Intercept Pharmaceuticals, Inc . ICPT reported mixed results for first-quarter 2018. The company reported a loss of $3.22 per share in the first quarter, narrower than the Zacks Consensus Estimate of a loss of $3.41 per share and the year-ago loss of $3.61 per share.
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise | Intercept Pharmaceuticals, Inc. Quote
Quarterly revenues were $35.9 million, up significantly from $21.1 million in the year-ago quarter but missed the Zacks Consensus Estimate of $37.8 million.
Quarter in Detail
Ocaliva recorded $35.2 million of sales, down from $37.3 million recorded in fourth-quarter 2017. Net sales in the United States came in at $28.5 million while the ex-U.S. Ocaliva net sales came in at $6.7 million.
Ocaliva was approved in the United States, in combination with ursodeoxycholic ("UDCA") for the treatment of primary biliary cholangitis ("PBC") in adults with an inadequate response to UDCA, or as monotherapy in adults who are unable to endure UDCA in 2016. The drug was also granted conditional approval by the European Commission. In February 2018, the Ocaliva label was updated in the United States to include a boxed warning and a dosing table that reinforced the existing dosing schedule in PBC patients with Child-Pugh Class B or C or decompensated cirrhosis.
Research and development expenses increased 11.1% year over year to $48.7 million primarily driven by increases in clinical development programs for Obeticholic acid ("OCA") and infrastructure to support such programs.
Selling, general and administrative expenses increased to $62.5 million from $61.1 million in the year-ago quarter.
Ocaliva net sales are expected between $170 million and $185 million in 2018. Intercept continues to expect operating expenses in the range of $390-$410 million in 2018.
OCA is being evaluated for other indications including non-alcoholic steatohepatitis ("NASH") and primary sclerosing cholangitis ("PSC").
The FDA earlier approved a redesign of the phase III trial, REGENERATE on OCA for the safety and efficacy in treating NASH patients with liver fibrosis. The company now needs to achieve only one co primary endpoint, either fibrosis improvement or NASH resolution as compared with the earlier target of achieving both. Enrolment of the interim analysis cohort was completed in the trial and results are expected in the first half of 2019.
Earlier, Intercept initiated a phase III trial, REVERSE, on OCA. The randomized phase III study will evaluate the efficacy and safety of OCA, in subjects with compensated cirrhosis due to NASH in approximately 540 patients with a biopsy-confirmed diagnosis of cirrhosis. The primary endpoint of the study is the percentage of subjects with histological improvement in fibrosis by at least one stage using the NASH Clinical Research Network ("CRN") scoring system after 12 months of treatment. Patients enrolled in the trial are being randomized in a 1:1:1 ratio to one of the three treatment arms - once-daily dosing of OCA 10 mg, once-daily OCA 10 mg with titration to 25 mg at three months, or placebo. The patients who successfully complete the double-blind phase of REVERSE will be enrolled in an open-label extension phase for up to 12 additional months. The trial is currently enrolling.
Intercept expects to submit marketing authorization for OCA as a treatment option for NASH patients with compensated cirrhosis, in the United States and international markets based on the positive results from the study. A subsequent outcome trial is also in the cards to confirm the clinical benefit on a post-marketing basis in a broader population of NASH patients with cirrhosis.
Intercept's first-quarter results were mixed as loss was narrower than expectations while sales missed expectations. While the updated label should help the stock turn around, it might be a while before the sales start to recover.
Intercept's stock has tumbled 39.6% over a year compared with the industry 's decline of 11.3%. The company's stock was hit due to the safety issues regarding Ocaliva.
Given the challenges faced by the drug in recent times, the label expansion of OCA will boost the growth prospects.
Per estimates, NASH is expected to surpass hepatitis C as the leading reason for liver transplants in the United States and Europe. NASH market has huge potential and a tentative approval will boost Ocaliva's prospects. However, bigwigs like Novartis AG NVS and Gilead Sciences GILD have FXR agonists in phase II or earlier stages of clinical or preclinical development that can be used to treat PBC, NASH and the other liver diseases.
Zacks Rank & Stock to Consider
Intercept currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is Exelixis EXEL which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
Exelixis' earnings per share estimates increased from 59 cents to 86 cents for 2018 over the last seven days after the company reported better-than-expected first-quarter results.
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