Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | May 13, 2022 | |
Cover [Abstract] | ||
Entity Registrant Name | PALATIN TECHNOLOGIES, INC. | |
Entity Central Index Key | 0000911216 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Current Fiscal Year End Date | --06-30 | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Document Period End Date | Mar. 31, 2022 | |
Entity Filer Category | Non-accelerated Filer | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Entity Common Stock Shares Outstanding | 231,773,670 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-15543 | |
Entity Incorporation State Country Code | DE | |
Entity Tax Identification Number | 95-4078884 | |
Entity Interactive Data Current | Yes | |
Entity Address Address Line 1 | 4B Cedar Brook Drive | |
Entity Address City Or Town | Cranbury | |
Entity Address State Or Province | NJ | |
Entity Address Postal Zip Code | 08512 | |
City Area Code | 609 | |
Local Phone Number | 495‑2200 | |
Security 12b Title | Common Stock, par value $.01 per share | |
Trading Symbol | PTN | |
Security Exchange Name | NYSEAMER |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Mar. 31, 2022 | Jun. 30, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 37,719,531 | $ 60,104,919 |
Accounts receivable | 790,005 | 1,580,443 |
Inventories | 1,031,988 | 1,162,000 |
Prepaid expenses and other current assets | 2,704,886 | 3,059,679 |
Total current assets | 42,246,410 | 65,907,041 |
Property and equipment, net | 544,622 | 94,817 |
Right-of-use assets - operating leases | 968,957 | 1,237,813 |
Other assets | 56,916 | 56,916 |
Total assets | 43,816,905 | 67,296,587 |
Current liabilities: | ||
Accounts payable | 2,402,739 | 640,650 |
Accrued expenses | 3,175,414 | 5,797,378 |
Short-term operating lease liabilities | 367,478 | 351,853 |
Short-term finance lease liabilities | 99,602 | 0 |
Other current liabilities | 5,931,414 | 3,721,907 |
Total current liabilities | 11,976,647 | 10,511,788 |
Long-term operating lease liabilities | 621,660 | 900,520 |
Long-term finance lease liabilities | 178,139 | 0 |
Other long-term liabilities | 2,955,000 | 6,232,907 |
Total liabilities | 15,731,446 | 17,645,215 |
Stockholders equity: | ||
Preferred stock of $0.01 par value authorized 10,000,000 shares; shares issued and outstanding designated as follows: Series A Convertible: authorized 264,000 shares: issued and outstanding 4,030 shares as of March 31, 2022 and June 30, 2021 | 40 | 40 |
Common stock of $0.01 par value authorized 300,000,000 shares: issued and outstanding 231,773,670 shares as of March 31, 2022 and 230,049,691 shares as of June 30, 2021 | 2,317,737 | 2,300,497 |
Additional paid-in capital | 400,993,760 | 399,146,232 |
Accumulated deficit | (375,226,078) | (351,795,397) |
Total stockholders equity | 28,085,459 | 49,651,372 |
Total liabilities and stockholders equity | $ 43,816,905 | $ 67,296,587 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Jun. 30, 2021 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 231,773,670 | 230,049,691 |
Common stock, shares outstanding | 231,773,670 | 230,049,691 |
Series A Convertible Preferred Stock | ||
Preferred stock, shares authorized | 264,000 | |
Preferred stock, shares issued | 4,030 | 4,030 |
Preferred stock, shares outstanding | 4,030 | 4,030 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | |
REVENUES | ||||
Product revenue, net | $ 216,097 | $ 88,741 | $ 447,719 | $ (363,790) |
License and contract | 0 | 0 | 250,000 | 0 |
Total revenues | 216,097 | 88,741 | 697,719 | (363,790) |
OPERATING EXPENSES | ||||
Cost of products sold | 46,908 | 55,440 | 130,012 | 110,040 |
Research and development | 4,980,074 | 2,509,490 | 13,891,235 | 9,444,759 |
Selling, general and administrative | 3,009,528 | 4,010,055 | 10,163,830 | 11,386,574 |
Gain on license termination agreement | 0 | 0 | 0 | (1,623,795) |
Total operating expenses | 8,036,510 | 6,574,985 | 24,185,077 | 19,317,578 |
Loss from operations | (7,820,413) | (6,486,244) | (23,487,358) | (19,681,368) |
OTHER INCOME (EXPENSE) | ||||
Investment income | 1,127 | 2,834 | 4,100 | 19,769 |
Foreign currency gain | 190,719 | 753,750 | 64,000 | 8,748 |
Interest expense | (3,019) | 0 | (11,423) | (9,360) |
Total other income, net | 188,827 | 756,584 | 56,677 | 19,157 |
NET LOSS | $ (7,631,586) | $ (5,729,660) | $ (23,430,681) | $ (19,662,211) |
Basic and diluted net loss per common share | $ (0.03) | $ (0.02) | $ (0.10) | $ (0.08) |
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 238,805,370 | 236,832,283 | 238,444,206 | 236,525,514 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Balance, shares at Jun. 30, 2020 | 4,030 | 229,258,400 | |||
Balance, amount at Jun. 30, 2020 | $ 80,172,849 | $ 40 | $ 2,292,584 | $ 396,079,127 | $ (318,198,902) |
Stock-based compensation, shares | 958,090 | ||||
Stock-based compensation, amount | 2,459,162 | $ 9,581 | 2,449,581 | ||
Withholding taxes related to restricted stock units, shares | (166,799) | ||||
Withholding taxes related to restricted stock units, amount | (93,638) | $ (1,668) | (91,970) | ||
Net loss | (19,662,211) | $ 0 | $ 0 | 0 | (19,662,211) |
Balance, shares at Mar. 31, 2021 | 4,030 | 230,049,691 | |||
Balance, amount at Mar. 31, 2021 | 62,876,162 | $ 40 | $ 2,300,497 | 398,436,738 | (337,861,113) |
Balance, shares at Dec. 31, 2020 | 4,030 | 230,034,307 | |||
Balance, amount at Dec. 31, 2020 | 67,835,126 | $ 40 | $ 2,300,343 | 397,666,196 | (332,131,453) |
Stock-based compensation, shares | 21,875 | ||||
Stock-based compensation, amount | 775,305 | $ 219 | 775,086 | ||
Withholding taxes related to restricted stock units, shares | (6,491) | ||||
Withholding taxes related to restricted stock units, amount | (4,609) | $ (65) | (4,544) | ||
Net loss | (5,729,660) | (5,729,660) | |||
Balance, shares at Mar. 31, 2021 | 4,030 | 230,049,691 | |||
Balance, amount at Mar. 31, 2021 | 62,876,162 | $ 40 | $ 2,300,497 | 398,436,738 | (337,861,113) |
Balance, shares at Jun. 30, 2021 | 4,030 | 230,049,691 | |||
Balance, amount at Jun. 30, 2021 | 49,651,372 | $ 40 | $ 2,300,497 | 399,146,232 | (351,795,397) |
Stock-based compensation, shares | 1,735,158 | ||||
Stock-based compensation, amount | 1,789,947 | 0 | $ 17,352 | 1,772,595 | 0 |
Withholding taxes related to restricted stock units, shares | (404,779) | ||||
Withholding taxes related to restricted stock units, amount | (221,311) | 0 | $ (4,048) | (217,263) | 0 |
Net loss | $ (23,430,681) | 0 | $ 0 | 0 | (23,430,681) |
Warrant exercises, shares | 43,600 | 350,000 | |||
Warrant exercises, amount | $ 280,000 | 0 | $ 3,500 | 276,500 | 0 |
Option exercises, shares | 43,600 | ||||
Option exercises, amount | 16,132 | $ 0 | $ 436 | 15,696 | 0 |
Balance, shares at Mar. 31, 2022 | 4,030 | 231,773,670 | |||
Balance, amount at Mar. 31, 2022 | 28,085,459 | $ 40 | $ 2,317,737 | 400,993,760 | (375,226,078) |
Balance, shares at Dec. 31, 2021 | 4,030 | 231,695,273 | |||
Balance, amount at Dec. 31, 2021 | 35,196,307 | $ 40 | $ 2,316,953 | 400,473,806 | (367,594,492) |
Stock-based compensation, shares | 111,000 | ||||
Stock-based compensation, amount | 533,779 | 0 | $ 1,110 | 532,669 | 0 |
Withholding taxes related to restricted stock units, shares | (32,603) | ||||
Withholding taxes related to restricted stock units, amount | (13,041) | 0 | $ (326) | (12,715) | 0 |
Net loss | (7,631,586) | $ 0 | $ 0 | 0 | (7,631,586) |
Balance, shares at Mar. 31, 2022 | 4,030 | 231,773,670 | |||
Balance, amount at Mar. 31, 2022 | $ 28,085,459 | $ 40 | $ 2,317,737 | $ 400,993,760 | $ (375,226,078) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (23,430,681) | $ (19,662,211) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 84,244 | 38,561 |
Cash received in excess of gain on termination agreement | 0 | 14,676,205 |
Decrease in right-of-use asset | 268,856 | 240,580 |
Unrealized foreign currency transaction gain | (64,000) | (8,748) |
Stock-based compensation | 1,789,947 | 2,459,162 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 790,438 | (1,869,120) |
Prepaid expenses and other assets | 354,793 | (2,022,026) |
Inventories | 130,012 | (296,923) |
Accounts payable | 1,762,089 | 148,340 |
Accrued expenses | (2,621,964) | (1,338) |
Operating lease liabilities | (263,235) | (229,661) |
Other liabilities | (1,004,400) | (7,584,420) |
Net cash used in operating activities | (22,203,901) | (14,111,599) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | 224,258 | 5,721 |
Net cash used in investing activities | (224,258) | (5,721) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of withholding taxes related to restricted stock units | (221,311) | (93,638) |
Payment of finance lease obligations | 32,050 | 0 |
Proceeds from exercise of warrants | 280,000 | 0 |
Proceeds from exercise of stock options | 16,132 | 0 |
Net cash provided by (used in) financing activities | 42,771 | (93,638) |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (22,385,388) | (14,210,958) |
CASH AND CASH EQUIVALENTS, beginning of period | 60,104,919 | 82,852,270 |
CASH AND CASH EQUIVALENTS, end of period | 37,719,531 | 68,641,312 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | $ 11,423 | $ 9,360 |
ORGANIZATION
ORGANIZATION | 9 Months Ended |
Mar. 31, 2022 | |
ORGANIZATION | |
ORGANIZATION | (1) ORGANIZATION Nature of Business Melanocortin Receptor System. The Company’s commercial product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 and was being marketed in the United States by AMAG Pharmaceuticals, Inc. (“AMAG”) for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women pursuant to a license agreement between them for Vyleesi for North America, which was entered into on January 8, 2017 (the “AMAG License Agreement”). As disclosed in Note 5, the AMAG License Agreement was terminated effective July 24, 2020, and the Company is now marketing Vyleesi in the United States. The Company’s product development activities focus primarily on MC1r agonists, with potential to treat inflammatory and autoimmune diseases such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease. The Company believes that the MC1r agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses. The Company is also developing peptides that are active at more than one melanocortin receptor, and MC4r peptide and small molecule agonists with potential utility in obesity and metabolic-related disorders, including rare disease and orphan indications. Natriuretic Peptide Receptor System Business Risks and Liquidity – As of March 31, 2022, the Company’s cash and cash equivalents were $37,719,531 and current liabilities were $11,976,647. Management intends to utilize existing capital resources for general corporate purposes and working capital, including establishing marketing and distribution capabilities for Vyleesi in the United States and preclinical and clinical development of the Company’s MC1r and MC4r peptide programs and natriuretic peptide program, and development of other portfolio products. Management believes that the Company’s cash and cash equivalents as of March 31, 2022 will be sufficient to fund its current operating plans through at least June 2023. The Company will need additional funding to complete required clinical trials for its other product candidates and, assuming those clinical trials are successful, as to which there can be no assurance, to complete submission of required applications to the FDA. If the Company is unable to obtain approval or otherwise advance in the FDA approval process, the Company’s ability to sustain its operations could be materially adversely affected. The Company may seek the additional capital necessary to fund its operations through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. Additional capital that is required by the Company may not be available on reasonable terms, or at all. In March 2020, the World Health Organization declared COVID-19, a disease caused by a novel strain of coronavirus, a pandemic. The Company has taken steps to ensure the safety and well-being of its employees and clinical trial patients to comply with guidance from federal, state, and local authorities, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve. In mid-March 2020, the Company transitioned to a company-wide work from home policy. Business-critical activities continue to be subject to heightened precautions to ensure safety of employees. The Company continues to assess its policies, business continuity plans, and employee support. The Company continues to evaluate the impact of COVID-19 on the healthcare system and work with contract research organizations supporting its clinical, research, and development programs to mitigate risk to patients and its business and community partners, taking into account regulatory, institutional, and government guidance and policies. The Company will receive a royalty on sales of Vyleesi by our licensees. We have licensed third parties to sell Vyleesi in China and Korea. The COVID-19 coronavirus could adversely impact the time required to obtain regulatory approvals to sell Vyleesi in China and Korea, which would delay when the Company receives royalty income from sales in those countries. The Company cannot be certain what the overall impact of the ongoing COVID-19 pandemic will be on its business, including manufacturing, distribution, sales and marketing of Vyleesi, and whether it has the potential to materially adversely affect its business, financial condition and results of operations and cashflows during the remainder of fiscal year ending June 30, 2022 (“fiscal 2022”) and beyond. Concentrations – |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 9 Months Ended |
Mar. 31, 2022 | |
ORGANIZATION | |
BASIS OF PRESENTATION | (2) BASIS OF PRESENTATION The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnote disclosures required to be presented for complete financial statements. In the opinion of management, these consolidated financial statements contain all adjustments (consisting of normal recurring adjustments) considered necessary for fair presentation. The results of operations for the three and nine months ended March 31, 2022 may not necessarily be indicative of the results of operations expected for the full fiscal year. The accompanying unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2021, filed with the U.S. Securities and Exchange Commission (“SEC”), which includes consolidated financial statements as of June 30, 2021 and 2020 and for the fiscal years then ended. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Mar. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | (3) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation Use of Estimates Cash and Cash Equivalents Fair Value of Financial Instruments Credit Risk Trade Accounts Receivable – Inventories On a quarterly basis, the Company reviews inventory levels to determine whether any obsolete, expired, or excess inventory exists. If any inventory is expected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined by internal sales forecasts, or fails to meet commercial sale specifications, the inventory is written down through a charge to operating expenses. Inventory consisting of Vyleesi has a shelf-life of three years from the date of manufacture. Property and Equipment Impairment of Long-Lived Assets Leases – The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented as an operating expense separately from interest expense on the lease liability. The Company has elected not to recognize an ROU asset and obligation for leases with an initial term of twelve months or less. The expense associated with short term leases is included in selling, general and administrative expense in the statements of operations. To the extent a lease arrangement includes both lease and non-lease components, the Company has elected to account for the components as a single lease component. During the nine months ended March 31, 2022, the Company recorded an additional $309,791 in property and equipment and lease obligations for two new finance leases, each with a term of three years. Revenue Recognition Revenue from Contracts with Customers In accordance with ASC Topic 606, the Company recognizes product revenue when its performance obligation is satisfied by transferring control of the product to a customer. Per the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the consolidated balance sheet, net of various allowances as described in the Trade Accounts Receivable policy above. Product revenues consist of sales of Vyleesi in the United States. The Company sells Vyleesi to specialty pharmacies at the wholesale acquisition cost and payment is currently made within approximately 30 days. In addition to distribution agreements with customers, the Company enters into arrangements with healthcare payers that provide for privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company records product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks and rebates. Product sales are also subject to return rights, which have not been significant to date. Gross product sales offset by product sales allowances for the three and nine months ended March 31, 2022 and 2021 are as follows: Three Months Ended March 31, Nine Months Ended March 31, 2022 2021 2022 2021 Gross product sales $ 1,294,560 $ 1,780,020 $ 3,497,110 $ 3,533,070 Provision for product sales allowances and accruals (1,078,463 ) (1,691,279 ) (3,049,391 ) (3,896,860 ) Net sales $ 216,097 $ 88,741 $ 447,719 $ (363,790 ) For licenses of intellectual property, the Company assesses at contract inception whether the intellectual property is distinct from other performance obligations identified in the arrangement. If the licensing of intellectual property is determined to be distinct, revenue is recognized for nonrefundable, upfront license fees when the license is transferred to the customer and the customer can use and benefit from the license. If the licensing of intellectual property is determined not to be distinct, then the license is bundled with other promises in the arrangement into one performance obligation. The Company needs to determine if the bundled performance obligation is satisfied over time or at a point in time. If the Company concludes that the nonrefundable, upfront license fees will be recognized over time, the Company will need to assess the appropriate method of measuring proportional performance. Regulatory milestone payments are excluded from the transaction price due to the inability to estimate the probability of reversal. Revenue relating to achievement of these milestones is recognized in the period in which the milestone is achieved. Sales-based royalty and milestone payments resulting from customer contracts solely or predominately for the license of intellectual property will only be recognized upon occurrence of the underlying sale or achievement of the sales milestone in the future and such sales-based royalties and milestone payments will be recognized in the same period earned. The Company recognizes revenue for reimbursements of research and development costs under collaboration agreements as the services are performed. The Company records these reimbursements as revenue and not as a reduction of research and development expenses as the Company is the principal in the research and development activities based upon its control of such activities, which is considered part of its ordinary activities. Development milestone payments are generally due 30 business days after the milestone is achieved. Sales milestone payments are generally due 45 business days after the calendar year in which the sales milestone is achieved. Royalty payments are generally due on a quarterly basis 20 business days after being invoiced. Research and Development Costs Accrued Expenses – Stock-Based Compensation – Income Taxes Net Loss per Common Share – Earnings per Share For the three and nine months ended March 31, 2022 and 2021, no additional common shares were added to the computation of diluted EPS because to do so would have been anti-dilutive. The potential number of common shares excluded from diluted EPS during the three and nine months ended March 31, 2022 and 2021 was 27,694,397 and 37,336,040 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 7,012,500 and 6,776,750 vested restricted stock units that had not been issued as of March 31, 2022 and 2021, respectively, due to a provision in the restricted stock unit agreements to delay delivery. Translation of foreign currencies – |
New and recently Adopted Accoun
New and recently Adopted Accounting Pronouncements | 9 Months Ended |
Mar. 31, 2022 | |
New and recently Adopted Accounting Pronouncements | |
New and recently Adopted Accounting Pronouncements | (4) New and recently Adopted Accounting Pronouncements In May 2021, the FASB issued Accounting Standards Update (“ASU”) No. 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options In August 2020, the FASB issued ASU No. 2020-06, Debt (Topic 470) and Derivatives and Hedging (Topic 815): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments, |
AGREEMENTS WITH AMAG
AGREEMENTS WITH AMAG | 9 Months Ended |
Mar. 31, 2022 | |
AGREEMENTS WITH AMAG | |
AGREEMENTS WITH AMAG | (5) AGREEMENTS WITH AMAG On January 8, 2017, the Company entered into the AMAG License Agreement pursuant to which the Company granted AMAG (i) an exclusive license in all countries of North America (the “Territory”), with the right to grant sub-licenses, to research, develop, and commercialize products containing Vyleesi (each a “Product”, and collectively, “Products”), (ii) a non-exclusive license in the Territory, with the right to grant sub-licenses, to manufacture the Products, and (iii) a non-exclusive license in all countries outside the Territory, with the right to grant sub-licenses, to research, develop, and manufacture (but not commercialize) the Products. Following the satisfaction of certain conditions to closing, the AMAG License Agreement became effective on February 2, 2017. Under the AMAG License Agreement, in addition to certain initial and milestone payments, AMAG reimbursed the Company for certain reasonable, documented, direct out-of-pocket expenses incurred by the Company following February 2, 2017, in connection with development and regulatory activities necessary to file a New Drug Application (“NDA”) for Vyleesi for HSDD in the United States. On June 4, 2018, the FDA accepted the Vyleesi NDA for filing and on June 21, 2019, the FDA granted approval of Vyleesi for use in the United States. Effective July 24, 2020, the Company entered into a termination agreement (the “Termination Agreement”) with AMAG terminating the AMAG License Agreement. Under the terms of the Termination Agreement, the Company regained all development and commercialization rights for Vyleesi in the Territory. AMAG made a $12,000,000 payment to the Company at closing of the Termination Agreement and a $4,300,000 payment to the Company on March 31, 2021. The Company initially recorded a liability related to estimated losses on inventory purchase commitments of $18,194,000 as well as accrued expenses for an inventory production run obligation assumed of $2,300,000. The Company assumed all Vyleesi manufacturing agreements, and AMAG transferred information, data, and assets related exclusively to Vyleesi to the Company, including existing inventory and prepaid expenses with an estimated fair value of $5,817,795 as of the date of the Termination Agreement. As a result, the Company initially recorded a net gain for the Termination Agreement of $1,623,795 during the three months ended September 30, 2020. During the three months ended June 30, 2021, the Company reassessed the estimated net realizable value of the inventory, prepaid expenses and losses on the inventory purchase commitments resulting in recording of a loss on the Termination Agreement of $4,407,987 for the three months ended June 30, 2021 and a total loss on the Termination Agreement for the year ended June 30, 2021 of $2,784,192. Under the Termination Agreement, AMAG provided certain transitional services to the Company for a period to ensure continued patient access to Vyleesi during the transition back to the Company. The Company reimbursed AMAG for the agreed upon costs of the transition services. |
MANUFACTURING SUPPLY AGREEMENTS
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | 9 Months Ended |
Mar. 31, 2022 | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | |
MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI | (6) MANUFACTURING SUPPLY AGREEMENTS FOR VYLEESI Pursuant to the Termination Agreement, the Company assumed Vyleesi manufacturing contracts with Catalent Belgium S.A. (“Catalent”); a subsidiary of Catalent Pharma Solutions, Inc., to manufacture drug product and prefilled syringes and assemble prefilled syringes into an auto-injector device (the “Catalent Agreement”), Ypsomed AG (“Ypsomed”); to manufacture the auto-injector device (the “Ypsomed Agreement”), and Lonza Ltd. (“Lonza”), to manufacture the active pharmaceutical ingredient peptide (the “Lonza Agreement”). On September 29, 2020, the Company and Catalent entered into an agreement to terminate the Catalent Agreement (the “Catalent Termination Agreement”) in consideration for a one-time payment of six million euros (€6,000,000) which was paid in October 2020 and accrued as part of the estimated losses on inventory purchase commitments assumed as part of the Termination Agreement as discussed in Note 5. The Company and Catalent then entered into a new Vyleesi manufacturing agreement (the “New Catalent Agreement”) which includes reduced minimum annual purchase requirements (see Note 12) as compared to the original Catalent Agreement and modification of other financial terms. The New Catalent Agreement provides that Catalent will provide manufacturing and supply services to Palatin related to production of Vyleesi, including that Catalent will supply specified minimums of Palatin’s requirements for Vyleesi during the term of the New Catalent Agreement through August 21, 2025, unless earlier terminated in accordance with the terms of the New Catalent Agreement. The initial term of the New Catalent Agreement will be automatically extended for one 24-month period unless either party notifies the other of its desire to terminate as of the end of the initial term. The New Catalent Agreement also includes customary terms and conditions relating to forecasting and minimum commitments, ordering, delivery, inspection and acceptance, and termination, among other matters. The term of the Lonza Agreement is through December 31, 2022. There are specified minimum purchase requirements under the Lonza Agreement, and under specified circumstances, termination fees may be payable upon termination of the Lonza Agreement by the Company (see Note 12). The initial term of the Ypsomed Agreement is through December 31, 2025, with automatic renewal for successive one-year periods unless either party terminates the Ypsomed Agreement by ten months’ written notice prior to the expiration of the Ypsomed Agreement or any automatic renewal period. There are specified minimum purchase requirements under the Ypsomed Agreement, and under specified circumstances, termination fees may be payable upon termination of the Ypsomed Agreement by the Company (see Note 12). |
AGREEMENT WITH FOSUN
AGREEMENT WITH FOSUN | 9 Months Ended |
Mar. 31, 2022 | |
AGREEMENT WITH FOSUN | |
AGREEMENT WITH FOSUN | (7) AGREEMENT WITH FOSUN On September 6, 2017, the Company entered into a license agreement with Shanghai Fosun Pharmaceutical Development Co. Ltd. (“Fosun”) for exclusive rights to commercialize Vyleesi in China (the “Fosun License Agreement”). Under the terms of the agreement, the Company received $4,500,000 in October 2017, which consisted of an upfront payment of $5,000,000 less $500,000 that was withheld in accordance with tax withholding requirements in China and recorded as an expense. Under the Fosun License Agreement, the Company is entitled to receive a $7,500,000 milestone payment when regulatory approval in China is obtained, provided that a commercial supply agreement for Vyleesi has been entered into. Palatin has the potential to receive up to $92,500,000 in additional sales related milestone payments and high single-digit to low double-digit royalties on net sales in the licensed territory. All development, regulatory, sales, marketing, and commercial activities and associated costs in the licensed territory will be the sole responsibility of Fosun. For the nine months ended March 31, 2022, the Company recorded $250,000 of license and contract revenue from the Fosun License Agreement. |
AGREEMENT WITH KWANGDONG
AGREEMENT WITH KWANGDONG | 9 Months Ended |
Mar. 31, 2022 | |
AGREEMENT WITH KWANGDONG | |
AGREEMENT WITH KWANGDONG | (8) AGREEMENT WITH KWANGDONG On November 21, 2017, the Company entered into a license agreement with Kwangdong Pharmaceutical Co. Ltd (“Kwangdong”) for exclusive rights to commercialize Vyleesi (the “Kwangdong License Agreement”) in Korea. Under the terms of the agreement, the Company received $417,500 in December 2017, consisting of an upfront payment of $500,000, less $82,500, which was withheld in accordance with tax withholding requirements in Korea and recorded as an expense. Under the Kwangdong License Agreement, the Company is entitled to receive a $3,000,000 milestone payment based on the first commercial sale in Korea. Palatin has the potential to receive up to $37,500,000 in additional sales related milestone payments and mid-single-digit to low double-digit royalties on net sales in the licensed territory. All development, regulatory, sales, marketing, and commercial activities and associated costs in the licensed territory will be the sole responsibility of Kwangdong. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 9 Months Ended |
Mar. 31, 2022 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | (9) PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses March 31, June 30, 2022 2021 Clinical / regulatory costs $ 1,037,350 $ 454,750 Insurance premiums 39,864 259,468 Vyleesi contractual advances 815,750 1,200,000 Other 811,922 1,145,461 $ 2,704,886 $ 3,059,679 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 9 Months Ended |
Mar. 31, 2022 | |
FAIR VALUE MEASUREMENTS | |
FAIR VALUE MEASUREMENTS | (10) FAIR VALUE MEASUREMENTS The fair value of cash equivalents is classified using a hierarchy prioritized based on inputs. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on management’s own assumptions used to measure assets and liabilities at fair value. A financial asset’s or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. The following table provides the assets carried at fair value: Carrying Value Quoted prices in Other quoted/observable inputs (Level 2) Significant unobservable inputs March 31, 2022: Money Market Account $ 37,651,838 $ 37,651,838 $ - $ - June 30, 2021: Money Market Account $ 59,730,428 $ 59,730,428 $ - $ - |
ACCRUED EXPENSES
ACCRUED EXPENSES | 9 Months Ended |
Mar. 31, 2022 | |
ACCRUED EXPENSES | |
ACCRUED EXPENSES | (11) ACCRUED EXPENSES Accrued expenses March 31, June 30, 2022 2021 Clinical / regulatory costs $ 1,338,025 $ 778,705 Other research related expenses 759,308 569,370 Professional services 47,797 84,094 Inventory purchases - 2,340,000 Selling expenses 910,545 1,839,724 Other 119,739 185,485 $ 3,175,414 $ 5,797,378 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Mar. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | (12) COMMITMENTS AND CONTINGENCIES Inventory Purchases Total Current 1 - 3 Years 4 - 5 Years Inventory purchase commitments $ 9,832,614 $ 5,931,414 $ 2,896,800 $ 1,004,400 As of March 31, 2022, the Company has $5,931,414 and $2,995,000 accrued within other current and long-term liabilities, respectively, in the consolidated balance sheet related to estimated losses for firm commitment contractual obligations under these agreements. As of June 30, 2021, $3,721,907 and $6,232,907 was accrued within other current and long-term liabilities, respectively. Losses on these firm commitment contractual obligations are recognized based upon the terms of the respective agreement and similar factors considered for the write-down of inventory, including expected sales requirements as determined by internal sales forecasts. The commitment contractual obligation amounts above are denominated in Swiss Francs and Euros and have been translated using period end exchange rates. The Company may experience a negative impact on future earnings and equity solely as a result of future foreign currency exchange rate fluctuations. Contingencies The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. The Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition, or results of operations. |
STOCKHOLDERS EQUITY
STOCKHOLDERS EQUITY | 9 Months Ended |
Mar. 31, 2022 | |
Stockholders equity: | |
STOCKHOLDERS EQUITY | (13) STOCKHOLDERS’ EQUITY Financing Transactions – No proceeds were raised under the 2019 Equity Distribution Agreement during the three and nine months ended March 31, 2022 and 2021. Stock Purchase Warrants – Stock Options – A summary of stock option activity is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value Outstanding - June 30, 2021 21,882,500 $ 0.72 7.2 $ 1,034,273 Granted 197,650 0.48 Forfeited (240,528 ) 0.69 Exercised (43,600 ) 0.37 Expired (103,349 ) 0.81 Outstanding - March 31, 2022 21,692,673 $ 0.72 6.5 $ 237,370 Exercisable at March 31, 2022 14,155,952 $ 0.75 5.5 $ 236,358 Expected to vest at March 31, 2022 7,536,721 $ 0.68 8.4 $ 1,012 Stock options granted to the Company’s executive officers and employees generally vest over a 48-month period, while stock options granted to its non-employee directors vest over a 12-month period. Included in the outstanding options in the table above are 1,605,573 and 332,785 unvested performance-based stock options granted to executive officers and other employees, respectively, which were granted in June 2020 and 2021. The performance-based stock options vest on annual performance criteria through the fiscal years ending June 30, 2025 relating to advancement of MC1r programs, including initiation of clinical trials and licensing of Vyleesi in additional countries or regions. Restricted Stock Units – A summary of restricted stock unit activity is as follows: Outstanding at June 30, 2021 14,840,762 Granted - Forfeited (157,467 ) Vested (1,735,158 ) Outstanding at March 31, 2022 12,948,137 Included in outstanding restricted stock units in the table above are 7,012,500 vested shares that have not been issued as of March 31, 2022 due to a provision in the restricted stock unit agreements to delay delivery. Time-based restricted stock units granted to the Company’s executive officers, employees, and non-employee directors generally vest over 48 months, 48 months, and 12 months, respectively. Included in the outstanding restricted stock units in the table above are 1,630,020 and 275,208 unvested performance-based restricted stock units granted to executive officers and other employees, respectively, which were granted in June 2019, 2020, and 2021. The performance-based restricted stock units vest on annual performance criteria through the fiscal years ending June 30, 2025 relating to advancement of MC1r programs, including initiation of clinical trials and licensing of Vyleesi in additional countries or regions. In June 2021, the Company granted 450,000 performance-based restricted stock units included in the table above to its executive officers which vest if, prior to June 22, 2023, the price per share of the Company’s common stock, as traded on the NYSE American, was at least $2.00 for at least twenty consecutive trading days. In connection with the vesting of restricted share units during the three and nine months ended March 31, 2022, the Company withheld 32,603, and 404,779 shares with aggregate values of $13,041 and $221,311, respectively in satisfaction of minimum tax withholding obligations. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Mar. 31, 2022 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | (14) SUBSEQUENT EVENTS On May 11, 2022, Palatin entered into a securities purchase agreement with institutional investors, and on May 12, 2022, Palatin issued and sold 8,100,000 shares of Series B Convertible Redeemable Preferred Stock (“Series B Preferred Stock”) and 900,000 shares of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”). Each share of Series B Preferred Stock and Series C Preferred Stock had a purchase price of $1.67 and is convertible into Palatin common stock at an initial conversion price of $0.45 per share. The investors in the Series B Preferred Stock and Series C Preferred Stock also received warrants to purchase up to 1,666,667 shares of common stock at an exercise price of $0.50 per share, which expire 48 months following issuance. Total gross proceeds from the offering, before deducting offering expenses, is $15 million. The Series B Preferred Stock and Series C Preferred Stock is convertible, at the option of the holder and until the earlier of 90 days from closing and 30 days following stockholder approval of a reverse stock split of Palatin’s common stock, into 33,333,333 shares of common stock, computed by dividing the aggregate stated value of the preferred stock of $15 million by the conversion price of $0.45. Alternatively, during the same period the holders of Series B Preferred Stock and Series C Preferred Stock can elect to redeem for cash in an amount equal to stated value or in notes, having an aggregate principal amount equal to stated value, and will also receive a redemption fee of $750,000, representing 5% of the aggregate stated value of the preferred shares. The Company expects to call a meeting of stockholders to seek approval of, among other things, an amendment to its certificate of incorporation authorizing a reverse stock split. Except as otherwise required by law, holders of the Series B Preferred Stock and Series C Preferred Stock are entitled to vote only on the reverse stock split and any adjournment of the meeting relating to the reverse stock split. The common stock, outstanding Series A Preferred Stock, the Series B Preferred Stock and the Series C Preferred Stock will vote as a single class on an as-if converted basis. The holders of Series B Preferred Stock have votes equal to the number of shares of common stock into which the Series B Preferred Stock is convertible. The holders of Series C Preferred Stock are entitled to 20,000 votes per share of common stock into which the Series C Preferred Stock is convertible but can only vote in the same proportion as the shares of common stock, Series A preferred stock, and Series B preferred stock are voted on the reverse stock split or any adjournment of the stockholder meeting relating thereto. To the extent any shares of Series B Preferred Stock or Series C Preferred Stock are converted to common shares or redeemed for debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Mar. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Principles of Consolidation | Principles of Consolidation |
Use of Estimates | Use of Estimates |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Fair Value of Financial Instruments | Fair Value of Financial Instruments |
Credit Risk | Credit Risk |
Trade Accounts Receivable | Trade Accounts Receivable – |
Inventories | Inventories On a quarterly basis, the Company reviews inventory levels to determine whether any obsolete, expired, or excess inventory exists. If any inventory is expected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined by internal sales forecasts, or fails to meet commercial sale specifications, the inventory is written down through a charge to operating expenses. Inventory consisting of Vyleesi has a shelf-life of three years from the date of manufacture. |
Property and Equipment | Property and Equipment |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Leases | Leases – The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date, plus any initial direct costs incurred less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus initial direct costs, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance leases, the ROU asset is subsequently amortized using the straight-line method from the lease commencement date to the earlier of the end of its useful life or the end of the lease term unless the lease transfers ownership of the underlying asset to the Company or the Company is reasonably certain to exercise an option to purchase the underlying asset. In those cases, the ROU asset is amortized over the useful life of the underlying asset. Amortization of the ROU asset is recognized and presented as an operating expense separately from interest expense on the lease liability. The Company has elected not to recognize an ROU asset and obligation for leases with an initial term of twelve months or less. The expense associated with short term leases is included in selling, general and administrative expense in the statements of operations. To the extent a lease arrangement includes both lease and non-lease components, the Company has elected to account for the components as a single lease component. During the nine months ended March 31, 2022, the Company recorded an additional $309,791 in property and equipment and lease obligations for two new finance leases, each with a term of three years. |
Revenue Recognition | Revenue Recognition Revenue from Contracts with Customers In accordance with ASC Topic 606, the Company recognizes product revenue when its performance obligation is satisfied by transferring control of the product to a customer. Per the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the consolidated balance sheet, net of various allowances as described in the Trade Accounts Receivable policy above. Product revenues consist of sales of Vyleesi in the United States. The Company sells Vyleesi to specialty pharmacies at the wholesale acquisition cost and payment is currently made within approximately 30 days. In addition to distribution agreements with customers, the Company enters into arrangements with healthcare payers that provide for privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company records product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks and rebates. Product sales are also subject to return rights, which have not been significant to date. Gross product sales offset by product sales allowances for the three and nine months ended March 31, 2022 and 2021 are as follows: Three Months Ended March 31, Nine Months Ended March 31, 2022 2021 2022 2021 Gross product sales $ 1,294,560 $ 1,780,020 $ 3,497,110 $ 3,533,070 Provision for product sales allowances and accruals (1,078,463 ) (1,691,279 ) (3,049,391 ) (3,896,860 ) Net sales $ 216,097 $ 88,741 $ 447,719 $ (363,790 ) For licenses of intellectual property, the Company assesses at contract inception whether the intellectual property is distinct from other performance obligations identified in the arrangement. If the licensing of intellectual property is determined to be distinct, revenue is recognized for nonrefundable, upfront license fees when the license is transferred to the customer and the customer can use and benefit from the license. If the licensing of intellectual property is determined not to be distinct, then the license is bundled with other promises in the arrangement into one performance obligation. The Company needs to determine if the bundled performance obligation is satisfied over time or at a point in time. If the Company concludes that the nonrefundable, upfront license fees will be recognized over time, the Company will need to assess the appropriate method of measuring proportional performance. Regulatory milestone payments are excluded from the transaction price due to the inability to estimate the probability of reversal. Revenue relating to achievement of these milestones is recognized in the period in which the milestone is achieved. Sales-based royalty and milestone payments resulting from customer contracts solely or predominately for the license of intellectual property will only be recognized upon occurrence of the underlying sale or achievement of the sales milestone in the future and such sales-based royalties and milestone payments will be recognized in the same period earned. The Company recognizes revenue for reimbursements of research and development costs under collaboration agreements as the services are performed. The Company records these reimbursements as revenue and not as a reduction of research and development expenses as the Company is the principal in the research and development activities based upon its control of such activities, which is considered part of its ordinary activities. Development milestone payments are generally due 30 business days after the milestone is achieved. Sales milestone payments are generally due 45 business days after the calendar year in which the sales milestone is achieved. Royalty payments are generally due on a quarterly basis 20 business days after being invoiced. |
Research and Development Costs | Research and Development Costs |
Accrued Expenses | Accrued Expenses – |
Stock-Based Compensation | Stock-Based Compensation – |
Income Taxes | Income Taxes |
Net Loss per Common Share | Net Loss per Common Share – Earnings per Share For the three and nine months ended March 31, 2022 and 2021, no additional common shares were added to the computation of diluted EPS because to do so would have been anti-dilutive. The potential number of common shares excluded from diluted EPS during the three and nine months ended March 31, 2022 and 2021 was 27,694,397 and 37,336,040 respectively. Included in the weighted average common shares used in computing basic and diluted net loss per common share are 7,012,500 and 6,776,750 vested restricted stock units that had not been issued as of March 31, 2022 and 2021, respectively, due to a provision in the restricted stock unit agreements to delay delivery. |
Translation of Foreign Currencies | Translation of foreign currencies – |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Mar. 31, 2022 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of gross product sales | Three Months Ended March 31, Nine Months Ended March 31, 2022 2021 2022 2021 Gross product sales $ 1,294,560 $ 1,780,020 $ 3,497,110 $ 3,533,070 Provision for product sales allowances and accruals (1,078,463 ) (1,691,279 ) (3,049,391 ) (3,896,860 ) Net sales $ 216,097 $ 88,741 $ 447,719 $ (363,790 ) |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 9 Months Ended |
Mar. 31, 2022 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other current assets | March 31, June 30, 2022 2021 Clinical / regulatory costs $ 1,037,350 $ 454,750 Insurance premiums 39,864 259,468 Vyleesi contractual advances 815,750 1,200,000 Other 811,922 1,145,461 $ 2,704,886 $ 3,059,679 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 9 Months Ended |
Mar. 31, 2022 | |
FAIR VALUE MEASUREMENTS | |
Schedule of assets at fair value | Carrying Value Quoted prices in Other quoted/observable inputs (Level 2) Significant unobservable inputs March 31, 2022: Money Market Account $ 37,651,838 $ 37,651,838 $ - $ - June 30, 2021: Money Market Account $ 59,730,428 $ 59,730,428 $ - $ - |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 9 Months Ended |
Mar. 31, 2022 | |
ACCRUED EXPENSES | |
Schedule of accrued expenses | March 31, June 30, 2022 2021 Clinical / regulatory costs $ 1,338,025 $ 778,705 Other research related expenses 759,308 569,370 Professional services 47,797 84,094 Inventory purchases - 2,340,000 Selling expenses 910,545 1,839,724 Other 119,739 185,485 $ 3,175,414 $ 5,797,378 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 9 Months Ended |
Mar. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of inventory purchase commitments | Total Current 1 - 3 Years 4 - 5 Years Inventory purchase commitments $ 9,832,614 $ 5,931,414 $ 2,896,800 $ 1,004,400 |
STOCKHOLDERS EQUITY (Tables)
STOCKHOLDERS EQUITY (Tables) | 9 Months Ended |
Mar. 31, 2022 | |
Stockholders equity: | |
Schedule of Stock Option Activity | Number of Shares Weighted Average Exercise Price Weighted Average Remaining Term in Years Aggregate Intrinsic Value Outstanding - June 30, 2021 21,882,500 $ 0.72 7.2 $ 1,034,273 Granted 197,650 0.48 Forfeited (240,528 ) 0.69 Exercised (43,600 ) 0.37 Expired (103,349 ) 0.81 Outstanding - March 31, 2022 21,692,673 $ 0.72 6.5 $ 237,370 Exercisable at March 31, 2022 14,155,952 $ 0.75 5.5 $ 236,358 Expected to vest at March 31, 2022 7,536,721 $ 0.68 8.4 $ 1,012 |
Schedule of Restricted Stock Unit Activity | Outstanding at June 30, 2021 14,840,762 Granted - Forfeited (157,467 ) Vested (1,735,158 ) Outstanding at March 31, 2022 12,948,137 |
ORGANIZATION (Details Narrative
ORGANIZATION (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | |
ORGANIZATION | ||||||
Accumulated deficit | $ 375,226,078 | $ 375,226,078 | $ 351,795,397 | |||
Net loss | (7,631,586) | $ (5,729,660) | (23,430,681) | $ (19,662,211) | ||
Cash and cash equivalents | 37,719,531 | $ 68,641,312 | 37,719,531 | $ 68,641,312 | 60,104,919 | $ 82,852,270 |
Total current liabilities | $ 11,976,647 | $ 11,976,647 | $ 10,511,788 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - Product Revenue - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | |
Gross product sales | $ 1,294,560 | $ 1,780,020 | $ 3,497,110 | $ 3,533,070 |
Provision for product sales allowances and accruals | 1,078,463 | 1,691,279 | 3,049,391 | 2,205,581 |
Net sales | $ 216,097 | $ 88,741 | $ 447,719 | $ (363,790) |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||||
Cash and cash equivalents | $ 37,651,838 | $ 37,651,838 | $ 59,730,428 | ||
Accumulated depreciation and amortization | $ 2,588,210 | $ 2,588,210 | $ 2,503,966 | ||
Potential number of common shares excluded from diluted EPS | 27,694,397 | 27,694,397 | 37,336,040 | 37,336,040 | |
Weighted average vested restricted stock units | 7,012,500 | 6,776,750 | |||
Additional Property and equipment | $ 309,791 | $ 309,791 | |||
Description of finance lease | lease obligations for two new finance leases, each with a term of three years |
AGREEMENTS WITH AMAG (Details N
AGREEMENTS WITH AMAG (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2022 | Mar. 31, 2021 | Jul. 24, 2020 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |||||
Contract Termination Agreement Payments | $ 4,300,000 | $ 12,000,000 | |||
Estimated loss on Invenntory purcahse | $ 18,194,000 | ||||
Accrued Expenses on Inventory Purchase | $ 2,300,000 | ||||
Gain on license termination agreement | $ 1,623,795 | ||||
Loss on the Termination Agreement | $ 4,407,987 | ||||
Total Loss on Agreement | $ 2,784,192 | ||||
Inventory and prepaid expenses estimated fair value | $ 5,817,795 |
AGREEMENT WITH FOSUN (Details N
AGREEMENT WITH FOSUN (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | |
Dec. 31, 2017 | Oct. 31, 2017 | Mar. 31, 2022 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | |||
Company License Agreement Recievables | $ 4,500,000 | ||
Upfront Payments | $ 500,000 | 5,000,000 | |
Tax Expense | 82,500 | 500,000 | |
Milestone payment receivable | 3,000,000 | 7,500,000 | |
Additional Sales Recievable | $ 37,500,000 | $ 92,500,000 | |
License and contract revenue | $ 250,000 |
AGREEMENT WITH KWANGDONG (Detai
AGREEMENT WITH KWANGDONG (Details Narrative) - USD ($) | 1 Months Ended | |
Dec. 31, 2017 | Oct. 31, 2017 | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Recievable under company agreement | $ 417,500 | |
Upfront payments | 500,000 | $ 5,000,000 |
Tax Expense | 82,500 | 500,000 |
Additional Sales Recievable | 37,500,000 | 92,500,000 |
Milestone payment receivable | $ 3,000,000 | $ 7,500,000 |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) | Mar. 31, 2022 | Jun. 30, 2021 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | ||
Clinical / regulatory costs | $ 1,037,350 | $ 454,750 |
Insurance premiums | 39,864 | 259,468 |
Vyleesi contractual advances | 815,750 | 1,200,000 |
Other | 811,922 | 1,145,461 |
Total prepaid expenses and other current assets | $ 2,704,886 | $ 3,059,679 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Mar. 31, 2022 | Jun. 30, 2021 |
Money Market Account | $ 37,651,838 | $ 59,730,428 |
Level 1 | ||
Money Market Account | 37,651,838 | 59,730,428 |
Level 2 | ||
Money Market Account | 0 | 0 |
Level 3 | ||
Money Market Account | $ 0 | $ 0 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Mar. 31, 2022 | Jun. 30, 2021 |
ACCRUED EXPENSES | ||
Clinical / regulatory costs | $ 1,338,025 | $ 778,705 |
Other research related expenses | 759,308 | 569,370 |
Professional services | 47,797 | 84,094 |
Inventory purchases | 0 | 2,340,000 |
Selling expenses | 910,545 | 1,839,724 |
Other | 119,739 | 185,485 |
Accrued expenses | $ 3,175,414 | $ 5,797,378 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | Mar. 31, 2022USD ($) |
Inventory purchase commitments | $ 9,832,614 |
Current | |
Inventory purchase commitments | 5,931,414 |
1 - 3 Years | |
Inventory purchase commitments | 2,896,800 |
4 - 5 Years | |
Inventory purchase commitments | $ 1,004,400 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) | Mar. 31, 2022 | Jun. 30, 2021 |
COMMITMENTS AND CONTINGENCIES | ||
Other Liabilities Current | $ 5,931,414 | $ 3,721,907 |
Accrued Other long-term Liabilities | $ 2,995,000 | $ 6,232,907 |
STOCKHOLDERS EQUITY (Details )
STOCKHOLDERS EQUITY (Details ) | 9 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
Stockholders equity: | |
Number of Shares Outstanding, Beginning | shares | 21,882,500 |
Number of Shares Granted | shares | 197,650 |
Number of Shares Forfeited | shares | (240,528) |
Number of Shares Exercised | shares | (43,600) |
Number of Shares Expired | shares | (103,349) |
Number of Shares Outstanding, Ending | shares | 21,692,673 |
Number of Shares Exercisable | shares | 14,155,952 |
Number of Shares Expected to vest | shares | 7,536,721 |
Weighted Average Exercise Price Outstanding, Beginning | $ / shares | $ 0.72 |
Weighted Average Exercise Price Granted | $ / shares | 0.48 |
Weighted Average Exercise Price Forfeited | $ / shares | 0.69 |
Weighted Average Exercise Price Exercised | $ / shares | 0.37 |
Weighted Average Exercise Price Expired | $ / shares | 0.81 |
Weighted Average Exercise Price Outstanding, Ending | $ / shares | 0.72 |
Weighted Average Exercise Price Exercisable | $ / shares | 0.75 |
Weighted Average Exercise Price Options Expected to vest | $ / shares | $ 0.68 |
Weighted Average Remaining Term in Years Options outstanding at beginning of year | 7 years 2 months 12 days |
Weighted Average Remaining Term in Years Options outstanding at end of year | 6 years 6 months |
Weighted Average Remaining Term in Years Options exercisable at end of year | 5 years 6 months |
Weighted Average Remaining Term in Years Options Expected to vest | 8 years 4 months 24 days |
Aggregate Intrinsic Value Options outstanding, Beginning | $ | $ 1,034,273 |
Aggregate Intrinsic Value Options outstanding, Ending | $ | 237,370 |
Aggregate Intrinsic Value Options exercisable | $ | 236,358 |
Aggregate Intrinsic Value Options expected to vest | $ | $ 1,012 |
STOCKHOLDERS EQUITY (Details 1)
STOCKHOLDERS EQUITY (Details 1) | 9 Months Ended |
Mar. 31, 2022shares | |
Stockholders equity: | |
Outstanding at beginning of year | 14,840,762 |
Forfeited | (157,467) |
Vested | (1,735,158) |
Outstanding at ending of year | 12,948,137 |
STOCKHOLDERS EQUITY (Details Na
STOCKHOLDERS EQUITY (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2020 | |
Stock based compensation, options | $ 329,146 | $ 453,439 | $ 1,108,693 | $ 1,409,224 | ||
Company received | $ 280,000 | $ 280,000 | ||||
Common stock share, issued | 350,000 | 350,000 | ||||
Exercise price | $ 2 | $ 0.80 | $ 0.80 | |||
Decription of commission | The Company pays Canaccord 3.0% of the gross proceeds as a commission | |||||
Aggregate shares | 40,000,000 | 40,000,000 | ||||
Aggregate value | $ 13,041 | $ 221,311 | ||||
Vesting of restricted share | 32,603 | 404,779 | ||||
Unvested performance-based restricted stock | $ 1,605,573 | $ 332,785 | ||||
Stock based compensation, restricted stock units | $ 204,633 | $ 321,866 | $ 681,254 | $ 1,049,938 | ||
Performance-based restricted stock | 450,000 | |||||
Vested shares not issued | $ 7,012,500 | |||||
Series J warrants | ||||||
Common stock share, issued | 350,000 | 350,000 | ||||
Executive Officers | ||||||
Unvested performance-based restricted stock units granted | 1,630,020 | 1,630,020 | ||||
Other Employees | ||||||
Unvested performance-based restricted stock units granted | 275,208 | 275,208 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] - USD ($) | May 13, 2022 | May 12, 2022 |
Series B Preferred Stock [Member] | ||
Preferred stock issued | 8,100,000 | |
Warrants to purchase shares | 1,666,667 | |
Exercise price | $ 0.5 | |
Convertible Preferred Stock | 33,333,333 | |
Aggregate value of preferred stock | $ 15,000,000 | |
Redemption fee | $ 750,000 | |
Series C Preferred Stock [Member] | ||
Preferred stock issued | 900,000 | |
Warrants to purchase shares | 1,666,667 | |
Exercise price | $ 0.50 | |
Convertible Preferred Stock | 33,333,333 | |
Aggregate value of preferred stock | $ 15,000,000 | |
Redemption fee | $ 750,000 | |
Purchase price | $ 1.67 | |
Conversion price | $ 0.45 | |
Votes per share | 20,000 |