Full Press Release Details
Aytu BioPharma Reports Fourth Quarter and Full-Year
Fiscal 2021 Financial Results
Quarterly net revenue increased 74% sequentially to $23.5M; 138%
year-over-year to $65.6M
Ended quarter with approximately $50M in cash, cash equivalents and
Planned pivotal study for AR101 in Vascular Ehlers-Danlos Syndrome
(VEDS) to begin in 1H22; scientific advisory board recently formed
Initiation of Healight randomized, sham-controlled study planned near-term;
recently published positive and validating data for UV-A light technology
Future revenue growth expected from newly consolidated sales force and
product portfolio supported by fully integrated and expanding RxConnect
patient support program
Management to host live conference call and webcast today at 4:30 p.m. ET
ENGLEWOOD, CO / September 27, 2021 / Aytu BioPharma, Inc. (Nasdaq: AYTU), a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today reported financial results for the fiscal fourth quarter and full-year ended June 30, 2021.
"This was our first quarter operating as a fully integrated, pediatric-focused, specialty pharmaceutical company, having closed the merger with Neos Therapeutics in March and acquiring the global license to pediatric-onset rare disease pipeline asset AR101 in April. We moved quickly into our post-merger plan, integrating the Aytu and Neos sales forces and consolidating the RxConnect patient access program. We have already begun to realize significant synergies from that consolidation, which we expect to support the continued growth of our commercial business," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "Going forward, we have many value creating milestones on the horizon. For AR101, we expect to begin our pivotal study in early 2022, are seeking Orphan Drug Designation from the FDA and EMA and will collaborate with our newly formed scientific advisory board. We are also seeking to maximize our Aytu-Neos merger synergy plan including removing redundant expenses, divesting and monetizing certain non-core products and outsourcing manufacturing of the Neos heritage products to significantly improve the financial performance of those brands. We expect fiscal 2022 to be a year of substantial progress as we begin to realize the economic benefits of this plan, grow our commercial prescription and consumer health product revenues and advance our late-stage development pipeline."
Fourth Quarter and Full-Year Fiscal 2021 Financial Results:
Recent Corporate and Pipeline Highlights:
Anticipated Upcoming Milestones and Events for Calendar Year 2021 and 2022:
Upcoming September Event:
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 1-844-602-0380 (toll-free) or 1-862-298-0970 (international).
The webcast will be accessible live and archived at the following link https://www.webcaster4.com/Webcast/Page/2142/42555 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 1-877-481-4010 (toll-free) or 919-882-2331 (international) and using the replay access code 42555.
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), Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER (amphetamine) extended-release oral suspension (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, and the anticipated future regulatory submissions, potential adverse changes to our financial position or our 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 June 30, | Year Ended June 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Product revenue, net | $ | 23,482 | $ | 14,861 | $ | 65,632 | $ | 27,632 | ||||
| Cost of sales | 12,183 | 4,817 | 36,432 | 8,281 | ||||||||
| Gross profit | 11,299 | 10,044 | 29,200 | 19,351 | ||||||||
| Operating expenses | ||||||||||||
| Research and development | 4,764 | 1,499 | 5,623 | 1,722 | ||||||||
| Selling and marketing | 12,180 | 5,198 | 30,308 | 11,403 | ||||||||
| General and administrative | 8,552 | 6,852 | 25,500 | 19,657 | ||||||||
| Acquisition related costs | 70 | 814 | 2,919 | 2,348 | ||||||||
| Restructuring costs | 11 | 531 | 4,886 | 667 | ||||||||
| Impairment of intangible assets | 8,539 | 195 | 12,825 | 195 | ||||||||
| Amortization of intangible assets | 1,255 | 1,590 | 6,009 | 4,490 | ||||||||
| Total operating expenses | 35,371 | 16,679 | 88,070 | 40,482 | ||||||||
| Loss from operations | (24,072) | (6,635) | (58,870) | (21,131) | ||||||||
| Other (expense) income | ||||||||||||
| Other (expense), net | (495) | (1,425) | (2,050) | (2,606) | ||||||||
| Gain / (Loss) from contingent consideration | 7,139 | 5,231 | 4,459 | 10,430 | ||||||||
| Gain (Loss) on extinguishment of debt | (1,311) | (316) | (1,569) | (316) | ||||||||
| Gain from warrant derivative liability | - | - | - | 2 | ||||||||
| Total other (expense) income | 5,333 | 3,490 | 840 | 7,510 | ||||||||
| Loss before income tax | (18,739) | (3,145) | (58,030) | (13,621) | ||||||||
| Income tax benefit | 259 | - | 259 | - | ||||||||
| Net loss | $ | (18,998) | $ | (3,145) | $ | (58,289) | $ | (13,621) | ||||
| Weighted average number of common shares outstanding | 23,519,870 | 11,335,425 | 16,746,679 | 4,519,201 | ||||||||
| Basic and diluted net loss per common share | $ | (0.81) | $ | (0.28) | $ | (3.48) | $ | (3.01) |
AYTU BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per-share)
| June 30, | ||||||
| 2021 | 2020 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 49,649 | $ | 48,082 | ||
| Restricted cash | 252 | 251 | ||||
| Accounts receivable, net | 28,176 | 5,633 | ||||
| Inventory, net | 16,339 | 9,999 | ||||
| Prepaid expenses | 9,780 | 5,715 | ||||
| Other current assets | 1,038 | 5,742 | ||||
| Total current assets | 105,234 | 75,422 | ||||
| Property and equipment, net | 5,140 | 259 | ||||
| Operating lease right-of-use asset | 3,563 | 634 | ||||
| Intangible assets, net | 85,464 | 48,855 | ||||
| Goodwill | 65,802 | 28,090 | ||||
| Other long-term assets | 465 | 33 | ||||
| Total long-term assets | 160,434 | 77,871 | ||||
| Total assets | $ | 265,668 | $ | 153,293 | ||
| Liabilities | ||||||
| Current liabilities | ||||||
| Accounts payable and other | $ | 19,255 | $ | 11,640 | ||
| Accrued liabilities | 51,295 | 8,831 | ||||
| Accrued compensation | 5,939 | 3,117 | ||||
| Short-term line of credit | 7,934 | - | ||||
| Current portion of debt | 16,668 | 982 | ||||
| Current portion of operating lease liabilities | 940 | 300 | ||||
| Current portion of fixed payment arrangements | 3,134 | 2,340 | ||||
| Current portion of CVR liabilities | 218 | 840 | ||||
| Current portion of contingent consideration | 4,055 | 713 | ||||
| Total current liabilities | 109,438 | 28,763 | ||||
| Long-term debt, net of current portion | 180 | - | ||||
| Long-term operating lease liability, net of current portion | 2,624 | 725 | ||||
| Long-term fixed payment arrangements, net of current portion | 6,324 | 11,172 | ||||
| Long-term CVR liabilities, net of current portion | 1,177 | 4,732 | ||||
| Long-term contingent consideration, net of current portion | 8,002 | 12,875 | ||||
| Other long-term liabilities | 355 | 11 | ||||
| Total liabilities | 128,100 | 58,278 | ||||
| Commitments and contingencies | ||||||
| Stockholders' equity | ||||||
| Preferred Stock, par value $.0001; 50,000,000 shares authorized; no shares issued or outstanding as of June 30, 2021 and 2020 | - | - | ||||
| Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 27,490,412 and 12,583,736, respectively, as of June 30, 2021 and 2020 | 3 | 1 | ||||
| Additional paid-in capital | 315,864 | 215,024 | ||||
| Accumulated deficit | (178,299) | (120,010) | ||||
| Total stockholders' equity | 137,568 | 95,015 | ||||
| Total liabilities and stockholders' equity | $ | 265,668 | $ | 153,293 |
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