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Last $30.95 USD
Change Today 0.00 / 0.00%
Volume 0.0
As of 8:10 PM 08/31/15 All times are local (Market data is delayed by at least 15 minutes).

h lundbeck a/s (HLUKF) Key Developments

H. Lundbeck A/S, Q2 2015 Earnings Call, Aug 19, 2015

H. Lundbeck A/S, Q2 2015 Earnings Call, Aug 19, 2015

H. Lundbeck A/S Reports Earnings Results for the Second Quarter of 2015

H. Lundbeck A/S reported earnings results for the second quarter of 2015. For the quarter, the company reported a DKK 4.8 billion in reported LBIT. Operating cash flow has been impacted by the payment to Otsuka in the spring of $200 million, and the company have a net debt of DKK 1.4 billion by the end of the quarter.

H. Lundbeck A/S Announces Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2015; Revised Earnings Guidance for the Full Year 2015; Provides Impairment Guidance for the Third Quarter of 2015

H. Lundbeck A/S announced unaudited earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported revenue of DKK 3,629 million against DKK 3,448 million a year ago. LBITDA was DKK 4,548 million against EBITDA of DKK 540 million a year ago. Loss from operations was DKK 4,833 million against profit from operations of DKK 274 million a year ago. Loss before tax was DKK 4,900 million against profit before tax of DKK 144 million a year ago. Loss for the period was DKK 3,906 million or DKK 19.86 per diluted share against profit of DKK 144 million or DKK 0.73 per diluted share a year ago. Cash flows used in operating activities were DKK 1,384 million against cash flows from operating activities of DKK 459 million a year ago. Negative return on equity was 31.9% against return on equity of 1.1% a year ago. Core profit from operations (core EBIT) was DKK 135 million against DKK 439 million a year ago. Negative cash flow per share was DKK 7.04 against cash flow per share of DKK 2.33 a year ago. The performance in revenue was caused by the generic competition of Cipralex in Canada where sales declined by 81% to DKK 51 million which was compensated for by growth in other products and geographies including emerging markets. The decrease in EBITDA margin is related to the reclassification of product rights and generic impact on the revenue from Cipralex as well as launch and pre-launch activities. For the six months, the company reported revenue of DKK 7,192 million against DKK 7,035 million a year ago. LBITDA was DKK 4,240 million against EBITDA of DKK 1,364 million a year ago. Loss from operations was DKK 4,865 million against profit from operations of DKK 843 million a year ago. Loss before tax was DKK 4,932 million against profit before tax of DKK 792 million a year ago. Loss for the period was DKK 3,987 million against profit of DKK 475 million a year ago. Diluted loss per share were DKK 20.28 against DKK 2.42 diluted earnings per share a year ago. Cash flows used in operating activities were DKK 1,766 million against cash flows from operating activities of DKK 308 million a year ago. Investments in intangible assets and property, plant and equipment was DKK 35 million against DKK 1,277 million a year ago. Negative return on equity was 33.6% against return on equity of 3.5% a year ago. Negative cash flow per share was DKK 8.99 against cash flow per share of DKK 1.57 a year ago. Core profit from operations (core EBIT) was DKK 351 million against DKK 1,168 million a year ago. The increase in revenue of 2% is caused by a positive development in main currencies. For 2015, the company expects core revenue of DKK 14 billion against previous forecast of DKK 13.2 to 13.7 billion and core EBIT of DKK 0.5 billion and reported LBIT of DKK 7 billion. For the third quarter, the company expects to recognize approximately DKK 0.6 billion in impairment loss due to changed management estimates of certain intangible rights and fixed assets.

H. Lundbeck A/S Revises Earnings Guidance for the Year of 2015

H. Lundbeck A/S revised earnings guidance for the year of 2015. The company now expects core profit from operations (core EBIT) assuming constant exchange rates to be around DKK 0.5 billion compared to the previous guidance around DKK 0 for 2015. Following the announced restructuring programme, the company is now also providing guidance for reported operating profit (EBIT), which is expected to be negative around DKK 7.0 billion. The company expected revenue around DKK 14.0 billion.

H. Lundbeck A/S and Takeda Pharmaceutical Company Limited Announce FDA Accepts a Supplemental New Drug Application for Review of Brintellix (Vortioxetine) Clinical Trial Data

H. Lundbeck A/S and Takeda Pharmaceutical Company Limited announced the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the US for the treatment of MDD in adults. The FDA is expected to take action on this filing by 28 March 2016. Depression includes a range of symptoms including cognitive ones. The cognitive symptoms of depression may go unrecognized by both healthcare providers and patients. Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking and forgetfulness. These symptoms are common and many of them often persist between major depressive episodes. According to a three-year prospective study of people treated for depression, cognitive symptoms (defined as diminished ability to think or concentrate and/or indecisiveness) were reported 94% of the time during major depressive episodes and 44% of the time between major depressive episodes (or during periods of partial remission). The sNDA is primarily based on the FOCUS and CONNECT studies, which were specifically designed to assess the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD utilizing objective measures of cognitive function. These two 8-week, randomized, double-blind, placebo-controlled studies of Brintellix 10 and 20 mg/day used a well-established neuropsychological test (the Digit Symbol Substitution Test or DSST). The DSST performance measurement involves executive function, processing speed and attention. The FDA approved Brintellix on 30 September 2013 for the treatment of MDD in adults. Brintellix is furthermore approved in 55 countries (including Europe, Canada, Chile, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa). It is available in approximately 30 countries to date.

 

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