Torbjörn Bjerke, CEO, comments: “The beginning of 2014 has been intense for Karolinska Development and for many of our portfolio companies. We are working focused with business development in the portfolio which has resulted in two deals in the first quarter. We have also reached some important development milestones in Aprea and Pharmanest. At the same time we have experienced a technical issue with the formulation of Akinion’s candidate drug AKN-028 for acute myeloid leukemia which we currently are addressing. Although this means that the project is delayed, we have good reasons to believe that this can be resolved and our positive view of the long term potential in the program is unchanged.
During the quarter, NovaSAID initiated a partnership with Cadila Pharmaceuticals to develop innovative treatments in inflammation and pain management. The partnership agreement stipulates that Cadila will bear all costs through to Phase II, making it possible to take the business forward with substantial resources. If development is successful, licensing and sales revenue will be shared by the two companies.
In addition, Dilafor AB and Hong Kong-based Lee's Pharmaceutical Holdings Ltd entered into a license agreement that gives Lee's Pharmaceutical the right to manufacture, develop and commercialize tafoxiparin for obstetrics and gynecological indications in China, Hong Kong, Macao and Taiwan. The agreement include both upfront payment, milestone payments and royalties on future sales. Importantly, Dilafor has the right to use all data generated in the partnership to develop the product in the rest of the world including Europe and the US. We are confident that Lee’s Pharmaceutical will be an excellent partner for Dilafor in the additional development and commercialization of tafoxiparin and that the agreement will enhance the value of potential future partnership agreements in markets that Dilafor has the right to.
Pharmanest AB announced positive results from a feasibility study of its local anesthetic SHACT in hysteroscopy. Pharmanest has previously presented strong data with SHACT in connection with Intra Uterine Device (IUD) insertion. Based on these positive data, Pharmanest is preparing the application for registration in the EU and at the same time seeking a partner.
In April, we announced that dosing of Aprea’s APR-246 has been initiated in a Phase I/II trial after the reporting period. The study combines APR-246 with chemotherapy in patients with relapsed platinum sensitive high grade serous ovarian cancer. About 60% of all ovarian cancer patients have mutated p53 and are less responsive to platinum than patients with wild type p53, and here APR-246 potentially may have a significant role.
Now we look forward to further developing our portfolio companies and at the right time seeking partners to take the projects to market and thereby add value to the patients and to our shareholders.”
Summary of significant events during the first quarter 2014
- NovaSAID initiated partnership with Cadila Pharmaceuticals to develop innovative treatments in inflammation and pain management
- Karolinska Development AB appointed new Chief Financial Officer
- Dilafor entered into license and partnership agreement with Lee’s Pharmaceutical
- New trial data suggest that SHACT could benefit women undergoing hysteroscopies
Summary of significant events after the first quarter 2014
- Dosing initiated in Phase I/II clinical trial of APR-246 in ovarian cancer
Financial summary
| Investment entity | 2014 | 2013 | 2013 | |
| Amounts in SEKm | Jan-Mar | Jan-Mar | Full-year | |
| Income statement | ||||
| Effect of change in fair value | -6.1 | 14.1 | -154.7 | |
| Net profit/loss | -18.4 | 65.9 | -103.8 | |
| Balance sheet | ||||
| Cash and cash equivalents | 17.3 | 414.0 | 35.3 | |
| Short-term investments | 153.7 | 0.0 | 165.3 | |
| Total cash, cash equivalents and short-term investments | 171.0 | 414.0 | 200.6 | |
| Share information | ||||
| Earnings per share before and after dilution (SEK) | -0.38 | 1.36 | -2.15 | |
| Net asset value per share (SEK) | 40.3 | 44.1 | 42.7 | |
| Equity per share (SEK) | 40.2 | 44.0 | 40.5 | |
| Share price, last trading day in the reporting period (SEK) | 26.3 | 29.0 | 30.9 | |
| Portfolio company information | ||||
| Portfolio companies net cash¹ | 74.6 | 100.5 | 111.6 | |
| Investments in portfolio companies | 15.5 | 15.7 | 266.2 | |
| Of which investments not affecting cash flow | 0.0 | 3.8 | 68.1 | |
| Valuation of total portfolio holdings | 1,738.9 | 1,652.0 | 1,729.5 | |
| ¹Portfolio companies net cash is comprised of the sum of cash, cash equivalents and short-term investments less external loans in portfolio companies regardless of Karolinska Development’s ownership interest | ||||
For further information, please contact: Torbjörn Bjerke, CEO, Karolinska Development AB Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com
Christian Tange, CFO, Karolinska Development AB Phone: +46 (0)73 712 14 30, e-mail: christian.tange@karolinskadevelopment.com
Benjamin Nordin, IRO, Karolinska Development AB Phone: +46 (0)73 093 60 80, e-mail: benjamin.nordin@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development AB Karolinska Development aims to create value for patients, researchers, investors and society by developing innovations from world class science into differentiated products that can be partnered. The business model is to: SELECT the most commercially attractive medical innovations that can potentially satisfy unmet medical needs; DEVELOP innovations to the stage where the greatest return on investment can be achieved; and COMMERCIALIZE the innovations through the sale of companies or out-licensing of products. An exclusive deal flow agreement with Karolinska Institutet Innovations AB, along with other cooperation agreements with leading universities, delivers a continuous flow of innovations. Today, the portfolio consists of 34 projects, of which 17 are in clinical development. For more information, please visit www.karolinskadevelopment.com.
Karolinska Development is listed on NASDAQ OMX. Karolinska Development may be required to disclose the information provided herein pursuant to the Securities Markets Act.
