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H. Lundbeck A — Interim / Quarterly Report 2011
Aug 10, 2011
3367_ir_2011-08-10_56fc8f2d-72e1-4dc1-9fcb-4e55c115bba3.pdf
Interim / Quarterly Report
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H. Lundbeck A/S
DK-2500 Valby, Copenhagen Fax +45 36 43 82 62 www.lundbeck.com CVR number: 56759913
Ottiliavej 9 Tel +45 36 30 13 11 E-mail [email protected]
10 August 2011
First half report 2011 The solid momentum continues – Expected full year results to be in the upper end of the guidance range
H. Lundbeck A/S (Lundbeck) reports second quarter revenue of DKK 4,100 million growing 9% compared to the same period last year. In constant exchange rates revenue for the quarter increased 13%. The growth was driven by increasing revenue from all key products and geographic regions. Profit from operations was DKK 1,102 million, increasing 18% and corresponding to an EBIT margin of 26.9%. Operating profit before depreciation and amortisation (EBITDA) was DKK 1,250 million, increasing 4% and corresponding to an EBITDA margin of 30.5%.
- Continued growth for the key products Cipralex® , Ebixa® and Azilect® , which grew 2%, 16% and 12% respectively.
- Revenue from Xenazine® was DKK 209 million and increased 42%.
- Revenue from Sabril® increased 113% to DKK 80 million.
- Net profit increased 21% to DKK 797 million, corresponding to earnings per share of DKK 4.06.
- As part of the ongoing optimization programme Lundbeck will reduce head count by 125-175 employees in R&D primarily in Denmark and the US. As a consequence of the optimization process there will be a write off mainly on buildings and IP of DKK 300-400 million.
- Lundbeck now anticipates revenue and EBITDA to be in the upper end of the guidance ranges of DKK 15.3-15.8 billion and 4.3-4.6 billion respectively. The EBIT and net profit guidance is maintained as the better performance reflected in the revenue and EBITDA guidance will be offset by write-offs.
| Growth | ||||
|---|---|---|---|---|
| DKK million | Q2 2011 | Q2 2010 | Growth | at CER* |
| Cipralex® | 1,531 | 1,507 | 2% | 6% |
| Lexapro® | 715 | 630 | 13% | 13% |
| Ebixa® | 707 | 610 | 16% | 19% |
| Azilect® | 299 | 267 | 12% | 14% |
| Xenazine® | 209 | 147 | 42% | 59% |
| Sabril® | 80 | 37 | 113% | 138% |
| Europe | 2,091 | 1,982 | 6% | 6% |
| USA | 1,123 | 950 | 18% | 24% |
| International Markets | 824 | 780 | 6% | 17% |
| Total revenue | 4,100 | 3,767 | 9% | 13% |
Distribution of revenue
* Constant exchange rates
In connection with the second quarter report, Lundbeck's President and CEO Ulf Wiinberg said:
"Again our key products deliver solid growth and during the quarter we received positive and encouraging data from the phase III trials with nalmefene. We continue to invest in product and geographical diversification in order to deliver on our growth opportunities. At the same time we maintain our optimization programme and as a consequence we plan to reduce staff in R&D particularly in Denmark and the US. This is something we very much regret, but it is necessary in order to strengthen our long term growth prospects."
| FINANCIAL HIGHLIGHTS AND KEY FIGURES3 |
|---|
| MANAGEMENT REVIEW 4 |
| Financial forecast 2011 4 |
| Lundbeck's development portfolio5 |
| Revenue6 |
| Expenses and income11 |
| Cash flow 13 |
| Balance sheet 14 |
| Other 14 |
| MANAGEMENT STATEMENT16 |
| FINANCIAL STATEMENTS 17 |
FINANCIAL HIGHLIGHTS AND KEY FIGURES
| 2011 | 2010 | 2011 | 2010 | 2010 | |
|---|---|---|---|---|---|
| Q2 | Q2 | H1 | H1 | FY | |
| Financial highlights (DKK million) | |||||
| Revenue | 4,100 | 3,767 | 8,203 | 7,616 | 14,765 |
| Operating profit before depreciation and amortisation (EBITDA) | 1,250 | 1,206 | 2,790 | 2,684 | 4,393 |
| Profit from operations (EBIT) | 1,102 | 936 | 2,407 | 2,190 | 3,357 |
| Net financials | (19) | (55) | (57) | (66) | (68) |
| Profit before tax | 1,083 | 881 | 2,350 | 2,124 | 3,289 |
| Tax | 286 | 220 | 623 | 518 | 823 |
| Profit for the period | 797 | 661 | 1,727 | 1,606 | 2,466 |
| Equity | 11,723 | 10,559 | 11,723 | 10,559 | 11,122 |
| Assets | 18,820 | 18,314 | 18,820 | 18,314 | 18,005 |
| Cash flows from operating and investing activities | 1,245 | 1,174 | 1,362 | 2,038 | 2,462 |
| Property, plant and equipment investments, gross | 107 | 57 | 184 | 95 | 383 |
| Key figures | |||||
| EBITDA margin (%)1 | 30.5 | 32.0 | 34.0 | 35.2 | 29.8 |
| EBIT margin (%)1 | 26.9 | 24.8 | 29.3 | 28.8 | 22.7 |
| Return on capital employed (%) | 8.6 | 7.8 | 18.6 | 18.5 | 27.6 |
| Research and development ratio (%) | 16.9 | 18.8 | 16.2 | 17.5 | 20.6 |
| Return on equity (%)1 | 7.0 | 6.4 | 15.1 | 16.6 | 24.8 |
| Solvency ratio (%)1 | 62.3 | 57.7 | 62.3 | 57.7 | 61.8 |
| Capital employed (DKK million) | 13,641 | 12,522 | 13,641 | 12,522 | 13,039 |
| Share data | |||||
| Number of shares for the calculation of EPS (million) | 196.1 | 196.1 | 196.1 | 196.1 | 196.1 |
| Number of shares for the calculation of DEPS (million) | 196.1 | 196.1 | 196.1 | 196.1 | 196.1 |
| Earnings per share (EPS) (DKK)1 | 4.06 | 3.37 | 8.81 | 8.19 | 12.57 |
| Diluted earnings per share (DEPS) (DKK)1 | 4.06 | 3.37 | 8.81 | 8.19 | 12.57 |
| Cash flow per share (DKK)1 | 6.41 | 6.35 | 10.54 | 11.02 | 16.65 |
| Net asset value per share (DKK)1 | 59.77 | 53.84 | 59.77 | 53.84 | 56.71 |
| Market capitalisation (DKK million) | 26,537 | 16,444 | 26,537 | 16,444 | 20,788 |
| Share price end of period (DKK) | 135.30 | 83.85 | 135.30 | 83.85 | 106.00 |
| Other | |||||
| Number of employees (FTE) | 5,795 | 5,726 | 5,795 | 5,726 | 5,644 |
1) Definitions according to the Danish Society of Financial Analysts' Recommendations & Financial Ratios 2010.
Comparative figures involving number of shares have been restated using a factor of 0.9999 for the effect of employees' exercise of warrants.
MANAGEMENT REVIEW
Financial forecast 2011
Financial guidance for the full year 2011 is maintained. Lundbeck continues to expect revenue of DKK 15.3-15.8 billion, EBITDA of DKK 4.3-4.6 billion and EBIT of DKK 3.3-3.6 billion. Net profit for 2011 is expected to reach DKK 2.3-2.6 billion. Following the solid momentum during the first half of the year, Lundbeck now anticipates revenue and EBITDA to be in the upper end of the guidance ranges.
Financial forecast 2011
| 2010 | 2011 | |
|---|---|---|
| DKK billion | actual | forecast |
| Revenue | 14.8 | 15.3-15.8 |
| EBITDA | 4.4 | 4.3-4.6 |
| EBIT | 3.4 | 3.3-3.6 |
| Net profit | 2.5 | 2.3-2.6 |
| Effective tax rate | 25.0% | 30-32% |
As part of its strategy, Lundbeck has in the past few years identified and executed on a number of initiatives that have and will have positive impact on revenue and profits going forward - a process that continues. Multiple product launches is in progress and several late-stage development projects with great market potential are ongoing, and also further growth opportunities in International Markets and the US are being pursued. A fundamental part of Lundbeck's Research and Development strategy is to establish greater flexibility in the use of external and internal capabilities. This allows the company to secure short term deliverables and execution of the R&D strategy despite reducing internal capacity costs in Research and Development.
Lundbeck will now reduce its permanent R&D work force by around 125-175 positions, primarily at Lundbeck Research USA in Paramus, New Jersey, USA, and at Lundbeck headquarters in Denmark. As part of the process, Lundbeck will initiate a consultation process with the relevant Works Councils.
In connection with the optimization programme in R&D, write offs will be carried out during the second part of the year. As a consequence, the unchanged EBIT guidance is expected to include additional write offs to the amount of DKK 300-400 million on IP rights and buildings and equipment. The expected effective tax rate for the full year is changed from 26-28% to 30-32%. However, the expected tax cash payment will be unchanged.
Forward-looking statements
Forward-looking statements provide current expectations or forecasts for events, such as product launches, product approvals and financial performance. Forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. Actual results may differ from expected results. Factors that may affect future results include fluctuations in interest rates and exchange rates, a delay in or failure of development projects, production problems, unexpected contract breaches or terminations, governmentmandated or market-driven price decreases for Lundbeck's products, introduction of a competing
product, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and their interpretation and unexpected growth in costs and expenses.
Lundbeck's development portfolio
Lundbeck is developing a number of new and promising pharmaceuticals for the treatment of brain disorders. The pipeline projects are targeting areas where Lundbeck currently has a market presence, such as depression, anxiety and other psychiatric disorders, as well as new areas such as stroke and alcohol dependence. Pipeline development is summarised as follows:
Regulatory review
The regulatory filing dossier for the investigational drug Onfi™ (clobazam), which was submitted to the US Food and Drug Administration (FDA) in December 2010, is progressing according to plan. The filing was assigned a standard review and an action letter is anticipated in the fourth quarter 2011.
Clinical phase III
In June 2011, Lundbeck announced the completion of the final study (ESENSE2) in the phase III clinical programme for nalmefene in patients with alcohol dependence. Across the clinical phase III programme consistency and robustness were observed and the studies support the overall positive clinical profile of nalmefene. The reduction in heavy drinking days and total alcohol consumption was seen within the first month of treatment in all three studies and was maintained throughout the 12-month safety study. Submission of a European Marketing Authorization Application (MAA) for nalmefene is expected by the end of 2011.
The additional clinical phase III studies with Lu AA21004 in Major Depressive Disorder (MDD) continue to recruit patients according to plan. The studies are based on the clinical data obtained to date, which demonstrate positive results for the potential efficacy and the tolerability profile of Lu AA21004.
The clinical phase III studies with desmoteplase in ischaemic stroke, DIAS-3 and DIAS-4, have now seen improved patient recruitment following several initiatives to speed up recruitment. However, the programme has as previously reported not recruited at the expected pace and desmoteplase will therefore be unable to deliver a filing as anticipated in the second half of 2012, but more likely in first half of 2014.
The pivotal program with zicronapine is ongoing. The first study in the programme is focused on schizophrenia and is expected to enrol 160 patients. The pivotal program is planned to include additional phase III studies to further investigate the compound's benefit and risk profile.
Clinical phase II
Lu AA24493 is an interesting tissue protective cytokine with potential for addressing medical needs in a number of severe CNS diseases. In November 2009, Lundbeck initiated a phase IIa clinical study with this innovative compound in patients suffering from Friedreich's ataxia in order to explore efficacy parameters of the drug via biomarkers as well as to evaluate the safety and tolerability of Lu AA24493.
In the study, Lu AA24493 did not meet the key efficacy endpoints and the results do not support further development of the drug in Friedreich's ataxia.
In November 2009, Lundbeck initiated a multi-centre, placebo-controlled, fixed-dose study of Lu AE58054 as an add-on to donepezil in patients with moderate Alzheimer's disease. The clinical phase II study plans to enrol approximately 270 patients. The purpose of this study is to investigate if Lu AE58054 treatment improves cognition and functional outcomes after 24 weeks in patients with moderate Alzheimer's disease already in treatment with donepezil. The patient enrolment develops in line with expectations and we expect to have the results in the first half of 2012.
The development programme for Lu AA39959 in bipolar disorder has been suspended since May 2009 as additional pre-clinical work needed to be conducted. Further pre-clinical investigation of the concept continues in order to decide on the future clinical development programme. It has therefore been decided to omit the project from the company's pipeline.
Clinical phase I
The pharmacological profiles of both Lu 02-750 and Lu AE04621 have been investigated in phase I and the conclusions do not support further development of the candidates. Therefore the clinical programme for these projects has been closed down.
Revenue
Total revenue for the second quarter was DKK 4,100 million corresponding to an increase of 9%, or 13% in constant exchange rates compared to the same quarter last year.
Total revenue
| Total revenue | 4,100 | 3,767 | 9% | 13% | 4,103 |
|---|---|---|---|---|---|
| Other revenue | 62 | 55 | 12% | 18% | 39 |
| Other pharmaceuticals | 497 | 514 | (3%) | 2% | 538 |
| Sabril® | 80 | 37 | 113% | 138% | 75 |
| Xenazine® | 209 | 147 | 42% | 59% | 208 |
| Azilect® | 299 | 267 | 12% | 14% | 278 |
| Ebixa® | 707 | 610 | 16% | 19% | 687 |
| Lexapro® | 715 | 630 | 13% | 13% | 741 |
| Cipralex® | 1,531 | 1,507 | 2% | 6% | 1,537 |
| DKK million | Q2 2011 | Q2 2010 | Growth | at CER | Q1 2011 |
| Growth |
In April, Sycrest® (asenapine) for the treatment of manic episodes associated with bipolar I disorder was launched in Denmark and has subsequently been launched in Germany. The launch is in its initial stage and Lundbeck is following the sales development closely. Lundbeck expects to launch Sycrest® in approximately 15 countries in 2011. Outside the EU, Saphris® (asenapine's brand name outside the EU) is now approved for both manic episodes associated with bipolar I disorder and schizophrenia in Australia, Brazil, Malaysia and the Philippines. Lundbeck has the commercial rights to Sycrest® /Saphris®
in all markets outside the US, Japan and China. Sycrest® /Saphris® is currently reported as a part of Other pharmaceuticals.
Revenue from Cipralex® (escitalopram) for the treatment of mood disorders rose to DKK 1,531 million, an increase of 2%, or 6% at constant exchange rates. Revenue from Lexapro® , escitalopram marketed in the US by Forest Laboratories, Inc. (Forest), was DKK 715 million for the quarter. This was an increase of 13% compared to the same period last year. The increase was primarily due to higher prices and increased bulk deliveries during the period.
Ebixa® (memantine) for the symptomatic treatment of Alzheimer's disease generated second quarter revenue of DKK 707 million, an increase of 16% compared to the same period last year. The increase corresponds to 19% growth at constant exchange rates. Lundbeck has the marketing rights to Ebixa® in most of the world, except Japan and the US
Revenue from Azilect® (rasagiline) for the treatment of Parkinson's disease was DKK 299 million, an increase of 12%, or 14% in constant exchange rates compared to the second quarter last year. Lundbeck has commercial rights to Azilect® in Europe (in co-promotion with Teva Pharmaceutical Industries Inc. in France, Germany and the UK) and some markets outside Europe, including six Asian countries.
Xenazine® 1 (tetrabenazine) for the treatment of chorea associated with Huntington's disease generated revenue of DKK 209 million in the second quarter, an increase of 42%, or 59% at constant exchange rates compared to the same period last year. Lundbeck has the marketing rights for Xenazine® in the US.
Sabril® (vigabatrin) for the treatment of refractory complex partial seizures (rCPS) and infantile spasms (IS) generated second quarter revenue of DKK 80 million, increasing 113%, or 138% in constant exchange rates compared to second quarter 2010. Sabril® was launched in the US in September 2009.
Revenue from Other pharmaceuticals, which comprise the remainder of Lundbeck's products, was DKK 497 million, and decreased 3% compared to the same quarter last year. In constant exchange rates revenue from Other pharmaceuticals increased 2%.
Other revenue was DKK 62 million, compared to DKK 55 million for the same period last year.
1 Xenazine® is a registered trademark of Biovail Laboratories International (Barbados) S.R.L.
Revenue per region Q2 2011 (growth in brackets) - DKKm
Europe
Second quarter revenue in Europe increased 6% compared to the same quarter last year. The increase was driven by the continued growth in Ebixa® and Azilect® . Revenue in Portugal, Greece and Ireland was impacted during the quarter by the current negative economic environment in these countries.
| Growth | |||||
|---|---|---|---|---|---|
| DKK million | Q2 2011 | Q2 2010 | Growth | at CER | Q1 2011 |
| Cipralex® | 1,001 | 1,001 | 0% | 1% | 991 |
| Ebixa® | 602 | 509 | 18% | 19% | 574 |
| Azilect® | 275 | 243 | 13% | 13% | 254 |
| Other pharmaceuticals | 213 | 229 | (7%) | (7%) | 237 |
| Total revenue | 2,091 | 1,982 | 6% | 6% | 2,056 |
Revenue – Europe
Cipralex® generated second quarter revenue of DKK 1,001 million in Europe and continues to gain market shares and reinforce its leading position in most countries in Europe. However, revenue was unchanged compared to the second quarter last year due to the launch of generic escitalopram in Spain and Finland in 2010 as well as price decreases and health care reforms implemented in some countries during 2010. At the end of May 2011, Cipralex® held a market share in value of 20.0% of the European antidepressant market, compared with a market share of 20.5% at the same time in 2010.
In February 2011, the Federal Joint Committee in Germany (G-BA) recommended to group escitalopram (Cipralex® ) together with citalopram in a reference price group, indicating a fixed price for reimbursement on escitalopram in Germany. The recommendation has now been approved by the German Ministry of Health. As a result, Lundbeck has withdrawn Cipralex® from the public market in Germany in July. Cipralex® will still be available in the private market in Germany constituting approximately 20% of current revenue.
Revenue from Ebixa® rose 18% to DKK 602 million during the quarter. At the end of May 2011 the product held 19.8% of the European Alzheimer's market measured in value, compared to a market share of 18.1% at the same time in 2010. Ebixa® continues to take market shares in several markets in
the EU, and revenue was also positively impacted by the re-launch of Ebixa® in the UK following support of the use of memantine from NICE (National Institute of Health and Clinical Excellence) in the UK.
Second quarter revenue from Azilect® amounted to DKK 275 million, an increase of 13% compared to the second quarter of 2010. At the end of May 2011 Azilect® held a market share in value of 16.0% of the total European Parkinson's market. This compares to a market share of 12.7% at the same time in 2010. Azilect® continues to gain market share in Europe, as it is increasingly recognised as an effective and easy-to-administer medication. The reimbursement of Azilect® in France last year continues to support sales. At the end of May, Azilect® had achieved a market share in France of 19.5%. The price reform in Spain had some negative impact on sales.
Revenue from Other pharmaceuticals was DKK 213 million, a decrease of 7% compared to last year. The decrease was primarily driven by decreasing revenue from Cipramil® .
USA
Lundbeck's second quarter revenue in the US was DKK 1,123 million, an increase of 18%, or 24% at constant exchange rates, compared to the second quarter 2010. The growth was driven by Lexapro® , Xenazine® and Sabril® .
| Growth | |||||
|---|---|---|---|---|---|
| DKK million | Q2 2011 | Q2 2010 | Growth | at CER | Q1 2011 |
| Lexapro® | 715 | 630 | 13% | 13% | 741 |
| Xenazine® | 209 | 139 | 50% | 67% | 184 |
| Sabril® | 80 | 37 | 113% | 138% | 75 |
| Other pharmaceuticals | 119 | 144 | (17%) | (7%) | 131 |
| Total revenue | 1,123 | 950 | 18% | 24% | 1,131 |
Revenue – USA
Revenue from Lexapro® was DKK 715 million for the quarter, an increase of 13% compared to the same quarter last year. The increase was primarily due to higher prices and increased bulk deliveries during the period. At the end of May, Lexapro® held a market share in value of 23.8% of the US aggregate market for antidepressants, compared to a market share of 23.4% in May 2010.
Prepayments from Forest, recorded in Lundbeck's balance sheet as the difference between the invoiced price and the minimum price of Forest's inventories, were DKK 519 million as of 30 June 2011. This compares to DKK 619 million as of the end of June 2010.
Revenue from Xenazine® was DKK 209 million for the quarter, an increase of 50% compared to the second quarter last year. The positive trend from the previous quarters continues as Xenazine® revenue is progressing well and is on track to meet our expectations.
Sabril® revenue for the quarter was DKK 80 million, growing 113% compared to the same quarter last year. The performance of Sabril® continues to be driven by increased compliance rates among existing patients as well as higher doses used.
Second quarter revenue from Other pharmaceuticals in the US was DKK 119 million, a decrease of 17% compared to same quarter last year. The decrease in revenue is mainly due to the temporary withdrawal of NeoProfen® from the market, as well as decreasing revenue from mature products.
International Markets
Revenue in International Markets, which comprise all of Lundbeck's markets outside Europe and the US, was DKK 824 million for the quarter. This is an increase of 6% compared to the second quarter 2010, or 17% at constant exchange rates. The growth was driven by all key products as well as Other pharmaceuticals.
| Growth | |||||
|---|---|---|---|---|---|
| DKK million | Q2 2011 | Q2 2010 | Growth | at CER | Q1 2011 |
| Cipralex® | 530 | 506 | 5% | 15% | 546 |
| Ebixa® | 105 | 101 | 3% | 20% | 113 |
| Azilect® | 24 | 24 | 5% | 21% | 24 |
| Other pharmaceuticals | 165 | 149 | 11% | 21% | 194 |
| Total revenue | 824 | 780 | 6% | 17% | 877 |
Revenue – International Markets
Cipralex® generated second quarter revenue of DKK 530 million in International Markets, an increase of 5% compared to the second quarter last year and corresponding to an increase of 15% at constant exchange rates. Cipralex® sales in Canada continue to show strong growth, and grew 35% during the quarter. Cipralex® now holds a market share in terms of value of 16.7% in Canada (May 2011), compared to 11.4% at the same time last year. At the end of May 2011, Cipralex® held a market share in terms of value of 11.6% of the aggregate market for antidepressants in International Markets2 , compared to a market share of 11.0% in the same period last year.
In December 2010, Lundbeck revised the agreement regarding Lexapro® with its partner in China, Xian-Janssen Pharmaceuticals Ltd. (Xian-Janssen). The new agreement changed the terms from a traditional license agreement to a co-promotion agreement, which means that both parties will invest substantially in joint sales and more marketing efforts for Lexapro® in China. The new sales set-up is now in place and, together with Xian-Janssen, Lundbeck has now established a very competitive antidepressant sales force in China. Since the beginning of the year Lundbeck has doubled its sales force in China to approximately 100 sales representatives promoting Lexapro® and Ebixa® .
In July 2011, Lundbeck entered into an agreement with SPIMACO (Saudi Pharmaceutical Industries & Medical Appliances Corporation), one of the largest pharmaceutical manufacturers in the Middle East. The partnership with SPIMACO starts in Saudi Arabia with the co-marketing of escitalopram and the copromotion of citalopram, with an option to include other markets and also include SPIMACO's CNS products.
Ebixa® generated second quarter revenue of DKK 105 million, an increase of 3%, or 20% at constant exchange rates. The increase was due to continued growth in most important markets. In May 2011,
2 Market shares for International Markets are based on IMS data from Australia, Brazil, Canada, China, Mexico, Saudi Arabia, South Africa, South Korea and Turkey.
Ebixa® held 8.8% of the total market in terms of value of pharmaceuticals for the treatment of Alzheimer's disease in International Markets. This compares to a market share of 8.4% in May 2010.
Other pharmaceuticals generated revenue of DKK 165 million during the quarter, an increase of 11%, or 21% at constant exchange rates, compared to the same quarter last year. The increase was due to a positive development in some of Lundbeck's mature products as well as quarterly fluctuations in revenue.
Expenses and income
Total costs for the quarter were DKK 2,998 million, an increase of 6% compared to the second quarter last year.
Distribution of costs
| DKK million | Q2 2011 | Q2 2010 | Growth | Q1 2011 |
|---|---|---|---|---|
| Cost of sales | 726 | 706 | 3% | 781 |
| Distribution | 1,040 | 914 | 14% | 905 |
| Administration | 540 | 504 | 7% | 479 |
| Research & Development | 692 | 707 | (2%) | 633 |
| Total costs | 2,998 | 2,831 | 6% | 2,798 |
Total cost of sales increased 3% to DKK 726 million. This corresponds to 18% of Lundbeck's total revenue, compared with 19% in the second quarter of 2010. Cost of sales for the period was affected by the higher cost of goods sold due to increasing revenue from in-licensed products (i.e. Xenazine®, Azilect® and Ebixa® ). The sale of production facilities in the UK (Seal Sands) affected cost of sales positively in the quarter by DKK 95 million.
Distribution costs were DKK 1,040 million, corresponding to 25% of revenue and an increase of 14% compared to the second quarter last year. The increase in distribution costs was due to launch cost for Sycrest® and pre-launch costs for OnfiTM and nalmefene. Administrative expenses were DKK 540 million and corresponded to 13% of the total revenue for the period, which was at the same level as second quarter last year. SG&A costs were DKK 1,580 million, compared to DKK 1,418 million in the same period last year. The SG&A margin for the period was 38% compared to 37% in the same period last year.
R&D costs for the quarter were DKK 692 million compared to DKK 707 million in the same period last year.
Operating profit before depreciation and amortisation (EBITDA)
EBITDA was DKK 1,250 million, compared to DKK 1,206 million for the second quarter of 2010. EBITDA margin for the period was 30.5%, compared to 32.0% in the same quarter last year.
Depreciation, amortisation and impairment charges
Depreciation, amortisation and impairment charges, which are included in the individual expense categories, amounted to DKK 148 million compared to DKK 270 million in second quarter last year.
| Depreciation, amortisation and impairment charges | |||||
|---|---|---|---|---|---|
| DKK million | Q2 2011 | Q2 2010 | Growth | Q1 2011 | |
| Cost of sales | (33) | 53 | (163%) | 54 | |
| Distribution | 98 | 129 | (23%) | 103 | |
| Administration | 25 | 20 | 31% | 18 | |
| Research & Development | 58 | 68 | (15%) | 60 | |
| Total depreciation, amortisation and | |||||
| impairment charges | 148 | 270 | (45%) | 235 |
Depreciation related to cost of sales was a net gain for the quarter due to profit from sale of the production facilities in the UK (Seal Sands). The lower depreciation in distribution is due to depreciation in 2010, which has not continued into 2011.
Profit from operations (EBIT)
EBIT for the second quarter of 2011 amounted to DKK 1,102 million, which corresponds to an increase of 18% compared to the same period in 2010 (DKK 936 million). The growth was driven by increasing revenue and was positively impacted by profit from the sale of Seal Sands in the UK.
The EBIT margin for the period was 26.9% compared to 24.8% in the same period the year before.
Net financials
Lundbeck generated net financial expenses of DKK 19 million in the second quarter, compared with net expenses of DKK 55 million in the second quarter of 2010.
| DKK million | Q2 2011 | Q2 2010 | Q1 2011 |
|---|---|---|---|
| Interest on financial assets and liabilities measured at amortised cost | (16) | (19) | (13) |
| Net gains on financial instruments measured at fair value | 3 | - | - |
| Net interest income, incl. net gains on the bond portfolio | (13) | (19) | (13) |
| Net gains regarding the trading portfolio | 1 | - | - |
| Net exchange gains | 3 | (35) | (23) |
| Net currency items relating to financial items | 4 | (35) | (23) |
| Net gains on available-for-sale financial assets, incl. dividends | - | 4 | 1 |
| Other financial income, net | (10) | (5) | (3) |
| Net financials | (19) | (55) | (38) |
Net interest income, including realised and unrealised gains and losses on the bond portfolio, amounted to a net expense of DKK 13 million, as compared to a net expense of DKK 19 million in the same period in 2010. The difference was primarily due to a higher cash position and bond portfolio in 2011.
Net exchange gains amounted to DKK 3 million, as compared to a net expense of DKK 35 million in the second quarter last year. The increase was due to favourable fluctuations in exchange rates.
Profit for the period
Profit after tax for the second quarter of 2011 was DKK 797 million, compared to DKK 661 million in the same period last year. This corresponds to an EPS of DKK 4.06 per share.
Hedging
Lundbeck hedges income from its products through currency hedging. As a result of Lundbeck's currency hedging policy, foreign exchange losses and gains on hedging transactions are allocated directly to the hedged transaction. Hedging had a positive effect on profit of DKK 60 million in the second quarter of 2011, compared with a situation where the income is not hedged and included at the current exchange rates during the period. The effect was a DKK 18 million gain in the second quarter of 2010. The currency with the most financial impact in the second quarter of 2011 was the US dollar and of the total effect, hedging of the US dollar had a net gain of DKK 54 million. This compares to a gain of DKK 42 million in the second quarter of 2010.
Lundbeck hedges cash flow in US dollars on a rolling basis, approximately 12 months in advance. The average rate for the US dollar hedging contracts for 2011 is approximately USD/DKK 567. The corresponding rate for 2010 was approximately USD/DKK 541. For the next 12 months, the average rate for the existing US dollar hedging contracts is approximately USD/DKK 558.
Cash flow
Lundbeck had a positive cash flow during the quarter of DKK 508 million, compared to DKK 564 million in the same period last year.
Cash flow
| DKK million | Q2 2011 | Q2 2010 | Q1 2011 |
|---|---|---|---|
| Cash flows from operating activities | 1,257 | 1,245 | 809 |
| Cash flows from investing activities | (12) | (71) | (692) |
| Cash flows from operating and investing activities | 1,245 | 1,174 | 117 |
| Cash flows from financing activities | (737) | (610) | (9) |
| Change in cash | 508 | 564 | 108 |
| Cash at beginning of period | 2,389 | 1,330 | 2,294 |
| Unrealised exchange adjustments for the period | (2) | 26 | (13) |
| Cash at end of period | 2,895 | 1,920 | 2,389 |
| Securities | 655 | 56 | 653 |
| Interest-bearing debt | (1,918) | (1,963) | (1,917) |
| Interest-bearing net cash and cash equivalents, end of period | 1,632 | 13 | 1,125 |
Operating activities generated a second quarter cash inflow of DKK 1,257 million, compared to an inflow of DKK 1,245 million in the same period last year.
Cash flows from investing activities represented an outflow of DKK 12 million.
Cash flows from financing activities equalled an outflow of DKK 737 million mainly due to dividend payment.
Balance sheet
As of 30 June 2011, Lundbeck had total assets of DKK 18,820 million, compared to DKK 18,314 million at the end of the second quarter of 2010.
As of 30 June 2011, Lundbeck's equity amounted to DKK 11,723 million, corresponding to a solvency ratio of 62.3% compared to 57.7% at the end of the second quarter 2010.
Cash as of 30 June 2011 was DKK 2,895 million. This compares to DKK 1,920 million by 30 June 2010 and DKK 2,294 million by 31 December 2010. At the end of June 2011, Lundbeck had a net cash position of DKK 1,632 million, compared to a net cash position of DKK 13 million at the end of June 2010.
As a consequence of the exercise of employee warrants, the share capital was increased during the quarter by DKK 96,420 (or 19,284 shares of nominally DKK 5). The increase was affected without any preemption rights for the existing shareholders of the company or others. The shares were subscribed in cash at DKK 115 per share. Proceeds to the company were approximately DKK 2.2 million. The increase corresponds to approx. 0.01% of the company's share capital. After the increase Lundbeck's share capital amounts to DKK 980,679,590.
Lundbeck paid out dividend of DKK 739 million during the quarter, corresponding to DKK 3.77 per share.
Other
Accounting policies
The interim report is presented in accordance with IAS 34 "Interim Financial Reporting" as adopted by the EU and additional Danish disclosure requirements for the interim reports of listed companies.
Accounting policies are unchanged compared to the annual report 2010, which contains a more detailed description of the Group's accounting policies.
Incentive plan in the Lundbeck Group
Members of Lundbeck's Executive Management and 113 key employees appointed by Lundbeck's Executive Management Group who are employed by Lundbeck or Lundbeck's subsidiaries were granted participation in Lundbeck's Long Term Incentive program on 1 April 2011. The above-mentioned subsidiaries comprise Danish and foreign enterprises in which Lundbeck directly or indirectly holds at least 50% of the shares. The members of the company's Supervisory Board are not comprised by the scheme.
For key employees in the US subsidiaries Stock Appreciation Rights and Restricted Cash Units with conditions and award criteria similar to the grant made to key employees of the parent company and its non-US subsidiaries was issued.
The Long Term Incentive program vest over a three year period and in the financial statements, the cost will be recognised in the income statement at fair value over the vesting period. The grant to the Executive Management Group is subject to achieving specific goals.
The incentive programmed granted in 2008 is fully vested. To fund the programme Lundbeck has purchased treasury shares with a value of DKK 9 million corresponding to 71,025 shares.
Protection of patents and other intellectual property rights
Intellectual property rights are a prerequisite for Lundbeck's continued investments in innovative pharmaceuticals. It is Lundbeck's policy to enforce its granted intellectual property rights wherever they may be violated. Lundbeck is involved in a number of trials around the world related to defending our intellectual property rights. With regards to escitalopram Lundbeck is presently involved in pending court trials in Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hungary, Latvia, Lebanon, Lithuania, the Netherlands, Norway, Portugal, Saudi Arabia, Spain, Taiwan, Turkey, UK and the US.
Risk factors
Lundbeck's overall risk exposure is unchanged and reflects the risk factors described in the annual report 2010.
Conference call
Today at 2.00 pm (CET), Lundbeck will be hosting a conference call for the financial community. You can listen to the call online at www.lundbeck.com under the section "Investors – Presentations".
MANAGEMENT STATEMENT
The Supervisory Board and the Executive Management have discussed and adopted the interim report of H. Lundbeck A/S for the period 1 January – 30 June 2011. The interim report is presented in accordance with IAS 34 "Interim financial reporting", as adopted by the EU and additional Danish disclosure requirements for the interim reports of listed companies.
We consider the accounting policies applied to be appropriate. Accordingly, the interim report gives a true and fair view of the Group's assets, liabilities and financial position as of 30 June 2011 and of the results of the Group's operations and cash flows for the first half of 2011, which ended on 30 June 2011.
In our opinion, the Management's report gives a true and fair view of activity developments, the Group's general financial position and the results for the period. It also gives a fair account of the significant risks and uncertainty factors that may affect the Group.
The interim report has not been subject to audit or review.
Valby, 10 August 2011
Executive Management
| Ulf Wiinberg President and CEO |
Peter Høngaard Andersen Executive Vice President |
Lars Bang Executive Vice President |
|---|---|---|
| Anders Götzsche Executive Vice President, CFO |
Anders Gersel Pedersen Executive Vice President |
|
| Supervisory Board | ||
| Mats Petterson Chairman |
Thorleif Krarup Deputy Chairman |
Håkan Björklund |
| Kim Rosenville Christensen | Christian Dyvig | Mona Elisabeth Elster |
| Peter Kürstein | Jørn Mayntzhusen | Jes Østergaard |
FINANCIAL STATEMENTS
Income statement
| DKK million | 2011 Q2 |
2010 Q2 |
2011 H1 |
2010 H1 |
2010 FY |
|---|---|---|---|---|---|
| Revenue | 4,100 | 3,767 | 8,203 | 7,616 | 14,765 |
| Cost of sales | 726 | 706 | 1,507 | 1,404 | 2,958 |
| Gross profit | 3,374 | 3,061 | 6,696 | 6,212 | 11,807 |
| Distribution costs | 1,040 | 914 | 1,945 | 1,734 | 3,496 |
| Administrative expenses | 540 | 504 | 1,019 | 952 | 1,909 |
| Profit before research and development costs | 1,794 | 1,643 | 3,732 | 3,526 | 6,402 |
| Research and development costs | 692 | 707 | 1,325 | 1,336 | 3,045 |
| Profit from operations | 1,102 | 936 | 2,407 | 2,190 | 3,357 |
| Net financials | (19) | (55) | (57) | (66) | (68) |
| Profit before tax | 1,083 | 881 | 2,350 | 2,124 | 3,289 |
| Tax on profit for the period | 286 | 220 | 623 | 518 | 823 |
| Profit for the period | 797 | 661 | 1,727 | 1,606 | 2,466 |
| Earnings per share (EPS) (DKK) | 4.06 | 3.37 | 8.81 | 8.19 | 12.57 |
| Diluted earnings per share (DEPS) (DKK) | 4.06 | 3.37 | 8.81 | 8.19 | 12.57 |
Statement of comprehensive income
| 2011 | 2010 | 2011 | 2010 | 2010 | |
|---|---|---|---|---|---|
| DKK million | Q2 | Q2 | H1 | H1 | FY |
| Profit for the period | 797 | 661 | 1,727 | 1,606 | 2,466 |
| Currency translation, foreign subsidiaries | (46) | 330 | (209) | 543 | 295 |
| Currency translation concerning additions to net investments in | |||||
| foreign subsidiaries | (68) | 337 | (300) | 527 | 240 |
| Realised currency translation concerning additions to net investments | |||||
| in foreign subsidiaries (transferred to the income statement) | 7 | - | 7 | - | - |
| Adjustment, deferred exchange gains/losses, hedging | 38 | (150) | 168 | (282) | (213) |
| Exchange gains/losses, hedging (transferred to the hedged items) | (74) | 65 | (108) | 33 | 163 |
| Exchange gains/losses, trading (transferred from hedging) | - | - | - | - | 1 |
| Accumulated exchange loss on divestment of associate | - | - | - | - | 2 |
| Fair value adjustment of available-for-sale financial assets | (4) | - | (5) | 3 | (4) |
| Tax on other comprehensive income | 24 | (63) | 56 | (79) | (47) |
| Other comprehensive income | (123) | 519 | (391) | 745 | 437 |
| Comprehensive income | 674 | 1,180 | 1,336 | 2,351 | 2,903 |
Balance sheet
| DKK million | 30.06.2011 | 30.06.2010 | 31.12.2010 |
|---|---|---|---|
| Assets | |||
| Intangible assets | 7,287 | 8,423 | 8,012 |
| Property, plant and equipment | 2,992 | 3,004 | 3,046 |
| Financial assets | 261 | 260 | 191 |
| Non-current assets | 10,540 | 11,687 | 11,249 |
| Inventories | 1,261 | 1,707 | 1,491 |
| Receivables | 3,469 | 2,944 | 2,917 |
| Securities | 655 | 56 | 54 |
| Cash | 2,895 | 1,920 | 2,294 |
| Current assets | 8,280 | 6,627 | 6,756 |
| Assets | 18,820 | 18,314 | 18,005 |
Equity and liabilities
| Share capital | 980 | 980 | 980 |
|---|---|---|---|
| Share premium | 226 | 224 | 224 |
| Currency translation reserve | (712) | 172 | (281) |
| Retained earnings | 11,229 | 9,183 | 10,199 |
| Equity | 11,723 | 10,559 | 11,122 |
| Provisions | 1,022 | 1,071 | 930 |
| Debt | 1,905 | 1,915 | 1,918 |
| Non-current liabilities | 2,927 | 2,986 | 2,848 |
| Provisions | 193 | 199 | 216 |
| Debt | 13 | 48 | - |
| Trade payables | 1,276 | 850 | 1,237 |
| Other payables | 2,169 | 3,053 | 2,065 |
| Prepayments from Forest | 519 | 619 | 517 |
| Current liabilities | 4,170 | 4,769 | 4,035 |
| Liabilities | 7,097 | 7,755 | 6,883 |
| Equity and liabilities | 18,820 | 18,314 | 18,005 |
Statement of changes in equity at 30 June 2011
| Share | Share | Currency translation |
Retained | ||
|---|---|---|---|---|---|
| DKK million | capital | premium | reserve | earnings | Equity |
| 2011 | |||||
| Equity at 01.01.2011 | 980 | 224 | (281) | 10,199 | 11,122 |
| Profit for the period | - | - | - | 1,727 | 1,727 |
| Other comprehensive income | - | - | (431) | 40 | (391) |
| Comprehensive income | - | - | (431) | 1,767 | 1,336 |
| Distributed dividends | - | - | - | (739) | (739) |
| Capital increase through exercise of warrants | - | 2 | - | - | 2 |
| Buyback of treasury shares | - | - | - | (9) | (9) |
| Incentive programmes | - | - | - | 11 | 11 |
| Other transactions | - | 2 | - | (737) | (735) |
| Equity at 30.06.2011 | 980 | 226 | (712) | 11,229 | 11,723 |
| 2010 | |||||
| Equity at 01.01.2010 | 980 | 224 | (757) | 8,356 | 8,803 |
| Profit for the period | - | - | - | 1,606 | 1,606 |
| Other comprehensive income | - | - | 929 | (184) | 745 |
| Comprehensive income | - | - | 929 | 1,422 | 2,351 |
| Distributed dividends | - | - | - | (602) | (602) |
| Incentive programmes | - | - | - | 7 | 7 |
| Other transactions | - | - | - | (595) | (595) |
| Equity at 30.06.2010 | 980 | 224 | 172 | 9,183 | 10,559 |
Cash flow statement
| DKK million | 2010 Q2 |
2011 H1 |
2010 H1 |
2010 FY |
|
|---|---|---|---|---|---|
| Profit from operations | 1,102 | 936 | 2,407 | 2,190 | 3,357 |
| Adjustments | 132 | 225 | 394 | 477 | 1,080 |
| Working capital changes | 101 | 141 | (457) | (326) | 88 |
| Cash flows from operations before financial receipts and | 1,335 | 1,302 | 2,344 | 2,341 | 4,525 |
| payments | |||||
| Financial receipts and payments | (22) | (9) | (46) | (30) | (78) |
| Cash flows from ordinary activities | 1,313 | 1,293 | 2,298 | 2,311 | 4,447 |
| Income tax paid | (56) | (48) | (232) | (151) | (1,182) |
| 1,257 | 1,245 | 2,066 | 2,160 | 3,265 | |
| Cash flows from operating activities | |||||
| Investments in and sale of bonds and other financial assets | (4) | 4 | (605) | 13 | 21 |
| Investments in and sale of intangible assets and property, plant and equipment |
(8) | (75) | (99) | (135) | (824) |
| Cash flows from investing activities | (12) | (71) | (704) | (122) | (803) |
| Cash flows from operating and investing activities | 1,245 | 1,174 | 1,362 | 2,038 | 2,462 |
| Dividends paid in the financial year | (739) | (602) | (739) | (602) | (602) |
| Capital contribution | 2 | - | 2 | - | |
| Other financing activities | - | (8) | (9) | (1,519) | (1,560) |
| Cash flows from financing activities | (737) | (610) | (746) | (2,121) | (2,162) |
| Change in cash | 508 | 564 | 616 | (83) | 300 |
| Cash at beginning of period | 2,389 | 1,330 | 2,294 | 1,960 | 1,960 |
| Unrealised exchange adjustments for the period | (2) | 26 | (15) | 43 | 34 |
| Change for the period | 508 | 564 | 616 | (83) | 300 |
| Cash at end of period | 2,895 | 1,920 | 2,895 | 1,920 | 2,294 |
Interest-bearing net cash and cash equivalents is
| composed as follows: | |||||
|---|---|---|---|---|---|
| Cash | 2,895 | 1,920 | 2,895 | 1,920 | 2,294 |
| Securities | 655 | 56 | 655 | 56 | 54 |
| Interest-bearing debt | (1,918) | (1,963) | (1,918) | (1,963) | (1,918) |
| Interest-bearing net cash and cash equivalents, end of | |||||
| period | 1,632 | 13 | 1,632 | 13 | 430 |
FINANCIAL CALENDAR 2011
9 November Interim report for third quarter 2011
CORPORATE RELEASES SINCE APRIL 2011
| 15 June | Nalmefene completes clinical phase III programme - submission of the European Marketing Authorization Application (MAA) is expected by the end of 2011 |
|---|---|
| 10 June | Lundbeck announces that Stig Løkke Pedersen, Executive Vice President, Commercial Operations, resigns |
| 6 June | Announcement of transactions with shares and linked securities in H. Lundbeck A/S made by executives and their closely associated persons and legal entities |
| 31 May | Update on Lundbeck's total number of voting rights and total share capital |
| 16 May | Capital increase in Lundbeck as a result of employee warrant programme and buy-back of shares to fund Long-Term Incentive scheme |
| 16 May | Data from four clinical phase III studies of Lu AA21004 presented for the first time at the 2011 Annual Meeting of the American Psychiatric Association (APA) |
| 13 May | Start up of clinical phase III study with Lu AA21004 in Japan |
| 4 May | First quarter report 2011 - Lundbeck is off to a good start in 2011 as key products maintain momentum |
| 22 April | Lundbeck's partner Mochida receives approval of Lexapro® in Japan |
| 4 April | Sycrest® roll-out starts with the launch of the product in the important European region |
For more information, please visit www.lundbeck.com
LUNDBECK CONTACTS
Investors: Media:
Palle Holm Olesen Mads Kronborg Chief Specialist, Investor Relations Media Relations Manager [email protected] [email protected] +45 36 43 24 26 +45 36 43 28 51
Magnus Thorstholm Jensen Simon Mehl Augustesen [email protected] [email protected] +45 36 43 38 16 +45 36 43 49 80
Jacob Tolstrup Vice President [email protected] +1 847 282 5713
Investor Relations Officer International Media Specialist
ABOUT LUNDBECK
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company's products are targeted at disorders such as depression and anxiety, schizophrenia, insomnia, epilepsy and Huntington's, Alzheimer's and Parkinson's diseases.
Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 5,900 people worldwide. Lundbeck is one of the world's leading pharmaceutical companies working with CNS disorders. In 2010, the company's revenue was DKK 14.8 billion (approximately EUR 2.0 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.