Englewood, CO – November 9, 2017 – Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty life sciences company focused on global commercialization of novel products in the field of urology, today provided an overview of its business, including the Company’s operational and financial results for its fiscal first quarter of 2018.  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.

“During the first fiscal quarter of 2018, we achieved our commercial objectives and experienced substantial prescription demand growth for Natesto®. The Company also increased our base of business outside the U.S. for the MiOXSYS® System, and received positive reception from clinicians during the early commercialization of our newly added commercial-stage product Fiera®,” commented Josh Disbrow, Chief Executive Officer of Aytu BioScience.

Q1 2018 Operational Highlights

  • Recognized $1.1 million in total net revenues for the first quarter of fiscal 2018, representing a 54% increase over Q1 fiscal 2017
  • Listed the Company’s common shares on the NASDAQ Capital Market, on which trading of shares under the ticker symbol “AYTU” began October 20, 2017
  • Increased Natesto prescription demand to 2,036 total prescriptions, representing a 411% increase over Q1 fiscal 2017
  • Increased shipped Natesto factory sales units to over 7,000, representing an increase of more than 85% over the previous quarter
  • Increased the number of Natesto prescribers across the U.S. to 991, which represented a 21% increase over the previous quarter
  • Increased the number of MiOXSYS System placements globally to 96 since Q1 fiscal 2017, and placed 29 instruments in six countries through the Company’s distribution partners
  • Initiated commercial integration of the women’s sexual wellness product line, Fiera, and the launch of the Company’s first international distribution agreement in Japan

Q1 2018 Financial Results

Net revenue for the Company, for the first quarter of 2018, totaled $1,076,000 from sales of Natesto, MiOXSYS, Fiera, and ProstaScint, compared to net revenue of $698,000 for the same period last year, an increase of 54%.  Natesto and MiOXSYS comprised the majority of sales in the first quarter of 2018.  Product sales in the same quarter of 2017 were mostly comprised of ProstaScint and Primsol, a product that was divested in late fiscal 2017.

Gross sales for the company totaled $2,243,000, representing an increase of 142% over the same period last year.

Sales, general, and administrative expenses for the first quarter of 2018 were $4,618,000, down 20% from the same quarter last year, and the Company’s net loss for the quarter was reduced by 26% to $4,245,000.

Cash and cash equivalents totaled $7.1M as of September 30, 2017.

With the increasing net revenues due to the sales growth of Natesto, expansion of MiOXSYS outside the US and the integration of Fiera, the Company believes it has adequate cash to achieve profitability and effectively operate into the middle of fiscal 2019.

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 (855) 656-0926 (U.S.)

1 (412) 542-4198 (international)

The webcast will be accessible live during the conference call 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 seven days. Access the replay by calling 1 (877) 344-7529 (U.S.) or 1 (412) 317-0088 (international) and using the replay access code 10114103.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty life sciences company focused on global commercialization of novel products in the field of urology, with a focus on products addressing vitality, sexual wellness, and reproductive health. The Company currently markets two prescription products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”) and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. 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 the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k 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 growing markets. For more information visit aytubio.com. Aytu also now owns wholly-owned subsidiary Aytu Women’s Health (formerly Nuelle, Inc.), a personal health and wellness company focused on women’s sexual wellbeing and intimacy. Aytu Women’s Health markets Fiera, a personal care device for women that is scientifically proven to enhance physical arousal and sexual desire. Fiera is a consumer device and is not intended to treat, mitigate, or cure any disease or medical condition. For more information about the Fiera personal care device visit fiera.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: the risks related to Natesto sales not increasing, MiOXSYS not expanding outside the US, and setbacks related to the integration of Fiera that would affect having adequate cash to achieve profitability and effectively operate into the middle of fiscal 2019, 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 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:

Amato and Partners, LLC

Investor Relations Counsel

admin@amatoandpartners.com

 

Aytu BioScience, Inc.
Consolidated Balance Sheets
Unaudited

September 30,
2017
June 30,
2016
Assets
Current assets
  Cash and cash equivalents $7,021,527 $75,214
  Restricted cas 75,371 528,039
  Accounts receivable, net 1,211,845 1,312,221
  Inventory, net 1,171,260 310,760
  Prepaid expenses and other 262,057 3,028,562
    Total current assets 9,742,060
Fixed assets, net 566,913 647,254
Developed technology, net 1,294,306 1,337,333
Custom contracts, net 76,667 77,667
Trade names, net 158,238 164,037
Natesto asset, net 8,901,391 9,231,072
Goodwill 238,426 238,426
Patents, net 264,944 271,278
Deposits 2,888 2,888
  Total long-term assets 11,503,773 11,969,955
Total assets 21,245,833 14,998,517
Libabilities and Stockholders’ Equity
Current liabilities
  Accounts payable and other 1,660,764 2,220,400
  Accrued liabilities 903,386 782,536
  Accrued compensation 680,545 339,704
  Deferred rent 6,455 6,673
  Current contingent consideration 257,036 261,155
    Total current liabilities 3,508,186 3,610,468
Long-term contingent consideration 7,566,443 7,386,782
Deferred rent 1,451
Warrant derivative liability 3,818,263
    Total liabilities 14,892,892 10,998,701
Commitments and contingencies
Stockholders’ equity
Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 2,250 (unaudited) and 0, respectively as of September 30, 2017 and June 30, 2017 1
Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued and outstanding 4,224,840 (unaudited) and 824,831, respectively as of September 30, 2017 and June 30, 2017 422 82
Additional paid-in capital 79,667,289 73,069,463
Accumulated deficit (73,314,771) (69,069,729)
Total stockholders’ equity
Total liabilities and stockholders’ equity 6,352,941 3,999,816
$21,245,833 $14,998,517

 

 Aytu BioScience, Inc.
Consolidated Statements of Operations
Unaudited

Three Months Ended September 30,
2017 2016
Product revenue $1,076,368 $697,980
Total revenue 1,076,368 697,980
Operating expenses 287,201 191,924
Cost of sales 140,954 232,022
Research and development – related party 47,998
Sales, general and administrative 4,618,403 5,704,750
Sales, general and administrative – related party 50,772
Amortization and impairment of intangible assets 385,841 437,014
Total operating expenses 5,432,399 6,664,480
   Loss from operations (4,356,031) (5,966,500)
Other income (expense)
  Interest (expense) (188,745) (415,381)
  Derivative income (expense) 299,734 (70,609)
  Unrealized gain on investment 728,100
    Total other (expense) income 110,989 242,110
Net loss (4,245,042) (5,724,390)
Weighted average number of Aytucommon shares outstanding 2,415,402 244,937
Basic and diluted Aytu net lossper common share (1.76) (23.37)

 

Aytu BioScience, Inc.
Consolidated Statements of Cash Flows
Unaudited

Three Months Ended September 30,
2017 2016
Cash flows from operating activities
  Net loss (4.245.043) (5,724,390)
Adjustments to reconcile net loss to cash provided by (used in) operating activities
Stock-based compensating expense 195,105 1,043,712
Issuance of restricted stock 72,306 75,466
Depreciation, amortization and accretion 653,313 822,161
Derivative (income) expense                                (299,734) 70,609
Amortization of prepaid research and development – related party 30,496
Unrealized (gain) on investment (728,100)
Compensation through issuance of stock 509,996
Issuance of warrants to initial investors                               589,377
Adjustments to reconcile net loss to net cash used in operating activities:
(Increase) in accounts receivable (683,806) (347,013)
Decrease (increase) in inventory 140,961 (60,650)
Decrease (increase) in prepaid expenses and other 48,703 (337,525)
(Decrease) in accounts payable and other (559,636) (109,365)
Increase (decrease) in accrued liabilities 120,850 (498,516)
Increase (decrease) in accrued compensation 340,841 (668,792)
(Decrease) increase in deferred rent (1,669) 75
Net cash used in operating activities (4,217,808) (5,332,459)
Cash flows used in investing activities
Purchases of property and equipment (4,721)
Installment payment for Primsol asset (500,000)
Net cash used in investing activities (504,721)
Cash flows from financing activities
Issuance of preferred, common stock and warrants 11,839,995
Issuance costs related to preferred, common stock and warrants (1,402,831)
Issuance of common stock to Lincoln Park Capital 631,481
Costs related to sale of common stock (24,247)
Net cash provided by financing activities 10,437,164 607,234
Net change in cash and cash equivalents 6,219,356 (5,229,946)
Cash and cash equivalents at beginning of period 877,542 8,054,190
Cash and cash equivalents at end of period $7,096,898 $2,824,244