Announcement • Sep 16

Intercept Announces Statement on FDA Advisory Committee Meeting

The Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) met to discuss Intercept’s supplemental New Drug Application (sNDA) for OCALIVA® (obeticholic acid, OCA) for the treatment of primary biliary cholangitis (PBC) – a rare, progressive disease that disproportionally affects women. The sNDA was submitted to support full approval of OCALIVA and to satisfy post-marketing requirements confirming a clinical benefit in patients with PBC. With more than 42,000 years of collective real-world patient experience over eight years of being on the market, OCALIVA is the first approved second-line therapy with multiple peer-reviewed study results. Intercept is grateful for the continuous support of the PBC community, including those patients and healthcare providers who contributed to today’s meeting, and will continue to work collaboratively with the FDA on behalf of patients. While the FDA will take into consideration the committee’s vote, the vote is not binding upon the agency. The FDA will make the final decision and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024. Primary biliary cholangitis (PBC) is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately one in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death. About OCALIVA®(obeticholic acid) OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Contraindications OCALIVA is contraindicated in patients with: decompensated cirrhosis or a prior decompensation event. compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). complete biliary obstruction. Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis. Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage. Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily, as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC. Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment. Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing. Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. For patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated, and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment. The most common adverse reactions (=5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. Drug Interactions: Bile Acid Binding Resins Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA.

Biotechs Industry Growth	12.91%
Revenue growth rate	10.64%
Return on equity	-257.95%
Net Margin	-58.84%
Last Earnings Update	31 Mar 2023

Date	Revenue	Earnings	G+A Expenses	R&D Expenses
31 Mar 23	295	-173	196	171
31 Dec 22	286	-175	176	177
30 Sep 22	277	-202	168	186
30 Jun 22	266	-115	166	187
31 Mar 22	263	-120	170	180
31 Dec 21	261	-136	177	183
30 Sep 21	275	-144	200	185
30 Jun 21	288	-193	230	189
31 Mar 21	297	-231	279	185
31 Dec 20	234	-273	261	189
30 Sep 20	301	-321	356	204
30 Jun 20	283	-339	362	216
31 Mar 20	272	-347	339	241
31 Dec 19	252	-345	317	243
30 Sep 19	234	-335	295	241
30 Jun 19	219	-314	275	229
31 Mar 19	196	-318	270	217
31 Dec 18	180	-309	255	207
30 Sep 18	164	-333	265	200
30 Jun 18	159	-341	269	198
31 Mar 18	146	-352	271	195
31 Dec 17	131	-360	270	190
30 Sep 17	107	-369	268	186
30 Jun 17	71	-385	261	175
31 Mar 17	46	-376	239	166
31 Dec 16	25	-413	229	154
30 Sep 16	12	-381	210	131
30 Jun 16	7	-343	181	123
31 Mar 16	2	-314	157	117
31 Dec 15	3	-226	119	113
30 Sep 15	3	-173	71	107
30 Jun 15	3	-158	55	107
31 Mar 15	3	-77	42	94
31 Dec 14	2	-283	35	80
30 Sep 14	2	-261	27	66
30 Jun 14	2	-257	21	47
31 Mar 14	2	-304	16	37
31 Dec 13	2	-68	13	28
30 Sep 13	2	-86	11	23
30 Jun 13	2	-61	8	18
31 Mar 13	2	-53	7	18
31 Dec 12	2	-46	5	16
30 Sep 12	3	-20	4	16
30 Jun 12	3	-17	4	15

Data	Last Updated (UTC time)
Company Analysis	2023/06/12 04:37
End of Day Share Price	2023/03/15 00:00
Earnings	2023/03/31
Annual Earnings	2022/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
James Birchenough	BMO Capital Markets Equity Research
Geoffrey Meacham	BofA Global Research
Chiara Russo	Brean Capital Historical (Janney Montgomery)

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Intercept Pharmaceuticals Past Earnings Performance

Past criteria checks 0/6

Key information

Recent past performance updates

Intercept Pharmaceuticals, Inc. to Report Q2, 2023 Results on Aug 02, 2023

Full year 2022 earnings released: US$5.17 loss per share (vs US$2.87 loss in FY 2021)

Third quarter 2022 earnings released: US$3.04 loss per share (vs US$0.11 loss in 3Q 2021)

Second quarter 2022 earnings released: US$0.68 loss per share (vs US$0.33 loss in 2Q 2021)

Recent updates

Intercept Pharmaceuticals, Inc. Receives Complete Response Letter from FDA Addressing OCALIVA Supplemental New Drug Application (sNDA)

Intercept Pharmaceuticals, Inc. Provides Regulatory Update Regarding sNDA for OCALIVA

Intercept Announces Statement on FDA Advisory Committee Meeting

Intercept Presents New Sub-Analyses of Phase 3 Poise Data Showcasing the Effect of Oca on Key Liver Biomarkers in Patients with PBC at EASL Congress 2024

Intercept Pharmaceuticals, Inc. Files Form 15

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage At AASLD the Liver Meeting® 2023

Intercept Pharmaceuticals, Inc. Announces New Findings from Long-Term Extension of Landmark POISE Trial in PBC Showing Importance of Biomarkers Beyond ALP at AASLD the Liver Meeting® 2023

Intercept Pharmaceuticals' Common Stock Ceased to be Traded on the NASDAQ Stock Market

Intercept Pharmaceuticals, Inc.(NasdaqGS:ICPT) dropped from NASDAQ Biotechnology Index

Persephone Biosciences Appoints Daniel Bradbury as Chair of the Board of Directors

Alfasigma S.p.A. entered into a definitive merger agreement to acquire Intercept Pharmaceuticals, Inc. (NasdaqGS:ICPT) for approximately $840 million.

Intercept Pharmaceuticals Provides Net Sales Guidance for the Full Year of 2023

Intercept Pharmaceuticals, Inc. to Report Q2, 2023 Results on Aug 02, 2023

Intercept Pharmaceuticals, Inc. Presents New Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Biomarkers of PBC-Induced Liver Damage

Intercept Pharmaceuticals, Inc. Announces New Data Showing Potential of Fixed-Dose Combination of OCA and Bezafibrate to Normalize Multiple Biomarkers in PBC to be Featured in Podium Presentation at EASL Congress 2023

Full year 2022 earnings released: US$5.17 loss per share (vs US$2.87 loss in FY 2021)

U.S. Food and Drug Administration Accepts Intercept Pharmaceuticals, Inc.'s New Drug Application for OCA for the Treatment of Pre-Cirrhotic Liver Fibrosis Due to Nash

Forecast breakeven date pushed back to 2025

Third quarter 2022 earnings released: US$3.04 loss per share (vs US$0.11 loss in 3Q 2021)

Second quarter 2022 earnings released: US$0.68 loss per share (vs US$0.33 loss in 2Q 2021)

Forecast breakeven date moved forward to 2022

Forecast breakeven date moved forward to 2022

Forecast breakeven date moved forward to 2022

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