Last $21.30 USD
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h lundbeck a/s (HLUKF) Key Developments

H. Lundbeck A/S, Q2 2014 Earnings Call, Aug 07, 2014

H. Lundbeck A/S, Q2 2014 Earnings Call, Aug 07, 2014

H. Lundbeck A/S Announces Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2014; Provides Earnings Guidance for the Year 2014

H. Lundbeck A/S announced unaudited earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported revenue of DKK 3,448 million against DKK 3,536 million a year ago. Profit from operations was DKK 274 million against loss from operations of DKK 506 million a year ago. Profit before tax was DKK 240 million against loss before tax of DKK 550 million a year ago. Profit for the period was DKK 144 million or DKK 0.73 per diluted share against loss of DKK 502 million or DKK 2.56 per diluted share a year ago. Cash flows from operating activities were DKK 459 million against DKK 1,346 million a year ago. Investments in intangible assets and property, plant and equipment was DKK 1,209 million against DKK 725 million a year ago. Return on equity was 1.1% against negative return on equity of 3.7% a year ago. Operating profit before depreciation and amortization (EBITDA) was DKK 540 million against DKK 10 million a year ago. Core profit from operations (core EBIT) was DKK 439 million against DKK 566 million a year ago. Cash flow per share was DKK 2.33 against DKK 6.86 a year ago. For the six months, the company reported revenue of DKK 7,035 million against DKK 8,112 million a year ago. Profit from operations was DKK 843 million against DKK 1,020 million a year ago. Profit before tax was DKK 792 million against DKK 974 million a year ago. Profit for the period was DKK 475 million against DKK 565 million a year ago. Diluted earrings per share were DKK 2.42 against DKK 2.88 a year ago. Cash flows from operating activities were DKK 308 million against DKK 1,973 million a year ago. Investments in intangible assets and property, plant and equipment was DKK 1,277 million against DKK 809 million a year ago. Return on equity was 3.5% against 4.2% a year ago. Cash flow per share was DKK 1.57 against DKK 10.06 a year ago. Operating profit before depreciation and amortization (EBITDA) was DKK 1,364 million against DKK 1,776 million a year ago. Core profit from operations (core EBIT) was DKK 1,168 million against DKK 1,487 million a year ago. For the fiscal year 2014, the company expects constant currency revenue to be around DKK 13.5 billion. The company expects core profit from operations (core EBIT) in constant currency to be in the range DKK 0.9-1.4 billion for 2014. Expected reported profit from operations (EBIT) in constant currency is unchanged at DKK 0.0-0.5 billion for 2014 as a result of the acquisition of Chelsea Therapeutics, increased generic erosion, continued investment in an unprecedented number of product launches and significant costs related to the continued progress of key late-stage clinical development projects. For 2015, the company announced that it is expects structural tax rate, due to the more heavy earnings from U.S, will change to between 28 to 30% points compared to revenue.

Otsuka and Lundbeck Submit New Drug Application for Brexpiprazole for Treatment of Schizophrenia and as Adjunctive Therapy for Treatment of Major Depression

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD). The clinical development program included data from more than 6,500 participants of whom more than 5,300 received brexpiprazole. Following the submission the FDA will determine if the NDA is sufficiently complete to allow for a substantive review of the data; a decision from the FDA on initiation of the substantive review is expected in September 2014. Brexpiprazole is a novel investigational psychotropic compound discovered by Otsuka and under co-development with Lundbeck. Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.

H. Lundbeck A/S Revised Earnings Guidance for the Year 2014; Provides Earnings Guidance for the Year 2015

H. Lundbeck A/S revised earnings guidance for the year 2014. For the year, the company expected revenue of DKK 13.5 billion, EBIT in the range of DKK 0.0 billion to DKK 0.5 billion and core EBIT of DKK 0.9 billion to DKK 1.4 billion against previous guidance for the revenue of DKK 13.5 billion, EBIT in the range of DKK 0.5 billion to DKK 1.0 billion and core EBIT of DKK 1.2 billion to DKK 1.7 billion a year ago. The expected impact on its profitability in 2014 will to some extent depend on the timing of the launch of NORTHERA due in the second half of 2014. The company provided earnings guidance for the year 2015. The company announced the completion of the tender offer by its wholly owned indirect subsidiary, Charlie Acquisition Corp., to purchase all of the outstanding shares of Chelsea Therapeutics International Ltd. and it is expected to be dilutive to both cash flow and EBIT for the year, and cash flow accretive in 2015.

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S Presents Results on Sexual Functioning in Well Treated MDD Patients Experiencing Treatment-Emergent Sexual Dysfunction

Takeda Pharmaceutical Company Limited and H. Lundbeck A/S (Lundbeck) announced that the companies presented results about sexual functioning from a head-to-head study of Brintellix® (vortioxetine) vs. escitalopram in patients with well treated major depressive disorder (MDD) experiencing treatment-emergent sexual dysfunction (TESD). The data, accepted as a late-breaker, was shared in a poster presentation #41. In the study, 447 patients with recent major depressive episodes who had responded to SSRI monotherapy but were experiencing TESD were discontinued on their initial treatment and then randomized to Brintellix 10 mg/day or escitalopram 10 mg/day (10 mg for week one and 20 mg for week two of treatment) for eight weeks. The dose of Brintellix or escitalopram could be adjusted after week two, four, or six, as judged by the investigator. The primary endpoint was change from baseline to week 8 in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) total score using mixed-effects model repeated measures approach (MMRM). The results demonstrated that patients treated with Brintellix (n=169) experienced a statistically significant improvement, with a mean treatment difference of 2.2 points (95% CI: 0.48-4.02) in the CSFQ-14 total score after eight weeks of treatment (P=0.013; MMRM) compared to escitalopram (n=179). The CSFQ-14 is a clinical and research instrument identifying five scales of sexual functioning and yields scores for three scales corresponding to the phases of the sexual response cycle.1 Numerically more Brintellix-treated patients were responders (change from baseline in CSFQ-14 total score >3; OR=1.51; P=0.06), as compared with escitalopram. Numerically similar responses on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score were observed between the two groups at the end of week eight. In this study, common adverse events for Brintellix were nausea, headache, and dizziness. These findings build on the global clinical trial program for Brintellix. The comprehensive clinical trial program evaluating the safety and efficacy of Brintellix was comprised of seven positive pivotal studies, including six 6-8 week short-term studies and one 24-64 week long-term maintenance study that demonstrated statistically significant improvements in overall symptoms of depression in adults with MDD.

 

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