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Cardinal Health Reports First Quarter Results for Fiscal Year 2019

On November 8, 2018 Cardinal Health (NYSE: CAH) reported first quarter fiscal year 2019 revenues of $35.2 billion, an increase of 8 percent (Press release, Cardinal Health, NOV 8, 2018, View Source [SID1234530990]). The company also reported growth in GAAP operating earnings of 211 percent to $816 million and a decrease in non-GAAP operating earnings of 11 percent to $542 million. GAAP operating earnings included a gain of $508 million ($378 million after-tax) related to the naviHealth divestiture. GAAP diluted earnings per share (EPS) from continuing operations increased 439 percent to $1.94, while non-GAAP diluted EPS increased 18 percent to $1.29.

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"We are pleased that the first quarter provided a solid start to fiscal year 2019," said Mike Kaufmann, CEO of Cardinal Health. "Operating performance came in as expected, and we are on track in executing on our strategic initiatives to deliver increased value to our shareholders, our customers and their patients. We look forward to making further strides over the balance of the year and building on Cardinal Health’s essential role in healthcare."

Tax rate

During the three months ended September 30, 2018 and 2017, GAAP effective tax rates were 19.4 percent and 34.2 percent, respectively, and non-GAAP effective tax rates were 14.0 percent and 34.1 percent, respectively.

This quarter’s lower effective tax rates are attributable to the lower U.S. federal income tax rate due to the U.S. Tax Cuts and Jobs Act, and the approximately $0.18 per share positive impact of discrete tax benefits primarily related to international legal entity changes.

Segment results
Pharmaceutical segment
First quarter revenue for the Pharmaceutical segment increased 9 percent to $31.4 billion due to sales growth from Pharmaceutical Distribution and Specialty Solutions customers, partially offset by the divestiture of the company’s China distribution business.

Fiscal year 2019 outlook
The company does not provide GAAP EPS outlook because it is unable to reliably forecast most of the items that are excluded from GAAP EPS to calculate non-GAAP EPS. These items could cause EPS to differ materially from non-GAAP EPS. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company reaffirmed its fiscal year 2019 guidance range for non-GAAP diluted EPS of $4.90 to $5.15.

Additional first-quarter and recent highlights

Announced Victor Crawford will join the company as chief executive officer of the Pharmaceutical segment on November 12

Exited transition services agreement (TSA) with Medtronic for the Europe, Middle East and Africa region during the last week of October and on track for TSA exits in the remaining regions in early 2019

The Cardinal Health board of directors approved a quarterly dividend of $0.4763 per share. The dividend will be payable on January 15, 2019 to shareholders of record at the close of business on January 2, 2019

Recently completed a $600 million share repurchase program, and this week, the board of directors approved a three-year authorization to repurchase up to an additional $1 billion of Cardinal Health common shares, which will expire on December 31, 2021. The company is now authorized to repurchase up to $1.3 billion of its common shares

Sponsored inaugural Women Pharmacist Day on October 12, in conjunction with National Pharmacist Month, to recognize the important contributions women pharmacists make to delivering quality care to patients

Webcast

Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss first quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Cardinal Health website at ir.cardinalhealth.com until November 7, 2019.

Upcoming webcasted investor events

Credit Suisse 27th Annual Healthcare Conference on November 14 at 8:35 a.m. Mountain in Scottsdale, Ariz.

37th Annual J.P. Morgan Healthcare Conference on January 7-10, 2019 in San Francisco, Calif.

Scholar Rock Reports Third Quarter 2018 Financial Results and Highlights Business Progress

On November 8, 2018 Scholar Rock Holding Corporation (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results for the third quarter ended September 30, 2018 and highlighted recent progress and upcoming milestones for its pipeline programs (Filing, 8-K, Scholar Rock, NOV 8, 2018, View Source [SID1234530987]).

"We continue to make important progress with our pipeline having now completed enrollment in the multiple ascending dose portion of the ongoing Phase 1 clinical trial for SRK-015 with interim results and the initiation of a Phase 2 proof-of-concept study in patients with Spinal Muscular Atrophy (SMA) expected in the first quarter of 2019," said Nagesh Mahanthappa, Ph.D, President and CEO of Scholar Rock. "We also look forward to our upcoming presentation of preclinical data at the SITC (Free SITC Whitepaper) annual meeting that will demonstrate the ability of a highly specific inhibitor of TGFβ1 to render resistant solid tumors vulnerable to anti-PD1 while minimizing the toxicities traditionally associated with pan-TGFβ inhibitors."

Key R&D Highlights and Upcoming Milestones

SRK-015 Program:

Completed Enrollment in Multiple Ascending Dose Portion of Phase 1 Clinical Trial for SRK-015 with Interim Results Expected the First Quarter of 2019. A placebo-controlled, double-blind Phase 1 clinical trial was initiated in May 2018 to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of intravenous SRK-015, a selective inhibitor of the activation of myostatin, in healthy adult volunteers. Enrollment in the single ascending dose and multiple ascending dose portions of the trial have been completed. Interim results from this ongoing Phase 1 trial are expected in the first quarter of 2019.
Plan to Initiate Phase 2 Proof-of-Concept Study for SRK-015 in SMA in the First Quarter of 2019. Pending supportive safety data from the Phase 1 clinical trial, Scholar Rock plans to initiate a Phase 2 proof-of-concept study in the first quarter of 2019 to evaluate the safety and efficacy of SRK-015 in patients with SMA as a monotherapy or in conjunction with an approved survival motor neuron (SMN) upregulator therapy as background standard of care.
Plan to Identify Second Indication for SRK-015 in the First Half of 2019. Scholar Rock is actively assessing numerous potential clinical settings in which the selective inhibition of the activation of myostatin may offer therapeutic benefit and intends to identify a second indication for SRK-015 in the first half of 2019.
TGFβ1 Program:

Presenting Preclinical Data at Upcoming SITC (Free SITC Whitepaper) Annual Meeting Highlighting the Role of TGFβ1 Inhibition in Overcoming Primary Resistance to Anti-PD1. At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 9-11, 2018, Scholar Rock will be presenting preclinical results demonstrating the ability of a highly specific inhibitor of TGFβ1, SRTβ1-Ab3, to render tumors vulnerable to checkpoint blockade therapy in syngeneic tumor models of primary resistance (Poster #550). Combination treatment with SRTβ1-Ab3 and anti-PD1 resulted in tumor regression or tumor control, and a significant survival benefit, while minimizing toxicities traditionally associated with pan-TGFβ inhibitors.
Plan to Nominate Product Candidate for TGFβ1 Program by the End of the First Half of 2019. Scholar Rock’s second antibody program is focused on the development of highly specific inhibitors of the activation of TGFβ1, and the company intends to nominate a product candidate and first indication in oncology, immuno-oncology or fibrosis by the end of the first half of 2019.
Third Quarter 2018 Financial Results

Net loss for the quarter ended September 30, 2018 was $10.8 million or $0.44 per share compared to a net loss of $5.9 million or $3.70 per unit for the same quarter last year.

Research and development expense was $8.1 million for the quarter ended September 30, 2018, compared to $4.8 million in the same quarter in 2017. The $3.3 million increase year-over-year reflects development and manufacturing costs associated with lead product candidate, SRK-015, research costs associated with preclinical studies, as well as increased personnel-related costs to support continued progress with the pipeline.
General and administrative expense was $3.2 million for the quarter ended September 30, 2018, compared to $1.2 million in the same quarter in 2017. The $2.0 million increase year-over-year was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and operating as a public company.
As of September 30, 2018, Scholar Rock had cash, cash equivalents, and marketable securities of $104.0 million, compared to $58.0 million at the end of 2017. Scholar Rock believes its cash and cash equivalents balance will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2020.

CytRx Corporation Highlights NantCell Inc’s Clinical Data with Aldoxorubicin Presented at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting

On November 8, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported its two poster presentations by its licensee NantCell, Inc. at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, taking place November 7-11, 2018 in Washington, DC (Press release, CytRx, NOV 8, 2018, View Source [SID1234530976]). The abstracts describe early safety and efficacy data from the Phase 1b portion of Phase 1b/2 clinical trials evaluating NantCell’s high-affinity natural killer (haNK) cell therapy in combination with anti-cancer agents, including aldoxorubicin, in patients with third-line or greater triple negative breast cancer (TNBC), fourth-line or greater head and neck squamous cell carcinoma (HNSCC) or recurrent metastatic pancreatic cancer.

Preliminary Phase 1b Results in TNBC and HNSCC

In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, cisplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N803), adenoviral vector-based CEA, MUC1, Brachyury, HER2 vaccine, yeast vector-based RAS, Brachyury and CEA vaccine, and an IgG1 PD-L1 inhibitor, avelumab plus cetuximab. All patients in both trials received aldoxorubicin. The primary endpoint is incidence of treatment-related adverse events (AEs). Secondary endpoints include overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

The abstract includes data from three patients with third-line or greater TNBC and two patients with fourth-line or greater HNSCC. All treatment was completed in the outpatient setting, with no immune-related AEs. Four hematologic dose limiting toxicities (DLTs) were observed and managed with a planned dose reduction of cisplatin. Of the three patients with TNBC, two (67%) experienced a partial response (PR). Of the two patients with HNSCC, both (100%) experienced objective tumor response (100% and 47% decrease, respectively). Overall, four out of the five TNBC and HNSCC patients (80%) had confirmed overall responses, including one patient (20%) with fifth-line metastatic disease who demonstrated a complete response (CR). All responding patients are still undergoing therapy. These preliminary data suggest that the NANT Cancer Vaccine (NCV), comprised of low-dose chemo-radiation combined with innate and adaptive immunotherapy, can be administered safely in an outpatient setting without any observed increase in immune-related AEs.

Preliminary Phase 1b Results in Metastatic Pancreatic Cancer

In this Phase 1b, single-arm, open-label trial, treatment was administered in 3-week cycles of low-dose chemotherapy (aldoxorubicin, cyclophosphamide, oxaliplatin, nab-paclitaxel, 5-FU/L), antiangiogenic therapy (bevacizumab), engineered allogeneic high affinity CD-16 NK-92 cells (haNK), IL-15RαFc (N-803), adenoviral vector-based CEA vaccine, yeast vector-based RAS vaccine, and an IgG1 PDL1 inhibitor, avelumab. All metastatic pancreatic cancer patients received aldoxorubicin. The primary endpoint is incidence of treatment-related AEs. Secondary endpoints include ORR, DCR, PFS, and OS.

The abstract includes data from ten patients with third-line or greater metastatic pancreatic cancer. All treatment was safely administered in the outpatient setting. AEs were primarily hematologic which were managed by appropriate planned chemo dose reductions. No DLTs have occurred and no haNK-related AEs have occurred to date. Of the ten evaluable patients, nine have achieved stable disease (SD) for ≥ 8 weeks for a DCR of 90%. Median PFS was 5.8 months (95% confidence interval: 3.3 – 8.8) and OS was 9.5 months (95% CI: 5.0 – upper limit not yet reached) with patients continuing treatment. One patient demonstrated resolution of a metastatic lung tumor within 8 weeks of initiating NCV therapy. These preliminary results suggest that the NCV treatment regimen was well tolerated and support the safety and tolerability of the regimen. These preliminary efficacy results are encouraging and the overall survival of 9.5 months currently exceeds all standards of care for patients at this advanced stage of disease.

Eric Curtis, CytRx’s President and Chief Operating Officer, stated, "The data presented by NantCell at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting are optimistic. We are pleased to see that these NCV regimens including aldoxorubicin are well tolerated and support the overall thesis being investigated. These data may ultimately lead to more combinations of aldoxorubicin with cutting edge therapies being studied in tumor types with high unmet needs. We look forward to seeing more data as these clinical trials progress."

"In the oncology marketplace, we have seen clear treatment trends by Big Pharma and recent regulatory approvals moving toward combining the category of potential Centurion drug candidates such as LADR 7, 8, 9 and 10 with immunotherapy."

Aldoxorubicin is a rationally-engineered cytotoxic which employs a linker bound to albumin to deliver doxorubicin directly into the tumor. CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to NantCell, Inc., a private subsidiary of NantWorks, LLC, in July 2017.

These data were highlighted at SITC (Free SITC Whitepaper)’s 33rd Annual Meeting in a presentation titled, "First in Human Data in Advanced Solid Tumors of NANT Cancer Vaccine: A Novel Temporospatial Orchestration of the Innate (NK) & Adaptive Immune System to Induce Antigen Cascade & Immunogenic Cell Death" which took place on Wednesday, November 7, 2018 from 5:45-6:00pm ET.

About the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Established in 1984, SITC (Free SITC Whitepaper), a 501(c)(3) not-for-profit organization, serves scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world. Currently, SITC (Free SITC Whitepaper) has more than 2,000 members who represent 22 medical specialties in 42 countries around the world. Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

Perrigo Company plc Reports Third Quarter 2018 Financial Results

On November 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the third quarter ended September 29, 2018 (Press release, Perrigo Company, NOV 8, 2018, View Source [SID1234530975]).

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the third quarter of calendar year 2018 were approximately $1.1 billion, which included new product sales of $35 million, partially offset by discontinued products of $9 million. Adjusted net sales decreased 5.7% on a constant currency basis. Unfavorable currency movements impacted net sales by $12 million.

Reported net loss was $68 million, or $0.49 per diluted share, versus net income of $45 million, or $0.31 per diluted share, in the prior year. Excluding charges as outlined in Table I, third quarter 2018 adjusted net income was $150 million, or $1.09 per diluted share, versus adjusted net income of $197 million, or $1.39 per diluted share, for the same period last year.

CHC Americas segment reported net sales were relatively flat compared to last year. Strong net sales in the smoking cessation, infant formula and dermatological categories coupled with new product sales of $13 million, were offset by lower net sales in the animal health and gastrointestinal categories and discontinued products of $1 million. Excluding the animal health business, net sales in the CHC Americas segment grew approximately 3%, on a constant currency basis.

CHC Americas third quarter reported gross profit margin was 31.0%. Adjusted gross profit margin was 32.7%, lower than the prior year due primarily to the animal health business, operating inefficiencies and relatively higher input costs.

Reported third quarter operating margin was (20.8)%. Third quarter adjusted operating margin was 19.0%, lower than the prior year due primarily to adjusted gross margin flow through.

CHC International net sales increased approximately 1%, excluding $2 million in net sales from exited businesses in 2017 and unfavorable foreign currency movements of $10 million. Growth was driven by net sales in the analgesic, anti-parasite and personal care categories in addition to new product sales of $19 million. Partially offsetting this growth were lower net sales in the lifestyle category and non-branded U.K. businesses. Discontinued products were $5 million.

Third quarter reported gross margin was 46.6%. Adjusted gross margin increased 120 basis points over the previous year to 52.6%, driven primarily by adjusted gross margin improvement initiatives including new product margin contributions.

Reported operating margin was (0.6)%. Adjusted operating margin expanded 230 basis points to 18.7% driven by gross margin flow through and improved operating leverage
RX reported net sales of $179 million were lower due primarily to challenging market dynamics in a number of authorized generic products and customer service challenges, resulting in lower sales volumes. Discontinued products were $4 million.

Reported gross margin was 41.0%. Adjusted gross margin was 52.3%, 260 basis points lower than the same quarter last year, due primarily to unfavorable product mix.

Reported operating margin was 20.1%. Adjusted operating margin was 31.9% compared to 42.4% in the prior year, due primarily to a 580 basis points increase in R&D investments as a percentage of net sales, compared to the prior year and adjusted gross margin flow through. R&D as a percentage to net sales was approximately 11% in the quarter.

Impairment

During the three months ended September 29, 2018, the animal health reporting unit continued to experience declines in its year-to-date financial results and had additional indications of impairment due to changes in channel dynamics, a strategic decision to re-prioritize our brands, and a decline in the forecasted outlook of the reporting unit. As a result, the Company realized an impairment in goodwill and intangible assets in this reporting unit within CHC Americas of approximately $213 million.

Guidance

The Company now expects calendar year 2018 net sales to be approximately $4.72 billion. The Company also expects calendar year 2018 adjusted diluted EPS in the range of $4.45 to $4.65, primarily due to revised expectation in the RX segment. In addition, reduced margin expectations in the CHC Americas segment are expected to be partially offset by improved margin expectations in the CHC International segment.

Conference Call

The Company will host a conference call at 8:30 a.m. EST (5:30 a.m. PDT), November 8, 2018. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID #4651574. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Thursday, November 8, until midnight November 15, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10125751.

Marker Therapeutics to Present at Three Upcoming Healthcare Conferences

On November 8, 2018 Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company, reported that its President and CEO, Peter L. Hoang, will participate in three upcoming healthcare conferences. Mr. Hoang will participate in a panel discussion titled "Drug Pricing and Development Challenges" at the CEO Life Sciences and Pharmaceuticals Symposium on November 13, 2018 in New York City, and will give corporate overviews at the Piper Jaffray 30th Annual Healthcare Conference on November 27, 2018 in New York City and at the Evercore ISI HealthconX Conference on November 28, 2018 in Boston (Press release, Marker Therapeutics, NOV 8, 2018, View Source [SID1234530974]).

November Conferences
November Conferences
CEO Life Sciences and Pharmaceuticals Symposium
Title: Drug Pricing and Development Challenges
Date: Tuesday, November 13, 2018
Time: 5:00pm – 6:30pm (EST)
Location: Yellow Room, 107 East 16th Street, New York City

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00pm – 12:25pm (EST)
Location: Lotte New York Palace, Holmes 1, 4th Floor

Evercore ISI HealthconX Conference
Date: Wednesday, November 28, 2018
Time: 10:35am – 10:55am (EST)
Location: Boston Harbor Hotel, South Atlantic Room, 2nd Floor

Webcasts for the Piper Jaffray and Evercore ISI conferences will be made available at View Source