CEO Timo Lappalainen's reviews 2015

Published on 2 February 2016

“Solid year in challenging environment”

“In 2015 our net sales and operating profit remained good despite declines in Stalevo and Precedex sales and clearly lower milestone payments than in the previous year. This was due to good growth in sales of other products and the better gross margin level than in the comparative period, which was enhanced by improved production efficiency and exchange rate changes.

 

“It was a strong year for the Specialty Products business division, with net sales continuing to grow well, especially in Scandinavia and Finland. In particular, sales of the biosimilar Remsima clearly increased. As regards Proprietary Products, the Easyhaler product family and Dexdor maintained their strong growth. The good progress of the Easyhaler product family was mainly due to growth in sales of the Bufomix Easyhaler combined formulation (budesonide-formoterol). Based on the research results received in 2015, we have submitted a marketing authorisation application for the budesonide-formoterol combined formulation in Germany, the United Kingdom and France.

 

"Sales of Simdax and Comtan, which have been in the markets for a long time, were also higher than last year. Comtan growth was mainly due to the good development of sales in Japan. In contrast, sales of Stalevo and Precedex continued to decline due to generic competition. However, In Europe extension of generic competition to Stalevo outside Germany did not materially affect Orion’s total sales in 2015. Growth in the Animal Health business division was due to good growth in sales of the animal sedative product family and a payment related to the sale of product rights received early in the year. Orion was granted marketing authorisation in Europe and approval in the United States for Sileo, a new proprietary drug that is indicated for alleviation of acute anxiety and fear associated with loud noise in dogs.

 

“During the year that has ended, jointly with Bayer we continued a Phase III clinical trial with the androgen receptor inhibitor (ODM-201) for treatment of prostate cancer. Bayer took charge of the project at the beginning of 2015. In addition, we commenced a Phase IIa clinical trial with a new formulation of an alpha-2c adrenoceptor antagonist (ORM-12741) for treatment of symptoms of Alzheimer’s disease that we have developed jointly with our partner Janssen Pharmaceuticals.

 

“The earlier part of our clinical pharmaceutical development pipeline was strengthened by altogether three new projects in 2015. We commenced Phase I clinical safety trials with  CYP17 enzyme and an androgen receptor inhibitor (ODM-204) for treatment of castration-resistant prostate cancer, and with a novel, highly potent, selective and reversible negative allosteric modulator of the TRPA1 ion channel (ODM-108) for treatment of neuropathic pain, and a Phase II clinical trial with orally administered levosimendan (ODM-109) for treatment of patients with amyotrophic lateral sclerosis (ALS). In addition, we commenced a Phase I clinical safety trial with ODM-106 for alleviation of symptoms of essential tremor, but we discontinued development of this drug candidate based on the toxicological and pharmacokinetic findings. However, we are continuing research work related to GABA-B receptor positive allosteric modulators.

 

“Generic competition to Stalevo is extending in Europe, but it is difficult to forecast accurately how fast it will extend and the intensity of competition. Growing products such as Dexdorand the Easyhaler product family will be able to compensate for part of the decrease in net sales and operating profit due to generic competition to Stalevo. We estimate that in 2016 net sales will be at similar level to 2015. We estimate that operating profit will exceed EUR 240 million”

 

Published on 27 October 2015

“Product sales developed well”

“In January–September 2015 our net sales and operating profit were at similar level to the previous year. Operating profit remained similar to the previous year despite lower Stalevo and Precedex sales and clearly lower milestone payments than a year ago. This was due to good growth in sales of other products and the better gross margin level than last year, which was enhanced by improved production efficiency and exchange rate changes.

 

“Net sales of the Specialty Products business division continued to grow well, especially in Scandinavia and Finland. Growth was particularly strong in the biosimilar Remsima. As regards Proprietary Products, the Easyhaler product family and Dexdor maintained their strong growth. Sales of Simdax and Comtan, which have been in the markets for a long time, were also higher than last year. The growth of Comtan is mainly due to good sales development in Japan. However, sales of Stalevo and Precedex continued to decline due to generic competition. In Europe extension of generic competition to Stalevo outside Germany has not yet materially affected Orion’s sales. Growth in the Animal Health business division was due to good growth in sales of the animal sedative product family and a payment related to the sale of product rights received early this year.

 

“We have completed the additional trials with the Bufomix Easyhaler combined formulation. Based on the results received, Orion is preparing to submit a marketing authorisation application by the end of the year in at least some of the countries that were not included in the decentralised marketing authorisation application process. We have decided to discontinue development of ODM-106 for alleviation of symptoms of essential tremor, but we however continue the research work related to GABA-B receptor positive allosteric modulators. In addition, during the review period we focused on progressing other research and development projects jointly with our collaboration partners.

“Our outlook estimate, which was updated in July and can be found in this report under ‘Outlook for 2015’ and ‘Basis for outlook’, remains unchanged. We estimate that in 2015 net sales will be at similar level to 2014. We estimate that operating profit will exceed EUR 260 million.”

Published on 28 July 2015

“Year continued strongly”

“In the first half of 2015 our net sales were at nearly the same level as in the comparative period and operating profit was slightly higher. However, this year substantially smaller proportions of net sales and especially operating profit than a year ago derived from milestone payments.
 

“Net sales of the Specialty Products business division continued to develop well in Finland, Scandinavia and Eastern Europe, the main market areas. As regards Proprietary Products, the Easyhaler® product family and Dexdor® maintained their strong growth. Sales of Simdax® and Comtan®, which have been in the markets for a long time, were also higher than in the previous year. Stalevo® and Precedex® sales continued to decrease due to generic competition, but good growth in other proprietary products was able to compensate for this decline in net sales, and as a whole net sales from sales of the Proprietary Products business division’s products were at nearly the same level as in the previous year. Growth in the Animal Health business division was due to good growth in sales of the animal sedative product family and a payment related to the sale of product rights received early this year.

“The increase in operating profit was due to good growth in product sales and higher gross profit, which enabled us to compensate for the decrease in profit due to lower Stalevo® and Precedex® sales and lower milestone payments. The margin level in the first half of the year was improved by enhanced production efficiency and exchange rate changes.

“During the review period, the European Commission granted marketing authorisation for Sileo® (dexmedetomidine), Orion’s Animal Health division’s new proprietary drug, which is indicated for alleviation of acute anxiety and fear associated with loud noise in dogs.

“Our early-phase research portfolio has developed well during the year. We have commenced Phase I clinical safety trials with an investigational CYP17 enzyme and androgen receptor inhibitor (ODM-204) for treatment of castration-resistant prostate cancer, with a GABA-B receptor positive allosteric modulator (ODM-106) for alleviation of symptoms of essential tremor and with a novel, highly potent, selective and reversible negative allosteric modulator of the TRPA1 ion channel (ODM-108) for treatment of neuropathic pain. In addition, we have commenced Phase II clinical trials with orally administered levosimendan (ODM-109) for treatment of patients with amyotrophic lateral sclerosis (ALS) and a Phase IIa trial with a new formulation of an alpha-2c adrenoceptor antagonist (ORM-12741) for treatment of symptoms ofAlzheimer's disease. Our other research projects also progressed as planned during the review period.

“After the end of the review period, we upgraded our outlook estimate for 2015 due to the good start to the year. Extension of generic competition to Stalevo outside Germany did not yet significantly affect the figures for the first half year. Because of the good growth in the first half of the year in the steadily growing business areas such as Specialty Products,Dexdor® and the Easyhaler® product family we expect them to compensate during the current year for the decreases in net sales due to some rapid changes, such as extension of generic competition to Stalevo® in Europe, decreasing royalties from Precedex® and the timing of milestone payments. We estimate that in 2015 net sales will be at similar level to 2014. We estimate that operating profit will exceed EUR 260 million.”

 

 

Published on 29 April 2015

“Year started strongly”

 “In the first quarter of 2015 our net sales were slightly higher and operating profit was clearly higher than in the comparative period.

“The net sales of the Specialty Products business division continued to develop well. As regards proprietary products, the Easyhaler® product family and Dexdor® maintained their strong growth. Sales of Simdax® and Comtan®, which have been in the markets for a long time, were also higher than in the previous year. Stalevo® and Precedex® sales continued to decrease due to generic competition, but good growth in other proprietary products was able to compensate for this decline in net sales, and as a whole the net sales of the Proprietary Products business division were similar to the previous year. Growth in the Animal Health business division was mainly due to good growth in sales of the animal sedative product family and a payment related to the sale of product rights.

“The increase in operating profit was due partly to good growth in sales, but especially to higher gross profit. The margin level in the first quarter of the year was improved by exchange rate changes, in addition to slightly lower production costs.

“As we announced already in Financial Statement release, during the first quarter of the year we commenced Phase I clinical safety trials with an investigational CYP17 enzyme and androgen receptor inhibitor (ODM-204) for treatment of castration-resistant prostate cancer, and with a GABA-B receptor positive allosteric modulator (ODM-106) for alleviation of symptoms of essential tremor.

“We have also commenced Phase I clinical safety trials with a novel, highly potent, selective and reversible negative allosteric modulator of the TRPA1 ion channel (ODM-108) for treatment of neuropathic pain. Our clinical drug development pipeline will be further strengthened when we commence Phase II clinical trials with orally administered levosimendan (ODM-109) for treatment of patients with amyotrophic lateral sclerosis (ALS). Our other research projects progressed as planned during the review period.

“Based on the good start for the year we have updated our outlook estimate for 2015. Extension of generic competition to Stalevo outside Germany did not yet significantly affect the first quarter figures. During the current year the steadily growing business areas such as Specialty Products, Dexdor and the Easyhaler product family will not be able to compensate fully for the decrease in net sales and operating profit due to some rapid changes, such as extension of generic competition to Stalevo in Europe, declining royalties from Precedex and the timing of milestone payments. We estimate that in 2015 net sales will be slightly lower than in 2014. We estimate that operating profit will exceed EUR 230 million.”