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Genmab — Annual Report 2010
Feb 28, 2011
3365_10-k_2011-02-28_764a9e15-ec79-458b-a82f-7430b35712e9.pdf
Annual Report
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Genmab A/S Bredgade 34 DK-1260 Copenhagen K CVR no. 21 02 38 84 www.genmab.com
..........
February 28, 2011
Genmab is dedicated to creating and developing human antibodies to improve patients' lives
Table of Contents
Directors Report
. . . . . . . . . .
| About Genmab 3 | |
|---|---|
| Clinical Product Pipeline as of February 28, 2011 3 | |
| 2010 Highlights 4 | |
| Shareholder Letter 6 | |
| Consolidated Key Figures 8 | |
| Our strategy 9 | |
| 2010 Overview 11 | |
| Outlook 12 | |
| Product Pipeline 13 | |
| Collaborations 19 | |
| Manufacturing 21 | |
| Antibody Technology, Streamlined Development and Intellectual Property 21 | |
| Human Resources 23 | |
| Financial Review 24 | |
| Subsequent Events 32 | |
| Corporate Governance 32 | |
| Corporate Social Responsibility (CSR) 38 | |
| Description of Management Reporting Systems and Internal Control Systems 41 | |
| Risk Management 42 | |
| Procedures for Changes in the Articles of Association 46 | |
| Change of Control 46 | |
| Distribution of the Year's Result 47 | |
| Financial Statements | |
| Genmab Group and the Parent Company 48 | |
| Supplementary Information (Unaudited) |
Conversion of Certain DKK Amounts into USD ..............................................111
Additional information:
Helle Husted, Vice President Investor Relations Telephone +45 33 44 77 30
This financial statements release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab does not undertake any obligation to update or revise forward looking statements in this financial statements release nor to confirm such statements in relation to actual results, unless required by law.
About Genmab
. . . . . . . . . .
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options.
Clinical Product Pipeline as of February 28, 2011
| Product | Disease Indications | $1/\mathrm{H}$ | п | Ш |
|---|---|---|---|---|
| Ofatumumab | Chronic lymphocytic leukemia (CLL) | |||
| 20 studies | Follicular lymphoma (FL) | |||
| Partner: GSK | Rheumatoid arthritis (RA) | |||
| Diffuse large B-cell lymphoma (DLBCL) | ||||
| Relapsing remitting multiple sclerosis (RRMS) | ||||
| Waldenstrom's Macroglobulinemia (WM) | ||||
| Zalutumumab 6 studies |
Head and neck cancer (SCCHN) | |||
| Daratumumab | Multiple myeloma | |||
| RG4930 Partner: Roche |
Asthma-Target: OX4oL | |||
| RG1512 Partner: Roche |
Cardiovascular disease - Target: P-selectin |
Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; HuMax-EGFr™; HuMax-IL8™; HuMax-TAC™; HuMax-CD38™; HuMax-TF™; HuMax-Her2™; HuMax-Wnt™; HuMax-cMet™; DuoBody™ and UniBody® are all trademarks of Genmab A/S. Arzerra® is a trademark of GlaxoSmithKline.
©2011, Genmab A/S. All rights reserved.
2010 Highlights
. . . . . . . . . .
Envisioning a New Future
- Appointed Jan van de Winkel, Ph.D. as new CEO
- Elected three Genmab employees to Board of Directors
- Updated Genmab's corporate strategy
- Implemented a reorganization, saving DKK 30 million annually
Maximizing the Value of Arzerra® (ofatumumab)
- Received conditional marketing authorization for Arzerra in Europe
- Achieved first full year of Arzerra sales GBP 31 million (DKK 270 million), resulting in DKK 54 million in royalty payments to Genmab
- Announced plans to focus on subcutaneous delivery in autoimmune indications
Advancing Our Pipeline
- Announced data from the Phase III study of zalutumumab in refractory head and neck cancer
- Provided update on potential regulatory pathway for zalutumumab
- Initiated six new clinical studies
- o Phase III study of ofatumumab in combination with bendamustine in follicular NHL in patients who did not respond to a rituximab containing regimen
- o Phase III maintenance study of ofatumumab versus no further treatment in patients with relapsed CLL who have responded to induction therapy
- o Phase III study of ofatumumab versus rituximab in rituximab-sensitive follicular NHL that has relapsed at least 6 months after treatment with a rituximab-containing regimen
- o Phase II study of ofatumumab in previously treated CLL in Japan
- o Phase II RG1512 study in cardiovascular disease initiated by Roche
- o Phase I study of cardiovascular effects of ofatumumab in refractory CLL
- Published data from seven clinical studies, including two Phase III trials
- Introduced DuoBody™, a novel, next generation bispecific antibody technology
- Announced new pre-clinical program HuMax-cMet™
Driving Value through Collaborations
. . . . . . . . . .
- Amended ofatumumab agreement with GSK
- Executed antibody development agreement with Lundbeck
- Entered research collaboration with Seattle Genetics for HuMax-TF™
- Reached three milestones totaling DKK 206 million two GSK and one Roche
Managing & Controlling Cash Burn
- Achieved lowest operating loss (from continuing operations) in 10 years
- Increased cash position by DKK 265 million from the end of 2009
- Reduced operating loss by 68% from 2009 levels
Includes expenses related to continuing and discontinuing operations. 2009 and 2010 exclude the non-cash Minnesota impairment charges of DKK 419 million and DKK 130 million, respectively.
Shareholder Letter
Dear Shareholder,
. . . . . . . . . .
Biotech is a volatile industry in which peaks and troughs are a fact of life. Genmab is no exception to this rule. We have faced such low points in the recent years and made the necessary course corrections. Thanks to our decisive actions, we have significantly strengthened our financial position. We worked hard to control our bottom line and looking back, our 2010 operating loss of DKK 161 million is less than half of the operating loss reported in 2005 and the lowest since 2000, the year of our IPO. We have likewise trimmed our R&D expenses to DKK 583 million while conducting an ever increasing number of late stage clinical trials.
During 2010, we benefited from the first full year of Arzerra (ofatumumab) sales. Our collaboration partner, GlaxoSmithKline (GSK), has successfully launched Arzerra in the US and Europe, resulting in DKK 270 million in sales and DKK 54 million in royalty payments to Genmab. Arzerra is now available to patients in 17 countries and we expect the sales to increase driven by the assignment of a permanent J-code for reimbursement in the US and new product launches around the world. We are thrilled to see, as a direct result of our efforts, that patients' lives are being transformed by treatment with Arzerra. As one chronic lymphocytic leukemia (CLL) patient so aptly put it, "Through the use of Arzerra, I have so far been able to live a normal life with all the fun things that can be part of it." It brings us tremendous satisfaction to see our life's work making a real difference. That is the true promise of Genmab.
2010 was a year of refocus for Genmab. My appointment as CEO served as a catalyst for change at the company. The very successful renegotiation of the ofatumumab agreement with GSK, the introduction of an updated corporate strategy and the execution of two new significant collaborations with Lundbeck and Seattle Genetics have turned the tide at Genmab. Through these and other steps we have taken since June, we regained our momentum and our focus on revolutionizing the treatment of cancer.
If 2010 can be called a year of transformation for Genmab, then 2011 is the time to take advantage of our fresh perspective. At our R&D Day in January 2011, we presented a pipeline update focusing on both naked human antibody therapeutics and antibody-drug conjugates (ADCs). ADCs combine the specificity of antibodies with the tumor toxicity of chemotherapy, selectively delivering cell-killing agents to a tumor while decreasing exposure to normal tissue. We are already developing one ADC, HuMax-TF, with Seattle Genetics and are investigating other opportunities with this technology, which we view as a promising next wave in cancer therapeutics. We also provided additional insights into our next-generation bispecific antibody technology, DuoBody. We are excited about this novel technology which Genmab scientists developed 100% in house. Our DuoBody technology effectively produces stable human bispecific antibodies that can enhance the selectivity of tumor therapy by dual antigen targeting or effectively increase tumor cell killing by redirecting the immune system towards the tumor. This technology may significantly expand development possibilities for Genmab. In addition, it presents us with a unique opportunity to create a business model as we can license this technology to other (bio)pharmaceutical companies.
We are looking forward to presenting key clinical data this year as well. Data from an increasing number of clinical studies with ofatumumab will become available. This includes data in the autoimmune diseases rheumatoid arthritis and multiple sclerosis as well as various types of cancer. We also expect the first clinical data from the Phase I/II study of daratumumab in multiple myeloma to be reported in 2011. This antibody has demonstrated extremely potent killing activity of multiple myeloma cells in pre-clinical studies and we are optimistic about its potential clinical activity. The market opportunity for daratumumab is also significant with multiple myeloma product sales reaching approximately USD 3.5 billion in 2009. Furthermore, daratumumab could potentially be used to treat other hematological malignancies such as CLL, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma and T-cell lymphoma.
We remain focused on selling our manufacturing facility in Minnesota. The sale process is active with several interested parties under confidentiality and further sales initiatives are planned this year. Despite difficult market conditions, we believe it is possible for Genmab to enter a sales agreement for the facility in 2011.
In October we provided clarification on the potential regulatory pathway for zalutumumab. Based on feedback we received from selected national authorities, we believe that a Marketing Authorization Application (MAA) for zalutumumab could be pursued based on data from the Phase III study in patients with refractory head and neck cancer, while additional data would be required prior to submitting a regulatory application in the US. We were encouraged by the overall regulatory feedback as we believe zalutumumab has significant potential in treating a range of difficult to treat cancers. We hope to find a partner to bring this important medicine to patients who are without further treatment options.
Genmab continues to be an innovative company that employs the best and brightest in the industry and we thank our employees for their dedication to the company and its goals. We have the skills, know-how and determination to succeed in our mission of revolutionizing cancer treatment, improving patients' lives and building a profitable and successful biotech company. We take our responsibility to patients and shareholders seriously and are committed to executing on our promises and building up confidence in the company. Thank you for keeping the faith in Genmab during challenging times and for your continued support as we rise to meet the challenges that lie ahead.
Sincerely yours,
. . . . . . . . . .
Jan van de Winkel, Ph.D. President & Chief Executive Officer
Consolidated Key Figures
. . . . . . . . . .
The following key figures and financial ratios have been prepared on a consolidated basis. The financial ratios have been calculated in accordance with the recommendations of the Danish Society of Financial Analysts of 2010.
Key figures comply with the requirements under the Danish financial reporting requirements and the IFRS. All key figures and financial ratios are in conformity with the current accounting policies.
| 2010 | 2009 | 2008 | 2007 | 2006 | |
|---|---|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Income Statement | |||||
| Revenues | 582,077 | 586,076 | 692,298 | 529,537 | 135,547 |
| Research and development costs | (582,512) | (935,361) | (1,270,799) | (849,202) | (513,065) |
| General and administrative expenses | (160,254) | (148,749) | (143,529) | (117,468) | (94,696) |
| Operating result | (160,689) | (498,034) | (722,030) | (437,133) | (472,214) |
| Net financial items | 38,246 | 156,045 | (94,835) | 53,764 | 33,978 |
| Net result for continuing operations | (143,317) | (347,898) | (817,448) | (383,369) | (438,236) |
| Balance Sheet | |||||
| Cash and marketable securities* | 1 ,546,221 | 1,281,356 | 1,762,012 | 3,693,443 | 1 ,724,333 |
| Non-current assets | 62,234 | 73,197 | 1,292,183 | 40,768 | 33,717 |
| Assets | 2,481,601 | 2,221,534 | 3,258,953 | 3,958,783 | 1,804,629 |
| Shareholders' equity | 1,080,067 | 1,297,192 | 2,188,562 | 2,883,279 | 1 ,607,582 |
| Share capital | 44 ,907 | 44,907 | 44,889 | 44,520 | 39 ,648 |
| Investments in intangible and tangible assets | 10 ,110 | 16,778 | 933,329 | 23,436 | 5 ,348 |
| Cash Flow Statement | |||||
| Cash flow from operating activities | 268 ,171 | (570,061) | (513,333) | 505,898 | (379,623) |
| Cash flow from investing activities | (738,496) | 974,726 | 460,104 | (2,362,934) | (451,373) |
| Cash flow from financing activities | (7,005) | (6,643) | 25,285 | 1,560,227 | 879 ,033 |
| Cash, cash equivalents and bank overdraft* | (2,088) | 464,446 | 70,013 | 131,753 | 429,075 |
| Cash increase/(Cash burn) | 264,865 | (480,656) | (1,931,431) | 1,969,110 | 471 ,431 |
| Financial Ratios | |||||
| Basic and diluted net loss per share | (7.16) | (22.51) | (21.62) | (8.72) | (11.26) |
| Basic and diluted net loss per share continuing | |||||
| operations | (3.19) | (7.75) | (18.31) | - | - |
| Year-end share market price | 65.50 | 82.00 | 203.00 | 309.00 | 380.00 |
| Price / book value | 2.72 | 2.84 | 4.16 | 4.77 | 9.37 |
| Shareholders' equity per share | 24.05 | 28.89 | 48.76 | 64.78 | 40.54 |
| Equity ratio | 44% | 58% | 67% | 73% | 89% |
| Average number of employees | 229 | 505 | 565 | 291 | 237 |
| Number of employees at year-end | 189 | 309 | 555 | 344 | 248 |
* In 2010 and 2009, cash and marketable securities includes DKK 13 million and DKK 4 million, respectively, in cash and cash equivalents which was been transferred to assets held for sale.
Our strategy
. . . . . . . . . .
Following the appointment of Jan van de Winkel, Ph.D., as our new CEO in June and the successful renegotiation of the ofatumumab partnership with GSK, which boosted Genmab's financial security and reduced funding concerns for the coming years, Genmab announced an update to its corporate strategy. Going forward the company will employ a three-pronged strategic approach:
- Focus on the research and development core competence, identifying the best disease targets and developing unique best-in-class or first-in-class antibodies, and be at the leading edge in developing next generation technologies;
- Turn science into medicine by producing differentiated antibody therapeutics with significant commercial potential that make business sense; and
- Build a profitable and successful biotech business by maintaining a flexible and capital efficient model by maximizing partnership relationships.
To achieve these strategic aims, Genmab will focus on its dominant priorities, act in a disciplined manner and balance scientific, medical and business factors to advance products through its pipeline.
Progress on Dominant Priorities
| Current Priorities | Progress to Date |
|---|---|
| Maximize value of ofatumumab | Contract amended with GSK as of July 1, 2010. New Phase III oncology trials announced. GSK to focus on subcutaneous delivery in autoimmune indications |
| Evaluate all opportunities for zalutumumab |
Update on potential regulatory pathway announced. Search for partner underway |
| Promote sale of manufacturing facility |
Focused on entering into a sales agreement in 2011 |
| Daratumumab, clinical proof of concept | Phase I/II study in progress. Data anticipated in 2011 and further combination studies are planned |
| Extract value from R&D engine and pipeline |
Signed an agreement with Lundbeck to create and develop human antibody therapeutics for disorders of the central nervous system |
| Enter into new strategic collaborations | Signed an agreement with Seattle Genetics for ADC technology to develop HuMax-TF |
| Optimize ways to advance next generation technologies |
Introduced DuoBody, a novel next generation bispecific antibody technology |
| Manage and control cash burn | Reduced operating expense from DKK 1,084 million in 2009 to DKK 743 million in 2010, with further reductions guided in 2011 |
2010 Overview
. . . . . . . . . .
For the continuing operations, Genmab reported consolidated revenues of DKK 582 million in 2010, an operating loss of DKK 161 million and a net loss of DKK 143 million. Genmab ended 2010 with a total cash position of DKK 1,546 million.
Overall, the total financial performance is in line with the most recent revised guidance issued on November 9, 2010. The operating loss and cash position is better than projected, partly driven by timing differences in development costs.
In April 2010, the European Commission (EC) granted a conditional marketing authorization for ofatumumab for the treatment of CLL in patients who are refractory (have not responded) to fludarabine and alemtuzumab. Full year worldwide sales for ofatumumab in 2010 totalled DKK 270 million, resulting in DKK 54 million of royalty income to Genmab.
We continued to make progress with our clinical trials, reporting results from seven clinical studies, including three Phase III trials. We also initiated five ofatumumab studies, including three Phase III studies and Roche started a Phase II study of RG1512. Genmab also provided an update on the potential regulatory pathway for zalutumumab.
As a result of the achievements in these development programs, Genmab reached two milestone payments under the GSK collaboration totaling DKK 203 million and received a milestone payment of DKK 3 million from Roche at the initiation of the Phase II RG1512 study.
We strengthened our relationship with GSK when we announced an amendment to our ofatumumab co-development and commercialization agreement in July. Under the terms of the amendment, GSK has taken full responsibility for developing ofatumumab in autoimmune indications while continuing to jointly fund and develop ofatumumab in oncology indications. For more information on the amendment to the ofatumumab agreement, please refer to the Collaborations section of this report. Following this amendment GSK announced plans to focus on the subcutaneous delivery of ofatumumab in autoimmune indications.
We also signed new collaboration agreements with H. Lundbeck A/S and Seattle Genetics, Inc. Under the Lundbeck agreement, Genmab will develop antibodies to central nervous system targets identified by Lundbeck. Genmab received an upfront payment of EUR 7.5 million (approximately DKK 56 million at the date of the agreement) upon entering the collaboration. In addition, Genmab entered an antibody-drug conjugate (ADC) research collaboration agreement with Seattle Genetics under which Genmab has rights to utilize Seattle Genetics' ADC technology with its HuMax-TF antibody. For more information on these collaborations, please refer to the Collaborations section of this report.
In June, Genmab announced changes to its management and Board of Directors. Three employee board members were elected to the board by the employees of the Genmab group. They were, Daniel J. Bruno, based in Princeton, NJ, USA, Nedjad Losic, based in Copenhagen, Denmark and Dr. Tom Vink, based in Utrecht, the Netherlands. In addition, Lisa N. Drakeman, Ph.D. retired from her position as Chief Executive Officer and Board Member of the company. The Chief Executive Officer position at Genmab was filled by Jan van de Winkel, Ph.D., the company's former President, Research and Development and Chief Scientific Officer.
As a result of Genmab's updated corporate strategy, the restructuring of the ofatumumab agreement with GSK and the intent to partner zalutumumab, Genmab announced plans to reorganize its workforce to match resources with the reduced workload. While no development programs were discontinued as a result of this reorganization, we anticipate annual savings of approximately DKK 30 million.
| MDKK | ||
|---|---|---|
| 2010 Actual | ||
| 2011 Guidance | Results | |
| Revenue | 325 – 350 | 582 |
| Operating expenses | (675) - (725) | (743) |
| Operating loss continuing operations | (350) - (400) | (161) |
| Discontinued operation | (50) | (178) |
| Cash at beginning of year* | 1,546 | 1,281 |
| Cash used in operations | (575) – (625) | (550) |
| GSK upfront payment | – | 815 |
| Facility sale | 660 | – |
| Cash at end of year* | 1,575 - 1,625 | 1,546 |
Outlook
. . . . . . . . . .
* Cash, cash equivalents, and marketable securities
We expect our 2011 revenue to be DKK 325 – 350 million compared to DKK 582 million reported for 2010. The reduction in revenue is mostly due to the inclusion of two development milestones related to our agreement with GSK totaling DKK 203 million in 2010. There are no GSK development milestones included in 2011. Our projected revenue for 2011 consists primarily of non-cash amortization of deferred revenue totaling DKK 226 million and royalties on sales of Arzerra of DKK 80 million an increase of 48% compared to 2010.
We anticipate that our 2011 operating expenses from continuing operations will be DKK 675 – 725 million compared to DKK 743 million in 2010. The decrease is primarily attributable to a continued strong focus on cost control while continuing to progress our pre-clinical and clinical pipeline. 2011 operating expenses include approximately DKK 80 million related to Zalutumumab and represents a full 12 months of development activity. This cost could potentially be reduced if we are able to enter into a licensing or other transaction.
We expect the operating loss from continuing operations for 2011 to be approximately DKK 350 - 400 million, compared to the operating loss of DKK 161 million reported for 2010.
The discontinued operation guidance of DKK 50 million relates to the ongoing running costs of the Minnesota manufacturing facility and represents a full 12 months of activity maintaining the facility in a validated state. This cost could be lower if the facility is sold before the end of the year. We remain focused on entering a sales agreement in 2011. Further details of the facility can be viewed at http://genmab-facility.com/. The fair value of the manufacturing facility less costs to sell is estimated at USD 120 million, approximately DKK 660 million, at an assumed exchange rate of USD 1.00 = DKK 5.50.
As of December 31, 2010, we had cash, cash equivalents and marketable securities of DKK 1,546 million and are projecting a cash burn in 2011, excluding proceeds from the facility sale, of DKK 575 – 625 million. Taking into account the planned sale of the manufacturing facility, we are projecting a cash balance at the end of the year of DKK 1,575 – 1,625 million.
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; fair value less cost to sell of our manufacturing facility; fluctuations in the value of our marketable securities; Arzerra sales and corresponding royalties to Genmab; and currency exchange rates. The financial guidance also assumes that no significant agreements are entered into during 2011 that could materially affect the results.
Product Pipeline
. . . . . . . . . .
Our scientific teams continuously investigate promising new disease targets for potential addition to our pipeline. As of December 31, 2010, we had 29 ongoing clinical trials compared to 25 at the end of December 2009.
An overview of the development status of each of our clinical products is provided in the following sections. More detailed descriptions of dosing, efficacy and safety data from certain clinical trials have been published in our stock exchange releases to the NASDAQ OMX Copenhagen, which are available on Genmab's website, www.genmab.com.
Ofatumumab (Arzerra)
- Successful GSK collaboration contract amended in 2010 (see Collaborations section)
- Arzerra brought to market in US and EU in less than 8 years
- Broad oncology and autoimmune disease potential
- 20 studies ongoing 10 Phase III studies
Ofatumumab, which is being marketed and developed under a co-development and commercialization agreement with GSK, has received accelerated approval from the FDA for use in the US and conditional marketing authorization in the EU in patients with CLL that is refractory to fludarabine and alemtuzumab under the trade name Arzerra. Ofatumumab is a novel human monoclonal antibody which targets a part of the CD20 molecule encompassing an epitope in the small loop (Teeling et al 2006). The CD20 molecule is a key target in CLL therapy, because it is expressed in most B cell malignancies (Cragg et al 2005). Ofatumumab is in development for CLL, follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Waldenstrom's macroglobulinemia (WM), rheumatoid arthritis (RA), and relapsing-remitting multiple sclerosis (RRMS).
Following the 2009 US and 2010 EU approval of ofatumumab, sales of DKK 270 million were achieved in 2010 with royalty income to Genmab of DKK 54 million. Arzerra is now available in 17 countries around the world, including the US, Germany, Denmark, the Netherlands and Sweden. Product launches in additional countries are planned for 2011.
. . . . . . . . . .
GSK and Genmab announced top-line results from the concluded pivotal trial of ofatumumab in patients with fludarabine and alemtuzumab refractory CLL in August 2010. A total of 95 patients with fludarabine and alemtuzumab refractory CLL were treated in the study. The objective response rate (ORR) in the study, as determined by an Independent Review Committee, was 51%. In addition to the 95 patients in the efficacy analysis the study also included 128 patients with relapsed or refractory CLL, who were not refractory to both fludarabine and alemtuzumab. There were no unexpected safety findings reported in the total study population (n=223).
Results from this concluded pivotal trial are consistent with the efficacy and safety data reported in the interim analysis and demonstrate the activity of single-agent ofatumumab in patients with heavily pre-treated fludarabine and alemtuzumabrefractory CLL.
In August, Genmab announced top-line interim results from a Phase II study of ofatumumab to evaluate the treatment of relapsed DLBCL in patients ineligible for or relapsed following a stem cell transplant. Ninety-six percent of the 81 patients in the study had received prior rituximab therapy. Fifty-four percent of the patients received between two and five prior courses of rituximab. Thirty-one percent had received a prior stem cell transplant and the remaining 69% were ineligible for transplant. The ORR observed at the interim analysis was 11% with a median duration of response of 6.9 months. There were no unexpected safety findings.
GSK and Genmab announced positive results from an ofatumumab Phase II safety and pharmacokinetics study in patients with RRMS in 2010. A total of 38 patients were randomized to receive two infusions of 100 mg, 300 mg or 700 mg of ofatumumab or placebo. After 24 weeks, the patients randomized to placebo were treated with ofatumumab and patients who were treated with ofatumumab received placebo. All patients were then followed for an additional 24 weeks. There were no dose limiting toxicities, no unexpected safety findings, and no patients tested positive for human anti-human antibodies.
Efficacy was assessed by MRI (magnetic resonance imaging) as a secondary endpoint. Although the study included a small number of patients, statistically significant reductions in the number of brain lesions (as measured on serial MRI scans from week 8 to week 24) were seen on ofatumumab as compared to placebo and the reductions were seen in all dose groups. Repeated MRI scans showed a sustained reduction in the number of brain lesions up to week 48 in patients (n=26) who were treated with ofatumumab followed by placebo. Patients who received placebo followed by ofatumumab (n=12) showed similar 24 week results to those who were treated with ofatumumab followed by placebo.
In September, GSK and Genmab announced plans to focus on the development of the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease. GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of ofatumumab in 2011 following discussion with regulatory authorities. Further work in RA with a subcutaneous administration of ofatumumab is under review.
In December, interim data from the Phase II study of ofatumumab in Waldenstrom's macroglobulinemia was presented at the 52nd American Society of Hematology (ASH) Annual Meeting and Exposition. The overall response rate achieved in the interim analyses was 43% (6 of 14 evaluable patients).
At Genmab's R&D Day in January 2011, we announced that a pre-planned interim analysis of the Phase II study of ofatumumab in combination with ICE or DHAP chemotherapy in relapsed/refractory DLBCL showed that the pre-specified minimum response rate was met or exceeded, warranting continued recruitment into the study. We plan to present primary endpoint data from this important study later in 2011.
A permanent Common Procedure Coding System (HCPCS) J-Code for ofatumumab became effective January 1, 2011. The new J-Code will facilitate insurance reimbursement for ofatumumab in the US.
During 2010, five new ofatumumab studies were initiated, including three new Phase III studies. A total of 20 ofatumumab studies were ongoing as of December 31, 2010 as shown below.
| Major Indication | Study Description |
|---|---|
| CLL | Phase III study of ofatumumab in combination with chlorambucil for front line CLL |
| Phase III study of ofatumumab in combination with FC for second line CLL |
|
| Phase III maintenance study of ofatumumab versus no further treatment in patients with relapsed CLL who have responded to induction therapy |
| Major Indication | Study Description |
|---|---|
| Phase III study in fludarabine and alemtuzumab refractory CLL | |
| Three Phase II trials and one Phase I trial | |
| FL | Phase III study in rituximab refractory follicular NHL |
| Phase III study of ofatumumab in combination with bendamustine | |
| Phase III study of ofatumumab versus rituximab in rituximab-sensitive follicular NHL that has relapsed at least 6 months after treatment with a rituximab-containing regimen |
|
| Phase II NHL study in Japan | |
| DLBCL | Phase III study of ofatumumab plus chemotherapy versus rituximab plus chemotherapy in relapsed or refractory DLBCL |
| Two Phase II trials | |
| WM | Phase II trial |
| RA | Phase III study in RA patients who had an inadequate response to methotrexate |
| Phase III study in RA patients who had an inadequate response to TNF alpha antagonist therapy |
|
| Phase II retreatment study | |
| RRMS | Phase II safety and pharmacokinetics study |
Zalutumumab
. . . . . . . . . .
- Significant patient population
- o Approximately 40,000 new head and neck cancer patients each year in US and EU
- o Potential for development in many tumor types
- Current leading EGFr therapy is Erbitux, which generated approximately USD 1.6 billion in sales in 2009
- Search for partner underway
Zalutumumab is a high-affinity human antibody that targets the Epidermal Growth Factor receptor (EGFr), a molecule found in abundance on the surface of many cancer cells, and is a clinically validated target. Zalutumumab has received a Fast Track designation from the FDA covering patients with head and neck cancer who have previously failed standard therapies.
In March 2010, we announced top-line results from the Phase III pivotal study to treat 286 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who failed standard platinum-based chemotherapy. Median overall survival in patients receiving zalutumumab in combination with best supportive care (BSC) was 6.7 months compared to 5.2 for BSC alone (p = 0.0648). Although this represented a 30% improvement, the result did not demonstrate a statistically significant difference in overall survival, the primary endpoint of the study. However, patients in the zalutumumab arm did experience a 61% increase in progression free survival compared to patients in the BSC alone arm (p=0.001). The safety profile observed for zalutumumab was as expected within this drug class in patients with SCCHN. Adverse events reported more frequently for patients in the zalutumumab plus BSC group were infusion related reactions, skin and nail disorders, electrolyte disturbances, gastrointestinal disorders, eye disorders, infections and headache.
In October we announced an update on the potential regulatory pathway for zalutumumab following preliminary, non-binding discussions with a number of selected national European regulatory authorities and the FDA. Based on overall feedback from regulatory authorities in Europe, Genmab believes a Marketing Authorization Application (MAA) for zalutumumab could be pursued based on the data from the Phase III study in patients with recurrent or metastatic SCCHN who failed standard platinum-based therapy. Additional clinical study data would, however, be required prior to submitting a regulatory application in the US.
Safety data from the Phase I/II study of zalutumumab in combination with chemoradiation was presented at the European Society for Therapeutic Radiology and Oncology (ESTRO) meeting in September 2010. Thirty patients were enrolled in the study. The most common adverse events observed during or up to 4 weeks after ended treatment were mucositis, dysphagia, radiation dermatitis, laryngitis, febrile neutropenia and headache. There were three cases of grade 4 radiation dermatitis and one grade 4 mucositis reported in three patients receiving 16 mg/kg of zalutumumab, compared to no grade 4 radiation toxicities in the lower dose groups. Thus the maximum tolerated dose and recommended dose for further development is 12 mg/kg.
A total of 6 zalutumumab studies were ongoing as of December 31, 2010, as described below.
| Major Indication | Study Description |
|---|---|
| SCCHN | Phase III study in recurrent or metastatic SCCHN patients who failed standard platinum-based chemotherapy |
| Phase III front line study of zalutumumab in combination with radiation or chemo-radiation (in cooperation with DAHANCA) |
|
| Phase II safety study | |
| Phase I/II front line study of zalutumumab in combination with chemo radiation |
|
| Phase I/II study of zalutumumab in combination with radiotherapy | |
| Phase I/II pharmacokinetics study |
Daratumumab
. . . . . . . . . .
- Target on multiple cancers, multiple myeloma, various leukemias (B-CLL, AML, B-ALL, plasma cell leukemias), NHL
- Broad-spectrum killing activity; mediates cell death via ADCC, CDC and apoptosis
- Inhibits growth of CD38-expressing tumors in mouse models at very low doses
- Significant patient population with sales of therapeutic products to treat multiple myeloma reaching approximately USD 3.5 billion in 2009
- Enhances cell killing in combination with lenalidomide and bortezomib
- Phase I/II study in progress; data anticipated in 2011
Daratumumab is a fully human antibody in clinical development to target the CD38 molecule which is highly expressed on the surface of multiple myeloma tumor cells. In pre-clinical studies, daratumumab induced potent immune system killing mechanisms such as antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) towards primary multiple myeloma tumors. Furthermore, daratumumab mediated cell death via apoptosis and inhibited the enzymatic activity of the CD38 molecule, which may contribute to its efficacy in killing primary multiple myeloma and plasma cell leukemia cells. Additional pre-clinical data presented in 2010 has shown that when daratumumab is added to standard treatments, it enhances the capacity of lenalidomide and bortezomib to kill multiple myeloma cells.
A Phase I/II safety and dose finding study of daratumumab for the treatment of multiple myeloma is underway. The study will include a maximum of 122 patients with multiple myeloma who are relapsed or refractory to at least two different prior treatments and are without further established treatment options. Genmab expects to report data from the study in 2011 and is currently planning new Phase I/II combination studies.
Other Clinical Programs
Our partner Roche is conducting clinical studies with two antibodies developed by Genmab under the companies' collaboration agreement. RG4930 is in Phase II development for asthma targeting OX40L. A Phase II study investigating RG1512 which targets P-selectin for treatment of cardiovascular disease was initiated in December 2010.
Genmab has licensed zanolimumab, a fully human antibody targeting CD4 to TenX Biopharma, Inc. Zanolimumab is in development for the treatment of cutaneous T-cell lymphoma (CTCL) and non-cutaneous T-cell lymphoma (NCTCL). TenX Biopharma filed for chapter 11 bankruptcy protection in November 2010 and Genmab awaits the outcome of these proceedings.
Pre-clinical Programs
Genmab has over ten programs in pre-clinical development. We continually work to create new antibodies to a variety of targets for a number of disease indications. We also evaluate disease targets identified by other companies for potential addition to our pipeline.
In April, Genmab announced a new pre-clinical program, HuMax-cMet. We have generated over 75 unique antibodies targeting cMet, a cancer target involved in cell growth and angiogenesis which is over-expressed on a wide variety of solid tumors including breast, lung, pancreatic, ovarian, prostate, renal, gastric and colorectal cancers.
Genmab is developing HuMax-TF, an antibody-drug conjugate, in collaboration with Seattle Genetics. HuMax-TF was selected from a panel of over 100 antibodies based on its ability to inhibit target cell signaling and induce ADCC and anti-tumor activity. Pre-clinical studies are currently being conducted.
Furthermore, Genmab has agreed to develop antibodies to three central nervous system targets under a collaboration initiated with Lundbeck in October 2010.
Collaborations
In support of our strategy to build a broad portfolio of products and facilitate their potential commercialization, Genmab has established collaborations with major pharmaceutical and biotechnology companies, through which our partner companies gain access to our antibody development capabilities, while helping us bring our products closer to the market. Genmab has also formed a number of partnerships to gain access to promising disease targets that may be suitable for additional antibody products. We have key collaborations with GSK, Roche, H. Lundbeck A/S and Seattle Genetics, world leading research-based pharmaceutical and healthcare companies.
GSK
. . . . . . . . . .
In December 2006, we granted exclusive worldwide rights to co-develop and commercialize ofatumumab to GSK.
Under the terms of the agreement, Genmab received a license fee of DKK 582 million, and GSK invested DKK 2,033 million to subscribe in Genmab shares. We may also receive potential milestone payments in addition to those already received. In addition, Genmab will be entitled to receive tiered double-digit royalties on global sales of ofatumumab. From 2008, the parties shared certain development costs, and GSK is responsible for commercial manufacturing and commercialization expenses.
Under the terms of a December 2008 amendment to the agreement, Genmab received a one-time payment of USD 4.5 million from GSK in exchange for terminating its option to co-promote ofatumumab.
In July 2010, GSK and Genmab announced a further amendment to the ofatumumab agreement. Under the terms of the amendment, GSK has taken responsibility for developing ofatumumab in autoimmune indications whilst continuing to jointly develop ofatumumab with Genmab in oncology indications. Genmab received an upfront payment of GBP 90 million (DKK 815 million at the date of the agreement) from GSK in connection with the amendment.
Genmab's future funding commitment for the development of ofatumumab in oncology indications will be capped at a total of GBP 145 million (DKK 1,314 million at the date of the agreement), including a yearly cash funding cap of GBP 17 million (DKK 154 million at the date of the agreement) for each of the next six years starting with 2010. Future milestones due to Genmab under the oncology development program will be reduced by 50%. The royalty tiers on the oncology indications were unchanged.
All development work on the autoimmune and oncology indications being performed by Genmab was substantially transferred to GSK by the end of 2010.
In 2010, Genmab achieved two milestones under this collaboration. A milestone payment of DKK 87 million was paid upon gaining conditional marketing authorization of ofatumumab in the EU and DKK 116 million was paid when the first patient was treated in the Phase III study of ofatumumab in patients with indolent B-cell non-Hodgkin's lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen.
Roche
. . . . . . . . . .
Under our agreement with Roche, we have utilized our broad antibody expertise and development capabilities to create human antibodies to a wide range of disease targets identified by Roche. If the products are successful, Genmab will receive milestone and royalty payments. Roche is fully responsible for the development of these products. Under certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche.
H. Lundbeck A/S
In October 2010, Genmab and Lundbeck entered an agreement to create and develop human antibody therapeutics for disorders of the central nervous system (CNS). Genmab will create novel human antibodies to three targets identified by Lundbeck. Lundbeck has access to Genmab's antibody creation and development capabilities, including its UniBody platform. Lundbeck will have an option to take selected antibodies into clinical development at its own cost and subject to the payment of milestones and single-digit royalties to Genmab upon successful development and commercialization. Genmab will have a similar option to take selected antibodies into clinical development for cancer indications at its own cost and subject to the payment of milestones and single-digit royalties to Lundbeck.
Under the terms of the agreement, Genmab received an upfront payment of €7.5 million (approximately DKK 56 million at the date of the agreement). Lundbeck will fully fund the development of the antibodies. If all milestones in the agreement are achieved, the total value of the agreement to Genmab would be approximately €38 million (approximately DKK 283 million), plus single-digit royalties.
Seattle Genetics
In September 2010, Genmab and Seattle Genetics, Inc. entered into an antibodydrug conjugate (ADC) research collaboration agreement. Under the agreement, Genmab has rights to utilize Seattle Genetics' ADC technology with its HuMax-TF antibody. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a co-development option for any resulting ADC products at the end of Phase I clinical development.
Genmab is responsible for research, manufacturing, preclinical development and Phase I clinical trials of ADCs under this collaboration. Seattle Genetics will receive research support payments for any assistance provided to Genmab. If Seattle Genetics opts into an ADC product at the end of Phase I, the companies would codevelop and share all future costs and profits for the product on a 50:50 basis. If Seattle Genetics does not opt in to an ADC product, Genmab would pay Seattle Genetics fees, milestones and mid-single digit royalties on worldwide net sales of the product.
TenX Biopharma, Inc.
. . . . . . . . . .
In February 2010, Genmab closed a license agreement granting exclusive worldwide rights to develop and commercialize zanolimumab to TenX Biopharma, Inc. Under the terms of the agreement, Genmab received a payment of USD 4.5 million and will be entitled to milestones and royalties on sales of zanolimumab. TenX Biopharma will be responsible for all future costs of developing, manufacturing and commercializing zanolimumab. TenX Biopharma filed for chapter 11 bankruptcy protection in November 2010 and Genmab awaits the outcome of these proceedings. All amounts owed by TenX were fully reserved as of December 31, 2010.
Manufacturing
As a part of the reorganization plan announced in November 2009, Genmab intends to sell its manufacturing facility located in Brooklyn Park, Minnesota, USA. Genmab's future manufacturing requirements will be met through working with contract manufacturing vendors. Prior to a potential sale, the Brooklyn Park facility is being kept in a validated state and will operate in a maintenance-only mode with a significantly reduced number of employees.
Genmab has hired an external sales agent with significant experience within the sale of pharmaceutical and biotechnology manufacturing facilities.
As announced in November 2010, the expected sale of the facility is moved to 2011 due to a change in market conditions. The change in market conditions includes, among other things, a further increase in capacity among contract manufacturers in the industry and the average time a facility is on the market is now anticipated to be above 24 months (previously 12 months).
As a consequence of the changed market conditions, the fair value less cost to sell has been further reduced from approximately USD 145 million to USD 120 million as of September 30, 2010. Sales related costs are still estimated to be approximately USD 5 million. As a result of the reduction in the fair value less cost to sell, a non-cash impairment charge of approximately DKK 130 million was recognized in the income statement. The impairment is included in the result of the discontinued operation.
The sale process is active and several parties have signed confidentiality agreements. Further sales initiatives are planned in 2011 and Genmab remains committed to its plan to sell the facility.
For further details, please refer to notes 1 and 19.
Antibody Technology, Streamlined Development and Intellectual Property
Antibodies are proven candidates for therapeutic products, with numerous monoclonal antibody products approved for use in the United States and Europe. To create our therapeutic products, Genmab uses transgenic mice to produce novel antibodies that are fully human. Some of our HuMax antibodies have been shown to be 100 to 1,000 times better at binding to their disease target than earlier generations of murine or laboratory-engineered antibodies, which are not fully human. In addition, we believe that fully human antibody therapies may have other advantages over older generation products, such as a more favorable safety profile and improved treatment regimens. Genmab has licensed the rights to use the UltiMAb® transgenic mouse technology platform from Medarex Inc., a wholly owned subsidiary of Bristol-Myers Squibb, under which we received 16 fully paidup commercial licenses. For any product we develop that does not use a fully paidup commercial license, we will owe, on a product-by-product basis, upfront license fees, milestone payments, and low single-digit percentage royalties.
We combine the UltiMAb transgenic mouse technology with our own intellectual property and in-house expertise to produce and evaluate new antibodies as product candidates. Once a panel of antibodies for a new disease target has been generated, we subject the antibodies to extensive and rigorous testing, employing our wide array of laboratory tests and animal disease models. Our goal is to use these broad pre-clinical capabilities to identify the clinical candidate with the best possible characteristics for treating a particular disease.
Our research and development teams have established a streamlined process to coordinate the activities of product discovery, manufacturing, pre-clinical testing, clinical trial design, data management and regulatory submissions across Genmab's international operations.
DuoBody Bispecific Antibody Technology
In 2010, Genmab announced its DuoBody technology, a novel next generation bispecific antibody technology. Bispecific antibodies combine the ability to bind two targets in a single antibody molecule. This may result in more precise targeting and increased efficiency of disease killing mechanisms. Previous generations of bispecific technologies suffered from manufacturing difficulties and/or instability of bispecific molecules and also only remained in the body for a very short period of time. Genmab's novel proprietary DuoBody technology results in efficient generation of the desired type of bispecific antibodies. The new bispecific DuoBody antibodies are human, stable and may remain in the body as long as regular human antibodies, giving them more time to attack disease.
UniBody Technology
UniBody is a proprietary antibody technology that creates a stable, smaller antibody format with an anticipated longer therapeutic window than current small antibody formats, based on pre-clinical studies to date. A UniBody molecule is about half the size of a regular type of inert antibody called IgG4 and binds with only one antibody arm to a therapeutic target. UniBody molecules are expected to be cleared from the body at a lower rate than other antibody fragments based on the preclinical studies to date. Unlike other antibodies which primarily work by killing targeted cells, a UniBody molecule will only inhibit or silence cells, which could be an advantage in the treatment of diseases such as asthma or allergies.
Intellectual Property
Proprietary protection for our products, processes, and know-how are important to our business. Currently, we own and license patents, patent applications, and other proprietary rights relating to our human antibody technology and our antibody products and/or uses of these products in the treatment of diseases. In
addition, under the terms of our Technology Agreement with Medarex, we have rights to file patent applications for future antibody products developed using our human antibody technology. Our policy is to file patent applications to protect technology, inventions and improvements relating to antibody products and technologies that we consider important to the development of our business. Please refer to the "Risk Management" section for further details.
Human Resources
. . . . . . . . . .
One of Genmab's greatest assets is its employees. Skill, knowledge, experience and employee motivation are essential to Genmab as a fast paced biotech company. The ability to organize our highly skilled and very experienced employees into interactive teams is a key factor in achieving the high goals we establish to ensure Genmab's success. Please refer to the "Risk Management" section for further details.
Genmab emphasizes an open and supportive professional work environment across our international locations.
During 2010, the number of Genmab employees decreased from 309 to 189. The net decrease of 120 employees reflects our decision to reduce staff as a result of the company's reorganization efforts in 2009 and 2010. The total number of employees, at the end of 2010 includes transition employees who will leave Genmab upon transferring their tasks.
Our workforce is concentrated in research and development. At the end of 2010, 163 people, or 86% of our employees, were employed in research and development activities compared to 269 or 87% at the end of 2009.
At the end of 2010, the average age of our workforce was 41 years (2009: 41 years) and the male to female ratio was 49% to 51% (2009: 42% to 58%).
The technical demands of biotechnology require a high employee education level. At the end of 2010, 50 employees or 26% (2009: 67/21%), hold a Ph.D. or a doctoral degree. In addition, 32 employees or 17% (2009: 78/25%), hold Master's degrees. In total, at the end of 2010, 43% of employees (2009: 47%) hold advanced degrees.
Genmab's team is also very experienced in the pharmaceutical and biotechnology industry, particularly among the more senior personnel.
Financial Review
. . . . . . . . . .
The financial statements have been prepared in accordance with the provisions of IFRS as issued by the International Accounting Standards Board and International Financial Reports Standards as endorsed by the EU and additional Danish disclosure requirements for annual reports of listed companies. Genmab's financial statements are reported in Danish Kroner (DKK). Please refer to notes 1 and 25 to the financial statements for a description of our accounting policies.
For the convenience of the reader, we have included a conversion of certain DKK amounts into US Dollars (USD) at a specified rate in the supplementary section to the annual report. The conversion is unaudited. Please refer to the section "Conversion of Certain DKK Amounts into USD – Supplementary Information".
Result for the Year
The group's operating loss from continuing operations for 2010 was DKK 161 million and the net loss was DKK 143 million. This compares to the 2009 operating loss and net loss of DKK 498 million and DKK 348 million, respectively.
As of December 31, 2010, our cash position amounted to DKK 1,546 million and has increased by DKK 265 million during the year. The increase is primarily related to the upfront payments received from GSK and Lundbeck, partially offset by the ongoing investment in our research and development activities.
In November 2010, we revised our 2010 financial guidance primarily as a result of a reduction in the fair value of the Minnesota manufacturing facility and a delay of the anticipated sale into 2011. We also, for the first time, included Arzerra royalty income in the financial guidance.
| MDKK | 2010 | ||
|---|---|---|---|
| Actual | Guidance | ||
| Revenue | 582 | 575 - 585 | |
| Operating expenses | (743) | (775) - (825) | |
| Operating loss continuing operations | (161) | (200) - (250) | |
| Discontinued operation | (48) | (55) | |
| Non-cash impairment charge | (130) | (130) | |
| Opening cash* | 1,281 | 1,281 | |
| GSK upfront payment | 815 | 815 | |
| Closing cash with GSK* | 1,546 | 1,475 - 1,525 | |
*Cash, cash equivalents and marketable securities
Overall, the total financial performance is in line with the latest revised guidance of November 9, 2010. The operating loss and cash position is better than projected, partly driven by timing difference in development costs.
The reorganization and transition charges amounted to DKK 44 million and include severance, retention payments, early termination of contracts and other employee costs related to the reorganization plans announced in November 2009 and October 2010. Please refer to note 19 for further details about the impairment charge related to our manufacturing facility.
Revenues
. . . . . . . . . .
Genmab's revenues were DKK 582 million for 2010 and DKK 586 million in 2009. The revenues arise primarily from the recognition of milestone payments, deferred revenue, royalties and reimbursement of certain development costs in relation to the co-development work under Genmab's development collaboration agreement with GSK.
As revenues comprise royalties, milestone payments and other income from our research and development agreements, recognition of revenues may vary from period to period.
| MDKK | 2010 | 2009 |
|---|---|---|
| Royalties | 54 | 6 |
| Milestone payments | 206 | 267 |
| Deferred revenue | 216 | 217 |
| One time payment from GSK | - | 25 |
| Other revenues | 106 | 71 |
| Total revenues | 582 | 586 |
Royalties:
. . . . . . . . . .
Arzerra was approved for sale in the US on October 26, 2009 and in the EU on April 19, 2010. The first sale occurred in the US in November 2009.
The net sales of Arzerra were DKK 270 million in 2010 with DKK 235 million in the US and DKK 35 million in the rest of the world. The total recognized royalties for 2010 related to net sales of Arzerra amounted to DKK 54 million compared to DKK 6 million in 2009.
Milestone Payments:
In April 2010, we announced that we had reached a milestone for Arzerra (ofatumumab) under the terms of our collaboration with GSK. A milestone payment of DKK 87 million was triggered when the European Commission's granted a conditional marketing authorization for ofatumumab for the treatment of refractory CLL.
In September, a milestone payment of DKK 116 million was triggered when we announced the start of a Phase III study in patients with indolent B-NHL who did not respond to or progressed during, or within 6 months of a rituximab containing regimen.
The 2009 milestone payments included the European Medicines Agency's (EMA's) acceptance of the MAA for ofatumumab in refractory CLL (DKK 58 million) and the FDA acceptance of our BLA filing under the same study (DKK 87 million). In addition, a milestone payment of DKK 116 million was triggered when the FDA approved Arzerra for the treatment of patients with CLL that is refractory to fludarabine and alemtuzumab.
As of December 31, 2010, total milestone payments received under the GSK agreement, including a DKK 25 million one-time payment received in 2009, have amounted to DKK 1,071 million since inception in 2007.
In December 2010, a milestone payment of DKK 3 million from Roche at the initiation of the Phase II RG1512 study was received.
Deferred Revenue:
In 2010 deferred revenue amounted to DKK 216 million compared to DKK 217 million in 2009.
As a result of the amended agreement with GSK, Genmab received an upfront payment of GBP 90 million (DKK 815 million at the date of the agreement) from GSK. As of June 30, 2010, the remaining part of deferred revenues received at the inception of the initial GSK Agreement amounted to DKK 326 million. This remaining amount equalled the last 18 months of the initial 60 month allocation period. It was not possible to obtain objective and reliable evidence of the value of the different components of the amendment and remaining deferred revenue and measure these on a stand alone basis as the past and future activities are highly interrelated. As such, the upfront payment and the remaining deferred revenues were considered as a single transaction and on a combined basis.
Together with the existing deferred revenue, the upfront payment was deferred and allocated and recognized as revenues on a straight line basis over the years July 1, 2010 to December 31, 2015 (66 months), at an amount of DKK 207 million per year.
In October, Genmab announced an agreement to create and develop human antibody therapeutics for disorders of the central nervous system (CNS) with H. Lundbeck A/S. Under the terms of the agreement, Genmab received an upfront payment of EUR 7.5 million (approximately DKK 56 million at the date of the agreement). In accordance with our accounting policies, the upfront payment will be deferred and recognized in the income statement as revenue on a straight line basis over a three year period.
As of December 31, 2010, DKK 1,089 million was included as deferred income in the balance sheet.
Other Revenues:
. . . . . . . . . .
Other revenues are mainly comprised of the reimbursement of certain development costs in relation to the co-development work under Genmab's development collaboration agreement with GSK.
As a result of the amended GSK agreement, the reimbursement of certain costs increased, including 100% of autoimmune development costs incurred by Genmab, as GSK are now fully responsible for development in this indication.
In the first quarter of 2010, we closed a license agreement under which Genmab granted exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4™) to TenX Biopharma, Inc. Under the terms of the agreement, Genmab received a payment of USD 4.5 million (approximately DKK 24 million).
Operating Expenses
Research and Development Costs
Research and development costs decreased by DKK 352 million, or 38%, from DKK 935 million in 2009 to DKK 583 million for the year ended December 31, 2010. The savings reflect our continued efforts to reduce cost despite an increasing number of Phase III trials and are driven by:
• the amendment of the ofatumumab co-development and commercialization agreement with GSK in July which resulted in eliminating the requirement for Genmab to fund any of the autoimmune development of ofatumumab from January 1, 2010 and reversal of accruals related to the development of ofatumumab (prior to the amendment of the agreement). During the third quarter of 2010, these development accruals which related to both 2009 and 2010 were adjusted; and
• the reorganization plans announced in November 2009 and October 2010 where we decided to sell our manufacturing facility and reduce headcount by approximately 300 and 33 positions, respectively.
As of December 31, 2010, we had 29 ongoing clinical trials compared to 25 at the end of December 2009. The overview includes both studies carried out and funded by Genmab and our collaborators GSK and Roche. Please refer to the Product Pipeline section in the annual report for further details about the ongoing studies.
The majority of our research and development cost is related to the ofatumumab and zalutumumab programs and staff costs. Research and development costs accounted for 78% of total operating expenses compared to 86% in 2009. The decrease in the ratio is a result of the items discussed above.
General and Administrative Expenses
General and administrative expenses were DKK 160 million in 2010 compared to DKK 149 million in 2009. The increase was driven by expenses related to the departure of Genmab's former Chief Executive Officer in June 2010. The total impact of the departure was DKK 41 million and included a one-time salary expense of DKK 23 million and a warrant expense of DKK 18 million. Excluding this one time charge general and administration expenses would have been DKK 119 million, 20% lower than 2009.
General and administrative expenses account for 22% of our total operating expenses compared to 14% in 2009.
Operating Result
. . . . . . . . . .
Genmab's operating loss for 2010 was DKK 161 million compared to DKK 498 million for 2009. The decrease of DKK 337 million or 68% is mainly due the amendment of the GSK agreement and our continued strong focus on cost savings and control.
On December 31, 2010, the total number of employees was 189 compared to 309 employees as of December 31, 2009. The decrease is a result of the reorganization plans announced in November 2009 and October 2010. As of December 31, 2010, the employees for the continuing operations include transition employees who will leave Genmab during 2011 when their tasks have been transferred. When the transition is finalized and vacancies are filled, the remaining organization will employ approximately 183 persons.
The transition period for employees affected by the November 2009 reorganization plan ended September 30, 2010.
| Workforce | 2010 | 2009 |
|---|---|---|
| Research and development employees | 140 | 242 |
| Administrative employees | 26 | 40 |
| 166 | 282 | |
| Total employees for continuing operations | ||
| Discontinued operation | 23 | 27 |
Restructuring and transition charges associated with the reorganization plan announced in November 2009 and October 2010 amounted to DKK 36 million in 2010 and DKK 54 million in 2009. The charges are included in the operating loss for continuing operations and are related to severance and retention payments, early termination of contracts and other costs related to the re-organization plans.
Net Financial Items
Net financial items for 2010 reflected a net income of DKK 38 million compared to a net income of DKK 156 million in 2009. The net financial items reflect a combination of interest income and unrealized and realized fair market value adjustments on our portfolio of marketable securities and realized and unrealized foreign exchange adjustments.
The total interest income amounted to DKK 26 million in 2010 compared to DKK 57 million in 2009. The decrease in our interest income is primarily due to the reduction of our average cash position compared to 2009, the transfer of funds into safer and more liquid assets and a general reduction in market interest rates. The upfront payment from the amended GSK agreement was received in July 2010 and invested in accordance with our investment policy in the third quarter of 2010.
In 2010, the net realized and unrealized gains on marketable securities amounted to DKK 2 million compared to DKK 119 million in 2009. During 2009, the net financial items experienced significant market volatility, reversing a large portion of the unrealized losses from 2008, which was largely attributable to the impact from the worldwide economic turmoil on our investment portfolio.
The financial items, net were also impacted by mainly non-cash foreign exchange rate adjustments due to the significantly fluctuating exchange rate between USD/DKK and GBP/DKK. During 2010, the USD/DKK exchange rate increased by approximately 8% and the GBP/DKK by approximately 5%. A portion of the proceeds received from GSK, as a part of the amendment signed in July 2010, has been kept in GBP to form a natural hedge of future expenses denominated in GBP.
The total exchange rate gains, net amounted to DKK 11 million in 2010 compared to exchange rate losses, net of DKK 23 million in 2009.
As of December 31, 2010, we had unrealized losses on our marketable securities of DKK 3 million. Please refer to note 13 in the financial statements for additional information about our marketable securities.
Net Result for Continuing Operations
Net loss for 2010 was DKK 143 million compared to DKK 348 million in 2009. The improvement is driven by the positive impact from the amendment of the ofatumumab co-development and commercialization agreement with GSK and savings from the re-organizations in 2009 and 2010 which more than offset the decrease in positive net financial items and the one-time expense related to our former CEO.
The net loss for continuing operations included corporate tax of DKK 21 million in 2010 compared to DKK 6 million in 2009. The corporate tax is related to corporate taxation in our subsidiaries.
Net Result for Discontinued Operation
Net loss for discontinued operation includes the results of our manufacturing facility, which has been classified as held for sale and presented as a discontinued operation due to our decision to sell the facility. The net loss for discontinued operation amounted to DKK 178 million in 2010 compared to DKK 663 million in 2009.
As mentioned in the Manufacturing section in the annual report, the fair value less cost to sell of the facility has been reduced from approximately USD 145 million to USD 120 million as of September 30, 2010, resulting in a non-cash impairment charge of approximately DKK 130 million. In 2009, a non-cash impairment charge
of approximately DKK 419 million was recognized. Both charges are included in the DKK 178 million and DKK 663 million mentioned above.
Prior to a potential sale, the Brooklyn Park facility is being kept in a validated state and will operate in a maintenance-only mode with a significantly reduced number of employees and this is reflected in the result for 2010 of DKK 48 million. The equivalent amount for 2009 was DKK 244 million which is higher than this year as the facility still was operating in the first ten months of 2009.
In the financial statements of the parent company, net loss for discontinued operation includes an impairment of DKK 289 million in 2010 and DKK 752 million in 2009, which is related to Genmab A/S' investment in Genmab MN, Inc. The facility is owned by Genmab MN, Inc. Please refer to note 10 for additional information about the impairment.
Cash Position
. . . . . . . . . .
As of December 31, 2010, the balance sheet reflected cash, cash equivalents, and marketable securities (cash position) of DKK 1,546 million compared to DKK 1,281 million as of December 31, 2009. This represents a net increase of DKK 265 million during the year, which is primarily related to the upfront payment of GBP 90 million (DKK 815 million at the date of the agreement) received from GSK and the upfront payment of EUR 7.5 million (approximately DKK 56 million at the date of the agreement) received from Lundbeck, partially offset by the ongoing investment in our research and development activities.
The cash position includes a negative balance, recorded on the balance sheet as an overdraft, of DKK 116 million related to one of our investment accounts due to acquisition of bonds on December 28, 2010. These bonds were paid for in the first few days of January 2011 when proceeds from matured bonds were transferred to the account. We recognize marketable securities at the trade date and not the settlement date, hence it was necessary to record the cash owed on this transaction, see note 25 for further details.
To reduce our overall risk profile within our marketable securities, we sold our Euro-denominated investment portfolio in the second quarter of 2010 and transferred these funds to our Danish investment managers. Together, with the proceeds received from the GSK amendment, the funds were reinvested during the third quarter in DKK, EUR and GBP highly liquid and high quality short term bonds in accordance with our investment policy.
Given the current market conditions, all future cash inflows and proceeds from the disposal of marketable securities are invested in highly liquid and conservative investments, such as government bonds.
Cash and cash equivalents amounted to DKK 101 million including marketable securities with a maturity of 3 months or less on the date of acquisition of DKK 49 million. As of September 30, 2010, bank deposits are no longer fully guaranteed by the Danish Government. To reduce the credit risk on our bank deposits, Genmab only maintains the major part of its bank deposits in large Danish financial institutions. In addition, Genmab will only maintain limited bank deposits at a level necessary to support the short term funding requirements of the Genmab group.
Balance Sheet
. . . . . . . . . .
As of December 31, 2010, total assets were DKK 2,482 million compared to DKK 2,222 million at the end of 2009. As of December 31, 2010, the assets were mainly comprised of marketable securities of DKK 1,548 million and assets held for sale of DKK 694 million related to our planned disposal of our manufacturing facility. Please refer to notes 8 and 19 for further details regarding the planned disposal of the facility.
Other liabilities have decreased from DKK 344 million as of December 31, 2009, to DKK 110 million as of December 31, 2010. The decrease was primarily driven by the payment of liabilities related to our development agreements with GSK.
Shareholders' equity, as of December 31, 2010, equaled DKK 1,080 million compared to DKK 1,297 million at the end of December 2009. On December 31, 2010, Genmab's equity ratio was 44% compared to the 58% reported at the end of 2009. The decrease in the equity ratio was driven by the recognition of the upfront payment received from the amendment of the GSK agreement as noninterest bearing deferred income in the balance sheet.
Subsequent Events
Subsequent to the balance sheet date we announced net sales for Arzerra (ofatumumab) during the fourth quarter of 2010 were GBP 9 million (approximately DKK 77 million), resulting in a royalty payment of approximately DKK 15.5 million to Genmab.
Subsequent to the balance sheet date, no other events that could significantly affect the financial statements as of December 31, 2010, have occurred.
Corporate Governance
Genmab is continuously working to improve its guidelines and policies for corporate governance taking into account the recent trends in international and domestic requirements and recommendations. Genmab's commitment to corporate governance is based on ethics and integrity and forms the basis of its effort to strengthen the confidence that existing and future shareholders, partners, employees and other stakeholders have in Genmab. The role of the shareholders and their interaction with Genmab is important. Genmab acknowledges that open communication is necessary to maintain the confidence of our shareholders and we achieve this through stock exchange releases, investor meetings, and company presentations. Genmab is committed to providing reliable and transparent information about the business, development programs, and results in an open and timely manner. As a part of these initiatives, Genmab's website (www.genmab.com) contains information about the parent company and the group, our products in development, news releases and events which Genmab participates in.
Given the international mix of Genmab's stakeholders, we believe that it is appropriate that the main content of the website is presented in English. All corporate documents and stock exchange releases are, however, available in both Danish and English. Furthermore, at Genmab's annual general meeting, wireless simultaneous interpretation is provided in English and Danish to enable participating shareholders to follow the discussions.
All Danish companies listed on the NASDAQ OMX Copenhagen are required to disclose in their annual reports how they address the Recommendations for Corporate Governance published by the NASDAQ OMX Copenhagen Committee on Corporate Governance of April 2010 (the "Recommendations"). The companies shall adopt the "comply-or-explain" principle with respect to the Recommendations. Genmab complies with the majority of the Recommendations, although specific sub-areas have been identified, where Genmab's corporate governance principles differ from the Recommendations. Areas of non-compliance with the Recommendations are explained in the relevant sections below. Unless specifically addressed, Genmab complies with the Recommendations.
The Work and Composition of the Board of Directors
The board of directors plays an important role within Genmab, being actively involved in determining the strategies and goals for Genmab and by monitoring the operations and results of the company. The board of directors also assesses Genmab's capital and share structure and is responsible for approving share issues and grant of warrants. Relevant knowledge and professional experience are key parameters when nominating board members.
On April 21, 2010, the shareholders re-elected Dr. Anders Gersel Pedersen and Dr. Burton G. Malkiel to the board of directors at Genmab's annual general meeting.
In June, three Genmab employees joined the board upon election by the employees of the Genmab Group in accordance with a voluntary arrangement incorporated in the Articles of Association as adopted at the Annual General Meeting on April 21, 2010. The voluntary arrangement allows a broad geographical representation of the employees. Thus both employees in Genmab A/S and its foreign subsidiaries can be elected as employee board members. The employee elected members are Daniel J. Bruno, based in Princeton, N.J. USA, Nedjad Losic, based in Copenhagen, Denmark and Dr. Tom Vink, based in Utrecht, The Netherlands.
In June, Genmab announced changes to its management and Board of Directors. Lisa N. Drakeman, Ph.D. retired from her position as Chief Executive Officer and Board Member of the company. The Chief Executive Officer position at Genmab was filled by Prof. Jan G.J. van de Winkel, Ph.D., the company's former President, Research and Development and Chief Scientific Officer.
Genmab's five board members elected through general meetings are all considered to be independent of Genmab under the Recommendations. The employee elected board members are not considered to be independent of Genmab.
| First | Term | Inde | Committee | |||
|---|---|---|---|---|---|---|
| Name | elected | expires | Nationality | Age | pendent | Membership |
| Michael B.Widmer (board chairman) |
2002 | 2011 | American | 63 | Yes | Chairman of Compensation Committee |
| First | Term | Inde | Committee | |||
|---|---|---|---|---|---|---|
| Name | elected | expires | Nationality | Age | pendent | Membership |
| Anders Gersel | 2003 | 2013 | Danish | 59 | Yes | Compensation; |
| Pedersen | Nominating & Corporate | |||||
| (deputy chairman) | Governance Committee | |||||
| Karsten Havkrog | 2002 | 2011 | Danish | 61 | Yes | Audit Committee; |
| Pedersen | Nominating & Corporate | |||||
| Governance Committee | ||||||
| Burton G. Malkiel | 2007 | 2013 | American | 78* | Yes | Chairman of Audit |
| Committee | ||||||
| Hans Henrik | 2007 | 2012 | Danish | 50 | Yes | Audit Committee; |
| Munch-Jensen | Chairman of Nominating | |||||
| & Corporate Governance | ||||||
| Committee | ||||||
| Daniel J. Bruno | 2010 | 2013 | American | 31 | No | |
| Nedjad Losic | 2010 | 2013 | Swedish | 41 | No | |
| Tom Vink | 2010 | 2013 | Dutch | 48 | No |
* According to the Company's Articles of Association, no individual can be a member of the Board after the first Annual General Meeting in the calendar year in which such person reaches the age of 75 years. In connection with Burton Malkiel's re-election in 2010 an exception was adopted by the Annual General Meeting.
During 2010, the board of directors held 12 scheduled meetings, in addition to the informal ongoing communication between the board members and the executive management.
In 2010 we entered into a collaboration with H. Lundbeck A/S. Deputy Chairman Anders Gersel Pedersen is member of Lundbeck's executive management. Adequate procedures have been established to avoid conflicts of interests in the board members' professional duties including conducting executive sessions. Such procedures have been followed in connection with the Lundbeck collaboration and with these measures we believe that none of the board members elected by general meeting has relations or interests that may be contrary to Genmab's businesses or may conflict with the duty as a board member.
The Recommendations prescribe that board members run for election every year, but Genmab has designated three-year election periods to provide continuity and stability on the board. The board of directors performs regular assessments of its own performance with a view to ensure that the board of directors is capable of fulfilling its function and responsibilities. The board of directors believes it has the right size and composition representing adequate expertise and skills within the relevant fields. Furthermore, the board of directors performs regular assessments of the executive management and of the collaboration between the parties to identify any areas in potential need of improvement. The collaboration is based on a natural element of control, but it is also characterized by interaction and teamwork for the purpose of developing and advancing Genmab. As Genmab is an
innovative and dynamic company, it is especially important for the board of directors to liaise actively with the executive management in a respectful and trusting manner.
Genmab has not established rules with respect to the number of board positions outside of Genmab that each board member is allowed to hold. It is considered that the individual board members and the Nominating and Corporate Governance Committee will be able to determine this on a case-by-case basis as no general guidelines can be made for the workload associated with such positions. Please refer to the sections "Board of Directors" and "Senior Management" in the annual report to see the board members' number of directorships held outside Genmab.
The Recommendations prescribe that the board of directors, from the moment it obtains knowledge that a takeover bid will be submitted, does not, without the acceptance of the general meeting, attempt to counter the takeover bid by making decisions which prevent the shareholders from deciding on the takeover bid. The Recommendations further prescribe that the board of directors gives the shareholders the opportunity to decide whether or not they wish to dispose their shares under the terms offered. These matters have been reviewed and discussed in detail by the board of directors and a formal policy will be constructed during 2011.
Committees
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To support the board of directors in its duties, three committees have been established, including:
| Meetings | |
|---|---|
| Committees | in 2010 |
| the Nominating and Corporate Governance Committee; | 1 |
| the Audit Committee; and | 5 |
| the Compensation Committee | 3 |
None of the employee board members are elected to the committees.
Written charters specifying the tasks and responsibilities have been adopted for each of these committees.
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee monitors the work of the board of directors, including regular reviews and assessments of the size, composition, authority, operations, diversity, including with respect to international experience, gender and age and performance of the board.
The tasks include performing at least annual evaluations of the board of directors and the individual board members and making recommendations to the board with respect to re-nomination of existing board members and identification of new candidates to serve on the board. The Committee aims to continuously hold a broad composition containing members with relevant knowledge, expertise and experience in biotechnology, commercialization, financial, legal and managerial aspects relevant to Genmab's business.
Furthermore, on an annual basis the Nominating and Corporate Governance Committee evaluates the composition, charter, authority and performance of each standing board committee and recommends to the board any changes considered appropriate with respect thereto.
Genmab believes the board of directors' professional experience, and use of external advisors, is adequate to ensure that the best suited candidates are identified and that the composition of the board of directors appropriately reflects the needs of the Company. Genmab believes that the current composition of the board of directors is adequate taking into account the criteria mentioned above. Special competences and skills possessed by each individual member of the board are outlined in the sections "Board of Directors" and "Senior Management" in the annual report.
The Nominating and Corporate Governance Committee also oversees the standards for independence of directors. Further, this committee oversees Genmab's corporate governance functions and works with the executive management to monitor important corporate governance issues and trends in corporate governance practices and recommendations.
Audit Committee
. . . . . . . . . .
The Audit Committee assists the board in fulfilling its responsibilities by monitoring the system of internal control and the financial reporting process and by examining Genmab's interim and annual reports prior to adoption by the board and release to the NASDAQ OMX Copenhagen. The committee evaluates the independence and competences of the auditors as well as makes recommendations concerning election of the auditors.
The Audit Committee also reviews Genmab's significant accounting policies and estimates as well as related party transactions, uncertainties and risks, including those related to the financial outlook. The Audit Committee agrees on the fees, terms and other conditions of engagements with the independent auditors and monitors the audit process.
On an annual basis the Audit Committee considers whether there is a need for an internal audit function in the Company. Due to the current size of Genmab and the business structure, it has been decided not to establish an internal audit function.
The independent auditors report directly to the Audit Committee with respect to audit findings and other recommendations, including issues regarding the accounting policies and financial reporting process. Audit findings and recommendations from the independent auditors are reviewed by the Audit Committee and Genmab's CFO to ensure that any issues are properly addressed, and all material items and conclusions are made available to the board of directors.
The Audit Committee consists of three members who are considered to be independent, including Hans Henrik Munch-Jensen and Burton Malkiel who are also designated as the Audit Committee's financial, accounting and audit experts.
Compensation Committee
The role of the Compensation Committee is to advise the board on the adoption of policies that govern Genmab's compensation programs, including warrant and benefit plans. The guidelines governing the incentive programs for the board of directors and executive board are adopted at the annual general meeting. The Compensation Committee shall
- (i) make proposals, for the approval of the board prior to approval at the general meeting, on the compensation policy, including the overall principles of incentive pay programs, for members of the board and the registered managers,
- (ii) review and make recommendations to the entire board regarding the compensation structure for registered managers and members of the board in accordance with the Incentive Guidelines, the Company's compensation policy and based on an evaluation of the performance of the individuals concerned, and
- (iii) oversee that the information in the annual report on the compensation of the board and the registered managers is correct, true and sufficient.
The Committee supports the board in setting goals and objectives for the executive management, evaluating performance and deciding on annual compensation. The Compensation Committee monitors the trends within executive management compensation plans to ensure that Genmab's executive compensation programs are able to attract, retain and motivate the executive managers and align the interests of key leadership with the long-term interest of Genmab's shareholders.
The Committee performs an annual review of the remuneration of the board of directors which is determined by taking into account relevant market and benchmark data. The remuneration is adopted at the annual general meeting.
The remuneration of the board of directors and executive management is disclosed in note 21 to the financial statements which also includes a reference to Genmab's General Guideline for Incentive Programs for the board of directors and the executive management pursuant to section 139 of the Danish Companies Act. According to the Recommendations, the board of directors shall preferably not be remunerated through share option (warrant) programs. In addition, it is recommended that if the executive management are granted warrants, then a limit shall be set on the warrant grants and the warrant programs shall be set up as rollover programs with a redemption price higher than the market price at the time of allocation. Genmab has adopted a remuneration system that we believe is most efficient to attract and retain suitably qualified people to the board and the executive management. The board members and the executive management participate in Genmab's warrant programs, under which warrants are granted at market price on the day of grant and the warrants vest over a period of four years.
The Recommendations prescribe that, in exceptional cases, companies should be able to reclaim in full or in part variable components of remuneration that were paid on the basis of data which proved to be manifestly misstated. Genmab has not currently adopted this option of reclaiming these components of remuneration, but the matter is being reviewed and discussed in detail by the board of directors. Such exceptional cases are also regulated by applicable Danish law.
Corporate Social Responsibility (CSR)
. . . . . . . . . .
In 2008, the Danish Government presented its action plan for CSR. The action plan focuses on the voluntary environmental, social, and ethical activities of businesses and aims at promoting businesses' communication on CSR to the outside world.
Genmab has chosen to include the CSR description within the annual report.
During 2009, a CSR project group was established to determine Genmab's CSR ambition. The purpose of the project was to provide an overview of the CSR topics that are most relevant to Genmab and map the activities currently undertaken by the company as well as preparing an action plan to progress Genmab's future CSR ambition. As a result, a business driven CSR strategy and action plan was prepared and approved in 2009 by the board of directors.
In general, Genmab's fundamental contribution to society is inherent in the company's mission to provide therapeutic agents for unmet medical needs and to improve patients' lives. Genmab has chosen to focus on products to treat various cancers and we have a number of potential products in clinical trials. As of December 31, 2010, Genmab had 29 ongoing clinical trials.
In 2009, Genmab received its first product approval when FDA gave an accelerated approval of Arzerra for use in patients in the US with CLL that is refractory to fludarabine and alemtuzumab and in April 2010, the European Commission also granted a conditional marketing authorization for Arzerra. During 2010, our partner, GSK, has successfully launched Arzerra in the US and Europe. We are encouraged and motivated by seeing, through a direct result of our efforts, that patients' lives are being transformed by treatment with Arzerra.
Genmab's CSR ambition is to be in compliance with all relevant laws, standards and guidelines. In addition, Genmab has selected focus areas on the CSR agenda where the company will excel; focus areas have been chosen based on a business case evaluation and will be adjusted and expanded as deemed necessary. Genmab's CSR ambition covers four distinct areas:
- Employee well-being including health and safety and development
- Ethics in relation to pre-clinical and clinical studies
- Environment including waste management and recycling
- Business ethics and transparency
As planned in 2010 a CSR governance structure (task force) was established to ensure that the CSR strategy and action plan is implemented throughout the Genmab group. Genmab will enhance the existing CSR activities during 2011 and will initiate further activities within the CSR focus areas in the following years. See the planned activities below
We expect the initiated and planned CSR activities to have a positive effect on the reputation of Genmab and reduce the risks associated with environmental, social, and ethical issues. We anticipate that the CSR initiatives will be an attractive proposition for current and prospective employees and investors.
CSR Focus: Employee well-being including health and safety and development
Policies and guidelines
. . . . . . . . . .
Genmab has numerous policies in place to ensure the well-being, health and safety and development of its employees. The area of employee well-being is mostly covered by corporate policies regarding regular physical and mental workplace checks, smoking and alcohol, different forms of leave, diversity and anti-discrimination and a local policy regarding the prevention of work-related stress (Genmab A/S). The area of health and safety is mostly covered by policies regarding safety in laboratories and handling of dangerous substances (Genmab B.V.) and a policy on annual health checks and vaccinations (Genmab A/S).
Action and results
Genmab management is focused on employee well-being. Management assures that employees are trained in the prevention of possible harmful effects in the workplace, how to handle hazardous goods and chemicals (Genmab B.V.), how to manage workload and to enhance motivation (Genmab B.V.) and how to deal with work-related stress (Genmab A/S).
Genmab management currently has a strong focus on the retention, motivation and engagement of its employees. This has become more important since the workforce reductions between 2008 and 2010. Genmab has decided not to include any indicators for the HR area in 2010 due to these reductions. However, future indicators will be considered in 2011.
Genmab considers the development of its employees as a key factor for the success of the company. Therefore Genmab invests in training and development of its employees and has started to conduct personal development interviews. During these interviews, development needs, ambitions and drivers of the employee are being discussed and how these relate to Genmab. At Genmab B.V. and Genmab A/S a team development program is being scheduled for 2011.
Future expectations and activities – 2011 and onwards
Genmab expects to implement a new Performance Planning & Review cycle at all Genmab locations and to implement its newly defined core values in 2011 at a company wide event. An Employee Satisfaction Survey will be conducted in 2011.
CSR Focus: Ethics in relation to pre-clinical and clinical studies
Policies and guidelines
In general, the biotech and pharmaceutical industry is governed by extensive and strict regulations. Genmab is subject to and complies with these international regulations, guidelines, and standards for drug development, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and current Good Manufacturing Practice (cGMP). The regulations and guidelines are intended to provide quality assurance of pre-clinical and clinical studies and the processing of data resulting from the studies.
Genmab is dedicated to comply with all relevant legislation, including the guidelines issued by international regulatory authorities such as the EMA and the FDA. Please refer to the "Risk Management" section of the annual report.
Action and results
As management believes that is important to be in compliance with all relevant regulations, laws, standards, and guidelines and to ensure compliance with these requirements, Genmab conducts internal and external audits according to an approved
CSR Focus: Ethics in relation to pre-clinical and clinical studies
audit schedule and approved standard operation procedures.
In 2010 Genmab adopted a business model based on the principle of outsourcing of development activities to Contract Research Organization (CROs). In connection with this change, a corporate compliance project was finalized to ensure that Genmab's drug development organization's standard operating procedures were in compliance with the regulatory requirements for drug development under the new business model. This also covered all Quality documents such as policies, procedures and guidelines
Future expectations and activities – 2011 and onwards
Genmab will continue to conduct internal and external audits according to an approved audit schedule and approved standard operation procedures.
CSR Focus: Environment including waste management and recycling
Policies and guidelines
. . . . . . . . . .
All relevant policies regarding environmental care have been included in the Employee and Facilities Handbooks. Genmab encourages employees to act in an environmentally friendly manner, to produce as little waste as possible and to collect waste for recycling where practicable. The Genmab B.V. management of lab waste is audited annually and the waste license is maintained on the basis of compliance with all rules and regulations. Genmab B.V. lab employees are instructed to replace highly toxic chemicals by less toxic versions where feasible.
Genmab contributes to energy-saving by using an environmentally friendly climate control system (Genmab B.V.) and to equip all locations with energy saving light switches and LCD screens. Genmab monitors the use of environmentally friendly power sources employed by local power supply companies. Green energy is used when the pro-green arguments can be balanced with the costs involved.
Action and results
Genmab management tries to draw attention to environmental care. Genmab encourages its employees to use public transport to come to work by partially reimbursing the incurred expenses. Genmab restricts its employees' use of travel by plane and encourages the use of teleconferencing and videoconferencing instead of business trips. This has not only saved money but may contribute to a reduction in CO2 emissions. Genmab is planning to decrease paper consumption and has partially implemented the recycling of non-confidential paper waste, and encourages "green" bike deliveries.
Genmab has decided not to include any indicators for the environmental area in 2010 due to the reduction in employees mentioned above. However, future indicators will be considered in 2011.
Future expectations and activities – 2011 and onwards
Genmab A/S aims to have an environmental policy implemented in 2011. This policy will be used as best practice for all Genmab locations.
For 2011, Genmab plans to use recycled paper for all printers and copiers, to implement two-sided printing as corporate standard and to have a "think-before-you-print" message included in the standard e-mail signature. Genmab B.V. plans to have all lab plastics recycled after use.
CSR Focus: Business ethics and transparency
Policies and guidelines
As mentioned in the "Risk Management" section, Genmab is committed to lawful and
CSR Focus: Business ethics and transparency
ethical behavior in financial and accounting matters as well as other activities and requires its employees to conduct themselves in a manner that complies with all applicable laws and regulations.
Genmab has implemented global pharma compliance guidelines in relation to interactions with healthcare professionals and a code of ethics for principal officers. Furthermore, Genmab has guidelines for Company communications regarding products in development.
Action and results
. . . . . . . . . .
As planned for 2010 training has been conducted of Genmab employees in the pharma compliance guidelines and our whistleblower program has been implemented upon approval by the Danish Data Protection Agency. The whistleblower policy has been made accessible on Genmab's intranet. Training of new employees in these guidelines and policies will be held as necessary.
Future expectations and activities – 2011 and onwards
During 2011, we expect to implement and communicate a code of ethics for all our employees.
Description of Management Reporting Systems and Internal Control Systems
As a publicly listed company, we are required to have established procedures which provide a reasonable basis for management to make proper judgments as to our financial position. The board of directors and the executive management have the overall responsibility for Genmab's internal control and risk management systems in connection with the financial reporting.
Genmab has utilized a top-down risk based approach to comply with EURO SOX that began with the identification and assessment of risks that impact Genmab's financial reporting process. This approach included the review of entity-level controls, fraud risk assessments, identification of significant accounts and disclosures and linking of significant accounts and disclosures to the relevant assertions and underlying processes.
Our approach is an integrated one where finance, operations and IT personnel work closely together to ensure that the appropriate business processes and technology elements are reviewed. The overall framework and approach are based on COSO (Committee of Sponsoring Organizations).
The board of directors and executive management have established overall standards and guidelines to identify and monitor the risk that a significant error could occur in connection with the financial reporting and put procedures in place to ensure significant errors are prevented, detected and corrected. Therefore, Genmab has documented and designed an effective internal control environment that provides reasonable assurance that the financial reporting of Genmab is timely, reliable and in accordance with IFRS.
The standards and guidelines include among others:
• Formalized annual budget, forecasting and projection procedures;
• Regular management reporting including:
| o | Financial performance and financial position including analysis of cash flow and finance structure; |
|
|---|---|---|
| o | The comparison of budget, prior-year and actual performance; |
|
| o | Project management and cost control, identification of responsible project managers and regular project reporting and follow-up; |
|
| o | Review of potential claims and litigation; | |
| o | Contract and collaboration agreement review and maintenance to ensure that all commitments, liabilities, and income are recorded; and |
|
| o | Review of critical accounting policies and estimates | |
| • | expenditures accordance |
Schedule of Authorizations to ensure that receipts and of Genmab are being made only in with authorizations of management and directors of Genmab; |
| • | A group control function to monitor the monthly financial reporting and performance of subsidiaries and the group. The most significant subsidiaries have their own controllers with extensive business and financial experience and in depth knowledge of the individual subsidiary; |
|
| • | transactions | Detailed controls to ensure the completeness and accuracy of the accounting records of the Genmab group including requirements for appropriate segregation of duties, requirements for the reconciliations and monitoring of and documentation of controls and procedures; and |
| • | Detailed controls and procedures to ensure all reporting to NASDAQ OMX Copenhagen are accurately and consistently presented in a timely manner in accordance with applicable stock exchange rules. |
The compliance with group standards is supported by periodic reviews of both the parent company and subsidiaries' controls and procedures. The results of the review are discussed with local management and summaries are submitted to the Audit Committee.
Risk Management
Genmab has facilities in three countries and performs research and development activities with clinical trials conducted around the globe. Through our activities, we are exposed to a variety of risks, some of which are beyond our control. These risks may have significant impact on our business if not properly assessed and controlled. Maintaining a strong control environment, with adequate procedures for identification and assessment of risks and adhering to operational policies designed to reduce such risks to an acceptable level, is essential for the continued development of Genmab. It is our policy to identify and reduce the risks derived
from our operations and to establish insurance coverage to hedge any residual risk, wherever considered practicable. The board of directors performs a yearly review of Genmab's insurance coverage to ensure that it is adequate.
We are exposed to a number of specific risks. Below is a summary of some of Genmab's key risk areas and how we attempt to address such risks.
Development Risk
. . . . . . . . . .
The creation and development of therapeutic products within the biotechnology and pharmaceutical industry is subject to considerable risks. Since all aspects can not be known about the nature of disease or the way new potential therapeutic products can affect the disease process, a significant number of products will not successfully reach the marketplace. Moreover, these factors, including unforeseen safety issues or change of regulatory requirements, can influence the timing and nature of our clinical development activities and costs and related revenues such as milestone payments and reimbursement of costs.
Genmab has established various committees to ensure the optimal selection of disease targets and antibody product candidates and to monitor the progress of all projects. The committees combine knowledge and competences of key employees across the organization with the primary focus of optimizing the development of our projects by closely monitoring and assessing data and other information.
We are subject to extensive governmental regulation and we are not able to market our products or develop product candidates before regulatory approvals are obtained. Accordingly, it is essential for Genmab to adhere to any requirements from the regulatory authorities and to continuously be aware of the standards issued by such authorities. To ensure compliance with regulatory requirements, Genmab has established a separate quality assurance department. Genmab also closely adheres to the recommendations and comments received from the regulatory authorities and complies with all requirements from such authorities with respect to the company's applications.
Commercial Risk
Genmab is subject to a number of commercial risk factors, including market size and competition for our products, product pricing and reimbursement policies of government and third-party payers, the ability to attract the interest of potential partners and investors, development time of new products and cost of our development programs, patent protection and the avoidance of patent infringements.
We have a flexible commercialization strategy and seek partners for some products and research and development capabilities. The successful marketing of some of our potential product candidates might be beyond the capabilities of all but the largest pharmaceutical companies. For this reason, we may consider licensing to major pharmaceutical companies or distribution partners, individual products that may serve very large markets or those that may be widely distributed geographically, if the products are approved by the FDA, European or other regulatory agencies.
Our reliance on and collaboration with external partners is very important for our business as our future growth and a significant part of our future revenues, in particular milestones and royalties, may depend on the continued collaboration and adherence to agreements with existing and possible future collaboration partners. Our business may be negatively affected if our collaboration partners do not devote sufficient resources to our programs or potential products or become unable to meet their obligations or if we are not able to establish additional partnerships.
In general, Genmab attempts to control the commercial risks by continually monitoring and evaluating current market conditions and patent positions. In order to ensure that Genmab is in a good position to accomplish the objective, the board of directors and management perform an ongoing assessment of the progress with external partnerships and any changes to the commercial risks. In addition, we pursue a close and open dialogue with our partners to share ideas and best practices within clinical development to increase the likelihood that we reach our targets.
Financial Risk and Capital Management
Our development activities require significant capital. Accordingly, we may require additional funds and may be unsuccessful in attempting to raise additional funds through equity or debt financings, collaborative agreements with partners or from other sources.
The group's financial results may also be exposed to different kinds of financial risks, including currency exposure, changes in interest rates and credit risks. Genmab's financial risks are disclosed in more details in note 14 to the financial statements.
Inability to Attract and Retain Suitably Qualified Personnel
We are highly dependent on the principal members of our senior management, scientific staff and other key personnel, the loss of whose services could adversely affect the achievement of planned development objectives. We may not be able to attract and retain personnel on acceptable terms, given the competition for such personnel among biotechnology, pharmaceutical and healthcare companies, universities and non-profit research institutions.
To attract and retain our highly skilled workforce, we offer competitive remuneration packages, including a warrant program under which warrants are granted to our employees. For further details on the warrant programs, please refer to note 18 of the financial statements.
Legal and Regulatory Risk
In general, Genmab's activities are exposed to legal risks. Amended legislation and reinterpretation of legislation in countries which are important to Genmab's activities may result in unintended or unexpected issues. In addition, the contracts which Genmab has entered into may correspondingly be subject to unforeseen interpretation and hence unforeseen consequences thereof. The contents of such contracts or the manner in which such contracts were drawn up may also subsequently appear inappropriate. The consequences of such circumstances may turn out to involve not only legal matters but also significant technical and financial issues.
Product Liability
In particular, Genmab may be exposed to product liability claims for products developed by us or our partners. Although Genmab's products are rigorously
tested for safety during clinical trials and are closely reviewed by regulatory bodies prior to approval, there may be an unforeseen side effect or injury that occurs before or after approval. This poses a risk of litigation due to consumer product safety claims, substantiated and unsubstantiated.
A successful product liability claim could possibly affect our financial position in a material manner and Genmab therefore maintains product liability insurance coverage for our clinical trials as well as coverage required under applicable laws.
Intellectual Property
. . . . . . . . . .
There is an inherent risk that Genmab's intellectual property may not be protected and be subsequently reproduced or that Genmab's products infringe on a competitor's intellectual property.
Genmab takes necessary steps to file necessary patent applications in an effort to protect its product technologies from outside entities. In an effort to protect trade secrets and technology, Genmab maintains strict confidentiality standards and agreements for internal employees and any collaborating parties.
In October 2009, under the collaboration agreement between GSK and Genmab, GSK filed a declaratory judgment action at the United States District Court for the Southern District of Florida seeking a declaration that US Patent No 6,331,415 (the "Cabilly" patent) owned by Genentech, Inc. and City of Hope, is invalid, unenforceable and not infringed by Arzerra. The case has been transferred to the United States District Court for the Central District of California. No trial date has been scheduled yet.
In March 2010, Genentech, Inc. and Biogen Idec, Inc. filed a declaratory relief complaint at the United States District Court for the Southern District of California against Genmab's collaboration partner GSK for patent infringement under US patent No 7,682,612 based on GSK's manufacture, marketing and sale of Arzerra in the United States for the treatment of fludarabine and alemtuzumab refractory CLL. No trial date has been scheduled yet. We believe this claim is without merit.
Regulatory Risk
Genmab's operations occur in various countries with diverse laws and regulations that govern the biotechnology industry. Any changes in these laws and regulations may result in an unfavorable impact on our financial, legal, and other position. This includes changes in tax laws, change in US or foreign regulatory approval processes, changes in intellectual property laws, and changes in environmental safety laws, among others. If Genmab does not comply with these laws and regulations, it may incur significant costs, and such non-compliance may result in future litigation proceedings.
Genmab makes every effort to stay abreast of regulatory changes to legislation that affect its business to ensure compliance.
Outsourcing Risk
Genmab is dependent upon outsourcing arrangements for services to support our objectives and strategic plans. Such outsourcing services may introduce unforeseen risks such as availability of resources, confidentiality of information and regulatory compliance.
The company's board of directors and management continuously oversee and evaluate outsourcing relationships to ensure consistency with strategic objectives and service provider performance. This includes assessment of contingency plans, including availability of alternative service providers, and costs and resources required to switch service providers.
Ethical Risk
. . . . . . . . . .
As a biotechnology company, Genmab's reputation as a trusted partner is crucial to the company, its shareholders and business partners, and is essential to the company's ability to conduct its business.
Genmab is committed to lawful and ethical behavior in financial and accounting matters as well as other activities and requires its employees to conduct themselves in a manner that complies with all applicable laws and regulations.
Therefore, a code of ethics for principal executives and senior financial officers which addresses ethical behaviour has been developed. Together with certain business ethics procedures, including a corporate social responsibility ("CSR") strategy, these procedures aim to mitigate Genmab's ethical and reputation risk. In 2010, our whistleblower program was approved by the Danish Data Protection Agency.
Environmental Risk
Genmab's in-house research activities are carried out from the company's laboratory facilities in Utrecht, which are designed to reduce environmental impact through a modular energy efficient set-up based on energy regeneration equipment. To reduce environmental burden, we have implemented policies for the handling of hazardous materials and established procedures for the disposal of waste materials from our laboratory facilities in accordance with regulatory requirements. As Genmab's activities have a limited impact on the environment, we have chosen not to issue separate environmental reports.
Procedures for Changes in the Articles of Association
Unless the Danish Companies Act otherwise provides, the adoption of any resolution to alter Genmab's articles of association shall be subject to the affirmative vote of not less than two thirds of the votes cast as well as of the voting share capital represented at the general meeting. Genmab's entire articles of association can be found on our website.
Change of Control
Collaboration, Development and License agreements
Genmab has not entered into any significant collaboration, development, and license agreements with external parties, which are subject to renegotiation in case of a change of control event in Genmab A/S.
Service Agreements with Executive Management and Employees
The service agreements with each member of the executive management team may be terminated by Genmab with no less than 12 months' notice and by the executive with no less than six months' notice. In the event of a change of control of Genmab, the termination notice due to Genmab's executive officers is extended to 24 months. In the event of termination by Genmab (unless for cause) or by an executive officer as a result of a change of control of Genmab, Genmab is obliged to pay the executive officer a compensation equal to his/her existing total salary (including benefits) for up to two years in addition to the notice period. In case of a change of control event and the termination of service agreements of the executive management, the total impact on our financial position is estimated to approximately DKK 52 million as of December 31, 2010.
In addition, Genmab has entered into service agreements with approximately 31 (2009: 35) employees according to which Genmab may become obliged to compensate the employees in connection with a change of control of Genmab. If Genmab terminates the service agreement without cause, or changes the working conditions to the detriment of the employee, the employee shall be entitled to terminate the employment relationship without further cause with one month's notice in which case Genmab shall pay the employee a compensation equal to one or two times the employee's existing annual salary (including benefits).
In case of the change of control event and the termination of all 31 service agreements the total impact on our financial position is estimated to approximately DKK 72 million as of December 31, 2010.
With respect to change of control clauses related to warrants granted to our management and employees, please refer to note 18 to the financial statements. As of December 31, 2010, a change of control event and the termination of all impacted service agreements are not expected to have a significant impact on our financial position.
Distribution of the Year's Result
The board of directors proposes that the year's loss of the parent company of DKK 279 million (2009: DKK 1,186 million) be carried forward to next year by transfer to accumulated deficit.
Financial Statements for the Genmab Group and the Parent Company
Statement of Comprehensive Income Balance Sheet Statement of Cash Flow Statement of Shareholders' Equity
Notes to the Financial Statements:
-
- Management's Judgment and Estimates under IFRS
-
- Segment Reporting
-
- Depreciation, Amortization and Impairments
-
- Staff
-
- Financial Income
-
- Financial Expenses
-
- Corporate and Deferred Tax
-
- Intangible Assets
-
- Tangible Assets
-
- Equity Interests in Subsidiaries
-
- Inventories
-
- Receivables
-
- Marketable Securities
-
- Financial Risk
-
- Provisions
-
- Deferred Income
-
- Other Liabilities
-
- Warrants
-
- Discontinued Operation
-
- Related Party Disclosures
-
- Remuneration of the Board of Directors and Executive Management
-
- Commitments
-
- Contingent Assets, Contingent Liabilities and Subsequent Events
-
- Fees to Auditors Appointed at the Annual General Meeting
-
- Accounting Policies
Statement of Comprehensive Income
Income Statement
. . . . . . . . . .
| Genmab Group | Parent Company | |||||
|---|---|---|---|---|---|---|
| Note | 2010 | 2009 | 2010 | 2009 | ||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |||
| Revenues | 2 | 582,077 | 586,076 | 581,965 | 585,944 | |
| Research and development costs | 3, 4 | (582,512) | (935,361) | (599,397) | (1,093,928) | |
| General and administrative expenses | 3, 4 | (160,254) | (148,749) | (159,330) | (142,082) | |
| Operating expenses | (742,766) | (1,084,110) | (758,727) | (1,236,010) | ||
| Operating result | (160,689) | (498,034) | (176,762) | (650,066) | ||
| Financial income | 5 | 39,648 | 181,099 | 187,016 | 255,823 | |
| Financial expenses | 6 | (1,402) | (25,054) | (1,088) | (39,774) | |
| Result for continuing operations before tax | (122,443) | (341,989) | 9,166 | (434,017) | ||
| Corporate tax | 7 | (20,874) | (5,909) | - | - | |
| Net result for continuing operations | (143,317) | (347,898) | 9,166 | (434,017) | ||
| Result from discontinued operation | 19 | (178,139) | (662,862) | (288,617) | (752,201) | |
| Net result | (321,456) | (1,010,760) | (279,451) | (1,186,218) | ||
| Basic and diluted net loss per share | (7.16) | (22.51) | ||||
| Basic and diluted net loss per share continuing operations |
(3.19) | (7.75) |
Statement of Comprehensive Income
| Net result | (321,456) | (1,010,760) | (279,451) | (1,186,218) |
|---|---|---|---|---|
| Other comprehensive income: Adjustment of foreign currency fluctuations on subsidiaries |
37,859 | (33,748) | - | - |
| Total comprehensive income | (283,597) | (1,044,508) | (279,451) | (1,186,218) |
Balance Sheet - Assets
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| December 31, | December 31, | December 31, | December 31, | ||
| Note | 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| Intangible assets | 8 | - | - | - | - |
| Tangible assets | 9 | 41,430 | 60,180 | 10,181 | 15,126 |
| Equity interests in subsidiaries | 10 | - | - | 31,314 | 31,314 |
| Other securities and equity interests | 365 | 468 | 365 | 468 | |
| Receivables | 12 | 7,174 | 7,915 | 252,638 | 474,577 |
| Deferred tax assets | 7 | 13,265 | 4,634 | - | - |
| Total non-current assets | 62,234 | 73,197 | 294,498 | 521,485 | |
| Inventories | 11 | - | - | - | - |
| Receivables | 12 | 65,427 | 103,752 | 511,849 | 351,815 |
| Prepayments | 10,952 | 9,763 | 4,715 | 8,529 | |
| Marketable securities | 13 | 1,548,309 | 816,910 | 1,548,309 | 816,910 |
| Cash and cash equivalents | 100,950 | 460,738 | 86,437 | 445,071 | |
| 1,725,638 | 1,391,163 | 2,151,310 | 1,622,325 | ||
| Asset classified as held for sale | 19 | 693,729 | 757,174 | - | - |
| Total current assets | 2,419,367 | 2,148,337 | 2,151,310 | 1,622,325 | |
| Total assets | 2,481,601 | 2,221,534 | 2,445,808 | 2,143,810 |
Balance Sheet – Shareholders' Equity and Liabilities
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| Note | December 31, 2010 |
December 31, 2009 |
December 31, 2010 |
December 31, 2009 |
|
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| Share capital | 44,907 | 44,907 | 44,907 | 44,907 | |
| Share premium | 5,375,256 | 5,375,256 | 5,375,256 | 5,375,256 | |
| Translation reserves | 89,758 | 51,899 | - | - | |
| Accumulated deficit | (4,429,854) | (4,174,870) | (4,340,122) | (4,127,143) | |
| Shareholders' equity | 1,080,067 | 1,297,192 | 1,080,041 | 1,293,020 | |
| Provisions | 15 | 22,864 | 4,871 | 22,864 | 4,871 |
| Lease liability | 9,22 | 11,846 | 17,938 | 11,846 | 17,938 |
| Other liabilities | 17 | 42,213 | 3,172 | 34,056 | 1,606 |
| Total non-current liabilities | 76,923 | 25,981 | 68,766 | 24,415 | |
| Provisions | 15 | 100 | 7,195 | 100 | 4,825 |
| Lease liability | 9,22 | 6,091 | 7,004 | 6,091 | 7,004 |
| Accounts payable | 32,761 | 44,808 | 29,772 | 33,498 | |
| Deferred income | 16 | 1,089,318 | 439,371 | 1,089,318 | 439,371 |
| Bank overdraft | 115,780 | - | 115,780 | - | |
| Other liabilities | 17 | 68,102 | 341,073 | 55,940 | 341,677 |
| 1,312,152 | 839,451 | 1,297,001 | 826,375 | ||
| Liabilities classified as held for sale | 19 | 12,459 | 58,910 | - | - |
| Total current liabilities | 1,324,611 | 898,361 | 1,297,001 | 826,375 | |
| Total liabilities | 1,401,534 | 924,342 | 1,365,767 | 850,790 | |
| Total shareholders' equity and liabilities | 2,481,601 | 2,221,534 | 2,445,808 | 2,143,810 |
Statement of Cash Flow
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| Note | 2010 DKK'000 |
2009 DKK'000 |
2010 DKK'000 |
2009 DKK'000 |
|
| Result for continuing operations before tax | (122,443) | (341,989) | 9,166 | (434,017) | |
| Result for discontinued operation before tax | 19 | (178,111) | (662,834) | (288,617) | (752,201) |
| Result before tax | (300,554) | (1,004,823) | (279,451) | (1,186,218) | |
| Reversal of financial items, net | 5, 6, 19 | (38,257) | (156,273) | (185,928) | (216,049) |
| Adjustments for non-cash transactions: | |||||
| Depreciation and amortization | 3 | 21,033 | 83,783 | 4,439 | 4,660 |
| Impairment loss | 3 | 137 ,526 | 381,001 | 1,870 | 386 |
| Impairment of Genmab MN, Inc. | 10 | - | - | 288,617 | 752,201 |
| Net loss (gain) on sale of equipment | (159) | 472 | 47 | (165) | |
| Warrant compensation expenses | 4 | 66,472 | 151,511 | 17,437 | 86,191 |
| Provisions Changes in current assets and liabilities: |
15 | 15,602 | 12,989 | 18,231 | 5,425 |
| Inventory and receivables | 35,304 | 69,087 | 33,247 | 34,648 | |
| Prepayments | (1,236) | (2,948) | 3,813 | (3,298) | |
| Provisions paid | 15 | (7,728) | (734) | (3,636) | (600) |
| Deferred income | 649,947 | (211,818) | 649,947 | (211,818) | |
| Accounts payable and other liabilities | (297,881) | 65,127 | (251,431) | 59,478 | |
| Cash flow from operating activities before financial items |
280,069 | (612,626) | 297,202 | (675,159) | |
| Financial receivables Corporate taxes paid |
18,460 (30,358) |
51,642 (9,077) |
17,430 - |
51,457 - |
|
| Cash flow from operating activities | 268,171 | (570,061) | 314,632 | (623,702) | |
| Purchase of intangible and tangible assets | 8, 9 | (10,110) | (16,778) | (1,668) | (702) |
| Sale of tangible assets | 1,425 | 368 | 257 | 363 | |
| Sale of other securities and equity interests | 170 | - | 170 | - | |
| Receivables from subsidiaries | - | - | (57,435) | 46,800 | |
| Marketable securities bought | 13 | (1,585,038) | (482,764) | (1,585,038) | (482,764) |
| Marketable securities sold | 855,057 | 1,473,900 | 855,057 | 1,473,900 | |
| Cash flow from investing activities | (738,496) | 974,726 | (788,657) | 1,037,597 | |
| Warrants exercised | - | 1,647 | - | 1,647 | |
| Costs related to issuance of shares | - | (20) | - | (20) | |
| Paid installments on lease liabilities | (7,005) | (8,270) | (7,005) | (8,270) | |
| Cash flow from financing activities | (7,005) | (6,643) | (7,005) | (6,643) | |
| Decrease in cash and cash equivalents | (477,330) | 398,022 | (481,030) | 407,252 | |
| Cash and cash equivalents at the beginning of the period | 464,446 | 70,013 | 445,071 | 37,819 | |
| Exchange rate adjustments | 10,796 | (3,589) | 6,616 | - | |
| Cash and cash equivalents at the end of the period | (2,088) | 464,446 | (29,343) | 445,071 | |
| Cash and cash equivalents include: | |||||
| Bank deposits and petty cash | 52,439 | 460,738 | 37,926 | 445,071 | |
| Short-term marketable securities | 48,511 | - | 48,511 | - | |
| Bank overdraft Cash and cash equivalents classified as assets held for |
(115,780) | - | (115,780) | - | |
| sale | 19 | 12,742 | 3,708 | - | - |
| (2,088) | 464,446 | (29,343) | 445,071 | ||
| Supplementary information to the statement of cash flows | |||||
| Total cash position includes: Cash and cash equivalents cf. above |
(2,088) | 464,446 | (29,343) | 445,071 | |
| Marketable securities | 13 | 1,548,309 | 816,910 | 1,548,309 | 816,910 |
| 1,546,221 | 1,281,356 | 1,518,966 | 1,261,981 |
Statement of Shareholders' Equity - Consolidated
| Number of shares |
Share capital | Share premium |
Translation reserves |
Accumulated deficit |
Shareholders' equity |
|
|---|---|---|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| December 31, 2008 | 44,888,829 | 44,889 | 5,373,647 | 85,647 | (3,315,621) | 2,188,562 |
| Total comprehensive income | (33,748) | (1,010,760) | (1,044,508) | |||
| Transaction with owners: | ||||||
| Exercise of warrants | 18,313 | 18 | 1,629 | 1,647 | ||
| Expenses related to capital increases | (20) | (20) | ||||
| Warrant compensation expenses | 151,511 | 151,511 | ||||
| December 31, 2009 | 44,907,142 | 44,907 | 5,375,256 | 51,899 | (4,174,870) | 1,297,192 |
| Total comprehensive income | 37,859 | (321,456) | (283,597) | |||
| Transaction with owners: | ||||||
| Warrant compensation expenses | 66,472 | 66,472 | ||||
| December 31, 2010 | 44,907,142 | 44,907 | 5,375,256 | 89,758 | (4,429,854) | 1,080,067 |
Statement of Shareholders' Equity – Parent Company
| Number of shares |
Share capital | Share premium | Accumulated deficit |
Shareholders' equity |
|
|---|---|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| December 31, 2008 | 44,888,829 | 44,889 | 5,373,647 | (3,092,436) | 2,326,100 |
| Total comprehensive income | (1,186,218) | (1,186,218) | |||
| Transaction with owners: | |||||
| Exercise of warrants | 18,313 | 18 | 1,629 | 1,647 | |
| Expenses related to capital increases | (20) | (20) | |||
| Warrant compensation expenses | 151,511 | 151,511 | |||
| December 31, 2009 | 44,907,142 | 44,907 | 5,375,256 | (4,127,143) | 1,293,020 |
| Total comprehensive income | (279,451) | (279,451) | |||
| Transaction with owners: | |||||
| Warrant compensation expenses | 66,472 | 66,472 | |||
| December 31, 2010 | 44,907,142 | 44,907 | 5,375,256 | (4,340,122) | 1,080,041 |
Statement of Shareholders' Equity
. . . . . . . . . .
Changes in Shareholders Equity during 2006 to 2010
| Number of | ||
|---|---|---|
| shares | Share capital | |
| DKK'000 | ||
| December 31, 2005 | 33,108,098 | 33,108 |
| Issuance of shares for cash | 5,750,000 | 5,750 |
| Exercise of warrants | 790,257 | 790 |
| December 31, 2006 | 39,648,355 | 39,648 |
| Issuance of shares for cash | 4,471,202 | 4,471 |
| Exercise of warrants | 400,270 | 401 |
| December 31, 2007 | 44,519,827 | 44,520 |
| Exercise of warrants | 369,002 | 369 |
| December 31, 2008 | 44,888,829 | 44,889 |
| Exercise of warrants | 18,313 | 18 |
| December 31, 2009 | 44,907,142 | 44,907 |
| Exercise of warrants | - | - |
| December 31, 2010 | 44,907,142 | 44,907 |
In January 2006, Genmab completed an international private placement with issuance of 5,750,000 new ordinary shares at a price of DKK 147.00 per share, raising gross proceeds to Genmab of DKK 845 million.
In February 2007, Genmab issued 4,471,202 new shares in connection with the worldwide GSK agreement to co-develop and commercialize ofatumumab. This transaction increased shareholders' equity by DKK 1.529 billion.
Shareholder Information
On December 31, 2010, the share capital of Genmab A/S comprised 44,907,142 shares of DKK 1 each with one vote. There are no restrictions related to the transferability of the shares. All shares are regarded as negotiable instruments and do not confer any special rights upon the holder, and no shareholder shall be under an obligation to allow his/her shares to be redeemed.
Until April 19, 2012, the board of directors are authorized to increase the nominal registered share capital on one or more occasions by up to nominally DKK 15,000,000 negotiable shares issued to the bearer that shall have the same rights as the existing shares of Genmab. The capital increase can be made by cash or by non-cash payment and with or without pre-emption rights for the existing shareholders.
By decision of the general meeting on April 23, 2008, the board of directors is authorized to issue on one or more occasions warrants up to a nominal value of 1,500,000. This authorization shall remain in force for a period ending on April 23, 2013. As of December 31, 2010, a total of 905,850 warrants have been issued hereunder.
Ownership
. . . . . . . . . .
As of December 31, 2010, the number of registered shareholders totaled 33,059 shareholders holding a total of 39,452,955 shares, which represented 88% of the share capital. Genmab is listed on the NASDAQ OMX Copenhagen under the symbol GEN.
The following are listed as owners of a minimum 5% of the votes or a minimum of 5% of the share capital:
- Glaxo Group Limited, Glaxo Welcome House, Berkley Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom
- Hendricks Hubertus Francisco's Siesta (partly through Mercury's Beleggingsmaatschappij B.V. and Stimex Participatiemaatschappij B.V.), Akerstraat 126, 6417 BR Heerlen, the Netherlands
- ATP and ATP Invest, Kongens Vænge 8, DK-3400 Hillerød, Denmark
- Meditor European Master Fund Ltd., 25 Old Broad Street, London, EC2N 1HQ, United Kingdom
Internal shareholders register, December 31, 2010 *"Other" includes other countries and shares not included in nominee accounts, including OTC traded shares.
Notes to the Financial Statements
. . . . . . . . . .
Note 1 – Management's Judgments and Estimates under IFRS
The financial statements of the Genmab group and the parent company have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB), and with the International Financial Reporting Standards as endorsed by the EU, and additional Danish disclosure requirements for annual reports of listed companies.
In preparing financial statements under IFRS, certain provisions in the standards require management's judgments, including various accounting estimates and assumptions. Such judgments are considered important to understand the accounting policies and Genmab's compliance with the standards.
Determining the carrying amount of some assets and liabilities requires judgments, estimates and assumptions concerning future events which are based on historical experience and other different factors, but which by their very nature are associated with uncertainty and unpredictability.
These assumptions may prove incomplete or incorrect, and unexpected events or circumstances may arise. The Genmab group is also subject to risks and uncertainties which may lead to actual results to differ from these estimates, both positively and negatively. Specific risks for the Genmab group are discussed in the relevant section of the directors' report and in the notes to the financial statements.
The following summarizes the most significant judgments and estimates made under Genmab's accounting policies. The group's accounting policies are described in detail in note 25.
Internally Generated Intangible Assets
According to the International Accounting Standard (IAS) 38, "Intangible Assets", intangible assets arising from development projects should be recognized in the balance sheet. The criteria that must be met for capitalization are that:
- the development project is clearly defined and identifiable and the attributable costs can be measured reliably during the development period;
- the technological feasibility, adequate resources to complete and a market for the product or an internal use of the product can be documented; and
- management has the intent to produce and market the product or to use it internally.
Such an intangible asset should be recognized if sufficient certainty can be documented that the future income from the development project will exceed the aggregate cost of production, development and the sale and administration of the product.
A development project involves a single product candidate undergoing a high number of tests to illustrate its safety profile and the effect on human beings prior to obtaining the necessary final approval of the product from the appropriate authorities. The future economic benefits associated with the individual development projects are dependent on obtaining such approval. Considering the significant risk and duration of the development period related to the development of biological products, management has concluded that the future economic benefits associated with the individual projects cannot be estimated with sufficient certainty until the project has been finalized and the necessary regulatory final approval of the product has been obtained. Accordingly, the group has not recognized such assets at this time and therefore all research and development costs are recognized in the income statement when incurred. The total research and development costs related to the continuing operations amounted to DKK 583 million in 2010 compared to DKK 935 million in 2009.
Revenue Recognition
. . . . . . . . . .
The group's revenues are comprised of milestone and upfront payments, royalty income and other income from research and development agreements and government grants. IAS 18, "Revenue", prescribes the criteria to be fulfilled for revenue being recognizable. Evaluating the criteria for revenue recognition with respect to the group's research and development and collaboration agreements requires management's judgment to ensure that all criteria have been fulfilled prior to recognizing any amount of revenue. In particular, such judgments are made with respect to determination of the nature of transactions, whether simultaneous transactions shall be considered as one or more revenue-generating transactions, allocation of the contractual price (upfront and milestone payments and obtained share premium to the market value on shares subscribed in connection with a collaboration agreement) to several elements included in an agreement, and the determination of whether the significant risks and rewards have been transferred to the buyer. Share premium is defined as the difference between the agreed share price and the market price at the time of the transaction.
Collaboration agreements are reviewed carefully to understand the nature of risks and rewards of the arrangement.
Upfront payments that are deemed attributable to subsequent research and development work are initially recognized as deferred income and recognized and allocated as revenue over the planned development period. This judgment is made when entering the agreement and is based on development budgets and plans. The planned development period is assessed on an annual basis. If the expected development period is changed significantly, this will require a reassessment of the allocation period.
In 2010, we amended the ofatumumab co-development and commercialization agreement with GSK. As a result of the amended agreement Genmab received an upfront payment of GBP 90 million (DKK 815 million at the date of the agreement) from GSK. The upfront payment related to the amendment to the initial GSK Agreement of December 19, 2006, and the amendment included, among other
items, reduction of future milestone payments and royalty rates and funding requirements.
As of June 30, 2010, the remaining part of deferred revenues received at the inception of the initial GSK Agreement amounted to DKK 326 million. This remaining amount equalled the last 18 months of the initial 60 month allocation period. It was not possible to obtain objective and reliable evidence of the value of the different components of the amendment and remaining deferred revenue and measure these on a stand alone basis as the past and future activities are highly interrelated. As such, the upfront payment and the remaining deferred revenues were considered as a single transaction and on a combined basis.
Together with the existing deferred revenue, the upfront payment will be deferred and allocated and recognized as revenues on a straight line basis over the years July 1, 2010 to December 31, 2015 (66 months), at an amount of DKK 207 million per year.
In October 2010, Genmab announced a research agreement with H. Lundbeck A/S. Under the terms of the agreement, Genmab received an upfront payment of EUR 7.5 million (approximately DKK 56 million at the date of the agreement). In accordance with our accounting policies, the upfront payment was deferred and recognized in the income statement as revenue on a straight line basis over a three year period.
As of December 31, 2010, DKK 1,089 million is included as deferred income in the balance sheet to be proportionally recognized as revenue in future periods. Please refer to note 16 for further details.
Milestone payments related to reaching particular stages in product development are recognized immediately if a separate earnings process relative to the milestone payment has been completed and achieved. This determination is judgmental and assessments made by management include, among other items, consideration of the efforts made in achieving a milestone, e.g., the level, skill, and expertise of the personnel involved, as well as the costs incurred. The milestone events must have real substance and they must represent achievement of specific defined goals.
In addition, the associated risks related to the achievement of each milestone are evaluated and compared to all milestone payments designated under the collaboration agreement.
Royalty income from licenses is based on third-party sales of licensed products and is recognized in accordance with contract terms when third-party results are available and are deemed to be reliable. Royalty estimates are made in advance of amounts collected using preliminary sales data received from the third-party.
All the group's revenue-generating transactions, including those with GSK and Lundbeck, have been subject to such evaluation by management.
The total revenues related to the continuing operations amounted to DKK 582 million in 2010 compared to DKK 586 million in 2009. Please refer to note 2 for further details about our revenues.
Antibody Clinical Trial Material Produced or Purchased for the Use in Clinical Trials
According to our accounting policies, antibody clinical trial material (antibodies) for the use in clinical trials which either are internally produced or purchased from third parties are recognized in the balance sheet at cost and expensed in the income statement when consumed, if all criteria for recognition as an asset are fulfilled.
During both 2009 and 2010, no antibodies either internally produced or purchased from third parties for the use in clinical trials have been capitalized, as these antibodies do not qualify for being capitalized as inventory under either the "Framework" to IAS/IFRS or IAS 2, "Inventories".
Management has concluded that the production and purchase of antibodies from third parties cannot be capitalized as the technical feasibility is not proven and no alternative use exists.
As a result of the planned disposal of the manufacturing facility, Genmab will no longer produce antibodies internally but will instead purchase these from external contract manufacturers.
Share-based Compensation
The parent company has granted warrants to employees, the management and the board of directors under various warrant programs. In accordance with IFRS 2 "Share-based Payment", the fair value of the warrants at grant date is recognized as an expense in the income statement over the vesting period, the period of delivery of work. Subsequently, the fair value is not re-measured.
The fair value of each warrant granted during the year is calculated using the Black-Scholes pricing model.
This pricing model requires the input of subjective assumptions and these assumptions can vary over time and can change the fair value of future warrants granted. A detailed description is outlined in note 18.
In 2010, warrant compensation expenses totalled DKK 66 million compared to DKK 152 million in 2009.
Collaboration Agreements
The group has entered into various collaboration agreements, primarily in connection with the group's research and development projects and the clinical testing of the product candidates, e.g., our worldwide collaboration agreement with GSK about ofatumumab and research agreement with Lundbeck. When accounting for new collaboration agreements, a judgment is made concerning the classification of the agreement. Collaborations are often structured so that each party contributes its respective skills in the various phases of the development
project. No joint control exists for such collaborations as the parties have not established an economic activity subject to joint control. Accordingly, the collaborations are not considered to be joint ventures as defined in IAS 31, "Financial Reporting of Interests in Joint Ventures". Expenses in connection with collaboration agreements are treated as described under "Research and Development Costs".
Assets Held for Sale and Discontinued Operation
In 2009, the board of directors announced its decision to dispose of Genmab's manufacturing facility as the facility no longer is core to Genmab's strategy.
The decision to sell the facility triggered an impairment review under IAS 36, "Impairment of Assets". The impairment test is based on an estimated fair value of approximately USD 150 million less cost to sell of approximately USD 5 million. As the carrying amount of the facility was higher than the recoverable amount, the facility was impaired in the fourth quarter of 2009. The total impairment charge amounted to approximately DKK 419 million.
In September 2010, a non-cash impairment charge of approximately DKK 130 million was recognized as a result of changed market conditions. The fair value less cost to sell has been reduced from approximately USD 145 million to USD 120 million as of September 30, 2010. Sales related costs are still estimated to approximately USD 5 million.
The revised fair value less cost to sell is determined based on benchmarks and advice received from our sales agent.
As no binding arm's length sales agreement has been entered into yet and as the Brooklyn Park facility is not considered to be traded in an active market due to its very specialized nature, the fair value less cost to sell is associated with a degree of uncertainty and judgement.
The fair value less cost to sell and impairment is based on the best information available and may be subject to change. Future changes, if any, in the fair value less cost to sell will be recognized in the income statement.
The sale process is active and based on information received from our sales agent the estimated sales price seems reasonable. Therefore, the facility continues to be actively marketed at a price that is reasonable given the change in market conditions. Further sales initiatives are planned and Genmab remains committed to its plan to sell the facility. Therefore Genmab has continued to classify the facility as held for sale and as a discontinued operation in accordance with IFRS.
For further details about the sale of the manufacturing facility, please refer to note 19.
Deferred Tax Assets
. . . . . . . . . .
Genmab recognizes deferred tax assets, including the tax base of tax loss carryforwards, if management assesses that these tax assets can be offset against positive taxable income within a foreseeable future.
This judgment is made on an ongoing basis and is based on budgets and business plans for the coming years, including planned commercial initiatives.
The creation and development of therapeutic products within the biotechnology and pharmaceutical industry is subject to considerable risks and uncertainties. Since inception, Genmab has reported significant losses, and as a consequence, we have unused tax losses. Genmab also projects a loss for 2011.
Therefore, management has concluded, except for two subsidiaries, that deferred tax assets should not be recognized as of December 31, 2010, and a 100% valuation allowance of the deferred tax asset is recognized in accordance with IAS 12, "Income Taxes". The remaining tax assets are currently not deemed to meet the criteria for recognition as management is not able to provide any convincing positive evidence that deferred tax assets should be recognized.
Details about the deferred tax assets can be found in note 7.
| Note 2 – Segment Reporting | Genmab Group | Parent Company | ||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Revenues: | ||||
| Milestone payments | 206,383 | 266,728 | 206,383 | 266,728 |
| Deferred revenue | 216 ,143 | 217,064 | 216,143 | 217 ,064 |
| Royalties | 54 ,139 | 5,749 | 54,139 | 5 ,749 |
| Other revenues | 105,412 | 96,535 | 105,300 | 96,403 |
| Non-current | Non-current | |||
|---|---|---|---|---|
| Group segment information: | Revenues | assets | Revenues | assets |
| 2010 | 2009 | |||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Denmark | 581,965 | 10,181 | 585,944 | 15,126 |
| The Netherlands | 112 | 30,198 | 132 | 35 ,648 |
| Other countries | - | 1,051 | - | 9 ,406 |
| 582,077 | 41,430 | 586,076 | 60,180 |
Non-current assets related to the US manufacturing facility have been transferred to assets held for sale. Please refer to note 19 for further details.
Revenues from our agreement with GSK represent approximately 94% (2009: 99%) of the group's total revenues.
586,076 582,077 581,965 585,944
Note 3 – Depreciation, Amortization, and Impairments
| Genmab Group | Parent Company | |||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Depreciation and amortization: | ||||
| Buildings | - | 19,240 | - | - |
| Leasehold improvements | 4,515 | 5,750 | 1,567 | 1,573 |
| Manufacturing equipment | - | 32,156 | - | - |
| Equipment, furniture and fixtures | 16,518 | 26,637 | 2,872 | 3,087 |
| 21,033 | 83,783 | 4,439 | 4,660 | |
| Depreciation and amortization are included in: | ||||
| Research and development costs | 16 ,667 | 19,608 | 3,554 | 3 ,728 |
| General and administrative expenses | 4 ,366 | 3,631 | 885 | 932 |
| Result of discontinued operation | - | 60,544 | - | - |
| 21,033 | 83,783 | 4,439 | 4,660 | |
| Impairments: | ||||
| Goodwill | - | 297,509 | - | - |
| Buildings | 105,929 | 67,312 | - | - |
| Leasehold improvements | 4 ,190 | - | - | - |
| Manufacturing equipment | 22 ,563 | 14,137 | - | - |
| Equipment, furniture and fixtures | 4 ,844 | 1,657 | 1,870 | - |
| Assets under constructions | - | 386 | - | 386 |
| 137,526 | 381,001 | 1,870 | 386 | |
| Impairments are included in: | ||||
| Research and development costs | 2 ,103 | 386 | 1,496 | 386 |
| General and administrative expenses | 5 ,286 | - | 374 | - |
| Result of discontinued operation | 130 ,137 | 380,615 | - | - |
| 137,526 | 381,001 | 1,870 | 386 |
| Note 4 – Staff | ||||
|---|---|---|---|---|
| Genmab Group | Parent Company | |||
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Wages and salaries | 201,032 | 336,974 | 83,248 | 156,540 |
| Warrant compensation expenses | 66,472 | 151,511 | 17,437 | 86,191 |
| Defined contribution plans | 14,752 | 24,449 | 6,751 | 12,114 |
| Other social security costs | 13 ,495 | 25,819 | 662 | 905 |
| 295,751 | 538,753 | 108,098 | 255,750 | |
| Staff costs are expensed as follows: | ||||
| Research and development costs | 159,893 | 296,901 | 80,580 | 181,675 |
| General and administrative expenses | 109,172 | 105,399 | 27,518 | 74,075 |
| Result of discontinued operation | 26 ,686 | 136,453 | - | - |
| 295,751 | 538,753 | 108,098 | 255,750 | |
| Average number of employees | 229 | 505 | 83 | 180 |
Note 4 – Staff (continued)
. . . . . . . . . .
For information regarding the remuneration of the Board of Directors and Executive Management, please refer to note 21.
Termination benefits excluding warrant expenses associated with the reorganization plan announced in November 2009 and October 2010 amounted to DKK 33 million in 2010 and DKK 63 million in 2009.
Warrant Compensation Expenses
The group accounts for share-based compensation by recognizing compensation expenses related to warrants granted to employees and board members in the income statement. Such compensation expenses represent calculated values of warrants granted and do not represent actual cash expenditures.
In 2010, warrant (share-based) compensation expenses totaled DKK 66 million compared to DKK 152 million in 2009. In the separate financial statements of the parent company, warrant compensation expenses were DKK 17 million in 2010 and DKK 86 million in 2009.
In 2010, the warrant compensation expenses include costs of DKK 22 million related to the departure of Genmab's former CEO and the employees affected by the reorganization plan announced in October 2010, which were expensed in connection with their termination in 2010.
In 2009, the warrant compensation expenses include costs of DKK 26 million related to the approximately 300 employees affected by the reorganization plan announced in November 2009, which were expensed in connection with their termination.
Note 5 – Financial Income
| Genmab Group | Parent Company | |||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Interest and other financial income | 25,881 | 57,323 | 25,637 | 57,210 |
| Interest from subsidiaries | - | - | 82,039 | 74,837 |
| Realized and unrealized gains on marketable securities (fair value through profit and loss), net |
2,210 | 119,445 | 2,210 | 119,445 |
| Fair value adjustments of derivative financial instruments |
- | 4,331 | - | 4,331 |
| Exchange rate gains, net | 11,438 | - | 77,011 | - |
| Gain on sale of available for sale financial assets | 119 | - | 119 | - |
| 39,648 | 181,099 | 187,016 | 255,823 | |
| Interest on financial assets measured at amortized cost | 846 | 1,383 | 82,641 | 76,107 |
Note 6 – Financial Expenses
. . . . . . . . . .
| Genmab Group | Parent Company | |||
|---|---|---|---|---|
| 2010 2009 |
2010 | 2009 | ||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Interest and other financial expenses | 1,402 | 1,488 | 997 | 1,199 |
| Interest to subsidiaries | - | - | 91 | 143 |
| Loss on available for sale financial assets | - | 145 | - | 145 |
| Exchange rate losses, net | - | 23,421 | - | 38,287 |
| 1,402 | 25,054 | 1,088 | 39,774 | |
| Interest on financial liabilities measured at amortized | ||||
| cost | 1,402 | 1,488 | 1,088 | 1,342 |
Note 7 – Corporate and Deferred Tax
| Genmab Group | Parent Company | |||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Current tax on result | 22,975 | 10,427 | - | - |
| Adjustment to prior years etc. | 6,558 | 10 | - | - |
| Adjustment to deferred tax | (143,208) | (309,561) | (9,183) | (85,608) |
| Adjustment to valuation allowance | 134,577 | 305,061 | 9,183 | 85,608 |
| Total corporate tax expense | 20,902 | 5,937 | - | - |
| Corporate tax is included in | ||||
| Result of continuing operations | 20,874 | 5,909 | - | - |
| Result of discontinued operation | 28 | 28 | - | - |
| 20,902 | 5,937 | - | - |
A reconciliation of income tax expense at the statutory rate of Genmab's effective tax rate is as follows:
| Genmab Group | Parent Company | |||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Loss before tax of continuing operations | (122,443) | (341,989) | 9,166 | (434,017) |
| Loss before tax of discontinued operation | (178,111) | (662,834) | (288,617) | (752,201) |
| Loss before tax | (300,554) | (1,004,823) | (279,451) | (1,186,218) |
| Computed 25% | (75,139) | (251,206) | (69,863) | (296,555) |
| Tax effect of: | ||||
| Non-taxable income | (16,026) | (25,184) | (16,026) | (25,184) |
| Non-deductible costs | 14,423 | 72,592 | 4,552 | 48,612 |
| Impairment of subsidiary | - | - | 72,154 | 188,050 |
| Additional tax deductions, deviations in corporate tax | ||||
| rates etc. | (53,333) | (91,647) | - | (531) |
| Tax on equity transactions | 16,399 | (3,674) | - | - |
| Change in valuation allowance deferred tax asset | 134,577 | 305,061 | 9,183 | 85,608 |
| Total tax effect | 96,040 | 257,148 | 69,863 | 296,555 |
| Total corporate tax | 20,902 | 5,942 | - | - |
Note 7 – Corporate and Deferred Tax (continued)
For financial reporting purposes, the value of the net deferred tax assets have been reduced to DKK 13 million due to the lack of certainty with respect to Genmab's ability to generate sufficient taxable income in the future. Deferred tax related to assets classified as held for sale has been reduced to zero in both 2010 and 2009.
On December 31, 2010, the group had net tax loss carry-forwards of DKK 3.3 billion (2009: DKK 3.8 billion) for income tax purposes, of which DKK 2.9 billion (2009: DKK 3.5 billion) can be carried forward without limitation. In addition, the group had deductible temporary differences of DKK 1.6 billion (2009: DKK 700 million).
Significant components of the deferred tax asset are as follows:
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | ||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| Tax deductible losses | 898,937 | 1,001,680 | 713,848 | 886,999 | |
| Deferred income | 237,988 | 59,475 | 237,988 | 59,475 | |
| Other temporary differences | 249,542 | 182,104 | 7,449 | 3,628 | |
| Deferred tax assets | 1,386,467 | 1,243,259 | 959,285 | 950,102 | |
| Valuation allowance | (1,373,202) | (1,238,625) | (959,285) | (950,102) | |
| Recorded deferred tax assets | 13,265 | 4,634 | - | - |
Note 8 – Intangible Assets – Genmab Group and Parent Company
| 2010 | Goodwill | Licenses and Rights |
Total Intangible Assets |
|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | |
| Cost per January 1, 2010 | 308,296 | 152,484 | 460,780 |
| Exchange rate adjustment | 24,702 | - | 24,702 |
| Disposals for the year | - | - | - |
| Cost per December 31, 2010 | 332,998 | 152,484 | 485,482 |
| Accumulated amortization and impairment per January 1, 2010 | (308,296) | (152,484) | (460,780) |
| Exchange rate adjustment | (24,702) | - | (24,702) |
| Impairment for the year | - | - | - |
| Disposals for the year | - | - | - |
| Accumulated amortization and impairment per December 31, 2010 | (332,998) | (152,484) | (485,482) |
| Net book value per December 31, 2010 | - | - | - |
| Licenses and | Total Intangible | ||
| 2009 | Goodwill | Rights | Assets |
| DKK'000 | DKK'000 | DKK'000 | |
| Cost per January 1, 2009 | 313,829 | 157,610 | 471,439 |
| Exchange rate adjustment | (5,533) | - | (5,533) |
| Disposals for the year | - | (5,126) | (5,126) |
| Cost per December 31, 2009 | 308,296 | 152,484 | 460,780 |
| Accumulated amortization and impairment per January 1, 2009 | - | (157,610) | (157,610) |
| Exchange rate adjustment | (10,787) | - | (10,787) |
| Impairment for the year | (297,509) | - | (297,509) |
| Disposals for the year | - | 5,126 | 5,126 |
| Accumulated amortization and impairment per December 31, 2009 | (308,296) | (152,484) | (460,780) |
| Net book value per December 31, 2009 | - | - | - |
Goodwill – Genmab Group
The carrying amount of goodwill relates to the acquisition of the manufacturing facility in 2008. In November 2009, Genmab announced that it intended to sell its manufacturing facility due a change in business strategy. This decision triggered an impairment review and as a result the goodwill was fully impaired in 2009. Please refer to note 19 for additional information regarding the impairment.
Research and development – Genmab Group and Parent Company
The group currently has no internally generated intangible assets from development, as the criteria for recognition as an asset are not met.
Licenses and Rights – Genmab Group and Parent Company
The group has previously acquired licenses and rights to technology at a total cost of DKK 152 million, which have been fully amortized during the period from 2000 to 2005. The licenses and rights are still in use by the parent company and the group and contribute to our research and development activities.
Note 9 – Tangible Assets – Genmab Group
. . . . . . . . . .
| Equipment, | ||||
|---|---|---|---|---|
| Leasehold | furniture and | Assets under | Total Tangible | |
| 2010 | improvements | fixtures | construction | Assets |
| DKK'000 | DKK'000 | DKK'000 986 - 2,776 - 3,762 (386) - - - - (386) 3,376 |
DKK'000 | |
| Cost per January 1, 2010 | 42,838 | 134,759 | 178,583 | |
| Exchange rate adjustment | 1,871 | 1,197 | 3,068 | |
| Additions for the year | 281 | 7,053 | 10,110 | |
| Disposals for the year | (7,308) | (6,261) | (13,569) | |
| Cost per December 31, 2010 | 37,682 | 136,748 | 178,192 | |
| Accumulated depreciation and impairment per January | ||||
| 1, 2010 | (30,257) | (87,760) | (118,403) | |
| Exchange rate adjustment | (1,346) | (894) | (2,240) | |
| Depreciation for the year | (4,515) | (16,518) | (21,033) | |
| Impairment for the year | (4,190) | (3,199) | (7,389) | |
| Disposals for the year | 7,184 | 5,119 | 12,303 | |
| Accumulated depreciation and impairment per | ||||
| December 31, 2010 | (33,124) | (103,252) | (136,762) | |
| Net book value per December 31, 2010 | 4,558 | 33,496 | 41,430 | |
| Net book value of assets under finance leases | ||||
| included above | - | 11,453 | - | 11,453 |
| Equipment, | ||||||
|---|---|---|---|---|---|---|
| Land and | Leasehold | Manufacturing | furniture and | Assets under | Total Tangible | |
| 2009 | buildings | improvements | equipment | fixtures | construction | Assets |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Cost per January 1, 2009 | 727,103 | 54,303 | 202,044 | 156,347 | 11,265 | 1,151,062 |
| Exchange rate adjustment | (13,042) | (407) | (3,625) | (824) | (119) | (18,017) |
| Additions for the year | 834 | 557 | 2,711 | 10,923 | 1,753 | 16,778 |
| Transfers between the classes | 34 | - | 6,089 | 5,790 | (11,913) | - |
| Disposals for the year | - | (11,615) | (899) | (7,531) | - | (20,045) |
| Transferred to assets classified as held for sale | (714,929) | - | (206,320) | (29,946) | - | (951,195) |
| Cost per December 31, 2009 | - | 42,838 | - | 134,759 | 986 | 178,583 |
| Accumulated depreciation and impairment per January | ||||||
| 1, 2009 | (18,577) | (36,186) | (30,984) | (87,718) | - | (173,465) |
| Exchange rate adjustment | (2,152) | 234 | 35 | 334 | - | (1,549) |
| Depreciation for the year | (19,240) | (5,750) | (32,156) | (26,637) | - | (83,783) |
| Impairment for the year | (67,312) | - | (14,137) | (1,657) | (386) | (83,492) |
| Disposals for the year | - | 11,445 | 351 | 7,409 | - | 19,205 |
| Transferred to assets classified as held for sale | 107,281 | - | 76,891 | 20,509 | - | 204,681 |
| Accumulated depreciation and impairment per | ||||||
| December 31, 2009 | - | (30,257) | - | (87,760) | (386) | (118,403) |
| Net book value per December 31, 2009 | - | 12,581 | - | 46,999 | 600 | 60,180 |
| Net book value of assets under finance leases | ||||||
| included above | - | - | - | 19,932 | - | 19,932 |
Please refer to note 19 for additional information regarding the impairments in 2009 and assets classified as held for sale.
| Note 9 – Tangible Assets (continued) – Parent Company | ||
|---|---|---|
| ------------------------------------------------------- | -- | -- |
| Net book value per December 31, 2010 | 3,947 | 3,987 | 2,247 | 10,181 |
|---|---|---|---|---|
| Accumulated depreciation and impairment per December 31, 2010 | (3,397) | (13,585) | (386) | (17,368) |
| Disposals for the year | 6,631 | 2,636 | 9 - ,267 | |
| Impairment for the year | - | (1,870) | - | (1,870) |
| Depreciation for the year | (1,567) | (2,872) | - | (4,439) |
| Accumulated depreciation and impairment per January 1, 2010 | (8,461) | (11,479) | (386) | (20,326) |
| Cost per December 31, 2010 | 7,344 | 17,572 | 2,633 | 27,549 |
| Disposals for the year | (6,733) | (2,838) | - | (9,571) |
| Additions for the year | - | 21 | 1,647 | 1 ,668 |
| Cost per January 1, 2010 | 14,077 | 20,389 | 986 | 35 ,452 |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| 2010 | improvements | fixtures | construction | Assets |
| Leasehold | Equipment, furniture and |
Assets under | Total Tangible | |
| 2009 | Leasehold improvements DKK'000 |
Equipment, furniture and fixtures DKK'000 |
Assets under construction DKK'000 |
Total Tangible Assets DKK'000 |
|---|---|---|---|---|
| Cost per January 1, 2009 | 25,464 | 26,059 | 716 | 52 ,239 |
| Additions for the year | 228 | 204 | 270 | 702 |
| Disposals for the year | (11,615) | (5,874) | - | (17,489) |
| Cost per December 31, 2009 | 14,077 | 20,389 | 986 | 35,452 |
| Accumulated depreciation and impairment per January 1, 2009 | (18,333) | (14,238) | - | (32,571) |
| Depreciation for the year | (1,573) | (3,087) | - | (4,660) |
| Impairment for the year | - | - | (386) | (386) |
| Disposals for the year | 11,445 | 5,846 | - | 17,291 |
| Accumulated depreciation and impairment per December 31, 2009 | (8,461) | (11,479) | (386) | (20,326) |
| Net book value per December 31, 2009 | 5 ,616 | 8,910 | 600 | 15 ,126 |
Note 10 – Equity Interests in Subsidiaries
Genmab A/S (parent company) holds investments in the following subsidiaries:
| Name | Domicile | Ownership and | Ownership |
|---|---|---|---|
| votes | and votes | ||
| 2010 | 2009 | ||
| Genmab B.V. | Utrecht, the | 100% | 100% |
| Netherlands | |||
| Genmab MN, Inc. | Minnesota, USA | 100% | 100% |
| Genmab, Inc. | New Jersey, USA | 100% | 100% |
| Genmab Ltd. | London, United | 100%* | 100% |
| Kingdom |
*Genmab Ltd. is under liquidation as development activities have ceased in the UK.
Investments in subsidiaries are subject to a yearly assessment by the group's management for impairment indications and, if necessary, an impairment test is carried out.
2010:
. . . . . . . . . .
In 2010, an additional impairment of DKK 289 million related to the manufacturing facility owned by Genmab MN, Inc. was recognized mainly due a change of the fair value of the manufacturing facility. The impairment was allocated to intercompany loans with Genmab MN, Inc. The impairment is included in discontinued operation in the financial statements of the parent company.
The investment related to the subsidiary was written down in 2009 to zero (see below).
2009:
In November 2009, Genmab announced that it intends to sell its manufacturing facility. The facility is owned by Genmab MN, Inc., and the decision to sell the facility triggered an impairment review of Genmab A/S' investment in Genmab MN, Inc.
The total impairment amounted to DKK 752 million, which was allocated to the carrying amount of Genmab A/S' investment (DKK 425 million) and intercompany loans in Genmab MN, Inc. (DKK 327 million). The impairment is included in discontinued operation in the financial statements of the parent company.
| Parent Company | |||
|---|---|---|---|
| 2010 | 2009 | ||
| DKK'000 | DKK'000 | ||
| Cost per January 1 Additions for the year |
456,777 - |
456,777 - |
|
| Cost per December 31 | 456,777 | 456,777 | |
| Impairment per January 1 | (425,463) | - | |
| Impairment for the year | - | (425,463) | |
| Impairment per December 31 | (425,463) | (425,463) | |
| Net book value per December 31 | 31,314 | 31,314 |
Note 10 – Equity Interests in Subsidiaries (continued)
Note 11 – Inventories
2010:
. . . . . . . . . .
No impairments have incurred during 2010.
2009:
As a result of the planned disposal of the manufacturing facility, raw materials and spare parts have been written down to net realizable value. The total impairment amounted to DKK 38 million and was included in the results of the discontinued operation.
Note 12 – Receivables
. . . . . . . . . .
| Genmab Group | Parent Company | |||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Receivables related to development agreements | 36,213 | 76,914 | 36,213 | 76,914 |
| Receivables from subsidiaries | - | - | 681,064 | 698,205 |
| Finance lease receivables from subsidiaries | - | - | 17,937 | 24,942 |
| Interest receivables | 18,233 | 13,072 | 18,177 | 12,632 |
| Tax receivable | 456 | - | - | - |
| Other receivables | 22,793 | 26,836 | 11,096 | 13,699 |
| Transferred to assets classified as held for sale | (5,094) | (5,155) | - | - |
| Total | 72,601 | 111,667 | 764,487 | 826,392 |
| Non-current receivables | 7,174 | 7,915 | 252,638 | 474,577 |
| Current receivables | 65,427 | 103,752 | 511,849 | 351,815 |
| Total | 72,601 | 111,667 | 764,487 | 826,392 |
In 2010 and 2009, losses related to receivables were insignificant on group level. The credit risk on receivables is considered to be limited. Please refer to note 20 for additional information regarding receivables from subsidiaries and related impairments.
Note 13 – Marketable Securities
All marketable securities are classified as "financial assets at fair value through profit or loss" and are reported at fair value, determined as the year end listed price.
For financial instruments that are measured in the balance sheet at fair value, IFRS 7 for financial instruments requires disclosure of fair value measurements by level of the following fair value measurement hierarchy for:
| • | quoted | prices | (unadjusted) | in | active | markets | for |
|---|---|---|---|---|---|---|---|
| identical assets or liabilities (Level 1) |
- inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices) (Level 2)
- inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs) (Level 3)
Note 13 – Marketable Securities (continued)
. . . . . . . . . .
All fair market values are determined by reference to external sources using unadjusted quoted prices in established markets for our marketable securities (Level 1).
The statements for the group and the parent company are identical. Please refer to note 14 for additional details on our marketable securities.
| 2010 | 2009 | |
|---|---|---|
| DKK'000 | DKK'000 | |
| Cost per January 1 | 847,726 | 1,915,108 |
| Additions for the year | 1,585,038 | 482,764 |
| Disposals for the year | (881,413) | (1,550,146) |
| Cost per December 31 | 1,551,351 | 847,726 |
| Fair value adjustment per January 1 | (30,816) | (223,109) |
| Fair value adjustment for the year | 27,774 | 192,293 |
| Fair value adjustment per December 31 | (3,042) | (30,816) |
| Net book value per December 31 | 1,548,309 | 816,910 |
| Net book value in percentage of cost | 100% | 96% |
As of December 31, 2010, the fair value adjustments (unrealized losses) amounted to DKK 3 million, with the net book value at 100% of cost compared to 96% as of December 31, 2009. The improvement is driven by the disposal of an investment held in Lehman Brothers in July 2010. The Lehman bond was written down to zero in 2008 resulting in a write-down of DKK 33 million.
Note 13 – Marketable Securities (continued)
Specification of the portfolio per December 31, 2010:
. . . . . . . . . .
| Market value 2010 |
Average ratings Moody |
Average effective duration |
Share % |
Market value 2009 |
Average ratings Moody |
Average effective duration |
Share % |
|
|---|---|---|---|---|---|---|---|---|
| DKK'000 | DKK'000 | |||||||
| Kingdom of Denmark bonds and | ||||||||
| treasury bills | 135,786 | Aaa | 0.96 | 8% | 64,804 | Aaa | 3.05 | 8% |
| Other Danish bonds | 806,649 | Aaa | 1.23 | 51% | 411,728 | Aaa | 1.26 | 50% |
| DKK portfolio | 942 ,435 | Aaa | 1.19 | 59% | 476 ,532 | Aaa | 1.51 | 58% |
| US government and federal agency | ||||||||
| notes | - | - | - | - | 976 | Aaa | 0.68 | 0% |
| US corporate notes | - | - | - | - | 2,505 | Aa2 | 0.03 | 0% |
| USD portfolio | - | - | - | - | 3,481 | Aa3 | 0.21 | 0% |
| UK government bonds and treasury bills | 240 ,305 | Aaa | 0.26 | 15% | - | - - | - | |
| GBP portfolio | 240,305 | Aaa | 0.26 | 15% | - | - - | - | |
| European government bonds and treasury bills European corporate bonds |
414,080 - |
Aaa - |
1.07 - |
26% 0% |
119,248 217 ,649 |
Aaa Aa1 |
3.46 1.37 |
15% 27% |
| EUR portfolio | 414 ,080 | Aaa | 1.07 | 26% | 336 ,897 | Aa3 | 2.11 | 42% |
| Total portfolio | 1,596,820 | Aaa | 1.02 | 100% | 816,910 | Aa1 | 1.75 | 100% |
| Transfered to cash and cash equivalents | (48,511) | - | ||||||
| Marketable securities | 1,548,309 | 816,910 |
Note 14 – Financial Risk
The financial risks of the Genmab group are managed centrally from the parent company. The overall risk management guidelines have been approved by the board of directors and include the group's foreign exchange and investment policy related to our marketable securities. The group's risk management guidelines are established to identify and analyze the risks faced by the Genmab group, to set the appropriate risk limits and controls and to monitor the risks and adherence to limits.
The primary objective of Genmab's investment activities is to preserve capital and ensure liquidity while at the same time maximizing the income derived from security investments without significantly increasing risk. Therefore, our investment policy includes among other items, guidelines and ranges for which investments (all of which are shorter-term in nature) are considered to be eligible investments for Genmab and which investment parameters are to be applied, including maturity limitations and credit ratings. In addition, specific diversification criteria and investment limits to minimize the future risk of loss resulting from over concentration of assets in a specific class, issuer, currency, country, or economic sector.
Currently, our marketable securities are administrated by two external Danish investment managers.
The guidelines and investment managers are reviewed regularly to reflect changes in market conditions, the group's activities and financial position.
The Audit Committee reviews how management monitors compliance with the group's risk management guidelines and the adequacy of the risk management guidelines to the risks and exposures faced by the Genmab group.
Group finance, which functionally reports to the CFO, is responsible for and establishes the accounting policies and procedures governing the valuation of the marketable securities and is responsible for ensuring that these comply with all relevant accounting standards.
The group has identified the following key financial risk areas, which are mainly related to our marketable securities portfolio:
| • | credit risk; |
|---|---|
| • | currency exposure; |
| • | interest rate risk; and |
| • | capital management |
All our marketable securities are traded in established markets. Given the current market conditions, all future cash inflows and re-investments of proceeds from the disposal of marketable securities are invested in highly liquid and conservative investments, such as government bonds with high credit ratings. As such we consider the liquidity risk to be at an acceptable and low level.
Credit Risk
. . . . . . . . . .
To reduce our overall risk profile within our marketable securities, we sold our Euro-denominated portfolio in the second quarter of 2010. The proceeds were transferred to our Danish investment managers. Together with the proceeds received from the GSK amendment, the total proceeds were - during the second half of 2010 - invested in DKK, EUR and GBP highly liquid and short term bonds in accordance with our investment policy.
As of September 30, 2010, bank deposits are no longer fully guaranteed by the Danish Government. To reduce the credit risk on our bank deposits, Genmab only maintains the major part of its bank deposits in large Danish financial institutions. Currently, these financial institutions have a short term Moody's rating of P-1. In addition, Genmab will only maintain limited bank deposits at a level necessary to support the short term funding requirements of the Genmab group.
To further manage and reduce credit risks on our securities, only securities from investment grade issuers are selectable for our portfolios. No issuer of marketable securities can be accepted if it is not assumed that the credit quality of the issuer would be at least equal to the rating shown below:
. . . . . . . . . .
| Category | S&P | Moody's | Fitch |
|---|---|---|---|
| Short-term | A-1 | P-1 | F-1 |
| Long-term | A- | A3 | A |
Our marketable securities are spread over a number of different securities. As of December 31, 2010, Genmab has only invested its cash in deposits with major Danish financial institutions, Danish mortgage bonds and notes issued by Danish and European governments.
The cash position is split between cash and cash equivalent and marketable securities as follows:
| MDKK | 2010 | % | 2009 | % |
|---|---|---|---|---|
| Marketable securities | 1,548 | 100% | 817 | 64% |
| Cash ,cash equivalents and | ||||
| bank overdrafts | (2) | 0% | 464 | 36% |
| 1,546 | 100% | 1,281 | 100% |
Cash and cash equivalents amounted to DKK (2) million including marketable securities with a maturity of 3 months or less on the date of acquisition of DKK 49 million and a short term bank overdraft of DKK 116 million related to the acquisition of bonds at the very end of the year that were settled a few days later at the beginning of January 2011.
Currency Exposure
As Genmab incurs income and expenses in a number of different currencies, the group is subject to a currency risk. Increases or decreases in the exchange rate of such foreign currencies against our functional currency, the DKK, can affect the group's results and cash position negatively or positively.
The most significant cash flows of the group are EUR, DKK, USD and GBP. Genmab maintains cash positions in all these major currencies. Our total marketable securities are invested in EUR (26%), DKK (59%), and GBP-denominated securities (15%), compared to 42%, 58%, and 0%, as of December 31, 2010 and December 31, 2009. respectively.
The following significant exchange rates have been applied during the year:
| DKK | Average rate | Closing rate | ||
|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | |
| 1 EUR | 7.448 | 7.446 | 7.454 | 7.442 |
| 1 USD | 5.721 | 5.301 | 5.613 | 5.190 |
| 1 GBP | 8.589 | 8.309 | 8.666 | 8.232 |
. . . . . . . . . .
Based upon the amount of assets and liabilities denominated in EUR, USD, and GBP as of December 31, 2010, 1% change in the EUR to DKK and a 10% change in both USD to DKK exchange rate and GBP to DKK exchange rate will impact our net financial items by approximately:
| MDKK | 2010 | ||
|---|---|---|---|
| EUR | USD | GBP | |
| Net exposure | 388 | 397 | 231 |
| Percentage change in | |||
| exchange rate | 1% | 10% | 10% |
| Net impact of change | |||
| in exchange rate | 3.9 | 39.7 | 23.1 |
| 2009 | |||
| EUR | USD | GBP | |
| Net exposure | 286 | 241 | (32) |
| Percentage change in | |||
| exchange rate | 1% | 10% | 10% |
| Net impact of change |
Accordingly, significant changes in exchange rates could cause our net result to fluctuate significantly. The USD currency exposure is mainly related to an intercompany loan between Genmab A/S and Genmab MN, Inc and the GBP currency exposure is mainly related to marketable securities denominated in GBP. A portion of the proceeds received from GSK, as a part of the amendment signed in July 2010, has been kept in GBP to form a natural hedge for some of future expenses denominated in GBP. Genmab's future funding commitment for the development of ofatumumab in oncology indications will be capped at a total of GBP 145 million (DKK 1,314 million at the date of the agreement), including a yearly cash funding cap of GBP 17 million (DKK 154 million at the date of the agreement) for each of the next six years starting with 2010.
As of December 31, 2010, no financial instruments, such as options or futures contracts, have been entered into to reduce the exposure to short-term changes in exchange rates.
The above analysis assumes that all other variables, in particular interest rates, remain constant.
The Genmab group holds a number of investments in foreign subsidiaries, where the translation of equity to DKK is exposed to foreign exchange risks. In addition,
Genmab has granted one loan to a subsidiary which is classified as an addition to the net investment. Foreign exchange adjustments of this loan are recognized directly in other comprehensive income. The equity, including loan, classified as an addition to net investment, is distributed as follows: USD 92% (2009: 97%) and other currencies 8% (2009: 3%). The foreign subsidiaries are not significantly affected by currency risks as both income and expenses primarily are settled in the foreign subsidiaries' functional currencies.
Interest Rate Risk
. . . . . . . . . .
Genmab's exposure to interest rate risk is primarily ascribable to the positions of cash, cash equivalents, and marketable securities, as we currently do not have significant interest bearing debts.
The securities which the group has invested in bear interest rate risk, as a change in market derived interest rates may cause fluctuations in the fair value of the investments. In accordance with the objective of the investment activities, the portfolio of securities is monitored on a total return basis.
To control and minimize the interest rate risk, the group maintains an investment portfolio in a variety of securities with a relatively short effective duration.
As of December 31, 2010, the portfolio has an average effective duration of approximately one year (2009: 2 years) and no securities have more than 6 years (2009: 5 years), which means that a change in the interest rates of one percentage point will cause the fair value of the securities to change by approximately 1% (2009: 2%). Due to the short-term nature of the current investments and to the extent that we are able to hold the investments to maturity, we consider our current exposure to changes in fair value due to interest rate changes to be insignificant compared to the fair value of the portfolio.
| Portfolio | 2010 | 2009 |
|---|---|---|
| DKK | 2.0% | 5.8% |
| GBP* | 0.1% | - |
| USD** | 0.3% | 3.2% |
| EUR (current portfolio)* | 0.1% | - |
| EUR (previous portfolio)** | 3.5% | 21.9% |
| * Established in 2010 | ||
| ** Liquidated in 2010 |
The portfolio has generated the following yields for 2010 and 2009:
The decrease in the yields compared to 2009 is driven by the transfer of funds into safer and more liquid assets and a general reduction in market interest rates.
Capital Management
. . . . . . . . . .
The board of directors' policy is to maintain a strong capital base so as to maintain investor, creditor and market confidence, and a continuous advancement of Genmab's product pipeline and business in general.
Genmab is primarily financed through equity and partnership collaboration income and had as of December 31, 2010, cash, cash equivalents, and marketable securities of DKK 1,546 million compared to DKK 1,281 million as of December 31, 2009. The cash position supports the advancement of our overall mission and strategy to maximize our chances for success.
On July 1, 2010, we announced an amendment to the ofatumumab codevelopment and commercialization agreement between GSK and Genmab, which has improved our financial position and strength significantly.
To the extent possible, Genmab shall attempt to match the maturity and income from its investments in marketable securities with anticipated cash flow requirements.
The adequacy of our available funds will depend on many factors, including scientific progress in our research and development programs, the magnitude of those programs, our commitments to existing and new clinical collaborators, our ability to establish commercial and licensing arrangements, our capital expenditures, market developments, and any future acquisitions. Accordingly, we may require additional funds and may attempt to raise additional funds through equity or debt financings, collaborative agreements with partners or from other sources.
The board of directors continuously assesses the share and capital structure to ensure that Genmab's capital resources support the strategic goals. There was no change in the group's approach to capital management procedures in 2010.
Neither Genmab A/S nor any of its subsidiaries are subject to externally imposed capital requirements.
. . . . . . . . . .
Categories of Financial Assets and Liabilities
In accordance with IFRS, Genmab has divided its financial assets and liabilities in the following categories:
| 2010 | 2009 | ||
|---|---|---|---|
| Category | Note | (DKK'000) | (DKK'000) |
| Financial assets at fair value through | |||
| profit or loss | |||
| Marketable securities | 13 | 1,548,309 | 816,910 |
| Cash and cash equivalents | 48,511 | - | |
| Loans and receivables | |||
| Receivables | 12 | 72,601 | 111,667 |
| Cash and cash equivalents | 52,439 | 460,738 | |
| Assets classified as held for sale | 17,836 | 8,863 | |
| Available-for-sale financial assets | 365 | 468 | |
| Financial liabilities measured at amortized | |||
| cost: | |||
| Lease liability | 22 | (17,937) | (24,942) |
| Accounts payable | (32,761) | (44,808) | |
| Bank overdraft | (115,780) | - | |
| Other liabilities | 17 | (110,315) | (344,245) |
| Liabilities classified as held for sale | (11,322) | (53,850) |
The accounting policy for each of the categories is outlined in note 25.
Note 15 – Provisions
. . . . . . . . . .
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | ||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| Provisions per January 1 | 12,066 | 4,707 | 9,696 | 4,707 | |
| Exchange rate adjustment | (1,482) | - | (1,498) | - | |
| Additions during the year | 19,431 | 12,989 | 19,431 | 5,425 | |
| Used during the year | (5,966) | (734) | (3,636) | (600) | |
| Released during the year | (1,256) | - | (1,200) | - | |
| Discounting | 171 | 164 | 171 | 164 | |
| Transferred to liabilities classified as held for sale | - | (5,060) | - | - | |
| Total | 22,964 | 12,066 | 22,964 | 9,696 | |
| Non-current provisions Current provisions |
22,864 100 |
4,871 7,195 |
22,864 100 |
4,871 4,825 |
|
| Total | 22,964 | 12,066 | 22,964 | 9,696 |
Provisions include mainly contractual and restoration obligations related to our lease of offices and development activities.
Note 16 – Deferred Income
Deferred income reflects upfront payments received from our collaboration agreements with GSK and Lundbeck which will be recognized as revenues over the future years.
The deferred income is expected to be recognized in the income statement as outlined below. Deferred income related to the GSK and Lundbeck agreements will be recognized as revenues until 2015 and 2013, respectively. Please refer to note 1 for additional information regarding the determination of the amortization period.
The statements for the group and the parent company are identical.
| 2010 DKK'000 |
2009 DKK'000 |
|
|---|---|---|
| To be recognized in the income statement: | ||
| 2010 | - | 222,307 |
| 2011 | 226,098 | 217,064 |
| 2012 | 226,098 | - |
| 2013 | 222,214 | - |
| 2014 | 207,454 | - |
| 2015 | 207,454 | - |
| Total | 1,089,318 | 439,371 |
Note 17 – Other Liabilities
. . . . . . . . . .
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | ||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| Liabilities related to development agreements | 33,108 | 236,745 | 33,108 | 236,745 | |
| Staff costs liabilities | 56,646 | 87,069 | 18,570 | 51,965 | |
| Other liabilities | 30,639 | 68,095 | 14,669 | 17,323 | |
| Corporate Tax Payable | 343 | 2,374 | - | - | |
| Payable to subsidiaries | - | - | 23,649 | 37,250 | |
| Transferred to liabilities held for sale | (10,421) | (50,038) | - | - | |
| Total | 110,315 | 344,245 | 89,996 | 343,283 | |
| Non-current other liabilities | 42,213 | 3,172 | 34,056 | 1,606 | |
| Current other liabilities | 68,102 | 341,073 | 55,940 | 341,677 | |
| Total | 110,315 | 344,245 | 89,996 | 343,283 |
Other liabilities are measured at amortized cost and comprise mainly liabilities which are due less than one year from the balance sheet date. The carrying amount of the liabilities corresponds essentially to fair value.
The non-current other liabilities include DKK 33 million which is related to our collaboration with GSK. As a result of the amended agreement with GSK in July 2010, the amount is not expected to be settled before after the end of 2016.
Please refer to note 20 for additional information regarding payable to subsidiaries.
Note 18 – Warrants
Warrant Program
Genmab A/S has established warrant programs (equity-settled share-based payment transactions) as an incentive for all the group's employees, including those in our subsidiaries, members of the board of directors and members of the executive management.
Warrants are granted by our board of directors in accordance with authorizations given to it by Genmab's shareholders. Warrant grants are based on the merits of the individual grantee and no employee is automatically entitled to receive warrants simply by virtue of being employed at Genmab. Warrant grants to our board of directors and management are subject to guidelines adopted by the general meeting. The most recent warrant program was adopted by the board of directors in August 2004.
Under the terms of the recent warrant programs, warrants are granted at an exercise price equal to the share price on the grant date. According to Genmab's articles of association, the exercise price cannot be fixed at a lower price than the market price at the grant date.
. . . . . . . . . .
The warrant programs contain anti-dilution provisions if changes occur in Genmab's share capital prior to the warrants being exercised.
Warrants Granted from August 2004
Under the most recent warrant program, effective from August 2004, warrants can be exercised from one year after the grant date. The warrant holder may, as a general rule, only exercise 25% of the warrants granted per full year of employment or affiliation with Genmab after the grant date. However, the warrant holder will be entitled to continue to be able to exercise all warrants on a regular schedule in instances where the employment is terminated by Genmab without the warrant holder providing a good reason to do so. All warrants lapse at the tenth anniversary of the grant date.
In case of a change of control event as defined in appendix C to our articles of association, the warrant holder will immediately be granted the right to exercise all of his/her warrants regardless of the fact that such warrants would otherwise only become fully vested at a later point in time. Warrant holders who are no longer employed by or affiliated with us will, however, only be entitled to exercise such percentages as would otherwise have vested under the terms of the warrant program.
Warrants Granted Prior to August 2004
The remaining outstanding warrants under the preceding warrant program were exercised during the first quarter of 2009.
Assumptions
The fair value of each warrant granted during the year is calculated using the Black-Scholes pricing model with the following assumptions:
| Weighted average | 2010 | 2009 |
|---|---|---|
| Fair value per warrant on grant date | 30 | 78 |
| Share price | 55 | 165 |
| Exercise price | 55 | 165 |
| Expected dividend yield | 0% | 0% |
| Expected stock price volatility | 61% | 50% |
| Risk-free interest rate | 2% | 3% |
| Expected life of warrants | 6 years | 6 years |
The expected stock price volatility is based upon the historical volatility of Genmab's stock price.
The risk-free interest rate is determined as the interest rate on Danish government bonds (bullet issues) with a maturity of five years.
Based on an average fair value per warrant of DKK 30 (2009: DKK 78) the total fair value of warrants granted amounted to DKK 17 million (2009: 48 million) on the grant date.
Warrant Activity
. . . . . . . . . .
As of December 31, 2010, the board of directors has been authorized to grant a total of 12,221,263 (2009: 12,221,263) warrants since Genmab's inception.
In 2010, Genmab granted warrants 4 times (2009: 4). The total number of granted warrants amounts to 569,500 in 2010 (2009: 620,700).
The statements for the group and the parent company are identical.
| Number of warrants held by employees |
Number of warrants held by the Executive Management |
Number of warrants held by the Board of Directors |
Total outstanding warrants |
Weighted average exercise price DKK |
|
|---|---|---|---|---|---|
| Outstanding at December 31, 2008 | 2,974,975 | 620,000 | 1,382,000 | 4,976,975 | 236.28 |
| Granted | 295,700 | 145,000 | 180,000 | 620,700 | 164.55 |
| Exercised | (18,313) | - | - | (18,313) | 89.96 |
| Expired incl. adjustment previous years | 23,351 | - | - | 23,351 | 54.44 |
| Cancelled | (165,830) | - | - | (165,830) | 253.48 |
| Transfers | 65,000 | - | (65,000) | - | - |
| Outstanding at December 31, 2009 | 3,174,883 | 765,000 | 1,497,000 | 5,436,883 | 227.05 |
| Granted | 156,000 | 225,000 | 188,500 | 569,500 | 55.14 |
| Cancelled | (63,693) | - | - | (63,693) | 308.58 |
| Transfers | 1,184,825 | - | (1,184,825) | - | - |
| Outstanding at December 31, 2010 | 4,452,015 | 990,000 | 500,675 | 5,942,690 | 210.47 |
The number of warrants held by employees includes both current and former employees in Genmab. Please see note 21 for further information about the number of warrants held by the executive management and the board of directors.
As of December 31, 2010, the 5,942,690 outstanding warrants amounted to 13% of the share capital (2009: 12%). No warrants were exercised in 2010. For exercised warrants in 2009, the weighted average share price at the exercise date amounted to DKK 224.
Weighted Average Exercise Price
The following table summarizes the weighted average exercise price of outstanding warrants which was DKK 210.47 as of December 31, 2010 (2009: DKK 227.05).
. . . . . . . . . .
For warrants exercisable at year end, the weighted average exercise price is DKK 218.09 (2009: DKK 203.13). The table also shows the calculated Black-Scholes option valuation model value of outstanding warrants at year end.
Weighted average exercise of outstanding warrants at December 31, 2010
| Weighted | |||||
|---|---|---|---|---|---|
| Number of | average remaining |
Value of outstanding |
Number of | ||
| warrants | contractual life | warrants at year | warrants | ||
| Exercise price | Warrants exercisable from | outstanding | (in years) | end | exercisable |
| DKK | DKK | ||||
| Current Warrant Scheme | |||||
| 46.74 June 2, 2011 | 337,500 | 9.42 | 46.07 | - | |
| 66.60 December 9, 2011 | 118,000 | 9.94 | 46.95 | - | |
| 67.50 October 14, 2011 | 49,500 | 9.79 | 46.70 | - | |
| 68.65 April 21, 2011 | 56,750 | 9.30 | 45.87 | - | |
| 77.00 December 9, 2010 | 9,500 | 8.94 | 45.22 | 2,375 | |
| 86.00 August 3, 2005 | 486,410 | 3.59 | 31.08 | 486,410 | |
| 89.50 September 22, 2005 | 12,650 | 3.73 | 31.59 | 12,650 | |
| 97.00 December 1, 2005 | 27,125 | 3.92 | 32.30 | 27,125 | |
| 101.00 August 10, 2006 | 186,266 | 4.61 | 34.69 | 186,266 | |
| 114.00 June 7, 2006 | 390,050 | 4.43 | 34.11 | 390,050 | |
| 115.00 September 21, 2006 | 1,975 | 4.72 | 35.06 | 1,975 | |
| 116.00 April 20, 2006 | 22,314 | 4.30 | 33.67 | 22,314 | |
| 129.75 October 8, 2010 | 193,000 | 8.77 | 44.91 | 49,188 | |
| 130.00 December 1, 2006 | 14,813 | 4.92 | 35.67 | 14,813 | |
| 173.00 June 21, 2007 | 573,970 | 5.47 | 37.31 | 573,970 | |
| 174.00 June 17, 2010 | 333,000 | 8.46 | 44.32 | 83,250 | |
| 184.00 March 2, 2007 | 119,820 | 5.16 | 36.42 | 119,820 | |
| 210.50 April 25, 2007 | 34,300 | 5.31 | 36.86 | 34,300 | |
| 224.00 September 19, 2007 | 118,833 | 5.72 | 38.00 | 118,833 | |
| 234.00 April 15, 2010 | 68,950 | 8.29 | 43.98 | 17,239 | |
| 234.75 December 17, 2009 | 36,250 | 7.96 | 43.33 | 18,500 | |
| 246.00 June 4, 2009 | 187,750 | 7.50 | 42.35 | 98,000 | |
| 254.00 April 24, 2009 | 650,500 | 7.34 | 42.00 | 330,100 | |
| 272.00 October 8, 2009 | 491,313 | 7.77 | 42.93 | 248,313 | |
| 326.50 October 4, 2008 | 151,100 | 6.76 | 40.68 | 117,588 | |
| 329.00 December 13, 2008 | 90,705 | 6.95 | 41.12 | 71,848 | |
| 330.00 December 13, 2007 | 61,500 | 5.95 | 38.63 | 61,500 | |
| 352.50 June 27, 2008 | 789,133 | 6.49 | 40.01 | 596,297 | |
| 364.00 April 19, 2008 | 329,713 | 6.30 | 39.54 | 252,964 | |
| 210.47 | 5,942,690 | 5.71 | 35.46 | 3,935,688 |
. . . . . . . . . .
Weighted average exercise of outstanding warrants at December 31, 2009
| Weighted | |||||
|---|---|---|---|---|---|
| average | Value of | ||||
| Number of | remaining | outstanding | Number of | ||
| warrants | contractual life | warrants at year | warrants | ||
| Exercise price | Warrants exercisable from | outstanding | (in years) | end | exercisable |
| DKK | DKK | ||||
| Current Warrant Scheme | |||||
| 77.00 December 9, 2010 | 12,500 | 9.94 | 56.50 | - | |
| 86.00 August 3, 2005 | 486,412 | 4.59 | 41.03 | 486,412 | |
| 89.50 September 22, 2005 | 12,650 | 4.73 | 41.57 | 12,650 | |
| 97.00 December 1, 2005 | 27,125 | 4.92 | 42.30 | 27,125 | |
| 101.00 August 10, 2006 | 186,266 | 5.61 | 44.83 | 186,266 | |
| 114.00 June 7, 2006 | 390,050 | 5.43 | 44.21 | 390,050 | |
| 115.00 September 21, 2006 | 1,975 | 5.72 | 45.23 | 1,975 | |
| 116.00 April 20, 2006 | 22,314 | 5.30 | 43.74 | 22,314 | |
| 129.75 October 8, 2010 | 199,750 | 9.77 | 56.14 | - | |
| 130.00 December 1, 2006 | 14,813 | 5.92 | 45.87 | 14,813 | |
| 173.00 June 21, 2007 | 573,970 | 6.47 | 47.65 | 431,410 | |
| 174.00 June 17, 2010 | 335,000 | 9.46 | 55.47 | - | |
| 184.00 March 2, 2007 | 119,820 | 6.16 | 46.69 | 89,886 | |
| 210.50 April 25, 2007 | 34,300 | 6.31 | 47.16 | 24,054 | |
| 224.00 September 19, 2007 | 119,487 | 6.72 | 48.41 | 90,669 | |
| 234.00 April 15, 2010 | 69,450 | 9.29 | 55.09 | - | |
| 234.75 December 17, 2009 | 36,250 | 8.96 | 54.34 | 9,625 | |
| 246.00 June 4, 2009 | 197,500 | 8.50 | 53.24 | 51,625 | |
| 254.00 April 24, 2009 | 654,250 | 8.34 | 52.85 | 167,900 | |
| 272.00 October 8, 2009 | 497,500 | 8.77 | 53.89 | 126,067 | |
| 326.50 October 4, 2008 | 162,400 | 7.76 | 51.36 | 84,075 | |
| 329.00 December 13, 2008 | 97,755 | 7.95 | 51.86 | 52,990 | |
| 330.00 December 13, 2007 | 61,500 | 6.95 | 49.10 | 47,003 | |
| 352.50 June 27, 2008 | 790,258 | 7.49 | 50.62 | 402,336 | |
| 364.00 April 19, 2008 | 333,588 | 7.30 | 50.10 | 174,577 | |
| 227.05 | 5,436,883 | 7.32 | 49.78 | 2,893,822 |
Note 19 – Discontinued Operation
In November 2009, we announced a reorganization plan to build a sustainable business with the objective of matching resources to workload now and in the future. As part of this strategy, Genmab intends to sell its manufacturing facility located in Brooklyn Park, Minnesota, USA. Genmab plans to meet its future manufacturing requirements through contract manufacturing vendors. The manufacturing environment has changed as contract manufacturing resources in the industry have become more available. This comes at a time when Genmab is anticipating limited short-term internal demand. The Brooklyn Park facility, which is ready for sale, is being kept in a validated state and will operate in a maintenance-only mode with a significantly reduced number of staff until a sale is agreed.
We have launched an active sales process and further details of the facility can be viewed at www.genmab-facility.com.
| Note 19 – Discontinued Operation (continued) | ||
|---|---|---|
| 2010 | 2009 | |
|---|---|---|
| DKK'000 | DKK'000 | |
| Result of discontinued operation | ||
| Revenues | 376 | 42,164 |
| Expenses | (48,361) | (286,316) |
| (47,985) | (244,152) | |
| Impairments to fair value less cost to sell | (130,137) | (418,910) |
| Loss from operating activities | (178,122) | (663,062) |
| Financial income, net | 11 | 228 |
| Net loss before tax | (178,111) | (662,834) |
| Corporate tax | (28) | (28) |
| Total loss for the period | (178,139) | (662,862) |
| Basic and diluted net loss per share discontinued operation | (3.97) | (14.76) |
| Cash flows from (used in) discontinued operation | ||
| Net cash used in operating activities | (98,127) | (146,767) |
| Net cash used in investing activities | - | (7,039) |
| Net cash used in discontinued operation | (98,127) | (153,806) |
| Assets and liabilities classified as held for sale | ||
| Tangible assets | 673,596 | 746,514 |
| Receivables and prepayments | 7,391 | 6,952 |
| Cash and cash equivalents | 12,742 | 3,708 |
| Assets | 693,729 | 757,174 |
| Provisions | (1,137) | (5,060) |
| Accounts payable/Other liabilities | (11,322) | (53,850) |
| Liabilities | (12,459) | (58,910) |
| Net assets in discontinued operation | 681,270 | 698,264 |
Revenues include income related to external production of clinical material or similar services. Expenses include production costs for clinical material and research and development costs such as salary expenses and depreciation.
As a result of the planned disposal, the facility's assets were initially measured at the lower of the carrying amount and fair value less cost to sell. We estimated the fair value of the facility to be approximately USD 150 million less sales related costs of approximately USD 5 million, resulting in a fair value less cost to sell of approximately USD 145 million, which resulted in a non-cash impairment charge of approximately DKK 419 million in 2009.
In September 2010, an additional non-cash impairment charge of approximately DKK 130 million was recognized as a result of changed market conditions. The fair value less cost to sell has been reduced from approximately USD 145 million to
Note 19 – Discontinued Operation (continued)
. . . . . . . . . .
USD 120 million as of September 30, 2010. Sales related costs are still estimated to approximately USD 5 million.
The above impairments are included in the result of the discontinued operation. The total impairment is allocated on a pro rata basis on the respective carrying amounts of the facility's non-current assets and was allocated as follows:
| MDKK | 2010 | 2009 |
|---|---|---|
| Goodwill | - | 298 |
| Land and buildings | 106 | 67 |
| Manufacturing equipment | 23 | 14 |
| Equipment, furniture, and fixtures | 1 | 2 |
| Impairment of non-current assets | 130 | 381 |
| Inventories, see note 11 | - | 38 |
| Total impairment | 130 | 419 |
Please refer to note 10 for information regarding the impairment related to the financial statements of the parent company.
The net cash used in the operating activities in 2010 was related to the settlement of liabilities from the re-organization plan in November 2009 and ongoing operating expenses.
Note 20 – Related Party Disclosures
Genmab's related parties are:
- the parent company's subsidiaries
- companies in which members of the parent company's board of directors, executive management, and close members of the family of these persons exercise significant influence
- the parent company's board of directors, executive management, and close members of the family of these persons
The Parent Company's Transactions with Subsidiaries
Genmab B.V., Genmab MN, Inc., Genmab, Inc., and Genmab Ltd. are 100% owned subsidiaries of Genmab A/S and are included in the consolidated financial statements. They primarily perform research and development and manufacturing activities on behalf of the parent company. All intercompany transactions have been eliminated in the consolidated financial statements of the Genmab group.
| Parent Company | ||
|---|---|---|
| 2010 | 2009 | |
| DKK'000 | DKK'000 | |
| Transactions with subsidiaries: | ||
| Service fee costs | 269,530 | (286,853) |
| Costs related to the antibody clinical material | - | (134,249) |
| Warrant compensation expenses - invoiced to subsidiaries | 49,035 | 65,320 |
| Financial income | 82,039 | 74,837 |
| Financial expenses | (91) | (143) |
| Impairment of Genmab MN, Inc., cf. note 10 | 288,617 | 752,201 |
| Balances with subsidiaries: | ||
| Non-current receivables (including impairment of TDKK 615,355) | 266,551 | 495,666 |
| Current receivables | 432,450 | 227,481 |
| Other current liabilities | (23,649) | (37,250) |
Note 20 – Related Party Disclosures (continued)
Companies in which Members of the Parent Company's Board of Directors, Executive Management, and Close Members of the Family of These Persons Exercise Significant Influence
In 2010 we entered into a collaboration with Lundbeck under which Genmab will create novel human antibodies to three targets identified by Lundbeck. As Deputy Chairman Anders Gersel Pedersen is member of Lundbeck's executive management. Lundbeck is considered as a related party.
Under the terms of the agreement, Genmab received an upfront payment of €7.5 million (approximately DKK 56 million). The upfront payment was deferred and recognized in the income statement as revenue on a straight line basis over a three year period.
Lundbeck will fully fund the development of the antibodies and during 2010 Lundbeck has reimbursed cost of DKK 2 million. The amount is included in revenues.
The Parent Company's Transactions with the Board of Directors and Executive Management
Genmab has not granted any loans, guarantees, or other commitments to or on behalf of any of the members in the board of directors and executive management.
Other than the remuneration and other transactions relating to the board of directors and executive management described in note 21, no other significant transactions have taken place with the board of directors or the executive management during 2009 and 2010.
At the 2008 annual general meeting, a general guideline for incentive programs for the board of directors and the executive management pursuant to section 139 of the Danish Companies Act was adopted. The guideline can be found in its full length on our website.
Note 20 – Related Party Disclosures (continued)
All incentive payments have been carried out in accordance with the 2008 adopted guidelines for incentive programs. Changes to the guidelines will be considered in connection with the Annual General Meeting in 2011.
Note 21 – Remuneration of the Board of Directors and Executive Management
For further information about the board of directors and the executive management, please refer to the sections "Board of Directors" and "Senior Management" in the annual report.
Remuneration to the Board of Directors
| Base board fee |
Fee Committes |
Warrant compensation expenses*** |
2010 DKK'000 |
Base board fee |
Fee Committes |
Warrant compensation expenses*** |
2009 DKK'000 |
|
|---|---|---|---|---|---|---|---|---|
| Michael Widmer | 513 | 79 | 2,145 | 2,737 | 452 | 60 | 3,184 | 3,696 |
| Anders Gersel Pedersen | 256 | 80 | 1,072 | 1,408 | 226 | 66 | 1,592 | 1,884 |
| Karsten Havkrog Pedersen | 256 | 105 | 1,072 | 1,433 | 226 | 107 | 1,592 | 1,925 |
| Ernst Schweizer* | - | - | - | - | 111 | - | 2,557 | 2,668 |
| Burton G. Malkiel | 256 | 142 | 1,419 | 1,817 | 226 | 118 | 2,224 | 2,568 |
| Hans Henrik Munch-Jensen | 256 | 125 | 1,419 | 1,800 | 226 | 112 | 2,224 | 2,562 |
| Daniel Bruno ** | 191 | - | 54 | 245 | - | - | - | - |
| Tom Vink ** | 191 | - | 54 | 245 | - | - | - | - |
| Nedjad Losic ** | 191 | - | 54 | 245 | - | - | - | - |
| 2,110 | 531 | 7,289 | 9,930 | 1,467 | 463 | 13,373 | 15,303 |
* Retired in 2009.
. . . . . . . . . .
** Employee representatives elected in 2010.
*** The warrant compensation expense in the tables above includes the amortization of the warrant expense relating to warrants granted over several periods, including a portion of the warrants granted in the year of the report. The Black Scholes value of the 68,500 (2009: 60,000) warrants granted to the current members of the Board of Directors in 2010 was DKK 2 million (2009: DKK 5 million).
Remuneration of the board of directors comprised of a fixed board fee and additional fees for the board committee obligations. The fees are denominated in USD.
In addition, the members of the board of directors participate in Genmab's warrant programs. According to our general guidelines for incentive programs, a new member of the board of directors is granted up to 50,000 warrants upon election. In addition, the members of the board of directors are usually granted up to 40,000 warrants on an annual basis dependent on the financial results of the year in question, the progress of our product pipeline, as well as specific major important events. Please refer to note 18 regarding information about Genmab's warrant program.
As of December 31, 2010 the warrants that were vested for the current board members do not hold any intrinsic value (out-of-the-money) as the exercise price of these warrants exceed the share price.
The statement for the group and the parent company are identical.
Note 21 – Remuneration of the Board of Directors and Executive Management (continued)
Remuneration to the Executive Management
| 2010 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Base salary |
Cash bonus | Defined contribution plans |
Other Benefits |
Severance payment |
Warrant compensation expenses** |
Genmab Group DKK'000 |
Parent Company DKK'000*** |
|
| Jan van de Winkel | 4,444 | 3,547 | 584 | 224 | - | 8,476 | 17,275 | 1,292 |
| David A. Eatwell | 2,744 | 1,226 | 95 | - | - | 4,983 | 9,048 | 758 |
| Lisa N. Drakeman* | 2,714 | - | 127 | - | 22,843 | 25,046 | 50,730 | 4,569 |
| 9,902 | 4,773 | 806 | 224 | 22,843 | 38,505 | 77,053 | 6,619 | |
| 2009 | ||||||||
| Base salary |
Cash bonus | Defined contribution plans |
Other Benefits |
Severance payment |
Warrant compensation expenses** |
Genmab Group DKK'000 |
Parent Company DKK'000*** |
|
| Jan van de Winkel | 4,061 | 820 | 573 | 202 | - | 12,473 | 18,129 | 406 |
| David A. Eatwell | 2,083 | 660 | 88 | - | - | 5,453 | 8,284 | 5,660 |
| Lisa N. Drakeman | 5,007 | 1,011 | 118 | 143 | - | 20,983 | 27,262 | 21,484 |
*Departed in 2010.
. . . . . . . . . .
** The warrant compensation expense in the tables above includes the amortization of the warrant expense relating to warrants granted over several periods, including a portion of the warrants granted in the year of the report. The Black Scholes value of the warrants granted in 2010 for Jan van de Winkel and David Eatwell were DKK 4 million (2009: DKK 6 million), and DKK 3 million (2009: DKK 6 million) respectively. In 2010 the warrant compensation expenses also included DKK 18 million which were expensed in connection with the departure of Genmabs former CEO.
*** Included base salary and other remuneration of DKK 3 million (2009: DKK 1 million) and warrant compensation expenses of DKK 4 million (2009: DKK 26 million).
Remuneration of the executive management team, which at the end of 2010 consists of the President & Chief Executive Officer and Executive Vice President & Chief Financial Officer, comprised base salary, cash bonus, non-monetary benefits such as company car, telephone etc. and participation in Genmab's defined contribution pension plans. The base salary and related benefits are denominated in EUR and USD.
In addition, the members of the management team participate in Genmab's warrant programs. According to our general guidelines for incentive programs, a new member of the executive management is usually granted warrants upon engagement. In addition the members of the executive management may be granted a predetermined maximum number of warrants annually in recognition of performance against strategic objectives established with the Board of Directors and as an incentive to increase the future value of the company. Please refer to note 18 regarding information about Genmab's warrant program.
As of December 31, 2010 the warrants that were vested for the current executive management do not hold any intrinsic value (out-of-the-money) as the exercise price of these warrants exceed the share price.
Bonus Program:
The bonus program for the members of executive management is based on the achievement of predetermined and well-defined milestones for each financial year as set by the board of directors. Currently, the executive management may
Note 21 – Remuneration of the Board of Directors and Executive Management (continued)
receive a maximum annual bonus of 60% to 100% of their base salaries. In addition, the executive management may receive an extraordinary bonus of a maximum up to 15% of their annual base salaries, based on the occurrence of certain special events or achievements. The bonus programs may enable the executive management to earn a bonus per calendar year of up to an aggregate amount of approximately DKK 6 million (annual) and DKK 1 million (extraordinary) for all current members of the executive management. In 2010, the current executive management team has received a total cash bonus of DKK 5 million (2009: DKK 1.5 million).
Severance Payments:
. . . . . . . . . .
The service agreements with each member of the executive management team may be terminated by Genmab with no less than 12 months' notice and by the executive with no less than six months' notice. In the event Genmab terminates the service agreement without cause, Genmab is obliged to pay the executive officer his/her existing salary for one or two years.
Please refer to the Directors Report section regarding the potential impact in the event of change of control of Genmab.
Number of ordinary shares owed and warrants held
| Number of ordinary shares owned | December 31, 2009 |
Acquired | Sold | Transfers | December 31, 2010 |
Market value DKK'OOO* |
|---|---|---|---|---|---|---|
| Board of Directors | ||||||
| Michael Widmer | - | - | - | - | - | - |
| Anders Gersel Pedersen | - | - | - | - | - | - |
| Karsten Havkrog Pedersen | - | - | - | - | - | - |
| Burton G. Malkiel | - | - | - | - | - | - |
| Hans Henrik Munch-Jensen | 300 | - | - | - | 300 | 19,650 |
| Lisa N. Drakeman*** | 361,040 | - | - | (361,040) | - | - |
| Daniel Bruno*** | - | - | - | - | - | - |
| Tom Vink*** | - | - | - | - | - | - |
| Nedjad Losic*** | - | - | - | 800 | 800 | 52,400 |
| 361,340 | - | - | (360,240) | 1,100 | 72,050 | |
| Executive Management | ||||||
| Jan van de Winkel | 120,000 | - | - | - | 120,000 | 7,860,000 |
| David A. Eatwell | - | - | - | - | - | - |
| Lisa N. Drakeman, see above *** | - | - | - | - | - | - |
| 120,000 | - | - | - | 120,000 | 7,860,000 | |
| Total | 481,340 | - | - | (360,240) | 121,100 | 7,932,050 |
The statement for the group and the parent company are identical.
Note 21 – Remuneration of the Board of Directors and Executive Management (continued)
| Number of warrants held | December 31, 2009 |
Granted | Exercised | Transfers | December 31, 2010 |
Fair value DKK'OOO** |
Weighted average exercise price DKK |
|---|---|---|---|---|---|---|---|
| Board of Directors | |||||||
| Michael Widmer | 144,000 | 15,000 | - | - | 159,000 | 6,231 | 191.66 |
| Anders Gersel Pedersen | 72,000 | 7,500 | - | - | 79,500 | 3,116 | 191.66 |
| Karsten Havkrog Pedersen | 72,000 | 7,500 | - | - | 79,500 | 3,116 | 191.66 |
| Burton G. Malkiel | 62,000 | 7,500 | - | - | 69,500 | 2,893 | 284.06 |
| Hans Henrik Munch-Jensen | 62,000 | 7,500 | - | - | 69,500 | 2,893 | 284.06 |
| Lisa N. Drakeman*** | 1,085,000 | 120,000 | - | (1,205,000) | - | - | - |
| Daniel Bruno*** | - | 7,500 | - | 11,000 | 18,500 | 832 | 114.95 |
| Tom Vink*** | - | 7,500 | - | 2,925 | 10,425 | 462 | 82.03 |
| Nedjad Losic*** | - | 8,500 | - | 6,250 | 14,750 | 605 | 81.25 |
| 1,497,000 | 188,500 | - | (1,184,825) | 500,675 | 20,148 | 208.94 | |
| Executive Management | |||||||
| Jan van de Winkel | 590,000 | 120,000 | - | - | 710,000 | 28,028 | 174.38 |
| David A. Eatwell | 175,000 | 105,000 | - | - | 280,000 | 12,427 | 154.47 |
| Lisa N. Drakeman, see above*** | - | - | - | - | - | - | - |
| 765,000 | 225,000 | - | - | 990,000 | 40,455 | 168.75 | |
| Total | 2,262,000 | 413,500 | - | (1,184,825) | 1,490,675 | 60,603 | 182.25 |
*Market value is based on a the closing price of the parent company's shares on the NASDAQ OMX Copenhagen at the balance sheet date or the last trading day prior to the balance sheet date.
** Fair value is based on the Black-Scholes pricing model at year end.
transfer column.
. . . . . . . . . .
***In June, we announced that three Genmab employees were elected to the company's Board of Directors. In addition, we announced that Lisa N. Drakeman departed from her position as Chief Executive Officer and as a member of the board of directors of Genmab. Therefore, her outstanding shares and warrants are not included in the list of outstanding shares and warrants as of December 31, 2010. The reclassification of her shares and warrants are shown in the table below in the
The Black Scholes value of the 68,500 warrants granted to the current members of the Board of Directors in 2010 was DKK 2 million and the Black Scholes value of the warrants granted to Jan van de Winkel and David Eatwell was DKK 4 million and DKK 3 million respectively.
Note 22 – Commitments
Guarantees and Collaterals
The group has, through a bank deposit, established a bank guarantee of DKK 3 million (2009: DKK 4 million) relating to the lease of an office building. In the separate financial statements of the parent company, no such guarantees have been established.
In connection with a payment of proceeds from a sale of a tangible asset, the group may under certain circumstances be obligated to repay a part of the sales proceeds until June 30, 2011. The amount to be repaid will be reduced during the period and amounts to DKK 1 million as of December 31, 2010 (2009: DKK 2 million).
The management does not expect to repay the amount. In the separate financial statements of the parent company, no such contingent liability exists.
Note 22 – Commitments (continued)
Operating Leases
. . . . . . . . . .
The group has entered into operating lease agreements with respect to office space, cars, and office equipment.
The leases are non-cancelable for various periods up to 2014.
Future minimum payments under our operating leases as of December 31, 2010, are as follows:
| Genmab Group | Parent Company | ||||
|---|---|---|---|---|---|
| 2010 | 2009 | 2010 | 2009 | ||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| Payment due | |||||
| Within 1 year | 22,389 | 26,299 | 9,559 | 8,997 | |
| From 1 to 5 years | 53,372 | 65,338 | 15,384 | 21,364 | |
| After 5 years | - | 9,398 | - | - | |
| Total | 75,761 | 101,035 | 24,943 | 30,361 | |
| Expenses recognized in the income statement | 22,708 | 40,023 | 7,734 | 20,841 |
Finance Leases
The parent company and the group have entered into finance lease contracts, primarily with respect to laboratory equipment. All finance lease contracts in the Dutch subsidiary (lessee) have been entered into by Genmab A/S (lessor). Therefore, the statements for the group and the parent company are identical.
This arrangement is neutral to the parent company, as all terms and conditions of the lease agreement are passed on to the subsidiary on the same terms as from the external lessor. As a result, Genmab A/S has lease receivables from the subsidiary totaling DKK 18 million (2009: DKK 25 million). All finance lease commitments recorded in the separate financial statements of the parent company are fully reflected in subleases entered into with the subsidiary Genmab B.V.
The average effective interest rate in the parent company's and the group's lease arrangements are approximately 4.6% (2009: 4.5%).
Future minimum lease payments under such finance leases and the net present value are as follows:
Note 22 – Commitments (continued)
. . . . . . . . . .
| 2010 | 2009 | |
|---|---|---|
| DKK'000 | DKK'000 | |
| Minimum lease payments | ||
| Within 1 year | 6,791 | 8,987 |
| From 1 to 5 years | 12,458 | 18,262 |
| 19,249 | 27,249 | |
| Future finance charges | (1,312) | (2,307) |
| Total | 17,937 | 24,942 |
| Net present value of future payments | ||
| Within 1 year | 6,091 | 7,004 |
| From 1 to 5 years | 11,846 | 17,938 |
| Total | 17,937 | 24,942 |
| Fair value | 17,986 | 25,054 |
Other Purchase Obligations
The parent company and the group have entered into a number of agreements primarily related to research and development activities carried out by Genmab. Under the current development plans, the contractual obligations amounted to DKK 95 million (2009: DKK 189 million). In the parent company, the contractual obligations amounted to DKK 94 million (2009: DKK 189 million).
Note 23 – Contingent Assets, Contingent Liabilities and Subsequent Events
Contingent Assets and Contingent Liabilities
We are entitled to potential milestone payments and royalties on successful commercialization of products developed under license and collaboration agreements with our partners. Since the size and timing of such payments are uncertain until the milestones are reached, the agreements may qualify as contingent assets. However, it is impossible to measure the value of such contingent assets, and, accordingly, no such assets have been recognized.
As part of the license and collaboration agreements that Genmab has entered into, once a product is developed and commercialized, Genmab will be required to make milestone and royalty payments. It is impossible to measure the value of such future payments, but Genmab expects to generate future income from such products which will exceed any milestone and royalty payments due.
Subsequent Events
Apart from the events disclosed elsewhere in the annual report, no events have occurred after the balance sheet date, which require recognition in our 2010 financial statements or disclosure in the annual report.
| 2010 | 2010 2009 |
|||
|---|---|---|---|---|
| DKK'000 | 2009 DKK'000 |
DKK'000 | DKK'000 | |
| PricewaterhouseCoopers | ||||
| Audit services | 1,373 | 1,482 | 866 | 815 |
| Audit-related services | 147 | 724 | 102 | 702 |
| Tax services | 706 | 988 | 493 | 71 |
| Other services | 10 | 33 | 10 | 33 |
| Total fees | 2,236 | 3,227 | 1,471 | 1,621 |
Note 24 – Fees to Auditors Appointed at the Annual General Meeting Genmab Group Parent Company
Note 25 - Accounting Policies
Basis of Presentation
. . . . . . . . . .
The financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB), and with the International Financial Reporting Standards as endorsed by the EU and additional Danish disclosure requirements for annual reports of listed companies.
The financial statements have been prepared under the historical cost convention, as modified by the revaluation of available-for-sale financial assets, and financial assets and financial liabilities (including derivative financial instruments) at fair value through profit or loss.
Non-current assets classified as held for sale are measured at the lower of the carrying amount before the changed classification and fair value less cost to sell.
Fair values have been determined for measurement and/or disclosure purposes. When applicable, further information about the assumptions made in determining fair values is disclosed in the notes specific to that asset or liability.
Functional and Presentation Currency
The financial statements have been prepared in Danish Kroner (DKK), which is the functional and presentation currency of the parent company. All financial information presented in DKK has been rounded to the nearest thousand.
New Accounting Policies and Disclosures
The International Accounting Standards Board (IASB) has issued and updated, and the EU has endorsed, a number of new and existing standards. Effective from January 1, 2010, Genmab has applied the following standards and interpretations with relevance for Genmab:
- IFRS 3, "Business Combinations" and related revisions to IAS 27, "Consolidated and Separate Financial Statements"
- IASB's Annual Improvements to IFRSs (issued by IASB in April 2009) which among others include amendments of IFRS 2, 5, 8, IAS 7, 18, 36, 38 and IFRIC 16
- Amendments to IFRS 2, "Share-based Payment"
The implementation of the standards and interpretations did not have any material impact on the financial position and performance of the group. IFRS 3 has effect from acquisitions carried out after January 1, 2010. No acquisitions have been made in 2010 and the accounting policies only outline the practice for historical acquisitions carried out prior to January 1, 2010.
Consolidated Financial Statements
. . . . . . . . . .
The consolidated financial statements include Genmab A/S (the parent company) and subsidiaries in which the parent company directly or indirectly exercises a controlling interest through shareholding or otherwise. Accordingly, the consolidated financial statements include Genmab A/S, Genmab MN, Inc., Genmab B.V., Genmab, Inc., and Genmab Ltd. (collectively referred to as the Genmab group or group).
The group's consolidated financial statements have been prepared on the basis of the financial statements of the parent company and subsidiaries – prepared under the group's accounting policies – by combining similar accounting items on a lineby-line basis. On consolidation, intercompany income and expenses, intercompany receivables and payables, and unrealized gains and losses on transactions between the consolidated companies are eliminated.
There was no change in the scope of consolidation during 2010.
The recorded value of the equity interests in the consolidated subsidiaries is eliminated with the proportionate share of the subsidiaries' equity. Subsidiaries are consolidated from the date when control is transferred to the group.
The income statements for subsidiaries with a different functional currency than the group presentation currency are translated into the group's presentation currency at the year's weighted average exchange rate, and the balance sheets are translated at the exchange rate in effect at the balance sheet date. Exchange rate differences arising from the translation of foreign subsidiaries shareholders' equity at the beginning of the year and exchange rate differences arising as a result of foreign subsidiaries' income statements being translated at average exchange rates are recorded in translation reserves in shareholders' equity.
Business Combinations – acquired before January 1, 2010
Entities acquired or formed during the year were recognized in the consolidated financial statements from the date of acquisition or formation. The acquisition date was the date when Genmab obtains control of the acquired subsidiary.
The purchase method is used for acquisitions of new subsidiaries. The cost of a business combination comprises the fair value of the consideration agreed upon and costs directly attributable to the acquisition.
The acquired entities' identifiable assets, liabilities, and contingent liabilities were measured at fair value at the acquisition date. Identifiable intangible assets were recognized if they were separable or arise from a contractual right and the fair value could be reliably measured. Deferred tax on revaluations was recognized.
. . . . . . . . . .
Any excess of the cost over the fair value of the identifiable assets, liabilities, and contingent liabilities acquired was recognized as goodwill under intangible assets.
Goodwill was not amortized but was tested annually for impairment. The first impairment test was performed before the end of the acquisition year.
Upon acquisition, goodwill was allocated to the cash-generating units, which subsequently formed the basis for the impairment test.
Goodwill and fair value adjustments in connection with the acquisition of a foreign subsidiary with a functional currency other than the presentation currency used in the Genmab group were treated as assets and liabilities belonging to the foreign subsidiary and translated into the foreign subsidiary's functional currency at the exchange rate at the transaction date.
If uncertainties regarding measurement of acquired identifiable assets, liabilities, and contingent liabilities existed at the acquisition date, initial recognition took place on the basis of preliminary fair values. If identifiable assets, liabilities and contingent liabilities were subsequently determined to have a different fair value at the acquisition date from that first assumed, goodwill was adjusted up until 12 months after the acquisition. The effect of the adjustments was recognized in the opening balance of equity, and the comparative figures were adjusted accordingly.
Subsequently, goodwill was only adjusted as a result of changes in estimates of contingent purchase considerations, except in cases of material error. Changes in estimates related to contingent purchase were recognized in the income statement. However, subsequent realization of the acquired subsidiary's deferred tax assets not recognized at the acquisition date will require recognition of the tax benefit in the income statement and simultaneous write-down of the carrying amount of goodwill to the amount which would have been recognized if the deferred tax asset had been recognized as an identifiable asset at the acquisition date.
Foreign Currency
Transactions in foreign currencies are translated at the exchange rates in effect at the date of the transaction.
Exchange rate gains and losses arising between the transaction date and the settlement date are recognized in the income statement as financial items.
Unsettled monetary assets and liabilities in foreign currencies are translated at the exchange rates in effect at the balance sheet date. Exchange rate gains and losses arising between the transaction date and the balance sheet date are recognized in the income statement as financial items.
Income Statement
Revenues
. . . . . . . . . .
Revenues comprise mainly milestone and upfront payments, royalties, government grants, and other income from research and development agreements.
Revenues are recognized when it is probable that future economic benefits will flow to the group and these benefits can be measured reliably. Further, revenue recognition requires that all significant risks and rewards of ownership of the goods included in the transaction have been transferred to the buyer.
Upfront payments including any share premiums related to equity investments that are deemed attributable to subsequent research and development work are recognized as deferred income and recognized as revenue over the planned development period.
Milestone payments related to reaching particular stages in product development are recognized immediately if a separate earnings process relative to the milestone payment has been completed and achieved.
Royalty income from licenses is based on third-party sales of licensed products and is recognized in accordance with contract terms when third-party results are available and are deemed to be reliable.
Other income received from our collaborations for separate research and development services are recognized as revenues when the related services are performed.
Research and Development Costs
Research and development costs primarily include salary and related expenses, license costs, manufacturing costs, clinical costs, amortization of licenses and rights, and depreciation and impairment of intangible and tangible assets; to the extent that such costs are related to the group's research and development activities.
Both research and development costs are recognized in the income statement in the period to which they relate. Please see note 1 for a more detailed description.
General and Administrative Expenses
General and administrative expenses relate to the administration of the group, including depreciation and impairment of intangible and tangible assets; to the extent such expenses are related to the administrative functions. General and administrative expenses are recognized in the income statement in the period to which they relate.
Share-Based Compensation
The parent company has granted warrants to employees and the board of directors under various warrant programs. For warrants granted after November 7, 2002, the group applies IFRS 2, according to which the fair value of the warrants at grant date is recognized as an expense in the income statement over the
vesting period. A corresponding amount is recognized in shareholders' equity as the warrant program is designated as an equity-settled share-based payment transaction.
Warrants granted prior to November 7, 2002, are not covered by IFRS 2.
Expenses and exercise proceeds related to employees in the subsidiaries are reinvoiced to the relevant subsidiary where the employee has entered an employment contract.
Financial Income and Expenses
Financial income and expenses include interest as well as realized and unrealized exchange rate adjustments and realized and unrealized gains and losses on marketable securities (designated as fair value through profit and loss), realized gains and losses and write-downs of other securities and equity interests (designated as available-for-sale financial assets), and realized and unrealized gains and losses on derivative financial instruments.
Interest and dividend income are shown separately from gains and losses on marketable securities and other securities and equity interests.
Exchange rate adjustments of balances with foreign subsidiaries, which are considered part of the total net investment in the subsidiary, are recognized in the income statement of the parent company.
Corporate Tax
. . . . . . . . . .
Corporate tax expense, which consists of current tax and the adjustment of deferred taxes for the year, is recognized in the income statement to the extent that the tax is attributable to the net result for the year. Tax attributable to entries directly related to shareholders' equity is recognized in other comprehensive income.
Current tax liabilities include taxes payable based on the expected taxable income for the year and any adjustments to prior years' tax expense as recorded in the income statement. Any current tax liabilities are recognized in other liabilities in the balance sheet.
Any prepaid taxes are recognized in other receivables in the balance sheet.
Balance Sheet
Non-current Assets
Goodwill
Goodwill is initially recognized in the balance sheet at cost as described under "Business Combinations". Goodwill is not amortized but tested annually for impairment and measured at cost less accumulated impairment losses. Impairment losses on goodwill are not reversed.
Based on management and financial structure goodwill is allocated to the group's cash-generating units that are expected to benefit from the business combination.
Licenses and Rights
. . . . . . . . . .
Licenses and rights are initially measured at cost and include the net present value of any future payments. The net present value of any future payments is recognized as a liability.
Genmab acquires licenses and rights, primarily to get access to targets identified by third parties.
Licenses and rights are amortized using the straight-line method over the estimated useful life of five years.
Amortization, impairment losses, and gains or losses on the disposal of intangible assets are recognized in the income statement as research and development costs, general and administrative expenses or as discontinued operation, as appropriate.
Tangible Assets
Tangible assets are mainly comprised of land and buildings, manufacturing equipment and fixtures, and fittings which are measured at cost less accumulated depreciation and any impairment losses.
The cost is comprised of the acquisition price and direct costs related to the acquisition until the asset is ready for use. The present value of estimated liabilities related to restore our offices in connection with the termination of the lease is added to the cost if the liabilities are provided for. The costs incurred are capitalized until the facilities are completed. Costs include direct costs, salary related expenses, and costs to subcontractors.
Depreciation, which is stated at cost net of any residual value, is calculated on a straight-line basis over the expected useful lives of the assets, which are as follows:
| Buildings | 30 years |
|---|---|
| Manufacturing equipment | 7 years |
| Equipment, furniture and fixtures | 3-5 years |
| Computer equipment | 3 years |
| Leasehold improvements | 5 years |
| or the lease term, if shorter |
The useful lives and residual values are reviewed and adjusted if appropriate on a yearly basis. Land and assets under construction are not depreciated.
Depreciation, impairment losses, and gains or losses on the disposal of tangible assets are recognized in the income statement as research and development costs, general and administrative expenses, or as discontinued operation as appropriate.
Equity Interests in Subsidiaries
. . . . . . . . . .
In the separate financial statements of the parent company Genmab A/S, equity interests in subsidiaries are recognized and measured at cost. Equity interests in foreign currencies are translated to the reporting currency by use of historical exchange rates prevailing at the time of investment. The cost is written down to the recoverable amount if this is lower.
Distributions from the investment are recognized as income when declared. An impairment test is performed if a distribution exceeds the current period's comprehensive income or the subsidiary exceeds the carrying amount of the net assets of the subsidiary in the consolidated financial statements.
Other Securities and Equity Interests
Other securities and equity interests include investments which have been acquired for long-term strategic holding. The financial assets have been designated as "available-for-sale" financial assets, as the group's management intends to hold these investments for an indefinite period of time. However, the assets can be sold if the group's business strategy changes. The group's management assesses the classification of financial assets at the time of acquisition.
Other securities and equity interests are measured at fair value at the balance sheet date. The fair value for listed shares is the listed price and the estimated value of unlisted securities based on observable market data and recognized valuation methods.
Realized gains and losses are recognized in the income statement as financial items, whereas unrealized gains and losses are recognized in other comprehensive income. Transactions are recognized at trade date.
Impairment losses on available-for-sale financial assets are recognized by transferring the cumulative loss that was recognized in other comprehensive income.
If, in a subsequent period, the fair value of an impaired available-for-sale financial asset recovers, the adjustment is recognized in other comprehensive income.
Impairment of Non-Current Assets
If circumstances or changes in Genmab's operations indicate that the carrying amount of goodwill together with the other non-current assets in the cashgenerating unit to which goodwill is allocated may not be recoverable, management reviews the asset for impairment.
The basis for the review is the recoverable amount of the assets, determined as the greater of the fair value less cost to sell or its value in use. Value in use is calculated as the net present value of future cash inflow generated from the asset.
If the carrying amount of an asset is greater than the recoverable amount, the asset is written down to the recoverable amount. An impairment loss is recognized in the income statement when the impairment is identified.
Current Assets
Inventories
. . . . . . . . . .
Inventories are comprised of raw materials, work in progress, and finished goods related to antibody clinical trial material (antibodies). As a result of the planned disposal of the manufacturing facility, Genmab will no longer produce antibodies internally but will instead purchase these from external contract manufacturers in the future.
Inventories are measured at the lower of cost and net realizable value.
As of December 31, 2010, no antibodies produced for third parties are capitalized (work-in-progress and finished goods).
Raw materials are capitalized until they are released for the use in production of antibodies for our own clinical trials or for the production of antibodies to third parties.
Antibody Clinical Trial Material Produced for Third Parties
Antibody clinical trial material (antibodies) produced for third parties are measured using the FIFO method and at the lower of cost and the net realizable value.
Raw materials are measured at standard cost, comprising most recent purchase price plus delivery costs. Finished goods and work in progress are measured at cost, comprising the cost of raw materials, consumables, direct wages and salaries, and indirect production overheads. Indirect production overheads comprise indirect materials, wages and salaries, maintenance and depreciation of production machinery, buildings and equipment, and facility administration and management.
Antibody Clinical Trial Material Produced or Purchased for the Use in Clinical Trials Antibody clinical trial materials (antibodies) which are either internally produced or purchased from third parties are recognized in the balance sheet at cost and expensed in the income statement when consumed if all criteria for recognition as an asset are fulfilled, in particular that sufficient certainty can be determined that future income from the use of such material will exceed the aggregate cost of the antibodies. If sufficient certainty cannot be obtained, such material is expensed in the income statement under research and development costs at the time of acquisition.
On a regular basis, the carrying value of such assets is reviewed to ensure that no impairment has occurred and that the quantities do not exceed the planned consumption in the development activities.
Receivables
Receivables are designated as loans and receivables and measured in the balance sheet at amortized cost, which generally corresponds to nominal value less provision for bad debts.
The provision for bad debts is calculated on the basis of an individual assessment of each receivable including analysis of capacity to pay, creditworthiness, and historical information on payment patterns and doubtful debts.
Prepayments
. . . . . . . . . .
Prepayments recognized as current assets include expenditures related to a future financial year. Prepayments are measured at nominal value.
Marketable Securities
Marketable securities consist of investments in securities with a maturity greater than three months at the time of acquisition. Genmab invests its cash in deposits with major financial institutions, in mortgage bonds, corporate bonds, and notes issued by the Danish, European, or US governments. The securities can be purchased and sold using established markets.
Genmab's portfolio of investments has been designated as financial assets at fair value through profit or loss as the portfolio is managed and evaluated on a fair value basis in accordance with Genmab's investment guidelines and the information provided internally to the management.
Marketable securities are measured at fair value, which equals the listed price. Realized and unrealized gains and losses (including unrealized foreign exchange rate gains and losses) are recognized in the income statement as financial items. Transactions are recognized at trade date.
Cash and Cash Equivalents
Cash and cash equivalents comprise cash, bank deposits, and marketable securities with a maturity of three months or less on the date of acquisition.
Shareholders' Equity
The share capital comprises the nominal amount of the parent company's ordinary shares, each at a nominal value of DKK 1. All shares are fully paid.
The share premium reserve comprises of the amount received, attributable to shareholders' equity, in excess of the nominal amount of the shares issued at the parent company's offerings, reduced by external expenses directly attributable to the offerings. The share premium reserve can be distributed.
Translation reserves in the consolidated financial statements include exchange rate adjustments of equity investments and balances considered to be a part of the total net investment in foreign subsidiaries arising from the translation of their financial statements from their functional currencies to the presentation currency of Genmab A/S (DKK). Translation reserves cannot be used for distribution.
Non-Current Liabilities
Provisions
Provisions are recognized when the group has an existing legal or constructive obligation as a result of events occurring prior to or on the balance sheet date, and it is probable that the utilization of economic resources will be required to settle
the obligation. Provisions are measured at management's best estimate of the expenses required to settle the obligation.
A provision for onerous contracts is recognized when the expected benefits to be derived by the group from a contract are lower than the unavoidable cost of meeting its obligations under the contract. The provision is measured at the present value of the lower of the expected cost of terminating the contract and the expected net cost of continuing with the contract.
When the group has a legal obligation to restore our office lease in connection with the termination, a provision is recognised corresponding to the present value of expected future costs.
Deferred Tax
. . . . . . . . . .
Deferred tax is accounted for under the liability method which requires recognition of deferred tax on all temporary differences between the carrying amount of assets and liabilities and the tax base of such assets and liabilities. This includes the tax value of tax losses carried forward.
Deferred tax is calculated in accordance with the tax regulations and current tax rates in the individual countries. Changes in deferred tax as a result of changes in tax rates are recognized in the income statement.
Deferred tax assets resulting from temporary differences, including the tax value of losses to be carried forward, are recognized only to the extent that it is probable that future taxable profit will be available against which the differences can be utilized. Deferred tax assets which are not recognized in the balance sheet are disclosed in note 7 to the financial statements.
Current Liabilities
Leasing
Lease contracts, which in all material respects transfer the significant risks and rewards associated with the ownership of the asset to the lessee, are classified as finance leases. Assets treated as finance leases are recognized in the balance sheet at the inception of the lease term at the lower of the fair value of the asset or the net present value of the future minimum lease payments. A liability equaling the asset is recognized in the balance sheet. Each lease payment is separated between a finance charge, recorded as a financial expense, and a reduction of the outstanding liability.
Fair value is calculated based on the present value of the future principal and interest cash flows, discounted at the market rate of interest at the balance sheet date.
Assets under finance leases are depreciated in the same manner as owned assets and are subject to regular reviews for impairment.
Lease contracts, where the lessor retains the significant risks and rewards associated with the ownership of the asset, are classified as operating leases.
Lease payments under operating leases are recognized in the income statement ratable over the lease term. The total lease commitment under operating leases is disclosed in the notes to the financial statements.
Accounts Payable
. . . . . . . . . .
Accounts payable are measured in the balance sheet at amortized cost, which is considered to be equal to the fair value due to the short-term nature of the liabilities.
Deferred Income
Deferred income reflects the part of revenues that has not been recognized as income immediately on receipt of payment and which concerns agreements with multiple components which cannot be separated.
Deferred income is measured at nominal value.
Other Liabilities
Other liabilities are measured in the balance sheet at amortized cost.
Wages and salaries, social security contributions, paid leave and bonuses, and other employee benefits are recognized in the financial year in which the employee performs the associated work.
Termination benefits are recognized as an expense, when the Genmab group is committed demonstrably without realistic possibility of withdrawal, to a formal detailed plan to terminate employment.
The group's pension plans are classified as defined contribution plans, and, accordingly, no pension obligations are recognized in the balance sheet. Costs relating to defined contribution plans are included in the income statement in the period in which they are accrued and outstanding contributions are included in other liabilities.
Assets Held for Sale
Assets or disposal groups comprising assets and liabilities, which upon initial recognition, are expected to be recovered primarily through sale within 12 months rather than through continuing use, are classified as held for sale.
Events or circumstances may extend the period to complete the sale beyond 12 months. An extension of the period required to complete a sale does not preclude an asset or disposal groups from being classified as held for sale if the delay is caused by events or circumstances beyond Genmab's control and there is sufficient evidence that the entity remains committed to its plan to sell the asset.
Immediately before classification as held for sale, the assets or components of a disposal group are re-measured in accordance with the group's accounting policies. Thereafter, generally the assets, or disposal group, are measured at the lower of their carrying amount and fair value less cost to sell.
Assets classified as held for sale are not amortized or depreciated.
Any impairment loss on a disposal group is initially allocated to goodwill and then to remaining assets and liabilities on pro rata basis, except that no loss is allocated to inventories, financial assets, or deferred tax assets that continue to be measured in accordance with the group's accounting policies. Impairment losses on initial classification as held for sale and subsequent gains or losses on remeasurement are recognized in the income statement and are disclosed in the notes. Gains are not recognized in excess of any cumulative impairment loss.
Assets classified as held for sale and related liabilities are presented separately in the balance sheet as current assets and liabilities. Comparative figures are not represented.
Discontinued Operation
. . . . . . . . . .
A discontinued operation is a component of the group's business that represents a separate major line of business that has been disposed of or is held for sale. Classification as a discontinued operation occurs upon disposal or when the operation meets the criteria to be classified as held for sale, if earlier.
When an operation is classified as a discontinued operation, the results of the discontinued operations are presented separately from continuing operations in the income statement. The comparative income statement information is reclassified for discontinued operations in a separate line item as if the operation had been discontinued from the start of the comparative period.
Additional information regarding discontinued operations is disclosed in the notes and includes among other items a split into revenue, expenses and pre-tax profit or loss of discontinued operations, the impairment and the gain or loss recognized on the measurement to fair value less cost to sell or on the disposal. In addition, related cash flow information is disclosed.
Cash Flow Statement
The cash flow statement is presented using the indirect method with basis in the loss before tax.
Cash flow from operating activities is stated as the net loss adjusted for net financial items, non-cash operating items such as depreciation, amortization, impairment losses, warrant compensation expenses, provisions, and for changes in working capital, interest paid and received, and corporate taxes paid. Working capital comprises current assets less current liabilities excluding the items included in cash and cash equivalents.
Cash flow from investing activities is comprised of cash flow from the purchase and sale of intangible assets, tangible assets and financial assets as well as acquisition of entities, and purchase and sale of marketable securities. The parent company's transactions with subsidiaries are included in receivables from subsidiaries.
Cash flow from financing activities is comprised of cash flow from the issuance of shares and payment of long-term loans including installments on lease liabilities.
Finance lease transactions are considered as non-cash transactions.
The cash flow statement cannot be derived solely from the financial statements.
Segment Reporting
. . . . . . . . . .
The Genmab group is managed and operated as one business unit which is reflected in the organizational structure and internal reporting.
The entire group is managed by a management team reporting to the Chief Executive Officer. The management team discusses operating activities, financial results, forecasts, or plans for the Genmab group. Therefore, no separate lines of business or separate business entities have been identified with respect to any of the product candidates or geographical markets. No segment information is currently disclosed in the internal reporting.
Accordingly, it has been concluded that it is not relevant to include segment disclosures in the annual report as the group business activities are not organized on the basis of differences in related product and geographical areas.
Geographical information is presented for the Genmab group's revenues and noncurrent assets are specified. Revenues are attributed to countries on the basis of the location of operations. Non-current assets comprise intangible and tangible assets.
Definition of Financial Ratios
The group discloses a number of financial ratios in the annual report. These financial ratios are defined as:
Basic Net Loss per Share
Basic net loss per share is calculated as the net loss for the year divided by the weighted average number of outstanding ordinary shares. Weighted average number of ordinary shares outstanding during the period amounted to 44,907,142 shares in 2010 and 44,903,736 shares in 2009.
Diluted Net Loss per Share
Diluted net loss per share is calculated as the net loss for the year divided by the weighted average number of outstanding ordinary shares adjusted for the dilutive effect of share equivalents. As the income statement shows a net loss, no adjustment has been made for the dilutive effect.
Year-End Share Market Price
The year-end share market price is determined as the closing price of the parent company's shares on the NASDAQ OMX Copenhagen at the balance sheet date or the last trading day prior to the balance sheet date.
Price/Book Value
Price/book value is calculated as the parent company's year-end share market price divided by the shareholders' equity per share at the balance sheet date.
Shareholders' Equity per Share
Shareholders' equity per share is calculated as shareholders' equity at the balance sheet date divided by the number of outstanding shares at the balance sheet date.
Equity Ratio
. . . . . . . . . .
Equity ratio is calculated as shareholders' equity at the balance sheet date divided by the total assets at the balance sheet date.
New International Financial Reporting Standards
The International Accounting Standards Board (IASB) has issued, and the EU has endorsed, a number of new standards and made updates to some of the existing standards, the majority of which are effective as of January 1, 2011, or later. The financial reporting of Genmab is expected to be affected by such new or improved standards to the extent described below. Only standards and interpretations issued before December 31, 2010 and with relevance for the Genmab group are described.
IAS 24 Related Party Disclosures (amendment):
The IASB has issued an amendment to IAS 24 "Related Party Disclosures" which clarifies the definition of a related party to simplify the identification of such relationship and to eliminate inconsistencies in its application. The amended standard is effective from January 1, 2011. The amendment will not have any material impact on the financial position and performance of the group.
IFRS 9 Financial Instruments: Classification and measurement:
IFRS 9 is the first phase of the IASB's work with the replacement of IAS 39. The new standard will change the classification and measurement guidelines for financial assets. The new standard operates with two categories (financial assets at fair value through profit or loss or comprehensive income and financial assets measured at amortized cost) instead of the current four categories outlined in IAS 39.
The standard is effective from January 1, 2013. The standard is not expected to have any material impact on the financial position and performance of the group. The group will quantify any effect in conjunction with the other phases, when issued, to present a comprehensive picture. As of December 31, 2010, the standard had not yet been endorsed by the EU.
Improvements of IFRSs
In May 2010, the IASB issued amendments to its standards which among others include amendments of IFRS 1, 3, 7, IAS 1, 27 and 34 primarily in order to remove inconsistencies and clarify wording. The group will apply these standards from January 1, 2011 in accordance with each standard's transitional provision. The amendments are not expected to have any material impact on the financial position and performance of the group. As of December 31, 2010, the standards had not yet been endorsed by the EU.
Directors' and Management's Statement on the Annual Report
The Executive Management and Board of Directors have today considered and adopted the Annual Report of Genmab A/S for 2010.
The Consolidated Financial Statements and the Parent Financial Statements are prepared in accordance with International Financial Reporting Standards as adopted by the EU. Further, the Annual Report is prepared in accordance with additional Danish disclosure requirements for listed companies.
In our opinion, the accounting policies used are appropriate and the Consolidated Financial Statements and the Parent Financial Statements give a true and fair view of the financial position at 31 December 2010 of the Group and the Parent Company and of the results of the Group and Parent Company operations and cash flows for the financial year 2010.
In our opinion, Management's Review includes a true and fair account of the development in the operations and financial circumstances of the Group and the Parent Company, of the results for the year and of the financial position of the Group and the Parent Company as well as a description of the most significant risks and elements of uncertainty facing the Group and the Parent Company.
We recommend that the Annual Report be adopted at the Annual General Meeting.
Copenhagen, February 28, 2011
Management
| Jan van de Winkel (President & CEO) |
David A. Eatwell (Executive Vice President & CFO) |
|
|---|---|---|
| Board of Directors | ||
| Michael B. Widmer (Chairman) |
Anders Gersel Pedersen (Deputy Chairman) |
Karsten Havkrog Pedersen |
| Burton G. Malkiel | Hans Henrik Munch-Jensen | Tom Vink (Employee representative) |
| Daniel J. Bruno (Employee representative) |
Nedjad Losic (Employee representative) |
Conversion of Certain DKK Amounts into USD – Supplementary Information - Unaudited
Solely for the convenience of the reader, the annual report contains a conversion of certain DKK amounts into US Dollars (USD) at a specified rate. The conversions are outlined below and are related to the consolidated financial statements (condensed).
These converted amounts are unaudited and should not be construed as representations that the DKK amounts actually represent such USD amounts or could be converted into USD at the rate indicated or at any other rate. The conversion is regarded as supplementary information to the annual report.
Unless otherwise indicated, conversion herein of financial information into USD has been made using the Danish Central Bank closing spot rate on December 31, 2010, which was USD 1.00 = DKK 5.6133.
Key figures in USD
| 2010 | 2009 | 2008 | 2007 | 2006 | |
|---|---|---|---|---|---|
| USD'000 | USD'000 | USD'000 | USD'000 | USD'000 | |
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |
| Income Statement | |||||
| Revenues | 103,696 | 104,408 | 123,332 | 94,336 | 24,147 |
| Research and development costs | (103,774) | (166,633) | (226,391) | (151,284) | (91,402) |
| General and administrative expenses | (28,549) | (26,499) | (25,569) | (20,927) | (16,870) |
| Operating loss | (28,627) | (88,724) | (128,628) | (77,875) | (84,125) |
| Net financial items | 6,813 | 27,799 | (16,895) | 9,578 | 6,053 |
| Net loss for continuing operations | (25,533) | (61,978) | (145,627) | (68,297) | (78,072) |
| Balance Sheet | |||||
| Cash and marketable securities | 275,457 | 228,271 | 313,899 | 657,981 | 307,187 |
| Non-current assets | 11,087 | 13,040 | 230,200 | 7,263 | 6,007 |
| Assets | 442,095 | 395,762 | 580,577 | 705,251 | 321,492 |
| Shareholders' equity | 192,412 | 231,093 | 389,889 | 513,651 | 286,388 |
| Share capital | 8,000 | 8,000 | 7,997 | 7,931 | 7,063 |
| Investments in intangible and tangible assets | 1,801 | 2,989 | 166,271 | 4,175 | 953 |
| Cash Flow Statement | |||||
| Cash flow from operating activities | 47,775 | (101,555) | (91,449) | 90,125 | (67,629) |
| Cash flow from investing activities | (131,562) | 173,646 | 81,967 | (420,953) | (80,411) |
| Cash flow from financing activities | (1,248) | (1,184) | 4,504 | 277,952 | 156,598 |
| Cash, cash equivalents and bank overdraft | (372) | 82,742 | 12,473 | 23,472 | 76,439 |
| Cash increase/(Cash burn) | 47,185 | (85,626) | (344,081) | 350,794 | 83,985 |
| Financial Ratios | |||||
| Basic and diluted net loss per share | (1.28) | (4.01) | (3.85) | (1.55) | (2.01) |
| Basic and diluted net loss per share continuing | |||||
| operations | (0.57) | (1.38) | (3.26) | - | - |
| Year-end share market price | 11.67 | 14.61 | 36.16 | 55.05 | 67.70 |
| Price / book value | 2.72 | 2.84 | 4.16 | 4.77 | 9.37 |
| Shareholders' equity per share | 4.28 | 5.15 | 8.69 | 11.54 | 7.22 |
| Equity ratio | 44% | 58% | 67% | 73% | 89% |
| Average number of employees | 229 | 505 | 565 | 291 | 237 |
| Number of employees at year-end | 189 | 309 | 555 | 344 | 248 |
Conversion of Certain DKK Amounts into USD – Supplementary Information – Unaudited (continued)
Genmab Group
Income Statement in USD
. . . . . . . . . .
| 2010 USD'000 (Unaudited) |
2009 USD'000 (Unaudited) |
|
|---|---|---|
| Revenues | 103,696 | 104,408 |
| Research and development costs General and administrative expenses Operating expenses |
(103,774) (28,549) (132,323) |
(166,633) (26,499) (193,132) |
| Operating result | (28,627) | (88,724) |
| Financial income Financial expenses |
7,063 (250) |
32,262 (4,463) |
| Result for continuing operations before tax | (21,814) | (60,925) |
| Corporate tax | (3,719) | (1,053) |
| Net result for continuing operations | (25,533) | (61,978) |
| Loss from discontinued operation | (31,735) | (118,088) |
| Net result | (57,268) | (180,066) |
| Basic and diluted net loss per share | (1.28) | (4.01) |
| Basic and diluted net loss per share continuing operations | (0.57) | (1.38) |
Statement of Comprehensive Income
| Net result | (57,268) | (180,066) |
|---|---|---|
| Other comprehensive income: | ||
| Adjustment of foreign currency fluctuations on subsidiaries | 6,745 | (6,012) |
| Total comprehensive income | (50,523) | (186,078) |
Conversion of Certain DKK Amounts into USD – Supplementary Information – Unaudited (continued)
Condensed Balance Sheet in USD
| Genmab Group | |||
|---|---|---|---|
| December 31, | December 31, | ||
| 2010 | 2009 | ||
| USD'000 | USD'000 | ||
| (Unaudited) | (Unaudited) | ||
| Total intangible assets | - | - | |
| Total tangible assets | 7,381 | 10,721 | |
| Total financial assets | 3,706 | 2,319 | |
| Total non-current assets | 11,087 | 13,040 | |
| Inventories | - | - | |
| Receivables | 11,656 | 18,483 | |
| Prepayments | 1,951 | 1,739 | |
| Marketable securities | 275,830 | 145,531 | |
| Cash and cash equivalents | 17,984 | 82,080 | |
| 307,421 | 247,833 | ||
| Asset classified as held for sale | 123,587 | 134,889 | |
| Total current assets | 431,008 | 382,722 | |
| Total assets | 442,095 | 395,762 | |
| Shareholders' equity | 192,412 | 231,093 | |
| Total non-current liabilities | 13,704 | 4,628 | |
| Current liabilities | 233,759 | 149,546 | |
| Liabilities classified as held for sale | 2,220 | 10,495 | |
| Total current liabilities | 235,979 | 160,041 | |
| Total liabilities | 249,683 | 164,669 | |
| Total shareholders' equity and liabilities | 442,095 | 395,762 | |
Conversion of Certain DKK Amounts into USD – Supplementary Information – Unaudited (continued)
Condensed Cash Flow Statement in USD
| Genmab Group | ||
|---|---|---|
| 2010 | 2009 | |
| USD'000 | USD'000 | |
| (Unaudited) | (Unaudited) | |
| Result for continuing operations before tax | (21,814) | (60,925) |
| Result for discontinued operation before tax | (31,730) | (118,083) |
| Result before tax | (53,544) | (179,008) |
| Reversal of financial items, net | (6,814) | (27,839) |
| Adjustments for non-cash transactions | 42,840 | 112,190 |
| Changes in current assets and liabilities: | 67,412 | (14,481) |
| Cash flow from operating activities before financial items | 49,894 | (109,138) |
| Financial receivables | 3,288 | 9,200 |
| Corporate taxes paid | (5,407) | (1,617) |
| Cash flow from operating activities | 47,775 | (101,555) |
| Purchase of intangible and tangible assets, net | (1,517) | (2,923) |
| Marketable securities bought | (282,372) | (86,004) |
| Marketable securities sold | 152,327 | 262,573 |
| Cash flow from investing activities | (131,562) | 173,646 |
| Warrants exercised | - | 293 |
| Costs related to issuance of shares | - | (4) |
| Paid installments on lease liabilities | (1,248) | (1,473) |
| Cash flow from financing actitivies | (1,248) | (1,184) |
| Decrease in cash and cash equivalents | (85,035) | 70,907 |
| Cash and cash equivalents at the beginning of the period | 82,740 | 12,473 |
| Exchange rate adjustments | 1,923 | (638) |
| Cash and cash equivalents at the end of the period | (372) | 82,742 |