EX-99.1 2 aytu_ex991.htm PRESS RELEASE Blueprint
 
Exhibit 99.1
 
Aytu BioScience Reports 100% Revenue Growth to $7.3 million in FY 2019
 
Results Do Not Include September 2019 Definitive Agreement to Acquire Innovus Pharmaceuticals: Combined LTM revenues of over $31M, Diversifies product line by 10x to over 30 products
 
ENGLEWOOD, CO / ACCESSWIRE / September 26, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today will provide an overview of its business, including the company's operational and financial results for its fiscal year 2019 that ended June 30, 2019. The company will host a live conference call and webcast today at 4:30 p.m. ET. Conference call details are provided at the end of this press release.
 
FY 2019 and Recent Operational Highlights
 
Fiscal Year ending June 30, 2019 revenue increased 100% to $7.3 million; results do not include any contribution from September 2019 Definitive Agreement to acquire Innovus Pharmaceuticals: combined last twelve-month revenues of over $31 million
 
Generated $5.1 million in FY 2019 gross profit, a 218% increase over prior year
 
Grew product portfolio from Natesto® only, to three products – with the acquisition of ZolpiMist™ and Tuzistra® XR
 
Natesto Spermatogenesis Study results were accepted for presentation as a “Late-Breaking Abstract” by the American Society for Reproductive Medicine (ASRM). The study results will be presented at the 75th ASRM Scientific Congress & Expo in Philadelphia, PA October 16, 2019
 
Used $2.1 million less cash than prior year despite cash used to purchase two new products, buy inventory and launch both quickly, within one-quarter of closing each transaction
 
Raised $20.6 million new capital (debt, equity and warrant exercises)
 
Added multiple high-quality, healthcare focused fundamental institutional investors
 
Added two sell-side analysts covering AYTU
 
Expanded the board to include Steve Boyd, Founder and CIO of healthcare institutional investor Armistice Capital, and Ketan Mehta, Founder, President, and Chief Executive Officer of Tris Pharma
 
 
 
 
Subsequent to Fiscal Year Ending June 30, 2019
 
Announced Innovus Pharmaceuticals acquisition to form an integrated specialty pharmaceutical company:
 
Combined trailing twelve-month revenues of over $31 million
 
Diversifies product line by 10x to over 30 products in both Rx and consumer segments
 
Adds a robust, growing consumer health business to complement current growing prescription product portfolio
 
Adds complementary, seasoned management team to continue the growth of the Innovus consumer health business
 
Innovus operating near breakeven; near-term commercial, administrative, and operational synergies, resulting in acceleration of time to EBIDTA positive, are expected to be realized through the rapid integration of the two companies’ operations.
 
Announced Natesto license re-negotiation with Acerus Pharmaceuticals to accelerate revenue growth and increase promotion to Low T specialists:
 
Doubles Natesto sales representatives; augments current Aytu sales force with nationwide specialty sales team focused on urology and endocrinology
 
Increases gross profit, eliminates milestone payments, removes regulatory fees and clinical trial expenses
 
Announced Tuzistra XR co-promotion with Poly Pharmaceuticals to accelerate Rxgrowth and increase physician coverage:
 
Doubles the Tuzistra XR sales representative headcount; potential to double revenue in FY2020
 
Expands primary care physician promotion by over 7,500 prescribers
 
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, “FY 2019 and subsequent activities reflect that Aytu is entering a period of hypergrowth. Revenue in FY 2019 increased 100% year over year to $7.3 million, as we grew the product portfolio 3x from one product to three. With our September 2019 definitive agreement to acquire Innovus Pharmaceuticals, combined trailing twelve-month revenue is more than $31 million, and this grows and diversifies our product line by 10x to over 30 products in both Rx and consumer health segments. The synergies from the combination are expected to result in accelerating our time to EBITDA positive, which we expect will be a significant catalyst that further increases shareholder value.”
 
 
 
 
FY19 Financial Results
 
Net revenue for the year-ended June 30, 2019 was $7.3 million, an increase of 100% over the prior year ended June 30, 2018.
 
Cash, cash equivalents, and restricted cash was approximately $11.3 million as of June 30, 2019 
 
Cash used in operations for the year ended June 30, 2019 decreased by $2.1 million from the prior year ended June 30, 2018.
 
Operating expenses excluding COGS for the year ended June 30, 2019 were $22 million, which were comparable to the prior year ended June 30, 2018.
 
The company retired all of its outstanding debt through an exchange with Armistice Capital in the fourth quarter of 2019, which increased its equity investment in the company. The $5 million exchange was approved by a shareholder vote with 95% of votes cast supporting the exchange.
 
Conference Call Information
 
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)
1- 862-298-0970 (international)
 
The webcast will be accessible live and archived on Aytu BioScience'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) and using the replay access code 53674.
 
About Aytu BioScience, Inc.
 
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product. Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information 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 presentation, 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. 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 relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
 
Contact for Investors:
 
James Carbonara 
Hayden IR
(646)-755-7412
 
 
 
 
Aytu BioScience, Inc.
Consolidated Statements of Operations Information
 
 
 
 Year Ended June 30,
 
 
 
2019
 
 
2018
 
 Revenues
 
 
 
 
 
 
 Product revenue, net
 $7,314,581 
 $3,660,120 
 License revenue, net
  5,776 
  
 Total product revenue
  7,320,357 
  3,660,120 
 
    
    
 Operating expenses
    
    
     Cost of sales
  2,202,041 
  2,050,544 
 Research and development
  589,072 
  167,595 
 Selling, general and administrative
  18,887,783 
  17,732,490 
 Selling, general and administrative - related party
  351,843 
  
  Impairment of intangible assets
  
  1,856,020 
 Amortization of intangible assets
 2,136,255 
  1,553,705 
 Total operating expenses
  24,166,994 
  23,360,354 
 
    
    
 Loss from operations
  (16,846,637)
  (19,700,234)
 
    
    
 Other (expense) income
    
    
 Other (expense), net
  (535,500)
  (749,423)
 (Loss) / gain from change in fair value of contingent consideration
  (9,830,550)
  6,277,873 
 Gain from warrant derivative liability
  80,779 
  3,983,921 
 Total other (expense) income
  (10,285,271)
  9,512,371 
 
    
    
 Net loss
 $(27,131,908)
 $(10,187,863)
 
    
    
 Weighted average number of common shares outstanding 
 $7,794,489 
 $665,605 
 
    
    
 Basic and diluted net loss per common share
 $(3.48)
  (15.31)
 
 
 
 
 
Aytu BioScience, Inc.
Consolidated Balance Sheet Information
 
 
 
 June 30,
 
 
 
2019
 
 
2018
 
 Assets
 Current assets
 
 
 
 
 
 
 Cash and cash equivalents
 $11,044,227 
 $7,012,527 
 Restricted cash
  250,000 
  100,000 
 Accounts receivable, net
  1,740,787 
  578,782 
 Inventory, net
  1,440,069 
  1,338,973 
 Prepaid expenses and other
  957,781 
  440,009 
 Total current assets
  15,432,864 
  9,470,291 
 
    
    
 Fixed assets, net
  203,733 
  218,684 
 Licensed assets, net
  18,861,983 
  11,120,086 
 Patents, net
  220,611 
  245,944 
 Deposits
  2,200 
  5,088 
 Total long-term assets
  19,288,527 
  11,589,802 
 
    
    
 Total assets
 $34,721,391 
 $21,060,093 
 
    
    
 Liabilities
 Current liabilities
    
    
 Accounts payable and other
 $2,297,270 
 $2,119,672 
 Accrued liabilities
  1,147,740 
  185,882 
 Accrued compensation
  849,498 
  540,674 
 Current deferred rent
   
  1,450 
 Current contingent consideration
  1,078,068 
  547,100 
 Total current liabilities
  5,372,576 
  3,394,778 
 
    
    
 Long-term contingent consideration
  22,247,796 
  4,146,829 
 Warrant derivative liability
  13,201 
  93,981 
 Total liabilities
  27,633,573 
  7,635,588 
 
    
    
 Commitments and contingencies
    
    
 
    
    
 Stockholders' equity
    
    
Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 3,594,981 and 0, respectively as of June 30, 2019 and 2018, respectively.
  359 
   
Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued and outstanding 17,538,071 and 1,794,762, respectively as of June 30, 2019 and 2018
  1,754 
  179 
 Additional paid-in capital
  113,475,205 
  92,681,918 
 Accumulated deficit
  (106,389,500)
  (79,257,592)
 Total stockholders' equity
  7,087,818 
  13,424,505 
 
    
    
 Total liabilities and stockholders' equity
 $34,721,391 
 $21,060,093 
 
 
 
 
Aytu BioScience, Inc.
Consolidated Statements of Cash Flows Information
 
 
 
 Year Ended June 30,
 
 
 
2019
 
 
2018
 
Operating Activities
 
 
 
 
 
 
Net loss
 $(27,131,908)
 $(10,187,863)
Adjustments to reconcile net loss to cash used in operating activities:
    
    
Depreciation, amortization and accretion
  2,727,067 
  2,591,270 
Impairment of intangible assets
   
  1,856,020 
Stock-based compensation expense
  1,022,202 
  596,934 
Loss / (gain) from change in fair value of contingent consideration
  9,830,550 
  (6,277,873)
Warrants issuance and amendments
   
  183,920 
Issuance of common stock to employee
  11,690 
   
Derivative income
  (80,779)
  (3,983,921)
Changes in operating assets and liabilities:
    
    
(Increase) in accounts receivable
  (1,162,005)
  (50,743)
(Increase) decrease in inventory
  (101,096)
  (26,752)
(Increase) in prepaid expenses and other
  (517,772)
  (129,249)
Increase / (decrease) in accounts payable and other
  134,775 
  (109,707)
Increase / (decrease) in accrued liabilities
  961,858 
  (596,654)
Increase in accrued compensation
  308,824 
  200,970 
Increase in interest payable - related party
  166,667 
   
(Decrease) in deferred rent
  (1,450)
  (6,674)
Net cash used in operating activities
  (13,831,377)
  (15,940,322)
 
    
    
Investing Activities
    
    
Deposit
  2,888 
  (2,200)
Purchases of fixed assets
  (59,848)
  (74,707)
Contingent consideration payment
  (505,025)
  (7,385)
Purchase of assets
  (500,000)
  (400,000)
Net cash used in investing activities
  (1,061,985)
  (484,292)
 
    
    
Financing Activities
    
    
Issuance of preferred, common stock and warrants
  15,180,000 
  11,839,995 
Issuance costs related to preferred, common stock and warrants
  (1,479,964)
  (1,402,831)
Issuance of preferred, common stock and warrants
  - 
  12,900,020 
Issuance costs related to preferred, common stock and warrants
  - 
  (1,294,235)
Warrant exercises
  375,026 
  677,100 
S-3 registered offering cost
  - 
  (60,450)
Issuance of debt - related party
  5,000,000 
  - 
Net cash provided by financing activities
  19,075,062 
  22,659,599 
 
    
    
Net change in cash, restricted cash and cash equivalents
  4,181,700 
  6,234,985 
Cash, restricted cash and cash equivalents at beginning of period
  7,112,527 
  877,542 
Cash, restricted cash and cash equivalents at end of period
 $11,294,227 
 $7,112,527