On May 6, 2020 Fresenius Medical reported that first quarter results underlining resilience of business model (Press release, Fresenius, MAY 6, 2020, View Source [SID1234557073])

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Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: "In these unprecedented times, it is our first and foremost priority to maintain the continuity and high quality of care. For months now, our employees have been working tirelessly to ensure that our patients receive their life-saving dialysis treatments. I cannot thank them enough. We appreciate the financial commitment that the U.S. administration has given in April to support healthcare providers. The strong revenue growth in the first quarter shows that the underlying business development remains intact and that our business model is resilient. In a global pandemic that is redefining priorities in other areas of the healthcare system, dialysis remains essential for millions of patients worldwide."
 

Fresenius Medical Care’s contribution in the fight against COVID-19
In order to ensure the continuity and high quality of care for dialysis patients during the COVID-19 pandemic and support its employees around the globe, Fresenius Medical Care has taken wide-ranging measures at a very early stage. The focus is on reducing the risk of infection in dialysis clinics for patients and employees.

Despite countries’ lockdown efforts to contain the COVID-19 pandemic, Fresenius Medical Care did not experience any major disruptions in its manufacturing facilities. As of today, all manufacturing plants worldwide are in operation and supply chains remain intact.

Costs in respect to the COVID-19 pandemic have been incurred for additional measures, like personal protective equipment, dedicated capacities for isolated treatments, additional personnel expense, patient transportation as well as increased distribution logistic costs.

Under the CARES Act (Coronavirus Aid, Relief, and Economic Security Act), the U.S. government initiated significant financial support for the health sector. This is intended, for example, to compensate for the increased costs for healthcare providers as a result of the COVID-19 pandemic and the corresponding protective measures. While Fresenius Medical Care had to adsorb a sizable negative impact in Q1, there is no benefit from the CARES Act included in the reported results.

In the U.S., Fresenius Medical Care is cooperating with other dialysis providers, to create isolation clinics and dedicated shifts for patients who are or may be infected with COVID-19. A critical aim of this collaboration is to keep dialysis patients out of the hospital whenever possible, freeing up limited hospital resources. In doing so, Fresenius Medical Care not only fulfils its responsibility towards patients, employees and families, but also makes an important contribution to the healthcare system and society as a whole.

Key figures (IFRS)

2020 targets confirmed: mid to high single digit growth rates
On the basis of the guidance given in February, which excludes the impact from the COVID-19 pandemic, 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, 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.

Patients, Clinics and Employees
As of March 31, 2020, Fresenius Medical Care treated 348,703 patients in 4,002 dialysis clinics worldwide. At the end of the first quarter, the Company had 121,403 employees (full-time equivalents) worldwide, compared to 118,308 employees as of March 31, 2019.

Strong revenue growth in the first quarter
Revenue increased by 9% to EUR 4,488 million (+7% at constant currency), with organic growth of 4%. Health Care Services revenue rose by 8% to EUR 3,595 million (+7% at constant currency), driven by growth in same market treatments, contributions from acquisitions and an increase in dialysis days. Health Care Products revenue grew by 10% and amounted to EUR 893 million (+9% at constant currency). This increase was mainly due to higher sales of products for acute care treatments, renal pharmaceuticals and bloodlines partially offset by lower sales of dialysis machines.

Operating income increased by 3% to EUR 555 million (+1% at constant currency), mainly driven by a favorable impact from higher treatment volume and lower costs for pharmaceuticals. The operating income margin amounted to 12.4% (Q1 2019: 13.0%). The decrease in margin was largely due to the unfavorable COVID-19 pandemic effect and the prior year reduction of a contingent consideration liability related to Xenios.

Despite the negative impact from the COVID-19 pandemic net income1 grew by 4% to EUR 283 million (+2% at constant currency) and declined on an adjusted basis by only 1% (-3% at constant currency). On the defined basis of the 2020 targets – excluding the negative impact from the COVID-19 pandemic – net income growth in the first quarter is at the top end of the target range for 2020.

Basic earnings per share (EPS) increased by 8% to EUR 0.95 (+5% at constant currency) driven by the earnings effects described above coupled with a decrease in the average weighted shares outstanding.

Solid cash-flow development
Fresenius Medical Care generated EUR 584 million of operating cash flow (Q1 2019: EUR 76 million) resulting in a margin of 13.0% (Q1 2019: 1.8%). The increase was largely driven by working capital improvement, including a positive effect from cash collections, timing of payments and change in year over year inventory levels.
Free cash flow (net cash used in operating activities, after capital expenditures, before acquisitions and investments) amounted to EUR 304 million (Q1 2019: EUR -123 million), resulting in a margin of 6.8% (Q1 2019: -3.0%).

Regional developments
In North America, revenue increased by 10% to EUR 3,186 million (+7% at constant currency, +3% organic). Operating income grew by 24% to EUR 463 million (+21% at constant currency), resulting in a margin of 14.5 % (Q1 2019: 12.9%). Despite the negative impact from the COVID-19 pandemic, the operating income margin increased mainly due to lower costs for pharmaceuticals and gains from divestitures.

EMEA revenue increased by 4% to EUR 679 million (+4% at constant currency, +3% organic). Operating income decreased by 27% to EUR 101 million (-27% at constant currency), resulting in a margin of 14.9% (Q1 2019: 21.1%). The decrease in operating income margin was mainly due to the prior year reduction of a contingent consideration liability related to Xenios.

In Asia-Pacific, revenue grew by 4% to EUR 443 million (+3% at constant currency, +2% organic). Operating income decreased by 19% to EUR 77 million (-20% at constant currency), resulting in a margin of 17.3 % (Q1 2019: 22.1). The decrease in operating income margin was mainly due to impacts from unfavorable foreign currency transaction effects, lower product sales as well as expansion into in-center dialysis services.

Latin America revenue increased by 4% to EUR 168 million (+24% at constant currency, +17% organic). Operating income decreased by 40% to EUR 7 million (-40% at constant currency), resulting in a margin of 4.1% (Q1 2019: 7.1%). The decrease in operating income margin was mainly due to unfavorable foreign currency impacts.

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 For a reconciliation of adjusted figures, please refer to the table at the end of the press release
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.

Conference call
Fresenius Medical Care will host a conference call to discuss the results of the first quarter 2020 on May 6, 2020 at 3:30 p.m. CEDT (UTC +2) / 09:30 a.m. EDT (UTC -4). 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 May 6, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes (Press release, AbbVie, MAY 6, 2020, View Source [SID1234557072]). AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on May 8, 2020 to 5:00 p.m., New York City time, on May 12, 2020 (the "Expiration Date"). AbbVie currently expects that there will be no further extensions of the Expiration Date.

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers, which is expected to occur on May 14, 2020.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020, March 9, 2020, March 23, 2020, April 6, 2020, April 20, 2020 and April 27, 2020 and as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

On May 5, 2020 Lamassu Pharma, a biotech startup that is developing small molecule therapeutics to treat acute pancreatitis, reported the company has found plenty of investors despite the ongoing COVID-19 pandemic (Press release, Lamassu Pharma, MAY 5, 2020, View Source [SID1234646264]).

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The Durham firm says in an SEC filing that it has raised nearly $2.7 million.

And 19 investors are backing the company with a minimum investment of $50,000.

Lamassu is looking to raise another $200,000 in a round of equity with a near-$3 million target.

"We capitalizing on our expertise in early translational research to bring products to phase I/II, then partner with clinical and commercial development specialists. Our innovative model ensures that early development efforts bring product to definitive clinical testing as efficiently as possible to benefit patients and ensure early investment will lead to clinical results," the company says.

"Our lead candidate is a novel small molecule therapy for acute pancreatitis. This was developed at Mayo Clinic by leading scientists, and has profound preclinical efficacy to completely mitigate mortality and morbidity associated with severe acute pancreatitis. We are currently focused on continued development of this compound through safety testing in preparation for definitive clinical trials. Our ultimate goal is saving the lives of patients afflicted with this disease."

Lamassu launched in 2018.

Founders include:

GABI HANNA, MD, CEO and Co-Founder
Physician, and co-founder of Lamassu Pharma. Research focus on translational medicine and commercialization, bringing innovations to clinical trial and patient benefit.

GREG PALMER, PHD, CSO and Co-Founder
Biomedical engineer with expertise in imaging, medical devices, and translational science.

RABI HANNA, MD, CMO and Co-Founder
Chair of Pediatric Oncology at Cleveland Clinical, brings translational and clinical expertise.

On May 5, 2020 NETRIS Pharma SAS, a private clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that it has entered into a clinical collaboration agreement with MSD to investigate the safety, clinical and biological activity of NP137 with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with locally advanced/metastatic uterine tumors. NP137 targets netrin-1, which is overexpressed in over two-thirds of uterine tumors (Press release, Netris Pharma, MAY 5, 2020, View Source [SID1234611183]).

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The companies have entered this collaboration based on promising clinical data obtained from a phase 1 trial investigating NP137 monotherapy in patients with advanced solid tumors and the growing evidence that resistance to an anti-PD-1 therapy, such as KEYTRUDA, can be alleviated when combined with blocking netrin-1.

Under the terms of the agreement, NETRIS will sponsor a large phase 1b/2 study, which will be conducted in collaboration with the Centre Léon Bérard and with support of the specialist French oncology group of clinicians, GINECO (Groupe d’Investigateurs National des Etudes des Cancers Ovariens). The study will investigate the safety and efficacy of NP137 combined with KEYTRUDA in patients with advanced/metastatic endometrial carcinoma or cervix carcinoma.

"We are excited to collaborate with MSD, an established leader in cancer immunotherapy, on our proof-of-concept phase1b/2 study as we work to improve the lives of cancer patients," said Patrick Mehlen, Founder and Chief Executive Officer of NETRIS Pharma. "Immunotherapies are revolutionizing the treatment of patients in several cancer indications, but there remain many other tumor types in which existing immunotherapies have not demonstrated sufficient efficacy. Based on our preclinical and clinical data demonstrating the role of netrin-1 in promoting tumor progression and modulating tumor plasticity and microenvironment, we believe NP137’s effect in combination with KEYTRUDA will lead superior patient response to immunotherapy."

"The preliminary safety data and anti-tumor activity observed in the Phase 1a trial, together with the unique mode of action of NP137, are very exciting and clearly support evaluating a combination with KEYTRUDA," said Isabelle Ray Coquard, MD, Ph.D. and Principal Investigator of the trial. "We anticipate starting the study summer 2020."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

The Phase 1b/2 clinical trial will enroll up to 240 patients and be divided into a Ph1b part to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of the NP137 KEYTRUDA combination and/or chemotherapeutic agents. The Phase 2 part will assess via randomization the clinical activity of the combination in both tumor types.

About NP137
NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

About GINECO
GINECO (Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein) is the French Cooperative Group in Oncology labelled by INCA (National Cancer Institute in France) developing and conducting gynecological and metastatic breast cancer clinical trials at the national and international level. The network comprises more than 700 specialized investigators representing more than 150 public or private oncology units.

On May 5, 2020 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its First Quarter Report for 2020 (Press release, Affibody, MAY 5, 2020, View Source [SID1234575698]).

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Financial Highlights

Revenue for the first Quarter 2020 amounted to SEK 9.6 (30.0) m
Operating result for the quarter amounted to SEK -58.2 (-24.9) m
Net result for the quarter amounted to SEK -58.9 (-24.7) m
Cash flow for the quarter amounted to SEK -78.4 (10.7) m
Cash and cash equivalents at the end of the period amounted to SEK 296.4 (101.6) m.
Significant Events during period

An EGM on February 17, 2020 elected José Suarez as Board member.
Significant Events after the close of the Reporting Period

On May 15, 2020, Affibody and Inmagene Biopharmaceuticals announced a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide. Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory
Affibody is a clinical stage Swedish biotech company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod.

The company operates a focused experimental medicine model and currently has three clinical stage programs. The first two are therapeutic programs that targets psoriasis, and B-cell driven autoimmune diseases respectively. The third program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.