MISSISSAUGA, ON, May 26, 2011 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products primarily for the
First Quarter and Recent Corporate Developments:
"While the acquisition of ZARS is a major step forward for Nuvo, we are also excited by record U.S. Pennsaid prescriptions, the continued development progress of Pennsaid Gel and the resumption of royalty revenue for Canadian Pennsaid sales," said Dan Chicoine, Chairman and Co-Chief Executive Officer of Nuvo Research. "In the near-term, we will focus on the integration of ZARS to maximize the commercial value of Pliaglis and Synera and to determine which of the pre-commercial stage opportunities in our newly expanded portfolio offer the best return on investment."
Pennsaid U.S. During the first quarter of 2011 U.S. sales of Pennsaid grew 6% quarter-over-quarter to a record 34,000 prescriptions according to IMS Health. Since the launch of the product in the U.S. by Covidien in late April 2010 sales have increased in each successive quarter. Data from IMS Health indicate that for each prescription filled, approximately 1.3 bottles of Pennsaid were dispensed in the quarter.
Operating Results Revenue, consisting of product sales, royalties, license fee revenue and research and other contract revenue for the three months ended March 31, 2011 decreased slightly to $3.8 million compared to $4.1 million for the three months ended March 31, 2010. The 2010 comparative period includes a significant quantity of low margin Pennsaid samples sold to Covidien as they prepared for the U.S. launch. In the current period the inclusion of royalty revenue earned on the sale of Pennsaid in the U.S. and Canada which was higher than the amortized license fees recognized in prior periods offset a portion of the decline in product sales revenue.
Gross margin percentage increased to 37% for the three months ended March 31, 2011 compared to 31% for the three months ended March 31, 2010 due to the significant decline in the number of low margin marketing samples that were sold to Covidien in the comparable period in 2010 to support the U.S. launch of Pennsaid.
Total operating expenses, which include R&D and SG&A expenses, increased 5% for the three months ended March 31, 2011 to $4.6 million versus $4.4 million for the comparable period in 2010.
R&D expenses were $2.1 million for the first quarter of 2011 compared to $2.3 million for the prior year period. The decrease in the quarter related to the Company's cost containment efforts, including closure of the Company's San Diego research facility at the end of January 2011, offset somewhat by the costs associated with preclinical work.
SG&A expenses increased to $2.5 million for the first quarter of 2011 compared to $2.0 million for the first quarter of 2010. The increase was a result of $0.7 million in consulting, professional and other fees incurred related to the ZARS acquisition.
Net loss for the quarter declined significantly to $2.4 million compared to $6.5 million for the quarter ended March 31, 2010. The $4.1 million improvement relates primarily to the absence, in 2011, of a $3.5 million loss recognized on the early redemption of debentures and a foreign currency gain in 2011 versus a loss in the quarter ended March 31, 2010.
Cash and cash equivalents were $27.1 million as at March 31, 2011.
Cash used in operating activities of $1.1 million was significantly lower than the $5.1 million of cash used in operating activities for the three-month period ended March 31, 2010. The improvement was primarily a result of new, cash-based revenue streams in the current quarter, while the licensing fees recognized in the prior period were non-cash. In addition, the recovery of $1.1 million in non-cash working capital in the current quarter compared to an investment of $2.3 million in the comparative period also led to lower cash utilization.
Management to Host Conference Call Management will host a conference call to discuss the first quarter results on May 27, 2011 at 8:30 am EST. Following management's presentation, there will be a question and answer session, at which time the operator will direct participants to the correct procedure for submitting questions. To participate in the conference call, please dial 647-427-7450 or 1-888-231-8191. Please call in 15 minutes prior to the call to secure a line. You will be put on hold until the conference call begins.
A taped replay of the conference call will be available two hours after the live conference call and will be accessible until Friday, June 3, 2011 by calling 416-849-0833 or 1-800-642-1687, reference number 63140440.
A live audio webcast of the conference call will be available through www.nuvoresearch.com. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.
About Nuvo Research Inc. Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company's Pain Group, located in West Chester, Pennsylvania, is focused on the development and commercialization of topically delivered pain products. The company's product portfolio includes Pennsaid, Pliaglis and Synera. Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee. Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company (NYSE: COV), in Canada by Paladin Labs Inc. (TSX:PLB) and in several European countries. Pliaglis is a topical local anesthetic cream, which is U.S. Food and Drug Administration (FDA) approved to provide topical local analgesia for superficial dermatological procedures. ZARS has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. ZARS currently markets Synera in the United States and its licensing partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan) in several European countries. Through its subsidiary, Nuvo Research AG, based in Leipzig, Germany, the Company is also developing the compound WF10, for the treatment of immune related diseases. For more information, please visit www.nuvoresearch.com.
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2010. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com
|NUVO RESEARCH INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION|
|Unaudited||As at March 31, 2011||As at December 31, 2010||As at January 1, 2010|
|(Canadian dollars in thousands)||$||$||$|
|Cash and cash equivalents||27,115||28,269||42,102|
|Other current assets||570||2,143||450|
TOTAL CURRENT ASSETS
|Property, plant and equipment||1,901||2,016||1,805|
|LIABILITIES AND EQUITY|
|Accounts payable and accrued liabilities||3,197||4,203||4,589|
|Current portion of finance lease obligations||3||63||79|
|Current portion of debentures||-||-||3,038|
TOTAL CURRENT LIABILITIES
Finance lease obligations
|Equity attributable to owners of the parent|
|Accumulated other comprehensive income||(160)||(257)||-|
|TOTAL LIABILITIES AND EQUITY||33,816||37,244||48,512|
|NUVO RESEARCH INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS|
|Unaudited||Three Months Ended March 31, 2011||Three Months Ended March 31, 2010|
|(Canadian dollars in thousands, except per share and share figures)||$||$|
|Cost of goods sold||1,617||2,248|
|Gross margin on product sales||964||1,019|
|Research and other contract revenue||39||224|
|Research and development||2,099||2,342|
|Selling, general and administrative expenses||2,517||2,023|
|Foreign currency loss (gain)||(12)||358|
Loss on early redemption of debentures
|Net loss before income taxes||(2,343)||(6,501)|
Other comprehensive income (loss)
Unrealized gains (losses) on translation of foreign operations
TOTAL COMPREHENSIVE LOSS
Net loss attributable to:
Owners of the parent
Total comprehensive loss attributable to:
Owners of the parent
Net Loss per common share - basic and diluted
Average number of common shares outstanding - basic and diluted (millions)
|NUVO RESEARCH INC. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS|
|Three months ended March 31, 2011||Three months ended March 31, 2010|
|(Canadian dollars in thousands)|| |
|Items not involving current cash flows:|
|Loss on early redemption of debentures||-||3,547|
|Deferred license revenue recognized||(85)||(560)|
|D Deferred royalty revenue, net of royalties earned||(73)||-|
|S Stock-based compensation||172||23|
|Accretion of interest on debentures||-||31|
|Unrealized foreign exchange loss||13||414|
|Deferred proceeds on research contracts||-||33|
|Net change in non-cash working capital||1,099||(2,290)|
CASH USED IN OPERATING ACTIVITIES
|Acquisition of property, plant and equipment||(33)||(234)|
CASH USED IN INVESTING ACTIVITIES
|Issuance of common shares||29||-|
|Repayments of finance lease obligations||(60)||(19)|
CASH USED IN FINANCING ACTIVITIES
|Effect of exchange rate changes on cash and cash equivalents||(4)||(403)|
|Net change in cash and cash equivalents during the period||(1,154)||(5,848)|
|Cash and cash equivalents, beginning of period||28,269||42,102|
CASH AND CASH EQUIVALENTS, END OF PERIOD
Income taxes paid
SOURCE Nuvo Research Inc.
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