Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting




Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting

– New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted

– Featured abstracts for ruxolitinib cream (Opzelura^®) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY #AAD2026–Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver.

“At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.”

Details on key data presentations at AAD include:

Late-Breaking Oral Presentations

Hidradenitis Suppurativa

Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies

(Session: S034 – Late-Breaking Research: Session 2. Saturday, March 28, 2026, 1:00 p.m. MT)

ePoster Exhibits

Atopic Dermatitis

Ruxolitinib Cream Improves Patient-Reported Outcomes in Adults With Moderate Atopic Dermatitis (TRuE-AD4)

​(Abstract #: 75312)

Ruxolitinib Cream Is Efficacious in Adults With Moderate Atopic Dermatitis Regardless of Baseline Disease Severity and Previous Medication History

​(Abstract #: 70667)

Hidradenitis Suppurativa

Povorcitinib for Moderate-to-Severe Hidradenitis Suppurativa: Week 24 Interim Phase 3 Results in Anti-TNF-Experienced Patients

(Abstract #: 75195)

Physician Perspectives on Diagnosis and Treatment of Hidradenitis Suppurativa: Results From the Global HERALD (Hidradenitis Suppurativa Experiences in the Real World) Survey

​(Abstract #: 75265)

Disease Burden and Treatment History of Hidradenitis Suppurativa: Patient Perspectives From the Global HERALD (Hidradenitis Suppurativa Experiences in the Real World) Survey

​(Abstract #: 75268)

Vitiligo

Association Between Repigmentation and Quality of Life Among Patients With Vitiligo Treated With Ruxolitinib Cream in the TRuE-V Studies

​(Abstract #: 75247)

Real-World Factors Influencing Vitiligo Care: Insights From a Patient Survey Assessing the Use of Ruxolitinib Cream

​(Abstract #: 75258)

More information regarding the 2026 AAD Annual Meeting can be found at: https://www.aad.org/member/meetings-education/am26/education.

About Povorcitinib

Povorcitinib (INCB54707) is an oral small-molecule JAK1 selective inhibitor currently in Phase 3 clinical trials for HS, vitiligo and prurigo nodularis (PN), as well as a Phase 2 trial for asthma.

About Opzelura^® (ruxolitinib) Cream

Opzelura^® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of Opzelura.

Opzelura is a registered trademark of Incyte.

About Incyte^®

Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline and the potential for povorcitinib to provide a safe and effective treatment option for HS and further strengthen the significant growth potential of Incyte’s Inflammation and Autoimmunity franchise, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

LEO Pharma to Present 17 Scientific Abstracts at AAD 2026 Highlighting Real‑World Evidence, Long‑Term Outcomes and Patient Experience Across Multiple Dermatological Conditions




LEO Pharma to Present 17 Scientific Abstracts at AAD 2026 Highlighting Real‑World Evidence, Long‑Term Outcomes and Patient Experience Across Multiple Dermatological Conditions

MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced it will present 17 scientific posters at the 2026 American Academy of Dermatology (AAD) Annual Meeting (March 27-31, Denver, Colorado), highlighting new real-world and clinical data across its medical dermatology portfolio and pipeline for inflammatory skin diseases.

Key data to be presented by LEO Pharma at AAD 2026 include:

• ADBRY^® (tralokinumab) 12‑month real‑world data from the TRACE study evaluating the safety and effectiveness of ADBRY among patients with atopic dermatitis (AD), including analyses in patients with hand and foot involvement and patients with skin of color.^1-3
• ANZUPGO^® (delgocitinib) data evaluating outcomes with ANZUPGO cream 20 mg/g in adults with moderate-to-severe chronic hand eczema (CHE), including results across patients with and without prior systemic therapy exposure, further characterizing treatment response in this difficult-to-treat population.⁴
• SPEVIGO^® (spesolimab) long-term data from the EFFISAYIL program evaluating intravenous and subcutaneous SPEVIGO for treatment of GPP flares and characterizing baseline non‑flaring disease phenotype.^5-7

“We’re proud to present LEO Pharma’s largest body of research to date at the AAD Annual Meeting, highlighting new real-world and clinical insights across Atopic Dermatitis, Generalized Pustular Psoriasis and Chronic Hand Eczema,” said Sophie Lamle, EVP, Development at LEO Pharma. “Together, these findings reflect continued advancements in the understanding and management of chronic dermatologic diseases and underscore our ambition to help address critical treatment gaps for patients.”

The company’s full roster of presentations at the 2026 AAD Annual Meeting is listed below.^1-17

About Atopic Dermatitis

Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.¹⁸ AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹⁹ Type 2 cytokines, including IL-13, play an important role in the key aspects of AD pathophysiology.^18-19 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.²⁰

About Generalized Pustular Psoriasis

Generalized Pustular Psoriasis (GPP) is a chronic, heterogeneous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.^21,22 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.^23,24 GPP symptoms appear unpredictably and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities and finances.^24,25

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year.²⁶ HE is one of the most common skin disorders of the hands, and in a substantial number of patients it can develop into a chronic condition.²⁷ CHE affects approximately one in ten adults in the U.S.²⁸ It is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists.²⁶ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.²⁹

CHE has been shown to cause psychological and functional burdens that impact patient quality of life.^30,31 Individuals living with CHE experience substantial impairment in daily activities, with an average activity impairment of more than 40%.³² Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.³³

About ADBRY^® (tralokinumab)/ADTRALZA^® (tralokinumab)

ADBRY^® (tralokinumab), which is marketed outside of the U.S. under the tradename ADTRALZA^® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^34,35 Tralokinumab specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).³⁶

Tralokinumab is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, South Korea, the U.S., and Saudi Arabia. Tralokinumab is approved for use in adults with moderate- to-severe AD in Switzerland and Japan.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY^® (TRALOKINUMAB)

What is ADBRY?

• ADBRY^® (tralokinumab) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
• It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

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

How should I use ADBRY?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
• Use ADBRY exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

• upper respiratory tract infections
• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

About SPEVIGO^® (spesolimab)

SPEVIGO^® (spesolimab) is a humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.³⁷ It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.^38-40

INDICATION AND IMPORTANT SAFETY INFORMATION FOR SPEVIGO^® (SPESOLIMAB)

INDICATION

SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age or older and weighing at least 40 kg.

CONTRAINDICATIONS

SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS).

WARNINGS AND PRECAUTIONS

Infections: SPEVIGO may increase the risk of infections. In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated.

Risk of Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection. Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment.

Hypersensitivity and Infusion-Related Reactions:

• SPEVIGO-associated hypersensitivity reactions may include immediate reactions, such as anaphylaxis, and delayed reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).
• Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in clinical trials with spesolimab in subjects with GPP.
• If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment.
• If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (e.g., systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.

Vaccinations: Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines.

ADVERSE REACTIONS

Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1): Most common adverse reactions reported in ≥5% of patients treated with SPEVIGO in the clinical trial were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection (UTI).

Specific Adverse Reactions

• Infections: The most frequent adverse reactions that occurred in subjects treated with intravenous SPEVIGO were infections. During the 1-week placebo-controlled period in Study Effisayil-1, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%).
• Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS): Two cases of DRESS were reported in Study Effisayil-1 in subjects with GPP who were treated with intravenous SPEVIGO. RegiSCAR DRESS validation scoring (with the following categories: “no,” “possible,” “probable,” or “definite” DRESS) was applied to the reported cases. Reported cases were assessed as “no DRESS” and “possible DRESS.”

Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2): Regarding the exposure-adjusted incidence rates for subjects on randomized treatment prior to receiving rescue treatment for flare or completing trial without a flare, the rate per 100-patient years for injection site reaction (including erythema, pain, swelling, induration, urticaria, and warmth at the injection site) was 31.6 for the subcutaneous SPEVIGO cohort (600 mg loading dose followed by 300 mg every 4 weeks) vs 12.7 for the placebo cohort. The rate per 100-patient years for UTI was 18 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for pruritus was 8.8 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for arthralgia was 13.3 for SPEVIGO vs 6 for the placebo cohort. There were 3 subjects who discontinued subcutaneous SPEVIGO due to treatment-emergent adverse events of psoriasis compared to no subjects in the placebo cohort who discontinued placebo for any treatment-emergent adverse event.

Safety in Study Effisayil-2 After Flare: In Effisayil-2, subjects who experienced a GPP flare and received at least one dose of an open-label single intravenous 900 mg dose of SPEVIGO were treated with open-label subcutaneous SPEVIGO 300 mg. These subjects (n=19) received subcutaneous dosing at every 12 weeks, which could have been increased to every 4 weeks based on GPPPGA total score or pustulation subscore increased by ≥1 from any previous open-label maintenance visit. The reported safety profile of open-label subcutaneous SPEVIGO use after treatment of GPP flare with open-label intravenous SPEVIGO use was consistent with the safety profiles of use of SPEVIGO from Trial Effisayil-1 and randomized controlled data from Trial Effisayil-2.

Clinical Development of Spesolimab

• Guillain-Barre Syndrome (GBS): Among approximately 835 subjects exposed to spesolimab during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab via various methods of administration in clinical trials for unapproved indications.

SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study, which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2), and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more. The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established.

Please see SPEVIGO Prescribing Information, including Medication Guide.

About ANZUPGO® (delgocitinib) Cream

ANZUPGO® (delgocitinib) cream is currently FDA-approved in the U.S. as the first and only topical pan-JAK treatment for chronic hand eczema (CHE). Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.⁴¹ ANZUPGO cream is also approved in the European Union, United Kingdom, Switzerland, United Arab Emirates and Canada under the brand name ANZUPGO for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or not advisable. ANZUPGO cream is also under investigation in other markets.

ANZUPGO cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.^41,42

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ANZUPGO^® (DELGOCITINIB) CREAM

What is ANZUPGO?

ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate-to-severe chronic hand eczema (CHE) in adults who are not well-controlled with or cannot use topical corticosteroids.

The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended.

IMPORTANT SAFETY INFORMATION

ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth or vagina.

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

ANZUPGO may cause serious side effects, including:

Serious Infections: ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Contacts

Samantha Cranko

U.S. & Canada Communications

Email: media@leo-pharma.com

Jes Broe Frederiksen

Global Communications

Email: jebfe@leo-pharma.com

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HealthWarehouse.com Reports Full Year 2025 Results




HealthWarehouse.com Reports Full Year 2025 Results

46% increase in revenues and positive cash flow for the year

Record year for prescriptions processed and cash generated from operations

CINCINNATI–(BUSINESS WIRE)–HealthWarehouse.com, Inc. (OTCQB:HEWA) announced today its results of operations for the year ended December 31, 2025. The Company reported net sales for the year of $49.0 million, a 46% increase over the year ended December 31, 2024, resulting from 87% growth in our partner services prescription revenues, offset in part by a decline in direct-to-consumer sales.

The Company reported net income of $265,000 for the year and positive cash flow of $1.6 million, as reflected by the non-GAAP measure of Adjusted EBITDA defined below. The Company reported net loss of $69,000 and Adjusted EBITDA of $189,000 for the fourth quarter.

HealthWarehouse.com, a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (NABP). HealthWarehouse.com provides a platform focused on increasing access to and reducing costs of healthcare products for consumers and business partners nationwide.

Joseph Peters, President and CEO, commented, “2025 was a record year for the Company for total sales and prescriptions processed, while generating record cash from operations. We were able to report net income and positive cash flow by leveraging our prior investments in infrastructure. Our financial results for the past two years, during which our sales have increased $28.7 million and our Adjusted EBITDA $1.5 million, are further proof that our business model can scale profitably.”

“As we said in our third-quarter release in November, our sales of compounded versions of certain GLP-1 prescription medications were declining. Despite slower growth, we generated positive cash flow during the fourth quarter. Additionally, we are optimistic about new product launches that will allow us to continue to serve longstanding partners, and we are focused on adding partners via our new-business pipeline,” Peters said.

HealthWarehouse.com continues to invest in proprietary technology to remain at the forefront of new developments and offerings in the world of healthcare, focusing on patient experience, operational efficiency, and scalability.

Peters added, “Our success would not be achievable without our dedicated employees, who are committed to our mission of providing world-class service to our customers. I truly appreciate their dedication.”

The Company also announced that it will hold its Annual Meeting of Shareholders virtually on May 12, 2026. Shareholders of record as of March 13, 2026, will receive notice of the meeting and instructions for participating in proxy materials to be distributed soon.

2025 Annual Overview

Net Sales: Net sales increased from $33.6 million for the year ended December 31, 2024, to $49.0 million for the year ended December 31, 2025, an increase of $15.4 million, or 45.8%. Prescription sales were $46.2 million for the year ended December 31, 2025, an increase of $15.3 million, or 49.3%, compared with $30.9 million for the year ended December 31, 2024. These increases were primarily due to growth in our partner services (B2B) business related to fulfillment of brand and compounded GLP-1 medications. Sales for the direct-to-consumer (B2C) prescription business were down 24.3% in 2025 due to a reduction in sales of higher-cost branded medications and increased competition. Over-the-counter net sales increased by 15.9% from $2.2 million in the year ended December 31, 2024, to $2.5 million in the year ended December 31, 2025. The increase in B2C over-the-counter sales was primarily due to higher marketplace sales.

Our authority to dispense high-dollar compounded GLP-1 medications has ended this year. That will have a significant impact on our sales in 2026, and beyond until that volume can be replaced with new partners and expansion of the catalogs of our existing partners. The Company currently expects positive cash from operations during 2026.

Gross Profit: Cost of sales was $31.9 million for the year ended December 31, 2025, compared with $19.5 million for the year ended December 31, 2024. That increase of $12.4 million, or 63.4%, was primarily the result of growth in sales of high-cost GLP-1 medications in our B2B prescription businesses. Gross profit for the year ended December 31, 2025, was $17.1 million, a $3.0 million or 21.4% increase compared with the same period in 2024, due to the increase in sales volume, offset in part by lower gross margins. Gross margin percentage decreased year-over-year from 42.0% for the year ended December 31, 2024, to 35.0% for the year ended December 31, 2025. In the B2B prescription business, branded and compounded drugs have lower gross margins, due to higher costs and price competition.

Operating Expenses: Selling, general and administrative (SG&A) expenses totaled $16.7 million for the year ended December 31, 2025, compared with $14.2 million for the year ended December 31, 2024, an increase of $2.5 million, or 17.7%. Despite the increase, SG&A expenses were significantly lower relative to sales, decreasing 8.2 percentage points to 34.1% of sales for the year ended 2025. The growth in sales of high cost GLP-1 medications in our B2B prescription businesses did not result in a comparable increase in operating expenses. For the year ended December 31, 2025, increased expenses were primarily related to the growth in order volume in the B2B segment, which included increases in shipping expense, salaries and related expenses, shipping supplies expense; legal expense, advertising and marketing expense, rent expense, software and engineering expenses, corporate taxes, maintenance and repairs expenses and accounting services expense. Those increases were partially offset by decreases in credit card fees, health and other benefits expense, and stock-based compensation.

Net Income and Adjusted EBITDA: Net income of $265,000 for the year ended December 31, 2025, improved by $598,000 from the net loss of $333,000 for the year ended December 31, 2024, primarily as a result of increased sales and gross profit and continued controls on expenses. Earnings before interest, taxes, depreciation and amortization including amortization of a right-of-use lease asset (“EBITDA”), as adjusted for stock-based compensation and certain non-recurring charges (“Adjusted EBITDA”), were $1.6 million for 2025, up from $1.1 million for 2024. EBITDA and Adjusted EBITDA are non-GAAP financial measures. Definitions of these non-GAAP terms and a reconciliation to GAAP measures are provided below.

2025 Fourth Quarter Overview

Net Sales: Total net sales were $9.9 million for the fourth quarter ended December 31, 2025, a decrease of $3.9 million, or 28.1%, compared with the fourth quarter of 2024. Prescription sales were $9.0 million for the fourth quarter, a decrease of $4.1 million, or 31.0%. That was due to lower sales in the B2B and B2C prescription business, primarily related to lower sales of compounded GLP1 medications. Over-the-counter sales increased by 40.2% to $776,000 due to an increase in marketplace sales.

Gross Profit: Gross profit for the fourth quarter of 2025 was $3.8 million, a $575,000 or 13.0% decrease compared with the fourth quarter of 2024. Lower revenues in the B2B and B2C prescription businesses were partly offset by higher gross margins. Gross margin was 39.0% in the fourth quarter of 2025 versus 32.2% in the same period in 2024, due primarily to improved margins in the prescription business.

Operating Expenses: Operating expenses were $4.0 million for the fourth quarter of 2025, a decrease of $250,000 or 6.0% compared with the same quarter in 2024. The decrease in 2025 was related to decreases in shipping and shipping-supplies expenses, salaries and related expenses, and credit card fees. The decreases were offset by increases in marketing and advertising expenses.

Net Income and (non-GAAP) Adjusted EBITDA: The Company reported a net loss of $69,000 for the fourth quarter of 2025, compared with net income of $189,000 during the same period in 2024. Adjusted EBITDA for the fourth quarter of 2025 was $189,000, compared with $523,000 in the fourth quarter of 2024.

Use of Non-GAAP Financial Measures

HealthWarehouse.com, Inc. (the “Company”) prepares its consolidated financial statements in accordance with the United States generally accepted accounting principles (“GAAP”). In addition to disclosing financial results prepared in accordance with GAAP, the Company discloses information regarding EBITDA and Adjusted EBITDA, which are commonly used. In addition to adjusting net income or net loss to exclude interest, taxes, depreciation and amortization, including amortization of right of use lease asset, (“EBITDA”), Adjusted EBITDA also excludes stock-based compensation, and certain nonrecurring charges. EBITDA and Adjusted EBITDA are not measures of performance defined in accordance with GAAP. However, Adjusted EBITDA is used internally in planning and evaluating the Company`s performance. Accordingly, management believes that disclosure of this metric offers lenders and other shareholders an additional view of the Company`s operations that, when coupled with GAAP results, provides a more complete understanding of the Company’s financial results.

Adjusted EBITDA should not be considered as an alternative to net income, net loss, or to net cash provided by or used in operating activities, as a measure of operating results or of liquidity. It may not be comparable to similarly titled measures used by other companies, and it excludes financial information that some may consider important in evaluating the Company`s performance.

Reconciliation of Net Loss (GAAP) to Adjusted EBITDA (Non-GAAP)

About HealthWarehouse.com

HealthWarehouse.com, Inc. (OTCQB: HEWA), a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (“NABP”). HealthWarehouse.com provides a platform focused on increasing access and reducing costs of healthcare products for consumers and business partners nationwide. Based in Florence, Kentucky, the Company operates America’s Leading Online Pharmacy and is a pioneer in affordable healthcare. As one of the first Approved Digital Pharmacies by the National Association of Boards of Pharmacy, HealthWarehouse.com services the mission of providing affordable healthcare and incredible patient services to help Americans. Learn more at www.HealthWarehouse.com

Forward-Looking Statements

This announcement and the information incorporated by reference herein contain “forward-looking statements” as defined in federal securities laws, including but not limited to Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which statements are based on our current expectations, estimates, forecasts and projections. Statements that are not historical facts, including statements about the beliefs, expectations and future plans and strategies of the Company, are forward-looking statements. Actual results may differ materially from those expressed in forward looking statements or in management’s expectations. Important factors which could cause or contribute to actual results being materially and adversely different from those described or implied by forward looking statements include, among others, risks related to competition, management of growth, access to sufficient capital to fund our business and our growth, new products, services and technologies, potential fluctuations in operating results, international expansion, outcomes of legal proceedings and claims, fulfillment center optimization, seasonality, commercial agreements, acquisitions and strategic transactions, foreign exchange rates, system interruption, cyber-attacks, access to sufficient inventory, government regulation and taxation and fraud. More information about factors that potentially could affect HealthWarehouse.com’s financial results is included in HealthWarehouse.com’s audited Annual Reports and Quarterly Reports available at otcmarkets.com and prior filings with the Securities and Exchange Commission.

Contacts

Dan Seliga, Chief Financial Officer, (800) 748-7001