Aytu BioPharma Talks Exxua MDD Launch, Differentiation and RxConnect Access at Investor Summit

Aytu BioPharma (NASDAQ:AYTU) Chief Executive Officer Josh Disbrow outlined the company’s plans for its newly launched major depressive disorder (MDD) treatment Exxua during a fireside chat at the Lithium Partners Investor Healthcare Summit, highlighting the drug’s differentiation in a crowded antidepressant market, the company’s psychiatry-focused commercial footprint, and its patient access strategy through the Aytu RxConnect program.

Exxua origins and launch focus

Disbrow said Aytu first connected with Exxua through business development discussions at the JPMorgan Healthcare Conference roughly a year prior and characterized the licensing arrangement with Fabre-Kramer Pharmaceuticals as a “true partnership,” emphasizing frequent interaction and alignment on strategy, resourcing, and economics. He said the company has been in a “full sprint” since mid-last year and described the timing as “absolutely perfect” as Aytu enters the launch phase.

Lake Street Capital Markets Senior Research Analyst Thomas Flatten, who moderated the discussion, noted the conversation was recorded in advance because Disbrow would be attending Aytu’s national sales meeting to support the Exxua launch.

How management says Exxua differentiates in antidepressants

Disbrow described the U.S. antidepressant market as large, citing more than 345 million prescriptions written annually, and said it is dominated by SSRIs and SNRIs. He said those therapies are “pan-selective,” broadly increasing serotonin (and sometimes norepinephrine), which he said can lead to side effects including sexual dysfunction and weight gain.

According to Disbrow, Exxua is not an SSRI or SNRI and is differentiated by a selective mechanism of action: it targets and agonizes (upregulates) the 5-HT1A serotonin receptor. He said Exxua is the “first and only” 5-HT1A agonist indicated for MDD.

When asked about selling messages within FDA promotional limits, Disbrow said field training centers on several core themes:

• Novel, targeted mechanism: selective 5-HT1A agonism as a differentiated approach that psychiatrists understand through receptor pharmacology.
• Efficacy from pivotal studies: he referenced two pivotal trials and said symptom improvement was observed over eight weeks, with effects beginning as early as week three.
• Tolerability profile based on labeling: he said physicians can observe that sexual side effects are not listed in the package insert and that weight gain is described as negligible and “clinically and statistically insignificant.”
• Access and affordability support: positioning RxConnect as a key element to reduce friction for patients and prescribers.

Commercial infrastructure and targeting strategy

Disbrow said Aytu’s existing U.S. commercial team includes about 44 sales representatives (generally 40 to 45) already aligned to psychiatry through the company’s ADHD franchise, which includes Adzenis and Cotempla. He described Exxua as “hand in glove” with the existing infrastructure, requiring additional training and some targeting changes.

He said the company moved from being roughly 60% to 70% aligned with depression prescribers to being fully aligned, and emphasized a “psychiatry only” approach targeting high-prescribing MDD psychiatrists and their nurse practitioner and physician assistant colleagues. Disbrow said Aytu is focusing on “thousands of doctors, not tens of thousands,” and is prioritizing brand-centric prescribers who already use newer branded therapies and may be more inclined to adopt a new branded medication.

RxConnect and expectations for uptake

Disbrow said Aytu RxConnect was built to address access barriers for branded drugs, aiming to provide predictable patient out-of-pocket costs and reduce prior authorizations and other pharmacy benefit manager hurdles. He described a network of roughly 1,000 partner pharmacies, along with select retail grocery chains, and said Aytu encourages prescribers to route prescriptions through these partners, which may also provide shipping or courier delivery and handle administrative requirements.

He characterized RxConnect as a “quadruple win” for patients, physicians, pharmacies, and the company, citing predictable copays, reduced friction for prescribers, pharmacy customer retention, and “sticky” prescriptions with improved adherence for Aytu. Disbrow said about 85% of Aytu’s ADHD prescriptions flow through RxConnect and said early Exxua prescribing activity was strongest among physicians already familiar with the program.

On where Exxua may fit in treatment sequencing, Disbrow said new therapies are typically not first-line due to clinical practice patterns and payer requirements favoring generics. He said Exxua would likely begin in later lines of therapy (fourth to sixth line, potentially) before moving earlier as prescribers become familiar with dosing and patient experience, and as the company addresses access barriers. He said that even if Exxua remains later-line, the company believes it can perform well.

Legacy business, generic competition, and cash position

Disbrow outlined Aytu’s legacy business as two main components:

• ADHD franchise: Adzenis and Cotempla, which he said generated $55.5 million over the trailing 12 months ended in September and has been relatively stable around $55 million to $57 million over the past several years.
• Pediatric products: a smaller, non-core portfolio including multivitamins with fluoride and an antihistamine, which he said has been stable at approximately $8 million to $8.5 million.

He said the overall business is about $64 million in revenue and has generated roughly $8 million to $9 million in EBITDA over the trailing 24 months, describing the brands as mature with limited growth, which led the company to seek a new growth driver in Exxua.

Regarding generic threats, Disbrow discussed a previously disclosed Paragraph IV settlement enabling Teva to enter with an approved ANDA as early as Sept. 1, 2025, and said Teva has now entered the market, with limited prescription impact so far. He added that Aytu launched its own authorized generic for Adzenis and said it is performing “phenomenally well,” helping mitigate competitive pressure, particularly given the company’s RxConnect channel concentration.

On financial resources, Disbrow said Aytu ended the September quarter with $32.6 million in cash and stated the company does not anticipate needing additional capital. He said management believes the company can reach profitability with existing cash and added that even if ADHD revenue declines materially, Exxua would need to backfill a comparatively modest amount of revenue to offset the reduction.

About Aytu BioPharma (NASDAQ:AYTU)

Aytu BioPharma, Inc is a specialty pharmaceutical company focused on the development, licensing and commercialization of novel therapeutics to address underserved medical needs. Headquartered in Englewood, Colorado, Aytu pursues a strategy of acquiring late-stage or approved products in areas such as urology, endocrinology, women’s health, pediatric care and supportive therapies. The company leverages in-house commercialization capabilities and targeted business development to build a diversified portfolio of prescription medicines and diagnostics.

Aytu’s marketed portfolio includes Natesto, a nasal testosterone gel for treatment of male hypogonadism; ZolpiMist, a zolpidem tartrate lingual spray for the short-term treatment of insomnia; and Tuzistra XR, an extended-release cough syrup formulation indicated for relief of cough and upper respiratory symptoms.