BG Medicine Reports 2013 Third Quarter Financial Results

BG Medicine Reports 2013 Third Quarter Financial Results

November 6, 2013

Capital Health Accountable Care Organization LLC Adopts BGM Galectin-3® Test

Network of Laboratories in U.S. Offering BGM Galectin-3Test Expanded

Full-Year 2013 Product Revenue and Cash Burn Guidance Confirmed

WALTHAM, Mass., Nov. 6, 2013 (GLOBE NEWSWIRE) -- BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3 Test, today reported financial results for the third quarter of 2013.

The Company reported product revenues of $1.0 million, a 65% increase from the $0.6 million in revenues reported in the third quarter of 2012. Net loss for the third quarter was $3.7 million, a 46% improvement from the $6.8 million net loss reported in the third quarter of 2012. Operating expenses in the quarter declined by 42% from the same period in the prior year. Net loss per share in the quarter was $0.13 compared to $0.34 for the third quarter of 2012. Operating cash burn decreased by $1.5 million, a 27% decrease, to $4.0 million compared to $5.5 million in the same period of 2012.

"We continue to make significant progress in addressing the fundamentals of our business," said Paul R. Sohmer, M.D., President and Chief Executive Officer. "We believe that we are setting the table for our go-forward success."

Q3 2013 Highlights

  • The Centers for Medicare and Medicaid Services (CMS) announced a preliminary decision to set the Medicare payment rate for testing for galectin-3 at the amount of a crosswalked test whose 2013 national limitation amount is $30.24, a 70% increase from the current national limitation amount for galectin-3, subject to a final determination by CMS by year-end 2013 and anticipated overall adjustments to the Clinical Laboratory Fee Schedule for 2014.
  • The Capital Health Accountable Care Organization (ACO), a community health improvement collaborative servicing communities in New Jersey and eastern Pennsylvania, adopted the BGM Galectin-3® Test throughout its organization to help identify heart failure patients at risk for unplanned hospital admissions and readmissions.
  • The network of clinical laboratories offering the BGM Galectin-3 Test in the U.S. was expanded by the addition of the SilverStaff Clinical Laboratories, headquartered in Tennessee. The results of a clinical research study published online in the European Journal of Heart Failure (Eur J Heart Fail. 2013 Oct; 15(10):1157-63) affirmed the near-term significance of repeat testing for galectin-3 in blood using the BGM Galectin-3 Test for subjects with chronic heart failure.
  • The results of a clinical research study of 2,450 participants of the National Heart, Lung, and Blood Institute's Framingham Heart Study published in the Journal of the American Society of Nephrology (J Am Soc Nephrol. 2013 Sep; 24(9):1470-7) revealed that elevated levels of galectin-3 in blood were significantly associated with increased risks of rapid loss of kidney function and of incident chronic kidney disease. The authors noted that their findings suggest that galectin-3 testing may detect kidney injury years before the clinical onset of kidney disease and may afford early and targeted strategies aimed at kidney disease prevention.

"We expect to drive adoption of the BGM Galectin-3 Test and grow our near-term revenues by leveraging: 1) the new CMS payment rate; 2) demand from physicians, health care provider groups, such as accountable care organizations and community health improvement collaboratives, hospitals and regional clinical laboratories; 3) the expanding network of laboratories offering galectin-3 testing; 4) the utility of our current FDA cleared and CE Marked indications for use; and 5) clinical research data that affirm the near-term significance of galectin-3 testing for patients with chronic heart failure," Dr. Sohmer continued. "Longer term, we expect to grow revenues from the future introduction of new patient selection tools that may incorporate new clinical indications for the BGM Galectin-3 Test, as well as, other biomarkers or combinations of biomarkers that we identify from our analyses of appropriate clinical cohorts, including the BG Medicine sponsored BioImage Study."

For the nine months ended September 30, 2013, product revenues grew 76% to $2.8 million from the $1.6 million reported for the same period in 2012. Net loss per share was $0.52 in the first nine months of 2013 compared to $1.04 for the same period of 2012. Operating cash burn decreased by $3.7 million, a 22% decrease, to $12.8 million in the first nine months of 2013 compared to $16.5 million in the same period in 2012. At September 30, 2013, the Company's unrestricted cash and cash equivalents totaled approximately $11.3 million.

"We will continue to aggressively manage our spending," added Dr. Sohmer. "Notwithstanding our ongoing commercial and development activities, we expect to continue to reduce our operating expenses. In fact, we believe that operating expenses in 2014 will be approximately 33% lower than what we are currently forecasting for the full year 2013. In addition, we will now consider our options for financing."

"For the remainder of 2013, we will continue to: 1) drive the adoption of galectin-3 testing of chronic heart failure patients with health care provider groups and laboratories for which galectin-3 could create the most value, such as accountable care organizations, hospitals, IDN's, and regional reference laboratories; 2) assist Abbott Diagnostics with its currently on-track resubmission to the FDA for 510(k) clearance of its ARCHITECT® Galectin-3 assay by year-end; 3) complete the medical review of data generated in support of BG Medicine's previous submission to the FDA for 510(k) clearance of the CardioSCORE™ test; and 4) rigorously control our investments," concluded Dr. Sohmer. "Our financial guidance for the year ending December 31, 2013 remains unchanged: revenues are expected to range between $3.8 and $4.0 million and the operating cash burn for the year is expected to range from $15.5 to $16.5 million and principal payments for 2013 on our term loan to be $2.5 million."

Conference Call and Web Cast

The Company will host a conference call and webcast today, November 6, 2013, beginning at 8:30 am Eastern Time. The conference call may be accessed by dialing (877) 845-1016 from the U.S. and Canada, or (708) 290-1155 from international locations. The conference call will also be available via the Internet at www.bg-medicine.com. The call will be archived and accessible on the Web site for approximately 30 days. Listeners are encouraged to login at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software.

About BG Medicine

BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3 Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.bg-medicine.com.