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 fourth quarter and full
year ended December 31, 2020.
“As we turn the page on 2020, I am proud of the Intercept team’s
efforts to support patients with PBC and grow our Ocaliva
foundational rare disease franchise during a global pandemic,” said
Jerry Durso, President and Chief Executive Officer of Intercept.
“We continued our regulatory dialogue with FDA and EMA and met with
the FDA in Q1 regarding the NISS for liver disorder in a subset of
PBC patients with cirrhosis. While interactions remain ongoing, the
process will ultimately result in a change to our label regarding
the use of Ocaliva to treat patients who reach the most advanced
stages of PBC.”
“Regarding our NASH regulatory process, we are laser-focused on
building alignment with FDA in advance of a potential NDA
resubmission, with the goal of increasing the probability of a
successful outcome for patients with advanced fibrosis due to
NASH,” Durso continued. “We are also looking forward to topline
results from our phase 3 REVERSE trial in patients with compensated
cirrhosis due to NASH this year.”
Ocaliva® (obeticholic acid) Commercial
Highlights
Full year 2020 Ocaliva net sales were $312.7 million, which
represented growth of 25% as compared to the prior year. Ocaliva
net sales in 2020 were comprised of U.S. net sales of $234.0
million and ex-U.S. net sales of $78.7 million, as
compared to U.S. net sales of $187.5 million and ex-U.S.
net sales of $62.1 million in 2019.
We recognized $83.3 million of Ocaliva net sales in
the fourth quarter of 2020, as compared to $70.3 million in the
prior year quarter. Ocaliva net sales in the fourth quarter of 2020
were comprised of U.S. net sales of $64.9 million and
ex-U.S. net sales of $18.4 million, as compared to U.S. net sales
of $53.5 million and ex-U.S. net sales of $16.8
million in the prior year quarter.
Selected Fourth Quarter and Full Year 2020 Financial
Results
Revenues
We recognized $83.3 million in total revenue in the
fourth quarter of 2020, as compared to $71.5 million in
total revenue in the prior year quarter. Total revenue in the
fourth quarter of 2019 included approximately $1.2 million of
licensing revenue.
We recognized $312.7 million in total revenue in 2020,
as compared to $252.0 million in 2019. Total revenue in
2019 included $249.6 million of Ocaliva net sales and
approximately $2.4 million of licensing revenue.
Operating Expenses
Our cost of sales was $0.8 million in the fourth
quarter of 2020, as compared to $2.5 million in the prior
year quarter. Cost of sales was $5.3 million in 2020, as
compared to $4.2 million in 2019. Our cost of sales for
the quarters and years ended December 31, 2020 and 2019
consisted primarily of packaging, labeling, materials and related
expenses.
Our selling, general and administrative expenses decreased
to $70.0 million in the fourth quarter of 2020,
from $93.7 million in the prior year quarter. The fourth
quarter period-over-period decrease was primarily driven by
reductions in spend resulting from actions taken following the
delay of the potential approval and commercialization of
obeticholic acid (OCA) for liver fibrosis due to nonalcoholic
steatohepatitis (NASH). Selling, general and administrative
expenses increased to $332.5 million in 2020, up from $317.4
million in 2019. The full year period-over-period increase was
primarily driven by expenses during the first half of 2020 relating
to our launch preparation activities associated with the potential
approval and commercialization of OCA for liver fibrosis due to
NASH.
Our research and development expenses decreased to $51.9
million in the fourth quarter of 2020, from $64.6
million in the prior year quarter. The fourth quarter
period-over-period decrease was primarily driven by lower NASH
development costs and the conclusion of enrollment activities for
the REGENERATE and REVERSE studies. Research and development
expenses decreased to $191.5 million in 2020, down from $242.8
million in 2019. The full year period-over-period decrease was
primarily driven by UK R&D tax credits of $22.0 million
recognized as a reduction of research and development expenses, and
lower NASH development costs and the conclusion of enrollment
activities for the REGENERATE and REVERSE studies.
Restructuring expenses were $1.2 million and $0 for the three
months ended December 31, 2020 and 2019, respectively.
Restructuring expenses were $14.6 million and $0 for the full year
ended December 31, 2020 and 2019, respectively. The fourth quarter
and full year period-over-period increases were both driven by
severance costs and other related termination benefits incurred in
conjunction with the 2020 Workforce Plan.
In the quarters ended December 31, 2020 and 2019, we
recorded $123.9 million and $160.8 million,
respectively, in total operating expenses and $106.6
million and $146.8 million, respectively, in non-GAAP
adjusted operating expenses, which excludes non-cash stock-based
compensation expense of $16.5 million and $13.2
million, respectively, and depreciation expense of $0.8
million and $0.8 million, respectively.
In the years ended December 31, 2020 and 2019, we
recorded $543.9 million and $564.4 million,
respectively, in total operating expenses and $480.0
million and $504.8 million, respectively, in non-GAAP
adjusted operating expenses, which excludes non-cash stock-based
compensation expense of $60.8 million and $56.0
million, respectively, and depreciation expense of $3.1
million and $3.7 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.”
Interest Expense
Interest expense in the quarters ended December 31,
2020 and 2019 was $12.3 million and $11.6
million, respectively. Interest expense in the years ended December
31, 2020 and 2019 was $48.1 million and $41.1 million,
respectively. Our interest expense is related to the $460.0
million aggregate principal amount of 3.25% Convertible Senior
Notes due 2023 (the “2023 Convertible Notes”) that we issued
in July 2016 and 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. Net Loss
In the fourth quarter and full year of 2020 we reported a net
loss of $52.1 million and $274.9 million, respectively, a
decrease compared to a net loss of $98.2 million and $344.7
million in the fourth quarter and full year 2019.
Cash Position
As of December 31, 2020, we had cash, cash equivalents,
restricted cash, and investment debt securities available for sale
of approximately $477.2 million. As of December 31, 2019, we had
cash, cash equivalents, restricted cash, and investment debt
securities available for sale of approximately $657.4 million.
2021 Financial Guidance
Our sales guidance range for full year 2021 provided below
reflects the potential impact of various Ocaliva label change
scenarios, and we plan to refine this range throughout the
year as we have more information from our discussions with
FDA.
We are announcing 2021 Ocaliva net sales guidance of $325
million to $355 million. In addition, we are announcing 2021
non-GAAP adjusted operating expense guidance of $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 February 25, 2021 at 8:30 a.m.
ET
We are hosting our fourth quarter and full year 2020 financial
results conference call and webcast on February 25, 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 (855)
232-3919 (toll-free domestic) or (315) 625-6894 (international)
passcode 7565656. 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
StatementsThis 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; 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 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 and short-term investments; our ability to
acquire, license and invest in businesses, technologies, product
candidates and products; our ability to attract and retain key
personnel to manage our business effectively; our ability to manage
the growth of our operations, infrastructure, personnel, systems
and controls; our ability to obtain and maintain adequate insurance
coverage; the impact of COVID-19, including any impact on our
results of operations or financial position, related quarantines
and 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, facility closures or other restrictions, and
the extent and duration thereof; the impact of
general U.S. and foreign economic, industry, market,
regulatory or political conditions, including the potential 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, 2019 and our Quarterly Report on Form 10-Q
for the quarter ended September 30, 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 December
31, |
|
Year Ended December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue: |
|
|
|
|
Product revenue, net |
$ |
83,268 |
|
|
$ |
70,284 |
|
|
$ |
312,690 |
|
|
$ |
249,570 |
|
Licensing revenue |
|
- |
|
|
|
1,216 |
|
|
|
- |
|
|
|
2,432 |
|
Total revenue |
|
83,268 |
|
|
|
71,500 |
|
|
|
312,690 |
|
|
|
252,002 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of sales |
|
767 |
|
|
|
2,474 |
|
|
|
5,322 |
|
|
|
4,212 |
|
Selling, general and administrative |
|
69,956 |
|
|
|
93,680 |
|
|
|
332,493 |
|
|
|
317,418 |
|
Research and development |
|
51,898 |
|
|
|
64,636 |
|
|
|
191,485 |
|
|
|
242,799 |
|
Restructuring |
|
1,249 |
|
|
|
- |
|
|
|
14,630 |
|
|
|
- |
|
Total operating expenses |
|
123,870 |
|
|
|
160,790 |
|
|
|
543,930 |
|
|
|
564,429 |
|
Operating loss |
|
(40,602 |
) |
|
|
(89,290 |
) |
|
|
(231,240 |
) |
|
|
(312,427 |
) |
|
|
|
|
|
Other income (expense): |
|
|
|
|
Interest expense |
|
(12,253 |
) |
|
|
(11,626 |
) |
|
|
(48,054 |
) |
|
|
(41,144 |
) |
Other income, net |
|
708 |
|
|
|
2,758 |
|
|
|
4,414 |
|
|
|
8,890 |
|
|
|
(11,545 |
) |
|
|
(8,868 |
) |
|
|
(43,640 |
) |
|
|
(32,254 |
) |
Net loss |
$ |
(52,147 |
) |
|
$ |
(98,158 |
) |
|
$ |
(274,880 |
) |
|
$ |
(344,681 |
) |
|
|
|
|
|
Net loss per common and potential common share: |
|
|
|
|
Basic and diluted |
$ |
(1.58 |
) |
|
$ |
(2.99 |
) |
|
$ |
(8.34 |
) |
|
$ |
(10.89 |
) |
|
|
|
|
|
Weighted average common and potential common shares
outstanding: |
|
|
|
|
Basic and diluted |
|
33,007 |
|
|
|
32,780 |
|
|
|
32,970 |
|
|
|
31,654 |
|
Condensed Consolidated Balance Sheet
Information(In
thousands)
|
December 31, 2020 |
|
December 31,2019 |
|
|
|
Cash, cash equivalents, restricted cash and investment debt
securities, available for sale |
$ |
477,170 |
|
|
$ |
657,347 |
Total assets |
$ |
580,489 |
|
|
$ |
754,886 |
Total liabilities (1) |
$ |
747,342 |
|
|
$ |
703,330 |
Stockholders’ (deficit) equity |
$ |
(166,853 |
) |
|
$ |
51,556 |
––––––––––––
(1) |
Includes $560.6 million and $532.1 million related to the 2023
Convertible Notes and the 2026 Convertible Notes (together, the
“Convertible Notes”) as of December 31, 2020 and December 31, 2019,
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
December 31, 2020, and December 31, 2019. |
Reconciliation of Non-GAAP Adjusted Operating Expenses
to Total Operating Expenses(Unaudited)(In
thousands)
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
Total operating expenses |
$ |
123,870 |
|
$ |
160,790 |
|
$ |
543,930 |
|
$ |
564,429 |
|
|
|
|
|
Adjustments: |
|
|
|
|
Stock-based compensation |
|
16,469 |
|
|
13,173 |
|
|
60,850 |
|
|
55,982 |
Depreciation |
|
836 |
|
|
824 |
|
|
3,118 |
|
|
3,663 |
Non-GAAP adjusted operating expenses |
$ |
106,565 |
|
$ |
146,793 |
|
$ |
479,962 |
|
$ |
504,784 |
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