I-Mab Biopharma and Bio-Cancer Treatment International Announce Intention for Collaboration on Arginine Depletion Therapy and Biomarker Study, with Plans for I-Mab to Establish a Translational Medicine Lab in Hong Kong

On February 1, 2019 I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, reported that it has entered into a memorandum of understanding (MOU) with Hong Kong-based Bio-Cancer Treatment International Limited (BCT) to jointly explore and investigate new therapeutic potentials for BCT’s arginine depletion therapy in autoimmune diseases and cancers (Press release, I-Mab Biopharma, FEB 1, 2019, View Source [SID1234533019]).

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I-Mab Biopharma and Bio-Cancer Treatment International Announce Intention for Collaboration on Arginine Depletion Therapy and Biomarker Study, with Plans for I-Mab to Establish a Translational Medicine Lab in Hong Kong
I-Mab Biopharma and Bio-Cancer Treatment International Announce Intention for Collaboration on Arginine Depletion Therapy and Biomarker Study, with Plans for I-Mab to Establish a Translational Medicine Lab in Hong Kong
Under the terms of the MOU, I-Mab and BCT will work together to explore the potential of arginine depletion therapy in autoimmune diseases, as well as biomarkers in arginine and other immunologic targets in the tumor microenvironment for experimental cancer immunotherapy.

In conjunction with this development collaboration, I-Mab also plans to establish a translational medicine lab in Hong Kong to conduct exploratory biomarker work on BCT’s lead drug candidate, BCT-100, as well as a number of important assets in I-Mab’s own pipeline. Over the longer term, I-Mab will consider expanding the lab into a full-functioning R&D center in Hong Kong, taking advantage of the local scientific talent pool, clinical resources and government initiatives to encourage life sciences development.

"BCT is a biotech company with an established unique focus on targeting arginine metabolism to treat cancers and immune disorders. We are especially impressed by BCT’s ability to bring about collaborations among like-minded academic groups and clinician-scientists, to really understand, exploit and expand the therapeutic potential of something as vital as amino acid metabolism. We look forward to working closely with BCT to explore creating synergy with our pipelines. The partnership also provides I-Mab with an opportunity to set up a world-class translational medicine hub in Hong Kong, with further potential to develop clinical presence in Hong Kong," said Jielun Zhu, Chief Financial Officer of I-Mab.

"BCT is extremely honored to be working with I-Mab’s team of highly experienced biotech professionals in developing first-in-class biologics in autoimmune diseases and cancers to find ways to collaborate. The proposed biomarker study is very important to BCT both as precision medicine to identify cancer patients that would benefit the most from the BCT-100 treatment and also to apply the arginine depletion therapy to a wider patient population," said Derek Wong, CFO of BCT.

CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer

On February 1, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, FEB 1, 2019, View Source [SID1234533003]). In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. Based on the positive CHMP recommendation, a final decision regarding the approval of this Tecentriq-based combination is expected from the European Commission in the near future.

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The CHMP recommendation is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin, paclitaxel and carboplatin helped people live significantly longer, compared with Avastin and chemotherapy (median overall survival [OS]=19.8 versus 14.9 months; hazard ratio [HR]=0.76; 95%, CI: 0.63–0.93; p=0.006) in the intention-to-treat (ITT) population.[1] The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

"We are pleased to receive a positive opinion from the CHMP for this Tecentriq-based combination, which represents a significant step towards bringing a new treatment option to people across Europe with advanced, non-squamous non-small cell lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The IMpower150 study, on which this opinion is based, demonstrated an overall survival benefit, including those in key populations such as people with EGFR- or ALK-positive mutations or liver metastases."

About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. A total of 1,202 people were enrolled and randomised (1:1:1) to receive:

Tecentriq plus carboplatin and paclitaxel (Arm A), or
Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm).
The co-primary endpoints comparing Arms B and C were OS and progression-free survival (PFS), as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) and assessed in the ITT-WT subpopulation. Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population.

A summary of the ITT data from the IMpower150 study that support this recommendation is included below:[1]

Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer, compared with Avastin and chemotherapy (median OS=19.8 versus 14.9 months; HR=0.76; 95% CI: 0.63–0.93; p=0.006).
In addition, Tecentriq in combination with Avastin and chemotherapy reduced the risk of disease worsening or death (PFS) by 41% compared with Avastin and chemotherapy (HR=0.59; 95% CI: 0.50–0.69, p<0.0001).
Tecentriq in combination with Avastin and chemotherapy shrank tumours (overall response rate [ORR]) in 56.4% of people (95% CI: 51.4–61.4) compared with 40.2% of people (95% CI: 35.3–45.2) on Avastin and chemotherapy.
2.8% of people receiving Tecentriq in combination with Avastin and chemotherapy experienced a complete response (CR), and 53.7% of people experienced a partial response (PR).
The median duration of response (DoR) for people receiving Tecentriq in combination with Avastin and chemotherapy was 11.5 months (95%, CI: 8.9–15.7) compared with 6.0 months (95% CI: 5.5–6.9) for people on Avastin and chemotherapy.
The most common adverse reactions (≥20%) in people receiving Tecentriq in combination with Avastin and chemotherapy were fatigue and lack of energy (asthenia; 50%), hair loss (alopecia; 48%), nausea (39%), diarrhoea (32%), constipation (30%), decreased appetite (29%), joint pain (arthralgia; 26%), hypertension (25%), and pain from nerve damage (peripheral neuropathy; 24%).
About NSCLC
Lung cancer is the leading cause of cancer death globally.[2] Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[3] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.[3]

About the Tecentriq (atezolizumab) and Avastin (bevacizumab) combination
There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T cell tumour infiltration and enabling priming and activation of T cell responses against tumour antigens.

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has nine Phase III lung cancer studies underway, evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq in combination with Avastin and chemotherapy was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.

About Avastin (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

Bausch Health Companies Announces Participation In Upcoming Investor Conferences

On February 1, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the Company will participate in two investor conferences in February and March (Press release, Valeant, FEB 1, 2019, View Source [SID1234533020]).

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Paul S. Herendeen, executive vice president and chief financial officer, and William Woodfield, vice president and treasurer, are scheduled to participate at the J.P. Morgan Global High Yield & Leveraged Finance Conference in Miami, Fla. on Feb. 25, 2019 at 11:40 a.m. EST.

Joseph C. Papa, chairman and chief executive officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Barclays Global Healthcare Conference 2019 in Miami, Fla. on March 13, 2019 at 10:45 a.m. EDT.

A live webcast and audio archive of the Barclays event will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

DrugCendR Announces Pancreatic Cancer Clinical Trial Data, New Member of Board of Directors and FDA Orphan Drug Designation

On January 31, 2019 DrugCendR Inc., a clinical-stage biopharmaceutical company dedicated to developing next generation cancer therapies designed to overcome the barriers of drug delivery in solid tumors, reported today positive progress with its ongoing pancreatic cancer clinical trial (Press release, CEND Therapeutics, JAN 31, 2019, View Source [SID1234619594]). In addition, the lead program received orphan-drug designation from the US Food and Drug administration (FDA) in pancreatic cancer. The company also announced a new member of board of directors.

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The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30 patients in the second quarter of 2019. The early results are reportedly encouraging, with high response rates as well as favorable safety profile, with no dose-limiting toxicities. "The progress with the pancreatic cancer trial has exceeded our expectations," said Harri Jarvelainen, Chief Operating Officer of DrugCendR Inc. "Our near term goal is to validate the CEND-1 platform technology in multiple indications so clinicians can treat patients with cancers with high unmet medical need more effectively."

Receiving the FDA orphan drug designation was also announced today. It is a significant development milestone as it can facilitate the future development through several benefits such as tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S.

Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its Board of Directors. "I am pleased to welcome Heidi Henson to our board, where her extensive expertise in financial management and strategy will be a major asset to DrugCendR as we continue to advance the company programs," said Erkki Ruoslahti, M.D., Ph.D., Founder, President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.

About CEND-1

DrugCendR’s proprietary technology platform is a based on a bifunctional molecular mimicry agent CEND-1. The agent is able to manipulate the tumor microenviroment, effectively making it into a temporary drug conduit. This allows an enhanced delivery and efficacy of various types of co-administered anti-cancer compounds. The action is tumor-specific, thanks to the tumor-homing RGD motif of the molecule. To date the compound has been investigated, by the company founders and by numerous independent groups, in more than 150 publications and it has shown efficacy in more than 40 different cancer models.

About DrugCendR

DrugCendR Inc. is a privately held biopharmaceutical company founded in 2015. The initial focus of company’s technology is pancreatic cancer because, in addition to its poor prognosis, it is characterized by a dense extracellular matrix stroma, which acts as a physical barrier to drug entry. Since the active transport process initiated by CEND-1 overcomes this obstacle, and the target receptors for are highly expressed in advanced pancreatic cancer, CEND-1 appears particularly well suited to target PDAC. The company is planning for additional clinical trials in other cancer indications for its lead program and has already started a follow-up CEND-2 program, which works through a well-validated immune-oncology pathway.

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.