Stockwinners Market Radar for April 14, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:50 EDT Markel issues statement on Markel CATCo - Markel previously reported that the U.S. Department of Justice, U.S. Securities and Exchange Commission and Bermuda Monetary Authority are conducting inquiries into loss reserves recorded in late 2017 and early 2018 at Markel CATCo Investment Management and its subsidiaries. These inquiries are limited to CATCo and do not involve the company or its other subsidiaries. As the Company previously disclosed, it retained outside counsel to conduct an internal review of CATCo's loss reserving in late 2017 and early 2018. The internal review has recently been completed. The internal review conducted by outside counsel found no evidence that CATCo personnel acted in bad faith in exercising business judgment in the setting of reserves and making related disclosures during late 2017 and early 2018. The company's outside counsel has met with the Governmental Authorities and reported the findings from the internal review. The Governmental Authorities' inquiries are ongoing and the company said it continues to fully cooperate with them, adding that it cannot currently predict the duration, scope or result of the Governmental Authorities' inquiries.

16:38 EDT State Street appoints Francisco Aristeguieta to lead international business - State Street (STT) announced that it has appointed Francisco Aristeguieta to chief executive officer for its international business. Aristeguieta, who joins the company in July, will report to State Street president and CEO, Ron O'Hanley and become a member of the company's Management Committee, its senior-most strategy and policy making group. Aristeguieta, age 53, joins State Street from Citigroup (C) where he most recently served as CEO of its Asia business.

16:17 EDT Publicis to acquire Epsilon for $4.40B in cash - Publicis (PUBGY) announced it has entered into an agreement with Alliance Data Systems (ADS) under which Publicis will acquire Alliance Data's Epsilon business for a net purchase price of $3.95B after tax step-up - total cash consideration of $4.40B - and build a strategic partnership with Alliance Data remaining business. The Directoire, or Management Board, and the Conseil de Surveillance, or Supervisory Board, of Publicis have unanimously approved this transaction. Arthur Sadoun, Chairman and CEO of Publicis, said that, "Our clients are facing increasing pressure from the rise in consumer expectations, the mainstreaming of direct-to-consumer brands and new data regulations. The only response is to deliver personalized experiences at scale. They have to transform to meet this new market imperative." Edward Heffernan, Alliance Data Systems' President and CEO, added that, "I'm pleased to say today's announcement represents a trifecta win for Alliance Data, Epsilon and Publicis Groupe. The announcement of this transaction represents theculmination of an extensive assessment of strategic options for our Epsilon business. With this transaction, we have found what we believe to be the right home for Epsilon's technology, data assets and associates. Publicis Groupe will be the ideal cultural and strategic fit for Epsilon and its Conversant business, and will help drive Publicis Groupe's own transformation in today's data-driven digital world. Furthermore, the unique relationships that have been cultivated between Epsilon and our other Alliance Data businesses will remain intact, and we look forward to working with Publicis Groupe to develop an even broader relationship promoting mutual and sustainable growth going forward." Under the terms of the agreed transaction, Publicis will acquire Epsilon for a cash consideration of $4.40B, representing a net purchase price of $3.95B after deducting the benefit of acquisition-related tax step-up. This implies an 8.2-times multiple, based on a 2018 Adjusted EBITDAof $485M. According to Publicis, the transaction will be double digit accretive to its headline EPS and free Cash Flow per share from year one. Publicis also said that it "remains committed" to its 45% dividend payout ratio and will put on hold its share repurchase program in the context of this acquisition. The transaction remains subject to customary approvals and is expected to close in Q3 2019.

15:56 EDT Alliance Data sells Epsilon business to Publicis for $4.4B in cash - Alliance Data Systems (ADS) announced it has entered into a definitive agreement to sell its Epsilon business to Publicis Groupe (PUBGY) for $4.4B in cash, representing an approximate 10 times trailing 12-month EBITDA multiple. The transaction was unanimously approved by Alliance Data's board and is expected to close in early Q3, subject to satisfaction of customary closing conditions and receipt of regulatory approvals. Net cash proceeds, after tax obligations and fees associated with the transaction, are expected to be $3.5B. Alliance Data expects to use the full amount to repurchase shares and pay down corporate debt. On a full-year run-rate basis, the transaction will be accretive to core earnings guidance of $22 and "highly accretive" on a GAAP basis, the company said in a statement. Ed Heffernan, CEO of Alliance Data, said, "The announcement of this transaction represents the culmination of an extensive assessment of strategic options for our Epsilon business. With this transaction, Alliance Data is executing on its previously announced goals of transitioning into a leaner, more focused organization and unlocking additional shareholder value while also finding what we believe to be the right home for Epsilon's technology, data assets and associates. We believe that Publicis Groupe will be the ideal cultural and strategic fit for Epsilon and its Conversant business, and will help drive Publicis Groupe's own transformation in today's data-driven digital world."

12:55 EDT Assembly Biosciences presents interim data from two Phase 2a ABI-H0731 trials - Assembly Biosciences presented interim results from two Phase 2a clinical trials of ABI-H0731, a novel antiviral in development for the treatment of chronic HBV infection. The data were presented during a late-breaker oral session at The International Liver Congress, the Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria. The oral presentation reviewed interim analyses from two ongoing double-blind, placebo-controlled Phase 2a studies of 731 in HBV subjects evaluating the potential benefit of combination with standard of care Nuc therapy. The studies explore the first two critical steps thought to be necessary for a direct acting antiviral therapy to achieve higher cure rates, including the ability to eliminate residual viremia and prevent new viral replication, and the prevention of new cccDNA generation. Interim analyses suggest faster and deeper declines in HBV DNA and HBV RNA are possible with combination therapy. The ABI-H0731-201 study enrolled 47 HBeAg positive and 26 negative subjects whose viral load was already suppressed on active Nuc therapy and the ABI-H0731-202 study enrolled 25 treatment naive HBeAg positive subjects. The primary efficacy endpoints are the log10 reduction in HBeAg or HBsAg at week 24 and the log10 reduction in HBV DNA at weeks 12 and 24. While 89 subjects have reached the 12 week interim endpoint across the two studies, few subjects on combination therapy have reached the 24 week endpoint. In Study 201, the interim analysis includes 65/73 subjects that have completed the week 12 assessments and 11 that have completed week 24. All subjects receiving 731 in combination with a Nuc had significant reductions in HBV RNA levels compared to the group receiving Nuc + placebo. Approximately 60% of subjects on combination therapy with quantifiable RNA at entry demonstrated RNA decline by week 16 compared to 0% on Nuc monotherapy. Additionally, DNA viremia was persistently detectable at the LOQ in all subjects on Nuc monotherapy, while several subjects on combination therapy showed a further reduction in HBV DNA to below the limits of a highly sensitive PCR assay. Reduction of residual viral replication may be a critical milestone for cure and does not occur on Nuc monotherapy. In Study 202, 24 treatment-naive subjects have completed week 12 assessments, and 12 have completed week 24. The combination of 731 + entecavir reduced both HBV DNA and HBV RNA significantly faster and deeper compared to ETV monotherapy as early as week 2. More subjects with liver inflammation at baseline experienced improvement on combination therapy. Blinded, pooled results across both studies indicate favorable safety and tolerability for 731 when combined with SOC Nuc therapy. Adverse events were mild, infrequent, and evaluated as generally unrelated to treatment. There were no treatment related discontinuations, no serious adverse events and no clinical AEs greater than Grade 2 observed. Lab abnormalities were mostly Grade 1, transient, and not thought to be related to drug. To date, across all clinical studies,731 has been dosed in over 150 subjects and has exhibited a favorable safety profile. Both studies are ongoing, with subjects receiving treatment through 24 weeks, and Assembly expects to report final data later in 2019. At the conclusion of 24 weeks of treatment, all subjects from both studies will have the opportunity to roll over to an open label combination extended treatment study for up to an additional year. The data generated over the course of these studies will help to inform timelines and Assembly's registration strategies for its core inhibitors.

12:46 EDT Merck presents results from Phase 3 trial evaluating ZERBAXA - Merck announced the first presentation of results from ASPECT-NP, a randomized, double-blind, multi-center Phase 3 clinical trial evaluating the efficacy and safety of ZERBAXA for the treatment of adult patients with ventilated nosocomial pneumonia. The results demonstrated non-inferiority of an investigational dose of ZERBAXA to meropenem, the active comparator, in the primary and key secondary endpoints. Based on these results, Merck has submitted supplemental new drug applications to the U.S. Food and Drug Administration and European Medicines Agency seeking regulatory approval for ZERBAXA for this potential new indication. The FDA Prescription Drug User Fee Act date is June 3, 2019. ASPECT-NP is a prospective, randomized, double-blind, multicenter, non-inferiority, Phase 3 clinical trial to evaluate the safety and efficacy of ZERBAXA compared to meropenem in ventilated patients diagnosed with nosocomial pneumonia, including hospital-acquired and ventilator-associated bacterial pneumonia. In the study, 726 patients were randomized 1:1 to receive an investigational 3g dose of ZERBAXA or meropenem 1g dose, administered intravenously every eight hours for eight to 14 days. Meropenem is an approved broad-spectrum injectable antibiotic widely used to treat serious infections. The primary and key secondary endpoints are Day 28 all-cause mortality and Clinical Response at test-of-cure in the intent-to-treat population. ZERBAXA was non-inferior to meropenem for the primary endpoint of 28-day all-cause mortality in the ITT population, 24.0% and 25.3% respectively, for a weighted proportion difference of 1.1%. In addition, ZERBAXA was non-inferior to meropenem in the key secondary endpoint, clinical cure at Test-of-Cure in the ITT population, 54.4% and 53.3% respectively, for a weighted proportion difference of 1.1%. Additionally, an analysis of efficacy outcomes by causative pathogens showed that clinical and microbiologic response rates for ZERBAXA were comparable to meropenem for Gram-negative respiratory tract pathogens, including Pseudomonas aeruginosa and Enterobacteriaceae. In the microbiologically evaluable population in patients with a Gram-negative pathogen at baseline clinical cure rates were 75.2% and 66.7% and microbiologic response rates were 69.9% and 62.4% for ZERBAXA and meropenem respectively. Results were consistent in the microbiologic intention-to-treat population with clinical cure rates of 73% and 67.9% for ZERBAXA and meropenem respectively. Treatment-emergent adverse events were reported in 85.9% of ZERBAXA versus 83.3% of meropenem treated patients. The incidence of treatment-related AEs was 10.5% in the ZERBAXA group and 7.5% in the meropenem group. The most commonly reported AEs with ZERBAXA were abnormal liver function tests, Clostridium difficile colitis and diarrhea. Comparable rates of AEs were reported for ZERBAXA and meropenem in critically ill patients, and approximately 1% of patients had treatment-related AEs leading to discontinuation of therapy.

12:35 EDT Goldcorp, Newmont announce receipt of investment Canada Act approval - Goldcorp (GG) announced that Newmont Mining (NEM) has received Investment Canada Act approval in connection with the previously-announced plan of arrangement, whereby Newmont will acquire all outstanding common shares of Goldcorp. The arrangement has previously received shareholder approval and clearance under the Competition Act. No further regulatory or shareholder approvals are required in connection with the Arrangement. Newmont and Goldcorp expect the transaction to close on April 18, 2019, subject the satisfaction of customary closing conditions. Immediately upon the closing of this transaction, the combined entity will be called Newmont Goldcorp, and is expected to target 6M-7M ounces of steady-state gold production over a decades-long time horizon, and begin delivering a combined $365M in expected annual pre-tax synergies, supply chain efficiencies and Full Potential improvements representing $4.4B in Net Present Value.