LipoScience Announces Termination of Contract With Health Diagnostics Laboratory

Fri Mar 28, 2014 6:45am EDT

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RALEIGH, N.C., March 28, 2014 (GLOBE NEWSWIRE) -- LipoScience, Inc. (Nasdaq:LPDX) today announced the termination of its relationship with Health Diagnostics Laboratory, Inc. ("HDL Inc."), one of its laboratory customers. On March 17, 2014, HDL Inc. began offering its own non-FDA cleared test for the measurement of low density lipoprotein particles ("LDL-P"). While the NMR LipoProfile® test may continue to be made available to HDL Inc. customers, LipoScience would like to ensure that physicians are able to differentiate with certainty which test result they are receiving.  In order to ensure that patients and physicians are aware of and have unlimited access to the NMR LipoProfile® test, the only FDA-cleared and clinically validated test for measuring LDL-P and for managing patients with cardiovascular disease, LipoScience has terminated its contractual relationship with HDL Inc. The Company plans to mitigate the effects of loss of revenues from HDL Inc. by focusing on its relationships with other national, regional and local lab partners and by alerting physicians to use LipoScience lab partners that offer the NMR LipoProfile test.

"We will take actions that are necessary to protect the interest of patients and physicians, as well as LipoScience's business. Our contract with HDL Inc. has accounted for a significant portion of our total revenues over the past few years and the discontinuation of our contract is unfortunate. However, we see this as an opportunity to expand our business with existing lab partners and continue to focus on the appropriate utilization of our test for physicians to manage patients with cardiovascular disease," said Howard Doran, President and Chief Executive Officer of LipoScience. "The NMR LipoProfile test is the only FDA-cleared test that quantifies the number of low density lipoprotein particles, an essential proprietary measure for physicians and their patients in the effective management of cardiovascular disease. Data from our NMR LipoProfile test has been featured and acclaimed in hundreds of scientific publications to date as an established test with clinical outcome validation that is highly differentiated versus HDL Inc.'s unproven, apparently lab-developed test that has neither demonstrated the clinical efficacy nor undergone the rigor of an FDA-clearance process."

Mr. Doran added, "We have discussed how LipoScience is planning to devote more resources to regions with both strong 'in-network' lab support and managed care coverage. In these regions, we have seen our direct sales efforts have an immediate, measurable and sustainable impact in creating physician demand. While the decision to terminate our agreement with HDL Inc. will reduce our sales in the near term, we believe this action will accelerate our shift to working with labs that have stronger in-network relationships with important payors."    

"We believe that over time we will be able to balance the revenue loss from HDL Inc.  However, in the short and medium term, we expect our revenues will be impacted negatively," continued Mr. Doran. Based on the recent change in this customer relationship, the Company now expects total revenue in the first quarter of 2014 to be approximately $11.8 million, compared to the Company's prior outlook of $12.2 million.

About LipoScience, Inc.

LipoScience, Inc. (Nasdaq:LPDX) is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. The NMR LipoProfile® test, the Company's first proprietary test, is an FDA-cleared blood test that directly quantifies LDL particles and provides physicians and their patients with actionable information to personalize management of heart disease. To date, more than 11 million NMR LipoProfile tests have been ordered. LipoScience is striving toward the NMR LipoProfile test becoming the preferred choice by physicians for the management of cardiovascular disease. 

The Vantera® Clinical Analyzer is the first FDA-cleared platform that utilizes NMR technology. Its ease of use and quick turnaround time helps maximize efficiency and throughput in the clinical laboratory. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: our industry, business strategy, goals and expectations concerning our future operations, performance or results, profitability, capital expenditures, liquidity and capital resources, timing or anticipated results of our FDA submissions and other financial and operating information. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward -looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

CONTACT: Investor Relations
         ICR, Inc.
         Bob Yedid
         Managing Director
         646-277-1250
         bob.yedid@icrinc.com
         
         LipoScience, Inc.
         Tori Hall
         tori.hall@liposcience.com
         (919) 256-1046