Date change for Genovis AB January-September 2013 interim report

October 29, 2013 | |
The Board of Directors of Genovis AB (publ) has decided to schedule the January – September 2013 interim report earlier. The report was to have been published on November 28 and the new publication date is November 18, 2013.

CEO Sarah Fredriksson will comment on the interim report at Financial Meetings Øresund’s morning meeting on November 18. Redeye analyst Klas Palin will ask questions immediately after the report is presented. The presentation will take place from 8 a.m. to 10 a.m. at Årstiderna By The Sea, Dockgatan 1, Malmö. Breakfast is served from 7:30. The morning meeting is free, but participants must register by November 13: rapport@financialmeetings.se

The presentation will be direct broadcast on the following technical platforms:

www.genovis.com/investors-swedish

www.financialmeetings.se

www.redeye.se

ABOUT FINANCIAL MEETINGS ØRESUND

Financial Meetings Øresund was founded in 2013 and is a brand new financial meeting place, an arena, with interesting financial arrangements for and with Öresund companies, market analysts, investors and media.

Genovis launches GlycINATOR™ for analysis of antibody molecules

October 21, 2013 | |
Genovis is launching GlycINATOR at the Well Characterized Biologicals conference in Washington DC on October 21. The product is the result of a collaboration between Genovis and a research group led by Mattias Collin at Lund University. GlycINATOR is a recombinant EndoS2* enzyme and the product is marketed as a single-use reagent to be used in characterization of monoclonal antibodies. Customers are mainly active in pharmaceutical and biotech companies.

“It has been exciting to watch this development project progress to finished product. The project involves working closely with Lund University and Genovis’ relationship with innovative scientists is an important competitive advantage for strategic product development. GlycINATOR is an excellent addition to our product portfolio and strengthens our offering of glycan analysis products. In Washington we will also demonstrate a method in which IgGZERO can be used in combination with GlycINATOR to carry out a relatively simple quantitative analysis of high-mannose molecules on monoclonal antibodies. Mannose is a particularly important parameter to understand and handle when developing production processes for antibody-based drugs,” says Sarah Fredriksson, CEO of Genovis.

Genovis has developed the product GlycINATOR, which can rapidly cleave carbohydrate molecules from IgG molecules. GlycINATOR is a recombinant enzyme. The yield is high, the reaction rate is fast and the enzyme does not affect the antibody molecule in general, but is very specific. Customers will primarily use the product for screening new drug substances, developing production processes and for quality control of new antibody-based drugs.

*EndoS2 is a specific endoglycosidase from the microorganism Streptococcus pyogenes. EndoS2 is a patented enzyme and Genovis owns all rights. GlycINATOR™ is the brand name of the recombinant EndoS2.

Genovis to launch FabULOUS™ for analysis and characterization of antibody molecules

October 15, 2013 | |
Genovis is launching FabULOUS at the Well Characterized Biologicals conference in Washington DC on October 21. The product, which complements FabRICATOR, has already been tested by key customers in Europe and the US with positive results and is now being launched in a first phase through in-house sales and later through the company’s global distributor network.

“This new product is a completely new enzyme that offers our customers several alternative strategies for characterization of antibody molecules. Fabulous is a great addition to FabRICATOR and by using the two products together, the customer gets a fast method to characterize the hinge region of an antibody in detail, which is important in many antibody drug conjugate (ADC) drug candidates. Our R & D activities focus on products that can save time, simplify work and improve the quality of analyses for our customers and FabULOUS is a great example of it,” says Sarah Fredriksson, CEO of Genovis.

Genovis has developed the product FabULOUS, which can quickly generate fragments from IgG molecules. FabULOUS is a recombinant enzyme that cleaves IgG specifically, thereby generating three intact fragments of an antibody. The yield is high, the reaction rate is fast and the enzyme does not generate any further fragmentation. Customers will primarily use the product for screening of new drug substances and quality control of new antibody-based drugs.


Genovis’ subsidiary GeccoDots introduces groundbreaking product and presents pipeline project results

September 9, 2013 | |
On September 17 GeccoDots will launch a new product intended for the preclinical market for medical imaging. The launch will occur at WMIC* in Savanna, George, USA. At the same time, new results from the Nanomotus project and the Sentinel Node project will be presented at the scientific portion of the conference.

The new product is a nanoparticle that serves as a contrast agent in magnetic resonance imaging, PET/SPECT, optical imaging and ultrasound. It is packaged in an extremely easy-to-use kit and takes less than 30 minutes to prepare. A single nanoparticle can be used in several different imaging techniques. The technology paves the way for comparative and supplementary studies using different imaging techniques, known as multimodal imaging, without needing to switch contrast agents. The product is being launched under the FeoDot Easy Label brand.

Six-month report January-June 2013

August 28, 2013 | |
April–June

· Net sales rose by 92% to SEK 2,200k (1,148k).

· Loss after financial items was SEK 3,903k (loss: 4,430k).

· Comprehensive income was a loss of SEK 3,852k (loss: 4,392k).

· Comprehensive income per share basic and diluted totaled SEK -0.27 (-0.53).

· Cash flow from operating activities during the period was SEK -3,251k (-4,474k).

· Cash and cash equivalents at the end of the period amounted to SEK 10,851k (14,772k).

· The rights issue in April raised about SEK 13.8 million before issue expenses for Genovis.

· Genovis and the wholly owned subsidiary GeccoDots are moving to new premises in Medicon Village, Lund, in September.

January – June

· Net sales rose by 96% to SEK 4,106k (2,092k).

· Loss after financial items was SEK 7,860k (loss: 8,438k).

· Comprehensive income was a loss of SEK 7,799k (loss: 8,363k).

· Comprehensive income per share basic and diluted totaled SEK -0.60 (-1.10).

· Cash flow from operating activities during the period was SEK -7,680k (-7,356k).

Events after the end of the period

Genovis signed an agreement with Respiratorius to test and evaluate RESP-3000 as a new biomarker for early diagnosis of cardiovascular disease using a “PET” camera. Genovis is coordinating the work, but GeccoDots AB, Genovis’ wholly owned subsidiary, will conduct the final evaluation. The evaluation is expected to be completed in late 2013 or early 2014. The agreement includes the option for Genovis to acquire technology and patents relating to RESP-3000 in preclinical applications and Genovis intends to initiate negotiations for an acquisition if the tests show favorable results.

Comments from CEO Sarah Fredriksson

We continued to prioritize meetings with clients during the spring. This strategy produces results and during the second quarter sales jumped 92%, number of orders rose by 36% and the average order value was up 42% compared with last year. An analysis of individual orders shows that the increase in number of orders is mainly attributable to new customers, while established customers account for the increase in volume per order. The number of publications and presentations at conferences featuring our products continue to grow. The FDA, Pfizer, and Bruker were among the participants at the American Society for Mass Spectrometry’s annual meeting in early June who featured methods and results based on the use of FabRICATOR. Marketing activities will hopefully yield long-term results, even if in the short-term they require an investment in staff, webinars, workshops, and an increased number of conferences and meetings.

The results for the second quarter and the first six months of the year improved somewhat compared with 2012. It is encouraging to see that our persistent long-term efforts are effective, although we have a ways to go before the protein engineering portfolio generates a positive result. To achieve this objective we will develop our business to include commercial production at the customer. Sales today are generated by products that the customer uses to screen new candidates, in production development and in preclinical development.

Our primary goal for 2013 is to continue to achieve robust sales growth. In September and October we will therefore launch two products in the protein engineering portfolio. Earlier product launches in the protein engineering portfolio have been well-received by existing customers and sales of smaller test volumes usually take off quickly. During the autumn our subsidiary GeccoDots will also introduce itself to the market and the first product will be launched in September.

Lund in August

Sarah Fredriksson

Genovis evaluates new technology for early diagnosis of cardiovascular disease

August 14, 2013 | |
Genovis signed an agreement with Repiratorius to test and evaluate RESP-3000 as a new biomarker for early diagnosis of cardiovascular disease using PET-Imaging. Genovis is coordinating the work, but GeccoDots AB, Genovis’ wholly owned subsidiary, will conduct the final evaluation. Work will begin immediately and the evaluation is expected to be completed in late 2013 or early 2014.

The agreement includes the option for Genovis to acquire technology and patents relating to RESP-3000 in preclinical applications and Genovis intends to initiate negotiations for an acquisition if the tests show favorable results.

“The collaboration with Respiratorius provides us with a unique opportunity to develop innovative technology in medical imaging of patients with coronary artery disease, the most common type of heart disease which also includes myocardial infarction. The project is an excellent fit with the development projects and products now being commercialized at GeccoDots and has great commercial potential. We look forward to carrying out the evaluation study in cooperation with Respiratorius and researchers at Lund University,” says Sarah Fredriksson, CEO of Genovis.

About Respiratorius

Respiratorius AB (publ) develops drug candidates with the ambition to launch drugs for common diseases such as cancer, chronic obstructive pulmonary disease (COPD) and severe asthma. The project portfolio also includes a project for improving the diagnosis of cardiovascular disease (biomarker for PET-Imaging).

Genovis is moving to new premises

June 13, 2013 | |

Genovis and the wholly owned subsidiary GeccoDots are joining forces and moving in September from their premises in Lund and Malmö, respectively, to new premises in Medicon Village, Lund.

“The new premises are ideal for our operations and the Medicon Village concept opens the door for inspiring meetings between academia, new technology and business. Unexpected ideas are often born in cross-border encounters between cutting edge expertise and enterprise,” says Sarah Fredriksson, CEO of Genovis.

Communiqué from Annual General Meeting for Genovis AB (publ) April 25, 2013

April 26, 2013 | |

The following decisions were adopted at the Annual General Meeting:

The balance sheet and income statement were ratified.

The Board of Directors and the CEO were discharged from liability.

The Board shall consist of seven ordinary members with no alternates until the next Annual General Meeting.

Ebba Åsly Fåhraeus, Thomas Laurell, Kenth Petersson, Carina Schmidt, Jacob Engellau, Peter Ragnarsson and Erik Walldén were re-elected as Board members.

Ebba Åsly Fåhraeus was re-elected as Chairman of the Board.

A Nominating Committee shall be formed and consist of representatives of the four largest shareholders at September 30, 2013, who are not members of the Board.

Guidelines for remuneration for the CEO and other leading employees were ratified in accordance with the Board’s proposal.

Genovis rights issue oversubscribed

April 22, 2013 | |
The issue was subscribed for SEK 15,129, 289, which it was oversubscribed by 10%.

Of the total issue volume of 3,945,189 shares, 77% were subscribed for with preferential rights. The rights issue raised about SEK 13.8 million before issue expenses for Genovis. Statements of account will be sent on April 23, 2013, to allot shares subscribed for without preferential rights.

INTERIM REPORT JANUARY – MARCH 2013

April 16, 2013 | |
January–March

· Net sales increased by 102 percent to SEK 1,906k (944k).

· Loss after financial items was SEK 3,957k (loss: 4,008k).

· Comprehensive income was a loss of SEK 3,946k (loss: 3,970k).

· Comprehensive income per share basic and diluted totaled SEK -0.33 (-0.57).

· Cash flow from operating activities during the period was SEK -4,429k (-2,871k).

· Cash and cash equivalents at the end of the period amounted to SEK 1,543k (3,959k).

· Genovis was allocated SEK 1.575 million in research support from VINNOVA (the Swedish Agency for Innovation Systems). VINNOVA chose to support the project “Nanoparticles in movement as contrast agents in medical ultrasound.”

· Genovis signed an agreement worth about USD 100,000 for a project for a major pharmaceutical company. The project will adapt Genovis’ products from the protein engineering portfolio to the customer’s technology platform.

· With the authorization of the 2012 Annual General Meeting, the Board of Directors of Genovis decided to conduct a rights issue for existing shareholders. The company will raise about SEK 13.8 million before issue expenses, which are expected to be SEK 600,000, if the rights issue is fully subscribed.

Comments from CEO Sarah Fredriksson

Net sales during the first quarter increased by more than 100 percent compared with the same quarter last year, which is gratifying since we want to continue to maintain a strong pace in sales and business growth. The average order value increased by 42 percent and the number of orders increased by 40 percent. We are pleased that we continue to reach completely new customers. Consolidated expenses increased by 19 percent compared with the first quarter of 2012; the increase is mainly due to increased marketing expenses as well as increased payroll costs. When comparing expenses on a consolidated basis with the preceding quarter, Q4 2012, however, they decreased by about 16 percent, mainly due to significantly lower royalty costs, and because we invested in more long-term marketing efforts during the fourth quarter.

During the first quarter we signed an agreement for a development project with a major pharmaceutical company. The one-year project is worth about USD 100,000 for Genovis. Recording of revenues will begin in the second quarter. The project will adapt Genovis’ products from the protein engineering portfolio to the customer’s technology platform. We look forward to starting the project, which in turn can have a positive impact and strengthen sales in the medium term.

In late March we also learned that VINNOVA, the Swedish Agency for Innovation Systems, chose to support a project in the nano portfolio with about SEK 1.6 million. The project has already been running for about 18 months and resulted in a new method for creating contrast for ultrasound. The contrast occurs when nanoparticles move in tissue. This small movement can be perceived with ultrasound. We developed this completely new and unique method together with Associate Professor Tomas Jansson’s research group at the Faculty of Engineering, Lund University (LTH). This grant from VINNOVA provides an injection of capital, inspiration and encouragement, while facilitating and strengthening our partnership with the research group at LTH.

Sarah Fredriksson, CEO

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