AMRN = The FDA posted briefing documents ahead of the November 14, 2019, Advisory Committee Meeting to discuss the benefits and risks of Vascepa for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated triglyceride levels and other risk factors for cardiovascular disease. “The major topics for the panel to address include the robustness of this single trial to support a new indication for CV risk reduction, identification of the appropriate indicated population, whether it is appropriate to include in the indication in labeling all of the components of the primary endpoint… Finally, although there is less plausibility for an interaction between mineral oil and other background cardiovascular medications with known CV benefits, we considered whether trial data indicated any effects on these drugs that might further impact the observed effect of AMR101 on outcomes. We concluded that these analyses showed no evidence of such a signal.”

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SE = Sea Limited (NYSE: SE) today announced its financial results for the quarter ended September 30, 2019.

Third Quarter 2019 Highlights

  • Total adjusted revenue was US$763.3 million, up 214.3% year-on-year from US$242.8 million for the third quarter of 2018.
  • Total adjusted EBITDA was US$(30.8) million compared to US$(183.8) million for the third quarter of 2018.
  • Adjusted revenue was US$451.0 million, up 212.0% year-on-year from US$144.6 million for the third quarter of 2018.
  • Adjusted EBITDA was US$266.0 million, up 395.0% year-on-year from US$53.7 million for the third quarter of 2018.
  • Adjusted EBITDA margin increased to 59.0% for the third quarter of 2019 from 37.2% for the third quarter of 2018.
  • Quarterly active users (“QAUs”) reached 321.1 million, an increase of 82.3% year-on-year from 176.1 million for the third quarter of 2018.
  • Quarterly paying users continued to grow, accounting for 9.1% of QAUs for the third quarter of 2019, increasing from 4.1% for the same period in 2018.
  • Average revenue per user was US$1.4 compared to US$0.8 for the third quarter of 2018.
  • Our self-developed global hit game, Free Fire, recently celebrated its second anniversary and continues to grow across different regions. Free Fire was the highest grossing mobile game in Latin America1 and in Southeast Asia in the third quarter of 2019, and was ranked among the top five most downloaded mobile games globally for the third straight quarter across the Google Play and iOS App Stores combined, according to App Annie. In October 2019, Free Fire was also the highest grossing mobile game in India on the Google Play Store, according to App Annie. As of the end of October 2019, Free Fire had recorded a total cumulative adjusted revenue of over US$1 billion since launch.
  • We launched Call of Duty®: Mobile, a mobile version of the classic action game of Activision, in Indonesia, Taiwan, Thailand, the Philippines, Malaysia, and Singapore on October 1. It was the most downloaded mobile game on both the Google Play and iOS App Stores in each of these markets for the month of October, according to App Annie.
  • We continue to focus on esports and community building activities. Since September, we have been running national qualifiers and regional leagues for our largest global esports tournament for Free Fire, the Free Fire World Series 2019, which has achieved over 100 million cumulative online views to date. For the final match of the Brazil qualifiers alone, we recorded over 1 million concurrent viewers online.
  • Adjusted revenue was US$257.2 million, up 261.1% year-on-year from US$71.2 million for the third quarter of 2018.
  • Adjusted revenue included US$208.1 million of marketplace revenue, up 313.6% year-on-year from US$50.3 million for the third quarter of 2018, and US$49.2 million of product revenue, up 134.9% year-on-year from US$20.9 million for the third quarter of 2018.
  • Gross orders for the quarter totaled 321.4 million, an increase of 102.8% year-on-year from 158.5 million for the third quarter of 2018.
  • Gross merchandise value (“GMV”) was US$4.6 billion, an increase of 69.9% year-on-year from US$2.7 billion for the third quarter of 2018.
  • Adjusted revenue as a percentage of total GMV increased to 5.6% in the third quarter of 2019, up from 2.6% for the same period a year ago. Adjusted marketplace revenue as a percentage of total GMV was 4.5% in the third quarter of 2019.
  • Sales and marketing expenses were US$199.2 million, an increase of 30.2% year-on-year from US$152.9 million for the third quarter of 2018.
  • Adjusted EBITDA was US$(253.7) million compared to US$(214.9) million for the third quarter of 2018. Adjusted EBITDA loss per order decreased by 41.9%, from US$1.36 to US$0.79 in the third quarter of 2019, compared to the same period in 2018.
  • In Indonesia, our largest market, Shopee further extended its leadership as the largest e-commerce platform by orders. We registered over 138 million orders for the market in the third quarter, or a daily average of over 1.5 million orders, an increase of 117.8% year-on-year. Shopee also ranked first by average monthly active users and downloads in the Shopping category across the Google Play and iOS App Stores combined in the third quarter of 2019, according to App Annie.
  • In Taiwan, we recorded a positive quarterly adjusted EBITDA, even after allocation of the headquarters’ common expenses in the third quarter of 2019.
  • Shopee ranked number one in the Shopping category by average monthly active users and by downloads in both Southeast Asia and Taiwan, and ranked number five worldwide by downloads in the same category, across the Google Play and iOS App Stores combined in the third quarter, according to App Annie.
  • In Southeast Asia as a whole, and in each of our five largest markets, Shopee ranked number one by total time spent in app on Android in the third quarter, according to App Annie.

The company said, “We now expect adjusted revenue for digital entertainment to be between $1.7B-$1.8B, representing 157.2% to 172.3% growth from 2018. This compares to the previously disclosed guidance of between $1.6B-$1.7B, representing 142.0% to 157.2% growth. We also expect adjusted revenue for e-commerce to be between $880M and $920M representing 202.7% to 216.5% growth from 2018. This compares to the previously disclosed guidance of between $780M and $820M, representing 168.3% to 182.1% growth.”

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ROK = Rockwell Automation, Inc. (NYSE: ROK) today reported fiscal 2019 fourth quarter results. Reports Q4 revenue $1.73B, consensus $1.65B.

  • Fourth quarter reported sales flat year over year; organic sales up 1.4 percent
  • Fourth quarter diluted EPS of $0.07; Adjusted EPS of $2.01
  • Full year diluted EPS of $5.83; Adjusted EPS of $8.67
  • Results include a restructuring charge of $0.14 and Sensia setup costs of $0.04 that were not included in July guidance
  • Fiscal 2020 EPS guidance: Diluted EPS $8.48 – $8.88; Adjusted EPS $8.70 – $9.10

“Our broadening portfolio helped deliver better-than-expected performance in the quarter,” said Blake D. Moret, chairman and chief executive officer of Rockwell Automation. “Organic sales growth of 1.4 percent was driven by continued strength in oil and gas, mining, and life sciences, as well as better performance in automotive and food and beverage.”

Fiscal 2019 fourth quarter sales were $1,730.2 million, flat compared to $1,729.5 million in the fourth quarter of fiscal 2018. Organic sales increased 1.4 percent, currency translation decreased sales by 1.5 percentage points, and an acquisition increased sales by 0.1 percentage points.

Fiscal 2019 fourth quarter net income was $8.1 million or $0.07 per share, compared to $345.9 million or $2.80 per share in the fourth quarter of fiscal 2018. The decreases in net income and EPS were primarily due to fair value adjustments in connection with the PTC investment (“the PTC adjustments”). Fiscal 2019 fourth quarter Adjusted EPS was $2.01, down 4 percent compared to $2.10 in the fourth quarter of fiscal 2018. Fourth quarter Adjusted EPS includes a restructuring charge of $0.14 and Sensia setup costs of $0.04.

Pre-tax margin was 3.3 percent in the fourth quarter of fiscal 2019, compared to 27.9 percent in the same period last year. The decrease in pre-tax margin was primarily due to the PTC adjustments.

Total segment operating margin was 20.2 percent compared to 20.8 percent a year ago. The decrease in total segment operating margin was primarily due to restructuring charges in both segments. Total segment operating earnings were $349.0 million in the fourth quarter of fiscal 2019, down 3 percent from $358.9 million in the same period of fiscal 2018.

Cash flow provided by operating activities in the fourth quarter of fiscal 2019 was $475.0 million and free cash flow was $450.9 million.

Full Fiscal Year 2019

Sales were $6,694.8 million in fiscal 2019, up 0.4 percent from $6,666.0 million in fiscal 2018. Organic sales increased 2.8 percent and currency translation decreased sales by 2.4 percentage points.

Fiscal 2019 net income was $695.8 million or $5.83 per share, compared to $535.5 million or $4.21 per share in fiscal 2018. The increase in EPS was primarily due to the absence of charges associated with the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) recognized in the prior year and a lower share count, partially offset by the PTC adjustments. Fiscal 2019 Adjusted EPS was $8.67, up 7 percent compared to $8.10 in fiscal 2018. The increase in Adjusted EPS was primarily due to higher organic sales.

Pre-tax margin was 13.5 percent in fiscal 2019, compared to 20.0 percent last year. The decrease in pre-tax margin was primarily due to the PTC adjustments.

Total segment operating margin was 22.0 percent compared to 21.6 percent a year ago. Total segment operating earnings were $1,473.6 million in fiscal 2019, up 2.2 percent from $1,441.8 million in fiscal 2018.

Cash flow provided by operating activities in fiscal year 2019 was $1,182.0 million and free cash flow was $1,049.2 million.

“We are pleased with our solid operating and financial performance for the year against the backdrop of a challenging macroeconomic environment. Organic sales grew 2.8 percent, supported by strong double-digit growth in Information Solutions and Connected Services, total segment operating margin expanded 40 basis points and Adjusted EPS was up 7 percent. We also delivered another year of strong free cash flow performance and successfully neutralized the impact of tariffs. We continue to find new ways to increase productivity for our customers as we play a larger role in their digital transformation journey,” said Moret.

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RETA = Reports Q3 revenue $8.24M, consensus $7.44M. At September 30, 2019, the company had $240.1M in cash and cash equivalents. The company added “We expect our current cash, along with our access to additional equity or debt funding, will enable us to meet our current obligations through December 31, 2020.” Baird analyst Brian Skorney raised his price target on Reata Pharmaceuticals to $245 from $162 following the positive Phase 3 readout of its CARDINAL study. The report showed a clear on-treatment washout effect of barboxolone that was clinically meaningful and statistically superior to the placebo on eGFR in patients with Alport Syndrome. Skorney reiterated his Outperform rating on Reata Pharmaceuticals shares.

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SNCR = Synchronoss Technologies, Inc. (NASDAQ:SNCR), a global leader and innovator of cloud, messaging, digital and IoT products, today announced that it is working with a new joint venture formed by the four largest mobile operators in the United States – AT&T, Sprint, T-Mobile and Verizon – to help deliver an advanced mobile messaging experience across all four mobile networks.

Based on the Rich Communications Services (RCS) standard, developed with technology partner WIT Software, this platform has the potential to create a messaging ecosystem that allows consumer brands to create a new level of engagement and meet growing preferences for content rich, personalized interactions via messaging communications. With customer consent, this technology will allow businesses to directly interact with their customers using branded, interactive multimedia communications and one-to-one messaging. The application will also allow users to add advanced multimedia capabilities to their text messages and accomplish, engage and interact with their favorite brands without switching from app to app.

“The cross-carrier messaging initiative has the potential to transition the wireless ecosystem to a new, innovative messaging service that will power new experiences – allowing U.S. wireless customers to manage their digital life and enabling efficient and convenient interactions with their favorite brands from a single application,” said Glenn Lurie, President and CEO of Synchronoss Technologies. “The launch of this initiative signals the beginning of the era of advanced messaging in the U.S. that will begin to unite communication, services and entertainment in entirely new ways. Synchronoss, along with our partner WIT Software, has seen first-hand how powerful advanced messaging can be around the globe, and we believe there is tremendous potential for this in the U.S. on multiple fronts. This collaboration exemplifies how working together can enhance the entire mobile ecosystem.”

Doug Garland, general manager of the CCMI joint venture, said, “By collaborating with Synchronoss, we’ll be able to successfully advance the messaging experience through RCS and take the next step to further the conversational commerce ecosystem. With new RCS capabilities all four wireless carriers together will be able to create better overall mobile messaging customer experience.”

Synchronoss and WIT Software are longstanding and proven messaging providers for companies around the world. Last year, the companies announced that they had partnered together with the Japanese operators to deliver the world’s first fully interoperable RCS-based advanced messaging cross-operator platform for Japanese mobile users.

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