On February 14, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported that it will host a conference call and webcast on Thursday, February 21, 2019, at 8:00 a.m. ET to review the data from its NAM-NK and NiCord programs being presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation (ASBMT) and Center for International Blood and Marrow Transplant Research (CIBMTR) (Press release, Gamida Cell, FEB 14, 2019, View Source [SID1234533329]). The meeting is taking place in Houston, Texas, February 20 – 24.

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A live webcast of the conference call can be accessed in the Investors section of Gamida Cell’s website at www.gamida-cell.com. To participate in the conference call, please dial 1-866-930-5560 (domestic) or 1-409-216-0605 (international) five minutes prior to start time. The conference ID number is 9462948. An archived version of the webcast will be available on Gamida Cell’s website for 30 days.

Details about the presentations are as follows:

Time: Wednesday, February 20, 2019, 6:45 p.m. – 7:45 p.m. CT (poster presentation)
Title: First-in-Human Phase I Study of Nicotinamide-Expanded Related Donor Natural Killer Cells for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma
Poster Number: 242
Lead Author: Veronika Bachanova, M.D., Ph.D., associate professor of medicine, division of hematology, oncology and transplantation, University of Minnesota
Location: George R. Brown Convention Center, Level 3, Hall B

Time: Wednesday, February 20, 2019, 6:45 p.m. – 7:45 p.m. CT (poster presentation)
Title: Ex Vivo Nicotinamide-Expanded (NAM-Expanded) Unrelated Cord Blood Transplantation (UCB) for Refractory Severe Aplastic Anemia Results in Rapid Engraftment and Expedites Immune Recovery
Poster Number: 295
Lead Author: Joseph Clara, M.D., Hematology Branch, National Heart, Lung, and Blood Institute
Location: George R. Brown Convention Center, Level 3, Hall B

Time: Saturday, February 23, 2019, 4:45 p.m. – 5:00 p.m. CT (oral presentation)
Title: Rapid and Robust CD4+ and CD8+ T-, NK-, B-Cell, Dendritic Cell, and Monocyte Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation
Abstract Number: 69
Lead Author: Jaap-Jan Boelens, M.D., Ph.D., Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer Center
Location: Hilton Americas Houston, Grand Ballroom G

Abstracts are available on the 2019 TCT Meetings of ASBMT and CIBMTR website.

About NAM-NK
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.1

About NiCord
NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 clinical study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia.2 NiCord is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as NiCord. For more information on clinical trials of NiCord, please visit www.clinicaltrials.gov.

NAM-NK and NiCord are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On February 14, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that Tait Shanafelt, M.D., will be the keynote speaker for the 23rd annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas and Myeloma (Press release, Physicians’ Education Resource, FEB 14, 2019, View Source [SID1234533330]). This year’s keynote presentation will take place Saturday, March 2, from 9:15 to 9:45 a.m. at the Eden Roc Miami Beach in Florida.

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"Dr. Shanafelt brings extensive knowledge and experience in the field of physician well-being," said Phil Talamo, president of PER. "We are delighted to have him as this year’s keynote speaker for the Winter Hematology annual meeting and look forward to his discussion on ways physicians can avoid burnout and balance their lives with practicing medicine."

During his keynote presentation, "Avoiding Physician Burnout," Shanafelt will discuss strategies on how to avoid burnout and find meaning, balance and personal satisfaction in the practice of medicine. Shanafelt will also be available for a meet and greet with attendees after his keynote concludes.

Shanafelt serves as the chief wellness officer at Stanford Medicine, associate dean at the Stanford School of Medicine and director of the Stanford WellMD Center. He is an international thought leader and researcher in the field of physician well-being and its implications for quality of care. His research in this area has involved physicians at all stages of their career, from medical school to established practices, and has included several multicenter and national studies. He has numerous published works in the Journal of Clinical Oncology, Annals of Internal Medicine, and JAMA. Shanafelt has also served as a keynote speaker for the Accreditation Council for Graduate Medical Education, Association of American Medical Colleges, American Medical Association, and American Board of Internal Medicine.

The 23rd annual congress is a three-and-a-half-day engaging and highly interactive meeting that provides community-based hematologists and medical oncologists interested in the treatment of hematologic malignancies with the opportunity to interact with internationally renowned experts in the management of leukemias, lymphomas, myeloma, myelodysplastic syndromes, myeloproliferative neoplasms and benign hematologic malignancies. During the congress, faculty experts will review latest information on pressing topics for 2019, including the expanding role of new immunologic approaches such as chimeric antigen receptor T cells and checkpoint inhibitors, the emergence of molecular-based therapies and new cytotoxic formulations in patients with acute leukemias, and new approaches for treatment and duration of therapy among patients with myeloproliferative neoplasms. The meeting will also feature several engaging Medical Crossfire discussion panels interspersed throughout the meeting to allow attendees to explore some of the most challenging clinical situations in the management of hematologic malignancies.

On February 14, 2019 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its financial results for the full year 2018 (Press release, Ipsen, FEB 14, 2019, View Source [SID1234533314])

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Financial highlights:
▪ Group sales growth of 16.6% as reported and 20.1% at constant exchange rates1, driven by Specialty Care sales growth of 24.7%1, reflecting strong performance across all major products and geographies, and sustained growth of Consumer Healthcare at 2.7%1,2
▪ Core operating margin at 29.7% of net sales, up 3.3 points and Core Operating Income growth of 31.0%
IFRS operating margin at 23.3% of net sales, up 2.5 points and IFRS Operating Income growth of 30.8%
▪ Financial guidance for 2019 of Group sales growth greater than 13.0% at constant exchange rate and Core operating margin around 31.0% of net sales, excluding incremental investments in pipeline expansion initiatives

Q4 2018 pipeline highlights:
▪ On 15 November 2018, approval from the European Commission for Cabometyx for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib
▪ On 5 December 2018, initiation with Exelixis of COSMIC-312, a Phase 3 pivotal trial of Cabometyx in combination with atezolizumab versus sorafenib in previously untreated advanced hepatocellular carcinoma (HCC)

David Meek, Chief Executive Officer of Ipsen, stated: "2018 was a tremendous year for Ipsen with industry-leading top-line growth and Somatuline achieving blockbuster status. We also delivered significant margin expansion while investing to advance our R&D pipeline. The momentum of the business is strong as we enter 2019 and are on track to deliver our 2020 financial targets to exceed €2.5 billion in sales and 30% margins, one year earlier.
In 2018, we advanced our pipeline with Cabometyx approvals in additional indications, acceleration of key programs and the establishment of new collaborations. We remain focused on executing our internal and external innovation strategy to build a robust pipeline, ensure continued growth and optimize value for patients and shareholders. We look forward to another outstanding year of strong industry-leading growth, expanding indications for our current medicines and advancing several innovative new chemical entities in the clinic."

Review of full year 2018 results

Note: Unless stated otherwise, all variations in sales are calculated excluding foreign exchange impacts established by recalculating net sales for the relevant period at the rate used for the previous period.

Group net sales reached €2,224.8 million, up 20.1% year-on-year.

Specialty Care sales reached €1,924.5 million, up 24.7%, driven by the strong growth of Somatuline and the €257.6 million contribution from the key Oncology launches of Cabometyx and Onivyde. Somatuline growth of 24.4% was driven by continued positive momentum in North America (38.2% growth in the U.S.) and solid performance throughout Europe. Dysport growth was fueled by strong performance and the resupply in Brazil, strong volume growth in the U.S. in the therapeutics market as well as the good performance of Galderma in the aesthetics market in Europe. Decapeptyl sales reflect good volume growth across Europe and a good performance in China.

Consumer Healthcare sales reached €300.3 million, up 2.7% year-on-year re-stated from Etiasa new contractual set-up (or down 2.9% as reported), driven by the good performance of Smecta and the contribution of the products acquired in 2017.

Core Operating Income reached €659.9 million in 2018, compared to €503.6 million in 2017, a growth of 31.0%, driven by the sales growth and after increased commercial investments for Cabometyx and Onivyde, and R&D investments to support the development of the growing pipeline.

Core operating margin reached 29.7% of net sales, up 3.3 points compared to 2017.

Core consolidated net profit was €491.6 million in 2018, an increase of 35.5% versus €362.7 million in 2017, driven by higher Core Operating Income and due to lower effective tax rate and net financing costs.

Fully diluted Core earnings per share grew by 35.5% to reach €5.91, compared to €4.36 in 2017.

IFRS Operating income was €519.4 million, up 30.8% after higher amortization of intangible assets (excluding software) and impairment charges. Operating margin of 23.3% was up 2.5 points compared to 2017.

IFRS Consolidated net profit was €389.1 million versus €272.9 million in 2017, up 42.6%.

IFRS Fully diluted EPS (Earning per share) was €4.68 versus €3.28 in 2017.

Free Cash Flow reached €458.4 million, up by €149.4 million or 48.3%, mainly driven by an improvement in Operating Cash Flow and lower restructuring costs, partially compensated by higher financial income and current income tax.

Closing net debt reached €242.5 million at the end of 2018, an improvement of €220.8 million over the closing net debt in 2017 of €463.3 million. This reflects positive Free Cash Flow generation of the Group which allowed the payment of milestones for Cabometyx and dividends in June.

Comparison of 2018 performance with financial objectives

The Group exceeded its upgraded guidance provided on 26 July 2018 for Group sales growth and for Core operating margin.

The table below shows the comparison between the financial objectives provided on 26 July 2018 and 2018 actuals.

Dividend for the 2018 financial year proposed for the approval of Ipsen’s shareholders

The Ipsen S.A. Board of Directors, which met on 13 February 2019, decided to propose at the Annual Shareholders’ meeting on 28 May 2019 the payment of a dividend of €1.00 per share for the 2018 financial year, unchanged from the prior year.

2019 Financial guidance

The Group has set the following financial targets for 2019:

Group sales growth year-on-year at constant currency greater than +13.0%; based on the current level of exchange rates, sales growth at current rates would be positively impacted by around 1.0%.
Core operating margin around 31.0% of net sales, excluding incremental investments in pipeline expansion initiatives.

Conference call

Ipsen will hold a conference call Thursday, 14 February 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 928000

France and continental Europe: +33 (0) 1 76 70 07 94

UK: 08-445-718-892

U.S.: 1-6315-107-495

Conference ID: 2989606

On February 14, 2019 Minomic International Ltd is reported the company has executed an agreement with Cirrus Dx, a CLIA Certified "High Complexity" Laboratory, enabling US clinicians and patients early access to the company’s novel test for Prostate Cancer (Press release, Minomic, FEB 14, 2019, View Source [SID1234533331]). The agreement allows Cirrus Dx to perform MiCheck as a Laboratory Developed Test (LDT) in the company’s Rockville MD based laboratory once internal validation is completed. Finalising this agreement completes an important step in commercialising MiCheck in the world’s largest healthcare market.

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Minomic’s CEO, Dr Brad Walsh, noted "being able to offer MiCheck as an LDT through our partnership with Cirrus Dx will provide the Company with three important outcomes, ‘Real World Data’ which can be used in subsequent FDA approval submissions, validation of MiCheck and its clinical utility and finally, royalty revenues. Our thanks to the Cirrus Dx team for making this possible with special acknowledgement for the hard work and vision provided by Cirrus’ Kyle Armantrout. We are very excited to be working with them as they continue to build their franchise in the urological testing space".

William M. Nelson, MD, Cirrus Dx’s President said "the ability of MiCheck to improve the diagnosis of Prostate Cancer and, in particular, reduce the number of unnecessary biopsies being performed is a game-changer and we look forward to working with Minomic to bring this vital improvement into the US market".

Minomic and Cirrus expect the required internal validation studies to be completed by the end of Quarter 1, 2019. Urologists and their patients in the US will have access to the MiCheck test shortly thereafter. A suitable reimbursement code has been identified and both companies believe that appropriate reimbursement will be available. Commercial details of the agreement will remain confidential.

On February 14, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release fourth quarter and fiscal year ended December 31, 2018 earnings results on March 11, 2019 before the market opens (Press release, Athenex, FEB 14, 2019, View Source;p=RssLanding&cat=news&id=2387476 [SID1234533315]). The Company will host a conference call and live audio webcast on Monday, March 11, 2019, at 8:30 a.m. Eastern Time to discuss the financial results and provide a business update.

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13687139. A replay of the call will be accessible two hours after its completion through March 18, 2019 by dialing 844-512-2921 (domestic) or 412-317-6671 (international) and entering passcode 13687139. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com.