2 Exiqon continues to push the frontiers in the mirna field through our LNA technology Henrik M. Pfundheller, Ph.D., VP Sales & Marketing
3 Exiqon at a glance Exiqon is a biotechnology company whose core business is to develop, manufacture and market research and diagnostic products. Exiqon pursues a two-tiered strategy based on our truly unique and proprietary LNA technology. Our research products target the market for nucleic acid analysis and are used to perform molecular analysis of gene expression. Our molecular diagnostic products target the market of treatment selection within cancer. Our goal is to be the leading company in the market segments in which we operate. Exiqon s research customers are molecular biologists in the biotech and pharma industry and within academic institutions. They are involved in basic biological research, research into diseases such as cancer, metabolic diseases, neurological disorders and stem-cell research. With the acquisition of Oncotech Inc., Exiqon has expanded its business and customer base to include more than 7,000 cancer treating physicians and 1,200 hospitals in the U.S. Exiqon s LNA technology facilitates very precise and sensitive measurements of gene expression. Our strategy is to use the LNA technology and the proprietary mirna biomarkers we identify by using our LNA based research products to build a strong portfolio of molecular diagnostic products. Oncotech s current product portfolio and customer base will serve as the basis for this. Exiqon was successfully listed on the OMX Nordic Exchange Copenhagen in May 2007 and is well ahead of the strategic goals set out in connection with the initial share offering. Reasons to invest in Exiqon: Strong growth in sales of research products for gene expression analysis based on proprietary LNA technology Market leader for cell based diagnostic tests for cancer treatment selection with strong growth potential Solid platform for the rapid development of new molecular diagnostic products based on proprietary mirna s Financed through to expected break even by 2011 High-growth markets with high profit margin potential Experienced management team. 1 EXIQON ANNUAL REPORT 2007 EXIQON AT A GLANCE Contents 2 Key figures and ratios Highlights 3 Outlook Letter to shareholders 7 Business review 10 The Oncotech acquisition 12 Financial review 14 Business and Strategy 16 Molecular research 18 mrna and mirna 20 Molecular diagnostics 23 Patent strategy 24 Major license agreements and partnerships 25 Organisation 26 Risk factors 28 Corporate governance 30 Shareholder information 32 Executive Management and Board of Directors 33 Statement 34 Independent auditor s report 35 Income statement 36 Balance sheet 38 Cash flow statement 39 Statement of changes in equity 40 Notes to the financial statements
4 5 year key figures and ratios 2 (DKK 000 except key figures) * EXIQON ANNUAL REPORT YEAR KEY FIGURES AND RATIOS Income statement Revenue 49,478 43,096 16,001 10,306 10,372 Production costs -25,174-11,936-5,427-4,744-2,707 Research and development costs -29,035-27,624-14,194-16,969-19,474 Sales and marketing costs -39,080-19,425-9,620-4,168-1,614 Administrative expenses -31,316-9,616-6,778-5,995-5,408 Operating profit/(loss) (EBIT) -75,127-25,505-20,018-21,570-18,831 Net financials 7, ,249-7,179-1,973 Profit/(loss) before tax -67,786-24,918-23,267-28,749-20,405 Profit/(loss) for the year -67,786-24,918-23,267-28,749-20,405 Balance sheet Assets: Intangible assets 11,061 8, ,232 Property, plant and equipment 21,449 10,607 7,441 4,581 6,355 Financial assets 3,631 1, Total non-current assets 36,141 19,719 8,915 5,988 11,251 Inventories 7,044 4,637 2,351 1,303 1,489 Receivables 17,266 22,233 2, ,814 Cash and cash equivalents 331,504 20,396 40,199 1,682 19,983 Current assets 355,814 47,266 44,861 3,945 23,286 Total assets 391,955 66,985 53,776 9,933 34,537 Equity and liabilities Equity 343,366 33,973 27,986-43,888-11,405 Non-current liabilities 7,818 5,275 2,771 1, Current liabilities 40,771 27,737 23,019 52,321 45,792 Total liabilities 48,589 33,012 25,790 53,821 45,942 Total equity and liabilities 391,955 66,985 53,776 9,933 34,537 Cash flow and investments Depreciation and write-downs 5,070 3,230 2,744 3,378 2,447 Cash flows from operating activities -38,171-35,590-4,978-16,279-20,222 Acquisition of intangible assets and property, plant and equipment -13,647-9,306-2,575-2, Cash flows from investing activities -16,222-9,883-2,387-2,023-2,242 Cash flows from financing activities 365,790 25,670 45,883-20,028 Cash and cash equivalents at 31 December 331,504 20,396 40,199 1,681 19,984 Key figures: Number of shares at 31 December 24,441,064 7,033,065 5,958,294 1,640,324 1,640,324 Number of shares, average 20,245,695 6,940,420 4,861,290 1,640,324 1,640,324 Basic and diluted EPS Assets / Equity Average number of employees Market price per share (DKK) 37.5 Market capitalization (DKK million) Price / net asset value 2.67 * The comparative figures for 2003 are not restated to the changed accounting policies on transition to IFRS reporting but are calculated in accordance with the former accounting policies based on provisions of the Danish Financial Statements Act. Note: The ratios are stated in accordance with Recommendations and Financial Ratios 2005 issued by the Danish Society of Financial Analysts.
5 2007 Highlights The key event for Exiqon in 2007 was the successful listing of the company s shares on OMX Nordic Exchange in Copenhagen on 29 May Through the initial public offering, Exiqon raised net proceeds of DKK 365 million. Other major milestones included: Continued strong development in the research products business: o Revenue increased by 15% from 2006 to DKK 49.5 million. o Growth in product sales to DKK 38.5 million, an 84% increase from o Decrease in margin on product sales, including services, to 35% (19% decrease compared to 2006 due to one time events). o Launch of new mircury LNA Array product line. o Launch of a new product line for quantitative measurement of mirna by real-time qpcr. o Research and development agreement with the U.S. National Cancer Institute (NCI) to develop microrna-based diagnostics for colon cancer. o Execution of a license to Applied Biosystems, an Applera Corporation unit, to use Exiqon s proprietary LNA technology in sirna. o Exclusive license agreement to a microrna quantitative real-time PCR technology from Rosetta Inpharmatics LLC, a Merck & Co. subsidiary, providing Exiqon with a validated product portfolio for quantitative analysis of mirna. o License to parts of Roche s and Applied Biosystems PCR patent portfolio providing Exiqon with the opportunity to market products for quantitative analysis of mirna using real-time qpcr technology. Announcement of Exiqon s intention to acquire privately held Oncotech Inc., a diagnostic company based in Tustin, California, U.S. Total operating expenses of DKK million, and a net loss of DKK 67.8 million. 3 EXIQON ANNUAL REPORT HIGHLIGHTS AND OUTLOOK 2008 Outlook 2008 Following the acquisition of Oncotech, Exiqon will focus on the development of new diagnostic products for cancer treatment selection: 2008 will be a year of significant initial investments resulting in the first diagnostic product launch. Exiqon expects revenue of DKK million in 2008 including both research product sales and 10 months of diagnostic sales from Oncotech s activities corresponding to full year revenues including Oncotech of DKK million. The loss for the year 2008 is expected to be DKK including the effect of costs of current incentive plans, including warrants, in the amount of DKK 6 million. Exiqon maintains its long term financial goal of reaching profitability by 2011 with its current cash position and break even of the research products business by 2009.
6 Letter to shareholders 4 EXIQON ANNUAL REPORT 2007 LETTER TO SHAREHOLDER Dear Shareholder, 2007 was a landmark year for Exiqon. It was a year where we achieved many important milestones in building a world leading company within mirna research and molecular diagnostics. One of the most significant events for the company was the successful listing of Exiqon s shares on the OMX Nordic Exchange in Copenhagen in May The offering was over subscribed more than seven times and we raised DKK 400 million in proceeds. The net proceeds of approximately DKK 365 million has provided us with a sound financial foundation for the continued development of Exiqon in accordance with our strategy. The offering also brought us about 2,450 new shareholders. Around 40 percent of the shares were acquired by investors outside Denmark a distribution of shares that reflected the international nature of our business and our markets. I would like to take this opportunity to again welcome our new shareholders and thank you for your support. I am committed to ensure a continued open and fruitful dialogue with our shareholders to our mutual benefit. Another key event in 2007 was the negotiations and subsequent announcement of our plans to buy the California-based specialised cancer laboratory and diagnostics company Oncotech Inc. The acquisition of Oncotech Inc. provides Exiqon with a solid foundation for its continued development of a leading diagnostics business based on mirna s. Oncotech already has a market leading position in the diagnostic market for cell-based cancer treatment selection for which we plan to develop a portfolio of diagnostic products based on mirna s. The many skilled employees of Oncotech possess a vital expertise and experience that it would have taken Exiqon years to build and attain. We therefore feel ensured that by the acquisition of Oncotech we now have a foundation for our molecular diagnostic business that will enable a faster and less uncertain development of our diagnostics business. In 2007, we also signed a research and development agreement with the U.S. National Cancer Institute (NCI) regarding diagnostics for colon cancer. We see the agreement with NCI as a validation of our proprietary LNA technology and as an acknowledgement of our aspirations within cancer diagnostics. We saw continued strong progress in our molecular research product business. In September, we launched our new mircury LNA Array product line and in December we launched a new product line for quantitative real-time PCR detection of mirna. As part of our strategy to capitalize on our unique LNA technology within markets that Exiqon does not pursue itself, we granted a license to Applied Biosystems to In 2007, we also signed a research and development agreement with the U.S. National Cancer Institute (NCI) regarding diagnostics for colon cancer. We see the agreement with NCI as a validation of our proprietary LNA technology and as an acknowledgement of our aspirations within cancer diagnostics.
7 5 use the LNA technology in sirna. Granting such a license to a major tool provider was originally a goal set for The key to all these significant achievements in 2007 is Exiqon s committed and talented staff. Also in terms of employees the company expanded strongly in 2007; from 62 in 2006 to 101 employees by the end of With the acquisition of Oncotech the Exiqon group will count in excess of 200 employees at the beginning of 2008 all of whom are dedicated to pushing the frontiers of molecular biology to help optimise the treatment selection for the benefit of cancer patients. I would like to thank all employees for their contributions to the success of our company will be another defining year for Exiqon. We expect to see a continued growth in our research product revenues and the first new molecular-based diagnostic product launches designed to support a strong development of our diagnostic revenues generated through Oncotech Inc. Yours sincerely, Lars Kongsbak, Chief Executive Officer EXIQON ANNUAL REPORT 2007 LETTER TO SHAREHOLDER
8 6 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Strong synergies The acquisition of Oncotech Inc. provides Exiqon with a solid foundation for its continued development of a leading diagnostics business based on mirna s. Oncotech already has a market leading position in the diagnostic market for cell-based cancer treatment selection for which we plan to develop a portfolio of diagnostic products based on mirna s. EXIQON Proprietary LNA detection technology & assays ONCOTECH Customer base & market knowledge Proprietary biomarkers (mirna) Product development CLIA laboratory & sample logistics Processes for reimbursement Ready access to biological material Proprietary LNA detection technology & assays Proprietary biomarkers (mirna) Product development Customer base & market knowledge CLIA laboratory & sample logistics Processes for reimbursement Ready access to biological material STRONG SYNERGIES
9 Business review During 2007, Exiqon strengthened its research product offerings by launching a new Array product line and a new product line for quantitative real-time PCR detection of mirna thereby taking significant steps towards realizing its strategy of becoming a total solution provider of research products for mirna analysis. Total sales of research products rose 84% compared to 2006 to DKK 38.5 million. In July, Exiqon entered a distribution agreement with Luminex under which Exiqon obtained non-exclusive rights to distribute current and new FlexmiR products and to sell Luminex systems to laboratories around the world. In addition to signing this new agreement, the companies launched two more FlexmiR products, the FlexmiR MicroRNA Mouse/ Rat Extension Panel and the FlexmiR MicroRNA Control Set. Both new products will help scientists and researchers save time and resources. In September, Exiqon launched its new mircury LNA Array product line. The product launch was followed up by a marketing campaign to secure a continued strong position on the U.S. market in particular, including fully sponsored inlets in both Nature and Science. In October, Exiqon signed a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) to develop microrna based diagnostics for colon cancer. The agreement calls for the partners to identify mirna expression signatures associated with the onset and progression of colon cancer, and to develop diagnostic tools for identifying patients so that they can receive the appropriate clinical course of treatment. 7 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT
10 8 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Strong synergies The market potential may increase with as much as a factor 5 in the U.S. alone compared to the market of Oncotech s current cellular based EDR products. STRONG SYNERGIES ONCOTECH EXIQON DISTRIBUTORS
11 In October, Exiqon was selected to receive funding by the EU for two research projects within mirna over the coming 4-5 years at a combined value of approximately DKK 7 million; one project - OncomiR focuses on basic research and the other project ProspeR focuses on diagnostic methods in the field of prostate cancer. In November, Exiqon granted a license to Applied Biosystems, an Applera Corporation business, to use Exiqon s proprietary LNA technology in sirna. The signing in November 2007 of a binding Letter of Intent to acquire Oncotech, a California based leading supplier of extreme drug resistance diagnostic tests in cancer for up to USD 45 million represented another key achievement in The Letter of Intent was a major leap forward in realizing our strategy of becoming a world leader in molecular diagnostic products based on mirna. During 2007 Exiqon also signed distribution contracts with partners in leading Asian markets, including Japan and China and in Australia, New Zealand, Spain and Italy for our research products. Important events after balance sheet date On 31 January, 2008, an extraordinary general assembly adopted the supervisory board s proposal to authorise the supervisory board to increase the share capital by up to nominal DKK 6,161,004 through one or more issues without pre-emption rights for the existing shareholders in connection with the acquisition of Oncotech. On 8 February, 2008, Exiqon published a prospectus for the purpose of a private placement of up to 6,161,004 new shares to the shareholders in Oncotech as consideration for the contribution in kind to Exiqon of Oncotech shares. The new shares were offered at DKK 36.4 per share. On 29 February, 2008, Exiqon announced that it had completed the acquisition of Oncotech. The purchase price paid for Oncotech by issuing of shares in Exiqon A/S amounted to 5,550,274 new shares based on an agreed maximum number of shares after the reduction of closing liabilities. 9 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT In September, Exiqon announced that Per Wold- Olsen, Chairman of the board of H. Lundbeck A/S, has accepted to candidate for Exiqon s Board of Directors at the next Annual Meeting. Per Wold-Olsen will bring extensive experience from the international pharmaceuticals industry to the Board of Exiqon. From 1994 to 2006, Per Wold-Olsen was a member of the Management Committee of the global pharmaceuticals company Merck & Co., Inc. The consideration paid for Oncotech may be calculated as follows: Max. number of new shares 6,161,004 Estimated Oncotech liabilities per 27 February 2008 USD million Accepted Oncotech liabilities (liabilities per 31 December 2006) USD million Estimated closing liabilities for Oncotech per 27 February 2008 USD million Closing liabilities converted to number of new shares (at a price of 37.9 and an exchange rate of ) (610,730) Consideration in new shares 5,550,274
12 The Oncotech acquisition 10 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Oncotech develops and markets diagnostic tests designed to optimize the treatment selection for cancer patients. Oncotech s EDR (Extreme Drug Resistance) test is the leading cell-based product to identify drug resistance for cancer patients with a U.S. market share close to 80 percent. Oncotech, with its about 100 employees, in 2006 reported total revenues of USD 13.7 million (DKK 72 million) and a net loss of USD 3.1 million (DKK 15.5 million) whereas 2007 revenues (unaudited) are expected in the region of USD 12 million (DKK 60 million) with a net loss of approximately USD 2.8 million (DKK 14 million). By combining the two companies, Oncotech will benefit from Exiqon s LNA -detection technology and proprietary mirna biomarkers, and Exiqon gains the necessary competencies and assets to build its molecular diagnostic business. Consequently, the acquisition of Oncotech has significantly reduced a number of risks associated with Exiqon s venture into molecular diagnostics. By applying Exiqon s LNA technology to Oncotech s current EDR products; effectively migrating the current EDR products to a molecular diagnostic platform based on proprietary mirna biomarkers, Exiqon expects to be able to achieve significant growth in Oncotech s diagnostic revenues and the value of its diagnostic business over the coming years: The market potential may increase with as much as a factor 5 in the U.S. alone compared to the market of Oncotech s current cellular based EDR products. This is due to the improved sensitivity of the corresponding molecular products, which will allow many more patients to benefit from the answers provided by the current EDR test. Molecular based tests can be performed on far smaller tissue samples compared to the amount of tumour sample required for Oncotech to perform its current EDR tests, i.e. more tests can be conducted at an earlier stage thus targeting more patients. Furthermore, the molecular based test can be performed on fixed tissue as opposed to living cells which will allow for a much more competitive product offering meeting the clinical needs and improve logistics. STRONG SYNERGIES EXIQON ONCOTECH LNA is perfect for detection of mirna: LNA is superior for the detection of mirna LNA is the only technology allowing detection of mirna directly in tissue LNA enables discrimination of even highly homologous mirnas Exiqon holds a unique patent position on LNA mirna is the ideal biomarker: mirna expression patterns relate to the development of cancer mirna is biologically stable facilitating diagnosis based on fixed tissue mirna expression shows high dynamic range which facilitates high accuracy Exiqon holds a unique patent position within the mirna field Oncotech provides the perfect infrastructure: A specialty sales force familiar with the oncology diagnostic market A large loyal customer base of cancer treating physicians and hospitals Regulatory expertise and reimbursement competences CLIA and CAP approved laboratory facilities The world s largest human tumour bank allowing for fast product development By combining the two companies, Oncotech will benefit from Exiqon s LNA -detection technologies and proprietary mirna biomarkers, and Exiqon now has gained the necessary competencies and assets to build a strong molecular diagnostic business.
13 11 We go to work to help improve cancer treatment selection for our patients Tiffany Schneggenburger, CFO and Site Manager at Oncotech Inc. EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT The value of each sale of a molecular diagnostic product compared to the current EDR products could potentially be much higher through an improved reimbursement profile for such new products, provided the necessary clinical data can be established by Exiqon. The potential value increase per product sale may be as much as a factor 3 compared to Oncotech s current average reimbursement per EDR product sale when considering the reimbursement profile of other U.S. marketed molecular diagnostic products. The value of new molecular diagnostic products may be improved even further by adding additional information based on mirnas to the tests. The use of mirna biomarkers may allow the new products to be used not only to determine drug resistance but also to provide information about disease prognosis, risk of relapse, primary origin of tumour, etc. all of which will help secure a long IP protection of the new molecular diagnostic products. Exiqon aims to launch its first molecular diagnostic test based on mirna within 12 months after the acquisition of Oncotech which is two to three years ahead of the expected first product launch at the time of the IPO of Exiqon in May More products are to follow shortly thereafter. In addition to the new molecular diagnostic test based on mirna for replacement of the current EDR tests, Exiqon also plans to develop and market different home brewed tests based on mirna within the diagnostic space and Exiqon will continue the development of its current product portfolio within molecular diagnostics. Following the acquisition of Oncotech, the Exiqon group is positioned at the forefront of personalized medicine through its current product offerings in the oncology diagnostic space and its portfolio of new molecular based products. The COGS of a molecular diagnostic test will improve over the current EDR test since the process may be automated and will reduce the turnaround time by 50% which equals 3-4 days compared to the time it takes to perform Oncotech s current EDR test.
14 Financial review 12 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Revenue Revenue totalled DKK 49.5 million in 2007 compared to DKK 43.1 million in 2006, representing an increase of 15%, however, the revenues in 2006 were affected by a non-recurring income from an agreement with Santaris Pharma A/S. In 2007 revenue from product sales increased 84% relative to the year-earlier period to a total of DKK 38.5 million in The improved product sales are mainly due to increased sales activities and continuing growth in the market. U.S. sales did not meet the expectations for the year. Gross profit Gross profit totalled DKK 24.3 million in 2007 compared to DKK 31.2 million in 2006, representing a decrease of 22%. The gross margin decreased to 49% from 72% in 2006, however, 2006 was affected by a non-recurring income from Santaris Pharma A/S without which the gross margin totalled 61% in The margin on product sales including services decreased to 35% from 43% in 2006 due to temporary supply chain issues in the third quarter and subsequent market positioning efforts. Initial supply of lower margin Amidites under a supply agreement also affected gross margins negatively in 2007, however, Exiqon is expected to generate royalty payments under a corresponding license agreement already in Research and development costs Research and development costs totalled DKK 29.0 million in 2007 compared to DKK 27.6 million in 2006, representing an increase of 5%. Research and development costs are charged with DKK 0.4 million in respect of share based payment. Net of this charge, research and development costs totalled DKK 28.6 million in 2007 compared to DKK 26.6 million in 2006, or an increase of 8%. The increase is mainly explained by a higher level of activity and recruitments relative to the year-earlier period. Sales and marketing costs and administrative expenses totalled DKK 70.4 million in 2007 compared to DKK 29.0 million in 2006, representing an increase of 143% (138% without the effect of share based payment): Sales and marketing costs Sales and marketing costs rose 102% to DKK 39.1 million in 2007 from DKK 19.4 million in Sales and marketing costs are charged with DKK 1.0 million in respect of share based payment. Net of this charge, sales and marketing costs totalled DKK 38.1 million in 2007 compared to DKK 17.1 million in 2006, corresponding to an increase of 123% reflective of the company s focus on building its market position. The increase relative to the year-earlier period is mainly due to the establishment of the company s own sales organisation in the U.S. as well as an expansion of our sales organisation and sales activities in Denmark. Administrative expenses Administrative expenses totalled DKK 31.3 million in 2007 against DKK 9.6 million in 2006, an increase that amounted to 226%. Administrative expenses are charged with DKK 8.9 million in respect of share based payment. Net of this charge, administrative expenses totalled DKK 22.4 million in 2007 compared to DKK 8.3 million in 2006, or an increase of 170%. The increase is mainly due to an increase in the administrative staff as well as a reorganisation and strengthening of the IT-function. Administrative expenses are furthermore charged with one-off expenses of DKK 4.9 million as a result of a restructuring and strengthening of the organisation. Total operating costs Operating costs totalled DKK million in 2007 compared to DKK 68.6 million in 2006, representing an increase of 82%. Operating costs are charged with DKK 10.5 million in respect of share based payment. Net of this charge, operating costs totalled DKK million in 2007 compared to DKK 63.7 million in 2006, representing an increase of 79%. Financial items Net financial income totalled DKK 7.3 million in 2007 compared to DKK 0.6 million in Financial income mainly consists of interest on fixed-term deposit accounts, while financial expenses mainly consist of interest on financial lease agreements. The increase is mainly due to the placement of the proceeds from the IPO in May 2007 on fixed-term deposit accounts. Net loss for the year and follow-up on expectations previously announced The net loss for 2007 totalled DKK 67.8 million compared to DKK 24.9 million in Although, revenue met announced expectations of DKK million, the net loss is higher than previously announced. This is mainly due to lower gross margin on product sales, increased SG & A costs and a lower financial income than anticipated.
15 Balance sheet items The Group had total assets of DKK million at 31 December Intangible assets amounted to DKK 11.1 million, property, plant and equipment DKK 21.4 million, while current assets amounted to DKK million, of which receivables represented DKK 15.9 million. Equity stood at DKK million at the end of 2007 as compared with DKK 34.0 million in The positive movements in equity were attributable to the capital increase as part of the IPO in May Cash flow statement Operating activities generated a cash outflow of DKK 38.2 million in 2007, while investing activities caused an outflow of DKK 16.2 million. Financing activities generated a cash inflow owing to the IPO in May 2007 with a resulting contribution of DKK million. 13 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Capital resources and liquidity Exiqon expects to generate positive cash flows within few years with the existing cash position. Exiqon reported a cash burn from operating activities and investing activities of DKK 54.4 million for the financial year 2007 and had cash and cash equivalents of DKK million at year end 2007.
16 Business and Strategy 14 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Exiqon pursues a two-tiered strategy based on our unique and patented LNA (Locked Nucleic Acid) technology. Our research products target the market for nucleic acid analysis and are used to perform molecular analysis of gene expressions. Our diagnostic products target the market of treatment selection within cancer. Our goal is to be the leading company in the market segments in which we operate. The global market for nucleic acid analysis represents a considerable market segment, estimated at a combined value of DKK 57 billion in 2007 (source: Business Communications Company Inc.) consisting of: Products for research DKK 35 billion Products for molecular diagnostics DKK 22 billion. In addition to our research product sales and future sales of the EDR-test through Oncotech, we generate income from the performance of services involving biological analysis for our customers. Both Oncotech and Exiqon have worked with a number of pharmaceutical companies to assist in preclinical drug development and following the acquisition of Oncotech, Exiqon will revisit these collaborations to focus on one of the most significant opportunities in molecular diagnostics; the development of companion diagnostics for the growing number of targeted therapies. Together Oncotech and Exiqon will aim to leverage our core competencies and our relationships with some of the leading pharmaceutical and biotech companies to develop companion diagnostic products. Marketing strategy We market our research products and services for gene activity profiling worldwide directly from our head office in Denmark and our sales organisation in the U.S. In addition, we have distributors in Asia and Australia and in parts of Europe. Most of our sales and marketing staff are experienced scientists with a background in molecular biology or similar areas as well as sales experience. Our distributors are carefully selected on the basis of their skills, know-how and network in products for gene expression profiling. Our customers have direct access via telephone and to our technical support teams in Denmark and the U.S. The technical support teams are staffed by researchers holding a Ph D or Master of Science We focus on this once in a life time opportunity to leverage our mirna research to improve molecular diagnostics for cancer treatment selection Anna Karina Busch, Sales & Marketing
17 degree, who are prepared to answer technical questions about our products and other molecular biology issues. This dialogue allows us to identify new market needs and business opportunities and gain further insight into the molecular biology challenges our customers face. The information collected is transferred into our dynamic innovation process, which we believe will ultimately ensure that we can retain our position as one of the most innovative and technologically advanced suppliers of products for measuring mirna activity. The diagnostic EDR test performed by Oncotech is marketed through a specialized sales force. Exiqon plans to expand Oncotech s sales force as part of its preparation for the launch of new molecular diagnostics tests and will continue targeting hospitals and cancer treating physicians to collaborate with in vitro diagnostics players in marketing and distribution arrangements. development of new medication and also contributes to the development of more precise diagnosis and, by extension, more personalised medication. With our proprietary LNA technology, Exiqon helps to meet this growing market demand for products for gene expression profiling. LNA is a laboratory manufactured derivative of DNA. The LNA technology allows for more precise and sensitive profiling of gene activity than the technologies applied to date. Today, the most commonly used technology for gene expression profiling is based on DNA. The LNA technology eliminates some of the limitations associated with DNA, giving Exiqon a competitive edge because we can use our LNA technology to develop and manufacture products with properties that cannot be designed using other technologies. 15 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT The LNA technology The sequencing of the human genome has created a rapidly growing demand and market for analysing gene activity in order to understand the function of our genes. Gene activity profiling bolsters the The LNA technology is fully compatible with the standard analysis and profiling equipment available in the market and can therefore easily be applied by scientists worldwide. The figure shows how LNA technology enables detection of mirna gene expression in cells and organs, here exemplified in zebra fish embryos. The analysis shown here can only be performed with our products, and none of our competitors have been able to market a similar product. Exiqon s technology LNA DNA Competing technologies RNA OME Source: Kloosterman et al., also partly published in Kloosterman et al., Nat Methods vol 3, No. 1, January 2006, p27-29.
18 Molecular research 16 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Based on our unique LNA technology, our primary business is gene expression profiling. We already have a broad product portfolio for analysing both mrna and mirna, which we intend to develop further. Our research products are highly value-added reagents consisting of optimized analysis reagents and thoroughly prepared protocols that allow the customer quickly and effectively to use our products in their own laboratory thus obtaining precise results. Our strategy for research products is to supply complete kit-based solutions so that our products cover the entire working process from sampling to the completed analysis as well as, where relevant, web based software systems supporting the use of the kit products. Customers for our research products include molecular biologists in the pharmaceutical, diagnostic and agro technology industries and academic institutions in the field of molecular biology. Exiqon s customers are typically involved in basic biological research, research into diseases such as cancer, metabolic diseases, neurological disorders, and stemcell research. Research service business In response to direct customer enquiries we have established a service business to increase the value of our product range. A number of potential customers do not have the necessary expertise or capacity to carry out the requested analyses themselves. By sending samples to us, our customers avoid investments in a complex infrastructure and expertise for performing mirna analyses. We return quality controlled and value-added data, which we have generated in our ISO 9001-certified laboratory in Denmark.
19 Fuji-Kenzai U.S.A. Inc. ( The Worldwide Biochip and Equipment market 2007 ) estimates the value of the combined market for microarray-based service research at DKK 600 million in By offering this service, our products reach a broader section of the market. On a short term basis, this brings us into contact with customers who might otherwise not have used our products. On a longer term basis, it gives us the opportunity to communicate directly with scientists in the pharmaceutical industry, which may potentially lead to strategic collaborations in areas such as classification of patients in clinical trials based on our services. With our service business we have taken a step up the value chain by offering our customers a more complete solution which includes quality control of their samples, mirna analysis and data analysis employing our mircury LNA products. 17 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT
20 mrna and mirna 18 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT mrna The market segment for mrna analysis is dominated by a few large international corporations. In order to optimize our market access, we have resolved to use Roche as the distributor of our product range for quantitative mrna analysis, as Roche is already a leading supplier of analysis instruments in this market segment. To be successful in this significant market, we have designed unique products that can only be developed using out patented LNA technology. mirna For the mirna research market, we have decided to establish direct sales through our own sales organisation and through a network of local distributors, as this strategy allows us to optimise and realign our market initiatives much faster than if we had collaborated with a major business partner. This new market segment calls for a high degree of technology insight and support, which we achieve through direct customer relations. By using our mircury LNA product range, the market s most comprehensive mirna detection tool, our customers can effectively and consistently study the mirna function. Exiqon recently launched the mircury microrna PCR System. The launch of this product addresses the need in the market for very sensitive mirna expression analysis in minimal amounts of biological material. The product was developed by Rosetta Inpharmatics (a wholly owned subsidiary of Merck Inc.) and has been exclusively licensed by Exiqon. The market for molecular research The market for our research products is divided into two segments: one for mrna analysis and one for mirna analysis. The market for mrna analysis is characterised by being relatively mature, while the mirna market is still in its infancy. Market specified by mirna and mrna analysis mirna market DKK 120m Market size mrna market DKK 6,000m The number of scientific publications is often used as an indicator for the scientific interest. The number of scientific publications including work on mirna shows a yearly increase of about 100% supporting the growing interest for mirna research. The increased interest in mirna relates to the fact that mirnas have been documented to regulate important genes involved in major diseases such as cancer, metabolic and neural disorders and in cellular differentiation thereby also being important for stemcell research. 80% per annum Market growth 15-20% per annum (Source: Fuji-Keizai U.S.A. Inc. The Worldwide Biochip and Equipment Market 2007, Frost & Sullivan Report #B079-55: European Nucleic Acids Amplification Kits and Reagents Market, Frost & Sullivan: US qrt-pcr Markets, 2006, Qiagen GmbH s annual report 2005, Fluidigm Inc. press release dated 18 December 2006, and the Company s own estimates, Luminex Corporation Inc. investor presentation 2007 and the Company s estimates.) About mirna micrornas (mirnas) are a novel class of regulatory RNA molecules with surprisingly widespread effects on gene regulation. Although recently identified as a class of molecules, initial studies indicate that mirnas may regulate 30% or more of all genes in the genome, thus comprising an up till now hidden level of regulation. Interestingly, mirnas have already been found to play important roles in several types of cancers and in processes involved in cellular differentiation. In the cell, mirnas are found in the form of single-stranded RNA molecules, which are typically nucleotides long in their active form.
21 Exiqon s existing and potential mrna products for research purposes Market needs mrna analysis products Customers Sequence information Knowledge about the genetic sequence composition and influence on diseases creates needs for: Analysis of gene activity Understanding the relationship between gene activity and diseases Understanding the function of the genes Products for purification of RNA from cells and tissues Products for detection and characterisation of gene activity Products for functional analysis of gene activity Universal ProbeLibrary mrna qpcr mrna in situ detection mrna knockdown Research laboratories Analysis laboratories Diagnostic laboratories The green colour indicates that the products have been launched, whilst blue indicates products to be developed. The grey colour indicates products launched through a license agreement with Applied Biosystems. 19 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Product overview: Exiqon s research products to measure mirna activity Market needs mrna analysis products Customers Sequence information Knowledge about the genetic Products for purification of RNA from cells and tissues mircury RNA purification Research laboratories sequence composition and influence on diseases creates needs for: Analysis of gene activity Understanding the relationship between gene activity and diseases Understanding the function of the genes Products for detection and characterisation of gene activity mircury LNA Array FlexmiR microrna detection (Luminex) mircury LNA mirna PCR System Analysis laboratories Diagnostic laboratories mircury in situ detection mircury Northern blot detection Products for functional analysis of gene activity mircury LNA knockdown mircury mir mimics Source: Exiqon 2008 The green colour indicates that the products have been launched, whilst blue indicates products under development.
22 Molecular diagnostics 20 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT In recent years, scientific literature has demonstrated that mirna activity is often involved in a specific disorder. This discovery opens up new business opportunities which we intend to pursue, using the products we have developed for research purposes as the foundation. The greater biological understanding and the development of enhanced systems for mirna gene expression profiling have opened up for the development and marketing of molecular diagnostics products that stratify patients based on mirna expression patterns with the purpose of prescribing the optimal treatment. We believe that our patented LNA technology and proprietary mirna biomarkers provide us with a competitive edge and, by extension, good possibilities to develop and market unique products in the growing market for stratification of patients based on molecular technologies. Based on scientific research and literature, own trials and a significant market need to improve treatment selection, an area in which only about 30% of the patients benefit from the prescribed therapy, we have decided to focus our molecular diagnostics business on cancer treatment selection. Through the acquisition of Oncotech, Exiqon now has a leading cancer diagnostics business. Applying Exiqon s LNA technology to Oncotech s existing EDR test products will enable the Exiqon group to increase the market, broaden the use of Oncotech s current tests and widen the diagnostic product offerings, providing revenue potential from multiple sources which it would otherwise have taken many more years to build. Cancer patients are now diagnosed much earlier than in the past, resulting in much smaller tumours and therefore a need for more sensitive diagnostic tests. Exiqon will initially focus on programs to identify differences between drug resistant tumours and drug responsive tumours and then further develop the new molecular diagnostic tests to include information about prognosis, recurrence, cancer origin and treatment selection. The molecular diagnostic product development programs of the Exiqon group are expected to provide sets of mirna biomarkers that are predictive of drug response. These tests will be performed on smaller tumours and paraffin embedded tissue thus increasing the already large potential market at a global level. These programs will not only focus on late stage cancers, but also focus on patients who are diagnosed at early stages (stage I and II). New research indicates that adjuvant chemotherapy will benefit patients who The strategy for the molecular diagnostics business has been revised after the acquisition of Oncotech, and the goal is now to: Upgrade current cell based products for chemotherapy resistance to molecular diagnostics products based on mirna analysis of fixed tissue Focus on the most common cancers (colon, breast, lung and ovarian) Market new molecular diagnostic products based on mirna to include information about treatment selection, recurrence, prognosis and cancer of unknown primary Launch of the first molecular diagnostic product based on mirna for drug resistance testing based within 12 months after closing of the transaction.
23 The Extreme Drug Resistance ( EDR ) Assay represents Oncotech s flagship product. Drug resistance is the principal reason that chemotherapy so often fails. Oncotech s laboratory has the unique ability to identify drug resistance in cancer patients prior to chemotherapy treatment, saving them unnecessary treatment related morbidity and cost. Oncotech performs its EDR assay on fresh human tumor tissue collected at time of surgery. The EDR assay requires fresh viable malignant tumor tissue sent to Oncotech immediately following surgery. To date, Oncotech has performed oncology services for more than 150,000 cancer patients from over 1,000 hospitals throughout the nation and Europe. have had surgery because of a high probability of recurrence. The market The nucleic acid analysis market for molecular diagnostic products is substantial and represents a value of DKK 22 billion. Following the acquisition of Oncotech, Exiqon is well positioned to exploit the potential in the market for treatment selection as the Exiqon group applies proprietary technologies such as the best detection technology ever invented for gene expression analyses, unique mirna biomarkers, and is a leader in the market for cell based tests for treatment selection. 21 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Our diagnostics products target the market for cancer. According to WHO, more than 11 million people are diagnosed with cancer every year, and the disease causes more than 7 million deaths each year, corresponding to 12.5% of all deaths worldwide. For 2007 the American Cancer Association expected more than 1.4 million new cases of cancer distributed among the various cancers as shown in the table. Expected new cancers in the U.S. in 2007 Frost & Sullivan estimates the present market for molecular diagnostics of cancer at approximately DKK 2.4 billion in The market for molecular diagnostics includes large companies such as Roche Diagnostics, Abbott Diagnostics, Celera Diagnostics, Qiagen and GenProbe, but also a large number of smaller companies. Especially the smaller businesses have sought to use more recent biomarkers such as mrna and mirna in their development of next generation molecular diagnostic products. Source: Business Communications Company, Inc., Report#RB-141R The DNA Diagnostic Business, Frost & Sullivan Report#B933-55, EU Molecular Diagnostics Markets, Frost & Sullivan Report#F743-55, U.S. Molecular Diagnostics Markets, Roche annual report for 2006, and the Company s estimates.) Type of cancer New cases in 2007 All types 1,444,920 Breast 180,510 Colon 112,340 Lung 213,380 Malignant melanoma 59,940 Ovarian 22,430 Pancreas 37,170 Prostate 218,890 Unknown primary tumour (3-5%)* 42-84,000 Source: American Cancer Association, Pavlidis N, et al. Eur J Cancer Sep;39(1 4): , American Cancer Society. Cancer Facts and Figures 2006, Co-operative Cancer Departments in Denmark: Treatment of unknown primary tumour, reference programme 2006 and Pavlidis N. Cancer of unknown primary: Biological and clinical characteristics. Ann Oncol. 2003;14 Suppl 3:iii * Unknown primary tumours are not registered separately but are calculated on the basis of published prevalence figures for unknown primary tumours in the U.S. The table shows some of the most significant cancers in the U.S.
24 22 EXIQON ANNUAL REPORT 2007 MANAGEMENT REPORT Diagnostic pipeline of the Exiqon group The Exiqon group has a robust new product pipeline of several molecular diagnostic tests based on mirna biomarkers for the coming years with particular focus on drug response and tumour recurrence for colon, lung, ovarian, breast and other high incidence cancers. Exiqon will initially focus on programs to identify differences between drug resistant tumours and drug responsive tumours and since further develop the new molecular diagnostic tests to include information about prognosis, recurrence, cancer of unknown origin and treatment selection. The figure demonstrates the products currently offered by Oncotech (in light blue) as well as the new molecular diagnostic tests (in blue). A major milestone for the Exiqon group is to have the first molecular diagnostic test based on mirna biomarkers to be developed by the Exiqon group marketed through Oncotech s existing CLIA laboratory at the beginning of Drug development The drug discovery industry increasingly employs molecular biology test systems in its product development initiatives to classify and characterize patient groups before and during clinical development projects. Such classification is expected to ensure a higher success rate in the pharmaceutical product development, and an increasing proportion of this classification is expected to be performed in collaboration with companies such as Exiqon. We will seek to generate revenue in this market before products with full regulatory approval can be launched, by forming partnerships with players in the pharmaceutical and biotechnology industries. Pipeline EDR* tests based on cellular assays Colon EDR* tests Breast EDR* tests Ovarian EDR* tests Lung (NSCLC) EDR* tests Colon treatment selection & recurrence Breast treatment selection & recurrence Ovarian treatment selection & recurrence Lung (NSCLC) treatment selection & recurrence Several molecular based tests CUP** test Various home brewed tests based on mirna Molecular diagnostic based Cellular based * EDR: Extreme Drug Resistance ** CUP: Cancer of Unknown Primary
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