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Aytu BioPharma (AYTU) 2026财年第四季度业绩电话会:EXXUA增长与2027财年展望

TradingKey2026年9月22日 23:46
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Aytu BioPharma公布2026财年第四季度净营收1610万美元,同比增长6%,全年净营收5760万美元。核心产品EXXUA实现净营收390万美元,处方量稳步增长,季度调整后EBITDA扭亏为盈至50万美元,净亏损大幅收窄至10万美元,现金余额保持2630万美元。管理层预计2027财年下半年实现调整后EBITDA盈利,并持续优化销售团队与费用结构。

该摘要由AI生成

核心要点

  • Aytu BioPharma公布2026财年第四季度净营收为1610万美元,同比增长6%,且高于第三财季的1240万美元。全年净营收为5760万美元
  • EXXUA在第四季度实现390万美元的净营收,高于第三财季的240万美元。季度处方量增加至3,323张,高于第三财季的1,398张,出货量达4,599件。
  • 该公司季度调整后EBITDA扭亏为盈,达到50万美元,而第三财季为亏损280万美元。第四季度净亏损收窄至10万美元
  • 现金余额保持相对稳定,为2630万美元(截至2026年6月30日,尽管债务有所减少)。Aytu在2026财年创造了330万美元的经营活动现金流,随后偿还了剩余的循环信用贷款余额。
  • 管理层预计2027财年GAAP运营费用为4900万至5400万美元,基于现金的运营费用为4500万至4900万美元。预计截至2027年6月30日的六个月内将实现调整后EBITDA盈利。
  • 季度末之后,EXXUA处方量继续上升,7月达到1,377张8月达到1,408张,并达到单周创纪录的394张(截至9月4日当周)。

关键财务数据

指标2026财年第四季度对比 / 背景
净营收1610万美元较上年同期的1510万美元增长6%;第三财季为1240万美元
EXXUA净收入390万美元高于第三季度的240万美元
ADHD产品组合收入1040万美元上年同期为1310万美元;第三季度为910万美元
儿科产品收入180万美元上年同期为200万美元;第三季度为90万美元
毛利润1040万美元上年同期为1030万美元
毛利率约为65%上年同期为68%,第三季度为61%
运营费用1120万美元上年同期为1790万美元,包含上年830万美元的减值损失
净亏损10万美元上年同期亏损1980万美元
调整后EBITDA50万美元上年同期为200万美元;第三季度为负280万美元
现金及现金等价物2630万美元截至3月31日为2670万美元,2025财年年末为3100万美元

2026财年,毛利润为3680万美元,即64%的毛利率。全年净亏损为1430万美元,而调整后EBITDA为负370万美元

经营性现金流改善了520万美元,转为正向的330万美元,而2025财年为流出190万美元。Aytu使用了790万美元用于融资活动,主要用于减少循环信贷额度、定期债务和固定付款义务。

业务与运营表现

EXXUA处方量持续增长

在2月下旬和3月初开展更广泛的现场推广后,EXXUA完成了其上市后的首个完整季度。月处方量从4月的973份增加至5月的1089份以及6月达到1,261份

1,200名独立开方医生已开具EXXUA处方,且有近2,500名独立患者接受了该疗法。管理层强调续方活动和重复开方呈增长趋势,尽管许多医生仅向一两名患者开具了EXXUA。

Aytu在应对业绩不佳问题时,将外勤销售团队人数从3月底的43名代表裁减至7月的32名,随后又重新扩充至约42名代表。每名代表的月均处方量从大约3月的18份增加到7月的约43份

业绩前10名的活跃销售专员平均每周开出近15份处方,而前5名平均达到18.5份。管理层表示,占当前销售团队约60%的24个销售区域贡献了70%的处方量。

管理层展示了潜在的规模效应,而非发布营收指引。在45个销售区域、每名代表每周开出15份处方的情况下,EXXUA的周处方量将达到675份,管理层认为按照当前的售价,这相当于约2,600万美元的年化运行率。更高的生产力情景意味着更大的运行率,但这些数据并非公司的预测。

准入与报销

管理层将EXXUA高于预期的净变现能力主要归因于商业支付方的批准率提高。政府业务占产品组合的比重远高于20%至25%,且保持增长。

Aytu尚未针对EXXUA签署商业支付方合同,也没有提供补充的医疗补助(Medicaid)或医疗保险(Medicare)回扣。管理层表示,当前的批准率降低了主动签订合同的必要性,除非提议的条款具有经济吸引力。

ADHD业务仍是现金流贡献来源

ADHD产品组合贡献了1,040万美元的第四季度营收,这主要得益于总额到净额变现率的改善。Adzenys及其授权仿制药保持了约80%的Adzenys及其同类仿制药市场处方量。

Cotempla的授权仿制药处方量按周持续增长。在两家公司和解协议允许的7月1日之后,Teva尚未推出其Cotempla仿制药,这较Aytu的基准假设创造了潜在的上行空间。管理层仍指出,由于儿童放假,ADHD产品的需求通常在Aytu财年的上半财年较为疲软。

管理层指引

Aytu未提供2027财年营收指引。其费用和盈利能力框架包括:

  • GAAP营业费用:约为4,900万至5,400万美元。
  • 现金营业费用:约为4,500万至4,900万美元。
  • 销售与营销投资:最高600万美元,从2026财年转移至2027财年,以支持EXXUA的销售覆盖、营销和教育。
  • 毛利率:预计在2027财年初期最低,并向2027财年第四季度的66%至67%改善,因为EXXUA规模扩大且固定成本得到消化。
  • 盈利能力:管理层预计截至2027年6月30日的六个月将实现调整后EBITDA正值。
  • 现金流:预计将在下半年改善,具体取决于回款情况、营运资金需求和付款时间。

管理层预计,由于计划中的EXXUA投资、ADHD季节性因素以及年度PDUFA费用支付,上半财年的调整后EBITDA和经营现金流将低于下半财年。

风险与关注事项

  • EXXUA 目前仍处于上市初期,许多开药医生仅有少数患者的使用经验。
  • 处方量与产品出货量属于不同的统计指标。已报告的营收反映的是扣除返利、折扣及其他调整后的渠道销售额,可能无法精准反映任何单一季度的处方量。
  • 管理层提醒称,随着支付方结构、报销政策和患者支持的发展演变,EXXUA 当前较为有利的总额至净额变现率可能会发生变化。
  • 新销售代表通常需要 6至9个月 才能具备足够的生产能力,并需要大约 9至12个月 才能实现盈亏平衡。
  • 季度盈利能力和现金流可能会随商业投资、ADHD 季节性、营运资金和年度监管费用而波动。

分析师问答要点

  • 预先批准: 管理层表示,通过其支持计划提交的申请批准率约为 70%,这得益于流程简单明确,且患者人群通常具备多种此前药物的使用经验。
  • 支付方合同: Aytu 并不预计单一的商业或政府合同会带来即时的需求增长。管理层强调,合同必须具备经济合理性,因为仅靠支付方准入并不能拉动处方开具。
  • RxConnect: 通过 RxConnect 合作药房配发的 EXXUA 处方占比仍低于 ADHD 产品组合高达 80% 的水平,但管理层预计随着时间推移,参与度将会提升。
  • 销售团队扩张: 管理层认为外勤销售团队具备远大于当前水平的扩充潜力,但节奏将取决于盈利能力和现金流,而非固定的招聘目标。
  • ADHD 业务韧性: 管理层将营收的环比改善主要归因于积极的总额至净额管理,以及药房在品牌原研药与授权仿制药之间灵活切换的能力。

业绩电话会议完整文字实录


完整财报电话会议逐字稿

管理层陈述

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.

分析师问答

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.

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