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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date
of report (Date of earliest event reported): August 2, 2023
Intercept
Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | |
001-35668 | |
22-3868459 |
(State or other jurisdiction | |
(Commission | |
(IRS Employer |
of incorporation) | |
File Number) | |
Identification No.) |
305 Madison Avenue, Morristown, NJ 07960
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code: (646) 747-1000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading
Symbol(s) |
Name of each exchange on which
registered |
Common Stock, par value $0.001 per share |
ICPT |
Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results of Operations and Financial
Condition.
On August 2, 2023, Intercept Pharmaceuticals, Inc. issued a press release
announcing its financial results for the quarter ended June 30, 2023.
A copy of the press release is attached as Exhibit 99.1 and incorporated
by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | |
Description |
99.1 | |
Press Release |
104 | |
Cover Page Interactive Data File (embedded as Inline XBRL document) |
The information in Item 2.02 and Exhibit 99.1 is being furnished, not
filed.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
INTERCEPT PHARMACEUTICALS,
INC. |
|
|
|
|
By: |
/s/ Andrew Saik |
|
Name: |
Andrew Saik |
|
Title: |
Chief
Financial Officer |
Date: August 2, 2023
Exhibit 99.1
Intercept Pharmaceuticals Reports Second Quarter
2023 Financial Results and Provides Business Updates
| • | Ocaliva® (obeticholic acid or OCA) net sales of $83.7 million, representing
17% growth over the prior year quarter |
| • | Company updates full-year 2023 Ocaliva net sales guidance to $320 million
to $340 million; reiterates non-GAAP adjusted operating expense guidance of $350 million to $370 million |
| • | Restructuring plan is on track to reduce operating expenses by approximately
$140 million |
| • | Company expects to achieve meaningful profitability in 2024 |
| • | OCA-bezafibrate combination making considerable progress; enrollment of
both Phase 2 studies completed; Company expects to have necessary data to submit request in 2023 for End-of-Phase 2 meeting with FDA |
| • | Company to host conference call today at 8:30 a.m. ET |
MORRISTOWN,
NJ, August 2, 2023 – 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. ET
The 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 Intercept
Intercept
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 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 the
Investigational OCA-bezafibrate Fixed-Dose Combination
Intercept 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 Cholangitis
Primary 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 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
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 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 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 co-administering OCALIVA and warfarin. |
| • | CYP1A2 Substrates with Narrow Therapeutic Index
Obeticholic 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 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
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 Statements
This 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 Relations
investors@interceptpharma.com
For media:
Karen Preble, Executive Director, Global Corporate Communications
media@interceptpharma.com
Intercept Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data)
| |
Three Months Ended June 30, | | |
Six Months Ended June 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 Ended June 30, | | |
Six Months Ended June 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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