Home » Archive by Category

News

San Diego biotech news from BioSpace, Xconomy, PR Newswire, Marketwired and other sources, click on headlines to read the full story.

Tandem Diabetes Care To Present At Healthcare Conference

November 7, 2014 – 5:00 am | Edit Post

SAN DIEGO, Nov. 6, 2014 (GLOBE NEWSWIRE) — Tandem Diabetes Care, Inc. (Nasdaq:TNDM), a medical device company and manufacturer of the t:slim Insulin Pump, today announced that Kim Blickenstaff, president and CEO, will present a company update at the Stifel Healthcare Conference in New York, NY. The…

Volcano Corporation Reports Third Quarter Results

November 7, 2014 – 5:00 am | Edit Post

SAN DIEGO, Nov. 6, 2014 /PRNewswire/ –Volcano Corporation (Nasdaq: VOLC), a leading company focused on improving patient and economic outcomes on a global basis by developing and delivering innovative minimally invasive coronary and peripheral visualization, physiology diagnostics and therapies, today reported…

CareFusion Reports $922 Million in First Quarter Revenue

November 6, 2014 – 3:55 pm | Edit Post

CareFusion Corp., a medical technology company in San Diego, reported $922 million in revenue for its first quarter of fiscal 2015, an 11 percent increase from the same quarter last year, according to financial statements.

Orexigen Therapeutics to Present at the Credit Suisse Healthcare Conference

November 6, 2014 – 2:30 pm | Edit Post

SAN DIEGO, Nov. 6, 2014 /PRNewswire/ — Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will present a company overview at the Credit Suisse Healthcare Conference in Phoenix. The presentation is scheduled for Tuesday, November 11th at 2:00 p.m. Mountain Time. To listen to the live webcast or a replay of the presentation, please visit the Investor Relations section of the Company’s Web site at www.orexigen.com. A replay will be available for 14 days after the event.

Orexigen Contact:

Media Contact: 

McDavid Stilwell

David Walsey

VP, Corporate Communications and Business Development

BrewLife

(858) 875-8629

(858) 617-0772

SOURCE Orexigen Therapeutics, Inc.

Trovagene, Inc. Announces Third Quarter 2014 Financial Results

November 6, 2014 – 2:05 pm | Edit Post

SAN DIEGO, Nov. 6, 2014 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today reported its financial results for the three months and nine months ended September 30, 2014.

“The clinical utility of Trovagene’s precision cancer monitoring technology continues to gain recognition within the medical community, as we begin to commercialize our technology,” said Antonius Schuh, Ph.D., chief executive officer of Trovagene. “Recently published data in the journal, Cancer Discovery, demonstrates that urinary cell-free DNA can outperform tissue biopsy for the detection of the BRAF V600E mutation. As a result, with our technology, physicians now have the ability to non-invasively determine mutational status and monitor response to therapy at the molecular level over time.”

Third Quarter 2014 Financial Results

For the third quarter ended September 30, 2014, Trovagene reported a net loss of $5.4 million, or $0.28 per share, as compared to a net loss of $4.4 million, or $0.25 per share, for the three months ended September 30, 2013. The increase in net loss is primarily due to an increase in operating expenses during the third quarter of 2014, as compared to the prior year comparable period.

Year to Date 2014 Financial Results

For the nine months ended September 30, 2014, Trovagene reported a net loss of $9.7 million, or $0.51 per share, as compared to a net loss of $10.8 million, or $0.66 per share, for the nine months ended September 30, 2013. The decrease in net loss is primarily due to an increase in operating expenses offset by changes in the fair market value of derivative instruments during the first nine months of 2014, as compared to the prior year comparable period.

Cash and Cash Equivalents

Trovagene had cash and cash equivalents of $31.2 million on September 30, 2014, as compared to $25.8 million on December 31, 2013. The Company secured debt financing in the amount of $15 million in June 2014.

Recent Announcements Demonstrate Continued Progress in Development Programs which Support Commercialization Efforts

Study recently published in Cancer Discovery demonstrates that urinary cell-free DNA outperforms tissue biopsy when identifying the BRAF V600E mutation in patients with histiocytic diseases.
Data presented at the Next Generation DX conference highlights the clinical utility of cell-free tumor DNA diagnostics with high sensitivity and quantitative analytical performance using Trovagene’s precision cancer monitoring technology.
Clinical study results presented at the Second Annual International ECD Medical Symposium demonstrates that Trovagene’s BRAF V600E assay improves determination of mutational status and allows monitoring of treatment response in patients with Erdheim-Chester disease (ECD).
Trovagene expanded its relationship with a leading cancer center including a new clinical study evaluating Trovagene’s precision cancer monitoring platform in lung cancer. The study focuses on the detection and quantitative monitoring of EGFR mutations. Reiteration of 2014 Goals and Objectives

Conduct additional clinical studies at major oncology centers and through collaborations with integrated healthcare networks
Present and publish clinical results for studies using Trovagene’s precision cancer monitoring platform as they become available
Expand applications of Trovagene’s precision cancer monitoring platform by completing CLIA development of additional non-invasive assays for the detection and monitoring of multiple clinically actionable oncogene mutations
Enter into additional R&D collaborations with pharmaceutical companies
Expand and enter into new partnerships with strategic diagnostic and life science companiesAbout Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission.

(Financial Information to Follow)

Contact

Investor Relations

Media Relations

David Moskowitz and Amy Caterina

Ian Stone

Investor Relations

Account Director

Trovagene, Inc.

Canale Communications, Inc.

858-952-7593

619-849-5388

ir@trovagene.com

ian@canalecomm.com

 

Trovagene, Inc. and Subsidiaries

Selected Financial Information

Consolidated Condensed Statements of Operations

(in thousands, except for per share amounts)

Three Months Ended September 30,

Nine Months Ended September 30,

2014

2013

2014

2013

(Unaudited)

(Unaudited)

Revenues

$

57

$

44

$

224

$

212

Costs and expenses:

Research and development

1,990

916

4,830

2,662

Selling and marketing

540

331

1,700

1,156

General and administrative

1,467

1,875

4,135

4,236

Total operating expenses

3,997

3,122

10,665

8,053

Loss from operations

(3,940)

(3,078)

(10,441)

(7,842)

Other expense, net

(406)

(6)

(421)

(7)

Change in fair value of derivative instruments – warrants

(1,029)

(1,317)

1,220

(2,933)

Net loss

$

(5,375)

$

(4,401)

$

(9,642)

$

(10,782)

Preferred stock dividend

(6)

(5)

(17)

(21)

Net loss attributable to common stockholders

$

(5,381)

$

(4,406)

$

(9,659)

$

(10,803)

Net loss per common share-basic and diluted

$

(0.28)

$

(0.25)

$

(0.51)

$

(0.66)

Weighted average shares outstanding- basic and diluted

18,903

17,871

18,903

16,330

 

Trovagene, Inc. and Subsidiaries

Consolidated Condensed Balance Sheet Information

(in thousands)

September 30, 2014

December 31, 2013

(unaudited)

Cash and cash equivalents

$

31,164

$

25,837

Other assets

757

568

Property and equipment, net

841

751

Total assets

$

32,762

$

27,156

Current portion of long-term debt

$

753

$

198

Accounts payable and accrued expenses

2,370

1,811

Long-term debt, less current portion

13,979

323

Other long-term liabilities

96

-

Derivative financial instruments

3,211

4,432

Stockholders’ equity

12,353

20,392

Total liabilities and stockholders’ equity

$

32,762

$

27,156

 

Logo - http://photos.prnewswire.com/prnh/20120620/LA28014LOGO
SOURCE Trovagene, Inc.

Volcano Reports Third Quarter Results

November 6, 2014 – 2:05 pm | Edit Post

SAN DIEGO, Nov. 6, 2014 /PRNewswire/ – Volcano Corporation (Nasdaq: VOLC), a leading company focused on improving patient and economic outcomes on a global basis by developing and delivering innovative minimally invasive coronary and peripheral visualization, physiology diagnostics and therapies, today reported results for the third quarter and first nine months of 2014.

For the quarter ended September 30, 2014, Volcano reported revenues of $97.5 million versus revenues of $95.8 million in the same period a year ago. Foreign currency had a negative impact on revenues of approximately $700,000. Medical segment revenues increased approximately two and three percent on a reported and constant currency basis, respectively.

The company reported a net loss on a GAAP basis of $8.0 million, or $0.16 per share, in the third quarter of 2014, versus a net loss of $8.5 million, or $0.15 per share, in the same period a year ago. The results for the third quarter of 2014 included amortization of intangibles of $2.8 million and  restructuring  benefits of $229,000 while the results for the third quarter of 2013 included amortization of intangibles of $834,000 and restructuring charges of $4.6 million. Excluding acquisition-related items, amortization of intangibles and non-cash interest expense on convertible notes, net of tax, the company reported a non-GAAP net loss of $0.04 per share, compared with a non-GAAP net loss per share of $0.08 in the third quarter a year ago.

For the first nine months of 2014, Volcano reported revenues of $294.6 million versus revenues of $290.4 million in the first nine months of 2013. On a constant currency basis, revenues increased three percent year-over-year after adjusting for a negative impact of approximately $3.4 million from foreign currency. Medical segment revenues increased approximately two and three percent on a reported and constant currency basis, respectively, versus the first nine months of 2013.

For the first nine months of 2014, the company reported a net loss on a GAAP basis of $18.6 million, or $0.36 per share, versus a net loss of $14.0 million, or $0.26 per share, in the same period a year ago. The results for the first nine months of 2014 included acquisition-related benefits of $3.8 million, amortization of intangibles of $6.4 million and  restructuring benefits of $197,000. The results for the first nine months of 2013 included acquisition-related charges of $3.7 million, amortization of intangibles of $2.5 million and restructuring charges of $4.9 million. Excluding acquisition-related items, amortization of intangibles and non-cash interest expense on convertible notes, net of tax, the company reported a non-GAAP net loss of $0.14 per share in the first nine months of 2014, compared with a non-GAAP net loss per share of $0.03 in the first nine months of 2013.

“We continued to demonstrate strong growth in Europe, where our FFR (Fractional Flow Reserve) and IVUS (Intravascular Ultrasound) disposable revenues each increased 24 percent year-over-year,” said Scott Huennekens, president and chief executive officer.

“In addition, our peripheral IVUS business in the U.S. increased approximately 60 percent, driven by continued adoption of our peripheral imaging and Pioneer® Re-Entry products. We also initiated the  limited market release of our Phoenix® Atherectomy System used in the treatment of peripheral artery disease, which we believe will advance our overall penetration of the peripheral market. Our growth in these areas helped offset the continued softness of the U.S. coronary IVUS market,” he added.

“At the same time, we are successfully implementing an operating strategy as we execute a more balanced approach between driving revenue growth and improving our bottom line performance. As evidenced by our third quarter results and guidance for the balance of the year, we have made measurable success in reducing operating expenses and will be taking additional steps to achieve improved operating leverage,” Huennekens noted.

Guidance

The company provided updated guidance for the full year 2014. The company expects that based on current foreign currency exchange rates, FX will have a negative impact of approximately $4.0 million on reported revenues through the balance of the year. As a result, the company now expects revenues for 2014 will be in the range of $393.0-$397.0 million. The company expects gross margins will be 63.0-63.5 percent and that operating expenses, including restructuring charges, will be 65.0-66.0 percent of revenues. As a result of continued expense management programs contributing to lower operating expenses as a percentage of revenues, the company now expects a two cent improvement in its loss per share on a GAAP basis, or a loss per share of $0.50-$0.52. On a non-GAAP basis, the company expects a loss of $0.16-$0.18 per share. Non-GAAP results exclude acquisition-related expenses, amortization of intangibles and non-cash interest expense, and assume an effective tax rate of 35.0 percent for the GAAP to non-GAAP adjustments. The company expects weighted average basic shares in 2014 will be approximately 51.6 million.

Conference Call Information

The company will hold a conference call at 2 p.m., Pacific Standard Time, (5 p.m., Eastern Standard Time) today. The teleconference can be accessed by calling (631) 291-4555, passcode 17203481, or via the company’s website at http://www.volcanocorp.com. Please dial in or access the webcast 10-15 minutes prior to the beginning of the call. A replay of the conference call will be available through November ninth, at (404) 537-3406, passcode 17203481, and via the company’s website at http://www.volcanocorp.com.

About Volcano Corporation

Through its multi-modality platform, Volcano Corporation is the global leader in intravascular imaging for coronary and peripheral applications, and physiology. The company also offers a suite of peripheral therapeutic devices. The company’s broad range of technologies makes imaging and therapy simpler, more informative and less invasive and offers physicians and their patients around the world with industry-leading tools that aid diagnosis and guide and provide therapy. Founded in cardiovascular care and expanding into other specialties, Volcano is focused on improving patient and economic outcomes. For more information, visit the company’s website at www.volcanocorp.com.

Notes Regarding the Use of Non-GAAP Financial Measures

The presentation of non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. The company uses non-GAAP financial measures for financial and operational decision making as a measure to compare period-to-period results. The company believes that they provide useful information about operating results, enhance the overall understanding of operating results and future prospects, and allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

Constant Currency Basis Revenues Changes: Volcano reports changes on a constant currency basis, which is a non-GAAP financial measure. Volcano believes that investors’ understanding of the company’s short-term and long-term financial results is enhanced by taking into consideration the impact of foreign currency translation on revenues. In addition, Volcano’s management uses results of operations before currency translation to evaluate the operational performance of Volcano and as a basis for strategic planning.

Volcano reports its expectations of earnings per share performance excluding certain expenses described below; for additional details please see the “Reconciliation of GAAP to non-GAAP EPS Guidance,” table in this press release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.

Exclusion of Acquisition-Related Expenses: Volcano excludes acquisition-related expenses because it does not consider these acquisition-related costs and adjustments to be related to the continuing organic operations of the acquired businesses and are generally not relevant to assessing or estimating the long-term performance of the acquired assets. In addition, the size, complexity and/or volume of past acquisitions, which often drive the magnitude of acquisition-related costs, may not be indicative of the size, complexity and/or volume of future acquisitions.

Exclusion of Amortization of Intangibles: Volcano excludes amortization of intangibles because it is a non-cash expense relating primarily to acquisitions. At the time of an acquisition, the intangible assets of the acquired company, which consist primarily of developed or in-process technology, are valued and amortized over their estimated lives. Volcano believes that since intangible assets represent efforts of the acquired company to build value prior to the acquisition, Volcano management eliminates the impact of the amortization when evaluating its current operating performance.

Exclusion of Non-Cash Interest Expenses: In addition to disclosing the financial statement impact of the authoritative guidance for convertible debt accounting, Volcano management believes that excluding the impact of this authoritative guidance is appropriate because it is non-cash in nature, may provide meaningful supplemental information regarding elements of the company’s borrowing costs in order to properly understand its operational performance and liquidity, and facilitates comparisons to competitors’ results.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding Volcano’s business that are not historical facts may be considered “forward-looking statements,” including statements regarding Volcano’s expected revenues, revenue growth, margins, financial results and foreign currency exchange rates for the fourth quarter and calendar year 2014, its growth, turnaround and other strategies and ability to execute on these strategies, the potential Axsun divestiture, competitive position, target markets, development of its base business and pipeline, product launches, benefits from recent acquisitions and benefits from its products and technologies, including new products. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause Volcano’s actual results to differ materially and adversely from statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include the risks that Volcano’s revenues or other projections may turn out to be inaccurate or Volcano may encounter unanticipated difficulty in achieving these projections; global and regional macroeconomic conditions, generally, and in the medical device and telecom industries, specifically; currency exchange rate fluctuations; the effect of competitive factors and the company’s reactions to those factors; purchasing decisions with respect to the company’s products; the pace and extent of market adoption of the company’s products and technologies; uncertainty in the process of obtaining regulatory approval or clearances for Volcano’s products or devices; the success of Volcano’s growth and other strategies, including the integration of recently-acquired businesses and our ability to integrate businesses from potential future acquisitions; risks associated with Volcano’s international operations; the ability to divest Axsun, if at all, and in a timely or beneficial manner; timing and achievement of product development milestones; outcome of ongoing and future litigation, investigations or claims; the impact and benefits of market development and the related size of Volcano’s addressable markets; our ability to protect our intellectual property; dependence upon third parties; unexpected new data, safety and technical issues; market conditions and other risk inherent to medical and/or telecom device development and commercialization. These and additional risks and uncertainties are fully described in Volcano’s filings made with the Securities and Exchange Commission, including our 10-Q for the quarter ended June 30, 2014, which should be read in conjunction with these financial results. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Volcano disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

 

 

 VOLCANO CORPORATION 

 CONDENSED CONSOLIDATED BALANCE SHEETS 

 (in thousands) 

 (unaudited) 

 September 30, 

 December 31, 

2014

2013

 Assets 

 Current assets: 

 Cash and cash equivalents 

$              31,959

$          107,159

 Short-term available-for-sale investments  

140,894

230,775

 Accounts receivable, net 

78,755

81,962

 Inventories 

76,342

60,970

 Prepaid expenses and other current assets 

34,485

28,525

 Total current assets 

362,435

509,391

 Long-term available-for-sale investments 

44,244

34,750

 Property and equipment, net 

122,077

118,094

 Intangible assets, net 

124,807

58,108

 Goodwill 

150,882

55,087

 Other non-current assets 

60,611

56,489

 Total Assets 

$            865,056

$          831,919

 Liabilities and Stockholders’ Equity 

 Current liabilities: 

 Accounts payable 

$              11,152

$             19,137

 Accrued compensation 

28,168

26,918

 Accrued expenses and other current liabilities 

27,060

28,453

 Deferred revenues 

11,203

10,652

 Current maturities of convertible senior notes 

23,882

-

 Contingent consideration 

365

3,750

 Total current liabilities 

101,830

88,910

 Convertible senior notes 

392,045

401,012

 Deferred revenues 

4,797

5,079

 Contingent consideration, non-current portion 

53,379

29,888

 Other non-current liabilities 

7,727

7,228

 Total liabilities 

559,778

532,117

 Total stockholders’ equity 

305,278

299,802

 Total Liabilities and Stockholders’ Equity 

$            865,056

$          831,919

 

VOLCANO CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

Three Months EndedSeptember 30,

Nine Months EndedSeptember 30,

2014

2013

2014

2013

Revenues

$

97,457

$

95,809

$

294,590

$

290,384

Cost of revenues, excluding amortization of intangibles

37,292

33,458

110,086

102,624

Gross profit

60,165

62,351

184,504

187,760

Operating expenses:

Selling, general and administrative

47,400

45,479

147,064

134,784

Research and development

13,508

16,609

41,165

50,214

Amortization of intangibles

2,804

834

6,405

2,488

Acquisition-related items

1,596

1,253

(3,809)

3,742

Restructuring (benefits) charges

(229)

4,616

(197)

4,874

Total operating expenses

65,079

68,791

190,628

196,102

Operating loss

(4,914)

(6,440)

(6,124)

(8,342)

Interest income

237

327

833

970

Interest expense

(7,370)

(6,756)

(21,868)

(19,908)

Exchange rate gain (loss)

20

54

91

(1,025)

Other, net

56

(33)

180

4,144

Loss before income tax

(11,971)

(12,848)

(26,888)

(24,161)

Income tax benefit

(3,971)

(4,392)

(8,266)

(10,156)

Net loss

$

(8,000)

$

(8,456)

$

(18,622)

$

(14,005)

Net loss per share:

Basic

$

(0.16)

$

(0.15)

$

(0.36)

$

(0.26)

Diluted

$

(0.16)

$

(0.15)

$

(0.36)

$

(0.26)

Shares used in calculating net loss per share:

Basic

51,529

54,652

51,596

54,466

Diluted

51,529

54,652

51,596

54,466

 

VOLCANO CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

Nine Months EndedSeptember 30,

2014

2013

Operating activities

Net loss

$

(18,622)

$

(14,005)

Adjustments to reconcile net loss  to net cash used in operating activities:

Depreciation and amortization

24,022

18,677

Amortization (accretion) of investment premium (discount), net

2,567

2,305

Accretion of debt discount on convertible senior notes and other liabilities

15,048

14,148

Change in contingent consideration

(4,841)

2,537

Non-cash stock compensation expense

10,721

12,098

Asset impairment related to restructuring

818

4,616

Gain on sale of other long-term investment

(365)

(4,153)

Effect of exchange rate changes and others

682

10,797

Deferred income taxes

2,211

-

Changes in operating assets and liabilities, net of acquisitions

(37,851)

(37,979)

Net cash (used in) provided by operating activities

(5,610)

9,041

Investing activities

Purchase of short-term and long-term available-for-sale securities

(161,882)

(342,715)

Sale or maturity of short-term and long-term available-for-sale securities

239,499

247,790

Cash paid related to acquisitions, net of cash acquired

(114,791)

(15,000)

Capital expenditures

(22,854)

(26,533)

Cash paid for intangible assets and other investments

(4,987)

(2,377)

Proceeds from sale of other long-term investments

665

5,654

Net cash used in investing activities

(64,350)

(133,181)

Financing activities

Repayment of capital lease and other liabilities

(179)

(22)

Cash paid for contingent liability related to acquisitions

(16,900)

-

Proceeds from sale of common stock under employee stock purchase plan

3,140

3,576

Proceeds from exercise of common stock options

9,523

2,203

Net cash (used in) provided by financing activities

(4,416)

5,757

Effect of exchange rate changes on cash and cash equivalents

(824)

(846)

Net decrease in cash and cash equivalents

(75,200)

(119,229)

Cash and cash equivalents, beginning of period

107,159

330,635

Cash and cash equivalents, end of period

$

31,959

$

211,406

 

VOLCANO CORPORATION

REVENUE SUMMARY

(in millions)

(unaudited)

Three Months Ended September 30,

PercentageChange 

Currency Impact 

Constant CurrencyPercentageChange

2014

2013

2013 to 2014

Dollar

Percentage

Medical segment:

Consoles:

United States

$   6.7

$   6.3

5%

$      -

-%

5%

Japan

0.2

0.6

(59)

-

(2)

(57)

Europe

1.7

2.5

(29)

-

1

(30)

Rest of world

0.9

1.6

(45)

-

-

(45)

Total Consoles

$   9.5

$11.0

(13)

$      -

-

(13)

IVUS single-procedure disposables:

United States

$22.2

$20.4

9%

$      -

-%

9%

Japan

14.2

18.7

(24)

(0.6)

(3)

(21)

Europe

6.6

5.3

24

0.1

1

23

Rest of world

1.9

1.6

21

-

-

21

Total IVUS single-procedure disposables

$44.9

$46.0

(2)

$(0.5)

(1)

(1)

FFR single-procedure disposables:

United States

$14.6

$14.3

2%

$      -

-%

2%

Japan

5.3

4.3

23

(0.2)

(5)

28

Europe

10.3

8.3

24

0.1

1

23

Rest of world

1.4

1.0

40

-

-

40

Total FFR single-procedure disposables

$31.6

$27.9

13

$(0.1)

-

13

Other

$   9.7

$   8.8

9%

$(0.1)

(1)%

10%

Sub-total medical segment

$95.7

$93.7

2

$(0.7)

(1)

3

Industrial segment

$   1.8

$   2.1

(14)

$      -

-

(14)

Total

$97.5

$95.8

2

$(0.7)

-

2

 

VOLCANO CORPORATION

REVENUE SUMMARY

(in millions)

(unaudited)

Nine Months Ended September 30,

PercentageChange 

Currency Impact 

Constant CurrencyPercentage Change

2014

2013

2013 to 2014

Dollar

Percentage

Medical segment:

Consoles:

United States

$   16.0

$   18.0

(12)%

$      -

-%

(12)%

Japan

1.4

1.7

(18)

(0.1)

(8)

(10)

Europe

7.3

6.7

8

0.3

4

4

Rest of world

3.6

5.1

(29)

-

-

(29)

Total Consoles

$   28.3

$   31.5

(11)

$   0.2

-

(11)

IVUS single-procedure disposables:

United States

$   65.9

$   60.4

9%

$      -

-%

9%

Japan

46.4

60.0

(23)

(3.8)

(7)

(16)

Europe

20.0

17.5

15

0.7

4

11

Rest of world

7.5

6.0

26

-

-

26

Total IVUS single-procedure disposables

$139.8

$143.9

(3)

$(3.1)

(3)

-

FFR single-procedure disposables:

United States

$   43.5

$   43.0

1%

$      -

-%

1%

Japan

15.2

13.2

15

(1.1)

(9)

24

Europe

30.3

24.1

26

1.0

5

21

Rest of world

3.4

3.0

13

-

-

13

Total FFR single-procedure disposables

$   92.4

$   83.3

11

$(0.1)

-

11

Other

$   28.9

$   25.7

12%

$(0.4)

(1)%

13%

Sub-total medical segment

$289.4

$284.4

2

$(3.4)

(1)

3

Industrial segment

$     5.2

$     6.0

(13)

$(0.0)

-

(13)

Total

$ 294.6

$ 290.4

1

$(3.4)

(2)

3

 

VOLCANO CORPORATION

RECONCILIATION OF GAAP RESULTS TO NON-GAAP RESULTS

(in thousands, except per share data)

(Unaudited)

Three Months Ended September 30, 2014

Pre-taxAdjustments

Net of Tax (1)

Earnings(Loss) PerShare

 GAAP net loss  

$           (8,000)

$     (0.16)

 Acquisition related items 

1,596

1,037

0.02

 Amortization of intangibles 

2,804

1,823

0.04

 Non-cash interest expense on convertible notes 

5,099

3,314

0.06

 Non-GAAP net loss 

$          9,499

$           (1,826)

$     (0.04)

 Weighted average shares outstanding—basic 

51,529

Nine Months Ended September 30, 2014

Pre-taxAdjustments

Net of Tax (1)

Earnings(Loss) PerShare

 GAAP net loss 

$        (18,622)

$     (0.36)

 Acquisition related items 

(3,809)

(2,476)

(0.05)

 Amortization of intangibles 

6,405

4,163

0.08

 Non-cash interest expense on convertible notes 

15,033

9,771

0.19

 Non-GAAP net loss 

$       17,629

$           (7,164)

$     (0.14)

 Weighted average shares outstanding—basic 

51,596

(1) Effective tax rate of 35% applied to non-GAAP adjustments

 

VOLCANO CORPORATION

RECONCILIATION OF GAAP TO NON-GAAP GUIDANCE

(in thousands, except per share data)

(Unaudited)

Q4 2014

Guidance Range

From

To

 GAAP net loss per share—basic 

$  (0.15)

$  (0.17)

 Acquisition related items 

0.02

0.02

 Amortization of intangibles 

0.03

0.03

 Non-cash interest expense 

0.07

0.07

 Non-GAAP net loss per share—basic 

$  (0.03)

$  (0.05)

 Weighted average shares outstanding—basic 

51,600

51,600

2014

Guidance Range

From

To

 GAAP net loss per share—basic 

$  (0.50)

$  (0.52)

 Acquisition related items 

(0.03)

(0.03)

 Amortization of intangibles 

0.12

0.12

 Non-cash interest expense 

0.25

0.25

 Non-GAAP net loss per share—basic 

$  (0.16)

$  (0.18)

 Weighted average shares outstanding—basic 

51,600

51,600

Note: Effective tax rate of 35% applied to non-GAAP adjustments

 
SOURCE Volcano Corporation

West Coast Biotech Roundup: Nevro, Coherus, Xenon, Rock Health, Etc.

November 6, 2014 – 11:56 am | Edit Post

The first week of November has brought the first taste of winter to much of the U.S., plenty of sunshine to California, and a flurry of IPOs. There have been three so far on the West Coast, the main…

[[Click headline to continue reading.]]

Before There Will Be Blood

November 6, 2014 – 10:00 am | Edit Post

Researchers at the University of California, San Diego School of Medicine describe the surprising and crucial involvement of a pro-inflammatory signaling protein in the creation of hematopoietic stem cells (HSCs) during embryonic development, a finding that could help scientists to finally reproduce HSCs for therapeutic use.

Wave Academy Makes Strides in Curbing Post-Traumatic Stress in Military Veterans; New Johns Hopkins University-Validated Research Reveals the Measurable Impact of Aquatic Bodywork Therapy as a Promising Intervention

November 6, 2014 – 8:00 am | Edit Post

San Diego Nonprofit Focuses on Stemming the PTS and Suicide Epidemic Among Returning Service Personnel of the Iraq and Afghanistan War Era; Calls for Access to Therapy Pools to Increase Capacity

Mast Therapeutics Announces Pricing Of Underwritten Public Offering

November 6, 2014 – 7:20 am | Edit Post

SAN DIEGO, Nov. 6, 2014 /PRNewswire/ – Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering that is expected to raise gross proceeds of approximately $21 million.

The Company is offering 30,941,102 Series A units at a purchase price per unit of $0.48.  Each Series A unit will consist of one share of common stock and one-half (0.5) of a warrant.  Each whole warrant will be exercisable for one share of common stock at an initial exercise price of $0.75 per share.

As a component of the offering and in lieu of Series A units that include common stock, the Company is also offering 13,081,428 Series B units at a purchase price per unit of $0.47.  Series B units are being offered only to those purchasers whose purchase of additional Series A units in the offering would otherwise result in the purchaser beneficially owning more than 4.99% of the Company’s outstanding common stock following the completion of the offering. Each Series B unit will consist of one pre-funded warrant to purchase one share of common stock at an initial exercise price of $0.01 per share and one-half (0.5) of a warrant.  Each whole warrant will be exercisable for one share of common stock at an initial exercise price of $0.75 per share. 

The offering is expected to close on or about November 12, 2014, subject to customary closing conditions.  All of the securities in the offering are being sold by the Company.

The Company expects to receive net proceeds from the offering of approximately $20 million, after deducting underwriting discounts and commissions and estimated offering expenses.  The Company intends to use the net proceeds primarily to fund its clinical development programs, including EPIC, the Company’s ongoing pivotal Phase 3 study of MST-188 in sickle cell disease, and for working capital and general corporate purposes.

Cowen and Company, LLC is acting as sole book-running manager. Canaccord Genuity Inc. is acting as lead manager and Laidlaw & Company and Highline Research Advisers are acting as co-managers for the offering.

The offering is being made pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission and declared effective on May 1, 2012.  The offering will be made only by means of the prospectus supplement related to the offering and accompanying prospectus that form part of the registration statement, copies of which may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806.  Copies also will be available on the Commission’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered by the prospectus supplement and accompanying prospectus related to the offering, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Mast Therapeutics

Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California.  The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop MST-188, its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes. 

Forward Looking Statements

Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the anticipated proceeds from the offering and their intended use and anticipated completion of the offering.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability to manage successfully and complete the offering; the uncertainty of outcomes in ongoing and future studies of the Company’s product candidates and the risk that its product candidates, including MST-188, may not demonstrate adequate safety, efficacy or tolerability in one or more such studies, including EPIC; delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a “clinical hold,” and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower return development paths if it is unable to raise sufficient additional capital as needed; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of a planned clinical study of a product candidate; the risk that, even if clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company’s reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of its product candidates, including clinical studies, manufacturing, and regulatory activities for its product candidates, and that such third parties may fail to perform as expected; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success with its products and may never generate revenue sufficient to achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and MST-188 or AIR001 and prevent competitors from duplicating or developing equivalent versions of its product candidates; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission, including the preliminary prospectus supplement related to the offering. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Logo - http://photos.prnewswire.com/prnh/20120612/LA22456LOGO-a

 

SOURCE Mast Therapeutics