On May 7, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported the online publication of a new manuscript, Discovery and Characterization of SY-1365, a Selective, Covalent Inhibitor of CDK7, in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) journal, Cancer Research (Press release, Syros Pharmaceuticals, MAY 7, 2019, View Source [SID1234535853]). SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, is currently being investigated in a Phase 1 clinical trial as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations that lack effective treatment options. This publication highlights the discovery, mechanism of action and promise of SY-1365 as a new targeted approach for a range of difficult-to-treat cancers.

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"SY-1365 represents a potentially transformative targeted approach for a number of cancers that have eluded treatment with existing approaches," said Eric R. Olson, Ph.D., Syros’ Chief Scientific Officer. "While CDK7 has long been a target of interest, it was historically difficult-to-drug. This new publication profiles our work in discovering SY-1365, which we believe to be the most advanced selective CDK7 inhibitor in clinical development, and the substantial anti-tumor activity seen in preclinical models that supported its advancement into the clinic. We are excited by the promise of CDK7 inhibition and the potential benefit SY-1365 may bring to patients who are in dire need of better therapies."

Syros is currently conducting a Phase 1 clinical trial assessing the safety and efficacy of SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. The trial includes cohorts evaluating SY-1365 as a single agent in patients with relapsed ovarian clear cell cancer and in high-grade serous ovarian cancer (HGSOC) patients who have had three or more prior lines of therapy; in combination with carboplatin in HGSOC patients who have had one or more prior lines of therapy; in combination with fulvestrant in metastatic hormone receptor-positive breast cancer patients who are resistant to treatment with a CDK4/6 inhibitor; and as a single agent in patients with solid tumors of any histology accessible for biopsy. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.

CDK7 plays a key role in the transcription of genes and in cell cycle regulation, and inhibiting CDK7 disrupts two important processes that cancer cells use to survive: 1) expression of cancer-promoting genes; and 2) uncontrolled cell cycle progression. SY-1365 has shown anti-tumor activity in preclinical models of a range of solid tumors and blood cancers, including cancers that have become resistant to treatment with existing therapies or where existing options have failed to provide meaningful benefit to patients. Further, data suggests that SY-1365 works to inhibit the growth of cell lines representing many different cancer types at nanomolar concentrations, decreases MCL1 protein levels, and demonstrates activity among cancer cells with low BCL-XL expression.

Building on its leadership in CDK7 inhibition, Syros is advancing SY-5609, a highly selective and potent oral CDK7 inhibitor, toward clinical development. In preclinical studies, SY-5609 has demonstrated substantial anti-tumor activity, including inducing complete regressions in cell line-derived xenograft models of breast and ovarian cancers. The company plans to complete investigational new drug application (IND)-enabling studies by the end of 2019 to support the initiation of a Phase 1 oncology trial in early 2020.

On May 7, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported a clinical trial collaboration with AstraZeneca to evaluate the safety, tolerability and preliminary activity of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with SNS-301 (Press release, Sensei Biotherapeutics, MAY 7, 2019, View Source [SID1234535852]). SNS-301, Sensei’s first-in-class immunotherapy candidate, is a therapeutic cancer vaccine utilizing a bacteriophage viral vector targeting aspartate β-hydroxylase (ASPH), a novel embryonic antigen.

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Under the terms of the agreement, AstraZeneca and Sensei will collaborate to evaluate the combination of SNS-301 and IMFINZI in patients with locally advanced head and neck cancer in the neoadjuvant setting in conjunction with TPF chemotherapy prior to surgical resection and in ASPH+ patients with various locally advanced unresectable or metastatic/recurrent solid tumors. AstraZeneca will supply IMFINZI for these clinical studies and Sensei will sponsor and fund the Phase 2 studies. AstraZeneca and Sensei will each retain full worldwide rights to their respective molecules.

"We are extremely pleased to collaborate with AstraZeneca, a leader in the cancer immunotherapy field. SNS-301 targets a novel mechanism to activate and direct ASPH-specific T-cells to tumors. We believe that when combined with IMFINZI, SNS-301 has the potential to deepen and broaden the overall immune-mediated response," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "This clinical collaboration strengthens our position as pioneers of precision oncology therapeutics by focusing on improved clinical outcomes for ASPH-positive patients through novel clinical combinations."

About SNS-301

SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Following fetal development, the protein is no longer expressed. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH expression levels are inversely correlated with disease prognosis. Though enhanced antigen presentation and other engineered immunotherapeutic features, SNS-301 is designed to overcome self-tolerance and induce robust and durable humoral and cellular immune responses that are specific to ASPH. SNS-301 is delivered through intradermal injection and avoids time consuming and uncomfortable infusions, greatly facilitating ease of use.

About IMFINZI (Durvalumab)

IMFINZI (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. As part of a broad development program, IMFINZI is being investigated as monotherapy and in combination with immuno-oncology (IO) agents, small molecules, and chemotherapies across a range of tumors and stages of disease.

On May 7, 2019 Kyn Therapeutics, a clinical-stage biotechnology company developing highly differentiated cancer immunotherapies, reported the appointment of Jeffrey Ecsedy, Ph.D., as its chief scientific officer and Jason Sager, M.D., as its chief medical officer (Press release, KYN Therapeutics, MAY 7, 2019, View Source [SID1234535851]). Dr. Ecsedy was formerly a member of the Oncology R&D leadership team at Takeda Pharmaceuticals as head of oncology translational medicine following more than a decade at Millennium Pharmaceuticals. Dr. Sager is a highly distinguished clinical oncologist with over 15 years of experience in biotech and pharma. Both executives joined Kyn in 2017, Dr. Sager serving as the company’s interim chief medical officer and Dr. Ecsedy as its senior vice president, R&D. Dr. Ecsedy will head the teams responsible for discovery, non-clinical and translational sciences, while Dr. Sager will provide leadership to Kyn’s clinical operations, clinical development and regulatory teams.

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"Jason and Jeff’s guidance and expertise have been invaluable to Kyn through the design and execution of the two ongoing Phase 1b/2 clinical studies of our lead candidate ARY-007, an EP4 receptor antagonist. Their input was also essential to our delivery of important preclinical milestones that validated the novel biology underlying our programs," said Mark Manfredi, Ph.D., Kyn’s president and chief executive officer. "We are now planning entry into the clinic for our AHR and Kynase programs, both partnered with Celgene. Jeff and Jason’s leadership will play a critical role during this significant phase of Kyn’s growth and development."

"At Kyn we have leveraged our discovery, translational and clinical development knowledge to build a differentiated pipeline, which is first and foremost defined by patient need," Dr. Ecsedy said. "By assembling a multi-talented research and development team complemented by a top-tier external scientific and clinical advisory network, we intend to drive our existing programs forward while evaluating compelling opportunities to expand our differentiated portfolio."

"This is an exciting time in cancer therapeutics and the Kyn team is doing outstanding work towards delivering multiple new advances for patients," Dr. Sager said. "I look forward to working together to expand the clinical portfolio and deliver on the two current clinical studies for ARY-007."

Dr. Sager is a pediatric oncologist with extensive experience in biotech, pharma and academic research. Previously, he was a senior medical director in Sanofi’s oncology division, leading development of an early-stage clinical portfolio. Prior to Sanofi, Dr. Sager served as a medical director at Genentech and Novartis, where he brought multiple drugs into the clinic and through to proof of concept. He has also served as advisor for medical technology companies Bionaut Labs and Privo Technologies. In addition to his biotechnology experience, Dr. Sager has worked as a pediatric oncologist at Johns Hopkins University, the National Cancer Institute and the Dana-Farber Cancer Institute. He is currently a Deshpande Center Catalyst at the Massachusetts Institute of Technology, where he mentors grant recipients establishing early stage companies. He is the founder of Sagely Health, a consultancy focused on reducing treatment information asymmetry for cancer patients. Dr. Sager received his B.A. from Johns Hopkins University and his M.D. from Cornell University.

Dr. Ecsedy has over 20 years of experience as a cancer researcher. Prior to joining Kyn, Dr. Ecsedy served as the head of oncology translational medicine at Takeda Pharmaceuticals. He and his team led translational science for a diverse portfolio of molecules spanning all stages of development, including pre-IND activities, FIH studies, regulatory approvals and life-cycle management. As a member of Takeda Oncology R&D leadership, Dr. Ecsedy helped shape a renewed strategic vision for the division. Prior to his roles at Takeda, he led numerous projects from the discovery phase into clinical development through roles of increasing responsibility at Millennium Pharmaceuticals. Dr. Ecsedy received a B.S. from the University of Connecticut, earned his Ph.D. in biological sciences at Boston College and trained as a post-doctoral fellow in genetics at Harvard Medical School.

On May 7, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported financial results for the quarter ended March 31, 2019 (Press release, Gamida Cell, MAY 7, 2019, View Source [SID1234535850]). The company also highlighted continued progress in advancing its clinical development candidates: omidubicel1 (formerly known as NiCord), an investigational advanced cell therapy in Phase 3 clinical development designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant, and GDA-201 (formerly known as NAM-NK), an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.

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"Gamida Cell is focused on transforming the treatment landscape for patients with blood cancers and rare, serious hematologic diseases. We are pleased that omidubicel has been selected as the nonproprietary name for NiCord, highlighting our progress toward bringing this important cell therapy to patients in need of a bone marrow transplant," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We have also made several key personnel appointments this year that reflect our strategic focus on commercial preparedness, including hiring our first chief commercial officer and nominating new board members who bring commercial, operational and financial experience to Gamida Cell’s board of directors."

Dr. Adams continued, "We are pleased that the multi-center, randomized Phase 3 study of omidubicel is progressing, with patient enrollment expected to be complete by the end of this year and topline data anticipated in the first half of 2020. Positive data from the study would enable the submission of our first biologics license application next year, which would be a significant achievement."

"Earlier this year, we also reported encouraging data from the Phase 1 clinical study of our natural killer cell product candidate, GDA-201, previously known as NAM-NK. The multiple complete responses observed emboldened us to begin scaling up our manufacturing process to enable the evaluation of a cryopreserved formulation of GDA-201 in a multi-center, multi-dose Phase 1/2 clinical study in patients with non-Hodgkin lymphoma next year," Dr. Adams concluded.

Company Highlights

Omidubicel selected as nonproprietary name for NiCord: Today Gamida Cell announced that the United States Adopted Names (USAN) Council selected omidubicel as the nonproprietary name for Gamida Cell’s investigational hematopoietic stem cell expanded through the company’s proprietary nicotinamide-based, or NAM, technology. The USAN Council aims for global standardization and unification of drug nomenclature to ensure that drug information is communicated accurately and unambiguously. Gamida Cell’s lead investigational product has two components: omidubicel (hematopoietic stem cells expanded through the company’s proprietary nicotinamide-based, or NAM, technology) and differentiated immune cells, including T cells. Gamida Cell refers to the two components collectively as "omidubicel." Going forward, Gamida Cell will use the name "omidubicel" in publications and public statements, at conferences and other forums, and in medical and commercial-related materials.
Reported encouraging data for omidubicel and GDA-201 at TCT Annual Meeting: In February, data from the omidubicel and GDA-201 clinical programs were reported at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant. Research from the completed Phase 1/2 clinical study of omidubicel demonstrated that recipients who received omidubicel had rapid and robust reconstitution of key immune cells. Successful immune reconstitution is an important factor in the recovery of patients undergoing bone marrow transplant.

Data were also reported from the ongoing Phase 1/2 study of omidubicel in patients with severe aplastic anemia. In the initial cohort of three patients, all successfully underwent a bone marrow transplant consisting of omidubicel plus a haploidentical stem cell graft. The results enable the initiation of a second cohort of patients to be treated with omidubicel as a stand-alone graft. Patient enrollment in the second cohort is expected to begin in the first half of 2019.

Additionally, data reported from the ongoing Phase 1 study of GDA-201 in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) demonstrated that GDA-201 was clinically active, with three complete responses observed in patients with NHL and one complete response in a patient with MM. These data, along with safety data showing that GDA-201 was generally well tolerated, support continued clinical development. Gamida Cell is planning to initiate a multi-center, Phase 1/2 clinical study of GDA-201 in patients with NHL in 2020.
Evolved Board of Directors to reflect company’s progress toward commercialization: In March, the company announced the nominations of Shawn Cline Tomasello and Stephen T. Wills to its board of directors. These nominations require approval at the Annual Shareholders Meeting, which will take place in June 2019. Ms. Tomasello has extensive experience in commercializing first-in-class medicines for the treatment of cancer, including Yescarta (at Kite Pharma, now part of Gilead Sciences) and Imbruvica (at Pharmacyclics, now part of AbbVie). Mr. Wills has extensive operational, financial and transactional experience over nearly three decades in the life sciences and accounting industries. He has served as chief financial officer of Palatin Technologies, a publicly-traded biotechnology company developing peptide therapeutics, since 1997 and also serves as Palatin’s chief operating officer and executive vice president.

In January, the company appointed Nurit Benjamini to Gamida Cell’s board of directors and chair of the board’s audit committee. Ms. Benjamini has served as chief financial officer of TabTale Ltd. since 2013. Previously, she held a number of chief financial officer positions, including at Wix.com Ltd., Sigma Designs Israel Ltd. and Compugen Ltd.
Appointed Thomas Klima as chief commercial officer: In January, the company announced the appointment of Thomas Klima as chief commercial officer. In this newly created role, Mr. Klima will be responsible for building the team and executing the strategy to potentially bring omidubicel to patients, including oversight of reimbursement and patient services. Klima brings nearly 20 years of global experience in the pharmaceutical industry with expertise in cellular therapy, hematology, oncology and transplantation. During his career, he has played key roles in building commercial organizations and leading multiple successful product launches.
Anticipated 2019-2020 Milestones
Gamida Cell’s anticipated program milestones in 2019-2020 are as follows:

Omidubicel

Initiate Cohort 2 in the Phase 1/2 study evaluating omidubicel as stand-alone graft in severe aplastic anemia in the first half of 2019
Complete enrollment in Phase 3 study of omidubicel in patients with hematologic malignancies in the second half of 2019
Report topline data from the Phase 3 study of omidubicel in patients with hematologic malignancies in the first half of 2020
Complete BLA submission for omidubicel in hematologic malignancies in the second half of 2020, should Phase 3 data be positive
GDA-201

Complete patient enrollment in the ongoing Phase 1 study in the second half of 2019
Present additional data at a medical meeting in the second half of 2019
Initiate multi-center, Phase 1/2 clinical study in patients with NHL in 2020
First Quarter 2019 Financial Results

As of March 31, 2019, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $50.3 million, compared to $60.7 million as of December 31, 2018.
Research and development expenses in the first quarter of 2019 were $7.3 million, compared to $5.1 million in the same period in 2018. The difference was attributable mainly to a $1.2 million increase in clinical activities relate to the advancement of omidubicel and GDA-201, $0.5 million reduction in grants received from the Israeli Innovation Authority (IIA) and an increase of $0.5 million in compensation and other R&D expenses.
General and administrative expenses were $3.8 million for the first quarter of 2019, compared to $1.7 million in the same period in 2018. The increase was due mainly to a $1.0 million increase in expenses related to hiring and establishing the U.S. headquarters, an increase of $0.5 million in non-cash stock-based compensation expenses, and $0.6 million in professional services, rent and other expenses.
Finance expenses, net, were $4.4 million for the three months ended March 31, 2019, compared to $0.7 million in income in the same period in 2018. The increase was primarily due to noncash expenses resulting from revaluation of warrants and the revaluation of royalty-bearing grant IIA liability.
Net loss for the first quarter of 2019 was $15.5 million, compared to a net loss of $7.4 million in the same period in 2018.
2019 Financial Guidance
Gamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35-$40 million, reflecting anticipated expenditures to advance the company’s clinical programs.

Gamida Cell expects that its cash, cash equivalents, available-for-sale securities and short-term debt will support the company’s capital needs through the data readout for the Phase 3 clinical study of omidubicel, which is expected in the first half of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Conference Call Information
Gamida Cell will host a conference call today, May 7, 2019, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 2277888. A replay of the webcast will be available for approximately 30 days.

About Omidubicel
Omidubicel (formerly known as NiCord), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers).1 Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated.2 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.3 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.4 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.5

Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On May 7, 2019 Premier Inc. (NASDAQ: PINC) reported financial results for the fiscal 2019 third quarter ended March 31, 2019 (Press release, Premier, MAY 7, 2019, View Source [SID1234535849]).

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The company adopted new revenue recognition standard ASC 606 on July 1, 2018, in conjunction with the beginning of fiscal 2019, using the modified retrospective approach and did not restate prior periods. Therefore, fiscal 2019 results of operations under the new revenue standard ASC 606 are compared with fiscal 2018 results under the previous revenue standard ASC 605 in the body of this press release, and the comparisons are not necessarily meaningful. However, solely for informational purposes, current period results under the previous standard are included in the tables at the back of this press release.

Q3 2019 Highlights:

GAAP net revenue was $422.9 million, compared with $425.3 million a year ago; Supply Chain Services segment revenue was $330.2 million, compared with $330.7 million a year ago; and Performance Services segment revenue was $92.6 million, compared with $94.6 million a year ago.
GAAP net income was $73.8 million, compared with $76.5 million a year ago, and diluted net income was $0.48 per share, compared with a loss of $1.93 per share a year ago.
Non-GAAP adjusted EBITDA* was $137.6 million, compared with $142.2 million a year ago.
Non-GAAP adjusted fully distributed net income* was $84.7 million, or $0.66 per diluted share, compared with $90.6 million, or $0.67 per diluted share a year ago.
Nine-month results demonstrate financial performance remains on track with existing guidance ranges for the full fiscal year, with net administrative fees up 4% from a year ago, supply chain services and performance services revenue up 1% and 3%, respectively, non-GAAP adjusted EBITDA up 6% and non-GAAP adjusted fully distributed earnings per share up 22%.
For full fiscal-year, Supply Chain Services revenue projected to perform near midpoint of existing range, Performance Services segment revenue near higher end of the range, non-GAAP adjusted EBITDA near lower end of the range, and non-GAAP adjusted fully distributed earnings per share near midpoint of the range.
Outlook raised for full fiscal-year non-GAAP free cash flow, which is now expected to exceed 55% of non-GAAP adjusted EBITDA for the full fiscal year.
On April 26, 2019, Premier’s board of directors authorized an additional $300.0 million for the potential repurchase of Class A stock, following the completion of the previous $250.0 million repurchase program during the fiscal third quarter.
* Descriptions of non-GAAP financial measures are provided in "Use and Definition of Non-GAAP Financial Measures," and reconciliations are provided in the tables at the end of this release.

"Our fiscal third-quarter results reflect the timing-related impact of revenue recognition under the new ASC 606 revenue standard, continuing headwinds in our products business, and, to a lesser extent, incremental investments in future growth opportunities that we believe will enhance our core capabilities across the supply chain, enterprise analytics and performance improvement businesses," said Susan DeVore, chief executive officer. "While our results are consistent with our expectation that the second half of our fiscal year would be less profitable than the first half, we remain on track to deliver full fiscal-year 2019 results within our previously disclosed guidance ranges.

"We are actively managing Premier’s portfolio, as underscored by our decision to exit the specialty pharmacy business, and focusing on our core capabilities to deliver best-in-class solutions for our member health systems and sustainable, long-term value creation for stockholders," DeVore continued. "The company’s flexible balance sheet and strong cash flow provide a solid foundation and support our balanced approach to pursuing both organic and external growth opportunities while returning capital to stockholders. The board’s decision to authorize a new $300.0 million stock repurchase program underscores its continued confidence in our strategy."