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Cephalon Announces Strong Third Quarter Financial Results
Date:11/8/2007

Company Also Announces Agreement in Principle with U.S. Attorney's Office;

Earnings Exceed Company Guidance; Company Again Increases 2007 Earnings Guidance and Introduces 2008 Guidance

FRAZER, Pa., Nov. 8 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today reported third quarter 2007 sales of $428.7 million, compared to adjusted sales of $457.2 million for the third quarter of 2006 and within the company's previously issued guidance. Basic loss per common share for the third quarter of 2007 was $4.58. Excluding the settlement reserve increase, amortization expense and certain other items, basic adjusted income per common share during the quarter was $1.08, which compares to $1.71 for the third quarter of 2006 and exceeds the high end of the company's guidance range of $0.85 to $0.95.

During the third quarter, central nervous system (CNS) franchise sales increased 9 percent to $230.9 million and the pain franchise reported strong sales of $121.8 million, a decrease of only 33 percent despite generic competition to ACTIQ(R). Sales of other products were $76.0 million, an increase of 20 percent over the same period last year.

The company also announced that it has reached an agreement in principle with the U.S. Attorney's Office in Philadelphia and the U.S. Department of Justice with respect to the previously disclosed investigation of the company's sales and marketing practices. The company expects to pay $425 million as part of a comprehensive settlement of Federal and related state Medicaid claims. The company has increased its existing financial reserves for this matter accordingly. In addition, the company will agree to a single misdemeanor violation of the U.S. Food, Drug, and Cosmetic Act and will enter into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The terms of the settlement are subject to the final negotiation and execution ortain

investments.

(6) To reflect the tax effect of pre-tax adjustments at the applicable tax

rates and certain other tax adjustments primarily related to changes

in valuation allowances and other changes in tax assets and

liabilities.

(7) To exclude the DoD Tricare program reversal as a result of the U.S.

Court of Appeals September 2006 ruling.

(8) To exclude charges associated with the settlement of the PROVIGIL

patent litigation ($6.0 million) and employee severance costs

associated with the European integration and restructuring ($4.0

million).

(9) To exclude charges related to the impairment of an intangible asset.

(10) To exclude the write-off of deferred debt issuance costs related to

the Zero Coupon convertible subordinated notes.

(11) Amounts shown no longer exclude the impact of SFAS 123(R). The

earnings press release issued on November 2, 2006 reflected

adjustments of $11.6 million in each of Research and development and

Selling, general and administrative expenses and $8.8 million in

Income tax expense related to SFAS 123(R).

CEPHALON, INC. AND SUBSIDIARIES

"ADJUSTED" CONSOLIDATED SALES DETAIL *

(In thousands)

(Unaudited)

Three Months Ended

September 30,

2007

United

States Europe Total

Sales:

PROVIGIL $202,202 $14,904 $217,106

GABITRIL 12,952 881 13,833

CNS 215,154 15,785 230,939

ACTIQ 45,946 10,007 55,953

Generic OTFC 32,689 - 32,689

FENTORA 33,193 - 33,193

Pain 111,828 10,007 121,835

Other 19,291 56,664 75,955

$346,273 $82,456 $428,729

2006

United

States Europe Total

Sales:

PROVIGIL $186,568 $11,081 $197,649

GABITRIL 13,729 723 14,452

CNS 200,297 11,804 212,101

ACTIQ 174,147 7,585 181,732

Generic OTFC - - -

FENTORA - - -

Pain 174,147 7,585 181,732

Other 13,292 50,115 63,407

$387,736 $69,504 $457,240

%

Increase

(Decrease)

United

States Europe Total

Sales:

PROVIGIL 8% 35% 10%

GABITRIL (6%) 22% (4%)

CNS 7% 34% 9%

ACTIQ (74%) 32% (69%)

Generic OTFC 100% 0% 100%

FENTORA 100% 0% 100%

Pain (36%) 32% (33%)

Other 45% 13% 20%

(11%) 19% (6%)

Nine Months Ended

September 30,

2007

United

States Europe Total

Sales:

PROVIGIL $593,394 $39,171 $632,565

GABITRIL 39,814 6,268 46,082

CNS 633,208 45,439 678,647

ACTIQ 157,097 28,638 185,735

Generic OTFC 97,562 - 97,562

FENTORA 101,224 - 101,224

Pain 355,883 28,638 384,521

Other 53,867 170,767 224,634

$1,042,958 $244,844 $1,287,802

2006

United

States Europe Total

Sales:

PROVIGIL $494,047 $29,219 $523,266

GABITRIL 41,291 3,510 44,801

CNS 535,338 32,729 568,067

ACTIQ 452,175 19,213 471,388

Generic OTFC - - -

FENTORA - - -

Pain 452,175 19,213 471,388

Other 41,661 152,436 194,097

$1,029,174 $204,378 $1,233,552

%

Increase

(Decrease)

United

States Europe Total

Sales:

PROVIGIL 20% 34% 21%

GABITRIL (4%) 79% 3%

CNS 18% 39% 19%

ACTIQ (65%) 49% (61%)

Generic OTFC 100% 0% 100%

FENTORA 100% 0% 100%

Pain (21%) 49% (18%)

Other 29% 12% 16%

1% 20% 4%

* For both the three and nine months ended September 30, 2006, amounts

exclude the impact of the DoD Tricare program reversal of $13.3 million

which reduced GAAP U.S. sales of PROVIGIL, GABITRIL and ACTIQ by $6.9

million, $0.9 million and $5.5 million, respectively.

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

(Unaudited)

September 30, December 31,

2007 2006

CURRENT ASSETS:

Cash and cash equivalents $661,982 $496,512

Investments 69,101 25,212

Receivables, net 302,748 270,045

Inventory, net 93,399 85,239

Deferred tax assets, net 204,140 184,518

Other current assets 34,626 47,278

Total current assets 1,365,996 1,108,804

PROPERTY AND EQUIPMENT, net 481,508 453,010

GOODWILL 476,605 467,167

INTANGIBLE ASSETS, net 839,255 793,037

DEFERRED TAX ASSETS, net 103,284 118,192

OTHER ASSETS 132,056 105,287

$3,398,704 $3,045,497

CURRENT LIABILITIES:

Current portion of long-term debt $1,237,285 $1,023,312

Accounts payable 74,528 90,586

Accrued expenses 685,864 263,478

Total current liabilities 1,997,677 1,377,376

LONG-TERM DEBT 4,373 224,992

DEFERRED TAX LIABILITIES, net 66,864 72,491

OTHER LIABILITIES 103,982 61,178

Total liabilities 2,172,896 1,736,037

STOCKHOLDERS' EQUITY:

Common stock, $0.01 par value 693 678

Additional paid-in capital 1,899,761 1,780,749

Treasury stock, at cost (151,196) (151,068)

Accumulated deficit (668,310) (425,256)

Accumulated other comprehensive income 144,860 104,357

Total stockholders' equity 1,225,808 1,309,460

$3,398,704 $3,045,497

Certain reclassifications of prior year amounts have been made to conform to the current year presentation. The NUVIGIL(R) (armodafinil) [C-IV] inventory balance of $89.1 million as of December 31, 2006 has been reclassified from inventory to other assets, as we do not presently intend to launch NUVIGIL commercially until around 2010.

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

Nine Months Ended

September 30,

2007 2006

CASH FLOWS FROM OPERATING ACTIVITIES:

Net income (loss) $(235,886) $149,725

Adjustments to reconcile net income

(loss) to net cash provided by operating

activities:

Deferred income tax expense 8,750 64,112

Shortfall tax benefits from stock-based

compensation (222) -

Depreciation and amortization 101,206 94,828

Amortization of debt issuance costs 180 387

Write-off of debt issuance costs

associated with convertible subordinated

notes - 13,105

Stock-based compensation expense 34,940 32,436

Gain on extinguishment of debt (5,319) -

Gain on sale of investment (5,791) -

Loss on disposals of property and

equipment 2,873 2,368

Impairment charge - 12,417

Changes in operating assets and

liabilities:

Receivables (26,218) (30,818)

Inventory (1,881) 15,761

Other assets (28,552) (43,731)

Accounts payable and

accrued expenses 380,776 (45,820)

Other liabilities 49,465 (13,580)

Net cash provided by

operating activities 274,321 251,190

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchases of property and

equipment (70,887) (97,122)

Acquisition of intangible assets (99,152) (115,000)

Proceeds from sale of investment 12,291 -

Sales and (purchases) of

available-for-sale investments, net (43,186) 242,660

Net cash provided by (used for)

investing activities (200,934) 30,538

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from exercises of

common stock options 74,375 112,794

Windfall tax benefits from

stock-based compensation 9,934 21,912

Acquisition of treasury stock (128) (433)

Payments on and retirements of long-term

debt (2,902) (2,528)

Net cash provided by financing activities 81,279 131,745

EFFECT OF EXCHANGE RATE CHANGES ON

CASH AND CASH EQUIVALENTS 10,804 11,830

NET INCREASE IN CASH AND CASH EQUIVALENTS 165,470 425,303

CASH AND CASH EQUIVALENTS, BEGINNING

OF PERIOD 496,512 205,060

CASH AND CASH EQUIVALENTS, END OF PERIOD $661,982 $630,363

CEPHALON, INC. AND SUBSIDIARIES

Reconciliation of Projected GAAP Basic Income (Loss) per Common Share

to Basic Adjusted Income Per Common Share Guidance

(Unaudited)

Twelve Months Twelve Months

Ended Ended

December 31, 2007 December 31, 2008

Projected GAAP basic income (loss) per

common share $(3.08)-- $(2.98) $4.13 -- $4.23

Amortization of current intangibles $1.35 -- $1.35 $1.52 -- $1.52

Research and development adjustments $0.62 -- $0.62 $- -- $-

Settlement reserve $6.38 -- $6.38 $- -- $-

Gain on extinguishment of debt $(0.08)-- $(0.08) $- -- $-

Gain on sale of investment $(0.09)-- $(0.09) $- -- $-

Tax effect of pre-tax adjustments at

the applicable tax rates * $(0.65)-- $(0.65) $(0.55)--$(0.55)

Basic adjusted income per common share

guidance $4.45 -- $4.55 $5.10 -- $5.20

* For the twelve months ended December 31, 2007, we have not yet recognized a tax benefit for the settlement reserve due to the uncertainty associated with the tax treatment of any potential settlement.

The company's 2007 guidance is being issued based on certain assumptions including:

-- Adjusted effective tax rate of approximately 36 to 37 percent; and

-- Weighted average number of common shares outstanding of 66.6 million

shares for the twelve months ended December 31, 2007.

The company's 2008 guidance is being issued based on certain assumptions including:

-- Entrance into the market of an additional generic version of ACTIQ by

mid-2008;

-- Approval of TREANDA and mid-2008 launch;

-- Reduction of interest income by $20 million resulting from payment of

the settlement with the U.S. Attorney's Office;

-- Adjusted effective tax rate of approximately 36 to 37 percent; and

-- Weighted average number of common shares outstanding of 67.5 million

shares for the twelve months ended December 31, 2008.

f definitive agreements. The previously disclosed investigation by the Connecticut Attorney General is ongoing.

"We are pleased with the strong financial performance we delivered in the third quarter of 2007," said Frank Baldino, Jr., Ph.D., Chairman and CEO. "We also are launching this month our latest product, AMRIX(TM), a once daily extended release muscle relaxant, and are excited about the continued development of our oncology business with TREANDA(R)."

Dr. Baldino continued, "We look forward to finalizing our settlement with the U.S. Attorney's Office. We have always taken seriously our responsibility to conduct our business in accordance with both the letter and spirit of the law. Over the past few years, we have devoted substantial resources to continually enhancing our compliance program and have built a strong foundation for our ongoing compliance efforts."

Based on the strong third quarter financial results announced today, the company is reiterating its guidance for 2007 total sales of $1.675 - $1.725

billion, and increasing its basic adjusted income per common share guidance from $4.40 - $4.50 per share to $4.45 - $4.55 per share.

Basic adjusted income per common share guidance for the full-year 2007 and 2008 is reconciled below and is subject to the assumptions set forth therein.

Cephalon is introducing 2008 sales guidance of $1.80 - $1.85 billion. This includes CNS franchise sales of $975 - $1,000 million, pain franchise sales of $500 - $525 million, which will include sales of AMRIX(TM) (cyclobenzaprine hydrochloride extended-release capsules), oncology franchise sales of $110 - $120 million, and other product sales of $190 - $205 million. SG&A and R&D guidance for 2008 are $710 - $730 million and $340 - $360 million, respectively.

The company also is introducing adjusted net income guidance for 2008 of $344 - $351 million and 2008 basic adjusted income per common share guidance of $5.10 - $5.20.

Cephalon's management will discuss the company's third quarter 2007 performance in a conference call with investors beginning at 5:00 p.m. U.S. EST on Thursday, November 8, 2007. To participate in the conference call, dial +1-913-981-5543 and refer to conference code number 6083046. Investors can listen to the call live by logging on to the company's website at http://www.cephalon.com and clicking on "Investor Information" then "Webcast." The conference call will be archived and available to investors for one week after the call.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon has delivered a seven-year compound annual growth rate (CAGR) through 2006 greater than 75% and 2006 revenue of $1.760 billion. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.

The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide), AMRIX, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval, including with respect to TREANDA; manufacturing development and capabilities; market prospects for its products, including with respect to AMRIX; sales, adjusted net income and basic adjusted income per common share guidance for 2007 and 2008; and other statements regarding matters that are not historical facts, including the Company's position and expected performance in 2007 and 2008, the final resolution or outcome of the ongoing investigations by the U.S. Attorney's Office and the Office of the Connecticut Attorney General and the final amount of any settlement and/or fines related thereto, and the relative strength of the foundation for the Company's ongoing compliance efforts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.

This press release and/or the financial results attached to this press release include "Adjusted Net Income," "Basic Adjusted Income per Common Share," "Basic Adjusted Income per Common Share Guidance," and "Diluted Adjusted Income Per Common Share," amounts that are considered "non-GAAP financial measures" under SEC rules. As required, we have provided reconciliations of these measures. Additional required information is located in the Form 8-K furnished to the SEC in connection with this press release.

CEPHALON, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

Three Months Ended Nine Months Ended

September 30, September 30,

2007 2006 2007 2006

REVENUES:

Sales $428,729 $470,513 $1,287,802 $1,246,825

Other revenues 9,692 11,820 34,865 32,562

438,421 482,333 1,322,667 1,279,387

COSTS AND EXPENSES:

Cost of sales 82,258 83,160 251,970 250,613

Research and development 93,527 86,439 274,078 294,899

Selling, general and

administrative 186,456 161,108 527,962 470,158

Settlement reserve 369,000 - 425,000 -

Impairment charge - - - 12,417

731,241 330,707 1,479,010 1,028,087

INCOME (LOSS) FROM OPERATIONS (292,820) 151,626 (156,343) 251,300

OTHER INCOME (EXPENSE):

Interest income 8,868 7,046 23,485 16,736

Interest expense (5,660) (4,749) (15,272) (13,523)

Write-off of deferred debt

issuance costs - - - (13,105)

Gain on extinguishment of

debt 5,319 - 5,319 -

Gain on sale of investment - - 5,791 -

Other income (expense), net 2,493 895 3,747 (116)

11,020 3,192 23,070 (10,008)

INCOME (LOSS) BEFORE INCOME

TAXES (281,800) 154,818 (133,273) 241,292

INCOME TAX EXPENSE 24,963 59,077 102,613 91,567

NET INCOME (LOSS) $(306,763) $95,741 $(235,886) $149,725

BASIC INCOME (LOSS) PER

COMMON SHARE $(4.58) $1.58 $(3.55) $2.48

DILUTED INCOME (LOSS) PER

COMMON SHARE $(4.58) $1.43 $(3.55) $2.17

WEIGHTED AVERAGE NUMBER OF

COMMON SHARES OUTSTANDING 66,931 60,762 66,398 60,415

WEIGHTED AVERAGE NUMBER OF

COMMON SHARES OUTSTANDING-

ASSUMING DILUTION 66,931 67,072 66,398 68,921

Certain reclassifications of prior year amounts have been made to conform to the current year presentation. Amounts reported in prior periods as amortization are included now as a component of cost of sales; amounts previously reported as depreciation (other than depreciation related to facilities used in the production of commercial inventory and previously included in cost of sales) are included as a component of research and development or selling, general and administrative, as appropriate.

CEPHALON, INC. AND SUBSIDIARIES

Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

(Unaudited)

Three Months Ended

September 30,

2007 2006

GAAP NET INCOME (LOSS) $(306,763) $95,741

Sales adjustments - (13,273)(6)

Cost of sales adjustments 22,255 (1) 20,804 (1)

Research and development adjustments 15,000 (2) - (8)

Selling, general and administrative

adjustments - 2,000 (7) (8)

Settlement reserve 369,000 (3) -

Gain on extinguishment of debt (5,319)(4) -

Income taxes (21,693)(5) (1,278)(5) (8)

379,243 8,253

ADJUSTED NET INCOME $72,480 $103,994

BASIC ADJUSTED INCOME PER COMMON SHARE $1.08 $1.71

DILUTED ADJUSTED INCOME PER COMMON SHARE $0.92 $1.55

WEIGHTED AVERAGE NUMBER OF COMMON

SHARES OUTSTANDING 66,931 60,762

WEIGHTED AVERAGE NUMBER OF COMMON

SHARES OUTSTANDING-ASSUMING DILUTION 79,030 67,072 Notes to Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

(1) To exclude the on-going amortization of acquired intangible assets.

(2) To exclude the recognition of a milestone related to the FDA's

acceptance of our NDA filing for TREANDA(R) (bendamustine HCl).

(3) To exclude the additional reserve established for the agreement in

principle reached with the U.S. Attorney's Office in Philadelphia.

(4) To exclude the forgiveness of a mortgage loan by the Pennsylvania

Industrial Development Board ("PIDA").

(5) To reflect the tax effect of pre-tax adjustments at the applicable

tax rates and certain other tax adjustments primarily related to

changes in valuation allowances and other changes in tax assets and

liabilities.

(6) To exclude the U.S. Department of Defense ("DoD") Tricare program

reversal as a result of the U.S. Court of Appeals September 2006

ruling.

(7) To exclude charges associated with the settlement of the PROVIGIL

patent litigation.

(8) Amounts shown no longer exclude the impact of Financial Accounting

Standards Board Statement No. 123(R) "Share Based Payment" ("SFAS

123(R)"). The earnings press release issued on November 2, 2006

reflected adjustments of $3.4 million in each of Research and

development and Selling, general and administrative expenses and $2.8

million in Income tax expense related to SFAS 123(R).

CEPHALON, INC. AND SUBSIDIARIES

Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

(Unaudited)

Nine Months Ended

September 30,

2007 2006

GAAP NET INCOME (LOSS) $(235,886) $149,725

Sales adjustments - (13,273)(7)

Cost of sales adjustments 64,236 (1) 69,375 (1)

Research and development adjustments 41,500 (2) 45,000 (2) (11)

Selling, general and administrative

adjustments - 9,987 (8) (11)

Settlement reserve 425,000 (3) -

Impairment charge - 12,417 (9)

Write-off of deferred debt issuance

costs - 13,105 (10)

Gain on extinguishment of debt (5,319)(4) -

Gain on sale of investment (5,791)(5) -

Income taxes (40,459)(6) (44,060)(6) (11)

479,167 92,551

ADJUSTED NET INCOME $243,281 $242,276

BASIC ADJUSTED INCOME PER COMMON

SHARE $3.66 $4.01

DILUTED ADJUSTED INCOME PER COMMON

SHARE $3.09 $3.52

WEIGHTED AVERAGE NUMBER OF COMMON

SHARES OUTSTANDING 66,398 60,415

WEIGHTED AVERAGE NUMBER OF COMMON

SHARES OUTSTANDING-ASSUMING DILUTION 78,814 68,921 Notes to Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income

(1) In 2007, to exclude the on-going amortization of acquired intangible

assets. In 2006, to exclude the reserve for SPARLON capitalized

inventory costs ($8.6 million) and the on-going amortization of

acquired intangible assets ($60.8 million).

(2) In 2007, to exclude charges related to payments for several research

and development collaborations ($26.5 million) and the recognition of

a milestone related to the FDA's acceptance of our NDA filing for

TREANDA ($15.0 million). In 2006, to exclude charges related to

payments for several research and development collaborations.

(3) To exclude the reserve established for the agreement in principle

reached with the U.S. Attorney's Office in Philadelphia.

(4) To exclude the forgiveness of a mortgage loan by the PIDA.

(5) To exclude the pre-tax gain related to the sale of ce
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SOURCE Cephalon, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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