SCOLR Pharma, Inc. Reports Second Quarter 2007 Financial Results.BELLEVUE, Wash. -- SCOLR Pharma, Inc. (AMEX AMEX See: American Stock Exchange : DDD DDD Direct Distance Dialing DDD Digital/Digital/Digital (audio CD format, recording/mixing/mastering) DDD Degenerative Disc Disease DDD Domain Driven Design DDD Data Display Debugger (GNU Project) ) today reported financial results for the three and six months ended June 30, 2007. The Company will host a live conference call today, August 7, 2007, at 11:30 a.m. (Eastern Daylight Time). Total revenues increased to $422,056 for the three months ended June 30, 2007, compared to $279,179 for the same period in 2006. The increase was primarily a result of higher royalty income from SCOLR's alliance with Perrigo, which has introduced five products based on its Controlled Delivery Technology (CDT CDT abbr. Central Daylight Time CDT Central Daylight Time CDT n abbr (US) (= Central Daylight Time) → hora de verano del centro; (BRIT [R]), including three in late 2006, and one in June 2007. Net loss decreased 7%, or $156,000, to $2.1 million for the three months ended June 30, 2007, as compared to $2.3 million for the same period in 2006. This decrease was primarily due to the higher level of revenues this year. Total revenues increased to $1.5 million for the six months ended June 30, 2007, compared to $372,000 for the same period in 2006. This increase was primarily due to non-recurring revenue payments of $609,000 of research and development income and approximately $173,000 of licensing fee income attributable to the terminated agreement with Wyeth. In addition, the Company recognized an increase in royalty income of $400,000 from Perrigo in the first six months of 2007 compared to the same period in 2006. Net loss decreased 25%, or $1.3 million to $4.0 million for the six months ended June 30, 2007, primarily due to increased revenues, as compared to $5.4 million for the same period in 2006. Second Quarter 2007 Highlights include: * SCOLR's alliance partner, Perrigo Company, launched the fifth sustained-release nutritional product based on SCOLR's proprietary CDT oral drug delivery platform. The new offering, a "once-daily" CDT-based calcium private label product, is manufactured by Perrigo and shipments have commenced to several national retailers. In addition to an extended-release CDT-based calcium product, Perrigo markets four other nutritional products based on SCOLR's proprietary CDT oral drug delivery technology; * SCOLR entered into contract manufacturing and clinical trial management agreements to position its OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). 12-hour CDT-based ibuprofen ibuprofen (ī`by prō'fən), nonsteroidal anti-inflammatory drug (NSAID) that reduces pain, fever, and inflammation. for the initiation of U.S. pivotal trials by Q-4, 2007;
* During the quarter we continued preparations for submission of our first Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar for a 12-hour CDT-based pseudoephedrine pseudoephedrine /pseu·do·ephed·rine/ (-e-fed´rin) one of the optical isomers of ephedrine; used as the hydrochloride or sulfate salt as a nasal decongestant. pseu·do·e·phed·rine n. product. The timing of this submission will depend on completion of the remaining submission-related information, guidance from our regulatory consultants, and input from a potential licensee; * Dosing of SCOLR's fenofibrate formulation has been completed and we expect to receive data in late 2007; * Preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. evaluations of early oral peramivir formulations were initiated while additional formulation work continues. Peramivir is currently being tested in clinical trials by BioCryst as a potential intramuscular intramuscular /in·tra·mus·cu·lar/ (-mus´ku-ler) within the muscular substance. in·tra·mus·cu·lar adj. Abbr. IM Within a muscle. and intravenous treatment for seasonal and life-threatening influenza; * Formulation development and prototype preparations were completed for commercial evaluation of an undisclosed CDT-based application for a major consumer products company. Prototype commercial viability testing is planned for Q-3 and Q-4 2007; and, * Development of SCOLR's once-daily CDT-based risperidone and rivastigmine formulations is continuing, with the goal to start testing in late 2007/early 2008. Risperidone is used for the management of schizophrenia and bipolar (1) See bipolar transmission. (2) One of two major categories of transistor; the other is "field effect transistor" (FET). Although the first transistors and first silicon chips were bipolar, most chips today are field effect transistors wired as CMOS logic, which mania. Rivastigmine is typically prescribed for the management of Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. . * The United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property issued SCOLR a fifth patent (#7,229,642) entitled "Amino acid amino acid (əmē`nō), any one of a class of simple organic compounds containing carbon, hydrogen, oxygen, nitrogen, and in certain cases sulfur. These compounds are the building blocks of proteins. modulated mod·u·late v. mod·u·lat·ed, mod·u·lat·ing, mod·u·lates v.tr. 1. To adjust or adapt to a certain proportion; regulate or temper. 2. extended release dosage form A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage form of a given drug. ". This new patent is the third for SCOLR's amino acid-based CDT drug delivery platform. SCOLR Pharma's amino acid-based technology is one of the patented/proprietary approaches within its CDT drug delivery platform for formulating novel tablets and capsules; Daniel O. Wilds, SCOLR Pharma's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , said, "We continue to be very excited about the momentum that Perrigo is developing with our sustained-release nutritional products based on our proprietary CDT oral drug delivery platform. The introduction in June of a fifth product is off to a solid start and we are also pleased with the progress of our CDT-based product development programs and research collaborations during the second quarter. We expect to begin pivotal trials of our ibuprofen formulation by the fourth quarter of 2007 and submit a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) in 2008. Additionally, we are encouraged by the licensing and partnering discussions underway with a number of pharmaceutical companies interested in our CDT-based extended-release ibuprofen program and we remain optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op that we will be able to identify a new partner in 2007. For the three months ended June 30, 2007, research and development expenses decreased 15% or $248,450, to approximately $1.4 million, compared to approximately $1.6 million for the same period in 2006. This decrease was primarily due to the timing of SCOLR's clinical trials. For the three months ended June 30, 2007, general and administrative expenses decreased 26%, or $400,702, to $1.1 million for, compared to $1.5 million for the same period in 2006, primarily due to reduced expenses associated with compliance with the Sarbanes-Oxley Act See SOX. of 2002, and Financial Accounting Standard 123R implementation costs in 2006. For the six months ended June 30, 2007, research and development expenses increased 7%, or $99,761, to approximately $3.2 million compared to approximately $3.0 million for the same period in 2006. The increase for the first six months of 2007 was primarily due to increases of $262,261 in salaries and wages and employee benefits costs for additional head count and salary increases, offset by a decrease of $154,863 in supplies and clinical trial expenses related to our projects. The lower clinical trials and supplies expense reflects the timing of certain clinical trials and acquisition of related materials. For the six months ended June 30, 2007, general and administrative expenses decreased 31%, or $1.0 million to $2.3 million for the six months ended June 30, 2007, compared to $3.3 million for the same period in 2006, primarily due to reduced costs associated with compliance with the Sarbanes-Oxley Act of 2002, Financial Accounting Standard 123R implementation costs in 2006, and a decrease in employee and director non-cash, share-based compensation costs in 2006. As of June 30, 2007, the Company had $13.1 million of working capital compared to $16.2 million as of December 31, 2006. The Company believes that its cash, cash equivalents and short-term investments will be sufficient to fund its operations at planned levels through early 2008. Product Information Peramivir is the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. in BioCryst's intramuscular and intravenous treatment being evaluated in clinical trials for seasonal and life threatening influenza. Risperidone is the active ingredient in Risperdal[R], Janssen, L.P.'s product for the management of schizophrenia and bipolar mania. Rivastigmine is the active ingredient in Excelon[R], Novartis' product for the management of Alzheimer's disease. Fenofibrate is the active ingredient in Tricor[R], an Abbott product for hypercholesterolemia Hypercholesterolemia Definition Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal. Description Cholesterol circulates in the blood stream. It is an essential molecule for the human body. (elevated total cholesterol). Conference Call As previously announced, SCOLR Pharma will host a conference call on August 7, 2007, at 11:30 a.m. (Eastern Daylight Time). Shareholders and other interested parties may participate in the conference call by dialing +1 800 901 5217 (domestic) or +1 617 786 2964 (international) and entering access code 89141846, a few minutes before 11:30 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT on August 7, 2007. The call will also be broadcast live on the Internet at www.streetevents.com, www.fulldisclosure.com and www.scolr.com. A replay of the conference call will be accessible two hours after its completion through August 21, 2007, by dialing +1 888 286 8010 (domestic) or +1 617 801 6888 (international) and entering access code 83931369. The call will also be archived for 90 days at www.streetevents.com, www.fulldisclosure.com, www.streetevents.com and www.scolr.com. Financial Information [TABLE OMITTED] [TABLE OMITTED] About SCOLR Pharma: Based in Bellevue, Washington Bellevue is a rapidly growing city in King County, Washington, U.S., across Lake Washington from Seattle. Long known as a suburb or satellite city of Seattle,[1] it is now categorized as an edge city or a boomburb. , SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.373.0171 or visit http://www.scolr.com/. This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products. And we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstance. |
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