Click here to close now.




















Welcome!

Agile Computing Authors: Elizabeth White, SmartBear Blog, Ian Khan, Greg Dickinson, Pat Romanski

News Feed Item

Genomic Health Announces Second Quarter 2014 Financial Results and Business Progress

17% Increase in Test Volume, 11% Increase in Total Revenue and 29% Increase in International Product Revenue Compared to Prior Year

REDWOOD CITY, Calif., Aug. 7, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the quarter ended June 30, 2014.

Product revenue was $70.5 million in the second quarter of 2014, compared with $63.7 million for the second quarter of 2013, an increase of 11 percent.  There was no contract revenue in either period.

International product revenue grew by 29 percent to $11.9 million compared to the same period last year and represented 17 percent of product revenue in the second quarter of 2014.

Net loss in the second quarter of 2014 was $4.6 million, compared with a net loss of $3.0 million in the second quarter of 2013.  Basic and diluted net loss per share applicable to common stockholders was $0.15 for the second quarter of 2014, compared with a basic and diluted net loss per share of $0.10 for the same period in 2013.

"In the second quarter, we delivered 17 percent growth in test volume and double-digit revenue growth by increasing penetration of the U.S. invasive breast cancer market and through continued strong international adoption and reimbursement success," said Kim Popovits, Chairman of the Board, Chief Executive Officer and President of Genomic Health. "Additionally, we delivered strong prostate cancer test growth and announced positive results from an additional large clinical validation study, which we believe will drive reimbursement and further adoption of our test.  We look forward to presenting complete results from this study and the landmark DCIS breast cancer study later this year."

Additional Second Quarter 2014 and Six Months Ended June 30, 2014 Financial Results

Total operating expenses for the second quarter of 2014 were $75.1 million, compared with total operating expenses for the comparable period in 2013 of $66.6 million.

Product revenue for the six months ended June 30, 2014 was $137.5 million, compared with $126.4 million for the six months ended June 30, 2013, an increase of 9 percent.   Total revenue for the six months ended June 30, 2014 was $137.5 million, compared to $126.8 million for the comparable period in 2013.

Net loss was $12.1 million for the six months ended June 30, 2014, compared with a net loss of $3.9 million for the six months ended June 30, 2013. 

Cash and cash equivalents and short-term investments at June 30, 2014 were $105.7 million, compared with $105.4 million at December 31, 2013. 

In the second quarter, more than 24,050 Oncotype DX® test results were delivered, an increase of 17 percent, compared with more than 20,650 test results delivered in the same period in 2013. International test results grew 32 percent during the quarter and represented approximately 20 percent of total test volume in the quarter.

"Our first half net loss reflects planned investments in the international and prostate cancer markets," said Brad Cole, Chief Operating Officer and Chief Financial Officer of Genomic Health.  "We anticipate planned investments in DCIS, prostate and international markets to continue through the end of the year, resulting in second half net losses similar to the first half."

Recent Business Highlights:

Oncotype DX Commercial Progress

  • In Canada, established Oncotype DX breast cancer test coverage for an additional 3.6 million lives in the province of Alberta, bringing the total lives covered to more than 86 percent of the country's population.
  • In Spain, the Agency for Health Technology Assessment of Andalusia (AETSA) published the Evaluation Report of Genomic Platforms, recommending Oncotype DX as the only breast cancer test to support therapeutic decision-making in patients with early-stage, hormone receptor-positive, invasive breast cancer.
  • In Mexico, private health insurer AXA granted reimbursement for the Oncotype DX breast cancer test, covering 1.2 million lives.
  • Announced that the Oncotype DX breast cancer test was the first multi-gene test for cancer management to be included in the National Institutes of Health's genetic testing registry.
  • Established Medicaid coverage in three additional states for the Oncotype DX breast cancer test.

Pipeline, Presentations and Publications

  • Announced positive preliminary results from an additional independent clinical validation study conducted by the Center for Prostate Disease Research (CPDR), demonstrating that the Oncotype DX Genomic Prostate Score (GPS) predicts multiple clinical endpoints related to disease aggressiveness in men with low- and intermediate-risk prostate cancer.  This study validated the Oncotype DX prostate cancer test as a predictor of biochemical recurrence, a rise in prostate-specific antigen (PSA) following surgery, which is a longer-term measure of outcomes for aggressive disease.  It also reconfirmed the test's ability to predict adverse pathology from the biopsy, as previously demonstrated in a published validation study performed by the University of California, San Francisco (UCSF). 
  • Announced positive preliminary results from a large, independent clinical validation study of Oncotype DX in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ). Complete data has been submitted for presentation at the 2014 San Antonio Breast Cancer Symposium. 
  • European Urology published groundbreaking results from three studies demonstrating that the Oncotype DX prostate cancer test predicts aggressiveness at diagnosis and significantly increases the number of low-risk patients who can confidently choose active surveillance.
  • Presented results from nine abstracts at the American Society of Clinical Oncology® (ASCO®) Annual Meeting, including data demonstrating that the Oncotype DX breast cancer test predicts late recurrence five to 15 years out; the unique, practice-changing impact of Oncotype DX to optimize cancer care; and the importance of utilizing multiple biological pathways to predict tumor behavior in prostate and renal cancers.
  • Presented results of a new analysis suggesting that the Oncotype DX prostate cancer test predicts recurrence risk after prostatectomy, regardless of post-surgery treatment, at the American Urological Association (AUA) Annual Meeting.
  • Received acceptance to present one study at the upcoming ASCO Breast Cancer Symposium September 4-6.
  • Received acceptance to present two studies at the upcoming American Society of Radiation Oncology® (ASTRO®) Meeting September 14-17.
  • Received acceptance to present eight studies in multiple tumor types at the upcoming European Society of Medical Oncology® (ESMO®) Congress September 26-30.

Conference Call Details
To access the live conference call today, August 7 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada or +1(224) 357-2389 internationally.  The conference ID is 66377262.  Please dial in approximately ten minutes prior to the start of the call.  To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company's website at http://investor.genomichealth.com/events.cfm. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from screening and surveillance, through diagnosis, treatment selection and monitoring.  Genomic Health's lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).  In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of June 30, 2014, more than 19,000 physicians in over 70 countries had ordered more than 465,000 Oncotype DX tests.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's belief that positive study results will drive further reimbursement and adoption of its prostate cancer test; the company's expectations regarding reporting study results; the company's intent to continue its investments in DCIS, prostate cancer and international markets; the company's expectations regarding second half financial results; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the company's beliefs regarding the benefits and attributes of its tests; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company's ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly  Report on Form 10-Q for the quarter ended March 31, 2014. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

 

GENOMIC HEALTH, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)









Three Months Ended


Six Months Ended




June 30,


June 30,




2014


2013


2014


2013


REVENUES:










Product revenues


$

70,477


$

63,691


$

137,479


$

126,400


Contract revenues


-


-


-


385


Total revenues


70,477


63,691


137,479


126,785












OPERATING EXPENSES (1)(2):










Cost of product revenues


12,207


10,757


24,262


20,503


Research and development


13,295


13,800


27,976


27,463


Selling and marketing


34,571


28,135


67,303


55,574


General and administrative


15,015


13,910


29,743


27,045


Total operating expenses


75,088


66,602


149,343


130,585


Loss from operations


(4,611)


(2,911)


(11,805)


(3,800)


Interest income


47


57


97


122


Other income (expense), net


34


(85)


(192)


(91)


Loss before income taxes


(4,530)


(2,939)


(11,900)


(3,769)












Income tax expense


88


55


163


108


Net loss


$

(4,618)


$

(2,994)


$

(12,063)


$

(3,877)


Basic and diluted net loss per share


$

(0.15)


$

(0.10)


$

(0.39)


$

(0.13)


Shares used in computing basic and diluted net loss per share


31,333


30,302


31,211


30,236


 


(1)

Included in operating expenses for the three months ended June 30, 2014 were non-cash charges of $6.1 million, including $4.3 million of stock-based compensation expense and $1.8 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2013 of $6.1 million, including $4.4 million of stock-based compensation expense and $1.7 million of depreciation and amortization expenses.



(2)

Included in operating expenses for the six months ended June 30, 2014 were non-cash charges of $12.1 million, including $8.6 million of stock-based compensation expense and $3.5 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2013 of $11.6 million, including $8.5 million of stock-based compensation expense and $3.1 million of depreciation and amortization expenses.

 

 

GENOMIC HEALTH, INC.
Condensed Consolidated Balance Sheets
(In thousands)









As of

June 30,
2014


As of December 31,
2013




(Unaudited)












Cash and cash equivalents


$

32,494


$

33,279


Short-term marketable securities


73,209


72,071


Accounts receivable, net


31,771


29,446


Prepaid expenses and other current assets


9,014


10,196


Total current assets


146,488


144,992








Property and equipment, net


17,342


18,290


Other assets


14,120


13,752


Total assets


$

177,950


$

177,034




















Accounts payable


$

5,560


$

5,160


Accrued expenses and other current liabilities


26,581


24,086


Deferred revenues


273


586


Other liabilities


2,083


2,221


Stockholders' equity


143,453


144,981


Total liabilities and stockholders' equity


$

177,950


$

177,034


The condensed consolidated balance sheet at December 31, 2013 has been derived from the audited consolidated financial statements at that date included in the Company's Form 10-K for the year ended December 31, 2013.

 

Genomic Health, Inc. logo.

Logo - http://photos.prnewswire.com/prnh/20130425/SF01493LOGO

SOURCE Genomic Health, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with APIs within the next year.
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect their organization.
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Akana has released Envision, an enhanced API analytics platform that helps enterprises mine critical insights across their digital eco-systems, understand their customers and partners and offer value-added personalized services. “In today’s digital economy, data-driven insights are proving to be a key differentiator for businesses. Understanding the data that is being tunneled through their APIs and how it can be used to optimize their business and operations is of paramount importance,” said Alistair Farquharson, CTO of Akana.
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI Intelligence, he worked analyzing bank technology for Corporate Insight and The Clearing House Payment...
"Optimal Design is a technology integration and product development firm that specializes in connecting devices to the cloud," stated Joe Wascow, Co-Founder & CMO of Optimal Design, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
SYS-CON Events announced today that CommVault has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. A singular vision – a belief in a better way to address current and future data management needs – guides CommVault in the development of Singular Information Management® solutions for high-performance data protection, universal availability and simplified management of data on complex storage networks. CommVault's exclusive single-platform architecture gives companies unp...
Electric Cloud and Arynga have announced a product integration partnership that will bring Continuous Delivery solutions to the automotive Internet-of-Things (IoT) market. The joint solution will help automotive manufacturers, OEMs and system integrators adopt DevOps automation and Continuous Delivery practices that reduce software build and release cycle times within the complex and specific parameters of embedded and IoT software systems.
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.