MISSISSAUGA, ON, Feb. 29, 2012 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10, today announced its financial and operational results for the fourth quarter and year ended December 31, 2011.
Fourth Quarter and Recent Corporate Developments:
Pennsaid® U.S. prescriptions continue to grow to new highs. U.S. prescriptions grew to 47,000 in the fourth quarter of 2011, an increase of approximately 2% over the previous quarter and have recently increased significantly due in part to temporary product shortages of Pennsaid’s main competitor product, Voltaren® Gel. U.S. prescriptions for the most recently reported week of February 17, 2012 were approximately double the average weekly prescriptions in Q4 2011;
Launched the marketing and sale of Synera® to U.S. interventional pain doctors with a dedicated 21 person contract sales force;
Galderma Pharma S.A. (Galderma) advised that applications for Pliaglis® approval are now under active review by regulatory authorities in the U.S., Canada and E.U. and that the U.S. Food and Drug Administration (FDA) has set a PDUFA (Prescription Drug User Fee Act) date of April 16, 2012 for action on the U.S. submission. The Company anticipates a response from the E.U. regulatory authorities in the second quarter of 2012. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma;
Mallinckrodt Inc., a Covidien company (NYSE: COV), advised that it intends to file a supplemental New Drug Application (sNDA) with the FDA for Pennsaid 2%, the follow-on product to Pennsaid, in the second quarter of 2012 and that Pennsaid 2% may be eligible for FDA approval in the fourth quarter of 2012 or the first quarter of 2013. Nuvo has licensed U.S. marketing rights for Pennsaid and Pennsaid 2% to Covidien; and
- Increased its ownership in Nuvo Research AG to 100% by acquiring the 40% interest held by the minority owner. Nuvo Research AG owns the rights to the immune modulating drug product, WF10.
“We are pleased with the progress of our three key commercial stage products - the U.S. launch of Synera, advancement towards Pliaglis’ approval and launch in the U.S. and Europe and the anticipated filing of the Pennsaid 2% sNDA with the FDA,” said Dan Chicoine, Chairman and Co-Chief Executive Officer of Nuvo Research. “These important milestones support our strategy to build Nuvo into a successful specialty pharmaceutical company focused on the treatment of pain.”
Pennsaid U.S.
According to IMS Health, during the fourth quarter of 2011, U.S. prescriptions of Pennsaid continued to grow quarter-over-quarter to a record of approximately 47,000 with an average 1.31 bottles of Pennsaid dispensed per script. This represents an increase of approximately 2% over the number of prescriptions in the third quarter of 2011. The 2010 Pennsaid prescriptions were generated over approximately eight months from the launch date in late April.
In the first quarter of 2012, Endo Pharmaceuticals Holdings Inc. (Endo) indicated that there will be temporary shortages in the U.S. of its licensed product, Voltaren Gel, the main competitor product to Pennsaid, as a result of manufacturing issues unrelated to Voltaren Gel at a facility owned by Novartis Consumer Health that was supplying Voltaren Gel for the U.S. market. Such product shortages may have contributed to recent substantial increases in Pennsaid U.S. prescriptions. According to the most recent available data from IMS Health, U.S. Pennsaid prescriptions for the week of February 17, 2012 were 7,184 which is approximately double the average weekly number of prescriptions in the fourth quarter of 2011. Endo has indicated that it does not expect normal Voltaren Gel availability until the end of the second quarter of 2012. The Company does not know how Voltaren Gel product shortages may impact Pennsaid prescriptions after Voltaren Gel supply shortages end.
For the year, approximately 167,000 Pennsaid prescriptions were dispensed, an increase of 149% over 2010, and for each prescription, approximately 1.3 bottles of Pennsaid were dispensed.
Operating Results
Revenue, consisting of product sales, royalties, license fee revenue and research and other contract revenue for the three months ended December 31, 2011 increased to $5.2 million compared to $4.8 million for the three months ended December 31, 2010. In the current quarter, the increased royalty revenue earned on Pennsaid sales in the U.S. and Canada and Synera sales in Europe more than offset a decrease in product sales. The decrease in product sales in the quarter is primarily related to a $0.8 million decrease in sales to our Greek distributor as all topical antirheumatics, including Pennsaid, lost government reimbursement in the first half of 2011 through one of Greece’s austerity measures and subsequently sales for the entire class declined materially. For the year, total revenue was $16.7 million compared to $17.0 million for the year ended December 31, 2010.
Gross margin on product sales decreased to $0.4 million for the three months ended December 31, 2011 compared to $0.9 million for the three months ended December 31, 2010. The decrease in gross margin was attributable to the decrease in Pennsaid sales and a $0.1 million write-down of WF10 finished goods inventory. For the year, gross margin on product sales decreased to $1.7 million compared to $4.0 million in 2010.
Total operating expenses for the three months ended December 31, 2011 increased to $5.4 million versus $3.6 million for the three months ended December 31, 2010. The increase in operating expenses was primarily due to the inclusion of a $1.3 million Qualifying Therapeutic Discovery Project (QTDP) grant as a reduction to R&D expenses in 2010. Excluding the impact of this grant, operating expenses increased by a more modest $0.5 million primarily due to higher G&A and S&M expenses which were partially offset by lower R&D expenses as the company scaled these activities back in the first half of 2011. Total operating expenses for the year ended December 31, 2011 were $18.8 million compared to $17.5 million for the year ended December 31, 2010.
R&D expenses for the quarter were unchanged at $1.7 million compared to the three months ended December 31, 2010. The prior year included the $1.3 million QTDP grant as a reduction to R&D expenses. Excluding this item, R&D expenses decreased by $1.3 million due to the closure of the Company’s San Diego research facility at the end of January 2011 and a corresponding reduction in the size of the Company’s early stage R&D team. For the year, R&D expenses decreased to $7.3 million compared to $9.3 million for the year ended December 31, 2010.
S&M expenses were $1.3 million for the three months and year ended December 31, 2011 and $nil for the comparable periods in 2010. S&M expenses relate entirely to Synera. Synera is directly marketed by the Company in the U.S. In 2011, the Company strengthened its commercial team by hiring experienced pharmaceutical executives to plan and begin preparations for a 2012 U.S. relaunch of Synera, targeting interventional pain physicians.
G&A expenses increased to $2.4 million for the three months ended December 31, 2011 compared to $1.9 million for the three months ended December 31, 2010. The increase in the quarter relates to the inclusion of ZARS in 2011 and termination benefits. For the year, G&A expenses increased to $10.3 million compared to $8.4 million for the year ended December 31, 2010.
Net loss was $2.6 million for the three months ended December 31, 2011 compared to $1.6 million for the three months ended December 31, 2010. The increased loss was substantially a result of the absence of the QTDP grant in the current quarter versus a year ago. For the year, net loss was $7.7 million compared to $13.3 million for the year ended December 31, 2010.
Cash and cash equivalents were $14.7 million as at December 31, 2011 compared to $18.0 million as at September 30, 2011 and $28.3 million at December 31, 2010.
Cash used in operating activities of $3.2 million was $0.9 million higher than the cash used in operating activities of $2.3 million for the three-month period ended December 31, 2010 due to the increase in the net loss. For the year cash used in operating activities decreased to $11.8 million compared to $12.4 million for the year ended December 31, 2010.
The number of common shares outstanding as at December 31, 2011 was 564.0 million.
Management to Host Conference Call
Management will host a conference call to discuss the fourth quarter and year-end results on Thursday, March 1, 2012 at 8:30 a.m. ET. 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 Thursday, March 8, 2012 by calling 416-849-0833 or 1-855-859-2056, reference number 45482035.
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. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in 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. Nuvo 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 GmbH, based in Leipzig, Germany, the Company is also developing the compound WF10, for the treatment of immune related diseases.
Forward-Looking Statements
