Full Press Release Details
BioScience Provides Fiscal Second Quarter 2018 Business Update - Live Conference Call and Webcast Today at 4:30 pm ET
prescriptions increased 23% over previous quarter, and 317% over the same quarter last year
Colo., Feb. 8, 2018 /PRNewswire/ -- 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 second quarter ended December 31, 2017. 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
am pleased to report Aytu's second quarter results, which reflect strong unit sales growth and cost management. Natesto
prescriptions increased 23% over our first quarter of this fiscal year to 2,501, which is up 317% over the same quarter last year,
while at the same time we reduced our sequential quarter cash burn," commented Josh Disbrow, Chief Executive Officer of
Disbrow continued, "While we are satisfied with Natesto unit sales growth, and cash management, our dollar net sales figure
is temporarily not at the same growth rate as unit sales. The reason for the temporary disparity is due to discounting and coupon
incentives which are used to increase sales to first time Natesto patients. However, we expect to be able to accelerate growth
and reduce the level of discounting we have experienced with three targeted strategic actions. The first action is to roll out
our recently piloted Natesto Support Program, which allows us to capture more prescription reimbursement, yielding more revenue
for each new prescription. The Natesto Support Program is also expected to lead to a higher refill rate on new prescriptions.
Second, we are pursuing third party payers to more broadly cover Natesto, and third, we are continuing to invest in increasing
the body of clinical evidence supporting Natesto's distinct efficacy and safety profile."
Disbrow concluded, "During the quarter we also had a number of additional operational highlights. First, we continued to
grow our business internationally for our MiOXSYS male infertility device, now sold in 36 countries worldwide. Second, we uplisted
to NASDAQ, expanding our reach into the investment community. Additionally, we announced the appointment of David Green as Chief
Financial Officer. Mr. Green is a highly accomplished CFO, who brings an extensive array of financial, accounting, and operational
experience to Aytu, including a background at both public and private life sciences companies over his twenty-five-year career.
There was also some recent news that further cemented barriers to entry in the nearly $2 billion U.S. testosterone replacement
therapy (TRT) market that Natesto addresses. Taken as a whole, the second quarter reinforced that Aytu has very strong momentum
with a well-positioned product portfolio and the personnel to maximize shareholder value."
2018 Operational Highlights
Q2 2018 Financial Results
revenue for the second quarter of 2018 was $1,050,000 compared to revenue of $794,000 for the same period last year, an increase
of 32%. Natesto and MiOXSYS comprised the majority of sales in the second 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.
expenses for the second quarter of 2018 were $5,045,000, which was in line with the same quarter last year.
used in operations for the quarter was $3,101,000, down 26% from the first quarter of 2018.
and cash equivalents totaled approximately $4,000,000 as of December 31, 2017.
Company will host a live conference call at 4:30 p.m. ET today. The conference call can be accessed by dialing
(855) 656-0926 (U.S.)
(412) 542-4198 (international)
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.
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
Aytu BioScience, Inc.
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 second 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.
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 effectively operate into fourth quarter fiscal 2018, 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.
Aytu BioScience, Inc.
Consolidated Balance Sheets
| December 31, | June 30, | |||||||
| 2017 | 2017 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 3,908,183 | $ | 802,328 | ||||
| Restricted cash | 75,534 | 75,214 | ||||||
| Accounts receivable, net | 1,377,436 | 528,039 | ||||||
| Inventory, net | 1,379,806 | 1,312,221 | ||||||
| Prepaid expenses and other | 1,003,766 | 310,760 | ||||||
| Total current assets | 7,744,725 | 3,028,562 | ||||||
| Fixed assets, net | 560,624 | 647,254 | ||||||
| Developed technology, net | 1,254,309 | 1,337,333 | ||||||
| Customer contracts, net | 74,667 | 77,667 | ||||||
| Trade names, net | 152,438 | 164,037 | ||||||
| Natesto asset, net | 8,571,710 | 9,231,072 | ||||||
| Goodwill | 238,426 | 238,426 | ||||||
| Patents, net | 258,611 | 271,278 | ||||||
| Deposits | 2,888 | 2,888 | ||||||
| Total long-term assets | 11,113,673 | 11,969,955 | ||||||
| Total assets | $ | 18,858,398 | $ | 14,998,517 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and other | $ | 3,414,854 | $ | 2,220,400 | ||||
| Accrued liabilities | 257,631 | 782,536 | ||||||
| Accrued compensation | 837,290 | 339,704 | ||||||
| Deferred rent | 4,787 | 6,673 | ||||||
| Current contingent consideration | 286,339 | 261,155 | ||||||
| Total current liabilities | 4,800,901 | 3,610,468 | ||||||
| Long-term contingent consideration | 7,726,698 | 7,386,782 | ||||||
| Long-term deferred rent | - | 1,451 | ||||||
| Warrant derivative liability | 3,300,213 | - | ||||||
| Total liabilities | 15,827,812 | 10,998,701 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred Stock, par value $.0001; 50,000,000 shares authorized; shares issued | ||||||||
| and outstanding 1,900 and 0, respectively as of | ||||||||
| December 31, 2017 and June 30, 2017 | 1 | - | ||||||
| Common Stock, par value $.0001; 100,000,000 shares authorized; shares issued | ||||||||
| and outstanding 4,894,638 and 824,831, respectively as of | ||||||||
| December 31, 2017 and June 30, 2017 | 489 | 82 | ||||||
| Additional paid-in capital | 80,017,545 | 73,069,463 | ||||||
| Accumulated deficit | (76,987,449 | ) | (69,069,729 | ) | ||||
| Total stockholders' equity | 3,030,586 | 3,999,816 | ||||||
| Total liabilities and stockholders' equity | $ | 18,858,398 | $ | 14,998,517 |
Consolidated Statements of Operations
| Three Months Ended December 31, | Six Months Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Product revenue | $ | 1,051,154 | $ | 794,172 | $ | 2,127,522 | $ | 1,492,152 | ||||||||
| Total revenue | 1,051,154 | 794,172 | 2,127,522 | 1,492,152 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of sales | 385,411 | 551,293 | 672,612 | 743,217 | ||||||||||||
| Research and development | (277,486 | ) | 263,457 | (136,532 | ) | 495,479 | ||||||||||
| Research and development - related party | - | 47,998 | - | 95,996 | ||||||||||||
| Sales, general and administrative | 4,553,366 | 3,642,332 | 9,171,769 | 9,347,082 | ||||||||||||
| Sales, general and administrative - related party | - | 50,772 | - | 101,544 | ||||||||||||
| Amortization and impairment of intangible assets | 383,811 | 437,014 | 769,652 | 874,029 | ||||||||||||
| Total operating expenses | 5,045,102 | 4,992,866 | 10,477,501 | 11,657,347 | ||||||||||||
| Loss from operations | (3,993,948 | ) | (4,198,694 | ) | (8,349,979 | ) | (10,165,195 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense | (196,781 | ) | (388,085 | ) | (385,526 | ) | (803,465 | ) | ||||||||
| Derivative income | 518,051 | 266,757 | 817,785 | 196,148 | ||||||||||||
| Unrealized (loss) gain on investment | - | (497,164 | ) | - | 230,936 | |||||||||||
| Total other income (expense) | 321,270 | (618,492 | ) | 432,259 | (376,381 | ) | ||||||||||
| Net loss | $ | (3,672,678 | ) | $ | (4,817,186 | ) | $ | (7,917,720 | ) | $ | (10,541,576 | ) | ||||
| Weighted average number of Aytu | ||||||||||||||||
| common shares outstanding | 4,113,256 | 392,540 | 2,481,110 | 295,546 | ||||||||||||
| Basic and diluted Aytu net loss | ||||||||||||||||
| per common share | $ | (0.89 | ) | $ | (12.27 | ) | $ | (3.19 | ) | $ | (35.67 | ) |
Consolidated Statements of Cash Flows
| Six Months Ended December 31, | ||||||||
| 2017 | 2016 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (7,917,720 | ) | $ | (10,541,576 | ) | ||
| Adjustments to reconcile net loss to cash provided by (used in) operating activities | ||||||||
| Stock-based compensation expense | 275,688 | 1,425,133 | ||||||
| Issuance of restricted stock | 103,635 | 156,814 | ||||||
| Depreciation, amortization and accretion | 1,315,063 | 1,722,965 | ||||||
| Derivative (income) | (817,785 | ) | (196,148 | ) | ||||
| Amortization of prepaid research and development - related party | - | 60,992 | ||||||
| Unrealized (gain) on investment | - | (230,936 | ) | |||||
| Compensation through issuance of stock | - | 509,996 | ||||||
| Issuance of warrants to initial investors | - | 596,434 | ||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| (Increase) in accounts receivable | (849,397 | ) | (419,966 | ) | ||||
| (Increase) decrease in inventory | (67,585 | ) | 85,741 | |||||
| (Increase) in prepaid expenses and other | (454,595 | ) | (221,015 | ) | ||||
| Increase (decrease) in accounts payable and other | 1,124,558 | (195,836 | ) | |||||
| (Decrease) in accrued liabilities | (524,905 | ) | (238,395 | ) | ||||
| Increase (decrease) in accrued compensation | 497,586 | (681,432 | ) | |||||
| (Decrease) in deferred rent | (3,337 | ) | (1,350 | ) | ||||
| Net cash used in operating activities | (7,318,794 | ) | (8,168,579 | ) | ||||
| Cash flows used in investing activities | ||||||||
| Purchases of property and equipment | (12,195 | ) | (44,876 | ) | ||||
| Installment payment for Natesto asset | - | (2,000,000 | ) | |||||
| Installment payment for Primsol asset | - | (750,000 | ) | |||||
| Net cash used in investing activities | (12,195 | ) | (2,794,876 | ) | ||||
| 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 | ) | |||||
| Registered offering of common stock and warrants | - | 8,602,500 | ||||||
| Registered offering costs | - | (997,865 | ) | |||||
| Over-allotment warrants purchased by placement agents | - | 2,852 | ||||||
| Net cash provided by financing activities | 10,437,164 | 8,214,721 | ||||||
| Net change in cash, cash equivalents and restricted cash | 3,106,175 | (2,748,734 | ) | |||||
| Cash, cash equivalents and restricted cash at beginning of period | 877,542 | 8,054,190 | ||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 3,983,717 | $ | 5,305,456 |