Acura Pharmaceuticals Inc. (ACUR, Financial) filed Quarterly Report for the period ended 2009-09-30.
Halsey Drug Company Inc. is engaged in the manufacture sale and distribution of generic drugs. A generic drug is the chemical and therapeutic equivalent of a brand-name drug for which patent protection has expired. The company sells its generic drug products under its Halsey label and under private-label arrangements with drugstore chains and drug wholesalers. Acura Pharmaceuticals Inc. has a market cap of $188.56 million; its shares were traded at around $4.39 with and P/S ratio of 4.24.
At October 26, 2009, we had cash and cash equivalents of approximately $32.0 million and estimate that our current cash reserves will be sufficient to fund operations and development of Aversion® Technology and related product candidates through at least the next 12 months. In December, 2007, we and King Research and Development Inc., ("King") closed a License, Development and Commercialization Agreement (the “King Agreement”) to develop and commercialize certain opioid analgesic products utilizing our proprietary Aversion® Technology in the United States, Canada and Mexico. During the nine months ended September 30, 2009, we recognized $2.7 million of the $30.0 million upfront cash payment received from King in December 2007 as program fee revenue and $0.4 million of collaboration revenue for reimbursement by King for our Acurox® Tablet development and regulatory expenses. We have yet to generate any royalty revenues from product sales. We expect to rely on our current cash resources and additional payments that may be made under the King Agreement and under similar license agreements with other pharmaceutical company partners, of which there can be no assurance, in funding our continued operations. Our cash requirements for operating activities may increase in the future as we continue to conduct pre-clinical studies and clinical trials for our product candidates, maintain, defend if necessary, and expand the scope of our intellectual property, hire additional personnel, or invest in other areas related to abuse deterrence.
King paid us a $30.0 million upfront fee in connection with the closing of the King Agreement in December 2007. Revenue recognized in the nine months ended September 30, 2009 and 2008 from amortization of this upfront fee was $2.7 million and $23.7 million, respectively. We assigned a portion of the program fee revenue to each of three product candidates identified under the King Agreement. Our development responsibilities for two of the three product candidates are complete. We expect to recognize the remainder of the program fee revenue for the third product candidate ratably over its remaining development period which we currently estimate to extend through July, 2010.
Collaboration revenue recognized in the nine months ending September 30, 2009 and 2008 was $0.4 million and $8.0 million, respectively, for reimbursement of our Acurox® Tablet development and regulatory expenses incurred pursuant to the King Agreement. We invoice King in arrears on a calendar quarter basis for our reimbursable development and regulatory expenses under the King Agreement. We expect the amount and timing of collaboration revenue to fluctuate in relation to the amount and timing of the underlying development and regulatory expenses.
Research and development expense during the nine months ending September 30, 2009 and 2008 were for developing our product candidates and related technologies, including costs of preclinical, clinical trials, clinical supplies and related formulation and design costs, salaries and other personnel related expenses, and facility costs. We incurred $1.3 million and $0.6 million of share-based compensation expense attributable to research and development staff for the nine months ended September 30, 2009 and 2008, respectively. Excluding this share-based compensation expense, we spent $7.8 million less in the nine months ended September 30, 2009 compared to the same period in 2008 on development, primarily attributable to fewer clinical study costs for Acurox® Tablets.
Marketing expenses during the nine months ending September 30, 2009 and 2008 consisted of Aversion® Technology primary market data research studies. Our general and administrative expenses primarily consisted of legal, audit and other professional fees, corporate insurance, and payroll. We incurred $5.2 million and $1.8 million share-based compensation expense attributable to general and administrative staff for the nine months ended September 30, 2009 and 2008, respectively.
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Halsey Drug Company Inc. is engaged in the manufacture sale and distribution of generic drugs. A generic drug is the chemical and therapeutic equivalent of a brand-name drug for which patent protection has expired. The company sells its generic drug products under its Halsey label and under private-label arrangements with drugstore chains and drug wholesalers. Acura Pharmaceuticals Inc. has a market cap of $188.56 million; its shares were traded at around $4.39 with and P/S ratio of 4.24.
Highlight of Business Operations:
As of September 30, 2009, we have received aggregate payments of $55.5 million from King, consisting of a $30.0 million non-refundable upfront cash payment, $14.5 million in reimbursed research and development expenses relating to Acurox® Tablets, $6.0 million in fees relating to King s exercise of its option to license the undisclosed opioid analgesic tablet product and Vycavert® Tablets, and a $5.0 million milestone fee for successful achievement of the primary endpoints for our pivotal Phase III clinical study for Acurox® Tablets. The King Agreement provides for King to pay us: (a) a $3.0 million option exercise fee for each future opioid product candidate King licenses, (b) up to $23 million in regulatory milestone payments for each King licensed product candidate, including Acurox® Tablets, in specific countries in the King Territory, and (c) a one-time $50 million sales milestone payment upon the first attainment of an aggregate of $750 million in net sales of all of our licensed products combined in all King Territories. In addition, for sales occurring following the one year anniversary of the first commercial sale of the first licensed product sold, King will pay us a royalty at one of 6 rates ranging from 5% to 25% based on the level of combined annual net sales for all products licensed by us to King in all King Territories, with the highest applicable royalty rate applied to such combined annual sales. No minimum annual fees are payable by either party under the King Agreement.At October 26, 2009, we had cash and cash equivalents of approximately $32.0 million and estimate that our current cash reserves will be sufficient to fund operations and development of Aversion® Technology and related product candidates through at least the next 12 months. In December, 2007, we and King Research and Development Inc., ("King") closed a License, Development and Commercialization Agreement (the “King Agreement”) to develop and commercialize certain opioid analgesic products utilizing our proprietary Aversion® Technology in the United States, Canada and Mexico. During the nine months ended September 30, 2009, we recognized $2.7 million of the $30.0 million upfront cash payment received from King in December 2007 as program fee revenue and $0.4 million of collaboration revenue for reimbursement by King for our Acurox® Tablet development and regulatory expenses. We have yet to generate any royalty revenues from product sales. We expect to rely on our current cash resources and additional payments that may be made under the King Agreement and under similar license agreements with other pharmaceutical company partners, of which there can be no assurance, in funding our continued operations. Our cash requirements for operating activities may increase in the future as we continue to conduct pre-clinical studies and clinical trials for our product candidates, maintain, defend if necessary, and expand the scope of our intellectual property, hire additional personnel, or invest in other areas related to abuse deterrence.
King paid us a $30.0 million upfront fee in connection with the closing of the King Agreement in December 2007. Revenue recognized in the nine months ended September 30, 2009 and 2008 from amortization of this upfront fee was $2.7 million and $23.7 million, respectively. We assigned a portion of the program fee revenue to each of three product candidates identified under the King Agreement. Our development responsibilities for two of the three product candidates are complete. We expect to recognize the remainder of the program fee revenue for the third product candidate ratably over its remaining development period which we currently estimate to extend through July, 2010.
Collaboration revenue recognized in the nine months ending September 30, 2009 and 2008 was $0.4 million and $8.0 million, respectively, for reimbursement of our Acurox® Tablet development and regulatory expenses incurred pursuant to the King Agreement. We invoice King in arrears on a calendar quarter basis for our reimbursable development and regulatory expenses under the King Agreement. We expect the amount and timing of collaboration revenue to fluctuate in relation to the amount and timing of the underlying development and regulatory expenses.
Research and development expense during the nine months ending September 30, 2009 and 2008 were for developing our product candidates and related technologies, including costs of preclinical, clinical trials, clinical supplies and related formulation and design costs, salaries and other personnel related expenses, and facility costs. We incurred $1.3 million and $0.6 million of share-based compensation expense attributable to research and development staff for the nine months ended September 30, 2009 and 2008, respectively. Excluding this share-based compensation expense, we spent $7.8 million less in the nine months ended September 30, 2009 compared to the same period in 2008 on development, primarily attributable to fewer clinical study costs for Acurox® Tablets.
Marketing expenses during the nine months ending September 30, 2009 and 2008 consisted of Aversion® Technology primary market data research studies. Our general and administrative expenses primarily consisted of legal, audit and other professional fees, corporate insurance, and payroll. We incurred $5.2 million and $1.8 million share-based compensation expense attributable to general and administrative staff for the nine months ended September 30, 2009 and 2008, respectively.
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