Lantheus to Present New Data at the ASNC Annual Scientific Session on the Novel PET Cardiac Imaging Agent Flurpiridaz F 18 in Patients with Suspected Heart Disease Undergoing Exercise Stress Testing
Sep 22 16
Lantheus Holdings, Inc. announced that new data from a sub-analysis of its first Phase 3 study of flurpiridaz F 18 for myocardial perfusion imaging (MPI) in patients undergoing exercise stress testing will be presented at the 21st Annual Scientific Session of the American Society of Nuclear Cardiology (ASNC) in Boca Raton, Florida. The findings show the superiority of flurpiridaz F 18, an investigational positron emission tomography (PET) agent for MPI, compared to MPI with single photon emission computed tomography (SPECT) for the assessment of coronary artery disease (CAD) during exercise stress testing. Based on a blinded read of PET and SPECT data, flurpiridaz F 18 PET imaging demonstrated a statistically greater sensitivity (67.0%) versus SPECT (54.9%). The first flurpiridaz F 18 Phase 3 study was designed to assess the diagnostic efficacy of flurpiridaz F 18 PET imaging versus SPECT with Tc99m-labeled agents for CAD detection in the same patients. Patients with known or suspected CAD who were either scheduled for or had completed invasive coronary angiography (without intervention) were included in the study. Each patient was studied using both one-day rest/stress flurpiridaz F 18 PET imaging and Tc99m-labeled SPECT imaging (one-day rest/stress or two-day protocol). Images were interpreted by three expert readers blinded to all clinical information. Quantitative coronary angiography (QCA) was used as the truth standard, with patients considered CAD positive with a stenosis = 50% in at least one major vessel by QCA. Flurpiridaz F 18 PET imaging substantially outperformed SPECT, in sensitivity, one of the study’s primary endpoints, but did not meet the study’s other primary endpoint, non-inferiority for specificity, implying a substantial and unexpected under-diagnosis of CAD with SPECT in the trial. Unlike flurpiridaz F 18 PET imaging, SPECT results were skewed with low sensitivity and high specificity when compared to the truth standard. In secondary endpoints, flurpiridaz F 18 PET imaging outperformed SPECT in image quality and diagnostic certainty with less than half of the radiation exposure for patients. Subsequent to the initial read of the data, LMI performed a re-read which confirmed the initial results as well as showed improved performance of flurpiridaz F 18 PET imaging as compared to SPECT in women and subjects with high body mass index. Based on the results of the first Phase 3 study, the Company redesigned the protocol for its second Phase 3 study, including different primary endpoints " namely, the performance of flurpiridaz F 18 on its own merit versus coronary angiography as the truth standard " and the Company has received a Special Protocol Assessment from the FDA in connection with its second study.
Lantheus Holdings, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2016; Provides Earnings Guidance for the Third Quarter and Year 2016
Aug 4 16
Lantheus Holdings, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2016. For the quarter, the company reported revenue of $77,966,000 against $73,314,000 a year ago. Operating income was $14,179,000 against $5,356,000 a year ago. Income before income taxes was $7,597,000 against loss of $23,248,000 a year ago. Net income was $7,350,000 or $0.24 basic and diluted per share against loss of $24,423,000 or $1.29 basic and diluted per share a year ago. Operating income, as adjusted was $14,062,000 against $11,883,000 a year ago. Net income, as adjusted was $7,233,000 against $882,000 a year ago. Adjusted diluted per share was $0.24 against $0.05 per share a year ago. Adjusted EBITDA was $21,407,000 against $17,985,000 a year ago. Net cash provided by operating activities were $17,635,000 against net cash used in operating activities of $11,438,000 a year ago. Capital expenditures were $736,000 against $2,614,000 a year ago. Free cash flow was $2,128,000 against $11,659,000 a year ago. The second quarter net income results also reflect a decrease in the amount of interest expense due to debt refinancing in June of 2015. Second quarter worldwide revenue results reflect continued strong sales of DEFINITY and stable revenues from the nuclear products portfolio driven by contracts with key radiopharmacy customers.
For the six months, the company reported revenue of $154,440,000 against $148,137,000 a year ago. Operating income was $31,852,000 against $16,734,000 a year ago. Income before income taxes was $18,310,000 against loss of $22,876,000 a year ago. Net income was $17,673,000 or $0.58 basic and diluted per share against loss of $24,048,000 or $1.30 basic and diluted per share a year ago. Operating income, as adjusted was $25,907,000 against $26,891,000 a year ago. Net income, as adjusted was $11,728,000 against $4,887,000 a year ago. Adjusted diluted per share was $0.39 against $0.26 per share a year ago. Adjusted EBITDA was $39,769,000 against $38,572,000 a year ago. Net cash provided by operating activities were $21,415,000 against $3,719,000 a year ago. Capital expenditures were $2,388,000 against $6,112,000 a year ago.
The company is increasing its outlook for worldwide revenue for full year 2016 to a range of $291 million to $295 million. The company is also increasing its outlook for full year 2016 adjusted EBITDA to a range of $70 million to $73 million.
For the third quarter of 2016, the company expects worldwide revenue in the range of $68 million to $70 million. For the third quarter of 2016, the company expects adjusted EBITDA in the range of $14 million to $16 million.