7:48 am Helix Energy provides FY17 guidance in slide presentation (see 4:03 for earnings) (HLX) :
- Co issues downside guidance for FY17 (Dec), sees FY17 (Dec) revs of ~$570 mln vs. $576.94 mln Capital IQ Consensus Estimate.
- Co sees FY17 EBITDA of approx $105-125 mln vs $90 mln last year.
- CO sees FY17 CapEx of approx $210 mln vs $189 mln last year
7:46 am On The Wires (:WIRES) :
- Cancer Genetics (CGIX) announced today the successful CLIA validation and approval of its immuno-oncology assay on Complete::IO.
- ATyr Pharma (LIFE) obtained promising clinical results from its Phase 1b/2 003 trial assessing the safety and potential activity of Resolari in patients with early onset facioscapulohumeral muscular dystrophy.
- 63% of Patients Observed Increased Muscle Strength
- 67% of patients measured had improvement in their Individualized Neuromuscular Quality of Life score
- Akers Biosciences (AKER) Akers Wellness app, which enables users to track the results of breath-based tests via their mobile device has been approved by the Apple App Store and is now available for download on iOS devices.
- Global Payments (GPN) agreed to renew its relationship with Caesars Entertainment Corporation (CZR). Terms not disclosed.
7:37 am Kimberly-Clark misses by $0.02, reports revs in-line; reaffirms FY17 EPS guidance (KMB) :
- Reports Q1 (Mar) earnings of $1.53 per share, excluding non-recurring items, $0.02 worse than the Capital IQ Consensus of $1.55; revenues rose 0.2% year/year to $4.48 bln vs the $4.5 bln Capital IQ Consensus. Changes in foreign currency exchange rates increased sales by 1%, while organic sales decreased 1%. Net selling prices fell more than 1%, while volumes rose ~1%.
- Organic sales were down 3% in North American consumer products, reflecting category softness, competitive activity and less promotion shipments. Organic sales increased 4% in developing and emerging markets. Results were impacted by lower net selling prices, along with $35 million of higher input costs, driven by increases in raw materials (other than pulp), energy and distribution costs.
- Co issues guidance for FY17, sees EPS of $6.20-6.35, excluding non-recurring items, vs. $6.32 Capital IQ Consensus Estimate; sees FY17 revs +1-2% (from similar to prior year) to ~$18.38-18.57 bln vs. $18.39 bln Capital IQ Consensus Estimate. Foreign currency translation effects on sales and operating profit neutral overall compared to previous estimate of negative 2%. Organic sales growth 1 to 2% (prior assumption ~2%), driven by higher volumes. Net selling prices and product mix expected to be similar, or down slightly, year-on-year (prior assumption similar, or up slightly). Input cost inflation $150 to $250 million compared to previous estimate of $50 to $200 million. The update reflects modestly higher assumptions on average for several raw materials, including pulp, recycled fiber and polypropylene resin.
7:33 am City Holding Co beats by $0.18; increases quarterly dividend to $0.44/share from $0.43/share (CHCO) :
- Reports Q1 (Mar) earnings of $1.04 per share, $0.18 better than the single analyst estimate of $0.86.
- Net interest income increased $1.9 million from the quarter ended March 31, 2016 (excluding accretion from fair value adjustments).
- Total loan growth of $27.9 million (3.7% annualized) from December 31, 2016 to March 31, 2017.
- Dividend: Increased quarterly dividend from $0.43/share to $0.44/share.
7:32 am Biogen presents Phase 3 end of study SPINRAZA, which demonstrated a highly statistically significant and clinically meaningful improvement in motor function in children with later-onset SMA (BIIB) :
In the CHERISH end of study analysis, children on SPINRAZA demonstrated meaningful improvement in motor function, as observed by the treatment difference of 4.9 points in the mean change from baseline to Month 15 in the Hammersmith Functional Motor Scale Expanded score (p=0.0000001).
- Co will also present new interim data from the Phase 2, multicenter, open-label, single-arm NURTURE study evaluating SPINRAZA for the treatment of infants under six weeks old with genetically diagnosed SMA who were presymptomatic at treatment initiation.
7:31 am Arrowhead presents data from a Phase 1a/1b study of ARC-AAT at The International Liver Congress; 'data demonstrated that an RNAi therapeutic can achieve deep durable, and dose dependent reductions of alpha-1 antitrypsin ' (ARWR) :
- The data demonstrated that an RNA interference ("RNAi") therapeutic can achieve deep durable, and dose dependent reductions of alpha-1 antitrypsin ("AAT"), with the highest dose studied in healthy volunteers achieving near full suppression of the liver production of the AAT protein.
- In addition, at doses of 2 and 4 mg/kg in AATD patients, ARC-AAT produced similar levels of knockdown as seen in healthy volunteers. These data support the continued advancement of ARO-AAT, Arrowhead's follow-on product candidate that utilizes the company's next generation, proprietary subcutaneously administered delivery vehicle.
7:30 am Rex Energy announces Q1 production and estimated pricing and provided an operational update; realizes natural gas prices improved 42% Q/Q, before hedging (REXX) :
Co's 1Q17 production was 173.4 MMcfe/d, consisting of 110.1 MMcf/d of natural gas, 9.7 Mboe/d of NGLs (including 5.0 Mboe/d of ethane) and 0.8 Mboe/d of condensate.
- Condensate and NGLs (including ethane) accounted for 36% of production during the quarter. C3+ NGL prices, before the effects of hedging, average ~59% of WTI oil prices.
- The improvement in C3+ NGL prices was largely due to continued improvement in Mont Belvieu prices and improved differentials for C3+ NGLs in the northeast.
- The company continues to expect full-year 2017 realized C3+ NGL prices to average ~50% - 55% of WTI.
7:30 am Biogen presents data on TECFIDERA and TYSABRI at the AAN annual meeting (BIIB) :
- These results show that TECFIDERA significantly reduced the risk of relapse by 30 percent compared to teriflunomide (hazard ratio [HR]: 1.302; p<0.01) in newly diagnosed patients and those previously treated with a prior DMT, and had comparable efficacy to fingolimod (HR: 0.995; p=0.94). These data are consistent with other comparative effectiveness data showing similar results to oral therapies and greater efficacy to interferon beta and glatiramer acetate.
- Results show that, over three years, the likelihood of disability improvement was significantly greater for patients treated with TYSABRI within one year of MS symptom onset (49.3%), than for those treated between one to five years (38.1%) or more than five years (26.3%) following symptom onset. TYSABRI treatment also significantly reduced ARR compared with baseline in all three cohorts. Additional TOP data presented at the meeting show patients who continued TYSABRI treatment experienced better clinical outcomes than those who switched to another therapy.
7:25 am European Markets Update: FTSE +1.8%, DAX +3.0%, CAC +4.6% (:SUMRX) :
Major European indices trade sharply higher in response to yesterday's vote in France, which has been deemed as favorable to the market. Centrist Emmanuel Macron (23.8%) received the most votes yesterday and will now take part in a run-off on May 7 against Marine Le Pen (21.5%). Investors have cheered yesterday's outcome, but it is worth noting that the strong support behind Ms. Le Pen suggests that parliamentary elections in June will result in National Front becoming the country's opposition party. The euro has jumped 1.2% against the dollar to 1.0860.
- In economic data:
- Germany's April Ifo Business Climate 112.9 (expected 112.5; last 112.4). April Current Assessment 121.1 (expected 119.2; last 119.5) and April Business Expectations 105.2 (expected 106.0; last 105.7)
- UK's April CBI Industrial Trends Orders 4 (expected 5; last 8)
- UK's FTSE has jumped 1.8% with financials leading the way. Barclays, Standard Chartered, Old Mutual, RSA Insurance, Prudential, Lloyds Banking, RBS, and HSBC are up between 1.9% and 5.0%. Select miners like BHP Billiton, Antofagasta, Glencore, and Rio Tinto hold gains between 2.3% and 3.0%.
- Germany's DAX has spiked 3.0% to a fresh record high. Commerzbank leads with a gain of 9.6% while Deutsche Bank has surged 7.8%. Heavyweights like Siemens, BASF, BMW, Bayer, Volkswagen, and Daimler have rallied between 2.6% and 4.9%.
- France's CAC has soared 4.6% to levels not seen since early 2008. Bank stocks like Societe Generale, Credit Agricole, and BNP Paribas are all up between 8.0% and 9.8%. Peugeot and Renault hold respective gains of 6.6% and 5.4% while LafargeHolcim is the lone decliner, sliding 1.1%.
7:16 am Akari Therapeutics presents positive response with coversin in ongoing phase 2 pnh trial and in additional clinical targets; interim Phase 2 PNH data demonstrate positive response with Coversin (AKTX) :
- In this 90 day, open labelPhase 2 trial conducted at five centers in the EU, five patients with PNH who had not received prior anti-complement therapy were enrolled and treated with Coversin self-administered subcutaneous injections twice a day for approximately the first month and then switched to once daily injections.
- The primary endpoint in this trial is reduction in serum LDH to =1.8 X ULN or 500 I U/L whichever is the lower from day 1 (pre-dose) to day 28.
- Secondary endpoints are LDH at days 60 and 90, hemoglobin, CH50, quality of life, and transfusion independence. The objectives of the Phase 2 study are to validate the safety and efficacy of Coversin, confirm convenience of our dosing regimen, and study dose ranging to identify the correct treatment dose in advance of Phase 3.
- Akari will present new data on its clinical development plan for Coversin based on its dual C5/LTB4 inhibition, focusing on new clinical indications in the eye and skin.
- Results in a rodent model of Experimental Immune Conjunctivitis, undertaken at the world leading Moorfields Hospital Institute of Ophthalmology, showed that Coversin demonstrated significant anti-inflammatory activity with both C5 and LTB4 inhibition believed to play a role. In this preclinical model of severe eye surface inflammation, Coversin, applied topically, resulted in a statistically significant reduction (64%, p<0.001) in late phase inflammation versus placebo.
- Akari will present an update on its pipeline of new molecules including:
- New data in an ex vivo model testing activity in the alternative pathway of Complement of its long acting version of Coversin, PAS Coversin, which is designed for weekly dosing, demonstrated that PAS Coversin could potentially be more potent than Coversin and eculizumab . This data will be presented by Professor Arne Skerra, Professor of Biological Chemistry at the University of Munich and Chairman of XL-protein GmbH. Akari anticipates a Phase 1 trial for PAS Coversin to commence in 3Q2018.
- positive data in a range of ex vivo lung models using a new Akari molecule that binds only to LTB4. This opens up a range of new inflammatory target conditions for Akari where LTB4 dysregulation is potentially the primary pathophysiology of disease. This data will be presented by Dr Robert Snelgrove, National Heart and Lung Institute, Imperial College London whose particular expertise lies in LTB4 and lung inflammation.
- Akari anticipates further preclinical pipeline data in 3Q2017.
- Company to webcast today's Research and Development Day at 8:00am ET.
7:11 am On The Wires (:WIRES) :
- CUI Global's (CUI) subsidiary, Orbital Gas Systems, has received notification that, effective April 13, 2017, the Gas and Electrical Market Authority, had formally relaxed the accuracy requirement of Ofgem-approved CVDDs to 0.2 MJ/m3 (approximately 0.5%).
- Paratek Pharmaceuticals (PRTK) announced that it has entered into a collaboration with Zai Lab, to support the development and commercialization of omadacycline for patients in China. Under the agreement, Paratek has granted to Zai Lab an exclusive license to develop, manufacture and commercialize omadacycline for the greater China territory. The companies will establish a joint steering committee to review and oversee all plans. Paratek will receive a $7.5 mln upfront payment in connection with the signing of the agreement and is eligible for additional milestone payments related to development, regulatory, and commercial milestones. In addition, Paratek will be eligible to receive royalty payments on sales of omadacycline in the territory.
- Energy Recovery (ERII) to receive total awards of roughly $3 mln to supply its Pressure Exchanger technology to retrofit several desalination plants in Europe. The orders are expected to ship in the in the second half of 2017.
- Redhill Biopharma (RDHL) announces enrollment of the last patient in the Phase II study with Bekinda (RHB-102)1 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome.
- Top-line results are expected in the third 3Q17.
- RedHill will host an R&D Day and live webcast on Bekinda on Thursday, April 27, 2017
7:11 am Fred's announces cooperation agreement w/ shareholder Alden Global and 2 new Board appointments (FRED) :
Co has appointed Steven B. Rossi, CEO of Digital First Media, and Timothy A. Barton, former CEO of Freightquote.com to its Board of Directors, effective immediately.
- Rossi and Barton have been added to the Fred's Pharmacy Board in connection with a Cooperation Agreement between Alden Global Capital, the Company's largest shareholder, and Fred's Pharmacy.
- The Cooperation Agreement contains terms regarding the parties working together for the long-term success of Fred's Pharmacy.
- Under the terms of the Cooperation Agreement, Alden is subject to certain customary standstill and other provisions.
- Alden's President states, "I have great confidence in the future of the business. With the right focus, Fred's can generate significant free cash flow per share at the existing business; the pending Rite Aid (RAD) transaction will provide extraordinary growth to Fred's business and free cash flow."
7:10 am Paratek Pharma has granted to Zai Lab an exclusive license to develop, manufacture and commercialize omadacycline for the greater China territory; co will receive $7.5 mln upfront payment (PRTK) :
Under the agreement, Paratek has granted to Zai Lab an exclusive license to develop, manufacture and commercialize omadacycline for the greater China territory, specifically the People's Republic of China, Hong Kong, Macau, and Taiwan markets.
- The companies will establish a joint steering committee to review and oversee all development, manufacturing, and commercialization plans.
- Paratek will receive a $7.5 million upfront payment in connection with the signing of the agreement and is eligible for additional milestone payments related to development, regulatory, and commercial milestones.
- In addition, Paratek will be eligible to receive royalty payments on sales of omadacycline in the territory.
7:06 am DHT takes delivery of two very large crude carriers (DHT) : Co announces that it has today taken delivery of the DHT Opal (formerly BW Opal) and the DHT Raven (formerly BW Lion), the second and third of the VLCCs acquired from BW Group Limited. The remaining six vessels in the water are expected to be delivered during the second quarter 2017.
7:05 am Fluor receives offshore contract from BP (FLR) :
- Co announced that it was selected by BP Trinidad and Tobago (BP) to perform the front-end engineering and design (:FEED) for the Cassia Compression Project off the east coast of Trinidad and Tobago. Fluor booked the undisclosed contract value into backlog in the first quarter of 2017
- Fluor's scope includes the design of a new offshore gas compression platform, new connecting bridge and modifications to the existing Cassia hub. The platform will compress gas produced from the existing Cassia platforms
7:04 am Paratek Pharma presents data from its Phase 3 study of omadacycline in acute skin infections found that once-daily treatment with IV-to-oral omadacycline is effective in treating the most frequently isolated bacterial pathogens associated with skin infections, including MRSA (PRTK) : Paratek also presented full clinical efficacy, safety and tolerability results from the study, which is known as OASIS (Omadacycline Acute Skin and Skin Structure Infections Study). The full results demonstrate the efficacy and safety of omadacycline compared to linezolid in acute bacterial skin and skin structure infections (:ABSSSI).
7:04 am Opus Bank misses by $0.06 (OPB) :
- Reports Q1 (Mar) earnings of $0.24 per share, excluding $0.03 net in expenses, $0.06 worse than the two analyst estimate of $0.30. Net interest margin decreased 22 basis points to 3.14% in the first quarter of 2017 from 3.36% in the fourth quarter of 2016. The linked-quarter change was primarily due to lower contribution from originated loans primarily as a result of the Freddie Mac multifamily loan transaction, as well as liquidity from loan payoffs and deposit growth that was invested in interest-earning cash and investment securities.
7:03 am Cara Therapeutics announces results from its Phase 1 safety trial showing that I.V. CR845 did not significantly differ from placebo across three quantitative measures of respiratory drive in healthy individuals (CARA) :
"We are very pleased that I.V. CR845 demonstrated no significant alteration in any measure of respiratory drive, even at doses five-fold greater than the projected therapeutic dose," said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. "These data further underscore the overall clinical safety profile of CR845 for use in postoperative pain management and continue to differentiate it from traditional mu opioids."
- The Phase 1 trial was a randomized, double-blind, placebo-controlled, three-way crossover trial of two doses of I.V. CR845 (1.0 ug/kg, and 5.0 ug/kg) versus placebo on three measures of respiratory drive in 15 healthy volunteers.
- Each subject was randomized to one of three treatment sequences and was administered I.V. bolus placebo, CR845 (1.0 ug/kg) and CR845 (5.0 ug/kg) on sequential 24-hour periods, with CR845 at 5.0 ug/kg representing a projected five-fold supra-therapeutic dose. After each administration, and continuing through four hours post-dosing, end-tidal CO2 (ETCO2), oxygen saturation (SpO2) and respiratory rate were continuously monitored.
- The primary safety endpoints were: a >10 mmHg sustained (>30 seconds duration) increase in ETCO2 above baseline or to >50 mmHg, and a sustained reduction in SpO2 to <92 percent.
7:02 am Matinas BioPharma will present 'positive' data at the ECCMID on 22-25 (MTNB) :
This preclinical study evaluated the oral or intramuscular injection administration of encochleated formulations of plasmid pCMV HIV-1 containing 3.5g or 17g of DNA, given to BALB/c mice.
- Investigators observed that oral administration of two 3.5g or 17g doses yielded strong splenocyte cytolytic responses (73 to 85% specific lysis at an E:T ratio of 100:1) analogous to intramuscular injection.
- Oral administration of a higher dose (50g) of naked DNA, was inactive. Low doses (3.5g) of orally administered encochleated DNA induced antigen specific splenocyte proliferation 8-11 fold above background, similar to intramuscular.
- Naked plasmid was negative.
- In an additional preclinical study, mice were immunized intramuscularly with HSV-2 gD2 DNA, 25g/dose, (pc DNA 3.1 vector backbone) and two IL12 plasmids (equal mixture of the p35 and p40 subunits), 35g/dose.
- From this study, investigators observed that the encochleation of gD and IL-12 plasmids induced 2X greater HSV-specific cytolytic T cell responses than Herpes infection, as well as enhancement of T helper 1 cellular responses and antibody.
- These studies affirmed that co-administration of cytokines can enhance the immunogenicity of a DNA-based vaccine.
7:02 am Uniti Group announces the planned offering of approx. $200 million aggregate principal amount of 7.125% senior notes due 2024 (UNIT) : The Issuers intend to use the net proceeds from this offering to fund a portion of the cash consideration payable in connection with their previously announced acquisition of Southern Light, LLC. Closing of the Southern Light acquisition will occur after the closing of this offering and is subject to various closing conditions.
7:02 am PDL BioPharma announces settlement agreement of $19.5 mln with subsidiaries of Merck (PDLI) :
Co announced that it entered into a settlement agreement with certain subsidiaries of Merck & Co.(MRK) to resolve the patent infringement lawsuit between the parties pending in the U.S. District Court for the District of New Jersey related to Merck's Keytruda humanized antibody product.
- Under the terms of the agreement, Merck will pay the Company a one time, lump-sum payment of $19.5 mln, and the Company will grant Merck a fully paid-up, royalty free, non-exclusive license to certain of the Company's Queen et al. patent rights for use in connection with Keytruda as well as a covenant not to sue Merck for any royalties regarding Keytruda.
- In addition, the parties agreed to dismiss all claims in the relevant legal proceedings.
7:01 am XOMA announces positive results from its Phase 2 proof-of-concept study of Prolactin Inhibition; 'X213 shown to be safe and effective, demonstrating complete suppression of lactation in study participants' (XOMA) :
"This proof-of-concept study was an important milestone in demonstrating the potential efficacy of this novel antibody. We believe that X213 could be a treatment option for a wide range of patients with hyperprolactinemia including prolactinoma and anti-psychotic induced HPRL as the signs and symptoms are similar irrespective of the etiology," said Jim Neal, Chief Executive Officer of XOMA. "Consistent with our business strategy, we intend to maximize the value of X213 for shareholders by seeking a license partner for the program."
- The results of the study indicate that X213, when given as a single 700mg intravenous infusion during the first day post-partum, was effective in suppressing milk secretion, as well as breast engorgement and pain in 100 percent of the treated women.
- In addition, none of the treated women experienced rebound breast symptomatology during the 21-day study period. While the study was not intended, or powered to show statistical significance, it demonstrated that X213 was: safe and well tolerated; caused no significant adverse events (SAEs); showed favorable pharmacokinetics with a terminal half-life of two weeks and; demonstrated target (prolactin receptor) engagement and mechanism of action confirmation by serum prolactin profiling.
7:01 am Albany Molecular: Denovo Biopharma announces that it has obtained an exclusive license to liafensine from AMRI (AMRI) :
Denovo Biopharma announced that it has obtained an exclusive license to liafensine (DB104), a serotonin-norepinephrine-dopamine reuptake inhibitor (:SNDRI), a late-stage CNS drug, from AMRI.
- The agreement between Denovo Biopharma and AMRI concludes AMRI's divesture of all its legacy intellectual property assets.
- Under the terms of the definitive agreement, Denovo Biopharma gains an exclusive license to all rights to develop, manufacture and commercialize liafensine globally. Liafensine represents the third late stage product in Denovo Biopharma's pipeline.
7:00 am Amedica granted marketing clearance for its Valeo interbody fusion devices in Australia (AMDA) :
6:58 am Global markets rally as centrist candidate Macron wins first round of French election (SPY) :
U.S. equity futures are higher by more than 1% this morning as global markets rally on the heels of the first round of France's Presidential election, which was won by centrist Emmanuel Macron.
Macron's victory in the first round of the French election has eased some market concern about the probability of more radical candidates being elected, and potential implications around France's membership in the EU. One of those more radical candidates, Marine Le Pen (far right), will oppose Macron in the runoff round, but polls are suggesting Macron has a 20 point lead. That final runoff round of the election will take place on May 7.
A presidential win for Macron would take the "Frexit" and EU disintegration idea off the table, so the more likely probability of that outcome is having a positive effect on risk assets globally.
The French results have had a positive effect on the euro, which is up 1.2% against the dollar (+0.0128 at $1.0852/euro). French equities are sharply higher, with France's CAC index +4.5%, and French bond yields have come down as concerns about the fate of the EU ease a bit.
The rest of Europe is gaining with France, with Germany's DAX +3.0% and the UK's FTSE is +1.9%. Japan's Nikkei is +1.4%.
Several related ETFs are moving, with French ETF (EWQ) and the German ETF (EWG) both gapping up in early trade. Other related ETFs include Vanguard FTSE Europe (VGK), iShares Europe (IEV), iShares MSCI Eurozone (EZU), SPDR Euro STOXX 50 ETF (FEZ) and the Currencyshares Euro trust (FXE).
6:57 am Asian Markets Close: Nikkei +1.4%, Hang Seng +0.4%, Shanghai -1.4% (:SUMRX) :
Equity indices in the Asia-Pacific region began the trading week on a mostly higher note. Results from the French presidential election saw Emmanuel Macron receive 23.8% of the vote, meaning he is headed for a May 7 run-off against Marine Le Pen, who secured 21.5% of yesterday's vote. Elsewhere, People's Bank of China Governor Zhou Xiaochuan said that China's 2017 GDP target of 6.5% is within reach.
- In economic data:
- Japan's Leading Index 104.8 (expected 104.4; last 104.4)
- Singapore's March CPI +0.7% year-over-year, as expected (last 0.7%) and Q1 Unemployment Rate held at 2.2%
- Japan's Nikkei gained 1.4%. Sony jumped 3.8% after boosting its guidance while Panasonic rallied 3.3%. Consumer names like Fast Retailing, Kikkoman, Rakuten, J Front Retailing, and Familymart added between 1.9% and 3.7%.
- Hong Kong's Hang Seng added 0.4%. Financials had a good showing with Hang Seng Bank, China Life Insurance, Ping An Insurance, HSBC Holdings, BoC Hong Kong, and ICBC rose between 0.8% and 1.7%. On the downside, Galaxy Entertainment lost 1.9% and Sands China fell 1.5%.
- China's Shanghai Composite lost 1.4%. Henan Oriental Silver Star Investment, Xinjiang Urban Construction, Xiamen Overseas Chinese Electronic, Zhonghang Heibao, and Furen Pharmaceutical all lost near the limit, 10.0%.
- India's Sensex advanced 1.0%. GAIL jumped 3.2% while financials like AXIS Bank, HDFC Bank, and SBI gained between 1.2% and 2.6%. ICICI Bank bucked the trend, shedding 0.2%.
- USDJPY +1.0% to 110.15
- USDCNY UNCH at 6.8849
- USDINR -0.3% to 64.441
6:53 am Halliburton beats by $0.01, reports revs in-line (HAL) :
- Reports Q1 (Mar) earnings of $0.04 per share, excluding non-recurring items, $0.01 better than the Capital IQ Consensus of $0.03; revenues rose 1.9% year/year to $4.28 bln vs the $4.3 bln Capital IQ Consensus.
- "Our total company revenue was $4.3 billion, a 6% improvement sequentially, while operating income was $203 million for the quarter. North America activity increased rapidly during the first quarter, which was highlighted by our U.S. land revenue growth of nearly 30%, outperforming the sequential average U.S. land rig count growth of 27%. In the international markets, activity declines due to seasonality were exacerbated by the current cyclical headwinds," said Dave Lesar, CEO. "First quarter revenue in North America increased 24% sequentially, significantly outperforming our largest peer. This result was primarily driven by increased activity in our pressure pumping and well construction product service lines. The first quarter is best described as one of change, but I love the opportunity that is developing in North America because our strategy is designed to take advantage of that opportunity," remarked Jeff Miller, President. "Eastern Hemisphere revenue declined by 12% sequentially, due to seasonality, reduced activity and pricing pressure. While we believe that the first quarter represents the bottom in the Eastern Hemisphere rig count, the full year average for 2017 will likely be only marginally higher than the full year average for 2016. "Latin America revenue increased by 8% sequentially. This increase was primarily due to improved activity levels in Brazil and Mexico. Although we are seeing improvement in certain basins, there are a variety of country specific headwinds that must be overcome for a meaningful recovery in this region."
6:52 am Auxilio's subsidiary CynergisTek added 5 new customers under its Compliance Assist Partner Program in 1Q17 (AUXO) :
6:45 am Eli Lilly announces MONARCH 3 trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (LLY) :
Co announces that following a pre-planned interim analysis for MONARCH 3, the trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival.
- Detailed efficacy and safety results will be presented at a medical meeting in the second half of the year.
- Co intends to begin global submissions of these results in the third quarter of 2017.
- Co intends to initiate MONARCH 1 and MONARCH 2 submissions beginning in the 2Q17
6:41 am On The Wires (:WIRES) :
- The European Commission has approved under the EU Merger Regulation the acquisition of Ficosa International, by Panasonic (PCRFY), of Travelopia and Travelopia, by KKR (KKR), and of Capsugel by Lonza (LZAGY)
- LSC Communications (LKSD) has been awarded a five-year Supply Chain Services contract for the print production and warehousing of educational materials for Great Minds. Terms not disclosed.
6:36 am Toshiba announced that it has decided to split off its four in-house companies into wholly-owned subsidiaries (TOSBF) :
- After the company splits, Toshiba Group will further enhance collaboration between the split-off companies, and, at the same time, aim to maximize the value of each business.
- In addition, it will establish an optimized structure for ensuring business continuity in respect of maintaining special construction business licenses required to do business in Japan.
- After executing the splits, Toshiba Corporate will further concentrate on maximizing the Group's value and strengthening its governance system.
- As of July 1, 2017, The Company will split off its in-house company, Infrastructure System & Solutions Company, and merge it into Toshiba Electric Service Corporation, which is responsible for part of the installation work, electrical construction, maintenance and inspection services in the social infrastructure business and holds special construction business licenses.
6:36 am Hasbro beats by $0.16 including employee share-based payments accounting change, beats on revs (HAS) :
- Reports Q1 (Mar) earnings of $0.54 per share, $0.16 better than the Capital IQ Consensus of $0.38; revenues rose 2.2% year/year to $849.7 mln vs the $818.27 mln Capital IQ Consensus, including revenue growth of 2% in the U.S. and Canada segment and 24% in the Entertainment and Licensing segment; International segment revenues were flat; Growth in Franchise Brands, Hasbro Gaming and Emerging Brands offset the expected decline in Partner Brands.
- Reported net earnings include a $0.11 per diluted share benefit versus first quarter 2016 from the adoption of FASB ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting. The first quarter 2017 was a 14-week period versus the first quarter 2016 which was a 13-week period.
- "As anticipated, operating profit in the quarter was negatively impacted by an extra week of expenses without the comparable revenue increase. This decline was more than offset by a favorable foreign exchange impact in non-operating income and the tax benefit from the new accounting standard. Based on our first quarter's performance, our full-year expectations remain in line with our previously stated objectives."
PPG's revised proposal represents:
- An increase of Eur 6.75, or 8%, over our prior proposal on March 22, 2017 and Eur 13.75, or 17%, over PPG's original proposal on March 2, 2017.
- A value for the total outstanding equity of AkzoNobel of approximately Eur 24.6 billion.
- A premium of 50% over the unaffected closing price of AkzoNobel of Eur 64.42 on March 8, 2017.
- A premium of 42% over the unaffected 12-month median broker target price per AkzoNobel share of Eur 68.00.
- A premium of 24% (cum dividend) over the closing price of AkzoNobel of Eur 78.20 on April 21, 2017, including the impact of AkzoNobel's new standalone strategy, and 26% over the calculated ex dividend price as adjusted for the payment of the proposed 2016 final dividend and 2017 enhanced regular and special dividends outlined as part of the new standalone plan.
- PPG believes the long-term value creation from a combination of the two companies will be significant for shareholders of both companies, including the benefits of annual synergies of at least $750 million, which PPG has estimated based on publicly available information.
- PPG believes its revised proposal is vastly superior to AkzoNobel's new standalone plan, as articulated on April 19, 2017. As evidenced by the decline in AkzoNobel's stock price since its investor update, the capital markets have not recognized any additional value from its new standalone plan, including the enhanced regular dividend and special dividend that AkzoNobel has proposed for 2017.
6:30 am TrueCar expects to offer 1,000,000 shares of common stock in the offering and certain existing stockholders of the co are expected to offer 7,500,000 shares in the offering (TRUE) : TrueCar will not receive any proceeds from the sale of the shares by the selling stockholders.
6:28 am Kennedy Wilson to combine w/ Kennedy Wilson Europe Real Estate; to increase Q1 dividend by 12% after the transaction close (KW) :
Under the terms of the transaction, each KWE shareholder will be entitled to receive 0.667 new KW shares for each KWE share held by it.
- Will be accretive to adjusted net income per share immediately following the closing and provides the potential to increase cash flows available for shareholder distribution.
- Co intends to increase its first quarterly dividend by ~12% upon completion of the transaction.
- The transaction is expected to close during 3Q17
- Co will host a conference call for research analysts and investors to discuss the transaction on April 24, 2017 at 1:30 p.m.
6:09 am Shanghai...-43.62 (-1.37%) (FXI) :
6:09 am S&P futures vs fair value: +29.50. Nasdaq futures vs fair value: +57.90. :
6:09 am European Markets : FTSE...7241.09...+126.50...+1.80%. DAX...12392.63...+344.10...+2.90%.
6:09 am Asian Markets : Nikkei...18876...+255.10...+1.40%. Hang Seng...24139.5...+97.50...+0.40%.
6:04 am RLJ Lodging Trust expected to merge w/into FelCor Lodging Trust (FCH); each share of FelCor common stock will be converted into 0.362 shares of newly issued common shares of RLJ common stock (RLJ) :
Under the terms of the Merger Agreement, each share of FelCor common stock will be converted into 0.362 shares of newly issued common shares of RLJ common stock in a taxable merger. FelCor's operating units will be exchanged for limited partnership units in RLJ's operating partnership at a similar exchange ratio of 0.362.
- Following the merger, RLJ's shareholders are expected to own ~71% of the combined co's fully diluted equity, and FelCor's shareholders are expected to own the remaining 29%.
- The merger will be immediately accretive to RLJ's RevPAR with Pro forma 2016 RevPAR increasing 5.4% to $137.
- Expected cash G&A expense savings of ~$12 million and ~$10 million of potential savings from stock-based compensation expense and capitalized cash G&A.
- Once the merger is consummated, the company will retain the RLJ Lodging Trust name and will trade under the ticker symbol "RLJ".
- The transaction is expected to close by the end of 2017.
- Cos will host a joint conference call on April 24, 2017 at 8:00 AM ET
6:02 am Precision Drilling beats by CAD 0.02, reports revs in-line (PDS) :
- Reports Q1 (Mar) loss of CAD $0.08 per share, CAD $0.02 better than the Capital IQ Consensus of (CAD $0.10); revenues rose 14.9% year/year to CAD $346.8 mln vs the CAD $345.06 mln Capital IQ Consensus.
- "Adjusted EBITDA this quarter of $84 million is a decrease of $15 million from the first quarter of 2016. Our adjusted EBITDA as a percentage of revenue was 24% this quarter, compared with 33% in the first quarter of 2016."
5:32 am Pfizer reports Phase III Study suggesting efficacy of Zavicefta (PFE) :
- Co reports positive results of the REPROVE1 Study showed that patients diagnosed with hospital-acquired pneumonia, treated with Zavicefta, a novel combination antibiotic for the treatment of certain known or suspected Gram-negative bacterial infections, or Meropenem, a broad spectrum carbapenem antibiotic currently considered the standard of care, experienced comparable rates of clinical cure at test-of-cure 21-25 days after randomization.
- Clinical cure was the primary endpoint of the study and defined as a complete resolution of all signs and symptoms of infection.
- In addition, patients treated with Zavicefta and Meropenem experienced comparable rates of tolerability consistent with the known profile of ceftazidime alone.
5:14 am On The Wires (:WIRES) :
- Actelion (ALIOY) announced that Janssen Holding GmbH, a Swiss subsidiary of Johnson & Johnson (JNJ), published the provisional notice of the end result of its all-cash public tender offer in Switzerland to acquire all publicly held shares of Actelion Ltd for $280 per share, payable in US dollars, per the offer prospectus of February 16, 2017.
- ASML Holding NV (ASML) notes the announcement by Nikon that Nikon has filed a legal claim for alleged patent infringement against ASML in three countries. ASML has not yet received a notification of a legal action and categorically denies any infringement allegations. ASML believes that Nikon's claim is without merit. We will defend ourselves vigorously against the allegations and we will consider all means at our disposal.
- Fujitsu (FJTSY) announced that it has signed a contract to supply The Boeing Company with FUJITSU RFID Integrated Labels, as part of a Boeing project to implement RFID technology that improves the efficiency of lifecycle management for aircraft components.
- Chevron (CVX) announced that its wholly-owned subsidiary, Chevron Global Ventures, has entered into an agreement to sell the shares of its wholly-owned indirect subsidiaries operating in Bangladesh to Himalaya Energy Co. Ltd. Chevron Bangladesh operates Block 12 and Blocks 13 and 14. Closing of the transaction is subject to the satisfaction of certain closing conditions.
- The subsequent offer period under the recommended public cash tender offer by Nokia (NOK) Solutions and Networks Oy, a wholly-owned indirect subsidiary of Nokia Corporation, to purchase all of the issued and outstanding shares and option rights in Comptel Corporation that are not owned by Comptel or any of its subsidiaries commenced on April 4, 2017 and expired on April 19
- ASM International N.V. (ASMIY) announced that it intends to sell a stake of 20 million shares of the total outstanding share capital in ASM Pacific Technology through a partial secondary share placement. Following the planned divestment ASMI will own ~34% of the shares in ASMPT. ASMI intends to use the proceeds for a new share buyback program.
4:50 am Anglo American reports Q1 production; copper down 3% YoY (NGLOY) :
Co reports Production Report for Q1
- Rough diamond production increased by 8% to 7.4 mln carats compared with Q1 2016. This reflected the contribution of Gahcho Ku in Canada, as well as increases in response to improved trading conditions.
- Platinum production (metal in concentrate) was broadly flat at 572,000 ounces. With the sale of Rustenburg, production from that operation is now treated as purchase of concentrate (which increased by 93%) rather than own mined production (which decreased by 26%). Refined platinum production increased by 121% to 577,000 ounces as Q1 2016 was impacted by a Section 54 safety stoppage at the Precious Metals Refinery.
- Copper production decreased by 3% to 142,600 tonnes. Continued strong performance at Collahuasi was offset by expected lower grades and increased ore hardness at Los Bronces, and the temporary suspension of mining operations at El Soldado which resulted in ~3,000 tonnes of lost production.
- Iron ore production from Kumba increased by 17% to 10.5 mln tonnes due to improved mining productivity at Sishen, and higher throughput at Kolomela.
- Iron ore production from Minas-Rio increased by 30% to 4.3 mln tonnes (wet basis) as the operation continued to ramp-up.
- Export metallurgical coal production increased by 28% to 5.2 mln tonnes, primarily due to a longwall move at Moranbah in Q1 2016 and the ramp-up at Grosvenor.
- Production of South African and Colombian export thermal coal increased by 6% to 6.8 mln tonnes, driven by higher productivity across most of the South African mines.
- Nickel production decreased by 12% to 9,900 tonnes due to unplanned maintenance of Barro Alto's electric furnaces, impacting throughput.
4:47 am Novartis reports new data confirming benefit of Gilenya on 4 key measures of disease activity in relapsing MS (NVS) :
Novartis announced data from the Phase IV Multiple Sclerosis and clinical outcome and MRI in the US study, which confirmed the effectiveness of Gilenya in the real-world setting, supporting previous findings from Phase III trials.
- Results show that Gilenya impacted four key measures of MS disease activity (relapses, MRI lesions, disability progression and brain shrinkage), in people with relapsing-remitting multiple sclerosis for up to 16 months
- This is also the first time a multicenter study has evaluated and shown that routine magnetic resonance imaging scans taken in the every-day clinical setting can reliably be used to measure brain shrinkage, a key measure of disease progression, in people with RRMS
4:43 am On The Wires (:WIRES) :
- Logitech (LOGI) announced the launch of the exclusive Spotlight Presentation Academy, a one-day bootcamp created with TED dedicated to giving 15 aspiring storytellers the confidence to crush every presentation.
- Catastrophe modeling firm AIR Worldwide today released ARC, a comprehensive cyber risk modeling application for the insurance and reinsurance markets. ARC can evaluate any commercial policy, measure and monitor aggregations of cyber risk within a portfolio, and estimate potential insured cyber losses for portfolios. AIR Worldwide is a Verisk Analytics (VRSK) business.
- Meridian Bioscience (VIVO) has developed illumigene Malaria, a molecular-based, field laboratory-deployed test for malaria that is up to 80,000 times more sensitive at detecting the malaria parasite than current testing options. The test was developed by Meridian with the technical assistance of the Centers for Disease Control and Prevention and Cheikh Anta Diop University of Dakar
- Cyberbit, the wholly owned subsidiary of Elbit Systems (ESLT) whose cybersecurity solutions protect the world's most sensitive systems, announced a new version of its adaptive Endpoint Detection and Response platform, which now provides advanced and semi-automated threat hunting, centralized response capabilities, and an improved Software Developer Kit for detection customization
- AXIS Capital Holdings (AXS) announced the unveiling of the "AXIS Re Actuarial Scholarship" in partnership with Renmin University. The scholarship fund will provide financial assistance to actuarial students in the School of Statistics at Renmin University to help further develop their actuarial science skills and acumen and to promote professional training in actuarial sciences in the Asia Pacific region.
- Juniper Networks (JNPR) announced that NEP The Netherlands, world leading media technology specialist, is using Juniper Networks' high-performance solutions to create the world's first IP multi-camera production platform for TV.
- SAP SE (SAP) launched SAP Distributed Manufacturing, a new application resulting from its co-innovation with customers and service providers to make 3D printing a seamless part of digital manufacturing.
4:40 am New Oriental Education & Technology beats by $0.06, beats on revs; guides Q4 revs in-line (EDU) :
- Reports Q3 (Feb) earnings of $0.48 per share, $0.06 better than the Capital IQ Consensus of $0.42; revenues rose 26.2% year/year to $437.9 mln vs the $418.67 mln Capital IQ Consensus.
- Total student enrollments in academic subjects tutoring and test preparation courses increased by 5.9% year-over-year to ~799,700 for Q3
- The total number of schools and learning centers was 803 as of February 28, 2017, an increase of 76 compared to 727 as of February 29, 2016, and an increase of 14 compared to 789 as of November 30, 2016. The total number of schools was 73 as of February 28, 2017.
- Co issues in-line guidance for Q4, sees Q4 revs of $465.1-479.9 mln vs. $471.14 mln Capital IQ Consensus Estimate.
4:38 am On The Wires (:WIRES) :
- SunPower (SPWR) announced today that it now offers the fully-integrated SunPower Oasis Power Plant platform directly to solar power plant developers and engineering, procurement and construction providers through a newly formed SunPower Solutions business unit.
- Shire plc (SHPG) is launching #PIPostsThanks, a social campaign to spotlight the unsung heroes who make a difference in the lives of people living with primary immunodeficiency. PI is a group of nearly 300 rare disorders in which part of the body's immune system is missing or does not function properly, in many cases making it more difficult to fight infections
- Qualcomm (QCOM) and Smartron India Private, announced they have entered into a 3G and 4G patent license agreement. Under the terms of this agreement, Qualcomm has granted Smartron a royalty-bearing patent license to develop, manufacture and sell WCDMA, CDMA2000, and 4G LTE complete devices. With this agreement, Smartron joins the growing list of key Indian OEMs to have direct access to Qualcomm's technology.
- Stratasys (SSYS) announced that the Mobility Division of global engineering and technology solutions leader, Siemens (SIEGY), is pioneering the use of Stratasys FDM 3D printing technology by producing customized final production parts for German transport services provider, Stadtwerke Ulm/Neu Ulm Verkehr GmbH.
- Parker Hannifin (PH) unveiled the Voice of the Machine IoT platform, an open, interoperable and scalable ecosystem of connected products and services.
4:34 am Netflix proposes offering of 1 bln of Senior Notes (NFLX) :
- The interest rate, redemption provisions, maturity date and other terms of the Notes will be determined by negotiations between Netflix and the initial purchasers.
4:32 am Achaogen reports Phase 3 data demonstrates sustained clinical cure with plazomicin compared to higher clinical relapse rate with meropenem (AKAO) :
Co announced multiple presentations that highlight the effectiveness of plazomicin against MDR gram-negative bacteria in multiple settings. Additional analyses highlight the efficacy of plazomicin in important patient subgroups and at the late follow up time point (24-32 days from first dose of intravenous study drug):
- Plazomicin demonstrated superior microbiological eradication rates at test-of-cure in both cUTI and AP subgroups. In patients with cUTI, the treatment difference in favor of plazomicin was 13.7% and in patients with AP, the treatment difference in favor of plazomicin was 17.5%.
- A lower rate of clinical relapse at the late follow up visit was observed for plazomicin. The clinical relapse rate was 1.8% for plazomicin vs. 7.9% for meropenem. Importantly, meropenem-treated patients with asymptomatic bacteriuria at the TOC visit had a higher likelihood of clinical relapse at the LFU visit.
- EPIC included an optional switch from intravenous to oral therapy. Efficacy by subgroups of patients who either did or did not receive oral switch therapy was presented. In the subgroup receiving intravenous only therapy the magnitude of the treatment benefit favoring plazomicin was consistent with the primary efficacy results, indicating that the oral antibiotic was unlikely to account for the observed superiority of plazomicin over meropenem at TOC.
4:29 am On The Wires (:WIRES) :
- Randgold (GOLD) announced it will seek to extend Tongon's life while building Ivorian portfolio. A continuing review of its Nielle permit, which hosts the Tongon gold mine, has confirmed multiple opportunities for extending the life of the operation beyond the current four-year horizon, Randgold Resources chief executive Mark Bristow said at an on-site media briefing.
- Riskonnect, the leading global provider of Integrated Risk Management Solutions, has entered into a strategic development agreement with Willis Towers Watson (WLTW) to integrate Risk Management Information System functionality into their broader client facing technology platform to support the development of a comprehensive client service strategy and improve digital client experience.
- Toshiba (TOSBF) Machine Co announced that its EC-SXII series of all-electric injection molding machines, one of the best-selling products in Japan, will add the EC280SXII, featuring a clamping force of 2,744 kN (280 tf), and the EC350SXII, featuring a clamping force of 3,430 kN (350 tf), as two additional models to its production lineup at its China factory.
4:15 am Regeneron Pharma and Sanofi receive positive CHMP opinion for Kevzara (REGN) :
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Kevzara, recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.
- The CHMP recommended the use of Kevzara in combination with methotrexate for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs.
- The European Commission is expected to make a final decision on the Marketing Authorization Application for Kevzara in the European Union in the coming months.
- The CHMP opinion is based on results from seven Phase 3 trials in the global SARIL-RA clinical development program, including SARIL-RA-MOBILITY, SARIL-RA-TARGET and SARIL-RA-MONARCH.
- These studies incorporate data from more than 3,300 adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.
4:14 am LafargeHolcim concludes Syria review; confirms remedial measures; no indication that the reported allegations are likely to have an adverse financial impact (HCMLY) :
- March 2, co communicated the initial findings of an independent internal investigation, commissioned by the Board of Directors, into allegations concerning the Lafarge plant in Syria: specifically that company personnel had engaged in dealings with armed groups and sanctioned parties during 2013 until the plant closed in September 2014.
- The Board has now concluded the independent investigation and confirmed that a number of measures taken to continue safe operations at the Syrian plant were unacceptable, and significant errors of judgement were made that contravened the applicable code of conduct.
- Following an in-depth review, the Board has concluded that CEO Eric Olsen was not responsible for, nor thought to be aware of, any wrongdoings that have been identified as part of its review. In light of current legal proceedings in France, the company will not comment further on the findings or individual conduct.
- The Board confirms the remedial measures announced on 2 March 2017, on the basis of the earlier findings including: the adoption of a more rigorous risk assessment process focusing on high risk third parties; introduction of a restricted party screening program and a new sanctions and export control program; as well as continuation of other efforts from an external benchmarking exercise.
- Having now concluded the review, the Board has mandated Eric Olsen and his executive management team to implement these remedial measures.
- Based on the updated information available, there remains no indication that the reported allegations are likely to have an adverse financial impact that is material to the Group.
- Board of Directors has accepted the resignation of Eric Olsen, CEO, and will leave on July 15, two years after taking up the CEO role and assuming responsibility for successfully implementing the merger of Lafarge and Holcim. A successor has not been named
4:09 am Syngenta reports Q1 sales results, slightly misses on revs (SYT) :
Reports Q1 sales declined 1% YoY to $3.71 bln vs $3.76 bln dual estimate
- Volumes were stable and pricing slightly lower.
- The more favourable currency trend which began in the second half of 2016 continued, with the Russian Ruble and the Brazilian Real strengthening against the dollar.
- Regional Performance
- Sales in Europe, Africa and the Middle East were unchanged despite a late start to the season in Northern and Central Europe, due to cold weather. This was offset by an excellent performance in South East Europe and ongoing growth in the CIS, as well as by solid growth in France due to the highly successful launch of ELATUS PLUS at the end of 2016.
- In North America, a decline in Seeds sales was largely due to a timing difference in the receipt of trait royalties. Crop Protection sales showed robust growth driven by the ongoing success of TRIVAPRO, based on SOLATENOL.
- In Latin America, sales were 3% lower. Dry weather in the second half of 2016, affecting the south of Brazil and Paraguay, reduced demand for fungicides and herbicides.
- In Asia Pacific sales were up 4%. The main driver was ASEAN, with a continuing good corn seed performance. China grew based on the adoption of fungicides, notably AMISTAR.
4:03 am Helix Energy beats by $0.02, misses on revs (HLX) :
- Reports Q1 (Mar) loss of $0.11 per share, $0.02 better than the Capital IQ Consensus of ($0.13); revenues rose 14.8% year/year to $104.5 mln vs the $112.17 mln Capital IQ Consensus.
- Well Intervention revenues decreased 6% in the first quarter of 2017 from the fourth quarter of 2016 and overall Well Intervention vessel utilization in the first quarter of 2017 decreased to 59% from 62% in the fourth quarter of 2016.
- Robotics revenues decreased 46% in the first quarter of 2017 from the fourth quarter of 2016. The decrease in revenue was primarily driven by overall weak market activity in addition to low seasonal activity in the North Sea.
4:01 am C.R. Bard beats by $0.22, beats on revs; guides FY17 EPS above consensus, revs above consensus (BCR) :
- Reports Q1 (Mar) earnings of $2.87 per share, $0.22 better than the Capital IQ Consensus of $2.65; revenues rose 7.5% year/year to $938.8 mln vs the $916.15 mln Capital IQ Consensus.
- Co issues upside guidance for FY17, sees EPS of $11.65-11.90 vs. $11.65 Capital IQ Consensus Estimate, up from $11.45-11.75 prior
- Co sees FY17 revs of +6-7% YoY to $3.95-3.99 bln vs. $3.89 bln Capital IQ Consensus Estimate, up from +4-5% to ~$3.86-3.90 bln
Briefing note: BDX announced acquisition of BCR - see 3:56
Becton Dickinson and Co (BDX) and C. R. Bard (BCR) announced a definitive agreement under which BD will acquire Bard for $317.00 per Bard common share in cash and stock, for a total consideration of $24 billion. The agreement has been unanimously approved by the Boards of Directors of both companies.
- Under the terms of the transaction, Bard common shareholders will be entitled to receive approximately $222.93 in cash and 0.5077 shares of BD stock per Bard share, or a total of value of $317.00 per Bard common share based on BD's closing price on April 21. At closing, Bard shareholders will own ~15% of the combined company.
- BD expects to contribute ~$1.7 billion of available cash to fund the transaction, along with, subject to market conditions, approximately $10 billion of new debt and ~$4.5 billion of equity and equity linked securities issued to the market.
- Bard shareholders will also receive $8 billion of BD common stock. BD has also obtained fully committed bridge financing. At closing, BD estimates the combined company will have pro forma leverage of ~4.7x and is committed to deleveraging to below 3.0x leverage within three years of closing.
- BD expects to continue the suspension of its share repurchase program. BD is also committed to annual dividend increases while reinvesting in the business to continue to drive long-term growth.
- Immediately accretive to BDX and expected to generate high single-digit accretion to Adjusted EPS in FY19
- BD expects to create a third segment within the company -- BD Interventional - where the Bard businesses will report both operationally and financially. BD is separately announcing the appointment of Tom Polen, currently executive vice president and president of the BD Medical Segment, as president of BD, effective immediately.
3:47 am On The Wires (:WIRES) :
- Ocean Rig UDW (ORIG) announced that it has agreed to extend the term of the early consent deadline under the restructuring support agreement dated March 23, for holders of the senior secured notes issued by the Company's direct subsidiary, Drill Rigs Holdings, to accede to the RSA and receive a pro rata portion of the DRH early consent fee of $2.5 million. The DRH early consent fee deadline has been extended from April 21, 2017 to 5:00 pm (New York time) on April 25, 2017.
- Avid (AVID) announced that it has entered into a strategic alliance agreement with Microsoft Corp. to cooperatively develop and market cloud-based solutions and cloud services aimed at the media and entertainment industry.
- Royal Philips (PHG) announced the debut of its eCareManager 4.1 enterprise telehealth software. This latest advanced telehealth technology builds on Philips' proven success in delivering population health management solutions to help combat shortages of critical care teams by providing actionable insights to help improve outcomes in the most complex patient cases.
3:37 am ContraVir Pharma presents data showing synergistic antiviral activity from the combination of its two investigational drugs for the treatment of hepatitis B viral (CTRV) :
Co presented data demonstrating the synergistic antiviral activity from the combination of its two investigational drugs for the treatment of hepatitis B viral infection, tenofovir exalidex a nucleotide reverse transcriptase inhibitor and CRV431, a cyclophilin inhibitor. In addition, the mode of action of CRV431 was further defined.
- Data demonstrated that CRV431 appears to exert an anti-HBV effect by interfering with the binding interaction between HBx and cyclophilin A, thereby reducing HBV replication.
- Overall, the results suggest that combining TXL and CRV431 can be a viable therapeutic drug strategy, and that the two agents' complementary actions may reasonably extend to drugs with other modes of activity.
3:25 am Merck presents new Phase 2 Data on investigational triple combination therapy MK-3682B showing high rates of sustained virologic response (MRK) :
Co announced the first sustained virologic response results 12 weeks after completion of therapy from C-SURGE, an ongoing, open label Phase 2 clinical trial evaluating MK-3682B, the company's investigational triple-combination therapy in treatment-experienced patients with hepatitis C virus genotype 1 infection for whom treatment with approved direct-acting antiviral regimens had failed.
- The study showed that 100 percent (43/43) of patients who completed 16 weeks of treatment plus ribavirin achieved SVR12 and 100 percent (49/49) of patients who completed 24 weeks of treatment achieved SVR12.
- Results from the modified full analysis set, which excludes one patient in the 16-week arm who withdrew after three doses of treatment, show that 100 percent of patients receiving treatment with MK-3682B for 16 weeks with RBV (43/43) and 100 percent of patients receiving treatment with MK-3682B for 24 weeks without RBV (49/49) achieved SVR12.
- Across the combined treatment arms, the most common adverse events (AEs) reported in the full analysis set were fatigue (35%), headache (13%), diarrhea (9%), rash (9%) and pruritus (5%). There were no drug-related serious AEs, and no patients discontinued treatment due to a drug-related AE.
3:22 am Arbutus Biopharma reports data showing ARB-1467 reduces serum HBsAg in Both HBeAg negative and HBeAg positive patients (ABUS) :
Co presented results of the first three cohorts of a Phase II study of its RNAi agent, ARB-1467
- The Phase II trial is a multi-dose study in chronic HBV patients who are also receiving stable nucleotide analog therapy.
- The trial consists of four cohorts, the first three of which enrolled eight subjects each (six receiving three monthly doses of ARB-1467 and two receiving placebo) and the fourth is enrolling twelve patients (all of whom will receive 5 bi-weekly doses of ARB-1467).
- Cohorts 1, 2, and 4 include HBeAg- patients and Cohort 3 included HBeAg+ patients.
- The protocol for Cohort 4 allows for dosing to be extended to up to one year of ARB-1467 dosing for patients who meet predefined response criteria.
- Next Steps for ARB-1467
- In addition to the ongoing Phase 2 Cohort 4, Arbutus will initiate a new study in 2H17 to study longer term dosing of ARB-1467 in combination with nucleot(s)ide analog therapy as well as pegylated interferon or another immune modulator. This study will explore the possibility of driving HBsAg to very low, if not undetectable, levels with ARB-1467 along with an immune modulating mechanism. While this study may include pegylated interferon as the immune boosting component that could lead to later stage development, Arbutus also plans to evaluate other immunomodulatory approaches, such as its proprietary checkpoint inhibitor program, in future combination studies.
3:20 am Achillion Pharma reports additional Phase 2 results including 100% SVR24 for Genotype 1 HCV after 6-weeks of once daily JNJ-4178 (ACHN) :
Achillion Pharmaceuticals (ACHN) announced the presentation of updated results from the ongoing phase 2 '604 Study' being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (JNJ).
- These results demonstrate that the triple combination of simeprevir, odalasvir and AL-335 has the ability to shorten treatment duration, offer high efficacy and be generally well tolerated in those whose disease is caused by hepatitis C virus genotype 1, one of the most prevalent causes of hepatitis C globally.
- The oral presentation features clinical trial data examining the safety, pharmacokinetics and efficacy of six and eight weeks of treatment with AL-335 and odalasvir with or without simeprevir to treat HCV in treatment nave subjects across a range of HCV genotypes and stages of liver disease.
- Data from this study demonstrate that JNJ-4178, the three-drug combination of simeprevir, odalasvir and AL-335, was highly effective in treatment nave patients with HCV genotype 1 infection without cirrhosis, achieving 100% SVR24 for treatment durations of both 6 and 8 weeks. The two-drug regimen of odalasvir and AL-335, a combination regimen not anticipated to move forward, achieved 84% SVR24 for treatment duration of 8 weeks in patients with HCV genotype 1 without cirrhosis.
- The three-drug regimen of simeprevir, odalasvir and AL-335 in HCV genotype 3 patients without cirrhosis achieved an SVR12 of 77% following 12 weeks of therapy, and is also not anticipated to move forward.
- Genomic sequencing results indicate that despite the presence of multiple NS5A mutations observed at baseline there was no apparent impact on SVR rates.
3:18 am Bristol-Myers reports BMS-986036 met primary endpoint of significant reduction in liver fat (BMY) :
Co announced data from a Phase 2 study of BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21, a key regulator of metabolism, in patients with biopsy-confirmed nonalcoholic steatohepatitis.
- The study achieved its primary endpoint of significant reduction in liver fat versus placebo. Statistically significant improvements were also seen in prespecified exploratory endpoints including biomarkers of fibrosis, metabolic parameters and markers of liver injury.
- This was a multicenter, randomized, double-blind, placebo-controlled study in adults with body mass index =25 kg/m2, biopsy-confirmed NASH, and hepatic fat fraction =10%, assessed by magnetic resonance imaging-proton density fat fraction, a noninvasive measurement of liver fat. Randomization was stratified by diabetes status. Patients received subcutaneous injections of BMS-986036 10 mg daily, BMS-986036 20 mg weekly, or placebo daily for 16 weeks.
- The primary efficacy endpoint was absolute change in MRI-PDFF at Week 16. Exploratory endpoints included serum Pro-C3, enzymes alanine aminotransferase and aspartate aminotransferase, and, in a subset of patients, liver stiffness, assessed by MR elastography.
3:14 am Albireo Pharma reports data supporting advancement of A4250 into a planned Phase 3 trial (ALBO) :
Co announced that the embargo on its late-breaker abstract discussing preliminary data from a Phase 2 clinical trial of its lead product candidate A4250 in children with cholestatic liver disease has been lifted.
- The data demonstrated improvement in pruritus and reduction in serum bile acids in most patients, particularly patients with progressive familial intrahepatic cholestasis, after four weeks of treatment with A4250.
- A4250 reduced mean levels of sBA in all five dose groups, with substantial sBA reductions observed in seven of nine PFIC patients (ranging from 43 percent to 98 percent). In addition, 14 of 19 patients showed improvement in pruritus using a visual analogue scale.
- The dose with the greatest improvement showed a mean decrease of 2.86 points from baseline.
- The trial was not powered for formal statistical analyses.
3:11 am Banco Macro plans to offer Peso denominated notes up to the equivalent amount of $300 mln due 2022 during Q2 (BMA) :
3:09 am On The Wires (:WIRES) :
- Alliance MMA (AMMA) announced that a shareholder has filed a lawsuit against the Company and two of its current officers in the United States District Court for the District of New Jersey, under the caption Shapiro v. Alliance MMA. The lawsuit alleges violations of the federal securities laws and purports to seek damages on behalf of a class of all shareholders who purchased the Company's common stock pursuant or traceable to the Company's initial public offering. The Company believes that the lawsuit is without merit and intends to vigorously defend against it.
- Barington/Hilco Acquisition Corp (BHAC), a blank check acquisition company, announced today that it has funded an additional 30-day extension of the date by which it must complete a business combination. The Company has deposited $84,546.73 into its trust account to fund the extension through May 11, 2017.
3:00 am Laureate Education prices offering of $800 mln of 8.250% senior notes due 2025 (LAUR) :