On February 19, 2020 Fresenius Medical reported that Care achieves 2019 guidance and confirms 2020 outlook of sustainable, profitable growth (Press release, Fresenius, FEB 19, 2020, View Source [SID1234554498])

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Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: "2019 was a successful year for Fresenius Medical Care. We achieved our revenue and net income targets and are therefore proposing our 23rd consecutive dividend increase. Last year we also invested more strongly in our future growth, particularly in the area of home dialysis and in developing economies. In addition, our measures to increase efficiency and optimize our cost base are progressing according to plan. As a consequence, we expect growth to accelerate, and confirm the 2020 outlook that we issued early last year."

2020 guidance confirmed: mid to high single digit growth rates
Fresenius Medical Care expects both revenue and net income to grow at a mid to high single digit rate in 2020. These targets are in constant currency and exclude special items3 and are based on the adjusted results 2019 including the effects of the operations of the NxStage acquisition and the IFRS 16 implementation.

Investment year 2019
The continued expansion of home dialysis in the U.S. is a key growth area for Fresenius Medical Care. As announced at the beginning of 2019, our investments focused on home training facilities, educational staff and materials along with scaling the distribution infrastructure to support both products and services. The closing of the acquisition of NxStage Medical, Inc. in February 2019 marked a milestone in our home dialysis strategy. In 2019, Fresenius Medical Care reported record growth with more than 25,000 patients being treated at home in North America.

The second major focus of investment were developing economies. In China, the world’s fastest-growing dialysis market, Fresenius Medical Care invested in expanding production capacities, research and development activities as well as in strengthening its services business, that has almost doubled with now 11 clinics. In September 2019, we launched the 4008A dialysis machine in China, laying an important foundation for the further development of the market.

In addition, Fresenius Medical Care invested EUR 91 million (EUR 83 million in North America) to sustainably improve the cost base of our clinical infrastructure. This 2019 cost optimization program is expected to be accretive to net income from the current financial year onwards. In 2019, we achieved further sustained cost improvements as part of our Global Efficiency Program (GEP II), in line with the originally anticipated contribution.

Creating shareholder value
Based on the solid results for 2019, the General Partner and the Supervisory Board will propose a new record dividend of EUR 1.20 per share, corresponding to a total payout of EUR 358 million, to the Annual General Meeting in May 2020. This proposal would result in the 23rd consecutive dividend increase.

In order to create additional shareholder value, Fresenius Medical Care launched a share buy-back program in 2019. Between March and December 2019, 8.9 million own shares were bought back at a total purchase price of EUR 600 million. The Company intends to use its residual authorization of EUR 400 million over the course of 2020.

Patients, Clinics and Employees
As of December 31, 2019, Fresenius Medical Care treated 345,096 patients in 3,994 dialysis clinics worldwide. At the end of 2019, Fresenius Medical Care had 120,659 employees (full-time equivalents) worldwide, compared to 112,658 employees as of December 31, 2018.

Strong organic revenue growth continued
Revenue for the fourth quarter of 2019 increased by 7% (+4% at constant currency) to EUR 4,580 million. Organic growth remained strong at 5%4. Adjusted revenue increased by 6% (+4% at constant currency) to EUR 4,546 million. For a detailed reconciliation, please refer to the table at the end of the press release.

Health Care Services revenue rose by 6% to EUR 3,607 million (+3% at constant currency), while Health Care Products revenue grew by 10% to EUR 973 million (+8% at constant currency). This includes the negative effect from a revenue recognition adjustment of EUR 86 million (FY 2019: EUR 170 million) for accounts receivable in legal dispute in North America.

Revenue for the full year 2019 rose by 6% to EUR 17,477 million (+2% at constant currency). Organic growth amounted to 5%. Adjusted revenue increased by 8% (+5% at constant currency) to EUR 17,329 million. Health Care Services revenue grew by 5% (+1% at constant currency) to EUR 13,872 million. Growth in same market treatments, contributions from acquisitions and increases in organic revenue per treatment were partly offset by decreases attributable to prior year revenue from divested activities of Sound Physicians and closed or sold clinics. Health Care Products revenue for the full year 2019 rose by 10% to EUR 3,605 million (+8% at constant currency). This increase was mainly driven by higher sales of home dialysis products as a result of the NxStage acquisition and by higher sales of dialyzers. This was partially offset by lower sales of machines as a result of changes in the accounting treatment for sale-leaseback transactions due to the IFRS 16 implementation.

In the fourth quarter operating income increased by 1% to EUR 616 million (-2% at constant currency), resulting in a margin of 13.5% (Q4 2018: 14.3%). Adjusted operating income grew by 3% to EUR 655 million (stable at constant currency), resulting in a margin of 14.4% (Q4 2018: 14.8%). The included negative effect from a revenue recognition adjustment for accounts receivable in legal dispute in North America is EUR 86 million (FY 2019: EUR 170 million). For a detailed reconciliation, please refer to the table at the end of the press release.

Operating income for the full year decreased by 25% to EUR 2,270 million (-28% at constant currency), resulting in a margin of 13.0% (FY 2018: 18.4%). The 2018 basis includes the gain from the divestiture of Care Coordination activities including Sound Physicians. On an adjusted basis, operating income remained stable at EUR 2,296 million (-4% at constant currency), resulting in a margin of 13.2% (FY 2018: 14.3%).

Net income2 for the fourth quarter decreased by 19% to EUR 343 million (-21% at constant currency). Adjusted net income2 increased by 3% to EUR 408 million (+0% at constant currency). For a detailed reconciliation, please refer to the table at the end of the press release. Basic earnings per share (EPS) decreased by 17% to EUR 1.14 (-20% at constant currency). On an adjusted basis, EPS increased by 6% to EUR 1.36 (+3% at constant currency).

For the full year, net income decreased by 39% to EUR 1,200 million (-42% at constant currency). EPS decreased by 39% to EUR 3.96 (-41% at constant currency). Here, too, the 2018 basis includes the gain from the divestiture of Care Coordination activities including Sound Physicians. On an adjusted basis, net income grew by 2% to EUR 1,369 million (-2% at constant currency). This resulted in a 3% increase in adjusted EPS to EUR 4.52 (-1% at constant currency).

Strong Cash-flow development
In the fourth quarter, Fresenius Medical Care generated EUR 771 million of operating cash flow (Q4 2018: EUR 698 million) resulting in a margin of 16.8% (Q4 2018: 16.2%). The increase was largely driven by the IFRS 16 implementation. Free cash flow (net cash used in operating activities, after capital expenditures, before acquisitions and investments) amounted to EUR 434 million (Q4 2018: EUR 397 million) resulting in a margin of 9.5% (Q4 2018: 9.2%).

In the full year, we generated operating cash flow of EUR 2,567 million resulting in a margin of 14.7% (FY 2018: EUR 2,062 million, 12.5%). The increase was mainly due to the IFRS 16 implementation. Free cash flow for the full year 2019 amounted to EUR 1,454 million resulting in a margin of 8.3% (FY 2018: EUR 1,059 million, 6.4%).

Regional developments
In North America, revenue in the fourth quarter of 2019 increased by 6% to EUR 3,174 million (+3% at constant currency, +5% organic growth). For the full year 2019, North America revenue rose by 5% to EUR 12,195 million (stable at constant currency, +4% organic).

Operating income for the fourth quarter grew by 5% to EUR 515 million (+2% at constant currency). For the full year, operating income decreased by 33% to EUR 1,794 million (-36% at constant currency). The 2018 basis includes the gain from the divestiture of Care Coordination activities including Sound Physicians.

In EMEA, revenue in the fourth quarter increased by 4% to EUR 709 million (+4% at constant currency, +3% organic). For the full year, EMEA revenue rose by 4% to EUR 2,693 million (+4% at constant currency, +4% organic).

Operating income for the fourth quarter rose by 17% to EUR 114 million (+17% at constant currency). For the full year, operating income grew by 12% to EUR 448 million (+13% at constant currency) resulting in a margin of 16.6% (FY 2018: 15.4%). This improvement was mainly driven by a reduction of a contingent consideration liability related to Xenios and a positive impact from the IFRS 16 implementation.

In Asia-Pacific, revenue in the fourth quarter 2019 grew by 10% to EUR 499 million (+7% at constant currency, +6% organic). For the full year, revenue increased by 10% to EUR 1,859 million (+7% at constant currency, +7% organic).

Operating income for the fourth quarter decreased by 13% to EUR 75 million (-14% at constant currency). The decline in margin in the fourth quarter was mainly due to investments in business growth and expenses for the cost optimization program. For the full year, operating income grew by 8% to EUR 329 million (+6% at constant currency).

Regarding the coronavirus (nCoV) outbreak the first priority is to ensure continuation of treatments for our patients and the safety of our employees. It is too early to quantify the potential impact to our Asia-Pacific operations.

In Latin America, revenue for the fourth quarter increased by 6% to EUR 193 million (+24% at constant currency, +19% organic). For the full year, Latin America revenue increased by 3% (+21% at constant currency, +17% organic) to EUR 709 million.

Operating income for the fourth quarter increased by 189% to EUR 15 million (+201% at constant currency). For the full year, operating income increased by 47% to EUR 43 million (+35% at constant currency). The improved margin was mainly due to favorable foreign currency transaction effects.

1 For a detailed reconciliation, please refer to the table at the end of the press release.
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
3 Special items are effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
4 Definition of organic growth excludes effects such as out of period adjustments or effects from IFRS 16 implementation.

Press conference
Fresenius Medical Care will hold a press conference at its headquarters in Bad Homburg, Germany to discuss the results of the fourth quarter and full year tomorrow on Thursday, February 20, 2020, at 10:00 a.m. CET / 4:00a.m. EST. The press conference will be webcasted on the company’s website www.freseniusmedicalcare.com in the "Media" section. A replay will be available shortly after the conference.

Conference call
We will also host a conference call to discuss the results of the fourth quarter tomorrow on Thursday, February 20, 2020, at 3:30 p.m. CET / 09:30 a.m. EST. Details will be available on the company’s website www.freseniusmedicalcare.com in the "Investors" section. A replay will be available shortly after the call.

On February 19, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported a global license agreement with Seattle Genetics, Inc. to develop and commercialize novel antibody-drug conjugate (ADC) therapies using monoclonal antibodies developed by Five Prime (Press release, Five Prime Therapeutics, FEB 19, 2020, View Source [SID1234554497]). ADCs harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.

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Under the terms of the agreement, Five Prime granted Seattle Genetics an exclusive worldwide license to a family of monoclonal antibodies that are directed to a single target and Seattle Genetics will be responsible for research, development, manufacturing and commercialization of ADC products based on these antibodies. For the multi-product deal, Five Prime will receive a $5 million upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Cumulative milestones may reach up to $295 million for the first ADC product that is developed and commercialized. Five Prime will additionally receive tiered mid-single digit royalties on net product sales.

"We are pleased to enter into this license agreement with Seattle Genetics, a global leader that develops and commercializes transformative targeted cancer therapies that utilize its industry-leading ADC technology," said William Ringo, Chairman and interim Chief Executive Officer of Five Prime Therapeutics. "This agreement allows Five Prime to realize value from our pre-clinical pipeline while prioritizing our clinical investments based on upcoming data readouts for our programs. Looking to the future, we will continue to seek strategic partnerships that allow us to maximize the value of our assets and the long-term potential of the company."

On February 19, 2020 Elicio Therapeutics, a next generation immuno-oncology company, reported Peter DeMuth, PhD., Elicio Vice President of Research, will present "Targeting the Lymph Nodes to Enhance Mutant KRAS-Specific Vaccine Responses," at the upcoming RAS-Targeted Drug Discovery Summit in Vienna, Austria, from February 25 to 27, 2020 (Press release, Elicio Therapeutics, FEB 19, 2020, View Source [SID1234554495]).

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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

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The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Elicio’s ELI-002 targets seven position 12 and 13 KRAS mutations, present in approximately 25% of all human solid tumors. Elicio believes that ELI-002 has the potential to become a multi-targeted mKRAS therapy with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal, lung, bile duct, endometrial, and ovarian.

"By precisely targeting the immune cells which orchestrate anti-tumor responses in lymph nodes, ELI-002 has been shown in preclinical studies to enhance the magnitude and functional characteristics of KRAS-specific immunity important for a robust anti-tumor effect" said Peter DeMuth, PhD, Vice President of Research of Elicio Therapeutics. "These responses were able to simultaneously target all 7 common KRAS mutants, indicating the potential to prevent tumor recurrence likely to arise from therapies specific to individual mutants."

At the conference Dr. DeMuth will discuss Elicio’s:

Amphiphile technology which allows "AMP KRAS-vaccine" ELI-002 to simultaneously generate immune response to the seven mutations commonly present in KRAS driven cancers by targeting peptides with a powerful adjuvant directly to the lymph nodes;
In vivo data showing the significant benefits of lymph node targeting versus systemic drug delivery;
Data showing induction of potent mKRAS-specific T cell responses using ELI-002, a first-in-class lymph node immunotherapy, and;
Plans for a prospective, multicenter First-in-Human Phase 1/2 Trial of ELI-002 Lymph Node Immunotherapy as Treatment for Minimal Residual Disease in Patients with KRAS mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors.
Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy activators to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses. ELI-002 is an "AMP KRAS-vaccine" containing seven Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, administered subcutaneously.

KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers. ELI-002has completed preclinical validation, IND-enabling GLP toxicology studies, and a pre-IND meeting with the FDA. P1/2 trials will be multi-site, starting with an open label dose escalation, progression to expansion cohorts in KRAS mutated solid tumors, and seamlessly progressing into a randomized, controlled cohort.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On February 19, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported that the Company will release its 2019 fourth quarter and full year financial results on Monday, March 2, 2020, before the market opens (Press release, Eagle Pharmaceuticals, FEB 19, 2020, View Source [SID1234554494]).

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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

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Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will host a conference call to discuss the results as follows:

Date

Monday, March 2, 2020

Time

8:30 a.m. EST

Toll free (U.S.)

877-876-9173

International

785-424-1667

Webcast (live and replay)

www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-3020 (US) or 402-220-7234 (International) and entering conference call ID EGRXQ419. The webcast will be archived for 30 days at the aforementioned URL.

On February 19, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has enrolled and begun dosing the final patient in its ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, FEB 19, 2020, View Source [SID1234554493]). The trial, which is being conducted at the Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, and in collaboration with Guangxi Wuzhou Pharmaceutical Company, is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (PFS). The current standard of care is first-line temozolomide (TMZ) with radiation.

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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

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"We are very pleased to have enrolled and started dosing our final patient in this important study. This earlier than predicted full enrollment is encouraging and will allow an earlier topline data readout," commented Professor Zhong-ping Chen, founder chairman of the Department of Neurosurgery/Neuro-oncology at Sun Yat-sen University Cancer Center, and who is also the study’s principal investigator. "The enrollment of the final patient also provides us the opportunity to corroborate the preliminary data we’ve recently published, which supports the possibility that VAL-083 can provide a new and valuable treatment option in this difficult-to-treat indication."

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. Efficacy will be measured based on tumor response to treatment, progression-free survival, progression-free survival at six months, and overall survival compared to historical results in the target population.

"Having completed enrollment of our first-line study ahead of schedule, we expect to complete analysis for the topline data in our most important Phase 2 trial for first-line GBM patients earlier than anticipated. We are optimistic that we will receive the initial data readout before the end of August 2020," commented Saiid Zarrabian, DelMar’s Chief Executive Officer. "In the meantime, we continue to rapidly advance our other Phase 2 program in the adjuvant and recurrent settings for VAL-083 at MD Anderson Cancer Center and look forward to providing further updates on the progress of our ongoing open label GBM trials at upcoming scientific meetings."

DelMar has been monitoring the coronavirus situation in China. Based on discussions with our principal investigator at SYSUCC, we believe the coronavirus outbreak will not have a significant impact on our patient treatment timeline.

In addition to the Phase 2 clinical trial in first-line treatment, DelMar is conducting an additional two-arm Phase 2 clinical trial in GBM. The adjuvant arm, which initiated in late 2019 will enroll up to 24 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy. The second arm treats patients with recurrent disease, administering VAL-083 in patients who have been heavily pre-treated with TMZ prior to disease recurrence. The recurrent arm will allow a total of 83 patients to be enrolled. Both arms are being conducted at the University of Texas MD Anderson Cancer Center.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

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