$ICPT (Intercept Pharmaceuticals, Inc.)

$ICPT {{ '2015-07-29T20:21:20+0000' | timeago}} • Announcement

$ICPT today announced that it will report 2Q15 financial results after the NASDAQ Market closes on Wednesday, August 5, 2015. Intercept management will conduct a conference call and audio webcast on Wednesday, August 5, 2015 at 4:30 p.m. ET to discuss these results.

$ICPT {{ '2015-12-15T17:28:39+0000' | timeago}} • SEC

As of Sept. 30, 2015, $ICPT had accumulated deficit of $607.3MM. $ICPT will continue to incur losses for at least next several years with R&D and general and administrative expenses will continue to increase. $ICPT may seek to obtain additional capital to fund its operations through equity offering, funding and other alliances.

$ICPT {{ '2015-12-15T17:24:37+0000' | timeago}} • SEC

$ICPT's research and development expenses for 3Q15 rose to $27.5MM from $27.4MM last year. This increase primarily reflects increased expenses related to personnel and activities to support increased development initiatives as well as research and discovery initiatives, increased costs associated with INT-767 program and increased indirect costs.

$ICPT {{ '2015-12-15T17:20:46+0000' | timeago}} • SEC

$ICPT plans to lift its research and development expenses for foreseeable future as it continue development of obeticholic acid, or OCA, for treatment of primary biliary cirrhosis (PBC), NASH and primary sclerosing cholangitis (PSC) and other indications and to further advance development of other product candidates.

$ICPT {{ '2015-12-15T17:11:43+0000' | timeago}} • SEC

On Oct. 28, $ICPT announced results of a 72-week Phase 2 dose ranging trial of OCA in 200 adult patients with NASH in Japan. In this trial, 202 Japanese biopsy-proven NASH patients were randomized into one of four arms to receive either a 10mg, 20mg or 40mg dose of OCA or placebo. The primary endpoints was histologic improvement.

$ICPT {{ '2015-12-15T16:57:48+0000' | timeago}} • SEC

$ICPT does not expect to generate revenue from product sales unless it successfully close development and obtain marketing approval for one or more of product candidates, which is subject to significant uncertainty. $ICPT sees that it need to raise additional capital to commercialize OCA on a worldwide basis and continue R&D activities.

$ICPT {{ '2015-11-09T14:56:52+0000' | timeago}} • Announcement

Biopharmaceutical company $ICPT reported 3Q15 net loss of $50.9MM or $2.10 per share compared to a loss of $35.8MM or $1.69 per share in 3Q14. The net loss increase was primarily the result of increases in G&A expenses related to $ICPT's corporate and pre-commercial activities and the increase in personnel in support of these initiatives.

$ICPT {{ '2015-11-09T14:25:51+0000' | timeago}} • Webcast

$ICPT anticipates greater commercial spending in FY15 driven by the anticipated approval of OCA in the U.S. in 1Q16 with increased spend in its European build out during the year. $ICPT expects substantial increases in R&D expenses in 2016 driven by execution of robust NASH development plan.

$ICPT {{ '2015-11-09T13:56:22+0000' | timeago}} • Webcast

$ICPT projects adjusted operating expense of about $240MM for FY15. Adjusted operating expenses in 2015 are planned to support the clinical development program for OCA in PBC, NASH and PSC, the expansion of $ICPT's clinical, regulatory, medical affairs and commercial infrastructure in the U.S., Europe and other countries such as Canada.

$ICPT {{ '2015-11-09T13:25:02+0000' | timeago}} • Webcast

In 3Q15, $ICPT announced the initiation of its REGENERATE Phase 3 trial, this is the first phase Phase 3 registrational trial in non-cirrhotic NASH patients with fibrosis, a serious chronic liver disease with no approved therapies. $ICPT is targeting enrollment of 1,400 biopsy-proven NASH patients with stage 2 and stage 3 fibrosis.

$ICPT {{ '2015-11-09T12:42:48+0000' | timeago}} • Announcement

At 3Q15-end $ICPT had cash, cash equivalents and investment securities available for sale of about $695.7MM compared to $732.2MM as of June 30, 2015.

$ICPT {{ '2015-11-09T12:41:38+0000' | timeago}} • Announcement

$ICPT projects that adjusted operating expenses for the year ending Dec. 31, 2015 will be below its previous guidance of $240MM, driven primarily by the timing of hiring of personnel, certain clinical trial and related expenses, market and medical research expenses and manufacturing related purchases for OCA.

$ICPT {{ '2015-08-05T23:00:31+0000' | timeago}} • Webcast

$ICPT 2Q15 Q&A: Joe of Citi questioned about strategy that build the best regimen in NASH, what type of mechanism or features would you see as complimentary at OCA and NASH. Rachel answered that there's something that we're currently evaluating and I’d love to be able to answer that, but at this point we're not ready to share any of those publicly

$ICPT {{ '2015-08-05T22:42:28+0000' | timeago}} • Webcast

$ICPT 2Q15 Q&A: John of Barclays: Any reference and suggestion of accelerated or priority review & hiring of the sales force. Did you announce that you will get priority review for this filing? Mark: We're hoping to give fast track a priority review. We’re planning our business on the basis of our priority reviews that will be launched in 1Q16.

$ICPT {{ '2015-08-05T22:32:21+0000' | timeago}} • Webcast

$ICPT 2Q15 Q&A: John of Barclays questions about any big picture regarding business development and how do you think about the Company leveraging the position most effectively? Rachel answered; we are not giving any specific guidance on business development. About big picture strategy, we do have a leadership position.

$ICPT {{ '2015-08-05T21:53:39+0000' | timeago}} • Webcast

$ICPT 2Q15 Call: We anticipated that stock based compensation expense will represent most significant noncash items that is excluded in this adjusted operating expense guidance as compared to operating expenses under GAAP.

$ICPT {{ '2015-08-05T21:42:55+0000' | timeago}} • Webcast

$ICPT 2Q15 Call: We ended the quarter with $773MM cash and cash equivalents and investment securities available for sale on our balance sheet. For FY15 we are increasing our non-GAAP adjusted operating expense guidance; from an $180MM to $200 to approx. $240mm. This represents approx. $170MM of adjusted operating expenses in 2H15.

$ICPT {{ '2015-08-05T21:26:15+0000' | timeago}} • Webcast

$ICPT 2Q15 Call: Infrastructure: Our plan is to launch OCA for PBC in the U.S., Canada and the major European countries with our own local teams. We are delighted with the progress that we’ve made over the past few months in assembling new guarded global team. We have mix of expertise in successfully launching orphan and specialty products.

$ICPT {{ '2015-08-05T21:14:36+0000' | timeago}} • Webcast

$ICPT 2Q15 Call: We will be evaluating Regenerate two doses 10mg and 25mg given once daily. Recalled that 25mg dose was the dose studied in FLINT. Our decision to add a 10mg lower dose in the phase III study was based on our experience in PBC. In our phase II PBC studies we found that doses higher than 10mg conferred no additional efficacy.

$ICPT {{ '2015-08-05T21:14:16+0000' | timeago}} • Webcast

$ICPT 2Q15 Call: We’ll target enrollment of 1400 NASH patients with stage II/III fibrosis. After 72 weeks of treatment these patients will undergo liver biopsy & interim analysis will be performed. Histology data collected in these patients will form basis for anticipated accelerated approval filing to market OCA for treatment of NASH with fibrosis

$ICPT {{ '2015-08-05T21:13:39+0000' | timeago}} • Webcast

$ICPT 2Q15 Call: In May, we announced the details of phase III Regenerate trail. This is the first phase III registrational trails in cirrhotic NASH patients with fibrosis, serious chronic liver disease with no proved therapies. We remain on track to initiate the Regenerate trails this quarter.

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