Pivotal Phase III Trial Primary Endpoints Achieved for SCOLR's 12-Hour
BOTHELL, Wash., Nov. 7 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) today reported financial results for the three and nine months ended September 30, 2008. The Company will host a live conference call today, November 7, 2008, at 11:30 a.m. (Eastern Standard Time).
Daniel O. Wilds, SCOLR Pharma's President and CEO, said, "We had a very productive third quarter making significant progress advancing our lead product candidates and securing additional non-dilutive operating capital while maintaining financial discipline. Most importantly, yesterday we reported favorable top-line results from our pivotal Phase III trial to evaluate the safety and efficacy of our 12 hour CDT(R) 600 mg extended-release (ER) ibuprofen for the over-the-counter (OTC) market. The trial incorporated FDA special protocol assessment design elements, met both co-primary endpoints (p<0.0001), and had no significant adverse events. This successful trial is an extremely important milestone for the Company. We expect that the successful results of this study will focus the attention of potential partners and facilitate an alliance for our lead product candidate."
Also during the quarter, SCOLR submitted an Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour pseudoephedrine tablet based on our patented Controlled Delivery Technology (CDT(R)) platform. Subsequently, we reported that the U.S. FDA had accepted our submission for review. This is the first product approval application filed by SCOLR Pharma, and, if approved, would further demonstrate the novel advantages of our proprietary drug delivery technology.
The Company also completed its previously announced lease termination and buyout transaction under which we received $4.1 million and successfully relocated its corporate headquarters to a more cost effective and better equipped facility."
Mr. Wilds concluded, "We are very encouraged by our achievement of important business and clinical milestones during the past quarter. By continuing to focus on partnering our lead product candidates, limiting additional drug development initiatives to those already partnered and in active collaborations, we expect that the net proceeds from the lease buyout and our current financial resources together with continuing expense management should be sufficient to fund our operations through 2009."
Total revenues, which consist of royalty revenue from our collaboration agreements, increased 14%, or $28,834 to $236,308 for the three months ended September 30, 2008, compared to $207,474 for the same period in 2007. This increase is primarily due to higher royalty income from our relationship with Perrigo.
Total revenues decreased 55% or $968,013 to $781,435 for the nine months ended September 30, 2008, compared to $1.7 million for the same period in 2007. The higher total revenues for 2007 were primarily due to approximately $621,222 of research and development fees and licensing revenues from an agreement terminated in the first quarter of 2007.
Net income for the three months ended September 30, 2008, was $890,370 compared to a net loss of ($3.1) million for the same period in 2007. Net loss for the nine months ended September 30, 2008, decreased 55%, or $3.9 million to $3.2 million, compared with a net loss of $7.1 million for the same period in 2007. The decrease in the net loss was primarily due to the $4.0 million net gain from the termination of the lease on our corporate facility.
In May 2008, we entered into an agreement to terminate the lease of our corporate facility for $4.1 million. Under the terms of the agreement, $1.0 million was paid upon execution of the agreement and the remaining $3.1 million was paid in September when we vacated our premises. We recognized in operating expense, the gain of $4.1 million and $116,867 of expense related to the new lease and our relocation to the new facility in September 2008.
Total operating expenses for the third quarter of 2008 were $(611,506), which included $4.0 million net lease termination gain, compared to $3.5 million in the same period in 2007. Total operating expenses decreased 55% to $4.2 million for the nine months ended September 30, 2008, from $9.4 million for the same period in 2007. The decreases in operating expenses were primarily due to the net gain of $4.0 million from the lease termination and surrender agreement associated with our corporate facility.
SCOLR had approximately $8.9 million in cash and cash equivalents, and $564,000 in restricted cash as of September 30, 2008. The Company is investing its cash and cash equivalents in government-backed securities.
As previously announced, SCOLR Pharma will host a conference call on November 7, 2008, at 11:30 a.m. (Eastern Standard Time). Shareholders and other interested parties may participate in the conference call by dialing +1- 888-713-4215 (domestic) or +1 617-213-4867 (international) and entering access code 67625263, a few minutes before 11:30 a.m. EST on November 7, 2008. The call will also be broadcast live on the Internet at http://www.streetevents.com, http://www.fulldisclosure.com or http://www.scolr.com.
A replay of the conference call will be accessible two hours after its completion through November 21, 2008, by dialing +1-888-286-8010 (domestic) or +1 617-801-6888 (international) and entering access code 60696221. The call will also be archived for 90 days at http://www.streetevents.com, http://www.fulldisclosure.com or http://www.scolr.com.
About SCOLR Pharma:
Based in Bothell, Washington, 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 425-368-1050 or visit http://www.scolr.com/.
This press release contains forward-looking statements (statements
which are not historical facts) within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements concerning
our ability to fund our operations through 2009, the success of our
products in the marketplace and in clinical trials and the availability of
potential partners. 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 unanticipated costs and expenses
associated with our product development and clinical activities, reductions
in our royalty revenues, our ability to successfully develop new
formulations and complete research and development, 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. 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
http://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.
SCOLR Pharma, Inc.
September 30, December 31,
Cash and cash equivalents $8,908,986 $11,825,371
Accounts receivable 244,214 225,900
Interest and other receivables - 16
Prepaid expenses and other assets 323,407 432,213
Total current assets 9,476,607 12,474,500
Property and Equipment - net of
accumulated depreciation of
$1,213,775 and $964,738, respectively 502,510 748,931
Intangible assets - net of
accumulated amortization of $443,435
and $385,452, respectively 522,403 464,023
Restricted cash 564,000 -
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $324,890 $757,420
Accrued expenses 738,330 586,849
Current portion of term loan 85,831 80,047
Total current liabilities 1,149,051 1,424,316
Long-term portion of term loan 46,004 111,119
Total liabilities 1,195,055 1,535,435
Commitments and Contingencies
Preferred stock, authorized 5,000,000
shares, $.01 par value, none
issued or outstanding - -
Common stock, authorized 100,000,000
shares, $.001 par value, 41,130,270
and 40,991,385 issued and outstanding
as of September 30, 2008, and
December 31, 2007, respectively 41,130 40,991
Additional paid-in capital 70,879,940 69,945,666
Accumulated deficit (61,050,605) (57,834,638)
Total stockholders' equity 9,870,465 12,152,019
SCOLR Pharma, Inc.
CONDENSED STATEMENTS OF OPERATIONS
Three months ended Nine months ended
September 30, September 30,
2008 2007 2008 2007
Licensing fees $- $- $- $173,077
Royalty income 236,308 207,474 781,435 955,149
development income - - - 621,222
Total revenues 236,308 207,474 781,435 1,749,448
Marketing and selling 116,840 198,520 545,579 673,776
development 2,307,103 2,236,852 4,387,636 5,410,226
administrative 947,684 1,017,177 3,242,614 3,305,918
3,371,627 3,452,549 8,175,829 9,389,920
Gain from lease
buyout (4,100,000) - (4,100,000) -
and lease Buyout 116,867 - 116,867 -
lease buyout (3,983,133) - (3,983,133) -
expenses (611,506) 3,452,549 4,192,696 9,389,920
Income or (loss)
from operations 847,814 (3,245,075) (3,411,261) (7,640,472)
Other income (expense)
Interest income 45,858 160,080 205,530 550,402
Interest expense (3,393) (5,191) (11,565) (10,967)
Other 91 - 1,329 2,941
income (expense) 42,556 154,889 195,294 542,376
Net income or (loss) $890,370 $(3,090,186) $(3,215,967) $(7,098,096)
Net income (loss)
per share, basic
and diluted $ .02 $(0.08) $(0.08) $(0.19)
Shares used in
net income (loss)
per share 41,043,770 38,153,316 41,037,128 38,123,071
Shares used in
net income (loss)
per share 41,561,623 38,153,316 41,037,128 38,123,071
|SOURCE SCOLR Pharma, Inc.|
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