Intercept Pharmaceuticals, Inc. (ICPT)
Chart Events
Performance Outlook
| Previous Close | 28.12 |
| Open | 28.59 |
| Bid | 28.01 x 900 |
| Ask | 28.09 x 800 |
| Day's Range | 27.13 - 28.64 |
| 52 Week Range | 23.78 - 98.03 |
| Volume | 496,783 |
| Avg. Volume | 1,024,898 |
| Market Cap | 930.056M |
| Beta (5Y Monthly) | 1.66 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -9.75 |
| Earnings Date | Feb 25, 2021 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 51.04 |
- GlobeNewswire
Intercept to Present at Upcoming Investor Conferences
NEW YORK, Feb. 19, 2021 (GLOBE NEWSWIRE) -- 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 that Jerry Durso, President and Chief Executive Officer, and Sandip Kapadia, Chief Financial Officer of Intercept, will present at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, 2021 at 1:00 p.m. ET, and at the Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021 at 10:30 a.m. ET. A live webcast of the events will be available on the investor page of Intercept’s website at http://ir.interceptpharma.com. An audio archive of the webcast will also be available on Intercept’s website for approximately two weeks. About InterceptIntercept 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. CONTACT For more information about Intercept, please contact: Investor inquiries: investors@interceptpharma.com Media inquiries: media@interceptpharma.com
- GlobeNewswire
Intercept Appoints Linda Richardson as Chief Commercial Officer
Lisa DeFrancesco, Senior Vice President, Corporate Affairs & Investor Relations, will join Intercept’s Executive Leadership Team NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- 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 the appointment of Linda Richardson as Chief Commercial Officer. Ms. Richardson was previously Senior Vice President and Head of the Global Cholestasis Program at Intercept, where she has guided long-range planning for Intercept’s rare disease franchise in PBC and other cholestatic liver diseases since 2018. “Linda’s deep global commercial experience makes her an ideal leader for Intercept’s next phase of growth and development,” said Jerry Durso, President and Chief Executive Officer of Intercept. “Linda will be responsible for overseeing our Ocaliva® franchise in the U.S. and International regions, as well as commercial strategy and execution for future indications and product opportunities.” Prior to joining Intercept, Ms. Richardson served as Chief Strategy & Commercial Officer at Chimerix, Inc., overseeing marketing, market access and reimbursement, market research and analytics, forecasting, supply chain and distribution strategies, commercial operations, product communications and sales. From 2008 to 2013, she held commercial leadership roles of increasing responsibility at Sanofi, where she oversaw multiple U.S. and global product launches. Prior to joining Sanofi, Ms. Richardson held marketing leadership roles at Reliant Pharmaceuticals and GlaxoSmithKline. “Intercept has established a proven track record of commercial execution with the launch of Ocaliva and I believe we have an opportunity to build on this strong foundation to support patients with PBC and other progressive non-viral liver diseases in the future,” said Ms. Richardson. “We have an amazing team at Intercept, and it is a great privilege to be taking on this new role during a pivotal year for the company.” In addition to Ms. Richardson, Lisa DeFrancesco will join Intercept’s Executive Leadership Team. Ms. DeFrancesco, Senior Vice President, Corporate Affairs & Investor Relations since December 2020, was previously Intercept’s Vice President of Investor Relations. Prior to joining Intercept, she served as Senior Vice President, Investor Relations, Corporate Communications and Government Affairs at Melinta Therapeutics where she was a member of the company’s Executive Leadership Team. From 2009 to 2017, Ms. DeFrancesco held roles of increasing responsibility at Allergan plc, most recently in the role of Vice President, Investor Relations. About InterceptIntercept 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. 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, 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 a 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 the newly identified safety signal relating to Ocaliva identified by the FDA in May 2020; 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 ongoing discussions with the FDA and European Medicines Agency regarding the feasibility of the COBALT and 401 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 prevent system failures, data breaches or violations of 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 and short-term investments; our ability to acquire, license and invest in businesses, technologies, product candidates and products; our ability to attract and retain key personnel to manage our business effectively; our ability to manage the growth of our operations, infrastructure, personnel, systems and controls; our ability to obtain and maintain adequate insurance coverage; the impact of COVID-19, including any impact on our results of operations or financial position, related quarantines and 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, facility closures or other restrictions, and the extent and duration thereof; the impact of general U.S. and foreign economic, industry, market, regulatory or political conditions, including the potential 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, 2019 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. CONTACT For more information about Intercept, please contact: Lisa DeFrancesco +1-646-565-4833 investors@interceptpharma.com Christopher Frates +1-646-757-2371 media@interceptpharma.com Source: Intercept Pharmaceuticals, Inc.
- GlobeNewswire
Avadel Pharmaceuticals Appoints Richard Kim as Chief Commercial Officer to Lead the Commercial Launch of Once-Nightly FT218
DUBLIN, Ireland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company’s lead program, once-nightly FT218, pending regulatory approval. “Richard joins our team at an important point in the company’s history,” said Greg Divis, Chief Executive Officer of Avadel. “Richard has over 25 years of biopharmaceutical commercial experience with direct leadership of successful product launches in the U.S. and around the world to treat specialty and orphan diseases. His hands-on experience in building world-class teams, capabilities and infrastructure to support the commercial launches of those innovative new drugs will play a critical role at Avadel as we accelerate our commercialization strategy for once-nightly FT218, in preparation for the highly anticipated U.S. regulatory approval.” “I was drawn to Avadel because of the potential its investigational, once-nightly FT218 product offers as a game changing therapy for patients living with narcolepsy,” said Mr. Kim. “I am excited to have the opportunity to work alongside the amazing Avadel team and build upon the positive momentum they have already established for the once-nightly FT218 program, including completion of the pivotal phase 3 study, submission of the NDA to the FDA at the end of last year, and the ongoing preparation for a successful commercial launch.” “It isn’t often that a new product has the potential to offer such a significant advancement in patient care for an established multi-billion dollar market. If approved, I believe FT218 will be the preferred choice for sodium oxybate drug therapy and provide a potentially life-changing option for narcolepsy patients, while creating value for our shareholders,” concluded Mr. Kim. Mr. Kim has over 25 years of commercialization, marketing, development and managerial experience in the biopharmaceutical industry in the U.S. and abroad. Prior to joining Avadel, he was at Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), where he most recently served as the President of U.S. Commercial & Strategic Marketing. During his time there he helped to successfully launch OCALIVA™ (obeticholic acid), the first new treatment in nearly 20 years in an orphan disease, Primary Billiary Cholangitis, and led the launch strategy for obeticholic acid for the treatment of NASH. Prior to joining Intercept, Mr. Kim worked at Bristol-Myers Squibb, where he served as General Manager, Hepatitis C Worldwide Commercialization where he led the successful worldwide launch of DAKLINZA™ (daclatasvir) for hepatitis C. Prior to this, Mr. Kim held a number of roles of increasing responsibility leading sales, operational and strategic marketing teams at Bristol-Myers Squibb, including Vice President, SPRYCEL™ Brand Lead, Oncology Global Marketing; Vice President, U.S. In-Line Oncology and Global Marketing; and Vice President, East Area Sales, Cardiovascular and Metabolics. Prior to his time at Bristol-Myers Squibb, Mr. Kim held a range of senior positions in the U.S., Canada and Australia at Schering-Plough, which was acquired by Merck & Co., Inc. About FT218FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product. About Avadel Pharmaceuticals plc:Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the FDA’s review of the NDA for FT218, the benefits of Orphan Drug Exclusivity for FT218, if granted by the FDA, the commercial launch of FT218, if approved, and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable). Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Contacts:Investor ContactsTom McHughChief Financial OfficerPhone: (636) 449-1843Email: tmchugh@avadel.com Tim McCarthyLifeSci Advisors, LLCPhone: (212) 915.2564Email: tim@lifesciadvisors.com Media ContactPatrick BurseyLifeSci Communications, LLCPhone: (646) 970-4688Email: pbursey@lifescicomms.com
