Aytu BioPharma Q2 Earnings Call Highlights

Aytu BioPharma (NASDAQ:AYTU) used its fiscal 2026 second-quarter earnings call to spotlight the early commercial rollout of EXXUA, its newly launched treatment for major depressive disorder (MDD), while also reviewing performance in its legacy ADHD and pediatric portfolios. Management emphasized that the EXXUA launch is in its earliest days, with limited data available so far, but said initial prescription activity and patient feedback have been encouraging.

EXXUA launch: early prescription activity and positioning

Chief Executive Officer Josh Disbrow said the company has now “commercially launched EXXUA,” describing it as “the first and only 5-HT1A agonist approved by the FDA for the treatment of MDD.” He recapped key themes from Aytu’s Investor Day held January 20, including the clinical rationale for targeting the 5-HT1A receptor and EXXUA’s clinical profile.

Disbrow relayed remarks from several clinicians who participated in the Investor Day discussion, including commentary that selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors can have tolerability limitations that may affect adherence. He said EXXUA was designed to specifically engage the 5-HT1A receptor and, based on clinical studies discussed on the call, “does not carry a warning for sexual dysfunction” and showed “no clinically meaningful weight gain compared to placebo across pivotal trials.”

On launch execution, Disbrow said the company is balancing “efficiency and comprehensiveness,” centered on a sales organization supported by performance management and incentives. He added that Aytu is expanding reach with a virtual sales team and a “rolling contract sales organization model” to flex in-person promotion depending on product performance and as profitability and cash flow allow.

RxConnect access strategy and early signals

Aytu repeatedly highlighted patient access and its A2 RxConnect platform as central to the EXXUA rollout. Disbrow said RxConnect was built to reduce friction by “guaranteeing predictable coverage for commercially insured patients” and capping out-of-pocket costs at “no more than $50 per prescription” for commercially insured patients. He also noted prescriptions can be filled outside the RxConnect network.

While noting the company is only weeks into launch, Disbrow shared several early data points derived largely from RxConnect insights:

• EXXUA prescriptions have been written in 27 states, including states without Aytu sales representatives.
• More than 100 doctors have prescribed EXXUA so far.
• With a little over 30 days of commercial availability, the company is “already seeing” initial refills through the platform.
• Early patient feedback has been “very good,” with reports of good tolerability and satisfaction among the small number of patients who have been on therapy for a month or longer.

During Q&A, Disbrow said early prescriber motivations have varied, including interest in a new mechanism of action, challenges with patients who have not had robust responses to prior therapies, and concerns about side effects such as sexual dysfunction or weight gain. He also cited “relative ease” of prescribing through RxConnect and minimal barriers as a factor.

Financial results: revenue decline, margin pressure from inventory write-down

Chief Financial Officer Ryan Selhorn reported fiscal second-quarter net revenue of $15.2 million, down from $16.2 million in the prior-year period. ADHD portfolio net revenue was $13.2 million versus $13.8 million a year ago and was flat sequentially. Selhorn attributed the year-over-year change primarily to lower total prescriptions driven by “broader de-emphasis in marketing” toward ADHD as commercial focus shifted to EXXUA, along with “some relatively small impact” from generic competition, partially offset by price increases and improved gross-to-net dynamics.

Pediatric portfolio net revenue was $1.7 million, down from $2.7 million a year earlier but up from $715,000 in the prior quarter. Management attributed the year-over-year decline to reduced marketing emphasis for pediatric products, citing commentary from the administration and FDA around fluoride. Disbrow said the pediatric products remain “non-core” as Aytu prioritizes EXXUA, though the company could revisit its approach if the FDA’s stance changes.

Gross margin was 63.5% compared with 66.5% in the year-ago quarter. Selhorn said the decline was primarily related to lower net revenue and transition-related expenses tied to the ADHD authorized generic, including an approximately $600,000 write-down of branded Adzenys inventory. Excluding the write-down, he said gross margin would have been 67.4%.

Operating expenses (excluding amortization of intangible assets and prior-year restructuring costs) were $11.1 million, up from $10.2 million, reflecting increased EXXUA launch investments partially offset by efficiencies such as reduced facilities expense. Selhorn added that the quarter included a one-time $400,000 FDA PDUFA fee for Cotempla.

Aytu reported a net loss of $10.6 million, or $5.00 per basic share, compared with net income of $0.8 million, or $0.13 per basic share, a year earlier. Selhorn said the results were impacted by an $8.2 million derivative warrant liability loss versus a $3.0 million gain in the year-ago quarter, driven primarily by changes in the company’s stock price. Adjusted EBITDA was -$0.8 million versus $1.3 million a year ago.

ADHD portfolio: early generic dynamics and RxConnect “stickiness”

Disbrow said ADHD net revenue of $13.2 million was “quite impressive” given sales force prioritization shifting toward EXXUA and the introduction of generic competition. He noted Teva launched its ANDA for Adzenys in mid-December, and Aytu launched its own authorized generic.

For the six-week period ending January 16, Disbrow said Teva’s generic represented approximately 5% of prescriptions written, while Aytu’s authorized generic represented just under 20% of total prescriptions, with the remaining volume continuing to be branded Adzenys. He said approximately 85% of branded ADHD prescriptions are dispensed through RxConnect and that the company expects much of any incremental non-A2 generic volume to come from the roughly 15% dispensed outside the RxConnect network in the near term. Management also noted a recent price increase intended to help offset script erosion through net pricing improvements.

Cash position and EXXUA launch economics

Selhorn reported cash and cash equivalents of $30.0 million at December 31, 2025, compared with $32.6 million at September 30, 2025, and said balance sheet movements were largely consistent with normal operations. He also discussed warrant mechanics, noting 550,000 pre-funded warrants were exercised during the quarter and that the company had 10.7 million common shares outstanding plus 8.8 million pre-funded warrants outstanding (19.5 million shares on an effective basis).

Looking ahead, Selhorn reiterated that early in the EXXUA launch, prescription growth is expected to outpace recognized net revenue due to deliberate access measures through RxConnect. He said the program includes a no-cost 14-day titration pack and, for commercially insured patients, a guarantee of coverage for months one and two “regardless of the insurance outcome,” with net revenue expected to improve as month three refills occur and the guarantees roll off beginning in the June 2026 quarter and beyond.

On EXXUA gross economics, Selhorn cited a 28% royalty plus a true-up on cost of goods sold, characterizing it as roughly a 31% cost of goods sold and a 69% gross contribution margin, with some fixed expenses anticipated in cost of goods sold. He also said the original EXXUA launch investment budget of $10 million has been reduced to under $8 million, including about $3 million of one-time items. For modeling, he suggested March-quarter OpEx could rise by $4 million to $5 million (excluding depreciation and amortization), then normalize toward an exit-rate of about $11.6 million per quarter, with roughly $500,000 non-cash. Based on those assumptions and gross margins in the mid- to high-60% range, he estimated breakeven at about $17.3 million of net revenue per quarter (and cash breakeven of about $16.6 million).

In Q&A, Disbrow said expanding the EXXUA sales force in fiscal 2026 would be “unexpected” and framed cash flow and profitability as the primary triggers for any expansion, adding that management intends to be “very judicious” and does not plan to raise capital specifically to fund sales force growth.

Management closed the call by saying it looks forward to providing more detail next quarter following what it expects will be the first full quarter of EXXUA commercial availability.

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.