On January 31, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release fourth-quarter and full-year 2018 financial results before the market opens on Thursday, February 14, 2019, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, JAN 31, 2019, View Source [SID1234532982]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 2287302.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the West website three hours after the live call and through Thursday, February 21, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 2287302.

On January 31, 2019 Oxford Vacmedix UK Limited (OVM), the UK-based biopharma company focused on the development of cancer vaccines, reported the first meeting of its Scientific Advisory Council (Press release, Oxford Vacmedix, JAN 31, 2019, View Source [SID1234532980]). World-class experts gathered to guide the research and preclinical development programmes of the company and to give input on the planned Phase 1 clinical trials of the lead development candidates; OVM-100 in cervical cancer and OVM-200 for the treatment of solid tumours.

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The Scientific Advisory Council met in Oxford on 17th January 2019 with the participation of:

Professor Sir Andrew McMichael, Emeritus Professor, former Professor of Molecular Medicine, and previously Director of the Weatherall Institute of Molecular Medicine at the University of Oxford. He was a pioneer in T cell research and has particular expertise in the field of T cell responses to viral infections and in vaccine development.
Professor Xu Xiao-Ning is a leading immunologist who was previously at the Institute of Molecular Medicine at the University of Oxford and then head of Novartis Vaccines in China. He is currently Chair of Human Immunology at Imperial College, London.
Dr Nicola Burgess-Brown, Head of the Structural Genomics Consortium (SGC) at Oxford and Principal Investigator in Biotechnology, responsible for the world class biotech research on soluble proteins, membrane proteins and epigenetics targets being led from the Oxford site.
Dr Wang-Jun Lee, Chairman and CEO of the Myongji Medical Foundation and Dr Baek-Seung Lee, Chief Technology Officer of Cancer ROP, the lead Series A investor in OVM also attended. The meeting focused on the manufacturing and preclinical development of the cancer vaccines and also the promising proof of concept research ongoing to test the potential synergies between the vaccines and immuno-oncology (IO) agents.

Spun out from the University of Oxford, OVM is commercialising the research led by Dr Shisong Jiang and developed in Oxford University’s Department of Oncology. The technology uses the novel, proprietary platform of recombinant overlapping peptides to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other IO agents.

Shisong Jiang, CSO and Founder of OVM, said:

"We are very pleased to have the input from such an experienced Scientific Advisory Council and to have the Advisors input to the research and development of our cancer vaccines. The expertise and experience brought by our new Advisors will be key to OVM’s cancer vaccines being progressed to important clinical milestones both to benefit patients and in the development of the company. We look forward to working with the Council to guide the development of our immunotherapy vaccines".

On January 31, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that in its lawsuit against Janssen Biotech and Genmab A/S, the parties have settled the dispute (Press release, MorphoSys, JAN 31, 2019, View Source [SID1234533001]). As a result of this, the parties to the dispute have agreed to drop the mutual claims related to this litigation.

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On April 4, 2016 MorphoSys had filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. In 2017, a second and a third patent with US Patent Numbers 9,200,061 and 9,758,590 were added to the lawsuit. MorphoSys had sought redress for alleged infringement by Janssen’s and Genmab’s daratumumab, a CD38-directed monoclonal antibody for the treatment of multiple myeloma. MorphoSys is dismissing those claims and will not appeal from the previously-announced court order dated January 25, 2019. Janssen and Genmab are dismissing their counterclaims

On January 31, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the fiscal year ended December 31, 2018 and forecasts for the fiscal year ending December 31, 2019 (Press release, Chugai, JAN 31, 2019, View Source [SID1234533002]).

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In 2018, both revenues and profits increased driven by: contribution from new products including the hemophilia A treatment Hemlibra and the immune checkpoint inhibitor Tecentriq; steady growth of mainstay products in Japan and overseas; and an increase in royalties and other operating income primarily due to one-time income from the transfer of long-term listed products and out-licensing of an investigational drug for diabetes. Revenues, operating profit and net income achieved record-high for two consecutive years. Reflecting the favorable results and based on our dividend policy, year-end dividends for the fiscal year 2018 are planned to be ¥55 per share, which is higher by ￥10 as increased regular dividend and ¥14 as special dividends than the forecast at the beginning of the fiscal year. As a result, total dividends for the fiscal year will be ¥86 per share, and the Core dividend payout ratio is 48.7%.

For the fiscal year 2019, Chugai expects growth in both revenues and profits owing to increases in overseas sales with a steady growth in Alecensa export to Roche and the continued growth in sales quantity of Actemra, and increases in royalties mainly for Hemlibra, while domestic sales are expected to decrease due to the negative impact from competition including generic competition and the NHI drug price revisions. Chugai expects total estimated dividends of ¥96. Accordingly, the forecast for the Core dividend payout ratio is 48.5%.

Domestic sales excluding Tamiflu were almost steady at ¥389.2 billion (+0.2%). Contribution from new products including the hemophilia A treatment Hemlibra created by Chugai and the immune checkpoint inhibitor Tecentriq, and the steady growth of mainstay products in bone and joint diseases area have offset the negative impact of the NHI drug price revisions. However, overall domestic sales slightly decreased to ￥399.9 billion (-1.3%) because Tamiflu sales for government stockpiles decreased remarkably.
Oncology: Sales were almost flat compared with the previous year. Sales of Tecentriq that was launched in April totaled ￥9.1 billion and sales of the mainstay product ALK inhibitor Alecensa reported steady growth. However, sales of Herceptin and Rituxan decreased mainly due to the NHI drug price revisions in April.
Bone and joint diseases: Sales increased due to the robust sales of mainstay products such as the anti-rheumatic agent Actemra and the osteoporosis agent Edirol.
Renal diseases: Sales declined mainly due to decreases in sales of the secondary hyperparathyroidism treatment Oxarol and the renal anemia agent Mircera, primarily as a result of the NHI drug price revisions in April.
Others: Sales recorded a double-digit decline due primarily to the long-term listed products transferred to Taiyo Pharma Co., Ltd., despite sales of ￥3.0 billion for Hemlibra launched in May experienced favorable market penetration.
Overseas sales increased to ¥127.9 billion (+36.1%) due to increases in exports of Alecensa and Actemra to Roche.
Royalties and other operating income increased remarkably to ￥51.9 billion (+48.7%) due to one-time income primarily from the transfer of long-term listed products to Taiyo Pharma Co., Ltd. and out-licensing of an investigational drug for diabetes OWL833 to Eli Lilly and Company.

Cost of sales ratio to revenues improved mainly due to a change in product mix and increases in royalties and other operating income. As a result, Core gross profit totaled ¥317.9 billion (+13.0%), achieving a double-digit growth.
Core operating expenses amounted to ¥187.6 billion (+5.3%) with a single-digit growth rate, contrary to Core gross profit. The increase in Core operating expenses was mainly driven by R&D expenses. As a result, Core operating profit totaled ¥130.3 billion (+26.3%). Core operating profit ratio to revenues was 22.5%, improved by 3.2 percentage points from the previous year.
Forecast for the fiscal year ending December 31, 2019
[Revenues]
Domestic sales are forecasted to decrease to ￥389.1 billion (-2.7%) compared to the previous year. The negative impact from competition including generic competition and the NHI drug price revisions will exceed the sales growth in new products including Hemlibra and Tecentriq.
Overseas sales are expected to increase to ¥138.9 billion (+8.6%), reflecting the steady growth in Alecensa export to Roche and the continued growth in sales quantity of Actemra.
Royalties and other operating income is expected to increase to ￥64.5 billion (+24.3%). Royalty and profit-sharing income is forecasted to rise to ¥53.5 billion (+122.0%) because of increases in royalties from Roche mainly for Hemlibra. Other operating income is expected to decrease to ¥11.0 billion (-60.6%) mainly because one-time income was recorded in the previous year from the transfer of long-listed products.
[Core operating profit]
Core gross profit is expected to rise to ¥340.0 billion (+7.0%) mainly due to the increase in revenues.
Core operating expenses are expected to amount to ¥197.0 billion (＋5.0%). Particularly, R&D expenses are expected to increase to ¥102.0 billion (+8.3%).
As a result, Core operating profit is expected to be ¥143.0 billion (+9.7%).
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 as the basis for payment-by-results such as a return to shareholders

On January 31, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the patent infringement lawsuit launched by MorphoSys relating to DARZALEX is finally over (Press release, Genmab, JAN 31, 2019, View Source [SID1234532986]).

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As previously reported, on January 25, 2019, the U.S. District Court of the District of Delaware ruled that all three patents that MorphoSys had asserted against Genmab and Janssen Biotech, Inc. (Janssen) are invalid. As noted at that time, Genmab and Janssen’s allegations that the patents were unenforceable for inequitable conduct remained to be resolved, and MorphoSys had the right to appeal the invalidity decision to the United States Court of Appeals for the Federal Circuit.

Today, MorphoSys dismissed its infringement claims with prejudice (for good), and Genmab and Janssen have, in turn, dismissed their inequitable conduct claims. As such, there will be no further proceedings in the case. The case is now over.

"Genmab is an antibody innovation powerhouse committed to conducting business in an ethical manner in accordance with our core values, and we are very pleased that this case is finally over and behind us," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.