This will be replaced by the player.

Posts Tagged ‘biotechnology’

SPX-106T Arrests Development of Atherosclerotic Plaques in Mouse Model of Cardiovascular Disease

Wednesday, March 7th, 2012

http://pennyomega.com/img/spex.jpg

BETHESDA, Md., March 7, 2012 (CRWENewswire) — Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today announced that one of its drug candidates, SPX-106T, arrested development and reduced atherosclerotic plaque area in the aortic arch, thoracic aorta and sinus of Valsalva in mice genetically predisposed to cardiovascular disease. Atherosclerosis can lead to myocardial infarction (MI) and stroke. Each year, about 770,000 people in the United States experience their first MI, and about one-third of these events are fatal.(1-3)

Two groups of apolipoprotein E-deficient mice (control and SPX-106T) were each fed a Western diet (high in fat and carbohydrates) for eight weeks. In the SPX-106T group, the sucrose portion of the dietary carbohydrates was replaced with D-tagatose and SPX-106 was added at 0.1%. Plaque area was quantified at three locations: the sinus of Valsalva on top of the heart, aortic arch, and thoracic aorta (Figure 1a). SPX-106T reduced atherosclerotic plaque areas almost 5-fold in all locations (p<0.05 in thoracic aorta, p?0.01 in aortic arch and sinus of Valsalva). Photomicrographs of the sinus of Valsalva illustrate the reduction of atherosclerosis with SPX-106T (Figure 1b).

These results expand on previous work done by Spherix, which was presented at the American Association of Pharmaceutical Scientists (AAPS) 2011 national meeting in October, showing that SPX-106T significantly reduced serum cholesterol, the amount of subcutaneous, retroperitoneal, and epididymal body fat, and prevented body weight gain. These data also support Spherix’s other findings that SPX-106T reduced atherosclerotic lesion areas in the aortic arches of LDL receptor-deficient mice fed fructose and glucose.

“As we continue the development program for SPX-106T, we are gaining valuable insight into the therapeutic potential for SPX-106T. We are looking forward to bringing SPX-106T into human clinical trials in 2012,” noted Dr. Claire Kruger, CEO of Spherix.

LDL-cholesterol is a known risk factor for the development of atherosclerosis in humans.(4) Spherix has previously shown that LDL-cholesterol is reduced in LDL receptor-deficient mice treated with SPX-106T.

“This is a very exciting time for Spherix,” remarked Dr. Robert Lodder, Spherix’s President. “We have now tested SPX-106T in two different genetic models and are looking into the underlying mechanisms by which SPX-106T prevents plaque development in the apolipoprotein E-deficient mice. We are also expanding the applications of SPX-106T to other indications where dyslipidemia may be a primary risk factor.”

About Spherix
Spherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research. The Company now leverages its scientific and technical expertise and experience through its two subsidiaries – Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis. Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke. Spherix’s Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides. For more information, please visit www.spherix.com.

Forward-Looking Statements
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of our products, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop products may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

1. NHLBI, http://www.nhlbi.nih.gov/health/health-topics/topics/heartattack/

2. WHO, http://www.who.int/mediacentre/factsheets/fs310.pdf

3. Genentech, http://www.gene.com/gene/products/education/vascular/hrtattack-factsheet.html

4. Cleeman, J.I. (2002). Executive Summary of the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).

Source: Spherix Incorporated

*********************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. crwenewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers.Our disclaimer (Read more at http://www.crwenewswire.com/disclaimer) is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold crwenewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
Share/Bookmark
 
 
 

Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress Syndrome

Tuesday, March 6th, 2012

http://pennyomega.com/img/dsco.jpg

SURFAXIN is the First FDA-Approved Synthetic, Peptide-Containing Surfactant

Conference Call Tomorrow at 10 a.m. EST

WARRINGTON, Pa., March 6, 2012 (CRWENewswire) — Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the United States Food and Drug Administration (FDA) has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012.

“The approval of SURFAXIN is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS,” said W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs. “This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care.”

RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants.

Discovery Labs will hold a conference call tomorrow, March 7th, 2012 at 10:00 a.m. EST to further discuss the foregoing. The call in number is (877) 215-0093. The international call in number is (706) 679-3237. The passcode is 58400332. This audio webcast will be available through a live broadcast on the Internet at http://us.meeting-stream.com/discoverylaboratories_030212 and www.discoverylabs.com. The replay number to hear the conference call is (855) 859-2056 or (404) 537-3406 using the same conference call password listed above.

ABOUT SURFAXIN

SURFAXIN (lucinactant intratracheal suspension) is a synthetic, peptide-containing surfactant. SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. Discovery Labs anticipates that SURFAXIN will be commercially available in late 2012.

IMPORTANT SAFETY INFORMATION

SURFAXIN (lucinactant intratracheal suspension) is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant’s clinical condition assessed and stabilized. SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).

For more information about SURFAXIN, please visit www.surfaxin.com.

ABOUT DISCOVERY LABS

Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care. Discovery Labs’ novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized, and aerosolized dosage forms. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies. Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the timing of a commercial launch of SURFAXIN and market acceptance of SURFAXIN, are described in Discovery Labs’ filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. The Company assumes no obligation to update or revise any forward-looking statements.

Source: Discovery Laboratories Inc.

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
Share/Bookmark
 
 
 

PAREXEL Reports Second Quarter Fiscal Year 2012 Financial Results

Tuesday, January 31st, 2012

http://pennyomega.com/img/siajan31.png

 

http://pennyomega.com/img/prxl.jpg

- Consolidated service revenue of $333.2 million grew 9.5% year-over-year
- GAAP operating margin of 6.8%; adjusted operating margin of 7.1% excluding net restructuring charges of $1.2 million
- GAAP diluted earnings per share of $0.21; adjusted earnings per share of $0.23 excluding restructuring and related charges
- Backlog at approximately $3.74 billion, up 23.8% from the December quarter one year ago, with a net book-to-bill ratio of 1.50

BOSTON, Jan. 30, 2012 (CRWENEWSWIRE) — PAREXEL International Corporation (NASDAQ:PRXL) today announced its financial results for the second quarter ended December 31, 2011.

For the three months ended December 31, 2011, PAREXEL’s consolidated service revenue increased by 9.5% to $333.2 million compared with $304.4 million in the prior year period. On a same store basis, excluding $1.4 million of service revenue in the prior year quarter related to subsequently divested Early Phase units, revenue increased 10.0%. On a year-over-year basis, foreign exchange had a de minimus impact on service revenue in the current quarter. The Company reported operating income under Generally Accepted Accounting Principles (GAAP) of $22.6 million, or 6.8% of consolidated service revenue, in the second quarter of Fiscal Year 2012, versus GAAP operating income of $28.2 million, or 9.3% of consolidated service revenue, in the same quarter of the prior fiscal year. GAAP net income for the quarter ended December 31, 2011 totaled $12.9 million, or $0.21 per diluted share, compared with GAAP net income of $16.8 million, or $0.28 per diluted share, for the quarter ended December 31, 2010. GAAP net income in the quarter decreased by 23.1% year-over-year, and earnings per diluted share decreased by 25.0%.

In Fiscal Years 2012 and 2011, the financial results for the respective December quarters each included special items, as detailed in the financial charts within this press release. Excluding the impact of these special items, adjusted operating income in the second quarter of Fiscal Year 2012 was $23.8 million, or 7.1% of consolidated service revenue. Excluding these special items in the prior year period, adjusted operating income was $27.6 million, or 9.1% of consolidated service revenue. On this adjusted basis, operating income in the quarter ended December 31, 2011 declined 14.0% year-over-year. Adjusted net income in the current and prior periods (which excludes the special items referenced above) was $13.9 million, or $0.23 per diluted share in the quarter ended December 31, 2011, and was $17.2 million, or $0.29 per diluted share in the quarter ended December 31, 2010. Using adjusted numbers in both periods, net income in the current quarter declined by 19.5% year-over-year, and adjusted earnings per diluted share declined by 20.7%.

The Company reported significant progress with regard to its initiative to reduce Days Sales Outstanding (DSO), which declined 10 days on a sequential basis to 57 days.

On a segment basis, consolidated service revenue for the second quarter of Fiscal Year 2012 was $247.9 million in Clinical Research Services (CRS), $38.5 million in PAREXEL Consulting and Medical Communications Services (PCMS), and $46.8 million in Perceptive Informatics.

For the six months ended December 31, 2011, consolidated service revenue was $647.9 million versus $600.2 million in the prior year period, an increase of 8.0%. GAAP operating income for the current six-month period was $35.0 million, or 5.4% of service revenue, compared with GAAP operating income of $58.2 million, or 9.7% of service revenue in the prior year period. GAAP net income for the six months ended December 31, 2011 was $22.5 million, or $0.37 per diluted share, compared with GAAP net income of $34.6 million, or $0.58 per diluted share, in the prior year period. Excluding the impact of special items as detailed in the attached financial charts in both six month periods, operating income was $38.9 million or 6.0% of consolidated service revenue for the six months ended on December 31, 2011, compared with $57.2 million or 9.5% of consolidated service revenue for the six months ended on December 31, 2010. On an adjusted basis, net income for the six months ended December 31, 2011 was $25.6 million, or $0.43 per diluted share, compared with $34.7 million or $0.58 per diluted share in the comparable prior year six month period.

Backlog at the end of December was approximately $3.74 billion, an increase of 23.8% year-over-year. The reported backlog included gross new business wins in the quarter of $622.2 million, cancellations of $121.7 million, a negative impact from foreign exchange rates of $29.7 million, and a downward backlog adjustment of $3.8 million related to dispositions in the Early Phase business. The net book-to-bill ratio was 1.50 in the quarter.

Mr. Josef H. von Rickenbach, PAREXEL’s Chairman and Chief Executive Officer stated, “In the second quarter, we continued our positive momentum, demonstrating solid achievements in a number of key financial and operational areas. On a sequential basis, highlights included accelerated revenue growth for the Company overall, an improved operating margin, and earnings per share that were in line with our projections. Our progress was broad-based, with each of our three reporting segments delivering higher gross margins on a sequential basis. This was the result of improved operating leverage, further benefits of productivity and efficiency initiatives, and the impact of recent restructuring activities. We also generated healthy cash flow from operations, related in part to a substantial reduction in net receivables and a corresponding decrease in DSO.”

Mr. von Rickenbach continued, “We are starting to hit our stride with recently-awarded strategic accounts, and with another quarter of strong new business wins in our backlog, I believe that we are well-positioned to deliver on our goals for Fiscal Year 2012. Operationally, we are committed to meeting the challenges of accelerating revenue growth, and we will continue to put into place the necessary resources to meet client and shareholder expectations for Fiscal Year 2012 and beyond.”

The Company issued forward-looking guidance for the third quarter of Fiscal Year 2012 (ending March 31, 2012), for Fiscal Year 2012, and for Calendar Year 2012. The Company expects to report consolidated service revenue for the third quarter (ending March 31, 2012) in the range of $350 to $358 million, GAAP earnings per diluted share in the range of $0.28 to $0.30, and adjusted earnings per diluted share in the range of $0.30 to $0.32 (which exclude the impact of restructuring and related charges). For Fiscal Year 2012, consolidated service revenue is expected to be in the range of $1.360 to $1.375 billion, GAAP earnings per diluted share in the range of $1.01 to $1.09, and adjusted earnings per diluted share in the range of $1.09 to $1.17 (which exclude the impact of restructuring and related charges). Previously issued guidance for Fiscal Year 2012 was for service revenue in the range of $1.355 to $1.385 billion, GAAP earnings per diluted share in the range of $0.99 - $1.14, and adjusted earnings per diluted share in the range of $1.07 to $1.22 (which exclude the impact of restructuring and related charges). For Calendar Year 2012, consolidated service revenue is expected to be in the range of $1.445 to $1.480 billion, GAAP earnings per share are expected to be in the range of $1.31 to $1.47, and adjusted earnings per diluted share are expected to be in the range of $1.33 to $1.47 (excluding the impact of restructuring and related charges).

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. The Company believes that presenting the non-GAAP financial measures contained in this press release assists investors and others in gaining a better understanding of its core operating results and future prospects, especially when comparing such results to previous periods or forecasted guidance, because such measures exclude items that are outside of the Company’s normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. Management uses non-GAAP financial measures, in addition to the measures prepared in accordance with GAAP, as the basis for measuring the Company’s core operating performance and comparing such performance to that of prior periods and to the performance of its competitors for the same reasons stated above. Such measures are also used by management in its financial and operating decision-making. Non-GAAP financial measures are not meant to be considered superior to or a substitute for the Company’s results of operations prepared in accordance with GAAP.

A conference call to discuss PAREXEL’s second quarter earnings, business, and financial outlook will begin at 10:00 a.m. ET on Tuesday, January 31, 2012 and will be broadcast live over the internet via webcast. The webcast may be accessed in the “Upcoming Events” portion of the main page of the Investor Relations section of the Company’s website at www.PAREXEL.com. Users should follow the instructions provided to assure that the necessary audio applications are downloaded and installed. A replay of this webcast will be archived on the website approximately two hours after the call and will continue to be accessible for approximately one year following the live event. To participate via telephone, dial +1 408-940-3886 and ask to join the PAREXEL quarterly conference call.

The Company notes that Fiscal Year 2011 numbers have been reclassified to conform to the current year’s presentation. A slide depicting the reclassified numbers for Fiscal Year 2011, in addition to other trended financial information, may be found in the Investor Relations section of the Company’s website under the “Additional Financials” section.

About the Company

PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 52 countries around the world, and has approximately 11,300 employees. For more information about PAREXEL International visit www.PAREXEL.com.

PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.

This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings, including the anticipated additional restructuring charges of approximately $2.0 million in the third quarter of Fiscal Year 2012; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 as filed with the SEC on November 9, 2011, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.

Source: PAREXEL International Corporation

CONTACTS:

James Winschel, Senior Vice President and Chief Financial Officer
Jill Baker, Corporate Vice President, Investor Relations
+1-781-434-4118

PAREXEL International Corporation

Consolidated Condensed Statement of Operations

Unaudited

Three Months Ended

Three Months Ended

(in thousands, except per share data)

December 31, 2011

December 31, 2010

As Reported

Adjustments

Non-GAAP

As Reported

Adjustments

Non-GAAP

Service revenue

$ 333,170

$ -

$ 333,170

$ 304,359

$ -

$ 304,359

Reimbursement revenue

54,641

54,641

59,691

59,691

Total revenue

387,811

-

387,811

364,050

-

364,050

Costs and expenses:

Direct costs

228,099

228,099

199,489

(a)

199,489

Reimbursable out-of-pocket expenses

54,641

54,641

59,691

59,691

Selling, general and administrative

64,358

64,358

61,182

(a)

61,182

Depreciation

14,752

14,752

13,605

13,605

Amortization

2,203

2,203

2,451

2,451

Restructuring charge (benefit)

1,162

(1,162)

(b)

-

(572)

572

(c)

-

Total costs and expenses

365,215

(1,162)

364,053

335,846

572

336,418

Income from operations

22,596

1,162

23,758

28,204

(572)

27,632

Other expense

(3,794)

-

(3,794)

(8,473)

1,166

(d)

(7,307)

Income before income taxes

18,802

1,162

19,964

19,731

594

20,325

Provision for income tax expense

5,862

233

(e)

6,095

2,899

199

(e)

3,098

Effective tax rate

31.2%

30.5%

14.7%

15.2%

Net income

$ 12,940

$ 929

$ 13,869

$ 16,832

$ 395

$ 17,227

Earnings per common share:

Basic

$0.22

$0.23

$0.29

$0.29

Diluted

$0.21

$0.23

$0.28

$0.29

Shares used in computing earnings per common share:

Basic

59,265

59,265

58,516

58,516

Diluted

60,249

60,249

59,686

59,686

(a) Prior year numbers have been reclassified to conform with the current year presentation.

(b) Restructuring charges include $1.7 million in severance costs and $0.5 million of facility-related costs, offset by a $1.0 million decrease in severance costs from an adjustment to the FY 2010 restructuring plan.

(c) Restructuring adjustments include $0.6 million in severance reductions.

(d) Impairment charge on an asset.

(e) Tax associated with items (b), (c), and (d), respectively.














Balance Sheet Information

Preliminary

December 31,

December 31,

June 30,

2011

2010

2011

Billed accounts receivable, net

$ 304,741

$ 311,377

$ 341,279

Unbilled accounts receivable, net

340,969

285,977

308,364

Deferred revenue

(373,952)

(285,576)

(332,662)

Net receivables

$ 271,758

$ 311,778

$ 316,981

Cash and marketable securities

$ 153,102

$ 87,552

$ 89,056

Working capital

$ 324,748

$ 217,170

$ 317,298

Total assets

$ 1,469,864

$ 1,356,032

$ 1,429,483

Short-term borrowings

$ 5,278

$ 110,019

$ 5,867

Long-term debt

$ 237,485

$ 172,230

$ 240,102

Stockholders’ equity

$ 550,642

$ 516,714

$ 566,004












PAREXEL International Corporation

Consolidated Condensed Statement of Operations

Unaudited

Six Months Ended

Six Months Ended

(in thousands, except per share data)

December 31, 2011

December 31, 2010

As Reported

Adjustments

Non-GAAP

As Reported

Adjustments

Non-GAAP

Service revenue

$ 647,905

$ -

$ 647,905

$ 600,179

$ -

$ 600,179

Reimbursement revenue

100,555

-

100,555

106,128

-

106,128

Total revenue

748,460

-

748,460

706,307

-

706,307

Costs and expenses:

Direct costs

450,273

-

450,273

389,133

(a)

-

389,133

Reimbursable out-of-pocket expenses

100,555

-

100,555

106,128

-

106,128

Selling, general and administrative

125,347

-

125,347

122,040

(a)

-

122,040

Depreciation

29,033

-

29,033

26,856

-

26,856

Amortization

4,344

-

4,344

4,908

-

4,908

Restructuring charge (benefit)

3,862

(3,862)

(b)

-

(962)

962

(c)

-

Total costs and expenses

713,414

(3,862)

709,552

648,103

962

649,065

Income from operations

35,046

3,862

38,908

58,204

(962)

57,242

Other expense

(2,170)

-

(2,170)

(15,788)

1,166

(d)

(14,622)

Income before income taxes

32,876

3,862

36,738

42,416

204

42,620

Provision for income taxes

10,375

766

(e)

11,141

7,793

89

(e)

7,882

Effective tax rate

31.6%

30.3%

18.4%

18.5%

Net income

$ 22,501

$ 3,096

$ 25,597

$ 34,623

$ 115

$ 34,738

Earnings per common share:

Basic

$ 0.38

$ 0.43

$ 0.59

$ 0.59

Diluted

$ 0.37

$ 0.43

$ 0.58

$ 0.58

Shares used in computing earnings per common share:

Basic

59,154

59,154

58,483

58,483

Diluted

60,164

60,164

59,673

59,673

(a) Prior year numbers have been reclassified to conform with the current year presentation.

(b) Restructuring charges include $2.5 million in severance costs (net of a $1.0 million reduction in the FY10 Plan) and $1.4 million of facility-related costs.

(c) Restructuring adjustments include $0.8 million in severance reductions and $0.2 million in reductions of facility-related costs.

(d) Impairment charge on an asset.

(e) Tax associated with items (b), (c), and (d), respectively.




PAREXEL International Corporation

Segment Information

Unaudited

Three Months Ended

Three Months Ended

(in thousands)

December 31, 2011

December 31, 2010 (a)

Clinical Research Services (CRS)

Service revenue

$ 247,871

$ 231,364

% of total service revenue

74.4%

76.0%

Gross profit

$ 70,030

$ 73,842

Gross margin % of service revenue

28.3%

31.9%

PAREXEL Consulting & Medical Communications

Services (PCMS)

Service revenue

$ 38,455

$ 32,013

% of total service revenue

11.5%

10.5%

Gross profit

$ 15,871

$ 12,864

Gross margin % of service revenue

41.3%

40.2%

Perceptive Informatics (PI)

Service revenue

$ 46,844

$ 40,982

% of total service revenue

14.1%

13.5%

Gross profit

$ 19,170

$ 18,164

Gross margin % of service revenue

40.9%

44.3%

Total service revenue

$ 333,170

$ 304,359

Total gross profit

$ 105,071

$ 104,870

Gross margin % of service revenue

31.5%

34.5%

Revenue by Geography (b)

The Americas

$ 138,215

$ 127,194

Europe, Middle East & Africa

144,832

136,201

Asia/Pacific

50,123

40,964

Total service revenue

$ 333,170

$ 304,359

Quarterly Supplemental Financial Data

Service revenue

$ 333,170

$ 304,359

Reimbursement revenue

54,641

59,691

Investigator fees

54,609

50,003

Gross revenue

$ 442,420

$ 414,053

Days sales outstanding

57

69

Capital expenditures

$ 15,893

$ 16,023

(a) Prior year numbers have been reclassified to conform with the current year presentation.

(b) See footnote (b) on six months ended December 31st Segment Information table.




PAREXEL International Corporation

Segment Information

Unaudited

Six Months Ended

Six Months Ended

(in thousands)

December 31, 2011

December 31, 2010 (a)

Clinical Research Services (CRS)

Service revenue

$ 483,280

$ 463,003

% of total service revenue

74.6%

77.1%

Gross profit

$ 132,689

$ 154,498

Gross margin % of service revenue

27.5%

33.4%

PAREXEL Consulting & Medical Communications

Services (PCMS)

Service revenue

$ 74,103

$ 60,348

% of total service revenue

11.4%

10.1%

Gross profit

$ 30,541

$ 23,977

Gross margin % of service revenue

41.2%

39.7%

Perceptive Informatics (PI)

Service revenue

$ 90,522

$ 76,828

% of total service revenue

14.0%

12.8%

Gross profit

$ 34,402

$ 32,571

Gross margin % of service revenue

38.0%

42.4%

Total service revenue

$ 647,905

$ 600,179

Total gross profit

$ 197,632

$ 211,046

Gross margin % of service revenue

30.5%

35.2%

Revenue by Geography (b)

The Americas

$ 278,255

$ 260,085

Europe, Middle East & Africa

267,991

261,730

Asia/Pacific

101,659

78,364

Total service revenue

$ 647,905

$ 600,179

(a) Prior year numbers have been reclassified to conform with the current year presentation.

(b) As reflected in the six month totals, the regional breakout of revenue for Q1 FY12 has been adjusted: The Americas revenue was $140,040; EMEA revenue was $123,159; and Asia/Pacific revenue was $51,536.

 

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
Share/Bookmark
 
 
 

Spherix Announces Successful Completion of Important Toxicology Study of SPX-106

Wednesday, January 11th, 2012

http://pennyomega.com/img/siajan11.png

 

http://pennyomega.com/img/spex.jpg

Readies IND Filing

BETHESDA, MD, Jan 11, 2012 (CRWENEWSWIRE) — Spherix Incorporated (NASDAQ:SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today reported the successful completion of its 28-day rat toxicology study of its drug candidate, SPX-106. Results demonstrated an ample margin of safety with the dosing planned for the first-in-human study. The toxicology report will be included in the Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA), which is expected to be submitted in the second quarter of 2012.

The study also established that SPX-106 does not accumulate and is rapidly excreted after multiple days of dosing. This study, in conjunction with earlier efficacy studies, continues to support SPX-106 as a component of a combination therapy for dyslipidemia. Earlier tests have shown reduced dyslipidemia in apolipoprotein E-deficient mice and Syrian Golden hamsters, as well as in LDL receptor-deficient mice. SPX-106T, which is SPX-106 combined with D-tagatose, is thought to treat dyslipidemia by simultaneously blocking carbohydrate conversion to lipids and promoting lipid catabolism (lipid breakdown). This latest study paves the way for the SPX-106T human clinical trial in 2012.

“I am pleased to report the successful achievement of a critical milestone, our first toxicology study of SPX-106. These results advance our current development plan and support our belief that there are significant opportunities for our Company in the development of SPX-106T for the dyslipidemia market,” reported Dr. Claire Kruger, CEO of Spherix.

About Spherix

Spherix Incorporated was launched in 1967 as a scientific research company under the name Biospherics Research. The Company now leverages its scientific and technical expertise and experience through its two subsidiaries – Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis. Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke. Spherix’s Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides. For more information, please visit www.spherix.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Source: Spherix Incorporated

 

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
Share/Bookmark
 
 
 

Spherix Announces Results from New Preclinical Studies Showing SPX-106T Produces Significant Reductions in Cholesterol, Fat Deposition and Body Weight

Tuesday, October 25th, 2011

http://crweselect.com/img/siaoct25.png

http://crweselect.com/img/spex.jpg

Results to Be Presented Wednesday, October 26, at AAPS National Meeting in Washington, DC

 

BETHESDA, MD, Oct. 24, 2011 (CRWENEWSWIRE) — Spherix Incorporated (NASDAQ:SPEX) — an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies — today announced that SPX-106T (the combination of D-tagatose and SPX-106) reduced dyslipidemia in new studies of apolipoprotein E-deficient mice and Syrian Golden hamsters. This finding corroborates data obtained in LDL receptor-deficient mice (see Spherix press release of September 8, 2011). Additionally, a new study in rats demonstrates that D-tagatose inhibits fructose absorption in the gastrointestinal tract, providing further insight into the mechanism of action of SPX-106T.

“Successful results in additional animal models increases our confidence going into human clinical trials with SPX-106T next spring,” noted Dr. Claire Kruger, CEO of Spherix.

In a poster at the American Association of Pharmaceutical Scientists (AAPS) National Meeting, Spherix summarizes results obtained with SPX-106T in two strains of genetically engineered mice prone to dyslipidemia. SPX-106T significantly reduced VLDL and LDL cholesterol in LDL receptor-deficient mice fed normal chow. In apolipoprotein E-deficient mice fed a Western (high fat/high carbohydrate) diet, SPX-106T significantly reduced serum cholesterol by 30% (-307 mg/dl; p<0.05), prevented body weight gain (p<0.05), and significantly reduced the amount of subcutaneous, retroperitoneal, and epididymal fat (77, 90, 85% reductions, respectively, p<0.01) (see photo). SPX-106T did not affect the weight of other organs (heart, spleen, etc.). A recent range-finding dose study in hamsters fed the same Western diet and given SPX-106T provided evidence that the combination was effective in reducing serum triglycerides.

“An important new element in our work with SPX-106T is that we are now performing studies designed specifically to test therapy in diet-induced lipidemia, using dosing and timing information derived from the studies completed a few months ago in LDL receptor-deficient mice,” said Dr. Robert Lodder, President of Spherix.

The poster is authored by Dr. Kruger; Dr. Lodder; Dr. Dietrich Conze, Science Consultant; and Dr. A. Wallace Hayes, Principal Advisor. It will be presented at the AAPS National Meeting from 8 a.m. to 12 noon local time on Wednesday, October 26, 2011. The Meeting is being held at the Walter E. Washington Convention Center in Washington, D.C. from October 23 through 27.

Spherix also demonstrates that D-tagatose blocks absorption of fructose through the gut. D-tagatose administered to Sprague-Dawley rats in ascending doses was given in combination with 14C-fructose and blood levels of 14C-fructose were quantified over 60 minutes. Results showed that D-tagatose significantly decreased the amount of plasma 14C-fructose up to 30% (p<0.05). The resulting decrease in systemically absorbed fructose is a mechanism by which D-tagatose can effectively reduce diet-induced dyslipidemia.

Together, the results from these new studies provide compelling evidence to support the use of SPX-106T as a therapy for dyslipidemia. Mechanistically, D-tagatose is a “sugar blocker” inhibiting carbohydrate-induced lipid synthesis. SPX-106 is a naturally synthesized peroxisome proliferator-activated receptor (PPAR) agonist. PPARs are nuclear receptors that bind DNA when activated and regulate the expression of genes involved in lipid catabolism and the uptake of oxidized LDLs. Thus, combining the mechanisms of action of D-tagatose and SPX-106, SPX-106T is thought to synergistically treat dyslipidemia by simultaneously blocking carbohydrate conversion to lipids and promoting lipid catabolism (lipid breakdown).

About Spherix
Spherix Incorporated
was launched in 1967 as a scientific research company under the name Biospherics Research. The Company now leverages its scientific and technical expertise and experience through its two subsidiaries — Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is dedicated to developing and licensing/marketing proprietary therapeutic products for treatment of diabetes, metabolic syndrome and atherosclerosis. Biospherics is actively seeking a pharmaceutical partner to continue the development of its Phase 3 compound for the treatment of diabetes, D-tagatose, while exploring new drugs and combinations for treatment of high triglycerides, a risk factor for atherosclerosis, myocardial infarction, and stroke. Spherix’s Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products and industrial chemicals and pesticides. For more information, please visit www.spherix.com.

Forward-Looking Statements
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

 

 

 

********************************************************************

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
Share/Bookmark
 
 
 
  • Site Translator:
Exclusive Videos



Hot stocks to watch!

iShares Russell 2000 Index Fund - IWM

Seagate Technology Plc - STX

Las Vegas Sands Corp - LVS

Cleantech Transit, Inc. - CLNO.OB

ProShares UltraShort 20+ Year - TBT

Crown Equity Holdings Inc. - CRWE.OB

VALE S A - VALE

RF Micro Devices - RFMD

ProShares Ultra S&P500 ETF - SSO

Mylan Laboratories Inc - MYL

AT&T Inc - T

Weatherford Internation Lt - WFT

Home Depot - HD

Ford Motor Co - F

Select Sector SPDR: Industrial Sector Fund - XLI

Altera Corp - ALTR

Sterling Financial Corp Wa - STSA

JPMorgan Chase & Co - JPM

Sprint Nextel Corp - S

iShares Down Jones U.S. Real Estate Index - IYR

Yahoo Inc - YHOO

NVIDIA Corp - NVDA

 
 
Live With Dr.StockPick
Coming Soon
 
 

 

Follow Dr Stock Pick at
PennyOmega.com Vision

Every success must begin with a vision. If you can see it, you can achieve it.