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CREG slipped back to even at 5.65 but that drew buying interest in this profitable Chinese company...tuna
Yeah Joe...CREG just dropped to 5.65 even on the day too btw...tuna
And Chinese CREG 5.76 +.12 in it's second day of "green" since starting to trade on NASDAQ Monday...high of 6.14 so far...and strong volume again today on it...tuna
Oops...Chinese CYXN .58 I'll correct that...thanks! tuna
APT 3.26 -.09 CHGI 2.76 NEWN 7.15 also looking cheap here imho...tuna
Yes it is Joe...nice on CHINA!! I just got back from the dentist 30 minutes ago...tuna
Chinese CYXN .58 -.02 w/.16 estimated earnings for '09 too cheap here imho...tuna
EBIG .143 -.022 now bid .15 x .165 improving...added more at .141 today...tuna
Yeah MB...I added more EBIG at .141 tuna
Nice on MILL 4.65 x 4.68 here wick!! And CHGY too...tuna
Thanks baroness...just back from a root canal...ugh! tuna
BLGW .95 has news:
Bloggerwave Network in U.S. Surpasses 10,000 Bloggers, Adding 4,000 New Bloggers Since the Start of 2010, Positioning Company for Leadership in U.S. Market
Press Release Source: Bloggerwave Inc. On Thursday March 25, 2010, 8:30 am
MOUNTAIN VIEW, CA--(Marketwire - 03/25/10) - Bloggerwave Inc. ("Bloggerwave") (OTC.BB:BLGW - News), an innovative commercial blogging company, announced today that its network of bloggers addressing the United States market has surpassed 10,000 bloggers, adding 4,000 new participants since the start of 2010.
"This represents an expansion of 250% in two and half months since we opened our U.S. offices last January," stated Ulrik Thomsen, Director of Bloggerwave Inc. "It signals our potential to engage an additional 15,000 bloggers by the end of 2010, giving us a total of about 25,000 bloggers in the U.S. alone and positioning us for leadership in the U.S. market. Our network in Europe of currently more than 30,000 bloggers is also growing. Together with our expanding multilingual capabilities and our international reach, we already offer a strong market advantage to our growing U.S. client base, and I believe we will meet our goal of becoming the U.S. leader in this field."
About Bloggerwave
Bloggerwave helps its corporate clients harness the power of the Internet by leveraging the power and credibility of blogs to promote products and services. It connects clients directly with thousands of pre-approved bloggers around the globe, giving the bloggers the opportunity to write about and review specific products or services and include a link to the company's website. Once a company is blogged about, it increases its Internet buzz, credibility, site hits, ranking on search engines -- and ultimately, its bottom line. Bloggerwave has shot to the top in just three years of operation, achieving status as the No. 1 company of its kind in Europe and 3rd in the U.S. market. Bloggerwave is now focusing on becoming the best among its U.S. competitors. The Company currently has offices in the United States and Europe, and a virtual presence worldwide.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may," "future," "plan" or "planned," "will" or "should," "expected," "anticipates," "draft," "eventually" or "projected." You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements; projected events in this press release may not occur due to unforeseen circumstances, various factors, and other risks identified in a company's annual report on Form 10-K and other filings made by such company.
For more information about Bloggerwave Inc. visit http://www.bloggerwaveinc.com/ or contact Stanley Wunderlich at (800) 625-2236 extension 7770 or info@cfsg1.com
Contact:
CONTACTStanley WunderlichConsulting For Strategic Growth 1, Ltd. 880 Third Ave, 6th Floor New York NY 10022 Telephone: (800) 625-2236 Fax: (646) 205-7771 Email: Email Contact
tuna
Probably all of it! But it's still a big improvement in their financials as they actually earned .03 for '09 vs a huge loss! I think the stock has more in it imho...probably a lot of shorts to cover also on that first run on the deal a month or so ago...tuna
WANG, watch CRXX up in PM earned .57 vs a loss in Q4 announced this morning:
CombinatoRx Reports Financial Results for the Fourth Quarter and Year-End 2009
-- Provides Key Goals for 2010 --
Press Release Source: CombinatoRx, Incorporated On Thursday March 25, 2010, 7:30 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) today reported financial results for the fourth quarter and year-ended December 31, 2009 and provided pipeline and business goals for 2010.
“With the successful approval of Exalgo and the Neuromed merger and integration complete, we are uniquely positioned to become a thriving biopharmaceutical business,” commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. “We will leverage our expertise and pipeline to develop innovative products for the treatment of pain and inflammation and have focused our portfolio and R&D efforts in these core therapeutic areas.”
2009 and Recent Accomplishments:
•The U.S. Food and Drug Administration (FDA) approved Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The approval of Exalgo triggered a $40.0 million milestone payment to CombinatoRx from Mallinckrodt Inc., a Covidien company, who acquired the U.S. marketing rights to Exalgo. Going forward, CombinatoRx is eligible to receive tiered royalties on net sales of Exalgo by Covidien.
•CombinatoRx and Neuromed Pharmaceuticals Inc. merged, bringing together the product assets and financial resources of both organizations, including Exalgo™ revenue, the combined portfolio of product candidates and both company’s unique drug discovery capabilities. Mark Corrigan, MD, former EVP of Research & Development at Sepracor and a member of the CombinatoRx board of directors, was appointed President and Chief Executive Officer of CombinatoRx.
•PrednisporinTM (FOV1101), a CombinatoRx-derived combination drug candidate, was recognized as a key asset by Sanofi-Aventis in its acquisition of our collaborator, Fovea Pharmaceuticals, based on positive clinical results with Prednisporin in subjects with persistent allergic conjunctivitis. CombinatoRx also enhanced its economic interest in Prednisporin and the other product candidates licensed to Fovea for ophthalmic development. CombinatoRx will be eligible to receive development and regulatory-based milestone payments for Prednisporin of up to approximately $40.0 million and increased tiered royalty payments of up to 12% of net sales.
•Phase 2 clinical data was presented on SynaviveTM (CRx-102) in knee osteoarthritis (OA) at the American College of Rheumatology (ACR) 2009 Annual Meeting and the Annual European Congress of Rheumatology meeting (EULAR) in which efficacy was observed early in treatment and sustained in all WOMAC measurement subscales including pain, stiffness and physical function. These efficacy levels were maintained throughout the 12-month knee OA extension trial and, importantly, no treatment-related increases in glucocorticoid associated adverse events were observed in the Synavive-treated subjects.
•A strategic alliance was established with the Novartis Institutes for Biomedical Research, Inc. focused on the discovery of novel anti-cancer combinations utilizing the CombinatoRx proprietary combination high throughput screening (cHTS) platform and Chalice analyzer software. This non-exclusive collaboration is exploring combination effects in cell lines representing a broad spectrum of cancers to provide a robust and systematic understanding of combination therapy opportunities. CombinatoRx received an upfront payment, research funding support for two years and is eligible to receive clinical, regulatory and commercial milestones. In addition, CombinatoRx retains the right to conduct oncology research on its own behalf as well as partner with others in the field of oncology, and retains certain intellectual property which may arise from the collaboration.
2010 Pipeline and Business Goals:
•Focus the CombinatoRx portfolio and development efforts in the core therapeutic areas of pain and inflammation:
•Exalgo, which is licensed to Covidien, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
•Synavive (CRx-102) for the treatment of immuno-inflammatory diseases.
•Prednisporin (FOV1101) which is licensed to Fovea, a subsidiary of Sanofi Aventis, for the treatment of inflammatory ocular diseases such as allergic conjunctivitis.
•N-Type and T-Type calcium channel blockers for the treatment of chronic pain.
•Advance development of an existing product candidate:
•Synavive (CRx-102) for the treatment of osteoarthritis
•Advance an N-type lead program from our Ion channel modulation platform into development.
•Continue to apply our state-of-the-art drug discovery technologies to discover new pain and inflammation product candidates for our internal portfolio:
•Selective Ion channel modulation platform
•cHTS drug discovery technology
•Continue to seek additional revenue-generating research and technology collaborations for our drug discovery platform.
•Maintain financial strength with sufficient resources to fund operations into 2014.
Fourth Quarter and Year-End 2009 Financial Results (Unaudited):
As of December 31, 2009, CombinatoRx had cash, cash equivalents, restricted cash and short-term investments of $25.9 million compared to $43.7 million on December 31, 2008.
Total revenue was $8.6 million in the fourth quarter of 2009 compared to $3.5 million reported in the fourth quarter of 2008. For the year ended December 31, 2009, revenue was $17.3 million compared to $12.3 million for 2008. Revenue increased from 2008 to 2009 due to the accelerated recognition of deferred revenue related to the early termination of our agreement with Angiotech.
Net income for the quarter ended December 31, 2009 was $25.2 million, or $0.57 per share, as compared to a $15.2 million loss, or ($0.43) per share, in the fourth quarter of 2008. Stock-based compensation expense was approximately $0.8 million in the fourth quarter of 2009 as compared to $0.9 million in the fourth quarter of 2008. For the year ended December 31, 2009, net income from continuing operations was $1.3 million, or $0.03 per share, compared to a net loss of $60.6 million, or $(1.74) per share, in the year ended December 31, 2008. Stock-based compensation expense was approximately $3.9 million and $5.7 million in the years ended December 31, 2009, and 2008, respectively.
Research and development expenses totaled $3.1 million in the fourth quarter of 2009 compared to $9.8 million in the fourth quarter of 2008. Research and development expenses were $21.2 million in the year ended December 31, 2009 compared to $55.3 million in the year ended December 31, 2008. The $34.1 million decrease from the 2008 period to the 2009 period was primarily due to a decrease of $16.7 million in preclinical and external clinical expenses, a $10.8 million decrease in compensation and benefit expenses, associated with reduced headcount attributable to the 2008 and 2009 restructurings, a $5.6 million decrease in consulting, lab supplies, facilities, depreciation and other overhead costs related to our 2008 and 2009 restructurings, as well as a $1.0 million decrease in non-cash stock-based compensation expense.
General and administrative expenses were $5.1 million in the fourth quarter of 2009 compared to $3.0 million in the fourth quarter of 2008. General and administrative expenses were $17.1 million in the year ended December 31, 2009 compared to $14.5 million in the year ended December 31, 2008. The increase was due primarily to professional and consulting expenses related to our merger with Neuromed.
Conference Call Information:
CombinatoRx senior management, including Mark H.N. Corrigan, MD, President and Chief Executive Officer and Justin Renz, Senior Vice President and Chief Financial Officer of CombinatoRx, will provide an update on the Company, discuss fourth quarter and year-end 2009 financial results and discuss expectations for the future via conference call at 8:30 a.m. EDT on Thursday, March 25, 2010. To access the call, please dial 866-383-7998 (domestic) or 617-597-5329 (international) five minutes prior to the start time and provide the passcode 67986161. A replay of the call will be available beginning at 11:30 a.m. ET on March 25, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the passcode 35427451. A live audio webcast of the call will also be available on the “Investors” section of the company’s website, http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=1&md5=0f5ade78402effaaf35d331fa0ae91ff. An archived audio webcast will be available on the CombinatoRx website two hours after the event.
About CombinatoRx:
CombinatoRx, Incorporated (CRXX) develops novel drug candidates with a focus on the treatment of pain and inflammation. The company applies its combination drug discovery capabilities and its selective ion-channel modulation platform to generate innovative therapeutics. To learn more about CombinatoRx, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=2&md5=9c112cfc5cdccbe7d58049d65a65d5d4.
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx, the product Exalgo™ and its ability to generate future royalty revenue for CombinatoRx, Fovea’s product candidate Prednisporin™, its clinical potential and the amended agreement with Fovea, the potential of the CombinatoRx product candidate Synavive, the CombinatoRx collaboration with Novartis, the CombinatoRx selective ion channel modulation platform, its combination drug discovery technology, and CombinatoRx’s financial condition, results of operations, projected expenses, cash positions and business plans. These forward-looking statements about future expectations, plans, objectives and prospects of CombinatoRx may be identified by words like "believe," "expect," "may," "will," "should," "seek," or “could” and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the sale and marketing of Exalgo by Covidien, risks related to the development and regulatory approval of CombinatoRx’s product candidates, the unproven nature of the CombinatoRx drug discovery technologies, the ability of Covidien, Novartis and Fovea to perform their obligations under their collaboration agreements with CombinatoRx, the ability of the Company or its collaboration partners to initiate and successfully complete clinical trials of its product candidates, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section beginning on page 31 of CombinatoRx's Form S-4 Registration Statement filed in connection with its merger with Neuromed (File No. 333-161146), on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended December 31, Twelve months ended December 31,
2009 2008 2009 2008
As Adjusted As Adjusted
Revenue
Collaborations $ 8,384 $ 3,248 $ 16,320 $ 11,462
Government contracts and grants 196 210 953 842
Total revenue 8,580 3,458 17,273 12,304
Operating expenses:
Research and development 3,120 9,819 21,244 55,296
General and administration 5,056 3,039 17,081 14,469
Restructuring 123 4,637 2,736 4,637
Amortization of intangible asset 520 - 520 -
Gain on legal settlement (3,700) - (3,700) -
Total operating expenses 5,119 17,495 37,881 74,402
Loss from operations 3,461 (14,037) (20,608) (62,098)
Interest income 15 199 257 2,264
Interest expense - (123) (28) (651)
Loss on early extinguishment of debt - (195) - (195)
Gain on revalue of contingent consideration 12,068 - 12,068 -
Gain on bargain purchase 9,809 - 9,809 -
Other expense (249) (24) (281) (4)
Net income (loss) before provision for income taxes 25,104 (14,180) 1,217 (60,684)
Benefit for income taxes 67 128 67 108
Net income (loss) from continuing operations 25,171 (14,052) 1,284 (60,576)
Discontinued Operations:
Loss from operations of discontinued subsidiary - (1,182) (1,536) (4,557)
Gain on disposal of discontinued operations - - 15,640 -
Gain (loss) on discontinued operations - (1,182) 14,104 (4,557)
Net income (loss) $ 25,171 $ (15,234) $ 15,388 $ (65,133)
Net income (loss) per share - basic and diluted:
From continuing operations $ 0.57 $ (0.41) $ 0.03 $ (1.74)
From discontinued operations - (0.02) 0.38 (0.13)
Net income (loss) per share - basic and diluted $ 0.57 $ (0.43) $ 0.41 $ (1.87)
Weighted average number of common shares used in net income (loss)
per share calculation:
Basic 44,198,131 35,095,516 37,338,042 34,848,701
Diluted 44,503,062 35,095,516 37,491,237 34,848,701
Note: The Statements of Operations for the three and twelve months ended December 31, 2008 reflect the financial results of CombinatoRx Singapore as a discontinued operation.
CombinatoRx, Incorporated
Consolidated Balance Sheets
(in thousands, except per share data)
(Unaudited)
December 31, 2009 December 31, 2008
As Adjusted
Assets
Current assets:
Cash and cash equivalents $ 8,779 $ 3,039
Restricted cash 750 1,250
Short-term investments 14,551 36,614
Accounts receivable 2,927 438
Prepaid expenses and other current assets 5,415 1,001
Current assets of discontinued operations - 7,837
Total current assets 32,422 50,179
Property and equipment, net 8,380 12,400
Property and equipment of discontinued operations, net - 995
Intangible asset, net 45,423 -
Restricted cash and other assets 1,927 2,923
Total assets $ 88,152 $ 66,497
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 4,269 $ 2,842
Accrued expenses 5,495 4,067
Accrued restructuring 1,274 1,902
Deferred revenue 2,750 5,384
Current portion of lease incentive obligation 284 575
Current liabilities of discontinued operations - 19,822
Total current liabilities 14,072 34,592
Deferred revenue, net of current portion 2,667 6,325
Deferred rent, net of current portion 775 1,680
Lease incentive obligation, net of current portion 1,726 4,074
Accrued restructuring, net of current portion - 968
Other long-term liabilities 3,235 -
Contingent consideration 12,764 -
Liabilities of discontinued operations - 66
Noncontrolling interest in discontinued operations - 2,917
Stockholders’ equity:
Preferred stock, $0.001 par value: 5,000 shares authorized; no shares
issued and outstanding - -
Common stock, $0.001 par value: 200,000 shares authorized; 117,829
and 35,090 shares issued and outstanding at December 31, 2009
and December 31, 2008, respectively 118 35
Additional paid-in capital 272,405 267,238
Accumulated other comprehensive (loss) income (2) 73
Accumulated deficit (219,608) (251,471)
Stockholders’ equity 52,913 15,875
Total liabilities and stockholders' equity $ 88,152 $ 66,497
Note: The Balance Sheet as of December 31, 2008 reflects the reclassification of CombinatoRx Singapore as a discontinued operation.
Contact:
CombinatoRx, IncorporatedJustin Renz, 617-301-7575Senior Vice President, CFOJRenz@combinatorx.comorGina Nugent, 857-753-6562gnugent@combinatorx.com
tuna
Check CRXX 1.26 close now 1.49 x 1.50 earned .57 vs a loss in Q4 announced in PM...still seems too cheap to me! tuna
Like CRXX 1.48 x 1.49 to get an "upgrade" today with these super earnings today and it would really rock!!! tuna
Thanks for the heads up on SMCE baroness and hope your day is a profitable one!! tuna
Nice Joe...Chinese CREG 5.80 x 5.92 vs 5.65 close...this fast growing company just moved up onto NASDAQ Monday of this week and yesterday was it's first up day...looking for 2-3 more in a row if the pattern for many of these uplisting Chinese stocks holds...tuna
Thx pf...looking for 1.50's to 1.60's or more on CRXX earnings imho...tuna
CRXX now 1.49 x 1.50 vs 1.26 close on .57 earnings for Q4 vs loss!!
You're welcome...always like Chinese stocks!! tuna
Yes...and CRXX 1.48 now from 1.26 close rising now w/.57 earnings for the Q vs a loss...should be worth much more imho...tuna
SCLN 4.10 x 4.14 now on it's news vs 3.69 close also...tuna
Thanks Joe...will take a look at CHINA...used to trade it years ago! GL today...tuna
CRXX 1.39 x 1.40 up on .57 earnings for Q4 vs a loss this morning!!! Worth more imho...tuna
Chinese CREG 5.75 x 5.79 after first rally day yesterday and in it's first week on NASDAQ!!
Chinese CREG 5.75 x 5.79 looking higher also!!
Me too Joe! But it's early...just 10 minutes of pm so far! tuna
SCLN 4.07 x 4.14 w/news vs 3.69 close!!!
And SCLN 3.69 close may go on approval news:
ondansetron RapidFilm(TM) Approved in 16 European Countries
SciClone Expects European Approvals to Support Efforts for Regulatory Approval in China, Vietnam, Hong Kong, and Macau
Press Release Source: SciClone Pharmaceuticals, Inc. On Wednesday March 24, 2010, 6:00 pm EDT
FOSTER CITY, CA--(Marketwire - 03/24/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union ("EU") countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China ("China"), Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China's rapidly growing pharmaceutical market. A key part of SciClone's strategy is to use its decade of experience in China and to grow its international business by adding commercial stage or near term commercial stage products to its portfolio.
"We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts," stated Friedhelm Blobel, Ph.D., President and Chief Executive officer of SciClone Pharmaceuticals. "The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval."
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
This novel dosage form was specifically designed to solve patient compliance problems found with existing formulations of ondansetron. Patients suffering from nausea and vomiting may have problems swallowing and difficulty retaining tablets in the gastrointestinal system long enough for tablets to dissolve fully. Ondansetron delivered in this polymeric film strip allows for fast absorption without requiring potentially nausea-worsening liquids to be introduced into the patient's system.
Serotonin 5-HT3 receptor antagonists, such as ondansetron, are the most commonly prescribed treatment for chemotherapy and radiotherapy-induced nausea and vomiting in China, where 2008 sales reached more than $110 million, according to SciClone's estimates.
About SciClone
SciClone Pharmaceuticals (NASDAQ:SCLN - News) is a profit-focused, global specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and overall expense management. ZADAXIN® (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug candidates includes thymalfasin, in clinical studies as an enhancer of vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; and SCV-07 in a phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead™ in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China, Vietnam Hong Kong, and Macau, for which it will seek regulatory approval. For additional information, please visit http://www.sciclone.com/.
Forward-Looking Statements
This press release contains forward-looking statements regarding development objectives and timing expectations. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "potential," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include that regulatory officials in China or Vietnam may not approve ondanestron RapidFilm for use in these countries, could impose commercial or other restrictions on SciClone's distribution of this produce or that the product could develop in the future unforeseen complications with its use. Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.
tuna
SCLN 3.69 close also may move ont this approval:
ondansetron RapidFilm(TM) Approved in 16 European Countries
SciClone Expects European Approvals to Support Efforts for Regulatory Approval in China, Vietnam, Hong Kong, and Macau
Press Release Source: SciClone Pharmaceuticals, Inc. On Wednesday March 24, 2010, 6:00 pm EDT
FOSTER CITY, CA--(Marketwire - 03/24/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union ("EU") countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China ("China"), Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China's rapidly growing pharmaceutical market. A key part of SciClone's strategy is to use its decade of experience in China and to grow its international business by adding commercial stage or near term commercial stage products to its portfolio.
"We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts," stated Friedhelm Blobel, Ph.D., President and Chief Executive officer of SciClone Pharmaceuticals. "The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval."
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
This novel dosage form was specifically designed to solve patient compliance problems found with existing formulations of ondansetron. Patients suffering from nausea and vomiting may have problems swallowing and difficulty retaining tablets in the gastrointestinal system long enough for tablets to dissolve fully. Ondansetron delivered in this polymeric film strip allows for fast absorption without requiring potentially nausea-worsening liquids to be introduced into the patient's system.
Serotonin 5-HT3 receptor antagonists, such as ondansetron, are the most commonly prescribed treatment for chemotherapy and radiotherapy-induced nausea and vomiting in China, where 2008 sales reached more than $110 million, according to SciClone's estimates.
About SciClone
SciClone Pharmaceuticals (NASDAQ:SCLN - News) is a profit-focused, global specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and overall expense management. ZADAXIN® (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug candidates includes thymalfasin, in clinical studies as an enhancer of vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; and SCV-07 in a phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead™ in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China, Vietnam Hong Kong, and Macau, for which it will seek regulatory approval. For additional information, please visit http://www.sciclone.com/.
Forward-Looking Statements
This press release contains forward-looking statements regarding development objectives and timing expectations. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "potential," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include that regulatory officials in China or Vietnam may not approve ondanestron RapidFilm for use in these countries, could impose commercial or other restrictions on SciClone's distribution of this produce or that the product could develop in the future unforeseen complications with its use. Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.
tuna
CRXX $1.26 may be a mover w/earnings of .57 vs a loss in latest Q:
CombinatoRx Reports Financial Results for the Fourth Quarter and Year-End 2009
-- Provides Key Goals for 2010 --
Press Release Source: CombinatoRx, Incorporated On Thursday March 25, 2010, 7:30 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) today reported financial results for the fourth quarter and year-ended December 31, 2009 and provided pipeline and business goals for 2010.
“With the successful approval of Exalgo and the Neuromed merger and integration complete, we are uniquely positioned to become a thriving biopharmaceutical business,” commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. “We will leverage our expertise and pipeline to develop innovative products for the treatment of pain and inflammation and have focused our portfolio and R&D efforts in these core therapeutic areas.”
2009 and Recent Accomplishments:
•The U.S. Food and Drug Administration (FDA) approved Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The approval of Exalgo triggered a $40.0 million milestone payment to CombinatoRx from Mallinckrodt Inc., a Covidien company, who acquired the U.S. marketing rights to Exalgo. Going forward, CombinatoRx is eligible to receive tiered royalties on net sales of Exalgo by Covidien.
•CombinatoRx and Neuromed Pharmaceuticals Inc. merged, bringing together the product assets and financial resources of both organizations, including Exalgo™ revenue, the combined portfolio of product candidates and both company’s unique drug discovery capabilities. Mark Corrigan, MD, former EVP of Research & Development at Sepracor and a member of the CombinatoRx board of directors, was appointed President and Chief Executive Officer of CombinatoRx.
•PrednisporinTM (FOV1101), a CombinatoRx-derived combination drug candidate, was recognized as a key asset by Sanofi-Aventis in its acquisition of our collaborator, Fovea Pharmaceuticals, based on positive clinical results with Prednisporin in subjects with persistent allergic conjunctivitis. CombinatoRx also enhanced its economic interest in Prednisporin and the other product candidates licensed to Fovea for ophthalmic development. CombinatoRx will be eligible to receive development and regulatory-based milestone payments for Prednisporin of up to approximately $40.0 million and increased tiered royalty payments of up to 12% of net sales.
•Phase 2 clinical data was presented on SynaviveTM (CRx-102) in knee osteoarthritis (OA) at the American College of Rheumatology (ACR) 2009 Annual Meeting and the Annual European Congress of Rheumatology meeting (EULAR) in which efficacy was observed early in treatment and sustained in all WOMAC measurement subscales including pain, stiffness and physical function. These efficacy levels were maintained throughout the 12-month knee OA extension trial and, importantly, no treatment-related increases in glucocorticoid associated adverse events were observed in the Synavive-treated subjects.
•A strategic alliance was established with the Novartis Institutes for Biomedical Research, Inc. focused on the discovery of novel anti-cancer combinations utilizing the CombinatoRx proprietary combination high throughput screening (cHTS) platform and Chalice analyzer software. This non-exclusive collaboration is exploring combination effects in cell lines representing a broad spectrum of cancers to provide a robust and systematic understanding of combination therapy opportunities. CombinatoRx received an upfront payment, research funding support for two years and is eligible to receive clinical, regulatory and commercial milestones. In addition, CombinatoRx retains the right to conduct oncology research on its own behalf as well as partner with others in the field of oncology, and retains certain intellectual property which may arise from the collaboration.
2010 Pipeline and Business Goals:
•Focus the CombinatoRx portfolio and development efforts in the core therapeutic areas of pain and inflammation:
•Exalgo, which is licensed to Covidien, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
•Synavive (CRx-102) for the treatment of immuno-inflammatory diseases.
•Prednisporin (FOV1101) which is licensed to Fovea, a subsidiary of Sanofi Aventis, for the treatment of inflammatory ocular diseases such as allergic conjunctivitis.
•N-Type and T-Type calcium channel blockers for the treatment of chronic pain.
•Advance development of an existing product candidate:
•Synavive (CRx-102) for the treatment of osteoarthritis
•Advance an N-type lead program from our Ion channel modulation platform into development.
•Continue to apply our state-of-the-art drug discovery technologies to discover new pain and inflammation product candidates for our internal portfolio:
•Selective Ion channel modulation platform
•cHTS drug discovery technology
•Continue to seek additional revenue-generating research and technology collaborations for our drug discovery platform.
•Maintain financial strength with sufficient resources to fund operations into 2014.
Fourth Quarter and Year-End 2009 Financial Results (Unaudited):
As of December 31, 2009, CombinatoRx had cash, cash equivalents, restricted cash and short-term investments of $25.9 million compared to $43.7 million on December 31, 2008.
Total revenue was $8.6 million in the fourth quarter of 2009 compared to $3.5 million reported in the fourth quarter of 2008. For the year ended December 31, 2009, revenue was $17.3 million compared to $12.3 million for 2008. Revenue increased from 2008 to 2009 due to the accelerated recognition of deferred revenue related to the early termination of our agreement with Angiotech.
Net income for the quarter ended December 31, 2009 was $25.2 million, or $0.57 per share, as compared to a $15.2 million loss, or ($0.43) per share, in the fourth quarter of 2008. Stock-based compensation expense was approximately $0.8 million in the fourth quarter of 2009 as compared to $0.9 million in the fourth quarter of 2008. For the year ended December 31, 2009, net income from continuing operations was $1.3 million, or $0.03 per share, compared to a net loss of $60.6 million, or $(1.74) per share, in the year ended December 31, 2008. Stock-based compensation expense was approximately $3.9 million and $5.7 million in the years ended December 31, 2009, and 2008, respectively.
Research and development expenses totaled $3.1 million in the fourth quarter of 2009 compared to $9.8 million in the fourth quarter of 2008. Research and development expenses were $21.2 million in the year ended December 31, 2009 compared to $55.3 million in the year ended December 31, 2008. The $34.1 million decrease from the 2008 period to the 2009 period was primarily due to a decrease of $16.7 million in preclinical and external clinical expenses, a $10.8 million decrease in compensation and benefit expenses, associated with reduced headcount attributable to the 2008 and 2009 restructurings, a $5.6 million decrease in consulting, lab supplies, facilities, depreciation and other overhead costs related to our 2008 and 2009 restructurings, as well as a $1.0 million decrease in non-cash stock-based compensation expense.
General and administrative expenses were $5.1 million in the fourth quarter of 2009 compared to $3.0 million in the fourth quarter of 2008. General and administrative expenses were $17.1 million in the year ended December 31, 2009 compared to $14.5 million in the year ended December 31, 2008. The increase was due primarily to professional and consulting expenses related to our merger with Neuromed.
Conference Call Information:
CombinatoRx senior management, including Mark H.N. Corrigan, MD, President and Chief Executive Officer and Justin Renz, Senior Vice President and Chief Financial Officer of CombinatoRx, will provide an update on the Company, discuss fourth quarter and year-end 2009 financial results and discuss expectations for the future via conference call at 8:30 a.m. EDT on Thursday, March 25, 2010. To access the call, please dial 866-383-7998 (domestic) or 617-597-5329 (international) five minutes prior to the start time and provide the passcode 67986161. A replay of the call will be available beginning at 11:30 a.m. ET on March 25, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the passcode 35427451. A live audio webcast of the call will also be available on the “Investors” section of the company’s website, http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=1&md5=0f5ade78402effaaf35d331fa0ae91ff. An archived audio webcast will be available on the CombinatoRx website two hours after the event.
About CombinatoRx:
CombinatoRx, Incorporated (CRXX) develops novel drug candidates with a focus on the treatment of pain and inflammation. The company applies its combination drug discovery capabilities and its selective ion-channel modulation platform to generate innovative therapeutics. To learn more about CombinatoRx, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=2&md5=9c112cfc5cdccbe7d58049d65a65d5d4.
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx, the product Exalgo™ and its ability to generate future royalty revenue for CombinatoRx, Fovea’s product candidate Prednisporin™, its clinical potential and the amended agreement with Fovea, the potential of the CombinatoRx product candidate Synavive, the CombinatoRx collaboration with Novartis, the CombinatoRx selective ion channel modulation platform, its combination drug discovery technology, and CombinatoRx’s financial condition, results of operations, projected expenses, cash positions and business plans. These forward-looking statements about future expectations, plans, objectives and prospects of CombinatoRx may be identified by words like "believe," "expect," "may," "will," "should," "seek," or “could” and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the sale and marketing of Exalgo by Covidien, risks related to the development and regulatory approval of CombinatoRx’s product candidates, the unproven nature of the CombinatoRx drug discovery technologies, the ability of Covidien, Novartis and Fovea to perform their obligations under their collaboration agreements with CombinatoRx, the ability of the Company or its collaboration partners to initiate and successfully complete clinical trials of its product candidates, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section beginning on page 31 of CombinatoRx's Form S-4 Registration Statement filed in connection with its merger with Neuromed (File No. 333-161146), on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended December 31, Twelve months ended December 31,
2009 2008 2009 2008
As Adjusted As Adjusted
Revenue
Collaborations $ 8,384 $ 3,248 $ 16,320 $ 11,462
Government contracts and grants 196 210 953 842
Total revenue 8,580 3,458 17,273 12,304
Operating expenses:
Research and development 3,120 9,819 21,244 55,296
General and administration 5,056 3,039 17,081 14,469
Restructuring 123 4,637 2,736 4,637
Amortization of intangible asset 520 - 520 -
Gain on legal settlement (3,700) - (3,700) -
Total operating expenses 5,119 17,495 37,881 74,402
Loss from operations 3,461 (14,037) (20,608) (62,098)
Interest income 15 199 257 2,264
Interest expense - (123) (28) (651)
Loss on early extinguishment of debt - (195) - (195)
Gain on revalue of contingent consideration 12,068 - 12,068 -
Gain on bargain purchase 9,809 - 9,809 -
Other expense (249) (24) (281) (4)
Net income (loss) before provision for income taxes 25,104 (14,180) 1,217 (60,684)
Benefit for income taxes 67 128 67 108
Net income (loss) from continuing operations 25,171 (14,052) 1,284 (60,576)
Discontinued Operations:
Loss from operations of discontinued subsidiary - (1,182) (1,536) (4,557)
Gain on disposal of discontinued operations - - 15,640 -
Gain (loss) on discontinued operations - (1,182) 14,104 (4,557)
Net income (loss) $ 25,171 $ (15,234) $ 15,388 $ (65,133)
Net income (loss) per share - basic and diluted:
From continuing operations $ 0.57 $ (0.41) $ 0.03 $ (1.74)
From discontinued operations - (0.02) 0.38 (0.13)
Net income (loss) per share - basic and diluted $ 0.57 $ (0.43) $ 0.41 $ (1.87)
Weighted average number of common shares used in net income (loss)
per share calculation:
Basic 44,198,131 35,095,516 37,338,042 34,848,701
Diluted 44,503,062 35,095,516 37,491,237 34,848,701
Note: The Statements of Operations for the three and twelve months ended December 31, 2008 reflect the financial results of CombinatoRx Singapore as a discontinued operation.
CombinatoRx, Incorporated
Consolidated Balance Sheets
(in thousands, except per share data)
(Unaudited)
December 31, 2009 December 31, 2008
As Adjusted
Assets
Current assets:
Cash and cash equivalents $ 8,779 $ 3,039
Restricted cash 750 1,250
Short-term investments 14,551 36,614
Accounts receivable 2,927 438
Prepaid expenses and other current assets 5,415 1,001
Current assets of discontinued operations - 7,837
Total current assets 32,422 50,179
Property and equipment, net 8,380 12,400
Property and equipment of discontinued operations, net - 995
Intangible asset, net 45,423 -
Restricted cash and other assets 1,927 2,923
Total assets $ 88,152 $ 66,497
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 4,269 $ 2,842
Accrued expenses 5,495 4,067
Accrued restructuring 1,274 1,902
Deferred revenue 2,750 5,384
Current portion of lease incentive obligation 284 575
Current liabilities of discontinued operations - 19,822
Total current liabilities 14,072 34,592
Deferred revenue, net of current portion 2,667 6,325
Deferred rent, net of current portion 775 1,680
Lease incentive obligation, net of current portion 1,726 4,074
Accrued restructuring, net of current portion - 968
Other long-term liabilities 3,235 -
Contingent consideration 12,764 -
Liabilities of discontinued operations - 66
Noncontrolling interest in discontinued operations - 2,917
Stockholders’ equity:
Preferred stock, $0.001 par value: 5,000 shares authorized; no shares
issued and outstanding - -
Common stock, $0.001 par value: 200,000 shares authorized; 117,829
and 35,090 shares issued and outstanding at December 31, 2009
and December 31, 2008, respectively 118 35
Additional paid-in capital 272,405 267,238
Accumulated other comprehensive (loss) income (2) 73
Accumulated deficit (219,608) (251,471)
Stockholders’ equity 52,913 15,875
Total liabilities and stockholders' equity $ 88,152 $ 66,497
Note: The Balance Sheet as of December 31, 2008 reflects the reclassification of CombinatoRx Singapore as a discontinued operation.
Contact:
CombinatoRx, IncorporatedJustin Renz, 617-301-7575Senior Vice President, CFOJRenz@combinatorx.comorGina Nugent, 857-753-6562gnugent@combinatorx.com
tuna
CRXX $1.26 may be a mover w/earnings of .57 vs a loss in latest Q:
CombinatoRx Reports Financial Results for the Fourth Quarter and Year-End 2009
-- Provides Key Goals for 2010 --
Press Release Source: CombinatoRx, Incorporated On Thursday March 25, 2010, 7:30 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) today reported financial results for the fourth quarter and year-ended December 31, 2009 and provided pipeline and business goals for 2010.
“With the successful approval of Exalgo and the Neuromed merger and integration complete, we are uniquely positioned to become a thriving biopharmaceutical business,” commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. “We will leverage our expertise and pipeline to develop innovative products for the treatment of pain and inflammation and have focused our portfolio and R&D efforts in these core therapeutic areas.”
2009 and Recent Accomplishments:
•The U.S. Food and Drug Administration (FDA) approved Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The approval of Exalgo triggered a $40.0 million milestone payment to CombinatoRx from Mallinckrodt Inc., a Covidien company, who acquired the U.S. marketing rights to Exalgo. Going forward, CombinatoRx is eligible to receive tiered royalties on net sales of Exalgo by Covidien.
•CombinatoRx and Neuromed Pharmaceuticals Inc. merged, bringing together the product assets and financial resources of both organizations, including Exalgo™ revenue, the combined portfolio of product candidates and both company’s unique drug discovery capabilities. Mark Corrigan, MD, former EVP of Research & Development at Sepracor and a member of the CombinatoRx board of directors, was appointed President and Chief Executive Officer of CombinatoRx.
•PrednisporinTM (FOV1101), a CombinatoRx-derived combination drug candidate, was recognized as a key asset by Sanofi-Aventis in its acquisition of our collaborator, Fovea Pharmaceuticals, based on positive clinical results with Prednisporin in subjects with persistent allergic conjunctivitis. CombinatoRx also enhanced its economic interest in Prednisporin and the other product candidates licensed to Fovea for ophthalmic development. CombinatoRx will be eligible to receive development and regulatory-based milestone payments for Prednisporin of up to approximately $40.0 million and increased tiered royalty payments of up to 12% of net sales.
•Phase 2 clinical data was presented on SynaviveTM (CRx-102) in knee osteoarthritis (OA) at the American College of Rheumatology (ACR) 2009 Annual Meeting and the Annual European Congress of Rheumatology meeting (EULAR) in which efficacy was observed early in treatment and sustained in all WOMAC measurement subscales including pain, stiffness and physical function. These efficacy levels were maintained throughout the 12-month knee OA extension trial and, importantly, no treatment-related increases in glucocorticoid associated adverse events were observed in the Synavive-treated subjects.
•A strategic alliance was established with the Novartis Institutes for Biomedical Research, Inc. focused on the discovery of novel anti-cancer combinations utilizing the CombinatoRx proprietary combination high throughput screening (cHTS) platform and Chalice analyzer software. This non-exclusive collaboration is exploring combination effects in cell lines representing a broad spectrum of cancers to provide a robust and systematic understanding of combination therapy opportunities. CombinatoRx received an upfront payment, research funding support for two years and is eligible to receive clinical, regulatory and commercial milestones. In addition, CombinatoRx retains the right to conduct oncology research on its own behalf as well as partner with others in the field of oncology, and retains certain intellectual property which may arise from the collaboration.
2010 Pipeline and Business Goals:
•Focus the CombinatoRx portfolio and development efforts in the core therapeutic areas of pain and inflammation:
•Exalgo, which is licensed to Covidien, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
•Synavive (CRx-102) for the treatment of immuno-inflammatory diseases.
•Prednisporin (FOV1101) which is licensed to Fovea, a subsidiary of Sanofi Aventis, for the treatment of inflammatory ocular diseases such as allergic conjunctivitis.
•N-Type and T-Type calcium channel blockers for the treatment of chronic pain.
•Advance development of an existing product candidate:
•Synavive (CRx-102) for the treatment of osteoarthritis
•Advance an N-type lead program from our Ion channel modulation platform into development.
•Continue to apply our state-of-the-art drug discovery technologies to discover new pain and inflammation product candidates for our internal portfolio:
•Selective Ion channel modulation platform
•cHTS drug discovery technology
•Continue to seek additional revenue-generating research and technology collaborations for our drug discovery platform.
•Maintain financial strength with sufficient resources to fund operations into 2014.
Fourth Quarter and Year-End 2009 Financial Results (Unaudited):
As of December 31, 2009, CombinatoRx had cash, cash equivalents, restricted cash and short-term investments of $25.9 million compared to $43.7 million on December 31, 2008.
Total revenue was $8.6 million in the fourth quarter of 2009 compared to $3.5 million reported in the fourth quarter of 2008. For the year ended December 31, 2009, revenue was $17.3 million compared to $12.3 million for 2008. Revenue increased from 2008 to 2009 due to the accelerated recognition of deferred revenue related to the early termination of our agreement with Angiotech.
Net income for the quarter ended December 31, 2009 was $25.2 million, or $0.57 per share, as compared to a $15.2 million loss, or ($0.43) per share, in the fourth quarter of 2008. Stock-based compensation expense was approximately $0.8 million in the fourth quarter of 2009 as compared to $0.9 million in the fourth quarter of 2008. For the year ended December 31, 2009, net income from continuing operations was $1.3 million, or $0.03 per share, compared to a net loss of $60.6 million, or $(1.74) per share, in the year ended December 31, 2008. Stock-based compensation expense was approximately $3.9 million and $5.7 million in the years ended December 31, 2009, and 2008, respectively.
Research and development expenses totaled $3.1 million in the fourth quarter of 2009 compared to $9.8 million in the fourth quarter of 2008. Research and development expenses were $21.2 million in the year ended December 31, 2009 compared to $55.3 million in the year ended December 31, 2008. The $34.1 million decrease from the 2008 period to the 2009 period was primarily due to a decrease of $16.7 million in preclinical and external clinical expenses, a $10.8 million decrease in compensation and benefit expenses, associated with reduced headcount attributable to the 2008 and 2009 restructurings, a $5.6 million decrease in consulting, lab supplies, facilities, depreciation and other overhead costs related to our 2008 and 2009 restructurings, as well as a $1.0 million decrease in non-cash stock-based compensation expense.
General and administrative expenses were $5.1 million in the fourth quarter of 2009 compared to $3.0 million in the fourth quarter of 2008. General and administrative expenses were $17.1 million in the year ended December 31, 2009 compared to $14.5 million in the year ended December 31, 2008. The increase was due primarily to professional and consulting expenses related to our merger with Neuromed.
Conference Call Information:
CombinatoRx senior management, including Mark H.N. Corrigan, MD, President and Chief Executive Officer and Justin Renz, Senior Vice President and Chief Financial Officer of CombinatoRx, will provide an update on the Company, discuss fourth quarter and year-end 2009 financial results and discuss expectations for the future via conference call at 8:30 a.m. EDT on Thursday, March 25, 2010. To access the call, please dial 866-383-7998 (domestic) or 617-597-5329 (international) five minutes prior to the start time and provide the passcode 67986161. A replay of the call will be available beginning at 11:30 a.m. ET on March 25, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the passcode 35427451. A live audio webcast of the call will also be available on the “Investors” section of the company’s website, http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=1&md5=0f5ade78402effaaf35d331fa0ae91ff. An archived audio webcast will be available on the CombinatoRx website two hours after the event.
About CombinatoRx:
CombinatoRx, Incorporated (CRXX) develops novel drug candidates with a focus on the treatment of pain and inflammation. The company applies its combination drug discovery capabilities and its selective ion-channel modulation platform to generate innovative therapeutics. To learn more about CombinatoRx, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=2&md5=9c112cfc5cdccbe7d58049d65a65d5d4.
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx, the product Exalgo™ and its ability to generate future royalty revenue for CombinatoRx, Fovea’s product candidate Prednisporin™, its clinical potential and the amended agreement with Fovea, the potential of the CombinatoRx product candidate Synavive, the CombinatoRx collaboration with Novartis, the CombinatoRx selective ion channel modulation platform, its combination drug discovery technology, and CombinatoRx’s financial condition, results of operations, projected expenses, cash positions and business plans. These forward-looking statements about future expectations, plans, objectives and prospects of CombinatoRx may be identified by words like "believe," "expect," "may," "will," "should," "seek," or “could” and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the sale and marketing of Exalgo by Covidien, risks related to the development and regulatory approval of CombinatoRx’s product candidates, the unproven nature of the CombinatoRx drug discovery technologies, the ability of Covidien, Novartis and Fovea to perform their obligations under their collaboration agreements with CombinatoRx, the ability of the Company or its collaboration partners to initiate and successfully complete clinical trials of its product candidates, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section beginning on page 31 of CombinatoRx's Form S-4 Registration Statement filed in connection with its merger with Neuromed (File No. 333-161146), on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended December 31, Twelve months ended December 31,
2009 2008 2009 2008
As Adjusted As Adjusted
Revenue
Collaborations $ 8,384 $ 3,248 $ 16,320 $ 11,462
Government contracts and grants 196 210 953 842
Total revenue 8,580 3,458 17,273 12,304
Operating expenses:
Research and development 3,120 9,819 21,244 55,296
General and administration 5,056 3,039 17,081 14,469
Restructuring 123 4,637 2,736 4,637
Amortization of intangible asset 520 - 520 -
Gain on legal settlement (3,700) - (3,700) -
Total operating expenses 5,119 17,495 37,881 74,402
Loss from operations 3,461 (14,037) (20,608) (62,098)
Interest income 15 199 257 2,264
Interest expense - (123) (28) (651)
Loss on early extinguishment of debt - (195) - (195)
Gain on revalue of contingent consideration 12,068 - 12,068 -
Gain on bargain purchase 9,809 - 9,809 -
Other expense (249) (24) (281) (4)
Net income (loss) before provision for income taxes 25,104 (14,180) 1,217 (60,684)
Benefit for income taxes 67 128 67 108
Net income (loss) from continuing operations 25,171 (14,052) 1,284 (60,576)
Discontinued Operations:
Loss from operations of discontinued subsidiary - (1,182) (1,536) (4,557)
Gain on disposal of discontinued operations - - 15,640 -
Gain (loss) on discontinued operations - (1,182) 14,104 (4,557)
Net income (loss) $ 25,171 $ (15,234) $ 15,388 $ (65,133)
Net income (loss) per share - basic and diluted:
From continuing operations $ 0.57 $ (0.41) $ 0.03 $ (1.74)
From discontinued operations - (0.02) 0.38 (0.13)
Net income (loss) per share - basic and diluted $ 0.57 $ (0.43) $ 0.41 $ (1.87)
Weighted average number of common shares used in net income (loss)
per share calculation:
Basic 44,198,131 35,095,516 37,338,042 34,848,701
Diluted 44,503,062 35,095,516 37,491,237 34,848,701
Note: The Statements of Operations for the three and twelve months ended December 31, 2008 reflect the financial results of CombinatoRx Singapore as a discontinued operation.
CombinatoRx, Incorporated
Consolidated Balance Sheets
(in thousands, except per share data)
(Unaudited)
December 31, 2009 December 31, 2008
As Adjusted
Assets
Current assets:
Cash and cash equivalents $ 8,779 $ 3,039
Restricted cash 750 1,250
Short-term investments 14,551 36,614
Accounts receivable 2,927 438
Prepaid expenses and other current assets 5,415 1,001
Current assets of discontinued operations - 7,837
Total current assets 32,422 50,179
Property and equipment, net 8,380 12,400
Property and equipment of discontinued operations, net - 995
Intangible asset, net 45,423 -
Restricted cash and other assets 1,927 2,923
Total assets $ 88,152 $ 66,497
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 4,269 $ 2,842
Accrued expenses 5,495 4,067
Accrued restructuring 1,274 1,902
Deferred revenue 2,750 5,384
Current portion of lease incentive obligation 284 575
Current liabilities of discontinued operations - 19,822
Total current liabilities 14,072 34,592
Deferred revenue, net of current portion 2,667 6,325
Deferred rent, net of current portion 775 1,680
Lease incentive obligation, net of current portion 1,726 4,074
Accrued restructuring, net of current portion - 968
Other long-term liabilities 3,235 -
Contingent consideration 12,764 -
Liabilities of discontinued operations - 66
Noncontrolling interest in discontinued operations - 2,917
Stockholders’ equity:
Preferred stock, $0.001 par value: 5,000 shares authorized; no shares
issued and outstanding - -
Common stock, $0.001 par value: 200,000 shares authorized; 117,829
and 35,090 shares issued and outstanding at December 31, 2009
and December 31, 2008, respectively 118 35
Additional paid-in capital 272,405 267,238
Accumulated other comprehensive (loss) income (2) 73
Accumulated deficit (219,608) (251,471)
Stockholders’ equity 52,913 15,875
Total liabilities and stockholders' equity $ 88,152 $ 66,497
Note: The Balance Sheet as of December 31, 2008 reflects the reclassification of CombinatoRx Singapore as a discontinued operation.
Contact:
CombinatoRx, IncorporatedJustin Renz, 617-301-7575Senior Vice President, CFOJRenz@combinatorx.comorGina Nugent, 857-753-6562gnugent@combinatorx.com
tuna
CRXX $1.26 may pop w/earnings of .57 vs a loss in latest Q:
CombinatoRx Reports Financial Results for the Fourth Quarter and Year-End 2009
-- Provides Key Goals for 2010 --
Press Release Source: CombinatoRx, Incorporated On Thursday March 25, 2010, 7:30 am
CAMBRIDGE, Mass.--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) today reported financial results for the fourth quarter and year-ended December 31, 2009 and provided pipeline and business goals for 2010.
“With the successful approval of Exalgo and the Neuromed merger and integration complete, we are uniquely positioned to become a thriving biopharmaceutical business,” commented Mark H.N. Corrigan, MD, President and CEO of CombinatoRx. “We will leverage our expertise and pipeline to develop innovative products for the treatment of pain and inflammation and have focused our portfolio and R&D efforts in these core therapeutic areas.”
2009 and Recent Accomplishments:
•The U.S. Food and Drug Administration (FDA) approved Exalgo™ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The approval of Exalgo triggered a $40.0 million milestone payment to CombinatoRx from Mallinckrodt Inc., a Covidien company, who acquired the U.S. marketing rights to Exalgo. Going forward, CombinatoRx is eligible to receive tiered royalties on net sales of Exalgo by Covidien.
•CombinatoRx and Neuromed Pharmaceuticals Inc. merged, bringing together the product assets and financial resources of both organizations, including Exalgo™ revenue, the combined portfolio of product candidates and both company’s unique drug discovery capabilities. Mark Corrigan, MD, former EVP of Research & Development at Sepracor and a member of the CombinatoRx board of directors, was appointed President and Chief Executive Officer of CombinatoRx.
•PrednisporinTM (FOV1101), a CombinatoRx-derived combination drug candidate, was recognized as a key asset by Sanofi-Aventis in its acquisition of our collaborator, Fovea Pharmaceuticals, based on positive clinical results with Prednisporin in subjects with persistent allergic conjunctivitis. CombinatoRx also enhanced its economic interest in Prednisporin and the other product candidates licensed to Fovea for ophthalmic development. CombinatoRx will be eligible to receive development and regulatory-based milestone payments for Prednisporin of up to approximately $40.0 million and increased tiered royalty payments of up to 12% of net sales.
•Phase 2 clinical data was presented on SynaviveTM (CRx-102) in knee osteoarthritis (OA) at the American College of Rheumatology (ACR) 2009 Annual Meeting and the Annual European Congress of Rheumatology meeting (EULAR) in which efficacy was observed early in treatment and sustained in all WOMAC measurement subscales including pain, stiffness and physical function. These efficacy levels were maintained throughout the 12-month knee OA extension trial and, importantly, no treatment-related increases in glucocorticoid associated adverse events were observed in the Synavive-treated subjects.
•A strategic alliance was established with the Novartis Institutes for Biomedical Research, Inc. focused on the discovery of novel anti-cancer combinations utilizing the CombinatoRx proprietary combination high throughput screening (cHTS) platform and Chalice analyzer software. This non-exclusive collaboration is exploring combination effects in cell lines representing a broad spectrum of cancers to provide a robust and systematic understanding of combination therapy opportunities. CombinatoRx received an upfront payment, research funding support for two years and is eligible to receive clinical, regulatory and commercial milestones. In addition, CombinatoRx retains the right to conduct oncology research on its own behalf as well as partner with others in the field of oncology, and retains certain intellectual property which may arise from the collaboration.
2010 Pipeline and Business Goals:
•Focus the CombinatoRx portfolio and development efforts in the core therapeutic areas of pain and inflammation:
•Exalgo, which is licensed to Covidien, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
•Synavive (CRx-102) for the treatment of immuno-inflammatory diseases.
•Prednisporin (FOV1101) which is licensed to Fovea, a subsidiary of Sanofi Aventis, for the treatment of inflammatory ocular diseases such as allergic conjunctivitis.
•N-Type and T-Type calcium channel blockers for the treatment of chronic pain.
•Advance development of an existing product candidate:
•Synavive (CRx-102) for the treatment of osteoarthritis
•Advance an N-type lead program from our Ion channel modulation platform into development.
•Continue to apply our state-of-the-art drug discovery technologies to discover new pain and inflammation product candidates for our internal portfolio:
•Selective Ion channel modulation platform
•cHTS drug discovery technology
•Continue to seek additional revenue-generating research and technology collaborations for our drug discovery platform.
•Maintain financial strength with sufficient resources to fund operations into 2014.
Fourth Quarter and Year-End 2009 Financial Results (Unaudited):
As of December 31, 2009, CombinatoRx had cash, cash equivalents, restricted cash and short-term investments of $25.9 million compared to $43.7 million on December 31, 2008.
Total revenue was $8.6 million in the fourth quarter of 2009 compared to $3.5 million reported in the fourth quarter of 2008. For the year ended December 31, 2009, revenue was $17.3 million compared to $12.3 million for 2008. Revenue increased from 2008 to 2009 due to the accelerated recognition of deferred revenue related to the early termination of our agreement with Angiotech.
Net income for the quarter ended December 31, 2009 was $25.2 million, or $0.57 per share, as compared to a $15.2 million loss, or ($0.43) per share, in the fourth quarter of 2008. Stock-based compensation expense was approximately $0.8 million in the fourth quarter of 2009 as compared to $0.9 million in the fourth quarter of 2008. For the year ended December 31, 2009, net income from continuing operations was $1.3 million, or $0.03 per share, compared to a net loss of $60.6 million, or $(1.74) per share, in the year ended December 31, 2008. Stock-based compensation expense was approximately $3.9 million and $5.7 million in the years ended December 31, 2009, and 2008, respectively.
Research and development expenses totaled $3.1 million in the fourth quarter of 2009 compared to $9.8 million in the fourth quarter of 2008. Research and development expenses were $21.2 million in the year ended December 31, 2009 compared to $55.3 million in the year ended December 31, 2008. The $34.1 million decrease from the 2008 period to the 2009 period was primarily due to a decrease of $16.7 million in preclinical and external clinical expenses, a $10.8 million decrease in compensation and benefit expenses, associated with reduced headcount attributable to the 2008 and 2009 restructurings, a $5.6 million decrease in consulting, lab supplies, facilities, depreciation and other overhead costs related to our 2008 and 2009 restructurings, as well as a $1.0 million decrease in non-cash stock-based compensation expense.
General and administrative expenses were $5.1 million in the fourth quarter of 2009 compared to $3.0 million in the fourth quarter of 2008. General and administrative expenses were $17.1 million in the year ended December 31, 2009 compared to $14.5 million in the year ended December 31, 2008. The increase was due primarily to professional and consulting expenses related to our merger with Neuromed.
Conference Call Information:
CombinatoRx senior management, including Mark H.N. Corrigan, MD, President and Chief Executive Officer and Justin Renz, Senior Vice President and Chief Financial Officer of CombinatoRx, will provide an update on the Company, discuss fourth quarter and year-end 2009 financial results and discuss expectations for the future via conference call at 8:30 a.m. EDT on Thursday, March 25, 2010. To access the call, please dial 866-383-7998 (domestic) or 617-597-5329 (international) five minutes prior to the start time and provide the passcode 67986161. A replay of the call will be available beginning at 11:30 a.m. ET on March 25, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the passcode 35427451. A live audio webcast of the call will also be available on the “Investors” section of the company’s website, http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=1&md5=0f5ade78402effaaf35d331fa0ae91ff. An archived audio webcast will be available on the CombinatoRx website two hours after the event.
About CombinatoRx:
CombinatoRx, Incorporated (CRXX) develops novel drug candidates with a focus on the treatment of pain and inflammation. The company applies its combination drug discovery capabilities and its selective ion-channel modulation platform to generate innovative therapeutics. To learn more about CombinatoRx, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.combinatorx.com&esheet=6227169&lan=en_US&anchor=www.combinatorx.com&index=2&md5=9c112cfc5cdccbe7d58049d65a65d5d4.
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx, the product Exalgo™ and its ability to generate future royalty revenue for CombinatoRx, Fovea’s product candidate Prednisporin™, its clinical potential and the amended agreement with Fovea, the potential of the CombinatoRx product candidate Synavive, the CombinatoRx collaboration with Novartis, the CombinatoRx selective ion channel modulation platform, its combination drug discovery technology, and CombinatoRx’s financial condition, results of operations, projected expenses, cash positions and business plans. These forward-looking statements about future expectations, plans, objectives and prospects of CombinatoRx may be identified by words like "believe," "expect," "may," "will," "should," "seek," or “could” and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the sale and marketing of Exalgo by Covidien, risks related to the development and regulatory approval of CombinatoRx’s product candidates, the unproven nature of the CombinatoRx drug discovery technologies, the ability of Covidien, Novartis and Fovea to perform their obligations under their collaboration agreements with CombinatoRx, the ability of the Company or its collaboration partners to initiate and successfully complete clinical trials of its product candidates, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section beginning on page 31 of CombinatoRx's Form S-4 Registration Statement filed in connection with its merger with Neuromed (File No. 333-161146), on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
Three months ended December 31, Twelve months ended December 31,
2009 2008 2009 2008
As Adjusted As Adjusted
Revenue
Collaborations $ 8,384 $ 3,248 $ 16,320 $ 11,462
Government contracts and grants 196 210 953 842
Total revenue 8,580 3,458 17,273 12,304
Operating expenses:
Research and development 3,120 9,819 21,244 55,296
General and administration 5,056 3,039 17,081 14,469
Restructuring 123 4,637 2,736 4,637
Amortization of intangible asset 520 - 520 -
Gain on legal settlement (3,700) - (3,700) -
Total operating expenses 5,119 17,495 37,881 74,402
Loss from operations 3,461 (14,037) (20,608) (62,098)
Interest income 15 199 257 2,264
Interest expense - (123) (28) (651)
Loss on early extinguishment of debt - (195) - (195)
Gain on revalue of contingent consideration 12,068 - 12,068 -
Gain on bargain purchase 9,809 - 9,809 -
Other expense (249) (24) (281) (4)
Net income (loss) before provision for income taxes 25,104 (14,180) 1,217 (60,684)
Benefit for income taxes 67 128 67 108
Net income (loss) from continuing operations 25,171 (14,052) 1,284 (60,576)
Discontinued Operations:
Loss from operations of discontinued subsidiary - (1,182) (1,536) (4,557)
Gain on disposal of discontinued operations - - 15,640 -
Gain (loss) on discontinued operations - (1,182) 14,104 (4,557)
Net income (loss) $ 25,171 $ (15,234) $ 15,388 $ (65,133)
Net income (loss) per share - basic and diluted:
From continuing operations $ 0.57 $ (0.41) $ 0.03 $ (1.74)
From discontinued operations - (0.02) 0.38 (0.13)
Net income (loss) per share - basic and diluted $ 0.57 $ (0.43) $ 0.41 $ (1.87)
Weighted average number of common shares used in net income (loss)
per share calculation:
Basic 44,198,131 35,095,516 37,338,042 34,848,701
Diluted 44,503,062 35,095,516 37,491,237 34,848,701
Note: The Statements of Operations for the three and twelve months ended December 31, 2008 reflect the financial results of CombinatoRx Singapore as a discontinued operation.
CombinatoRx, Incorporated
Consolidated Balance Sheets
(in thousands, except per share data)
(Unaudited)
December 31, 2009 December 31, 2008
As Adjusted
Assets
Current assets:
Cash and cash equivalents $ 8,779 $ 3,039
Restricted cash 750 1,250
Short-term investments 14,551 36,614
Accounts receivable 2,927 438
Prepaid expenses and other current assets 5,415 1,001
Current assets of discontinued operations - 7,837
Total current assets 32,422 50,179
Property and equipment, net 8,380 12,400
Property and equipment of discontinued operations, net - 995
Intangible asset, net 45,423 -
Restricted cash and other assets 1,927 2,923
Total assets $ 88,152 $ 66,497
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 4,269 $ 2,842
Accrued expenses 5,495 4,067
Accrued restructuring 1,274 1,902
Deferred revenue 2,750 5,384
Current portion of lease incentive obligation 284 575
Current liabilities of discontinued operations - 19,822
Total current liabilities 14,072 34,592
Deferred revenue, net of current portion 2,667 6,325
Deferred rent, net of current portion 775 1,680
Lease incentive obligation, net of current portion 1,726 4,074
Accrued restructuring, net of current portion - 968
Other long-term liabilities 3,235 -
Contingent consideration 12,764 -
Liabilities of discontinued operations - 66
Noncontrolling interest in discontinued operations - 2,917
Stockholders’ equity:
Preferred stock, $0.001 par value: 5,000 shares authorized; no shares
issued and outstanding - -
Common stock, $0.001 par value: 200,000 shares authorized; 117,829
and 35,090 shares issued and outstanding at December 31, 2009
and December 31, 2008, respectively 118 35
Additional paid-in capital 272,405 267,238
Accumulated other comprehensive (loss) income (2) 73
Accumulated deficit (219,608) (251,471)
Stockholders’ equity 52,913 15,875
Total liabilities and stockholders' equity $ 88,152 $ 66,497
Note: The Balance Sheet as of December 31, 2008 reflects the reclassification of CombinatoRx Singapore as a discontinued operation.
Contact:
CombinatoRx, IncorporatedJustin Renz, 617-301-7575Senior Vice President, CFOJRenz@combinatorx.comorGina Nugent, 857-753-6562gnugent@combinatorx.com
tuna
I agree fully on CYXN stanley! I've been adding for over a week now and will likely get more before earnings arrive...this is way too cheap a valuation based on the earnings improvement imho! All the best...other Chinese stocks I'm in that I like are newly listed CREG, CHGI, SNBP, NEWN, and CSGH, though I have more CYXN than any of these. Btw, CREG had it's first up day since moving to NASDAQ on Monday of this week...looking for follow-through as the volume was huge for it, way more than any other day in the last 6 month chart and maybe in it's trading history! All the best! tuna
News in AH has SCLN up ico:
ondansetron RapidFilm(TM) Approved in 16 European Countries
SciClone Expects European Approvals to Support Efforts for Regulatory Approval in China, Vietnam, Hong Kong, and Macau
Press Release Source: SciClone Pharmaceuticals, Inc. On Wednesday March 24, 2010, 6:00 pm EDT
FOSTER CITY, CA--(Marketwire - 03/24/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union ("EU") countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China ("China"), Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China's rapidly growing pharmaceutical market. A key part of SciClone's strategy is to use its decade of experience in China and to grow its international business by adding commercial stage or near term commercial stage products to its portfolio.
"We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts," stated Friedhelm Blobel, Ph.D., President and Chief Executive officer of SciClone Pharmaceuticals. "The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval."
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
This novel dosage form was specifically designed to solve patient compliance problems found with existing formulations of ondansetron. Patients suffering from nausea and vomiting may have problems swallowing and difficulty retaining tablets in the gastrointestinal system long enough for tablets to dissolve fully. Ondansetron delivered in this polymeric film strip allows for fast absorption without requiring potentially nausea-worsening liquids to be introduced into the patient's system.
Serotonin 5-HT3 receptor antagonists, such as ondansetron, are the most commonly prescribed treatment for chemotherapy and radiotherapy-induced nausea and vomiting in China, where 2008 sales reached more than $110 million, according to SciClone's estimates.
About SciClone
SciClone Pharmaceuticals (NASDAQ:SCLN - News) is a profit-focused, global specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and overall expense management. ZADAXIN® (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug candidates includes thymalfasin, in clinical studies as an enhancer of vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; and SCV-07 in a phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead™ in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China, Vietnam Hong Kong, and Macau, for which it will seek regulatory approval. For additional information, please visit http://www.sciclone.com/.
Hope it runs in the morning!
Hope you all have a great night!! tuna
Btw, SCLN up in AH with news in some!!
ondansetron RapidFilm(TM) Approved in 16 European Countries
SciClone Expects European Approvals to Support Efforts for Regulatory Approval in China, Vietnam, Hong Kong, and Macau
Press Release Source: SciClone Pharmaceuticals, Inc. On Wednesday March 24, 2010, 6:00 pm EDT
FOSTER CITY, CA--(Marketwire - 03/24/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union ("EU") countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China ("China"), Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China's rapidly growing pharmaceutical market. A key part of SciClone's strategy is to use its decade of experience in China and to grow its international business by adding commercial stage or near term commercial stage products to its portfolio.
"We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts," stated Friedhelm Blobel, Ph.D., President and Chief Executive officer of SciClone Pharmaceuticals. "The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval."
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
This novel dosage form was specifically designed to solve patient compliance problems found with existing formulations of ondansetron. Patients suffering from nausea and vomiting may have problems swallowing and difficulty retaining tablets in the gastrointestinal system long enough for tablets to dissolve fully. Ondansetron delivered in this polymeric film strip allows for fast absorption without requiring potentially nausea-worsening liquids to be introduced into the patient's system.
Serotonin 5-HT3 receptor antagonists, such as ondansetron, are the most commonly prescribed treatment for chemotherapy and radiotherapy-induced nausea and vomiting in China, where 2008 sales reached more than $110 million, according to SciClone's estimates.
About SciClone
SciClone Pharmaceuticals (NASDAQ:SCLN - News) is a profit-focused, global specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and overall expense management. ZADAXIN® (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug candidates includes thymalfasin, in clinical studies as an enhancer of vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; and SCV-07 in a phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead™ in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China, Vietnam Hong Kong, and Macau, for which it will seek regulatory approval. For additional information, please visit http://www.sciclone.com/.
Hope it runs in the morning!
tuna
Wishing you the best zab!! I'm having a root canal in the morning which though not fun isn't on the scale of you're situation! Just glad you're catching it before it developed into something worse....God bless...tuna
SCLN up in AH with news!!
ondansetron RapidFilm(TM) Approved in 16 European Countries
SciClone Expects European Approvals to Support Efforts for Regulatory Approval in China, Vietnam, Hong Kong, and Macau
Press Release Source: SciClone Pharmaceuticals, Inc. On Wednesday March 24, 2010, 6:00 pm EDT
FOSTER CITY, CA--(Marketwire - 03/24/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today announced the European approval of ondansetron RapidFilm™, co-developed by APR Applied Pharma Research s.a. ("APR"), and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union ("EU") countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm™ from APR for the People's Republic of China ("China"), Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone is planning to expand its commercial operations, currently located primarily in China, with the goal of becoming a significant pharmaceutical company in China's rapidly growing pharmaceutical market. A key part of SciClone's strategy is to use its decade of experience in China and to grow its international business by adding commercial stage or near term commercial stage products to its portfolio.
"We are pleased that ondansetron RapidFilm has been approved in these key European markets. Our regulatory approach for China is based on the European approvals for this product and with this important milestone reached we are now moving forward with these efforts," stated Friedhelm Blobel, Ph.D., President and Chief Executive officer of SciClone Pharmaceuticals. "The European Health Authorities clearly appreciated the therapeutic value of ondansetron RapidFilm, as well as the innovative drug delivery technology it incorporates. We believe that officials in China and other territories will likely view the product in the same manner and look forward to working with the appropriate regulatory agencies on our approval."
Ondansetron RapidFilm is an innovative oral thin film formulation of ondansetron, a serotonin 5-HT3 receptor antagonist that is commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery. Ondansetron is currently marketed in China in both branded and generic products, and in a variety of formulations including injectables and oral tablets. Ondansetron RapidFilm is the first formulation based on a new technology that delivers the drug using a thin film made up of a water soluble polymer. Once the film comes into contact with water or saliva, it disintegrates within seconds, releasing the drug in the mouth and promoting gastrointestinal absorption.
This novel dosage form was specifically designed to solve patient compliance problems found with existing formulations of ondansetron. Patients suffering from nausea and vomiting may have problems swallowing and difficulty retaining tablets in the gastrointestinal system long enough for tablets to dissolve fully. Ondansetron delivered in this polymeric film strip allows for fast absorption without requiring potentially nausea-worsening liquids to be introduced into the patient's system.
Serotonin 5-HT3 receptor antagonists, such as ondansetron, are the most commonly prescribed treatment for chemotherapy and radiotherapy-induced nausea and vomiting in China, where 2008 sales reached more than $110 million, according to SciClone's estimates.
About SciClone
SciClone Pharmaceuticals (NASDAQ:SCLN - News) is a profit-focused, global specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and overall expense management. ZADAXIN® (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone's pipeline of drug candidates includes thymalfasin, in clinical studies as an enhancer of vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; and SCV-07 in a phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead™ in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China, Vietnam Hong Kong, and Macau, for which it will seek regulatory approval. For additional information, please visit http://www.sciclone.com/.
Hope it runs in the morning! tuna
Thanks mm for the heads up...not in it but have followed it in the past at times...tuna