Cancer vaccine firm Oxford Vacmedix holds first meeting of Scientific Advisory Council

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".

MorphoSys Announces Settlement in Patent Lawsuit with Janssen and Genmab

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

Chugai Announces 2018 Full Year Results and Forecasts for 2019

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

Genmab Announces that the Patent Infringement Lawsuit Relating to DARZALEX® is Over

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.

AmerisourceBergen Reports Fiscal 2019 First Quarter Results

On January 31, 2019 AmerisourceBergen Corporation (NYSE:ABC) reported that in its fiscal year 2019 first quarter ended December 31, 2018, revenue increased 12.2 percent to $45.4 billion (Press release, AmerisourceBergen, JAN 31, 2019, View Source [SID1234532987]). On the basis of U.S. generally accepted accounting principles (GAAP), diluted earnings per share (EPS) was $1.84 for the December quarter of fiscal 2019, compared to $3.90 in the prior year quarter. Adjusted diluted EPS, which is a non-GAAP measure that excludes items described below, increased 3.2 percent to $1.60 in the fiscal first quarter.

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The Company narrowed its adjusted diluted EPS guidance for fiscal 2019 to $6.65 to $6.85. The Company does not provide forward-looking guidance on a GAAP basis, as discussed below in Fiscal Year 2019 Expectations.

"We are pleased with the strong start in the first quarter of fiscal 2019. The overall strength and performance of AmerisourceBergen’s portfolio of core Pharmaceutical Distribution businesses delivered outstanding results to help offset the headwind from PharMEDium. We are extremely proud and recognize that this would not have been possible without the execution by our dedicated associates," said Steven H. Collis, Chairman, President and Chief Executive Officer of AmerisourceBergen.

"Our fiscal 2019 outlook remains strong, even as we narrowed fiscal 2019 guidance to reflect the extended delay in the reopening of PharMEDium’s Memphis facility. AmerisourceBergen’s strategic partnerships, leadership in Specialty distribution and services, and strong balance sheet position the company to continue to deliver growth, while we actively work to resolve the challenges at PharMEDium," Mr. Collis continued. "We remain confident in our ability to execute, evolve and transform our business to meet the complex needs of our customers, drive long-term value for our shareholders and ultimately enable access for patients. More than ever, we are united in our responsibility to create healthier futures."

Below, AmerisourceBergen presents descriptive summaries of the Company’s GAAP quarterly results as well as its adjusted (non-GAAP) quarterly results. In the tables that follow, GAAP results and GAAP to non-GAAP reconciliations are presented. For more information related to non-GAAP financial measures, including our fiscal year 2019 expectations, please refer to the Supplemental Information Regarding non-GAAP Financial Measures following the tables.

First Quarter GAAP Results

Revenue: In the first quarter of fiscal 2019, revenue was $45.4 billion, up 12.2 percent compared to the same quarter in the previous fiscal year, reflecting a 12.3 percent increase in Pharmaceutical Distribution Services revenue and an 8.2 percent increase in revenue within Other. The significant increase in revenue growth of our Pharmaceutical Distribution Services segment is due primarily to growth of some of its largest customers, overall market growth, strong oncology product sales, the January 2018 acquisition of H. D. Smith and the January 2018 consolidation of Profarma.
Gross Profit: Gross profit in the fiscal 2019 first quarter was $1.3 billion, a 16.6 percent increase compared to the same period in the previous fiscal year. The increase was primarily due to a 10.8 percent increase in Pharmaceutical Distribution Services gross profit and a 1.4 percent increase in gross profit within Other. Pharmaceutical Distribution Services benefited from an increase in revenue, the January 2018 acquisition of H. D. Smith, and the January 2018 consolidation of Profarma, and was partially offset by a lower contribution from PharMEDium. Gross profit was also favorably impacted by gains from antitrust litigation settlements and the reversal of a previously-estimated assessment related to the New York State Opioid Stewardship Act, offset in part by PharMEDium remediation costs. Gross profit as a percentage of revenue was 2.86 percent, an increase of 11 basis points from the prior year quarter.
Operating Expenses: In the first quarter of fiscal 2019, operating expenses were $819.8 million, compared to $693.7 million in the same period last fiscal year. The increase in operating expenses was due to an increase in operating expenses within Pharmaceutical Distribution Services primarily driven by the January 2018 acquisition of H. D. Smith and the January 2018 consolidation of Profarma. Operating expenses as a percentage of revenue in the fiscal 2019 first quarter was 1.81 percent, compared to 1.71 percent for the same period in the previous fiscal year.
Operating Income: In the fiscal 2019 first quarter, operating income was $477.8 million versus $419.0 million in the prior year quarter as the increase in gross profit exceeded the increase in operating expenses. Operating income as a percentage of revenue increased 1 basis point to 1.05 percent in the fiscal 2019 first quarter compared to the previous fiscal year’s first quarter.
Interest Expense, Net: In the fiscal 2019 first quarter, net interest expense of $42.2 million was up 17.6 percent versus the prior year quarter, primarily due to the debt issued to finance the H. D. Smith acquisition and the consolidation of Profarma’s debt and related interest expense.
Effective Tax Rate: The effective tax rate was 9.4 percent for the first quarter of fiscal 2019 and (140.1) percent in the prior year quarter. The effective tax rates for both periods were significantly lower than the Company’s statutory tax rates due to the 2017 Tax Act.
Diluted Earnings Per Share: Diluted earnings per share was $1.84 in the first quarter of fiscal 2019 compared to $3.90 in the previous fiscal year’s first quarter. This decrease was primarily due to the significant income tax benefit recognized in the prior year period as a result of the 2017 Tax Act.
Diluted Shares Outstanding: Diluted weighted average shares outstanding for the first quarter of fiscal 2019 were 214 million, a 3.1 percent decline versus the prior fiscal year first quarter, due primarily to share repurchases, net of stock option exercises.
Definition of Adjusted (non-GAAP) Results

The comments below compare adjusted results, which exclude:

Gain from antitrust litigation settlements;
LIFO expense / credit;
PharMEDium remediation costs;
New York State Opioid Stewardship Act;
Acquisition-related intangibles amortization;
Employee severance, litigation, and other;
Loss on early retirement of debt; and
One-time tax reform adjustments.
First Quarter Adjusted (non-GAAP) Results

Revenue: No adjustments were made to the GAAP presentation of revenue. In the first quarter of fiscal 2019, revenue was $45.4 billion, up 12.2 percent compared to the same quarter in the previous fiscal year, reflecting a 12.3 percent increase in Pharmaceutical Distribution Services revenue and an 8.2 percent increase in revenue within Other. The significant increase in revenue growth of our Pharmaceutical Distribution Services segment is due primarily to growth of some of its largest customers, overall market growth, strong oncology product sales, the January 2018 acquisition of H. D. Smith and the January 2018 consolidation of Profarma.
Adjusted Gross Profit: Adjusted gross profit in the fiscal 2019 first quarter was $1.2 billion, which was up 8.1 percent when compared to the same period in the previous year, primarily due to the increase in adjusted gross profit in Pharmaceutical Distribution Services, which benefited from an increase in revenue, the January 2018 acquisition of H. D. Smith, and the January 2018 consolidation of Profarma, and was partially offset by a lower contribution from PharMEDium. Adjusted gross profit as a percentage of revenue was 2.65 percent, a decrease of 10 basis points from the prior year quarter.
Adjusted Operating Expenses: In the first quarter of fiscal 2019, adjusted operating expenses were $731.3 million, an increase of 17.1 percent compared to the same period in the last fiscal year, primarily due to the January 2018 acquisition of H. D. Smith and the January 2018 consolidation of Profarma. Adjusted operating expenses as a percentage of revenue in the fiscal 2019 first quarter was 1.61 percent, compared to 1.54 percent for the same period in the previous fiscal year.
Adjusted Operating Income: In the fiscal 2019 first quarter, adjusted operating income of $471.8 million decreased 3.3 percent from the prior year period due to a loss at PharMEDium. Adjusted operating income as a percentage of revenue decreased 17 basis points to 1.04 percent in the fiscal 2019 first quarter compared to the previous fiscal year’s first quarter.
Interest Expense, Net: No adjustments were made to the GAAP presentation of net interest expense. In the fiscal 2019 first quarter, net interest expense of $42.2 million was up 17.6 percent versus the prior year quarter, primarily due to the debt issued to finance the H. D. Smith acquisition and the consolidation of Profarma’s debt and related interest expense.
Adjusted Effective Tax Rate: The adjusted effective tax rate for the first quarter of fiscal 2019 was 19.9 percent and 24.2 percent in the previous fiscal year’s first quarter. The prior year adjusted effective tax rate did not benefit in full from the 2017 Tax Act, which was effective January 1, 2018.
Adjusted Diluted Earnings Per Share: Adjusted diluted earnings per share was up 3.2 percent to $1.60 in the first quarter of fiscal 2019 compared to $1.55 in the previous fiscal year’s first quarter, driven by the benefit from a lower share count.
Diluted Shares Outstanding: No adjustments were made to the GAAP presentation of diluted shares outstanding. Diluted weighted average shares outstanding for the first quarter of fiscal 2019 were 214 million, a 3.1 percent decline versus the prior fiscal year first quarter, due primarily to share repurchases, net of stock option exercises.
Segment Discussion

The Company’s operations are comprised of the Pharmaceutical Distribution Services reportable segment and other operating segments that are not significant enough to require separate reportable segment disclosure and, therefore, have been included in Other for the purpose of reportable segment presentation. Other consists of operating segments that focus on global commercialization services and animal health and includes AmerisourceBergen Consulting Services (ABCS), World Courier and MWI Animal Health (MWI).

Pharmaceutical Distribution Services Segment

Pharmaceutical Distribution Services revenue was $43.7 billion, an increase of 12.3 percent compared to the same quarter in the prior fiscal year. Segment operating income of $373.2 million in the December quarter of fiscal 2019 was down 3.9 percent compared to the same period in the previous fiscal year, due to a loss at PharMEDium compared to a significant contribution in the prior year period.

Other

Revenue in Other was $1.7 billion in the first quarter of fiscal 2019, an increase of 8.2 percent compared to the same period in the prior fiscal year, primarily due to the January 2018 consolidation of the specialty joint venture in Brazil, growth at World Courier and ABCS’s growth in its Canadian operations. Operating income in Other decreased 1.3 percent to $98.9 million in the first quarter of fiscal 2019. This decrease was primarily driven by a decline in operating income at MWI and the Lash consulting group within ABCS, and was partially offset by the increased contribution from World Courier.

Recent Company Highlights & Milestones

AmerisourceBergen announced the appointment of Silvana Battaglia to its executive team as Executive Vice President and Chief Human Resources Officer.
Good Neighbor Pharmacy, AmerisourceBergen’s independent pharmacy network, was ranked #1 for "Best Customer Service" by Newsweek.
The AmerisourceBergen Foundation announced its collaboration with more than 20 not-for-profit organizations over the past year to provide necessary funding to mitigate prescription drug misuse and abuse. As part of the Foundation’s comprehensive approach, it has also distributed nearly one million drug deactivation resources through its Safe Disposal Support Program to 44 states and 140 organizations across the U.S.
World Courier, a worldwide leader in specialty logistics, announced a multimillion dollar technology transformation initiative to improve customer experience, quality assurance and operational efficiencies.
Biosimilars Canada, an association representing Canada’s biosimilar makers, announced that it had chosen AmerisourceBergen’s Canadian operations business unit, Innomar Strategies, to be the preferred provider for the association’s Patient Support Program (PSP) platform.
AmerisourceBergen announced the installation of more than two megawatts of solar arrays at its California Distribution Facility. As the Company’s most high-profile commitment to renewable energy to date and with a system capacity of nearly 2,300 kilowatts, the solar installation will reduce operating costs and offset more than 80 percent of the facility’s annual electricity consumption from the grid.
Lash Group, AmerisourceBergen’s patient support services business, received a Leadership in Energy and Environmental Design (LEED) Gold Certification for its newest building in Fort Mill, South Carolina.
AmerisourceBergen was named one of Philly.com’s Top Workplaces for the sixth consecutive year.
Fiscal Year 2019 Expectations

The Company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. Please refer to the Supplemental Information Regarding Non-GAAP Financial Measures following the tables for additional information.

Fiscal Year 2019 Expectations on an Adjusted (non-GAAP) Basis

AmerisourceBergen has updated its fiscal year 2019 financial guidance based upon the Company’s evaluation of business expectations at PharMEDium which reflect the assumption that its Memphis facility will not reopen in this fiscal year. Updated guidance also incorporates the higher than anticipated level of share repurchases in the first quarter of the fiscal year. The company now expects:

Adjusted Diluted EPS range narrowed to $6.65 to $6.85 from the previous range of $6.65 to $6.95.
Additional expectations now include:

Adjusted operating income growth in the low-single digit percent range, down from low- to mid-single digit percent range;
Pharmaceutical Distribution Services segment operating income growth in the low-single digit percent range, down from low- to mid-single digit percent range;
Weighted average diluted shares are now expected to be approximately 215 million for the fiscal year, down from the previous expectation of 216 million.
All other previously communicated aspects of the Company’s fiscal year 2019 financial guidance and assumptions remain the same.

Conference Call & Slide Presentation

The Company will host a conference call to discuss the results at 8:30 a.m. ET on January 31, 2019. A slide presentation for investors has also been posted on the Company’s website at investor.amerisourcebergen.com. Participating in the conference call will be:

Steven H. Collis, Chairman, President & Chief Executive Officer
James F. Cleary, Jr., Executive Vice President & Chief Financial Officer
The dial-in number for the live call will be (612) 234-9960. No access code is required. The live call will also be webcast via the Company’s website at investor.amerisourcebergen.com. Users are encouraged to log on to the webcast approximately 10 minutes in advance of the scheduled start time of the call.

Replays of the call will be made available via telephone and webcast. A replay of the webcast will be posted on investor.amerisourcebergen.com approximately two hours after the completion of the call and will remain available for 30 days. The telephone replay will also be available approximately two hours after the completion of the call and will remain available for seven days. To access the telephone replay from within the U.S., dial (800) 475-6701. From outside the U.S., dial (320) 365-3844. The access code for the replay is 461495.

Upcoming Investor Events

AmerisourceBergen management will be attending the following investor conferences in the coming months:

CECP CEO Investor Forum, February 25, New York;
Barclays Global Healthcare Conference, March 12-14, Miami.
Please check the website for updates regarding the timing of the live presentation webcasts, if any, and for replay information.