On May 8, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported its results for the first quarter and provided an update on the company’s recent activities (Press release, Five Prime Therapeutics, MAY 8, 2019, View Source [SID1234535957]).

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The company also provided an update on the Phase 3 FIGHT trial testing bemarituzumab in combination with mFOLFOX6 in patients with gastric (GC) or gastroesophageal junction (GEJ) cancer that overexpresses FGFR2b.

"We and our partners have made steady progress advancing all five clinical programs in our pipeline, and we are swiftly responding to new information from the Phase 3 FIGHT trial," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "In light of biomarker screening results from the FIGHT trial, we have made the decision to conduct an early futility analysis, which we expect to occur in the first half of 2020. We believe this is both clinically and fiscally responsible."

First Quarter 2019 Business Highlights and Milestones

Clinical Pipeline:

Bemarituzumab (FPA144) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b.

Based on the FIGHT trial design, patients are being selected for enrollment by: (a) tissue IHC testing (FGFR2b protein overexpression), (b) blood ctDNA testing (FGFR2 gene amplification), or (c) both IHC and ctDNA testing, as data support that patients with tumors meeting criteria in any of the three biomarker categories may benefit from the addition of bemarituzumab to front-line chemotherapy.
The FIGHT trial marks the first time that FGFR2b protein overexpression has been measured on a large scale in front-line patients with advanced gastric and GEJ cancers. Greater than 30% of patients screened have tested positive for FGFR2b overexpression by IHC alone, which is significantly higher than expected. The company expected 10% of patients to test positive by either IHC and/or ctDNA tests in the FIGHT trial. Also, the company expected that patients who tested positive for FGFR2b overexpression by IHC alone would represent a minority of the patients enrolled in the FIGHT trial, but these patients represent the vast majority of biomarker positive patients in the FIGHT trial.
Because the composition of the enrolled patient population differs from the company’s expectations, Five Prime plans to conduct an early futility analysis.
FPA150 (anti-B7-H4) is a first-in-class anti-B7-H4 antibody designed to target tumor cells by blocking B7-H4 from sending an inhibitory signal to CD8 T cells and by enhancing killing of B7-H4 overexpressing tumors through ADCC. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

The company initiated dosing in the Phase 1b monotherapy expansion portion of the Phase 1a/1b trial in February 2019. The company expects to initiate dosing in May 2019 in a safety lead-in evaluating FPA150 in combination with Keytruda (pembrolizumab) in patients with advanced ovarian cancer that overexpresses B7-H4.
The abstract titled "Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors" was accepted for a poster presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Preliminary safety data from the Phase 1a/1b trial will be presented.
Additional safety data along with preliminary efficacy data from the Phase 1b monotherapy expansion cohorts are expected to be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

The company presented preclinical data regarding FPT155 during the New Drugs on the Horizon Oral Session at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
The company expects to present data from the Phase 1a dose escalation portion of the ongoing Phase 1a/1b trial at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2019.
Cabiralizumab (FPA008) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages.

A Phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy is ongoing at sites in the U.S., Canada, Europe, Japan, Korea and Taiwan.
BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that may limit the duration and magnitude of T cell responses. This is the first clinical candidate from the discovery collaboration between Five Prime and BMS that includes targets in three immune checkpoint pathways.

The Phase 1/2 clinical trial continues to progress.
Corporate Highlights

In January 2019, the company announced a corporate restructuring to focus resources on clinical development and late-stage research programs, primarily eliminating positions in research, pathology and manufacturing.
Summary of Financial Results and Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $237.0 million as of March 31, 2019, compared to $270.1 million as of December 31, 2018. The decrease in cash, cash equivalents and marketable securities was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the first quarter of 2019 decreased by $27.1 million, or 84%, to $5.3 million from $32.5 million for the first quarter of 2018. This decrease was primarily related to the $25.0 million milestone earned in the first quarter of 2018 relating to the dosing of the first patient in the BMS Phase 2 clinical trial of cabiralizumab in combination with Opdivo with and without chemotherapy.

R&D Expenses: Research and development expenses for the first quarter of 2019 decreased by $11.8 million, or 27%, to $31.8 million from $43.6 million for first quarter of 2018. This decrease was primarily related to companion diagnostic expense incurred in the first quarter of 2018, with no corresponding expense in the first quarter of 2019 and lower compensation costs, and lower clinical trial expenses that were partially offset by higher manufacturing costs related to the FPA150 program.

G&A Expenses: General and administrative expenses for both the first quarters of 2019 and 2018 were $10.5 million.

Net Loss: Net loss for the first quarter of 2019 was $35.4 million, or ($1.02) per basic and diluted share, compared to a net loss of $20.4 million, or ($0.63) per basic and diluted share, for the first quarter of 2018.

Shares Outstanding: Total shares outstanding were 34,838,684 as of March 31, 2019.

Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 9689855. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

About the FIGHT Trial

The Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial is a double-blind randomized and controlled study evaluating 15 mg/kg of bemarituzumab or placebo given every two weeks combined with modified FOLFOX6 (mFOLFOX6) chemotherapy in patients with GC or GEJ cancer whose tumors overexpress FGFR2b. The primary endpoint is overall survival (OS), with key secondary endpoints being progression-free survival (PFS), objective response rate (ORR), safety and pharmacokinetic (PK) parameters.

The Phase 3 FIGHT trial is the first prospective FGFR2b-specific front-line gastric study that is evaluating bemarituzumab and mFOLFOX6 in advanced GC and GEJ cancer across clinical trial sites in Asia, the US, and Europe. Zai Lab and Five Prime have a strategic development collaboration under which Zai Lab will manage the Phase 3 portion of the FIGHT trial in China.

Unmet Need in Gastric Cancer (GC) and Gastroesophageal Junction (GEJ) cancer

Gastric cancer, including GEJ cancer, is the fifth most common cancer worldwide and third leading cause of cancer death. Gastric cancer is the second most common cancer in China.

Current first-line chemotherapy treatment delays progression by approximately six months compared to best supportive care, but median OS remains poor with literature-reported ranges of approximately 10 to 11 months and PFS of approximately six months. The presence of FGFR2b overexpression is present in patients with GC/GEJ and is associated with a worse prognosis. Few treatment options following progression are available after first-line chemotherapy, and a significant unmet need remains in the treatment of GC/GEJ worldwide.

Five Prime has partnered with two companion diagnostics companies to identify FGFR2b overexpression using an immunohistochemistry (IHC) test and FGFR2 gene amplification using circulating tumor DNA (ctDNA) analysis. Five Prime is using both assays to select patients for the FIGHT trial.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab blocks FGFs 7, 10 and 22 from binding to FGFR2b, and has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

On May 8, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that it has entered into an agreement to transfer the Adimab Platform to Takeda Pharmaceuticals (Takeda) for the discovery and optimization of antibody- and non-antibody-based protein therapeutics (Press release, Adimab, MAY 8, 2019, View Source [SID1234535974]). This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2016.

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The Adimab transfer will provide Takeda with technology licenses at multiple research sites for discovery and optimization of novel modalities across therapeutic areas. This engineering solution provides Takeda the internal capability to engineer different complex molecules as part of its ongoing pipeline diversification strategy in biologics and other modalities.

"Takeda is building a world-class network of capabilities and partnerships to deliver the best therapeutics to address the unmet needs of specific patient populations," said Takeda’s Head of Global Biologics Research, Robert Mabry. "Adimab’s antibody discovery platform will help us diversify our pipeline beyond small molecules, expand our modalities for monoclonal antibody therapeutics, and advance other mechanisms of action enabled by antibody binders, including cell therapies, cytotoxic payloads, immunomodulatory payloads and others."

"For the past three years, we’ve been initiating approximately 35 programs per year internally; this typically involves discovery, optimization and often bispecifics, including using our proprietary CD3 antibodies," said Tillman Gerngross, Chief Executive Officer and Co-Founder at Adimab. "The Adimab Platform can be broadly applied to Takeda’s growing biologics pipeline, across many different modalities, so we’re excited to provide Takeda with the capability to advance its protein-based therapeutic efforts."

"Of the 280-plus Adimab programs initiated to date, almost one-third have come from our Platform Transfer partners, and we see the enablement of more external users as an active area of growth," added Guy Van Meter, Chief Business Officer at Adimab.

Under the terms of the agreement, Takeda will have exclusive access to unique human antibody libraries and will receive a license to the Adimab Platform for use in all therapeutic areas without any target restrictions. Takeda has also secured options to receive continued improvements to the Adimab Platform, including access to new antibody libraries. Adimab will receive an undisclosed upfront fee, future payments upon achievement of specified preclinical and clinical milestones, and royalties on therapeutic products.

On May 8, 2019 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported financial results for the first quarter ended March 31, 2019, and highlighted recent corporate developments (Press release, pSivida, MAY 8, 2019, View Source [SID1234535925]).

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"The initial launches of our two commercial ocular products, DEXYCUTM and YUTIQTM, have generated a strong initial reception by treating physicians and patients, which we will look to leverage to drive sales growth in the coming quarters," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are now a fully-integrated, commercial-stage specialty ophthalmology company and are very pleased with the early momentum we are seeing for our two new innovative ocular products, each of which have significant market potential. We are also optimistic that we are well-positioned financially to execute on our goals following the addition of a new credit facility in February with CRG and the recent equity offering that we completed in April to support our operations through to positive cash flow in 2020."

Recent Highlights

YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye was made commercially available on February 4, 2019. YUTIQ received a preliminary recommendation from the Centers for Medicare & Medicaid Services (CMS) for a specific J-code through the Healthcare Common Procedure Coding System (HCPCS).

Ten Key Account Managers (KAMs) are dedicated to calling predominantly uveitis specialists across the U.S.

Since the February launch, approximately 95% of the top decile uveitis specialists have been visited by 10 KAMs.

Since launch, over 100 YUTIQ orders have been shipped for use in patients.

Over 300 benefit investigations have been received.

YUTIQ has been included in 9 academic formularies and is pending inclusion for an additional 11.

As of April 30, our market access initiatives have resulted in over 93% of commercial lives covered, over 75% of Medicare Advantage lives covered and 95% of Medicare Fee-For-Service lives covered.

DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following cataract surgery was made commercially available on March 12, 2019.

34 KAMs dedicated to the promotion of DEXYCU have focused on a phased launch program to ensure proper physician training for the preparation, application and administration of DEXYCU.

Since launch, nearly 200 surgeons in more than 150 ambulatory surgical centers (ASCs) have completed the training/certification program and are now able to purchase DEXYCU.

Since launch, over 1,200 patients have been injected with DEXYCU via the Company’s sampling program.

Since launch, over 2,000 medical professionals and office staff have been called on to discuss DEXYCU.

As of April 30, our market access initiatives have resulted in over 90% of commercial lives covered, over 75% of Medicare Advantage lives covered and 100% of Medicare Fee-For-Service lives covered.

At the 2019 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Vancouver, British Columbia, 36-month efficacy and safety data supporting YUTIQ was presented in an oral session entitled, "Treatment of Non-infectious Uveitis that Affects the Posterior Segment with a Single Intravitreal Fluocinolone Acetonide Insert (FAi) – 3-year Results." The 36-month follow up data of the Phase 3 clinical trial of YUTIQ showed a 56.3% recurrence rate of uveitis eye flares, significantly lower than eyes treated with sham (92.9%). The p-value was <0.001. 19.5% of YUTIQ treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 69.0% for sham treated eyes. 34.5% of YUTIQ treated eyes needed the assistance of an adjunctive systemic steroid or immunosuppressant compared to 50.0% for sham treated eyes. Intraocular pressure (IOP) lowering drops were used in 42% of YUTIQ treated eyes and 33% of sham treated eyes with IOP lowering surgeries performed in 6% of YUTIQ treated eyes and 12% of sham treated eyes. Safety and side effects were consistent with those reported for previous analyses of earlier timepoints. These durable 36-month results continue to reinforce the potential of YUTIQ as a long-acting treatment option for patients suffering from this chronic disease.

At the 2019 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting in San Diego, California, data supporting DEXYCU was presented in a paper session entitled, "Effect of Dexamethasone Intraocular Suspension 9% on IOP after Cataract Surgery: Results of Two Phase 3 Studies." An analysis of the IOP data from two Phase 3 studies of DEXYCU showed that the IOP effect of DEXYCU was comparable to short-term topically administered prednisolone acetate or placebo in cataract surgery patients. Mean IOP was only slightly elevated, to approximately 19 and 18 mmHg at postoperative Day 1 in the DEXYCU and prednisolone acetate arms, respectively, and it returned to baseline in both arms by Day 3. The proportion of patients at each measured IOP category in both studies were similar between the DEXYCU and control group cohorts. These data further support DEXYCU’s safety profile for the treatment of post-operative inflammation.

On April 1, 2019, the Company completed a public offering of 10,526,500 shares of its common stock at a public offering price of $1.90 per share. The net proceeds of the offering to the Company were approximately $18.6 million.

During April 2019, the Company exercised its option to draw an additional $15.0 million under the CRG Loan Agreement and paid a $15.0 million development milestone that was due to the former Icon security holders following the first commercial sale of DEXYCU. At April 30, 2019, the Company had $56.9 million of cash and cash equivalents.

Review of First Quarter Results Ended March 31, 2019

For the three months ended March 31, 2019, total net revenue was $2.0 million compared to $928,000 for the three months ended March 31, 2018. Net revenue from DEXYCU was $684,000, and for YUTIQ net revenue was $543,000. Neither of these products had net revenue in the corresponding quarter in 2018. Net revenue from royalties and collaborations for the three months ended March 31, 2019 totaled $785,000 compared to $928,000 in the corresponding quarter in 2018.

Operating expenses for the three months ended March 31, 2019 increased to $16.7 million from $5.6 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, professional services, stock-based compensation and amortization of the DEXYCU intangible asset. Non-operating expense, net, for the three months ended March 31, 2019 totaled $4.6 million and consisted of $777,000 of net interest expense and $3.8M from the loss on extinguishment of debt related to the pay off of the SWK term loan. Net loss for the three months ended March 31, 2019 was $19.2 million, or $0.20 per share, compared to a net loss of $7.0 million, or $0.15 per share, for the prior year quarter.

Cash and cash equivalents at March 31, 2019 totaled $43.4 million compared to $45.3 million at December 31, 2018. At April 30, 2019, the total amount outstanding under the CRG debt facility was $50 million and cash and cash equivalents as of that date were $56.9 million.

Financial Outlook

Early sales of YUTIQ and DEXYCU have been encouraging, and the Company is optimistic that existing cash and cash equivalents at April 30, 2019, and cash inflows from anticipated YUTIQ and DEXYCU product sales, will be sufficient to fund the Company’s current and planned operations through to the generation of positive cash flow in 2020.

Conference Call Information

EyePoint will host a conference call today, Wednesday, May 8, 2019, at 8:30 AM ET to discuss the results for the first quarter ended March 31 and recent operational developments. To access the conference call, please dial (877) 312-7507 from the U.S. and Canada or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 1192368. A live webcast will be available on the Investor Relations section of the corporate website at View Source A replay of the webcast will also be available on the corporate website.

On May 8, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present at the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 14, 2019 at 2:20 p.m. PT / 5:20 p.m. ET. The conference will be held May 14-16, 2019 in Las Vegas (Press release, Kura Oncology, MAY 8, 2019, View Source [SID1234535941]).

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A live audio webcast of the presentation will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

On May 8, 2019 McKesson Corporation (NYSE:MCK) reported that revenues for the fourth quarter ended March 31, 2019, were $52.4 billion compared to $51.6 billion a year ago, an increase of 2% on a reported basis and an increase of 3% on an FX-adjusted basis. For the fiscal year, McKesson had revenues of $214.3 billion, compared to $208.4 billion a year ago, an increase of 3% on a reported and FX-adjusted basis (Press release, McKesson, MAY 8, 2019, View Source [SID1234535958]).

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"McKesson delivered solid adjusted operating results, and we are pleased to conclude fiscal 2019 with adjusted EPS growth of 8%," said Brian Tyler, chief executive officer. "We successfully executed in a challenging environment and took action to address the headwinds in our European business. McKesson exits fiscal 2019 with improving momentum across many of our businesses. Our financial flexibility, reinforced by a strong balance sheet and solid cash flow generation, positions us to continue delivering shareholder value."

On the basis of U.S. generally accepted accounting principles ("GAAP"), fourth-quarter loss per diluted share from continuing operations was $(4.17), compared to loss per diluted share of $(5.58) a year ago. Full-year GAAP earnings per diluted share from continuing operations was $0.17, compared to GAAP earnings per diluted share from continuing operations of $0.30 a year ago. Fourth-quarter GAAP loss per diluted share and full-year GAAP earnings per diluted shared included after-tax net charges totaling approximately $1.5 billion and $2.2 billion, respectively, or $7.63 and $11.00 per diluted share, respectively, reflecting non-cash goodwill and long-lived asset impairment charges, as well as restructuring charges largely in the company’s European businesses.

Fourth-quarter Adjusted Earnings per diluted share was $3.69, an increase of 6% compared to $3.49 a year ago, primarily driven by a lower share count and growth in the Medical-Surgical business, partially offset by weakness in the U.K. retail pharmacy business, including an inventory charge recorded in the fourth quarter, and a higher adjusted tax rate. Full-year Adjusted Earnings per diluted share was $13.57, an increase of 8% compared to $12.62 for the prior year, primarily driven by a lower share count, growth in the McKesson Prescription Technology Solutions (MRxTS) and Medical-Surgical businesses and a lower adjusted tax rate, partially offset by lower profit contribution from the U.S. Pharmaceutical business related to the fourth quarter fiscal 2018 customer losses and weakness in the U.K. retail pharmacy business.

For the full year, McKesson generated cash from operations of $4.0 billion, and invested $557 million internally, resulting in free cash flow of $3.5 billion. During the year, McKesson paid $905 million for acquisitions, repurchased approximately $1.6 billion of its common stock, and paid $292 million in dividends. The company ended the quarter with cash and cash equivalents of $3.0 billion.

U.S. Pharmaceutical and Specialty Solutions Segment

Fourth Quarter: Revenues were $40.9 billion, up 3%, driven primarily by market growth, partially offset by branded to generic conversions and fourth-quarter fiscal 2018 customer losses. GAAP operating profit was $873 million and GAAP operating margin was 2.13%. Adjusted operating profit was $752 million, down 1%, and adjusted operating margin was 1.84%.
Full Year: Revenues were $167.8 billion, up 3%, driven primarily by market growth and acquisitions, partially offset by fourth-quarter fiscal 2018 customer losses and branded to generic conversions. GAAP operating profit was $2.7 billion and GAAP operating margin was 1.61%. Adjusted operating profit was $2.5 billion, down 2%, and adjusted operating margin was 1.50%.
European Pharmaceutical Solutions Segment

Fourth Quarter: Revenues were $6.8 billion, down 6% on a reported basis and up 2% on an FX-adjusted basis, driven primarily by market growth, partially offset by the fiscal 2018 actions to sell or divest owned retail pharmacies and a challenging market environment in the U.K. GAAP operating loss was $(1.5) billion and GAAP operating margin was (21.52)%. The segment recorded non-cash impairment charges of $1.4 billion in the fourth quarter, mainly due to declines in estimated future cash flows primarily attributed to the continued effects of U.K. government reimbursement reductions and competitive pressures in the U.K. Adjusted operating profit was $23 million, down 72%, and adjusted operating margin was 0.34%. On an FX-adjusted basis, adjusted operating profit was $26 million, down 68%, and adjusted operating margin was 0.36%. The segment results include an inventory charge of approximately $20 million in the fourth quarter.
Full Year: Revenues were $27.2 billion, flat on a reported basis and up 1% on an FX-adjusted basis, driven primarily by market growth, partially offset by the fiscal 2018 reduction in owned retail pharmacies and a challenging market environment in the U.K. and France. GAAP operating loss was $(2.0) billion and GAAP operating margin was (7.26)%. The segment GAAP results include full-year pre-tax restructuring charges of $63 million as a result of actions taken to address performance in the segment. Adjusted operating profit was $219 million, down 36%, and adjusted operating margin was 0.80%. On an FX-adjusted basis, adjusted operating profit was $220 million, down 35%, and adjusted operating margin was 0.80%.
Medical-Surgical Solutions Segment

Fourth Quarter: Revenues were $2.0 billion, up 13%, driven primarily by an acquisition and growth in the Primary Care and Lab Solutions businesses. GAAP operating profit was $121 million and GAAP operating margin was 6.19%. Adjusted operating profit was $172 million, up 21%, and adjusted operating margin was 8.80%.
Full Year: Revenues were $7.6 billion, up 15%, driven primarily by an acquisition and growth in the Primary Care and Lab Solutions businesses. GAAP operating profit was $455 million and GAAP operating margin was 5.97%. Adjusted operating profit was $605 million, up 11%, and adjusted operating margin was 7.94%.
Other remaining businesses (primarily including McKesson Canada, MRxTS and equity accounting method investment in Change Healthcare)

Fourth Quarter: Revenues were $2.8 billion, down 6% on a reported basis and down 1% on an FX-adjusted basis, driven primarily by April 2018 government actions taken in Canada, partially offset by market growth. GAAP operating profit was $111 million and adjusted operating profit was $258 million, up 6%. On an FX-adjusted basis, adjusted operating profit was $261 million, up 7%.
Full Year: Revenues were $11.7 billion, down 1% on a reported basis and up 1% on an FX-adjusted basis, driven primarily by market growth, partially offset by government actions enacted in Canada and the fiscal 2018 sale of the company’s Enterprise Information Solutions business. GAAP operating profit was $394 million and adjusted operating profit was $995 million, up 7%. On an FX-adjusted basis, adjusted operating profit was $1.0 billion, up 8%.
Company Updates

Renewed pharmaceutical distribution relationship with CVS Health through June 2023.
McKesson relocated its global corporate headquarters from San Francisco, California, to Irving, Texas, effective April 1, 2019.
Board of Directors elected Dominic Caruso and Brad Lerman as new independent directors.
In January of 2019, the Board of Directors formed a Compliance Committee to enhance oversight of the company’s compliance programs and management’s identification and evaluation of the principal legal and regulatory compliance risks. Brad Lerman, who has significant experience leading global legal, government affairs, ethics and compliance functions, chairs the committee.
Following McKesson’s announcement of a $100 million contribution to create a non-profit foundation to address the opioid epidemic in March 2018, the Foundation for Opioid Response Efforts (FORE) appointed Dr. Andrea Barthwell as board chair and Dr. Karen A. Scott as president.
Enhanced leadership and executive teams: appointed Kirk Kaminsky president of U.S. Pharmaceutical and Specialty Solutions business effective April 15, 2019, and appointed Tracy Faber executive vice president and chief human resources officer effective October 1, 2019, following Jorge Figueredo’s announced retirement.
Cost Savings Target Update

As a result of actions taken in the second half of fiscal 2019 to address challenges in the European business and to better position the U.S. and Canadian businesses, the company now anticipates it will generate approximately $400 million to $500 million in annual pre-tax savings that will be substantially realized by the end of fiscal 2021, an increase from the prior expectation of $300 million to $400 million as previously announced on October 25, 2018.

"We are making important progress towards our initiatives and are confident that the actions we are taking position us for growth in fiscal 2020 and beyond," Tyler concluded.

Fiscal 2020 Outlook and Key Assumptions

McKesson expects full-year fiscal 2020 Adjusted Earnings per diluted share of $13.85 to $14.45, which reflects solid growth across the company’s operating segments, a continuation of disciplined, efficient capital deployment, investments in the business, increased costs for opioids litigation and modest improvement in the U.K. business.

The fiscal 2020 outlook is based on the following key assumptions and expectations, and is also subject to risk factors such as those described below:

McKesson to deliver low- to mid-single digit percent revenue growth and flat to low-single digit percent adjusted income from operations decline in fiscal 2020.
U.S. Pharmaceutical and Specialty Solutions to deliver low- to mid-single digit percent revenue and adjusted operating profit growth in fiscal 2020.
European Pharmaceutical Solutions to deliver low- to mid-single digit percent revenue and adjusted operating profit growth in fiscal 2020.
Medical-Surgical Solutions to deliver high-single digit percent revenue growth and high-single to low double-digit percent adjusted operating profit growth in fiscal 2020.
Other to deliver approximately flat to low-single digit percent revenue decline and adjusted operating profit is expected to decline low- to mid-single digit percent in fiscal 2020, which assumes the company’s continued 70% equity interest in Change Healthcare through March 31, 2020.
Adjusted corporate expenses to be between approximately $725 million and $775 million, primarily driven by an anticipated increase in opioid-related litigation costs, and investments in technology-related infrastructure and growth-oriented data and analytics capabilities.
Interest expense to be between $245 million and $265 million.
The guidance range assumes a full-year adjusted tax rate of approximately 18-19%, which may vary from quarter to quarter.
Foreign currency exchange rate movements to have a net neutral impact to adjusted earnings per diluted share year over year.
Free cash flow to be $2.8 billion to $3.0 billion, which is net of expected payments for property, plant and equipment and capitalized software expenditures of between $500 million and $700 million.
Weighted average diluted shares used in the calculation of earnings per share to be approximately 185 million for the year.
Conference Call Details

The company has scheduled a conference call for today, Wednesday, May 8th, at 8:00 AM ET. The dial-in number for individuals wishing to participate on the call is 323-794-2093. Holly Weiss, senior vice president, Investor Relations, is the leader of the call, and the password to join the call is ‘McKesson’. A telephonic replay of this conference call will be available for five calendar days. For individuals wishing to listen to the replay, the dial-in number is 719-457-0820 and the pass code is 3096337. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Bank of America Merrill Lynch Health Care Conference, May 14, 2019, in Las Vegas, Nevada; and
Goldman Sachs 40th Annual Global Healthcare Conference, June 11, 2019, in Rancho Palos Verdes, California.
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community is available on the company’s Investor Relations website.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income from continuing operations, excluding amortization of acquisition-related intangible assets, acquisition-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments. A reconciliation of McKesson’s GAAP financial results to Adjusted Earnings is provided in Schedules 2 and 3 of the financial statement tables included with this release.

The company does not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

FX-Adjusted

McKesson also presents its financial results on an FX-adjusted basis, which is the same measure formerly designated Constant Currency. The company conducts business worldwide in local currencies, including the Euro, British pound and Canadian dollar. As a result, the comparability of the financial results reported in U.S. dollars can be affected by changes in foreign currency exchange rates. FX-adjusted information is presented to provide a framework for assessing how the company’s business performed excluding the effect of foreign currency exchange rate fluctuations. The supplemental FX-adjusted information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

Free Cash Flow

McKesson also provides free cash flow, a non-GAAP measure. Free cash flow is defined as net cash provided by operating activities less payments for property, plant and equipment and capitalized software expenditures, as outlined in the company’s condensed consolidated statements of cash flows.