Ipsen delivers strong results for the first half of 2019 with robust double-digit sales growth and improved Core Operating margin and upgrades its guidance for full year 2019

On July 25, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported financial results for the first half of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

David Meek, Chief Executive Officer of Ipsen, stated: "In the first half of 2019, the strong operational execution of our growth strategy led to robust double-digit sales growth, continued Core Operating margin expansion and an upgrade in our sales guidance for full year 2019. The value of our pipeline was further strengthened by the closing of the Clementia acquisition and promising interim Phase 2 data for Onivyde in first-line pancreatic cancer. Going forward, we will continue to advance our strategic priorities to deliver sustained top-line, bottom-line and pipeline growth."

Upgraded Full Year 2019 guidance

Group sales growth greater than +14.0% at constant currency and consolidation scope1 (versus initial guidance of greater than +13.0%)
Impact of currencies estimated at +1.5% based on the current level of exchange rates
Impact of consolidation scope reflecting the consolidation under the equity method for joint arrangements related to the Schwabe partnership estimated at -1.0%
Core Operating margin at around 30.0% of net sales, including the impact of Clementia but excluding potential incremental investments in pipeline expansion initiatives

Initial guidance

Updated guidance

Sales growth1

> +13.0%

> +14.0%

Core Operating margin (as a % of net sales)

around 30.0%

around 30.0%

1 Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Q2 2019 Pipeline highlights

17 April: Completion of the Clementia Pharmaceuticals acquisition
24 June: U.S. FDA approval of the Somatuline New Delivery System
5 July: Presentation at ESMO (Free ESMO Whitepaper)-GI of promising interim data from the Phase 1/2 study of the investigational use of Onivyde in combination with 5-fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer (PDAC)
H1 2019 Financial highlights

Group sales growth of 15.5% as reported and 14.3% at constant exchange rates and consolidation scope1, driven by the strong performance of Specialty Care across all major products and geographies.
Core Operating margin at 31.5% of net sales, up 1.2 points and Core Operating Income growth of 20.1% after higher R&D investments including Clementia
IFRS operating margin at 25.8% of net sales, up 0.5 points and IFRS Operating Income growth of 17.8%.

Refinancing update

Full refinancing following the acquisition of Clementia Pharmaceuticals to increase debt capacity for future business development, extend the maturity horizon and diversify sources of financing.
24 May: Signature of a new 5-year revolving credit facility (RCF) of €1.5 billion with two possible one-year extensions to replace existing bank facilities with specific indicators linked to CSR (Corporate Social Responsibility).
23 July: Closing of a $300 million dual-tranche issuance of notes with 7- and 10-year maturities on the U.S. market (U.S. Private Placement – USPP) from a group of long-term U.S. investors.
First issuance in the private placement market and in the U.S. debt market for the company, illustrating the high level of confidence of investors in Ipsen and in the quality of its credit profile.

The transaction in this press release is not an offer for sale of the securities in the United States. No public offering of the securities will be made in the United States. The securities have not been registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be sold in the United States absent registration or an exemption from registration under the Securities Act.

1 Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Review of the first half 2019 results

Note: Unless stated otherwise, all variations of year-on-year sales are stated at constant exchange rates and consolidation scope. Subsidiaries involved in the partnership between Ipsen and Schwabe Group are consolidated in accordance with the equity method starting 1 January, 2019. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Group sales reached €1,229.6 million, up 14.3% year-on-year.

Specialty Care sales reached €1,100.0 million, up 16.9%, driven by the growth in Oncology of +20.7% from the continuous growth of Cabometyx and Onivyde as well as Somatuline and Decapeptyl across all geographies.

Consumer Healthcare sales reached €129.6 million, down 3.7%, mainly from the competitive environment for Smecta in China.

Core Operating Income was €387.5 million, up 20.1%, driven by the growth of Specialty Care sales, a sound management of Selling expenses and an increased investment in Research and Development (including Clementia costs from Q2 2019).

Core Operating margin reached 31.5% of sales, up 1.2 points versus the first half of 2018 despite the dilutive impact of Clementia expenses.

Core consolidated net profit was €283.0 million, compared to €237.1 million in 2018, up 19.3%, after increased financing costs mainly linked to the Clementia acquisition.

Core earnings per share fully diluted grew by 18.5% to reach €3.38, compared to €2.86 in 2018.

IFRS Operating Income was €317.8 million after amortization of intangible assets and higher Other operating expenses, mainly related to Clementia integration costs and costs arising from the Group’s transformation programs. Operating Income margin of 25.8% is up 0.5 points compared to the first half of 2018.

IFRS Consolidated net profit was €220.6 million versus €197.3 million in 2018, up 11.8% impacted by the Onivyde revised contingent earn-out and milestones accounting following the recent publication of positive results related to the ongoing developments on Onivyde.

IFRS Fully diluted EPS (Earnings per share) was €2.64 versus €2.38 in 2018, up 10.9%.

Free Cash Flow reached €101.0 million, down by €63.5 million versus 2018, mainly driven by a lower Operating Cash Flow combined with higher Other operating expenses and Restructuring costs.

Closing net debt reached €1,499.5 million at the end of June 2019, versus €438.0 million at the end of June 2018, notably after the impact of Clementia’s acquisition for €986 million and of IFRS16 – Leases standard implemented starting 1 January 2019 for €188 million.

The company’s auditors performed a limited review of the accounts.

The interim financial report, with regard to regulated information, is available on the Group’s website, under the Regulated Information tab in the Investor Relations section.

Conference call

Ipsen will hold a conference call Thursday, 25 July 2019 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately five to ten minutes prior to its start. No reservation is required to participate in the conference call.

Standard International: +44 (0) 2071-928-000
France and continental Europe: + 33 (0) 1 76 70 07 94
UK: 08-445-718-892
United States: 1-6315-107-495

Conference ID: 3574629

A recording will be available for seven days on Ipsen’s website.

Corcept Therapeutics to Announce Second Quarter Financial Results, Provide Corporate Update and Host Conference Call

On July 25, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report second quarter financial results and provide a corporate update on August 1, 2019 (Press release, Corcept Therapeutics, JUL 25, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-second-quarter-financial-results-2 [SID1234537737]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call Information

To participate, dial 1-888-394-8218 from the United States or 1-323-794-2590 internationally approximately ten minutes before the start of the call. The passcode will be 9712194.

A replay will be available through August 15, 2019 at 888-203-1112 in the United States and 719-457-0820 internationally. The passcode will be 9712194.

Vertex Announces Dr. Jeffrey Leiden to Transition to Role of Executive Chairman, Effective April 1, 2020 and Dr. Reshma Kewalramani Appointed as New Chief Executive Officer

On July 25, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that its Board of Directors has approved the planned transition of Chairman, President and Chief Executive Officer Jeffrey Leiden, M.D., Ph.D, into the role of Executive Chairman of the Board, effective April 1, 2020 (Press release, Vertex Pharmaceuticals, JUL 25, 2019, View Source [SID1234537753]). At that time, Vertex’s Chief Medical Officer Reshma Kewalramani, M.D., will become President and Chief Executive Officer and will be appointed to serve on the company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Jeff’s leadership has transformed Vertex and delivered extraordinary value for patients and shareholders through the discovery, development and commercialization of multiple transformative medicines. Vertex has never been stronger and is well-positioned for the future with a clear and differentiated research and business strategy, an exceptionally strong financial position, a deep leadership team, and an inclusive culture of innovation," said Bruce I. Sachs, Lead Independent Director of Vertex’s Board. "The Board of Directors is immensely grateful to Jeff for his strategic vision and relentless dedication to science and serial innovation, which has both transformed the treatment of cystic fibrosis and produced a pipeline of breakthrough medicines for other serious diseases. The Board looks forward to Jeff’s ongoing leadership and strategic guidance in his role as Executive Chairman."

Sachs continued, "The Board has been working with Jeff for several years to plan for a smooth and effective leadership transition that will ensure strategic and operational continuity for Vertex. The entire Board is excited that Reshma will become Vertex’s next CEO. She is an accomplished scientist and physician with more than 20 years of experience in medicine and biotechnology, and has a deep understanding and appreciation of Vertex’s strategy, business and culture."

"It has been a tremendous privilege to lead Vertex and our outstanding senior leadership team since 2012. I look forward to playing a continued, active role in the company over the next several years, and supporting Reshma and our team through this transition," said Dr. Leiden. "Having worked closely with Reshma for the last several years, I know that she is tremendously talented, extremely passionate about our patient-centric mission, and fully prepared to lead Vertex as we enter our next phase as a company. Her background as a physician/scientist gives her a deep understanding of the core of Vertex – our outstanding science and commitment to serial innovation. She also is a strong, collaborative leader with a proven ability to execute against our strategy to deliver results. Importantly, she has a track record of putting patients first and driving innovation to have a transformative impact on patients’ lives."

Dr. Kewalramani commented, "I am honored to become Vertex’s next CEO and to continue to work alongside Jeff, the Board and our leadership team at a time of such opportunity for the company. Consistent execution of our strategy has produced a leading portfolio of products for CF that will potentially treat up to 90 percent of patients with the disease; a productive research engine that has already led to an enviable clinical stage pipeline of potentially breakthrough medicines in five additional diseases, including Alpha-1 Antitrypsin Deficiency, Pain, Sickle Cell Disease, Beta Thalassemia, and APOL1-mediated kidney diseases; and the financial strength to continue to invest in future innovation. Most importantly, we have a talented and dedicated team of people across the company that I will be incredibly proud to lead."

Dr. Kewalramani joined Vertex in February 2017 and currently serves as the company’s Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer. In this role, she oversees clinical development, medical affairs, drug safety and other related functions, and is responsible for developing, advising and driving execution of Vertex’s clinical development programs. Prior to Vertex, Dr. Kewalramani spent more than 12 years at Amgen where she held a variety of roles across Research and Development, including as Vice President, Global Clinical Development, Nephrology & Metabolic Therapeutic Area and Vice President, U.S. Medical Organization, a group she established and grew to assume responsibility for the full portfolio of molecules across six therapeutic areas.

Dr. Kewalramani completed her internship and residency in Internal Medicine at the Massachusetts General Hospital and her fellowship in Nephrology at the Massachusetts General Hospital and Brigham and Women’s Hospital combined program. She received her medical degree, with honors, from the Boston University School of Medicine. Dr. Kewalramani also completed the General Management Program at Harvard Business School and is an alumnus of the school. She is the industry representative to the FDA’s Endocrine and Metabolic Drug Advisory Committee.

Dr. Leiden has agreed to serve as Executive Chairman through the first quarter of 2023.

Amgen Announces Webcast Of 2019 Second Quarter Financial Results

On July 25, 2019 Amgen (NASDAQ:AMGN) reported that it will report its second quarter financial results on Tuesday, July 30, 2019, after the close of the U.S. financial markets (Press release, Amgen, JUL 25, 2019, View Source [SID1234537769]). The announcement will be followed by a conference call with the investment community at 2:30 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Selvita Appoints Setareh Shamsili, M.D., Ph.D., as Chief Medical Officer

On July 25, 2019 Selvita, S.A. (WSE: SLV), a leading clinical stage drug discovery company committed to developing innovative medicines for treatment of patients with cancer, reported the appointment of Setareh Shamsili, M.D., Ph.D., to the role of Chief Medical Officer (Press release, Selvita, JUL 25, 2019, View Source [SID1234537718]). A seasoned veteran, Dr. Shamsili brings more than 20 years of clinical oncology and drug development experience to the company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Setareh’s impressive track record advancing novel oncology compounds through clinical development will significantly strengthen Selvita’s capabilities in moving our first clinical study forward in the U.S. with SEL120, our fully proprietary oral, selective inhibitor of CDK8 for the treatment of acute myeloid leukemia and myelodysplastic syndromes," commented Pawel Przewiezlikowski, Chief Executive Officer of Selvita. "We are pleased to welcome Dr. Shamsili to our executive team and look forward to her strategic leadership as we advance our rich pipeline of novel anti-cancer therapeutic candidates."

"I feel honored to become a member of the Selvita executive team," said Dr. Shamsili. "This role provides the opportunity to make key contributions to the advancement of the novel and promising anti-cancer candidates of the Selvita pipeline and bring new hope to cancer patients. Selvita candidates are generated from its own, well-established discovery platform, which enables a steady strategic renewal of the pipeline. The discovery platform allows evaluation of several novel first-in-class or best-in-class compounds in a parallel manner. In addition, each platform program addresses a distinct mechanism of action and is staffed with a team of highly talented scientists supported by experienced clinical professionals."

Dr. Shamsili has been an independent industry consultant for a number of immuno-oncology companies in the U.S. and Europe, contributing to programs in various stages of development and therapeutic classes including small molecules, antibodies and cancer vaccines, with her latest position being the interim Chief Medical Officer at AxImmune, a U.S.-based immuno-oncology company. She was the first Chief Medical Officer of Merus NV, where she brought the initial two candidates to the clinic for development in acute myeloid leukemia and the treatment of solid tumors. During her tenure at Merus until about end 2016, Dr. Shamsili was instrumental in providing support for successful fundraising activities and establishing strategic alliances. From 2006-2012, Dr. Shamsili served as Global Medical Leader Oncology at Astellas Pharma Global Development. Dr. Shamsili received her M.D. degree and board certification in internal medicine from the National University of Medical Sciences in Tehran, with a focus in oncology, and her Ph.D. in Oncology from the international Erasmus Medical University in Rotterdam. She recently also has completed the University of Pennsylvania Wharton Business School Global Strategic Leadership Program.