Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat progressive non-viral liver diseases, today
announced its financial results for the quarter ended June 30,
2022.
“This is a transformative time for Intercept,” said Jerry Durso,
President and Chief Executive Officer of Intercept. “The recent
sale of our international business significantly strengthened our
balance sheet and now, more than ever, we are poised to continue
driving long term growth of Ocaliva in PBC while also building for
future success.”
“Regarding NASH, we are thrilled with the results of the topline
readout we announced last month from our landmark REGENERATE study
in patients with fibrosis due to NASH,” Durso continued. “In
addition to reinforcing the efficacy of OCA as an antifibrotic,
with this second analysis, we now have the benefit of a deeper
understanding of safety over a longer period of time. We had a
constructive pre-submission meeting with FDA in July, and we look
forward to resubmitting our NDA by the end of the year. Given the
data we have gathered, we are confident in the improved
benefit:risk profile of OCA and its potential role as the first
therapy in NASH.”
Program Highlights
Primary Biliary Cholangitis (PBC)
- Data from our post-marketing study, COBALT, along with
supplementary real-world evidence from large datasets in the U.S.
and Europe, will be included in a regulatory submission to FDA
later this year in support of fulfilling our post-marketing
requirements.
- We continue to add clinical sites and screen patients in our
U.S.-based Phase 2 OCA/bezafibrate fixed-dose combination trial in
PBC and continue to enroll patients in our Phase 2 OCA/bezafibrate
fixed-dose combination trial in Europe. Our Phase 1 study of this
combination in the U.S. has completed enrollment.
Nonalcoholic Steatohepatitis (NASH)
- We held our pre-submission meeting with FDA in July, and plan
to resubmit our NDA for OCA in fibrosis due to NASH by the end of
2022.
- We expect a topline readout in late Q3 for our Phase 3 REVERSE
study in patients with compensated cirrhosis due to NASH. This is a
separate investigational new drug (IND) application from our filing
in fibrosis due to NASH. These data will provide important insights
on this advanced patient population.
Pipeline
- Our comprehensive Phase 1 study for our next-generation FXR
agonist, INT-787, has progressed to the final cohorts. We look
forward to sharing data from our Phase 1 studies, as well as our
intended indication and development plans for INT-787 later this
year.
Financial Results
Revenue
- We recognized $100.4 million in non-GAAP adjusted net sales and
$71.8 million in U.S. net sales in the second quarter 2022 as
compared to non-GAAP adjusted net sales of $96.6 million and $68.2
million in U.S. net sales in the prior year quarter.
- References in this press release to “non-GAAP adjusted net
sales” mean our total revenue, as calculated and presented in
accordance with U.S. Generally Accepted Accounting
Principles (“GAAP”), adjusted for the effects of total revenue from
discontinued operations. See “Non-GAAP Financial Measures” below. A
reconciliation of non-GAAP adjusted net sales to total revenue for
all historical periods presented is included below under the
heading “Reconciliation of Non-GAAP Adjusted Net Sales to Total
Revenue.”
Operating Expenses
- In the quarter ended June 30, 2022, we recorded $85.1
million in total operating expenses and $89.8 million in
non-GAAP adjusted operating expenses, which excludes non-cash
stock-based compensation expense of $8.5 million and
depreciation expense of $2.5 million and adds back ex-U.S.
operating expense of $15.7 million. This compares to the quarter
ended on June 30, 2021, where we recorded $81.6 million in total
operating expenses and $86.5 million in non-GAAP adjusted operating
expenses, which excluded non-cash stock-based compensation expense
of $8.4 million and depreciation expense of $0.9 million
and added back ex-U.S. operating expense of $14.2 million.
- References in this press release to “non-GAAP adjusted
operating expenses” mean our total operating expenses, as
calculated and presented in accordance
with U.S. Generally Accepted Accounting Principles
(“GAAP”), adjusted for the effects of two non-cash items:
stock-based compensation and depreciation and one item for
discontinued operations. See “Non-GAAP Financial Measures” below. A
reconciliation of non-GAAP adjusted operating expenses to total
operating expenses for all historical periods presented is included
below under the heading “Reconciliation of Non-GAAP Adjusted
Operating Expenses to Total Operating Expenses.”
Cost of Sales
- Our cost of sales were $0.3 million for quarters ended
June 30, 2022, and 2021. Our cost of sales for the quarters
ended June 30, 2022 and 2021 consisted primarily of
packaging, labeling, materials and related expenses.
Sales, General & Administrative
Expenses
- Our selling, general and administrative expenses
were $40.0 million in the second quarter of 2022, down
from $43.9 million in the prior year quarter. The decrease was
driven by our ongoing efforts to manage our operational costs.
Research & Development Expenses
- Our research and development expenses were $44.8 million
in the second quarter of 2022, up from $37.7 million in
the prior year quarter. The increase between periods was a result
of a reduction in UK R&D tax credit recognized in the current
period.
Interest Expense
- Interest expense in the quarters ended June 30,
2022 and 2021 was $6.7 million and $12.6
million, respectively. For the quarter ended June 30, 2022,
interest expense is related to the principal amounts outstanding
for the 2023 Convertible Notes, 2026 Convertible Notes and 2026
Convertible Secured Notes and no longer include any accretion of
debt discounts upon adoption of ASU 2020-06. For the quarter ended
June 30, 2021, interest expense is related to the principal amounts
outstanding for the 2023 Convertible Notes and 2026 Convertible
Notes.
Net Loss
- In the second quarter 2022, we reported a net loss of $7.5
million, a decrease compared to a net loss of $11.1 million in the
second quarter 2021.
Cash Position
- As of June 30, 2022, we had cash, cash equivalents, restricted
cash, and investment debt securities available for sale of
approximately $412.3 million. As of December 31, 2021, we had cash,
cash equivalents, restricted cash, and investment debt securities
available for sale of approximately $427.8 million.
- On July 1, 2022, Intercept completed the sales of its
international business for $405 million. Total cash consideration
received upon closing was $366.5 million. Additional consideration
of $38.5 million will be settled in connection with the completion
statements, which will also include adjustments for cash, working
capital, and assumed liabilities.
2022 Financial Guidance
After previously suspending guidance due to the impact and lack
of clarity on the timing for closing the sale of our international
business, we are reissuing our full year 2022 guidance:
- Ocaliva non-GAAP adjusted net sales guidance of $325 million to
$345 million from $375 million to $405 million.
- Non-GAAP adjusted operating expense guidance of $335 million to
$365 million from $360 million to $390 million.
This guidance includes our international business for the first
six months of the year and our ongoing business for the remainder
of the year.
See “Non-GAAP Financial Measures” below. A
quantitative reconciliation of projected non-GAAP adjusted net
sales to total revenue is included below under the heading
“Reconciliation of Non-GAAP Adjusted Net Sales to Total Revenue. 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.
Conference Call on August 3, 2022, at 8:30 a.m.
ET
We are hosting our second quarter 2022 financial results
conference call and webcast on August 3, 2022, at 8:30 a.m. ET. The
conference call will be available via a listen-only webcast on the
investor page of our 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 our website shortly following the
completion of the call and will be available for one year.
About Intercept
Intercept is a biopharmaceutical company focused on the
development and commercialization of novel therapeutics to treat
progressive non-viral liver diseases, including primary biliary
cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). For more
information, please visit www.interceptpharma.com or
connect with the company on Twitter and LinkedIn.
Non-GAAP Financial
Measures
This press release presents non-GAAP adjusted net sales and
non-GAAP adjusted operating expenses on a historical and projected
basis. For the periods presented, non-GAAP adjusted net sales
include in total revenue, as calculated and presented in GAAP, the
effect of one item: total revenue from discontinued operations. For
the periods presented, 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 and one item for
discontinued operations. Non-GAAP adjusted net sales and adjusted
operating expenses are financial measures that have not been
prepared in accordance with GAAP. Accordingly, investors should
consider non-GAAP adjusted net sales and adjusted operating
expenses in addition to, but not as a substitute for, total revenue
and 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 net sales and non-GAAP adjusted
operating expenses provides investors and management with helpful
supplemental information relating to operating performance and
trends. A table reconciling non-GAAP adjusted net sales to total
revenue for all historical periods presented is included below
under the heading “Reconciliation of Non-GAAP Adjusted Net Sales to
Total Revenue”. A table reconciling non-GAAP adjusted
operating expenses to total operating expenses for all historical
periods presented is included below under the heading
“Reconciliation of Non-GAAP Adjusted Operating Expenses to Total
Operating Expenses”. A quantitative reconciliation of projected
non-GAAP adjusted net sales to total revenue is included below
under the heading “Reconciliation of Non-GAAP Adjusted Net Sales to
Total Revenue”. 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.
About Liver Fibrosis and Cirrhosis due to Nonalcoholic
Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a serious progressive
liver disease caused by excessive fat accumulation in the liver
that induces chronic inflammation, resulting in progressive
fibrosis (scarring) that can lead to cirrhosis, eventual liver
failure, cancer and death. There are currently no medications
approved for the treatment of NASH.
About the REGENERATE Study
REGENERATE (Randomized Global Phase 3 Study to Evaluate the
Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an
ongoing Phase 3, randomized, double-blind, placebo-controlled,
multicenter, international study assessing the safety and efficacy
of obeticholic acid (OCA) on clinical outcomes in patients with
liver fibrosis due to NASH. A pre-specified 18-month interim
analysis was conducted on 931 subjects who had scheduled biopsy at
Month 18 to assess the effect of OCA on liver histology comparing
Month 18 biopsies with baseline biopsies. REGENERATE is fully
enrolled with 2,480 randomized participants and is expected to
continue through clinical outcomes for verification and description
of clinical benefit. The end-of-study analysis will evaluate the
effect of OCA on all-cause mortality and liver-related clinical
outcomes, as well as long-term safety.
About the REVERSE StudyREVERSE is a randomized,
double-blind, placebo-controlled, multicenter Phase 3 study
evaluating the safety and efficacy of OCA in NASH patients with
compensated cirrhosis. The primary endpoint is the percentage of
patients with histological improvement in fibrosis by at least one
stage with no worsening of NASH using the NASH Clinical Research
Network (CRN) scoring system after 18 months of treatment. Over 900
patients have been randomized in a 1:1:1 ratio to the three
treatment arms: once-daily OCA 10 mg, once-daily OCA 10 mg for the
first three months with titration in accordance with the study
protocol up to OCA 25 mg for the remaining study period, or
once-daily placebo. Patients who successfully complete the
double-blind phase of REVERSE will be eligible to enroll in an
open-label extension phase for up to 12 additional months.
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
Cirrhosis
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 (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 Pruritus
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.
Reduction in HDL-C
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
(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 Reactions
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 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.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements, including, but not limited to, statements
regarding:
- the progress, timing and results of our clinical trials,
including our clinical trials for the treatment of nonalcoholic
steatohepatitis (“NASH”),
- the safety and efficacy of our approved product, Ocaliva
(obeticholic acid or “OCA”) for primary biliary cholangitis
(“PBC”), and our product candidates, including OCA for liver
fibrosis due to NASH,
- the timing and acceptance of our regulatory filings and the
potential approval of OCA for liver fibrosis due to NASH,
- the review of our New Drug Application (“NDA”) for OCA for the
treatment of liver fibrosis due to NASH by the U.S. Food and Drug
Administration (the “FDA”),
- our intent to work with the FDA to address the issues raised in
a complete response letter (“CRL”),
- the potential commercial success of OCA, and
- our strategy, future operations, future financial position,
future revenue, projected costs, financial guidance, prospects,
plans and objectives.
These statements constitute forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. The words “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,”
“potential,” “will,” “would,” “could,” “should,” “possible,”
“continue” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Readers are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of their dates, and we undertake no obligation
to update any forward-looking statement except as required by
law.These forward-looking statements are based on estimates and
assumptions by our management that, although believed to be
reasonable, are inherently uncertain and subject to a number of
risks.The following represent some, but not necessarily all, of the
factors that could cause actual results to differ materially from
historical results or those anticipated or predicted by our
forward-looking statements:
- the success of our existing business and operations, including
Ocaliva for PBC;
- our ability to successfully commercialize Ocaliva for PBC and,
if approved, OCA for NASH;
- our ability to maintain our regulatory approval of Ocaliva for
PBC;
- our ability to timely and cost-effectively file for and obtain
regulatory approval of our product candidates on an accelerated
basis or at all, including OCA for liver fibrosis due to NASH;
- our ability to address the issues raised in the complete
response letter (“CRL”) received in June 2020 with respect to OCA
for NASH;
- any advisory committee recommendation or dispute resolution
determination that our product candidates, including OCA for liver
fibrosis due to NASH, should not be approved or approved only under
certain conditions;
- any future determination that the regulatory applications and
subsequent information we submit for our product candidates,
including OCA for liver fibrosis due to NASH, do not contain
adequate clinical or other data or meet applicable regulatory
requirements for approval;
- the progress, timing, and results of our REGENERATE clinical
trial, including the safety and efficacy of OCA for liver fibrosis
due to NASH, and the use of a consensus panel approach to histology
reads;
- our pre-submission meeting with the FDA in July 2022 in which
we reviewed with the FDA the planned content and the timing of the
submission of our NDA for OCA for liver fibrosis due to NASH;
- our planned resubmission of an NDA to the FDA for OCA for liver
fibrosis due to NASH, and the potential timing, review, acceptance,
and approval of the NDA;
- conditions that may be imposed by regulatory authorities on our
marketing approvals for our products and product candidates,
including OCA for liver fibrosis due to NASH, such as the need for
clinical outcomes data (and not just results based on achievement
of a surrogate endpoint), any risk mitigation programs such as a
Risk Evaluation and Mitigation Strategies (“REMS”) program, and any
related restrictions, limitations and/or warnings contained in the
label of any of our products or product candidates;
- any potential side effects associated with Ocaliva for PBC, OCA
for liver fibrosis due to NASH or our other product candidates that
could delay or prevent approval, require that an approved product
be taken off the market, require the inclusion of safety warnings
or precautions, or otherwise limit the sale of such product or
product candidate, including in connection with our update to the
Ocaliva prescribing information in May 2021 contraindicating
Ocaliva for patients with PBC and decompensated cirrhosis, a prior
decompensation event, or compensated cirrhosis with evidence of
portal hypertension;
- the initiation, timing, cost, conduct, progress and results of
our research and development activities, preclinical studies and
clinical trials, including any issues, delays or failures in
identifying patients, enrolling patients, treating patients,
retaining patients, meeting specific endpoints, or completing and
timely reporting the results of our NASH or PBC clinical
trials;
- the outcomes of interactions with regulators including the FDA
regarding our clinical trials;
- our ability to establish and maintain relationships with, and
the performance of, third-party manufacturers, contract research
organizations and other vendors upon whom we are substantially
dependent for, among other things, the manufacture and supply of
our products, including Ocaliva for PBC and, if approved, OCA for
liver fibrosis due to NASH, and our clinical trial activities;
- our ability to identify, develop and successfully commercialize
our products and product candidates, including our ability to
successfully launch OCA for liver fibrosis due to NASH, if
approved;
- our ability to obtain and maintain intellectual property
protection for our products and product candidates, including our
ability to cost-effectively file, prosecute, defend and enforce any
patent claims or other intellectual property rights;
- the size and growth of the markets for our products and product
candidates and our ability to serve those markets;
- the degree of market acceptance of Ocaliva for PBC and, if
approved, OCA for liver fibrosis due to NASH or our other product
candidates among physicians, patients and healthcare payors;
- the availability of adequate coverage and reimbursement from
governmental and private healthcare payors for our products,
including Ocaliva for PBC and, if approved, OCA for liver fibrosis
due to NASH, and our ability to obtain adequate pricing for such
products;
- our ability to establish and maintain effective sales,
marketing and distribution capabilities, either directly or through
collaborations with third parties;
- competition from existing drugs or new drugs that become
available;
- our ability to attract and retain key personnel to manage our
business effectively;
- our ability to prevent or defend against system failures or
security or data breaches due to cyber-attacks, or cyber
intrusions, including ransomware, phishing attacks and other
malicious intrusions;
- our ability to comply with data protection laws;
- costs and outcomes relating to any disputes, governmental
inquiries or investigations, regulatory proceedings, legal
proceedings or litigation, including any securities, intellectual
property, employment, product liability or other litigation;
- our collaborators’ election to pursue research, development and
commercialization activities;
- our ability to establish and maintain relationships with
collaborators with development, regulatory and commercialization
expertise;
- our need for and ability to generate or obtain additional
financing;
- our estimates regarding future expenses, revenues and capital
requirements and the accuracy thereof;
- our use of cash, cash equivalents and short-term
investments;
- our ability to acquire, license and invest in businesses,
technologies, product candidates and products;
- our ability to manage the growth of our operations,
infrastructure, personnel, systems and controls;
- our ability to obtain and maintain adequate insurance
coverage;
- continuing threats from COVID-19, including additional waves of
infections, and their impacts including quarantines and other
government actions; delays relating to our regulatory applications;
disruptions relating to our ongoing clinical trials or involving
our contract research organizations, study sites or other clinical
partners; disruptions relating to our supply chain or involving our
third-party manufacturers, distributors or other distribution
partners; and facility closures or other restrictions; and the
impact of the foregoing on our results of operations and financial
position;
- the impact of general economic, industry, market, regulatory or
political conditions;
- how we use the funds received from the sale of our ex-U.S.
business to Advanz Pharma;
- disagreements or legal, operational, or other business problems
arising from our ongoing relationship with Advanz Pharma, including
the licensing of the ex-U.S. rights to Ocaliva for PBC and, if
approved, OCA for NASH, our operational separation from our former
ex-U.S. commercial operations, and our agreement to supply Advanz
Pharma with OCA;
- unexpected tax, regulatory, litigation, or other
liabilities;
- whether we receive any future earn-outs or royalties under the
Advanz Pharma transaction documents; and
- the other risks and uncertainties identified in our periodic
filings filed with the U.S. Securities and Exchange Commission (the
“SEC”), including our latest Annual Report on Form 10-K and/or
Quarterly Report on Form 10-Q.
Contact
For 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
Intercept Pharmaceuticals,
Inc. Condensed Consolidated Statements of
Operations (Unaudited) (In thousands, except per
share data)
|
|
Three Months Ended June
30, |
|
Six Months Ended June
30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenue: |
|
|
|
|
Product revenue, net |
$ |
71,757 |
|
$ |
68,178 |
|
$ |
130,903 |
|
$ |
125,477 |
|
Total revenue |
|
71,757 |
|
|
68,178 |
|
|
130,903 |
|
|
125,477 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of sales |
|
309 |
|
|
254 |
|
|
532 |
|
|
547 |
|
Selling, general and administrative |
|
39,985 |
|
|
43,882 |
|
|
77,739 |
|
|
88,984 |
|
Research and development |
|
44,826 |
|
|
37,668 |
|
|
92,719 |
|
|
88,279 |
|
Restructuring |
|
- |
|
|
(160 |
) |
|
- |
|
|
(284 |
) |
Total operating expenses |
|
85,120 |
|
|
81,644 |
|
|
170,990 |
|
|
177,526 |
|
Operating loss |
|
(13,363 |
) |
|
(13,466 |
) |
|
(40,087 |
) |
|
(52,049 |
) |
|
|
|
|
|
Other income (expense): |
|
|
|
|
Interest expense |
|
(6,669 |
) |
|
(12,589 |
) |
|
(13,342 |
) |
|
(25,008 |
) |
Other (expense)/income, net |
|
(289 |
) |
|
721 |
|
|
(342 |
) |
|
2,179 |
|
Loss from continuing operations |
$ |
20,321 |
|
$ |
25,334 |
|
$ |
53,771 |
|
$ |
74,878 |
|
Income from discontinued operations |
$ |
12,793 |
|
$ |
14,240 |
|
$ |
28,959 |
|
$ |
23,364 |
|
Net loss |
$ |
(7,528 |
) |
$ |
(11,094 |
) |
$ |
(24,812 |
) |
$ |
(51,514 |
) |
|
|
|
|
|
Net income/(loss) per common and potential common share: |
|
|
|
|
Net loss from continuing operations |
$ |
(0.68 |
) |
$ |
(0.76 |
) |
$ |
(1.81 |
) |
$ |
(2.26 |
) |
Net income from discontinued operations |
$ |
0.43 |
|
$ |
0.43 |
|
$ |
0.97 |
|
$ |
0.70 |
|
Net loss |
$ |
(0.25 |
) |
$ |
(0.33 |
) |
$ |
(0.83 |
) |
$ |
(1.55 |
) |
|
|
|
|
|
Weighted average common and potential common shares
outstanding: |
|
|
|
|
Basic and diluted |
|
29,747 |
|
|
33,179 |
|
|
29,721 |
|
|
33,159 |
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Information (Unaudited)(In
thousands)
|
June 30, 2022 |
|
December 31,2021
(1) |
Cash, cash equivalents, restricted cash and investment debt
securities, available for sale |
$ |
412,313 |
|
$ |
427,808 |
|
Total assets, including current assets of discontinued
operations |
$ |
498,597 |
|
$ |
527,023 |
|
Total liabilities, including current liabilities of discontinued
operations (2) |
$ |
868,430 |
|
$ |
710,985 |
|
Stockholders’ deficit |
$ |
(369,833 |
) |
$ |
(183,962 |
) |
––––––––––––
(1) |
|
Derived from the reclassified
financial statements included in Intercept's Quarterly Report on
Form 10-Q for the period ended June 30, 2022. |
|
|
|
(2) |
|
Includes $713.9 million and
$539.8 million related to the 2023 Convertible Notes, 2026
Convertible Notes and the 2026 Secured Convertible Notes (together,
the “Convertible Notes”) as of June 30, 2022 and December 31, 2021,
respectively. The aggregate outstanding principal amount of the
Convertible Notes was $725.2 million as of June 30, 2022 and $729.0
million as of December 31, 2021. |
Reconciliation of Non-GAAP Adjusted Net Sales to Total
Revenue (Unaudited) (In thousands)
|
Three Months Ended June
30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
Total revenue |
$ |
71,757 |
|
$ |
68,178 |
|
$ |
130,903 |
|
$ |
125,477 |
|
|
|
|
|
|
|
Adjustment: |
|
|
|
|
|
|
ex-U.S. revenue (discontinued operations) |
|
28,628 |
|
|
28,398 |
|
|
58,065 |
|
|
52,760 |
Non-GAAP adjusted net sales |
$ |
100,385 |
|
$ |
96,576 |
|
$ |
188,968 |
|
$ |
178,237 |
|
2022 Financial Guidance |
|
Low |
|
High |
Total revenue |
$ |
266,935 |
|
$ |
286,935 |
|
|
|
|
|
Adjustment: |
|
|
|
|
ex-U.S. revenue (discontinued operations) |
|
58,065 |
|
|
58,065 |
Non-GAAP adjusted net sales |
$ |
325,000 |
|
$ |
345,000 |
Reconciliation of Non-GAAP Adjusted Operating Expenses
to Total Operating Expenses (Unaudited) (In
thousands)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
Total operating expenses |
$ |
85,120 |
|
$ |
81,644 |
|
$ |
170,990 |
|
$ |
177,526 |
|
|
|
|
|
Adjustments: |
|
|
|
|
Add: ex-U.S. operating expenses (discontinued
operations) |
|
15,739 |
|
|
14,172 |
|
|
28,723 |
|
|
29,298 |
Less: Stock-based compensation |
|
8,543 |
|
|
8,448 |
|
|
15,264 |
|
|
16,867 |
Depreciation |
|
2,491 |
|
|
879 |
|
|
2,866 |
|
|
1,749 |
Non-GAAP adjusted operating expenses |
$ |
89,825 |
|
$ |
86,489 |
|
$ |
181,583 |
|
$ |
188,208 |
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