Intercept Pharmaceuticals Announces 2012 Financial Results and Provides Business Update

Intercept Pharmaceuticals Announces 2012 Financial Results and Provides
Business Update

Continued Development Progress and a Strong Cash Position 

Conference Call Scheduled Today at5:30 p.m. ET

NEW YORK, March 18, 2013 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc.
(Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused
on the development and commercialization of novel bile acid therapeutics to
treat chronic liver diseases, today reported financial results for the fourth
quarter and full year ended December 31, 2012 and provided an update on
corporate developments.

"2012 was an extraordinary year for Intercept with the significant progress we
made advancing our lead product candidate OCA, while raising over $115 million
in equity capital through the completion of our Series C financing and IPO,
which improved our cash position while diversifying our stockholder base.
These accomplishments have set the stage for what we expect will be an
important year in 2013 as we move toward completion of our Phase 3 POISE trial
in PBC and build further on the analyses from two large international clinical
data sets closely correlating the biochemical response we are evaluating in
POISE with clinical outcomes," said Mark Pruzanski, M.D., Chief Executive
Officer and President of Intercept.

OCA Development

Completion of Enrollment in POISE

We completed enrollment of POISE in December 2012. By randomizing 217
patients, we exceeded the target of 180 patients by approximately 20% while
completing enrollment in POISE more than three months faster than originally
anticipated. The demographics and baseline disease characteristics of the
patients enrolled are similar to those seen in our Phase 2 trial of OCA as a
combination therapy in PBC patients. Results from the 12-month double-blind
portion of POISE are anticipated to be available in the second quarter of

Strong Statistical Correlation of PBC Endpoint with Clinical Outcomes

We are sponsoring an independent study involving at least 15 leading PBC
centers worldwide, collectively named the Global PBC Study Group, that are
pooling their long-term patient data to further corroborate the ability of the
biochemical parameters alkaline phosphatase (ALP) and bilirubin to predict
clinical outcomes such as liver transplant and death. We anticipate data from
at least 4,000 patients will be collected and analyzed as part of this study.
Results for more than 2,100 patients will be disclosed in a poster
presentation at the annual meeting of the European Association for the Study
of the Liver (EASL) to be held in April 2013. The analysis confirms that the
POISE trial primary endpoint, a composite of ALP and bilirubin, has a highly
statistically significant correlation with improved long-term liver
transplant-free survival. We anticipate that final results will be available
by the end of 2013 and will support what we believe is an emerging consensus
among PBC opinion leaders concerning the clinical utility of our selected

Another independent PBC study group in the United Kingdom (UK) recently
published data in the March 2013 issue of Gastroenterology from an
observational study of over 2,300 PBC patients recruited from every hospital
in the UK. The results show that there is a highly statistically significant
correlation between ALP, both alone and together with other biochemical
parameters such as bilirubin, and clinical outcomes. Several different
threshold values of ALP were tested and it was demonstrated that reductions in
ALP levels down through to less than 1.5 times upper limit normal (ULN) are
strongly predictive of clinical benefit.

Positive Initial Data in Phase 2 Portal Hypertension Trial (PESTO):

We announced initial results from PESTO, an open-label Phase 2a trial
evaluating the effects of OCA for the treatment of portal hypertension. Twelve
patients with established alcoholic cirrhosis and portal hypertension were
administered a 10mg daily dose of OCA for seven or more days. OCA was well
tolerated in all twelve patients and five of the eight patients assessed for
changes in portal pressure met the primary efficacy endpoint of a reduction in
hepatic venous pressure gradient (HVPG) of at least 15% or to less than 12 mm
Hg. These results were presented at the American Association for the Study of
Liver Disease (AASLD)'s annual Liver Meeting in Boston on November 12, 2012.
We anticipate completing the trial in the fourth quarter of 2013.

Progress in Phase 2 NASH Trials (FLINT and DSP Japanese Trial):

In November 2012, the National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) of the National Institutes of Health (NIH) informed us that
enrollment of the FLINT trial had been completed with 280 adult NASH patients
randomized to either a once-daily 25mg dose of OCA or placebo. The trial
duration is 72 weeks and we anticipate that final results will be available in
late 2014.

Our collaborator Dainippon Sumitomo Pharma (DSP) has initiated a second Phase
2 clinical trial of OCA in adult NASH patients in Japan. The trial is
evaluating the efficacy and safety of a once-daily dose of OCA as compared to
placebo, with the goal of enrolling 200 patients. DSP expects to complete the
trial in the first half of 2016.

Positive Data in Phase 2 Primary Bile Acid Diarrhea Trial (OBADIAH)

Investigators at the Imperial College of London are conducting an ongoing
Phase 2a trial of OCA, named OBADIAH, as a treatment for primary bile acid
diarrhea (PBAD). PBAD is a common chronic diarrheal condition caused by
excessive bile acid production and loss due to inadequate release of FGF19, a
hormone that directly regulates bile acid synthesis in the liver. The initial
results from this trial demonstrate that treatment with OCA is associated with
a statistically significant improvement in clinical symptoms and increased
levels of FGF19. An abstract based on initial results in OBADIAH has been
accepted for presentation at the 2013 Digestive Diseases Week (DDW) annual
conference in May 2013. We currently anticipate that the enrollment for the
OBADIAH trial will be completed in mid-2013 and that final results for all
three study groups will be available in the second half of 2013.

2012 Fourth Quarter and Full-Year Financial Results

Cash Position

As of December 31, 2012, our cash, cash equivalents and investment securities
available for sale totaled approximately $110.2 million, compared to $17.7
million atDecember 31, 2011. In October 2012, we sold 5.75 million shares of
common stock at $15.00 per share in our IPO for net proceeds of approximately
$78.7 million. In August 2012, we completed a $30 million private placement
led by OrbiMed Advisors. Based upon our currently expected level of operating
expenditures, we believe that we will be able to fund our operations through
mid-2015. This estimate reflects our enrollment of a greater number of
patients in our POISE trial than originally planned; additional nonclinical
studies and clinical trials to support our planned regulatory submissions for
OCA in PBC; and an anticipated increase in pre-commercial activities for OCA
in PBC.

Net Income/Loss

Year EndedDecember 31, 2012

Net loss attributable to common stockholders for the full year 2012 was$46.3
million, or$7.36 per share, compared to a net loss of$15.7 million, or$4.73
per share, for the full year 2011.

Our results show an increase in research and development expenses of$4.8
millionin 2012 as compared to 2011, primarily due to increased activities in
our development program for OCA. This increase in R&D expense includes $1.2
million of additional non-cash stock-based compensation compared to
2011.General and administrative expenses increased by $1.0 million compared
to 2011, primarily due to a $243,000 increase in non-cash stock-based

Other expenses increased by $25.8 millionin 2012 as compared to 2011,
primarily due to an increase of$25.7 millionin the non-cash charge related
to the periodic revaluation of our warrant liability in 2012 as compared to
2011. This increase was primarily attributable to the significant increase in
the market price of our common stock in 2012 subsequent to our IPO. In
connection with prior equity financings, Intercept issued warrants that are
classified as liabilities and are adjusted to fair value on a quarterly basis
with the change in fair value being included in net loss. The amount included
in net loss is a non-cash item as Intercept is not required to expend any cash
to settle the warrant liability. The warrant liability is primarily affected
by changes in Intercept's stock price during each financial reporting period,
which causes the warrant liability to fluctuate as the market price of
Intercept's stock fluctuates.

Quarter EndedDecember 31, 2012

Net loss attributable to common stockholders for the fourth quarter
endedDecember 31, 2012was$30.8 million, or$2.02per share, compared to a
net loss of$4.4 million, or$1.32 per share, for the same period in 2011. The
increase in net loss is primarily due to the increase of$25.0 millionin the
non-cash charge related to the periodic revaluation of our warrant liability,
caused by the significant increase in the market price of our common stock
compared to 2011, and to a lesser extent an increase in operating expenses of
$1.8 million, reflecting increased expenses for development of OCA.

Today's Conference Call at5:30 p.m. ET

We will hold our 2012 financial results and business update conference call
and webcast today at5:30 p.m. ET. The live event will be available on the
investor page of our website at or by calling
(877) 312-5376 (domestic) or (216) 586-6841 (international) five minutes prior
to the start time and providing the pass code 22293430. A replay of the call
will be available on our website approximately two hours after the completion
of the call and will be archived for two weeks.

About Intercept

Intercept is a biopharmaceutical company focused on the development and
commercialization of novel therapeutics to treat orphan and more prevalent
liver diseases utilizing its expertise in bile acid chemistry. The company's
lead product candidate, obeticholic acid (OCA), is a bile acid analog and
first-in-class agonist of the farnesoid X receptor (FXR). OCA is initially
being developed for the second line treatment of primary biliary cirrhosis
(PBC) in patients with an inadequate response to, or who are unable to
tolerate, ursodiol, the only approved therapy for this indication. OCA has
received orphan drug designation in both the United States and Europe for the
treatment of PBC. Intercept owns worldwide rights to OCA outside of Japan and
China, where it has out-licensed the product candidate to Dainippon Sumitomo
Pharma. For more information about Intercept, please visit the Company's
website at:

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding the clinical, preclinical and regulatory
developments for our product candidates, the anticipated results of our
clinical and preclinical trials and other development activities, potential
timeframes for our and our collaborators' clinical and preclinical trials and
other development activities, the clinical utility of our selected endpoint
and any potential consensus relating thereto, anticipated trends relating to
our financial position, and our strategic directives under the caption "About
Intercept." These "forward-looking statements" are based on management's
current expectations of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially and
adversely from those set forth in or implied by such forward-looking
statements. These risks and uncertainties include, but are not limited to: the
initiation, cost, timing, progress and results of Intercept's development
activities, preclinical studies and clinical trials; the timing of and
Intercept's ability to obtain and maintain regulatory approval of OCA and any
other product candidates it may develop, and any related restrictions,
limitations, and/or warnings in the label of any approved product candidates;
Intercept's plans to research, develop and commercialize future product
candidates; the election by Intercept's collaborators to pursue research,
development and commercialization activities; Intercept's ability to attract
collaborators with development, regulatory and commercialization expertise;
Intercept's ability to obtain and maintain intellectual property protection
for its product candidates; Intercept's ability to successfully commercialize
its product candidates; the size and growth of the markets for Intercept's
product candidates and its ability to serve those markets; the rate and degree
of market acceptance of any future products; the success of competing drugs
that are or become available; regulatory developments in the United States and
other countries; the performance of third-party suppliers and manufacturers;
Intercept's ability to obtain additional financing; Intercept's use of the
proceeds from its recently completed initial public offering; the accuracy of
Intercept's estimates regarding expenses, future revenues, capital
requirements and the need for additional financing; the loss of key scientific
or management personnel; and other factors discussed under the heading "Risk
Factors" contained in Intercept's quarterly report on Form 10-Q filed on
November 26, 2012 and its annual report on Form 10-K for the year ended 2012
to be filed with the Securities and Exchange Commission, as well as any
updates to these risk factors filed from time to time in Intercept's other
filings with the Securities and Exchange Commission. All information in this
press release is as of the date of the release, and Intercept undertakes no
duty to update this information unless required by law.

Intercept Pharmaceuticals,                                      
Condensed Consolidated Statements of                             
(In thousands, except per                                       
share data)
                             Three Months Ended      Year Ended
                             December 31,            December 31,
                             2011        2012        2011        2012
                             (Unaudited) (Unaudited)            (Unaudited)
Licensing revenue             $759      $405      $1,805    $2,446
Costs and expenses:                                            
Research and development      4,163      4,787      11,426     16,183
General and administrative    1,035      2,183      4,209      5,177
Total operating expenses      $5,198    $6,970    $15,635   $21,360
Other income (expense)                                         
Revaluation of warrants       776        (24,187)   1,045      (24,626)
Other income (expense), net   18         61         48         (104)
Net loss                      $(3,645)  $(30,691) $(12,737) $(43,644)
Dividends on preferred        (750)      (130)      (3,000)    (2,630)
stock, not declared
Net loss attributable to      $(4,395)  $(30,821) $(15,737) $(46,274)
common stockholders
Net loss per common share,    $(1.32)   $(2.02)   $(4.73)   $(7.36)
basic and diluted:
Weighted average number of
shares of common stock        3,329,266   15,223,010  3,329,666   6,283,238
outstanding, basic and
Condensed Consolidated Balance Sheet Information                  
(In thousands)                                                 
                                                   December 31,
                                                   2011        2012
Cash, cash equivalents and investment                 $17,707   $110,194
Total assets                                        $19,470   $112,179
Working capital                                     $14,872   $98,814
Deferred revenue, total                             $14,608   $12,162
Warrant liability, total                            $5,836    $30,359
Total liabilities                                   $22,030   $46,267
Stockholders' equity                                $(2,560)  $65,912

CONTACT: Intercept Pharmaceuticals, Inc.
         For Investors
         Mark Pruzanski, M.D., or Barbara Duncan, 1-646-747-1000
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