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AXMP looking good for a run over .10 nice buying into the bell
ANGO earnings news AH
AngioDynamics Reports Fiscal Third Quarter 2010 Results
* Net Sales Increase 6% to $52.2 million
* NanoKnife® IRE System Net Sales of $724,000
* Net Income of $3.3 Million, or $0.13 EPS
* Operating Cash Flow of $11.4 Million
* Company Reiterates Fiscal 2010 Guidance
* Conference Call Begins Today at 4:30 p.m. Eastern Time
ALBANY, N.Y.--(BUSINESS WIRE)--AngioDynamics (NASDAQ:ANGO), a leading provider of innovative medical devices for the minimally-invasive treatment of cancer and peripheral vascular disease, today reported financial results for the fiscal third quarter ended February 28, 2010.
“Our third quarter results were driven by continued revenue growth in our Oncology/Surgery and Peripheral Vascular businesses, offset by market pricing pressure and delayed product launches in our Access business”
Net sales in the third quarter totaled $52.2 million, a 6% increase over the $49.4 million reported for the third quarter last year. Oncology/Surgery sales increased 19% to $13.7 million from the third quarter a year ago and included $724,000 in NanoKnife® IRE System sales. Year-to-date NanoKnife IRE System sales totaled $1.5 million. Peripheral Vascular sales grew 8% from the third quarter a year ago to $22.4 million. Access sales were $16.1 million in the quarter, a decrease of 6% from the third quarter a year ago.
Gross margin was 58.0% compared with 61.1% a year ago, with the decline primarily attributable to lower selling prices for certain Access and Peripheral Vascular products due to a competitive pricing environment and higher material costs for certain Access products. Operating income was $5.6 million in the quarter compared with $2.6 million a year ago, which included $2.8 million in costs associated with the CEO transition. Net income was $3.3 million, or $0.13 per share, compared with $1.9 million, or $0.08 per share, a year ago.
The Company generated $11.4 million in cash flow from operations in the third quarter. At February 28, 2010, cash and investments totaled $85.8 million, and long-term debt was $6.6 million.
For the nine months ended February 28, 2010, net sales were $155.8 million, a 10% increase over the $142.2 million reported for the prior year period; gross margin was 59.1% compared with 61.4% for the prior year; operating income was $14.5 million compared with $11.3 million for the prior year; and net income was $8.6 million, or $0.35 per share, compared with $7.0 million, or $0.29 per share, last year.
“Our third quarter results were driven by continued revenue growth in our Oncology/Surgery and Peripheral Vascular businesses, offset by market pricing pressure and delayed product launches in our Access business,” said Jan Keltjens, President and CEO. “We are pleased with the revenue generated by our NanoKnife IRE System in its second quarter of commercial launch. Our IRE technology continues to gain clinician interest and five hospitals acquired the system this quarter. In addition, we are also pleased with the increasing strength of our Varicose Vein business, as well as the performance of our recently launched new Micro-Introducer product line.
“In the face of the difficult pricing environment for some of our products, we have managed operating expenses tightly to offset the resulting pressure on gross margins, thereby preserving operating profitability and margin,” Mr. Keltjens continued. “New product launches, sales momentum in Peripheral Vascular and Oncology, strong expense management and the impact of operational improvements position us for continued growth in fiscal 2010 and we expect sequential improvement in our gross margin in the fiscal fourth quarter. In addition, today we are reiterating our overall guidance for the year.”
Highlights of the quarter, and more recent activities, include the following:
* The strong market response to AngioDynamics’ NanoKnife IRE System commercial sales program continued as physicians at numerous institutions treated an additional 50 patients since early January. The total number of patients treated to date with the NanoKnife system at 11 centers now stands at 154. Procedures have been performed in many organs, including prostate, liver, lung, and pancreas.
* The protocol for an international pilot study of the use of the NanoKnife IRE System in the treatment of early stage hepatocellular carcinoma was approved and patient recruitment has started. This study, titled “A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC),” is being conducted under the supervision of Dr. Riccardo Lencioni of the University of Pisa School of Medicine and Dr. Jordi Bruix of the Barcelona Liver Cancer Group of the University of Barcelona. Updates on the status of the study can be found at www.clinicaltrials.gov.
* A book titled “Irreversible Electroporation” was recently published by Springer Berlin Heidelberg. It is edited by Boris Rubinsky, a Professor of the Graduate School at the University of California, Berkeley. The book’s chapters include one by the book’s editor and Dr. Gary Onik of the School of Medicine at the University of Central Florida, titled, ‘Irreversible Electroporation: First Patient Experience Focal Therapy of Prostate Cancer,’ and another by Dr. Kenneth Thomson of The Alfred hospital in Melbourne Australia titled, ‘Human Experience with Irreversible Electroporation.’
* AngioDynamics entered into a Fourth Amendment of the Company’s April 2006 agreement with Biocompatibles UK Limited under which AngioDynamics’ exclusive US distribution rights to the embolization product, LC Bead™, were extended to December 31, 2011.
* The new Centros® self-centering, chronic hemodialysis access catheter was introduced. Using Curved Tip™ Catheter Technology, Centros is designed to reduce clots and sheathing by preventing contact between the catheter tips and vascular wall.
* The Benephit® PROVIDE registry has made substantial progress and is actively enrolling patients. As of today, 18 patients have been enrolled at six sites, and additional sites are expected to begin enrolling patients in the near future. PROVIDE is an independently managed clinical registry designed to gather data from interventional radiologists, nephrologists and surgeons on the clinical use of the Benephit catheter for Targeted Renal Therapy from approximately 1,000 patients during the next year.
Fiscal 2010 Guidance
The Company’s outlook for fiscal 2010 remains unchanged from its last update on January 5, 2010, and is as follows:
* Net sales in the range of $214 million to $217 million, an increase of 10-11% over fiscal 2009 net sales
* Gross margin in the range of 59-60% of net sales
* GAAP operating income in the range of $19 million to $21 million
* EBITDA in the range of $31 million to $33 million
* GAAP EPS in the range of $0.46 to $0.48, inclusive of a $0.24 EPS impact from IRE investments
Conference Call
AngioDynamics management will host a conference call to discuss its fiscal third quarter results today beginning at 4:30 p.m. Eastern Time. To participate in the live call by telephone, please dial 1 (800) 762-8779.
In addition, individuals can listen to the call on the Internet by visiting the investor relations portion of the AngioDynamics Web site at http://investors.angiodynamics.com. To listen to the live call, please go to the Web site 15 minutes prior to its start to register, download and install the necessary audio software. In addition, a replay of the call will be available at http://investors.angiodynamics.com.
Use of Non-GAAP Measures
Management uses non-GAAP measures to establish operational goals, and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported non-GAAP EBITDA (income before interest, taxes, depreciation and amortization). Management uses this measure in its internal analysis and review of operational performance. Management believes that this measure provides investors with useful information in comparing AngioDynamics’ performance over different periods. By using this non-GAAP measure, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of Operating Income to non-GAAP measures.
About AngioDynamics
AngioDynamics, Inc. (“AngioDynamics” or the “Company”) is a leading provider of innovative medical devices used by interventional radiologists, surgeons and other physicians for the minimally-invasive treatment of cancer and peripheral vascular disease. The Company’s diverse product lines include market-leading radiofrequency and irreversible electroporation ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.angiodynamics.com.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the ability of AngioDynamics to develop its existing and new products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to integrate purchased businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2009. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS
(in thousands, except per share data)
Three months ended Nine months ended
Feb 28, Feb 28, Feb 28, Feb 28,
2010 2009 2010 2009
(unaudited) (unaudited)
Net sales $ 52,207 $ 49,447 $ 155,758 $ 142,234
Cost of sales 21,934 19,225 63,746 54,862
Gross profit 30,273 30,222 92,012 87,372
% of net sales 58.0 % 61.1 % 59.1 % 61.4 %
Operating expenses
Research and development 4,289 4,692 13,901 13,079
Sales and marketing 14,032 13,906 44,433 41,516
General and administrative 4,075 3,830 12,183 11,578
CEO Transition Costs - 2,841 - 3,041
Amortization of intangibles 2,284 2,323 7,007 6,816
Total operating expenses 24,680 27,592 77,524 76,030
Operating income 5,593 2,630 14,488 11,342
Other income (expense), net (233 ) 93 (688 ) (658 )
Income before income taxes 5,360 2,723 13,800 10,684
Provision for income taxes 2,027 811 5,227 3,654
Net income $ 3,333 $ 1,912 $ 8,573 $ 7,030
Earnings per common share
Basic $ 0.14 $ 0.08 $ 0.35 $ 0.29
Diluted $ 0.13 $ 0.08 $ 0.35 $ 0.29
Weighted average common shares
Basic 24,622 24,366 24,523 24,342
Diluted 24,867 24,484 24,722 24,501
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS
(in thousands, except per share data)
Reconciliation of Operating Income to non-GAAP EBITDA:
Three months ended Nine months ended
Feb 28, Feb 28, Feb 28, Feb 28,
2010 2009 2010 2009
(unaudited) (unaudited)
Operating income $ 5,593 $ 2,630 $ 14,488 $ 11,342
Amortization of intangibles 2,284 2,323 7,007 6,816
Depreciation 753 709 2,249 1,998
EBITDA $ 8,630 $ 5,662 $ 23,744 $ 20,156
EBITDA per common share
Basic $ 0.35 $ 0.23 $ 0.97 $ 0.83
Diluted $ 0.35 $ 0.23 $ 0.96 $ 0.82
Weighted average common shares
Basic 24,622 24,366 24,523 24,342
Diluted 24,867 24,484 24,722 24,501
ANGIODYNAMICS, INC. AND SUBSIDIARIES
NET SALES BY BUSINESS UNIT AND BY GEOGRAPHY
(in thousands)
Three months ended Nine months ended
Feb 28, Feb 28, Feb 28, Feb 28,
2010 2009 2010 2009
(unaudited) (unaudited)
Net Sales by Business Unit
Peripheral Vascular $ 22,412 $ 20,743 $ 66,639 $ 60,947
Access 16,087 17,176 48,994 48,931
Oncology/Surgery 13,708 11,528 40,125 32,356
Total $ 52,207 $ 49,447 $ 155,758 $ 142,234
Net Sales by Geography
United States $ 46,380 $ 44,074 $ 138,781 $ 126,262
International 5,827 5,373 16,977 15,972
Total $ 52,207 $ 49,447 $ 155,758 $ 142,234
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands)
Feb 28, May 31,
2010 2009
(unaudited)
(2)
Assets
Current Assets
Cash and cash equivalents $ 37,513 $ 27,909
Marketable securities 48,265 40,278
Total cash and investments 85,778 68,187
Receivables, net 26,536 27,181
Inventories, net 34,115 36,928
Deferred income taxes 6,049 9,337
Prepaid income taxes 3,986 3,694
Prepaid expenses and other 1,887 3,271
Total current assets 158,351 148,598
Property, plant and equipment, net 23,293 22,183
Intangible assets, net 60,738 67,770
Goodwill 161,974 161,974
Deferred income taxes 2,641 4,263
Other non-current assets 5,298 3,915
Total Assets $ 412,295 $ 408,703
Liabilities and Stockholders' Equity
Current portion of long-term debt $ 255 $ 265
Contractual payments on acquisition of business, net - 5,227
Other current liabilities 18,515 24,207
Long-term debt, net of current portion 6,615 6,810
Total Liabilities 25,385 36,509
Stockholders' equity 386,910 372,194
Total Liabilities and Stockholders' Equity $ 412,295 $ 408,703
Shares outstanding 24,725 24,428
(2) Derived from audited financial statements
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Nine months ended
Feb 28, Feb 28,
2010 2009
(unaudited) (unaudited)
Cash flows from operating activities:
Net income $ 8,573 $ 7,030
Depreciation and amortization 9,256 8,814
Tax effect of exercise of stock options (145 ) (104 )
Deferred income taxes 4,943 2,438
Stock-based compensation 3,672 4,508
Other (652 ) 912
Changes in operating assets and liabilities
Receivables 713 1,198
Inventories 3,170 (6,444 )
Accounts payable and accrued liabilities (5,708 ) 1,704
Litigation provision - (6,757 )
Other (8 ) (259 )
Net cash provided by operating activities 23,814 13,040
Cash flows from investing activities:
Additions to property, plant and equipment (3,394 ) (3,472 )
Acquisition of intangible assets and businesses (5,342 ) (17,078 )
Change in restricted cash - 68
Purchases, sales and maturities of marketable securities, net (8,185 ) 10,516
Net cash provided by (used in) investing activities (16,921 ) (9,966 )
Cash flows from financing activities:
Repayment of long-term debt (205 ) (9,955 )
Proceeds from exercise of stock options and ESPP 2,934 1,765
Net cash provided by (used in) financing activities 2,729 (8,190 )
Effect of exchange rate changes on cash (18 ) (148 )
Increase (Decrease) in cash and cash equivalents 9,604 (5,264 )
Cash and cash equivalents
Beginning of period 27,909 32,040
End of period $ 37,513 $ 26,776
Contacts
AngioDynamics, Inc.
D. Joseph Gersuk, CFO, 800-772-6446 ext. 1608
jgersuk@AngioDynamics.com
or
EVC Group, Inc.
Doug Sherk or Jenifer Kirtland, 415-896-6820 (Investor Relations)
dsherk@evcgroup.com
jkirtland@evcgroup.com
or
Chris Gale, 646-201-5431 (Media)
cgale@evcgroup.com
Permalink: http://www.businesswire.com/news/home/20100331006679/en/AngioDynamics-Reports-Fiscal-Quarter-2010-Results
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BPSG news AH
Broadpoint.Gleacher Announces Corporate Changes
Firm to Be Renamed Gleacher & Company
Robert Turner resigns as CFO, Jeffrey Kugler named Acting CFO
Company plans to reincorporate in Delaware
NEW YORK--(BUSINESS WIRE)--Broadpoint Gleacher Securities Group, Inc. (NASDAQ: BPSG) today announced that its Board of Directors has voted to rename the Company “Gleacher & Company, Inc.” and to reincorporate in Delaware. The Company plans to submit these proposals to its shareholders at its 2010 Annual Meeting of Shareholders scheduled for May 27, 2010. In addition, the Company announced today that Jeffrey Kugler, the Controller of the Company’s principal broker-dealer subsidiary, Broadpoint Capital, Inc., has been named Acting Chief Financial Officer following the resignation of Robert Turner from the firm. The Company is conducting a search to find a permanent Chief Financial Officer and will consider both internal and external candidates.
“I want to offer my sincere thanks to Rob Turner for helping to build our finance and administrative functions. We wish him all the best with his future endeavors.”
Eric Gleacher, Chairman and Chief Executive Officer, said, “Our firm has grown substantially over the last two years and there continues to be unprecedented opportunities to further expand and grow. Our culture is based on teamwork and our team is clearly focused on capitalizing on the opportunities that exist in the market today.” Mr. Gleacher also said, “I want to offer my sincere thanks to Rob Turner for helping to build our finance and administrative functions. We wish him all the best with his future endeavors.”
Peter McNierney, President and Chief Operating Officer, said, “Growth in our advisory and capital markets origination businesses is key to our success in 2010 and over the long-term. The Gleacher name has been synonymous with high-quality investment banking services for over 30 years and is the strongest brand for us to unify under in marketing to our clients.”
Mr. Kugler has been Controller and Chief Operations Officer of Broadpoint Capital, Inc. since March 2008. He has over 20 years of experience in the securities and financial services industries. Mr. Kugler received his B.A. from Rutgers University and is a registered C.P.A. in the states of New York and New Jersey.
About Broadpoint.Gleacher
Broadpoint Gleacher Securities Group, Inc. (NASDAQ: BPSG) is an independent investment bank that provides corporations and institutional investors with strategic, research-based investment opportunities, capital raising, and financial advisory services, including merger and acquisition, restructuring, recapitalization and strategic alternative analysis services. The Company offers a diverse range of products through the Debt Capital Markets, Investment Banking and Broadpoint DESCAP divisions of Broadpoint Capital, Inc., its Equity Capital Markets subsidiary, Broadpoint AmTech, and FA Technology Ventures Inc., its venture capital subsidiary. For more information, please visit www.bpsg.com.
Forward Looking Statements
This press release contains "forward-looking statements." These statements are not historical facts but instead represent the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. The Company's forward-looking statements are subject to various risks and uncertainties, including the conditions of the securities markets, generally, and acceptance of the Company's services within those markets and other risks and factors identified from time to time in the Company's filings with the Securities and Exchange Commission. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in its forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update any of its forward-looking statements.
ADDITIONAL INFORMATION AND WHERE TO FIND IT
This press release is not a substitute for the proxy statement that the Company intends to file with the SEC. In connection with the Company name change and reincorporation in Delaware, the Company will prepare a proxy statement for the Company’s shareholders. When completed, a definitive proxy statement and form of proxy will be filed with the SEC and mailed to the Company’s shareholders of record. BEFORE MAKING ANY VOTING DECISION, THE COMPANY’S SHAREHOLDERS ARE ADVISED TO CAREFULLY READ THE PRELIMINARY PROXY STATEMENT AND THE DEFINITIVE PROXY STATEMENT, WHEN AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSALS TO BE ACTED UPON AT THE COMPANY’S ANNUAL MEETING. The Company’s stockholders may obtain a free copy of the preliminary proxy statement and the definitive proxy statement (when available) and other documents filed by the Company with the SEC at the SEC’s website at www.sec.gov. The Company’s shareholders may also obtain a free copy of the preliminary proxy statement and definitive proxy statement (when available) and such other documents by visiting the Company’s website at www.bpsg.com under the heading “Investor Relations – Proxy” or by directing such request to Broadpoint Gleacher Securities Group, Inc., 12 East 49 th Street, 31 st Floor, New York, New York, 10017, Attn: Corporate Secretary.
The Company and its directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed name change and reincorporation. Information concerning the Company and its directors and executive officers will be set forth in the Company’s proxy statement.
Contacts
Investor
Broadpoint Gleacher Securities Group, Inc.
Peter McNierney, 212-273-7100
President and Chief Operating Officer
or
Media
Halldin Public Relations
Ray Young, 916-781-0659
ray@halldinpr.com
AXMP ask pounded into the bell
AXMP, looking like a gapper tomorrow .10+
PSGI up 5%, bid UT
AXMP tanking here?
AXMP could make a run for .10 into the close
AXMP dropping a bit here
hmmm, shell play HAVA up 33% at .02
GETA news
Genta Initiates Confirmatory Phase 2b Trial of Tesetaxel in Gastric Cancer
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GETA) today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The trial is currently open to enrollment at Northwestern University, Chicago, IL, which will be joined by M.D. Anderson Cancer Center in Houston, TX and several additional sites.
“While several taxanes are approved as agents for 1st-line treatment of gastric cancer, most actual use in practice is as 2nd- or 3rd- line therapy due to their toxicity”
The new trial is designed to confirm the efficacy results observed in a preliminary Phase 2a study of tesetaxel as 2nd-line treatment of patients with advanced gastric cancer (see results below) and will enroll patients who have progressed on a single 1st-line chemotherapy regimen. Unlike conventional taxanes (paclitaxel [Taxol®] or docetaxel [Taxotere®]) that must be infused intravenously, tesetaxel is a capsule that is taken by mouth. Endpoints of the new Phase 2b study include response rate, durable response, disease control, progression-free survival, and safety. The dose for the new trial was determined from Genta’s recently completed dose-ranging and pharmacokinetic study, whose results have been accepted for presentation at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in June 2010.
“While several taxanes are approved as agents for 1st-line treatment of gastric cancer, most actual use in practice is as 2nd- or 3rd- line therapy due to their toxicity,” said Dr. Raymond P. Warrell, Jr., Genta’s Chairman and Chief Executive Officer. “Patients who progress on 1st-line treatment have a poor prognosis, and the side-effects of standard taxanes in this setting are an important issue in clinical care. By eliminating serious hypersensitivity infusion reactions, as well as potentially reducing nerve damage and overcoming resistance to conventional taxanes, tesetaxel may offer important new treatment options for patients with gastric cancer. We look forward to rapidly confirming the initial promising data and progressing to pivotal trials that may enable global registration.”
About Tesetaxel
Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Tesetaxel is a novel taxane that is administered by mouth as a capsule. The drug was developed with a goal of maintaining the high antitumor activity while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is combined with other anticancer drugs (such as “all oral” chemotherapy programs). Tesetaxel has demonstrated high activity against cell lines that were resistant to paclitaxel and docetaxel.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with other taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity. More than 280 patients worldwide have been treated with oral tesetaxel in Phase 1 and Phase 2 clinical trials.
Tesetaxel in Advanced Gastric Cancer
In the completed Phase 2 study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m2 once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine (Xeloda®; Hoffmann-La Roche, Inc.). All but 2 of these patients had also received a third chemotherapy drug along with this regimen. Final intent-to-treat analysis, including all patients enrolled in the study, showed that 5 patients achieved a partial response, 2 patients achieved a partial response unconfirmed by CT scan, and 14 patients achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta has initiated a broad clinical program to evaluate the safety and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is exclusively marketing Ganite® (gallium nitrate injection), which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:
* the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
* the safety and efficacy of the Company’s products or product candidates;
* the commencement and completion of any clinical trials;
* the Company’s assessment of its clinical trials;
* the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
* the Company’s ability to enter into and successfully execute any license and collaborative agreements;
* the adequacy of the Company’s capital resources and cash flow projections, or the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations;
* the adequacy of the Company’s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; and
* the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2009 and its most recent quarterly report on Form 10-Q.
Contacts
Genta Investor Relations
908-286-3980
info@genta.com
Rite Aid Reports 0.1 Percent Same Store Sales Decrease for March
CAMP HILL, Pa.--(BUSINESS WIRE)--Rite Aid Corporation (NYSE: RAD) today announced sales results for March.
Monthly Sales
For the four weeks ended March 27, 2010, same store sales decreased 0.1 percent over the prior-year period. Front end same store sales increased 1.8 percent, positively impacted by an earlier Easter (April 4, 2010 versus April 12, 2009). Pharmacy same store sales, which included an approximate 189 basis points negative impact from new generic introductions, declined 1.0 percent. Prescriptions filled at comparable stores decreased 1.3 percent over the prior-year period.
Total drugstore sales for the four-week period decreased 1.4 percent to $1.968 billion compared to $1.996 billion for the same period last year. Prescription revenue accounted for 68.7 percent of drugstore sales, and third party prescription revenue represented 96.3 percent of pharmacy sales.
Rite Aid is one of the nation’s largest drugstore chains. On March 27, 2010, the company operated 4,777 stores compared to 4,882 stores in the like period a year ago. Information about Rite Aid, including corporate background and press releases, is available through the company’s website at http://www.riteaid.com.
Contacts
Rite Aid Corporation
INVESTORS:
Matt Schroeder
(717) 214-8867
or investor@riteaid.com
or
MEDIA:
Karen Rugen
(717) 730-7766
CPQQ earnings
China Power Equipment Reports Higher Revenues and Net Income
Last update: 3/31/2010 7:30:00 AM
XI'AN, China, March 31, 2010 /PRNewswire via COMTEX/ -- China Power Equipment, Inc. ("China Power Equipment" or the "Company") (CPQQ), the manufacturer of a new generation of energy saving electric transformers and transformer cores in the People's Republic of China, today reported higher revenues and net income for the year ended December 31, 2009.
Year 2009 Highlights -- Net revenues increased 154.0% to $23.87 million in 2009 from $9.39 million in 2008. -- Gross profit increased 143.1% to $5.70 million in 2009 from $2.34 million in 2008. -- Net income increased 190.0% to $4.22 million in 2009 from $1.46 million in 2008. -- Diluted earnings per common share decreased 357.1% to $(0.32) per share in 2009 from $(0.07) per share in 2008, mainly due to a deemed dividend from the beneficial conversion feature of preferred stock and higher average common shares outstanding.
Net revenues increased $14.47 million or 154.0 percent to $23.87 million for the year ended December 31, 2009 from $9.39 million in the year 2008, mainly due to higher volumes of amorphous alloy cores and transformers sold. Net income increased $2.76 million or 190.0 percent to $4.22 million in 2009 from $1.46 million in 2008, mainly due to the higher revenues and continuing good control of expenses. Diluted earnings per share decreased 357.1 percent to $(0.32) per common share in 2009 from $(0.07) per share in 2008, mainly due to a deemed dividend from the beneficial conversion feature of preferred stock and higher average common shares outstanding that increased 35.1 percent in 2009 from 2008.
Mr. Yong Xing Song, Chairman of the Board of China Power Equipment, said, "Our strong increases in revenues and net income for the year 2009 reflect the high demand in the Chinese market for our energy-efficient amorphous alloy electric transformer equipment."
Looking at the company's products, revenues from amorphous alloy cores were up $10.84 million or 202.1 percent to $16.21 million in 2009 from $5.37 million in 2008. Revenues from amorphous alloy transformers were up $4.05 million or 115.4 percent to $7.56 million in 2009 from $3.51 million in 2008. Revenues from traditional silicon steel transformers and cores were down $0.42 million or (81.1) percent to $0.10 million in 2009 from $0.52 million in 2008 because the Company exited that business entirely in 2009.
To help fulfill the large increase in customers' orders for amorphous alloy transformers and cores, the Company subcontracted out some of the production to another manufacturer in 2009.
Operating expenses remained under good control, with its gross profit margin declining just 1 percentage point to 23.9 percent in 2009 from 24.9 percent in 2008 on somewhat higher prices for its primary raw material. The Company's operating profit margin increased to 18.9 percent in 2009 from 16.7 percent in 2008.
Total other income increased $0.32 million or 197.4 percent to $0.48 million in 2009 from $0.16 million in 2008, mainly due to higher consulting income for technical support work performed in 2009 that was not offered in 2008 and due to lower interest expense on lower average borrowings in 2009 compared with 2008. The Company's effective income tax rate was down a little to 15.3 percent in 2009 from 15.7 percent in 2008.
As a result, China Power Equipment's net income increased $2.76 million or 190.0 percent to $4.22 million in 2009 from $1.46 million in 2008. Its net profit margin improved to 17.68 percent in 2009 from 15.50 percent in 2008.
Net cash flow provided by operating activities was $5.38 million in 2009, net cash flow used in investing activities was $(2.51) million, mostly in support of capacity expansion, and net cash flow provided from financing activities was $4.94 million, with nearly all of that provided by the net proceeds the Company received from issuing preferred stock in 2009. Adding in a small cash flow benefit due to foreign currency exchange rate changes, China Power Equipment's net cash flow in 2009 resulted in a net increase in cash of $7.81 million. The Company's cash outstanding on December 31, 2009 was $8.88 million.
The Company's debt leverage at yearend 2009 was very modest at 0.3 percent, since it had only one small interest-bearing note payable.
Mr. Song continued, "I believe our results in 2009 represent a very good performance in a very high growth year. With our good cash position, internal cash generation, modest debt leverage, and financing flexibility, we believe we have sufficient financial strength to continue to invest in new product development, capacity expansion, and working capital to support good sales growth in our amorphous alloy cores and amorphous alloy transformers."
Mr. Song continued, "We expect that a new source of amorphous alloy strip will soon be available from Beijing Advanced Technology & Science Materials Co., Ltd. ("AT&M"). We have signed an agreement with AT&M in which we have been given priority to purchase amorphous alloy strip products.
"In September 2009, AT&M completed their test production of amorphous alloy strip, using their facility that has an annual capacity of 10,000 metric tons. We have used some of AT&M's test strip to manufacture test cores and transformers and are pleased to be the first company to do so. Our test cores and transformers are permitting electric power grid organizations and other transformer makers to test and to validate that our cores and transformers using AT&M's amorphous alloy will perform as expected, are essentially equivalent in quality and performance to production that uses Hitachi's amorphous alloy, and are qualified for production purchases. We believe that this second source for amorphous alloy strip, when approved for production, is likely to help alleviate the raw material constraint that has been a concern in the global transformer industry. AT&M's alloy is likely to be quite cost competitive and may accelerate the use of amorphous alloy transformers by China's electric power grid companies."
Mr. Song concluded, "China's economic outlook continues to be encouraging, and China's adoption of amorphous alloy electric transformers in both urban and rural areas appears to be increasing at an increasing rate. As a result, we believe that the high demand for amorphous alloy cores and transformers should continue for several years."
Financial statements follow. China Power Equipment, Inc. Consolidated Statements of Operations Year Ended December 31, 2009 2008 Revenue, net $23,866,239 $9,394,491 Cost of goods sold (18,167,768) (7,050,739) Gross profit 5,698,471 2,343,752 Operating expenses: Selling, general, and administrative expenses 1,170,932 779,350 Stock-based compensation 25,697 -- Total operating expenses 1,196,629 779,350 Net income from operations 4,501,842 1,564,402 Other income (expenses) Gain on investment 89,755 67,505 Other income 393,224 279,436 Interest income 12,902 3,119 Interest expense (14,268) (188,110) Total other income 481,613 161,950 Net income before income taxes 4,983,455 1,726,352 Income taxes 763,455 270,559 Net income $4,220,000 $1,455,793 Deemed dividend from beneficial conversion feature of preferred stocks (9,045,005) (2,193,483) Net loss applicable to common shareholders $(4,825,005) $(737,690) Loss per share - basic $(0.32) $(0.07) Loss per share - diluted $(0.32) $(0.07) Weighted average common shares outstanding: Basic 14,908,313 11,036,692 Diluted 14,908,313 11,036,692 The accompanying notes are an integral part of these consolidated financial statements. China Power Equipment, Inc. Consolidated Balance Sheets December 31, December 31, 2009 2008 Assets Current Assets Cash $8,883,188 $1,071,038 Accounts receivable, net 1,949,818 2,013,305 Advance to suppliers -- 771,407 Inventory, net (Note 3) 363,312 461,634 Prepaid expenses and other receivables 220,939 257,700 Total Current Assets 11,417,257 4,575,084 Related party receivables (Note 11) 731 97,248 Property, plant and equipment, net (Note 4) 4,593,068 3,116,422 Intangible assets, net (Note 6) 391,513 220,742 Long-term investment (Note 5) 282,897 236,384 Deposit on contract rights (Note 12) 1,316,328 1,313,064 Deposit for purchase of equipment 767,858 -- Prepaid capital lease (Note 9) 111,482 116,694 Total Assets $18,881,134 $9,675,638 Liabilities and Stockholders' Equity Current Liabilities Accounts payable $549,065 $710,480 Accrued liabilities and other payables 395,486 409,040 Advance from customers 32,760 142,156 Lease payable - current portion (Note 9) 2,156 1,944 Note payable (Note 8) 58,503 58,358 Value-added tax payable 219,398 64,686 Income taxes payable (Note 7) 365,751 235,262 Related party payable (Note 11) 1,170 1,167 Total Current Liabilities 1,624,289 1,623,093 Long-term Liabilities Lease payable - non current portion (Note 9) 115,463 117,327 Total Long-term Liabilities 115,463 117,327 Stockholders' Equity Series B convertible preferred stock, $0.001 par value, 5,000,000 shares authorized, 4,166,667 shares and Nil issued and outstanding at December 31, 2009 and 2008 4,167 -- Common stock: par value $0.001 per share, 100,000,000 shares authorized; 14,908,313 shares issued and outstanding at December 31, 2009 and 2008 14,908 14,908 Additional paid-in capital 21,182,026 7,176,041 Statutory surplus reserve fund (Note 10) 642,819 202,665 Retained earnings (Accumulated deficit) (5,728,130) (462,971) Accumulated other comprehensive income 1,025,592 1,004,575 Total stockholders' equity 17,141,382 7,935,218 Total Liabilities and Stockholders' Equity $18,881,134 $9,675,638 The accompanying notes are an integral part of these consolidated financial statements. China Power Equipment, Inc. Consolidated Statements of Cash Flows Year Ended December 31, 2009 2008 Cash Flows from Operating Activities Net income $4,220,000 $1,455,793 Adjustments to reconcile net income to net cash: Depreciation and amortization expense 249,592 232,607 Stock-based compensation 25,697 -- Provision of bad debts 90,594 40,467 Provision of impairment loss of advance to suppliers -- 107,885 Gain on investment (89,755) (67,505) Changes in operating assets and liabilities: Accounts receivable (22,138) (210,710) Advance to suppliers 772,909 83,518 Inventory 99,416 (92,297) Prepaid expenses and other receivables 37,380 17,051 Accounts payable (163,094) (442,875) Accrued expenses and other payables (14,558) (39,973) VAT tax payable 154,468 (36,449) Income taxes payable 129,834 105,293 Advance from customers (109,690) (17,473) Net cash provided by (used in) operating activities 5,380,655 1,135,332 Cash Flows from Investing Activities Acquisitions of property, plant, and equipment (18,422) (49,266) Addition in construction in progress (1,620,844) -- Acquisitions of intangible assets (219,270) -- Deposit for purchase of equipment (767,445) -- Repayment from related parties 72,913 65,724 Dividend from equity interest subsidiary 43,854 71,816 Net cash provided by (used in) investing activities (2,509,214) 88,274 Cash Flows from Financing Activities Principal payments on capital lease (1,948) (1,731) Repayment to related parties -- (186,575) Proceeds from issuing preferred stock 4,939,450 -- Repayment to short-term loans -- (1,098,783) Net cash provided by (used in) financing activities 4,937,502 (1,287,089) Effect of exchange rate changes on cash and cash equivalents: 3,207 60,626 Increase (decrease) in cash and cash equivalents 7,812,150 (2,857) Cash and cash equivalents, beginning of period 1,071,038 1,073,895 Cash and cash equivalents, end of period $8,883,188 $1,071,038 Supplemental disclosure of cash flow information Interest paid in cash $14,268 $188,110 Income taxes paid in cash $633,621 $165,265 Non-cash investing and financing activities: Issuance of stocks for advance from investor $-- $100,000 Reclass long-term investment to advance to suppliers $-- $706,823 Conversion of preferred stock to common stock $-- $93 Construction in progress in lieu of repayment from related party $23,794 $-- The accompanying notes are an integral part of these consolidated financial statements." China Power Equipment, Inc. Consolidated Statements Of Stockholders' Equity Additional Preferred Stock Capital Stock Paid-in Shares Amount Shares Amount Capital BALANCE, JANUARY 1, 2008 92,500 $93 10,451,613 $10,452 $4,886,921 Conversion of Series A preferred stock (92,500) (93) 4,021,900 4,022 (3,929) Deemed dividend on preferred stock -- -- -- -- 2,193,483 Issuance of common stock -- -- 434,800 434 99,566 Transfer to statutory reserve -- -- -- -- -- Comprehensive income: Net income -- -- -- -- -- Foreign currency translation adjustment -- -- -- -- -- Total comprehensive income BALANCE, DECEMBER 31, 2008 -- -- 14,908,313 14,908 7,176,041 Issuance of preferred stock 4,166,667 4,167 -- -- 4,935,283 Deemed dividend on preferred stock -- -- -- -- 9,045,005 Stock-Based Compensation -- -- -- -- 25,697 Transfer to statutory reserve -- -- -- -- -- Comprehensive income: Net income -- -- -- -- -- Foreign currency translation adjustment -- -- -- -- -- Total comprehensive income BALANCE, DECEMBER 31, 2009 4,166,667 $4,167 14,908,313 $14,908 $21,182,026 China Power Equipment, Inc. Consolidated Statements Of Stockholders' Equity Accumulated Retained Other Statutory Earnings Compre- Total Surplus (Accumulated hensive Stockholders' Reserve deficit) Income (Loss) Equity BALANCE, JANUARY 1, 2008 $38,629 $438,755 $585,381 $5,960,231 Conversion of Series A preferred stock -- -- -- -- Deemed dividend on preferred stock -- (2,193,483) -- -- Issuance of common stock -- -- -- 100,000 Transfer to statutory reserve 164,036 (164,036) -- -- Comprehensive income: Net income -- 1,455,793 -- 1,455,793 Foreign currency translation adjustment -- -- 419,194 419,194 Total comprehensive income 1,874,987 BALANCE, DECEMBER 31, 2008 202,665 (462,971) 1,004,575 7,935,218 Issuance of preferred stock -- -- -- 4,939,450 Deemed dividend on preferred stock -- (9,045,005) -- -- Stock-Based Compensation -- -- -- 25,697 Transfer to statutory reserve 440,154 (440,154) -- -- Comprehensive income: Net income -- 4,220,000 -- 4,220,000 Foreign currency translation adjustment -- -- 21,017 21,017 Total comprehensive income 4,241,017 BALANCE, DECEMBER 31, 2009 $642,819 $(5,728,130) $1,025,592 $17,141,382 The accompanying notes are an integral part of these consolidated financial statements.
About China Power Equipment, Inc.
China Power Equipment, Inc., is a U.S. corporation, which through its wholly-owned subsidiary, An Sen (Xi'an) Power Science & Technology Co., Ltd. and its affiliated operating company, Xi'an Amorphous Zhongxi Co., Ltd., designs, manufactures, and distributes amorphous alloy transformer cores and amorphous alloy core electricity transformers in the People's Republic of China. The company currently manufactures 59 different products, primarily amorphous alloy cores and amorphous alloy core transformers.
Safe harbor
Certain statements in this release concerning our future growth prospects are forward-looking statements, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.
The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China.
Additional risks that could affect our future operating results are more fully described in our filings with United States Securities and Exchange Commission. These filings are available at .
We may, from time to time, make additional written and oral forward- looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statements that may be made from time to time by or on our behalf.
For more information on China Power Equipment please visit our website at .
For more information, please contact: China Power Equipment, Inc. Phone: +1-646-623-6999 in the USA Email: xa-fj@xa-fj.com or Christensen Mr. Yuanyuan Chen (English and Chinese) Mobile: +86-139-2337-7882 in Beijing Email: ychen@christensenir.com Mr. Tom Myers (English) Mobile: +86-139-1141-3520 in Beijing Email: tmyers@christensenir.com Ms. Kathy Li (English and Chinese) Telephone +1-212-618-1978 in the USA Email: kli@christensenir.com
SOURCE China Power Equipment, Inc.
Copyright (C) 2010 PR Newswire. All rights reserved
SCOXQ, screaming buy here
CAE news AH, also like DEPO here
just grabbed a few for a bounce
SCOXQ here we go
SCOXQ could run into the close here
SCOXQ power hour runner !!!
AEN going for 2.50 + here, looking for a close over 2.60 and an AH move near $3
ALNS involved with MSFT too, right?
still not too late to get in on AEN
hey, it's all good, I was just hassling the other guy
hey, ya know, there are probably thousands of people here with multiple aliases, just pipe down there, sport and make some cake
ROHI ask getting hit now, break of .60 and it flys
AEN moving again, not that anyone cares, because it doesn't have any ZEROES in front of it
In at $ 1.43 here !
AEN approaching HOD again, after 2.50 she's cleared for $3 +
AEN a thing of beauty !!!
XRM news PM
Xerium Technologies Receives Overwhelming Support from Lenders for Plan to Reduce Approximately $150 Million in Debt
Operations to Continue as Usual
Company Files Papers to Assure Customers, Employees, and Suppliers Are Not Impacted
RALEIGH, N.C.--(BUSINESS WIRE)--Xerium Technologies, Inc. (NYSE:XRM), a leading global manufacturer of industrial textiles and rolls used primarily in the paper production process, today announced that it has received overwhelming support from its lenders for a restructuring plan to reduce the Company’s debt by approximately $150 million and significantly strengthen its long-term financial health. The Company will implement the “pre-packaged” plan of reorganization with court assistance under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware.
“This is a major accomplishment for the Company that will enable us to continue implementing our three-part operating strategy; reducing our debt load, introducing new products that our customers value and maximizing the contribution of our employees.”
The Company will operate as usual during the court process, which is anticipated to be concluded in 30 to 60 days. The restructuring involves Xerium’s companies located in the United States, Canada, Austria and its non-operating holding companies in Italy and Germany. The Company’s operating entities in Europe, Asia, South America, Italy, and Germany are not part of the court process or the restructuring.
“We are delighted to receive such overwhelming support from our lenders, which allows us to quickly move forward with our pre-packaged restructuring plan,” commented Stephen R. Light, Xerium’s Chairman, CEO and President. “This is a major accomplishment for the Company that will enable us to continue implementing our three-part operating strategy; reducing our debt load, introducing new products that our customers value and maximizing the contribution of our employees.”
“As a result of the restructuring, the Company will be well positioned to compete successfully in our served markets,” said Mr. Light. “The restructuring will allow the company to remain focused on our primary goals, manufacturing and supplying the best products possible to our global customers.”
The filing is not intended to impact employees, suppliers or customers. As part of its initial filings, the Company filed motions seeking assurances from the court that employees will continue to receive their usual pay and benefits on an uninterrupted basis, customers receive goods as they normally would, and suppliers will receive all amounts owed to them both before and after the filing in the normal course of business. Additionally, to assure its liquidity during the restructuring process, the Company has secured a commitment from its lenders for an $80 million term and revolving credit facility and has filed motions seeking the Court’s approval of the financing.
Among other things, the pre-packaged plan provides that approximately $620 million of existing debt would be exchanged for approximately $10 million in cash, $410 million in new terms loans maturing in 2015, and approximately 82.6% of the common stock of the Company. Existing shareholders would retain a meaningful minority equity ownership of the Company of approximately 17.4% of the common stock and receive four year warrants to purchase up to an additional 10% of the common stock. In addition, the Company would enter into a new revolving loan of up to $20 million and a term loan of $60 million. The implementation of the pre-packaged plan is dependent upon a number of factors, including final documentation, the approval of a disclosure statement and confirmation of the plan in accordance with the provisions of the Bankruptcy Code.
The Company expects that the NYSE will continue the listing of its common stock in light of the expected meaningful continuing equity value to be received by current common equity holders and the anticipated accelerated path to emergence facilitated by a pre-packaged Chapter 11 filing. However, the continued listing will be subject to ongoing reassessment by the staff of NYSE Regulation, Inc. based on current information and circumstances. Separately, the Company is operating under an NYSE-approved plan to address quantitative non-compliance with certain continued listing requirements. If the proposed restructuring is successfully completed, the Company expects that its quantitative non-compliance would also be addressed within the timeframes required under NYSE rules.
Parties who have additional questions regarding Xerium’s Chapter 11 filing may contact the Company’s Information Hotline at 888-369-8914. All media inquiries should be referred to Geoffrey Buscher at 1-508-532-1790, or email IR@xerium.com.
About Xerium Technologies
Xerium Technologies, Inc. (NYSE: XRM) is a leading global manufacturer and supplier of two types of consumable products used primarily in the production of paper: clothing and roll covers. The Company, which operates around the world under a variety of brand names, utilizes a broad portfolio of patented and proprietary technologies to provide customers with tailored solutions and products integral to production, all designed to optimize performance and reduce operational costs. With 32 manufacturing facilities in 13 countries around the world, Xerium has approximately 3,300 employees.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements involving risks and uncertainties, both known and unknown, that may cause actual results to differ materially from those indicated. These risks and uncertainties include the following items: (1) the Company’s ability to obtain court approval with respect to motions in the Chapter 11 proceedings; (2) court rulings in the Chapter 11 case, including whether the court approves the Company’s pre-packaged plan; (3) the possibility of delays in the Chapter 11 proceedings; (4) the Company’s ability to enter into the debtor-in-possession financing; (5) the potential adverse impact of any restructuring and the Chapter 11 filing on our business, results of operations, financial condition and liquidity; (6) the Company’s ability to achieve compliance with NYSE continued listing standards or otherwise maintain its NYSE listing status; (7) management of cash resources; (8) restrictions imposed by, and as a result of, the Company’s substantial leverage; (9) the Company’s ability to obtain and maintain normal terms with customers, suppliers and service providers and to retain key executives, managers and employees; (10) the effects of the global economic crisis and associated unpredictable market conditions; (11) the rate of market improvement in the industry occurring slower than expected; and (12) the other risks and uncertainties discussed elsewhere in this press release, our Form 10-K for the year ended December 31, 2009, and our subsequent SEC filings. If any of these risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected. Any forward-looking statement in this press release reflects our current views with respect to future events. We assume no obligation to publicly update or revise these forward-looking statements for any reason, whether as a result of new information, future events, or otherwise. As discussed above, we are subject to substantial risks and uncertainties related to the current economic downturn and our credit issues, and we encourage investors to refer to our SEC filings for additional information. Copies of these filings are available from the SEC and in the investor relations section of our website at www.xerium.com.
Contacts
SBG Investor Relations
Geoffrey Buscher, 508-532-1790
IR@xerium.com
CLDA news, PM
March 30, 2010 07:09 AM Eastern Daylight Time
Clinical Data, Inc. Reports Results of Phase I Studies of Stedivaze™ Demonstrating Safety and Tolerability in Patients with Asthma and COPD
Enrollment continues in Phase III ASPECT trial of Stedivaze
NEWTON, Mass.--(BUSINESS WIRE)--Clinical Data, Inc. (NASDAQ: CLDA), today announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI). Currently available adenosine agonists must be used with caution or are contraindicated in patients with asthma and COPD. The high selectivity of Stedivaze offers a potential advantage for the safe use in this population, accounting for approximately 10 percent of the 7.6M MPI tests performed annually.1 The Company is also actively enrolling patients in ASPECT 1, a Phase III trial designed to demonstrate the safety and effectiveness of Stedivaze.
“A2A – adenosine Receptor Reserve for Coronary Vasodilation”
“The positive results from our preliminary studies in asthmatics and COPD patients are encouraging and represent a milestone toward our goal of developing a coronary vasodilator that is both safe and well tolerated in these populations,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “We intend to expand these findings by initiating further safety studies of Stedivaze in patients with asthma and COPD, while continuing to evaluate the efficacy and potential for superior tolerability of Stedivaze in our ongoing Phase III program.”
In both of these placebo-controlled studies, Stedivaze was administered as a single IV bolus, at the same dose utilized in the ASPECT 1 trial. In 49 patients with mild to moderate asthma and 50 patients with moderate to severe COPD, Stedivaze had no effects on pulmonary function tests. Adverse events overall were similar in both incidence and severity to the adverse event profile seen in previous studies of Stedivaze in patients without lung disease, and continue to support its potential for improved tolerability. Most frequently observed adverse events, common to this class of agents, included palpitations, flushing, chest discomfort and shortness of breath. Results of both of these trials support the continued study of Stedivaze in patients with asthma and COPD.
In addition to completing these Phase I studies, the Company is continuing to enroll patients in its ASPECT 1 trial of Stedivaze, a Phase III randomized, double blind, active control study initiated in November 2009, which is designed to demonstrate both efficacy and the potential for improved tolerability for Stedivaze in patients undergoing SPECT MPI. ASPECT 2, a second Phase III trial similar in design to ASPECT 1, is expected to begin in the second half 2010.
About Stedivaze
Stedivaze (apadenoson) is a potent agonist of the adenosine A2A receptor subtype and offers improved selectivity for this receptor over other subtypes (A1 and A2B). Phase II studies suggest that Stedivaze produces ample coronary artery vasodilation required for SPECT MPI testing and has a pharmacokinetic profile that will allow it to be administered as a fixed dose bolus injection. Because of its superior selectivity for the A2A receptor subtype and its optimal pharmacokinetic profile, Stedivaze may offer improved tolerability over other adenosine receptor agonists currently marketed for use in pharmacologic stress MPI.
About Myocardial Perfusion Imaging
Myocardial perfusion imaging is used as a primary screen to identify the presence of coronary artery disease (CAD) as evidenced by detection of areas of poor blood flow in the heart that can be caused by the presence of plaques that can reduce or block the normal flow of blood to the heart. A pharmacologic stress agent is used to temporarily increase blood flow through normal coronary arteries in order to define areas of the heart that may be receiving reduced blood flow under rest and then stress conditions. The A2A adenosine receptor is the receptor subtype responsible for coronary vasodilation, or the widening of blood vessels that supply the heart muscle.2
The U.S. market for MPI testing is projected to be $800 million in 2011. Over 7.6 million MPI tests were performed in the U.S. in 2008 and approximately 3.5 million of these tests required the use of a pharmacological agent to generate maximum coronary blood flow in lieu of exercise.3 The market is expected to continue to grow due to an aging population, a rise in the number of patients unable to perform exercise during diagnostic procedures, and emerging imaging modalities that require the use of a vasodilator.
About Clinical Data, Inc.
Clinical Data develops first-in-class and best-in-category therapeutics. The Company is advancing its late-stage drug candidates for central nervous system disorders and cardiovascular diseases, to be followed by promising drug candidates in other major therapeutic areas. Clinical Data combines its drug development and biomarker expertise in an effort to develop products with enhanced efficacy and tolerability to improve patient health and reduce costs. To learn more, please visit the Company's website at www.clda.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information and statements that are intended to be covered by the safe harbor for forward looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements about our ability to obtain regulatory approval for, and successfully introduce Stedivaze; our ability to expand our long-term business opportunities; and all other statements regarding future performance. All such information and statements are subject to certain risks and uncertainties, the effects of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to, risks related to whether Stedivaze or any of our therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether Stedivaze or any of our other therapeutic products will be successfully marketed if approved; and those risks identified and discussed by Clinical Data in its filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward looking statements that speak only as of the date hereof. Clinical Data does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in Clinical Data's SEC periodic and interim reports, including but not limited to its Annual Report on Form 10-K for the fiscal year ended March 31, 2009, Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2009, and Current Reports on Form 8-K filed from time to time by the Company.
1Eliana Reyes, MD, et al. Adenosine myocardial perfusion scintigraphy in obstructive airway disease. Journal of Nuclear Cardiology, November/December 2007
2Shryock, J.C., Snowdy, S., Baraldi, P.G., et al. “A2A – adenosine Receptor Reserve for Coronary Vasodilation,” Circulation, 1998, pp. 711-718.
3AMR Monthly Monitor SNM: Advanced Molecular Imaging and Therapy, September 15, 2008.
Looking for AEN to open tomorrow in the $2s all over yahoo about a deal in the works with Pfizer
anyone on CHINA? steady climber of late, sweet chart
I think MRNA and AEN are strong buys now, as well as ATPG
re ABIO here's the post from the clown du jour http://investorshub.advfn.com/boards/read_msg.aspx?message_id=48353561
ABIO, some clown was calling for it to be the play of the day today, lol
AEN 1.90 AH, should open over 2.00 tomorrow, news out after the bell...big rumor of Pfizer buyout on yahoo
AEN 1.90 now, $2.25 easy from here AH
AEN looking to break 1.85 here, cleared for liftoff after that
ABOI...? for a clear winner, it sure is tanking PM