Full Press Release Details
Aytu BioPharma Reports First Quarter 2022 Financial
Quarterly net revenue increased 62% to $21.9 million
Ended quarter with approximately $40.6 million in cash, cash equivalents
Fully integrated and expanding RxConnect patient support program and
salesforce drove growth across prescription portfolio
Planned pivotal study for AR101 in Vascular Ehlers-Danlos Syndrome
(VEDS) to begin in 1H22
Initiation of Healight randomized, sham-controlled study by year-end 2021
Management to host live conference call and webcast today at 4:30 p.m. ET
ENGLEWOOD, CO / November 15, 2021 / Aytu BioPharma, Inc. (Nasdaq: AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today reported financial results for its fiscal first quarter 2022 ended September 30, 2021.
"We posted a very strong quarter with net revenues of $21.9 million and two of our commercial products, Poly-Vi-Flor and Adzenys XR-ODT, hitting all-time highs in prescription performance. We have begun delivering on our projection that fiscal 2022 will be a year of substantial progress, as we continued to realize the economic benefits of our merger synergy plan following the Neos Therapeutics acquisition, organically grew our commercial prescription and consumer health product revenues and advanced our late-stage development pipeline toward key milestones," commented Josh Disbrow, chief executive officer of Aytu BioPharma. "Regarding AR101, we expect to begin our pivotal study in early 2022, are seeking Orphan Drug Designation from the FDA and EMA, and have already begun collaborating with our newly formed scientific advisory board. We are also nearing the start of our sham-controlled study of Healight at a leading academic center in Barcelona, Spain and expect to have data in the first half of calendar year 2022. With the establishment of key fundamentals across our business, we are excited about the future as we continue building a leading specialty pharmaceutical company."
First Quarter Fiscal 2022 Financial Results:
Recent Corporate Highlights:
Recent Pipeline Highlights:
Key Anticipated Upcoming Milestones and Events:
Conference Call Details
The company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing either 877-545-0320 (toll-free) or 973-528-0002 (international), participant access code 664921. The webcast will be accessible live and archived at the following link https://www.webcaster4.com/Webcast/Page/2142/43552 and on Aytu BioPharma's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days. A replay of the call will be available for fourteen days. Access the replay by calling 877-481-4010 (toll-free) or 919-882-2331 (international), using the replay access code 43552.
About Aytu BioPharma, Inc.
Aytu BioPharma is a specialty pharmaceutical company with a growing commercial portfolio of prescription therapeutics and consumer health products. The company's primary prescription products treat attention deficit hyperactivity disorder (ADHD) and other common pediatric conditions. Aytu markets ADHD products Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING). The company also markets ZolpiMist, a short-term treatment for insomnia characterized by difficulties with sleep initiation (see Full Prescribing Information, including Boxed WARNING). The company's other pediatric products include Karbinal ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor and Tri-Vi-Flor , two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. The company's evolution has been driven by strategic in-licensing, acquisition-based transactions and organic product growth. Aytu is building a complimentary therapeutic development pipeline including a prospective treatment (AR101/enzastaurin) for vascular Ehlers-Danlos Syndrome (VEDS), a rare genetic disease resulting in high morbidity and a significantly shortened lifespan. VEDS is a devastating condition for which there are no currently approved treatments. AR101 is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K and AKT pathways. AR101 has been studied in more than 3,300 patients across a range of solid and hematological tumor types, and we are now planning a randomized, controlled, pivotal clinical study with AR101 in VEDS. To learn more, please visit aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others, risks associated with: the company's plans relating to the clinical development and commercialization of AR101, the company's overall financial and operational performance, the anticipated start dates, durations and completion dates, as well as the potential future results of the company's ongoing and future clinical trials, the anticipated designs of the company's future clinical trials, the company's ability to transfer its technology and the anticipated benefits of that transfer, and the anticipated future regulatory submissions, potential adverse changes to our financial position or the company's business, the results of operations, strategy and plans, changes in capital markets and the ability of the company to finance operations in the manner expected, risks relating to gaining market acceptance of our products, risks related to the ongoing COVID-19 pandemic and its impact on our operations, our ability to effectively integrate operations and manage integration costs following our acquisitions, our partners performing their required activities, our anticipated future cash position, regulatory and compliance challenges and future events under current and potential future collaboration. We also refer you to (i) the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu's most recent Annual Report on Form 10-K and in the other reports and documents it files with the Securities and Exchange Commission and (ii) the Risk Factors set forth in Aytu's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
AYTU BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(In thousands, except share and per-share)
| Three Months Ended | ||||||
| September 30, | ||||||
| 2021 | 2020 | |||||
| Product revenue, net | $ | 21,897 | $ | 13,520 | ||
| Cost of sales | 9,441 | 4,063 | ||||
| Gross profit | 12,456 | 9,457 | ||||
| Operating expenses | ||||||
| Research and development | 2,096 | 183 | ||||
| Selling and marketing | 9,297 | 5,826 | ||||
| General and administrative | 8,216 | 5,420 | ||||
| Impairment of goodwill | 19,453 | - | ||||
| Amortization of intangible assets | 1,093 | 1,585 | ||||
| Total operating expenses | 40,155 | 13,014 | ||||
| Loss from operations | (27,699) | (3,557) | ||||
| Other (expense) income | ||||||
| Other (expense), net | (40) | (751) | ||||
| Gain / (Loss) from contingent consideration | (219) | 2 | ||||
| Total other (expense) income | (259) | (749) | ||||
| Loss before income tax | (27,958) | (4,306) | ||||
| Income tax expense (benefit) | (107) | - | ||||
| Net loss | $ | (27,851) | $ | (4,306) | ||
| Weighted average number of common shares outstanding | 25,597,319 | 12,158,594 | ||||
| Basic and diluted net loss per common share | $ | (1.09) | $ | (0.35) |
AYTU BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per-share)
| (Unaudited) September 30, | June 30, | |||||
| 2021 | 2020 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 40,308 | $ | 49,649 | ||
| Restricted cash | 252 | 252 | ||||
| Accounts receivable, net | 21,626 | 28,176 | ||||
| Inventory, net | 16,314 | 16,339 | ||||
| Prepaid expenses | 9,343 | 9,780 | ||||
| Other current assets | 1,195 | 1,038 | ||||
| Total current assets | 89,038 | 105,234 | ||||
| Property and equipment, net | 4,666 | 5,140 | ||||
| Operating lease right-of-use asset | 3,826 | 3,563 | ||||
| Intangible assets, net | 83,385 | 85,464 | ||||
| Goodwill | 46,349 | 65,802 | ||||
| Other long-term assets | 465 | 465 | ||||
| Total long-term assets | 138,691 | 160,434 | ||||
| Total assets | $ | 227,729 | $ | 265,668 | ||
| Liabilities | ||||||
| Current liabilities | ||||||
| Accounts payable and other | $ | 9,383 | $ | 19,255 | ||
| Accrued liabilities | 54,380 | 51,295 | ||||
| Accrued compensation | 4,762 | 5,939 | ||||
| Short-term line of credit | 4,520 | 7,934 | ||||
| Current portion of debt | 16,508 | 16,668 | ||||
| Current portion of operating lease liabilities | 1,084 | 940 | ||||
| Current portion of fixed payment arrangements | 3,221 | 3,134 | ||||
| Current portion of CVR liabilities | 1 | 218 | ||||
| Current portion of contingent consideration | 4,138 | 4,055 | ||||
| Total current liabilities | 97,997 | 109,438 | ||||
| Long-term debt, net of current portion | 154 | 180 | ||||
| Long-term operating lease liability, net of current portion | 2,758 | 2,624 | ||||
| Long-term fixed payment arrangements, net of current portion | 5,485 | 6,324 | ||||
| Long-term CVR liabilities, net of current portion | 1,347 | 1,177 | ||||
| Long-term contingent consideration, net of current portion | 8,169 | 8,002 | ||||
| Other long-term liabilities | 319 | 355 | ||||
| Total liabilities | 116,229 | 128,100 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity | ||||||
| Preferred Stock, par value $.0001; 50,000,000 shares authorized; no shares issued or outstanding as of September 30, 2021 and June 30, 2021 | - | - | ||||
| Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 27,771,912 and 27,490,412, respectively, as of September 30, 2021 and June 30, 2021 | 3 | 3 | ||||
| Additional paid-in capital | 317,647 | 315,864 | ||||
| Accumulated deficit | (206,150) | (178,299) | ||||
| Total stockholders' equity | 111,500 | 137,568 | ||||
| Total liabilities and stockholders' equity | $ | 227,729 | $ | 265,668 |
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