On May 23, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported the abstract (Poster 61) entitled, "A Phase 1 Clinical Trial of NLG802, a Prodrug of Indoximod with Enhanced Pharmacokinetic Properties," was presented at the Immuno-Oncology 2019 2nd World Congress in Barcelona, Spain (Press release, NewLink Genetics, MAY 23, 2019, View Source [SID1234536550]).

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The Phase 1 dose-escalation study evaluated the safety, toxicity and PK of NLG802 to determine the maximum tolerated dose (MTD) or maximum biologically achievable dose (MBAD). Data from the study was used to recommend a Phase 2 dose (RP2D) of NLG802.

NLG802 was administered orally at five dose levels up to 1452 mg BID in 26 patients with recurrent advanced solid tumors. At the time of analysis for this presentation, five (19%) patients remain on study, 14 (54%) alive, and four patients withdrew from follow-up. Six patients achieved a best response of stable disease per RECIST 1.1 criteria, with 1 patient having durable stable disease greater than nine months. No subject experienced a dose-limiting toxicity within the first 28-day cycle. The most frequently reported adverse events (AE) regardless of attribution were fatigue (54%), nausea (46%), vomiting (35%), decreased appetite (31%), and diarrhea (23%).

PK results were also reported from this study. After continuous twice-daily dosing with NLG802 at all levels, significantly higher PK exposure was observed. At 1452 mg BID, the highest dose administered, NLG802 produced a 6-fold increase in Cmax and a 4.7-fold increase in AUC compared with molar equivalent indoximod dosing.

The treatment regimen was well tolerated with no NLG802-related serious adverse events (SAE) reported. MTD/MBAD had not been reached, and recommended Phase 2 dose (RP2D) was established at 1452 mg BID based on achieving preclinical exposure levels required for pharmacodynamic effects of indoximod.

An interesting response was observed during this study involving a patient with metastatic pancreatic cancer who had failed three prior lines of therapy (gemcitabine plus nab-paclitaxel, FOLFIRI, and irinotecan HCl plus gemcitabine). NLG802 was administered to this patient as 4th line therapy and was discontinued after five weeks upon disease progression. The patient was subsequently re-challenged with gemcitabine plus nab-paclitaxel. Imaging three months after re-challenge showed a partial response (PR) with 75% reduction in total tumor burden. In addition, the CA19-9 levels dropped 94% from levels prior to this line of therapy. No objective responses were observed after any earlier rounds of chemotherapy prior to administration of NLG802. This suggests that prior treatment with NLG802 may have contributed to the response ultimately observed in this patient.

"These results corroborate earlier data demonstrating NLG802’s ability to produce significantly higher exposure levels in patients compared with molar equivalent dosing of indoximod, while maintaining tolerability," said Eugene P. Kennedy, MD, Chief Medical Officer of NewLink Genetics. "We are encouraged by these results, which reinforce our belief that NLG802 has the potential to be an important component of an immuno-oncology treatment regimen."

The poster can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Posters & Presentations" or by clicking here.

About NLG802

NLG802, an orally-available prodrug of indoximod, was specifically engineered to increase the bioavailability of indoximod by leveraging existing mechanisms of absorption, increasing the exposure of indoximod approximately 5-fold. NewLink Genetics is currently evaluating NLG802 in a Phase 1 dose-escalation clinical trial in cancer patients to assess the safety and pharmacokinetics of NLG802.

On May 23, 2019 Medtronic plc (NYSE:MDT) reported financial results for its fiscal year and fourth quarter 2019, which ended April 26, 2019 (Press release, Medtronic, MAY 23, 2019, View Source;p=RssLanding&cat=news&id=2399522 [SID1234536549]).

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Medtronic’s fiscal year 2019 revenue of $30.557 billion increased 2.0 percent, or 5.5 percent on an organic basis, adjusting for the divestiture of certain businesses to Cardinal Health that occurred in the second quarter of fiscal year 2018 and the $455 million negative impact from foreign currency. As reported, fiscal year 2019 net earnings were $4.631 billion or $3.41 per diluted share. As detailed in the link at the end of this release, fiscal year 2019 non-GAAP earnings and diluted earnings per share (EPS) were $7.089 billion and $5.22, respectively, both representing increases of 9 percent. Adjusting for the divestiture and a positive 7 cent impact from foreign currency, fiscal year 2019 non-GAAP diluted EPS increased 10 percent.

Fiscal year 2019 cash flow from operations was $7.007 billion. Fiscal year 2019 free cash flow was $5.873 billion versus $3.616 billion in the prior year, an increase of 62 percent.

The company reported fourth quarter worldwide revenue of $8.146 billion, flat as reported or 3.6 percent growth on an organic basis, which adjusts for a $289 million negative impact from foreign currency. As reported, fourth quarter GAAP net income and diluted EPS were $1.172 billion and $0.87, respectively. As detailed in the financial schedules included through the link at the end of this release, fourth quarter non-GAAP net income and non-GAAP diluted EPS were $2.077 billion and $1.54, respectively, increases of 7 percent and 8 percent, respectively. Adjusting for a negative 1 cent impact from foreign currency, fourth quarter non-GAAP diluted EPS increased 9 percent.

Fourth quarter U.S. revenue of $4.284 billion represented 52 percent of company revenue and increased 2.3 percent as reported. Non-U.S. developed market revenue of $2.575 billion represented 32 percent of company revenue and decreased 5.3 percent as reported and increased 1.7 percent on a constant currency basis. Emerging market revenue of $1.287 billion represented 16 percent of company revenue and increased 3.9 percent as reported and 12.0 percent on a constant currency basis.

"Q4 was a solid finish to a strong fiscal year for Medtronic. In fiscal year 2019, we executed and delivered revenue growth, EPS, and free cash flow all above the guidance we set at the beginning of the year," said Omar Ishrak, Medtronic chairman and chief executive officer. "Our organization overcame challenges and relied upon the diversification of our business to deliver another quarter of solid top- and bottom-line results, with excellent free cash flow generation."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic, Peripheral & Venous (APV) divisions. CVG fiscal year 2019 revenue of $11.505 billion increased 1.3 percent as reported and 2.9 percent on a constant currency basis. CVG fourth quarter revenue of $3.050 billion decreased 2.7 percent as reported and increased 1.1 percent on a constant currency basis. CVG fourth quarter revenue performance was driven by mid-single digit growth in APV and CSH, offset by low-single digit declines in CRHF, all on a constant currency basis.

Cardiac Rhythm & Heart Failure fourth quarter revenue of $1.554 billion decreased 4.8 percent as reported or 1.4 percent on a constant currency basis. Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by high-twenties growth of the TYRX Absorbable Antibacterial Envelope, high-teens growth of the Reveal LINQ(TM) Insertable Cardiac Monitoring System, and mid-teens growth in AF Solutions, all on a constant currency basis. This was offset by low-double digit declines in Heart Failure, including high-thirties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.

Coronary & Structural Heart fourth quarter revenue of $994 million decreased 1.1 percent as reported or increased 3.6 percent on a constant currency basis, led by low-double digit constant currency growth in sales of transcatheter aortic valves, reflecting the clinical benefits of the CoreValve Evolut PRO platform, and high-single digit growth in Cardiac Surgery. Coronary declined in the low-single digits, as mid-single digit declines in drug-eluting stents offset mid-teens growth in coronary balloons and high-single digit growth in guide catheters, all on a constant currency basis.

Aortic, Peripheral & Venous fourth quarter revenue of $502 million increased 1.0 percent as reported or 4.4 percent on a constant currency basis. Venous grew in the high-single digits on a constant currency basis on continued strong adoption of the VenaSeal(TM) closure system. Aortic grew in the mid-single digits on a constant currency basis, reflecting strong demand for the Valiant Navion(TM) thoracic stent graft system. Peripheral grew in the low-single digits, as low-double digit growth in PTA balloons and high-single digit growth in atherectomy offset high-single digit declines in drug-coated balloons, all on a constant currency basis.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG fiscal year 2019 revenue of $8.478 billion decreased 2.7 percent as reported and increased 5.8 percent on a comparable, constant currency basis. MITG fourth quarter revenue of $2.255 billion increased 0.8 percent as reported or 5.1 percent on a constant currency basis. MITG fourth quarter revenue was driven by balanced growth across both divisions, with mid-single digit constant currency growth in both SI and RGR.

Surgical Innovations fourth quarter revenue of $1.529 billion increased 1.1 percent as reported or 5.8 percent on a constant currency basis, driven by high-single digit constant currency growth in Advanced Energy on continued strong sales of LigaSure(TM) vessel sealing instruments with innovative nano-coating and Valleylab(TM) FT10 energy platform. Advanced Stapling grew in the mid-single digits on a constant currency basis, driven by strong demand for Tri-Staple(TM) 2.0 endo stapling specialty reloads and the Signia(TM) powered stapler. Surgical Innovations managed through a difficult issue in its sterilization supply chain, which had no net impact on revenue but did impact quarterly operating profit.

Respiratory, Gastrointestinal & Renal fourth quarter revenue of $726 million increased 0.3 percent as reported or 3.6 percent on a constant currency basis. Respiratory and Patient Monitoring grew in the mid-single digits on a constant currency basis on strong sales of Puritan Bennett(TM) 980 ventilators, McGRATH(TM) MAC video laryngoscopes, Microstream(TM) capnography monitoring products, and INVOS(TM) cerebral oximetry systems. Renal Care Solutions grew mid-single digits on a constant currency basis, and GI Solutions grew low-single digits on a constant currency basis, with solid growth in PillCam(TM) systems.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Brain Therapies, Spine, Specialty Therapies, and Pain Therapies divisions. RTG fiscal year 2019 revenue of $8.183 billion increased 5.7 percent as reported and 6.6 percent on a constant currency basis. RTG fourth quarter revenue of $2.215 billion increased 4.1 percent as reported or 6.5 percent on a constant currency basis. RTG fourth quarter results were driven by low-double digit growth in Brain Therapies, high-single digit growth in Specialty Therapies, mid-single digit growth in Pain Therapies, and low-single digit growth in Spine, all on a constant currency basis.

Brain Therapies fourth quarter revenue of $737 million increased 9.7 percent as reported or 12.8 percent on a constant currency basis, driven by high-teens constant currency growth in Neurovascular and mid-teens constant currency growth in Neurosurgery. Neurovascular results were broad-based, with low-twenties growth in stent retrievers, coils, flow diversion, and high-teens growth in neuro access, all on a constant currency basis. Neurosurgery was led by strong capital equipment sales of Mazor X(TM) robotic guidance systems, StealthStation S8 surgical navigation systems, Midas Rex powered surgical instrument systems, and O-arm surgical imaging systems.

Spine fourth quarter revenue of $691 million decreased 1.1 percent as reported and or increased 0.7 percent on a constant currency basis. When combined with the company’s sales of enabling technology used in spine surgeries, including robotics, navigation, imaging, and powered surgical instruments that are recognized in the Brain Therapies division, global Spine revenue grew in the mid-single digits and U.S. Core Spine revenue grew in the low-double digits on a constant currency basis. Cervical spine products grew mid-single digits on a constant currency basis, driven by the continued launch of the Infinity(TM) OCT system and solid growth of the Prestige LP(TM) cervical disc system.

Specialty Therapies fourth quarter revenue of $445 million increased 5.0 percent as reported or 6.8 percent on a constant currency basis. Results were led by high-teens constant currency growth in Transformative Solutions, on strong sales of Aquamantys(TM) bipolar sealers and PlasmaBlade(TM) dissection devices, and high-single digit constant currency growth in ENT.

Pain Therapies fourth quarter revenue of $342 million increased 3.0 percent as reported or 5.4 percent on a constant currency basis. The division had high-single digit constant currency growth in Targeted Drug Delivery, and mid-single digit constant currency growth in Pain Stimulation on the continued strength of the Intellis(TM) platform.

Diabetes Group
The Diabetes Group includes the Advanced Insulin Management (AIM) and Emerging Technologies divisions. Diabetes Group fiscal year 2019 revenue of $2.391 billion increased 11.7 percent as reported and 13.4 percent on a constant currency basis. Diabetes Group fourth quarter revenue of $626 million decreased 2.9 percent as reported or increased 0.6 percent on a constant currency basis. Despite facing more difficult comparisons on pump sales given the backlog of patient orders that the company cleared in the prior year, revenue increased 2.6 percent versus the prior quarter as reported.

Advanced Insulin Management fourth quarter revenue decreased low-single digits constant currency. Strong, mid-teens growth in international markets, driven by the ongoing launch of the MiniMed(TM) 670G hybrid closed loop insulin pump system with the Guardian(TM) Sensor 3, was offset by difficult comparisons and increased competition in the U.S. Global adoption of sensor-augmented insulin pump systems has resulted in strong sensor attachment rates, with integrated CGM sales growing in the high-teens on a constant currency basis.

Emerging Technologies fourth quarter revenue grew in the low-sixties on a constant currency basis, driven by the ongoing launch of the Guardian(TM) Connect CGM system with Sugar.IQ(TM) personal diabetes assistant, which grew triple digits for the fourth consecutive quarter.

Guidance
The company today issued its fiscal year 2020 revenue and EPS growth guidance.

The company expects revenue growth in its fiscal year 2020 to approximate 4.0 percent on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2020 would be negatively affected by 1.0 to 1.5 percent.

In fiscal year 2020, the company expects diluted non-GAAP EPS in the range of $5.44 to $5.50, including an estimated 10 cent negative impact from foreign exchange based on current rates.

"The company continues to make significant progress on our pipeline," said Ishrak. "We expect our revenue growth to accelerate over the course of fiscal year 2020 and into fiscal year 2021, driven by the anniversary of recent headwinds, combined with a series of major product launches over the next 12 months."

Webcast Information
Medtronic will host a webcast today, May 23, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the fourth quarter and fiscal year 2019 financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter and fiscal year 2019 earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

On May 23, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported a publication in Cell Reports describing two new monoclonal antibodies, IPH5201 and IPH5301, that target CD39 and CD73, respectively, to inhibit the adenosine pathway and promote activation of the immune system against cancer (Press release, Innate Pharma, MAY 23, 2019, View Source [SID1234536548]). The full manuscript, titled "Blocking antibodies targeting the CD39/CD73 immunosuppressive pathway unleash immune responses in combination cancer therapies" appeared in the online issue of Cell Reports on May 21st, 2019.

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Cancer immune evasion largely involves the generation of high amounts of immunosuppressive adenosine (Ado) within the tumor environment. An increase in CD39 and CD73 at the tumor bed signals an immunosuppressive environment inhibiting anti-tumor immune responses and favoring tumor spreading. The impact of blocking CD39 and CD73 ectoenzymes to overcome Ado-mediated immunosuppression and to reinforce anti-tumor immunity has been investigated by combining genetic and antibody-mediated approaches.

The work published by Innate Pharma and collaborators shows that CD39 deficiency enhances the benefits from combined cancer therapies in preclinical mouse solid tumor models. We report the generation and characterization of two blocking antibodies against human CD39 and CD73, referred to as IPH5201 and IPH5301, respectively. The anti-CD39 antibody IPH5201 blocked ATP hydrolysis by both membrane and soluble CD39, thereby promoting DC maturation and macrophage activation, whereas the anti-CD73 antibody IPH5301 blocked the degradation of AMP into immunosuppressive Ado and displays different functional characteristics over currently used antibodies. Both IPH5201 and IPH5301 prevented the Ado-mediated inhibition of T cells purified from patients with breast cancer or melanoma. We also observed that IPH5201 efficiently increased the anti-tumor activity of the ATP-inducing chemotherapeutic drug oxaliplatin in a mouse tumor model. These data provide the scientific rationale for the clinical development of IPH5201 and IPH5301 and their use in cancer immunotherapy.

"The published data continue to support our rationale to evaluate IPH5201 and IPH5301 in cancer, particularly if these antibodies are used in combination with each other, with immune checkpoint inhibitors or with chemotherapies", commented Pr. Eric Vivier, Innate Pharma CSO. "We are excited to further explore the potential of these antibodies as an innovative and differentiated approach to reverse immunosuppression in the tumor microenvironment and expect INDs to be filed for IPH5201 in the second half of 2019 and for IPH5301 in the first half of 2020."

In October 2018, Innate Pharma and AstraZeneca entered into a development collaboration and option agreement for further co-development and co-commercialization for IPH5201.

Reference

Ivan Perrot, Henri-Alexandre Michaud, Marc Giraudon-Paoli, Séverine Augier, Aurélie Docquier, Laurent Gros, Rachel Courtois, Cécile Déjou, Diana Jecko, Ondine Becquart, Hélène Rispaud-Blanc, Laurent Gauthier, Benjamin Rossi, Stéphanie Chanteux, Nicolas Gourdin, Beatrice Amigues, Alain Roussel, Armand Bensussan, Jean-François Eliaou, Jérémy Bastid, François Romagné, Yannis Morel, Emilie Narni-Mancinelli, Eric Vivier, Carine Paturel, and Nathalie Bonnefoy. Blocking Antibodies Targeting the CD39/CD73 Immunosuppressive Pathway Unleash Immune Responses in Combination Cancer Therapies. Cell Reports, May 21, 2019.

On May 23, 2019 Incyte Corporation (Nasdaq:INCY) reported that it will present at the 40th Annual Goldman Sachs Global Healthcare Conference onTuesday, June 11, 2019 at 2:00 pm (PDT) / 5:00 pm (EDT) in Rancho Palos Verdes (Press release, Incyte, MAY 23, 2019, View Source [SID1234536547]).

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The presentation will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations". Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

On May 23, 2019 DXC Technology (NYSE: DXC) reported results for the three and twelve months ended March 31, 2019 (Press release, DynPort Vaccine Company, MAY 23, 2019, View Source [SID1234536546]).

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"DXC Technology closed out our fourth quarter, and our fiscal year, by delivering strong digital performance and sequential growth in revenue, bookings, and cash flow," said Mike Lawrie, chairman, president and CEO. "We continued to enhance our portfolio of digital offerings, and we are re-skilling current employees to equip them with new digital capabilities and certifications. We have also hired thousands of new employees with advanced digital skills, and added more through acquisitions, to further scale our digital workforce. Our acquisition of Luxoft is expected to be completed as planned by the end of June, and this will further strengthen DXC’s ability to design and deploy transformative digital solutions for clients at scale."

Financial Highlights – Fourth Quarter Fiscal 2019

Diluted earnings per share from continuing operations was $1.01 in the fourth quarter, including $(0.13) per share of restructuring costs, $(0.24) per share of transaction, separation and integration-related costs, $(0.37) per share of amortization of acquired intangible assets, and $(0.43) per share of pension and OPEB actuarial and settlement losses. This compares with $1.80 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $2.19.
Revenue in the fourth quarter was $5,280 million compared with $5,584 million in the year ago period.
Income from continuing operations before income taxes was $354 million for the fourth quarter, including $(47) million of restructuring costs, $(96) million of transaction, separation and integration-related costs, $(138) million of amortization of acquired intangibles, and $(143) million of pension and OPEB actuarial and settlement losses. This compares with $588 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $778 million compared with $812 million in the year ago period.
Net income was $271 million for the fourth quarter, including $(35) million of restructuring costs, $(66) million of transaction, separation and integration-related costs, $(101) million of amortization of acquired intangibles, and $(116) million of pension and OPEB actuarial and settlement losses. This compares with $565 million in the prior year period.
Non-GAAP net income was $589 million.
Adjusted EBIT was $827 million in the fourth quarter compared with $882 million in the prior year. Adjusted EBIT margin was 15.7% compared with 15.8% in the year ago quarter.
Net cash provided by operating activities was $748 million in the fourth quarter, compared with $557 million in the year ago period.
Adjusted free cash flow was $917 million in the fourth quarter.
Financial Highlights – Fiscal 2019

Diluted earnings per share from continuing operations was $4.35 in fiscal 2019, including $(1.25) per share of restructuring costs, $(1.06) per share of transaction, separation and integration-related costs, $(1.42) per share of amortization of acquired intangible assets, $(0.41) per share of pension and OPEB actuarial and settlement losses, and $0.16 per share of tax adjustment related to U.S. tax reform. This compares with $5.23 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $8.34.
Revenue in fiscal 2019 was $20,753 million compared with $21,733 million in the year ago period.
Income from continuing operations before income taxes was $1,515 million for fiscal 2019, including $(465) million of restructuring costs, $(401) million of transaction, separation and integration-related costs, $(539) million of amortization of acquired intangibles, and $(143) million of pension and OPEB actuarial and settlement losses. This compares with $1,304 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $3,063 million compared with $2,758 million in the prior year.
Net income was $1,262 million for fiscal 2019, including $(353) million of restructuring costs, $(299) million of transaction, separation and integration-related costs, $(401) million of amortization of acquired intangibles, $(116) million of pension and OPEB actuarial and settlement losses, and $44 million of tax adjustment related to U.S. tax reform. This compares with $1,782 million in the prior year period.
Non-GAAP net income was $2,387 million.
Adjusted EBIT was $3,269 million in fiscal 2019 compared with $2,989 million in the prior year. Adjusted EBIT margin was 15.8% compared with 13.8% in the prior year.
Net cash provided by operating activities was $1,783 million in fiscal 2019, compared with $2,567 million in the prior year.
Adjusted free cash flow was $2,105 million in fiscal 2019.
Global Business Services (GBS)
GBS revenue was $2,191 million in the quarter compared to $2,361 million for the prior year. GBS revenues decreased 7.2% year-over-year, reflecting headwinds in the traditional applications business, including the impact of accelerated cloud adoption. GBS profit margin in the quarter was 20.4%, up from 19.4% in the prior year, reflecting ongoing workforce optimization. New business awards for GBS were $2,857 million in the fourth quarter.

Global Infrastructure Services (GIS)
GIS revenue was $3,089 million in the quarter compared to $3,223 million for the prior year. GIS revenues decreased 4.2% year-over-year. The GIS revenue reflects the ongoing migration out of legacy infrastructure environments, offset by growth in cloud infrastructure and digital workplace. GIS profit margin in the quarter was 14.1%, down from 14.6% in the prior year, reflecting investments in digital capabilities and assets. New business awards for GIS were $2,968 million in the fourth quarter.

Returning Capital to Shareholders
During the fourth quarter, DXC Technology returned $142 million to shareholders, consisting of $51 million of common stock dividends and $91 million in share repurchases.

Earnings Conference Call and Webcast
DXC Technology senior management will host a conference call and webcast today at 5 p.m. EDT. The dial-in number for domestic callers is (888) 394-8218. Callers who reside outside of the United States should dial +1 (323) 794-2588. The passcode for all participants is 9706900. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until May 30, 2019. The replay passcode is also 9706900.

Non-GAAP Measures
In an effort to provide investors with supplemental financial information, in addition to the preliminary and unaudited financial information presented on a GAAP and pro forma basis, we have also disclosed in this press release preliminary non-GAAP information including: constant currency, earnings before interest and taxes ("EBIT"), EBIT margin, adjusted EBIT, adjusted EBIT margin, non-GAAP income before income taxes, non-GAAP net income, non-GAAP EPS and adjusted free cash flow. Reconciliations of the preliminary non-GAAP measures to the respective most directly comparable measures calculated on a GAAP or pro forma basis, as well as the rationale for management’s use of non-GAAP measures, are included below.