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,
2021.
“Our results in Q3 2021 demonstrate the underlying strength of
our PBC business and we are raising sales guidance for Ocaliva,”
said Jerry Durso, President and Chief Executive Officer of
Intercept. “We are also lowering the top end of our operating
expense guidance as we focus on maintaining a strong cash position.
Additionally, we remain committed to generating important PBC data,
and look forward to sharing a late-breaking podium presentation at
The Liver Meeting® this month titled, ‘Patients with primary
biliary cholangitis treated with long-term obeticholic acid in a
trial-setting demonstrate better transplant-free survival than
external controls from the GLOBAL PBC and UK-PBC study
groups’.”
“As we approach 2022, we are also entering a pivotal phase for
our NASH clinical development program,” Durso continued. “We expect
topline results from the Phase 3 REVERSE study in compensated
cirrhosis due to NASH to be available near the end of the year. We
are also on track with compiling a new data package from the Phase
3 REGENERATE study in fibrosis due to NASH to support a potential
resubmission meeting with FDA in the first half of 2022. I’m
pleased with the progress our R&D team is making under the
leadership of Dr. Michelle Berrey and expect we will have the
necessary data to drive our strategic decisions and regulatory
dialogue. As we continue to advance our pipeline and explore
opportunities to leverage our strong commercial foundation,
Intercept is well positioned for success in 2022 and beyond.”
Financial Results
Revenue
- We recognized $92.8 million in total revenue in the
third quarter of 2021, as compared to $79.5 million in
total revenue in the prior year quarter. Ocaliva net sales in the
third quarter of 2021 were comprised of U.S. net sales
of $66.6 million and ex-U.S. net sales of $26.2
million, as compared to U.S. net sales of $58.6
million and ex-U.S. net sales of $20.9 million in
the prior year quarter.
Operating Expenses
- In the quarters ended September 30, 2021 and 2020, we recorded
$99.0 million and $134.7 million, respectively, in total operating
expenses and $89.6 million and $118.1 million, respectively, in
non-GAAP adjusted operating expenses, which excludes non-cash
stock-based compensation expense of $8.6 million and $15.8 million,
respectively, and depreciation expense of $0.8 million and $0.7
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.”
Cost of Sales
- Our cost of sales was $0.7 million in the third quarter of
2021, as compared to $1.8 million in the prior year quarter. Our
cost of sales for the quarters ended September 30, 2021 and 2020
consisted primarily of packaging, labeling, materials and related
expenses.
Sales, General & Administrative
Expenses
- Our selling, general and administrative expenses were $53.3
million in the third quarter of 2021, down from $70.6 million in
the prior year quarter. The decrease was primarily driven by
actions taken to decrease expenses relating to launch preparation
activities associated with the potential approval and
commercialization of OCA for liver fibrosis due to NASH.
Research & Development Expenses
- Our research and development expenses decreased to $45.0
million in the third quarter of 2021, down from $48.9 million in
the prior year quarter. The decrease was primarily driven by lower
personnel and development costs.
Interest Expense
- Interest expense for the quarters ended September 30, 2021
and 2020 was $14.1 million and $12.1 million,
respectively. For the three months ended September 30, 2021,
interest expense related to the Convertible Senior Secured Notes
due 2026 (the “2026 Convertible Secured Notes”) that we issued in
August 2021, the Convertible Senior Notes due 2026 (the “2026
Convertible Notes”) that we issued in May 2019 and the Convertible
Senior Notes due 2023 (the “2023 Convertible Notes”) that we issued
in July 2016. For the three months
ended September 30, 2020, interest expense related to the 2026
Convertible Notes and the 2023 Convertible Notes.
Net Loss
- In the third quarter of 2021 we reported a net loss of $3.6
million, a decrease compared to a net loss of $66.5 million in the
third quarter 2020.
Cash Position
- As of September 30, 2021, we had cash, cash equivalents,
restricted cash, and investment debt securities available for sale
of approximately $428.8 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.
Capital Structure
Convertible Notes Exchange, New Issuance, and Stock
Repurchase
In August 2021, we exchanged $306.5 million of 2023 Convertible
Notes and $114.7 million of 2026 Convertible Notes for $382.4
million of 2026 Convertible Secured Notes and sold $117.6 million
of new 2026 Convertible Secured Notes for cash. We issued
$500.0 million principal amount of new notes to participating
noteholders.
We also completed a buyback of approximately 4.5 million shares
of common stock for $75.8 million in cash.
Convertible Notes Repurchase
In September 2021, we repurchased $39.9 million of 2023
Convertible Notes for $38.1 million in cash. As a result of this
repurchase and the convertible notes exchange, the principal
balance of the 2023 Convertible Notes was reduced by approximately
75% to $113.7 million.
2021 Financial Guidance
We are increasing our full year 2021 worldwide
Ocaliva net sales guidance to $355 million to $370
million from $325 million to $340 million.
We are narrowing our full year
2021 non-GAAP adjusted operating expense guidance
to $380 million to $395 million from $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 November 3, 2021 at 8:30 a.m.
ET
We are hosting our third quarter 2021 financial results
conference call and webcast on November 3, 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 6266006. 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. 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 PRIMARY
BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS
-
Hepatic decompensation and failure, sometimes fatal or
resulting in liver transplant, have been reported with OCALIVA
treatment in primary biliary cholangitis (PBC) patients with either
compensated or decompensated cirrhosis.
-
OCALIVA is contraindicated in PBC patients with
decompensated cirrhosis, a prior decompensation event, or with
compensated cirrhosis who have evidence of portal
hypertension.
-
Permanently discontinue OCALIVA in patients who develop
laboratory or clinical evidence of hepatic decompensation; have
compensated cirrhosis and develop evidence of portal hypertension,
or experience clinically significant hepatic adverse reactions
while on treatment.
Contraindications
OCALIVA is contraindicated in patients with:
- decompensated
cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation
event
- compensated
cirrhosis who have evidence of portal hypertension (e.g., ascites,
gastroesophageal varices, persistent thrombocytopenia)
- complete biliary
obstruction
Warnings and Precautions
Hepatic Decompensation and Failure in PBC Patients with
Cirrhosis
Hepatic decompensation and failure, sometimes fatal or resulting
in liver transplant, have been reported with OCALIVA treatment in
PBC patients with cirrhosis, either compensated or decompensated.
Among postmarketing cases reporting it, median time to hepatic
decompensation (e.g. new onset ascites) was 4 months for patients
with compensated cirrhosis; median time to a new decompensation
event (e.g. hepatic encephalopathy) was 2.5 months for patients
with decompensated cirrhosis.
Some of these cases occurred in patients with decompensated
cirrhosis when they were treated with higher than the recommended
dosage for that patient population; however, cases of hepatic
decompensation and failure have continued to be reported in
patients with decompensated cirrhosis even when they received the
recommended dosage.
Hepatotoxicity was observed in the OCALIVA clinical trials. A
dose-response relationship was observed for the occurrence of
hepatic adverse reactions including jaundice, worsening ascites,
and primary biliary cholangitis flare with dosages of OCALIVA of 10
mg once daily to 50 mg once daily (up to 5-times the highest
recommended dosage), as early as one month after starting treatment
with OCALIVA in two 3-month, placebo-controlled clinical trials in
patients with primarily early stage PBC.
Routinely monitor patients for progression of PBC, including
hepatic adverse reactions, with laboratory and clinical assessments
to determine whether drug discontinuation is needed. Closely
monitor patients with compensated cirrhosis, concomitant hepatic
disease (e.g., autoimmune hepatitis, alcoholic liver disease),
and/or with severe intercurrent illness for new evidence of portal
hypertension (e.g., ascites, gastroesophageal varices, persistent
thrombocytopenia), or increases above the upper limit of normal in
total bilirubin, direct bilirubin, or prothrombin time to determine
whether drug discontinuation is needed. Permanently discontinue
OCALIVA in patients who develop laboratory or clinical evidence of
hepatic decompensation (e.g., ascites, jaundice, variceal bleeding,
hepatic encephalopathy), have compensated cirrhosis and develop
evidence of portal hypertension (e.g., ascites, gastroesophageal
varices, persistent thrombocytopenia), experience clinically
significant hepatic adverse reactions, or develop complete biliary
obstruction. If severe intercurrent illness occurs, interrupt
treatment with OCALIVA and monitor the patient’s liver function.
After resolution of the intercurrent illness, consider the
potential risks and benefits of restarting OCALIVA treatment.
Severe Pruritus
Severe pruritus was reported in 23% of patients in the OCALIVA
10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of
patients in the placebo arm in a 12-month double-blind randomized
controlled clinical trial of 216 patients. Severe pruritus was
defined as intense or widespread itching, interfering with
activities of daily living, or causing severe sleep disturbance, or
intolerable discomfort, and typically requiring medical
interventions. Consider clinical evaluation of patients with new
onset or worsening severe pruritus. Management strategies include
the addition of bile acid binding resins or antihistamines, OCALIVA
dosage reduction, and/or temporary interruption of OCALIVA
dosing.
Reduction in HDL-C
Patients with PBC generally exhibit hyperlipidemia characterized
by a significant elevation in total cholesterol primarily due to
increased levels of high-density lipoprotein-cholesterol (HDL-C).
Dose-dependent reductions from baseline in mean HDL-C levels were
observed at 2 weeks in OCALIVA-treated patients, 20% and 9% in the
10 mg and titration arms, respectively, compared to 2% in the
placebo arm. Monitor patients for changes in serum lipid levels
during treatment. For patients who do not respond to OCALIVA after
1 year at the highest recommended dosage that can be tolerated
(maximum of 10 mg once daily), and who experience a reduction in
HDL-C, weigh the potential risks against the benefits of continuing
treatment.
Adverse Reactions
The most common adverse reactions (≥5%) are: pruritus, fatigue,
abdominal pain and discomfort, rash, oropharyngeal pain, dizziness,
constipation, arthralgia, thyroid function abnormality, and
eczema.
Drug Interactions
- Bile Acid Binding
ResinsBile acid binding resins such as cholestyramine, colestipol,
or colesevelam adsorb and reduce bile acid absorption and may
reduce the absorption, systemic exposure, and efficacy of OCALIVA.
If taking a bile acid binding resin, take OCALIVA at least 4 hours
before or 4 hours after taking the bile acid binding resin, or at
as great an interval as possible.
- WarfarinThe
International Normalized Ratio (INR) decreased following
coadministration of warfarin and OCALIVA. Monitor INR and adjust
the dose of warfarin, as needed, to maintain the target INR range
when co-administering OCALIVA and warfarin.
- CYP1A2 Substrates
with Narrow Therapeutic IndexObeticholic acid may increase the
exposure to concomitant drugs that are CYP1A2 substrates.
Therapeutic monitoring of CYP1A2 substrates with a narrow
therapeutic index (e.g., theophylline and tizanidine) is
recommended when co-administered with OCALIVA.
- Inhibitors of Bile
Salt Efflux PumpAvoid concomitant use of inhibitors of the bile
salt efflux pump (BSEP) such as cyclosporine. Concomitant
medications that inhibit canalicular membrane bile acid
transporters such as the BSEP may exacerbate accumulation of
conjugated bile salts including taurine conjugate of obeticholic
acid in the liver and result in clinical symptoms. If concomitant
use is deemed necessary, monitor serum transaminases and
bilirubin.
Please click here for Full
Prescribing Information, including Boxed
WARNING.
To report SUSPECTED ADVERSE REACTIONS, contact Intercept
Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Cautionary Note Regarding Forward-Looking
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 our update to Ocaliva
prescribing information in May 2021 contraindicating Ocaliva for
patients with PBC and decompensated cirrhosis, a prior
decompensation event, or compensated cirrhosis with evidence of
portal hypertension; the initiation, timing, cost, conduct,
progress and results of our research and development activities,
preclinical studies and clinical trials, including any issues,
delays or failures in identifying patients, enrolling patients,
treating patients, retaining patients, meeting specific endpoints
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 interactions with regulators
(e.g., the FDA and the European Medicines Agency) regarding our
clinical trials; our ability to establish and maintain
relationships with, and the performance of, third-party
manufacturers, contract research organizations and other vendors
upon whom we are substantially dependent for, among other things,
the manufacture and supply of our products, including Ocaliva for
PBC and, if approved, OCA for liver fibrosis due to NASH, and our
clinical trial activities; our ability to identify, develop and
successfully commercialize our products and product candidates,
including our ability to successfully launch OCA for liver fibrosis
due to NASH, if approved; our ability to obtain and maintain
intellectual property protection for our products and product
candidates, including our ability to cost-effectively file,
prosecute, defend and enforce any patent claims or other
intellectual property rights; the size and growth of the markets
for our products and product candidates and our ability to serve
those markets; the degree of market acceptance of Ocaliva for PBC
and, if approved, OCA for liver fibrosis due to NASH or our other
product candidates among physicians, patients and healthcare
payors; the availability of adequate coverage and reimbursement
from governmental and private healthcare payors for our products,
including Ocaliva for PBC and, if approved, OCA for liver fibrosis
due to NASH, and our ability to obtain adequate pricing for such
products; our ability to establish and maintain effective sales,
marketing and distribution capabilities, either directly or through
collaborations with third parties; competition from existing drugs
or new drugs that become available; our ability to attract and
retain key personnel to manage our business effectively; our
ability to prevent or defend against system failures or security or
data breaches due to cyber-attacks, or cyber intrusions, including
ransomware, phishing attacks and other malicious intrusions; our
ability to comply with data protection laws; costs and outcomes
relating to any disputes, governmental inquiries or investigations,
regulatory proceedings, legal proceedings or litigation, including
any securities, intellectual property, employment, product
liability or other litigation; our collaborators’ election to
pursue research, development and commercialization activities; our
ability to establish and maintain relationships with collaborators
with development, regulatory and commercialization expertise; our
need for and ability to generate or obtain additional financing;
our estimates regarding future expenses, revenues and capital
requirements and the accuracy thereof; our use of cash, cash
equivalents and short-term investments; our ability to acquire,
license and invest in businesses, technologies, product candidates
and products; our ability to manage the growth of our operations,
infrastructure, personnel, systems and controls; our ability to
obtain and maintain adequate insurance coverage; continuing threats
from COVID-19, including additional waves of infections, and their
impacts including quarantines and other government actions, delays
relating to our regulatory applications, disruptions relating to
our ongoing clinical trials or involving our contract research
organizations, study sites or other clinical partners, disruptions
relating to our supply chain or involving our third-party
manufacturers, distributors or other distribution partners, and
facility closures or other restrictions, and 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:
Lisa DeFrancesco investors@interceptpharma.com
Christopher Fratesmedia@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, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
92,827 |
|
|
$ |
79,521 |
|
|
$ |
271,064 |
|
|
$ |
229,422 |
|
Total revenue |
|
92,827 |
|
|
|
79,521 |
|
|
|
271,064 |
|
|
|
229,422 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
658 |
|
|
|
1,826 |
|
|
|
2,086 |
|
|
|
4,555 |
|
Selling, general and administrative |
|
53,339 |
|
|
|
70,619 |
|
|
|
170,265 |
|
|
|
262,537 |
|
Research and development |
|
45,048 |
|
|
|
48,858 |
|
|
|
133,606 |
|
|
|
139,587 |
|
Restructuring |
|
2 |
|
|
|
13,381 |
|
|
|
(86 |
) |
|
|
13,381 |
|
Total operating expenses |
|
99,047 |
|
|
|
134,684 |
|
|
|
305,871 |
|
|
|
420,060 |
|
Operating loss |
|
(6,220 |
) |
|
|
(55,163 |
) |
|
|
(34,807 |
) |
|
|
(190,638 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(14,095 |
) |
|
|
(12,091 |
) |
|
|
(39,103 |
) |
|
|
(35,801 |
) |
Gain on extinguishment of debt |
|
16,511 |
|
|
|
- |
|
|
|
16,511 |
|
|
|
- |
|
Other income, net |
|
172 |
|
|
|
785 |
|
|
|
2,253 |
|
|
|
3,706 |
|
|
|
2,588 |
|
|
|
(11,306 |
) |
|
|
(20,339 |
) |
|
|
(32,095 |
) |
Net loss |
$ |
(3,632 |
) |
|
$ |
(66,469 |
) |
|
$ |
(55,146 |
) |
|
$ |
(222,733 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common and potential common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.11 |
) |
|
$ |
(2.01 |
) |
|
$ |
(1.69 |
) |
|
$ |
(6.76 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common and potential common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
31,736 |
|
|
|
32,989 |
|
|
|
32,679 |
|
|
|
32,957 |
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Information(In thousands) |
|
|
|
|
September 30, 2021 |
|
December 31,2020 (1) |
|
|
|
(Unaudited) |
|
Cash, cash equivalents, restricted cash and investment debt
securities, available for sale |
$ |
428,766 |
|
|
$ |
477,170 |
|
Total assets |
$ |
523,074 |
|
|
$ |
580,489 |
|
Total liabilities (2) |
$ |
679,104 |
|
|
$ |
747,342 |
|
Stockholders’ deficit |
$ |
(156,030 |
) |
|
$ |
(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 $530.4
million related to the 2023 Convertible Notes, 2026 Convertible
Notes and the 2026 Secured Convertible Notes (together, the
“Convertible Notes”) as of September 30, 2021 and $560.6 million
related to the 2023 Convertible Notes and 2026 Convertible Notes as
of December 31, 2020. Intercept separately accounts for the debt
and equity components of the Convertible Notes. The aggregate
outstanding principal amount of the Convertible Notes was $729.0
million as of September 30, 2021, and $690.0 million as of December
31, 2020. |
|
|
|
Reconciliation of Non-GAAP Adjusted Operating Expenses to
Total Operating Expenses(Unaudited)(In thousands) |
|
|
|
|
Three Months Ended September
30, |
Nine Months Ended September
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Total operating expenses |
$ |
99,047 |
|
$ |
134,684 |
|
$ |
305,871 |
|
$ |
420,060 |
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
8,616 |
|
|
15,825 |
|
|
25,483 |
|
|
44,381 |
Depreciation |
|
808 |
|
|
710 |
|
|
2,557 |
|
|
2,282 |
Non-GAAP adjusted operating expenses |
$ |
89,623 |
|
$ |
118,149 |
|
$ |
277,831 |
|
$ |
373,397 |
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