Nuvo announces 2009 third quarter financial results
MISSISSAUGA, ON,
Reent Corporate Developments:
- Received funding commitments from the Development Bank of Saxony in
Germany for two co-operative drug development projects with the
Fraunhofer Institute in Leipzig, Germany. These two projects will
focus on the preclinical and clinical development of WF10 as
potential treatments for allergic rhinitis and rheumatoid arthritis;
- Announced that the U.S. Food and Drug Administration (FDA) set a new
action date of November 4, 2009 under the Prescription Drug User Fee
Act (PDUFA) for the FDA's response to the Company's application for
U.S. marketing approval of Pennsaid, the Company's topical diclofenac
product for the treatment of the signs and symptoms of knee
osteoarthritis; and,
- As at September 30, 2009, had $29.5 million in cash and cash
equivalents, that included $6.1 million in proceeds from warrants
exercised in July 2009.
"We remain optimistic that the FDA will approve Pennsaid for marketing in the U.S.," said Henrich Guntermann, President and Chief Executive Officer of Nuvo Research. "In addition, our early stage pipeline of topical pain products, the emergence of WF10 as a potential treatment for allergic rhinitis and rheumatoid arthritis, and our strong cash position put Nuvo on a path to achieving our goal of becoming a diversified, well capitalized, profitable drug development company."
Financial Results:
(thousands of Canadian dollars)
Three Three Nine Nine
months months months months
ended ended ended ended
September September September September
30, 2009 30, 2008 30, 2009 30, 2008
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Revenue $ 3,234 $ 3,289 $ 8,987 $ 7,610
Net loss $ (2,725) $ (3,004) $ (7,257) $ (8,139)
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Revenue, consisting of product sales, license fee revenue, and research and other contract revenue, for the three months ended
For the three months ended
Total operating expenses, excluding foreign currency losses, for the three months ended
Research and development expenses were
SG&A expenses increased to
Net loss declined to
Cash and cash equivalents were
Cash used in operations was
Net cash used in investing activities totaled
Net cash provided by financing activities totaled
Detailed financial statements and the MD&A are available at www.nuvoresearch.com or www.sedar.com.
About Pennsaid
Pennsaid, the Company's lead product, is used to treat the pain and symptoms associated with knee osteoarthritis. Pennsaid combines a transdermal carrier (containing dimethyl sulfoxide, popularly known as "DMSO") with diclofenac sodium, a leading non-steroidal anti-inflammatory drug ("NSAID"), and delivers the active drug through the skin directly to the site of pain. While, conventional oral NSAIDs expose patients to potentially serious systemic side effects such as gastrointestinal bleeding and cardiovascular risks, Nuvo's clinical trials suggest that some of these systemic side effects occur less frequently with topically applied Pennsaid. There are more than 27 million Americans suffering from osteoarthritis and the
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies and WF10, its immune modulating drug candidate. Nuvo's lead product is Pennsaid, a topical NSAID used for the treatment of osteoarthritis of the knee. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications.
Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben,
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. The Company 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 the Company's Annual Information Form for the year ended
Summary financial statements attached:
NUVO RESEARCH INC.
CONSOLIDATED BALANCE SHEETS
As at As at
September 30, December 31,
2009 2008
Unaudited Audited
(thousands of Canadian dollars) $ $
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ASSETS
CURRENT
Cash and cash equivalents 29,489 15,219
Accounts receivable 2,959 2,294
Inventories 1,768 1,393
Prepaid expenses and other 309 446
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TOTAL CURRENT ASSETS 34,525 19,352
Restricted cash 71 93
Property, plant and equipment 1,842 1,990
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TOTAL ASSETS 36,438 21,435
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LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT
Accounts payable and accrued liabilities 3,136 2,736
Deferred revenue 2,241 2,241
Current portion of long-term debt and capital
lease obligations 150 181
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TOTAL CURRENT LIABILITIES 5,527 5,158
Deferred revenue 12,982 3,321
Long-term debt and capital lease obligations 158 320
Debentures 2,912 4,774
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TOTAL LIABILITIES 21,579 13,573
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SHAREHOLDERS' EQUITY
Common shares 209,845 189,603
Warrants 4,652 10,847
Contributed surplus 7,801 6,890
Accumulated other comprehensive income 114 114
Deficit (207,553) (199,592)
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TOTAL SHAREHOLDERS' EQUITY 14,859 7,862
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 36,438 21,435
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NUVO RESEARCH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
Three months Nine months
Unaudited ended ended
(thousands of Canadian September September September September
dollars except per share 30, 2009 30, 2008 30, 2009 30, 2008
and share amounts) $ $ $ $
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REVENUE
Product sales 2,567 1,808 7,025 5,578
Cost of goods sold 1,555 1,281 4,138 3,366
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Gross margin on product sales 1,012 527 2,887 2,212
Other revenue
Licensing fees 560 1,453 1,680 1,953
Research and other contract revenue 107 28 282 79
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1,679 2,008 4,849 4,244
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EXPENSES
Research and development 1,810 2,556 5,586 6,793
Selling, general and administrative
expenses 1,638 1,278 4,792 3,564
Stock-based compensation 131 131 395 497
Amortization of property, plant,
and equipment and intangibles 153 221 450 633
Foreign currency loss 525 255 306 12
Interest expense 169 418 642 1,046
Interest income (22) (146) (65) (461)
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4,404 4,713 12,106 12,084
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Loss from operations (2,725) (2,705) (7,257) (7,840)
Loss on extinguishment of
convertible debenture - (299) - (299)
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Net Loss and total comprehensive
loss (2,725) (3,004) (7,257) (8,139)
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Net loss per common share - basic
and diluted (0.01) (0.01) (0.02) (0.03)
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Average number of common shares
outstanding - basic and diluted
(millions) 388.8 310.1 353.9 304.2
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NUVO RESEARCH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Three months Nine months
ended ended
Unaudited September September September September
(thousands of Canadian 30, 2009 30, 2008 30, 2009 30, 2008
dollars $ $ $ $
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OPERATING ACTIVITIES
Net loss (2,725) (3,004) (7,257) (8,139)
Items not involving current cash
flows:
Amortization 153 221 450 633
Deferred revenue recognized (560) (560) (1,680) (1,271)
Stock-based compensation and
payments 131 131 395 497
Deferred stock unit expense 12 - 251 -
Accretion of interest on
debentures 117 295 412 729
Loss on extinguishment of
convertible debenture - 299 - 299
Other 721 408 464 147
Net change in non-cash working
capital (422) 1,400 (998) 1,058
Proceeds from licensing
arrangements and advances on
research contracts - 1,093 11,341 1,093
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CASH PROVIDED BY (USED IN)
OPERATING ACTIVITIES (2,573) 283 3,378 (4,954)
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INVESTING ACTIVITIES
Acquisition of property, plant
and equipment (130) (36) (333) (120)
Proceeds from sale of assets - - - 28
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CASH USED IN INVESTING ACTIVITIES (130) (36) (333) (92)
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FINANCING ACTIVITIES
Issuance of common shares and
warrants, net of related costs 6,142 (1) 11,584 946
Issuance of debentures, net of
related costs - 1,932 - 1,932
Repayments of long-term debt and
capital lease obligations (45) (548) (139) (608)
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CASH PROVIDED BY FINANCING
ACTIVITIES 6,097 1,383 11,445 2,270
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Effect of exchange rate changes
on cash and cash equivalents (165) (76) (220) (113)
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Net change in cash and cash
equivalents during the period 3,229 1,554 14,270 (2,889)
Cash and cash equivalents,
beginning of period 26,260 17,348 15,219 21,791
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CASH AND CASH EQUIVALENTS, END
OF PERIOD 29,489 18,902 29,489 18,902
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Interest paid 10 6 271 160
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%SEDAR: 00002418E
For further information: about Nuvo, please contact: Media and Investor Relations, Adam Peeler, The Equicom Group Inc., Tel: (416) 815-0700 x225, email: [email protected]
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