Naz Rahman

Naz Rahman inquired about the expected stabilization of annual sales and contributions from the base ADHD and pediatric franchises, considering the shift in salesforce focus to Exua. He also asked for details on the medical affairs efforts for Exua, including plans for conferences, physician education, and publications.

Answer

CEO Josh Disbrow indicated that while promotional resources are shifting, the base business has relative stickiness and should remain margin positive due to expense removal. CFO Ryan Selhorn added that the ADHD and pediatric portfolios would primarily cover G&A, requiring about $13 million quarterly to break even. Mr. Disbrow detailed extensive medical affairs efforts, including hiring Dr. Gerwin Westfield, aligning with key opinion leaders, planning surgical conference presence, outlining educational programs, and developing abstracts for future publications and presentations.

Naz Rahman, VP and Biopharmaceuticals Equity Research Analyst at Maxim Group, asked about the expected stabilization of annual sales and contributions from Aytu's ADHD and pediatric franchises, given the shift of salesforce efforts towards Exua. He also sought details on the medical affairs strategy for Exua, including plans for conferences, physician education, publications, and investigator-initiated trials.

Answer

CEO Josh Disbrow indicated that while promotional resources are shifting to Exua, the base ADHD and pediatric businesses have relative stickiness and should remain margin positive even with lower volumes, as expenses will be largely removed. CFO Ryan Selhorn added that the base business needs to generate about $13 million per quarter to break even, leveraging the new cost structure. Disbrow detailed an extensive medical affairs effort led by Dr. Gerwin Westfield, including alignment with key opinion leaders, surgical presence at medical conferences, educational programs (branded and unbranded) to familiarize psychiatrists with Exua's novel MOA, and plans for subsequent publications, presentations, and investigator-initiated trials.

Naz Rahman asked about the expected annual sales and contribution levels for Aytu BioPharma's ADHD and pediatric franchises, considering the reallocation of sales force efforts to Exua and historical sales volatility. He also sought clarification on the ongoing medical affairs strategy for Exua, including conference participation and educational initiatives.

Answer

CEO Josh Disbrow indicated that while promotional resources are shifting to Exua, the base business (ADHD and pediatric) has inherent volume stickiness and may see improved net selling prices, remaining margin positive even at lower volumes due to expense reallocation. CFO Ryan Selhorn clarified that the base business needs approximately $13 million quarterly to break even, with sales and marketing expenses largely shifting to Exua. Mr. Disbrow detailed extensive medical affairs efforts led by Dr. Gerwin Westfield, including engagement with key opinion leaders, surgically precise conference presence, educational programs on Exua's novel MOA, and plans for publications and investigator-initiated trials.

Nazibur Rahman of Maxim Group asked about potential one-time revenue effects, the sustainability of ADHD franchise growth, the recovery potential for the Pediatrics business, gating factors for business development, and the potential impact of tariffs or other legislation.

Answer

Executive Joshua Disbrow confirmed there were no one-time stocking effects, attributing growth to organic performance. He expressed confidence in maintaining and growing ADHD revenue levels. For the Pediatrics business, he projected growth from current levels but likely not back to its peak $25M annualized run rate. Disbrow identified finding the 'right fit' for an acquisition—a commercial-stage CNS asset—as the primary gating factor for business development, noting valuations are somewhat high. He also stated that tariffs would have a 'de minimis' impact due to U.S.-based manufacturing and that the company is monitoring potential regulatory changes around fluoride.

Nazibur Rahman of Maxim Group asked a series of questions regarding Aytu's performance and strategy, including the drivers behind Q4 ADHD sales weakness, the go-forward plan for managed care contracting, the potential impact from increased generic Vyvanse supply, the strategic outlook for the recovering pediatric business, and the company's long-term vision for growth beyond its current portfolio.

Answer

CEO Joshua Disbrow addressed the questions, explaining that Q4 ADHD revenue was impacted by the normalization of a prior-quarter payer issue and that underlying prescription demand remains at an all-time high. He stated Aytu remains flexible on payer contracts, leveraging its RxConnect platform to ensure patient access. Disbrow sees minimal impact from Vyvanse quota changes, as Aytu's growth comes from gaining small market share. He affirmed the pediatric business is a core asset not for sale, with recovery efforts expected to drive meaningful EBITDA contribution. Long-term, the strategy involves tucking in synergistic products via RxConnect and disciplined M&A once free cash flow is achieved.

Naz Rahman from Maxim Group asked for the basis of the company's confidence in activating new clinical sites on schedule and whether the recent enrollment acceleration was driven by better site selection or by drug shortages.

Answer

Chief Medical Officer Dr. Shakil Aslam stated that confidence in site activation comes from vetting new sites on their historical timelines and improving internal processes. CEO Vincent Angotti added that several new sites are already in the final stages of activation. Both executives clarified that the enrollment acceleration is a direct result of shifting to a new site profile with nephrologist PIs in medical ICUs, who are more engaged with CRRT. Dr. Aslam asserted that the spike is due to PI enthusiasm and the right patient population, not the ongoing drug shortages.

Nazibur Rahman from Maxim Group questioned what gives management confidence in completing the Phase III NEPHRO trial by year-end, considering the time required to activate new clinical sites.

Answer

CEO Vince Angotti expressed confidence due to the advanced stage of new site activation and the favorable math of having 13 sites to enroll the remaining patients. Chief Medical Officer Dr. Shakil Aslam added that his confidence stems from the high level of engagement from new nephrologist PIs, who are highly motivated to get Niyad approved as it solves a significant, daily clinical challenge for them and their patients.

Naz Rahman of Maxim Group inquired about the STATA partnership's market opportunities, the company's retail strategy and brand consolidation, current manufacturing capacity, the potential revenue from the iRhythm partnership, and the impact of tariffs on the business.

Answer

CEO Adam Levy explained that upcoming enzyme products with STATA target larger markets than HistoSolve, which is key to their retail strategy. He noted retail entry is being explored via private label deals, dismissing brand consolidation due to distinct market segments. Levy confirmed that manufacturing capacity is very high, with plant utilization in the high teens. While unable to provide specific figures for the iRhythm deal due to an NDA, he categorized it as a steady opportunity in the $300k to $1M annual range. Regarding tariffs, Levy mentioned a mild negative margin impact but also a positive increase in domestic interest for their gels.

Naz Rahman of Maxim Group inquired about the market opportunities for upcoming STATA partnership launches, the company's retail strategy, manufacturing capacity, the economic potential of the iRhythm partnership, and the impact of tariffs.

Answer

CEO Adam Levy explained that new enzyme products with STATA target larger markets than HistoSolve, aiding a future retail strategy. He confirmed manufacturing capacity is still low (high teens utilization), offering significant room for growth. Levy positioned the iRhythm partnership in the $300k-$800k annual revenue range and noted that tariffs have a mild negative impact on some product margins but positively stimulate domestic interest in their hydrogels.

Nazibur Rahman of Maxim Group inquired about the impact of the AbbVie launch delay on 2025 revenue guidance, the market opportunity for the new product with STADA, and the growth trajectory and marketing strategy for the Histosol product, particularly regarding TikTok. He also asked about the operational and financial implications of potentially moving manufacturing to Texas due to tariffs and sought details on further margin optimization for the company's consumer brands.

Answer

Adam Levy, an executive, clarified that the AbbVie delay has a minimal impact on the $13 million revenue guidance as little was initially factored in. He explained the new STADA product is another digestive enzyme in a line extension strategy. Levy noted that Histosol sales continue to grow monthly, but a TikTok marketing push is on hold pending clarity on the platform's future. Regarding tariffs, moving manufacturing to Texas is a contingency plan ('Plan C') if rates become untenable, but the current 35% rate is manageable. He also confirmed that brand margins are improving through more efficient ad spend, with Q1 being the most profitable quarter for the brand despite not having the highest sales.

Nazibur Rahman asked about the expected cadence to achieve positive adjusted EBITDA, the size and breadth of the new customer pipeline, the market opportunity and promotional strategy for the innovative optics partnership, and for an update on the AbbVie Resonic device launch.

Answer

Executive Adam Levy stated that NEXGEL expects to reach positive adjusted EBITDA 'pretty quickly,' with improvements in Q1 and a significant ramp-up in Q2 driven by new customers. He described the new customer pipeline as having 4-5 large, long-cycle opportunities at any given time, spanning simple devices to more complex diagnostics. For the innovative optics product, Levy noted they are partnering with a firm that has existing industry relationships and expect to begin selling mid-year 2025. Regarding AbbVie, he confirmed they are on schedule to ship initial product orders in Q2 2025.

Nazibur Rahman asked about NEXGEL's strategic initiatives after achieving positive cash flow, the regulatory steps and commercial timeline for the laser hair removal hydrogel, the expected revenue impact from the holiday season, and the progress on expanding distribution into Europe and U.S. retail.

Answer

CEO Adam Levy explained that reaching positive cash flow enables a strategic shift to 'offense,' including potential acquisitions and expansion. He clarified the laser hair removal study is for commercial marketing claims, not regulatory approval, with revenues anticipated in the first half of 2025. Levy expects a significant holiday sales increase for the Silly George brand, though the exact scale is uncertain. He also mentioned European distribution deals are expected in H1 2025, and discussions with major U.S. retailers for Silverseal are ongoing for a potential 2025 launch.

Naz Rahman of Maxim Group questioned the current and expected impact of same-day dosing data on ROLVOIDON sales, the timeline for NCCN guideline inclusion, the potential peak sales for SYMPAZAN, and whether resources from OTREXUP could be redirected to accelerate growth in core products.

Answer

CEO Brendan O’Grady stated that interest in ROLVOIDON's same-day dosing is increasing and expects a peer-reviewed publication this year to be a further catalyst, with potential NCCN guideline inclusion by 2026. He projected that SYMPAZAN net sales could potentially double to the $25-30 million range in the coming years. O'Grady confirmed that resources are indeed being redirected to ROLVOIDON and SYMPAZAN, but this strategic shift was already factored into the company's existing financial projections.

Nazibur Rahman of Maxim Group inquired about the progress of expanding Rolvedon into the hospital setting and sought rationale for maintaining the full-year adjusted EBITDA guidance despite Q1 results.

Answer

Executive Brendan O’Grady explained that successful hospital expansion for Rolvedon is contingent on growing commercial payer coverage, which the company is actively pursuing with plans for expansion in the second half of the year. Regarding guidance, O'Grady stated that it is too early to make adjustments and the company is still tracking within its established ranges for both net sales and EBITDA, with a potential update in August.

Nazibur Rahman asked about the commercial impact of the Rolvedon same-day dosing data, questioning if there has been an uptick in its use and the timeline for getting the data included in NCCN guidelines to drive future adoption.

Answer

CEO Brendan O’Grady stated that there has not yet been a significant commercial impact from the same-day dosing data, which was first presented in December. He outlined the strategy for 2025, which involves publishing the data in a peer-reviewed journal and then approaching the NCCN for guideline inclusion in the second half of the year, though inclusion is not guaranteed. He anticipates a gradual increase in usage as physician awareness grows.

Nazibur Rahman from Maxim Group asked two questions regarding ROLVEDON: first, at what point the pricing decline might stabilize, and second, the potential timeline and logistics for incorporating the upcoming same-day dosing data into NCCN guidelines.

Answer

CFO Ajay Patel addressed pricing, stating that the GCSF market remains highly competitive, and he anticipates the trend of pricing declines will continue as market share stabilizes. An executive, Brendan O’Grady, handled the NCCN question, explaining that after the data is presented in December, there is roughly a six-month window to work with NCCN, suggesting a potential guideline update between the middle and end of the following year.

Naz Rahman asked for clarification on the proposed Ambulatory Specialty Model (ASM), specifically regarding the timelines for physician evaluation and the implementation process, including whether it requires congressional approval.

Answer

CEO John Tucker explained that the ASM rule is currently under review, with an anticipated rollout in January 2027 for data collection that will affect 2028 payments. He confirmed that CMS has the authority to implement the program without a vote from Congress. Tucker outlined the timeline, with the public comment period closing in September 2025 and physicians being notified in mid-2026, expressing strong optimism about its alignment with Furosex's value proposition.

Naz Rahman of Maxim Group inquired about several aspects of Processa's oncology pipeline, including the enrollment timeline for the next-gen capecitabine 300mg cohort, the potential design of its Phase 2b trial, the status of the macromolecule assay for next-gen gemcitabine, details on the next-gen irinotecan dosing regimen and selectivity, and the estimated costs for upcoming Phase 2b trials.

Answer

Dr. David Young, President & CEO, addressed the questions by stating that the capecitabine cohort enrollment should complete within a month or two, and the Phase 2b trial design, likely involving 3-4 arms, will be finalized after an upcoming FDA meeting. Regarding next-gen gemcitabine, he confirmed the biomarker assay is in the analytical stage, with clinical validation planned for the Phase 2b trial, but declined to specify its nature due to IP concerns. For next-gen irinotecan, Dr. Young explained it's a prodrug with enhanced cancer cell attraction, not a new formulation, and confirmed a significant but undisclosed improvement in selectivity. He concluded that trial cost estimates are premature as they depend on FDA negotiations and final study designs.

Naz Rahman of Maxim Group asked for details on the upcoming gastroparesis symptom data, the regulatory pathway regarding symptom scores, whether gastric emptying improved over the 28-day trial, and the nature of any study discontinuations or adverse events. He also inquired about the planned duration for the Phase 2B trial and the development path for PCS3117.

Answer

President & CEO Dr. David Young stated that for gastroparesis, they expect to see a trend in symptom improvement and that FDA approval can be based on a composite score. He confirmed they only measured gastric emptying at the beginning and end of the 28-day study. Discontinuations were not related to the mild-to-moderate adverse events observed. The upcoming Phase 2B trial will have a minimum 12-week treatment period to meet FDA guidance for chronic conditions. For PCS3117, the company plans to meet with the FDA in H1 2023 to define the development path.

Naz Rahman of Maxim Group LLC asked for an update on the PCS3117 gemcitabine program, specifically the status of the macromolecule assay development and the timeline for an FDA meeting. He also questioned what data to expect from the PCS12852 top-line results versus the full analysis and inquired if the study included an open-label portion.

Answer

President and CEO Dr. David Young stated that the PCS3117 assay development is ongoing to determine the optimal sampling method, and an FDA meeting is targeted for early 2023, pending sufficient progress. For PCS12852, he explained that initial top-line data, expected around October, will focus on gastric emptying rates, while later data will cover symptomology. Dr. Young confirmed there is no open-label portion for the current PCS12852 study, as the goal is to proceed directly to a Phase 2B trial.

Naz Rahman from Maxim Group asked for the patient screening pass/fail rate for PCS499, the company's confidence in meeting year-end data milestones for PCS499 and PCS12852, and the timeline for an FDA meeting regarding PCS3117.

Answer

CEO Dr. David Young clarified that a precise screening pass rate for PCS499 is difficult to provide due to a recent process change, but a new pre-screening procedure is improving qualification. He expressed high confidence in meeting the PCS12852 timeline but noted the PCS499 timeline is more dependent on the COVID-19 situation. Dr. Young also stated they plan to meet with the FDA about PCS3117 at the end of the year and clarified they are evaluating 'macromolecules' as potential biomarkers, which are not yet validated.

Naz Rahman questioned the clinical value of the three different histology reading methodologies, whether Galmed had discussed them with the FDA, if there were any biomarker correlations with the AI readings, and if the company was considering partnering Amilo-5MER.

Answer

President and CEO Allen Baharaff stated that the different methodologies address the issue of sensitivity, with AI and paired reading being more sensitive than the categorical NASH CRN system. He confirmed plans to discuss this data with the FDA and KOLs. While hinting at interesting biomarker correlations, he deferred details for an upcoming AASLD presentation. He affirmed that the company is absolutely considering partnerships for Amilo-5MER's later-stage development.