Genovis AB has signed a strategic cooperation agreement with Alphalyse A/S
Much of Genovis’ customer base works with mass spectrometry in the analysis of biologics. Genovis and Alphalyse will actively market new methods based on Genovis’ products, which directly focus on this customer group. This strategy will strengthen Genovis, which will be able to expand its customer base and thus increase sales.
“Alphalyse has world-leading expertise in mass spectrometric analysis of proteins. Their knowledge of sample processing and the limitations of current enzymes enable us to use existing and upcoming products in applications where they will have maximum value. We are very pleased to have the opportunity to market and develop methods of mass spectrometric analysis together with Alphalyse and I am convinced that this will be a long-term and mutually rewarding collaboration,” says Fredrik Olsson, CEO of Genovis.
“Genovis has unique enzymes and products that allow for better and faster analysis of protein-based drugs when using mass spectrometry. The collaboration with Genovis provides Alphalyse with a major advantage in our work helping pharmaceutical companies that develop products such as monoclonal antibodies, antibody drug conjugates for cancer treatment and de-novo-sequencing of new antibodies in the discovery phase,” says Ejvind Mørtz, COO of Alphalyse.
MORE ABOUT ALPHALYSE
Alphalyse is a contract research company (CRO) with cutting-edge expertise in mass spectrometry-based protein analysis for research, production and clinical development of native and recombinant proteins. Through its PICK ‘n POST™ protein analysis services and customized analytical services, the company offers a range of unique high-quality protein analyses to identify and characterize biopharmaceutical proteins such as monoclonal antibodies and vaccines. The services are used by the biotech industry, pharmaceutical companies and academic research groups worldwide. Alphalyse has offices in Odense, Denmark and Palo Alto, California, USA.
MORE ABOUT GENOVIS PRODUCTS
Genovis’ products are marketed under the name “Smart Enzymes” and are used to process antibodies and split them into smaller fragments. To date, the products have been marketed primarily for characterization of biologics. Customers use small quantities of the products in a large number of samples to divide the drug candidate into smaller fragments, which are then analyzed. All of the products are also highly effective in production of large quantities of antibody fragments, which are required in several different studies in preclinical drug discovery.
YEAR-END REPORT JANUARY-DECEMBER 2015
· Net sales rose by about 67 percent to SEK 3,499k (2,099k).
· Gross profit/loss improved by SEK 1,959 to SEK –137k (loss: 2,096k).
· Gross margin improved, 74 percent in 2015, compared with 63 percent in 2014.
· Profit/loss after tax improved by SEK 4,799k to SEK -3,062k (loss: 7,861).
· Comprehensive income improved by SEK 4,757 to SEK -3,104k (loss: 7,861k).
· Comprehensive income per share totaled SEK -0.08 (-0.36).
· Cash flow from operating activities was SEK -3,940k (-5,676k).
· GingisKHAN™Fab kit, Genovis launched a further development of the product GingisKHAN™ that will be marketed under the name GingisKHAN™Fab kit.
Summary: full-year 2015
· Net sales improved by about 61% to SEK 13,268k (8,252k).
· Gross profit/loss improved by SEK 4,550k to SEK -1,429k (loss: 5,979k).
· Gross margin improved, 82 percent in 2015, compared with 58 percent in 2014.
· Profit/loss after tax improved by SEK 2,143k to SEK -19,906 (loss: 22,049). Non-recurring expenses had a negative impact on earnings of SEK 6,071k.
· Comprehensive income improved by SEK 2,121k to SEK -19,928k (loss: 22,049).
· Comprehensive income per share totaled SEK -0.66 (-1.02).
· Cash flow from operating activities was SEK -16,117k (-22,193).
· Genovis reorganized, discontinued operations in the subsidiary GeccoDots and sold the intellectual property rights behind the Nanomotus project to the inventors against future royalties.
COMMENTS FROM FREDRIK OLSSON, CEO
In early 2014 we decided to change our marketing and sales strategy and shift completely to direct sales with our own organization in the most important markets. In 2015 we were able to fully implement this decision. The effect is clear: we increased sales for the full year by more than 60 percent to SEK 13.3 million. Direct contact with the end customer is a strong contributing factor for growth in each quarter of 2015 compared with 2014.
We streamlined operations during the year to focus on products based on our unique enzymes, which are principally used in the biopharma industry. The restructuring process had a negative impact on twelve-month earnings of about SEK 6 million, attributable to impairment losses and personnel costs. We are now entering 2016 with a cost-effective organization that is adapted for growth.
Our gross margin improved significantly during the year: 82 percent in 2015, compared with 58 percent in 2014. Our production is now efficient and scalable to be able to meet increased demand.
In the fourth quarter of 2015 our sales surged by 67 percent compared with the corresponding period in 2014. Exchange rate effects in this context are marginal (approximately 7 percent), which means we are growing organically – and this is important for Genovis’ employees, as well as for our shareholders. This achievement reaffirms our conviction to follow and further strengthen our sales strategy in 2016.
Genovis develops and sells products that meet the current and future needs of our customers. In order to continue doing what is necessary, we need not only innovative and talented employees, but also the resources to further strengthen the marketing organization. We intend to further expand our marketing campaigns in 2016 by strengthening existing markets with more resources to drive sales even stronger. We will also seek a local presence in markets where we see significant potential, especially in Asia. We also plan to launch products for new markets and applications to drive growth further during the year. My assessment is that these initiatives will double sales within 18 months and create an organization that can handle continued rapid growth.
Genovis has always had a clear strategy in which interaction with customers guides how we conduct business – every day! This strategy applies to our products, customer care, support and delivery, as well as the simplicity of ordering our products. Our main focus is to solve challenges for our customers in a better way than our competitors do and I am convinced that we have the right strategy to optimally increase value for Genovis shareholders moving forward.
Genovis launches new enzyme product
The GingisKHAN®Fab kit is a further development of the product GingisKHAN®,, which rapidly and specifically splits antibodies (IgG1) into Fab and Fc fragments. With the GingisKHAN®Fab kit, the customer can quickly and easily obtain intact Fab fragments with the right quality to be used further in the analysis.
Today, about 80 percent of all antibody-based drugs are based on IgG1 molecules, human immunoglobulin of subclass 1, which is also the most common antibody in the natural composition of human antibodies.
“The GingisKHAN®Fab kit is the basis for expanding our product portfolio toward new business areas, mainly in the biopharma industry. Our existing products are mainly used in mass spectrometry, but now we are broadening usage toward other analysis technologies. The GingisKHAN®Fab kit improves the quality and yield of the fragments that the customer generates and we have also simplified processing and reduced the time by more than 75 percent compared with currently available technologies on the market,” says Fredrik Olsson, CEO of Genovis.
For more information about the GingisKHAN®Fab kit: www.genovis.com/gingiskhan-fabkit
GingisKHAN® is a registered EU trademark
Genovis Interim Report January – September 2015
· Net sales increased by 105% to SEK 3,358k (1,639k).
· Gross profit improved by SEK 3,084 to SEK 822k (-2,262k).
· Loss after tax worsened to SEK 6,647k (loss: 5,545k). Non-recurring expenses had a negative impact on earnings of SEK 4,888k. Excluding non-recurring expenses, the result is better than last year.
· Comprehensive income was a loss of SEK 6,470k (loss: 5,545k).
· Comprehensive income per share totaled SEK -0.18 (-0.25).
· Cash flow from operating activities was SEK -2,698k (-4,537k).
· Cash and cash equivalents including short-term investments amounted to SEK 6,145k (12,003k) at the end of the period.
· Genovis reorganized, discontinued operations in the subsidiary GeccoDots and sold the intellectual property rights behind the Nanomotus project to the inventors against future royalties.
Summary of the first nine months of 2015
· Net sales rose by about 59% to SEK 9,770k (6,153k).
· Gross profit/loss improved by SEK 2,590 to SEK –1,293k (-3,883k).
· Loss after tax worsened to SEK 16,844k (loss: 14,187k). Non-recurring expenses had a negative impact on earnings of SEK 6,036k. Excluding non-recurring expenses, the result is better than last year.
· Comprehensive income was a loss of SEK 16,825k (loss: 14,187k).
· Comprehensive income per share totaled SEK -0.61 (-0.66).
· Cash flow from operating activities was SEK -12,177k (-16,515k).
Comments from CEO Fredrik Olsson
It is extremely satisfying to note that we more than doubled our sales in the third quarter compared with the same period last year. So far this year, sales have increased by almost 60 percent and for the first time in years, we can report a positive gross profit. Cash flow also improved substantially in the third quarter compared with previous quarters this year and the same period last year.
Operating earnings before depreciation (EBITDA) improved by almost SEK 3 million compared with the corresponding period last year. Even compared with the first and second quarters of this year, the improvement in earnings in the third quarter is significant.
Operations in GeccoDots were discontinued in the third quarter and we have divested parts of the company’s intellectual property rights to the inventors against future royalties. By discontinuing operations at GeccoDots we will also reduce costs moving forward, primarily relating to patent and personnel costs. Although some restructuring costs were already taken in the second quarter, most are charged to the current quarter. In connection with the restructuring, we also decided to write down all intangible assets in GeccoDots, which has a negative impact on earnings. In total, restructuring costs for the third quarter amounted to SEK 4.9 million; excluding these costs, third quarter results improved significantly compared with previous quarters this year and clearly demonstrate our commitment to move toward a profitable business.
Genovis’ product portfolio consists of two types of enzymes, proteases and glycosidases. The market for proteases for use throughout the life science area is approximately USD 100 million annually. All proteases that Genovis introduced in this market since 2010 currently account for about 2 percent of the market, and we intend to further increase our market share moving forward. Since its inception, Genovis has built on the idea that a good business is based on delivering a unique product that has a high value for the customer. Genovis has also chosen a path that has not been trodden before, and our philosophy for achieving high value is that it is necessary to go where others have not gone before. The products launched earlier this year continue to grow beyond expectations and thereby contribute to reducing Genovis’ dependence on individual products. The products we will launch in the future will also be unique and solve important problems for our customers.
We can conclude that the third quarter confirms that we are improving our business through close relationships with our customers. Solving our customers’ problems and challenges with unique products will drive our sales even further. We will therefore continue to prioritize sales and marketing with the launch of new products.
In addition, the number of scientific publications in which our enzymes were used almost doubled this year compared with last year, yet another confirmation of the uniqueness and relevance of our products to our customers. I am extremely pleased and proud of all employees at Genovis who contribute their energy and creativity every day to find new and more effective solutions to our customers’ problems.
Genovis AB (publ) to publish Q3 2015 report ahead of schedule
The Interim Report for January-September, which was to be announced on November 23, 2015, will be published ahead of schedule. The new publication date for the report is November 3, 2015.
Genovis is reorganizing and closing its subsidiary GeccoDots
To date, Genovis has focused solely on customers who work with antibodies, but will now focus fully on the enzyme market and this fall will launch the first products aimed at all customers working in protein characterization.
“For the Group and everyone who works at Genovis it is extremely important to have a clear focus and dedicate all resources to the enzyme business. Both existing and new enzyme products will contribute to continued increased sales and help Genovis to achieve a positive cash flow,” says Fredrik Olsson, CEO of Genovis.
SIX-MONTH REPORT JANUARY – JUNE 2015
· Net sales rose by about 39% to SEK 3,526k (2,530k).
· Loss after financial items was SEK 5,287k (loss: 4,803k).
· Comprehensive income was a loss of SEK 5,348 (loss: 4,803k).
· Comprehensive income per share basic and diluted totaled SEK -0.22 (-0.22).
· Cash flow from operating activities during the period was SEK -4,624k (-5,767k).
· Cash and cash equivalents including short-term investments amounted to SEK 9,240k (16,829k) at the end of the period.
· Genovis launched a follow-up FabRICATOR® that is marketed under the name FabRICATOR®Z for customers primarily in the pharmaceutical industry for preclinical research.
· Genovis presented data from the mAbCHECK project. The system is based on Genovis’ enzymes combined with Capsenze’s unique technology and Bruker’s cutting-edge expertise in mass spectrometry.
January – June
· Net sales rose by about 42% to SEK 6,412k (4,514k).
· Loss after financial items was SEK 10,292k (loss: 8,642k).
· Comprehensive income was a loss of SEK 10,355k (loss: 8,642k).
· Comprehensive income per share basic and diluted totaled SEK -0.45 (-0.41).
· Cash flow from operating activities during the six-month period was SEK -9,478k (-11,980k).
Comments from CEO Fredrik Olsson
We are extremely pleased to be able to present the best quarterly sales figures in the history of the Company. Sales surged 39 percent compared with the same period last year and 22 percent against the previous quarter. In the first half of 2015 sales climbed 42 percent compared with last year, which means that after the first six months we reached nearly 80 percent of total sales for 2014. Sales increased significantly in both the US market (42 percent) and the European market (37 percent) compared with last year. Gross profit for the second quarter improved significantly compared with the corresponding period last year. However, legal expenses attributable to the judicial process in the US still had a negative impact, which we expect will diminish over time.
As a result of our successful strategy to transition to direct sales, customers have quickly accepted new products and placed orders. Our customer base is steadily growing, which allows more interaction with our customers. Contact with the end customer is crucial in order to rapidly identify market trends and needs. Direct sales strengthen our future product development and sales, which is an important tool to be able to compete in the US and European markets.
Now that we face clear competition in the US, prompt delivery and good customer service are crucial. Sales growth in the first six months strengthens our conviction that Genovis is on the on the right track. In particular, it shows that we can hold our own in a globally competitive market. With our subsidiary Genovis Inc. and warehouse in the US, we can now provide next-day delivery throughout North America.
We can conclude that the new products GingisKHAN and FabRICATOR® Z, which were launched in mid-March and May, respectively, are already responsible for more than 10 percent of total sales since they were introduced. This shows that Genovis can develop new products that customers need. It is extremely gratifying that during the first six months we have shown that we can compete with the largest companies in both the US and Europe. We will continue to introduce new products in the autumn to further strengthen the product portfolio and expect continued positive sales growth.
Genovis rights issue oversubscribed by 63 %
Of the total issue volume of 14,563,768 shares, 96 % were subscribed for with preferential rights. The rights issue raised about SEK 14.5 million before issue expenses for Genovis. Statements of account will be sent on June 5, 2015, to allot shares subscribed for without preferential rights.
Genovis to present data from mAbCHECK™ system on ASMS June 4.
The automated mAbCHECK™ technology allows researchers within the biopharma industry to rapidly obtain critical product quality data via a completely automated workflow. Researchers will no longer have to do manual sample handling, as every step will be handled automatically in very short time.
– We are exited to show data for the first time using the mAbCHECK™ technology, which utilizes our enzymes in a completely new setting. This first application proves that the system is able to rapidly generate important analytical results to our customers developing monoclonal antibodies for therapeutic use. The mAbCHECK platform will help us expand our customer base and the use of our enzyme within biopharma process development. We plan to accelerate the development of this technology and start beta testing together with customers this fall, says Fredrik Olsson, CEO of Genovis.
Additional information about mAbCHECK:
The mAbCHECK system is designed to sample a bioreactor and automatically digest and separate individual antibody subdomains for direct analysis by mass spectrometry or other technologies. The system is built on the VersAFLo liquid handling system from Capsenze adapted for use with Genovis enzyme. The first data presented at ASMS will show rapid glycan analysis of monoclonal antibodies and Fc-fusions proteins using Bruker UHR MaXis Mass Spectrometry. Glycan pattern is an important quality attribute that developers and producers of therapeutic antibodies need to monitor.
Press release from Genovis AB (publ) Annual General Meeting May 5, 2015
The Annual General Meeting adopted the following resolutions:
- The balance sheet and income statement were adopted after the Meeting resolved to reduce the statutory reserve by SEK 6,178,264 to cover the loss so that SEK 0 is carried forward.
- The Board and the Chief Executive Officer were discharged from liability.
- The Board shall consist until the next AGM of five ordinary members without deputies.
- Ordinary members Kenth Petersson, Jacob Engellau, Mikael Lönn and Lena Mårtensson Wernrud were re-elected. Sarah Fredriksson was elected to serve as a new Board member. Sarah Fredriksson was elected Chairperson of the Board. Erik Walldén declined re-election.
- Remuneration will be paid to the Board of Directors in the amount of SEK 75,000 to Board members and SEK 150,000 to the Chairperson of the Board.
- Remuneration to the auditors will be paid on approved account.
- A Nomination Committee will be formed with representatives of the four largest shareholders at September 30, 2015.
- Guidelines for remuneration to the Chief Executive Officer and other senior executives were adopted in accordance with the Board’s proposal.
- The Meeting resolved to reduce share capital by SEK 3,276,847.80 for allocation to the unrestricted fund.
- The Meeting resolved to amend the Articles of Association so that the share capital shall be not less than five million two hundred fifty thousand (SEK 5,250,000) kronor and not more than twenty-one million (SEK 21,000,000) kronor and that the number of shares that may be issued by the company shall be not less than twenty-one million (21,000,000) and not more than eighty four million (84,000,000).
- The Meeting resolved to approve the Board’s proposal to conduct a preferential rights issue in which three (3) existing shares entitle the holder to subscription for two (2) new shares at a subscription price of SEK 1. As a result of this decision share capital could increase by a maximum of SEK 3,640,942 through the issuance of up to 14,563,768 shares.
- The Meeting decided on a directed share issue to the guarantors of the rights issue on the same terms as the rights issue. As a result of this resolution share capital could increase by a maximum of SEK 113,338.75 through the issuance of a maximum of 453,355 shares. Payment for the issuance shall be by set-off.
Swedish Shareholders’ Association, representing 176 shares, protested against the decision.
- The AGM resolved on the authorization to issue shares with or without preferential rights for existing shareholders. As a result of this resolution, share capital could increase by a maximum of SEK 1,850,000 through the issuance of a maximum of 7,400,000 shares.
Swedish Shareholders’ Association, representing 176 shares, protested against the decision.
