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Chugai Announces 2019 Half Year Results

On July 25, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first half of the fiscal year ended December 31, 2019 (Press release, Chugai, JUL 25, 2019, View Source [SID1234537724]).

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Chugai reported record high revenues, operating profit and net income for the second consecutive quarter. Revenues increased by 12.3% due to a double-digit sales growth driven by the contribution of new products, mainstay products and strong exports as well as increases in royalties and other operating income related to Hemlibra. Operating profit increased by 44.6% due to a better cost to sales ratio as the proportion of in-house products increased in the total product mix.

Revenues]
Domestic sales increased to ¥210.0 billion (+9.9%) driven by contribution from new products including the hemophilia A treatment Hemlibra created by Chugai and the immune checkpoint inhibitor Tecentriq as well as the strong growth of mainstay products chiefly in oncology area and bone and joint diseases area, despite the negative impact from generic competition and the NHI drug price revisions last year.

Oncology: Sales increased driven by the contribution of new product Tecentriq and Gazyva, as well as solid growth of Perjeta and Alecensa, despite the negative impact from generic competition facing Rituxan.
Bone and joint diseases: Sales recorded a double-digit increase due to steady growth of mainstay products such as anti-rheumatic agent Actemra and the osteoporosis agent Edirol.

Renal diseases: Sales were almost flat while sales of the renal anemia agent Mircera and the secondary hyperparathyroidism treatment Oxarol approximated the previous year’s level.

Others: Sales increased by about 20% due to steady market penetration of the new hemophilia A treatment Hemlibra, despite the negative impact from the transfer of long-term listed products last year.

Overseas sales increased to ¥72.4 billion (+12.2%) due to increase in exports of Alecensa to Roche.

Royalties and other operating income increased to ¥37.9 billion (+28.5%) due to increase in royalties and profit sharing income relating to Hemlibra.

Core gross profit increased to ¥192.7 billion (+23.1%) due to sales growth and the better cost to sales ratio with a high proportion of in-house products in the total product mix.

Core operating expenses grew by a single-digit percentage to ¥89.2 billion (+5.1%), more modestly than the growth in Core gross profit. As a result, Core operating profit totaled ¥103.5 billion (+44.6%).

About Core results
Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

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.

"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.

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.

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%

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.

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.

Gray Foundation Awards $25M in Cancer Research Grants

On July 24, 2019 The Gray Foundation reported that it has awarded $25 million in funding to seven multi-institute teams conducting research related to the prediction, prevention, and treatment of BRCA-related cancers (Press release, The Gray Foundation, JUL 24, 2019, View Source [SID1234537849]).

The teams will receive up to $5 million each for their projects, which include ones focusing on the validation of liquid biopsy assays for the early detection of cancer in high-risk BRCA mutation carriers; tracking and preventing breast cancer in BRCA mutation carriers; identifying and targeting post-transcriptionally modified neoantigens in BRCA mutant tumors; and researching the relationship between the local microbiome and host immune system in breast cancer.

Other funded projects are investigating the determinants of immune activity and molecular features in BRCA mutation carriers; examining the pathogenesis of early BRCA-associated cancer for risk prediction and disease prevention; and dissecting BRCA-mediated tumor suppression pathways.

Scientists leading the research are from Weill Cornell Medicine, the Cleveland Clinic, the University of Pennsylvania, the University of Texas Health Science Center at San Antonio, and Johns Hopkins University School of Medicine.

Other participating institutes include the Massachusetts Institute of Technology, the Wellcome Sanger Institute, Beth Israel Deaconess Medical Center, the University of Cambridge, Dana Farber Cancer Institute, the University of British Columbia, Brigham and Women’s Hospital, Stanford University, QIMR Berghofer, Memorial Sloan Kettering Cancer Center, and Case Western Reserve University.

Mustang Bio Receives Orphan Drug Designation for MB-102 (CD123 CAR T) for the Treatment of Acute Myeloid Leukemia

On July 24, 2019 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of acute myeloid leukemia (AML) (Press release, Mustang Bio, JUL 24, 2019, View Source [SID1234537797]). The FDA also previously granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are pleased that MB-102 has received Orphan Drug Designation in two indications, AML and BPDCN. AML most commonly occurs in senior adults, many of whom have to forgo chemotherapy due to other health conditions. MB-102 has the potential to be an important new treatment for these and other patients, and to potentially address multiple areas of high unmet medical need. We expect to initiate a multicenter Phase 1/2 clinical trial in patients with AML, BPDCN and high-risk myelodysplastic syndrome in the coming months."

MB-102 is currently being studied in a City of Hope, first-in-human Phase 1 dose-escalation clinical trial evaluating the safety and anti-tumor activity of escalating doses of MB-102 in patients with relapsed or refractory AML (cohort 1) and BPDCN (cohort 2). Patients receive a single dose of MB-102 with an option for a second infusion if they continue to meet safety and eligibility criteria and still have CD123+ disease. MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities. City of Hope developed CD123 CAR T.

The FDA grants Orphan Drug Designation to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials and prescription drug user fee waivers. If a product holding Orphan Drug Designation receives the first FDA approval for the disease in which it has such designation, the product is entitled to seven years of market exclusivity, which is independent from intellectual property protection.

About Acute Myeloid Leukemia
AML is a cancer of the myeloid line of blood cells, characterized primarily by the rapid growth of abnormal white blood cells that build up in the bone marrow and interfere with the production of normal blood cells. CD123 is an attractive target for T cell-based adoptive immunotherapy due to high levels of CD123 expression in AML.

About MB-102 (CD123 CAR T)
MB-102 (CD123 CAR T) is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndromes, as well as in hematologic malignancies, including AML, B-cell acute lymphoblastic leukemia, hairy cell leukemia, BPDCN, chronic myeloid leukemia and Hodgkin’s lymphoma.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017 and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy in November 2018. Dose escalation continues at City of Hope in both indications.