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.
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
Aytu BioScience, Inc.
Consolidated Balance Sheets
|Cash and cash equivalents||$7,021,527||$75,214|
|Accounts receivable, net||1,211,845||1,312,221|
|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|
|Total long-term assets||11,503,773||11,969,955|
|Libabilities and Stockholders’ Equity|
|Accounts payable and other||1,660,764||2,220,400|
|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|
|Warrant derivative liability||3,818,263||–|
|Commitments and contingencies|
|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|
|Total stockholders’ equity|
|Total liabilities and stockholders’ equity||6,352,941||3,999,816|
Aytu BioScience, Inc.
Consolidated Statements of Operations
|Three Months Ended September 30,|
|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)|
|Derivative income (expense)||299,734||(70,609)|
|Unrealized gain on investment||–||728,100|
|Total other (expense) income||110,989||242,110|
|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
|Three Months Ended September 30,|
|Cash flows from operating activities|
|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|