– Closed merger with Neos Therapeutics creating a proforma combined $100 million revenue specialty pharmaceutical company –
– Added late-stage pediatric onset rare disease asset, protein kinase C β isoform (PKCβ) inhibitor, AR101 (enzastaurin) to development pipeline –
– Record quarter for consumer health division with revenue reaching $8.4 million and Rx division revenue up 9% over same quarter last year –
– Grew leadership team with three executives including CFO, Rich Eisenstadt –
– Management to host live conference call and webcast today at 4:30 p.m. ET –
ENGLEWOOD, CO / ACCESSWIRE / May 17, 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 third quarter ended March 31, 2021 and provided recent business highlights.
“This quarter we accomplished several key milestones that further solidified our position as a leading specialty pharmaceutical company. We continued to grow our commercial portfolio of prescription therapeutics and consumer health products, notably through the close of our merger with Neos Therapeutics. Additionally, subsequent to the quarter end, we expanded our development pipeline by acquiring a late-stage pediatric-onset rare disease pipeline asset from Rumpus Therapeutics, which we now call AR101. We expect the AR101 enzastaurin pivotal program to get underway soon following the finalization of the pivotal study protocol and submission of an IND application to the FDA,” commented Josh Disbrow, chief executive officer of Aytu BioPharma. “During the quarter we continued our year-over-year growth in both business segments and grew our leadership team, including the recent appointment of Rich Eisenstadt as chief financial officer. Q3 was a pivotal quarter for the company, and we have already begun the integration of the Neos business while beginning to leverage the operational and financial synergies we expect to realize over the coming quarters.”
Third Quarter Fiscal 2021 Financials:
Recent Corporate and Pipeline Highlights:
Anticipated Upcoming Milestones and Events for Calendar Year 2021 and 2022:
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 877-407-9124 (toll-free) 201-689-8584 (international). The webcast will be accessible live and archived at the following link https://www.webcaster4.com/Webcast/Page/2142/40724 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 40724.
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. As Aytu continues this trajectory, the company is building a complimentary therapeutic development pipeline that will address significant unmet needs. For more information, 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, including but not limited to any statements regarding the financial results and statements presented in this press release and during the business update call following its release. 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: 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 combined 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 restructure or refinance our current indebtedness on favorable terms, obtaining reimbursement by third-party payors, the potential future commercialization of the company’s product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results of our ongoing and future clinical trials, anticipated future regulatory submissions and events, our ability to effectively integrate operations and manage integration costs following our acquisitions, our partners performing their required activities, our ability to effectively transfer the manufacturing process for the Neos products, our anticipated future cash position 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 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 Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC.
AYTU BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(unaudited)
|
Three Months Ended | Nine Months Ended | ||||||||||||||
|
March 31, | March 31, | ||||||||||||||
|
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues
|
||||||||||||||||
Product revenue, net
|
$ | 13,482,282 | $ | 8,156,173 | $ | 42,149,561 | $ | 12,771,235 | ||||||||
|
||||||||||||||||
Operating expenses
|
||||||||||||||||
Cost of sales
|
13,682,297 | 1,998,659 | 23,499,842 | 2,980,425 | ||||||||||||
Research and development
|
389,262 | 78,502 | 858,698 | 223,197 | ||||||||||||
Selling, general and administrative
|
12,851,087 | 9,190,386 | 35,825,175 | 19,494,368 | ||||||||||||
Acquisition related costs
|
1,536,800 | 311,083 | 2,849,037 | 1,533,723 | ||||||||||||
Restructuring costs
|
4,818,064 | ??? | 4,874,723 | 135,981 | ||||||||||||
Amortization and impairment of intangible assets
|
5,870,436 | 1,370,986 | 9,039,597 | 2,899,553 | ||||||||||||
Total operating expenses
|
39,147,946 | 12,949,616 | 76,947,072 | 27,267,247 | ||||||||||||
Loss from operations
|
(25,665,664 | ) | (4,793,443 | ) | (34,797,511 | ) | (14,496,012 | ) | ||||||||
Other (expense) income
|
||||||||||||||||
Other (expense), net
|
(425,425 | ) | (538,862 | ) | (1,555,924 | ) | (1,181,206 | ) | ||||||||
Gain / (Loss) from change in fair value of contingent consideration
|
631,298 | – | (2,680,022 | ) | – | |||||||||||
Gain from derecognition of contingent consideration
|
– | – | – | 5,199,806 | ||||||||||||
Gain from warrant derivative liability
|
– | – | – | 1,830 | ||||||||||||
Loss on debt exchange
|
– | – | (257,559 | ) | – | |||||||||||
Total other (expense) income
|
205,873 | (538,862 | ) | (4,493,505 | ) | 4,020,430 | ||||||||||
Net loss
|
$ | (25,459,791 | ) | $ | (5,332,305 | ) | $ | (39,291,016 | ) | $ | (10,475,582 | ) | ||||
Weighted average number of common shares outstanding
|
18,092,465 | 3,527,530 | 14,490,219 | 2,261,697 | ||||||||||||
Basic and diluted net loss per common share
|
$ | (1.41 | ) | $ | (1.51 | ) | $ | (2.71 | ) | $ | (4.63 | ) | ||||
AYTU BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
|
March 31, | June 30, | |||||||||
|
2021 | 2020 | |||||||||
|
(Unaudited) | ||||||||||
Assets | |||||||||||
Current assets
|
|||||||||||
Cash and cash equivalents
|
$ | 46,537,958 | $ | 48,081,715 | |||||||
Restricted cash
|
251,995 | 251,592 | |||||||||
Accounts receivable, net
|
28,228,434 | 5,632,717 | |||||||||
Inventory
|
16,575,757 | 9,999,441 | |||||||||
Prepaid expenses
|
6,803,583 | 5,715,089 | |||||||||
Other current assets
|
1,615,024 | 5,742,011 | |||||||||
Total current assets
|
100,012,751 | 75,422,565 | |||||||||
|
|||||||||||
Fixed assets, net
|
5,557,727 | 258,516 | |||||||||
Operating lease right-of-use asset
|
3,781,737 | 634,093 | |||||||||
Intangible assets, net
|
96,236,796 | 48,854,561 | |||||||||
Goodwill
|
65,802,636 | 28,090,407 | |||||||||
Other long-term assets
|
164,954 | 32,981 | |||||||||
Total long-term assets
|
171,543,850 | 77,870,558 | |||||||||
Total assets
|
$ | 271,556,601 | $ | 153,293,123 | |||||||
AYTU BIOPHARMA, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets, cont‘d
|
March 31, | June 30, | |||||||||
|
2021 | 2020 | |||||||||
|
(Unaudited) | ||||||||||
Liabilities | |||||||||||
Current liabilities
|
|||||||||||
Accounts payable and other
|
$ | 16,528,646 | $ | 11,824,560 | |||||||
Accrued liabilities
|
43,181,920 | 8,645,984 | |||||||||
Accrued compensation
|
10,510,228 | 3,117,177 | |||||||||
Notes payable
|
– | 982,076 | |||||||||
Short-term line of credit
|
4,738,825 | – | |||||||||
Current portion of debt
|
725,357 | – | |||||||||
Current portion of operating lease liabilities
|
910,885 | 300,426 | |||||||||
Current portion of fixed payment arrangements
|
1,998,012 | 2,340,166 | |||||||||
Current portion of CVR liabilities
|
911,826 | 839,734 | |||||||||
Current portion of contingent consideration
|
4,177,282 | 713,251 | |||||||||
Total current liabilities
|
83,682,981 | 28,763,374 | |||||||||
|
|||||||||||
Long-term debt, net of current portion
|
16,930,682 | – | |||||||||
Long-term operating lease liability, net of current portion
|
2,871,845 | 725,374 | |||||||||
Long-term fixed payment arrangements, net of current portion
|
9,422,768 | 11,171,491 | |||||||||
Long-term CVR liabilities, net of current portion
|
4,679,227 | 4,731,866 | |||||||||
Long-term contingent consideration, net of current portion
|
10,726,691 | 12,874,351 | |||||||||
Other long-term liabilities
|
92,894 | 11,371 | |||||||||
Total liabilities
|
128,407,088 | 58,277,827 | |||||||||
|
|||||||||||
Commitments and contingencies (Note 10)
|
|||||||||||
|
|||||||||||
Stockholders’ equity
|
|||||||||||
Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 0 and 0, respectively as of March 31, 2021 and June 30, 2020, respectively.
|
– | – | |||||||||
Common Stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 23,457,887 and 12,583,736, respectively as of March 31, 2021 and June 30, 2020.
|
2,346 | 1,259 | |||||||||
Additional paid-in capital
|
302,448,362 | 215,024,216 | |||||||||
Accumulated deficit
|
(159,301,195 | ) | (120,010,179 | ) | |||||||
Total stockholders’ equity
|
143,149,513 | 95,015,296 | |||||||||
Total liabilities and stockholders’ equity
|
$ | 271,556,601 | $ | 153,293,123 | |||||||
Contact for Media and Investors:
Sarah McCabe
Stern Investor Relations, Inc.
sarah.mccabe@sternir.com
SOURCE: Aytu BioPharma, Inc.
View source version on accesswire.com:
https://www.accesswire.com/647604/Aytu-BioPharma-Reports-Fiscal-Third-Quarter-2021-Financial-Results-and-Recent-Business-Highlights
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