Tag Archives: Year End

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Synta Provides Company Updates and Reports Fourth Quarter and Year-End 2012 Financial Results

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Synta Provides Company Updates and Reports Fourth Quarter and Year-End 2012 Financial Results

— Expects mid-year overall survival results from the GALAXY-1 trial for ganetespib in second-line non-small cell lung cancer –

— Expects enrollment of the pivotal GALAXY-2 Phase 3 trial to commence this month —

— Announces key addition to executive management team –

LEXINGTON, Mass.–(BUSINESS WIRE)– Synta Pharmaceuticals Corp. (NAS: SNTA) today provided an update on recent progress with its clinical programs and reported financial results for the fourth quarter and year ended December 31, 2012.

“Over the past year, we have made strong progress in the development of ganetespib, our Hsp90 inhibitor,” said Dr. Safi Bahcall, President and CEO of Synta. “Interim results presented last year from our GALAXY-1 trial evaluating ganetespib as second-line treatment of non-small cell lung cancer showed encouraging clinical activity. We look forward to presenting more mature results from the 240-patient target population of this trial mid-year, and enrolling the first patient in our GALAXY-2 Phase 3 trial before the end of this month.”

“Ganetespib represents a distinct cancer treatment paradigm – targeting one protein, the chaperone, which simultaneously destabilizes a broad range of oncogenic pathways,” said Dr. Sumant Ramachandra, President of Research and Development. “This approach is differentiated: existing cancer therapies are generally either non-specific, for example anti-mitotic chemotherapies, or target one particular signaling protein involved in a limited number of cancer signaling pathways, for example tyrosine kinase inhibitors.”

“The clinical evidence to date, together with the preclinical results that show treatment with ganetespib changes the broader biology of cancer cells, reducing tumor aggressiveness, are encouraging,” continued Dr. Ramachandra. “Results expected later this year will be important in confirming the clinical activity and establishing the potential for ganetespib beyond lung cancer.”

The safety profile of ganetespib has been favorable in over 700 patients treated to date in more than 20 clinical trials. Transient, mild or moderate diarrhea has been the most commonly reported adverse event.

Key accomplishments in 2012

1. At the 2012 Congress of the European Society for Medical Oncology (ESMO), investigators …read more
Source: FULL ARTICLE at DailyFinance

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Columbia Laboratories Reports Fourth Quarter and Year-End 2012 Financial Results

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Columbia Laboratories Reports Fourth Quarter and Year-End 2012 Financial Results


Management will host Conference Call at 11:00 AM ET Today

LIVINGSTON, N.J.–(BUSINESS WIRE)– Columbia Laboratories, Inc. (NAS: CBRX) today reported financial results for the three- and twelve-month periods ended December 31, 2012.

Fourth Quarter Financial Highlights

  • Total net revenues increased 11% to $7.1 million in the fourth quarter of 2012, compared to $6.4 million in the fourth quarter of 2011.
  • Net product revenues increased 13% to $6.1 million in the fourth quarter of 2012, compared to $5.4 million in the fourth quarter of 2011, mainly due to higher sales of CRINONE® 8% (progesterone gel) to Merck Serono S.A. (“Merck Serono”).
  • Operating income was $1.0 million in the fourth quarter of 2012, compared to $1.1 million in the fourth quarter of 2011 due to a $1.2 million increase in total operating expenses over fourth quarter 2011 levels. In the fourth quarter of 2012, the Company recorded a $0.9 million write-off of fixed assets relating to excess capacity at Maropack and $0.9 million in severance charges, which were offset in part by lower personnel costs following the 2012 workforce reduction.
  • Net income for the fourth quarter of 2012 was $2.6 million, or $0.03 per basic and $0.01 per diluted share, compared to a net loss of $1.0 million, or $0.01 per basic and diluted share, in the fourth quarter of 2011.
  • Cash, equivalents and short-term investments increased to $28.6 million at December 31, 2012.

2012 Financial Highlights

  • Total net revenues were $25.8 million in 2012, compared to $43.1 million in 2011. The Company’s 2011 revenues included $17.0 million for the amortization of the $34 million gain on the sale of the progesterone assets in July 2010 to Actavis Inc. (NYS: ACT) (“Actavis”), formerly Watson …read more
    Source: FULL ARTICLE at DailyFinance
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OFS Capital Corporation Schedules Fourth Quarter and Year End 2012 Earnings Release and Conference C

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OFS Capital Corporation Schedules Fourth Quarter and Year End 2012 Earnings Release and Conference Call

ROLLING MEADOWS, Ill.–(BUSINESS WIRE)– OFS Capital Corporation (NAS: OFS) announced today that it will report its fourth quarter and year end 2012 financial results on Tuesday, March 26, 2013 at 10:00 AM Eastern Daylight Time. To participate in the call, please dial (888) 317-6016 (domestic dial-in) and (412) 317-6016 (international dial-in) approximately 15 minutes prior to the call.

A telephone replay of the conference call will be available from 2:00 PM Eastern Daylight Time on March 26, 2013 until 11:59 PM on May 26, 2013 and may be accessed by calling (877) 344-7529 (domestic dial-in) or (412) 317-0088 (international dial-in) and the passcode is 10026498.

ABOUT OFS CAPITAL

OFS Capital is an externally managed, closed-end, non-diversified management investment company that has elected to be regulated as a business development company under the Investment Company Act of 1940. For tax purposes, OFS Capital intends to be treated as a regulated investment company under the Internal Revenue Service Code. OFS Capital’s investment objective is to provide its shareholders with both current income and capital appreciation primarily through debt investments and, to a lesser extent, equity investments. OFS Capital closed its IPO on November 14, 2012.

Headquartered in Rolling Meadows, Illinois, with additional offices in New York and Los Angeles, OFS Capital invests primarily in middle-market companies in the United States. OFS Capital generally focuses its investment activities on private companies that are owned by private equity sponsors or owner/operators, and have annual EBITDA between $5 million and $50 million. OFS Capital offers flexible solutions through a variety of asset classes including senior secured, unitranche, second-lien and mezzanine loans, and to a lesser extent, equity securities.

OFS Capital’s investment activities are managed by OFS Capital Management, LLC, which is an investment advisor registered under the Investment Advisers Act of 1940.

Mendel Communications
Bill Mendel, 212-397-1030
bill@mendelcommunications.com

KEYWORDS:   United States  North America  Illinois

INDUSTRY KEYWORDS:

The article OFS Capital Corporation Schedules Fourth Quarter and Year End 2012 Earnings Release and Conference Call originally appeared on Fool.com.

Try any of our Foolish newsletter services free for 30 days. …read more
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Genie Energy Ltd. Reports Fourth Quarter and Year End 2012 Results

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Genie Energy Ltd. Reports Fourth Quarter and Year End 2012 Results

NEWARK, N.J.–(BUSINESS WIRE)– Genie Energy Ltd. (NYSE: GNE, GNEPRA) reported EBITDA and income from operations of $1.9 million and net income attributable to common stockholders of $1.8 million for the fourth quarter, the three months ended December 31, 2012. For the full year 2012, Genie Energy reported EBITDA of $3.2 million and income from operations of $3.0 million. The full year net loss attributable to common stockholders was $3.5 million.

Genie Energy‘s Board of Directors has declared a quarterly dividend of $0.1594 per share of Series 2012-A Preferred Stock (NYS: GNEPRA) for the first quarter of its 2013 fiscal year, the three months ending March 31, 2013. The quarterly dividend will be paid on May 15, 2013 to shareholders of record as of the close of business on May 8, 2013. The ex-dividend date is May 6, 2013. The tax treatment of the dividend will be announced on the investor relations page of the Genie Energy website prior to the payment date. On February 15, 2013 Genie distributed $0.1317 per preferred share which will be treated as a return of capital and not as a dividend for tax purposes.


RECENT AND 4Q12 HIGHLIGHTS

  • Consolidated revenues (+$21.8 million), gross profit (+$7.7 million) and EBITDA (+$4.8 million) increased strongly year over year on higher gas and electric consumption
  • IDT Energy increased EBITDA by $6.4 million compared to 4Q11, to $7.9 million
  • In early March, 2013, AMSO, LLC initiated start up of its oil shale pilot test in Colorado.
  • On February 20, 2013, the government of Israel awarded a Genie Energy subsidiary an exclusive petroleum exploration license covering 396.5 square kilometers in the Southern portion of the Golan Heights. The Company believes that the license area may contain significant quantities of conventional oil and gas in relatively tight formations
  • Also in Israel, the Supreme Court rejected both pending legal challenges to IEI‘s oil shale exploration license during 4Q12

    • …read more
    Source: FULL ARTICLE at DailyFinance

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GTT Announces Fourth Quarter and Year End 2012 Earnings Call

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GTT Announces Fourth Quarter and Year End 2012 Earnings Call

MCLEAN, Va.–(BUSINESS WIRE)– GTT (OTCQB: GTLT), the premiere cloud network provider to clients in over 80 countries worldwide, announced today its plans to release results for the fourth quarter and year ended December 31, 2012, on Tuesday, March 19, 2013. In conjunction with the release, GTT has scheduled a conference call, which will also be broadcast live over the Internet, on Tuesday, March 19, 2013 at 10:00 A.M. Eastern Time.

What: GTT‘s Fourth Quarter and Year Ended 2012 Financial Results Conference Call

When: Tuesday, March 19, 2013 at 10:00 A.M. Eastern Time

Where: Via phone by dialing +1.877.638.9067 or +1.647.438.1131, entering passcode 5514956 and asking for the GTT call or via webcast at www.gt-t.net.

A telephonic replay of the conference call will be available for one month and may be accessed by calling +1.888.203.1112 or +1.719.457.0820 and using the passcode 5514956. The webcast will be archived in the investor relations section of the company’s web site.

About GTT

GTT is the premiere cloud network provider to the world. Powered by our global Ethernet and IP backbone, GTT operates the most interconnected network on the globe. With 15 years of proven experience, GTT delivers simplicity, speed and agility, with an absolute client focus. For more information visit GTT at www.gt-t.net.

GTT Investor Contact:
Nazir Rostom, +1-703-442-5586
nazir.rostom@gt-t.net
or
GTT Media Inquiries:
Michelle Reilly, +1-703-442-5582
michelle.reilly@gt-t.net

KEYWORDS:   United States  North America  Virginia

INDUSTRY KEYWORDS:

The article GTT Announces Fourth Quarter and Year End 2012 Earnings Call originally appeared on Fool.com.

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Verastem Announces Timing for Year-End 2012 Financial Results, Webcast and Conference Call

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Verastem Announces Timing for Year-End 2012 Financial Results, Webcast and Conference Call

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Verastem, Inc., (NAS: VSTM) , a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced that financial results for the year ended December 31, 2012, will be released before the market opens on Wednesday, March 27, 2013. The Verastem management team will host a conference call discussing the Company’s financial results, recent developments and management’s outlook for 2013 on Wednesday, March 27, 2013, at 8:00 AM (ET). The call can be accessed by dialing 1-866-700-6293 five minutes prior to the start of the call and providing the passcode 40173121. A replay will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 and providing the passcode 58773105. The replay will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for two weeks following the call.

About Verastem, Inc.

Verastem, Inc. (NAS: VSTM) is a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. Verastem is developing small molecule inhibitors of signaling pathways that are critical to cancer stem cell survival and proliferation: FAK, PI3K/mTOR and Wnt. For more information, please visit www.verastem.com.

Forward-looking statements:

Any statements in this press release about future expectations, plans and prospects for the Company constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Verastem, Inc.
Investor contact:
Brian Sullivan, 617-252-9314
bsullivan@verastem.com
or<br …read more
Source: FULL ARTICLE at DailyFinance

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GenMark Diagnostics Reports Fourth Quarter and Year End 2012 Results

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GenMark Diagnostics Reports Fourth Quarter and Year End 2012 Results


GenMark Exceeds 2012 Revenue Guidance; 2012 Sales Top $20 million


  • Quarterly Reagent Revenue Grows 404% and Annual Reagent Revenue Grows 367%

  • Installed Base Grows to 297 Analyzers

  • Quarterly Gross Margin Reaches 50% and Annual Gross Margin Reaches 43%

  • Annuity Per Analyzer Increased to $143,000

  • FY 2013 Revenue Guidance at $35 Million

CARLSBAD, Calif.–(BUSINESS WIRE)– GenMark Diagnostics, Inc. (Nasdaq: GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today reported financial results for the fourth quarter and year ended December 31, 2012.

Revenues for the quarter ended December 31, 2012 were $9.4 million compared with $2.0 million during the fourth quarter of 2011. The 364% year-over-year increase in quarterly total revenue reflects an increase in the number of systems in the field, growth in test menu and a significant increase in the number …read more
Source: FULL ARTICLE at DailyFinance

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Crimson Exploration Announces Fourth Quarter and Year-End 2012 Earnings Release and Conference Call

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Crimson Exploration Announces Fourth Quarter and Year-End 2012 Earnings Release and Conference Call Schedule

HOUSTON–(BUSINESS WIRE)– Crimson Exploration Inc. (NasdaqGM:CXPO) today announced it expects to issue its fourth quarter and year-end 2012 earnings press release after the market close on Friday, March 15, 2013. In conjunction with the release, Crimson will conduct a conference call to discuss contents of that release on Monday, March 18, 2013 at 9:30am Central Daylight Time.

Those interested in participating in the earnings conference call may do so by calling the following phone number: 888-359-3627, (International 719-325-2458) and entering the following participation code 5562645. A replay of the call will be available from Monday, March 18, 2013 at 11:30am CDT through Sunday, March 24, 2013 at 11:30pm CDT by dialing toll free 888-203-1112, (International 719-457-0820) and asking for replay ID code 5562645.

Crimson Exploration is a Houston, Texas-based independent energy company engaged in the exploitation, exploration, development and acquisition of crude oil and natural gas, primarily in the onshore Gulf Coast regions of the United States. Additional information on Crimson Exploration Inc. is available on the Company’s website at http://crimsonexploration.com.

Crimson Exploration Inc.
E. Joseph Grady, 713-236-7400
Senior Vice President and Chief Financial Officer
or
Josh Wannarka, 713-236-7400
Manager of Investor Relations and FP&A

KEYWORDS:   United States  North America  Texas

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The article Crimson Exploration Announces Fourth Quarter and Year-End 2012 Earnings Release and Conference Call Schedule originally appeared on Fool.com.

Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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Safety Announces Fourth Quarter and Year End 2012 Results

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Safety Announces Fourth Quarter and Year End 2012 Results

BOSTON–(BUSINESS WIRE)– Safety Insurance Group, Inc. (NAS: SAFT) today reported fourth quarter and year end 2012 results. Net income for the quarter ended December 31, 2012 was $9.6 million, or $0.62 per diluted share, compared to $4.8 million, or $0.31 per diluted share, for the comparable 2011 period. Net income for the year ended December 31, 2012 was $58.1 million, or $3.80 per diluted share, compared to $13.7 million, or $0.90 per diluted share, for the comparable 2011 period. Safety’s book value per share increased to $45.31 at December 31, 2012 from $43.22 at December 31, 2011. Safety paid $0.60 per share in dividends to investors during the quarter ended December 31, 2012, compared to $0.50 per share during the comparable 2011 period. Safety paid $2.20 per share in dividends to investors during the year ended December 31, 2012 compared to $2.00 per share during the comparable 2011 period.

Direct written premiums for the quarter ended December 31, 2012 increased by $10.3 million, or 7.1%, to $155.1 million from $144.8 million for the comparable 2011 period. Direct written premiums for the year ended December 31, 2012 increased by $47.0 million, or 7.2%, to $696.2 million from $649.2 million for the comparable 2011 period. The 2012 increase occurred primarily in our personal automobile and homeowners business lines, which experienced increases of 4.9% and 4.1%, respectively, in average written premium per exposure. Written exposures remained consistent in our personal automobile line and increased by 7.2% in our homeowners line.

Net written premiums for the quarter ended December 31, 2012 increased by $9.1 million, or 6.7%, to $145.9 million from $136.8 million for the comparable 2011 period. Net written premiums for the year ended December 31, 2012 increased by $43.6 million, or 7.0%, to $663.9 million from $620.3 million for the comparable 2011 period. Net earned premiums for the quarter ended December 31, 2012 increased by $11.6 million, or 7.6%, to $165.4 million from $153.8 million for the comparable 2011 period. Net earned premiums for the year ended December 31, 2012 increased by $44.1 million, or 7.4%, to $642.5 million from $598.4 million for the comparable 2011 period. Net written and net earned premiums increased primarily due to the factors that increased direct written premiums.

Net investment income for the quarter ended December 31, 2012 increased by $1.0 million, or 10.4%, to $10.3 million from $9.3 million for the comparable 2011 period. Net investment income for the year ended December 31, 2012 increased by $1.8 million, or 4.6%, to …read more
Source: FULL ARTICLE at DailyFinance

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XenoPort Reports Fourth Quarter and Year-End 2012 Financial Results

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XenoPort Reports Fourth Quarter and Year-End 2012 Financial Results

SANTA CLARA, Calif.–(BUSINESS WIRE)– XenoPort, Inc. (NAS: XNPT) announced today its financial results for the fourth quarter and year ended December 31, 2012. Revenues for the quarter were $0.5 million, compared to $5.4 million for the same period in 2011. Net income for the fourth quarter was $3.0 million, which resulted from a non-cash gain on XenoPort’s litigation settlement with Glaxo Group Limited (GSK), compared to a net loss of $16.9 million for the same period in 2011. At December 31, 2012, XenoPort had cash and cash equivalents and short-term investments of $139.0 million.

XenoPort Business Updates

Since the beginning of the fourth quarter of 2012:

  • XenoPort and GSK announced that they had terminated their collaboration agreement concerning Horizant® (gabapentin enacarbil) Extended-Release Tablets under which GSK held commercialization rights and certain development rights in the United States. The termination and transition agreement also released all claims and resolved all pending litigation between the parties. During a transition period that will end on April 30, 2013, GSK will continue to exclusively commercialize, promote, manufacture and distribute Horizant in the United States.Following the transition period, XenoPort will assume all responsibilities for the further development, manufacturing and commercialization of Horizant in the United States.
  • As part of the termination and settlement, GSK purchased $40.0 million of common stock of XenoPort, or 4,031,212 shares at an average price of $9.923 per share. Such shares were purchased in two tranches at a 12.5% premium to the average of the closing price of XenoPort common stock during a ten-trading-day period prior to each tranche.
  • XenoPort completed enrollment in its Phase 3 pivotal trial of arbaclofen placarbil (AP) as a potential treatment for spasticity in patients with multiple sclerosis (MS).
  • XenoPort announced favorable preliminary results from a Phase 1 clinical trial in healthy adults designed to assess the pharmacokinetics (PK), safety and tolerability of single doses of four different oral formulations of XP23829, a novel fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF). The trial demonstrated that administration of XP23829 resulted in the expected levels of MMF in the blood. XP23829 was generally well-tolerated in the trial.
  • XenoPort initiated a Phase 1, multiple ascending …read more
    Source: FULL ARTICLE at DailyFinance
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Steel Excel Inc. Reports Fourth Quarter and Year End 2012 Financial Results and Outlook for 2013

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Steel Excel Inc. Reports Fourth Quarter and Year End 2012 Financial Results and Outlook for 2013

SAN RAMON, Calif.–(BUSINESS WIRE)– Steel Excel Inc. (Other OTC: SXCL) (“Steel Excel“, “SXCL” or the “Company”), which operates in two reportable segments, Steel Energy and Steel Sports, today announced operating results for the fourth quarter and year ended December 31, 2012. They are summarized in the following paragraphs. For a full discussion of the results, please see the Company’s Form 10-K, which can be found at www.steelexcel.com.

Fourth Quarter Results

Steel Excel reported aggregate revenues of $26.9 million for the quarter, as compared to $1.8 million for the same period of 2011. The loss from continuing operations before tax was $0.3 million in the fourth quarter of 2012, as compared to a loss of $1.3 million in the 2011 period. The net loss for the fourth quarter of 2012 was $0.1 million, or $0.01 per diluted common share, as compared to a net loss of $1.7 million, or $0.15 per diluted common share for the same period in 2011. For the quarter, Steel Energy net revenues were $26.4 million, compared to $1.4 million in 2011, while Steel Sports had net revenues of $0.5 million, versus $0.4 million in 2011.

Twelve Month Results

For the year, Steel Excel reported net revenues of $100.1 million, as compared to $2.5 million in 2011. Income from continuing operations before tax was $6.5 million, versus a loss of $0.2 million in 2011. Net income for the year was $20.7 million or $1.71 per diluted common share, which included a net loss from discontinued operations of $1.9 million, or $0.16 per share, as compared to net income of $6.8 million, or $0.62 per diluted common share in 2011, which included net income from discontinued operations of $6.6 million, or $0.61 per share.

Steel Energy reported net revenues for the year of $97.2 million, as compared to $1.4 million the prior year. Steel Sports reported revenues of $2.9 million compared to $1.1 million in 2011.

The principal reason for the increase in revenue and net income for both the fourth quarter and full year was related to the acquisitions completed in 2012 for Steel Energy and the release of $15.1 million of a deferred tax valuation allowance as a result of acquired deferred tax liabilities.

…read more
Source: FULL ARTICLE at DailyFinance

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Zalicus Reports Financial Results for the Fourth Quarter and Year End 2012

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Zalicus Reports Financial Results for the Fourth Quarter and Year End 2012

Provides Key Goals for 2013

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Zalicus Inc. (Nasdaq Global Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported financial results for the fourth quarter and year ended December 31, 2012.

“We are focused on advancing the development of our ion channel programs, including Z160, our first-in-class, oral N-type calcium channel blocker for the treatment of chronic neuropathic pain and Z944, a novel oral T-type calcium channel blocker,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “During 2012 we made a number of advances with our novel ion channel programs, including advancing Z160 into Phase 2a clinical development and Z944 into the clinic. We plan to build on this success in 2013 by generating proof-of-concept data for Z160 in multiple indications and continuing the clinical development of Z944.”

Fourth Quarter 2012 and Recent Accomplishments:

  • Z160. Advanced Z160, a first-in-class, oral, state dependent, selective N-type calcium channel (Cav 2.2) blocker into the second of two Phase 2a clinical trials for the potential treatment of chronic neuropathic pain, including lumbosacral radiculopathy which began in the third quarter of 2012 and postherpetic neuralgia which began in the fourth quarter of 2012. Top line data from both studies are expected to be available late in the second half of 2013.
  • Z944. Received a key U.S. patent issued in February 2013 providing broad patent coverage for Z944, a novel, oral, T-type calcium channel blocker, through April 2029. Z944 completed Phase 1 single and multiple ascending dose clinical studies in late 2012 and the Company plans to continue further clinical development with Z944 during 2013.
  • cHTS™. Generated approximately $7.3 million of revenue in 2012 from our combination High Throughput Screening (cHTS) collaborations.

2013 Zalicus Pipeline and Business Goals:

Zalicus has set the following goals for 2013, which include internal research and development programs, collaborations and financial goals:

Business, Finance, Occupation & Industry

POZEN Reports Fourth Quarter &amp; Year End 2012 Results

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POZEN Reports Fourth Quarter & Year End 2012 Results

NDA Filing for PA32540/PA8140 Expected by Q2 2013

CHAPEL HILL, N.C.–(BUSINESS WIRE)– POZEN Inc. (Nasdaq: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2012.

2012 and Recent Corporate Highlights

  • POZEN is currently preparing a New Drug Application (NDA) for its investigational products containing enteric-coated (EC) aspirin and immediate release omeprazole, including two dosage forms, PA32540 containing 325 mg of aspirin and PA8140, a low dose formulation containing 81 mg aspirin. POZEN continues to anticipate filing the NDA for both products no later than Q2 2013.
  • POZEN announced positive top-line results from two randomized, double-blind, multi-center, pivotal Phase 3 clinical trials of PA32540. Detailed results were presented in the fall at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting and the American Heart Association (AHA) Scientific Sessions 2012.
  • In August 2012, POZEN gained clarity from the Medicines Evaluation Board (MEB) in the Netherlands regarding the development program required for the approval in the European Union of PA including a lower dosage form containing 100 mg of aspirin and 40 mg of omeprazole (PA10040). The MEB agreed that no Phase 3 clinical trials for PA10040 to demonstrate the reduction of gastric ulcers vs. EC aspirin 100 mg would be necessary. MEB required 2 additional Phase 1 studies: a pharmacodynamic study demonstrating appropriate gastric pH control with PA10040 as well as a study to demonstrate bioequivalence of PA10040 to a currently marketed EC aspirin 100 mg product using aspirin as the analyte. The MEB also agreed to be the Reference Member State in a decentralized filing procedure for PA32540/PA10040.
  • Partnership discussions for PA continue to progress. While there can be no assurances, the Company expects to close a partnership deal in 2013.
  • Q4 2012 global net sales of VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tablets by AstraZeneca, as defined under our agreement, were $18.4 million, up 33% from Q4 2011 and 38% vs. Q3 2012. VIMOVO sales for 2012 were $64.3 million, up 90% over the prior year, led by strong growth outside the U.S. POZEN earned a royalty of …read more
    Source: FULL ARTICLE at DailyFinance
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Symbion, Inc. Announces Fourth Quarter and Year-End 2012 Conference Call

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Symbion, Inc. Announces Fourth Quarter and Year-End 2012 Conference Call

NASHVILLE, Tenn.–(BUSINESS WIRE)– Symbion, Inc., an owner and operator of short stay surgical facilities, announced today that it will provide an online Web simulcast of its fourth quarter and year-end 2012 earnings conference call on Tuesday, March 19, 2013. The Company will file an Annual Report on Form 10-K for the year ended December 31, 2012, prior to the call, a copy of which will be available through the Investor tab of the Company’s website at www.symbion.com.

The live broadcast of Symbion’s conference call is scheduled to begin at 11:00 a.m. Eastern Time on Tuesday, March 19, 2013. An online replay will be available for 30 days beginning approximately an hour following the conclusion of the live broadcast. A link to these events can be found on the Company’s website at www.symbion.com or at www.earnings.com.

Symbion, Inc., headquartered in Nashville, Tennessee, owns and operates a network of short stay surgical facilities that provide non-emergency surgical procedures across many specialties. At December 31, 2012, the Company owned and operated 51 surgical facilities and managed ten additional facilities in 24 states.

Symbion, Inc.
Teresa F. Sparks, 615-234-5900
Chief Financial Officer

KEYWORDS:   United States  North America  Tennessee

INDUSTRY KEYWORDS:

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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

IGI Laboratories Announces 4th Quarter 2012 and Year End 2012 Results

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By Business Wirevia The Motley Fool

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IGI Laboratories Announces 4 th Quarter 2012 and Year End 2012 Results

BUENA, N.J.–(BUSINESS WIRE)– IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based topical generic drug development and manufacturing company, announced its financial results for the fourth quarter and year ended December 31, 2012.

Fourth Quarter 2012 Highlights vs. 2011

  • Total Revenues of $2.3 million, increase of 10% over same quarter in 2011
  • Invested in the infrastructure of our commercialization strategy and successfully launched the first ever IGI label generic topical pharmaceutical products
  • Raised approximately $2.0 million in cash through the sale of treasury stock to fund the purchase of the topical pharmaceutical product econazole nitrate cream 1%
  • Net loss was $1.2 million and $0.5 million for the fourth quarter of 2012 and 2011
  • Net loss included research and development costs of $1.1 and $0.6 million in 2012 and 2011
  • Increase in research and development costs in the fourth quarter of 2012 over the same quarter last year due to additional costs related to approximately $0.3 million of Generic Drug User Fee Amendments of 2012 (GDUFA) fees required by the US FDA and $0.3 million of costs related to clinical studies

Year to Date 2012 Highlights vs. 2011

  • Total Revenues of $8.6 million in 2012, an increase of 10% over 2011
  • Net loss was $3.9 million in 2012 as compared to a net loss of $3.0 million in 2011
  • Net loss included research and development costs of $2.8 million and $2.2 million in 2012 and 2011
  • IGI has filed nine Abbreviated New Drug Applications (ANDAs) to date

IGI‘s President and Chief Executive Officer, Jason Grenfell-Gardner, stated, “I am extremely pleased with the progress IGI made in 2012. We launched the first ever IGI labeled topical pharmaceutical product; we filed five ANDAs with the US FDA, three for our own pipeline; we hired a proven …read more
Source: FULL ARTICLE at DailyFinance