Posts Tagged ‘US Securities and Exchange Commission’

2012 Omics Tools and Molecular Diagnostics: average CEO Compensation at Publicly Traded Firms

Reporter: Aviva Lev-Ari, PhD, RN

GenomeWeb Feature: CEOs at Omics Tools, MDx Firms See Compensation Rise an Average 7 Percent in 2012

July 15, 2013

NEW YORK (GenomeWeb News) – The average CEO compensation at publicly traded omics tools and molecular diagnostics firms rose nearly 7 percent year over year in 2012, according to documents filed with the US Securities and Exchange Commission.

Based on proxy statements filed by 28 of the 29 firms in the GenomeWeb Daily NewsIndex, CEO compensation for 2012 averaged more than $4.8 million, up from a little less than $4.5 million in 2011.

One firm, Rosetta Genomics, based in Rehovot, Israel, did not report compensation for its CEO, Kenneth Berlin, either in 2011 or 2012. The firm did not respond to requests for information.

The base salary for CEOs in 2012 averaged $686,017, also up about 7 percent from $644,109 in 2011, according to the proxy statements.

As a total dollar amount, CEO compensation for the 28 companies in the GWDN Index reached about $135.3 million last year, up about 8 percent from $125.7 million, while the base salaries in 2012 totaled $19.2 million, an increase of 6 percent from $18.0 million in 2011.

Executive compensation across all industries has become a lightning rod in recent years with shareholders and the general public seeking greater transparency in how compensation is determined and justification for sometimes extravagant pay perks.

According to Susan Stemper, managing director at executive compensation consulting firm Pearl Meyer & Partners, investors need to scrutinize executive compensation because they provide a window into the strategic direction that a board has set for the business and whether a board’s decisions around CEO pay are competitive and appropriate for the business.

Investors need to focus on how executive compensation levels are designed, said Stemper. “I’d say, ‘Don’t look at the numbers, look at the design,'” she toldGenomeWeb Daily News, adding that, in particular, it is important to focus on achievements made in the past year and how they compare to the company’s goals and objectives.

Setting appropriate compensation levels for executives, which include stock and other option awards, is a tricky art that, in addition to using measurable metrics, often include more difficult to measure factors that are meant to reward executives for their performance during the past year.

Such pay-for-performance components, however, present special challenges to omics tools/MDx firms, Stemper said.

“The challenge is when you’re looking at these sectors where the return from the research and development — if it follows at all — perhaps only follow quarters or years after that initial investment has been made,” she said. “The conundrum that we face is trying to look at this year’s pay and trying to align it with this year’s financial performance of the business.”

In the omics/MDx sector, “you need a lot of shots on goal” before a target is hit, and “you can’t count on all those shots on goal happening in a given year,” Stemper said. “So does it really make sense not to grant the stock, or not award the stock because we didn’t make the shot on goals when we recognize that that is just part of how we do business?”

As a result, companies in the omics tools/MDx space have come to rely on time-vested stock and option grants, which become exercisable after a defined amount of time has elapsed.

“To me, those are the perfect performance-based vehicles, because if the stock price doesn’t perform, the executive is not going to realize the value that you’re reading in the table,” she said. The values for such options that are listed on a company’s proxy statement are based on the value at the time they are issued to the CEO and may go up or down as time passes. “They’ve got 10 years to do it, typically on the term, but the stock price has to exceed, by some measure, what it was at the time of grant,” Stemper added.

Many companies also look at how their competitors compensate their executives as benchmarks for paying their own executives. For example, Illumina’s compensation committee used a peer group of 18 firms to set 2012 compensation levels for their executives, including President and CEO Jay Flatley, whose total compensation for the year dropped 18 percent to $8.2 million.

Among the firms in Illumina’s peer group were

In its proxy, it said that it “considered a number of factors in defining the peer group, including industry competitors of similar revenue range, net income, growth rates, employee size, and market capitalization range that we believe reflects the market for talent and stockholder investment.”

Illumina said that it targets its direct compensation to its executives at between the 60th percentile and 75th percentile of compensation that executives in its peer group receive. The largest component of the total direct compensation is delivered through equity-based awards in order to retain its executives, while aligning their interests with those of its shareholders, it said in its proxy, although it may “deviate from these general target levels to reflect the executive’s experience, the executive’s sustained performance level, and market factors as deemed appropriate by the compensation committee.”

Such a peer group approach, though, also provides challenges, because in such a niche market, the pool of such firms is shallow, Stemper said, and different firms may be at different stages of the business cycle. They may not have similar experiences in terms of success and regulatory approvals, either, or may have dissimilar financial dynamics.

Because of this, firms often include in their benchmark peer groups companies that may be analogous to where they are in terms of their business but which have only the vaguest connection, if any, to what they do. Affymetrix, for instance, included in its peer group for 2012 Nordion, a health science firm that provides targeted therapies, sterilization technologies, and medical isotopes. Genomic Health, meanwhile, looked at, among others, ultrasound shop FujiFilm Sonosite to determine its compensation levels, and Thermo Fisher Scientific had diversified manufacturing and technology company Emerson Electric in its peer group.

In niche markets, such as the omics tools/MDx space, “it will be difficult to simply say ‘I want to look at the median'” compensation offered by competitors, Stemper said. “It’s more likely going to be ‘I want to look at the universe at a dataset level and understand where we believe our CEO fits in best.'”

2012 Winners

Among the firms in the GWDN Index, the CEO with the highest year-over-year compensation increase in 2012 was Thermo Fisher’s Marc Casper, whose total compensation climbed 146 percent to almost $13.6 million from $5.5 million in 2011. The uptick was largely driven by a stock award of $10.4 million granted in 2012, compared to none in 2011.

Two other CEOs whose compensation doubled year over year in 2012 were Bruker’s Frank Laukien, who took in $1.9 million last year, compared to $892,100 in 2011, and Exact Sciences’ Kevin Conroy, whose compensation reached $2.7 million from $1.3 million in 2011.

Frank Witney of Affymetrix had the biggest year-over-year drop, 76 percent, as his 2012 compensation of $657,291 was down from $2.7 million in 2011. The drop-off is largely attributable to a decrease in stock awards in 2012 to $115,750, compared to $1.4 million the year before. Witney became president and CEO of Affy on July 1, 2011.

Another whose compensation narrowed significantly was Waters’ Douglas Berthiaume, who made $1.1 million in 2012, down 60 percent from $2.6 million the year before. Also, William Moffitt, the former CEO of Nanosphere, who was succeeded this past February by Michael McGarrity, saw his compensation fall 48 percent to $457,885 in 2012 from $885,946 in 2011.

And GenMark Diagnostics’ Hany Massarany’s 2012 compensation was down 33 percent at $1.3 million last year from $2.0 million in 2011.

Among the CEOs of firms in the GWDN Index, Danaher’s Lawrence Culp raked in the most in compensation last year, making $21.9 million in total compensation, up from $21.7 million in 2011. Four others made more than $10 million in 2012: Thermo Fisher’s Casper; William Sullivan of Agilent with $10.1 million; Life Technologies’ Greg Lucier with $10.3 million; and PerkinElmer’s Robert Friel with $10.8 million.



Read Full Post »

Obstructive Coronary Artery Disease diagnosed by RNA levels of 23 genes – CardioDx, a Pioneer in the Field of Cardiovascular Genomic Diagnostics

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 11/15/2013

CardioDx, Inc. Nixes IPO, Cites Unfavorable Market Conditions

11/15/2013 10:31:01 AM


CardioDx postpones its initial public offering, citing ‘unfavorable market conditions.’ California molecular diagnostics company CardioDx spiked its initial public offering, citing “unfavorable market conditions,” according to news reports. The 5.8-million-share offering by Palo Alto-based CardioDx was slated to raise $92 million at a share price of $14-$16 apiece. The IPO, originally scheduled for yesterday, would have seen CardioDx shares trade under the “CDX” symbol.



CardioDx had planned to use some of the funds to expand its commercial efforts, including its sales and marketing workforce; to fund operations as the company pursues more insurance coverage and reimbursement; to “conduct additional clinical and marketing activities” for the company’s Corus CAD blood-based gene expression test; to fund R&D activity; and for “general corporate purposes.” CardioDx will later specify just the how much it plans to put toward each of those activities.

Investors in the company include V-Sciences Investments, Longitude Venture Partners, Artiman Ventures, Kleiner Perkins Caufield & Byers, JP Morgan and Mohr Davidow Ventures.



CardioDX pulls IPO, citing poor market conditions

CardioDX, led by David Levison, was one of three medical technology companies to postpone their IPOs on Thursday due to poor market conditions.

Senior Technology Reporter-Silicon Valley Business Journal
CardioDX postponed an IPO on Thursday after deciding that the market is unfavorable at this time.


The Palo Alto company led by CEO David Levison was one of three planned medical tech companies that postponed going public on Thursday. San Diego-basedCelladon and Monrovia-based Xencor also decided to hold off due to poor market conditions.

Redwood City pharmaceutical developer Relypsa, meanwhile, went ahead with a drastically reduced IPO that raised about half of what it had been projected for it.

CardioDX, which sells diagnostic tests for cardiovascular disease, reported total revenue in in 2012 of $2.5 million and a net loss of $25.6 million. The company expects to continue to show losses for the next several years and has an accumulated deficit through June totaling $165.9 million. As of June 30, it had $46.8 million in cash, equivalents and investments.

The company’s biggest existing stakeholder is V-Sciences Investments, a wholly owned subsidiary of Temasek Life Sciences Private Ltd., which holds 19.9 percent of outstanding shares.

Other big stakeholders are Longitude Venture Partners, with a 17.9 percent stake; Artiman Ventures, 13.9 percent; Kleiner Perkins Caufield & Byers, 9.5 percent; JP Morgan, 6.4 percent; and Mohr Davidow Ventures, 5.8 percent.



Cardiovascular MDx Firm CardioDx Files to Go Public

UPDATED on 10/14/2013

October 14, 2013

NEW YORK (GenomeWeb News) – Cardiovascular molecular diagnostics firm CardioDx has filed with the US Securities and Exchange Commission to go public with an intended offering of up to $86.3 million of common stock.

The Palo Alto, Calif.-based firm has not priced its offering yet or said how many shares it plans on offering. Bank of America Merrill Lynch and Jefferies are listed as joint book-running managers on the offering, while Piper Jaffray and William Blair are co-managers.

The company plans on listing on the Nasdaq Global Market under ticker symbol “CDX.”

In its Form S-1, CardioDx said that its tests provide healthcare professionals with “critical, actionable information to improve patient care and management,” with an initial focus on coronary artery diseases (CAD), arrhythmia, and heart failure.

Its flagship product is the Corus CAD, a gene expression-based test for assessing non-diabetic patients who display symptoms suggestive of obstructive CAD. The test was launched in 2009 and through June 30, CardioDx delivered results for more than 40,000 tests, it said.

Corus CAD received Medicare Part B coverage in August 2012, making it a covered benefit for about 48 million Medicare beneficiaries, the company added.

In 2012, CardioDx posted $2.5 million in revenues with a net loss of $25.6 million. Through the first six months of 2013, the firm had revenues $2.9 million and a net loss of $18.4 million.

It had $46.8 million in cash, cash equivalents, and investments as of June 30, it said.

In August 2012, CardioDx raised $58 million in private financing. Before that, it raised $60 million in a financing round. In 2010, GE Healthcare invested $5 million in the company as part of a Series D financing round.

David Levison heads the firm as President and CEO. Other members of the management team include CFO Andrew Guggenhime; Chief Scientific Officer Steven Rosenberg; Chief Medical Officer Mark Monane; and Chief Commercial Officer Deborah Kilpatrick.

CardioDx is the latest in a recent string of omics-related companies who have gone public or have filed to go public in the US. Cancer GeneticsNanoString Technologies, and Foundation Medicine launched their IPOs earlier this year. Meanwhile, VeracyteBiocept, and Evogene have filed to float.

UPDATED on 2/25/2013

CardioDx Announces Publication of COMPASS Study Demonstrating the Corus CAD Test Outperforms Myocardial Perfusion Imaging in Overall Diagnostic Accuracy for Obstructive Coronary Artery Disease

February 24, 2013
CardioDx Announces Publication of COMPASS Study Demonstrating the Corus CAD Test Outperforms Myocardial Perfusion Imaging in Overall Diagnostic Accuracy for Obstructive Coronary Artery Disease

Tue Feb 19, 2013 8:30am EST

– Study Highlights the Validity of Corus CAD as a First-Line Test to Help Clinicians Exclude Obstructive CAD as a Cause of the Patient’s Symptoms – PALO ALTO, Calif.,  Feb. 19, 2013

/PRNewswire/ — CardioDx, Inc., a pioneer in the field of  cardiovascular genomic diagnostics, today announced the publication of the COMPASS (Coronary  Obstruction Detection by  Molecular
Personalized Gene Expression) study in  Circulation: Cardiovascular Genetics,  a journal of the American Heart Association. 

Results of the prospective, multi-center U.S. study showed that  Corus®  CAD, a blood-based  gene expression test, demonstrated high accuracy with both a high negative predictive value (96 percent) and high sensitivity (89 percent) for assessing  obstructive coronary artery disease  (CAD) in a population of patients referred for stress testing with myocardial perfusion imaging (MPI).  The study’s authors conclude that using Corus CAD earlier in the diagnostic algorithm could reduce the number of invasive cardiac tests by more accurately evaluating the presence of obstructive coronary artery disease compared to the traditional algorithm of stress myocardial perfusion imaging (MPI) in these patients.

COMPASS enrolled stable patients with symptoms suggestive of CAD who had been referred for MPI at 19 U.S. sites.  A blood sample was obtained in all 431 patients prior to MPI and Corus CAD gene expression testing was performed with study investigators blinded to Corus CAD test results. Following MPI, patients underwent either invasive coronary angiography or coronary CT angiography, gold-standard anatomical tests for the diagnosis of coronary artery disease. 

The study was designed to provide additional independent validation of the Corus CAD test in a real-world intended use patient population of patients presenting for MPI, a common noninvasive test for CAD, and builds on the results of the previous PREDICT validation study. Corus CAD requires only a simple blood draw for testing, making it safe, convenient, and easy to administer. The study evaluated results in stable non-diabetic patients with typical or atypical symptoms suggestive of CAD and found that Corus CAD surpassed the accuracy of MPI, a test that was administered more 10 million times in the U.S. in 2010.[1]

“The evaluation of stable patients with chest pain and other symptoms suggestive of CAD is a common challenge for clinicians, accounting for as many as 10,000 outpatient visits each day,” said the publication’s lead author,  Gregory S. Thomas, M.D., M.P.H., Medical Director of the MemorialCare Heart & Vascular Institute at Long Beach Memorial Medical Center and Clinical Professor of Medicine and Director of Nuclear Cardiology Education at the  University of California-Irvine  School of Medicine. “In the U.S., MPI testing is often performed in these patients and is followed by referral to invasive coronary angiography. Based on the results of this study of the Corus CAD gene expression test, we now have a reliable diagnostic approach for evaluating patients with symptoms of obstructive CAD.  With its high sensitivity and negative predictive value, Corus CAD may help clinicians accurately and efficiently exclude the diagnosis of obstructive CAD early in the diagnostic pathway, so they can assess for other causes of their patients’ symptoms.”

The pre-specified primary endpoint of the COMPASS study was the receiver-operator characteristics (ROC) analysis to evaluate the ability of Corus CAD to identify coronary arterial blockages of 50 percent or greater by quantitative coronary angiography.  Corus CAD outperformed MPI in overall diagnostic accuracy for assessing obstructive CAD, with an area under the curve (AUC) of 0.79 for the Corus CAD test compared to MPI site and core-lab read AUCs of 0.59 and 0.63 respectively (p<0.001).  In addition, Corus CAD performed better than MPI in sensitivity (89 percent vs. 27 percent, p<0.001) and negative predictive value (96 percent vs. 88 percent, p<0.001) parameters, thus demonstrating excellent performance for excluding obstructive CAD as the cause of a patient’s symptoms.  The COMPASS results corroborated earlier findings from the PREDICT multicenter U.S. validation study[2] demonstrating that the Corus CAD score is proportional to coronary artery stenosis severity.

“Corus CAD can help solve an enormous unmet need in healthcare by providing clinicians with a safe, convenient and reliable tool to help evaluate common patient symptoms and triage them more appropriately for subsequent therapy or additional testing,” said  David Levison, President and CEO of CardioDx.  “In addition to its higher diagnostic accuracy, Corus CAD holds potential to reduce a major healthcare expense category – unnecessary noninvasive imaging and/or invasive coronary angiography procedures and their associated risks and side effects. We have worked closely with leading clinicians to build a solid clinical and economic foundation for Corus CAD, leading to its growing acceptance in the medical and payer communities as evidenced by the more than 35,000 tests performed to date and Medicare’s decision to cover the test.”



CardioDx is promoting yet another post-marketing study whose data may help the company’s gene expression test for obstructive coronary artery disease reach more patients, better compete with the standard of care and also build vital market share.

Executives at the California-based 2012 Fierce 15 company say they wanted more data on Corus CAD‘s real-world use, building on its previous PREDICT validation trial as a result. The test has been on sale commercially since 2009 and won crucial Medicare reimbursement last fall. Chief Scientific Officer Steven Rosenberg told FierceMedicalDevices via email that the results from the latest study pointed in a number of positive directions.

“It demonstrates performance at least as good as that seen in the PREDICT study, but in the population the Corus CAD is indicated for,” Rosenberg said, “It shows significantly higher performance for obstructive CAD than MPI, which is the most common non-invasive imaging test used in this regard.”

A 431-patient clinical study of the blood diagnostic rated the test with a 96% negative predictive value and 89% high sensitivity, in assessing the condition in patients who were referred for stress testing with myocardial perfusion imaging (MPI). (Last November, CardioDx heralded similar results from another study using Corus CAD on 98 geriatric patients.) Details are published in the journal Circulation: Cardiovascular Genetics.

The blood test, conducted at 19 U.S. sites through multiple academic institutions, determined that using Corus CAD earlier in the diagnostic process better assessed the presence of coronary artery disease versus MPI. This might encourage doctors to cut back on invasive, more expensive cardiac tests by ruling out obstructive CAD sooner. In other words, determining a patient doesn’t have obstructive CAD eliminates the need for diagnostic procedures such as coronary angiography or coronary CT angiography, the company explains.

Post-marketing studies are increasingly important in today’s health care market, with the need to demonstrate the utility of a device or diagnostic in as most detailed a way possible. And it’s not just boosting the standard of care; the Affordable Care Act means value matters, too, more than ever before. Success with this mission can help broaden market share and also increase the chance of private as well as government insurance coverage. Additionally, new post-marketing trials can also set the stage for expanded indications down the line.



A Blood Based Gene Expression Test for Obstructive Coronary Artery Disease Tested in Symptomatic Non-Diabetic Patients Referred for Myocardial Perfusion Imaging: The COMPASS Study

  1. Gregory S. Thomas1*,
  2. Szilard Voros2,
  3. John A. McPherson3,
  4. Alexandra J. Lansky4,
  5. Mary E. Winn5,
  6. Timothy M. Bateman6,
  7. Michael R. Elashoff7,
  8. Hsiao D. Lieu7,
  9. Andrea M. Johnson7,
  10. Susan E. Daniels7,
  11. Joseph A. Ladapo8,
  12. Charles E. Phelps9,
  13. Pamela S. Douglas10 and
  14. Steven Rosenberg7

+Author Affiliations

  1. 1Long Beach Memorial Medical Center, Long Beach & University of California, Irvine, CA

  2. 2Stony Brook University Medical Center, Stony Brook, NY

  3. 3Vanderbilt University, Nashville, TN

  4. 4Yale University School of Medicine, New Haven, CN

  5. 5Scripps Translational Science Institute, La Jolla, CA

  6. 6University of Missouri, Kansas City, MO

  7. 7CardioDx, Inc., Palo Alto, CA

  8. 8New York University School of Medicine, New York, NY

  9. 9University of Rochester, Rochester, NY

  10. 10Duke Clinical Research Institute, Duke University, Durham, NC
  1. * MemorialCare Heart and Vascular Institute, Long Beach Memorial Medical Center, 2801 Atlantic Avenue, Long Beach, CA 90806 gthomas@mimg.com


Background—Obstructive coronary artery disease (CAD) diagnosis in symptomatic patients often involves non-invasive testing before invasive coronary angiography (ICA). A blood-based gene expression score (GES) was previously validated in non-diabetic patients referred for ICA but not in symptomatic patients referred for myocardial perfusion imaging (MPI).

Methods and Results—This prospective multi-center study obtained peripheral blood samples for GES before MPI in 537 consecutive patients. Patients with abnormal MPI usually underwent ICA; all others had research coronary CT-angiography (CTA), with core laboratories defining coronary anatomy. A total of 431 patients completed GES, coronary imaging (ICA or CTA), and MPI. Mean age was 56±10 (48% women). The pre-specified primary endpoint was GES receiver-operator characteristics (ROC) analysis to discriminate ≥50% stenosis (15% prevalence by core laboratory analysis). ROC curve area (AUC) for GES was 0.79 (95% CI 0.73-0.84, p<.001), with sensitivity, specificity, and negative predictive value (NPV) of 89%, 52%, and 96%, respectively, at a pre-specified threshold of ≤15 with 46% of patients below this score. The GES outperformed clinical factors by ROC and reclassification analysis and also showed significant correlation with maximum percent stenosis. Six-month follow-up on 97% of patients showed that 27/28 patients with adverse cardiovascular events or revascularization had GES >15. Site and core-lab MPI had AUCs of 0.59 and 0.63, respectively, significantly less than GES.

ConclusionsA GES has high sensitivity and NPV for obstructive CAD. In this population clinically referred for MPI, the GES outperformed clinical factors and MPI.

Clinical Trial Registration Information—www.clinicaltrials.gov; Identifier: NCT01117506.

  • Received June 6, 2012.
  • Revision received January 15, 2013.
  • Accepted February 5, 2013.



CardioDx heart disease test wins Medicare coverage

San Francisco Business Times by Ron Leuty, Reporter

Date: Wednesday, August 8, 2012, 4:00am PDT

CardioDx's test for obstructive heart disease will be covered by Medicare retroactive to Jan. 1.
Photo supplied by CardioDx

CardioDx’s test for obstructive heart disease will be covered by Medicare retroactive to Jan. 1.

Reporter- San Francisco Business Times

A key national Medicare contractor will cover the cost of a coronary artery disease test developed by CardioDx Inc.

The move is important for Palo Alto-based CardioDx because private insurers tend to follow the federal government’s Medicare health insurance program. The company has had to seek reimbursement on a case-by-case basis with those private insurers since its Corus CAD gene expression test hit the market in June 2009.

The decision disclosed Tuesday by Palmetto GBA, a national contractor that administers Medicare benefits in Columbia, S.C., means that Medicare will cover the test for as many as 40 million enrollees. Coverage is retroactive to Jan. 1.

Corus CAD is a shoebox-size kit that uses a simple blood draw to measure the RNA levels of 23 genes. Using an algorithm, it then creates a score that determines the likelihood that a patient has obstructive coronary artery disease.

“By providing Medicare beneficiaries access to Corus CAD, this coverage decision enables patients to avoid unnecessary procedures and risks associated with cardiac imaging and elective invasive angiography, while helping payers address an area of significant healthcare spending,” CardioDx President and CEO David Levison said in a press release.

The decision represents the latest Medicare-coverage win for Bay Area diagnostic test makers. Palmetto earlier this year opted to cover the Afirma gene expression test from South San Francisco’s Veracyte Inc. to diagnosis thyroid nodules, and last summer Palmetto said it would cover Redwood City-based Genomic Health Inc.’s (NASDAQ: GHDX)colon cancer recurrence test.

Read Full Post »

%d bloggers like this: