Intercept Pharma (ICPT) Tops Q1 EPS by 22c

Intercept Pharma (NASDAQ: ICPT) reported Q1 EPS of ($1.22), $0.22 better than the analyst estimate of ($1.44). Revenue for the quarter came in at $81.66 million versus the consensus estimate of $81.2 million.

“Our global commercial strategy and our continued progress in educating specialists including gastroenterologists have produced another quarter of double-digit sales growth for Ocaliva,” said Jerry Durso, President and Chief Executive Officer of Intercept. “As we continue our dialogue with FDA, which is reaching its conclusion regarding updates to the Ocaliva U.S. Prescribing Information, we expect that the final label will restrict Ocaliva in patients with decompensated cirrhosis and in a subset of patients with compensated cirrhosis. Following this label update, Ocaliva will remain an important option for the significant majority of second line PBC patients.

“We are currently preparing for a NASH safety update from the ongoing Phase 3 REGENERATE study that will reflect more than twice the patient exposure to OCA relative to our first submission. We are also planning to generate additional data pursuant to upcoming discussions with the agency. While we are making progress, significant work remains and alignment with FDA on the necessary elements will be a key dependency for a potential resubmission in support of accelerated approval. So at this time we cannot reiterate our potential filing timing for this year and expect to provide an update in the third quarter of this year,” Durso continued. “We have also formally received a 6-month clock stop of the review of OCA for development of NASH fibrosis in the EU in order to allow us to focus on executing on the feedback we have received. Additionally, our Phase 3 REVERSE study in NASH patients with compensated cirrhosis is ongoing and we expect to have top-line data by end-of-year, and we continue to make progress on our pipeline programs including our combination program with bezafibrate.”

2021 Financial Guidance

As a result of the latest dialogue with the FDA, which we expect to result in a label update restricting the use of Ocaliva in patients with decompensated cirrhosis and in a subset of patients with compensated cirrhosis, we are narrowing our Ocaliva net sales guidance range.

We now expect full year 2021 worldwide Ocaliva net sales to be between $325 million to $340 million. ​ Once the label is finalized and as we monitor post-label update market dynamics, we will plan to refine this range throughout the year as necessary.

We are reiterating our full year 2021 non-GAAP adjusted operating expenses to be between $380 million to $410 million.

For earnings history and earnings-related data on Intercept Pharma (ICPT) click here.

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