Aytu BioPharma : Corporate Presentation May 2026 View Presentation Investor Day January 2026 View Presentation

Published: 2026-05-13 17:45:17 ET AYTU

Published on 05/13/2026 at 05:45 pm EDT

May 2026

Actor portrayals.

Medicines Made for Life.

Actor portrayals.

Novel, Patent-Protected Prescription Portfolio

MDD BRAND

ADHD BRANDS

PEDIATRIC BRANDS

Net Revenue by Product Portfolio

June 30 Fiscal Year-End

$57.8

$57.6

$46.9

$48.6

$42.9

$25.4

$16.1

$10.9$12.4 $9.4

$7.3

$8.8

$5.3

$2.2

$1.6

$0.1

$0.0

$2.6

$0.0

$70

$60

$50

$ Million

$40

$30

$20

$10

2021 2022 2023 2024 2025 TTM Q3 2026

Aytu RxConnect® Patient Access Program

Aytu RxConnect® is a proprietary, best-in-class patient access program, supported by an efficient commercial infrastructure, to support patient access to Aytu Rx products.

Offers prescribers and patients predictable, hassle-free, and affordable access to Aytu brands for all commercially insured patients

patient adherence (i.e., higher refill rate)

Focused Specialty Sales Force

Rx Connect

Platform

Non-personal Promotion

Best-in-class Analytics

Specialty Distributors & Partners

Commercial Infrastructure

Efficient, experienced, and leverageable commercial infrastructure for Rx Portfolio through initial 40 territories allows for rapid scalable promotional expansion opportunities

Lean, direct sales force covers core branded MDD prescribers in our current sales footprint

Sales force augmented by rolling CSO model to support rapid expansion opportunities

Further support enabled through in-house analytics platform, virtual/tele-sales and select, efficient direct-to-patient initiatives

EXXUA

A New Way to Treat Major Depressive Disorder

EXXUA (gepirone) Extended-Release Tablets

Major Competitive

Advantage

Demonstrated efficacy in treating MDD in two well-controlled clinical trials (and five additional supportive studies) while avoiding sexual dysfunction seen with SSRIs and SNRIs, and no statistically significant weight changes

Novel Mode Of Action

EXXUA specifically and directly targets pathophysiology of MDD through a novel MOA well-characterized to improve MDD and anxiety - as a 5HT1A agonist

Large & Growing Market

Large and growing US MDD market of over

$22B, with continued market growth expected

Patent Protection

Orange Book patent through late 2030 in addition to Hatch-Waxman NCE exclusivity through 9/28

Additional Indications

Additional indications and active metabolite offer life cycle management opportunities to potentially extend franchise and further improve clinical profile

Better Pricing

Profile

Premium pricing in line with newer, branded psychiatric treatments; government reimbursement mandated for MDD treatments

Significant Unmet Needs Exist in MDD

Major Depressive Disorder affects an estimated 21 million people in the United States

creating a $22B+ Rx therapeutics market

Greater than 40% of MDD patients switch from initial therapy indicating a high level of treatment ineffectiveness and side effects

Up to 70% of MDD patients complain of treatment emergent sexual dysfunction; greater

than 65% complain of weight gain

50-75% of patients with MDD meet the DSM-5 criteria for anxious depression

EXXUA: First and Only 5HT1A Agonist for MDD

Selectively targets 5-HT1A, a key regulator of mood, emotion, and pleasure1-3

Significantly lower affinity for 5-HT2A, which is associated with sexual dysfunction1,4

No serotonin reuptake inhibition, like SSRIs and SNRIs1

1. EXXUA (gepirone) Prescribing Information. Fabre-Kramer Pharmaceuticals, Inc. 2. Lorenz TK, Johnson MF, Clayton AH. Effects of gepirone-ER on sexual function in patients with major depressive disorder. J Clin Psychiatry. 2024; 85(4):24m15357. 10.4088/JCP.24m15357. 3. Albert PR, Francios BL, Millar AM. Transcriptional dysregulation of 5-HT1A autoreceptors in mental illness. Mol Brain. 2011;4:21. doi: 10.1186/1756-6606-4-21. 4. Fabre LF, Clayton AH, Smith LC, Goldstein I, Derogatis LR. The effect of gepirone-ER in the treatment of sexual dysfunction in depressed men. J Sex Med. 2012;9(3):821-829. doi: 10.1111/j.1743-6109.2011.02624.x.

EXXUA: Demonstrated Efficacy in MDD

Efficacy was demonstrated in two eight-week, randomized, double-blind, placebo-controlled, flexible-dose studies in adults with MDD1

Placebo-subtracted difference in HAMD-17 total score reduction with EXXUA (-2.5 points) was in the range seen with commonly prescribed antidepressants1-2

Statistically significant difference vs placebo seen as soon as Week 3 in Study 1 (P=0.013)3

1. EXXUA (gepirone) Prescribing Information. Fabre-Kramer Pharmaceuticals, Inc. 2. Hengartner MP, Jakobsen JC, Sorensen A, Ploderl M. Efficacy of new-generation antidepressants assessed with the Montgomery-Asberg Depression Rating Scale, the gold standard clinical rating scale: a meta-analysis of randomized placebo-controlled trials. Plos One. 2020;15(2):e0229381. doi:10.1371/journal.pone.0229381. 3. Data on file. Clinical Trial Report 134001. Organon Inc. 2001.

EXXUA: A Favorable Adverse Event Profile

Only 7% (15/226) of patients discontinued treatment with EXXUA due to an adverse reaction vs 3% (6/230) of patient s receiving placebo1

The most common adverse reactions leading to discontinuation for patients taking EXXUA were dizziness and nausea1

2.9% in Study 1 and 1.6% in Study 2

discontinued due to dizziness2-3

2.0% in Study 1 and 1.6% in Study 2 discontinued due to nausea2-3

1. EXXUA (gepirone) Prescribing Information. Fabre-Kramer Pharmaceuticals, Inc. 2. Data on file. Clinical Trial Report 134001. Organon Inc. 2001. 3. Data on file. Clinical Study Report FKGBE007. Fabre-Kramer Pharmaceuticals, Inc. 2005.

EXXUA: A Clear Position in the MDD Market

Dosing

EXXUA has a unique profile due to its MOA, which helps explain the lack of impact on sexual function or weight - key issues for many MDD patients

Brand

Novel Mechanism of Action

No Impact of Sexual Function

Weight Neutral Once Daily

EXXUA

SSRIs

SNRIs

Wellbutrin®/Bupropion

Trintellix®

Auvelity®

EXXUA Promotional Mix & Commercial Priorities

EXXUA Launch Focus

Efficient, multi-faceted launch with emphasis on sales force promotion and metrics-based performance management

Targeted virtual promotion and pull-through to support broad customer adoption

Focused non-personal, web-based promotion to increase brand awareness and adoption

Broad Aytu RxConnect footprint for enhanced patient access, adoption, & adherence

Full retail distribution to achieve broad-based availability

New Chemical Entity (NCE) education led by cost-effective

Medical Affairs-led publication and KOL support

Strategic payor assessments with commercial and government payors

Sales force

promotion

Strategic payor assessments

Targeted virtual HCP promotion

New Chemical Entity (NCE) education

Focused non-personal, web-based promotion

Full retail distribution

Broad Aytu RxConnect

EXXUA TRxs and Shipments

1,912

1,315

872

546

551

1,000

2,500

900

800

700

2,000

600

1,500

920

731

398

186

500

400

1,000

300

200

500

100

Dec-25 Jan-26 Feb-26 Mar-26 Apr-26

ADHD & Pediatrics

Legacy Portfolios

Established Revenue Generating Prescription Portfolio

Differentiated Rx brands focused on ADHD and Pediatrics

ADHD BRANDS

First & only extended-release ODT amphetamine

Only branded amphetamine that is FDA-approved as bioequivalent to Adderall XR

First & only extended-release ODT methylphenidate

Strong clinical data in patients 6-17 years old, demonstrated 61% symptom improvement @ 1 hour

PEDIATRIC BRANDS

Only FDA-approved, extended-release carbinoxamine liquid

Broad indications for use, including as an adjunctive

treatment for anaphylaxis

First and only multi-vitamin + supplement containing novel L-methylfolate Arcofolin®

ADHD and Pediatric Portfolio TRxs

500,000

134,310

90,623 91,380

75,183

64,948

54,182

49,592

42,930

41,601

44,978

36,441

33,294

25,591

23,347

23,36221,616

20,962

12,332

160,000

450,000

400,000

350,000

352,431

376,996

433,041 438,467

415,110

380,155

140,000

120,000

300,000

250,000

200,000

150,000

100,000

50,000

212,633

139,798

235,458

141,538

292,307

140,734

305,260

133,207

298,976

121,943

263,368

112,945

100,000

80,000

60,000

40,000

20,000

FY 2021 FY 2022 FY 2023 FY 2024 FY 2025 TTM Q3 2026

Source: IQVIA NPA for scripts through FY 2024; Symphony utilized for scripts in FY 2025 and YTD FY 2026. Total ADHD includes Metadate CD. Adzenys XR-ODT includes Adzenys AG. FY

19 2025 includes routine Symphony data refresh for previously reported script data.

Financials

Disclaimer

Aytu Biopharma Inc. published this content on May 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 13, 2026 at 21:44 UTC.