Phyton Biotech Partners with PellePharm to Develop Renewable Supply of Cyclopamine for Investigational Topical Cancer Therapy

On January 31, 2019 Phyton Biotech and PellePharm reported an exclusive partnership to develop a plant cell culture-based process to enable the future renewable production of the raw material for PellePharm’s patidegib, an investigational topical therapy for Gorlin Syndrome and High Frequency Basal Cell Carcinoma (BCC) (Press release, Phyton Biotech, JAN 31, 2019, View Source [SID1234532991]). PellePharm is currently investigating the safety and efficacy of patidegib topical gel for the reduction of surgically-eligible BCCs in Gorlin Syndrome patients in a Phase 3 trial.

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The foundation for this joint initiative is Phyton Biotech’s proprietary Plant Cell Fermentation (PCF) technology, a unique platform that enables renewable, reliable and scalable supply of plant-derived compounds like cyclopamine, the key building block in the synthesis of patidegib. Under its agreement with PellePharm, Phyton Biotech will begin development of the new process immediately.

"We are incredibly excited to partner with PellePharm as pioneers in precision medicine to advance this topical skin cancer treatment to the next level of excellence with our patented PCF technology," said Colin Marr, president of Phyton Biotech. "This application of our ‘green chemistry’ process is just the latest example of how Phyton Biotech is advancing traditional manufacturing approaches for high-value phytochemicals and markedly improving patient care."

Currently, cyclopamine is sourced from the perennial herb Veratrum californicum (corn lily), a member of the Liliaceae plant family found in remote mountainous parts of western North America.

"PellePharm’s partnership with Phyton Biotech underscores our commitment to bring a new therapeutic option to patients with Gorlin Syndrome and other skin cancers," said Sanuj Ravindran, president and chief executive officer of PellePharm. "As we begin our pivotal Phase 3 clinical trial of patidegib topical gel and prepare for commercial-scale production of patidegib if approved, we anticipate the demand for cyclopamine will grow, spurring the need for a supplemental and more scalable source."

Gorlin Syndrome, also known as Basal Cell Carcinoma Nevus Syndrome, is a rare, genetic disease that leads to the chronic formation of multiple basal cell carcinomas, often on the face. With no FDA-approved drugs currently available for Gorlin Syndrome, the standard of care is surgery. People with severe Gorlin Syndrome may have as many as 30 or more surgeries per year, which can be repetitive, scarring and disfiguring.

The partnership with PellePharm follows Phyton Biotech’s successful demonstration of its ability to express cyclopamine directly from Veratrum californicum plant cell cultures via PCF. Further development and full scale-up into commercial-size bioreactors of up to 75 m³ in volume, operated in Phyton Biotech’s facility in Germany, is anticipated to follow the current program.

In addition to this project with PellePharm, Phyton Biotech is working on expanding its patent for the renewable production of alkaloids by Liliaceae cell culture to Europe as it is already granted in the United States and other jurisdictions.

Phyton Biotech’s award-winning green chemistry model focuses on plant cell culture development and offers superior quality, reliability, environmental and cost advantages over other methods of production of complex small molecules, plant-based actives and recombinant proteins.

Invenra and WARF Initiate a Collaboration to Discover and Develop Novel Therapeutics to Fight Neuroblastoma in Children

On January 31, 2019 Invenra and WARF (Wisconsin Alumni Research Foundation) reported they have entered into a collaboration to discover and develop a bispecific antibody therapeutic for the treatment of neuroblastoma, a cancer that is the third most common childhood cancer, after leukemia and brain tumors (Press release, Invenra, JAN 31, 2019, View Source [SID1234532990]). The collaboration will use Invenra’s proprietary SNIPERTM technology to allow for precise targeting of the cancer cells while sparing normal nerve cells, and potentially alleviating unwanted toxicities and pain related side effects. The idea for the therapeutic candidate came out of a collaboration between Invenra and University of Wisconsin, Madison Professor, Dr. Paul Sondel, a pediatric oncologist who treats these children in his practice.

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"Invenra’s SNIPERTM technology should enable creation of antibody-based therapies that are specifically able to target tumor cells while not binding to normal tissues. We are excited to be working with Invenra to initiate this approach by directing it towards improving treatment for pediatric neuroblastoma," notes Sondel.

Roland Green, Ph.D., Chief Executive Officer and Co-Founder of Invenra states, "We are very excited about this program and the potential it has for helping these children with neuroblastoma. This program also has the potential to treat patients with a variety of other cancers such as glioblastoma (a form of brain cancer), melanoma and small cell lung cancer (SCLC). This collaboration is a good example of the benefits that can come from partnerships between the UW-Madison and industry."

AVEO Oncology Announces NDA Timing Update

On January 31, 2019 AVEO Oncology (NASDAQ: AVEO) reported that it has accepted the recommendation of the U.S. Food and Drug Administration (FDA) not to submit a New Drug Application (NDA) for tivozanib (FOTIVDA) with the preliminary overall survival (OS) results from the Phase 3 TIVO-3 trial (Press release, AVEO, JAN 31, 2019, View Source [SID1234532989]). The FDA indicated that these preliminary OS results do not allay their concerns about the potential detriment in OS outlined in the complete response letter dated June 6, 2013. The Company now plans to make a NDA filing decision following the availability of more mature OS results.

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As disclosed in November 2018, a preliminary analysis of the secondary endpoint of OS in the TIVO-3 trial showed a hazard ratio (HR) > 1. The Company previously planned to conduct the final OS analysis in August 2019. Due to the longer-than-expected median OS in both arms, and following discussions with the FDA, the Company plans to designate the August 2019 OS analysis as interim. Results of this analysis are expected to be reported in the fourth quarter.

Since initially conducting the preliminary analysis of the OS endpoint in November 2018, the Company has identified the survival status of a group of patients that were previously lost to follow up. With the identification of these OS events, the October 4, 2018 preliminary OS HR was revised from 1.06 to 1.12. The Company has not performed any OS analyses beyond the preliminary October 4, 2018 data cut-off date.

AVEO intends to present detailed results of the TIVO-3 study, the Company’s Phase 3 randomized, controlled, multi-center, open-label study comparing tivozanib to sorafenib in 350 subjects with highly refractory advanced or metastatic Renal Cell Carcinoma (RCC) during an oral session at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) being held February 14-16, 2019 in San Francisco.

"We are hopeful that the positive PFS outcome will translate into an improved hazard ratio when we evaluate a more mature interim OS outcome in the fourth quarter of 2019," said Michael Bailey, president and chief executive officer of AVEO. "We look forward to continuing to work with the FDA to determine tivozanib’s benefit-risk profile as a single agent in RCC patients."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3, and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

GT Medical Technologies Announces $10 Million Financing to Support Launch of Targeted Therapy for Patients with Recurrent Brain Tumors

On January 31, 2019 GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, reported that it has raised $10 million in a Series A financing led by MedTech Venture Partners with participation from BlueStone Venture Partners (Press release, GT Medical Technologies, JAN 31, 2019, View Source [SID1234532988]). Funds from the round will support the commercialization of GammaTile Therapy, an FDA-cleared, surgically targeted radiation therapy (STaRT) for patients with recurrent intracranial neoplasms (brain tumors). The company recently launched a limited market release of GammaTile Therapy and is making it available at select medical centers in the United States.

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"GT MedTech’s mission is in line with our investment goal of supporting innovative technologies that address unmet needs in vital disease areas," said Radu Cautis, partner and managing director of MedTech Venture Partners. "We are enthusiastic about the potential of GammaTile Therapy to address the shortcomings of current treatments and elevate the standard of care for patients with brain tumors."

Approximately 400,000 Americans are newly diagnosed with some type of brain tumor each year.1 Despite the efforts of the most skilled brain tumor specialists throughout the world, outcomes for patients with brain tumors have improved very little over the past 30 years. Recurrence of brain tumors is common, and about half of all patients treated for brain tumors have their disease recur within a year.

GammaTile Therapy is placed directly at the site of the tumor after excision is complete and immediately begins targeting residual tumor cells before they can replicate. Designed to protect healthy brain tissue and facilitate rapid, accurate placement during the procedure, the therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source. GammaTile Therapy is indicated for the treatment of all types of recurrent brain tumors, including primary (benign or malignant) and metastatic tumors.

Data supporting the efficacy and safety profile of the therapy for patients with recurrent, previously-treated meningiomas were published last month in the Journal of Neurosurgery (JNS), the official journal of the American Association of Neurological Surgeons. Additional clinical data from other types of tumors will be presented at the AANS Annual Scientific Meeting in April.

"GammaTile Therapy was developed by a team of brain tumor specialists who were running out of options for their patients. Their urgency to find a viable solution for these patients led to the creation of GammaTile Therapy, which is designed to be immediate, safe, predictable, and effective," said Matthew Likens, president and CEO of GT MedTech. "With this funding, in addition to adding seasoned industry executives to our team, we look forward to building and expanding our commercialization efforts so that we can offer this new option to patients at brain tumor treatment centers across the United States."

Company Announces Appointments of Seasoned Executives

GT Medical Technologies also announced that Prattipati Laxminarain has joined the company’s Board of Directors, having previously served as the worldwide president of Codman Neuro, a neurosurgical medical device business recently acquired by Integra Life Sciences from Johnson & Johnson for more than $1 billion. Laxminarain had a 30-year career at Johnson & Johnson, spanning international markets. He remains active in the healthcare sector as a board member of the Global Neuro Foundation, Microbot Medical, Oculogica, Stratus Global LLC, and the Brain Aneurysm Foundation.

In addition, Mara Aspinall, co-founder and managing director of BlueStone Venture Partners, has been appointed as an observer to the company’s Board of Directors. Formerly the president and CEO of Ventana Medical Systems, which was acquired by Roche for $3.4 billion, Aspinall brings more than 20 years of industry experience in medical device development, biomedical diagnostics, personalized medicine, and digital health. Aspinall also currently holds various board of director roles, including Blue Cross Blue Shield of Arizona, OraSure Technologies, Allscripts, and others.

"GT MedTech’s innovative technology has the potential to significantly improve the lives of patients with brain tumors and their caregivers," said Aspinall. "By taking part in this funding round and working alongside the Board of Directors, BlueStone Venture Partners hopes to help further advance GT MedTech’s vital technology."

About GammaTile Therapy

GammaTile Therapy is a FDA-cleared, surgically targeted radiation therapy (STaRT) that is placed at the end of brain tumor excision surgery and immediately begins targeting residual tumor cells. GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile and uniform radiation source. This therapy offers advantages over the most common treatment for patients undergoing surgery for recurrent brain tumors: a course of External Beam Radiation Therapy (EBRT), which requires daily treatments for up to six weeks. Some patients may not be candidates for EBRT, and those patients who are candidates typically have to wait two weeks or more for surgical wound healing before beginning treatment, giving any residual tumor cells a chance to replicate. Patients treated with GammaTile Therapy require no additional trips to the hospital or clinic for radiation therapy. Because the therapy is targeted, patients receive radiation only where it is needed, and may receive a lower overall level of exposure to radiation.

GammaTile Therapy received FDA 510(k) clearance in July 2018 for the treatment of all types of recurrent brain tumors, including primary (benign or malignant) and metastatic tumors, and has an established CMS code for Medicare reimbursement

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.