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 September 30,
2020.
“We were pleased to reengage with FDA at our recent Type A
end-of-review meeting to discuss the Agency’s benefit-risk
assessment in the CRL based on its review of the available data, as
well as our proposed way forward to resubmitting our NDA for OCA in
NASH fibrosis,” said Mark Pruzanski, M.D., President and Chief
Executive Officer of Intercept. “The meeting was constructive and
FDA has provided us with helpful guidance regarding supplemental
data we can provide to further characterize OCA’s efficacy and
safety profile that could support resubmission based on our Phase 3
REGENERATE 18-month biopsy data, together with a safety update from
our ongoing studies. We are advancing accordingly and plan to hold
additional meetings with the Agency with the goal of achieving
sufficient alignment to proceed on this basis and potentially
resubmit our NDA next year. Of note, the REGENERATE outcomes
phase is ongoing and our Phase 3 REVERSE study in NASH
patients with compensated cirrhosis is expected to read
out by the end of next year. We continue to lead the
NASH field and believe that, if approved, OCA has the potential to
become an important treatment for patients with advanced fibrosis
due to NASH. Meanwhile, our PBC business continued its strong
performance in the third quarter and we have updated our 2020
financial guidance with anticipated Ocaliva net sales of
$310 to $320 million and non-GAAP adjusted operating expenses of
$460 to $480 million, providing us with a strong financial footing
for the future.”
Ocaliva®
(obeticholic acid)
Commercial Highlights
We recognized $79.5 million of Ocaliva net sales in
the third quarter of 2020, as compared to $61.5 million in the
prior year quarter. Ocaliva net sales in the third quarter of 2020
were comprised of U.S. net sales of $58.6 million and
ex-U.S. net sales of $20.9 million, as compared to U.S. net
sales of $45.2 million and ex-U.S. net sales
of $16.3 million in the prior year quarter.
Selected Third Quarter
2020 Financial Results
Revenues
We recognized $79.5 million in total revenue in the
third quarter of 2020, as compared to $61.9 million in
total revenue in the prior year quarter. Total revenue in the third
quarter of 2019 included approximately $0.4 million of
licensing revenue.
Operating Expenses
Our cost of sales was $1.8 million in the third
quarter of 2020, as compared to $0.5 million in the prior
year quarter. Our cost of sales for the quarters
ended September 30, 2020 and 2019 consisted primarily of
packaging, labeling, materials and related expenses.
Our selling, general and administrative expenses decreased
to $70.6 million in the third quarter of 2020,
from $76.8 million in the prior year quarter. The
decrease was primarily driven by reductions in spend resulting from
the delay of the potential approval and commercialization of
obeticholic acid (OCA) for liver fibrosis due to nonalcoholic
steatohepatitis (NASH).
Our research and development expenses decreased to $48.9
million in the third quarter of 2020, from $60.2
million in the prior year quarter. The decrease was primarily
driven by lower NASH development costs, including the conclusion of
enrollment activities for the REGENERATE and REVERSE studies and
reduced costs related to our preparations for regulatory
interactions.
Restructuring expenses were $13.4 million and $0 for the three
months ended September 30, 2020 and 2019, respectively. The
increase between periods was driven primarily by severance costs
and other related termination benefits incurred in conjunction with
the previously announced plan to reduce workforce in response to
the receipt of the complete response letter.
In the quarters ended September 30, 2020 and 2019, we
recorded $134.7 million and $137.5 million,
respectively, in total operating expenses and $118.1
million and $123.4 million, respectively, in non-GAAP
adjusted operating expenses, which excludes non-cash stock-based
compensation expense of $15.8 million and $13.1
million, respectively, and depreciation expense of $0.7
million and $0.9 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 September 30,
2020 and 2019 was $12.1 million and $11.8
million, respectively. For the quarter ended September 30, 2020,
interest expense related to the $460.0 million aggregate
principal amount of 3.25% Convertible Senior Notes due 2023 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 third quarter of 2020 we reported a net loss
of $66.5 million, a decrease compared to a net loss
of $84.8 million in the third quarter 2019.
Cash Position
As of September 30, 2020, we had cash, cash equivalents,
restricted cash, and investment debt securities available for sale
of approximately $496.8 million. As of December 31, 2019, we had
cash, cash equivalents, restricted cash, and investment debt
securities available for sale of approximately $657.3 million.
2020 Financial Guidance
We are updating our 2020 Ocaliva net sales guidance to narrow
the range at the upper end of our previously announced guidance,
and now anticipate Ocaliva net sales of $310 million to $320
million. We are also updating our non-GAAP adjusted operating
expenses guidance to narrow the range at the lower end of the
previously announced guidance, and now anticipate non-GAAP adjusted
operating expenses of $460 million to $480 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 November
9, 2020 at 8:30 a.m.
ET
We are hosting our third quarter 2020 financial results
conference call and webcast on November 9, 2020 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 3798851. 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; 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;
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
June 30, 2020.
Contact
For more information about Intercept, please contact:
Lisa DeFrancesco+1-646-565-4833investors@interceptpharma.com
Christopher Frates+1-646-757-2371media@interceptpharma.com
Intercept Pharmaceuticals,
Inc.Condensed Consolidated Statements of
Operations(Unaudited)(In thousands, except per share
data)
|
|
Three Months Ended
September
30, |
|
|
Nine Months
Ended September
30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
79,521 |
|
|
$ |
61,545 |
|
|
$ |
229,422 |
|
|
$ |
179,286 |
|
Licensing revenue |
|
- |
|
|
|
405 |
|
|
|
- |
|
|
|
1,216 |
|
Total revenue |
|
79,521 |
|
|
|
61,950 |
|
|
|
229,422 |
|
|
|
180,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
1,826 |
|
|
|
487 |
|
|
|
4,555 |
|
|
|
1,738 |
|
Selling, general and administrative |
|
70,619 |
|
|
|
76,828 |
|
|
|
262,537 |
|
|
|
223,738 |
|
Research and development |
|
48,858 |
|
|
|
60,168 |
|
|
|
139,587 |
|
|
|
178,163 |
|
Restructuring |
|
13,381 |
|
|
|
- |
|
|
|
13,381 |
|
|
|
- |
|
Total operating expenses |
|
134,684 |
|
|
|
137,483 |
|
|
|
420,060 |
|
|
|
403,639 |
|
Operating loss |
|
(55,163 |
) |
|
|
(75,533 |
) |
|
|
(190,638 |
) |
|
|
(223,137 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(12,091 |
) |
|
|
(11,795 |
) |
|
|
(35,801 |
) |
|
|
(29,518 |
) |
Other income, net |
|
785 |
|
|
|
2,495 |
|
|
|
3,706 |
|
|
|
6,132 |
|
|
|
(11,306 |
) |
|
|
(9,300 |
) |
|
|
(32,095 |
) |
|
|
(23,386 |
) |
Net loss |
$ |
(66,469 |
) |
|
$ |
(84,833 |
) |
|
$ |
(222,733 |
) |
|
$ |
(246,523 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common and
potential common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(2.01 |
) |
|
$ |
(2.59 |
) |
|
$ |
(6.76 |
) |
|
$ |
(7.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common and
potential common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
32,989 |
|
|
|
32,717 |
|
|
|
32,957 |
|
|
|
31,275 |
|
Condensed Consolidated Balance Sheet
Information(In thousands)
|
|
September
30,
2020 |
|
|
|
December 31,2019
(1) |
|
|
|
(Unaudited) |
|
|
|
|
|
Cash, cash equivalents,
restricted cash and investment debt securities, available for
sale |
$ |
496,760 |
|
|
$ |
657,347 |
|
Total assets |
$ |
591,352 |
|
|
$ |
754,886 |
|
Total liabilities (2) |
$ |
721,639 |
|
|
$ |
703,330 |
|
Stockholders’ (deficit)
equity |
$ |
(130,287 |
) |
|
$ |
51,556 |
|
______________
(1) |
Derived from the audited financial statements included in
Intercept’s Annual Report on Form 10-K for the year ended December
31, 2019 |
(2) |
Includes $553.2 million and $532.1 million related to the 2023
Convertible Notes and the 2026 Convertible Notes (together, the
“Convertible Notes”) as of September 30, 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 September 30, 2020, and December 31, 2019. |
Reconciliation of Non-GAAP Adjusted Operating Expenses
to Total Operating Expenses(Unaudited)(In thousands)
|
Three Months Ended September
30, |
|
Nine Months
Ended September
30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Total operating expenses |
$ |
134,684 |
|
|
$ |
137,483 |
|
|
$ |
420,060 |
|
|
$ |
403,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
15,825 |
|
|
|
13,130 |
|
|
|
44,381 |
|
|
|
42,809 |
|
Depreciation |
|
710 |
|
|
|
914 |
|
|
|
2,282 |
|
|
|
2,839 |
|
Non-GAAP adjusted operating
expenses |
$ |
118,149 |
|
|
$ |
123,439 |
|
|
$ |
373,397 |
|
|
$ |
357,991 |
|
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