INTERCEPT PHARMACEUTICALS, INC.
interceptpharma.comNo Longer Reporting
The company has not filed an annual or quarterly report since its Q3 FY2023 10-Q, filed Nov 6, 2023. Its latest SEC filing is a 15-12G from Nov 20, 2023.
10-Q for Q3 FY2023, filed Nov 6, 2023
The sections below describe the company as of the FY2022 annual report.
What Did They Do?
Sells Ocaliva for people with primary biliary cholangitis and develops potential medicines for people with other liver diseases.
10-K for FY2022, filed Mar 2, 2023We are a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral…View ↗
In addition to commercializing OCA for PBC under the Ocaliva brand name, we are also currently developing OCA for additional indications…View ↗
Ocaliva was approved for PBC by the U.S. Food and Drug Administration (“FDA”) in May 2016 under the accelerated approval pathway. We…View ↗
How Did They Make Money?
Intercept sells Ocaliva to specialty pharmacies, with sales counted when the pharmacies receive the product; rebates, discounts and customer incentives reduce the net amount.
10-K for FY2022, filed Mar 2, 2023
$285.7M
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10-K for FY2022, filed Mar 2, 2023
$285.7M ↗
Who Were Their Customers?
Intercept sells Ocaliva to a limited number of specialty pharmacies, which dispense it directly to patients.
10-K for FY2022, filed Mar 2, 2023We commenced our commercial launch of Ocaliva for the treatment of PBC in the United States in June 2016. In December 2016, the European…View ↗
10-K for FY2022, filed Mar 2, 2023
On a consolidated basis, for the year ended December 31, 2022, the Company’s two largest customers (as defined below under “Revenue…View ↗
Did Revenues Turn Into Profits?
Yes. It kept 78 cents of every revenue dollar as net income in FY2022, but spent more cash than it brought in: free cash flow was −$27.3M.
10-K for FY2022, filed Mar 2, 2023
−$68.2MView ↗
10-K for FY2022, filed Mar 2, 2023
$221.8MView ↗
10-K for FY2022, filed Mar 2, 2023
−$27.3MView ↗
How Were They Changing?
- Net income
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Sources
10-Q for Q3 FY2023, filed Nov 6, 2023
−$2.8MView ↗
- ▼ Now a loss
- vs $267.5M in Q3 FY2022
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Nov 8, 2023
Alfasigma completed its acquisition of Intercept
Intercept became a wholly owned subsidiary of Alfasigma after the merger.
Sources
8-K, filed Nov 8, 2023
On September 26, 2023, the Company entered into an Agreement and Plan of Merger, dated as of September 26, 2023 (the “Merger Agreement”)…View ↗
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Aug 2, 2023
Intercept updated 2023 Ocaliva sales guidance
The range changed to $320-$340 million from $310-$340 million.
Sources
8-K, filed Aug 2, 2023
Intercept has updated its full-year 2023 Ocaliva® net sales guidance to $320-$340 million from $310-$340 million.View ↗
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Jun 23, 2023
Intercept lowered 2023 operating expense guidance
The revised range was $350–$370 million, and the restructuring ends NASH-related investment.
Sources
8-K, filed Jun 23, 2023
Company lowers 2023 non-GAAP adjusted operating expense guidance to $350–$370 million, inclusive of restructuring costs; reiterates 2023…View ↗
Grew. Revenue grew 59% in 4 years, from $179.8M in FY2018 to $285.7M in FY2022, about 12% a year.
Ex-U.S. commercial operations
The older report described launching Ocaliva in Europe and pursuing approvals in international markets. The latest report describes the sale of ex-U.S. commercial operations to Advanz and sublicensing its right to commercialize Ocaliva outside the United States.
10-K for FY2019, filed Feb 25, 2020 10-K for FY2022, filed Mar 2, 2023Ocaliva was approved for PBC by the U.S. Food and Drug Administration (“FDA”) in May 2016 under the accelerated approval pathway. We…View ↗
Who Did They Compete With?
Competes with Genfit, Ipsen Pharma, CymaBay, Calliditas Therapeutics, Zydus, Genkyotex, Mirum Pharmaceuticals, Cour Pharmaceuticals, Ironwood Pharmaceuticals, GlaxoSmithKline, Madrigal Pharmaceuticals, Novo Nordisk, Akero Therapeutics, Inventiva, AstraZeneca, 89bio, Viking Therapeutics, Axcella Health, Novartis, and Metacrine
10-K for FY2022, filed Mar 2, 2023Ocaliva is indicated for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in…View ↗
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