EX-99.1 2 aytu_ex991.htm PRESS RELEASE Blueprint
 
 
Exhibit 99.1
 
Aytu BioScience Reports 71% Revenue Growth in Q2 FY19
 
Company Posts Highest Ever Quarterly Revenue
 
ENGLEWOOD, CO / ACCESSWIRE / February 7, 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 second quarter of fiscal year 2019 that ended December 31, 2018. The company will host a live conference call and webcast today at 9:00 a.m. ET. Conference call details are provided at the end of this press release.
 
Q2 FY19 and Recent Operational Highlights
 
Recorded all-time high net revenue of $1.8 million, 71% growth over Q2 FY18 and a 25% increase sequentially from Q1 FY19.
 
Natesto® net revenue for the second quarter increased 37% sequentially from Q1 FY19.
 
Cash balance of approximately $18 million on December 31, 2018.
 
Announced positive interim results from Natesto spermatogenesis study. If confirmed in the final data read out this summer, Natesto would be the only testosterone replacement therapy that preserves fertility in hypogonadal men.
 
Acquired the exclusive U.S. license to Tuzistra® XR, the only 12-hour codeine-based antitussive oral suspension. Tuzistra XR competes in the $3 billion prescription antitussive category and generated approximately 40,000 prescriptions in 2017.
 
Completed its first full quarter of sales force promotion for ZolpiMist™, a product competing in the $1.8 billion U.S. sleep aid market.
 
Closed a $15.2 million underwritten public offering and full exercise of over-allotment option, led by a fundamental healthcare investor.
 
Announced a strategic financing with Armistice Capital, LLC in the form of a $5 million secured note, which was tied to the acquisition of Tuzistra XR.
 
Announced appointment of Ketan Mehta to the board of directors. Announced that Steven Boyd is expected to be appointed to the board of directors in the near future.
 
Josh Disbrow, CEO of Aytu BioScience commented, "Fiscal Q2 2019 was a record quarter for Aytu. Revenue grew 71%, over Q2 2018, to the highest level in company history, driven largely by Natesto’s performance, which was bolstered by the Natesto Direct patient support program. The company is now annualizing at over $7 million in revenue, and we expect to continue on our growth trajectory in the coming quarters. We recorded our first full quarter of sales force promotion for our second product, ZolpiMist, a novel sleep aid competing in a $1.8 billion prescription category. Further, we acquired a third product, Tuzistra XR, a unique antitussive competing in a $3 billion market and bringing our total addressable market to nearly $7 billion. We look forward to continuing Natesto’s sales growth, launching our newest products and selectively acquiring unique products with similar physician call points, to build shareholder value.”
 
 
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Mr. Disbrow continued, “We completed an equity financing in October and had a cash balance of approximately $18 million at the end of December. Furthermore, we announced positive interim results from the Natesto spermatogenesis study, the appointment of Ketan Mehta to the board of directors, and the expected appointment of Steven Boyd to the board of directors in the near future.”
 
Q2 FY19 Financial Results
 
Cash, cash equivalents, and restricted cash totaled approximately $18 million as of December 31, 2018.
 
Net revenue for Q2 FY19 was $1.8 million, an increase of 71% over Q2 FY18 and 25% growth sequentially, compared to $1.4 million in Q1 FY19. 
 
Cash used in operations for the quarter was $4.3 million. The change in cash use resulted from a large purchase of ZolpiMist inventory, annual PDUFA fees paid to the FDA, along with one-time cash uses of approximately $0.4 million for Q2 FY19.
 
Operating expenses for the quarter were $6.3 million, which include specific one-time expenses associated with the commercial start-up costs for ZolpiMist and Tuzistra XR. Excluding these commercial start-up costs, pro forma operating expenses were approximately $5.9 million.
 
Following the end of the quarter, Armistice Capital, owner of 4.99% of the company’s common stock based on Armistice’s most recent filing, proposed to increase its equity investment in the company through an equity issuance in exchange for retiring the company’s $5 million secured note. Upon shareholder approval at the company’s upcoming annual meeting, the $5 million note will be retired in exchange for an issuance of common stock, Series E convertible preferred stock, and warrants.
 
Conference Call Information
 
The company will host a live conference call at 9:00 a.m. ET today. The conference call can be accessed by dialing either:
 
1-866-682-6100 (toll-free)
 
1-862-298-0702 (international)
 
The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Corporate Presentations & Media, 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 1-919-882-2331 (international) and using the replay access code 42857.
 
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, and 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.
 
 
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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. Such forward-looking statements include, but are not limited to, our expectations related to coupon rates in subsequent quarters and the timing and results of the Natesto spermatogenesis study. 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: the risks related to the company’s operational results for the fiscal second quarter 2019 being presented on Thursday, February 7, 2019, at 9:00 a.m. ET, risks relating to gaining market acceptance of our products, obtaining 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 revenue growth, 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 Aytu BioScience, Inc.'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 
james@haydenir.com
 
SOURCE: Aytu BioScience, Inc. 
 
 
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Aytu BioScience, Inc.
Consolidated Balance Sheets
Unaudited
 
 
 
 December 31,
 
 
 June 30,
 
 
 
2018
 
 
2018
 
 
 
 
 
 
 
 
 
 Assets
 
 
 
 
 Current assets
 
 
 
 
 
 
 Cash and cash equivalents
 $17,804,887 
 $7,012,527 
 Restricted cash
  100,225 
  100,000 
 Accounts receivable, net
  1,482,490 
  578,782 
 Inventory, net
  1,644,861 
  1,338,973 
 Prepaid expenses and other
  944,766 
  440,009 
 Total current assets
  21,977,229 
  9,470,291 
 
    
    
 
    
    
 Fixed assets, net
  186,944 
  218,684 
 Licensed assets, net
  19,999,550 
  11,120,086 
 Patents, net
  233,278 
  245,944 
 Deposits
  2,200 
  5,088 
 Total long-term assets
  20,421,972 
  11,589,802 
 
    
    
 Total assets
 $42,399,201 
 $21,060,093 
 
    
    
 
 Liabilities and Stockholders' Equity
 
    
 Current liabilities
    
    
 Accounts payable and other
 $2,371,785 
 $2,119,672 
 Accrued liabilities
  932,690 
  185,882 
 Accrued compensation
  743,834 
  540,674 
 Current deferred revenue
  13,990 
  - 
 Current deferred rent
  - 
  1,450 
 Current contingent consideration
  593,173 
  547,100 
 Total current liabilities
  4,655,472 
  3,394,778 
 
    
    
 Long-term contingent consideration
  12,783,710 
  4,146,829 
 Long-term debt
  5,036,164 
  - 
 Warrant derivative liability
  25,992 
  93,981 
 Total liabilities
  22,501,338 
  7,635,588 
 
    
    
 Commitments and contingencies
    
    
 
    
    
 Stockholders' equity
    
    
 Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued
    
    
    and outstanding 4,532,664 and 0, respectively as of
    
    
     December 31, 2018 and June 30, 2018
  453 
  - 
 Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued
    
    
    and outstanding 10,504,769 and 1,794,762, respectively as of
    
    
     December 31, 2018 and June 30, 2018
  1,050 
  179 
 Additional paid-in capital
  107,258,097 
  92,681,918 
 Accumulated deficit
  (87,361,737)
  (79,257,592)
 Total stockholders' equity
  19,897,863 
  13,424,505 
 
    
    
 Total liabilities and stockholders' equity
 $42,399,201 
 $21,060,093 
 
 
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Aytu BioScience, Inc.
Consolidated Statements of Operations
Unaudited
 
 
 
 Three Months Ended December 31,
 
 
 Six Months Ended December 31,
 
 
 
2018
 
 
2017
 
 
2018
 
 
2017
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Product revenue, net
 $1,795,011 
 $1,051,154 
 $3,226,820 
 $2,127,522 
 
    
    
    
    
 Operating expenses
    
    
    
    
     Cost of sales
  525,138 
  385,411 
  936,097 
  672,612 
 Research and development
  149,029 
  (277,486)
  304,907 
  (136,532)
 Selling, general and administrative
  5,046,174 
  4,553,366 
  8,622,754 
  9,171,769 
 Selling, general and administrative - related party
  91,337 
  - 
  345,046 
  - 
 Amortization and impairment of intangible assets
  534,063 
  383,811 
  986,020 
  769,652 
 Total operating expenses
  6,345,741 
  5,045,102 
  11,194,824 
  10,477,501 
 
    
    
    
    
 Loss from operations
  (4,550,730)
  (3,993,948)
  (7,968,004)
  (8,349,979)
 
    
    
    
    
 Other (expense) income
    
    
    
    
 Other expense, net
  (127,569)
  (196,781)
  (204,130)
  (385,526)
 Derivative income
  20,637 
  518,051 
  67,989 
  817,785 
 Total other (expense) income
  (106,932)
  321,270 
  (136,141)
  432,259 
 
    
    
    
    
 Net loss
 $(4,657,662)
 $(3,672,678)
 $(8,104,145)
 $(7,917,720)
 Weighted average number of
    
    
    
    
 common shares outstanding
  6,477,004 
  205,663 
  4,183,591 
  124,056 
 
    
    
    
    
 Basic and diluted net loss
    
    
    
    
 per common share
 $(0.72)
 $(17.86)
 $(1.94)
 $(63.82)
 
 
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Aytu BioScience, Inc.
Consolidated Statements of Cash Flows
Unaudited
 
 
 
 Six Months Ended December 31,
 
 
 
2018
 
 
2017
 
 
 
 
 
 
 
 
Cash flows from operating activities
 
 
 
 
 
 
Net loss
 $(8,104,145)
 $(7,917,720)
Adjustments to reconcile net loss to cash used in operating activities
    
    
Stock-based compensation expense
  106,671 
  275,688 
Issuance of restricted stock
  239,505 
  103,635 
Depreciation, amortization and accretion
  1,230,671 
  1,315,063 
Issuance of common stock to employee
  11,690 
  - 
Derivative (income)
  (67,989)
  (817,785)
Changes in operating assets and liabilities:
    
    
(Increase) in accounts receivable
  (903,708)
  (849,397)
(Increase) in inventory
  (305,888)
  (67,585)
(Increase) in prepaid expenses and other
  (504,757)
  (454,595)
Increase in accounts payable and other
  252,113 
  1,124,558 
Increase (decrease) in accrued liabilities
  746,808 
  (524,905)
Increase in accrued compensation
  203,160 
  497,586 
Increase in interest payable
  36,164 
  - 
Increase in deferred revenue
  13,990 
  - 
(Decrease) in deferred rent
  (1,450)
  (3,337)
Net cash used in operating activities
  (7,047,165)
  (7,318,794)
 
    
    
Cash flows used in investing activities
    
    
Deposit
  2,888 
  - 
Purchases of property and equipment
  (12,954)
  (12,195)
Contingent consideration payment
  (50,221)
  - 
Purchase of assets
  (800,000)
  - 
Net cash used in investing activities
  (860,287)
  (12,195)
 
    
    
Cash flows from financing activities
    
    
Issuance of preferred, common stock and warrants
  15,180,000 
  11,839,995 
Issuance costs related to preferred, common stock and warrants
  (1,479,963)
  (1,402,831)
Issuance of debt
  5,000,000 
  - 
Net cash provided by financing activities
  18,700,037 
  10,437,164 
 
    
    
Net change in cash, cash equivalents and restricted cash
  10,792,585 
  3,106,175 
Cash, cash equivalents and restricted cash at beginning of period
  7,112,527 
  877,542 
Cash, cash equivalents and restricted cash at end of period
 $17,905,112 
 $3,983,717 
 
 
 
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