Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Sep. 30, 2015 | Nov. 10, 2015 | |
Document And Entity Information | ||
Entity Registrant Name | PALATIN TECHNOLOGIES INC | |
Entity Central Index Key | 911,216 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --06-30 | |
Is Entity a Well-known Seasoned Issuer? | No | |
Is Entity a Voluntary Filer? | No | |
Is Entity's Reporting Status Current? | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 68,030,008 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2,016 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unuadited) - USD ($) | Sep. 30, 2015 | Jun. 30, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 47,523,791 | $ 27,299,268 |
Prepaid expenses and other current assets | 1,810,151 | 1,896,747 |
Total current assets | 49,333,942 | 29,196,015 |
Property and equipment, net | 130,199 | 123,158 |
Other assets | 219,983 | 155,279 |
Total assets | 49,684,124 | 29,474,452 |
Current liabilities: | ||
Accounts payable | 3,436,844 | 1,106,484 |
Accrued expenses | 6,247,586 | $ 6,223,483 |
Notes payable, net of discount | 907,259 | |
Capital lease obligations | 26,251 | $ 25,871 |
Total current liabilities | 10,617,940 | 7,355,838 |
Notes payable, net of discount, net of current portion | 18,618,459 | 9,781,086 |
Capital lease obligations | 35,041 | 41,749 |
Other non-current liabilities | 178,261 | 91,304 |
Total liabilities | 29,449,701 | 17,269,977 |
Stockholders' equity: | ||
Preferred stock of $0.01 par value - authorized 10,000,000 shares; Series A Convertible; issued and outstanding 4,030 shares as of September 30, 2015 and 4,697 shares as of June 30, 2015, respectively | 40 | 47 |
Common stock of $0.01 par value - authorized 300,000,000 shares; issued and outstanding 68,029,352 shares as of September 30, 2015 and 57,128,433 shares as of June 30, 2015, respectively | 680,293 | 571,284 |
Additional paid-in capital | 323,663,325 | 303,332,460 |
Accumulated deficit | (304,109,235) | (291,699,316) |
Total stockholders' equity | 20,234,423 | 12,204,475 |
Total liabilities and stockholders' equity | $ 49,684,124 | $ 29,474,452 |
Consolidated Balance Sheets (U3
Consolidated Balance Sheets (Unuadited) (Parenthetical) - $ / shares | Sep. 30, 2015 | Jun. 30, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, Series A Convertible, shares issued | 4,030 | 4,697 |
Preferred stock, Series A Convertible, shares outstanding | 4,030 | 4,697 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 68,029,352 | 57,128,433 |
Common stock, shares outstanding | 68,029,352 | 57,128,433 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
REVENUES: | ||
License revenue | $ 4,932,315 | |
OPERATING EXPENSES: | ||
Research and development | $ 10,597,714 | 2,923,966 |
General and administrative | 1,199,937 | 1,114,461 |
Total operating expenses | 11,797,651 | 4,038,427 |
(Loss) income from operations | (11,797,651) | 893,888 |
OTHER INCOME (EXPENSE): | ||
Interest income | 15,740 | 3,799 |
Interest expense | $ (628,008) | (1,730) |
Foreign exchange transaction loss | (101,283) | |
Total other income (expense), net | $ (612,268) | (99,214) |
NET (LOSS) INCOME | $ (12,409,919) | $ 794,674 |
Basic net (loss) income per common share | $ (0.08) | $ 0.01 |
Diluted net (loss) income per common share | $ (0.08) | $ 0.01 |
Weighted average number of common shares outstanding used in computing basic net (loss) income per common share | 156,357,755 | 106,953,898 |
Weighted average number of common shares outstanding used in computing diluted net (loss) income per common share | 156,357,755 | 107,946,021 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net (loss) income | $ (12,409,919) | $ 794,674 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 10,654 | $ 27,593 |
Non-cash interest expense | 80,739 | |
Stock-based compensation | 300,394 | $ 252,471 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 137,095 | (9,285) |
Accounts payable | 2,239,604 | 300,081 |
Accrued expenses | $ 156,062 | 427,334 |
Deferred revenue | $ 3,932,315 | |
Other non-current liabilities | $ 86,957 | |
Net cash (used in) provided by operating activities | (9,398,414) | $ 5,725,183 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (17,695) | |
Net cash used in investing activities | (17,695) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payments on capital lease obligations | (6,328) | |
Payment of withholding taxes related to restricted stock units | (131,959) | $ (122,068) |
Proceeds from the sale of warrants, net of costs | 19,919,883 | |
Proceeds from the issuance of notes payable and warrants | 10,000,000 | |
Payment of debt issuance costs | (140,964) | |
Net cash provided by (used in) financing activities | 29,640,632 | $ (122,068) |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 20,224,523 | 5,603,115 |
CASH AND CASH EQUIVALENTS, beginning of period | 27,299,268 | 12,184,605 |
CASH AND CASH EQUIVALENTS, end of period | 47,523,791 | 17,787,720 |
SUPPLEMENTAL CASH FLOW INFORMATION: | ||
Cash paid for interest | 460,313 | $ 1,730 |
Issuance of warrants in connection with debt financing | 305,196 | |
Non-cash equity financing costs in accounts payable | 85,605 | |
Non-cash debt financing costs in accounts payable | $ 5,151 |
ORGANIZATION
ORGANIZATION | 3 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION | Nature of Business The Companys primary product in development is bremelanotide for the treatment of female sexual dysfunction (FSD). The Company also has drug candidates or development programs for obesity, erectile dysfunction, cardiovascular diseases, pulmonary diseases, inflammatory diseases and dermatologic diseases. Key elements of the Companys business strategy include using its technology and expertise to develop and commercialize therapeutic products; entering into alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that the Company is developing; and partially funding its product candidate development programs with the cash flow generated from third parties. Business Risk and Liquidity As discussed in Note 10, on July 2, 2015, the Company closed a $20.0 million private placement of Series E 2015 warrants to purchase 21,917,808 shares of common stock and Series F 2015 warrants to purchase 2,191,781 shares of common stock and also concurrently closed a $10.0 million venture loan led by Horizon Technology Finance Corporation (Horizon), as discussed in Note 9. As of September 30, 2015, the Companys cash and cash equivalents were $47.5 million. The Company intends to utilize existing capital resources for general corporate purposes and working capital, including the Phase 3 clinical trial program with bremelanotide for FSD and preclinical and clinical development of our other product candidates and programs, including PL-3994 and melanocortin recetptor-1 and melanocortin receptor-4 programs. Management believes that the Phase 3 clinical trial program with bremelanotide, including regulatory filings for product approval, will cost at least $80.0 million. Management believes that the Companys existing capital resources will be adequate to fund its planned operations through the quarter ending September 30, 2016. Concentrations |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION | The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles 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 months ended September 30, 2015 may not necessarily be indicative of the results of operations expected for the full year, except that the Company expects to incur a significant loss for the fiscal year ending June 30, 2016. The accompanying consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Companys annual report on Form 10-K for the year ended June 30, 2015, filed with the Securities and Exchange Commission (SEC), which includes consolidated financial statements as of June 30, 2015 and 2014 and for each of the fiscal years in the three-year period ended June 30, 2015. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | Principles of Consolidation Use of Estimates Cash and Cash Equivalents Fair Value of Financial Instruments Credit Risk Property and Equipment Impairment of Long-Lived Assets Revenue Recognition Revenue resulting from license fees is recognized upon delivery of the license for the portion of the license fee payment that is non-contingent and non-refundable, if the license has standalone value. Revenue resulting from the achievement of development milestones is recorded in accordance with the accounting guidance for the milestone method of revenue recognition. Research and Development Costs Accrued Expenses Stock-Based Compensation Income Taxes Net (Loss) Income per Common Share The Series B 2012 warrants to purchase up to 35,488,380 shares of common stock were considered contingently issuable shares and were not included in computing basic net loss per common share until the Company received stockholder approval for the increase in authorized underlying common stock on September 27, 2012. For diluted EPS, contingently issuable shares are to be included in the calculation as of the beginning of the period in which the conditions were satisfied, unless the effect would be anti-dilutive. The Series B 2012 warrants were excluded from the calculation of diluted net loss per common share during the period from July 3, 2012 until September 27, 2012 as the impact would be anti-dilutive. The Series C 2014 warrants to purchase up to 24,949,325 shares of common stock were exercisable starting at December 23, 2014 and, therefore are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on December 23, 2014. The Series E 2015 warrants to purchase up to 21,917,808 shares of common stock were exercisable starting at July 2, 2015 and, therefore are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on July 2, 2015 (Note 10). The following table is a reconciliation of net (loss) income and the shares used in calculating basic and diluted net (loss) income per common share for the three months ended September 30, 2015 and 2014: Three Months Ended September 30, 2015 2014 Numerator: Net (loss) income $ (12,409,919 ) $ 794,674 Denominator: Weighted average common shares outstanding - Basic 156,357,755 $ 106,953,898 Effect of dilutive shares: Common stock equivalents arising from stock options and warrants - 799,139 Restricted stock units - 192,984 Weighted average common shares outstanding - Diluted 156,357,755 107,946,021 Net (loss) income per common share: Basic $ (0.08 ) $ 0.01 Diluted $ (0.08 ) $ 0.01 As of September 30, 2015 and 2014, common shares issuable upon conversion of Series A Convertible Preferred Stock, the exercise of outstanding options and warrants (excluding the Series A 2012, Series B 2012, Series C 2014, and Series E 2015 warrants issued in connection with the July 3, 2012, December 23, 2014, and July 2, 2015 private placement offerings), and the vesting of restricted stock units amounted to an aggregate of 32,908,798, and 27,911,551 shares, respectively, and are excluded in the weighted average number of common shares outstanding used in computing diluted net (loss) income per common share as they are anti-dilutive. For the three months ended September 30, 2015, no additional common shares were added in the computation of diluted EPS because to do so would have been anti-dilutive for this period. |
NEW AND RECENTLY ADOPTED ACCOUN
NEW AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Sep. 30, 2015 | |
Notes to Financial Statements | |
NEW AND RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS | In April 2015, the FASB issued ASU No. 2015-03, Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented on the balance sheet as a direct deduction from the debt liability, similar to the presentation of debt discounts. In August 2015, the FASB issued a clarification that debt issuance costs related to line-of-credit arrangements were not within the scope of the new guidance and therefore should continue to be accounted for as deferred assets in the balance sheet, consistent with existing GAAP. The new standard is effective for the Company for its fiscal year ending June 30, 2017. The Company is evaluating the effect of the standard on its consolidated financial statements. In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements-Going Concern: Disclosures of Uncertainties about an Entitys Ability to Continue as a Going Concern. The amendments in this update provide guidance in U.S. GAAP about management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. In doing so, the amendments should reduce diversity in the timing and content of footnote disclosures. The new standard is effective for the Company for its fiscal year ending June 30, 2017. The Company is evaluating the effect of the standard, if any, on its consolidated financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In July 2015, the FASB voted to defer the effective date of the new standard until fiscal years beginning after December 15, 2017 with early application permitted for fiscal years beginning after December 15, 2016. With the deferral, the new standard is effective for the Company on July 1, 2018, with early adoption permitted one year prior. The standard permits the use of either the retrospective or cumulative effect transition method. The Company is evaluating the effect that ASU 2014-09 will have on its consolidated financial statements and related disclosures. The Company has not yet selected a transition method nor has it determined the effect of the standard on its ongoing financial reporting. |
AGREEMENT WITH ASTRAZENECA
AGREEMENT WITH ASTRAZENECA | 3 Months Ended |
Sep. 30, 2015 | |
Agreement With Astrazeneca | |
AGREEMENT WITH ASTRAZENECA | In January 2007, the Company entered into an exclusive global research collaboration and license agreement with AstraZeneca to discover, develop and commercialize compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome. This agreement expired because AstraZeneca ceased developing a compound covered by the agreement. All rights and licenses that we granted to AstraZeneca terminated upon expiration of the agreement. |
AGREEMENT WITH GEDEON RICHTER
AGREEMENT WITH GEDEON RICHTER | 3 Months Ended |
Sep. 30, 2015 | |
Notes to Financial Statements | |
AGREEMENT WITH GEDEON RICHTER | In August 2014, the Company entered into a license, co-development and commercialization agreement with Gedeon Richter on bremelanotide for FSD in Europe and selected countries. On September 16, 2015, the Company and Gedeon Richter mutually and amicably agreed to terminate the license, co-development and commercialization agreement. In connection with the termination of the license agreement, all rights and licenses to co-develop and commercialize bremelanotide for FSD indications granted by the Company under the license agreement to Gedeon Richter terminated and reverted to the Company, and neither party is expected to have any future material obligations under the license agreement. Neither the Company nor Gedeon Richter incurred any early termination penalties or other payment or reimbursement obligations as a result of the termination of the license agreement. The Company viewed the delivery of the license for bremelanotide as a revenue generating activity that is part of its ongoing and central operations. The other elements of the agreement with Gedeon Richter were considered non-revenue activities associated with the collaborative arrangement. The Company believes the license had standalone value from the other elements of the collaborative arrangement because it conveyed all of the rights necessary to develop and commercialize bremelanotide in the licensed territory. In August 2013, the Company received an initial payment of $1.0 million from Gedeon Richter as a non-refundable option fee on the license, co-development and commercialization agreement, and in September 2014, the Company received 6.7 million ($8.8 million) on execution of the definitive agreement. During the three months ended September 30, 2014, the portion of the license payment that was non-contingent and non-refundable was recorded as license revenue in the consolidated statements of operations. As a result of fluctuations in the conversion rates between the Euro and the U.S. Dollar between the transaction date and the settlement date, the Company recorded a foreign exchange transaction loss of $101,283 for the three months ended September 30, 2014. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
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 managements own assumptions used to measure assets and liabilities at fair value. A financial asset or liabilitys 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 active markets (Level 1) Other quoted/observable inputs (Level 2) Significant unobservable inputs (Level 3) September 30, 2015: Money Market Account $ 47,363,849 $ 47,363,849 $ - $ - June 30, 2015: Money Market Account $ 26,946,378 $ 26,946,378 $ - $ - |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Sep. 30, 2015 | |
Accrued Expenses | |
ACCRUED EXPENSES | Accrued expenses consist of the following: September 30, 2015 June 30, 2015 Clinical study costs $ 5,676,759 $ 5,594,839 Other research related expenses 418,823 176,105 Professional services 90,635 201,831 Other 61,369 250,708 $ 6,247,586 $ 6,223,483 |
NOTES PAYABLE
NOTES PAYABLE | 3 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | Notes payable consist of the following: September 30, 2015 June 30, 2015 Notes payable under venture loan $ 20,000,000 $ 10,000,000 Unamortized related debt discount (474,282 ) (218,914 ) Notes payable $ 19,525,718 $ 9,781,086 Less: current portion 907,259 - Long-term portion $ 18,618,459 $ 9,781,086 On July 2, 2015, the Company closed on a $10.0 million venture loan led by Horizon. The debt facility is a four year senior secured term loan that bears interest at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus 8.50% and which includes an interest-only payment period for the first eighteen months followed by monthly payments of principal payments of $333,333 plus accrued interest through August 1, 2019. The lenders also received five-year immediately exercisable Series G warrants to purchase 549,450 shares of Palatin common stock exercisable at an exercise price of $0.91 per share. The Company has recorded a debt discount of $305,196 equal to the fair value of these warrants at issuance, which is being amortized to interest expense over the term of the related debt. This debt discount will offset against the note payable balance and is included in additional paid-in capital on the Companys balance sheet at September 30, 2015. In addition, a final incremental payment of $500,000 is due on August 1, 2019, or upon early repayment of the loan. This final incremental payment is being accreted to interest expense over the term of the related debt. The Company incurred approximately $146,000 of costs in connection with the loan agreement. These costs were capitalized as deferred financing costs and are being amortized to interest expense over the term of the related debt. In addition, if the Company repays all or a portion of the loan prior to the applicable maturity date, it will pay the lenders a prepayment penalty fee, based on a percentage of the then outstanding principal balance, equal to 3% if the prepayment occurs on or before 18 months after the funding date thereof or 1% if the prepayment occurs more than 18 months after, but on or before 30 months after, the funding date. On December 23, 2014, the Company closed on a $10.0 million venture loan which was led by Horizon. The debt facility is a four year senior secured term loan that bears interest at a floating coupon rate of one-month LIBOR (floor of 0.50%) plus 8.50%, and provides for interest-only payments for the first eighteen months followed by monthly payments of principal payments of $333,333 plus accrued interest through January 1, 2019. The lenders also received five-year immediately exercisable Series D 2014 warrants to purchase 666,666 shares of common stock exercisable at an exercise price of $0.75 per share. The Company recorded a debt discount of $267,820 equal to the fair value of these warrants at issuance, which is being amortized to interest expense over the term of the related debt. This debt discount is offset against the note payable balance and included in additional paid-in capital on the Companys balance sheet at September 30, 2015, and June 30, 2015. In addition, a final incremental payment of $500,000 is due on January 1, 2019, or upon early repayment of the loan. This final incremental payment is being accreted to interest expense over the term of the related debt. The Company incurred $209,000 of costs in connection with the loan agreement. These costs were capitalized as deferred financing costs and are being amortized to interest expense over the term of the related debt. In addition, if the Company repays all or a portion of the loan prior to the applicable maturity date, it will pay the lenders a prepayment penalty fee, based on a percentage of the then outstanding principal balance, equal to 3% if the prepayment occurs on or before 18 months after the funding date thereof or 1% if the prepayment occurs more than 18 months after, but on or before 30 months after, the funding date. The Companys obligations under these loan agreements are secured by a first priority security interest in substantially all of its assets other than its intellectual property. The Company also has agreed to specified limitations on pledging or otherwise encumbering its intellectual property assets. These loan agreements include customary affirmative and restrictive covenants, but do not include any covenants to attain or maintain specified financial metrics. These loan agreements include customary events of default, including payment defaults, breaches of covenants, change of control and a material adverse change default. Upon the occurrence of an event of default and following any applicable cure periods, a default interest rate of an additional 5% may be applied to the outstanding loan balances, and the lenders may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the loan agreement. As of September 30, 2015, the Company was in compliance with all of its loan covenants. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 3 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
STOCKHOLDERS' EQUITY | Stock Warrants - The Series E warrants, which may be exercised on a cashless basis, are exercisable immediately upon issuance at an initial exercise price of $0.01 per share and expire on the tenth anniversary of the date of issuance. The Series E warrants are subject to limitation on exercise if QVT and its affiliates would beneficially own more than 9.99% (4.99% for the other accredited investment fund holder) of the total number of Palatin's shares of common stock following such exercise. The Series F warrants are exercisable at an initial exercise price of $0.91 per share, exercisable immediately upon issuance and expire on the fifth anniversary of the date of issuance. The Series F warrants are subject to the same beneficial ownership limitation as the Series E warrants. The purchase agreement for the private placement provides that the purchasers have certain rights until the earlier of approval of bremelanotide for FSD by the U.S. Food and Drug Administration and July 3, 2018, including rights of first refusal and participation in any subsequent equity or debt financing. The purchase agreement also contains certain restrictive covenants so long as the funds continue to hold specified amounts of warrants or beneficially own specified amounts of the outstanding shares of common stock. During the three months ended September 30, 2015, the Company issued 10,890,889 shares of common stock pursuant to the cashless exercise provisions of warrants at an exercise price of $0.01. Stock Options In June 2014, the Company granted 325,000 options to its executive officers, 143,400 options to its employees and 135,000 options to its non-employee directors under the Companys 2011 Stock Incentive Plan. The Company is amortizing the fair value of these options of $265,726, $117,247 and $97,530, respectively, over the vesting period. The Company recognized $20,683 and $45,219, respectively, of stock-based compensation expense related to these options during the three months ended September 30, 2015 and 2014. Stock options granted to the Companys executive officers and employees vest over a 48 month period, while stock options granted to its non-employee directors vest over a 12 month period. Restricted Stock Units In June 2014, the Company granted 325,000 restricted stock units to its executive officers, 143,400 restricted stock units to its employees and 135,000 restricted stock units to its non-employee directors under the Companys 2011 Stock Incentive Plan. The Company is amortizing the fair value of these restricted stock units of $331,500, $146,268 and $137,700, respectively, over the vesting period. The Company recognized $29,901, and $115,627, respectively, of stock-based compensation expense related to these restricted stock units during the three months ended September 30, 2015 and 2014. Restricted stock units granted to the Companys executive officers, employees and non-employee directors in 2015 and 2014 vest over 24 months, 48 months and 12 months, respectively. Stock-based compensation cost for the three months ended September 30, 2015 for stock options and equity-based instruments issued other than the stock options and restricted stock units described above was $41,905, and $91,625 for the three months ended September 30, 2014. |
ORGANIZATION (Policies)
ORGANIZATION (Policies) | 3 Months Ended |
Sep. 30, 2015 | |
Organization Policies | |
Nature of Business | Nature of Business The Companys primary product in development is bremelanotide for the treatment of female sexual dysfunction (FSD). The Company also has drug candidates or development programs for obesity, erectile dysfunction, cardiovascular diseases, pulmonary diseases, inflammatory diseases and dermatologic diseases. Key elements of the Companys business strategy include using its technology and expertise to develop and commercialize therapeutic products; entering into alliances and partnerships with pharmaceutical companies to facilitate the development, manufacture, marketing, sale and distribution of product candidates that the Company is developing; and partially funding its product candidate development programs with the cash flow generated from third parties. |
Business Risk and Liquidity | Business Risk and Liquidity As discussed in Note 10, on July 2, 2015, the Company closed a $20.0 million private placement of Series E 2015 warrants to purchase 21,917,808 shares of common stock and Series F 2015 warrants to purchase 2,191,781 shares of common stock and also concurrently closed a $10.0 million venture loan led by Horizon Technology Finance Corporation (Horizon), as discussed in Note 9. As of September 30, 2015, the Companys cash and cash equivalents were $47.5 million. The Company intends to utilize existing capital resources for general corporate purposes and working capital, including the Phase 3 clinical trial program with bremelanotide for FSD and preclinical and clinical development of our other product candidates and programs, including PL-3994 and melanocortin recetptor-1 and melanocortin receptor-4 programs. Management believes that the Phase 3 clinical trial program with bremelanotide, including regulatory filings for product approval, will cost at least $80.0 million. Management believes that the Companys existing capital resources will be adequate to fund its planned operations through the quarter ending September 30, 2016. |
Concentrations | Concentrations |
SUMMARY OF SIGNIFICANT ACCOUN17
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Sep. 30, 2015 | |
Summary Of Significant Accounting Policies 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 |
Property and Equipment | Property and Equipment |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets |
Revenue Recognition | Revenue Recognition Revenue resulting from license fees is recognized upon delivery of the license for the portion of the license fee payment that is non-contingent and non-refundable, if the license has standalone value. Revenue resulting from the achievement of development milestones is recorded in accordance with the accounting guidance for the milestone method of revenue recognition. |
Research and Development Costs | Research and Development Costs |
Accrued Expenses | Accrued Expenses |
Stock-Based Compensation | Stock-Based Compensation |
Income Taxes | Income Taxes |
Net (Loss) Income per Common Share | Net (Loss) Income per Common Share The Series B 2012 warrants to purchase up to 35,488,380 shares of common stock were considered contingently issuable shares and were not included in computing basic net loss per common share until the Company received stockholder approval for the increase in authorized underlying common stock on September 27, 2012. For diluted EPS, contingently issuable shares are to be included in the calculation as of the beginning of the period in which the conditions were satisfied, unless the effect would be anti-dilutive. The Series B 2012 warrants were excluded from the calculation of diluted net loss per common share during the period from July 3, 2012 until September 27, 2012 as the impact would be anti-dilutive. The Series C 2014 warrants to purchase up to 24,949,325 shares of common stock were exercisable starting at December 23, 2014 and, therefore are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on December 23, 2014. The Series E 2015 warrants to purchase up to 21,917,808 shares of common stock were exercisable starting at July 2, 2015 and, therefore are included in the weighted average number of common shares outstanding used in computing basic and diluted net loss per common share starting on July 2, 2015 (Note 10). The following table is a reconciliation of net (loss) income and the shares used in calculating basic and diluted net (loss) income per common share for the three months ended September 30, 2015 and 2014: Three Months Ended September 30, 2015 2014 Numerator: Net (loss) income $ (12,409,919 ) $ 794,674 Denominator: Weighted average common shares outstanding - Basic 156,357,755 $ 106,953,898 Effect of dilutive shares: Common stock equivalents arising from stock options and warrants - 799,139 Restricted stock units - 192,984 Weighted average common shares outstanding - Diluted 156,357,755 107,946,021 Net (loss) income per common share: Basic $ (0.08 ) $ 0.01 Diluted $ (0.08 ) $ 0.01 As of September 30, 2015 and 2014, common shares issuable upon conversion of Series A Convertible Preferred Stock, the exercise of outstanding options and warrants (excluding the Series A 2012, Series B 2012, Series C 2014, and Series E 2015 warrants issued in connection with the July 3, 2012, December 23, 2014, and July 2, 2015 private placement offerings), and the vesting of restricted stock units amounted to an aggregate of 32,908,798, and 27,911,551 shares, respectively, and are excluded in the weighted average number of common shares outstanding used in computing diluted net (loss) income per common share as they are anti-dilutive. For the three months ended September 30, 2015, no additional common shares were added in the computation of diluted EPS because to do so would have been anti-dilutive for this period. |
SUMMARY OF SIGNIFICANT ACCOUN18
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Sep. 30, 2015 | |
Summary Of Significant Accounting Policies Tables | |
Schedule of earnings per share | Three Months Ended September 30, 2015 2014 Numerator: Net (loss) income $ (12,409,919 ) $ 794,674 Denominator: Weighted average common shares outstanding - Basic 156,357,755 $ 106,953,898 Effect of dilutive shares: Common stock equivalents arising from stock options and warrants - 799,139 Restricted stock units - 192,984 Weighted average common shares outstanding - Diluted 156,357,755 107,946,021 Net (loss) income per common share: Basic $ (0.08 ) $ 0.01 Diluted $ (0.08 ) $ 0.01 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Sep. 30, 2015 | |
Fair value of restricted stock units granted, amortized over 24 month vesting period | |
Schedule of assets at fair value | Carrying Value Quoted prices in active markets (Level 1) Other quoted/observable inputs (Level 2) Significant unobservable inputs (Level 3) September 30, 2015: Money Market Account $ 47,363,849 $ 47,363,849 $ - $ - June 30, 2015: Money Market Account $ 26,946,378 $ 26,946,378 $ - $ - |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Sep. 30, 2015 | |
Accrued Expenses | |
Accrued Expenses | September 30, 2015 June 30, 2015 Clinical study costs $ 5,676,759 $ 5,594,839 Other research related expenses 418,823 176,105 Professional services 90,635 201,831 Other 61,369 250,708 $ 6,247,586 $ 6,223,483 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 3 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
Notes Payable | September 30, 2015 June 30, 2015 Notes payable under venture loan $ 20,000,000 $ 10,000,000 Unamortized related debt discount (474,282 ) (218,914 ) Notes payable $ 19,525,718 $ 9,781,086 Less: current portion 907,259 - Long-term portion $ 18,618,459 $ 9,781,086 |
ORGANIZATION (Details Narrative
ORGANIZATION (Details Narrative) - USD ($) | 3 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Jun. 30, 2015 | |
Accumulated deficit | $ (304,109,235) | $ (291,699,316) | |
Net loss | $ (12,409,919) | $ 794,674 | |
Gedeon Richter [Member] | Revenue [Member] | |||
Concentration risk revenue | 100.00% |
SUMMARY OF SIGNIFICANT ACCOUN23
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 3 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Numerator: | ||
Net (loss) income | $ (12,409,919) | $ 794,674 |
Denominator: | ||
Weighted average common shares outstanding - Basic | 156,357,755 | 106,953,898 |
Effect of dilutive shares: | ||
Common stock equivalents arising from stock options and warrants | 799,139 | |
Restricted stock units | 192,984 | |
Weighted average common shares outstanding - Diluted | 156,357,755 | 107,946,021 |
Net (loss) income per common share: | ||
Basic | $ (0.08) | $ 0.01 |
Diluted | $ (0.08) | $ 0.01 |
SUMMARY OF SIGNIFICANT ACCOUN24
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | Sep. 30, 2015 | Jun. 30, 2015 |
Summary Of Significant Accounting Policies Details | ||
Cash equivalents | $ 47,363,849 | $ 26,946,378 |
AGREEMENT WITH GEDEON RICHTER (
AGREEMENT WITH GEDEON RICHTER (Details Narrative) - USD ($) | 3 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Notes to Financial Statements | ||
Foreign exchange transaction loss | $ (101,283) |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Sep. 30, 2015 | Jun. 30, 2015 |
Money Market Account | $ 47,363,849 | $ 26,946,378 |
Level 1 | ||
Money Market Account | $ 47,363,849 | $ 26,946,378 |
Level 2 | ||
Money Market Account | ||
Level 3 | ||
Money Market Account |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) | Sep. 30, 2015 | Jun. 30, 2015 |
Accrued Expenses | ||
Clinical study costs | $ 5,676,759 | $ 5,594,839 |
Other research related expenses | 418,823 | 176,105 |
Professional services | 90,635 | 201,831 |
Other | 61,369 | 250,708 |
Accrued expenses | $ 6,247,586 | $ 6,223,483 |
NOTES PAYABLE (Details)
NOTES PAYABLE (Details) - USD ($) | Sep. 30, 2015 | Jun. 30, 2015 |
Notes Payable Details | ||
Notes payable under venture loan | $ 20,000,000 | $ 10,000,000 |
Unamortized related debt discount | (474,282) | (218,914) |
Notes payable | 19,525,718 | $ 9,781,086 |
Less: current portion | 907,259 | |
Long-term portion | $ 18,618,459 | $ 9,781,086 |