Intercept Pharma (ICPT) Misses Q3 EPS by 8c, Revenues Beat; Offers FY20 Ocaliva Net Sales Mid-Point Guidance Above Consensus

Intercept Pharma (NASDAQ: ICPT) reported Q3 EPS of ($2.01), $0.08 worse than the analyst estimate of ($1.93). Revenue for the quarter came in at $79.52 million versus the consensus estimate of $78.63 million.

“We were pleased to reengage with FDA at our recent Type A end-of-review meeting to discuss the Agency’s benefit-risk assessment in the CRL based on its review of the available data, as well as our proposed way forward to resubmitting our NDA for OCA in NASH fibrosis,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The meeting was constructive and FDA has provided us with helpful guidance regarding supplemental data we can provide to further characterize OCA’s efficacy and safety profile that could support resubmission based on our Phase 3 REGENERATE 18-month biopsy data, together with a safety update from our ongoing studies. We are advancing accordingly and plan to hold additional meetings with the Agency with the goal of achieving sufficient alignment to proceed on this basis and potentially resubmit our NDA next year. Of note, the REGENERATE outcomes phase is ongoing and our Phase 3 REVERSE study in NASH patients with compensated cirrhosis is expected to read out by the end of next year. We continue to lead the NASH field and believe that, if approved, OCA has the potential to become an important treatment for patients with advanced fibrosis due to NASH. Meanwhile, our PBC business continued its strong performance in the third quarter and we have updated our 2020 financial guidance with anticipated Ocaliva net sales of $310 to $320 million and non-GAAP adjusted operating expenses of $460 to $480 million, providing us with a strong financial footing for the future.”

GUIDANCE:

Intercept Pharma sees FY2020 revenue of $310-320 million, versus the consensus of $311.93 million.

We are updating our 2020 Ocaliva net sales guidance to narrow the range at the upper end of our previously announced guidance, and now anticipate Ocaliva net sales of $310 million to $320 million. We are also updating our non-GAAP adjusted operating expenses guidance to narrow the range at the lower end of the previously announced guidance, and now anticipate non-GAAP adjusted operating expenses of $460 million to $480 million.

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