BioCryst Pharma (BCRX) Posts Q4 Loss of 16c/Share; Updates on Pipeline, FY15 Outlook

BioCryst Pharma (NASDAQ: BCRX) reported Q4 EPS of ($0.16), $0.05 better than the analyst estimate of ($0.21). Revenue for the quarter came in at $5.4 million versus the consensus estimate of $3.64 million.

Clinical Development Update & Outlook

• On December 18, 2014, the first patient was dosed in OPuS-2 (Oral ProphylaxiS-2), a blinded, randomized, placebo-controlled clinical trial of orally-administered BCX4161 in patients with HAE. OPuS-2 is a 12-week, three-arm, parallel cohort design trial to evaluate the efficacy and safety of two doses of BCX4161, 300 mg and 500mg, administered three-times daily compared with placebo. This trial is being conducted in the U.S. and several European countries. The trial is expected to enroll approximately 100 HAE patients. The primary efficacy endpoint is the mean angioedema attack rate.
• On December 19, 2014, the U.S. Food and Drug Administration (FDA) approved RAPIVABTM (peramivir injection), an intravenous (I.V.) viral neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.
• Orphan drug designation for BCX4161 was granted by the FDA in December 2014 for the prevention of acute attacks of angioedema in patients with HAE, and the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) issued a positive opinion on the application for orphan drug designation for BCX4161 for the treatment of patients with HAE in January 2015, which subsequently has been confirmed by the European Commission. In addition, BCX4161 was granted Fast Track designation by the FDA in January 2015.
• In December 2014, we announced the start of a randomized, placebo-controlled Phase 1 clinical trial to evaluate intramuscular (I.M.) administration of BCX4430 in healthy volunteers. We also announced positive results showing a survival benefit from BCX4430 in a proof-of-concept study of Ebola virus infection in rhesus macaques. BCX4430 is being developed as a potential treatment for hemorrhagic fever viruses, including Ebola and Marburg virus disease.
• On February 12, the National Institute of Allergy and Infectious Diseases (NIAID) exercised an additional option under its BCX4430 development contract, which provides $2.7 million to BioCryst for I.V. BCX4430 investigational new drug ("IND") enablement and submission. $25.0 million of option funding has been awarded to date under the NIAID contract, which totals $29.1 million, if all options are exercised.
• In January, Ms. Lynne Powell joined BioCryst as Senior Vice President and Chief Commercial Officer. Lynne's primary responsibility will be to formulate our global commercial strategy and to build the global organization that launches our oral kallikrein inhibitors for the prophylactic treatment of hereditary angioedema.

Financial Outlook for 2015

Based upon development plans and assumptions and our awarded government contracts, BioCryst expects its 2015 net operating cash use to be in the range of $65 to $80 million, and its 2015 operating expenses to be in the range of $75 to $95 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense as it is impacted by the volatility and price of the Company's stock, as well as by the vesting of the Company's outstanding performance-based stock options.

For earnings history and earnings-related data on BioCryst Pharma (BCRX) click here.

You May Also Be Interested In

• Tesla touts acceleration of new models, but Q1 results fall short of estimates
• Stride Inc. (LRN) Tops Q3 EPS by 17c, provides guidance
• Steel Dynamics (STLD) Tops Q1 EPS by 16c