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 March 31,
2021.
“Our global commercial strategy and our continued progress in
educating specialists including gastroenterologists have produced
another quarter of double-digit sales growth for Ocaliva,” said
Jerry Durso, President and Chief Executive Officer of Intercept.
“As we continue our dialogue with FDA, which is reaching its
conclusion regarding updates to the Ocaliva U.S. Prescribing
Information, we expect that the final label will restrict Ocaliva
in patients with decompensated cirrhosis and in a subset of
patients with compensated cirrhosis. Following this label update,
Ocaliva will remain an important option for the significant
majority of second line PBC patients.
“We are currently preparing for a NASH safety update from the
ongoing Phase 3 REGENERATE study that will reflect more than twice
the patient exposure to OCA relative to our first submission. We
are also planning to generate additional data pursuant to upcoming
discussions with the agency. While we are making progress,
significant work remains and alignment with FDA on the necessary
elements will be a key dependency for a potential resubmission in
support of accelerated approval. So at this time we cannot
reiterate our potential filing timing for this year and expect to
provide an update in the third quarter of this year,” Durso
continued. “We have also formally received a 6-month clock stop of
the review of OCA for development of NASH fibrosis in the EU in
order to allow us to focus on executing on the feedback we have
received. Additionally, our Phase 3 REVERSE study in NASH patients
with compensated cirrhosis is ongoing and we expect to have
top-line data by end-of-year, and we continue to make progress on
our pipeline programs including our combination program with
bezafibrate.”
Program Highlights
Primary Biliary Cholangitis
- Process with FDA regarding updates to the U.S. Prescribing
Information is nearing completion. Final label will restrict
Ocaliva in patients with decompensated cirrhosis and in a subset of
patients with compensated cirrhosis.
- Discussion remains ongoing with FDA and EMA regarding the
COBALT post-marketing trial.
NASH
- Held multiple formal interactions with FDA regarding our NASH
fibrosis development program and are preparing for a safety update
that will reflect a doubling of patient exposure to OCA relative to
our first submission. We are also gathering data that will be the
subject of upcoming interactions.
- The REVERSE Phase 3 study in patients with compensated
cirrhosis due to NASH remains ongoing and a top-line readout is
expected to be available by the end of 2021.
- We have formally received a 6-month clock stop of the review of
OCA for development of NASH fibrosis in the EU to allow us to focus
on executing on the feedback we have received and the data we are
developing for potential U.S. resubmission.
Additional Pipeline
- The Company continues to enroll the OCA/bezafibrate combination
trial outside the U.S. and will provide updates when enrollment is
complete. Intercept now has an open IND for the combination in the
U.S.
- Intercept intends to initiate first-in-human work with INT-787
in 2021.
Financial Results
Revenue
- We recognized $81.7 million in total revenue in the
first quarter of 2021, as compared to $72.7 million in
total revenue in the prior year quarter. Ocaliva net sales in the
first quarter of 2021 were comprised of U.S. net sales
of $57.3 million and ex-U.S. net sales of $24.4
million, as compared to U.S. net sales of $50.8
million and ex-U.S. net sales of $21.9 million in
the prior year quarter.
Operating Expenses
- In the quarters ended March 31, 2021 and 2020, we recorded
$111.0 million and $156.1 million, respectively, in total operating
expenses and $101.7 million and $142.9 million, respectively, in
non-GAAP adjusted operating expenses, which excludes non-cash
stock-based compensation expense of $8.4 million and $12.5 million,
respectively, and depreciation expense of $0.9 million and $0.8
million, respectively.
- 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. 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 was $0.8 million in the first quarter of
2021, as compared to $0.9 million in the prior year quarter. Our
cost of sales for the quarters ended March 31, 2021 and 2020
consisted primarily of packaging, labeling, materials and related
expenses.
Sales, General & Administrative
Expenses
- Our selling, general and administrative expenses were $59.3
million in the first quarter of 2021, down from $98.6 million in
the prior year quarter. The decrease was primarily driven by
actions taken to decrease expenses relating to our launch
preparation activities associated with the potential approval and
commercialization of OCA for liver fibrosis due to NASH following
the complete response letter in 2020.
Research & Development Expenses
- Our research and development expenses decreased to $50.8
million in the first quarter of 2021, down from $56.7 million in
the prior year quarter. The decrease was primarily driven by lower
NASH and Ocaliva API development costs.
Interest Expense
- Interest expense in the quarters ended March 31,
2021 and 2020 was $12.4 million and $11.8
million, respectively. For the three months ended March 31, 2021
and 2020, interest expense related to the $230.0 million aggregate
principal amount of 2.00% Convertible Senior Notes due 2026 (the
“2026 Convertible Notes”) that we issued in May 2019 and the $460.0
million aggregate principal amount of 3.25% Convertible Senior
Notes due 2023 (the “2023 Convertible Notes” and together with the
2026 Convertible Notes, the “Convertible Notes”) that we issued in
July 2016.
Net Loss
- In the first quarter of 2021 we reported a net loss of $40.4
million, a decrease compared to a net loss of $93.0 million in the
first quarter 2020.
Cash Position
- As of March 31, 2021, we had cash, cash equivalents, restricted
cash, and investment debt securities available for sale of
approximately $418.6 million. As of December 31, 2020, we had cash,
cash equivalents, restricted cash, and investment debt securities
available for sale of approximately $477.2 million.
2021 Financial Guidance
As a result of the latest dialogue with the FDA, which we expect
to result in a label update restricting the use of Ocaliva in
patients with decompensated cirrhosis and in a subset of patients
with compensated cirrhosis, we are narrowing our Ocaliva net sales
guidance range.
We now expect full year 2021 worldwide
Ocaliva net sales to be between $325 million
to $340 million. Once the label is finalized
and as we monitor post-label update market dynamics, we will plan
to refine this range throughout the year as necessary.
We are reiterating our full year
2021 non-GAAP adjusted operating expenses to be
between $380 million to $410 million.
See “Non-GAAP Financial Measures” below. 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 May 6, 2021 at 8:30 a.m.
ET
We are hosting our first quarter 2021 financial results
conference call and webcast on May 6, 2021 at 8:30 a.m. ET. The
conference call will be available on the investor page of our
website at http://ir.interceptpharma.com or by calling (888)
517-2458 (toll-free domestic) or (847) 413-3538 (international)
passcode 9873 994. A replay of the call will be available on our
website shortly following the completion of the call and will be
available for two weeks.
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). Founded
in 2002 in New York, Intercept has operations in the United States,
Europe and Canada. 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 operating expenses
on a historical and projected basis. 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. Non-GAAP adjusted operating expenses is 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 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 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 due to 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. Advanced fibrosis is associated with a
substantially higher risk of liver-related morbidity and mortality
in patients with NASH. In the United States, NASH is currently the
second leading cause for liver transplantation overall, and in
females, the leading cause. NASH is anticipated to become the
leading indication for liver transplantation in Europe within the
next decade. There are currently no medications approved for the
treatment of NASH.
About the REGENERATE Study
REGENERATE is a Phase 3, randomized, double-blind,
placebo-controlled, multicenter 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 analysis
was conducted to assess the effect of OCA on liver histology
comparing month 18 biopsies with baseline. REGENERATE has completed
target enrollment for the clinical outcomes cohort, with 2,480
adult NASH patients randomized at over 300 qualified centers
worldwide, 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 Ocaliva® (obeticholic
acid)
Ocaliva is indicated in the United States for the treatment of
primary biliary cholangitis (PBC) in combination with
ursodeoxycholic acid (UDCA) in adults with an inadequate response
to UDCA, or as monotherapy in adults unable to tolerate UDCA.
This indication is approved under the accelerated approval
pathway based on a reduction in alkaline phosphatase (ALP) as a
surrogate endpoint which is reasonably likely to predict clinical
benefit, including an improvement in liver transplant
free-survival. 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. We are conducting a Phase
4 clinical outcomes trial, which we refer to as our COBALT trial,
of OCA in patients with PBC with the goal of confirming clinical
benefit on a post-marketing basis.
In December 2016, Ocaliva received conditional marketing
authorization in Europe for the treatment of PBC in combination
with UDCA in adults with an inadequate response to UDCA or as
monotherapy in adults unable to tolerate UDCA, conditioned upon us
providing further data post-approval to confirm benefit. For
detailed safety information for Ocaliva 5 mg and 10 mg tablets
including posology and method of administration, special warnings,
drug interactions and adverse drug reactions, please see the
European Summary of Product Characteristics that can be found on
www.ema.europa.eu.
U.S. IMPORTANT SAFETY INFORMATION FOR OCALIVA IN
PBC
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN
INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR
DECOMPENSATED CIRRHOSIS
- In postmarketing reports, hepatic decompensation and
failure, in some cases fatal, have been reported in patients with
Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or
Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed
more frequently than recommended.
- The recommended starting dosage of OCALIVA is 5 mg once
weekly for patients with Child-Pugh Class B or C hepatic impairment
or a prior decompensation event.
Contraindications
OCALIVA is contraindicated in PBC patients with complete biliary
obstruction.
Warnings and Precautions
Hepatic Decompensation and Failure in Incorrectly-Dosed
PBC Patients with Child-Pugh Class B or C or Decompensated
Cirrhosis
In postmarketing reports, hepatic decompensation and failure, in
some cases fatal, have been reported in PBC patients with
decompensated cirrhosis or Child-Pugh B or C hepatic impairment
when OCALIVA was dosed more frequently than the recommended
starting dosage of 5 mg once weekly. Reported cases typically
occurred within 2 to 5 weeks after starting OCALIVA and were
characterized by an acute increase in total bilirubin and/or ALP
concentrations in association with clinical signs and symptoms of
hepatic decompensation (e.g., ascites, jaundice, gastrointestinal
bleeding, worsening of hepatic encephalopathy).
Routinely monitor patients for progression of PBC disease,
including liver-related complications, with laboratory and clinical
assessments. Dosage adjustment, interruption or discontinuation may
be required. Close monitoring is recommended for patients at an
increased risk of hepatic decompensation. Severe intercurrent
illnesses that may worsen renal function or cause dehydration
(e.g., gastroenteritis), may exacerbate the risk of hepatic
decompensation. Interrupt treatment with OCALIVA in patients with
laboratory or clinical evidence of worsening liver function
indicating risk of decompensation, and monitor the patient’s liver
function. Consider discontinuing OCALIVA in patients who have
experienced clinically significant liver-related adverse reactions.
Discontinue OCALIVA in patients who develop complete biliary
obstruction.
Liver-Related Adverse Reactions
Dose-related, liver-related adverse reactions including
jaundice, worsening ascites and primary biliary cholangitis flare
have been observed in clinical trials, as early as one month after
starting treatment with OCALIVA 10 mg once daily up to 50 mg once
daily (up to 5-times the highest recommended dosage). Monitor PBC
patients during treatment with OCALIVA for elevations in liver
biochemical tests and for the development of liver-related adverse
reactions.
Severe Pruritus
Severe pruritus was reported in 23% of PBC patients in the
OCALIVA 10 mg arm, 19% of PBC patients in the OCALIVA titration
arm, and 7% of PBC patients in the placebo arm in a 12-month
double-blind randomized controlled trial of 216 PBC 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
PBC patients with new onset or worsening severe pruritus.
Management strategies include the addition of bile acid 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 PBC patients, 20% and 9% in
the 10 mg and titration arms, respectively, compared to 2% in the
placebo arm. Monitor PBC patients for changes in serum lipid levels
during treatment. For PBC 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 from subjects taking OCALIVA
for PBC were 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. 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.
Warfarin
The 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 coadministering OCALIVA and warfarin.
CYP1A2 Substrates with Narrow Therapeutic
Index
Obeticholic acid, the active ingredient in OCALIVA, 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 coadministered with OCALIVA.
Inhibitors of Bile Salt Efflux Pump
Avoid 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 see Full Prescribing Information, including Boxed
WARNING and Medication Guide for
OCALIVA.
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 for OCA for the
treatment of liver fibrosis due to NASH by the U.S. Food and Drug
Administration (FDA), our intent to work with the FDA to address
the issues raised in the complete response letter (CRL), the
potential commercial success of OCA, as well as 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 the date of this release, 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: our ability to successfully
commercialize Ocaliva for PBC; our ability to maintain our
regulatory approval of Ocaliva for PBC in the United
States, Europe, Canada, Israel, Australia and
other jurisdictions in which we have or may receive marketing
authorization; 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 following the issuance of the CRL by the FDA; 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; 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 REMS, 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 the newly identified safety
signal relating to Ocaliva identified by the FDA in May 2020 and
with respect to patients with PBC with decompensated cirrhosis
and in a subset of patients with compensated
cirrhosis; 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 in the
jurisdictions in which we intend to seek approval or completing and
timely reporting the results of our NASH or PBC clinical trials;
the outcomes of ongoing discussion with the FDA and the European
Medicines Agency regarding the feasibility of the COBALT and 401
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 system failures, data breaches or violations of
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 impact of the
foregoing on our results of operations and financial position; the
impact of general U.S. and foreign economic, industry,
market, regulatory or political conditions, including the impact of
Brexit; and the other risks and uncertainties identified in our
periodic filings filed with the U.S. Securities and Exchange
Commission, including our Annual Report on Form 10-K for the year
ended December 31, 2020.
Contact
For more information about Intercept, please contact:
Caileigh Doughertyinvestors@interceptpharma.com
Christopher Fratesmedia@interceptpharma.com
|
Intercept
Pharmaceuticals, Inc.Condensed Consolidated
Statements of Operations(Unaudited)(In thousands, except
per share data) |
|
|
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
81,661 |
|
|
$ |
72,652 |
|
Total revenue |
|
81,661 |
|
|
|
72,652 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of sales |
|
810 |
|
|
|
852 |
|
Selling, general and administrative |
|
59,271 |
|
|
|
98,558 |
|
Research and development |
|
50,766 |
|
|
|
56,687 |
|
Restructuring |
|
161 |
|
|
|
- |
|
Total operating expenses |
|
111,008 |
|
|
|
156,097 |
|
Operating loss |
|
(29,347 |
) |
|
|
(83,445 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest expense |
|
(12,419 |
) |
|
|
(11,777 |
) |
Other income, net |
|
1,346 |
|
|
|
2,239 |
|
Total other (expense), net |
|
(11,073 |
) |
|
|
(9,538 |
) |
Net loss |
$ |
(40,420 |
) |
|
$ |
(92,983 |
) |
|
|
|
|
|
|
|
|
Net loss per common and potential
common share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.22 |
) |
|
$ |
(2.86 |
) |
|
|
|
|
|
|
|
|
Weighted average common and
potential common shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
33,139 |
|
|
|
32,561 |
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheet Information(In thousands) |
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31,2020 (1) |
|
(Unaudited) |
|
|
Cash, cash equivalents, restricted cash and investment debt
securities, available for sale |
$ |
418,616 |
|
|
$ |
477,170 |
|
Total assets |
$ |
520,111 |
|
|
$ |
580,489 |
|
Total liabilities (2) |
$ |
720,109 |
|
|
$ |
747,342 |
|
Stockholders’ (deficit)
equity |
$ |
(199,998 |
) |
|
$ |
(166,853 |
) |
_____________(1) Derived from the audited financial statements
included in Intercept's Annual Report on Form 10-K for the year
ended December 31, 2020.
(2) Includes $568.1 million and $560.6 million related to the
Convertible Notes as of March 31, 2021 and December 31, 2020,
respectively. Intercept separately accounts for the debt and equity
components of the Convertible Notes. The aggregate outstanding
principal amount of the Convertible Notes was $690.0 million as of
March 31, 2021 and December 31, 2020, respectively.
|
Reconciliation of Non-GAAP Adjusted Operating Expenses to
Total Operating Expenses(Unaudited)(In thousands) |
|
|
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
Total operating expenses |
$ |
111,008 |
|
|
$ |
156,097 |
|
|
|
|
Adjustments: |
|
|
Stock-based compensation |
|
8,419 |
|
|
|
12,473 |
|
Depreciation |
|
870 |
|
|
|
764 |
|
Non-GAAP adjusted operating
expenses |
$ |
101,719 |
|
|
$ |
142,860 |
|
|
|
|
|
|
|
|
|
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