Financial Data and Key Metrics Changes - For the fiscal year ended June 30, 2021, net revenue was $65.6 million, up from $27.6 million for the previous year [20] - Fourth quarter revenue reached an all-time high of $23.5 million, compared to $13.5 million in the previous quarter and $14.9 million in the same quarter last year [20][21] - The company ended the quarter with approximately $50 million in cash, providing sufficient capital to reach operating breakeven [7][24] Business Line Data and Key Metrics Changes - The consumer health division generated $8.9 million in revenue for the quarter, an increase from $6.9 million in the same quarter last year [21] - Prescription division revenue was $14.6 million, compared to $7.9 million in the same quarter last year [21] - The ADHD product revenue for the quarter was $10.6 million, reflecting a full three months of revenue from the Neos acquisition [21] Market Data and Key Metrics Changes - The total addressable market for the company's prescription products is approximately $24 billion across five therapeutic categories [7] - The ADHD market is estimated to exceed $70 million annually, with significant growth expected [8][28] Company Strategy and Development Direction - The company aims to focus on becoming a premier pediatric-focused specialty pharmaceutical company, supported by a growing prescription portfolio and consumer health subsidiary [5][27] - Aytu plans to expand its RxConnect pharmacy network to enhance patient access and drive prescription refills [10][11] - The company is pursuing Orphan Drug Designation for AR101 and plans to initiate a pivotal study for VEDS in early 2022 [18][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth of the ADHD market, particularly as children return to school [28] - The company anticipates continued revenue growth from both prescription products and consumer health through new product launches and e-commerce strategies [12][27] - Management highlighted the importance of the RxConnect platform in driving prescription volume and improving patient access [11][48] Other Important Information - The company reported a net loss of $58.3 million for the fiscal year, compared to a loss of $13.6 million the previous year [22] - One-time costs in the fourth quarter included approximately $13.5 million related to asset write-offs and acquisition fees [23] - The company plans to close the Neos manufacturing facility to improve gross profit margins and reduce expenses [26] Q&A Session Summary Question: Can you provide insights on ADHD revenues and back-to-school trends? - Management noted that the market is trending as expected, with a rebound in ADHD prescriptions as the school year begins [31][34] Question: What is the normalized cash burn rate? - The normalized cash burn for the quarter was approximately $3.2 million, excluding one-time costs [40][41] Question: What are the expectations for the Healight study timeline? - Results from the Healight study in Spain are expected to be available in the first half of 2022 [52][53]

Product Development and Portfolio - Aytu BioPharma reported a focus on commercializing novel products in prescription and consumer health categories, particularly in ADHD and insomnia[17] - The company completed a merger with Neos Therapeutics on March 19, 2021, enhancing its ADHD product portfolio[17] - The ADHD portfolio includes three FDA-approved products: Adzenys XR-ODT, Cotempla XR-ODT, and Adzenys ER oral suspension, launched between May 2016 and February 2018[19] - The pediatric portfolio includes Cefaclor, Karbinal® ER, and Poly-Vi-Flor® and Tri-Vi-Flor®, which target large pediatric markets with distinct clinical features[20] - The primary care portfolio features ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup[21] - N-desethyloxybutynin (NT0502) is being developed as a treatment for chronic sialorrhea, with a Phase 1 pilot study completed in January 2020[30] - The company aims to advance AR101 (enzastaurin) for treating vEDS, an ultra-rare pediatric-onset disease, with expectations for Orphan Drug Designation by Q1 2022[29] - The Healight™ technology platform is being studied for treating severe respiratory infections, including those caused by SARS-CoV-2, with pre-clinical safety and effectiveness data[32] Financial Performance and Capital Needs - Aytu BioPharma has incurred significant losses since inception and expects to continue incurring losses, requiring additional capital for operations[9] - The company’s competitive advantage lies in its history of acquisitions and in-licensing, enabling growth through both organic and strategic means[36] - Approximately 55% of total gross revenues in fiscal 2021 came from the largest three drug wholesalers in the U.S.[104] Market Competition and Strategy - The company operates in a competitive environment, with new risk factors emerging that could affect its business performance[5] - The ADHD market is competitive, with major players like Takeda and Janssen Pharmaceuticals, but the company aims to leverage its unique product offerings[49] - The strategic focus includes increasing market share for ADHD and pediatric brands, with a specific emphasis on Adzenys XR-ODT and Cotempla XR-ODT[34] Regulatory and Compliance Challenges - The company faces risks related to the commercialization of its products, including potential reimbursement issues from third-party payors[10] - Regulatory approval processes for new products are lengthy and uncertain, posing risks to the company's future product candidates[12] - The FDA requires substantial resources and time for obtaining regulatory approval, which can take several years[188] - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of a new product outweigh its risks[185] Intellectual Property and Licensing - The company holds patents for its ADHD products, with expiration dates in 2026 and 2032, ensuring intellectual property protection[55] - Neos entered into a license agreement with Shire Pharmaceuticals for Adzenys ER, paying a non-refundable license fee of less than $1.0 million and a single-digit royalty on net sales[63] - The company has exclusive license rights for its Primary Care Portfolio and Pediatric Portfolio products, with royalties ranging from 0% to 23.5% based on net product revenue[157] Manufacturing and Supply Chain - The company has adequate manufacturing capacity through third-party manufacturers to meet anticipated commercial demands for its products[121] - The manufacturing facility in Grand Prairie, Texas, spans 77,112 square feet and includes dedicated cGMP manufacturing suites for ADHD products[122] - The company has begun outsourcing the manufacture of Adzenys XR-ODT and Cotempla XR-ODT to a contract manufacturing organization (CMO) and is conducting pilot studies for technology transfer[126] Consumer Health Division - The consumer health division, acquired in February 2020, focuses on OTC specialty pharmaceuticals and offers products in five core categories, including diabetes management and sexual health[23] - The company acquired Innovus, which commercializes over 30 consumer health products, expanding its market presence in various healthcare categories[40] - Aytu Consumer Health launched 12 new products in fiscal 2021 and signed an exclusive agency supply and distribution agreement with Amman Pharmaceutical Industries for over 20 products in the U.S.[99] Clinical Studies and Future Plans - The development pipeline includes AR101, an investigational drug for treating Vascular Ehlers-Danlos Syndrome (vEDS), with pivotal Phase 3 studies currently underway[128] - A larger clinical study is planned to enroll 40 critically ill, mechanically ventilated COVID-19 patients, with primary endpoints focused on viral load reduction in endotracheal tube aspirates[143] - The company expects to explore commercialization and regulatory options in key markets globally following the readout of the larger clinical study[144] Marketing and Sales Strategy - Aytu employs around 50 sales representatives targeting approximately 10,000 physician targets, focusing on high-volume prescribers[105] - The company has expanded its pharmacy network to approximately 1,200 participating pharmacies through the Aytu RxConnect program[109] - Aytu's commercialization efforts are focused on delivering tailored messaging for each product to targeted clinicians[108]

Financial Data and Key Metrics Changes - Net revenue for Q3 2021 was $13.5 million, up from $8.2 million in the same quarter last year, reflecting a significant growth driven by the consumer health division [7][19] - The company ended the quarter with $46.8 million in cash, cash equivalents, and restricted cash after paying down $15 million on the Neos term loan [8][18] - Net loss for the quarter was $25.5 million, or $1.41 per share, compared to a net loss of $5.3 million, or $1.51 per share, for the same period last year [21] Business Line Data and Key Metrics Changes - Consumer health division net revenue reached a record $8.4 million, up from $3.5 million in the same quarter last year, driven by multiple product launches and e-commerce growth [19] - Prescription revenue for the Rx division was $5.1 million, up from $4.7 million in the same quarter last year, including revenue from Neos ADHD products only for the period after the merger [19][21] Market Data and Key Metrics Changes - The merger with Neos Therapeutics transformed Aytu into a pro forma $100 million annual revenue specialty pharma company, enhancing its footprint in pediatrics and adjacent specialty care segments [4][5] - The company expects to see continued growth in its e-commerce channel, which allows for efficient sales with lower marketing spend [11] Company Strategy and Development Direction - Aytu is focusing on building a leading pediatrics company by divesting non-core products like Netesto and reallocating resources to ADHD and pediatric brands [7] - The company plans to integrate Aytu heritage products into the Neos RxConnect pharmacy network to improve patient access and drive growth [9][10] - Aytu is pursuing acquisitions and partnerships to enhance its late-stage development pipeline, particularly in pediatric onset rare diseases [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving annual operating cost synergies of approximately $15 million starting in fiscal year 2022 following the Neos merger [5][18] - The company anticipates a return to historical gross margins for ADHD products after the technology transfer is completed in 2023, potentially exceeding 80% [24] Other Important Information - Aytu is advancing its Healight technology, which has shown potential antiviral effects and plans to initiate a Phase II trial for SARS-CoV-2 in the second half of the calendar year [14] - The company has acquired a global license for AR101, targeting the treatment of vascular Ehlers-Danlos Syndrome, with plans to start pivotal trials in the second half of the year [15] Q&A Session Summary Question: Plans on ADHD business and outsourcing impact - Management indicated that the technology transfer costs are expected to be less than $2.5 million over the next 18 months, with anticipated gross margins for ADHD products potentially exceeding 80% post-transfer [24] Question: Incremental contribution from ADHD products - Management noted that while they do not provide guidance, they expect revenue to be similar to historical figures, with margins affected by inventory write-offs in the next quarter [26][27] Question: FDA discussions and pivotal trial updates - Management confirmed ongoing discussions with the FDA regarding the AR101 program, with an IND submission expected by the end of the year and trials starting early next year [29] Question: Operating expenses outlook - Management acknowledged that operating expenses would be higher than usual in the coming quarter due to one-time costs, with a new normal expected in the following fiscal year [30][32]

Financial Data and Key Metrics Changes - Aytu BioScience reported a record net revenue of over $15.1 million for Q2 2021, representing a 377% increase compared to the same quarter last year and a 12% sequential growth over Q1 2021 [4][8] - The adjusted EBITDA loss was approximately $1.8 million, an improvement of over $1 million compared to the adjusted EBITDA loss of $2.9 million in Q2 2020 [8][11] - Gross profit for Q2 was $9.1 million, with a gross profit margin of approximately 60%, down from 81% in the same quarter last year due to lower margins from COVID-19 test kit sales [9][10] Business Line Data and Key Metrics Changes - The consumer health division achieved an all-time revenue high of $7.9 million, while the Rx division generated $7.2 million, a 25% increase from the previous quarter [6][14] - The pediatric segment, particularly Poly-Vi-Flor, contributed to Rx revenue growth, alongside revenue from COVID-19 test kits [15][19] Market Data and Key Metrics Changes - The COVID-19 testing market remains robust, with Aytu having successfully sourced an antigen test that has seen strong market acceptance [27][28] - The company anticipates continued demand for antibody testing as the market evolves [28] Company Strategy and Development Direction - Aytu is focused on integrating the Innovus Consumer Health business and the Cerecor pediatric assets, while also pursuing additional growth drivers and acquisitions [5][18] - The planned merger with Neos Therapeutics is expected to close by Q2 2021, creating a specialty pharmaceutical company with pro forma annual revenue exceeding $100 million [5][18] - The merger is anticipated to yield annual cost synergies of approximately $15 million starting in FY '22 [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's strategic transformation and the potential of the Healight technology in treating respiratory diseases [17][20] - The focus remains on top-line growth and achieving profitability, with a strong cash balance of over $62 million to support future initiatives [7][12] Other Important Information - Aytu completed a $28.75 million public offering, which will help pay down a substantial portion of Neos' debt upon merger closing [12] - The company ended the quarter with total assets of $167 million and equity of $113 million [12] Q&A Session Summary Question: Growth expectations for the pediatric side of the business - Management expects continued growth in the pediatric segment, leveraging experience from the Cerecor acquisition and the upcoming Neos transaction [22][24] Question: Contribution of COVID-19 business to overall revenues - The COVID-19 testing business has been meaningful, with management noting the importance of being opportunistic in this market while focusing on broader growth [25][27][28] Question: Future expectations for gross margins - Management indicated that gross margins are expected to stabilize between 70% to 80%, depending on the contributions from the Rx and consumer health segments [31][32]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38247 AYTU BIOSCIENCE, INC. (www.aytubio.com) Delaware 47-0883144 (State or other jurisdiction of incorporation or organization) (IRS Emp ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 333-146542 AYTU BIOSCIENCE, INC. (Exact Name of Registrant as Specified in Its Charter) 47-0883144 | --- | --- | |---------------------------|------------------------------------ ...

Aytu BioScience, Inc. (NASDAQ:AYTU) Q3 2020 Results Earnings Conference Call May 14, 2020 4:30 PM ET Company Participants Joshua Disbrow - Chairman & CEO David Green - CFO Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Operator Good afternoon, and thank you for joining us at the Aytu BioScience Third Quarter Fiscal 2020 Business Update Call for the quarter ending March 31, 2020. With me this afternoon are Aytu's Chairman and Chief Executive Officer, Josh Disbrow; and Chief Financial Officer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share AYTU The NASDAQ Stock Market LLC FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended: March 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...