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Genmab Interim / Quarterly Report 2011

Aug 3, 2011

3365_iss_2011-08-03_ff7fefa8-fe98-495a-a8b2-5a19a5f3e48a.pdf

Interim / Quarterly Report

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- Continued strong focus on cost control with improvement in first half operating loss and cash burn over 2010

  • Improving 2011 guidance as result of DKK 25 million reduction in operating expenses
  • Announced HuMax-CD74™ antibody-drug conjugate program with Seattle Genetics

- Decisive move to minimize future spending by winding down the zalutumumab program

Copenhagen, Denmark; August 3, 2011 – Genmab A/S (OMX: GEN) announced today results for the six month period ended June 30, 2011 and slightly improved 2011 guidance.

"This quarter we reaffirm Genmab's commitment to disciplined spending by reducing operating expenses from previous guidance," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

For the first half of 2011 Genmab reported the following results:

  • Revenues were DKK 167 million (USD 32 million) for the first half of 2011. In the first half of 2010, Genmab recognized revenues of DKK 276 million (USD 54 million). The revenues consist primarily of royalties, deferred revenue and reimbursement of certain research and development costs related to our collaboration agreements. The decrease was mainly due to the inclusion of a milestone from GSK in 2010.

  • An operating loss of DKK 127 million (USD 25 million). This compares to an operating loss of DKK 240 million (USD 46 million) for the corresponding period of 2010. This was an improvement of DKK 113 million or 47% and was mainly related to a reduction in operating expenses due to the amended GSK agreement, a continued strong focus on cost control and the inclusion of a one time expense related to our former CEO in 2010.

  • A net loss for continuing operations of DKK 173 million (USD 33 million) compared to a net loss of DKK 191 million (USD 37 million) for the corresponding period of 2010. The net loss per share for continuing operations was DKK 3.84 for the first half of 2011 compared to DKK 4.25 for the first half of 2010.

  • A net loss of DKK 192 million (USD 37 million) compared to DKK 219 million (USD 43 million) in the first half of 2010. This 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 loss for discontinued operations amounted to DKK 19 million (USD 4 million) in the first half of 2011 compared to DKK 28 million (USD 6 million) in the same period of 2010.

  • Genmab ended the six month period with a cash position of DKK 1,308 million (USD 253 million) compared to DKK 1,546 million (USD 300 million) as of December 31, 2010. This represents a cash burn of DKK 238 million (USD 47 million) in the first half of 2011 compared to DKK 350 million (USD 68 million) in the corresponding period in 2010. The cash burn was primarily related to the ongoing investment in our research and development activities.

Second Quarter 2011 Highlights

  • Genmab and Seattle Genetics expanded the companies' antibody-drug conjugate (ADC) research collaboration to include HuMax-CD74. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a co-development and co-commercialization option for any resulting ADC products at the end of Phase I clinical development.

  • We announced the decision to wind down the zalutumumab program (an antibody targeting the Epidermal Growth Factor receptor).

  • During the quarter Toon Wilderbeek was elected to the Board of Directors and we appointed Rachel Curtis Gravesen as Senior Vice President, Investor Relations and Communication.

Subsequent to the balance sheet date

  • In July, we announced a royalty payment of DKK 17.7 million following net sales for Arzerra for the second quarter of 2011 of GBP 10.5 million (approximately DKK 88.6 million).

Outlook

We are slightly improving our 2011 financial guidance as a result of a reduction in operating expenses of DKK 25 million.

We expect our 2011 revenue to remain the same as the previous guidance at DKK 325 – 350 million compared to DKK 582 million reported for 2010. The reduction in revenue from 2010 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 now be DKK 650 – 700 million, a reduction of DKK 25 million from the previous guidance of DKK 675 – 725 million. The reduction is due to a continued focus on strong cost controls and lower development costs primarily due to beneficial foreign exchange rates impacting costs under the GSK collaboration. The operating expenses were DKK 743 million in 2010. The 2011 operating expenses include approximately DKK 80 - 90 million related to the zalutumumab program, and although we have announced the wind down of the current clinical studies, savings will mostly be realized in 2012.

We expect the operating loss from continuing operations for 2011 to be approximately DKK 325 - 375 million, again an improvement of DKK 25 million compared to the previous guidance of DKK 350 – 400 million. An operating loss of DKK 161 million was reported for 2010.

The discontinued operation guidance of DKK 40 - 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. If converted at the quarter end spot rate of 5.1607 then the sales value would be DKK 619 million.

As of December 31, 2010, we had a cash position of DKK 1,546 million and are projecting a cash burn in 2011, excluding proceeds from the facility sale, of DKK 550 – 600 million, compared to the previous guidance of DKK 575 – 625 million, due to the reduction in operating expenses. Taking into account the planned sale of the manufacturing facility at DKK 660 million, we are projecting a cash position at the end of the year of DKK 1,600 – 1,650 million.

MDKK
New
2011 Guidance
Previous
2011 Guidance
Revenue 325 – 350 325 – 350
Operating expenses (650) - (700) (675) - (725)
Operating loss continuing
operations
(325) - (375) (350) - (400)
Discontinued operation (40) - (50) (50)
Cash position beginning of year* 1,546 1,546
Cash used in operations (550) – (600) (575) – (625)
GSK upfront payment
Facility sale 660 660
Cash position at end of year* 1,600 - 1,650 1,575 - 1,625

* Cash, cash equivalents, bank overdrafts and marketable securities

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.

Conversion of Certain DKK Amounts to USD

For the convenience of the reader certain DKK amounts have been converted to USD. Unless otherwise indicated, conversion herein of financial information from DKK to USD has been made using the Danish Central Bank closing spot rate on June 30, 2011 of USD 1.00 = DKK 5.1607.

Conference Call

Genmab will hold a conference call to discuss the 2011 second quarter results tomorrow, Thursday, August 4, at

3.00 pm CEST 2.00 pm BST 9.00 am EDT

The conference call will be held in English.

The dial in numbers are as follows:

+1 877 317 6789 (in the US) and ask for the Genmab conference call +1 412 317 6789 (outside the US) and ask for the Genmab conference call

A live webcast of the call and relevant slides will be available at www.genmab.com. The webcast will also be archived on Genmab's website.

Selected Consolidated Key Figures

June 30, 2011
DKK'000
6 months ended 6 months ended 6 months ended 6 months ended
June 30, 2010
DKK'000
June 30, 2011
USD'000
June 30, 2010
USD'000
Income Statement
Revenues 167,000 276,321 32,360 53,543
Research and development costs (259,022) (413,264) (50,191) (80,079)
General and administrative expenses (35,144) (103,367) (6,810) (20,030)
Operating result (127,166) (240,310) (24,641) (46,566)
Net result for continuing operations (172,662) (190,652) (33,457) (36,943)
Balance Sheet
Cash position* 1,308,228 930,983 253,498 180,399
Non-current assets 55,199 74,875 10,696 14,509
Assets 2,052,818 1,954,929 397,779 378,812
Shareholders' equity 880,508 1,204,248 170,618 233,350
Share capital 44,907 44,907 8,702 8,702
Cash Flow Statement
Cash flow from operating activities (215,427) (363,919) (41,743) (70,518)
Cash flow from investing activities 323,572 340,092 62,699 65,900
Cash flow from financing activities (3,034) (3,596) (588) (697)
Cash position increase/(decrease) (237,993) (350,373) (46,116) (67,893)
Financial Ratios
Basic and diluted net result per share (4.27) (4.88) (0.83) (0.95)
Basic and diluted net result per share continuing operations (3.84) (4.25) (0.75) (0.82)
Period-end share market price 40.00 43.45 7.75 8.42
Price/book value 2.04 1.62 2.04 1.62
Shareholders' equity per share 19.61 26.82 3.80 5.20
Equity ratio 43% 62% 43% 62%
Average number of employees 182 256 182 256
Number of employees at the end of the period 187 217 187 217

* Cash, cash equivalents, bank overdrafts and marketable securities

About Genmab A/S

Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, Arzerra® (ofatumumab), was approved to treat fludarabine and alemtuzumab refractory chronic lymphocytic leukemia after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.

Contact:

Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communication T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]

This Company Announcement 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. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's Annual Report, which is available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.

Genmab® ; the Y-shaped Genmab logo® ; HuMax® ; HuMax-CD20® ; HuMax-EGFr™; HuMax-IL8™; HuMax-TAC™; HuMax-CD38™; HuMax-TF™; HuMax-Her2™; HuMax-cMet™, HuMax-CD74™, DuoBody™ and UniBody® are all trademarks of Genmab A/S. Arzerra® is a trademark of GlaxoSmithKline.