Intercept Pharmaceuticals reports mixed Q1 results

Intercept Pharmaceuticals (NASDAQ: ICPT) reported wider-than-expected losses in the first quarter of 2019, primarily due to higher R&D expenses related to NASH (nonalcoholic steatohepatitis) trials. Q1 net loss was $3.03 per share, wider than the Street’s projection of $2.57 per share.

Revenues for the quarter surged 45% year-over-year to $52.2 million. Analysts had, on an average, expected revenues of $51.71 million in Q1.

Q1 revenues included $51.8 million of Ocaliva net sales and approximately $0.4 million of licensing revenue.

Intercept shares have gained 21% in the trailing 52 weeks. However, the stock has been highly volatile this year and is currently down 12.5%.

Research and development expenses increased to $58.4 million in Q1, from $48.7 million in the prior year quarter.  Last month, the New York-based firm had announced that it’s NASH drug candidate obeticholic acid (OCA) showed better efficacy than placebo in the Phase 3 trials.

READ: WHAT IS NASH AND WHICH BIOTECH FIRMS ARE VYING FOR THE FIRST-MOVER STATUS

OCA is the most advanced drug candidate in the highly-competitive and potentially lucrative NASH space. Numerous other drugmakers including Pfizer (NYSE: PFE), Novartis (NYSE: NVS), Gilead Sciences (NASDAQ: GILD) and Allergan (NYSE: AGN) are also in the race to bring out NASH drugs.

Outlook

Based on the first quarter results, Intercept raised its 2019 Ocaliva net sales guidance range to between $235 million and $245 million. The company also updated its 2019 adjusted operating expenses guidance range to between $470 million and $500 million, in connection with the acceleration of our NASH NDA filing and launch preparation activities.  

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