Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Mar. 31, 2020 | May 01, 2020 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | AYTU BIOSCIENCE, INC | |
Entity Central Index Key | 0001385818 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --06-30 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Is Entity's Reporting Status Current? | Yes | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-38247 | |
Entity Common Stock, Shares Outstanding | 120,261,423 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Current assets | ||
Cash and cash equivalents | $ 62,264,676 | $ 11,044,227 |
Restricted cash | 251,407 | 250,000 |
Accounts receivable, net | 10,203,423 | 1,740,787 |
Inventory, net | 3,854,685 | 1,440,069 |
Prepaid expenses and other | 4,830,881 | 957,781 |
Other current assets | 1,849,598 | 0 |
Total current assets | 83,254,670 | 15,432,864 |
Fixed assets, net | 288,415 | 203,733 |
Right-of-use-asset | 675,980 | 0 |
Licensed assets, net | 17,155,632 | 18,861,983 |
Patents and tradenames, net | 11,724,626 | 220,611 |
Product technology rights, net | 21,754,166 | 0 |
Deposits | 38,981 | 2,200 |
Goodwill | 24,061,333 | 0 |
Total long-term assets | 75,699,133 | 19,288,527 |
Total assets | 158,953,803 | 34,721,391 |
Current liabilities | ||
Accounts payable and other | 6,956,091 | 2,133,522 |
Accrued liabilities | 9,830,373 | 1,311,488 |
Accrued compensation | 2,210,288 | 849,498 |
Current lease liability | 289,238 | 0 |
Current contingent consideration | 947,449 | 1,078,068 |
Current portion of fixed payment arrangements | 17,395,219 | 0 |
Current portion of CVR liabilities | 786,564 | 0 |
Notes payable, net | 3,617,680 | 0 |
Total current liabilities | 42,032,902 | 5,372,576 |
Long-term contingent consideration, net of current portion | 17,806,573 | 22,247,796 |
Long-term lease liability, net of current portion | 804,393 | 0 |
Long-term fixed payment arrangements, net of current portion | 8,162,494 | 0 |
Long-term CVR liabilities, net of current portion | 4,432,254 | 0 |
Warrant derivative liability | 11,371 | 13,201 |
Total liabilities | 73,249,987 | 27,633,573 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity | ||
Preferred stock, par value $.0001; 50,000,000 shares authorized; shares issued and outstanding 9,805,845 and 3,594,981, respectively as of March 31, 2020 (unaudited) and June 30, 2019. | 981 | 359 |
Common stock, par value $.0001; 200,000,000 shares authorized; shares issued and outstanding 100,610,380 and 17,538,071, respectively as of March 31, 2020 (unaudited) and June 30, 2019. | 10,061 | 1,754 |
Additional paid-in capital | 202,557,856 | 113,475,205 |
Accumulated deficit | (116,865,082) | (106,389,500) |
Total stockholders' equity | 85,703,816 | 7,087,818 |
Total liabilities and stockholders' equity | $ 158,953,803 | $ 34,721,391 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Jun. 30, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ .0001 | $ .0001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 9,805,845 | 3,594,981 |
Preferred stock, shares outstanding | 9,805,845 | 3,594,981 |
Common stock, par value | $ .0001 | $ .0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 100,610,380 | 17,538,071 |
Common stock, shares outstanding | 100,610,380 | 17,538,071 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues | ||||
Total revenue | $ 8,156,173 | $ 2,377,792 | $ 12,771,235 | $ 5,604,612 |
Operating expenses | ||||
Cost of sales | 1,998,659 | 616,853 | 2,980,425 | 1,552,950 |
Research and development | 78,502 | 108,901 | 223,197 | 413,808 |
Selling, general and administrative | 9,501,469 | 5,368,762 | 21,164,072 | 13,991,516 |
Selling, general and administrative - related party | 0 | 6,797 | 0 | 351,843 |
Amortization of intangible assets | 1,370,986 | 575,117 | 2,899,553 | 1,561,137 |
Total operating expenses | 12,949,616 | 6,676,430 | 27,267,247 | 17,871,254 |
Loss from operations | (4,793,443) | (4,298,638) | (14,496,012) | (12,266,642) |
Other (expense) income | ||||
Other (expense), net | (538,862) | (194,703) | (1,181,206) | (398,833) |
Gain from derecognition of contingent consideration | 0 | 0 | 5,199,806 | 0 |
Gain from warrant derivative liability | 0 | (2,521) | 1,830 | 65,468 |
Total other (expense) income | (538,862) | (197,224) | 4,020,430 | (333,365) |
Net loss | $ (5,332,305) | $ (4,495,862) | $ (10,475,582) | $ (12,600,007) |
Weighted average number of common shares outstanding | 35,275,296 | 9,061,023 | 22,616,962 | 5,785,669 |
Basic and diluted net loss per common share | $ (0.15) | $ (0.50) | $ (0.46) | $ (2.18) |
Product Revenue | ||||
Revenues | ||||
Total revenue | $ 8,156,173 | $ 2,372,016 | $ 12,771,235 | $ 5,598,836 |
License Revenue | ||||
Revenues | ||||
Total revenue | $ 0 | $ 5,776 | $ 0 | $ 5,776 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning balance, shares at Jun. 30, 2018 | 0 | 1,794,762 | |||
Beginning balance, amount at Jun. 30, 2018 | $ 0 | $ 179 | $ 92,681,918 | $ (79,257,592) | $ 13,424,505 |
Stock-based compensation, amount | 152,114 | 152,114 | |||
Adjustment for rounding of shares due to stock split, shares | 6,649 | ||||
Adjustment for rounding of shares due to stock split, amount | $ 1 | (1) | 0 | ||
Net loss | (3,446,483) | (3,446,483) | |||
Ending balance, shares at Sep. 30, 2018 | 0 | 1,801,411 | |||
Ending balance, amount at Sep. 30, 2018 | $ 0 | $ 180 | 92,834,031 | (82,704,075) | 10,130,136 |
Beginning balance, shares at Jun. 30, 2018 | 0 | 1,794,762 | |||
Beginning balance, amount at Jun. 30, 2018 | $ 0 | $ 179 | 92,681,918 | (79,257,592) | 13,424,505 |
Cashless warrant exercise, amount | 0 | ||||
Net loss | (12,600,007) | ||||
Ending balance, shares at Mar. 31, 2019 | 2,335,665 | 12,848,499 | |||
Ending balance, amount at Mar. 31, 2019 | $ 234 | $ 1,287 | 107,893,259 | (91,857,599) | 16,037,179 |
Beginning balance, shares at Sep. 30, 2018 | 0 | 1,801,411 | |||
Beginning balance, amount at Sep. 30, 2018 | $ 0 | $ 180 | 92,834,031 | (82,704,075) | 10,130,136 |
Stock-based compensation, shares | 2,707,022 | ||||
Stock-based compensation, amount | $ 270 | 193,792 | 194,062 | ||
Common stock issued to employee, shares | 9,000 | ||||
Common stock issued to employee, amount | $ 1 | 11,689 | 11,690 | ||
Issuance of preferred and common stock, net of cash issuance costs, shares | 8,342,993 | 1,777,007 | |||
Issuance of preferred and common stock, net of cash issuance costs, amount | $ 834 | $ 178 | 11,810,373 | 11,811,385 | |
Warrants issued in connection with the registered offering | 1,827,628 | 1,827,628 | |||
Warrants issued in connection with the registered offering to the placement agents, non-cash issuance costs | 61,024 | 61,024 | |||
Preferred stocks issued in connection with the purchase of assets, shares | 400,000 | ||||
Preferred stocks issued in connection with the purchase of assets, amount | $ 40 | 519,560 | 519,600 | ||
Preferred stock converted into common stock, shares | (4,210,329) | 4,210,329 | |||
Preferred stock converted into common stock, amount | $ (421) | $ 421 | 0 | ||
Net loss | (4,657,662) | (4,657,662) | |||
Ending balance, shares at Dec. 31, 2018 | 4,532,664 | 10,504,769 | |||
Ending balance, amount at Dec. 31, 2018 | $ 453 | $ 1,050 | 107,258,097 | (87,361,737) | 19,897,863 |
Stock-based compensation, shares | (25,600) | ||||
Stock-based compensation, amount | $ (2) | 376,668 | 376,666 | ||
Preferred stock converted into common stock, shares | (2,196,999) | 2,196,999 | |||
Preferred stock converted into common stock, amount | $ (219) | $ 219 | 0 | ||
Warrant exercises, shares | 172,331 | ||||
Warrant exercises, amount | $ 17 | 258,495 | 258,512 | ||
Net loss | (4,495,862) | (4,495,862) | |||
Ending balance, shares at Mar. 31, 2019 | 2,335,665 | 12,848,499 | |||
Ending balance, amount at Mar. 31, 2019 | $ 234 | $ 1,287 | 107,893,259 | (91,857,599) | 16,037,179 |
Beginning balance, shares at Jun. 30, 2019 | 3,594,981 | 17,538,071 | |||
Beginning balance, amount at Jun. 30, 2019 | $ 359 | $ 1,754 | 113,475,205 | (106,389,500) | 7,087,818 |
Stock-based compensation, amount | 165,171 | 165,171 | |||
Preferred stock converted into common stock, shares | (443,833) | 443,833 | |||
Preferred stock converted into common stock, amount | $ (44) | $ 44 | 0 | ||
Net loss | (4,929,030) | (4,929,030) | |||
Ending balance, shares at Sep. 30, 2019 | 3,151,148 | 17,981,904 | |||
Ending balance, amount at Sep. 30, 2019 | $ 315 | $ 1,798 | 113,640,376 | (111,318,530) | 2,323,959 |
Beginning balance, shares at Jun. 30, 2019 | 3,594,981 | 17,538,071 | |||
Beginning balance, amount at Jun. 30, 2019 | $ 359 | $ 1,754 | 113,475,205 | (106,389,500) | 7,087,818 |
Cashless warrant exercise, amount | 792 | ||||
Net loss | (10,475,582) | ||||
Ending balance, shares at Mar. 31, 2020 | 9,805,845 | 100,610,380 | |||
Ending balance, amount at Mar. 31, 2020 | $ 981 | $ 10,061 | 202,557,856 | (116,865,082) | 85,703,816 |
Beginning balance, shares at Sep. 30, 2019 | 3,151,148 | 17,981,904 | |||
Beginning balance, amount at Sep. 30, 2019 | $ 315 | $ 1,798 | 113,640,376 | (111,318,530) | 2,323,959 |
Stock-based compensation, amount | 162,264 | 162,264 | |||
Issuance of Series F preferred stock from October 2019 private placement financing, net, shares | 10,000 | ||||
Issuance of Series F preferred stock from October 2019 private placement financing, net, amount | $ 1 | 5,249,483 | 5,249,484 | ||
Warrants issued in connection with the private placement | 4,008,866 | 4,008,866 | |||
Issuance of Series G preferred stock due to acquisition of the Cerecor Portfolio of Pediatrics Therapeutics, shares | 9,805,845 | ||||
Issuance of Series G preferred stock due to acquisition of the Cerecor Portfolio of Pediatrics Therapeutics, amount | $ 981 | 5,558,933 | 5,559,914 | ||
Preferred stock converted into common stock, shares | (2,751,148) | 2,751,148 | |||
Preferred stock converted into common stock, amount | $ (275) | $ 275 | 0 | ||
Net loss | (214,247) | (214,247) | |||
Ending balance, shares at Dec. 31, 2019 | 10,215,845 | 20,733,052 | |||
Ending balance, amount at Dec. 31, 2019 | $ 1,022 | $ 2,073 | 128,619,922 | (111,532,777) | 17,090,240 |
Stock-based compensation, shares | 1,067,912 | ||||
Stock-based compensation, amount | $ 107 | 263,284 | 263,391 | ||
Cashless warrant exercise, shares | 7,915,770 | ||||
Cashless warrant exercise, amount | $ 792 | (792) | 0 | ||
Issuance of preferred and common stock, net of cash issuance costs, shares | 36,365,274 | ||||
Issuance of preferred and common stock, net of cash issuance costs, amount | $ 3,637 | 33,275,119 | 33,278,756 | ||
Warrants issued in connection with the registered offering | 9,723,161 | 9,723,161 | |||
Warrants issued in connection with the registered offering to the placement agents, non-cash issuance costs | 1,458,973 | 1,458,973 | |||
Issuance of Series H preferred stock and common stock due to acquisition of Innovus, shares | 1,997,902 | 3,809,712 | |||
Issuance of Series H preferred stock and common stock due to acquisition of Innovus, amount | $ 200 | $ 381 | 4,405,603 | 4,406,184 | |
Preferred stock converted into common stock, shares | (2,407,902) | 12,397,902 | |||
Preferred stock converted into common stock, amount | $ (241) | $ 1,240 | 91,881 | 92,880 | |
Warrant exercises, shares | 17,082,994 | ||||
Warrant exercises, amount | $ 1,708 | 22,987,958 | 22,989,666 | ||
CVR payouts, shares | 1,237,764 | ||||
CVR payouts, amount | $ 123 | 1,732,747 | 1,732,870 | ||
Net loss | (5,332,305) | (5,332,305) | |||
Ending balance, shares at Mar. 31, 2020 | 9,805,845 | 100,610,380 | |||
Ending balance, amount at Mar. 31, 2020 | $ 981 | $ 10,061 | $ 202,557,856 | $ (116,865,082) | $ 85,703,816 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (10,475,582) | $ (12,600,007) |
Adjustments to reconcile net loss to cash used in operating activities | ||
Depreciation, amortization and accretion | 3,780,310 | 1,974,213 |
Stock-based compensation expense and restricted stock issuance | 590,826 | 722,842 |
Derecognition of contingent consideration | (5,199,806) | 0 |
Gain on the change in fair value of CVR payout | (267,130) | 0 |
Issuance of common stock to employee | 0 | 11,690 |
Derivative income | (1,830) | (65,468) |
Changes in operating assets and liabilities: | ||
(Increase) in accounts receivable | (8,183,810) | (797,576) |
(Increase) in inventory | (345,452) | (191,110) |
(Increase) in prepaid expenses and other | (1,611,681) | (364,831) |
(Increase) in other current assets | (358,022) | 0 |
(Decrease) in accounts payable and other | (4,912,245) | (191,331) |
Increase in accrued liabilities | 6,761,319 | 758,370 |
Increase in accrued compensation | 271,560 | 250,912 |
(Decrease) in fixed payment arrangements | (657,655) | 0 |
Increase in interest payable | 0 | 134,795 |
Net cash used in operating activities | (20,609,198) | (10,357,501) |
Cash flows used in investing activities | ||
Deposit | 0 | 2,888 |
Purchases of fixed assets | 0 | (59,848) |
Contingent consideration payment | (151,648) | (408,917) |
Cash received from acquisition | 390,916 | 0 |
Purchase of assets | (5,850,000) | (500,000) |
Net cash used in investing activities | (5,610,732) | (965,877) |
Cash flows from financing activities | ||
Issuance of preferred, common stock and warrants | 58,999,666 | 15,180,000 |
Issuance costs related to preferred, common stock and warrants | (5,280,426) | (1,479,963) |
Warrant exercises | 22,989,666 | 258,512 |
Preferred stock converted in common stock | 92,880 | 0 |
Issuance of note payable | 640,000 | 5,000,000 |
Net cash provided by financing activities | 77,441,786 | 18,958,549 |
Net change in cash, restricted cash and cash equivalents | 51,221,856 | 7,635,171 |
Cash, restricted cash and cash equivalents at beginning of period | 11,294,227 | 7,112,527 |
Cash, restricted cash and cash equivalents at end of period | 62,516,083 | 14,747,698 |
Supplemental disclosures of cash and non-cash investing and financing transactions | ||
Cash paid for interest | 392,641 | 0 |
Fair value of right-to-use asset and related lease liability | 354,929 | 0 |
Issuance of Series G preferred stock due to acquisition of the Cerecor portfolio of pediatrics therapeutics | 5,559,914 | 0 |
Issuance of Series H preferred stock due to acquisition of the Innovus | 12,805,263 | 0 |
Inventory payment included in accounts payable | 460,416 | 0 |
Contingent consideration included in accounts payable | 27,571 | 29,348 |
Fixed payment arrangements included in accounts payable | 501,766 | 0 |
Exchange of convertible preferred stock into common stock | 1,559 | 0 |
Return deductions received by Cerecor | 2,000,000 | 0 |
Issuance of restricted stock | 107 | 0 |
Cashless warrant exercises | 792 | 0 |
Fair value of warrants issued to investors and underwriters | 0 | 1,888,652 |
Issuance of preferred stock related to purchase of asset | 0 | 519,600 |
Contingent consideration related to purchase of asset | $ 0 | $ 8,833,219 |
Nature of Business, Financial C
Nature of Business, Financial Condition, Basis of Presentation | 9 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business, Financial Condition, Basis of Presentation | Nature of Business. The Company is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant healthcare needs in both prescription and consumer health categories. Through the Company’s heritage prescription business, the Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist™, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The Company’s recently acquired prescription pediatric portfolio includes (i) AcipHex® Sprinkle™, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. On February 14, 2020, the Company acquired Innovus Pharmaceuticals Inc. (“Innovus”), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health (the “Consumer Health Portfolio”). The Consumer Health Portfolio is commercialized through direct-to-consumer marketing channels utilizing Innovus’s proprietary Beyond Human® marketing and sales platform. The Company recently acquired exclusive U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. These rapid tests have been validated in multi-center clinical trials. Most recently, the Company signed a licensing agreement with Cedars-Sinai Medical Center for worldwide rights to various potential uses of Healight, an investigational medical device platform technology. Healight has demonstrated safety and efficacy in pre-clinical studies, and the Company plans to advance this technology and assess its safety and efficacy in human studies. The Company’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. Financial Condition. Revenues for the three-months ended March 31, 2020 increased approximately 243% compared to the three-months ended March 31, 2019, and revenues increased 100% and 14% for each of the years ended June 30, 2019 and 2018, respectively. Revenue is expected to continue to increase long-term, allowing the Company to rely less on our existing cash and cash equivalents, and proceeds from financing transactions. Cash used in operations during the nine-months ended March 31, 2020 was $20.6 million compared to $10.4 million for the nine-months ended March 31, 2019. The increase is due primarily to the Company’s acquisition and integration of the Pediatric Portfolio and merger with Innovus, which consumed additional cash resources, coupled with an increase in working capital. On November 1, 2019, the Company closed an asset acquisition with Cerecor, Inc. (“Cerecor”) whereby the Company acquired certain of Cerecor’s portfolio of pediatric therapeutics (the “Pediatric Portfolio”) for $4.5 million in cash, approximately 9.8 million shares of Series G Convertible Preferred Stock, the assumption of Cerecor’s financial and royalty obligations, which includes not more than $3.5 million of Medicaid rebates and products returns as they come due, and other assumed liabilities associated with the Pediatric Portfolio (see Note 2). As of March 31, 2020, the Company has paid down approximately $3.2 million of those assumed liabilities. In addition, the Company assumed obligations in connection with the Pediatric Portfolio acquisition due to an investor including fixed and variable payments. The Company assumed fixed monthly payments equal to $0.1 million from November 2019 through January 2021 plus $15 million due in January 2021. Monthly variable payments due to the same investor are equal to 15% of net revenue generated from a subset of the Product Portfolio, subject to an aggregate monthly minimum of $0.1 million, except for January 2020, when a one-time payment of $0.2 million was paid. The variable payment obligation continues until the earlier of: (i) aggregate variable payments of approximately $9.5 million have been made, or (ii) February 12, 2026. On February 14, 2020 the Company completed a merger with Innovus after approval by the stockholders of both companies on February 13, 2020 (the “Merger”). Upon closing the Merger, the Company merged with and into Innovus and all outstanding Innovus common stock was exchanged for approximately 3.8 million shares of the Company’s common stock and up to $16 million of Contingent Value Rights (“CVRs”). The outstanding Innovus warrants with cash out rights were exchanged for approximately 2.0 million shares of Series H Convertible Preferred stock of Aytu and retired. The remaining Innovus warrants outstanding at the time of the Merger continue to be outstanding, and upon exercise, retain the right to the merger consideration offered to Innovus stockholders, including any remaining claims represented by CVRs at the time of exercise. Innovus will continue as a wholly owned subsidiary of the Company. In addition, as part of the Merger, the Company assumed approximately $3.1 million of notes payable, $0.8 million in lease liabilities, and other assumed liabilities associated with Innovus. Of the $3.1 million of notes payable, approximately $1.8 million was converted into approximately 1.5 million shares of the Company’s common stock on April 27, 2020. During the three months ended March 31, 2020, the Company completed three separate equity offerings, on March 10, 2020, March 12, 2020 and March 19, 2020 (the “March Offerings”), in which the Company issued a combination of common stock and warrants. The following summarizes the March Offerings, including total capital raised from both the issuance of common stock and subsequent warrant exercises. On March 19, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 12,539,197 shares of the Company’s common stock (the “Common Stock”) at a purchase price per share of $1.595 and (ii) warrants to purchase up to 12,539,197 shares of Common Stock (the “March 19, 2020 Warrants”) at an exercise price of $1.47 per share, for aggregate gross proceeds to the Company of $20.0 million, before deducting placement agent fees and other offering expenses payable by the Company. The March 19, 2020 Warrants are exercisable immediately upon issuance and have a term of one year from the issuance date. In addition, the Company issued warrants with an exercise price of $1.9938 per share to purchase up to 815,047 shares of common stock (the “March 19, 2020 Placement Agent Warrants”) as a portion of the fees paid to the placement agent. The March 19, 2020 Placement Agent Warrants have a term of five year from the issuance date. A total of 1.2 million March 19, 2020 Warrants have been exercised through May 5, 2020, for total proceeds of $1.7 million, of which 0.7 million March 19, 2020 Warrants were exercised through March 31, 2020, for total proceeds of $1.1 million. On March 12, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 16,000,000 shares of the Company’s common stock at a purchase price per share of $1.25 and (ii) warrants to purchase up to 16,000,000 shares of Common Stock (the “March 12, 2020 Warrants”) at an exercise price of $1.25 per share, for aggregate gross proceeds to the Company of $20.0 million, before deducting placement agent fees and other offering expenses payable by the Company (the “Registered Offering”). The March 12, 2020 Warrants are exercisable immediately upon issuance and have a term of one year from the issuance date. In addition, the Company issued warrants with an exercise price of $1.5625 per share to purchase up to 1,040,000 shares of common stock (the “March 12, 2020 Placement Agent Warrants”) as a portion of the fees paid to the placement agent. The March 12, 2020 Placement Agent Warrants have a term of five year from the issuance date. A total of 13 million March 12, 2020 Warrants have been exercised through May 5, 2020, for total proceeds of approximately $16.3 million, of which approximately 10.5 million March 12, 2020 Warrants were exercised through March 31, 2020, for total proceeds of $13.1 million. On March 10, 2020, Company entered into a securities purchase agreement with an institutional investor, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 4,450,000 shares of the Company’s common stock (the “Common Stock”) at a purchase price per share of $1.15 and (ii) pre-funded warrants to purchase up to 3,376,087 shares of Common Stock (the “Pre-Funded Warrants”) at an effective price of $1.15 per share ($1.1499 paid to the Company upon the closing of the offering and $0.0001 to be paid upon exercise of such Pre-Funded Warrants), for aggregate gross proceeds to the Company of approximately $9.0 million, before deducting placement agent fees and other offering expenses payable by the Company (the “Registered Offering”). The Pre-Funded Warrants were immediately exercised upon close. In addition, the Company issued warrants with an exercise price of $1.4375 per share to purchase up to 508,696 shares of common stock (the “March 10, 2020 Placement Agent Warrants”). The March 10, 2020 Placement Agent Warrants have a term of five year from the issuance date. Since March 10, 2020, a total of 6.0 million shares of the Company’s October 2018 $1.50 Warrants (the “October 18 $1.50 Warrants”) were exercised, resulting in proceeds of approximately $9.0 million. In total, the Company has raised net proceeds of approximately $71.5 million from the March Offerings and related warrant exercises, as well as exercises of the October 2018 $1.50 Warrants. The net proceeds received by the Company from the March Offerings and related warrant exercise will be used for general corporate purposes, including working capital. On October 11, 2019, the Company entered into Securities Purchase Agreements (the “Purchase Agreement”) with two institutional investors (the “Investors”) providing for the issuance and sale by the Company (the “October 2019 Offering”) of $10.0 million of, (i) 10,000 shares of the Company’s Series F Convertible Preferred Stock (the “Preferred Stock”) which are convertible into 10,000,000 shares of common stock (the “Conversion Shares”) for a stated value of $1,000 per unit and (ii) 10,000,000 warrants (the “October 2019 Warrants”) which are exercisable for shares of common stock (the “Warrant Shares”), which expire January 10, 2025,. The closing of the October 2019 offering occurred on October 16, 2019. The Warrants had an exercise price equal to $1.25 and contain a cashless exercise provision. This provision was dependent on (i) performance of the Company’s stock price between October 11, 2019 and the date of exercise of all, or a portion of the Warrants, and (ii) subject to shareholder approval of the October 2019 Offering, which was approved January 24, 2020. As of March 31, 2020, all of the Series F Convertible Preferred Stock were converted into 10 million shares of the Company’s common stock, and 5.0 million of the October 2019 Warrants were exercised using the cashless exercise provision to acquire 5.0 million shares of the Company’s common stock. In April of 2020, the remaining 5 million October 2019 Warrants were exercised using the cashless exercise provision into 5.0 million shares of the Company’s common stock. The net proceeds that the Company received from the October 2019 Offering were approximately $9.3 million. The net proceeds received by the Company from the October 2019 Offerings have been used for general corporate purposes, including working capital. As of the date of this Report, the Company expects its commercial costs for its current operation to increase modestly as the Company integrates the acquisition of the Pediatrics Portfolio and Innovus and continues to focus on revenue growth through increasing product sales. The Company’s total asset position totaling approximately $168.5 million plus the proceeds expected from ongoing product sales will be used to fund operations. The Company may continue to access the capital markets to fund operations when needed, and to the extent it is required. The timing and amount of capital that may be raised is dependent on market conditions and the terms and conditions upon which investors would require to provide such capital. There is no guarantee that capital will be available on terms favorable to the Company and its stockholders, or at all. However, the Company has been successful in accessing the capital markets in the past and is confident in its ability to access the capital markets again, if needed. Since the Company has sufficient cash and cash equivalents on-hand as of March 31, 2020 to cover potential net cash outflows for the twelve months following the filing date of this Quarterly Report, ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40) the Company reports that there does not exist indication of substantial doubt about its ability to continue as a going concern. As of the date of this report, while the Company has adequate capital resources to complete its near-term operating and transaction objectives, there is no guarantee that such capital resources will be sufficient until such time the Company reaches profitability. However, the Company has been successful in accessing the capital markets in the past, and the Company is confident in its ability to access the capital markets again, if needed. If the Company is unable to raise adequate capital in the future when it is required, the Company can adjust its operating plans to reduce the magnitude of the capital need under its existing operating plan. Some of the adjustments that could be made include delays of and reductions to commercial programs, reductions in headcount, narrowing the scope of the Company’s commercial plans, or reductions to its research and development programs. Without sufficient operating capital, the Company could be required to relinquish rights to products or renegotiate to maintain such rights on less favorable terms than it would otherwise choose. This may lead to impairment or other charges, which could materially affect the Company’s balance sheet and operating results. Nasdaq Listing Compliance. , On March 24, 2020, the Company received a letter from the Nasdaq notifying the Company that the Nasdaq has determined that the Company’s stock price has traded above at least $1.00 for at least 10 consecutive business days since the previously announced February 19, 2020 notice, and therefore, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), commonly referred to as the Bid Price Rule. Basis of Presentation. Adoption of New Accounting Pronouncements Leases (“ASU 2016-02”). Topic 842 Leases. The Company has elected to apply the short-term scope exception for leases with terms of 12 months or less at the inception of the lease and will continue to recognize rent expense on a straight-line basis. As a result of the adoption, on July 1, 2019, the Company recognized a lease liability of approximately $0.4 million, which represented the present value of the remaining minimum lease payments using an estimated incremental borrowing rate of 8%. As of July 1, 2019, the Company recognized a right-to-use asset of approximately $0.4 million. Lease expense did not change materially as a result of the adoption of ASU 2016-02. In addition, in conjunction with the Innovus Merger, the Company recognized a lease liability of approximately $0.8 million relating to Innovus’ corporate offices and related warehouse as part of the purchase price allocation (see Note 2). Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) (“ASU 2017-11”) . Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) Recently Accounting Pronouncements Fair Value Measurements (“ASU 2018-03”). The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of ASU 2018-13. An entity is permitted to early adopt any removed or modified disclosures upon issuance of ASU 2018-13 and delay adoption of the additional disclosures until their effective date. The Company is currently assessing the impact that ASU 2018-13 will have on its financial statements Financial Instruments – Credit Losses (“ASU 2016-13”). This Quarterly Report on Form 10-Q does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition, results of operations, cash flows or disclosures. |
Acquisitions
Acquisitions | 9 Months Ended |
Mar. 31, 2020 | |
Business Combinations [Abstract] | |
Acquisitions | The Pediatric Portfolio On October 10, 2019, the Company entered into the Purchase Agreement with Cerecor, Inc. (“Cerecor”) to purchase and acquire Cerecor’s Pediatric Portfolio, which closed on November 1, 2019. The Pediatric Portfolio consists of six prescription products consisting of (i) AcipHex® Sprinkle™, (ii) Cefaclor for Oral Suspension, (iii) Karbinal® ER, (iv) Flexichamber™, (v) Poly-Vi-Flor® and Tri-Vi-Flor™. Total consideration transferred to Cerecor consisted of $4.5 million cash and approximately 9.8 million shares of Series G Convertible Preferred Stock. The Company also assumed certain of Cerecor’s financial and royalty obligations, and not more than $3.5 million of Medicaid rebates and products returns, of which $3.2 million has been incurred. The Company also retained the majority of Cerecor’s workforce focused on sales, commercial contracts and customer relationships. In addition, the Company assumed Cerecor obligations due to an investor that include fixed and variable payments aggregating to $25.6 million. The Company assumed fixed monthly payments equal to $0.1 million from November 2019 through January 2021 plus $15 million due in January 2021. Monthly variable payments due to the same investor are equal to 15% of net revenue generated from a subset of the Product Portfolio, subject to an aggregate monthly minimum of $0.1 million, except for January 2020, when a one-time payment of $0.2 million was paid to the investor. The variable payment obligation continues until the earlier of: (i) aggregate variable payments of approximately $9.5 million have been made, or (ii) February 12, 2026. Further, certain of the products in the Product Portfolio require royalty payments ranging from 12% to 15% of net revenue. One of the products in the Product Portfolio requires the Company to generate minimum annual sales sufficient to represent annual royalties of approximately $1.8 million, in the event the minimum sales volume is not satisfied. While no equity was acquired by the Company, the transaction was accounted for as a business combination under the acquisition method of accounting pursuant to Topic 805. Accordingly, the tangible and identifiable intangible assets acquired and liabilities assumed were recorded at fair value as of the date of acquisition, with the remaining purchase price recorded as goodwill. The goodwill recognized is attributable primarily to strategic opportunities related to an expanded commercial footprint and diversified product portfolio that is expected to provide revenue and cost synergies. Transaction costs of $0.00 and $0.7 million were included as general and administrative expense in the consolidated statements of operations for the three and nine months ended March 31, 2020. The following table summarized the preliminary fair value of assets acquired and liabilities assumed at the date of acquisition. These estimates are preliminary, pending final evaluation of certain assets, and therefore, are subject to revisions that may result in adjustments to the values presented below: As of November 1, 2019 Consideration Cash and cash equivalents $ 4,500,000 Fair value of Series G Convertible Preferred Stock Total shares issued 9,805,845 Estimated fair value per share of Aytu common stock $ 0.567 Estimated fair value of equity consideration transferred $ 5,559,914 Total consideration transferred $ 10,059,914 Recognized amounts of identifiable assets acquired and liabilities assumed Inventory, net $ 459,123 Prepaid assets 1,743,555 Other current assets 2,548,187 Intangible assets – product technology rights 22,700,000 Accrued product program liabilities (6,320,853 ) Assumed fixed payment obligations (26,457,162 ) Total identifiable net assets $ (5,327,150 ) Goodwill $ 15,387,064 The fair values of intangible assets, including product technology rights were determined using variations of the income approach. Varying discount rates were also applied to the projected net cash flows. The Company believes the assumptions are representative of those a market participant would use in estimating fair value (see Note 10). As of November 1, 2019 Acquired product technology rights $ 22,700,000 The fair value of the net identifiable asset acquired was determined to be $22.7 million, which is being amortized over ten years. The aggregate amortization expense was $0.6 million and $0, for the three months ended March 31, 2020 and 2019 respectively. The aggregate amortization expense was $0.9 million and $0, for the nine months ended March 31, 2020 and 2019 respectively. Innovus Merger (Consumer Health Portfolio) On February 14, 2020, the Company completed the merger with Innovus Pharmaceuticals after approval by the stockholders of both companies on February 13, 2020. Upon the effectiveness of the Merger, the Company merged with and into Innovus and all outstanding Innovus common stock was exchanged for approximately 3.8 million shares of the Company’s common stock and up to $16 million of Contingent Value Rights (“CVRs”). The outstanding Innovus warrants with cash out rights were exchanged for approximately 2.0 million shares of Series H Convertible Preferred stock of the Company and retired. The remaining Innovus warrants outstanding at the time of the Merger continue to be outstanding, and upon exercise, retain the right to the merger consideration offered to Innovus stockholders, including any remaining claims represented by CVRs at the time of exercise. Innovus will continue as a subsidiary of the Company. On March 31, 2020, the Company paid out the first CVR Milestone in the form of approximately 1.2 million shares of the Company’s common stock to satisfy the $2.0 million obligation as a result of Innovus achieving the $24 million revenue milestone for the calendar year ended December 31, 2019. As a result of this, the Company recognized a gain of approximately $0.3 million. In addition, as part of the merger, the Company assumed approximately $3.1 million of notes payable, $0.8 million in lease liabilities, and other assumed liabilities associated with Innovus. Of the $3.1 million of notes payable, approximately $1.8 million was converted into approximately 1.5 million shares of the Company’s common stock on April 27, 2020. The following table summarized the preliminary fair value of assets acquired and liabilities assumed at the date of acquisition. Goodwill recorded in connection with the acquisition represents, among other things, future economic benefits expect to be recognized from the Company's expansion of products and customer base. As this was a tax-exempt transaction, goodwill is not tax deductible in future periods. These estimates are preliminary, pending final evaluation of certain assets acquired and liabilities assumed, and therefore, are subject to revisions that may result in adjustments to the values presented below. The estimates of the fair value of the assets acquired assumed at the date of the Acquisition are subject to adjustment during the measurement period (up to one year from the Acquisition date). While the Company believes that such preliminary estimates provide a reasonable basis for estimating the fair value of assets acquired, it evaluates any necessary information prior to finalization of the fair value. During the measurement period, the Company will adjust assets if new information is obtained about facts and circumstances that existed as of the Acquisition date that, if known, would have resulted in the revised estimated values of those assets as of that date. The impact of all changes that do not qualify as measurement period adjustments are included in current period earnings. As of February 14, 2020 Consideration Fair value of Aytu Common Stock Total shares issued at close 3,810,393 Estimated fair value per share of Aytu common stock $ 0.756 Estimated fair value of equity consideration transferred $ 2,880,581 Fair value of Series H Convertible Preferred Stock Total shares issued 1,997,736 Estimated fair value per share of Aytu common stock $ 0.756 Estimated fair value of equity consideration transferred $ 1,510,288 Fair value of former Innovus warrants $ 15,315 Fair value of Contingent Value Rights $ 7,049,079 Forgiveness of Note Payable owed to the Company $ 1,350,000 Total consideration transferred $ 12,805,263 Recognized amounts of identifiable assets acquired and liabilities assumed Cash and cash equivalents 390,916 Accounts receivables, net $ 278,826 Inventory, net 1,149,625 Prepaid expenses and other current assets 1,736,796 Other long-term assets 36,781 Right-to-use assets 328,410 Property, plant and equipment 190,393 Trademarks and patents 11,744,000 Accounts payable and accrued other expenses (6,983,969 ) Other current liabilities (446,995 ) Notes payable (3,056,361 ) Lease liability (754,822 ) Preacquisition contingent consideration (182,606 ) Total identifiable net assets 4,430,994 Goodwill $ 8,374,269 The fair values of intangible assets, including product distribution rights were determined using variations of the income approach, specifically the relief-from-royalties method. It also includes customer lists using an income approach utilizing a discounted cash flow model. Varying discount rates were also applied to the projected net cash flows. The Company believes the assumptions are representative of those a market participant would use in estimating fair value (see Note 10). As of February 14, 2020 Acquired product distribution rights $ 11,354,000 Acquired customer lists 390,000 Total intangible assets $ 11,744,000 The fair value of the net identifiable assets acquired was determined to be $11.7 million, which is being amortized over a range between 1.5 to 10 years. The aggregate amortization expense was $0.2 million and $0, for the three and nine months ended March 31, 2020 and 2019 respectively. Pro Forma Impact due to Business Combinations The following supplemental unaudited proforma financial information presents the Company’s results as if the following acquisitions had occurred on July 1, 2018: · Acquisition of the Pediatric Portfolio, effective November 1, 2019; · Merger with Innovus effective February 14, 2020. Three Months Ended March 31, Nine Months Ended March 31, 2020 2019 2020 2019 Unaudited (aa) (bb) Pro forma Unaudited Pro forma Unaudited (cc) Pro forma Unaudited Total revenues, net $ 10,331,629 $ 10,575,866 $ 34,276,368 $ 36,916,501 Net income (loss) (5,850,703 ) (8,740,850 ) (18,197,902 ) (17,205,490 ) Net income / (loss) per share (dd) $ (0.17 ) $ (0.39 ) $ (0.80 ) $ (0.76 ) (aa) For the three months ended March 31, 2020, Pediatric Portfolio acquisition occurred prior to the three months ended March 31, 2020, and accordingly, the results of the Pediatric Portfolio are fully consolidated into the Company’s results for the three months ended March 31, 2020. (bb) Due to the absence of discrete financial information for Innovus, covering the period from February 1, 2020 through February 13, 2020, the Company did not include the impact of that stub-period for the pro forma results for the three and nine months ended March 31, 2020. (cc) Due to a lack of financial information covering the period from October 1, 2019 through November 1, 2019, the Company was not able to provide pro forma adjusted financial statements for the nine months ended March 31, 2020 without making estimated extrapolations that the Company did not believe would be material or useful to users of the above pro forma information. (dd) Pro forma net loss per share calculations excluded the impact of the issuance of the (i) Series G Convertible Preferred Stock and the, (ii) Series H Convertible Preferred Stock under the assumption those shares would continue to remain non-participatory during the periods reported above. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Mar. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | The Company sells its prescription products related products from both the (i) Pediatric Portfolio and its (ii) Lifestyle Portfolio (Natesto, Tuzistra and ZolpiMist) principally to a limited number of wholesale distributors and pharmacies in the United States, which account for the largest portion of our total prescription products revenue. International sales are made primarily to specialty distributors, as well as to hospitals, laboratories, and clinics, some of which are government owned or supported (collectively, its “Customers”). The Company’s Customers in the United States subsequently resell the products to pharmacies and patients. Revenue from product sales is recorded at the established net sales price, or “transaction price,” which includes estimates of variable consideration that result from coupons, discounts, chargebacks and distributor fees, processing fees, as well as allowances for returns and government rebates. In accordance with ASC 606, the Company recognizes net revenues from product sales when the Customer obtains control of the Company’s product, which typically occurs upon delivery to the Customer. The Company’s payment terms are between 30 to 60 days in the United States and consistent with prevailing practice in international markets. The Company generates revenues from its Consumer Health Portfolio from product sales and the licensing of the rights to market and commercialize our products. The Company recognizes revenue when it satisfies a performance obligation in a contract by transferring control over a product to a customer when product is shipped. Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of product sales. In addition, the Company’s Consumer Health Portfolio enters into exclusive distributor and license agreements that are within the scope of ASC Topic 606. The license agreements normally generate three separate components of revenue: (1) an initial nonrefundable payment due on signing or when certain specific conditions are met; (2) royalties that are earned on an ongoing basis as sales are made or a pre-agreed transfer price; and (3) sales-based milestone payments that are earned when cumulative sales reach certain levels. Revenue from the initial nonrefundable payments or licensing fees are recognized when all required conditions are met. If the consideration for the initial license fee is for the right to sell the licensed product in the respective territory with no other required conditions to be met, such type of nonrefundable license fee arrangement for the right to sell the licensed product in the territory is recognized ratably over the term of the license agreement. For arrangements with licenses that include sales-based royalties, including sales-based milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. The achievement of the sales-based milestone underlying the payment to be received predominantly relates to the licensee’s performance of future commercial activities. Revenues by Geographic location The following table reflects our product revenues by geographic location as determined by the billing address of our customers: Three Months Ended March 31, Nine Months Ended March 31, 2020 2019 2020 2019 U.S. $ 7,273,000 $ 2,024,000 $ 11,582,000 $ 5,025,000 International 883,000 348,000 1,189,000 574,000 Total net revenue $ 8,156,000 $ 2,372,000 $ 12,771,000 $ 5,599,000 As of March 31, 2020, approximately 40% of outstanding trade accounts receivables, net were comprised of a single counter-party, for which the Company and the counter-party have an arrangement in which initially, the counterparty was collecting the Company’s customer payments on its behalf for certain products acquired as part of the Pediatric Portfolio acquisition, and upon a final transition, the Company is now collecting all amounts relating to the Pediatric Portfolio, including on behalf of the counter-party, for products still retained by the counter-party. |
Product Licenses and Acquisitio
Product Licenses and Acquisitions | 9 Months Ended |
Mar. 31, 2020 | |
Product Licenses And Acquisitions | |
Product Licenses and Acquisitions | The Company licensed three of its existing product offerings from third parties: (i) Natesto, (ii) ZolpiMist, and (iii) Tuzistra XR. Each of these license agreements are subject to terms and conditions specific to each agreement. The Company acquired an additional six pharmaceutical products upon the closing of the Asset Purchase Agreement with Cerecor. The Company recognized an intangible asset of approximately $22.7 million relating the Product technology rights acquired from the Pediatric Portfolio and an intangible asset of approximately $11.7 million relating the patent rights and trademarks acquired from the Innovus Merger. License and Supply Agreement—Natesto In April 2016, Aytu entered into a license and supply agreement to acquire the exclusive U.S. rights to commercialize Natesto® (testosterone) nasal gel from Acerus Pharmaceuticals Corporation, or Acerus. We acquired the rights effective upon the expiration of the former licensee’s rights, which occurred on June 30, 2016. The term of the license runs for the greater of eight years or until the expiry of the latest to expire patent, including claims covering Natesto or until the entry on the market of at least one AB-rated generic product. On July 29, 2019, the Company and Acerus agreed-to an Amended and Restated License and Supply Agreement (the “Acerus Amendment”), subject to certain conditions being satisfied prior to the Acerus Amendment becoming effective and enforceable. The Acerus Amendment eliminated the previously disclosed revenue-based milestone payments expected to be made to Acerus.The maximum aggregate milestones payable under the original agreement were $37.5 million. Upon the effectiveness of the Acerus Amendment on December 1, 2019, all royalty and milestone liabilities were eliminated. Upon the effectiveness of the Acerus Amendment, Acerus was granted the right to earn commissions on certain filled Natesto prescriptions. Additionally, Acerus assumed certain ongoing sales, marketing and regulatory obligations from the Company. This Acerus Amendment became effective December 1, 2019, resulting in a $5.2 million unrealized gain during the nine months ended March 31, 2020, due to the elimination of the revenue-based product milestones. Accordingly, there is no remaining value attributable to the contingent consideration relating to the Natesto License and Supply Agreement. The fair value of the net identifiable Natesto asset acquired was determined to be $10.5 million, which is being amortized over eight years. The aggregate amortization expense for each of the three-month periods ended March 31, 2020 and 2019 was $0.3 million. The aggregate amortization expense for each of the nine-month periods ended March 31, 2020 and 2019 was $1.0 million. License Agreement—ZolpiMist In June 2018, Aytu signed an exclusive license agreement for ZolpiMist™ (zolpidem tartrate oral spray) from Magna Pharmaceuticals, Inc., (“Magna”). This agreement allows for Aytu’s exclusive commercialization of ZolpiMist in the U.S. and Canada. Aytu made an upfront payment of $0.4 million to Magna upon execution of the agreement. The ZolpiMist license agreement was valued at $3.2 million and is amortized over the life of the license agreement up to seven years. The amortization expense for each of the three months ended March 31, 2020 and 2019 was $116,000. The aggregate amortization expense for each of the nine-month periods ended March 31, 2020 and 2019 was $348,000. We also agreed to make certain royalty payments to Magna which will be calculated as a percentage of ZolpiMist net sales and are payable within 45 days of the end of the quarter during which the applicable net sales occur. The contingent consideration related to these royalty payments was valued at $2.6 million using a Monte Carlo simulation, as of June 11, 2018. As of June 30, 2019, the contingent consideration was revalued at $2.3 million using the same Monte Carlo simulation methodology, and based on current interest rates, expected sales potential, and Aytu stock trading variables. The Company reevaluates the contingent consideration on a quarterly basis for changes in the fair value recognized after the acquisition date, such as measurement period adjustments. The contingent consideration accretion expense for the three months ended March 31, 2020 and 2019 was $59,000 and $64,000, respectively. The contingent consideration accretion expense for each of the nine-month periods ended March 31, 2020 and 2019 was $169,000, and $184,000, respectively. As of March 31, 2020, none of the milestones had been achieved, and therefore, no milestone payment was made. License, Development, Manufacturing and Supply Agreement—Tuzistra XR On November 2, 2018, the Company entered into a License, Development, Manufacturing and Supply Agreement (the “Tris License Agreement”) with TRIS Pharma, Inc. (“TRIS”). Pursuant to the Tris License Agreement, TRIS granted the Company an exclusive license in the United States to commercialize Tuzistra XR. In addition, TRIS granted the Company an exclusive license in the United States to commercialize a complementary antitussive referred to as “CCP-08” (together with Tuzistra XR, the “Products”) for which marketing approval has been sought by TRIS under a New Drug Application filed with the Food and Drug Administration (“FDA”). As consideration for the Products license, the Company: (i) made an upfront cash payment to TRIS; (ii) issued shares of Series D Convertible preferred stock to TRIS; and (iii) will pay certain royalties to TRIS and another predecessor product owner throughout the license term in accordance with the Tris License Agreement, including certain minimum royalties to TRIS.. The Tris License Agreement was valued at $9.9 million and will be amortized over the life of the Tris License Agreement up to twenty years. The amortization expense for each of the three-month periods ended March 31, 2020 and 2019 was $123,000, respectively. The aggregate amortization expense for each of the nine-month periods ended March 31, 2020 and 2019 was $369,000 and $205,000. We also agreed to make certain quarterly royalty payments to TRIS which will be calculated as a percentage of our Tuzistra XR net sales, payable within 45 days of the end of the applicable quarter. As of November 2, 2018, the contingent consideration, related to this asset, was valued at $8.8 million using a Monte Carlo simulation. As of June 30, 2019, the contingent consideration was revalued at $16.0 million using the same Monte Carlo simulation methodology, and based on current interest rates, expected sales potential, and Aytu stock trading variables. The Company reevaluates the contingent consideration on a quarterly basis for changes in the fair value recognized after the acquisition date, such as measurement period adjustments. The contingent consideration accretion expense for the three months ended March 31, 2020 and 2019 was $125,000, and $73,000, respectively. The contingent consideration accretion expense for each of the nine-month periods ended March 31, 2020 and 2019 was $322,000, and $119,000, respectively. As of March 31, 2020, none of the milestones had been achieved, and therefore, no milestone payment was made. Asset Purchase Agreement—the Pediatric Portfolio In November 2019, Aytu Therapeutics, LLC., a wholly-owned subsidiary of Aytu, acquired the portfolio of pediatric therapeutic commercial products from Cerecor, Inc (the “Pediatric Portfolio”). This transaction expanded our product portfolio with the addition of six prescription products, (i) AcipHex® Sprinkle™, (ii) Cefaclor for Oral Suspension, (iii) Karbinal® ER, (iv) Flexichamber™, (v) Poly-Vi-Flor® and Tri-Vi-Flor™. Aytu paid $4.5 million in cash, issued approximately 9.8 million shares of Series G Convertible Preferred Stock and assumed certain of Seller’s financial and royalty obligations, and not more than $3.5 million of Medicaid rebates and products returns. In addition, the Company has assumed obligations due to an investor including fixed and variable payments. The Company assumed fixed monthly payments equal to $0.1 million from November 2019 through January 2021 plus $15 million due in January 2021. Monthly variable payments due to the same investor are equal to 15% of net revenue generated from a subset of the Product Portfolio, subject to an aggregate monthly minimum of $0.1 million, except for January 2020, when a one-time payment of $0.2 million was paid. The variable payment obligation continues until the earlier of: (i) aggregate variable payments of approximately $9.5 million have been made, or (ii) February 12, 2026. Supply and Distribution Agreement, As Amended – Karbinal® ER The Company acquired and assumed all rights and obligations pursuant to the Supply and Distribution Agreement, as Amended, with TRIS for the exclusive rights to commercialize Karbinal® ER in the United States (the “TRIS Karbinal Agreement”). The TRIS Karbinal Agreement’s initial term terminates in August of 2033, with an optional initial 20-year extension. The Company owes royalties on sales of Karbinal of 23.5% of net revenues on a quarterly basis. As part of the agreement, the Company has agreed to pay TRIS a product make-whole payment of approximately $1.8 million per year through July 2023, totaling a minimum of $6.6 million (see Note 12). Supply and License Agreement – Poly-Vi-Flor & Tri-Vi-Flor The Company acquired and assumed all rights and obligations pursuant to a Supply and License Agreement and various assignment and release agreements, including a previously agreed to Settlement and License Agreements (the “Poly-Tri Agreements”) for the exclusive rights to commercialize Poly-Vi-Flor and Tri-Vi-Flor in the United States. The Company owes royalties to multiple parties totaling approximately 29.0% of net revenues on a quarterly basis. There are no milestones, make-whole payments other otherwise any contingencies related to these agreements. License and Assignment Agreement – AcipHex Sprinkle The Company acquired and assumed all rights and obligations pursuant to the License and Assignment Agreement with Eisai, Inc. for exclusive rights to commercialized AcipHex Sprinkle in the United States (the “Eisai AcipHex Agreement”). The Eisai AcipHex Agreement includes quarterly royalties totaling 15% of net revenues, but offset by amounts paid for certain regulatory costs otherwise the responsibility of Eisai Co., Ltd. In addition, there are certain milestone provisions triggering potential payments of between $3.0 - $5.0 million, for which the Company has preliminarily estimated to have a value of $0.00. License, Supply and Distribution Agreement – Cefaclor The Company acquired and assumed all rights and obligations pursuant to the License, Supply and Distribution Agreement involving multiple counterparties to commercialize Cefaclor in the United States. (the “Cefaclor Agreement”). The Cefaclor Agreement includes quarterly royalties totaling approximately 15% of net products sales. In addition, there are certain milestone provisions triggering potential payments of between $0.5 - $2.5 million, for which the Company has preliminarily estimated to have a value of $0.00. Innovus Merger On February 14, 2020, the Company and Innovus Pharmaceuticals, Inc. (“Innovus”) completed the Merger after successful approval of the Merger by the shareholders of the Company and Innovus at separate special meetings held on February 13, 2020. Upon completion of the Merger, the Company obtained a combination of 18 registered trademarks and/or patent rights including, but not limited to the following: Patented Products ● Recalmax ● Sensum ● Vessele ● Zestra Trademarks ● Diabasens – ● Fluticare – ● Urivarx – ● Beyond Human Testosterone Booster - |
Inventories
Inventories | 9 Months Ended |
Mar. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories consist of raw materials and finished goods and are recorded at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis. Aytu periodically reviews the composition of its inventories to identify obsolete, slow-moving or otherwise unsaleable items. If unsaleable items are observed and there are no alternate uses for the inventory, Aytu will record a write-down to net realizable value in the period that the impairment is first recognized. There was no inventory write-down during the three and nine months ended March 31, 2020 or 2019, respectively. Inventory balances consist of the following: As of As of March 31, June 30, 2020 2019 Raw materials $ 363,000 $ 117,000 Finished goods 3,491,000 1,323,000 $ 3,854,000 $ 1,440,000 |
Fixed Assets
Fixed Assets | 9 Months Ended |
Mar. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets | Fixed assets are recorded at cost and, once placed in service, are depreciated on a straight-line basis over the estimated useful lives. Leasehold improvements are amortized over the shorter of the estimated economic life or related lease term. Fixed assets consist of the following: Estimated As of As of Useful March 31, June 30, Lives in years 2020 2019 Manufacturing equipment 2 - 5 $ 389,000 $ 83,000 Leasehold improvements 3 297,000 112,000 Office equipment, furniture and other 2 - 5 392,000 315,000 Lab equipment 3 - 5 90,000 90,000 Software 3 - 5 339,000 - Less accumulated depreciation and amortization (1,219,000 ) (396,000 ) Fixed assets, net $ 288,000 $ 204,000 Depreciation and amortization expense totaled $24,000 for each of the three-months ended March 31, 2020 and 2019, respectively, and $56,000 and $59,000 for the nine months ended March 31, 2020 and 2019. |
Leases, Right-to-Use Assets and
Leases, Right-to-Use Assets and Related Liabilities | 9 Months Ended |
Mar. 31, 2020 | |
Leases Right-to-use Assets And Related Liabilities | |
Leases, Right-to-Use Assets and Related Liabilities | In September 2015, the Company entered into a 37-month operating lease in Englewood, Colorado. In October 2017, the Company signed an amendment to extend the lease for an additional 24 months beginning October 1, 2018. In April 2019, the Company extended the lease for an additional 36 months beginning October 1, 2020. This lease has base rent of approximately $10 thousand a month, with total rent over the term of the lease of approximately $355 thousand. In June 2018, the Company entered into a 12-month operating lease, beginning on August 1, 2018, for office space in Raleigh, North Carolina. This lease has base rent of approximately $1 thousand a month, with total rent over the term of the lease of approximately $13 thousand. In October 2017, the Company’s subsidiary, Innovus, entered into a commercial lease agreement for 16,705 square feet of office and warehouse space in San Diego, California that commenced on December 1, 2017 and continues until April 30, 2023. The initial monthly base rent was $21,000 with an approximate 3% increase in the base rent amount on an annual basis, as well as, rent abatement for rent due from January 2018 through May 2018. The Company holds an option to extend the lease an additional 5 years at the end of the initial term. On November 18, 2019 (“decision date”), Innovus determined it would no longer utilize the warehouse portion of the lease space, representing approximately 9,729 square feet, and as of December 31, 2019 (“cease use date”) ceased using any such space. In accordance with ASC 842, Leases As discussed within Note 1 “Leases (Topic 842)” Total 2020 2021 2022 2023 2024 Thereafter Remaining Office leases $ 1,268,000 $ 93,000 $ 383,000 $ 396,000 $ 356,000 $ 40,000 − Less: Discount Adjustment (175,000 ) Total lease liability 1,093,000 Lease liability - current portion 289,000 Long-term lease liability $ 804,000 Rent expense for the three months ended March 31, 2020 and 2019 totaled $61 thousand and $31 thousand, respectively. Rent expense for the nine months ended March 31, 2020 and 2019 totaled $126 thousand and $94 thousand, respectively. |
Patents
Patents | 9 Months Ended |
Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Patents | The cost of the oxidation-reduction potential (“ORP”) technology related patents for the MiOXSYS Systems was $380,000 when they were acquired and are being amortized over the remaining U.S. patent life of approximately 15 years as of the date, which expires in March 2028. Patents consist of the following: As of As of March 31, June 30, 2020 2019 Patents - MiOXSYS $ 380,000 $ 380,000 Less accumulated amortization (178,000 ) (159,000 ) Patents, net $ 202,000 $ 221,000 The amortization expense was $6 thousand for the three months ended March 31, 2020 and 2019, respectively, and $19 thousand for the nine months ended March 31, 2020 and 2019 respectively. On February 14, 2020, upon completion of the Merger with Innovus, the Company recognized the fair value of the rental of the customer lists for $390,000 and will amortize the asset over a useful life of 1.5 years. As of As of March 31, June 30, 2020 2019 Patents & tradenames $ 11,354,000 $ - Customers contracts 390,000 - Less accumulated amortization (221,000 ) - Patents & tradenames, net $ 11,523,000 $ - |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Mar. 31, 2020 | |
Accrued Liabilities Abstract | |
Accrued Liabilities | Accrued liabilities consist of the following: As of As of March 31 June 30, 2020 2019 Accrued legal settlement $ 205,000 $ − Accrued program liabilities 1,299,000 736,000 Accrued product-related fees 1,644,000 295,000 Credit card liabilities 941,000 − Contract liability 180,000 4,000 Medicaid liabilities 3,255,000 61,000 Return reserve 1,671,000 98,000 Sales taxes payable 172,000 − Other accrued liabilities* 463,000 117,000 Total accrued liabilities $ 9,830,000 $ 1,311,000 * Other accrued liabilities consist of franchise tax, accounting fee, interest payable, merchant services charges, none of which individually represent greater than five percent of total current liabilities. |
Fair Value Considerations
Fair Value Considerations | 9 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Considerations | The Company’s financial instruments include cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued liabilities, warrant derivative liability, and contingent consideration. The carrying amounts of financial instruments, including cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and accrued liabilities approximate their fair value due to their short maturities, including those acquired or assumed on November 1, 2019 as a result of the acquisition of the Pediatric Portfolio. The fair value of the warrant derivative liability was valued using the lattice valuation methodology. The fair value of acquisition-related contingent consideration is based on a Monte-Carlo methodology using estimated discounted future cash flows and periodic assessments of the probability of occurrence of potential future events. The valuation policies are determined by management, and the Company’s Board of Directors is informed of any policy change. Authoritative guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. The guidance establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions of what market participants would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy is broken down into three levels based on reliability of the inputs as follows: Level 1: Inputs that reflect unadjusted quoted prices in active markets that are accessible to Aytu for identical assets or liabilities; Level 2: Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and Level 3: Unobservable inputs that are supported by little or no market activity. The Company’s assets and liabilities which are measured at fair value are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. The Company’s policy is to recognize transfers in and/or out of fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. Aytu has consistently applied the valuation techniques discussed below in all periods presented. Recurring Fair Value Measurements The following table presents the Company’s financial liabilities that were accounted for at fair value on a recurring basis as of March 31, 2020 and June 30, 2019, by level within the fair value hierarchy. Fair Value Measurements at March 31, 2020 Fair Value at March 31, 2020 Quoted Priced in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Recurring: Warrant derivative liability $ 11,000 – – $ 11,000 Contingent consideration 18,754,000 – – 18,754,000 CVR liability 5,219,000 – – 5,219,000 $ 23,984,000 – – $ 23,984,000 Fair Value Measurements at June 30, 2019 Fair Value at June 30, 2019 Quoted Priced in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Recurring: Warrant derivative liability $ 13,000 – – $ 13,000 Contingent consideration 23,326,000 – – 23,326,000 CVR liability – – – – $ 23,339,000 – – $ 23,339,000 Warrant Derivative Liability. As of March 31, 2020 As of June 30, 2019 Warrant Derivative Liability Volatility 163.2 % 163.2 % Equivalent term (years) 2.88 3.13 Risk-free interest rate 1.71 % 1.71 % Dividend yield 0.00 % 0.00 % Contingent Consideration. The Company derecognized the contingent consideration liability related to Natesto as a result of the December 1, 2019 effectiveness of the Acerus Amendment, which eliminated product milestone payments underlying the contingent consideration liability. Due to the derecognition of the Natesto contingent consideration, the Company recognized a, non-operating gain of approximately $5.2 million during the three and nine months ended March 31, 2020. The Company recognized approximately $0.2 million in contingent consideration as a result of the February 14, 2020 Innovus Merger. The fair value was based on a discounted value of the future contingent payment using a 30% discount rate based on the estimates risk that the milestones are achieved. There was no material change in this valuation as of March 31, 2020. Contingent value rights. Non-Recurring Fair Value Measurements The following table represents those asset and liabilities measured on a non-recurring basis for the nine months ended March 31, 2020 as a result of the (i) November 1, 2019 acquisition of the Pediatrics Portfolio and (ii) the February 14, 2020 Innovus Merger. Fair Value at Measurement Date Quoted Priced in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Non-recurring Pediatric Portfolio (November 1, 2019) Product technology rights $ 22,700,000 – – 22,700,000 Goodwill 15,687,064 – – 15,687,064 Fixed payment arrangements 26,457,162 – – 26,457,162 Innovus Merger (February 14, 2020) Customer lists 390,000 – – 390,000 Product distribution rights (trademarks and patents) 11,354,000 – – 11,354,000 Right-to-use asset 675,980 675,980 Goodwill 8,374,269 – – 8,374,269 Notes payable 3,056,361 – – 3,056,361 $ 88,694,836 – – $ 88,694,836 Acquisition of the Pediatric Portfolio Product technology rights. As of November 1, 2019 (*) Product technology rights Re-levered Beta 1.60 Market risk premium 6.00 % Small stock risk premium 5.20 % Risk-free interest rate 2.00 % Company specific discount 25.00 % (*) Valuation performed as of November 1, 2019. As a non-recurring fair value measurement, there is no remeasurement at each reporting period unless indications exist that the fair value of the asset has been impaired. There were no indicators as of March 31, 2020 that the fair value of the Product technology rights was impaired. Goodwill. Fixed payment arrangements. As of November 1, 2019 (≠) Fixed payment obligations Discount rate 1.8% to 12.4% (≠) Valuation performed as of November 1, 2019. As a non-recurring fair value measurement, there is no remeasurement at each reporting period unless indicates that the circumstances that existed as of the November 1, 2019 measurement date indicate that the carrying value is no longer indicative of fair value. Innovus Merger Customer lists. Trademarks and patents. As of February 14, 2020 Trademarks and patents Re-levered Beta 0.84 % Market risk premium 6.17 % Small stock risk premium 4.99 % Risk-free interest rate 1.89 % Company specific discount 20.00 % Goodwill y 14, 2020 through March 31, 2020. Innovus Notes Payable The ten unsecured Innovus Notes consist of ten separate loans with implied effective interest rates ranging between 14.1% and 73.4%. The weighted average interest rate for these notes was 39.5%, while the weighted average interest rate for the most recent loan (January 9, 2020) was 41.4%. All ten of the notes are unsecured, and as of the valuation date there was significant risk associated with their repayment. Accordingly, the Company has revalued the notes using an effective rate of 40% and concluded that the fair value at the February 14, 2020 Innovus Merger date was approximately $2.7 million. The secured Innovus Notes due to Amazon had had maturities of less than one year and stated rates of 17.2% and 14.7% respectively. Due to the fact that the most recent loan had a stated rate of 14.7% and that the weighted average rate for these two loans was 15.6%, the Company has estimated the current value of the loans using an effective rate of 15% and concluded that the fair value of the secured Innovus Notes totaled approximately $0.4 million. Summary of Level 3 Input Changes The following table sets forth a summary of changes to those fair value measures using Level 3 inputs for the nine months ended March 31, 2020: Product Technology Rights Innovus Assets Goodwill Liability Classified Warrants CVR Liability Contingent Consideration Fixed Payment Arrangements Balance as of June 30, 2019 – – – $ 13,000 – $ 23,326,000 – Transfers into Level 3 – – – – – – – Transfer out of Level 3 – – – – – – – Total gains, losses, amortization or accretion in period (946,000 ) (221,000 ) – – – – – Included in earnings – – – (2,000 ) 170,000 (4,576,000 ) 647,000 Included in other comprehensive income – – – – – Purchases, issues, sales and settlements – Purchases 22,700,000 11,744,000 24,061,000 – 7,049,000 183,000 – Issues – – – – – – 26,457,000 Sales – – – – – – – Settlements – – – – (2,000,000 ) (179,000 ) (1,547,000 ) Balance as of March 31, 2020 $ 21,754,000 $ 11,523,000 $ 24,061,000 $ 11,000 $ 5,219,000 $ 18,754,000 $ 25,557,000 |
Note Receivable
Note Receivable | 9 Months Ended |
Mar. 31, 2020 | |
Note Receivable | |
Note Receivable | On September 12, 2019, the Company announced it had entered into a definitive merger agreement with Innovus (see Note 1) to acquire Innovus which specializes in commercializing, licensing and developing safe and effective supplements and over-the-counter consumer health products. As part of the negotiations with Innovus, the Company agreed to provide a short-term, loan in the form of a $1.0 promissory note on August 8, 2019 (the “Innovus Note”). In addition, on October 11, 2019, the Company amended the original promissory note, providing an additional approximately $0.4 million of bridge financing under the same terms and conditions as the Innovus Note. Upon the closing of the Merger, this note receivable was used to offset a portion of the $8 million initial closing purchase price and was deducted from the consideration value used when determining the number of shares of Aytu common stock to be issued upon closing of the acquisition. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and contingencies are described below and summarized by the following as of March 31, 2020: Total 2020 2021 2022 2023 2024 Thereafter Prescription database $ 1,762,000 $ 262,000 $ 767,000 $ 733,000 $ – $ – $ – Pediatric portfolio fixed payments and product minimums 28,715,000 998,000 18,471,000 2,950,000 2,950,000 1,346,000 2,000,000 CVR liability 5,219,000 787,000 1,210,000 2,327,000 895,000 – – Inventory purchase commitments 2,943,000 1,266,250 1,716,750 – – – – Product contingent liability 183,000 – – – – – 183,000 Product milestone payments 3,000,000 – – 3,000,000 – – – $ 41,822,000 $ 3,273,250 $ 22,164,750 $ 9,010,000 $ 3,845,000 $ 1,346,000 $ 2,183,000 Prescription Database In May 2016, the Company entered into an agreement with a vendor that will provide it with prescription database information. The Company agreed to pay approximately $1.6 million over three years for access to the database of prescriptions written for Natesto. In January 2020, the Company amended the agreement and agreed to pay additional $0.6 million to add access to the database of prescriptions written for the Pediatric Portfolio. The payments have been broken down into quarterly payments. Pediatric Portfolio Fixed Payments and Product Milestone The Company assumed two fixed, periodic payment obligations to an investor (the “Fixed Obligation”). Beginning November 1, 2019 through January 2021, the Company will pay monthly payments of $86,840, with a balloon payment of $15,000,000 due in January 2021. A second fixed obligation requires the Company pay a minimum of $100,000 monthly through February 2026, except for $210,767 paid in January 2020. There is the potential for the second fixed obligation to increase an additional $1.8 million depending on product sales, which could trigger additional amounts to be paid. In addition, the Company acquired a Supply and Distribution Agreement with TRIS Pharma (the “Karbinal Agreement”), under which the Company is granted the exclusive right to distribute and sell the product in the United States. The initial term of the Karbinal Agreement was 20 years. The Company will pay TRIS a royalty equal to 23.5% of net sales. A third party agreed to offset the 23.5% royalty payable by 8.5%, for a net royalty equal to 15%, in fiscal year 2018 and 2019 for net sales of Karbinal. The Karbinal Agreement make-whole payment is capped at $1,750,000 each year. The Karbinal Agreement also contains minimum unit sales commitments, which is based on a commercial year that spans from August 1 through July 31, of 70,000 units through 2023. The Company is required to pay TRIS a royalty make whole payment of $30 for each unit under the 70,000-unit annual minimum sales commitment through 2033. The annual payment is due in August of each year. The Karbinal Agreement also has multiple commercial milestone obligations that aggregate up to $3.0 million based on cumulative net sales, the first of which is triggered at $40.0 million of net revenues. CVR Liability On February 14, 2020 the Company closed on the Merger with Innovus Pharmaceuticals after approval by the stockholders of both companies on February 13, 2020. Upon closing the Merger, the Company merged with and into Innovus and entered into a Contingent Value Rights Agreement (the “CVR Agreement”). Each CVR will entitle its holder to receive its pro rata share, payable in cash or stock, at the option of Aytu, of certain payment amounts if the targets are met. If any of the payment amounts is earned, they are to be paid by the end of the first quarter of the calendar year following the year in which they are earned. Multiple revenue milestones can be earned in one year. On March 31, 2020, the Company paid out the first CVR Milestone in the form of approximately 1.2 million shares of the Company’s common stock to satisfy the $2.0 million obligation as a result of Innovus achieving the $24.0 million revenue milestone for calendar year ended December 31, 2019. As a result of this, the Company recognized a gain of approximately $0.3 million. Product Contingent Liability In February 2015, Innovus acquired Novalere, which included the rights associated with distributing Fluticare. As part of the Merger, Innovus is obligated to make 5 additional payments of $0.5 million when certain levels of Fluticare sales are achieved. Inventory Purchase Commitment In May 1, 2020, the Company entered into a Settlement Agreement and Release (the “Settlement Agreement”) with Hikma Pharmaceuticals USA Inc. (“Hikma”). Pursuant to the settlement agreement, Innovus has agreed to purchase and Hikma has agreed to manufacture a minimum amount of our branded fluticasone propionate nasal spray USP, 50 mcg per spray (FlutiCare®), under Hikma’s FDA approved ANDA No. 207957 in the U.S. The commitment requires Innovus to purchase three batches of product through fiscal year 2022 each of which amount to $1.0 million Milestone Payments In connection with the Company’s intangible assets, Aytu has certain milestone payments, totaling $3.0 million, payable at a future date, are not directly tied to future sales, but upon other events certain to happen. These obligations are included in the valuation of the Company’s contingent consideration (see Note 10). |
Capital Structure
Capital Structure | 9 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Capital Structure | The Company has 200 million shares of common stock authorized with a par value of $0.0001 per share and 50 million shares of preferred stock authorized with a par value of $0.0001 per share. At March 31, 2020 and June 30, 2019, Aytu had 100,610,380 and 17,538,071 common shares outstanding, respectively, and 9,805,845 and 3,594,981 preferred shares outstanding, respectively. The Company has 50 million shares of non-voting, non-cumulative preferred stock authorized with a par value of $0.0001 per share, of which, 9,805,845 are designated as Series G Convertible preferred stock as of March 31, 2020. Liquidation rights for all series of preferred stock are on an as-converted to common stock basis. Included in the common stock outstanding are 3,345,766 shares of restricted stock issued to executives, directors, employees and consultants. During the three months ended September 30, 2019, investors holding shares of Series C preferred stock exercised their right to convert 443,833 shares of Series C preferred stock into 443,833 shares of common stock. There are no remaining Series C preferred stock outstanding. In October 2019, Armistice Capital converted 2,751,148 shares of Series E convertible preferred stock into 2,751,148 shares of common stock. There are no remaining Series E preferred stock outstanding. In October 2019, the Company issued 10,000 shares of Series F Convertible Preferred Stock, with a face value of $1,000 per share, and convertible at a conversion price of $1.00 (the “Current Conversion Price”). The terms of the Series F Convertible Preferred include a conversion price reset provision in the event a future financing transaction is priced below the Current Conversion Price. The Company has determined that concurrent with the adoption of ASU 2017-11, this down-round provision feature reflects a beneficial conversion feature contingent on a future financing transaction at a price lower than the Current Conversion Price. As the Series F Convertible Preferred stock is an equity classified instrument, any accounting arising from a future event giving rise to the beneficial conversion feature would have no net impact on the Company’s financial statements, as all activity would be recognized within Additional Paid-in-Capital and offset. In addition and concurrent with the Series F Convertible preferred stock issuance, the Company issued 10,000,000 warrants, with an exercise price of $1.25 and a term of five years. These warrants feature a contingent cashless exercise provision. During the three months ended December 31, 2019, the cashless exercise contingency was satisfied, reducing the strike price of the October 2019 Warrants to $0. During the three months ended March 31, 2020, an investor exercised 5,000,000 of the warrants using the cashless exercise provision. In April 2020, another investor exercised the remaining 5,000,000 of the October 2019 warrants using the cashless exercise provision, resulting in no remaining October 2019 warrants. In November 2019, in connection with the Pediatric Portfolio acquisition, the Company issued 9,805,845 shares of Series G Convertible Preferred stock, of which, Pediatric Portfolio converted 9,805,845 shares of the Series G Convertible Preferred stock into 9,805,845 shares of common stock in April of 2020. During the three months ended March 31, 2020, the Company entered into three separate offerings, on March 10, 2020, March 12, 2020 and March 19, 2020 (the “March Offerings”) in which the Company issued a combination of common stock and warrants. The following summarizes the March Offerings, including total capital raised from both the issuance of common stock and subsequent warrant exercises. On March 19, 2020, the Company entered into a securities purchase agreement with certain institutional investors (the “the March 19, 2020 Purchasers”), pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 12,539,197 shares of the Company’s common stock (the “Common Stock”) at a purchase price per share of $1.595 and (ii) warrants to purchase up to 12,539,197 shares of Common Stock (the “March 19, 2020 Warrants”) at an exercise price of $1.47 per share, for aggregate gross proceeds to the Company of $20.0 million, before deducting placement agent fees and other offering expenses payable by the Company. The March 19, 2020 Warrants are exercisable immediately upon issuance and have a term of one year from the issuance date. In addition, the Company issued warrants with an exercise price of $1.9938 per share to purchase up to 815,047 shares of common stock (the “March 19, 2020 Placement Agent Warrants”). The March 19, 2020 Placement Agent Warrants have a term of five years from the issuance date. A total of 1.2 million March 19, 2020 Warrants have been exercised through May 5, 2020, for total proceeds of $1.7 million, of which 0.7 million March 19, 2020 Warrants were exercised through March 31, 2020, for total proceeds of $1.1 million. On March 12, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 16,000,000 shares of the Company’s common stock at a purchase price per share of $1.25 and (ii) warrants to purchase up to 16,000,000 shares of Common Stock (the “March 12, 2020 Warrants”) at an exercise price of $1.25 per share, for aggregate gross proceeds to the Company of $20.0 million, before deducting placement agent fees and other offering expenses payable by the Company (the “Registered Offering”). The March 12, 2020 Warrants are exercisable immediately upon issuance and have a term of one year from the issuance date. In addition, the Company issued warrants with an exercise price of $1.5625 per share to purchase up to 1,040,000 shares of common stock (the “March 12, 2020 Placement Agent Warrants”). The March 12, 2020 Placement Agent Warrants have a term of five years from the issuance date. A total of 13 million March 12, 2020 Warrants have been exercised through May 5, 2020, for total proceeds of approximately $16.3 million, of which approximately 10.5 million March 12, 2020 Warrants were exercised through March 31, 2020, for total proceeds of $13.1 million. On March 10, 2020, Company entered into a securities purchase agreement with an institutional investor, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 4,450,000 shares of the Company’s common stock (the “Common Stock”) at a purchase price per share of $1.15 and (ii) pre-funded warrants to purchase up to 3,376,087 shares of Common Stock (the “Pre-Funded Warrants”) at an effective price of $1.15 per share ($1.1499 paid to the Company upon the closing of the offering and $0.0001 to be paid upon exercise of such Pre-Funded Warrants), for aggregate gross proceeds to the Company of approximately $9.0 million, before deducting placement agent fees and other offering expenses payable by the Company (the “Registered Offering”). The Pre-Funded Warrants were immediately exercised upon close. In addition, the Company issued warrants with an exercise price of $1.4375 per share to purchase up to 508,696 shares of common stock (the “March 10, 2020 Placement Agent Warrants”). The March 10, 2020 Placement Agent Warrants have a term of five years from the issuance date. Between March 10, 2020 and March 31, 2020, a total of 6.0 million shares of the Company’s October 2018 $1.50 Warrants (the “October 18 $1.50 Warrants”) were exercised, resulting in proceeds of approximately $9.0 million. In total, the Company has raised net proceeds of approximately $71.5 million from the March Offerings and related warrant exercises, as well as exercises of the October 2018 Warrants. The net proceeds received by the Company from the March Offerings and related warrant exercise will be used for general corporate purposes, including working capital. During the three months ended March 31, 2020, the following Convertible Preferred Stock issuances were converted into the Company’s common stock: ● 400,000 shares of the Series D Convertible Preferred Stock were converted into 400,000 shares of the Company’s common stock. There are no remaining shares of the Series D Convertible Preferred Stock outstanding at March 31, 2020; ● 10,000 shares of the Series F Convertible Preferred Stock issuances were converted into 10,000,000 shares of the Company’s common stock. There are no remaining shares of the Series F Convertible Preferred stock outstanding at March 31, 2020; ● 1,997,902 shares of the Company’s Series H Convertible Preferred Stock were converted into 1,997,902 shares of the Company’s common stock. There are no remaining shares of the Series H Convertible Preferred stock outstanding at March 31, 2020. |
Equity Incentive Plan
Equity Incentive Plan | 9 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Equity Incentive Plan | Share-based Compensation Plans On June 1, 2015, Aytu’s stockholders approved the Aytu BioScience 2015 Stock Option and Incentive Plan (the “2015 Plan”), which, as amended in July 2017, provides for the award of stock options, stock appreciation rights, restricted stock and other equity awards for up to an aggregate of 3.0 million shares of common stock. The shares of common stock underlying any awards that are forfeited, canceled, reacquired by Aytu prior to vesting, satisfied without any issuance of stock, expire or are otherwise terminated (other than by exercise) under the 2015 Plan will be added back to the shares of common stock available for issuance under the 2015 Plan. As of March 31, 2020, we have 1,317,337 shares that are available for grant under the 2015 Plan. On December 23, 2019, the Company filed Form S-4 related to the proposed Innovus merger, in which shareholders are asked to approve an increase to 5.0 million total shares of common stock in the 2015 Plan. As of the date of this report, Aytu shareholders approved the proposal to increase the total number of common shares in the 2015 Plan. Stock Options Employee Stock Options: In November 2019, the Company granted 327,000 shares of stock options to 28 employees pursuant to the 2015 Plan, which vest over four years. Compensation expense related to these options will be fully recognized over the four-year vesting period. In January 2020, the Company granted 12,500 shares of stock options to 5 employees pursuant to the 2015 Plan, which vest immediately upon grant. Compensation expense related to these options were fully recognized in the three months ended March 31, 2020. The fair value of the options is calculated using the Black-Scholes option pricing model. In order to calculate the fair value of the options, certain assumptions are made regarding components of the model, including the estimated fair value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield and expected option life. Changes to the assumptions could cause significant adjustments to valuation. Aytu estimates the expected term based on the average of the vesting term and the contractual term of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. Aytu has computed the fair value of all options granted during the nine months ended March 31, 2019 using the following assumptions: As of March 31, 2020 Volatility 100.0 % Equivalent term (years) 10.00 Risk-free interest rate 1.82 % Dividend yield 0.00 % Stock option activity is as follows: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding June 30, 2019 $ 1,607 $ 325.73 6.13 Granted 339,500 0.98 10.00 Exercised (2,500 ) 0.97 – Expired (170 ) 328.00 – Outstanding March 31, 2020 338,437 2.36 9.62 Exercisable at March 31, 2020 11,437 41.74 9.30 As of March 31, 2020, there was $133,015 unrecognized option-based compensation expense related to non-vested stock options. Restricted Stock Restricted stock activity is as follows: Number of Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Life in Years Unvested at June 30, 2019 2,346,214 $ 1.83 9.1 Granted 1,067,912 0.73 1.7 Vested – – – Forfeited (69,900 ) 2.03 – Unvested at March 31, 2020 3,344,226 $ 1.47 7.2 During the quarter ended September 30, 2019, 5,150 shares of restricted stock were exchanged with common stock, and the Company recognized an increase in aggregate stock compensation expense of $2,600. During the quarter ended December 31, 2019, 34,750 shares of restricted stock were exchanged with common stock, and the Company recognized an increase in aggregate stock compensation expense of $6,200. During the quarter ended March 31, 2020, 30,000 shares of restricted stock were exchanged with common stock, and the Company recognized an increase in aggregate stock compensation expense of $12,000. Under the 2015 Plan, there was $4,124,000 of total unrecognized stock-based compensation expense related to the non-vested restricted stock as of March 31, 2020. The Company expects to recognize this expense over a weighted-average period of 7.20 years. In January 2020, the Company issued 285,000 shares of restricted stock to directors and employees pursuant to the 2015 Plan. Of the 285,000 shares, 200,000 shares vest in November 2021 and share-based compensation expense will be recognized over a two-year period. 85,000 shares vest in January 2030 and share-based compensation expense will be recognized over a ten-year period. In February 2020, the Company issued 783,000 shares of restricted stock to employees pursuant to the 2015 Plan, which vest in February 2021. Expense will be recognized over the one-year vesting period. The Company previously issued 1,540 shares of restricted stock outside the Company’s 2015 Plan, which vest in July 2026. The unrecognized expense related to these shares was $1,247,000 as of March 31, 2020 and is expected to be recognized over the weighted average period of 6.27 years. Stock-based compensation expense related to the fair value of stock options and restricted stock was included in the statements of operations as selling, general and administrative expenses as set forth in the table below: Three Months Ended March 31, Nine Months Ended March 31, Selling, general and administrative: 2020 2019 2020 2019 Stock options $ 7,000 $ 15,000 $ 14,000 $ 122,000 Restricted stock 257,000 362,000 577,000 601,000 Total stock-based compensation expense $ 264,000 $ 377,000 $ 591,000 $ 723,000 |
Warrants
Warrants | 9 Months Ended |
Mar. 31, 2020 | |
Warrants Abstract | |
Warrants | In connection with the October 2019 private placement financing, the Company issued warrants (the October 2019 Warrants) to the investors to purchase an aggregate of 10,000,000 shares of the Company’s common stock at an exercise price of $1.25 and a term of five years. These warrants feature a contingent cashless exercise provision. During the three months ended December 31, 2019, the cashless exercise contingency was satisfied, reducing the strike price of the October 2019 Warrants to $0. During the three months ended March 31, 2020, an investor exercised 5,000,000 of the warrants using the cashless exercise provision. In April 2020, another investor exercised the remaining 5,000,000 of the October 2019 warrants using the cashless exercise provision, resulting in no remaining October 2019 warrants as of April 30, 2020. In connection with the March Offerings, the following warrants were granted, and potentially subsequently exercised: ● On March 10, 2020, the Company granted 3,376,087 Pre-Funded Warrants for total proceeds of $3.9 million, which were fully exercised as of March 31, 2020. In addition, the Company issued 508,696 of Placement Agent Warrants with an exercise price of $1.4375 to purchase 508,696 shares of the Company’s common stock, which expire five years after the grant date. None of the Placement Agent Warrants have been exercised as of March 31, 2020. ● On March 12, 2020, the Company granted 16,000,000 March 12, 2020 $1.25 Warrants to purchase 16,000,000 shares of the Company’s common stock for an exercise price of $1.25 per share of common stock, and expire one-year after the grant date, of which 10,450,000 were exercised as of March 31, 2020 for total proceeds of approximately $13.1 million. In addition, the Company granted 1,040,000 of the March 12, 2020 Placement Agent Warrants with an exercise price of $1.5625 per share of common stock to purchase 1,040,000 shares of the Company’s common stock, which expire five years after the grant date. As of March 31, 2020, there were no exercises of the March 12, 2020 Placement Agent Warrants. ● On March 19, 2020, the Company granted 12,539,197 March 19, 2020 $1.47 Warrants to purchase 12,539,197 shares of the Company’s common stock for an exercise price of $1.47 per share of common stock, and expire one-year after the grant date, of which 700,000 were exercised as of March 31, 2020 for total proceeds of approximately $1.0 million. In addition, the Company granted 815,047 of the March 19, 2020 Placement Agent Warrants with an exercise price of $1.9938 per share of common stock to purchase 815,047 shares of the Company’s common stock, which expire five years after the grant date. As of March 31, 2020, there were no exercises of the March 19, 2020 Placement Agent Warrants. While these warrants are classified as a component of equity, in order to allocate the fair value of the March offerings between the investor warrants and the placement agent warrants, the Company was required to calculate the fair value of the warrants issued in March. These warrants issued had a relative fair value of $11.2 million. All warrants issued in March 2020 were valued using a Black-Scholes model. In order to calculate the fair value of the warrants, certain assumptions were made, including the selling price or fair market value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield, and contractual life. Changes to the assumptions could cause significant adjustments to valuation. The Company estimated a volatility factor utilizing a weighted average of comparable published betas of peer companies. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. Significant assumptions in valuing the warrants issued during the quarter are as follows: Warrants Issued Three Months Ended March 31, 2020 Expected volatility 100 % Equivalent term (years) 1 - 5 Risk-free rate 0.20% - 0.66 % Dividend yield 0.00 % A summary of equity-based warrants is as follows: Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding June 30, 2019 16,218,908 $ 3.15 4.36 Warrants issued 44,627,120 1.21 1.88 Warrants expired – – – Warrants exercised (*) (29,859,990 ) – – Outstanding March 31, 2020 30,986,038 $ 2.39 2.31 (*) During the quarter ended March 31, 2020, investor exercised 5.0 million of the October 2019 private placement warrants under the cashless exercise provision. In April 2020, another investor exercised all remaining 5.0 million October 2019 private placement warrants. There are no more October 2019 private placement warrants outstanding as of April 30, 2020. During the quarter ended March 31, 2020, warrants issued from the October 2018 registered offering and March 2020 offerings to purchase an aggregate of 17,082,994 shares of common stock were exercised for aggregate gross proceeds to our Company of approximately $23.0 million. A summary of liability warrants is as follows: Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding June 30, 2019 240,755 $ 72.00 3.16 Warrants expired – – – Warrants exercised – – – Outstanding March 31, 2020 240,755 $ 72.00 2.37 |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Basic income (loss) per common share is calculated by dividing the net income (loss) available to the common shareholders by the weighted average number of common shares outstanding during that period. Diluted net loss per share reflects the potential of securities that could share in the net loss of Aytu. For each three- and nine-month period presented, the basic and diluted loss per share were the same for 2019 and 2018, as they were not included in the calculation of the diluted net loss per share because they would have been anti-dilutive. The following table sets-forth securities that could be potentially dilutive, but as of the quarters ended March 31, 2020 and 2019 are anti-dilutive, and therefore excluded from the calculation of diluted earnings per share. Nine Months Ended March 31 2020 2019 Warrants to purchase common stock - liability classified (Note 15) 240,755 240,755 Warrant to purchase common stock - equity classified (Note 15) 30,986,038 11,893,175 Employee stock options (Note 14) 338,437 1,666 Employee unvested restricted stock (Note 14) 3,344,226 2,719,312 Performance-based options (*) (Note 14) – 75,000 Convertible preferred stock (Note 13) 9,805,845 2,335,665 44,715,301 17,265,573 (*) During the year ended June 30, 2019, the Company issued 75,000 performance-based stock options out of the 2015 Plan to a consultant. These options vest based on meeting certain market criteria with an exercise price of $1.00. At June 30, 2019, the first of three market targets were not achieved, and all 75,000 performance stock options were forfeited. During the quarter ended March 31, 2020, 5.0 million equity classified warrants were cashless exercised pursuant to the terms of the October 2019 warrants |
Notes Payable
Notes Payable | 9 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Notes Payable | The Aytu BioScience Note. The Innovus Notes. On April 27, 2020, approximately $1.8 million of outstanding notes were exchanged for approximately 1.5 million shares of the Company’s common stock, leaving a remaining obligation of approximately $2.1 million after the exchange, with a remaining carrying value of approximately $1.4 million. |
Segment Reporting
Segment Reporting | 9 Months Ended |
Mar. 31, 2020 | |
Segment Reporting [Abstract] | |
Segment Reporting | The Company’s chief operating decision maker (the “CODM”), who is the Company’s Chief Executive Officer, allocates resources and assesses performance based on financial information of the Company. The CODM reviews financial information presented for each reportable segment for purposes of making operating decisions and assessing financial performance. Aytu manages our Company and aggregated our operational and financial information in accordance with two reportable segments: Aytu BioScience and Aytu Consumer Health. The Aytu BioScience segment consists of the Company’s prescription products. The Aytu Consumer Health segment contains the Company’s consumers healthcare products line, which was the result of the Innovus Merger. Select financial information for these segments is as follows: Three months Ended March 31, Nine months Ended March 31, 2020 2019 2020 2019 Consolidated revenue: Aytu BioScience $ 4,703,000 $ 2,378,000 $ 9,318,000 $ 5,605,000 Aytu Consumer Health 3,453,000 3,453,000 Consolidated revenue 8,156,000 2,378,000 12,771,000 5,605,000 Consolidated net loss: Aytu BioScience (4,421,000 ) (4,496,000 ) (9,565,000 ) (12,600,000 ) Aytu Consumer Health (911,000 ) (911,000 ) Consolidated net loss (5,332,000 ) (4,496,000 ) (10,476,000 ) (12,600,000 ) March 31, 2020 June 30, 2019 Total assets: Aytu BioScience $ 137,825,000 $ 34,721,000 Aytu Consumer Health 21,129,000 - Total assets $ 158,954,000 $ 34,721,000 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | See Footnotes 1, 14, 15 and 16, 17, for information relating to certain events occurring subsequent to March 31, 2020 impacting information disclosed above. In addition, the following subsequent events were considered: In May 1, 2020, the Company entered into a Settlement Agreement and Release (the “Settlement Agreement”) with Hikma Pharmaceuticals USA Inc. (“Hikma”). Pursuant to the settlement agreement, Innovus has agreed to purchase and Hikma has agreed to manufacture a minimum amount of our branded fluticasone propionate nasal spray USP, 50 mcg per spray (FlutiCare®), under Hikma’s FDA approved ANDA No. 207957 in the U.S. The commitment requires Innovus to purchase three batches of product through fiscal year 2022 each of which amount to $1 million. On April 24, 2020, the Company received notification it had received approximately $2.5 million in the form of the Small Business Administration (“SBA”) Payroll Protection Program loan. Under the terms of the loan, the loan is due in April 2022, and bears interest of 1% per annum. On April 23, 2020, the Company announced the signing of a definitive agreement with Singapore-based Biolidics, Ltd to exclusively distribute Biolidics’ COVID-19 IgG/IgM Rapid Test in the United States. On April 20, 2020, the Company announced that it has signed an exclusive worldwide license from Cedars-Sinai to develop and commercialize the Healight Platform Technology (“Healight”). This medical device technology platform, discovered and developed by scientists at Cedars-Sinai, is being studied as a potential first-in-class treatment for coronavirus and other respiratory infections. |
Nature of Business, Financial_2
Nature of Business, Financial Condition, Basis of Presentation (Policies) | 9 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business. The Company is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant healthcare needs in both prescription and consumer health categories. Through the Company’s heritage prescription business, the Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist™, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The Company’s recently acquired prescription pediatric portfolio includes (i) AcipHex® Sprinkle™, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal® ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. On February 14, 2020, the Company acquired Innovus Pharmaceuticals Inc. (“Innovus”), a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health (the “Consumer Health Portfolio”). The Consumer Health Portfolio is commercialized through direct-to-consumer marketing channels utilizing Innovus’s proprietary Beyond Human® marketing and sales platform. The Company recently acquired exclusive U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. These rapid tests have been validated in multi-center clinical trials. Most recently, the Company signed a licensing agreement with Cedars-Sinai Medical Center for worldwide rights to various potential uses of Healight, an investigational medical device platform technology. Healight has demonstrated safety and efficacy in pre-clinical studies, and the Company plans to advance this technology and assess its safety and efficacy in human studies. The Company’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. |
Financial Condition | Financial Condition. Revenues for the three-months ended March 31, 2020 increased approximately 243% compared to the three-months ended March 31, 2019, and revenues increased 100% and 14% for each of the years ended June 30, 2019 and 2018, respectively. Revenue is expected to continue to increase long-term, allowing the Company to rely less on our existing cash and cash equivalents, and proceeds from financing transactions. Cash used in operations during the nine-months ended March 31, 2020 was $20.6 million compared to $10.4 million for the nine-months ended March 31, 2019. The increase is due primarily to the Company’s acquisition and integration of the Pediatric Portfolio and merger with Innovus, which consumed additional cash resources, coupled with an increase in working capital. On November 1, 2019, the Company closed an asset acquisition with Cerecor, Inc. (“Cerecor”) whereby the Company acquired certain of Cerecor’s portfolio of pediatric therapeutics (the “Pediatric Portfolio”) for $4.5 million in cash, approximately 9.8 million shares of Series G Convertible Preferred Stock, the assumption of Cerecor’s financial and royalty obligations, which includes not more than $3.5 million of Medicaid rebates and products returns as they come due, and other assumed liabilities associated with the Pediatric Portfolio (see Note 2). As of March 31, 2020, the Company has paid down approximately $3.2 million of those assumed liabilities. In addition, the Company assumed obligations in connection with the Pediatric Portfolio acquisition due to an investor including fixed and variable payments. The Company assumed fixed monthly payments equal to $0.1 million from November 2019 through January 2021 plus $15 million due in January 2021. Monthly variable payments due to the same investor are equal to 15% of net revenue generated from a subset of the Product Portfolio, subject to an aggregate monthly minimum of $0.1 million, except for January 2020, when a one-time payment of $0.2 million was paid. The variable payment obligation continues until the earlier of: (i) aggregate variable payments of approximately $9.5 million have been made, or (ii) February 12, 2026. On February 14, 2020 the Company completed a merger with Innovus after approval by the stockholders of both companies on February 13, 2020 (the “Merger”). Upon closing the Merger, the Company merged with and into Innovus and all outstanding Innovus common stock was exchanged for approximately 3.8 million shares of the Company’s common stock and up to $16 million of Contingent Value Rights (“CVRs”). The outstanding Innovus warrants with cash out rights were exchanged for approximately 2.0 million shares of Series H Convertible Preferred stock of Aytu and retired. The remaining Innovus warrants outstanding at the time of the Merger continue to be outstanding, and upon exercise, retain the right to the merger consideration offered to Innovus stockholders, including any remaining claims represented by CVRs at the time of exercise. Innovus will continue as a wholly owned subsidiary of the Company. In addition, as part of the Merger, the Company assumed approximately $3.1 million of notes payable, $0.8 million in lease liabilities, and other assumed liabilities associated with Innovus. Of the $3.1 million of notes payable, approximately $1.8 million was converted into approximately 1.5 million shares of the Company’s common stock on April 27, 2020. During the three months ended March 31, 2020, the Company completed three separate equity offerings, on March 10, 2020, March 12, 2020 and March 19, 2020 (the “March Offerings”), in which the Company issued a combination of common stock and warrants. The following summarizes the March Offerings, including total capital raised from both the issuance of common stock and subsequent warrant exercises. On March 19, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 12,539,197 shares of the Company’s common stock (the “Common Stock”) at a purchase price per share of $1.595 and (ii) warrants to purchase up to 12,539,197 shares of Common Stock (the “March 19, 2020 Warrants”) at an exercise price of $1.47 per share, for aggregate gross proceeds to the Company of $20.0 million, before deducting placement agent fees and other offering expenses payable by the Company. The March 19, 2020 Warrants are exercisable immediately upon issuance and have a term of one year from the issuance date. In addition, the Company issued warrants with an exercise price of $1.9938 per share to purchase up to 815,047 shares of common stock (the “March 19, 2020 Placement Agent Warrants”) as a portion of the fees paid to the placement agent. The March 19, 2020 Placement Agent Warrants have a term of five year from the issuance date. A total of 1.2 million March 19, 2020 Warrants have been exercised through May 5, 2020, for total proceeds of $1.7 million, of which 0.7 million March 19, 2020 Warrants were exercised through March 31, 2020, for total proceeds of $1.1 million. On March 12, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 16,000,000 shares of the Company’s common stock at a purchase price per share of $1.25 and (ii) warrants to purchase up to 16,000,000 shares of Common Stock (the “March 12, 2020 Warrants”) at an exercise price of $1.25 per share, for aggregate gross proceeds to the Company of $20.0 million, before deducting placement agent fees and other offering expenses payable by the Company (the “Registered Offering”). The March 12, 2020 Warrants are exercisable immediately upon issuance and have a term of one year from the issuance date. In addition, the Company issued warrants with an exercise price of $1.5625 per share to purchase up to 1,040,000 shares of common stock (the “March 12, 2020 Placement Agent Warrants”) as a portion of the fees paid to the placement agent. The March 12, 2020 Placement Agent Warrants have a term of five year from the issuance date. A total of 13 million March 12, 2020 Warrants have been exercised through May 5, 2020, for total proceeds of approximately $16.3 million, of which approximately 10.5 million March 12, 2020 Warrants were exercised through March 31, 2020, for total proceeds of $13.1 million. On March 10, 2020, Company entered into a securities purchase agreement with an institutional investor, pursuant to which the Company agreed to sell and issue, in a registered direct offering, an aggregate of (i) 4,450,000 shares of the Company’s common stock (the “Common Stock”) at a purchase price per share of $1.15 and (ii) pre-funded warrants to purchase up to 3,376,087 shares of Common Stock (the “Pre-Funded Warrants”) at an effective price of $1.15 per share ($1.1499 paid to the Company upon the closing of the offering and $0.0001 to be paid upon exercise of such Pre-Funded Warrants), for aggregate gross proceeds to the Company of approximately $9.0 million, before deducting placement agent fees and other offering expenses payable by the Company (the “Registered Offering”). The Pre-Funded Warrants were immediately exercised upon close. In addition, the Company issued warrants with an exercise price of $1.4375 per share to purchase up to 508,696 shares of common stock (the “March 10, 2020 Placement Agent Warrants”). The March 10, 2020 Placement Agent Warrants have a term of five year from the issuance date. Since March 10, 2020, a total of 6.0 million shares of the Company’s October 2018 $1.50 Warrants (the “October 18 $1.50 Warrants”) were exercised, resulting in proceeds of approximately $9.0 million. In total, the Company has raised net proceeds of approximately $71.5 million from the March Offerings and related warrant exercises, as well as exercises of the October 2018 $1.50 Warrants. The net proceeds received by the Company from the March Offerings and related warrant exercise will be used for general corporate purposes, including working capital. On October 11, 2019, the Company entered into Securities Purchase Agreements (the “Purchase Agreement”) with two institutional investors (the “Investors”) providing for the issuance and sale by the Company (the “October 2019 Offering”) of $10.0 million of, (i) 10,000 shares of the Company’s Series F Convertible Preferred Stock (the “Preferred Stock”) which are convertible into 10,000,000 shares of common stock (the “Conversion Shares”) for a stated value of $1,000 per unit and (ii) 10,000,000 warrants (the “October 2019 Warrants”) which are exercisable for shares of common stock (the “Warrant Shares”), which expire January 10, 2025,. The closing of the October 2019 offering occurred on October 16, 2019. The Warrants had an exercise price equal to $1.25 and contain a cashless exercise provision. This provision was dependent on (i) performance of the Company’s stock price between October 11, 2019 and the date of exercise of all, or a portion of the Warrants, and (ii) subject to shareholder approval of the October 2019 Offering, which was approved January 24, 2020. As of March 31, 2020, all of the Series F Convertible Preferred Stock were converted into 10 million shares of the Company’s common stock, and 5.0 million of the October 2019 Warrants were exercised using the cashless exercise provision to acquire 5.0 million shares of the Company’s common stock. In April of 2020, the remaining 5 million October 2019 Warrants were exercised using the cashless exercise provision into 5.0 million shares of the Company’s common stock. The net proceeds that the Company received from the October 2019 Offering were approximately $9.3 million. The net proceeds received by the Company from the October 2019 Offerings have been used for general corporate purposes, including working capital. As of the date of this Report, the Company expects its commercial costs for its current operation to increase modestly as the Company integrates the acquisition of the Pediatrics Portfolio and Innovus and continues to focus on revenue growth through increasing product sales. The Company’s total asset position totaling approximately $168.5 million plus the proceeds expected from ongoing product sales will be used to fund operations. The Company may continue to access the capital markets to fund operations when needed, and to the extent it is required. The timing and amount of capital that may be raised is dependent on market conditions and the terms and conditions upon which investors would require to provide such capital. There is no guarantee that capital will be available on terms favorable to the Company and its stockholders, or at all. However, the Company has been successful in accessing the capital markets in the past and is confident in its ability to access the capital markets again, if needed. Since the Company has sufficient cash and cash equivalents on-hand as of March 31, 2020 to cover potential net cash outflows for the twelve months following the filing date of this Quarterly Report, ASU 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40) the Company reports that there does not exist indication of substantial doubt about its ability to continue as a going concern. As of the date of this report, while the Company has adequate capital resources to complete its near-term operating and transaction objectives, there is no guarantee that such capital resources will be sufficient until such time the Company reaches profitability. However, the Company has been successful in accessing the capital markets in the past, and the Company is confident in its ability to access the capital markets again, if needed. If the Company is unable to raise adequate capital in the future when it is required, the Company can adjust its operating plans to reduce the magnitude of the capital need under its existing operating plan. Some of the adjustments that could be made include delays of and reductions to commercial programs, reductions in headcount, narrowing the scope of the Company’s commercial plans, or reductions to its research and development programs. Without sufficient operating capital, the Company could be required to relinquish rights to products or renegotiate to maintain such rights on less favorable terms than it would otherwise choose. This may lead to impairment or other charges, which could materially affect the Company’s balance sheet and operating results. |
Nasdaq Listing Compliance | Nasdaq Listing Compliance. , On March 24, 2020, the Company received a letter from the Nasdaq notifying the Company that the Nasdaq has determined that the Company’s stock price has traded above at least $1.00 for at least 10 consecutive business days since the previously announced February 19, 2020 notice, and therefore, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), commonly referred to as the Bid Price Rule. |
Basis of Presentation | Basis of Presentation. |
Accounting Pronouncements | Adoption of New Accounting Pronouncements Leases (“ASU 2016-02”). Topic 842 Leases. The Company has elected to apply the short-term scope exception for leases with terms of 12 months or less at the inception of the lease and will continue to recognize rent expense on a straight-line basis. As a result of the adoption, on July 1, 2019, the Company recognized a lease liability of approximately $0.4 million, which represented the present value of the remaining minimum lease payments using an estimated incremental borrowing rate of 8%. As of July 1, 2019, the Company recognized a right-to-use asset of approximately $0.4 million. Lease expense did not change materially as a result of the adoption of ASU 2016-02. In addition, in conjunction with the Innovus Merger, the Company recognized a lease liability of approximately $0.8 million relating to Innovus’ corporate offices and related warehouse as part of the purchase price allocation (see Note 2). Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) (“ASU 2017-11”) . Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) Recently Accounting Pronouncements Fair Value Measurements (“ASU 2018-03”). The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. Early adoption is permitted upon issuance of ASU 2018-13. An entity is permitted to early adopt any removed or modified disclosures upon issuance of ASU 2018-13 and delay adoption of the additional disclosures until their effective date. The Company is currently assessing the impact that ASU 2018-13 will have on its financial statements Financial Instruments – Credit Losses (“ASU 2016-13”). This Quarterly Report on Form 10-Q does not discuss recent pronouncements that are not anticipated to have an impact on or are unrelated to its financial condition, results of operations, cash flows or disclosures. |
Acquisitions (Tables)
Acquisitions (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Business Combinations [Abstract] | |
Summary of assets acquired and liabilities assumed | The Pediatric Portfolio As of November 1, 2019 Consideration Cash and cash equivalents $ 4,500,000 Fair value of Series G Convertible Preferred Stock Total shares issued 9,805,845 Estimated fair value per share of Aytu common stock $ 0.567 Estimated fair value of equity consideration transferred $ 5,559,914 Total consideration transferred $ 10,059,914 Recognized amounts of identifiable assets acquired and liabilities assumed Inventory, net $ 459,123 Prepaid assets 1,743,555 Other current assets 2,548,187 Intangible assets – product technology rights 22,700,000 Accrued product program liabilities (6,320,853 ) Assumed fixed payment obligations (26,457,162 ) Total identifiable net assets $ (5,327,150 ) Goodwill $ 15,387,064 Innovus Merger (Consumer Health Portfolio) As of February 14, 2020 Consideration Fair value of Aytu Common Stock Total shares issued at close 3,810,393 Estimated fair value per share of Aytu common stock $ 0.756 Estimated fair value of equity consideration transferred $ 2,880,581 Fair value of Series H Convertible Preferred Stock Total shares issued 1,997,736 Estimated fair value per share of Aytu common stock $ 0.756 Estimated fair value of equity consideration transferred $ 1,510,288 Fair value of former Innovus warrants $ 15,315 Fair value of Contingent Value Rights $ 7,049,079 Forgiveness of Note Payable owed to the Company $ 1,350,000 Total consideration transferred $ 12,805,263 Recognized amounts of identifiable assets acquired and liabilities assumed Cash and cash equivalents 390,916 Accounts receivables, net $ 278,826 Inventory, net 1,149,625 Prepaid expenses and other current assets 1,736,796 Other long-term assets 36,781 Right-to-use assets 328,410 Property, plant and equipment 190,393 Trademarks and patents 11,744,000 Accounts payable and accrued other expenses (6,983,969 ) Other current liabilities (446,995 ) Notes payable (3,056,361 ) Lease liability (754,822 ) Preacquisition contingent consideration (182,606 ) Total identifiable net assets 4,430,994 Goodwill $ 8,374,269 |
Summary of intangible assets acquired | The Pediatric Portfolio As of November 1, 2019 Acquired product technology rights $ 22,700,000 Innovus Merger (Consumer Health Portfolio) As of February 14, 2020 Acquired product distribution rights $ 11,354,000 Acquired customer lists 390,000 Total intangible assets $ 11,744,000 |
Pro forma information | Three Months Ended March 31, Nine Months Ended March 31, 2020 2019 2020 2019 Unaudited (aa) (bb) Pro forma Unaudited Pro forma Unaudited (cc) Pro forma Unaudited Total revenues, net $ 10,331,629 $ 10,575,866 $ 34,276,368 $ 36,916,501 Net income (loss) (5,850,703 ) (8,740,850 ) (18,197,902 ) (17,205,490 ) Net income / (loss) per share (dd) $ (0.17 ) $ (0.39 ) $ (0.80 ) $ (0.76 ) (aa) For the three months ended March 31, 2020, Pediatric Portfolio acquisition occurred prior to the three months ended March 31, 2020, and accordingly, the results of the Pediatric Portfolio are fully consolidated into the Company’s results for the three months ended March 31, 2020. (bb) Due to the absence of discrete financial information for Innovus, covering the period from February 1, 2020 through February 13, 2020, the Company did not include the impact of that stub-period for the pro forma results for the three and nine months ended March 31, 2020. (cc) Due to a lack of financial information covering the period from October 1, 2019 through November 1, 2019, the Company was not able to provide pro forma adjusted financial statements for the nine months ended March 31, 2020 without making estimated extrapolations that the Company did not believe would be material or useful to users of the above pro forma information. (dd) Pro forma net loss per share calculations excluded the impact of the issuance of the (i) Series G Convertible Preferred Stock and the, (ii) Series H Convertible Preferred Stock under the assumption those shares would continue to remain non-participatory during the periods reported above. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of product revenues by geographic location | Three Months Ended March 31, Nine Months Ended March 31, 2020 2019 2020 2019 U.S. $ 7,273,000 $ 2,024,000 $ 11,582,000 $ 5,025,000 International 883,000 348,000 1,189,000 574,000 Total net revenue $ 8,156,000 $ 2,372,000 $ 12,771,000 $ 5,599,000 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory balances | As of As of March 31, June 30, 2020 2019 Raw materials $ 363,000 $ 117,000 Finished goods 3,491,000 1,323,000 $ 3,854,000 $ 1,440,000 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Schedule of fixed assets and depreciation expense | Estimated As of As of Useful March 31, June 30, Lives in years 2020 2019 Manufacturing equipment 2 - 5 $ 389,000 $ 83,000 Leasehold improvements 3 297,000 112,000 Office equipment, furniture and other 2 - 5 392,000 315,000 Lab equipment 3 - 5 90,000 90,000 Software 3 - 5 339,000 - Less accumulated depreciation and amortization (1,219,000 ) (396,000 ) Fixed assets, net $ 288,000 $ 204,000 |
Leases, Right-to-Use Assets a_2
Leases, Right-to-Use Assets and Related Liabilities (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Leases Righttouse Assets And Related Liabilities Tables Abstract | |
Summary of lease liability | Total 2020 2021 2022 2023 2024 Thereafter Remaining Office leases $ 1,268,000 $ 93,000 $ 383,000 $ 396,000 $ 356,000 $ 40,000 − Less: Discount Adjustment (175,000 ) Total lease liability 1,093,000 Lease liability - current portion 289,000 Long-term lease liability $ 804,000 |
Patents (Tables)
Patents (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of patents and tradenames | As of As of March 31, June 30, 2020 2019 Patents - MiOXSYS $ 380,000 $ 380,000 Less accumulated amortization (178,000 ) (159,000 ) Patents, net $ 202,000 $ 221,000 As of As of March 31, June 30, 2020 2019 Patents & tradenames $ 11,354,000 $ - Customers contracts 390,000 - Less accumulated amortization (221,000 ) - Patents & tradenames, net $ 11,523,000 $ - |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Accrued Liabilities Abstract | |
Schedule of accrued liabilities | As of As of March 31 June 30, 2020 2019 Accrued legal settlement $ 205,000 $ − Accrued program liabilities 1,299,000 736,000 Accrued product-related fees 1,644,000 295,000 Credit card liabilities 941,000 − Contract liability 180,000 4,000 Medicaid liabilities 3,255,000 61,000 Return reserve 1,671,000 98,000 Sales taxes payable 172,000 − Other accrued liabilities* 463,000 117,000 Total accrued liabilities $ 9,830,000 $ 1,311,000 * Other accrued liabilities consist of franchise tax, accounting fee, interest payable, merchant services charges, none of which individually represent greater than five percent of total current liabilities. |
Fair Value Considerations (Tabl
Fair Value Considerations (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value on a recurring basis | Fair Value Measurements at March 31, 2020 Fair Value at March 31, 2020 Quoted Priced in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Recurring: Warrant derivative liability $ 11,000 – – $ 11,000 Contingent consideration 18,754,000 – – 18,754,000 CVR liability 5,219,000 – – 5,219,000 $ 23,984,000 – – $ 23,984,000 Fair Value Measurements at June 30, 2019 Fair Value at June 30, 2019 Quoted Priced in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Recurring: Warrant derivative liability $ 13,000 – – $ 13,000 Contingent consideration 23,326,000 – – 23,326,000 CVR liability – – – – $ 23,339,000 – – $ 23,339,000 |
Schedule of significant assumptions in valuing the warrant derivative liability | As of March 31, 2020 As of June 30, 2019 Warrant Derivative Liability Volatility 163.2 % 163.2 % Equivalent term (years) 2.88 3.13 Risk-free interest rate 1.71 % 1.71 % Dividend yield 0.00 % 0.00 % |
Schedule of fair value on a nonrecurring basis | Fair Value at Measurement Date Quoted Priced in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Non-recurring Pediatric Portfolio (November 1, 2019) Product technology rights $ 22,700,000 – – 22,700,000 Goodwill 15,687,064 – – 15,687,064 Fixed payment arrangements 26,457,162 – – 26,457,162 Innovus Merger (February 14, 2020) Customer lists 390,000 – – 390,000 Product distribution rights (trademarks and patents) 11,354,000 – – 11,354,000 Right-to-use asset 675,980 675,980 Goodwill 8,374,269 – – 8,374,269 Notes payable 3,056,361 – – 3,056,361 $ 88,694,836 – – $ 88,694,836 |
Schedule of significant assumptions in valuing intangible assets | Acquisition of the Pediatric Portfolio As of November 1, 2019 (*) Product technology rights Re-levered Beta 1.60 Market risk premium 6.00 % Small stock risk premium 5.20 % Risk-free interest rate 2.00 % Company specific discount 25.00 % (*) Valuation performed as of November 1, 2019. As a non-recurring fair value measurement, there is no remeasurement at each reporting period unless indications exist that the fair value of the asset has been impaired. There were no indicators as of March 31, 2020 that the fair value of the Product technology rights was impaired. Innovus Merger As of November 1, 2019 Trademarks and patents Re-levered Beta 0.84 % Market risk premium 6.17 % Small stock risk premium 4.99 % Risk-free interest rate 1.89 % Company specific discount 20.00 % |
Schedule of fixed payment obligations discount rate | As of November 1, 2019 (≠) Fixed payment obligations Discount rate 1.8% to 12.4% (≠) Valuation performed as of November 1, 2019. As a non-recurring fair value measurement, there is no remeasurement at each reporting period unless indicates that the circumstances that existed as of the November 1, 2019 measurement date indicate that the carrying value is no longer indicative of fair value. |
Schedule of changes in Level 3 inputs | Product Technology Rights Innovus Assets Goodwill Liability Classified Warrants CVR Liability Contingent Consideration Fixed Payment Arrangements Balance as of June 30, 2019 – – – $ 13,000 – $ 23,326,000 – Transfers into Level 3 – – – – – – – Transfer out of Level 3 – – – – – – – Total gains, losses, amortization or accretion in period (946,000 ) (221,000 ) – – – – – Included in earnings – – – (2,000 ) 170,000 (4,576,000 ) 647,000 Included in other comprehensive income – – – – – Purchases, issues, sales and settlements – Purchases 22,700,000 11,744,000 24,061,000 – 7,049,000 183,000 – Issues – – – – – – 26,457,000 Sales – – – – – – – Settlements – – – – (2,000,000 ) (179,000 ) (1,547,000 ) Balance as of March 31, 2020 $ 21,754,000 $ 11,523,000 $ 24,061,000 $ 11,000 $ 5,219,000 $ 18,754,000 $ 25,557,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of commitments and contingencies | Total 2020 2021 2022 2023 2024 Thereafter Prescription database $ 1,762,000 $ 262,000 $ 767,000 $ 733,000 $ – $ – $ – Pediatric portfolio fixed payments and product minimums 28,715,000 998,000 18,471,000 2,950,000 2,950,000 1,346,000 2,000,000 CVR liability 5,219,000 787,000 1,210,000 2,327,000 895,000 – – Inventory purchase commitments 2,943,000 1,266,250 1,716,750 – – – – Product contingent liability 183,000 – – – – – 183,000 Product milestone payments 3,000,000 – – 3,000,000 – – – $ 41,822,000 $ 3,273,250 $ 22,164,750 $ 9,010,000 $ 3,845,000 $ 1,346,000 $ 2,183,000 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of assumptions for options granted | As of March 31, 2020 Volatility 100.0 % Equivalent term (years) 10.00 Risk-free interest rate 1.82 % Dividend yield 0.00 % |
Schedule of stock option activity | Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding June 30, 2019 $ 1,607 $ 325.73 6.13 Granted 339,500 0.98 10.00 Exercised (2,500 ) 0.97 – Expired (170 ) 328.00 – Outstanding March 31, 2020 338,437 2.36 9.62 Exercisable at March 31, 2020 11,437 41.74 9.30 |
Schedule of restricted stock activity | Number of Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Contractual Life in Years Unvested at June 30, 2019 2,346,214 $ 1.83 9.1 Granted 1,067,912 0.73 1.7 Vested – – – Forfeited (69,900 ) 2.03 – Unvested at March 31, 2020 3,344,226 $ 1.47 7.2 |
Schedule of stock-based compensation expense | Three Months Ended March 31, Nine Months Ended March 31, Selling, general and administrative: 2020 2019 2020 2019 Stock options $ 7,000 $ 15,000 $ 14,000 $ 122,000 Restricted stock 257,000 362,000 577,000 601,000 Total stock-based compensation expense $ 264,000 $ 377,000 $ 591,000 $ 723,000 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Warrants Tables Abstract | |
Summary of significant assumptions in valuing the warrants issued | Warrants Issued Three Months Ended March 31, 2020 Expected volatility 100 % Equivalent term (years) 1 - 5 Risk-free rate 0.20% - 0.66 % Dividend yield 0.00 % |
Summary of all warrants | A summary of equity-based warrants is as follows: Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding June 30, 2019 16,218,908 $ 3.15 4.36 Warrants issued 44,627,120 1.21 1.88 Warrants expired – – – Warrants exercised (*) (29,859,990 ) – – Outstanding March 31, 2020 30,986,038 $ 2.39 2.31 (*) During the quarter ended March 31, 2020, investor exercised 5.0 million of the October 2019 private placement warrants under the cashless exercise provision. In April 2020, another investor exercised all remaining 5.0 million October 2019 private placement warrants. There are no more October 2019 private placement warrants outstanding as of April 30, 2020. A summary of liability warrants is as follows: Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Outstanding June 30, 2019 240,755 $ 72.00 3.16 Warrants expired – – – Warrants exercised – – – Outstanding March 31, 2020 240,755 $ 72.00 2.37 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Securities excluded from the calculation of diluted earnings per share | Nine Months Ended March 31 2020 2019 Warrants to purchase common stock - liability classified (Note 15) 240,755 240,755 Warrant to purchase common stock - equity classified (Note 15) 30,986,038 11,893,175 Employee stock options (Note 14) 338,437 1,666 Employee unvested restricted stock (Note 14) 3,344,226 2,719,312 Performance-based options (*) (Note 14) – 75,000 Convertible preferred stock (Note 13) 9,805,845 2,335,665 44,715,301 17,265,573 (*) During the year ended June 30, 2019, the Company issued 75,000 performance-based stock options out of the 2015 Plan to a consultant. These options vest based on meeting certain market criteria with an exercise price of $1.00. At June 30, 2019, the first of three market targets were not achieved, and all 75,000 performance stock options were forfeited. |
Segment Reporting (Tables)
Segment Reporting (Tables) | 9 Months Ended |
Mar. 31, 2020 | |
Segment Reporting [Abstract] | |
Schedule of segment financial information | Three months Ended March 31, Nine months Ended March 31, 2020 2019 2020 2019 Consolidated revenue: Aytu BioScience $ 4,703,000 $ 2,378,000 $ 9,318,000 $ 5,605,000 Aytu Consumer Health 3,453,000 3,453,000 Consolidated revenue 8,156,000 2,378,000 12,771,000 5,605,000 Consolidated net loss: Aytu BioScience (4,421,000 ) (4,496,000 ) (9,565,000 ) (12,600,000 ) Aytu Consumer Health (911,000 ) (911,000 ) Consolidated net loss (5,332,000 ) (4,496,000 ) (10,476,000 ) (12,600,000 ) March 31, 2020 June 30, 2019 Total assets: Aytu BioScience $ 137,825,000 $ 34,721,000 Aytu Consumer Health 21,129,000 - Total assets $ 158,954,000 $ 34,721,000 |
Acquisitions (Details)
Acquisitions (Details) - USD ($) | 9 Months Ended | |
Mar. 31, 2020 | Jun. 30, 2019 | |
Recognized amounts of identifiable assets acquired and liabilities assumed | ||
Goodwill | $ 24,061,333 | $ 0 |
Cerecor, Inc. | ||
Consideration | ||
Cash and cash equivalents | 4,500,000 | |
Total consideration transferred | 10,059,914 | |
Recognized amounts of identifiable assets acquired and liabilities assumed | ||
Inventory, net | 459,123 | |
Prepaid expenses and other current assets | 1,743,555 | |
Other current assets | 2,548,187 | |
Intangible assets | 22,700,000 | |
Accrued product program liabilities | (6,320,853) | |
Assumed fixed payment obligations | (26,457,162) | |
Total identifiable net assets | (5,327,150) | |
Goodwill | $ 15,387,064 | |
Cerecor, Inc. | Series G Convertible Preferred Stock | ||
Consideration | ||
Shares issued | 9,805,845 | |
Estimated fair value per share of Aytu common stock | $ 0.567 | |
Estimated fair value of equity consideration transferred | $ 5,559,914 | |
Innovus Pharmaceuticals | ||
Consideration | ||
Fair value of former Innovus warrants | 15,315 | |
Fair value of contingent value rights | 7,049,079 | |
Forgiveness of note payable owed to the Company | 1,350,000 | |
Total consideration transferred | 12,805,263 | |
Recognized amounts of identifiable assets acquired and liabilities assumed | ||
Cash and cash equivalents | 390,916 | |
Accounts receivables, net | 278,826 | |
Inventory, net | 1,149,625 | |
Prepaid expenses and other current assets | 1,736,796 | |
Other long-term assets | 36,781 | |
Right-to-use assets | 328,410 | |
Property, plant and equipment | 190,393 | |
Intangible assets | 11,744,000 | |
Accounts payable and accrued other expenses | (6,983,969) | |
Other current liabilities | (446,995) | |
Notes payable | (3,056,361) | |
Lease liability | (754,822) | |
Preacquisition contingent consideration | (182,606) | |
Total identifiable net assets | 4,430,994 | |
Goodwill | $ 8,374,269 | |
Innovus Pharmaceuticals | Aytu Common Stock | ||
Consideration | ||
Shares issued | 3,810,393 | |
Estimated fair value per share of Aytu common stock | $ 0.756 | |
Estimated fair value of equity consideration transferred | $ 2,880,581 | |
Innovus Pharmaceuticals | Series H Convertible Preferred Stock | ||
Consideration | ||
Shares issued | 1,997,736 | |
Estimated fair value per share of Aytu common stock | $ 0.756 | |
Estimated fair value of equity consideration transferred | $ 1,510,288 |
Acquisitions (Details 1)
Acquisitions (Details 1) | Mar. 31, 2020USD ($) |
Cerecor, Inc. | Product Technology Rights | |
Acquired intangible assets | $ 22,700,000 |
Innovus Pharmaceuticals | |
Acquired intangible assets | 11,744,000 |
Innovus Pharmaceuticals | Product Distribution Rights | |
Acquired intangible assets | 11,354,000 |
Innovus Pharmaceuticals | Customer Lists | |
Acquired intangible assets | $ 390,000 |
Acquisitions (Details 2)
Acquisitions (Details 2) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Mar. 31, 2020 | [1],[2] | Mar. 31, 2019 | Mar. 31, 2020 | [3] | Mar. 31, 2019 | ||
Business Combinations [Abstract] | |||||||
Total revenues, net | $ 10,331,629 | $ 10,575,866 | $ 34,276,368 | $ 36,916,501 | |||
Net income (loss) | $ (5,850,703) | $ (8,740,850) | $ (18,197,902) | $ (17,205,490) | |||
Net income (loss) per share | [4] | $ (0.17) | $ (0.39) | $ (0.80) | $ (0.76) | ||
[1] | Due to the absence of discrete financial information for Innovus, covering the period from February 1, 2020 through February 13, 2020, the Company did not include the impact of that stub-period for the pro forma results for the three and nine months ended March 31, 2020. | ||||||
[2] | For the three months ended March 31, 2020, Pediatric Portfolio acquisition occurred prior to the three months ended March 31, 2020, and accordingly, the results of the Pediatric Portfolio are fully consolidated into the Company's results for the three months ended March 31, 2020. | ||||||
[3] | Due to a lack of financial information covering the period from October 1, 2019 through November 1, 2019, the Company was not able to provide pro forma adjusted financial statements for the nine months ended March 31, 2020 without making estimated extrapolations that the Company did not believe would be material or useful to users of the above pro forma information. | ||||||
[4] | Pro forma net loss per share calculations excluded the impact of the issuance of the (i) Series G Convertible Preferred Stock and the, (ii) Series H Convertible Preferred Stock under the assumption those shares would continue to remain non-participatory during the periods reported above. |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Total net revenue | $ 8,156,000 | $ 2,372,000 | $ 12,771,000 | $ 5,599,000 |
U.S. | ||||
Total net revenue | 7,273,000 | 2,024,000 | 11,582,000 | 5,025,000 |
International | ||||
Total net revenue | $ 883,000 | $ 348,000 | $ 1,189,000 | $ 574,000 |
Product Licenses and Acquisit_2
Product Licenses and Acquisitions (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Natesto | ||||
Amortization expense | $ 300,000 | $ 300,000 | $ 1,000,000 | $ 1,000,000 |
ZolpiMist | ||||
Amortization expense | 116,000 | 116,000 | 348,000 | 348,000 |
Contingent consideration accretion expense | 59,000 | 64,000 | 169,000 | 184,000 |
Tuzistra XR | ||||
Amortization expense | 123,000 | 123,000 | 369,000 | 205,000 |
Contingent consideration accretion expense | $ 125,000 | $ 73,000 | $ 322,000 | $ 119,000 |
Inventories (Details)
Inventories (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 363,000 | $ 117,000 |
Finished goods | 3,491,000 | 1,323,000 |
Inventory, net | $ 3,854,685 | $ 1,440,069 |
Inventories (Details Narrative)
Inventories (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | ||||
Inventory write-down | $ 0 | $ 0 | $ 0 | $ 0 |
Fixed Assets (Details)
Fixed Assets (Details) - USD ($) | 9 Months Ended | |
Mar. 31, 2020 | Jun. 30, 2019 | |
Less accumulated depreciation and amortization | $ (1,219,000) | $ (396,000) |
Fixed assets, net | 288,415 | 203,733 |
Manufacturing Equipment | ||
Fixed assets, gross | $ 389,000 | 83,000 |
Manufacturing Equipment | Minimum | ||
Estimated useful lives in years | 2 years | |
Manufacturing Equipment | Maximum | ||
Estimated useful lives in years | 5 years | |
Leasehold Improvements | ||
Estimated useful lives in years | 3 years | |
Fixed assets, gross | $ 297,000 | 112,000 |
Office Equipment, Furniture and Other | ||
Fixed assets, gross | $ 392,000 | 315,000 |
Office Equipment, Furniture and Other | Minimum | ||
Estimated useful lives in years | 2 years | |
Office Equipment, Furniture and Other | Maximum | ||
Estimated useful lives in years | 5 years | |
Lab Equipment | ||
Fixed assets, gross | $ 90,000 | 90,000 |
Lab Equipment | Minimum | ||
Estimated useful lives in years | 3 years | |
Lab Equipment | Maximum | ||
Estimated useful lives in years | 5 years | |
Software | ||
Fixed assets, gross | $ 339,000 | $ 0 |
Software | Minimum | ||
Estimated useful lives in years | 3 years | |
Software | Maximum | ||
Estimated useful lives in years | 5 years |
Fixed Assets (Details Narrative
Fixed Assets (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization expense | $ 24,000 | $ 24,000 | $ 56,000 | $ 59,000 |
Leases, Right-to-Use Assets a_3
Leases, Right-to-Use Assets and Related Liabilities (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Leases Righttouse Assets And Related Liabilities Details Abstract | ||
2020 | $ 93,000 | |
2021 | 383,000 | |
2022 | 396,000 | |
2023 | 356,000 | |
2024 | 40,000 | |
Thereafter | 0 | |
Total | 1,268,000 | |
Less:discount adjustment | (175,000) | |
Total lease liability | 1,093,000 | |
Lease liability current portion | 289,238 | $ 0 |
Long-term lease liability | $ 804,393 | $ 0 |
Leases, Right-to-use Assets a_4
Leases, Right-to-use Assets and Related Liabiliities (Details 1) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Leases Right-to-use Assets And Related Liabiliities | ||||
Rent expense | $ 61,000 | $ 31,000 | $ 126,000 | $ 94,000 |
Patents (Details)
Patents (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Intangible assets, net | $ 11,724,626 | $ 220,611 |
Patents - MiOXSYS | ||
Intangible assets, gross | 380,000 | 380,000 |
Less accumulated amortization | (178,000) | (159,000) |
Intangible assets, net | 202,000 | 221,000 |
Patents & Trademarks | ||
Intangible assets, gross | 11,354,000 | 0 |
Customers Contracts | ||
Intangible assets, gross | 390,000 | 0 |
Total Patents & Tradenames | ||
Less accumulated amortization | (221,000) | 0 |
Intangible assets, net | $ 11,523,000 | $ 0 |
Patents (Details Narrative)
Patents (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||
Patent amortization expense | $ 6,000 | $ 6,000 | $ 19,000 | $ 19,000 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 | |
Accrued Liabilities Abstract | |||
Accrued legal settlement | $ 205,000 | $ 0 | |
Accrued program liabilities | 1,299,000 | 736,000 | |
Accrued product-related fees | 1,644,000 | 295,000 | |
Credit card liabilities | 941,000 | 0 | |
Contract liability | 180,000 | 4,000 | |
Medicaid liabilities | 3,255,000 | 61,000 | |
Return reserve | 1,671,000 | 98,000 | |
Sales taxes payable | 172,000 | 0 | |
Other accrued liabilities | [1] | 463,000 | 117,000 |
Total accrued liabilities | $ 9,830,373 | $ 1,311,488 | |
[1] | Other accrued liabilities consist of franchise tax, accounting fee, interest payable, merchant services charges, none of which individually represent greater than five percent of total current liabilities. |
Fair Value Considerations (Deta
Fair Value Considerations (Details) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Warrant derivative liability | $ 11,371 | $ 13,201 |
Fair Value, Measurements, Recurring | ||
Warrant derivative liability | 11,000 | 13,000 |
Contingent consideration | 18,754,000 | 23,326,000 |
CVR liability | 5,219,000 | 0 |
Total | 23,984,000 | 23,339,000 |
Level 1 | Fair Value, Measurements, Recurring | ||
Warrant derivative liability | 0 | 0 |
Contingent consideration | 0 | 0 |
CVR liability | 0 | 0 |
Total | 0 | 0 |
Level 2 | Fair Value, Measurements, Recurring | ||
Warrant derivative liability | 0 | 0 |
Contingent consideration | 0 | 0 |
CVR liability | 0 | 0 |
Total | 0 | 0 |
Level 3 | Fair Value, Measurements, Recurring | ||
Warrant derivative liability | 11,000 | 13,000 |
Contingent consideration | 18,754,000 | 23,326,000 |
CVR liability | 5,219,000 | 0 |
Total | $ 23,984,000 | $ 23,339,000 |
Fair Value Considerations (De_2
Fair Value Considerations (Details 1) - Warrant Derivative Liability | 9 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Jun. 30, 2019 | |
Volatility | 163.20% | 163.20% |
Equivalent term (years) | 2 years 10 months 17 days | 3 years 1 month 17 days |
Risk-free interest rate | 1.71% | 1.71% |
Dividend yield | 0.00% | 0.00% |
Fair Value Considerations (De_3
Fair Value Considerations (Details 2) - USD ($) | Mar. 31, 2020 | Jun. 30, 2019 |
Right-to-use asset | $ 675,980 | $ 0 |
Fair Value, Measurements, Nonrecurring | ||
Total | 88,694,836 | |
Level 1 | Fair Value, Measurements, Nonrecurring | ||
Total | 0 | |
Level 2 | Fair Value, Measurements, Nonrecurring | ||
Total | 0 | |
Level 3 | Fair Value, Measurements, Nonrecurring | ||
Total | 88,694,836 | |
Cerecor, Inc. | Fair Value, Measurements, Nonrecurring | ||
Product technology rights | 22,700,000 | |
Goodwill | 15,687,064 | |
Fixed payment arrangements | 26,457,162 | |
Cerecor, Inc. | Level 1 | Fair Value, Measurements, Nonrecurring | ||
Product technology rights | 0 | |
Goodwill | 0 | |
Fixed payment arrangements | 0 | |
Cerecor, Inc. | Level 2 | Fair Value, Measurements, Nonrecurring | ||
Product technology rights | 0 | |
Goodwill | 0 | |
Fixed payment arrangements | 0 | |
Cerecor, Inc. | Level 3 | Fair Value, Measurements, Nonrecurring | ||
Product technology rights | 22,700,000 | |
Goodwill | 15,687,064 | |
Fixed payment arrangements | 26,457,162 | |
Innovus Pharmaceuticals | Fair Value, Measurements, Nonrecurring | ||
Customer lists | 390,000 | |
Product distribution rights (trademarks and patents) | 11,354,000 | |
Right-to-use asset | 675,980 | |
Goodwill | 8,374,269 | |
Notes payable | 3,056,361 | |
Innovus Pharmaceuticals | Level 1 | Fair Value, Measurements, Nonrecurring | ||
Customer lists | 0 | |
Product distribution rights (trademarks and patents) | 0 | |
Right-to-use asset | 0 | |
Goodwill | 0 | |
Notes payable | 0 | |
Innovus Pharmaceuticals | Level 2 | Fair Value, Measurements, Nonrecurring | ||
Customer lists | 0 | |
Product distribution rights (trademarks and patents) | 0 | |
Right-to-use asset | 0 | |
Goodwill | 0 | |
Notes payable | 0 | |
Innovus Pharmaceuticals | Level 3 | Fair Value, Measurements, Nonrecurring | ||
Customer lists | 390,000 | |
Product distribution rights (trademarks and patents) | 11,354,000 | |
Right-to-use asset | 675,980 | |
Goodwill | 8,374,269 | |
Notes payable | $ 3,056,361 |
Fair Value Considerations (De_4
Fair Value Considerations (Details 3) | Feb. 14, 2020 | Nov. 01, 2019Beta | |
Cerecor, Inc. | Product Technology Rights | |||
Re-levered Beta | [1] | 1.60 | |
Market risk premium | [1] | 6.00% | |
Small stock risk premium | [1] | 5.20% | |
Risk-free interest rate | [1] | 2.00% | |
Company specific discount | [1] | 25.00% | |
Innovus Pharmaceuticals | Patents & Trademarks | |||
Re-levered Beta | 0.0084 | ||
Market risk premium | 6.17% | ||
Small stock risk premium | 4.99% | ||
Risk-free interest rate | 1.89% | ||
Company specific discount | 20.00% | ||
[1] | Valuation performed as of November 1, 2019. As a non-recurring fair value measurement, there is no remeasurement at each reporting period unless indications exist that the fair value of the asset has been impaired. There were no indicators as of March 31, 2020 that the fair value of the Product technology rights was impaired. |
Fair Value Considerations (De_5
Fair Value Considerations (Details 4) - Cerecor, Inc. | Nov. 01, 2019 | [1] |
Minimum | ||
Fixed payment obligations discount rate | 1.80% | |
Maximum | ||
Fixed payment obligations discount rate | 12.40% | |
[1] | Valuation performed as of November 1, 2019. As a non-recurring fair value measurement, there is no remeasurement at each reporting period unless indicates that the circumstances that existed as of the November 1, 2019 measurement date indicate that the carrying value is no longer indicative of fair value. |
Fair Value Considerations (De_6
Fair Value Considerations (Details 5) | 9 Months Ended |
Mar. 31, 2020USD ($) | |
Liability Classified Warrants | |
Beginning balance | $ 13,000 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | 0 |
Total gains, losses, amortization or accretion in period included in earnings | (2,000) |
Total gains, losses, amortization or accretion in period included in other comprehensive income | 0 |
Purchases | 0 |
Issues | 0 |
Sales | 0 |
Settlements | 0 |
Ending balance | 11,000 |
CVR Liability | |
Beginning balance | 0 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | 0 |
Total gains, losses, amortization or accretion in period included in earnings | 170,000 |
Purchases | 7,049,000 |
Issues | 0 |
Sales | 0 |
Settlements | (2,000,000) |
Ending balance | 5,219,000 |
Contingent Consideration | |
Beginning balance | 23,326,000 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | 0 |
Total gains, losses, amortization or accretion in period included in earnings | (4,576,000) |
Total gains, losses, amortization or accretion in period included in other comprehensive income | 0 |
Purchases | 183,000 |
Issues | 0 |
Sales | 0 |
Settlements | (179,000) |
Ending balance | 18,754,000 |
Fixed Payment Arrangements | |
Beginning balance | 0 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | 0 |
Total gains, losses, amortization or accretion in period included in earnings | 647,000 |
Purchases | 0 |
Issues | 26,457,000 |
Sales | 0 |
Settlements | (1,547,000) |
Ending balance | 25,557,000 |
Product Technology Rights | |
Beginning balance | 0 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | (946,000) |
Total gains, losses, amortization or accretion in period included in earnings | 0 |
Total gains, losses, amortization or accretion in period included in other comprehensive income | 0 |
Purchases | 22,700,000 |
Issues | 0 |
Sales | 0 |
Settlements | 0 |
Ending balance | 21,754,000 |
Innovus Assets | |
Beginning balance | 0 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | (221,000) |
Total gains, losses, amortization or accretion in period included in earnings | 0 |
Total gains, losses, amortization or accretion in period included in other comprehensive income | 0 |
Purchases | 11,744,000 |
Issues | 0 |
Sales | 0 |
Settlements | 0 |
Ending balance | 11,523,000 |
Goodwill | |
Beginning balance | 0 |
Transfers into Level 3 | 0 |
Transfer out of Level 3 | 0 |
Total gains, losses, amortization or accretion in period | 0 |
Total gains, losses, amortization or accretion in period included in earnings | 0 |
Total gains, losses, amortization or accretion in period included in other comprehensive income | 0 |
Purchases | 24,061,000 |
Issues | 0 |
Sales | 0 |
Settlements | 0 |
Ending balance | $ 24,061,000 |
Commitments and Contingencies_2
Commitments and Contingencies (Details) | Mar. 31, 2020USD ($) |
2020 | $ 3,273,250 |
2021 | 22,164,750 |
2022 | 9,010,000 |
2023 | 3,845,000 |
2024 | 1,346,000 |
Thereafter | 2,183,000 |
Total | 41,822,000 |
Prescription Database | |
2020 | 262,000 |
2021 | 767,000 |
2022 | 733,000 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | 1,762,000 |
Pediatric Portfolio Fixed Payments and Product Minimums | |
2020 | 998,000 |
2021 | 18,471,000 |
2022 | 2,950,000 |
2023 | 2,950,000 |
2024 | 1,346,000 |
Thereafter | 2,000,000 |
Total | 28,715,000 |
CVR Liability | |
2020 | 787,000 |
2021 | 1,210,000 |
2022 | 2,327,000 |
2023 | 895,000 |
2024 | 0 |
Thereafter | 0 |
Total | 5,219,000 |
Inventory Purchase Commitment | |
2020 | 1,226,250 |
2021 | 1,716,750 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | 2,943,000 |
Product Contingent Liability | |
2020 | 0 |
2021 | 0 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Thereafter | 183,000 |
Total | 183,000 |
Product Milestone Payments | |
2020 | 0 |
2021 | 0 |
2022 | 3,000,000 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | $ 3,000,000 |
Capital Structure (Details Narr
Capital Structure (Details Narrative) - $ / shares | Mar. 31, 2020 | Jun. 30, 2019 |
Equity [Abstract] | ||
Preferred stock, par value | $ .0001 | $ .0001 |
Preferred stock, shares authorized | 50,000,000 | 50,000,000 |
Preferred stock, shares issued | 9,805,845 | 3,594,981 |
Preferred stock, shares outstanding | 9,805,845 | 3,594,981 |
Common stock, par value | $ .0001 | $ .0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 100,610,380 | 17,538,071 |
Common stock, shares outstanding | 100,610,380 | 17,538,071 |
Equity Incentive Plan (Details)
Equity Incentive Plan (Details) - Stock Options | 9 Months Ended |
Mar. 31, 2020 | |
Volatility | 100.00% |
Equivalent term (years) | 10 years |
Risk-free interest rate | 1.82% |
Dividend yield | 0.00% |
Equity Incentive Plan (Details
Equity Incentive Plan (Details 1) - Stock Options | 9 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Number of Options | |
Number of options outstanding, beginning balance | shares | 1,607 |
Granted | shares | 339,550 |
Exercised | shares | (2,500) |
Expired | shares | (170) |
Number of options outstanding, ending balance | shares | 338,437 |
Number of options, exercisable | shares | 11,437 |
Weighted Average Exercise Price | |
Weighted average exercise price, beginning balance | $ / shares | $ 325.73 |
Granted | $ / shares | .98 |
Exercised | $ / shares | .97 |
Expired | $ / shares | 328 |
Weighted average exercise price, ending balance | $ / shares | 2.36 |
Weighted average exercise price, exercisable | $ / shares | $ 41.74 |
Weighted Average Remaining Contractual Life in Years | |
Weighted average remaining contractual life in years, outstanding, beginning balance | 6 years 1 month 17 days |
Weighted average remaining contractual life in years, | 10 years |
Weighted average remaining contractual life in years, outstanding, ending balance | 9 years 7 months 13 days |
Weighted average remaining contractual life in years, exercisable | 9 years 3 months 18 days |
Equity Incentive Plan (Detail_2
Equity Incentive Plan (Details 2) - Restricted Stock | 9 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Number of Shares | |
Unvested, beginning balance | shares | 2,346,214 |
Granted | shares | 1,067,912 |
Vested | shares | 0 |
Forfeited | shares | (69,900) |
Unvested, ending balance | shares | 3,344,226 |
Weighted Average Grant Date Fair Value | |
Unvested, beginning balance | $ / shares | $ 1.83 |
Granted | $ / shares | .73 |
Vested | $ / shares | .00 |
Forfeited | $ / shares | 2.03 |
Unvested, ending balance | $ / shares | $ 1.47 |
Weighted Average Remaining Contractual Life in Years | |
Unvested beginning, weighted average remaining contractual life in years | 9 years 1 month 6 days |
Granted | 1 year 8 months 12 days |
Unvested ending, weighted average remaining contractual life in years | 7 years 2 months 12 days |
Equity Incentive Plan (Detail_3
Equity Incentive Plan (Details 3) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Mar. 31, 2020 | Mar. 31, 2019 | |
Total share-based compensation expense | $ 264,000 | $ 377,000 | $ 591,000 | $ 723,000 |
Stock Options | ||||
Total share-based compensation expense | 7,000 | 15,000 | 14,000 | 122,000 |
Restricted Stock | ||||
Total share-based compensation expense | $ 257,000 | $ 362,000 | $ 577,000 | $ 601,000 |
Equity Incentive Plan (Detail_4
Equity Incentive Plan (Details Narrative) | 9 Months Ended |
Mar. 31, 2020USD ($)shares | |
Unrecognized stock-based compensation expense related to non-vested restricted stock | $ 1,247,000 |
Recognition period | 6 years 3 months 7 days |
2015 Plan | |
Shares available for grant | shares | 1,317,337 |
Unrecognized option-based compensation expense related to non-vested stock options | $ 133,015 |
Unrecognized stock-based compensation expense related to non-vested restricted stock | $ 4,124,000 |
Recognition period | 7 years 2 months 12 days |
Warrants (Details)
Warrants (Details) - Warrants | 9 Months Ended |
Mar. 31, 2020 | |
Expected volatility | 100.00% |
Dividend yield | 0.00% |
Minimum | |
Equivalent term (years) | 1 year |
Risk-free rate | 0.20% |
Maximum | |
Equivalent term (years) | 5 years |
Risk-free rate | 0.66% |
Warrants (Details 1)
Warrants (Details 1) | 9 Months Ended | |
Mar. 31, 2020$ / sharesshares | ||
Equity-Based Warrants | ||
Number of Warrants | ||
Number of warrants, outstanding beginning balance | shares | 16,218,908 | |
Issued | shares | 44,627,120 | |
Expired | shares | 0 | |
Exercised | shares | (29,859,990) | [1] |
Number of warrants outstanding, ending balance | shares | 30,986,038 | |
Weighted Average Exercise Price | ||
Weighted average exercise price, beginning balance | $ / shares | $ 3.15 | |
Issued | $ / shares | 1.21 | |
Expired | $ / shares | .00 | |
Exercised | $ / shares | .00 | |
Weighted average exercise price, ending balance | $ / shares | $ 2.39 | |
Weighted Average Remaining Contractual Life in Years | ||
Weighted average remaining contractual life in years, outstanding, beginning balance | 4 years 4 months 10 days | |
Issued | 1 year 10 months 17 days | |
Weighted average remaining contractual life in years, outstanding, ending balance | 2 years 3 months 22 days | |
Liability Warrants | ||
Number of Warrants | ||
Number of warrants, outstanding beginning balance | shares | 240,755 | |
Expired | shares | 0 | |
Exercised | shares | 0 | |
Number of warrants outstanding, ending balance | shares | 240,755 | |
Weighted Average Exercise Price | ||
Weighted average exercise price, beginning balance | $ / shares | $ 72 | |
Expired | $ / shares | .00 | |
Exercised | $ / shares | .00 | |
Weighted average exercise price, ending balance | $ / shares | $ 72 | |
Weighted Average Remaining Contractual Life in Years | ||
Weighted average remaining contractual life in years, outstanding, beginning balance | 3 years 1 month 28 days | |
Weighted average remaining contractual life in years, outstanding, ending balance | 2 years 4 months 13 days | |
[1] | During the quarter ended March 31, 2020, investor exercised 5.0 million of the October 2019 private placement warrants under the cashless exercise provision. In April 2020, another investor exercised all remaining 5.0 million October 2019 private placement warrants. There are no more October 2019 private placement warrants outstanding as of April 30, 2020. |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - shares | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | ||
Antidilutive securities | 44,715,301 | 17,265,573 | |
Liability Warrants | |||
Antidilutive securities | 240,755 | 240,755 | |
Equity-Based Warrants | |||
Antidilutive securities | 30,986,038 | 11,893,175 | |
Stock Options | |||
Antidilutive securities | 338,438 | 1,666 | |
Employee Unvested Restricted Stock | |||
Antidilutive securities | 3,344,226 | 2,719,312 | |
Performance-Based Options | |||
Antidilutive securities | 0 | 75,000 | [1] |
Convertible Preferred Stock | |||
Antidilutive securities | 9,805,845 | 2,335,665 | |
[1] | During the year ended June 30, 2019, the Company issued 75,000 performance-based stock options out of the 2015 Plan to a consultant. These options vest based on meeting certain market criteria with an exercise price of $1.00. At June 30, 2019, the first of three market targets were not achieved, and all 75,000 performance stock options were forfeited. |
Segment Reporting (Details)
Segment Reporting (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||
Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Mar. 31, 2020 | Mar. 31, 2019 | Jun. 30, 2019 | |
Consolidated revenue | $ 8,156,173 | $ 2,377,792 | $ 12,771,235 | $ 5,604,612 | |||||
Consolidated net loss | (5,332,305) | $ (214,247) | $ (4,929,030) | (4,495,862) | $ (4,657,662) | $ (3,446,483) | (10,475,582) | (12,600,007) | |
Total assets | 158,953,803 | 158,953,803 | $ 34,721,391 | ||||||
Aytu BioScience | |||||||||
Consolidated revenue | 4,703,000 | 2,738,000 | 9,318,000 | 5,605,000 | |||||
Consolidated net loss | (4,421,000) | (4,496,000) | (9,565,000) | (12,600,000) | |||||
Total assets | 137,825,000 | 137,825,000 | 34,721,000 | ||||||
Aytu Consumer Health | |||||||||
Consolidated revenue | 3,453,000 | 0 | 3,453,000 | 0 | |||||
Consolidated net loss | (911,000) | $ 0 | (911,000) | $ 0 | |||||
Total assets | $ 21,129,000 | $ 21,129,000 | $ 0 |