LEO Pharma

With topline growth of 7% in 2019, margin improvements and pipeline success, LEO Pharma paves the way for an ambitious future


LEO Pharma helped 92 million patients and reached revenue of DKK 10,805 million in 2019

-       2019 revenue up by 4% to DKK 10,805 million – with a strong fourth quarter demonstrating further momentum. This was driven by strong performances of Enstilar®, Kyntheum® and the prescription portfolio acquired from Bayer.

-       Underlying revenue grew by 7%. This excludes currency effects, divestments of non-core business to Karo Pharma and other one-time effects.

-       Revenue in region Europe+ grew 5% to DKK 6,840 million, due to Enstilar®, Kyntheum® and the acquired Bayer portfolio.

-       Sales in region International grew 12% to DKK 3,117 million, due to the acquired Bayer portfolio.

-       US sales declined 22% to DKK 848 million, due to generic competition and price pressure. We continue to see the US as a key growth driver in the future and are stepping up the launch preparations for tralokinumab accordingly.

Established business remains the backbone with continued growth and improved profitability

-       Topline of the established dermatology portfolio (ie, excluding thrombosis) grew by 10% compared to 2018, driven by Enstilar®, Fucidin® and the prescription portfolio acquired from Bayer. Europe+ and region International with solid growth.

-       Enstilar® is now the best-selling product in the psoriasis portfolio and continues to gain market share from corticosteroid generics. More than a third of all worldwide topical psoriasis treatments by volume are produced by LEO Pharma.

-       Adjusted for the non-recurring divestment of products to Karo Pharma, EBITDA for the total established portfolio was DKK 3,198 million, with margin improving by 4 percentage points from 27% in 2018 to 31% in 2019.

LEO Pharma invested 23% of its revenue in R&D in 2019 and saw significant advancement across the pipeline

-       Tralokinumab met the primary and secondary endpoints in its pivotal phase 3 studies. These results enable LEO Pharma to prepare filing in the US, Europe and Japan, for its first global biologics launch.

-       Patidegib (developed and owned by partner PellePharm) is now in phase 3. The partnership with PellePharm represents LEO Pharma’s entry into rare dermatology.

-       LEO Pharma now has one product in phase 3 (tralokinumab) with an option for a second (patidegib) through an acquisition of PellePharm, and two in phase 2 (delgocitinib and an oral PDE4 inhibitor), which is a significant advancement of its late-stage pipeline.

-       With these advancements, LEO Pharma is well positioned to address dermatology, which is among the three fastest growing therapeutic areas.

-       New partnerships – Ubiquigent Ltd. option agreement for two novel compounds, Elektrofi to co-develop formulation technologies for antibodies, Epicore Biosystems on their wearable technologies, and Portal Instruments on innovative needle-free drug delivery systems.

Adjusted for the non-recurring divestment of non-core products to Karo Pharma, EBIT rose by 5%

-       Significant investments in innovative new treatments within atopic dermatitis, eczema, psoriasis and Gorlin Syndrome.

-       R&D investments increased from 18% to 23% of revenue, primarily due to investments in tralokinumab.

-       Net loss in 2019 is a consequence of increased research and development costs, integration cost for the Bayer portfolio and an impairment loss.

Focus on profitability improvements and increased investments in innovation for 2020

-       Anticipated revenue growth of 2-5% to DKK 11.0-11.4 billion in 2020.

-       Continued focus on profitability improvements in the established portfolio, while also significantly increasing spending on research and development activities after the successful development in the pipeline in 2019 to continue the transformation into an innovative-driven growth company.

-       Anticipated operating loss in 2020 of DKK 1.8 – 2.0 billion.

Catherine Mazzacco, CEO and President of LEO Pharma commented:

“2019 was a significant year for LEO Pharma with a solid clinical and financial performance. With an underlying growth of 7%, we met expectations and a strong fourth quarter gives us confidence for 2020. At the same time, we made significant progress with our transformation into an innovation-driven growth company. The tralokinumab phase 3 data enables us to soon file for marketing authorization in US, Europe and Japan, and we have progressed important projects and partnerships. With the improved profitability of our established business we are well positioned to continue the transformation. Our overall results reflect these investments.

Innovation is critical to LEO Pharma’s long-term success in dermatology which is among the three fastest growing therapeutic areas. On the back of clinical success in 2019 we will invest even more in our pipeline in 2020. We are building on a strong legacy towards our ambition to be the leader in terms of market position, breadth of portfolio and pipeline, and in how we enable patients to live healthy lives free of interference from their disease.”

Key figures

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*Change in local currencies and adjusted for divestments and other one-time effects

Annual report 2019

The full results are available in the LEO Pharma Annual Report 2019 on the company’s website at www.leo-pharma.com/annual-report-2019



Henrik Kyndlev
Global External Communications
+45 3140 6180

About LEO Pharma

LEO Pharma
LEO Pharma
Industriparken 55
2750 Ballerup

4494 5888http://www.leo-pharma.com/

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. For more information about LEO Pharma, visit www.leo-pharma.com.

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Latest releases from LEO Pharma

LEO Pharma Enters License Agreement with Oneness Biotech and Microbio Shanghai for FB825 a Novel Atopic Dermatitis and Asthma Drug Candidate15.4.2020 07:45:16 CESTPress release

BALLERUP, Denmark, April 15, 2020 – LEO Pharma A/S, a global leader in medical dermatology, today announced that is has signed a worldwide exclusive licensing agreement with Oneness Biotech (Taiwan, TPEx: 4743) and Microbio Shanghai (China) covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825.

LEO Pharma Group completes divestment of Emollients and Proctology Portfolio to Karo Pharma2.3.2020 12:05:26 CETPress release

Ballerup, DENMARK, March 2, 2020 – LEO Pharma today announced that the divestment of its emollients and proctology portfolio to Karo Pharma for 90 MEUR has been completed. The initial agreement with Karo Pharma was announced on December 23, 2019 and approved by relevant competition authorities on February 20, 2020. This divestment marks an important step for LEO Pharma towards strategically aligning its portfolio and increasing focus on innovation and dermatology. The divested products include four anti-hemorrhoid products (Sheriproct®, Doloproct®, Neriproct® and Ultraproct®) and six dermatology products, mainly over-the-counter products (Ultrabas®, Ultralip®, Ultraphil®, Ultrasicc®, Neribas® and Ultralan®).

LEO Pharma Signs Agreement to Divest Emollients and Proctology Portfolio to Karo Pharma23.12.2019 12:10:00 CETPress release

Ballerup, DENMARK, December 23, 2019 – Today, LEO Pharma announced the sale of 10 products to Karo Pharma AB for 90 MEUR. The divested portfolio isnon-core to LEO Pharma’s business, and was part of the portfolio acquired from Bayer in July 2019. “This divestment is an important step for LEO Pharma towards strategically aligning our portfolio and increasing focus on innovation and dermatology. This well-established portfolio will be better served by Karo Pharma and its team,” said Anders Kronborg, Chief Financial Officer, LEO Pharma. The product portfolio includes four anti-haemorrhoid products (Sheriproct®, Doloproct®, Neriproct® and Ultraproct®) and six dermatology, mainly over-the-counter products (Ultrabas®, Ultralip®, Ultraphil®, Ultrasicc®, Neribas® and Ultralan®). Karo Pharma is a fast-growing specialty pharma company that develops and markets products to physicians, pharmacies and directly to healthcare providers. The company is listed on the Swedish stock exchange, Nasdaq Stock

LEO Pharma announces positive top-line results for tralokinumab from three Phase 3 studies in adult patients with moderate-to-severe AD11.12.2019 08:05:00 CETPress release

BALLERUP, Denmark, December 11, 2019 – LEO Pharma A/S, a global leader in medical dermatology, today announced that tralokinumab – an investigational, fully human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine – met all primary and secondary endpoints in its three pivotal Phase 3 studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo. IL-13 is a key driver of the type 2 inflammation that plays a major role in AD,(1) which is the most common inflammatory skin disease in the developed world,(2) affecting up to five percent of adults across the United States, Canada, Europe and Japan.(3) AD can have a significant, negative impact on patients’ well-being, primarily due to distressing itch, sleep deprivation and social stigmatization due to visible lesions.(4) “In its moderate-to-severe form, AD can cause unbearable

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