CEO Timo Lappalainen's reviews 2016

Published on 8 February 2017

“Another strong year for hundred-year-old Orion”

 “In 2016 our net sales and operating profit were higher than in the previous year. The clear growth in operating profit is explained by the growth in net sales and about EUR 22 million of total capital gains.

 

“The Easyhaler product family for treatment of asthma and chronic obstructive pulmonary disease maintained its strong growth, led by the Bufomix Easyhaler combined formulation. During the year, through the decentralised procedure we received marketing authorisations for the budesonide-formoterol combined formulation in Germany, the United Kingdom and France. The national approval process has been completed in Germany and is ongoing in the United Kingdom and France. In addition, following the positive findings in the pharmacokinetic trials with a salmeterol-fluticasone combined formulation we received in December, we are planning to apply for marketing authorisation for the product in Europe. It is currently estimated that the marketing authorisation application in Europe could be submitted during the first half of 2017.

 

“As regards our other key proprietary products, intensive care sedative Dexdor continued to grow strongly and sales of Simdax for treatment of acute decompensated heart failure, which has been in the markets for a long time, also continued to grow well. Sales of Orion’s branded Parkinson’s drugs Stalevo, Comtess and Comtan continued to decline, but more slowly than expected. However, growing products were able to compensate for the decline in sales of Parkinson’s drugs and increase the total sales of the Proprietary Products business division. The net sales of the business division turned to growth in 2016 for the first time since the start of generic competition for the Parkinson’s franchise.

 

“Net sales of the Specialty Products business division grew in all the key market areas: Finland, Scandinavia and Eastern Europe. As regards the business division’s products, sales of the biosimilar Remsima remained strong relative to the comparative period, although the growth rate has clearly slowed since the start of the year due to the timings of tendering competitions and periods covered by delivery agreements. As regards our other businesses, net sales reached the previous year’s level in Animal Health and contract manufacturing. Fermion’s sales declined due to the challenging market situation and the increasing focus of production on the parent company Orion’s products. The decline in Orion Diagnostica’s net sales was mainly due to the ending of some collaboration related to the distribution of products.

 

“A lot happened in Orion's research and development in 2016. Jointly with Bayer we have expanded the clinical development programme for androgen receptor antagonist (ODM-201) for treatment of prostate cancer and commenced a new Phase III trial with patients having metastatic hormone-sensitive prostate cancer. In a new project we commenced a Phase I clinical trial with a BET protein inhibitor (ODM-207) which inhibits transcription of key oncogenes in many cancers. In January, after the review period, our partner Tenax completed the Phase III clinical trial with levosimendan. According to the preliminary findings, the trial did not achieve its primary objectives. Tenax has announced that it will continue analysing the findings and will discuss the trial results and possible continuance of development work with the US Food and Drug Administration (FDA). We at Orion completed the Phase II clinical trial with orally administered levosimendan (ODM-109) for treatment of patients with ALS. Although the trial did not achieve its primary objective, the findings were, however, promising. Based on the findings, we are planning to continue the development programme. During the year the project for treatment of symptoms of Parkinson’s disease (ODM-104) and the project for treatment of solid cancerous tumours (ODM-203) progressed into Phase II clinical trials. During the year, we discontinued two early-phase clinical trials based on the findings.

 

“In addition, we strengthened our early-phase research through strategic collaboration agreements with the German Center for Neurodegenerative Diseases (DZNE) in treatment of neurodegenerative diseases, with the Japanese pharmaceutical company Asahi Kasei Pharma in treatment of pain and with the US University of Wisconsin in treatment of oncological diseases.

 

“We estimate that in 2017 net sales will be at similar level to 2016. We estimate that operating profit excluding material capital gains will be at least EUR 280 million.

 

Published on 25 October 2016

"Business developed well – capital gains enhanced strong operating profit growth"

“In January–September 2016 our net sales and operating profit were higher than in January–September 2015. The clear growth in operating profit is explained by the growth in net sales and about EUR 22 million of total capital gains received in the third quarter.

 

“As regards our key proprietary products, the Dexdor sedative used in intensive care and Easyhaler product family for treatment of asthma and chronic obstructive pulmonary disease maintained their strong growth. Sales of Simdax for treatment of acute decompensated heart failure also continued to grow well. After the review period, through the decentralised procedure the budesonide-formoterol Easyhaler combined formulation received marketing authorisation for Germany, where the national approval process has commenced. Sales of Orion’s branded Parkinson’s drugs Stalevo, Comtessand Comtan continued to decline, but more slowly than expected.

 

“Net sales of the Specialty Products business division rose in all the key market areas: Finland, Scandinavia and Eastern Europe. As regards the business division’s products, sales of the biosimilar Remsima remained strong relative to the comparative period, but the growth rate has clearly slowed since the start of the year due to the timings of tendering competitions and periods covered by delivery agreements.

 

“There have been changes in our clinical pharmaceutical development portfolio since the summer. We are commencing a new Phase I clinical trial with a BET protein inhibitor (ODM-207) which inhibit transcription of key oncogenes in many cancers. We have decided to discontinue trials with a CYP17 enzyme and androgen receptor inhibitor (ODM-204) for treatment of castration-resistant prostate cancer based on the pharmacokinetic findings of the Phase I clinical trial. Other ongoing clinical pharmaceutical development projects in various phases have progressed as planned.

 

“Our outlook estimate for 2016 remains unchanged. We estimate that in 2016 net sales will be slightly higher than in 2015. We estimate that operating profit excluding possible capital gains will exceed EUR 270 million.

 

Published on 19 July 2016

“Sales developed strongly in the first half of the year”

 “In the first half of 2016 our net sales and operating profit were higher than in January–June 2015.

“As regards our key proprietary products, the Dexdor sedative used in intensive care and Easyhaler product family for treatment of asthma and chronic obstructive pulmonary disease maintained their strong growth. Sales of Simdax, which has been in the markets for a long time, also grew well. Growth in sales of these products in the first half of the year was able to compensate for the decline in sales of Orion’s branded Parkinson’s drugs Stalevo, Comtessand Comtan. In Europe generic competition to Stalevo extended more slowly than expected in the first half of the year.

“Net sales of the Specialty Products business division grew in all key market areas, but especially strongly in Scandinavia and Finland, where we were again able to grow clearly faster than the market. As regards the business division’s products, there was strong growth in the biosimilar Remsima compared with the comparative period, but sales of other products in the portfolio also developed well.

“Our late-phase clinical pharmaceutical development pipeline is being strengthened as jointly with Bayer we are expanding the clinical development programme for the ODM-201 androgen receptor antagonist for treatment of prostate cancer and commencing a new Phase III trial with patients having metastatic hormone-sensitive prostate cancer. The ODM-201 Phase III trial commenced in 2014 is continuing and progressing as planned. As regards early-phase projects, we have decided to discontinue trials with ODM-108 for treatment of neuropathic pain based on findings from the Phase I trial. Other ongoing clinical pharmaceutical development projects in various phases have progressed as planned.

“In the first half of the year we strengthened our early-phase research through, for example, collaboration agreements with the German Center for Neurodegenerative Diseases (DZNE) in the field of neurodegenerative diseases and with Japan’s Asahi Kasei Pharma in treatment of pain.

“Mainly because of the strong sales development, we updated our full-year outlook for 2016 during the review period. We estimate that in 2016 net sales will be slightly higher than in 2015. We estimate that operating profit excluding possible capital gains will exceed EUR 270 million.

 

Published on 27 April 2016

“Year started well as a whole”

“In the first quarter of 2016 our net sales were at similar level to January–March 2015 and our operating profit was slightly lower.

 

“As regards Proprietary Products, the Easyhaler product family for treatment of asthma and chronic obstructive pulmonary disease maintained its strong growth, led by the Bufomix Easyhaler combined formulation. The Dexdor sedative used in intensive care also grew strongly, and sales of Simdax, which has been in the markets for a long time, increased too. Growth in sales of these products in the first quarter of the year was able to compensate almost fully for the decline in sales of Orion’s branded Parkinson’s drugs Stalevo, Comtessand Comtan due to generic competition. Generic competition to Stalevo is extending in Europe, and this is reducing sales of the product. In addition, in Japan the first marketing authorisations for generic Comtan products were granted, but generic competition has not yet commenced.

 

“Net sales of the Specialty Products business division grew in all key market areas, but especially well in Scandinavia and Finland, where we were again able to grow clearly faster than the market and strengthen our position as market leader. As regards the business division’s products, there was strong growth in the biosimilar Remsima compared with the comparative period, but sales of other products in the portfolio also developed well.

 

“Net sales of the other business divisions declined in the first quarter of the year. In Animal Health, net sales in the comparative period were increased by a payment related to the sale of product rights. The decrease in sales in Fermion was mainly due to the timing of deliveries and in Orion Diagnostica due to the ending of sales of certain products that had been represented and the slowing of market growth in China.

 

“Further progress is being made in our clinical pharmaceutical development pipeline as we commence a Phase II clinical trial with a drug candidate for treatment of symptoms of Parkinson’s disease in which the COMT inhibitor (ODM-104) developed by Orion is combined with the pharmaceutical ingredients carbidopa and long-acting levodopa used to treat Parkinson’s disease. We also completed Phase I clinical safety trials with a new targeted FGFR+VEGFR inhibitor (ODM-203) for treatment of cancers. The project has continued to a Phase II clinical trial to investigate the efficacy of the drug candidate in slowing the growth of solid cancerous tumours in patients in which FGFR changes in cancerous tumours have been detected. Our other ongoing clinical development projects in different phases have also progressed as planned.

 

“Significant investment and production reorganisation projects undertaken in recent years to develop and ensure future growth, delivery reliability and quality standards will be continued through our investment in a new production unit at Fermion’s Hanko manufacturing plant. In addition, we have commenced expansion of Easyhaler production at the Espoo pharmaceuticals production plant.

 

“Our outlook estimate for 2016 remains unchanged. We estimate that in 2016 net sales will be at similar level to 2015. We estimate that operating profit will exceed EUR 240 million.