Full Press Release Details
Aytu BioScience Reports 55% Sequential
Revenue Growth in Q1 FY19; Adds Tuzistra XR to Portfolio
Company Posts Highest Ever Quarterly Revenue
ENGLEWOOD, CO / ACCESSWIRE / November
7, 2018 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization
of novel products addressing significant medical needs, today will provide an overview of its business, including the company's
operational and financial results for its first quarter of fiscal year 2019 that ended September 30, 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.
Q1 FY19 and Recent Operational
Josh Disbrow, CEO of Aytu BioScience
commented, "Our fiscal 2019 is off to a strong start. Revenue grew by 55%, driven largely by the continued growth of Natesto
in the $1.8 billion-dollar testosterone replacement therapy market and an early contribution from ZolpiMist. In addition to Natesto
unit sales, the Natesto gross-to-net increased substantially. An important factor in those results, was our continued commitment
to lower coupon use, having reduced Natesto couponing to just 21% of gross revenue. Additionally, initial results this quarter
from the Natesto spermatogenesis study indicate that Natesto could be an alternative for the 20% of hypogonadal men wishing to
be treated for Low T while preserving their fertility. These men currently have no FDA-approved treatment options to address both
concerns, so Natesto could be the first and only such treatment option."
Mr. Disbrow continued, "We also
received revenue contribution from ZolpiMist, the second therapeutic we sell in the United States, through initial customer stocking
and early retail pull-through. This product also competes in a large $1.8 billion category, the U.S. prescription sleep aid market.
We acquired ZolpiMist in June 2018 and launched ahead of schedule in August 2018. We are encouraged by the early commercial results.
On the expense line, we continue to manage costs and reduce cash usage. Additionally, we have the strongest balance sheet in our
history based on a cash balance of $4.1 million as of September 30th and the closing of an oversubscribed $15.2 million
public offering shortly after the end of the quarter."
Mr. Disbrow concluded, "We are
pleased with the growth of Natesto, the rapid introduction of ZolpiMist, and the exciting new addition to our portfolio, Tuzistra
XR. Tuzistra XR adds another novel product we believe can be efficiently integrated into our portfolio while leveraging our sales
force. Aytu BioScience is building a solid portfolio of unique pharmaceutical products, which have a total addressable market of
nearly $7 billion in aggregate. We are excited to grow organically and opportunistically by adding products with common call points,
to maximize shareholder value."
Q1 FY19 Financial Results
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:
1-877-407-9124 (toll-free)
1-201-689-8584 (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,
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
This press release shall not constitute an offer to sell or
the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in
any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under
the securities laws of any such state or jurisdiction. The securities described herein have not been registered under the Securities
Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from
registration requirements.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage
specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. The
company currently markets Natesto , the only FDA-approved nasal formulation of testosterone for men with hypogonadism, ZolpiMist ,
an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties
with sleep initiation, and recently acquired Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive 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, growing 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.
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 not being able to present operational results for the fiscal first quarter 2019 on Wednesday, November
7, 2018, at 4:30 p.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 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:
Consolidated Balance Sheets
| September 30, | June 30, | |||||||
| 2018 | 2018 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 3,964,717 | $ | 7,012,527 | ||||
| Restricted cash | 100,148 | 100,000 | ||||||
| Accounts receivable, net | 760,056 | 578,782 | ||||||
| Inventory, net | 1,310,103 | 1,338,973 | ||||||
| Prepaid expenses and other | 736,980 | 440,009 | ||||||
| Total current assets | 6,872,004 | 9,470,291 | ||||||
| Fixed assets, net | 196,420 | 218,684 | ||||||
| Licensed assets, net | 10,674,462 | 11,120,086 | ||||||
| Patents, net | 239,611 | 245,944 | ||||||
| Deposits | 2,200 | 5,088 | ||||||
| Total long-term assets | 11,112,693 | 11,589,802 | ||||||
| Total assets | $ | 17,984,697 | $ | 21,060,093 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and other | $ | 2,111,783 | $ | 2,119,672 | ||||
| Accrued liabilities | 428,851 | 185,882 | ||||||
| Accrued compensation | 796,848 | 540,674 | ||||||
| Current deferred rent | - | 1,450 | ||||||
| Current contingent consideration | 249,631 | 547,100 | ||||||
| Total current liabilities | 3,587,113 | 3,394,778 | ||||||
| Long-term contingent consideration | 4,220,819 | 4,146,829 | ||||||
| Warrant derivative liability | 46,629 | 93,981 | ||||||
| Total liabilities | 7,854,561 | 7,635,588 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued | ||||||||
| and outstanding 0 and 0, respectively as of | ||||||||
| September 30, 2018 (unaudited) and June 30, 2018 | - | - | ||||||
| Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued | ||||||||
| and outstanding 1,801,411 (unaudited) and 1,794,762, respectively as of | ||||||||
| September 30, 2018 and June 30, 2018 | 180 | 179 | ||||||
| Additional paid-in capital | 92,834,031 | 92,681,918 | ||||||
| Accumulated deficit | (82,704,075 | ) | (79,257,592 | ) | ||||
| Total stockholders' equity | 10,130,136 | 13,424,505 | ||||||
| Total liabilities and stockholders' equity | $ | 17,984,697 | $ | 21,060,093 |
Consolidated Statements of Operations
| Three Months Ended September 30, | ||||||||
| 2018 | 2017 | |||||||
| Product revenue, net | $ | 1,431,809 | $ | 1,076,368 | ||||
| Total revenue | 1,431,809 | 1,076,368 | ||||||
| Operating expenses | ||||||||
| Cost of sales | 410,959 | 287,201 | ||||||
| Research and development | 155,878 | 140,954 | ||||||
| Sales, general and administrative | 3,576,580 | 4,618,403 | ||||||
| Sales, general and administrative - related party | 253,709 | - | ||||||
| Amortization of intangible assets | 451,957 | 385,841 | ||||||
| Total operating expenses | 4,849,083 | 5,432,399 | ||||||
| Loss from operations | (3,417,274 | ) | (4,356,031 | ) | ||||
| Other (expense) income | ||||||||
| Interest (expense) | (76,561 | ) | (188,745 | ) | ||||
| Derivative income | 47,352 | 299,734 | ||||||
| Total other (expense) income | (29,209 | ) | 110,989 | |||||
| Net loss | $ | (3,446,483 | ) | $ | (4,245,042 | ) |
Consolidated Statements of Cash Flows
| Three Months Ended September 30, | ||||||||
| 2018 | 2017 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (3,446,483 | ) | $ | (4,245,042 | ) | ||
| Adjustments to reconcile net loss to cash used in operating activities | ||||||||
| Stock-based compensation expense | 65,563 | 195,105 | ||||||
| Depreciation, amortization and accretion | 556,807 | 653,313 | ||||||
| Issuance of restricted stocks | 86,551 | 72,306 | ||||||
| Derivative income | (47,352 | ) | (299,734 | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| (Increase) in accounts receivable | (181,274 | ) | (683,806 | ) | ||||
| Decrease in inventory | 28,870 | 140,961 | ||||||
| (Increase) decrease in prepaid expenses and other | (296,971 | ) | 48,703 | |||||
| (Decrease) in accounts payable and other | (7,889 | ) | (559,636 | ) | ||||
| Increase in accrued liabilities | 242,969 | 120,850 | ||||||
| Increase in accrued compensation | 256,174 | 340,841 | ||||||
| (Decrease) in deferred rent | (1,450 | ) | (1,669 | ) | ||||
| Net cash used in operating activities | (2,744,485 | ) | (4,217,808 | ) | ||||
| Cash flows used in investing activities | ||||||||
| Deposits | 2,888 | - | ||||||
| Purchases of fixed assets | (6,065 | ) | - | |||||
| Purchase of licensed assets | (300,000 | ) | - | |||||
| Net cash used in investing activities | (303,177 | ) | - | |||||
| 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 | ) | |||||
| Net cash provided by financing activities | - | 10,437,164 | ||||||
| Net change in cash, cash equivalents and restricted cash | (3,047,662 | ) | 6,219,356 | |||||
| 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 | $ | 4,064,865 | $ | 7,096,898 |