alk-abello a/s (AKBLF) Key Developments
Alk Abello A/S and Merck Announce Encouraging Results from Phase III Allergic Rhinitis Trial
Jun 15 15
Alk Abello A/S has announced encouraging results from its partner, Merck, or MSD's North-American Phase III clinical trial of ALK's investigational sublingual allergy immunotherapy tablet, or SLIT-tablet, for the treatment of house dust mite, or HDM, allergic rhinitis. The trial demonstrated a statistically significant improvement in the primary endpoint in favour of HDM SLIT-tablet compared with placebo. The primary endpoint of the trial was to demonstrate a reduction in the 'Total Combined Rhinitis Score' (TCRS) which is the sum of the average daily rhinitis symptom score and the average daily medication score. The trial also showed that the treatment was generally well tolerated. The trial, a randomised, multi-centre, placebo controlled, double-blind, comparative trial, was initiated by MSD in March 2014 to further investigate the safety and efficacy of the HDM SLIT-tablet in patients with HDM allergic rhinitis. It involved approximately 1,500 patients in the USA and Canada and is part of the world's large ever allergy immunotherapy development programme, which also includes trials in Europe and Japan. MSD has informed ALK that they now plan to discuss the data and the plans for a regulatory submission of a Biological License Application (BLA) for the HDM SLIT-tablet with the FDA. The HDM SLIT-tablet is currently undergoing regulatory reviews in Europe and Japan based on a combined clinical development programme involving more than 4,000 patients, including the completion of two positive Phase III clinical trials for the treatment of HDM allergic rhinitis and one positive Phase III trial for the treatment of HDM allergic asthma.
ALK-Abelló A/S Presents at Nordic Mid/Small Cap Seminar, Jun-02-2015
Jun 2 15
ALK-Abelló A/S Presents at Nordic Mid/Small Cap Seminar, Jun-02-2015 . Venue: Stockholm, Sweden.
ALK-Abelló A/S Presents at Goldman Sachs 36th Annual Global Healthcare Conference, Jun-10-2015 08:40 AM
May 27 15
ALK-Abelló A/S Presents at Goldman Sachs 36th Annual Global Healthcare Conference, Jun-10-2015 08:40 AM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States. Speakers: Flemming Pedersen, Chief Financial Officer, Executive Vice President and Member of Management Board.
ALK-Abelló A/S Presents at Jefferies 2015 Global Healthcare Conference, Jun-02-2015 01:30 PM
May 27 15
ALK-Abelló A/S Presents at Jefferies 2015 Global Healthcare Conference, Jun-02-2015 01:30 PM. Venue: The Grand Hyatt Hotel, New York, New York, United States. Speakers: Jens Bager, Chief Executive Officer, President and Member of the Board of Management.
ALK-Abelló A/S Reports Unaudited Earnings Results for the First Quarter of 2015; Provides Earnings Guidance for 2015
May 5 15
ALK-Abello A/S reported unaudited earnings results for the first quarter of 2015. For the first quarter, the company reported revenue of DKK 650 million against DKK 684 million a year ago. Operating profit before depreciation and amortisation (EBITDA) was DKK 128 million against DKK 206 million a year ago. Operating profit (EBIT) was DKK 91 million against DKK 174 million a year ago. Profit before tax (EBT) was DKK 159 million against DKK 183 million a year ago. Net profit was DKK 89 million against DKK 108 million a year ago. Cash flow from operating activities was DKK 31 million against DKK 93 million a year ago. Earnings per share (DEPS), diluted was DKK 9 against DKK 11 a year ago. Cash flow per share (CFPS) was DKK 3 against DKK 10 a year ago. Exchange rate developments impacted revenue growth positively by approximately 4% points. Cash flow decrease was primarily caused by lower milestone payments. Additions, intangible assets were DKK 9 million against DKK 18 million a year ago. Additions, tangible assets were DKK 25 million against DKK 18 million a year ago.
For 2015, ALK still expects to grow revenue in the base business by 0-5% in local currencies based on low, single-digit growth in Europe and high single-digit growth in non-European markets. Growth initiatives are expected to outweigh the impact of European austerity measures. To reflect current exchange rates, reported revenue in the base business is now expected at DKK 2.25-2.35 billion (previously DKK 2.2-2.3 billion). Operating profit (EBITDA before special items), excluding sales royalties and milestone payments from partnerships, is expected in the range of DKK 225 - DKK 300 million. Exchange rates are not expected to materially affect EBITDA. CAPEX is projected at approximately DKK 200 million, while free cash flow is expected to be negative in the range of DKK 100 - DKK 200 million.