Aytu BioPharma Reports Record Fourth Quarter and Fiscal Year 2022 Revenue
Aytu BioPharma reported record fourth quarter net revenue of $27.4 million, a 17% increase from last year, driven by a 28% growth in the Prescription segment. Full year revenue rose 47% to $96.7 million, with Prescription products achieving 87% growth at $61.1 million. Adjusted EBITDA for Prescription was $1.1 million, contrasting with $(5.5) million last year. Despite a 2% decline in Consumer Health revenue due to supply chain issues, the overall Gross Profit margin improved to 54%. Net loss for the quarter was $(17.7) million, improving from $(19.0) million year-over-year.
- Record Q4 net revenue of $27.4 million, a 17% YoY increase.
- Prescription segment revenue up by 28% YoY, totaling $18.7 million.
- Full-year revenue increased by 47% to $96.7 million.
- Prescription products revenue grew 87% YoY to $61.1 million.
- Positive adjusted EBITDA of $1.1 million in Q4 for Prescription segment.
- Net loss of $(17.7) million for Q4, despite improvement from $(19.0) million.
- Consumer Health revenue decreased by 2% due to supply chain disruptions.
- Total impairment expense for FY 2022 was $75.5 million, largely impacting financials.
Record fourth quarter and fiscal year net revenue driven by strong growth in Prescription segment
Positive Adjusted EBITDA within Prescription segment
Company to Host Conference Call Today at 4:30pm ET
ENGLEWOOD, CO / ACCESSWIRE / September 27, 2022 / Aytu BioPharma, Inc. (Nasdaq:AYTU), a pharmaceutical company focused on commercializing novel therapeutics, with a development pipeline addressing rare, pediatric-onset disorders, today announced financial and operational results for the fourth quarter and fiscal year ended June 30, 2022.
Q4 2022 Commercial Highlights (3 months ending June 30, 2022)
- Total net revenue was
$27.4 million , a new quarterly record, and an increase of17% over the$23.5 million in net revenue in the year ago period. - Net revenue from Prescription products was
$18.7 million during Q4 2022, also a new quarterly record, compared to$14.6 million in the year ago period, growth of28% .- ADHD (Adzenys XR-ODT and Cotempla XR-ODT) net revenue increased by
21% to$12.2 million from$10.1 million in the year ago period. - Pediatric (Poly-Vi-Flor, Tri-Vi-Flor, and Karbinal ER) net revenue of
$6.1 million , an increase of64% , compared to$3.7 million in the year ago period.
- ADHD (Adzenys XR-ODT and Cotempla XR-ODT) net revenue increased by
- Consumer Health revenue during Q4 2022 was
$8.7 million , a decrease of2% compared to the year ago period of$8.9 million , driven by short-term supply chain disruptions which the Company believes have been addressed. - Prescription segment Adjusted EBITDA1 (see Table A-1) was a positive
$1.1 million , while Consumer Health (see Table A-1) was$(2.1) million resulting in a combined Adjusted EBITDA of$(1.0) million for the Company's commercial business. This compares to Adjusted EBITDA of$(5.5) million for the Prescription segment and$(2.7) million for the Consumer Health segment in Q4 2021, resulting in a combined Adjusted EBITDA of$(8.2) million for the Company's commercial business.
FY 2022 Commercial Highlights (12 months ending June 30, 2022)
- Total net revenue increased
47% to$96.7 million from$65.6 million in FY21. - Net revenue from Prescription products was
$61.1 million , compared to$32.7 million last year, growth of87% .- ADHD (Adzenys XR-ODT and Cotempla XR-ODT) net revenue of
$42.9 million , an increase of294% , reflecting the acquisition of Neos Therapeutics and the ADHD franchise in Q3 FY2021. - Pediatric (Poly-Vi-Flor, Tri-Vi-Flor, and Karbinal ER) net revenue of
$16.1 million , an increase of29% .
- ADHD (Adzenys XR-ODT and Cotempla XR-ODT) net revenue of
- Consumer Health net product revenue of
$35.5 million , an increase of8% compared to$33.0 million in FY 2021. - FY 2022 Prescription segment Adjusted EBITDA (see Table A-2) was a
$(5.5) million , while Consumer Health (See Table A-2) was$(4.9) million , resulting in a combined Adjusted EBITDA of$(10.4) million for the commercial business. This is in comparison to Adjusted EBITDA of$(25.5) million for the Prescription segment and$(5.3) million for the Consumer Health segment, in fiscal 2021 resulting in a combined Adjusted EBITDA of$(30.8) million for the commercial business.
Pipeline Highlights
- In July 2022, initiated the global Phase 3, PREVEnt (Prevention of Ruptures with Enzastaurin for Vascular Ehlers-Danlos Syndrome) clinical trial of enzastaurin (AR101) for the treatment of patients with COL3A1-positive Vascular Ehlers-Danlos Syndrome (VEDS).
- In April 2022, announced positive preclinical data in ventilator-associated pneumonia (VAP) for Healight, the Company's proprietary ultraviolet A (UV-A) light endotracheal catheter. Following the completion of this porcine study, the Company expects to explore monetization opportunities for Healight, potentially in the form of regional or global out-licensing arrangements.
Management Discussion
"I am extremely pleased with the traction we are achieving in our commercial operations as we achieved record fourth quarter and fiscal year net revenues driven by strong growth in our prescription business and high-single digit growth in our consumer health segment during the year, despite some short-term supply chain disruptions on the consumer side of the business," commented Josh Disbrow, Chief Executive Officer of Aytu BioPharma. "The
"As we look to the future, I believe Aytu is well positioned as we expect continued growth in our portfolio of prescription and consumer health products. This organic growth when coupled with operational and manufacturing efficiencies, as well as portfolio prioritization, should drive us towards positive adjusted EBITDA. As previously reported, we expect to remove approximately
Segment Reporting
| Year Ended | Quarter Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (In thousands) | (In thousands) | |||||||||||||||
Consolidated revenue: | ||||||||||||||||
Prescription | $ | 61,121 | $ | 32,678 | $ | 18,734 | $ | 14,587 | ||||||||
Consumer Health | 35,548 | 32,954 | 8,714 | 8,895 | ||||||||||||
Consolidated revenue | $ | 96,669 | $ | 65,632 | $ | 27,448 | $ | 23,482 | ||||||||
Prescription | ||||||||||||||||
ADHD | $ | 42,855 | $ | 10,883 | $ | 12,243 | $ | 10,085 | ||||||||
Pediatric | 16,084 | 12,437 | 6,125 | 3,734 | ||||||||||||
Other* | 2,182 | 9,358 | 366 | 768 | ||||||||||||
| $ | 61,121 | $ | 32,678 | $ | 18,734 | $ | 14,587 | |||||||||
*Other includes COVID-related test kits and discontinued or deprioritized products.
AR101/enzastaurin Pipeline Update
AR101/enzastaurin is a protein kinase C β-isoform (PKCβ) inhibitor, initially developed by Eli Lilly for the treatment of solid and hematological cancers. Based on the research performed in the laboratory of Dr. Hal Dietz at Johns Hopkins University, AR101 has shown remarkable success in mouse models in addressing the cellular dysfunction associated with upregulation of PKC, which is now believed to be the primary driver of VEDS-related arterial events.
The Company announced in July 2022 it had initiated the global Phase 3 clinical trial of AR101/enzastaurin for the treatment of patients with COL3A1-positive Vascular Ehlers-Danlos Syndrome (VEDS). The PREVEnt Trial is global in nature with an anticipated 30+ sites across the US and Europe. The Company received an FDA Safe to Proceed Letter, and in Europe has garnered Regulatory Authority and Ethics Commission approvals to begin clinical work in multiple countries.
The trial is a prospective, Phase 3, global, randomized, double-blind, placebo-controlled efficacy trial designed to evaluate AR101/enzastaurin in patients with genetically confirmed COL3A1-positive VEDS. The primary aim of the trial is to determine whether enzastaurin reduces the occurrence of VEDS-related arterial events (ruptures, dissections, pseudoaneurysms, carotid-cavernous fistula, and aneurysm) requiring medical intervention compared to placebo. The Company expects to enroll approximately 260 VEDS patients in the trial, with enrollment beginning in early 2023.
Q4 2022 Financial Results
Net revenue for the fourth quarter of fiscal 2022 was
Net revenue from Prescription sales in the fourth quarter of fiscal 2022 was
Net revenue for the fourth quarter of fiscal 2022 from the Consumer Health franchise was
Gross profit increased to
Operating expenses, excluding impairment expense and amortization of intangible assets, were
Net loss was impacted by impairment of
Net loss for the fourth quarter of fiscal 2022 was
Fiscal 2022 Financial Results
Net revenue for fiscal 2022 was
Net revenue from Prescription products for fiscal 2022 was
Net revenue for fiscal 2022 from the Consumer Health franchise was
Gross profit increased to
Operating expenses, excluding impairment expense and amortization of intangible assets, was
During the year ended June 30, 2022, the Company recognized total impairment expense of
Net loss for fiscal 2022 was
Balance Sheet and Operational Improvements
Cash and cash equivalents at the end of the fiscal year ended June 30, 2022 were
The Company completed a
Conference Call Details
Aytu will host a conference call on Tuesday, September 27th, 2022, at 4:30 PM Eastern Time to discuss the Company's corporate progress and other developments, as well as financial results for its fiscal year ended June 30th, 2022.
The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or for international callers 973-528-0011 and using entry code 367672. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2142/46589.
A webcast replay will be available on the Investors News/Events section of the Company's website. A telephone replay of the call will be available approximately one hour following the call, through October 11, 2022, and can be accessed by dialing 877-481-4010 for U.S. callers or 919-882-2331 for international callers and entering replay access code 46589.
About Aytu BioPharma, Inc.
Aytu BioPharma is a pharmaceutical company with a portfolio of commercial prescription therapeutics and consumer health products, and a growing therapeutics pipeline focused on treating rare, pediatric-onset disorders. The Company's prescription products include 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) for the treatment of attention deficit hyperactivity disorder (ADHD), as well as Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu is also building a therapeutic pipeline, which includes AR101 (enzastaurin), a PKCβ inhibitor in development for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). VEDS is a rare genetic disease typically diagnosed in childhood resulting in high morbidity and a significantly shortened lifespan, and for which there are no currently approved treatments. AR101 has received Orphan Drug designation and Fast Track designation from the U.S. Food and Drug Administration and has received Orphan Drug designation from the European Commission. Aytu is also researching and advancing the development of the Healight ultraviolet light A (UVA) endotracheal catheter, a patented, investigational medical device with potential application in the treatment of severe, difficult-to-treat respiratory infections. To learn more, please visit aytubio.com.
Forward-Looking Statement
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.
Contacts for Investors:
Mark Oki, Chief Financial Officer
Aytu BioPharma, Inc.
moki@aytubio.com
Robert Blum or Roger Weiss
Lytham Partners
AYTU@lythampartners.com
AYTU BIOPHARMA, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per-share)
(Three Month Period Unaudited)
| Three Months Ended | Year Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
Product revenue, net | $ | 27,448 | $ | 23,482 | $ | 96,669 | $ | 65,632 | ||||||||
Cost of sales | 12,606 | 12,183 | 44,386 | 36,432 | ||||||||||||
Gross profit | 14,842 | 11,299 | 52,283 | 29,200 | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development | 3,697 | 4,764 | 14,439 | 5,623 | ||||||||||||
Selling and marketing | 10,013 | 12,180 | 38,713 | 30,308 | ||||||||||||
General and administrative | 7,383 | 8,552 | 31,167 | 25,500 | ||||||||||||
Acquisition related costs | - | 70 | - | 2,919 | ||||||||||||
Restructuring costs | - | 11 | - | 4,886 | ||||||||||||
Impairment expense | 10,809 | 8,539 | 75,458 | 12,825 | ||||||||||||
Amortization of intangible assets | 853 | 1,255 | 4,067 | 6,009 | ||||||||||||
Total operating expenses | 32,755 | 35,371 | 163,844 | 88,070 | ||||||||||||
Loss from operations | (17,913 | ) | (24,072 | ) | (111,561 | ) | (58,870 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Other (expense), net | (787 | ) | (495 | ) | (862 | ) | (2,050 | ) | ||||||||
Gain from contingent consideration | 999 | 7,139 | 1,760 | 4,459 | ||||||||||||
Gain (loss) on extinguishment of debt | - | (1,311 | ) | 169 | (1,569 | ) | ||||||||||
Gain on derivative warrant liability | - | - | 211 | - | ||||||||||||
Total other income | 212 | 5,333 | 1,278 | 840 | ||||||||||||
Loss before income tax | (17,701 | ) | (18,739 | ) | (110,283 | ) | (58,030 | ) | ||||||||
Income tax expense (benefit) | - | 259 | (110 | ) | 259 | |||||||||||
Net loss | $ | (17,701 | ) | $ | (18,998 | ) | $ | (110,173 | ) | $ | (58,289 | ) | ||||
Weighted average number of common shares outstanding | 35,971,882 | 23,519,870 | 29,397,504 | 16,746,679 | ||||||||||||
Basic and diluted net loss per common share | $ | (0.49 | ) | $ | (0.81 | ) | $ | (3.75 | ) | $ | (3.48 | ) | ||||
AYTU BIOPHARMA, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per-share)
| June 30, | ||||||||
| 2022 | 2021 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 19,360 | $ | 49,649 | ||||
Restricted cash | - | 252 | ||||||
Accounts receivable, net | 21,712 | 28,176 | ||||||
Inventory, net | 10,849 | 16,339 | ||||||
Prepaid expenses | 7,375 | 9,780 | ||||||
Other current assets | 633 | 1,038 | ||||||
Total current assets | 59,929 | 105,234 | ||||||
Property and equipment, net | 3,025 | 5,140 | ||||||
Operating lease right-of-use asset | 3,271 | 3,563 | ||||||
Intangible assets, net | 70,632 | 85,464 | ||||||
Goodwill | - | 65,802 | ||||||
Other non-current assets | 766 | 465 | ||||||
Total non-current assets | 77,694 | 160,434 | ||||||
Total assets | $ | 137,623 | $ | 265,668 | ||||
Liabilities | ||||||||
Current liabilities | ||||||||
Accounts payable and other | $ | 10,987 | $ | 19,255 | ||||
Accrued liabilities | 44,187 | 57,234 | ||||||
Short-term line of credit | 3,813 | 7,934 | ||||||
Current portion of debt | 96 | 16,668 | ||||||
Other current liabilities | 5,359 | 8,347 | ||||||
Total current liabilities | 64,442 | 109,438 | ||||||
Debt, net of current portion | 14,279 | 180 | ||||||
Other non-current liabilities | 12,810 | 18,482 | ||||||
Total liabilities | 91,531 | 128,100 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity | ||||||||
Preferred Stock, par value $.0001; 50,000,000 shares authorized; no shares issued or outstanding as of June 30, 2022 and June 30, 2021 | - | - | ||||||
Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 38,578,825 and 27,490,412, respectively, as of June 30, 2022 and June 30, 2021 | 4 | 3 | ||||||
Additional paid-in capital | 334,560 | 315,864 | ||||||
Accumulated deficit | (288,472 | ) | (178,299 | ) | ||||
Total stockholders' equity | 46,092 | 137,568 | ||||||
Total liabilities and stockholders' equity | $ | 137,623 | $ | 265,668 | ||||
Table A-1 - Segment Adjusted EBITDA (Quarterly)
(in thousands)
| Three Months Ended | Three Months Ended | |||||||||||||||||||||||||||||||
| Aytu BioPharma | Consumer Health | Pipeline R&D | June 30, 2022 | Aytu BioPharma | Consumer Health | Pipeline R&D | June 30, 2021 | |||||||||||||||||||||||||
Reconciliation of net loss to Adjusted EBITDA: | ||||||||||||||||||||||||||||||||
Net loss | $ | (1,332 | ) | $ | (13,352 | ) | $ | (3,017 | ) | $ | (17,701 | ) | $ | (12,224 | ) | $ | (3,257 | ) | $ | (3,517 | ) | $ | (18,998 | ) | ||||||||
Addback: | - | |||||||||||||||||||||||||||||||
Depreciation and Amortization | 1,582 | 382 | - | 1,964 | 2,241 | 447 | - | 2,688 | ||||||||||||||||||||||||
Impairment expense | - | 10,809 | - | 10,809 | 8,539 | - | - | 8,539 | ||||||||||||||||||||||||
Stock based compensation | 1,146 | 16 | 68 | 1,230 | 1,075 | 14 | - | 1,089 | ||||||||||||||||||||||||
Interest expense | 1,028 | 37 | - | 1,065 | 1,198 | 96 | - | 1,294 | ||||||||||||||||||||||||
Other income | (278 | ) | - | - | (278 | ) | (803 | ) | 4 | - | (799 | ) | ||||||||||||||||||||
Gain from contingent considerations | (999 | ) | - | - | (999 | ) | (7,139 | ) | - | - | (7,139 | ) | ||||||||||||||||||||
Gain on extinguishment of debt | - | - | - | - | 1,311 | - | - | 1,311 | ||||||||||||||||||||||||
Gain on derivative warrant liability | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||
Income tax benefit | - | - | - | - | 259 | - | - | 259 | ||||||||||||||||||||||||
Adjusted EBITDA | $ | 1,147 | $ | (2,108 | ) | $ | (2,949 | ) | $ | (3,910 | ) | $ | (5,543 | ) | $ | (2,696 | ) | $ | (3,517 | ) | $ | (11,756 | ) | |||||||||
Table A-2 - Segment Adjusted EBITDA (Annual)
(in thousands)
| Year Ended | Year Ended | |||||||||||||||||||||||||||||||
| Aytu BioPharma | Consumer Health | Pipeline R&D | June 30, 2022 | Aytu BioPharma | Consumer Health | Pipeline R&D | June 30, 2021 | |||||||||||||||||||||||||
Reconciliation of net loss to Adjusted EBITDA: | ||||||||||||||||||||||||||||||||
Net loss | $ | (81,109 | ) | $ | (17,465 | ) | $ | (11,599 | ) | $ | (110,173 | ) | $ | (46,518 | ) | $ | (7,760 | ) | $ | (4,011 | ) | $ | (58,289 | ) | ||||||||
Addback: | ||||||||||||||||||||||||||||||||
Depreciation and Amortization | 7,821 | 1,557 | - | 9,378 | 5,887 | 1,801 | - | 7,688 | ||||||||||||||||||||||||
Impairment expense | 64,649 | 10,809 | - | 75,458 | 12,825 | - | - | 12,825 | ||||||||||||||||||||||||
Stock based compensation | 4,674 | 58 | 515 | 5,247 | 3,138 | 436 | - | 3,574 | ||||||||||||||||||||||||
Interest expense | 3,310 | 132 | - | 3,442 | 2,605 | 231 | - | 2,836 | ||||||||||||||||||||||||
Other income | (2,583 | ) | 3 | - | (2,580 | ) | (803 | ) | 17 | - | (786 | ) | ||||||||||||||||||||
Gain from contingent considerations | (1,760 | ) | - | - | (1,760 | ) | (4,459 | ) | - | - | (4,459 | ) | ||||||||||||||||||||
Gain on extinguishment of debt | (169 | ) | - | - | (169 | ) | 1,569 | - | - | 1,569 | ||||||||||||||||||||||
Gain on derivative warrant liability | (211 | ) | - | - | (211 | ) | - | - | - | - | ||||||||||||||||||||||
Income tax benefit | (110 | ) | - | - | (110 | ) | 259 | - | - | 259 | ||||||||||||||||||||||
Adjusted EBITDA | $ | (5,488 | ) | $ | (4,906 | ) | $ | (11,084 | ) | $ | (21,478 | ) | $ | (25,497 | ) | $ | (5,275 | ) | $ | (4,011 | ) | $ | (34,783 | ) | ||||||||
1Aytu uses the term EBITDA, which is a term not defined under United States Generally Accepted Accounting Principles. The Company uses this term because it is a widely accepted financial indicator utilized to analyze and compare companies on the basis of operating performance. The Company believes that presenting EBITDA by segments allows investors to evaluate the various performance of these segments. The Company's method of computation of adjusted EBITDA may or may not be comparable to other similarly titled measures used by other companies. We believe that net loss is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to EBITDA.
SOURCE: Aytu BioPharma, Inc.
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FAQ
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