Intec Says Phase 3 Trial Did Not Achieve Statistical Superiority To Sinemet
Intec Pharma Ltd. (NTEC) announces Monday top-line data from the Company’s pivotal Phase 3 ACCORDANCE trial evaluating the safety and efficacy of the Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet) as a treatment for the symptoms of advanced Parkinson’s disease (PD).
The company announced that the ACCORDANCE study did not achieve statistical superiority to Sinemet on the primary endpoint of reduction in daily OFF time.
Levodopa is the most widely used and most effective drug for the symptomatic therapy of PD. However, chronic levodopa therapy is problematic due to the development of motor complications and may limit the usefulness of the drug.
The Phase 3 ACCORDANCE study is a multi-center, global, 13-week randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with advanced PD. The study was conducted at over 90 clinical sites throughout the U.S., Europe and Israel.
The primary efficacy endpoint of the study was the change from baseline to endpoint in the percent of daily OFF time during waking hours based on Hauser home diaries.
Lennox International Inc Q2 adjusted earnings Miss Estimates
Lennox International Inc (LII) announced a profit for second quarter that dropped from the same period last year.
The company’s profit totaled $110.7 million, or $2.80 per share. This compares with $137.6 million, or $3.35 per share, in last year’s second quarter.
Excluding items, Lennox International Inc reported adjusted earnings of $147.6 million or $3.74 per share for the period.
Analysts had expected the company to earn $4.12 per share, according to figures compiled by Thomson Reuters. Analysts’ estimates typically exclude special items.
The company’s revenue for the quarter fell 6.8% to $1.10 billion from $1.18 billion last year.
Lennox International Inc earnings at a glance:
-Earnings (Q2): $147.6 Mln. vs. $150.6 Mln. last year.
-EPS (Q2): $3.74 vs. $3.67 last year.
-Analysts Estimate: $4.12
-Revenue (Q2): $1.10 Bln vs. $1.18 Bln last year.
Full year EPS guidance: $11.30-$11.90
Lennox International Lowers FY19 Outlook – Quick Facts
While reporting its second-quarter financial results on Monday, Lennox International Inc. (LII) lowered its financial outlook for fiscal 2019.
For fiscal 2019, Lennox now forecasts adjusted earnings per share from continuing operations in a range of $11.30 to $11.90, down from the prior range of $12.00 to $12.60 per share.
The company also lowered its outlook for full-year adjusted revenue growth to a range of 2 percent to 5 percent, from the prior range of 3 percent to 7 percent growth.
On average, analysts polled by Thomson Reuters expect the company to report earnings of $12.29 per share for the year on revenue growth of 2.00 percent to $3.89 billion. Analysts’ estimates typically exclude special items.
“Slower moving shipments in the industry due to adverse weather has slowed regaining market share following the tornado and extends our recovery timeline to include the fourth quarter,” Chairman and CEO Todd Bluedorn said.
However, Lennox reiterated its guidance for stock repurchases of $400 million in 2019.
Group 1 Automotive Acquires Five Volkswagen Franchises In The UK
Automotive retailer Group 1 Automotive, Inc. (GPI) announced Monday the acquisition of five Volkswagen franchises in the UK. The transaction includes four Volkswagen franchises and one Volkswagen Commercial Vehicle franchise located east of London in the county of Essex.
This territory is contiguous with several other existing automotive dealerships currently owned and operated by Group 1 Automotive in the UK. Specifically, the acquired operations are located in the cities of Chelmsford, Colchester, Romford and Southend.
This acquisition is expected to generate approximately $115 million in annualized revenues. The addition of these stores increases the Company’s UK operations to 49 dealerships (65 franchises), which includes 11 existing brands (Audi, BMW, Ford, Jaguar, Kia, Land Rover, MINI, SEAT, Skoda, Toyota, and Volkswagen Commercial Vehicles).
PPG To Buy Dexmet Corp. – Quick Facts
PPG (PPG) has agreed with private equity firm Sverica Capital Management LP to acquire Dexmet Corp. Headquartered in Wallingford, Connecticut, Dexmet specializes in customized, highly-engineered, expanded and perforated metal foils and polymers used for mission-critical applications in aerospace, energy storage, and other industrial applications. It has approximately 75 employees.
“The acquisition will enable PPG to provide further value to our customers by enhancing our range of product offerings, expanding our research and development capabilities, and increasing our market reach across PPG’s aerospace, automotive and industrial coatings businesses,” said Michael McGarry, PPG CEO.
Lennox’s stock falls after ‘adverse’ weather led to earnings miss, lowered guidance
Shares of Lennox International Inc. LII, -1.78% slumped 5.7% in premarket trading Monday, after the heating, ventilation and air conditioning (HVAC) company reported second-quarter earnings that missed expectations and cut its full-year outlook, citing adverse weather conditions. Net income fell to $110.7 million, or $2.80 a share, from $137.6 million, or $3.35 a share, in the year-ago period. Excluding non-recurring items, adjusted earnings per share rose 2% to $3.74, but was below the FactSet consensus of $4.12. Revenue fell 6% to $1.10 billion, missing the FactSet consensus of $1.15 billion. Residential heating and cooling revenue fell 4% to $689 million, missing the FactSet consensus of $733 million, commercial heating and cooling revenue rose 4% to $261 million to beat expectations of $258 million and refrigeration revenue increased 2% to $149 million to top expectations of $148 million. For 2019, Lennox cut its guidance for adjusted EPS to $11.30 to $11.90 from $12.00 to $12.60 and for revenue growth to 2% to 5% from 3% to 7%. "Significantly cooler temperatures and higher precipitation across the United States adversely impacted the HVAC market in the second quarter, and especially in key Central regions where cooling degree days were down over 30% and precipitation was up over 60%," said Chief Executive Todd Bluedorn. The stock has rallied 27.4% year to date, while the Dow Jones Industrial Average DJIA, -0.25% has advanced 16.4%.