GENOVIS SIGNS DISTRIBUTION AGREEMENT WITH FINNZYMES INC. IN US
Genovis offers new technological solutions in Transfection, RNAi, Imaging, and Antibody Engineering to customers who are performing sophisticated research in pharmaceutical companies and within the academic research community.
– We are excited about the opportunity this distribution agreement presents for Genovis. It is a means of broadening our presence within the US marketplace and we are looking forward to working with Finnzymes experienced team, says Sarah Fredriksson, CEO of Genovis.
Finnzymes Inc is a wholly owned subsidiary of Finnzymes Oy and a distributor of Finnzymes products in North America. Finnzymes Oy, located in Finland and founded in 1986, refines scientific innovations into useful commercial products for molecular biologists and is a leader in the development of PCR, quantitative real-time PCR, transposon and RNA technologies. Their product line includes all components required for PCR: DNA polymerases, PCR instruments and reaction vessels.
-Our mission at Finnzymes Inc. is to offer products which will measurably improve the lab bench experience for researchers throughout the US scientific community. We are therefore extremely pleased to be able to work with Genovis, which has a unique portfolio of products based upon highly advanced technologies, such as their proprietary nanoparticles for ultra-high efficiency transfection, says Mike Mortillaro, President of Finnzymes Inc.
Genovis publish a new share issue prospectus
Genovis AB (publ)
The board of directors
Report from the extraordinary general meeting of Genovis AB (publ)
By a decision on a new share issue based on the authorization, the share capital will at the most rise by 2 177 246,4 SEK by the issuing of new shares at market price, but to a maximum of 5 443 116 shares at full subscription.
New share issue
The share capital in the company will increase by up to SEK 1 451 497,6 through a new share issue of up to 3 628 744 shares with preference for existing shareholders. Three (3) existing shares, will qualify for subscription of one (1) new share. The proposed issue price is SEK three (3).
January 8, 2009
Last trading day for the Genovis share that includes the right to participate in the new share issue.
January 13, 2009
Record day for participation in the new share issue, i.e., shareholders listed in the Genovis share register on this day receive subscription rights for participation in the new share issue.
January 16 – 30, 2009
Subscription period. Subscription with preemptive rights occurs through cash payment during the subscription period. Notification of interest in subscribing can be done during the entire subscription period.
January 16 – 27, 2009
Rights trading.
Notice of extraordinary general meeting of Genovis AB
Registration
To participate in the meeting, shareholders must:
– Be entered in the share register kept by VPC AB by Wednesday, December 11, 2008.
AND
– Register with the company by 12:00 PM on Wednesday, December 11, 2008, by mail at IDEON, SE-223 70, Lund, Sweden; by fax at +46-46-12 80 20; by email at info@genovis.com; or by phone at +46-46-10 12 38. Please provide your name, personal/corporate ID number, and registered share holdings.
Shareholders who have nominee-registered shares must temporarily register the shares in their own names through their agents before December 11, 2008, in order to participate in the meeting.
Proposed agenda
1. Opening of the meeting.
2. Election of meeting chairperson.
3. Preparation and approval of voting list.
4. Approval of agenda.
5. Election of one or two persons to verify the minutes.
6. Confirmation that the meeting was duly convened.
7. Approval of the board’s proposed new share issue of up to 3 628 744 shares, each with a par value of SEK 0.40 with preemptive rights for current shareholders at a price of SEK 3 per share. The proceeds of the issue will be used to carry out the business development plan of the company and to further develop intangible values within medical imaging and delivery.
8. Authorization for the board to decide upon a new share issue
The Board propose that the shareholders’ meeting decide upon authorization for the board to, up until the next annual general meeting, at one or more occasions, decide upon a new share issue, with or without preemptive rights for current shareholders. By a decision on a new share issue with support of the authorization the share capital will at the most rises by 2 177 246 SEK by issuing new shares at market price, yet in all maximum 5 443 116 shares at full subscription.
9. Closing of the meeting.
Meeting-related documents
The complete proposal as per item 7 and 8 above will be available at the company’s office at Scheelevägen 22, Box 790, 220 07 Lund, Sweden, and on the company web site at www.genovis.com from December 3, 2008, and will be sent to shareholders on request after providing us with their mailing address.
Lund, Sweden
November, 2008
The board of Genovis AB (publ)
Genovis Carries Out New Share Issue
Genovis has now achieved the company’s primary operational objectives for 2008, which are to initiate sales, launch four products, and establish sales channels in US, Europe and Asia. Customers have generated revenues on these markets and the goal for 2009 is to continue the business development of the product portfolio. Genovis is an R&D intense company and the research projects involving the use of nanoparticles for medical device purposes are successful. In order to accomplish the company’s business development plan, as well as to further develop the intangible value of medical imaging and delivery, additional capital is necessary. The Board of Directors has therefore resolved to carry out a new share issue, subject to the approval of the extra annual general meeting on December 17, 2008. The company’s operations will be financed until such time that the proceeds of the share issue become available by bridge financing through a bank loan.
The principal owners intend to subscribe for their portions of the issue.
Resolution on new share issue in January
The Board of Directors has, subject to the approval of the extra annual general meeting, resolved to carry out a new share issue with preferential rights for existing shareholders whereby three existing shares will entitle the holder to subscription of one new share at a subscription price of SEK 3/share. As a result, share capital will be able to increase by an aggregate maximum of SEK 1,451,497.6 through the issue of 3,628,744 shares. The company will receive about SEK 10.8 million before share issue expenses.
Authorization for the Board to resolve on new share issue
The Board of Directors proposes that the annual meeting of shareholders resolve to authorize the Board, until the next Annual General Meeting, to resolve to carry out a new share issue of shares on one or more occasions, with or without preferential rights for existing shareholders.
As a result, under the authorization share capital could increase by an aggregate maximum of SEK 2,177,246 through the issue of new shares on market-based terms, though an aggregate maximum of 5,443,116 shares upon full subscription.
The reason for the authorization for possible deviation from the preferential rights of shareholders is that to provide the company with the opportunity to expand its ownership with one or more owners of strategic significance for the company.
The complete proposals for the aforementioned resolutions will be available at the company’s office (street address: Scheelevägen 22, postal address: Box 790, 220 07, Lund, Sweden) and at the company’s website (www.genovis.com) commencing on December 3, 2008 and will be sent upon request to shareholders who provide their mailing address.
Genovis nanostructures in new diagnostic method
“The opportunity to conduct interdisciplinary projects together with leading research groups in medical imaging is incredibly worthwhile for us. In the long run, successful animal studies will mean a new market for Genovis products and our knowledge,” says Sarah Fredriksson, CEO of Genovis.
In order to develop better drugs and more effective treatment for malignant diseases we need more reliable diagnoses at an early stage, as well as better opportunities to follow up various therapies and medication dosages. A new contrast medium for humans must be able to be used at low doses with high efficacy and without any side effects. Genovis has focused on nanostructures that are used as tools to study different types of cells from animals and humans. Genovis optimizes the nanostructures to ensure that they are not harmful or cause cell death in these extremely sensitive cells. The experience and knowledge that Genovis has built up over the years is valuable for the design and production of new nanostructures that are now being tested in animal models, after which they will be taken one step further toward a reliable diagnostic method for humans.
The project is being carried out in cooperation with the Department of Radiophysics at Lund University Hospital and is based on a brand new generation of nanoparticles with combined magnetic, radioactive and fluorescent properties for MRI/PET imaging. The project will focus on the combination of two different imaging and diagnostic methods with a single effective contrast agent that delivers both anatomical and functional information. The contrast agent is based on ultrasmall superparamagnetic iron oxide nanoparticles marked with a radioactive trace element. Genovis will evaluate and produce this contrast agent.
Magnetic Resonance Imaging (MRI) is a biomedical imaging technique for diagnostic imaging with a scanner. The technique is used on patients to detect, locate and classify certain diseases and injuries that are hidden or difficult to see by x-ray or CT scan.
Positron emission tomography (PET) is a medical imaging technique based on the decay of radioactive isotopes and provides three-dimensional images of the movements of neurotransmitters in the body.
Genovis AB nomination committee appointed
The AGM will be held on April 23, 2009 at 5:00 PM in Genovis new facilities at Scheelevägen 22 in Lund, Sweden.
Thomas Svensson resigned from the board effective. The nomination committee will decide on the future composition of the board
Interim Report January-September 2008
January 1 – September 30, 2008
Group net sales amounted to KSEK 375 (KSEK 5)
Net profit/loss for the period KSEK -10,134 (KSEK – 6 090)
Earnings per share for the period amounted to SEK -0.93 (-0.70)
Cash and cash equivalents at the end of the period totaled KSEK 512 (3 856)
July 1 – September 30, 2008
•Genovis entered into a distribution agreement with Biolegio BV for the Dutch, Belgian and German market.
•Genovis moved to larger offices more suited for production and quality-control demands.
•Genovis took part in a number of conferences and expos.
Important events at the end of the period
Genovis financial plan for 2008 is delayed
In the fall of 2007 Genovis launched the first products through its website. The company has thereafter introduced the products on selected geographic markets through appointed distributors, and with an increasing number of orders and customers. In parallel there are ongoing discussions with potential partners interested in OEM and licensing of Genovis current products as well as those in the pipeline. Before these business activities are completed Genovis will not generate sufficient revenues to meet the previously stated ambition to reach positive cash-flow in 2008.
For the financing of the running operation and the further development of the intellectual property, additional capital is needed. The board has decided on a short-term bridge financing and to await the outcome of ongoing business discussions, and thereafter decide on form and scope of the most appropriate financing for the long-term and strategic development needs of Genovis.
The Board of Directors has decided, given the insecurity of our times and the financial unrest in the world, not to issue any projection for the immediate future.
Two novel products were launched within the Antibody Tools area of application.
IgGZero™
The first of its kind in the world: a protein that specifically cleaves the sugar molecules that naturally exist on antibodies. Removing the sugar molecules can improve the performance of the antibody in various applications. As another example, IgGZero™ can help wash away antibody molecules from primary cells.
FcDOCKER™
Binds specifically to the antibody. This protein is very useful in the antibody production process. Using FcDOCKER entails a gentler production process than competing methods and offers great technical and economic advantages.
Genovis entered into distribution agreements with Innovative Biotech Pte Ltd. in Singapore.
Innovative Biotech Pte Ltd was founded in 1994 and is a subsidiary of Rotary Engineering Limited. The company’s main focus is sales and marketing of products in the medical, pharmaceutical, and biotech fields to universities, laboratories, and research institutions.
Comments from the CEO
During the period we have focused on expanding our line of products, while retaining and strengthening the projects in the pipeline without incurring increased expenses. We have further increased the number of sales channels via distributors and we will reach our objective for the year. At the same time we are conducting discussions with partners pertaining to the sale of OEM products and new product concepts in order to increase sales volumes over the long term.
We have effectively reorganized Genovis and now have an extremely well functioning team. The company has also moved to more appropriate premises, allowing us to offer our customers
and future partners better quality and larger quantities in terms of production, as well as a support and development organization that continues to be extremely strong. Our internal development projects, in vivo projects for imaging and delivery, have made good progress during the period, which means that in the future we will focus on them internally and through external partnerships.
Genovis also pursues intensive development operations were the design and production of nano structures for the Life Science industry is the focus. We have started to commercialize our first products and persue revenues from our accumulated R&D portfolio and hence the analysis of
advances and performance in relation to established goals is a mixture of concrete results and subjective evaluations.
The number of satisfied customers, order bookings, new customers, interested potential partners, and the commercial potential of our research projects are important measures of value. It is gratifying to see that
we succeeded in increasing all of them during the third quarter and that we have excellent prospects to continue doing so in the future.
Operations
Third quarter 2008
The Genovis product portfolio consists of nano-sized particles, a group of proteins, and the know-how to use them as effective research tools. Today, Genovis markets products in three different areas of application: imaging, biomolecule delivery, and antibody tools. Our customers include those who work with advanced research at pharmaceutical companies or within the academic research community.
Genovis has moved to new offices that are better suited for its production operations. The new offices were necessary for Genovis to carry out production and quality assurance on a larger scale. The company’s move went according to plan and did not delay any ongoing projects. During this period, two client reference projects took place in the Netherlands, which resulted in an agreement with Biolegio for the exclusive right to sell and market Genovis products in Belgium and the Netherlands, and non-exclusive rights in Germany.
Genovis has continued the work initiated during the first and second quarters to establish sales channels via new distributors in Europe. Genovis marketed the technology at various industry-specific conferences and scientific meetings, including RNAi Europe in Stockholm, ScanLab in Copenhagen together with Nordic Biolabs, and BIOSPAIN´08 together with the Spanish distributor Teknokroma.
Genovis has made the organization in Lund more effective and adapted it to current priorities – product development, production, sales, and support.
Areas of Application
Imaging
Imaging, a market segment undergoing strong growth, is used by researchers for in vivo and ex vivo studies. In order to see what happens in a cell and to be able to follow the cell inside an animal model, the cell must be marked in some way. One method is to introduce magnetic nanoparticles into the cell, NIMT® FeOlabel, and then follow the cell using magnetic resonance imaging (MRI).
The objective is for customers to be able to use Genovis products from the first tests in test tubes to more advanced experiments in animal models (in vivo).
Biomolecule Delivery
There is a large market for technologies that deliver molecules (e.g., DNA or genes) into cells. One such technology is NIMT®FeOfection, which offers high efficiency and low toxicity compared with rival products. RNAi is another field undergoing dramatic growth, where researchers are interested in technologies to silence gene activity in order to treat conditions such as viral infections, cardiovascular diseases, cancer, and metabolic diseases in the future. With its high efficiency and low toxicity, Genovis’ NIMT®FeOfection is also extremely suitable for these studies.
Antibody Tools
FabRICATOR®is a genetically modified enzyme that cleaves antibodies into two parts, a Fab fragment and an Fc fragment. Unlike other technologies on the market, FabRICATOR cleaves all antibodies in a very short time in exactly the same place, and each antibody is only cleaved once.
FabRICATOR is also sold as a kit that allows customers to cleave and isolate pure Fab fragments in less than one hour, unlike other methods which may take up to twenty-four hours to achieve the same results.
Geographic Markets
The market for the products Genovis develops and markets is currently estimated at about USD 900 million. The North American market is the largest (approx. 40%), followed by the European market (30%), while the Asian market is the fastest growing geographic market.
During the first eight months of 2008 (up to September 30), Genovis signed five distributor agreements involving a total of 10 countries. Sellers have been trained and sales on the new markets have begun. The
total number of incoming orders has increased and Genovis expects continued improvement during the fourth quarter.
Regions – third quarter
Europe
Nordic Biolabs is a leading supplier of products for medical research, diagnostics, microbiology, and transfusion drugs, and represents more than 40 strong suppliers and brands. Its customers are at labs, hospitals, and universities, as well as the pharmaceutical and biotech industries. Nordic Biolabs has initiated sales to customers.
Stratech Scientific Ltd, with headquarters in Suffolk, UK, is an efficient company that has provided competitive, high-quality, and reliable products to research laboratories in the UK and the rest of Europe for 25 years. Stratech initiated sales with customers during the third quarter.
Teknokroma is an international enterprise with 30 years of experience and a product portfolio consisting of more than 40,000 products. With a team of highly qualified chemists, pharmacists, and technicians, Teknokroma began sales during the third quarter.
Biolegio is a Dutch oligonucleotide synthesis company that was founded in 1996. With more than ten years in the industry, the company has extensive experience with oligonucleotide synthesis, and provides high-
quality DNA/RNA oligos, probes, and siRNA to hospitals, universities, and biotech companies in Europe. With its trained and well-educated team, Biolegio offers high quality and service. Biolegio will begin sales of Genovis products during the fourth quarter.
North America
Genovis is represented through its subsidiary Genovis Inc. and is now concentrating on expanding operations with local distributors and collaboration partners.
Asia
Di Biotech Ltd in Korea, the spin-off company of Pharmacia Biotech Korea, was founded in 2007 and is a pioneer and market leader on the Korean life science market. The company works with customers with a focus on three areas of research: genomics, molecule interaction, and cell imaging. The company has begun to work with customers, and Genovis expects an increase in incoming orders during the fourth quarter.
Product Launch
The planned launch of IgGZero™ and Fc Docker™ was postponed to the fourth quarter and Genovis is planning an additional product launch for this quarter.
Sales
Third quarter
Net sales during the third quarter amounted to KSEK 224 (0). During the quarter a distributor agreement was signed with Biolegio for Belgium, Germany, and the Netherlands. The distributor will begin sales of Genovis products in the fourth quarter, though it has already begun working with customers and generated revenue for Genovis during the third quarter. The rest of the company’s revenue was primarily generated by its own sales of nanoparticles and proteins.
Net Result
Third Quarter
The operating loss during the third quarter was KSEK 4,257 (loss: 3,429). The increased operating expenses are mainly attributable to increased personnel costs.
Depreciation during the third quarter amounted to KSEK -229 (loss: 136) of which KSEK -136 (loss:136) were tangible assets and KSEK -93 (0) were intangible assets.
Loss after financial items was KSEK 4,271 (loss: 3,474). Deferred tax during the quarter totaled KSEK 1,226 (722)
Cash Flow and Financial Position
Third Quarter
Cash flow from operating activities was KSEK –3,738 (loss: 2,048). Cash flow from change in working capital was KSEK 273 (1,223). At the end of the period, cash and cash equivalents amounted to KSEK 512.
The Group’s net investments during the period totaled KSEK 6 (412). Net investments included KSEK 6 (9) for tangible assets and KEK 0 (403) for intangible assets.
January – September
Cash flow from operating activities was KSEK –13,538 (loss: 8,662). Cash flow from change in working capital was KSEK -154 (loss: 986).
The Group’s net investments during the period totaled KSEK 6 (5,023). Net investments included KSEK 6 (651) for tangible assets and KSEK 0 (4,372) for intangible assets.
Organization and Personnel
Genovis’ Lund division is responsible for the centrally coordinated functions in the business and finance areas, as well as production, research and development, and customer sales support. The CEO and COO have overall responsibility for the Group’s business
Genovis Inc. USA is responsible for sales and marketing in the US market.
The number of employees decreased during the third quarter by one full-time position. At the end of the period, the Group had eleven employees, ten in the parent company and one in the US, compared with ten employees in the parent company during the same period last year.
Other Information
Risks and Uncertainties
Genovis’ general view of the financial risks that could affect operations have not changed since the description published in the most recent annual report. For a detailed overview of the company’s financial risks please refer to page 41 of Genovis’ 2007 annual report.
Warrants program
The company has issued 187,000 warrants for subscription. The warrant rights can be exercised for subscription of shares between February 28, 2012 and May 31, 2012. When all warrants are fully exercised, share capital will increase by a total of SEK 74,800 through the issue of 187,000 shares, with a par value of SEK 0.40. If the warrants are fully exercised, the new shares will constitute 1.7% of capital and votes.
Genovis shares are listed on the First North OMX Nordic Exchange. Mangold Fondkommission is our certified advisor and liquidity guarantor.
GENOVIS SIGNS DISTRIBUTION AGREEMENT WITH INNOVATIVE BIOTECH PTE LTD I SINGAPORE
Singapore is an important emerging biotech-hub where the government is doing large investments for the country to become a major factor of power within Biotech and Life Science.
Through this latest distribution agreement Genovis is taking another important step in its expansion on the rapid growing Asian market. Genovis has earlier signed an agreement with a distributor for the Korean market.
Genovis offers new technological solutions in Transfection, RNAi, Imaging, and Antibody Engineering to customers who work with sophisticated research in pharmaceutical companies and within the academic research community. To provide customers with effective support and service Genovis market strategy is to choose partners with strong customer relations in strategic geographic markets.
In Europe Genovis has signed agreements with distributors for the Swedish, Danish, British, Irish, Spanish, Portuguese, Dutch, Belgian and German markets. In the United States Genovis works through its subsidiary Genovis Inc.
-Innovative Biotech continues to grow in the very important Life Science industry in Singapore. Therefore, this agreement means a lot for Genovis continuing expansion. Innovative Biotech is the perfect partner and has long experience of distribution with specialization in Genovis target areas such as antibody reagents and transfection technologies,” says Sarah Fredriksson, CEO
Innovative Biotech Pte Ltd, incorporated in 1994, is a subsidiary of Rotary Engineering Limited, which is a public company listed on the Stock Exchange of Singapore. The company’s primary business is in the sales and marketing of medical, healthcare and biotechnology products to the research institution, universities, clinical lab, hospital and industrial clients.
-Our mission, ‘Commitment to Excellence’, is delivered through high quality products and unmatched service / application support. We are therefore extremely pleased to be able to work with Genovis, which has the latest and most advanced technology and completely unique products, sais Ragu Thina, Snr Vice President
Genovis expands Antibody engineering with the launch of two novel products; IgGZero™ and FcDocker™
The new products are launched today with the premiere show of the animation ‘ IgGZero adventures’ on Genovis website, www.genovis.com.
The target customer for IgGZero™ and FcDOCKER™ are Pharma and Biotech industry focusing on antibody based drug development and the producers of antibody reagents for diagnostic and research applications. Research concerning antibody molecules in drug development increase rapidly and so is the market for effective and high performing research tools and technologies. The total market for Antibody Engineering products is estimated to reach 80 MUSD and the two novel products are examples of products within this particular target market.
-The two novel products are fabulous complementary products to our current product assortment and they add competing value to our customers. We began the development of these products less than one year ago in cooperation with a research group at Lund University. Hence it is even more exiting that we can already now launch these products, says Sarah Fredriksson, CEO at Genovis.
Genovis already holds two unique products within Antibody engineering and with the release of IgGZero™ and FcDOCKER™ this products group is twice as big.
The launched products is to be marketed through out the rest of 2008 with various activities like; advertising, mailing, web activities, customer meetings and seminars and through the distribution network. In addition the two products, the scientific discoveries and data behind them will be presented at the European Antibody Congress 2008 in the beginning of December.
The two novel groups of products launched by Genovis today can be described as tools for efficient down stream processing and modification of antibody molecules.
•IgGZero™ is a unique enzyme which highly specific degrades naturally occurring carbohydrates from the large antibody protein. By removing the carbohydrates the performance of the antibody is significantly enhanced in certain applications such as immunoassaying. Another good example is the removal of antibody molecules from the surface of primary cells using IgGZero™.
•FcDOCKER™ binds with high specificity to the antibody molecule. This protein is accordingly very handy in the production process of antibody molecules. By using FcDOCKER™ the production process is much milder, which in turn enhances the recovery, output and performance in comparison with existing technologies.
