Aytu BioPharma (AYTU) 2026 財年第四季財報電話會議：EXXUA 成長與 2027 財年展望

重點總覽

• Aytu BioPharma 公布 2026 財年第四季淨營收為 1,610 萬美元，年增 6%，且高於第三財季的 1,240 萬美元。全年淨營收為 5,760 萬美元。
• EXXUA 於第四財季產生 390 萬美元 的淨營收，高於第三財季的 240 萬美元。單季處方量成長至 3,323，高於前一季的 1,398，出貨量則為 4,599 單位。
• 該公司單季調整後 EBITDA 恢復正數，達到 50 萬美元，相較於第三財季的 虧損 280 萬美元。第四財季淨虧損縮小至 10 萬美元。
• 現金餘額維持相對穩定，為 2,630 萬美元（截至 2026 年 6 月 30 日），儘管同時削減了債務。Aytu 產生了 330 萬美元 的 2026 財年營運現金流，隨後償還了剩餘的循環信貸餘額。
• 管理層預計 2027 財年 GAAP 營業費用為 4,900 萬美元至 5,400 萬美元，現金基礎營業費用為 4,500 萬美元至 4,900 萬美元。公司預計截至 2027 年 6 月 30 日止的六個月將產生正向調整後 EBITDA。
• 季度結束後，EXXUA 處方量持續上升，分別達到 7 月的 1,377 張、8 月的 1,408 張，以及單週新高的 394 張（截至 9 月 4 日當週）。

關鍵財務數據

2026 財年毛利為 3,680 萬美元，即 64% 的毛利率。全年淨虧損為 1,430 萬美元，而調整後 EBITDA 則為負 370 萬美元。

營業現金流改善了 520 萬美元，轉為正數 330 萬美元，相較於 2025 財年的 190 萬美元流出。Aytu 使用了 790 萬美元於融資活動，主要用於償還循環貸款、定期債務與固定支付義務。

業務與營運績效

EXXUA 處方數持續成長

EXXUA 在 2 月底至 3 月初擴大實地推廣後，完成了第一個完整的上市季度。每月處方數從 4 月的 973 張 增加至 5 月的 1,089 張，且 6 月達 1,261 份。

接近 1,200 位不重複的開方醫師已開立 EXXUA 處方，且近 2,500 位不重複的患者已接受該治療。管理層特別指出重新調劑與重複開立處方的活動有所增加，儘管許多醫師僅向一至兩位患者開立過 EXXUA 處方。

Aytu 為了處理解約效益不佳的問題，將外勤業務人員從 3 月底的 43 名減少至 7 月的 32 名，隨後重新組建至約 42 名業務代表。每位業務代表的月平均處方量從約 3 月的 18 份增加至約 7 月的 43 份。

前 10 名最活躍的銷售專家平均每週開出近 15 份處方，而前 5 名平均達 18.5 份。管理層表示，占目前銷售團隊約 60% 的 24 個銷售區域，貢獻了 70% 的處方量。

管理層展示了潛在的規模效應，而非發布營收指引。在 45 個銷售區域且每位代表每週開出 15 份處方的情況下，EXXUA 每週處方量將達到 675 份，管理層將其等同於按目前售價計算約 2,600 萬美元的年化跑率。更高生產力的情境將意味著更大的年化跑率，但這些數字並非公司預測。

藥物給付與報銷

管理層將 EXXUA 優於預期的淨實現價格主要歸因於商業保險機構的核准率較高。政府業務占產品組合的比例遠高於 20% 至 25%，且持續成長。

Aytu 尚未針對 EXXUA 簽訂商業保險合約，亦無額外的醫療補助 (Medicaid) 或醫療保險 (Medicare) 折讓。管理層表示，目前的核准率降低了主動簽約的需求，除非提出的條款在經濟效益上具吸引力。

注意力不足過動症 (ADHD) 業務仍為現金流貢獻來源

ADHD 產品組合貢獻了 1,040 萬美元的第四季營收，主要受到更好的總金額至淨金額轉化所支持。Adzenys 及其授權學名藥維持了 Adzenys 及其同等學名藥市場中約 80% 的處方量。

Cotempla 的授權學名藥處方量每週持續成長。在雙方和解協議允許的 7 月 1 日之後，Teva 尚未推出其 Cotempla 學名藥產品，相較於 Aytu 的基本情境假設，創造了潛在的上行空間。然而管理層指出，由於學童放假，ADHD 的需求通常在 Aytu 財年的上半年較為疲弱。

管理層指引

Aytu 未提供 2027 財年營收指引。其費用與獲利能力框架包括：

• GAAP 營業費用： 約 4,900 萬美元至 5,400 萬美元。
• 現金基礎營業費用： 約 4,500 萬美元至 4,900 萬美元。
• 銷售與行銷投資： 高達 600 萬美元，從 2026 財年延至 2027 財年，以支持 EXXUA 的銷售覆蓋率、行銷與推廣教育。
• 毛利率： 預計在 2027 財年初期最低，並朝 2027 財年第四季的 66% 至 67% 改善，主要得益於 EXXUA 規模擴展及固定成本被吸收。
• 獲利能力： 管理層預計截至 2027 年 6 月 30 日止的六個月將產生正向的調整後 EBITDA。
• 現金流： 預計下半年將有所改善，具體取決於帳款回收、營運資金需求與付款時點。

由於預定的 EXXUA 投資、ADHD 季節性因素以及年度 PDUFA 費用開支，管理層預計上半年的調整後 EBITDA 和營運現金流將低於下半年。

風險與關注事項

• EXXUA 仍處於上市初期，許多開方醫師僅有少數患者的使用經驗。
• 處方量與產品出貨量是不同的衡量指標。呈報的營收反映了扣除回扣、折扣及其他調整後的通路銷售額，可能無法完全反映單一季度的處方狀況。
• 管理層提醒，隨著支付方結構、報銷情況和患者支援計畫的演變，EXXUA 目前有利的總額轉淨額 (gross-to-net) 變現率可能會發生變化。
• 新任銷售代表通常需要 6 至 9 個月 才能具備充分的生產力，並大約需要 9 至 12 個月 才能達到損益平衡。
• 季度獲利能力和現金流可能會隨商業投資、ADHD（過動症）季節性、營運資金及年度法規費用而波動。

分析師問答重點

• 事前審查授權： 管理層表示，透過其支援計畫提交的申報核准率約為 70%，這得益於簡便的流程，以及患者群體通常具有使用過多種先前藥物的經驗。
• 支付方合約： Aytu 不預期單一商業或政府合約會帶來需求的立即增加。管理層強調，合約必須具備經濟合理性，因為僅靠支付方的納入許可並不能直接推動醫師開立處方。
• RxConnect： 透過 RxConnect 合作藥局調劑的 EXXUA 處方比例，目前仍低於 ADHD 產品組合高達 80% 的水準，但管理層預期參與度隨著時間推移將會提升。
• 銷售團隊擴張： 管理層認為外勤銷售團隊規模有潛力顯著大於當前水準，但擴張步調將取決於獲利能力與現金流，而非固定的招聘目標。
• ADHD 業務韌性： 管理層將營收的季增改善主要歸因於積極的總額轉淨額 (gross-to-net) 管理，以及藥局在原廠藥與授權學名藥之間靈活切換的能力。

法人說明會完整逐字稿

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完整財報電話會議逐字稿

管理層陳述

Operator

Greetings. Welcome to the Aytu BioPharma Fiscal 2026 Full Year and Q4 Earnings Call. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to your host, Robert Blum with Lytham Partners. You may begin.

Robert Blum

All right. Thank you, and good afternoon, everyone. As the operator indicated, during today's call, we will be discussing Aytu BioPharma's fiscal 2026 fourth quarter and full year operational and financial results for the period ended June 30, 2026.

Joining us on today's call is Aytu's Chief Executive Officer, Josh Disbrow; and Ryan Selhorn, the company's Chief Financial Officer. At the conclusion of today's prepared remarks, we will open the call for a question-and-answer session. I'd like to remind everyone that today's call is being recorded. A replay of today's call will be available by using the telephone numbers and conference ID provided in the press release issued earlier today or by utilizing the link on the company's website under Events and Presentations.

Finally, I'd also like to call to your attention the customary safe harbor disclosure regarding forward-looking information. The conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations and future potential operating results of Aytu BioPharma. Although management believes these statements are reasonable based on estimates, assumptions and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay.

Actual results may differ materially as a result of risks, uncertainties and other factors, including, but not limited to, the factors set forth in the company's filings with the SEC. Aytu undertakes no obligation to update or revise any of these forward-looking statements, except as required by law.

With that said, let me turn the call over to Josh Disbrow, Chief Executive Officer of Aytu BioPharma. Josh, please proceed.

Joshua Disbrow

Thanks, Robert, and welcome, everyone. I'm very excited about the progress we're making and the opportunity ahead for Aytu. We finished fiscal 2026 with an encouraging fourth quarter as EXXUA continued to build, our ADHD business performed better than anticipated, and Aytu returned to positive adjusted EBITDA. EXXUA gives us something special to build around. It's the first and only selective serotonin 5-HT1A receptor agonist approved by the FDA for the treatment of major depressive disorder in adults. Its novel mechanism and differentiated tolerability profile address an important need in a category where many patients struggle to find a treatment that works well for them and that they can stay on.

As a reminder, the opportunity is substantial. An estimated 21 million Americans are affected by MDD, and the U.S. prescription MDD market exceeds $22 billion. Even a modest foothold in a market of that size would be meaningful for Aytu. We strongly believe EXXUA has the potential to become an important treatment option and a major growth driver for our company. It's one thing to have had excitement before the launch occurs, but what makes this especially exciting is that we are now seeing that opportunity begin to take shape in clinical practice. Physicians are gaining experience, patients are continuing treatment, and our prescription base is expanding.

These early results reinforce our conviction in EXXUA and give us a strong reason to keep building with the same focus on execution and financial discipline. As we have discussed for some time, our approach to EXXUA is methodical. We are building the business with a clear focus on productivity, the return on our commercial investment, and preserving cash. As we have communicated, this was never going to be an oversized "spend-at-all-costs, boom-or-bust type of launch." This quarter gives us meaningful evidence that our approach is working.

Today, let me spend most of my prepared remarks discussing the EXXUA execution, including what we're seeing in the field and the decisions we are making as the launch develops. I'll also spend a little more time on ADHD because the notable durability of that business certainly deserves attention. Ryan will then cover our financial results and our fiscal 2027 outlook.

EXXUA generated $3.9 million of net revenue in the fourth quarter, up from $2.4 million in the third quarter, bringing its fiscal '26 contribution to $6.6 million. As a reminder, our formal launch only occurred at the beginning of January and broader field deployment in late February and early March. We remain early in building physician awareness and experience with EXXUA, having only just completed our first full quarter of launch.

During the June quarter, total prescriptions were 3,323 compared with 1,398 in the March quarter. The monthly progression was 973 prescriptions in April, 1,089 in May, and 1,261 in June. As we entered fiscal '27, July increased further to 1,377, August was up at 1,408 prescriptions. Importantly, EXXUA grew from July to August despite the overall MDD market declining. That is meaningful progress as more physicians begin using EXXUA and patients move from initial treatment into refills.

One item I think is important to understand as we look at the trajectory in the early going is that we have consistently said we would manage this launch methodically, and that includes expecting a high-performing sales organization and holding that sales organization accountable for performance. Where representatives have not been performing at high levels or at the high levels we need, we have made adjustments in real time. As a result, we've seen ebbs and flows in the number of sales individuals on a month-by-month basis. Importantly, several of those changes occurred during June and July, and our field force reached a low of 32 representatives in July. That was down from 43 reps at the end of March.

This was intentional as we are demanding high performance across the sales organization. Standards have been set and will be upheld, and we'll remain disciplined with our capital deployment throughout the launch. Those changes temporarily reduced our coverage while we work to fill territories and optimize the profile of our sales specialist position. Since that low, we brought the sales force back to approximately 42 representatives, and we continue to fill open positions. We're also adjusting territory coverage based on what we're learning, adding resources where the opportunity supports them and combining sales specialist coverage where that makes better economic sense.

One of the key metrics we're watching is weekly and monthly prescriptions per sales rep. Using monthly sales field force headcount as a directional measure, in March, we had 761 prescriptions and 43 sales specialists, or about 18 prescriptions per sales rep per month. In July, we had 1,377 prescriptions and 32 representatives, or approximately 43 prescriptions per rep for the month. That's more than a twofold increase in prescriptions per rep with total monthly prescriptions also increasing 81% over that period. We're continuing to be proactive and fine-tuning the team, but we view that as an encouraging measure of the productivity of our commercial effort.

To add some additional color on rep performance, which is clearly going to be the key driver of our success with EXXUA, consider some other numbers. If you look at our current active sales specialists, the top 10 are averaging almost 15 prescriptions per week. The top 5 are averaging 18.5 prescriptions per week. But importantly, as I share these numbers, I should note that we are not top-heavy with respect to the percentage of territories driving the majority of the actual prescriptions. In fact, 24 territories, or approximately 60% of the current sales force, are driving 70% of the actual prescriptions, demonstrating very good breadth across many geographies and across many sales specialists. So that gives us great confidence in knowing that we have a product that is being and can be broadly adopted and broadly sold.

To see what actual weekly scripts could be in the relative near term as some of our newer sales specialists we've onboarded to come up the curve, consider what a weekly run rate looks like by simply having 45 territories at the weekly script rate of the top 5 or 10 territories. By simply generating 15 prescriptions per rep per week, that gets us to 675 TRxs per week. And at the current selling price, that's already a $26 million annual run rate if you were to simply dollarize TRxs for ease of math.

Taking that weekly rep average to 20 TRxs per week, which, again, 5 territories are already averaging that, plus or minus. And then you're looking at -- excuse me, 900 TRxs weekly or about a $35 million run rate annually. And then at 30 TRxs per rep per week, again, a weekly number achieved by multiple reps already, and that takes the annual run rate to over $50 million, again, by simply dollarizing prescriptions.

So with the refined sales team that will be getting us to 40-plus and more likely closer to 45 territories, you can see why we're excited about a significant lift of script levels in the relative near term. And speaking of near term, and this is happening really before any of the newly hired reps are even up the curve, we're seeing EXXUA take that next leg up. For the week ending September 4, just before Labor Day, we generated 394 prescriptions, a significant jump from July and August levels. Again, when the newly onboarded folks get their feet under them, we're excited to see what the script trends look like.

Growing refill activity is also part of the picture alongside the work our representatives are doing to develop prescribing relationships. We look at this measure together with total prescriptions, new and repeat prescribers, and the economics of the business as we decide where to put the next dollar of investment. This is what we mean by a methodical launch. We are using the data to make staffing and spending decisions, learning from the territories that are performing well and addressing the ones that need improvement. We believe that's how we build a commercial organization that can support EXXUA over time while maintaining the financial discipline we've worked hard to establish.

Perhaps most importantly, the feedback from physicians who are gaining experience with EXXUA remains highly encouraging. In our latest launch-to-date update, nearly 1,200 unique prescribers have written EXXUA and nearly 2,500 unique patients have received it. We're seeing repeat prescribing from physicians who are developing a broader base of experience with the product, along with encouraging feedback on patient response and on patient tolerability. At the same time, many physicians in that prescriber base have only used EXXUA for 1 or 2 patients. Of course, we know it takes time for a physician to identify appropriate patients and then assess their experience and then ultimately become comfortable using a new medicine more broadly. That process develops over time.

Our opportunity is to deepen utilization among those early adopters while continuing to introduce EXXUA to additional prescribers. We remain very encouraged by the response from physicians who are moving beyond their first few patients and continuing to prescribe. And it's precisely those prescribers who have written EXXUA for a handful or more patients that are most impressed with the results. We continue to hear that across the country. And of course, that gives us great confidence in the product.

Access also continues to support the launch. Reimbursement approval rates remain encouraging, and we are seeing a growing contribution from Medicaid and Medicare alongside the commercial business. RxConnect remains an important part of helping patients initiate and continue treatment and helping prescribers and their practices navigate access. Ryan will touch on this a bit, but gross-to-nets are significantly higher than our initial expectations.

As we move into fiscal '27, we will continue investing in EXXUA sales and marketing and in the medical and scientific education that supports physician understanding of the product. We will continue assessing the results and directing resources toward the activities that are producing the strongest return. Our fourth quarter results are an encouraging indication of what this model can deliver. We grew EXXUA revenue, benefited from the continued contribution of our legacy products, and generated positive EBITDA at the company level while keeping cash relatively stable.

Profitability and cash preservation remains central to how we're managing the launch. Of course, there will continue to be variability in quarterly results as we invest and as the business moves through its normal seasonal patterns. Again, Ryan will walk through that in more detail. Our objective, however, remains to build a durable, profitable EXXUA business on the platform we already have with commercial spending tied to strong ROIs.

Turning to ADHD. The portfolio performed better than anticipated in the fourth quarter. Net revenue was $10.4 million compared to $9.1 million in the March quarter and $13.1 million in the fourth quarter prior year. For Adzenys, our brand and authorized generic together continue to retain approximately 80% of the prescriptions in the market for Adzenys and its generic equivalents. We believe this speaks to the durability of the franchise and the value of the RxConnect model even with substantially less commercial support behind the brand.

We also have our Cotempla authorized generic in the market, and it's gained prescriptions week-over-week. As of today, Teva has not yet launched its generic version of Cotempla following the July 1 date permitted under our settlement agreement with Teva, presenting potential upside to our base case assumptions around Cotempla's revenue run rate. As always, ADHD has normal seasonality with the earlier part of our -- the first half of our fiscal year typically softer due to kids being out of school. The fourth quarter performance, however, reinforces our confidence in the value this portfolio brings to Aytu. It remains an important source of profit and cash to support our investment in EXXUA.

Rounding out the legacy business, our pediatrics portfolio generated $1.8 million of net revenue in the fourth quarter compared to $0.9 million in the March quarter and $2 million in the prior year quarter. These are mature products that we continue to service efficiently. And while smaller, pediatrics does remain a useful and durable contributor to the legacy business and the financial foundation supporting EXXUA. Overall, we are highly encouraged by the progress in EXXUA and the durability of our legacy business. Our focus remains on execution, profitability, and preserving cash.

With that, let me turn the call over to Ryan for financial results and fiscal 2027 outlook. Ryan?

Ryan J. Selhorn

Thank you, Josh. Let's jump right into it. I'll primarily cover our fourth quarter results and then spend a few minutes on our outlook and how we expect fiscal 2027 to unfold.

Let's start on the revenue line. Net revenue for the fourth quarter of fiscal 2026 was $16.1 million compared to $15.1 million in the prior year period, an increase of 6%. Revenue also improved from $12.4 million in the third quarter with sequential increases across all 3 portfolios. For fiscal 2026, net revenue was $57.6 million.

Breaking that down, EXXUA contributed $3.9 million in the fourth quarter compared to $2.4 million in the third quarter. We are encouraged by that progression as we build the prescriber base and expand our commercial activity. The recent prescription data Josh discussed show continued progress with 3,300 scripts written during the fourth quarter. Remember, however, that prescriptions and unit shipments are different measures. During the fourth quarter, we shipped 4,599 units. Revenue reflects product sales into the channel, net of estimated rebates, discounts, and other adjustments, and will not necessarily move in lockstep with prescriptions in any given period.

We continue to see favorable gross-to-net for EXXUA relative to our initial launch assumptions. Payer mix, reimbursement, and the level of patient access support all influence these economics. It is still early, and we want to see how those factors develop over a longer period before assuming the current realization rates will hold. The ADHD portfolio generated $10.4 million in the fourth quarter net revenue compared to $13.1 million in the prior year period and $9.1 million in the third quarter. The sequential improvement benefited primarily from better gross-to-net realization. We continue to view this portfolio as an important source of cash flow with limited promotional spending behind it.

The Pediatric Portfolio generated $1.8 million in fourth quarter net revenue compared to $2 million a year ago and $0.9 million in the third quarter. These are mature products, and payer mix, returns, and ordering patterns can affect the quarterly results. However, they continue to contribute to the cash generation of the legacy business.

Gross profit was $10.4 million in the fourth quarter with a gross margin of approximately 65% compared to $10.3 million and 68% in the prior year period. Sequentially, gross margin improved from 61% in the third quarter, which included a $0.7 million inventory write-down. For fiscal 2026, gross profit was $36.8 million or 64%.

EXXUA's underlying economics remain attractive. As we discussed last quarter, the royalty and product cost structure equates to approximately 31% of cost of goods sold, or roughly a 69% gross contribution margin before certain fixed costs. Our consolidated reported margin also reflects those fixed costs, product mix, and inventory adjustments. I'll come back to margin outlook in a moment.

Turning to operating expenses. Total operating expenses were $11.2 million in the fourth quarter compared to $17.9 million a year ago. The prior year quarter included an $8.3 million impairment charge. So excluding impairment, restructuring costs, and intangible asset amortization from both periods, operating expenses were $10.4 million compared to $8.7 million on an apples-to-apples basis.

The year-over-year increase primarily reflects EXXUA commercialization costs, partially offset by continued cost discipline elsewhere in the organization. We spent less on certain commercial programs than originally planned during fiscal 2026, and some of that planned activity will shift into fiscal 2027. As Josh mentioned, we want to make sure we have strong ROIs on all investments made. If we don't believe we can get the returns or need to adjust the plan to get it right, we will.

Interest expense was $0.4 million in the fourth quarter compared to $0.7 million a year ago. For the full year, interest expense declined to $1.9 million from $3.7 million, primarily due to the paydown of our fixed payment arrangements. Those arrangements had no remaining balance at June 30.

For the fourth quarter, we reported a net loss of $0.1 million. On a per share basis, the loss rounded to $0.00 per share. This is compared to a net loss of $19.8 million or $2.92 per share in the prior year period. For fiscal 2026, net loss was $14.3 million. The fourth quarter included a $1 million noncash derivative warrant liability gain. The prior year fourth quarter included $18.1 million of combined impairment expense and derivative warrant liability loss. These items have a significant effect on the GAAP comparisons.

Adjusted EBITDA was a positive $0.5 million for the fourth quarter compared to a positive $2 million a year ago and a negative $2.8 million in the third quarter. For fiscal 2026, adjusted EBITDA was negative $3.7 million. The reconciliation of this non-GAAP measure to net loss is included in today's earnings release.

Turning now to the balance sheet. Cash and cash equivalents were $26.3 million at June 30 compared to $26.7 million at March 31 and $31 million at the end of fiscal 2025. While cash was relatively stable during the quarter, we also reduced our revolving credit facility balance to $6.1 million from $10.4 million at March 31. Subsequent to year-end, we repaid the remaining revolver balance.

Separately, the carrying value of our term debt, including the current and noncurrent portion, was approximately $11 million at June 30. For fiscal 2026 as a whole, we generated $3.3 million of cash from operating activities compared to using $1.9 million in fiscal 2025, an improvement of $5.2 million. Improved receivable collections and inventory turnover were meaningful contributors. We also used $7.9 million in financing activities, primarily to reduce our revolver, term debt and fixed payment arrangements. Accordingly, the year-over-year reduction in cash reflects significant balance sheet deleveraging rather than operating cash burn.

Stockholders' equity was $35.3 million at June 30, 2026, compared to $19 million a year earlier. As discussed last quarter, the March warrant amendments reclassified $26.4 million from warrant liabilities to equity. This was a noncash reclassification that reduced our exposure to future earnings volatility associated with those warrants.

Before I turn it back over to Josh, I want to walk through the financial framework for fiscal 2027. We are not providing revenue guidance, but we do want to give you a clear view of our planned expenses, margin expectations, and the expected progression of profitability and cash flow.

Our current plan calls for approximately $49 million to $54 million of operating expenses on a GAAP basis. Excluding noncash expenses, total cash-based operating expenses are expected to be approximately $45 million to $49 million. The largest increase is in sales and marketing, where we expect to invest up to $6 million, now planned for fiscal '27 rather than fiscal '26. This was always part of the plan, but it has been deferred from fiscal '26 to fiscal '27. The increase will support sales force coverage, marketing programs, and physician and patient education for EXXUA. We also expect a more modest increase in G&A, including medical affairs and support for the commercial organization.

Research and development expense should remain minimal, and we expect interest expense to continue to decline steadily on a full year basis. As we mentioned, we will manage spending against the results we are seeing. The budget gives us room to support the opportunity, and the timing and level of investment will depend on the prescription trends, access, commercial performance and available liquidity. We currently expect consolidated gross margin to be lowest in the first part of fiscal 2027 and to improve as the year progresses, driven principally by anticipated product mix as EXXUA continues to scale and the absorption of fixed manufacturing and supply chain costs.

Our current expectation is to approach 66% to 67% gross margin in the fourth quarter of fiscal 2027. The timing of the aforementioned investments as well as the normal seasonality are important to understanding the year. We expect lower adjusted EBITDA and operating cash flow in the first half of fiscal 2027 than in the second half. We will be making planned investments in EXXUA sales and marketing ahead of their full contribution, while the ADHD business is typically seasonally softer in the first quarter to half of our fiscal year. From a cash flow perspective, we also have our annual PDUFA fees that come out in the first half of the year.

As we move into the second half, we expect that seasonal pressure to reverse and EXXUA to make a larger contribution as our commercial efforts build. Based on our current plans taken together, we expect the 6-month period ending June 30, 2027, to generate positive adjusted EBITDA. We also expect cash flow to improve in the second half, although the timing of collections, working capital requirements, and payments will continue to affect cash balances. As always, I'm happy to go over any details during Q&A.

With that, Josh, let me turn it back over to you.

Joshua Disbrow

Thank you, Ryan. As we look ahead, our conviction in the EXXUA opportunity remains extremely strong. We're seeing physicians gain experience with the product, a growing patient base, and improving prescriptions per sales specialist rate. We're also taking action where execution needs to improve. This is consistent with the approach we've described from the outset.

Overall, we're extremely pleased with the progress this quarter and remain excited about the path ahead. As always, I want to thank our entire team for their work and everyone participating on today's call.

We'll now be happy to answer any questions. Operator?

Operator

[Operator Instructions] The first question comes from Thomas Flaten with Lake Street Capital.

分析師問答

Thomas Flaten

Just to start off, Ryan, well, both of you mentioned that the GTN discount was more favorable than you had expected, and it looks like it's more favorable than our model. Can you talk a little bit about the puts and takes that made that more favorable?

Joshua Disbrow

I can take that to start, and then Ryan, feel free to fill in. And thanks, Thomas, for the question.

In short, it's just a higher-than-anticipated approval rate really across commercial payers. That's the simple answer. We're seeing it consistent. We're seeing it hang on really month-to-month. It is lower for the titration pack, but frankly, that's come in materially higher than we modeled initially. And the 30-counts of regular way prescriptions are coming in at a higher approval rate as well. So that's the key piece. And they are holding on.

And I think I don't want to suggest have the potential for improvement. But as we build a higher percentage of government business, as you probably know, that's an even higher -- excuse me, even higher -- or yes, better GTN, I should say. So that is representing well north of 20%, 25% of the business. If you look at analog products in the category, some have achieved upwards of 35% to 40% of the business coming from Medicare and Medicaid.

And so it's a combination of that portion of the business growing and then just overall improvements in overall approval rates better than, again, we had initially modeled and initially anticipated. And this, I'll remind you, is all without the commercial contracts, and we have no supplemental Medicaid or Medicare rebates.

Thomas Flaten

And then can you talk a little bit about your utilization of RxConnect for EXXUA? I know it represented a significant chunk of your ADHD portfolio, but maybe some commentary around that would be great.

Joshua Disbrow

Yes. It is -- we look at shipments into RxConnect partner pharmacies, and then we look at dispensed claims. I'm most interested in dispensed claims because ultimately, that's where the rubber meets the road, and that's where the patient obviously gets the prescription. It's lower than the current percentage of ADHD, but certainly, we would expect it to grow over time. When you look at sort of, dispensed claims for ADHD, that's in any given month, upwards of 80% of our total prescriptions are dispensed through an RxConnect partner pharmacy or as part of the program.

It's not to that level, but it is growing because we do have quite a few prescriptions coming from white space and from areas where we don't have rep coverage, we do have some, what we call free-range prescriptions. And we also are going to build a materially higher base of government business. And some of those we don't track at the moment. And while those can and are filled at RxConnect partner pharmacies, in many cases, those are just filled at a pharmacy outside of the network.

And so that having been said, we would expect over time to continue to drive more and more prescribing to the RxConnect pharmacies, just given the moat that, that represents and what we think can really prove out to be an elongated tail even post-loss of exclusivity. But obviously, we've got some time before we get there.

Thomas Flaten

And then final one for me, speaking of which, you obviously had a nice sequential uptick on the ADHD portfolio. And I realize that the Cotempla generic didn't come to market. But can you talk a little bit about how you've been able to not only maintain but then grow sequentially the ADHD portfolio with limited coverage? Is it just one of those things that happened? Or was there something proactive that you did?

Joshua Disbrow

Well, we're always monitoring the base business as it relates to gross-to-net reimbursement rates, pharmacy reimbursement in particular. And there certainly is real-time adjustments going on to ensure that we're optimizing sort of the payer sort of the mix there as it relates to dispensing and filled prescriptions and claims. So that's a piece of it. So certainly, there's an element of being proactive. So I would say GTNs had some improvement and some uptick. There was -- and that's -- I mean, that's the bulk of it really.

So yes, I would say that has been actively managed, and that's something that could be managed with relatively few resources. We have, of course, internal resources dedicated to that. And so it largely has just been optimizing GTNs and ensuring that the pharmacies are sort of in adequate shape with respect to the AG and the brand. And of course, we're able to seamlessly toggle, or they're able to seamlessly toggle between the brand and the AG.

And again, I'll remind you that the ANDA has really been slow. The Teva product has kind of hardly scratched 20% when you look at the overall available market of prescriptions. And while prescriptions have come down year-on-year, that's largely attributable to just the full promotion that we pulled over a year ago.

Operator

The next question is from Naz Rahman with Maxim Group.

Nazibur Rahman

Congrats on the progress. Just a couple. So first, in terms of the prior auths, could you provide some color on, I guess, how the prior auths are evolving? And what I mean by that is, are you seeing the prior auths get approved first pass more frequently? Or do you know what percentage of the prior auths get approved in the first pass and versus how many requiring multiple back and forth? And I have a follow-up after that.

Joshua Disbrow

Yes. Thanks for the question, Naz. In terms of prior auths, it's still relatively early stage. And what I'll say is because of the nature of this patient with multiple failures, we absolutely are having success from a prior authorization perspective. So obviously, we're not doing them. We can't do them on behalf of the customers. It's the prescribers that ultimately complete the paperwork. But we've made it very simple for them. It's a really straightforward process.

Physicians are increasingly utilizing the service. They have to engage with a specific vendor to get signed up and so forth, and they log in and essentially do a very, very simple process. And the approval rates for prior authorizations are quite high. If you look at the success we're having with claims that are submitted sort of through the program, it's in the neighborhood of 70%. So it's we're having quite a lot of success. That's materially higher than most categories. And I think it's because of the ease of use of the program that we've implemented, also the class and the patient type. Again, this is going to be a patient that's often been on multiple medications. So it's been very, very encouraging in the early stages of this.

Nazibur Rahman

Got it. That was helpful. And one last question. In terms of coverage and reimbursement, I mean, previously, you've talked a lot about the importance of government payers. At this point, when can we expect, I guess, the next large bolus of payments in terms of both commercial and government payers? And what would you expect first?

Joshua Disbrow

Yes, that's a good question. We don't really think of it as bringing on any sort of 1 big lever. We think it will sort of organically evolve. Frankly, if these GTN levels just maintained with the coverage we have today without any contracts, that would be a really, really good situation, a really good story. So we continue to really scrutinize the need to contract proactively. In fact, I think we're at the point of not proactively contracting same on both sides, government and commercial. It doesn't do us any good to contract on the government side and pay large supplemental rebates when states in one way, shape or form will cover this. They might require prior authorization. But as I just described, those are not exceedingly difficult to get.

And on the commercial side, we're seeing good approval rates without any active contracts in place. Again, understanding the placement of this product is not first-line. And so the ability to get claims approved, understanding that this is often for a patient that's been on 2 or 3 or maybe more medications. So we'll, of course, continue to keep ourselves open to contracting, but we don't think of it as necessarily saying, okay, we're going to have a step function.

And because one of the things that we know is payer contracts don't drive demand. So if you sign an agreement with a large PBM, you don't automatically get a step function in your demand. It still comes down to prescribers sending prescriptions to pharmacies, and that's, of course, driven by us. So what you can do from a payer perspective is you can optimize and tweak sort of GTNs and pricing, but you don't necessarily think of those as just because you have a contract with 1 of the big 3 PBMs doesn't mean a physician will automatically prescribe.

Really, it's the contrary because we have the RxConnect setup and to some degree, we serve as the backstop, if you will, to guarantee that, that patient never pays more than $50 on the commercial claim, we don't really have a need for to go out and shout from the rooftops that we have a contract with a large PBM. It doesn't preclude the possibility that we would engage with one, but it has to be on the terms that make sense for us economically. And we're generating enough demand to start to generate some interest and some inbound conversations. But time will tell as to really how valuable those conversations turn out to be, and we're really in a good spot based on the GTNs today. And again, don't feel a need to proactively contract on either side of the ledger, commercial or government.

Operator

[Operator Instructions] The next question is from Ed Woo with Ascendiant Capital.

Edward Woo

Yes. Congratulations on all the progress. My question is on the sales rep. You mentioned that you were at 43 in March, 32 in July, 42 now. Do you have a goal in mind of where you think you want to be maybe in 6 months? And I know you mentioned that these reps get up to speed pretty fast. Is it within 3 months that you feel that they are able to hit their stride?

Joshua Disbrow

Yes. Good question, Ed. Thanks for that. The goal will be dictated, obviously, by cash flow. We said that from the beginning, but certainly materially higher than 42 or 49. I mean, we have a plan that's at least a multiple of that, if not higher, in terms of where ultimately we see the footprint getting from a sales specialist perspective, but that will be driven -- the timeline will be driven by profitability and cash flow to enable us to expand in a prudent fashion.

And so we don't have a specified goal that it has to be 60 reps by the end of the calendar year and then 120 by the middle of next, although that type of cadence would suggest that we're on a good trajectory and are generating an adequate level of cash flow to justify that level of investment. And we're being very judicious in how we think about territories. In some cases, we are doubling up in areas. In other cases, we're -- have a -- keeping a single territory just because it's able to be efficiently managed that way. And ultimately, that's sort of how we think about it.

Sorry, I missed the second part of your question?

Edward Woo

In terms of -- how quickly do these sales rep ramp up, is it quarter or 6 months?

Joshua Disbrow

Yes, 6 to 9 months realistically is a good timeframe to really think of somebody as sort of adequately tooled for the job. And if you look at really sort of a breakeven analysis, you would look at something closer to 9 or 12 months. But in terms of really identifying -- I guess there's a couple of components there, identifying that the person has the requisite skills, drive to meet all the things you need to be successful, that takes less time to ultimately get that rep to turn that into action on the part of the prescribers. That's something more like 6 to 9 months.

And so as we think about a phased approach of getting to that next layer of geographies, we sort of think of it with a 6- to 9-month ramp-up period in mind. So that's what's really encouraging. We had an all-time high prescription -- a weekly prescription level the week ending September 4 of almost 400 prescriptions. I'll remind you, that's still with something south of 40 reps really active when you think about really that we had a crop that came in a few months ago. They're still just kind of getting their feet under them.

So you get another 3 months down the road and that crop of reps starts to get turned on and deliver, and then another crop that we'll have coming in here in the fall. And so you can really envision that leg up. And that's why I use sort of the numbers I did of if you just got some of those reps up to 10, 15, and certainly, it's realistic to think that they could all be at 20 to 30 a week. It's actually -- that's significantly lower than any of our reps got on Adzenys if you looked at its historical highs. So quite confident that 40 to 45 reps and then expanding to 50 and beyond getting to 20, 30 and then ultimately 50-plus prescriptions a week, it's pretty exciting to think where that puts us from a revenue trajectory perspective.

Edward Woo

And just to clarify, the amount -- I think you mentioned 3,000 prescriptions for the quarter, does that include refills?

Joshua Disbrow

That includes refills, yes. That would be starter, and that would be initiation. It will be the starter titration packs would be sort of the initiation. And then we think of refills as once they get transitioned to the 30-count, regular sort of stable dose and then a refill beyond that.

And so yes -- and again, keeping in mind that many of these patients, they just got started over the first month or so. Some patients are titrating more slowly than the label sort of indicates. And so some of these patients are just getting into their first month or so. So we've not yet to see anything resembling sort of the compounding effect that we would expect to see as the months move forward.

Edward Woo

All right. That sounds good. And I wish you guys good luck.

Joshua Disbrow

Thanks, Ed.

Operator

We have reached the end of the question-and-answer session. And I will now turn the call over to management for closing remarks.

Joshua Disbrow

Thank you, John. Again, just to reiterate, we're extremely pleased with the progress this quarter, particularly as it relates to the trajectory we're seeing with EXXUA. We're increasingly encouraged by the number of territories driving meaningful prescriptions and ultimately, the breadth of prescribing. We're most excited about the response that we're hearing through physicians due to the feedback they're getting from their patients, patients saying things back to their physicians like it's been life-changing and haven't felt this good in years. And that's just why you do -- why we do what we do. So we continue to have the pedal down, work very hard every single day to ensure that as many prescribers as we can hear about the EXXUA story and ultimately put pen to paper to prescribe what we think is an outstanding treatment, and it's proving to be that in the real world.

So with that, we're very encouraged. We are now, of course, into our fiscal '27, towards the end already of our first quarter. So we look forward to sharing those results with you all in November. Until then, thank you for your interest in Aytu. Thanks for your time, and have a good evening.

Operator

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.