Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) today announced a
restructuring to strengthen the Company’s focus on rare and serious
liver diseases and significantly reduce operating expenses,
including discontinuing all nonalcoholic steatohepatitis
(NASH)-related investment.
“We are taking decisive actions that we believe will improve our
ability to drive long-term growth and maintain leadership with our
PBC business, continue to develop innovative new medicines, and
achieve profitability beginning in 2024,” said Jerry Durso,
President and Chief Executive Officer of Intercept. “We will move
quickly to make a strategic shift that puts Intercept in the best
position to create value for shareholders while fully supporting
our patient-driven mission.”
Durso added, “We understand the implications of these changes on
our employees and are committed to supporting them throughout this
process.”
Planned Actions and Financial Impacts
- The Company will promptly begin the
process of closing out the REGENERATE study. The Company expects to
substantially complete the trial shut-down process by the end of
2023.
- In addition to closing out
REGENERATE, Intercept is quickly winding down all other
NASH-related spending within the Company’s R&D, commercial,
medical affairs and administrative functions.
- Actions taken by Intercept to reduce
its operating expenses are projected to result in a workforce
reduction of approximately one third of the Company. Intercept
expects to initiate workforce reductions in the third quarter of
2023, with the vast majority completed by the end of 2023.
Intercept plans to maintain the scale of its current field sales
organization to support the growth potential of Ocaliva®
(obeticholic acid or OCA).
- Intercept is targeting a net reduction in annual non-GAAP
adjusted operating expenses of approximately $140 million. These
savings will be relative to updated 2023 non-GAAP adjusted
operating expense guidance and will be effective upon completion of
the restructuring and close out of the REGENERATE study.
Strengthened Focus on Rare and Serious Liver
Diseases
- Intercept will continue its strong
investment to support Ocaliva, the only U.S. Food and Drug
Administration (FDA)-approved second-line treatment for people
living with primary biliary cholangitis (PBC). The Company has
generated meaningful new data with innovative studies that
leverage real-world evidence and will continue to do so going
forward.
- Intercept remains on track for a
planned regulatory submission to the FDA in 2023 in support of
fulfilling post-marketing requirements for Ocaliva in PBC. This
submission will include data from the post-marketing study COBALT
and supplementary real-world evidence from large datasets in the
U.S. and Europe.
- Intercept will prioritize R&D
investment on its fixed-dose combination of OCA and bezafibrate, a
peroxisome proliferator-activated receptor agonist. The first Phase
2 interim analysis for the OCA-bezafibrate combination was
presented today at the 2023 European Association for the Study of
the Liver Congress (click here). The Company believes that
OCA-bezafibrate offers the potential to establish best-in-class
clinical benefits that can help further improve the treatment of
PBC. Two ongoing Phase 2 studies are exploring a range of
therapeutic doses for the combination, with planned interim
analyses from both studies expected to be completed in 2023. The
planned interim analyses from Phase 2 studies, in addition to Phase
1 and preclinical data, will serve as the basis for an end-of-phase
2 meeting with FDA.
- The Company continues to advance the Phase 2a FRESH study for
INT-787, a next-generation farnesoid X receptor (FXR) agonist, to
establish a proof-of-concept in severe alcohol-associated
hepatitis.
2023 Financial Targets
- The Company has lowered 2023
non-GAAP adjusted operating expense guidance to $350 million to
$370 million. This guidance includes expenses to wind down the
REGENERATE study and stop all other NASH-related activity, as well
as estimated charges of approximately $16 million relating to the
planned workforce reduction in 2023. The Company expects the
majority of restructuring costs to be incurred during the third
quarter of 2023.
- Intercept reiterated its full-year
2023 Ocaliva net sales guidance of $310 million to $340 million, as
compared to 2022 Ocaliva U.S. net sales of $285.7 million.
- As of March 31, 2023, Intercept had
cash, cash equivalents, restricted cash, and investment debt
securities available for sale of $435.2 million. As previously
disclosed, the Company will use available cash to settle $110
million of convertible notes on or around July 1, 2023.
Conference Call on Friday, June 23, 2023, at 8:30 a.m.
ETAs previously announced, the Company will host a
conference call on Friday, June 23, 2023, at 8:30 a.m. ET to
address the restructuring and provide updated financial guidance.
The conference call will be available via a listen-only webcast on
the investor page of the Company’s website at
http://ir.interceptpharma.com. Participants who wish to ask a
question may register here to receive dial-in numbers and a unique
pin to join the call. A replay of the call will be available on the
Intercept website shortly following the completion of the call and
will be available for one year.
About InterceptIntercept is a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat rare and serious liver diseases, including
primary biliary cholangitis (PBC) and severe alcohol-associated
hepatitis (sAH). For more information, please visit
www.interceptpharma.com or connect with the Company on Twitter and
LinkedIn.
About the Investigational OCA-bezafibrate Fixed-Dose
CombinationIntercept is investigating a fixed-dose
combination of OCA and bezafibrate for the potential treatment of
individuals with PBC. OCA, a farnesoid X receptor (FXR) agonist, is
marketed by Intercept as Ocaliva in the United States for the
treatment of PBC (see below for full indication and Important
Safety Information). Bezafibrate, a pan-peroxisome
proliferator-activated receptor (pan-PPAR) agonist, is not approved
in the United States for any indication.
FXR and PPAR are distinct pathways that each play a role in PBC.
Simultaneously targeting both pathways may offer the greatest
potential to impact bile acid synthesis, metabolism, and clearance
that underly cholestatic liver diseases. Published studies
establish a clinical proof-of-concept that suggests that the
combination of OCA and bezafibrate may provide additive clinical
efficacy and tolerability benefits in the treatment of PBC.
OCA-bezafibrate combination therapy is investigational; safety and
efficacy have not been established.
About Primary Biliary CholangitisPrimary
biliary cholangitis (PBC) is a rare, progressive, and chronic
autoimmune disease that affects the bile ducts in the liver and is
most prevalent (approximately 1 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.
IMPORTANT SAFETY INFORMATION
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY
BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS
- Hepatic decompensation and
failure, sometimes fatal or resulting in liver transplant, have
been reported with Ocaliva treatment in primary biliary cholangitis
(PBC) patients with either compensated or decompensated
cirrhosis.
- Ocaliva is contraindicated
in PBC patients with decompensated cirrhosis, a prior
decompensation event, or with compensated cirrhosis who have
evidence of portal hypertension.
- Permanently discontinue
Ocaliva in patients who develop laboratory or clinical evidence of
hepatic decompensation; have compensated cirrhosis and develop
evidence of portal hypertension; or experience clinically
significant hepatic adverse reactions while on
treatment.
Contraindications
OCALIVA is contraindicated in patients with:
- decompensated cirrhosis (e.g.,
Child-Pugh Class B or C) or a prior decompensation event
- compensated cirrhosis who have
evidence of portal hypertension (e.g., ascites, gastroesophageal
varices, persistent thrombocytopenia)
- complete biliary obstruction
Warnings and Precautions
Hepatic Decompensation and Failure in PBC Patients with
CirrhosisHepatic 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 (up to 5-times the highest
recommended dosage), 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 PruritusSevere 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.
Reduction in HDL-CPatients 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 (maximum of 10 mg once
daily), and who experience a reduction in HDL-C, weigh the
potential risks against the benefits of continuing treatment.
Adverse ReactionsThe 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 ResinsBile 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. If taking a
bile acid binding resin, take OCALIVA at least 4 hours before or 4
hours after taking the bile acid binding resin, or at as great an
interval as possible.
- WarfarinThe International Normalized
Ratio (INR) decreased following coadministration of warfarin and
OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to
maintain the target INR range when co-administering OCALIVA and
warfarin.
- CYP1A2 Substrates with Narrow
Therapeutic IndexObeticholic acid may increase the exposure to
concomitant drugs that are CYP1A2 substrates. Therapeutic
monitoring of CYP1A2 substrates with a narrow therapeutic index
(e.g., theophylline and tizanidine) is recommended when
co-administered with OCALIVA.
- Inhibitors of Bile Salt Efflux
PumpAvoid concomitant use of inhibitors of the bile salt efflux
pump (BSEP) such as cyclosporine. Concomitant medications that
inhibit canalicular membrane bile acid transporters such as the
BSEP may exacerbate accumulation of conjugated bile salts including
taurine conjugate of obeticholic acid in the liver and result in
clinical symptoms. If concomitant use is deemed necessary, monitor
serum transaminases and bilirubin.
Please click here for Full
Prescribing Information, including Boxed
WARNING. To report SUSPECTED ADVERSE REACTIONS,
contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Non-GAAP Financial Measures
This news release presents non-GAAP adjusted operating expenses
on a projected basis. Non-GAAP adjusted operating expenses exclude
from total operating expenses, as calculated and presented in
accordance with GAAP, the effects of two non-cash items:
stock-based compensation and depreciation. Non-GAAP adjusted
operating expenses are a financial measure that has not been
prepared in accordance with GAAP. Accordingly, investors should
consider non-GAAP adjusted operating expenses in addition to, but
not as a substitute for, total operating expenses that we calculate
and present in accordance with GAAP. Among other things, our
management uses non-GAAP adjusted operating expenses to establish
budgets and operational goals and to manage our business. Other
companies may define or use this measure in different ways. We
believe that the presentation of non-GAAP adjusted operating
expenses provides investors and management with helpful
supplemental information relating to operating performance and
trends. A quantitative reconciliation of projected non-GAAP
adjusted operating expenses to total operating expenses is not
available without unreasonable effort primarily due to our
inability to predict with reasonable certainty the amount of future
stock-based compensation expense.
Forward-Looking StatementsThis news release
contains forward-looking statements (“FLS”), including regarding a
planned corporate restructuring, restructuring timing and
implementation, corporate strategy and priorities, corporate
financial performance and profitability, timing of profitability,
Ocaliva net sales, expense levels and expense reductions,
restructuring costs, workforce size, investments in new drug
development, payment of debt, results and timing of clinical trial
activity, regulatory submission activity, meetings with regulators,
contents and timing of a submission to the FDA in support of
post-marketing requirements for Ocaliva for PBC, success with
existing and pipeline products, and drug efficacy, safety, and
tolerability. Important factors could cause actual results to
differ materially from the FLS. For example, we may be less
effective than expected in implementing strategic changes,
restructuring and clinical trial wind-down may be slower and have
greater costs than expected, Ocaliva sales may be lower than
expected, our clinical trials could be unsuccessful, and regulators
could object to our plans on the basis of drug efficacy, safety, or
tolerability, or on the basis of clinical trial and real-world
evidence methodology.
ContactsFor more information about Intercept,
please contact:
For investors:Nareg Sagherian, Executive Director, Global
Investor Relationsinvestors@interceptpharma.com
For media:Karen Preble, Executive Director, Global Corporate
Communicationsmedia@interceptpharma.com
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