Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat rare and serious liver diseases, today
announced its financial results for the quarter ended on June 30,
2023.
“Intercept delivered strong double-digit growth of Ocaliva for
the fourth consecutive quarter and made considerable progress with
the OCA-bezafibrate combination program, including presenting
positive new data that suggest best-in-class potential,” said Jerry
Durso, President and Chief Executive Officer of Intercept. “Our
exceptional execution in PBC, coupled with the implementation of
our restructuring plan to significantly reduce costs, has Intercept
well on the way toward quickly achieving profitability while
advancing our leadership position in rare and serious liver
diseases.”
Selected Second Quarter 2023 Highlights
Revenue
- Intercept recognized $83.7 million in net sales in the second
quarter 2023, representing 17% growth compared to $71.8 million in
net sales in the prior year quarter.
Operating Expenses
- In the quarter ended June 30, 2023, Intercept recorded $90.8
million in total operating expenses and $84.5 million in non-GAAP
adjusted operating expenses, which excludes non-cash stock-based
compensation expense of $6.2 million and depreciation expense of
$0.1 million. This compares to the quarter ended on June 30, 2022,
where Intercept recorded $85.1 million in total operating expenses
and $79.6 million in non-GAAP adjusted operating expenses, which
excluded non-cash stock-based compensation expense of $5.4 million
and depreciation expense of $0.1 million.
- Selling, general and administrative expenses increased to $53.3
million in the second quarter of 2023, from $40.0 million in the
prior year quarter. The increase was primarily driven by investment
in NASH launch preparation costs.
- Research and development expenses decreased to $37.3 million in
the second quarter of 2023, from $44.8 million in the prior year
quarter. The decrease was primarily driven by the completion of the
REVERSE study and R&D cost-sharing reimbursements.
- 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 June 30,
2023, and 2022 was $2.8 million and $6.7
million, respectively. For the quarters ended June 30, 2023 and
2022, interest expense was related to our Convertible Notes.
Net Loss
- In the second quarter 2023, Intercept reported a net loss from
continuing operations of $5.8 million, a decrease compared to a net
loss from continuing operations of $20.3 million in the second
quarter 2022.
Cash Position
- As of June 30, 2023, Intercept had cash, cash equivalents,
restricted cash, and investment debt securities available for sale
of $415.0 million. As of December 31, 2022, Intercept had cash,
cash equivalents, restricted cash, and investment debt securities
available for sale of approximately $490.9 million.
- The 2023 Convertible Notes matured on July 1, 2023, upon which
the Company made a cash repayment for the total principal amount
due of $109.8 million.
2023 Financial Guidance
- Intercept has updated its full-year 2023 Ocaliva® net sales
guidance to $320-$340 million from $310-$340 million.
- In June 2023, the Company lowered 2023 non-GAAP adjusted
operating expense guidance to $350-$370 million, inclusive of
restructuring costs.
- The Company remains on track to achieve an expected net
reduction in annual non-GAAP adjusted operating expenses of
approximately $140 million – relative to updated 2023 non-GAAP
adjusted operating expense guidance.
Corporate Restructuring
- In June 2023, Intercept announced an organizational
restructuring to significantly reduce operating expenses, including
discontinuing all nonalcoholic steatohepatitis (NASH)-related
investment.
- The Company has initiated its workforce reduction, which
affects most areas of the company, and anticipates completing the
majority of measures by the end of this year. The Company has
completed the first wave of notifications, which impacts commercial
and general & administrative functions. Intercept plans to
maintain the scale of its current field sales organization to
support the growth potential of Ocaliva.
- The Company continues to make progress in closing out the
REGENERATE study. The closeout process is being actively
implemented. REGENERATE trial sites have been notified and the
process is expected to be substantially completed by the end of
this year.
Primary Biliary Cholangitis (PBC)
- Intercept’s combination program for OCA, a farnesoid X receptor
(FXR) agonist, and bezafibrate, a pan-peroxisome
proliferator-activated receptor (pan-PPAR) agonist, has made
considerable progress. The Company has now completed enrollment of
both Phase 2 studies (747-213 / NCT04594694, 747-214 / NCT05239468)
that are exploring a range of therapeutic doses for the combination
of OCA and bezafibrate.
- On June 23rd, Intercept shared new data at the 2023 European
Association for the Study of the Liver (EASL) Congress from a
planned interim analysis of Phase 2 study 747-213 assessing
improvements in serum biomarkers of cholestasis in patients with
PBC after treatment with OCA and bezafibrate. Results showed that
the combination of OCA 5-10 mg and bezafibrate 400 mg was effective
in normalizing key biochemical markers associated with PBC-induced
liver damage.
- The Company expects to have the necessary data from the
OCA-bezafibrate combination program to submit a request in 2023 for
an End-of-Phase 2 meeting with the FDA. These data include analyses
from both Phase 2 studies, in addition to Phase 1 and preclinical
data.
- Intercept remains on track for its sNDA submission to the FDA
this year in support of fulfilling post-marketing requirements for
Ocaliva in PBC. This submission will include data from the
Company’s post-marketing study, COBALT, and supplementary
real-world evidence from large datasets in the U.S. and
Europe.
Pipeline
- The Company continues to progress its FRESH (FXR Effect on
Severe Alcohol-Associated Hepatitis) study, a Phase 2a trial
evaluating the safety, tolerability, efficacy and pharmacokinetics
of INT-787 in patients with severe alcohol-associated hepatitis
(sAH).
Conference Call on August 2, 2023, at 8:30
a.m. ETThe conference call and webcast discussing the
Company’s second quarter 2023 financial results will take place
on August 2, 2023, at 8:30 a.m. ET. The conference call
will be available via a listen-only webcast on the investor page of
our website at http://ir.interceptpharma.com. Participants who
wish to ask a question may register here to receive dial-in
numbers and a unique pin to join the call. A replay of the call
will be available on our website shortly following the completion
of the call and will be available for one year.
About InterceptIntercept is a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat rare and serious liver diseases, including
primary biliary cholangitis (PBC) and severe alcohol-associated
hepatitis (sAH). For more information, please
visit www.interceptpharma.com or connect with the Company
on Twitter and LinkedIn.
Non-GAAP Financial MeasuresThis 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 the Investigational OCA-bezafibrate Fixed-Dose
CombinationIntercept is investigating a fixed-dose
combination of OCA and bezafibrate for the potential treatment of
individuals with PBC. OCA, a farnesoid X receptor (FXR) agonist, is
marketed by Intercept as Ocaliva in the United States for
the treatment of PBC (see below for full indication and Important
Safety Information). Bezafibrate, a pan-peroxisome
proliferator-activated receptor (pan-PPAR) agonist, is not approved
in the United States for any indication.
FXR and PPAR are distinct pathways that each play a role in PBC.
Simultaneously targeting both pathways may offer the greatest
potential to impact bile acid synthesis, metabolism, and clearance
that underly cholestatic liver diseases. Published studies
establish a clinical proof-of-concept which suggests that the
combination of OCA and bezafibrate may provide additive clinical
efficacy and tolerability benefits in the treatment of PBC.
OCA-bezafibrate combination therapy is investigational; safety and
efficacy have not been established.
About Primary Biliary CholangitisPrimary
biliary cholangitis (PBC) is a rare, progressive and chronic
autoimmune disease that affects the bile ducts in the liver and is
most prevalent (approximately 1 in 10,000) in women over the age of
40. PBC causes bile acid to build up in the liver, resulting in
inflammation and scarring (fibrosis), which, if left untreated, can
lead to cirrhosis, a liver transplant, or death.
About
Ocaliva® (obeticholic
acid)OCALIVA, a farnesoid X receptor (FXR) agonist, is
indicated for the treatment of adult patients with primary biliary
cholangitis (PBC)
- without cirrhosis or
- with compensated cirrhosis who do not have evidence of portal
hypertension,
either in combination with ursodeoxycholic acid (UDCA) with an
inadequate response to UDCA or as monotherapy in patients unable to
tolerate UDCA.
This indication is approved under accelerated approval based on
a reduction in alkaline phosphatase (ALP). 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.
IMPORTANT SAFETY INFORMATION
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
CirrhosisHepatic 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 post-marketing 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 PruritusSevere 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-CPatients 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 ReactionsThe 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;
- the safety and efficacy of our approved product, Ocaliva
(obeticholic acid or “OCA”) for primary biliary cholangitis
(“PBC”), and our product candidates;
- the timing, acceptance, review, feedback, and potential
approval for our regulatory filings with the U.S. Food and Drug
Administration (the “FDA”) or other regulators;
- the commercial prospects of our products or product
candidates;
- our planned corporate restructuring; and
- 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 their dates, 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:
- the success of our existing business and operations, including
Ocaliva for PBC;
- our ability to successfully commercialize our products and
product candidates;
- our ability to maintain our regulatory approval of Ocaliva for
PBC;
- our ability to timely and cost-effectively file for and obtain
regulatory approval of our product candidates on an accelerated
basis or at all;
- any advisory committee recommendation or dispute resolution
determination that any of our products or product candidates should
not be approved, or should be approved only under certain
conditions;
- any future determination that the regulatory applications and
subsequent information that we submit for our products and product
candidates 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, 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 Risk Evaluation and Mitigation Strategies
(“REMS”) program, and any related restrictions, limitations, and/or
warnings contained in the labels of any of our products or product
candidates;
- any potential side effects associated with Ocaliva for PBC or
our other products or 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, or completing and
timely reporting the results of our clinical trials;
- the outcomes of interactions with regulators, including the
FDA, 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 our clinical trial
activities;
- our ability to identify, develop, and successfully
commercialize our products and product candidates;
- 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 or our other
products or 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 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 our operations, infrastructure,
personnel, systems, and controls, including our planned corporate
restructuring;
- our ability to obtain and maintain adequate insurance
coverage;
- the impact of general economic, industry, market, regulatory,
or political conditions;
- how we use our cash on hand, as well as cash equivalents and
investment securities;
- disagreements or legal, operational, or other business problems
arising from our ongoing relationship with Advanz Pharma and its
affiliates (collectively, “Advanz”), the purchaser of our ex-U.S.
business, including the licensing of the ex-U.S. rights to Ocaliva
for PBC, our operational separation from our former ex-U.S.
commercial operations, and our agreement to supply Advanz with
OCA;
- unexpected tax, regulatory, litigation, or other
liabilities;
- whether we receive any future earn-outs under the transaction
documents with Advanz; and
- the other risks and uncertainties identified in our periodic
filings filed with the U.S. Securities and Exchange
Commission (the “SEC”), including our latest Annual Report on
Form 10-K and/or Quarterly Report on Form 10-Q.
Contact
For more information about Intercept, please contact:
For investors:Nareg Sagherian, Executive Director, Global
Investor Relationsinvestors@interceptpharma.com
For media:Karen Preble, Executive Director, Global
Corporate Communicationsmedia@interceptpharma.com
Intercept Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited) (In thousands, except per share data)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
|
Product revenue, net |
$ |
83,718 |
|
|
$ |
71,757 |
|
|
$ |
151,676 |
|
|
$ |
130,903 |
|
Total revenue |
|
83,718 |
|
|
|
71,757 |
|
|
|
151,676 |
|
|
|
130,903 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of sales |
|
185 |
|
|
|
309 |
|
|
|
407 |
|
|
|
532 |
|
Selling, general and administrative |
|
53,346 |
|
|
|
39,985 |
|
|
|
111,003 |
|
|
|
77,739 |
|
Research and development |
|
37,306 |
|
|
|
44,826 |
|
|
|
79,017 |
|
|
|
92,719 |
|
Total operating expenses |
|
90,837 |
|
|
|
85,120 |
|
|
|
190,427 |
|
|
|
170,990 |
|
Operating loss |
|
(7,119 |
) |
|
|
(13,363 |
) |
|
|
(38,751 |
) |
|
|
(40,087 |
) |
|
|
|
|
|
Other income (expense): |
|
|
|
|
Interest expense |
|
(2,812 |
) |
|
|
(6,669 |
) |
|
|
(5,621 |
) |
|
|
(13,342 |
) |
Other income (expense), net |
|
4,105 |
|
|
|
(289 |
) |
|
|
6,665 |
|
|
|
(342 |
) |
Loss from continuing operations |
$ |
(5,826 |
) |
|
$ |
(20,321 |
) |
|
$ |
(37,707 |
) |
|
$ |
(53,771 |
) |
(Loss)/Income from discontinued operations |
$ |
(36 |
) |
|
$ |
12,793 |
|
|
$ |
(290 |
) |
|
$ |
28,959 |
|
Net loss |
$ |
(5,862 |
) |
|
$ |
(7,528 |
) |
|
$ |
(37,997 |
) |
|
$ |
(24,812 |
) |
|
|
|
|
|
Net income/(loss) per common and potential common share: |
|
|
|
|
Net loss from continuing operations |
$ |
(0.14 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.81 |
) |
Net (loss)/income from discontinued operations |
$ |
- |
|
|
$ |
0.43 |
|
|
$ |
(0.01 |
) |
|
$ |
0.97 |
|
Net loss |
$ |
(0.14 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.91 |
) |
|
$ |
(0.83 |
) |
|
|
|
|
|
Weighted average common and potential common shares
outstanding: |
|
|
|
|
Basic and diluted |
|
41,731 |
|
|
|
29,747 |
|
|
|
41,700 |
|
|
|
29,721 |
|
|
|
|
|
|
Condensed Consolidated Balance Sheet
Information(Unaudited)(In thousands)
|
June 30,2023 |
|
December 31,2022 (1) |
Cash, cash equivalents, restricted cash and investment debt
securities, available for sale |
$ |
414,991 |
|
|
$ |
490,909 |
|
Total assets |
$ |
484,635 |
|
|
$ |
553,711 |
|
Total liabilities (2) |
$ |
417,089 |
|
|
$ |
460,634 |
|
Stockholders’ equity (deficit) |
$ |
67,546 |
|
|
$ |
93,077 |
|
____________________
(1) |
|
Derived from
the financial statements included in Intercept's Annual Report on
Form 10-K for the period ended December 31, 2022. |
(2) |
|
Includes $333.4 million and $332.7 million related to the 2023
Convertible Notes, 2026 Convertible Notes and the 2026 Secured
Convertible Notes (together, the “Convertible Notes”) as of June
30, 2023 and December 31, 2022, respectively. The aggregate
outstanding principal amount of the Convertible Notes was $336.3
million as of June 30, 2023 and December 31, 2022,
respectively. |
Reconciliation of Non-GAAP Adjusted Operating Expenses
to Total Operating Expenses (Unaudited) (In thousands)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Total operating expenses |
$ |
90,837 |
|
|
$ |
85,120 |
|
|
$ |
190,427 |
|
|
$ |
170,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
6,262 |
|
|
|
5,489 |
|
|
|
12,126 |
|
|
|
10,870 |
|
Depreciation |
|
90 |
|
|
|
70 |
|
|
|
179 |
|
|
|
411 |
|
Non-GAAP adjusted operating
expenses |
$ |
84,485 |
|
|
$ |
79,561 |
|
|
$ |
178,122 |
|
|
$ |
181,583 |
|
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