dermatology, and its innovative pipeline.

“We’re bringing impactful new science to this year’s AAD meeting, with new data on Nemluvio – our treatment for prurigo nodularis and atopic dermatitis – and the latest from our Dermatological Skincare and Injectable Aesthetics portfolios. This demonstrates how Galderma continues to move from strength to strength, as a category leader in dermatology with a strong portfolio spanning the full spectrum of this fast-growing market.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

New data on atopic dermatitis and prurigo nodularis

New data on Nemluvio reinforce its benefit for a broad range of patients with prurigo nodularis and atopic dermatitis.

An oral presentation will report new data on the efficacy of Nemluvio treatment up to Week 16 across different pruriginous lesion types in patients with prurigo nodularis from the phase III OLYMPIA program. This will be presented on Friday, March 7.

The company will also share data demonstrating the continuous response with Nemluvio up to 56 weeks in patients with moderate-to-severe atopic dermatitis who had a partial or no response to treatment at Week 16 in the ARCADIA 1&2 trials and long-term extension study.

Alongside this, real-world evidence on atopic dermatitis will be shared, including an oral e-poster presentation with findings from a retrospective analysis of access disparities for atopic dermatitis patients across ethnic groups using the U.S. Medicaid database (Sunday, March 9), and data exploring the association between itch severity and initiation of biologic therapy.

On Sunday, March 9, Galderma will also host an Industry Session Theatre titled ‘Targeting the IL-31 Neuroimmune Pathway: Transforming Itch and Inflammation Outcomes’. Presented by Dr. Jonathan Silverberg and Dr. Sarina Elmariah, this patient and expert panel discussion will delve into the crucial need to address neuroimmune interactions with atopic dermatitis and prurigo nodularis, the impact of IL-31, and how a targeted treatment improves real patient outcomes.

Aesthetic advancements across Galderma’s portfolio

Galderma will also present the latest data from across its Injectable Aesthetics portfolio, including updates on Restylane, Sculptra, and Relfydess.

Interim data from a study exploring the benefits of Restylane Lyft or Contour with Sculptra in patients with medication-driven weight loss with associated facial volume loss will be shared.

Results from a comparative study evaluating the synergistic effects for midface improvement when pairing Sculptra with a skincare regimen will also be presented, as well as a comparative analysis of suggested genetic pathways affected by Sculptra vs another biostimulator, and consensus and evidence-based recommendations on the impact of minimally invasive treatments on subsequent facial surgery for additional aesthetic enhancement.

Additional data from Galderma’s Restylane portfolio includes the first ever ultrasound comparison of the tissue integration, dynamic support, and lifting capacity of Restylane Contour versus another rheologically different hyaluronic acid filler. Data from an AI-enabled Manufacturer and User Facility Device Experience database analysis of delayed complications with hyaluronic acid fillers will also reveal technology-based differences.

Finally, data from the phase III READY-4 study, designed to evaluate the safety of Relfydess for the long-term treatment of moderate-to-severe frown lines and crow’s feet, as well as from the phase IIIb RELAX study, evaluating the long-lasting efficacy and satisfaction of Relfydess in adults with moderate-to-severe frown lines over a 12-month period, will be presented. A separate subgroup analysis of pooled phase III data will explore the benefits of Relfydess treatment for frown lines and crow’s feet of different baseline severity. These presentations build on previously announced data from the READY clinical trial program, which demonstrated that up to 39% of patients see effects from day one and up to 75% of patients maintain improvements for six months for frown lines and crow’s feet when treated with Relfydess.^1-3

Updates on innovative solutions for acne and sensitive skin

Galderma will also present updates on its product portfolio for sensitive skin, including a dermal patch for acne-prone skin, a Ceramide Serum and Vitamin C Serum, and a novel cream designed to improve the appearance of aging skin.

In acne, results of a worldwide profiling survey on the association between adult acne and sensitive skin will be shared. Presentations on Galderma’s CTMP™: Cleanse, Treat, Moisturize, Protect regimen will also reveal its impact on adherence, treatment outcomes, patient satisfaction, and overall skin quality in patients with acne and sensitive skin.

More details on Galderma’s scientific presentations at AAD can be found here.

About Nemluvio (Nemolizumab)

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^4,5 Nemluvio has been approved by the European Commission for both moderate-to-severe atopic dermatitis and moderate-to-severe prurigo nodularis in the European Union (EU).⁶ It is now approved in the EU for subcutaneous use for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy, and for subcutaneous use for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.⁶ The U.S. FDA has also approved Nemluvio for the treatment of adults with prurigo nodularis and patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when the disease is not adequately controlled with topical prescription therapies.⁷ Nemluvio is also under review for the treatment of both diseases by several additional regulatory authorities around the world. Further submissions to regulatory authorities in additional countries are ongoing.

About Relfydess (RelabotulinumtoxinA)

Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.^8-10 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months.^1-3,8-10 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.^8-10 It was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. RelabotulinumtoxinA is an investigational drug product in the U.S. Following the completion of the European Decentralized Procedure resulting in a positive decision for the use of Relfydess, Galderma has received national approvals in 14 European countries, as well as a marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Shridharani SM, et al. Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines. Aesthet Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131
2. Ablon G, et al. Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study. Dermatol Surg. 2024. doi: 10.1097/DSS.0000000000004470
3. Relfydess. EU Summary of Product Characteristics 2024
4. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed February 2025
5. ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate- to-Severe Atopic Dermatitis (NCT03985943). Available online. Accessed February 2025
6. Nemluvio. EU Summary of Product Characteristics 2025
7. NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024
8. Sundberg AL and Stahl U. Relabotulinum toxin – a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting
9. Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) – RelabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA
10. Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin

Contacts

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Sébastien Cros

Corporate Communications Director

sebastien.cros@galderma.com
+41 79 529 59 85

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

BostonGene to Showcase Multi-Modal AI-Powered Platform at the 22nd Annual Meeting of the Japanese Society of Medical Oncology




BostonGene to Showcase Multi-Modal AI-Powered Platform at the 22nd Annual Meeting of the Japanese Society of Medical Oncology

Advancing Precision Oncology with AI-Driven Multiomics for Optimized Therapy Selection and Improved Patient Outcomes

WALTHAM, Mass.–(BUSINESS WIRE)–BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, today announced its participation in the 22nd Annual Meeting of the Japanese Society of Medical Oncology (JSMO2025) from March 6–8, 2025, in Kobe, Japan. This premier conference is dedicated to advancing precision oncology and fostering collaboration among global oncology experts.

BostonGene will present research demonstrating how its AI-powered multiomics platform transforms cancer biology understanding and enhances treatment selection by integrating multi-scale, multi-modal data analysis.

During the event, Nathan Fowler, MD, Chief Medical Officer at BostonGene, will deliver a keynote presentation titled “Cutting Edge of Genomic Medicine and Novel Therapy in Hematologic Malignancies.” Dr Fowler will highlight how BostonGene, in collaboration with renowned clinical partners, leverages multiomics techniques to identify biomarker predictors of treatment success, driving the next evolution of drug development.

• Thursday, March 6 | 8:30 AM – 10:00 AM JST
• Symposium 3 – Room 4

Oral presentations

Multiomic clustering of cutaneous melanoma patients to reveal survival trends based on tumor immune evasion features:

The presentation highlights BostonGene’s innovative approach of combining genomic and transcriptomic data to identify tumor immune microenvironment patterns linked to survival in patients with cutaneous melanoma.

• Saturday, March 8 | 8:30 AM – 9:30 AM JST

Unraveling sarcomatoid features in clear cell renal cell carcinoma with RNA-seq:

This presentation will showcase the value of predictive modeling in developing targeted therapy to treat clear cell renal carcinoma, emphasizing BostonGene’s Tumor Portrait^TM test in identifying unique and targetable clinical characteristics in cancer.

• Saturday, March 8 | 8:30 AM – 9:30 AM JST

Poster presentations

Effective immune-based treatment of extraskeletal myxoid chondrosarcoma guided by next-generation gene profiling:

The presentation demonstrates cases of advanced disease with limited treatment options where BostonGene’s comprehensive genomic profiling guided targeted therapy selection.

• Thursday, March 6 | 1:05 PM – 1:50 PM JST

Leveraging mappability and analysis of allele frequencies to mitigate false positive germline variant calling:

This study describes BostonGene’s advanced bioinformatic approaches to improve the reliability of germline variant detection in next-generation sequencing analysis.

• Friday, March 7 | 2:05 PM – 2:50 PM JST

Evaluating the clinical utility of RNA- and DNA-based comprehensive genomic profiling in patients with advanced cancers:

This large prospective research study describes the diagnostic and clinical utility of BostonGene’s comprehensive genomic profiling in patients with advanced malignancies.

• Friday, March 7 | 2:05 PM – 2:50 PM JST

Machine learning (ML)-enabled automation for high-throughput data processing in flow cytometry:

This study highlights BostonGene’s novel machine learning-based cell classification algorithm to significantly reduce turnaround time for analyzing cell populations.

• Saturday, March 8 | 1:05 PM – 1:50 PM JST

For more information or to schedule a meeting with BostonGene during the event, please contact Zlata Polyakova at zlata.polyakova@bostongene.com.

About BostonGene Corporation

BostonGene is a biotechnology company specializing in advanced computational biology and precision medicine. Founded in 2015, BostonGene has consistently pushed the boundaries of innovation to improve patient care and accelerate drug development. Our AI-powered multiomics platform decodes cancer patients’ molecular profiles, including their immune system and tumor microenvironment, to uncover key disease drivers, identify novel drug targets and recommend the most effective treatments. With advanced bioanalytics, an indication-specific cancer library and a next-generation CLIA-certified, CAP-accredited high-complexity laboratory, we deliver precise, clinically validated insights that drive precision medicine and advance oncology research. For more information, visit www.BostonGene.com.

About BostonGene Japan

BostonGene Japan Inc., a Tokyo-based joint venture formed by BostonGene, NEC Corporation and Japan Industrial Partners aims to advance personalized medicine and dramatically improve patient outcomes. The company leverages BostonGene’s AI-powered multiomics platform to accelerate drug development and personalize cancer therapies for each patient.

Contacts

Media Contact:

BostonGene
Erin Keleher

+1-617-283-2285

Erin.Keleher@bostongene.com

Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies




Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies

– First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) –

– Results were featured as late-breakers at the 2025 AAAAI Annual Meeting –

– Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored Phase III OUtMATCH study, which provide further evidence supporting the role of Xolair^® (omalizumab) for the treatment of one or more food allergies. Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches. OIT involves ingesting the food allergen, initially with a very small amount and gradually increasing the amount. These findings were largely driven by the high rates of adverse events (AEs) leading to study discontinuation in the OIT-treated group.

Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient’s diet after stopping Xolair. These findings were featured as late-breaking symposiums at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

“Food allergies are becoming more common, leaving millions of families to grapple with constant vigilance, strict dietary restrictions and disruptions to everyday activities,” said R. Sharon Chinthrajah, M.D., OUtMATCH co-lead study investigator and associate professor of medicine, Stanford School of Medicine, Sean N. Parker Center for Allergy and Asthma Research. “These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients.”

“These latest data provide additional evidence demonstrating the importance of Xolair as a treatment option for the food allergy community,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are deeply grateful to the leading research institutions who partnered with us on this groundbreaking study, along with the inspiring dedication of the study’s participants and their families.”

Xolair versus multi-allergen OIT for the treatment of food allergies: Stage 2 results of the OUtMATCH study

In the first head-to-head trial comparing Xolair to OIT, the study met its primary endpoint showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein (about eight peanuts) and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group (odds ratio=2.6, p=0.031).

After Stage 1 of the OUtMATCH study, which served as the basis for the FDA approval of Xolair for the treatment of food allergies, 117 patients (median age: 7 years) moved on to Stage 2, where they all initially received 8 weeks of open-label Xolair. Patients were then randomized to receive either multi-allergen OIT or placebo OIT while continuing Xolair for another 8 weeks. After that, the OIT group switched to placebo injections for an additional 44 weeks while the other group continued Xolair with placebo OIT.

After the full treatment period, patients were re-challenged with their three study-specific foods (peanut and two other foods from milk, egg, wheat, cashew, hazelnut, and/or walnut). The primary endpoint was tolerance of 2,000 mg or more for all three foods, which was met. Superiority was also demonstrated for numerous secondary endpoints, including tolerating two or more foods (p=0.004). These findings were largely driven by the high rates of AEs in the OIT group. Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%) and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.

The introduction of allergenic foods after treatment with Xolair: initial Stage 3 results of the OUtMATCH study

The first 60 patients (median age: 8.5 years) from Stage 1 of the OUtMATCH study entered a 24-week open-label extension followed by Stage 3, which included dietary consumption of allergenic foods, rescue oral immunotherapy or food avoidance, depending on the results of the final food challenge and patient preferences. Patients were no longer receiving Xolair.

Each of the 60 patients received a treatment plan for each of their three study allergens. Of the 180 treatment plans, 82% (n=148) of initial treatment plans included dietary consumption of allergenic foods. After 12 months of follow-up, many patients were able to introduce allergenic foods in dietary form, although success rates were higher for milk, egg and wheat (61-70%) than for peanuts and tree nuts (38-56%). Success was defined as tolerating a median daily consumption of at least 300 mg of allergenic protein. The study found that reduced consumption of allergenic foods appeared to be related to symptoms and other factors (such as taste and aversion), with no clear predictors of dietary consumption success. Many patients returned to avoidance due to AEs and other factors. AEs included anaphylaxis, epinephrine use and two cases of eosinophilic esophagitis possibly related to dietary consumption. Stage 3 is ongoing and study investigators are continuing to analyze data from additional patients who completed Stage 2 and then entered Stage 3.

On February 16, 2024, the FDA approved Xolair for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

About Food Allergy

Food allergies have been on the rise for the past 20 years. Based on estimates for 2024, about 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies. Allergic reactions can range from hives and swelling to life-threatening anaphylaxis. More than 40% of children and more than half of adults with food allergies have experienced an anaphylactic reaction at least once. It is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency room visits in the U.S. each year.

About the OUtMATCH Study

The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is an NIH-sponsored, three-stage, multicenter, randomized, double-blind, placebo-controlled study evaluating Xolair safety and efficacy in patients aged 1 to 55 years with peanut allergy and at least two other food allergies (including milk, egg, wheat, cashew, hazelnut, and walnut allergy).

The pivotal Stage 1 involved 180 participants, who were randomized to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. After 16 to 20 weeks of treatment, each participant completed blinded food challenges in a carefully controlled setting. Stage 1 of the study served as the basis for the FDA approval of Xolair for children and adults with one or more food allergies, and the data were published in the New England Journal of Medicine in February 2024.

The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is being conducted by the NIAID-funded Consortium for Food Allergy Research (CoFAR) at 10 clinical sites across the U.S. led by Johns Hopkins Children’s Center and co-led by Stanford School of Medicine. The study is also supported by Genentech and Novartis Pharmaceuticals Corporation.

About Xolair^® (omalizumab)

Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is given as an injection under the skin, either by a healthcare provider or at home through self-injection (after initiating treatment in a healthcare setting). Healthcare providers will determine appropriate candidates for self-injection.

Xolair is designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

Food allergy is the fourth FDA-approved indication for Xolair. Other indications include moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). Since its initial approval in 2003, more than 850,000 people have been treated with Xolair in the U.S.

Genentech and Novartis are committed to helping people access the medicines they are prescribed and offer comprehensive services for people prescribed Xolair to help minimize barriers to access and reimbursement. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is available at 866-4ACCESS/866-422-2377.

Indications and Important Safety Information

What is XOLAIR?

XOLAIR^® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:

• moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.
• chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age.
• food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.
• chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. XOLAIR should also not be used to treat other forms of hives, or sudden breathing problems.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

• wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
• flushing, itching, hives, or feeling warm
• swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

• have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
• have sudden breathing problems (bronchospasm)
• have ever had a severe allergic reaction called anaphylaxis
• have or have had a parasitic infection
• have or have had cancer
• are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?

• When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting.
• If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR.
• Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
• The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
• See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
• XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
• In people with asthma, CRSwNP and food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
• In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
• Do not decrease or stop taking any of your other asthma, CRSwNP, hive medicine, food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to.
• You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
• If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

• Cancer. Cases of cancer were observed in some people who received XOLAIR.
• Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
• Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
• Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
• Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR:

• In adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.
• In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.
• In adults with chronic rhinosinusitis with nasal polyps: headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.
• In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
• In people with food allergy: injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide for additional Important Safety Information and Instructions for Use, or visit https://www.Xolair.com.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Lindsey Mathias, (650) 467-6800

Advocacy Contact:

Julie Burns, (860) 881-6594

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, 011 41 61 687 8503

Positive results from the TEZSPIRE Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps




Positive results from the TEZSPIRE Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps

TEZSPIRE significantly reduced nasal congestion, polyp size and nearly eliminated the need for surgery in patients with chronic rhinosinusitis with nasal polyps

WAYPOINT data published in New England Journal of Medicine and highlighted as late-breaking oral presentation at AAAAI/WAO 2025

WILMINGTON, Del.–(BUSINESS WIRE)–Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen’s TEZSPIRE^® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.^1,2 These data were published in the New England Journal of Medicine and presented today as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, CA.^1,2

Treatment with TEZSPIRE significantly reduced nasal polyp severity measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.065 (95% CI: -2.389, -1.742; p<0.0001) and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 (95% CI: -1.201, -0.855; p<0.0001) at week 52 compared to placebo.^1,2 Improvements in NPS were observed as early as week four and NCS as early as week two (the first post-treatment assessment respectively) and were sustained through week 52.¹

Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.¹ Importantly, TEZSPIRE significantly reduced the need for subsequent nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% ( p<0.0001) compared to placebo.¹

Dr Joseph Han, Vice Chair of Department of Otolaryngology – Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the trial, said: “Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids. The WAYPOINT results are clinically meaningful and suggest that tezepelumab could greatly reduce the burden of nasal polyps for patients by nearly eliminating the need for future surgery and corticosteroid use and by significantly reducing nasal polyp size and congestion.”

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said, “The WAYPOINT results demonstrate the potential for TEZSPIRE to provide a much-needed option for patients with chronic rhinosinusitis with nasal polyps. With its first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, the data add to the body of evidence that tezepelumab can transform care for patients with epithelial-driven inflammatory diseases.”

Table M1: Summary of co-primary and key secondary efficacy endpoints^1,2

TEZSPIRE was generally well tolerated in patients with CRSwNP and had a safety profile consistent with its approved severe asthma indication.^1,2 The most frequently reported adverse events for TEZSPIRE in the WAYPOINT trial were COVID-19, nasopharyngitis and upper respiratory tract infection.¹ There were no clinically meaningful differences in safety results between the TEZSPIRE and placebo group.¹

TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan, and over 60 countries across the globe.^3-5 It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.^3,4 Regulatory filings for tezepelumab in CRSwNP are currently under review by regulatory authorities in multiple regions.

INDICATION AND LIMITATION OF USE / ISI

TEZSPIRE^® (tezepelumab-ekko)

INDICATION

TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

CONTRAINDICATIONS

Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease

TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines

The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

USE IN SPECIFIC POPULATIONS

There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please see full Prescribing Information, including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products.

Notes

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

CRSwNP is a complex inflammatory disorder, characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.^6,7 Nasal polyps and the accompanying inflammation can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.^8-10 Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics.^7,10-16

Phase III WAYPOINT trial

WAYPOINT was a double-blind, multi-centre, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP.^1,2,17 Participants received tezepelumab or placebo, administered via subcutaneous injection.^1,2,17 The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.^1,17

TEZSPIRE

TEZSPIRE^® (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic, and other types of epithelial-driven inflammation associated with severe asthma and other inflammatory diseases.^18,19

TSLP is released in response to multiple epithelial triggers and insults (including allergens, viruses, bacteria, smoke, air pollution and other airborne particles) associated with asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other diseases.^19,20 Expression of TSLP is increased in these patients and has been correlated with disease severity.^10,18 Blocking TSLP can prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of exacerbations and improved disease control.^18,19,21 Tezepelumab acts at the top of the inflammatory cascade and research indicates that targeting TSLP released by the airway and gastrointestinal epithelium may be a potential approach to treating other diseases in the future.^18,22,23

TEZSPIRE is approved in the US, the EU and over 60 countries for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.^3-5

Beyond CRSwNP, tezepelumab is also in development for other potential indications including COPD and EoE.^24,25 In October 2021, tezepelumab was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of EoE. In July 2024, the US FDA granted a Breakthrough Therapy Designation for tezepelumab for the add-on maintenance treatment of patients with moderate to very severe COPD characterized by an eosinophilic phenotype.

Amgen collaboration

In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit inventor royalty to Amgen. AstraZeneca continues to lead development, and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca

References

1. Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025.
2. Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology /World Allergy Organization Joint Congress 2025 (28 February – 03 March).
3. TEZSPIRE (tezepelumab) US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf. [Last accessed: February 2025].
4. TEZSPIRE (tezepelumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf. [Last accessed: February 2025].
5. AstraZeneca plc. TEZSPIRE approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. [Last accessed: February 2025].
6. Bachert C, et al. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016; 4 (4): 621-628.
7. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560746/ [Last accessed: February 2025].
8. Stevens WW, et al. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016; 4 (4): 565-572.
9. Abdalla S, et al. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol. 2012; 37 (4): 276-282.
10. Chen S et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911.
11. Xolair (omalizumab) Summary of Product Characteristics; Available at: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf. [Last accessed: February 2025].
12. Xolair (omalizumab) US prescribing information; Available at: https://www.gene.com/download/pdf/xolair_prescribing.pdf [Last accessed: February 2025].
13. Nucala (mepolizumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf. [Last accessed: February 2025].
14. Nucala (mepolizumab) US prescribing information; Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf. [Last accessed: February 2025].
15. Dupixent (dupilumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf. [Last accessed: February 2025].
16. Dupixent (dupilumab) US prescribing information; Available at: https://www.regeneron.com/downloads/dupixent_fpi.pdf. [Last accessed: February 2025].
17. Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: https://clinicaltrials.gov/ct2/show/NCT04851964. [Last accessed: February 2025].
18. Corren J, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377:936-946.
19. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.
20. Zhang M, et al. Hypoxia induces the production of epithelial-derived cytokines in eosinophilic chronic rhinosinusitis with nasal polyps. Int Immunopharmacol. 2023;121:110559.
21. Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018;200: 2253–2262.
22. Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809.
23. Laidlaw TM et al. Tezepelumab Efficacy in Patients with Severe, Uncontrolled Asthma with Comorbid Nasal Polyps in NAVIGATOR. J Asthma Allergy. 2023 Sep 4:16:915-932.
24. Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT04039113. [Last accessed: February 2025].
25. Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227?rank=1. [Last accessed: February 2025].

Contacts

Media Inquiries
Fiona Cookson +1 212 814 3923

Jillian Gonzales +1 302 885 2677

US Media Mailbox: usmediateam@astrazeneca.com

Nuclera Appoints Seth Benson as Chief Financial Officer




Nuclera Appoints Seth Benson as Chief Financial Officer

Appointment to drive commercial growth of eProtein Discovery and support strategic expansion

CAMBRIDGE, England–(BUSINESS WIRE)–Nuclera, the biotechnology company accelerating protein expression and optimization through its benchtop eProtein Discovery™ system, today announced that it has appointed Seth Benson as Chief Financial Officer. Seth joins CEO, Dr Michael Chen, on the executive team to advance commercial and strategic initiatives, drive revenue and support expansion of the business following the close of the Company’s USD $75 million financing round¹.

Seth’s appointment comes after Nuclera strengthened its leadership team with three key appointments² as the Company continues to scale during this next phase of commercial development. Bringing extensive financial expertise in building operational and financial infrastructure, Seth will be instrumental in guiding Nuclera’s next phase of commercial expansion across key global markets.

With over 20 years of leadership experience in finance, strategy and operations in the life sciences and healthcare sectors, Seth has a proven track record of scaling businesses, driving strategic growth, optimizing operations and leading strategic financial initiatives. He has successfully led fundraising efforts, acquisitions, restructurings and IPOs including at Akoya Biosciences where he helped grow the company to more than 300 people and played a pivotal role in its IPO.

Seth joins Nuclera from Vizgen, a company improving human health through spatial genomics, where he led the finance, operations and IT functions as CFO and guided the organization through its acquisition of Ultivue, a spatial proteomics company. Previously, as SVP Finance and Operations at Invaio Sciences, Seth managed a multi-national finance team during early product commercialization and fundraising. He has held investment banking positions at Morgan Stanley and Bank of America Merril Lynch. Seth earned his MBA from Northwestern University’s Kellogg School of Management and his BSc in Biology from Duke University.

Seth Benson, CFO, Nuclera, said: “I am delighted to join Nuclera, especially at such an exciting time for the company. Nuclera’s eProtein Discovery system addresses a critical bottleneck in protein production workflows, with the potential to significantly impact drug discovery. I look forward to working with Michael and the team to build on the Company’s strong foundation and drive commercial growth.”

Dr Michael Chen, CEO and co-founder, Nuclera, commented: “We are pleased to welcome Seth to Nuclera at such a pivotal stage in our journey. His expertise in financial leadership and strategic planning within high-growth life science organizations will be instrumental as we accelerate the commercial rollout of our eProtein Discovery system. I would also like to thank Jiahao for his contributions to Nuclera’s growth and success since co-founding the company in 2013. He has played a key role in shaping the company’s foundation and progress.”

1. Nuclera closes $75 million USD financing
2. Nuclera strengthens team with three key appointments

For more information about Nuclera’s eProtein Discovery system, please visit: https://www.nuclera.com/system/

Contacts

Media contact:
Dr Ben Rutter

Zyme Communications

Tel: +44(0)7920 770 935

Email: ben.rutter@zymecommunications.com

Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 – Entering an Era of Sustained Growth and Further Advancing Its Medical Dermatology Pipeline




Almirall 2024 Full-Year Results: Almirall Surpassed Guidance for 2024 – Entering an Era of Sustained Growth and Further Advancing Its Medical Dermatology Pipeline

• Almirall’s net sales growth in 2024 was 10.2% YoY (total of €985.7 MM) with EBITDA growth of 10.6% YoY (total of €192.6 MM) – surpassing guidance for the year with all key growth drivers delivering double digit growth.
• Company revenue growth continues to be driven by the strong performance of the European Dermatology business (+22.5% YoY, total sales of €484.1 MM), specifically biologics.
• Ebglyss^® achieved 34% growth in Q4 compared to Q3, delivering a total of €33.2 MM sales in 2024, mainly in Germany. The product is now available in 11 markets across Europe and continues to receive very positive feedback from dermatologists.
• Ilumetri^® continued its very strong growth trajectory with 25.5% sales increase YoY, delivering sales of €208.8 MM – based on continued market expansion and taking a higher share from competition.
• Strong performance of Almirall´s broad dermatology portfolio: Wynzora^® grew 53.3% YoY (total of €25.9 MM), and Klisyri^® grew 17.8% YoY (total of €24.5 MM). Sustained solid growth of the medical dermatology portfolio overall: 17.8% (total of €548.1 MM).
• Promising pipeline progress driven by Almirall’s sustained investment in R&D at 12.6% of net sales. Achieved milestones include the approval of the large field supplementary NDA for Klisyri^® in the US, and the completion of the decentralized procedure for Efinaconazole in Europe. Several phase 1 studies are ongoing, and the rights for several early-stage assets were acquired.
• Guidance for 2025: Net Sales growth of 10%-13% and Total EBITDA between €220 MM and €240 MM

BARCELONA, Spain–(BUSINESS WIRE)–Almirall, S.A. (ALM):

Financial highlights (€ rounded million)

“2024 was an important year for Almirall as European leader in Medical Dermatology: we delivered impactful products to more patients and the medical community. Our double-digit sales growth and increased profitability demonstrate that our strategy is working and that our teams are delivering. In 2024 we achieved net sales growth of 10.2% and increased our total EBITDA by 10.6%, which was largely driven by our European dermatology business and our biologics. We continued to progress our exciting pipeline in medical dermatology by investing 12.6% of net sales in R&D and explore external opportunities for early and mid-stage assets.

We are very confident in our strategy, commercial success, and our R&D capabilities which are the foundation for entering an era of sustained double-digit growth and increased growth margins. Our focus, sustained financial performance, and dedication to innovation and patient care continue to grow our impact on people living with skin conditions, and the medical community.” Carlos Gallardo, Almirall Chairman and CEO

Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, today announced its full-year 2024 financial results.

Summary of results

• Almirall surpassed guidance for 2024 achieving Net Sales of €985.7 MM – which represents a year-on-year growth of 10.6%. This growth was mainly driven by the strong performance of the European Dermatology business and the biologics portfolio.
• Total EBITDA was €192.6 MM, increasing 10.6% year-on-year – above guidance. This was mainly driven by the strong sales growth achieved in 2024, which – in line with Almirall’s business strategy – is beginning to exceed investment growth, specifically SG&A.
• Almirall finished 2024 at 0.2x Net Debt to EBITDA, which remains highly favorable despite the continued investment in expanding the biologics portfolio, especially the launch of Ebglyss^® across Europe.
• Gross Margin of 64.7% was in line with expectations and impacted by increased royalties based on the sales growth of Ilumetri^®.
• Sustained investment in Research & Development of €124.2 MM, at 12,6% of Net Sales 2024.
• SG&A expenses were up 10% to €464.6 MM, due to the continued support for the launch of Ebglyss^® across Europe to further drive its anticipated growth trajectory.
• Net Income was €10.1 MM – moderately impacted by smaller impairments.
• Operating cash flow was €160.8 MM in 2024 which was mainly based on stabilized working capital and represents a significant improvement vs the previous year.

Leading medical dermatology in Europe

Dermatology continues to be a large, underpenetrated market with significant unmet needs and an estimated annual growth rate of +7.5% over the next five years, projected to reach €71 billion by 2030*. With significant increase in the scientific understanding of skin diseases and a resulting stream of new product launches in recent years, the dermatology market is forecasted to show significant growth potential in the foreseeable future. Almirall has successfully built a broad and relevant presence in dermatology based on a continuous stream of product launches broadening its dermatology portfolio, and strong commercial executions in its markets. Almirall sales of c. €485 million and its commercial efforts extend to covering 60% of office dermatologists and 90% of hospital dermatologists across Europe.

Almirall has become a recognized leader in medical dermatology in Europe thanks to its portfolio of more than 50 products in different modalities, predominantly topical, systemic and biologics. Almirall’s strategy is focused on its strong position in the area of immune-mediated inflammatory diseases, including atopic dermatitis and psoriasis, rare dermatological diseases, as well as non-melanoma skin cancer, and actinic keratosis. This has led to the company achieving a consistent 21% annual growth rate (CAGR) in Dermatology in Europe between 2020 and 2024.

Almirall’s continued investment in its R&D capabilities has resulted in a significant evolution of its medical dermatology pipeline. The company’s sustained focus on building leading innovation capabilities includes both, internal research and development, and in-licensing capabilities to achieve sustained pipeline growth, leveraging its highly flexible balance sheet. Almirall’s sustained financial strength and commercial excellence provide the foundation for continued growth, enabling Almirall to extend its impact within Europe and beyond to help patients and healthcare professionals.

^* CARG. Source: Evaluate Pharma’s sales by indication. Accessed December 2024

Biologics

Atopic dermatitis and psoriasis are key indications within medical dermatology, and both – although at different stages of market maturity – represent significant opportunities for Almirall due to the forecasted increase of the numbers of people diagnosed and the transition of diagnosed patients to advanced treatment options.

Given these dynamics, Almirall can reach increasing numbers of patients with the psoriasis and atopic dermatitis biologics, and therefore the potential peak sales of the biologics portfolio was recently updated to above €800 MM by 2030. With the atopic dermatitis market emerging as a major field for advanced therapies, it is expected to grow through products with new mechanisms of action. It is anticipated that the atopic dermatitis market will mirror the trajectory seen in the psoriasis market in recent years, where Ilumetri^® continues to show strong sustained growth supporting Almirall’s position as European leader in medical dermatology.

Atopic Dermatitis (AD)

After the approval of Ebglyss^® (lebrikizumab) by the European Commission (EC), the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and Switzerland, the product has now launched in 11 countries in Europe (in 2023: Germany, in 2024: Norway, UK, Spain, Denmark, the Czech Republik, the Netherlands, and in 2025: Italy, Switzerland, Austria, Belgium, and Sweden). The rollout in the remaining European countries is expected throughout 2025. In 2024, Almirall’s collaborator Lilly received US FDA approval for lebrikizumab and subsequently launched the product in the US.

Lebrikizumab is an anti-IL13 monoclonal antibody for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy.

The AD market is in its early stages of development with limited availability of impactful treatments – especially considering that the disease requires a wide variety of options to provide optimal care for patients. The expected increase in prescription of advanced therapies for AD patients, combined with the forecasted increase of newly diagnosed patients represent a significant opportunity for growth. Lebrikizumab has the potential to become a best-in-class treatment for moderate-to-severe AD – it represents a significant step forward for patients due to its selective mechanism of action,¹ proven short and long-term efficacy and safety – demonstrated up to 3 years² with a monthly maintenance dosing for all patients.³

Lebrikizumab will continue to increase its contribution to the performance of European dermatology and the growth of Almirall over the coming years – together with the continued strong growth of the psoriasis biologic tildrakizumab.

Psoriasis

Ilumetri^®, an anti-IL-23 high-affinity humanized monoclonal antibody indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis, delivered very strong growth across all regions and achieved €209 MM in 2024, an impressive year-on-year growth of 26% after an already strong performance in 2023. This continued exceptional performance of the product is further supported by the recent launch of the 200mg dose option as an alternative to the 100mg dose. This gives dermatologists a unique opportunity to provide optimized treatment solutions for certain patient populations with tildrakizumab.

Almirall anticipates sustaining the momentum of Ilumetri^® in the short to mid-term and therefore has recently updated its peak sales guidance to above €300 MM by 2030.

Other key dermatological products

Additionally, Wynzora^® cream, a once-daily aqueous cream with a fixed combination of calcipotriene and betamethasone dipropionate (CAL/BDP), indicated for the topical treatment of mild to moderate psoriasis vulgaris in adults, including scalp, experienced a continued significant sales increase driven by a combination of in-market growth and recent country launches. Net Sales of €25.9 MM of the product were achieved in 2024, an impressive year-on-year increase of 53.3% after an already strong performance in 2023.

^*Wynzora^® is authorized with this name in Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Spain, Sweden, Switzerland, the UK, and The Netherlands. In Austria, it is authorized under a different tradename: Winxory®

Klisyri^® (tirbanibulin), a microtubule inhibitor for the topical treatment of actinic keratosis (AK) of the face or scalp, continued to grow significantly across major markets, generating total sales of €24.5 MM in Europe and the US. The company anticipates that the favorable growth trend for this product will continue in Europe and will be further fuelled by the recent approval of the large field application in the US which opens up opportunities for dermatologists to treat a wide range of patients.

Unlocking the value of Almirall’s innovative pipeline

Almirall’s R&D pipeline is solely focused on medical dermatology: in 2024 the company invested 12.6% of net sales in R&D which enables its R&D organisation to further advance the scientific understanding of skin diseases, and the development of innovative, novel, and impactful treatments across different modalities

The company has continuously invested in R&D over many years, laying the foundation for sustained growth and acceleration in the future. It has created and advanced a strong pipeline in key areas, both in clinical and preclinical stages. The company focuses on building collaborations with partners that have new platforms and technologies to further develop its innovative pipeline. Almirall accesses the latest available technologies, including small molecules, biologics, and other modalities such as mRNA/LNP. The company’s collaborative mindset has allowed to continue and expand the work with leading experts in dermatology around the globe to innovate and to initiate the development of novel technologies such as AI-based drug discovery, immunology, biological treatments, and others.

Late-stage pipeline and lifecycle management

In Almirall’s late-stage pipeline, it successfully completed the decentralized regulatory approval procedure for Efinaconazole in Europe and is expecting national marketing authorizations in Europe during the first half of 2025.

Sarecycline’s (Seysara^®) regulatory review in China is ongoing with an anticipated approval in the second half of 2025.

To expand the label for Klisyri^® to include large field application also in Europe, a current clinical study is aimed at enabling approval for an anticipated launch in 2026.

Almirall’s strategy on providing more value of the established biologic products – Ilumetri^® and Ebglyss^® – is focused on close collaborations with its partners. Sun Pharma is running two Phase III studies to assess the efficacy and safety of tildrakizumab in patients suffering from psoriatic arthritis. First results are expected in the second half of 2025.

Almirall, together with its collaborator Eli Lilly, are running a comprehensive program of clinical trials with the aim of further expanding the indications for Lebrikizumab. This includes a Phase III study run by Lilly which explores its safety and efficacy in patients from 6 months to under 18 years to make the benefits of lebrikizumab accessible to the pediatric population.

Almirall is currently conducting the ADTrust study, a 1200 patient pan-European, prospective observational 2-year study that aims to explore the physical, psychological and social impact of Atopic Dermatitis and the treatment with lebrikizumab on patient’s lives over 24 months in real-world clinical practice settings. The first patient was recruited into the study in January 2025, and its conclusion is forecasted for 2028.

Early-stage pipeline – autoimmune dermatological diseases

Almirall continues to make progress in its early-stage pipeline, which features a range of promising assets providing potentially great opportunity for patients across different important dermatological diseases. In the next 15 months, the start of four Proof of Concept (PoC) clinical studies across a spectrum of different diseases is planned.

The company is continuing to advance the asset ALM27134*, a first-in-class fully human, high-affinity monoclonal antibody that targets IL-1RAP (Interleukin-1 Receptor Accessory Protein) for the treatment of autoimmune dermatological diseases. This monoclonal antibody has the potential to address the unmet needs in several autoimmune dermatology indications. The phase I study of ALM27134 is ongoing with single and multiple ascending doses in healthy volunteers completed, and now advancing to explore the pharmacokinetics and safety of this novel treatment candidate. The start of a Phase II study is planned for later this year in patients suffering from Hidradenitis Suppurativa.

Phase I of ALM223**, an IL-2 mutant fusion protein (IL-2muFc) drug candidate developed in collaboration with Simcere is ongoing. This molecule is designed to activate regulatory T-cells and has the potential to rebalance the immune system in several autoimmune diseases^4,5.

Clinical supply manufacturing of the company’s anti-IL-21 monoclonal antibody*** is ongoing to prepare for the launch of phase II testing. IL-21 is cytokine involved both in B- and T-cell biology and likely to be involved in several immune-mediated skin diseases.

ZKN-013**** is an oral readthrough inducer designed to overcome nonsense mutations that cause a premature stop codon. ZKN-013 has promising potential in several rare indications such as Dystrophic Epidermolysis Bullosa (RDEB), Junctional Epidermolysis Bullosa (JEB) and familial adenomatous polyposis (FAP). The phase I clinical study with ZKN-013 in healthy volunteers is currently ongoing.

*Previously referred to as ISB 880
** ALM223 in licensed from Simcere. Formally referred to as SIM-0278, worldwide ex-Greater China.
*** Licensed from Novo Nordisk
**** Licensed from Eloxx

New partnerships for progressing the future development of the pipeline

Throughout 2024, Almirall continued to build disruptive partnerships to advance science and technology with the goal of delivering meaningful and relevant innovation in medical dermatology.

In January 2024, Almirall announced a collaboration with Microsoft to advance its capabilities in the area of generative Artificial Intelligence (genAI) for the rapid analysis of extensive datasets creating a digital, agile, and patient-centric approach. Within Almirall R&D, the focus includes accelerating the discovery of new therapeutic targets, and to generate new product technologies for Almirall’s dermatology pipeline. Furthermore, Almirall will establish a new approach to technology-aided data management to optimize access to high quality data, including data governance, quality processes, and digital identity management, amongst others.

In February, the company announced a partnership with the Centre for Genomic Regulation (CRG) to identify biomarkers to build new disease models for atopic dermatitis which will lead to the development of new treatment options for AD. This new collaboration is complementary to the ongoing partnership with CRG aimed at developing and characterizing novel preclinical models as the basis for developing new treatment options for non-melanoma skin cancer (NMSC).

Conclusions

Almirall exceeded its guidance and further grew the outstanding performance of its European dermatology business in 2024. The strategic focus on medical dermatology has created a strong position for the company as it is entering an era of sustained growth and profitability. The impact Almirall has on patients and the medical community is significant, and set to grow based on the clear business strategy and the company’s ambition as leader in Medical Dermatology

Throughout 2024, the company achieved double-digit growth in all key growth drivers, specifically the successful launch and expansion of Ebglyss^® across key markets in Europe, the continued strong sales growth of Ilumetri^®, and the broader medical dermatology portfolio.

Almirall’s business strategy to continue maximizing the potential of the biologics portfolio, resulted in an upgrade of the peak sales forecast to above €800 MM. The positive momentum of the broad dermatology portfolio of products will deliver continued growth in the future – spearheaded by Klisyri^® and Wynzora^® in European markets.

The progress of Almirall’s pipeline is based on its sustained investment in advancing the scientific understanding of skin diseases and developing impactful products and technologies to effectively treat key diseases with remaining unmet medical needs. The company is entering an era of sustained double-digit growth (net sales CAGR 2023-2030) and profitability – enabling Almirall to reach more patients with relevant and impactful products. This growth trajectory is complemented by a strategic approach to add valuable assets to Almirall’s portfolio by new agreements based on scientific, strategic, and financial considerations.

Almirall’s unique dedication to medical dermatology and its long-term view on its contributions to patients, the medical community, and society are its foundation to leadership in medical dermatology, and to continued shareholder value creation.

2025 Full Year Guidance

Net Sales: Growth of 10-13%.

Total EBITDA: Between €220 MM and €240 MM

Investor Calendar 2025

• Annual General Meeting – 9^th May 2025
• Q1 2025 Financial Results – 13th May 2025
• H1 2025 Financial Results – 22nd July 2025
• 9M 2025 Financial Results – 11th November 2025

About Almirall

Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.

For more information, please visit almirall.com

Disclaimer

This document includes only summary information and does not intend to be comprehensive. Facts, figures and opinions contained herein, other than historical, are “forward-looking statements”. These statements are based on currently available information and on best estimates and assumptions believed to be reasonable by the Company. These statements involve risks and uncertainties beyond the Company’s control. Therefore, actual results may differ materially from those stated by such forward-looking statements. The Company expressly disclaims any obligation to review or update any forward-looking statements, targets or estimates contained in this document to reflect any change in the assumptions, events or circumstances on which such forward-looking statements are based unless so required by applicable law.

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¹ Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7

² Silverberg JI et al ADvocate1 and ADvocate2 Investigators. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091

³ Thaci E, et al. Efficacy and Safety of Lebrikizumab is Maintained up to Three Years in Patients with Moderate-to-Severe Atopic Dermatitis: ADvocate 1, ADvocate 2, and ADjoin Long Term Extension Trial. 2024 European Academy of Dermatology and Venereology Congress. September 25, 2024

⁴ Hernandez R, Põder J, LaPorte KM, Malek TR. Engineering IL-2 for immunotherapy of autoimmunity and cancer. Nat Rev Immunol. 2022 Oct;22(10):614-628. doi: 10.1038/s41577-022-00680-w. Epub 2022 Feb 25. PMID: 35217787.

⁵ Raeber ME, Sahin D, Karakus U, Boyman O. A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases. EBioMedicine. 2023 Apr;90:104539. doi: 10.1016/j.ebiom.2023.104539. Epub 2023 Mar 31. PMID: 37004361; PMCID: PMC10111960.

Contacts

Corporate Communications
corporate.communication@almirall.com
Phone: (+34) 93 291 35 08

Investor Relations
investors@almirall.com
Phone: (+34) 93 291 30 87