Positive topline results from pivotal Phase 3
REGENERATE study of obeticholic acid in patients with liver
fibrosis due to NASH: the largest and first successful pivotal
Phase 3 NASH study
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, 2018.
“This past year was a great year of execution against our key
strategic priorities in our Phase 3 NASH program and our PBC
commercial efforts,” said Mark Pruzanski, M.D., President and Chief
Executive Officer of Intercept. “We were thrilled to recently
report positive topline data from our pivotal Phase 3 REGENERATE
study, with OCA clearly meeting the study’s primary objective by
demonstrating its anti-fibrotic benefit in patients with NASH,
truly a first in the field. We intend to file for regulatory
approval in the U.S. and Europe in the second half of this year and
believe that the REGENERATE results support our long-held
conviction that OCA will become the first approved medicine and
backbone therapy for those living with liver fibrosis due to NASH.
This underscores our ongoing commitment to drive scientific
innovation to address the unmet medical needs of patients with
progressive non-viral liver diseases, both large and small.”
Ocaliva® (obeticholic acid or OCA) Commercial
Highlights
We recognized $52.9 million of Ocaliva net sales in the fourth
quarter of 2018, as compared to $37.3 million in the prior year
quarter. Ocaliva net sales in the fourth quarter of 2018 were
comprised of U.S. net sales of $41.1 million and ex-U.S. net sales
of $11.8 million, as compared to U.S. net sales of $32.0 million
and ex-U.S. net sales of $5.3 million in the prior year
quarter.
Full year 2018 Ocaliva net sales were $177.8 million, as
compared to $129.2 million in 2017. Ocaliva net sales in 2018 were
comprised of U.S. net sales of $140.8 million and ex-U.S. net sales
of $37.0 million, as compared to U.S. net sales of $115.8 million
and ex-U.S. net sales of $13.4 million in 2017.
Ocaliva was approved in the United States by the U.S. Food and
Drug Administration (“FDA”) in May 2016 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. We
commenced sales and marketing of Ocaliva in the United States
shortly after receiving marketing approval, and Ocaliva is now
available to patients primarily through a network of specialty
pharmacy distributors.
Ocaliva was granted conditional approval by the European
Commission in December 2016 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, and we commenced our
European commercial launch in January 2017. Since January 2017,
Ocaliva has also received regulatory approval in several of our
target markets outside the United States and Europe, including
Canada, Israel and Australia.
Selected Fourth Quarter and Full Year 2018 Financial
Results
Revenues
We recognized $53.3 million in total revenue in the fourth
quarter of 2018, as compared to $37.7 million in total revenue in
the prior year quarter. Total revenue in the fourth quarter of 2018
included $52.9 million of Ocaliva net sales and approximately $0.4
million of licensing revenue, as compared to $37.3 million and
approximately $0.4 million, respectively, in the prior year
quarter.
We recognized $179.8 million in total revenue in 2018, as
compared to $131.0 million in 2017. Total revenue in 2018 included
$177.8 million of Ocaliva net sales and approximately $2.0 million
of licensing revenue, as compared to $129.2 million and
approximately $1.8 million, respectively, in 2017. Included in
total revenue in 2017 was $4.1 million of previously deferred
revenue recognized in connection with our adoption of a sell-in
basis revenue recognition policy in 2017.
Operating Expenses
Our cost of sales was $1.0 million in the fourth quarter of
2018, as compared to $0.8 million in the prior year quarter. Cost
of sales was $2.5 million in 2018, as compared to $1.4 million in
2017. Our cost of sales for the quarters and years ended December
31, 2018 and 2017 consisted primarily of packaging and labeling
expenses.
Our selling, general and administrative expenses decreased to
$71.0 million in the fourth quarter of 2018, down from $84.3
million in the prior year quarter. Selling, general and
administrative expenses decreased to $255.5 million in 2018, down
from $273.7 million in 2017. The fourth quarter and full year
period-over-period decreases were both primarily driven by a lease
termination fee and restructuring-related charges incurred in
December 2017.
Our research and development expenses increased to $63.3 million
in the fourth quarter of 2018, up from $57.5 million in the prior
year quarter. Research and development expenses increased to $207.3
million in 2018, up from $191.5 million in 2017. The fourth quarter
and full year period-over-period increases were both primarily
driven by a $9.0 million payment made in December 2018 in
connection with our acquisition from Aralez Pharmaceuticals Canada
Inc. of its license to develop and commercialize bezafibrate in the
United States.
In the quarters ended December 31, 2018 and 2017, we recorded
$135.3 million and $142.7 million, respectively, in total operating
expenses and $122.7 million and $125.9 million, respectively, in
non-GAAP adjusted operating expenses, which excludes non-cash
stock-based compensation expense of $11.5 million and $15.4
million, respectively, and depreciation expense of $1.0 million and
$1.3 million, respectively.
In the years ended December 31, 2018 and 2017, we recorded
$465.3 million and $466.6 million, respectively, in total operating
expenses and $410.8 million and $405.0 million, respectively, in
non-GAAP adjusted operating expenses, which excludes non-cash
stock-based compensation expense of $49.9 million and $57.0
million, respectively, and depreciation expense of $4.6 million and
$4.6 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, 2018 and
2017 was $7.8 million and $7.4 million, respectively. Interest
expense in the years ended December 31, 2018 and 2017 was $30.5
million and $29.3 million, respectively. Our interest expense is
related to the $460.0 million aggregate principal amount of 3.25%
Convertible Senior Notes due 2023 (the “Convertible Notes”) that we
issued in July 2016. Net Loss
In the fourth quarter and full year 2018, we reported a net loss
of $88.0 million and $309.2 million, respectively, down from a net
loss of $111.3 million and $360.4 million in the fourth quarter and
full year 2017.
Cash Position
As of December 31, 2018, we had cash, cash equivalents and
investment securities available for sale of approximately $436.2
million. As of December 31, 2017, we had cash, cash equivalents and
investment securities available for sale of approximately $414.9
million.
2019 Financial
Guidance
We are announcing our 2019 Ocaliva net sales guidance range of
between $225 million and $240 million. In addition, we are
announcing our 2019 non-GAAP adjusted operating expenses guidance
range of between $450 million and $470 million, which includes
expected resources to support our NASH filing and launch
preparation activities. 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 28, 2019 at 8:30 a.m.
ET
We are hosting our fourth quarter and full year 2018 financial
results conference call and webcast on Thursday, February 28, 2019
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) five minutes
prior to the start time (no passcode is required). 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.
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 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 accelerated approval 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
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 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 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
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 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 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
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 from subjects taking OCALIVA
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 development candidates, including OCA for
NASH, the timing and acceptance of our potential regulatory filings
and potential approval of OCA for NASH or any other indications in
addition to PBC, the timing and potential commercial success of OCA
and any other product candidates we may develop and our strategy,
future operations, future financial position, future revenue,
projected costs, financial guidance, prospects, plans, objectives
of management and expected market growth.
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; 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, 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; our ability to timely and cost-effectively file
for and obtain regulatory approval of our product candidates,
including OCA for NASH, in the United States, Europe and our other
target markets; conditions that may be imposed by regulatory
authorities on our marketing approvals for our products and product
candidates, such as the need for clinical outcomes data (and not
just results based on achievement of a surrogate endpoint), 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 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; 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 NASH, and our clinical
trial activities; our ability to identify, develop and successfully
commercialize our products and product candidates, including our
ability to timely and successfully launch OCA for 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 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 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, 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
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, 2017.
Contact
For more information about Intercept, please contact:
Mark Vignola+1-646-747-1000investors@interceptpharma.com
Christopher Frates+1-646-757-2371media@interceptpharma.com
Intercept Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations(In thousands, except per share data)
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
Product revenue,
net |
$ |
52,874 |
|
$ |
37,242 |
|
$ |
177,782 |
|
$ |
129,175 |
|
Licensing revenue |
|
406 |
|
|
445 |
|
|
2,022 |
|
|
1,781 |
|
Total
revenue |
|
53,280 |
|
|
37,687 |
|
|
179,804 |
|
|
130,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Cost of
sales |
|
1,007 |
|
|
823 |
|
|
2,519 |
|
|
1,371 |
|
Selling, general
and administrative |
|
70,971 |
|
|
84,335 |
|
|
255,474 |
|
|
273,698 |
|
Research and
development |
|
63,273 |
|
|
57,498 |
|
|
207,301 |
|
|
191,499 |
|
Total operating expenses |
|
135,251 |
|
|
142,656 |
|
|
465,294 |
|
|
466,568 |
|
Operating loss |
|
(81,971) |
|
|
(104,969) |
|
|
(285,490) |
|
|
(335,612) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
Interest
expense |
|
(7,754) |
|
|
(7,431) |
|
|
(30,523) |
|
|
(29,271) |
|
Other income,
net |
|
1,720 |
|
|
1,128 |
|
|
6,771 |
|
|
4,516 |
|
|
|
(6,034) |
|
|
(6,303) |
|
|
(23,752) |
|
|
(24,755) |
|
Net loss |
$ |
(88,005) |
|
$ |
(111,272) |
|
$ |
(309,242) |
|
$ |
(360,367) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common and
potential common share: |
|
|
|
|
|
Basic and
diluted |
$ |
(2.97) |
|
$ |
(4.43) |
|
$ |
(10.86) |
|
$ |
(14.38) |
|
|
|
|
|
|
|
Weighted average common
and potential commonshares outstanding: |
|
|
|
|
|
Basic and
diluted |
|
29,674 |
|
|
25,146 |
|
|
28,464 |
|
|
25,054 |
|
Condensed Consolidated Balance Sheet
Information(In thousands)
|
December 31, |
|
December 31, |
|
2018 |
|
2017 |
|
|
|
Cash, cash equivalents
and investment securities |
$ |
436,160 |
|
$ |
414,917 |
Total assets |
$ |
509,167 |
|
$ |
484,347 |
Deferred revenue,
total |
$ |
2,432 |
|
$ |
4,454 |
Total liabilities
(1) |
$ |
490,037 |
|
$ |
467,961 |
Stockholders’
equity |
$ |
19,130 |
|
$ |
16,386 |
(1) |
|
|
Includes $371.2 million
and $355.7 million related to the Convertible Notes as of December
31, 2018 and 2017, respectively. Intercept separately accounts for
the debt and equity components of the Convertible Notes. The
aggregate outstanding principal amount of the Convertible Notes was
$460.0 million as of December 31, 2018 and 2017. |
|
|
|
|
Reconciliation of Non-GAAP Adjusted Operating Expenses
to Total Operating Expenses(Unaudited)(In thousands)
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
Total operating
expenses |
$ |
135,251 |
|
$ |
142,656 |
|
$ |
465,294 |
|
$ |
466,568 |
|
|
|
|
|
Adjustments: |
|
|
|
|
Stock-based
compensation |
|
11,499 |
|
|
15,384 |
|
|
49,914 |
|
|
56,968 |
Depreciation |
|
1,031 |
|
|
1,345 |
|
|
4,582 |
|
|
4,601 |
Non-GAAP adjusted
operating expenses |
$ |
122,721 |
|
$ |
125,927 |
|
$ |
410,798 |
|
$ |
404,999 |
Intercept Pharmaceuticals (NASDAQ:ICPT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Intercept Pharmaceuticals (NASDAQ:ICPT)
Historical Stock Chart
From Apr 2023 to Apr 2024