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Karolinska Development

Interim / Quarterly Report Oct 21, 2014

3168_10-q_2014-10-21_7a72e543-08d1-48dd-b7e9-75812e6289e9.pdf

Interim / Quarterly Report

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Interim Report January – September 2014 Q3

Karolinska Development AB (publ) Corporate Identity Number 556707-5048

For more information, please contact:

Bruno Lucidi, Chief Executive Officer +46 72 245 98 92

Christan Tange, Chief Financial Officer +46 73 712 14 30

Significant events during the third quarter

  • Klaus Wilgenbus appointed as acting CEO
  • Umecrine Mood announced final results from an exploratory Phase I/II study with UC1010 in premenstrual dysphoric disorder
  • Bruno Lucidi appointed as CEO in Karolinska Development oncology companies

Significant events after the third quarter

  • Bruno Lucidi appointed as new CEO of Karolinska Development
  • Forendo Pharma announced the US licensing of fispemifene to Apricus Biosciences
  • Clanotech received orphan drug designation in the EU
  • OssDsign's Cranioplug received marketing approval in the US
  • Athera initiated Phase I study with cardiovascular antibody PC-mAb
  • Karolinska Development presented an updated strategy
  • Danske Bank appointed as financial advisor

Financial Summary

2013 2013
2014 Jul-Sep 2014 Jan-Sep 2013
SEKm Jul-Sep (restated) Jan-Sep (restated) (restated)
Condensed Income Statement
Change in fair value of portfolio companies -107.7 -80.6 -291.1 -16.6 -140.0
Net profit/loss -128.1 -91.6 -336.0 -58.1 -157.3
Condensed Balance sheet
Cash, cash equivalents and short-term
investments 112.3 232.1 200.7
Share information
Earnings per share, weighted average, before
and after dilution (SEK) -2.65 -1.90 -6.96 -1.20 -3.25
Net asset value per share (SEK) (Note 1) 33.9 42.6 40.7
Equity per share (SEK) (Note 1) 33.6 42.6 40.5
Share price, last trading day in the reporting
period (SEK) 13.0 31.0 30.9
Portfolio information
Portfolio companies´net cash¹) -2.8 186.9 111.6
Investments in portfolio companies 7.2 2.7 56.5 176.9 266.2
Of which investments not affecting cash flow 0.0 0.0 6.7 3.8 68.1
Fair value of portfolio holdings 1,494.0 1,767.8 1,729.5

¹ ) Portfolio companies' net cash is comprised of sum of cash, cash equivalents and short-term investments less external loans in portfolio companies regardless of Karolinska Development's ownership interest (cash, cash equivalents and short-term investments amounting to SEK 92.7m less external loans amounting to SEK -95.5m)

Bruno Lucidi, CEO

CEO's Comment

My appointment as CEO of Karolinska Development coincides with the announcement of a new strategy for the future investments in our portfolio. I am convinced that these strategic measures will be a good foundation for our continued efforts to realize value in the portfolio.

Our portfolio companies have been selected into a Strategic and an Opportunistic Portfolio that we further specify in this report. We will focus our financial and managerial efforts in the Strategic Portfolio and develop those towards important near-to mid-term value inflection point within specialized care areas and orphan diseases such as Dilaforette's program in sickle-cell disease or OssDsign's advanced implant technology. At the same time we will utilize a more differentiated investment strategy depending on the properties of the programs within the portfolio. In order to maximize value and future returns, the investment horizon for each asset will for example vary depending on the optimal exit strategy within the specific therapeutic fields.

We were pleased to announce Forendo Pharma's licensing agreement granting Apricus Bioscience US development and commercialization rights for fispemifene after the reporting period. The agreement does not only signify the Forendo team's expert abilities in developing drug candidates that targets organ specific hormone mechanisms, but also exemplifies the value potential in our portfolio of carefully selected innovations based on outstanding science. According to the deal terms, Forendo is entitled to a total of USD 310 million in milestone and upfront payments, common shares in Apricus and tiered double-digit royalties on US net sales. The fispemifene development program will focus on hypogonadism, a condition that results in low testosterone levels in men, where two Phase II studies has shown therapeutic potential. In addition, Apricus will expand the development into other urological conditions where the fispemifene mode of action is believed to able to ameliorate symptoms.

It is important to emphasize that the Opportunistic Portfolio also hold a considerable value potential. During the third quarter, Umecrine Mood presented final data from the company's exploratory Phase I/II study in patients with premenstrual dysphoric disorder (PMDD). While the study's primary endpoint was not met, as we announced during the summer, post-hoc analyses correcting for some important issues identified in the study, shows significant reductions in symptoms compared to placebo. Should these data be confirmed in new studies, UC1010 could make a profound difference to the millions of women who suffer from PMDD. Based on these data, Umecrine Mood are now in the process of finding a partner to continue the clinical development of UC1010.

In October, Athera Biotechnologies passed an important milestone in the development of PC-mAb for the treatment of cardiovascular disease when the first patients were dosed in a Phase I study. In addition, Clanotech received orphan drug designation in the EU for the development of the company's lead candidate within glaucoma surgery. Furthermore, OssDsign received 510(k) clearance by the US FDA for the burr hole plug Cranioplug.

In our continuous effort to evaluate the portfolio, the fair value of Biosergen has written down as the company has not been able to secure external financing to the systemic fungal infection in preclinical development.

I am looking forward to leading Karolinska Development in this decisive period for the company. With a new strategy in place, we will move forward determinately to unlock the value in our portfolio. Our belief that investing in outstanding life science innovations will shape future treatments for patients that today are not offered adequate treatment options. The management in our portfolio companies are key to the success of our ambitions. The new strategy will also take into consideration the specific needs within the portfolio of accountable and experienced leadership.

Bruno Lucidi Chief Executive Officer

Net asset value

Karolinska Development invests in medical innovations that addresses unmet medical needs and develop them to the phase when the highest return on investments may be generated by IPO, trade sale of companies or licensing of projects. Karolinska Development intends to finance its investments through capital injections from its shareholders, proceeds from trade sales of shares in its portfolio companies, and dividends from its portfolio companies. Karolinska Development holds a number of portfolio companies at varying degrees of ownership in the form of subsidiaries, joint ventures, associates, as well as other long term securities holdings. The holdings are valued at fair value.

Company Overview

New Strategy

After the end of the quarter, Karolinska Development's Board and management have decided on a new and more focused strategy to optimize and unlock the value in the existing portfolio.

Firstly, Karolinska Development will focus on company programs with drug candidates, which address relevant unmet medical needs of patients with serious debilitating and/or lifethreatening diseases, so-called orphan diseases. This Strategic Portfolio will contain companies with scientifically and commercially attractive programs with significant near- to mid-term value inflection points.

The strategic portfolio will be supported by a second portfolio, an Opportunistic Portfolio, with a number of company programs that have entered into third party development agreements or already have products on the market. Through pay-offs from near- to midterm exits in the opportunistic portfolio, Karolinska Development will have further investment capabilities to invest in the Strategic Portfolio.

Secondly, Karolinska Development will enforce and reward strong leadership at portfolio company level by requiring management in portfolio companies to have a strong focus on deal flow and return on investments. Karolinska Development will strengthen its active ownership approach and remain actively engaged as a committed investor, e.g. via its representation on the boards, either directly or via experienced professional independent board directors, and will provide the right incentives for management to be responsible and accountable for running and developing their respective companies

Thirdly, Karolinska Development will maximize value creation in the company programs through a differentiated asset-centric and patient-focused investment approach. This means that Karolinska Development - as part of every investment decision – will consider significant valueinflection points, exit scenarios and capital requirements to be reached. As a consequence, company programs may be supported throughout development, if relevant from a value inflection point of view.

Finally, Karolinska Development will broaden the portfolio companies' access to capital by building strong investor relations and by proactively seeking syndicated financing together with other specialized life science investors. The proactive syndication strategy enables Karolinska Development to strengthens governance, not only by its own representation in the company boards, but also to add to the boards further committed and experienced life science expertise from co-investors or its network of specialized investors.

Karolinska Development's Board and management are convinced this new strategy will put Karolinska Development in a stronger position to take advantage of the business opportunities that the portfolio companies offer.

Karolinska Development KDEV Investments
(KDEV Investments owned 87% by KD
and 13% by Rosetta Capital)
Strategic
portfolio
Forendo Pharma
OssDsign
۰
Pharmanest
٠
Umecrine Cognition
٠
XSpray
۰
Net Asset Value:
MSEK 343
Investment Strategy: Proceeds from exits/new
funds, existing KD funds and
co-investors
Aprea
٠
Akinion
Clanotech
Dilaforette
٠
Net Asset Value:
MSEK 573
Investment Strategy: Primarily existing KD and
Rosetta Capital funds combined
with co-investors
Opportunistic
portfolio
Athera
BioArctic
Lipidor
Net Asset Value:
MSEK128
Investment Strategy: Limited investments
required, co-investors.
- Axelar
· NovaSaid
- BioSergen
· Pergamum
Dilafor
· Promimic
m.
· Umecrine Mood
$-$ ISS
· NeoDynamics
Net Asset Value:
MSEK 450
Investment Strategy: Rosetta Capital, license deals,
co-development, co-investors.

-

Significant events during the third quarter

Bruno Lucidi appointed as CEO in Karolinska Development oncology companies.

Bruno Lucidi was appointed Chief Executive Officer of the wholly owned subsidiary KDev Oncology and the portfolio companies Aprea and Akinion Pharmaceuticals. KDev Oncology assists the clinical portfolio companies in developing cancer drugs and attracting strategic partners and co-investors.

Umecrine Mood announced final results from an exploratory Phase I/II study with UC1010 in premenstrual dysphoric disorder

In an exploratory double blind, randomized multicenter study, 120 patients with PMDD received placebo or one of two doses of UC1010 during one menstrual cycle. The objectives of the trial were to study the safety and efficacy of UC1010. The primary efficacy end-point was assessed using a validated daily rating scale (DRSP), to measure the average late luteal phase symptoms in patients treated with UC1010 vs. those given placebo. As previously reported in June 2014, the primary efficacy end-point of the study was not met.

Following final analysis of the study data, post hoc analysis revealed that two key variables that impacted the study outcome: (i) despite patient randomization, the baseline follicular phase symptoms showed a skewed distribution between study groups. Correcting for individual follicular symptoms indicate a statistically significant improvement of symptoms by UC1010 compared to placebo in the total study population (p<0.05 for the total premenstrual symptom score). (ii) due to inconsistencies in the assessment of ovulation, 32% of patients did not receive treatment as intended according to the protocol. Inclusion only of patients treated as intended results in significant beneficial effects of UC1010 (both doses) compared to placebo, both for the cardinal PMDD symptoms (p=0.003) and total premenstrual symptom scores (p=0.006) as well as for the impairment score (p=0.01), which specifically measures the impact of symptoms on daily life in the week prior to menstruation. There were no safety concerns with UC1010 and it was well tolerated. These encouraging data based on post hoc analysis needs to be confirmed in future trial.

Klaus Wilgenbus was appointed acting CEO of Karolinska Development

Torbjörn Bjerke left his position as CEO on September 30 and Klaus Wilgenbus was appointed acting CEO until the appointment of a new permanent CEO. Klaus Wilgenbus simultaneously left his directorship at the Karolinska Development Board.

Significant events after the third quarter

Bruno Lucidi appointed as CEO of Karolinska Development

Bruno Lucidi was appointed CEO of Karolinska Development on October 15. Bruno Lucidi has extensive international experience in the pharmaceutical, biotechnology and financial industry. In his previous positions as founding CEO of Idenix and Chairman of Pharmasset, he has contributed to maturing the companies to a level that eventually resulted in both companies being acquired by multinational pharmaceutical companies. He has also held senior positions within Bristol-Myers Squibb, Johnson & Johnson and at GlaxoSmithKline. Since September 8, 2014, Bruno Lucidi is CEO of the Karolinska Development's wholly owned subsidiary KDev Oncology as well as of the portfolio companies Aprea and Akinion. Bruno will keep these positions and will assume his new role as CEO of Karolinska Development.

About Forendo Pharma Oy

Forendo Pharma's development programs are based on research conducted at Turku University, Oulu University and Åbo Akademi. The company is specialized in pharmaceutical development within tissue specific hormone mechanisms.

About OssDsign AB

The mission of OssDsign is advancing bone repair based on its innovative bioceramics technology platform. OssDsign has started sales in selected EU countries of lead product OssDsign® Craniomosaic, a next generation patient-specific implant for cranial repair. OssDsign was founded by researchers at the Karolinska University Hospital and Uppsala University.

About Clanotech AB

Clanotech is a Swedish biotech company active in ophthalmology and based on research conducted at Karolinska Institutet. Clanotech's lead candidate is an inhibitor of the α5β1-integrin receptor which is present in fibroblast and on vascular endothelial cells. α5β1-integrin is strongly up-regulated in fibroblast when switching to the fibrotic state and in scars after glaucoma surgery , which is the company's primary therapeutic focus.

About Athera Biotechnologies AB

Athera is a pharmaceutical company focused on development of drugs and diagnostics around antiinflammatory targets. The company's current programs were initiated in 2005 and are based on innovative research at Karolinska Institutet.

Forendo Pharma announced the US licensing of fispemifene to Apricus Biosciences

Forendo Pharma announced today that it has entered into a definitive agreement to out-license the US development and commercialization rights for fispemifene to Apricus Biosciences Inc. Under the terms of the agreement, Apricus will make a \$5 million upfront cash payment to Forendo, and will transfer approximately 3.6 million Apricus common shares, representing \$7.5 million in value based on the 360-day average market price of the Apricus stock. The agreement includes additional potential clinical and regulatory milestones payments to Forendo for up to \$45 million, including FDA approval, as well as commercial milestone payments totaling up to \$260 million based on achieving specified annual net sales of fispemifene levels up to \$1 billion in the US. Apricus will also pay tiered double-digit royalties based on net sales once the product is commercialized. Apricus will be responsible for the clinical development and costs of the program, as well as all future commercialization in the US. Apricus anticipates to commence a Phase IIb clinical trial during the first half of 2015 to confirm the optimal fispemifene doses to treat men with secondary hypogonadism, and provide proof-of-concept data to evaluate the antiestrogenic and anti-inflammatory effects on the lower urinary tract and prostate in aging men.

OssDsign's Cranioplug received marketing approval in the US

OssDsign AB today that its bioceramic burr hole plug - Cranioplug - had received 510(k) clearance by the US Food and Drug Administration (FDA). In the 500,000 open brain surgeries carried out annually worldwide, burr holes and circular cuts between the burr holes are made to allow the surgeon to remove a piece of the skull - the bone flap - and thereby access the brain for the intended intervention. The bone flap is then re-anchored to the surrounding skull bone after the procedure is completed. Cranial fixation today uses metal-based devices that anchor the bone flap to the skull. These devices typically leave the burr hole open, to the cosmetic and psychological detriment of patients. Cranioplug, based on bone-like ceramic materials, in contrast to metal-based competitors, has the potential of integrating with surrounding bone.

Clanotech received orphan drug designation in the EU

Clanotech AB received orphan drug designation by the European Medicines Agency (EMA) for prevention of scarring post glaucoma filtration surgery. Clanotech's lead substance, an α5β1 integrin antagonist, has anti-angiogenic, anti-fibrotic and anti-inflammatory properties that are expected to benefit the wound healing processes following glaucoma surgery. The orphan drug designation will significantly shorten a future market approval process and reinforce market exclusivity for a launched product.

Athera initiated Phase I study with cardiovascular antibody PC-mAb

Athera Biotechnologies AB announced that first dosing of healthy volunteers has been done in a Phase I study of its fully human antibody PC-mAb. Athera's fully human monoclonal antibody PCmAb is intended for the treatment of patients with cardiovascular disease, who are at an increased risk of secondary events and death. It is known from previous published studies that low plasma levels of endogenous antibodies against phosphorylcholine (anti-PC) are linked to poor prognosis in acute heart attack patients, as well as in patients with peripheral arterial disease undergoing vein graft surgery. The current Phase I study will include up to 48 healthy volunteers in a single ascending dose protocol with safety outcome measures.

Danske Bank appointed as financial advisor

Danske Bank has been appointed as financial advisor to Karolinska Development and will assist in the evaluation of upcoming financing alternatives.

Portfolio Development

As a part of Karolinska Development's strategy, the portfolio is divided into a Strategic Portfolio and an Opportunistic Portfolio, as below. During the third quarter Umecrine Mood announced final results from a Phase I/II study in premenstrual dysphoric disorder, Forendo Pharma selected a drug candidate for the company's planned clinical studies in endometriosis and OssDsign has initiated a wider market launch of its implant product and also received FDA approval for a follow-up product to the company's cranial implant. After the end of the third quarter, Athera initiated a Phase I study with PC-mAb

Strategic Portfolio

PHARMACEUTICALS Indication Owner
ship*
Research
Phase
Preclinical
Development
Phase I Phase II
Pharmanest AB SHACT Pain at IUD-insertions 63%
Aprea AB APR-246 Ovarian cancer 62%
Akinion Pharmaceuticals AB AKN-028 Acute myeloid leukemia 81%
Pharmanest AB SHACT Pain at hysteroscopies 63%
Forendo Pharma Oy FP-5677 Endometriosis 21%
Dilaforette AB Sevuparin Sickle-cell disease 64%
Clanotech AB CLT28643 Glaucoma surgery 80%
Umecrine Cognition AB Hepatic encephalopathy 67%
TECHNOLOGY Application Owner
ship*
Concept
Development
Prototype Development Product Launch
OssDsign AB Cranio PSI Cranial implants 26%
XSpray Microparticles AB RightSize™ Drug formulation technology 63%

Opportunistic Portfolio

PHARMACEUTICALS Indication Owner
ship*
Research
Phase
Preclinical
Development
Phase I Phase II
Axelar AB AXL1717 Non-small cell lung cancer 43%
BioArctic Neuroscience AB BAN2401 Alzheimer's 3%
Dilafor AB Tafoxiparin Protracted labor 49%
Dilaforette AB Sevuparin Malaria 64%
Forendo Pharma Oy Fispemifene Hypogonadism 21%
Pergamum AB DPK-060 Infected eczema 56%
Pergamum AB DPK-060 External otitis 56%
Pergamum AB PXL01 Surgical adhesions 56%
Umecrine Mood AB UC1010 PMDD and severe PMS 38%
Pergamum AB LL-37 Venous leg ulcers 56%
Athera Biotechnologies AB PC-mAb Acute coronary syndrome 65%
Biosergen AS BSG005 Systemic fungal infection 60%
Pergamum AB PXL181 Skin infection 56%
NovaSAID AB Inflammatory pain 77%
TECHNOLOGY Application Owner
ship*
Concept
Development
Prototype Development Product Launch
Promimic AB HAnano SurfaceTM Bone implant surface 31%
Athera Biotechnologies AB CVDefine® Cardiovascular diagnostic kit 65%
Inhalation Sciences Sweden AB PreciseInhale™
Respiratory precision dosing
68%
Lipidor AB AKVANO™ Topical drug delivery 51%
NeoDynamics AB Fourier Fine needle biopsy 18%
NeoDynamics AB PRFA Tumor ablation 18%

*Includes indirect ownership Status as per October 20, 2014 Solid color = Completed phase Shaded color = Current phase

Financial development – Investment Entity*

Revenue

During the nine-month period ended 30 September 2014, the effect of the change in fair value of portfolio investments amounted to SEK -291.1m (SEK -16.6m).

During the third quarter ended 30 September 2014, the effect of the change in fair value of portfolio investments amounted to SEK -107.7m (SEK -80.6m).

Value development

During the nine-month period, the Investment Entity's operating loss amounted to SEK -331.9m (SEK -60.1m), a change of SEK -271.8m compared with the same period in 2013. During the ninemonth period, several projects in the portfolio met development milestones, which had a positive effect on the fair values of these portfolio companies. At the same time a number of projects in the portfolio developed at a slower rate than previously projected, which resulted in negative changes in fair values. Operating loss during the nine-month period was affected by a change in fair value of the holding by KDev Investments in Axelar AB amounting to -220.7 due to the partnering progress not reaching expectations, and in Biosergen AS amounting to -28.3m due to lack of financing for future development. During the nine-month period, the fair value was affected positively by adjustments of the discount rates (WACC) (see 'Information on fair value measurement in level 3' in note 2). Other expenses have decreased by SEK 8.1m year-over-year. Expenses for legal services, consultants and travel have decreased year-over-year, and the comparative period's operating result was charged with one-off expenses of SEK 3.5m related to the Rosetta transaction. During the period, personnel costs were charged with severance provisions for the former CEO of SEK 8.7m, including pension and social security expenses.

The portion of the change in fair value affecting income related to portfolio holdings amounted to SEK -291.1m (SEK -16.6m) during the nine-month period.

During the third quarter, the Investment Entity's operating loss amounted to SEK -124.4m (SEK -92.8m), a change of SEK -31.6m compared with the same period in 2013. The portion of the change in fair value affecting income related to portfolio holdings amounted to SEK -107.7m (SEK -80.6m) during the third quarter. The change in fair value of the holding by KDev Investments in Biosergen AS amounted to -28.3m during the third quarter. Other expenses have decreased by SEK 2.4m year-over-year due to lower expenses for legal services, consultants and travel. During the quarter, personnel costs were charged with severance provisions for the former CEO of SEK 8.7m, including pension and social security expenses.

Results

The Investment Entity's loss before tax during the nine-month period amounted to SEK -336.0m (SEK -58.1m).

The Investment Entity's loss before tax during the third quarter amounted to SEK -128.1m (SEK -91.6m).

Investments in portfolio companies

Investments in portfolio companies during the nine-month period amounted to SEK 56.5m (SEK 176.9m).

During the nine-month period investments were made in KDev Investments' portfolio at SEK 33.4m (Dilaforette Holding AB, SEK 10.7m; Dilafor AB, SEK 6.0m, Umecrine Mood AB, SEK 4.8m; Aprea AB, SEK 4.6m; Clanotech AB, SEK 2.8m; Pergamum AB, SEK 1.8m; Promimic AB, SEK 1.8m; and Inhalation Sciences Sweden AB, SEK 0.9m) as well as in Umecrine Cognition AB, SEK 11.8m; XSpray Microparticles AB, SEK 4.9m; Pharmanest AB, SEK 4.1m; and KCIF Co-Investment Fund KB, SEK 2.3m.

Investments in portfolio companies during the third quarter amounted to SEK 7.2m (SEK 2.7m).During the third quarter investments were made in KDev Investments' portfolio at SEK 6.4m (Aprea AB, SEK 4.6m and Pergamum AB, SEK 1.8m) as well as in Umecrine Cognition AB, SEK 0.8m.

* The Investment Entity refers to the Parent Company, Karolinska Development AB, and all subsidiaries, joint ventures, associated companies and other long-term securities holdings which are all recognized at fair value.

Financial position (comparative figures refer to 31 December 2013)

The Investment Entity's equity to total assets ratio was 98% (99%) on 30 September 2014 and equity amounted to SEK 1,621.9m (SEK 1,957.6m).

Cash, cash equivalents and short-term investments in the Investment Entity amounted to SEK 112.3m (SEK 200.7m), of which SEK 69.8m is provisionally allocated for anticipated follow-on investments in the KDev Investments portfolio. In addition, up to SEK 75.0m will be allocated to these portfolio companies as additional liquidity becomes accessible to Karolinska Development. Total assets amounted to SEK 1,651.3m (SEK 1,979.6m).

Change in accounting policy to Investment Entity

Karolinska Development is an Investment Entity in accordance with IFRS 10 Consolidated Financial Statements. Karolinska Development has retroactively changed its accounting policy in accordance with IFRS 10 and IAS 8. Note 3 shows effects of the change in accounting policy for the comparative periods.

Financial development – Parent Company

During the nine-month period ended 30 September 2014, the Parent Company's operating loss amounted to SEK -55.4m (SEK 61.1m), a change of SEK -116.5m compared with the same period in 2013. Operating profit for the comparative period includes a capital gain of SEK 123.7m on the sale of shares in KDev Investments AB to Rosetta. The operating result for the nine-month period was charged with write-downs of shares in portfolio companies of SEK -14.5m. Other expenses have decreased by SEK 8.1m year-over-year. Expenses for legal services, consultants and travel have decreased year-over-year, and the comparative period's operating result was charged with one-off expenses of SEK 3.5m related to the Rosetta transaction. During the period, personnel costs were charged with severance provisions for the former CEO of SEK 8.7m, including pension and social security expenses.

During the third quarter, the Parent Company's operating loss amounted to SEK -30.9m (SEK - 17.4m), a change of SEK -13.5m compared with the same period in 2013. The operating result for the third quarter was charged with write-downs of share in portfolio companies of SEK -14.2m. Other expenses have decreased by SEK 2.4m year-over-year due to lower expenses for legal services, consultants and travel. During the quarter, personnel costs were charged with severance provisions for the former CEO of SEK 8.7m, including pension and social security expenses.

The Parent Company's net loss during the nine-month period amounted to SEK -57.6m (SEK 62.0m).

The Parent Company's net loss during the third quarter amounted to SEK -34.3m (SEK -16.2m).

Information on risks and uncertainties

Parent Company and Investment Entity

Valuation risks

Companies active in pharmaceutical development and medical technology at an early phase are, by their very nature, difficult to value, as lead times are very long and development risks are high. Due to the uncertainty and subjectivity in these assessments, the estimated value of the portfolio may deviate substantially from future generated value. This is largely due to sensitivities in the valuation calculations to movement of expected milestone or exit dates, costs of trials and similar assumptions, which are not necessarily accounted for in arriving at an actual deal value in negotiations with partners. Decisions about investment strategies may also have an impact on the valuations.

Project development risks

Risks and uncertainties are primarily associated with investments in portfolio companies and the development of projects in these companies. The operations of the portfolio companies consist of the development of early stage pharmaceutical projects. By their very nature such operations are distinguished by very high risk and uncertainty in terms of results.

Financial risks

Financial risks consist of investments in portfolio companies as well as risks in the management of liquid assets.

Future financing needs

Future investments in new and current portfolio companies will require additional capital in order for Karolinska Development to maintain or increase its share of the value in these companies. As an investor, however, we can make no guarantees that the necessary capital to fund the projects can be obtained on favorable terms or that such capital can be obtained at all. Investments in portfolio companies will decrease compared to the prior year due to license agreements that several portfolio companies have entered into licensing agreements with partners, expected increases in EU subsidies and an increased share of third party financing. However, the value of the portfolio companies in general assumes additional future investments to be made in order to materialize the values in the portfolio companies. If Karolinska Development does not invest as planned, this could have a negative impact on Karolinska Development's valuation of the portfolio companies.

As of September 30, 2014, it is the board's view that the liquidity available to the Karolinska Development AB is sufficient for the parent company's current operations before investments for a period of at least 12 months from the balance sheet date. Consequently the report has been prepared under the assumption of going concern.

No new risk areas have been identified since 31 December 2013. For a detailed description of risks and uncertainties, see the annual report 2013.

The Board of Directors and the CEO hereby certify that this interim report gives a true and fair view of the operations, financial position and results of operations of the Parent Company and the Investment Entity and describes the material risks and uncertainties faced by the company.

Solna, 21 October 2014

Chairman

Bo Jesper Hansen Charlotte Edenius Vlad Artamonov

Hans Wigzell Carl Johan Sundberg Henrijette Richter

Robert Holland Bruno Lucidi

CEO

Dates for publication of financial information

Year-end report January-December 2014 18 February 2015 Annual report 2014 10 April 2015 Interim report January-March 2015 6 May 2015 Annual General Meeting 20 May 2015 Interim report January-June 2015 26 August 2015 Interim report January-September 2015 25 November 2015

Karolinska Development is required by law to publish the information in this interim report. The information was published on 21 October 2014.

This interim report, together with additional information, is available on Karolinska Development's website, www.karolinskadevelopment.com.

For further information, please contact: Bruno Lucidi, CEO +46 72 245 98 92

Christan Tange, CFO +46 73 712 14 30

See also www.karolinskadevelopment.com

Karolinska Development AB (publ) Tomtebodavägen 23A SE-171 65 Solna, Sweden

Note: This report is a translation of the Swedish year-end report. In case of any discrepancies, the Swedish version shall prevail.

Auditors' review report

Introduction

We have reviewed the condensed financial information (interim report) for Karolinska Development AB (publ) (the "Investment Entity")as per 30 September 2014 and the nine-month period ended on this date. The Board of Directors and the CEO are responsible for the preparation and presentation of this financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this financial information based on our review.

Scope of review

We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (ISA) and other generally accepted auditing standards. The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Therefore, the conclusion expressed based on a review does not give the same level of assurance as a conclusion based on an audit.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the interim report for the Investment Entity is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, and for the Parent Company in accordance with the Swedish Annual Accounts Act.

Stockholm, 21 October 2014 Deloitte AB

Thomas Strömberg Authorized Public Accountant

Financial statements

Condensed income statement for the Investment Entity

SEK 000 Note 2014
Jul-Sep
2013
Jul-Sep
(restated)
2014
Jan-Sep
2013
Jan-Sep
(restated)
2013
Full year
(restated)
Revenue 1,094 1,567 3,450 4,003 4,948
Other expenses -3,174 -5,572 -11,679 -19,818 -25,292
Personnel costs -14,759 -8,230 -34,151 -27,637 -38,290
Depreciation of tangible non-current assets -53 -2 -159 -7 -114
Change in fair value of shares in portfolio companies 2 -107,739 -80,571 -291,098 -16,619 -139,996
Result from sale of shares in portfolio companies 205 - 1,736 - -
Operating profit/loss -124,426 -92,808 -331,901 -60,078 -198,744
Financial net -3,700 1,179 -4,113 1,953 41,429
Profit/loss before tax -128,126 -91,629 -336,014 -58,125 -157,315
Deferred taxes - - - - -
Curren taxes - - - - -
NET PROFIT/LOSS FOR THE PERIOD -128,126 -91,629 -336,014 -58,125 -157,315

Earnings per share for the Investment Entity

SEK 000 Note 2014
Jul-Sep
2013
Jul-Sep
(restated)
2014
Jan-Sep
2013
Jan-Sep
(restated)
2013
Full year
(restated)
Earnings per share, weighted average, before and
after dilution
-2.65 -1.90 -6.96 -1.20 -3.25
Number of shares, weighted average 48,287,132 48,352,304 48,287,132 48,371,208 48,350,016

Condensed statement of comprehensive income for the Investment Entity

SEK 000 Note 2014
Jul-Sep
2013
Jul-Sep
(restated)
2014
Jan-Sep
2013
Jan-Sep
(restated)
2013
Full year
(restated)
Net/profit loss for the period -128,126 -91,629 -336,014 -58,125 -157,315
Total comprehensive income for the period -128,126 -91,629 -336,014 -58,125 -157,315

Condensed balance sheet for the Investment Entity

SEK 000 Note 30 Sep 2014 30 Sep 2013
(restated)
31 Dec 2013
(restated)
31 Dec 2012
(restated)
ASSETS
Non-current assets
Tangible non-current assets 370 1 529 9
Shares in portfolio companies, at fair value through profit or
loss
1,494,027 1,767,772 1,729,465 1,827,190
Loans receivable from portfolio companies 2,744 30,152 5,894 12,856
Other financial assets 38,113 38,113 38,113 8,907
Total non-current assets 1,535,254 1,836,038 1,774,001 1,848,962
Current assets
Accounts receivable 1 12 3 106
Receivables from portfolio companies 600 698 254 563
Other short-term receivables 1,819 3,795 3,225 2,476
Prepaid expenses and accrued income 1,295 2,995 1,477 2,463
Short-term investments, at fair value through profit or loss 104,416 167,174 165,334 174,160
Cash and cash equivalents 7,915 64,908 35,323 108,680
Total current assets 116,046 239,582 205,616 288,448
TOTAL ASSETS 1,651,300 2,075,620 1,979,617 2,137,410
EQUITY AND LIABILITIES
Equity
Share capital 24,266 24,266 24,266 24,266
Share premium 1,768,179 1,768,179 1,768,179 1,768,179
Retained earnings -170,592 263,589 165,159 323,060
Total equity 1,621,853 2,056,034 1,957,604 2,115,505
Long-term liabilities
Other financial liabilities 11,373 9,878 9,438 10,889
Total long-term liabilities 11,373 9,878 9,438 10,889
Current liabilities
Accounts payable 3,115 1,391 2,426 2,510
Liabilities to portfolio companies 442 453 442 473
Other current liabilities 1,162 1,566 1,593 1,512
Accrued expenses and prepaid income 13,355 6,298 8,114 6,521
Total current liabilities 18,074 9,708 12,575 11,016
Total liabilities 29,447 19,586 22,013 21,905
TOTAL EQUITY AND LIABILITIES 1,651,300 2,075,620 1,979,617 2,137,410

Condensed statement of changes in the Investment Entity's equity

Equity attributable to Parent Company's shareholder
SEK 000 Note Share capital Share
premium
Retained
earnings
Total Non
controlling
interests
Total equity
Opening equity at 1 Jan 2014 24,266 1,768,179 165,159 1,957,604 1,957,604
Net profit/loss for the period -336,014 -336,014 -336,014
Total comprehensive income for the period -336,014 -336,014 -336,014
Effect of incentive programs 263 263 263
Closing equity at 30 Sep 2014 24,266 1,768,179 -170,592 1,621,853 1,621,853
Opening equity at 1 Jan 2013 (restated) 24,266 1,768,179 323,060 2,115,505 - 2,115,505
Net profit/loss for the period -58,125 -58,125 -58,125
Total comprehensive income for the period -58,125 -58,125 -58,125
Effect of incentive programs 1,137 1,137 1,137
Share repurchase -2,483 -2,483 -2,483
Closing equity at 30 Sep 2013 (restated) 24,266 1,768,179 263,589 2,056,034 - 2,056,034
Opening equity at 1 Jan 2013 (restated) 24,266 1,768,179 323,060 2,115,505 - 2,115,505
Net profit/loss for the year -157,315 -157,315 -157,315
Total comprehensive income for the year -157,315 -157,315 -157,315
Effect of incentive programs 1,897 1,897 1,897
Share repurchase -2,483 -2,483 -2,483
Closing equity at 30 Dec 2013 (restated) 24 266 1,768,179 165,159 1,957,604 - 1,957,604
Opening equity at 1 Jan 2012 24,266 1,768,179 -122,547 1,669,898 354,294 2,024,192
Effect of change in accounting policy to
Investment Entity
3 404,640 404,640 -354,294 50,346
Adjusted opening equity at 1 Jan 2012 24,266 1,768,179 282,093 2,074,538 - 2,074,538
Net profit/loss for the year 43,210 43,210 43,210
Total comprehensive income for the year 43,210 43,210 43,210
Share repurchase -2,243 -2,243 -2,243
Closing equity at 31 Dec 2012 (restated) 24,266 1,768,179 323,060 2,115,505 - 2,115,505

Condensed statement of cash flows for the Investment Entity

2014 2013
Jan-Sep
2013
Full year
SEK 000 Note Jan-Sep (restated) (restated)
Operating activities
Operating profit/loss -331,901 -60,078 -198,744
Adjustments for items not affecting cash flow
Depreciation 159 7 114
Change in fair value 2 291,098 16,619 139,996
Result from sale of shares in portfolio companies -1,736 - -
Other items 9,017 2,245 2,171
Proceeds from short-term investments 946 1,072 1,062
Interest paid/received 334 1,753 5,312
Cash flow from operating activities before changes in
working capital and operating investments
-32,083 -38,382 -50,089
Cash flow from changes in working capital
Increase (-)/Decrease (+) in operating receivables 397 -2,051 1,116
Increase (+)/Decrease (-) in operating liabilities -3,256 -292 2,575
Operating investments
Proceeds from sales of shares in portfolio companies 1,923 190,793 194,924
Acquisitions of shares in portfolio companies -49,866 -173,126 -198,120
Loans provided to portfolio companies -6,394 -25,581 -27,750
Proceeds from sales of short-term investments¹) 61,871 7,350 7,105
Investments in tangible non-current assets - - -635
Cash flow from operating activities -27,408 -41,289 -70,874
Financing activities
Repurchased shares - -2,483 -2,483
Cash flow from financing activities - -2,483 -2,483
Cash flow for the period -27,408 -43,772 -73,357
Cash and cash equivalents at the beginning of the year 35,323 108,680 108,680
CASH AND CASH EQUIVALENTS AT THE END OF PERIOD 7,915 64,908 35,323

Supplemental disclosure1)

CASH AND CASH EQUIVALENTS AT THE END OF PERIOD 7,915 64,908 35,323
Short-term investments, market value at closing date 104,416 167,174 165,334
CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTSAT THE END OF PERIOD 112,331 232,082 200,657

1) Surplus liquidity in the investment entity is invested in interest-bearing instruments and is recognized as short-term investments with a maturity exceeding three months. These investments are consequently not reported as cash and cash equivalents and are therefore included in the statements of cash flows from operating activities. The supplemental disclosure is presented to provide a total overview of the investment entity's available funds including cash, cash equivalents and short-term investments described here.

Condensed income statement for the Parent Company

SEK 000
Note
2014
Jul-Sep
2013
Jul-Sep
2014
Jan-Sep
2013
Jan-Sep
2013
Full year
Net sales 1,094 1,567 3,450 4,003 4,948
Revenue 1,094 1,567 3,450 4,003 4,948
Other expenses -3,174 -5,570 -11,679 -19,816 -25,293
Personnel costs -14,759 -8,230 -34,151 -27,637 -38,290
Depreciation of tangible non-current assets -53 -2 -159 -7 -114
Impairment losses on shares in subsidiaries, joint
ventures, associated companies and other long-term
securities holdings -14,154 -5,131 -14,523 -19,162 -24,701
Result from sale of shares in portfolio companies 154 0 1,685 123,678 90,909
Operating profit/loss -30,892 -17,366 -55,377 61,059 7,459
Financial net -3,360 1,179 -2,178 941 39,855
NET PROFIT/LOSS FOR THE PERIOD -34,252 -16,187 -57,555 62,000 47,314

Condensed statement of comprehensive income for the Parent Company

SEK 000 Note 2014
Jul-Sep
2013
Jul-Sep
2014
Jan-Sep
2013
Jan-Sep
2013
Full year
Net profit/loss for the period -34,252 -16,187 -57,555 62,000 47,314
Total comprehensive income for the period -34,252 -16,187 -57,555 62,000 47,314

Condensed balance sheet for the Parent Company

SEK 000 Note 30 Sep 2014 30 Sep 2013 31 Dec 2013
ASSETS
Non-current assets
Tangible non-current assets 370 1 529
Shares in subsidiaries, joint ventures, associated companies
and other long-term securities holdings 1,111,683 1,023,959 1,070,597
Loans receivable on portfolio companies 2,744 30,152 5,894
Other financial assets 32,746 32,038 32,522
Total non-current assets 1,147,543 1,086,150 1,109,542
Current assets
Accounts receivable 576 562 202
Receivables from subsidiaries 25 148 55
Other receivables 1,819 3,795 3,225
Prepaid expenses and accrued income 1,295 2,995 1,477
Short-term investments 104,416 167,174 165,334
Cash and cash equivalents 7,915 64,908 35,323
Total current assets 116,046 239,582 205,616
TOTAL ASSETS 1,263,589 1,325,732 1,315,158
EQUITY AND LIABILITIES
Equity
Restricted equity
Share capital 24,266 24,266 24,266
Unrestricted equity
Share premium reserve 1,778,253 1,778,253 1,778,253
Accumulated losses -502,989 -551,326 -550,566
Net profit/loss for the period -57,555 62,000 47,314
Total equity 1,241,975 1,313,193 1,299,267
Long-term liabilities
Pension obligations 3,540 2,831 3,315
Total long-term liabilities 3,540 2,831 3,315
Current liabilities
Accounts payable 3,115 1,391 2,426
Liabilities to subsidiaries 442 453 442
Other current liabilities 1,162 1,566 1,594
Accrued expenses and prepaid income 13,355 6,298 8,114
Total current liabilities 18,074 9,708 12,576
Total liabilities 21,614 12,539 15,891
TOTAL EQUITY AND LIABILITIES 1,263,589 1,325,732 1,315,158

Pledged assets and contingent liabilities

SEK 000 Note 30 Sep 2014 30 Sep 2013 31 Dec 2013
Pledged assets 3,540 2,831 3,315
Total 3,540 2,831 3,315

Condensed statement of changes in equity for the Parent Company

Restricted
equity Unrestricted equity
Share Share Accumulated Net profit/loss Total
SEK 000 Note capital premium
reserve
losses for the period equity
Opening equity at 1 Jan 2014 24,266 1,778,253 -550,566 47,314 1,299,267
Appropriation of loss 47,314 -47,314
Net profit/loss for the period -57,555 -57,555
Total 24,266 1,778,253 -503,252 -57,555 1,241,712
Effect of incentive programs 263 263
Closing equity at 30 Sep 2014 24,266 1,778,253 -502,989 -57,555 1,241,975
Opening equity at 1 Jan 2013 24,266 1,778,253 -397,269 -152,711 1,252,539
Appropriation of profit -152,711 152,711
Net profit/loss for the period 62,000 62,000
Total 24,266 1,778,253 -549,980 62,000 1,314,539
Effect of incentive programs 1,137 1,137
Share repurchase -2,483 -2,483
Closing equity at 30 Sep 2013 24, 266 1,778,253 -551,326 62,000 1,313,193
Opening equity at 1 Jan 2013 24,266 1,778,253 -397,269 -152,711 1,252,539
Appropriation of profit -152,711 152,711
Net profit/loss for the year 47,314 47,314
Total 24,266 1,778,253 -549,980 47,314 1,299,853
Effect of incentive programs 1,897 1,897
Share repurchase -2,483 -2,483
Closing equity at 31 Dec 2013 24,266 1,778,253 -550,566 47,314 1,299,267

Notes to the financial statements

NOTE 1 Accounting policies

This report has been prepared in accordance with the International Accounting Standard (IAS) 34 Interim Financial Reporting and the Annual Accounts Act. The accounting policies applied to the Investment Entity and the Parent Company correspond, unless otherwise stated below, to the accounting policies and valuation methods used in the preparation of the most recent annual report.

Information on the Parent Company

Karolinska Development AB (publ), Corporate identity Number 556707-5048, is a limited liability company with its registered office in Solna, Sweden. Karolinska Development AB aims to create value for investors, patients and researchers by developing innovations from world-class science into products that can be sold or out-licensed with high returns. The business model is to select the most commercially attractive medical innovations, 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. At the end of the nine-month period ended 30 September 2014 the portfolio consisted of 33 projects, of which 16 are in clinical development.

New and revised accounting principles 2014

Karolinska Development AB ("Karolinska Development" or the "Company"), together with its subsidiaries, is an investment entity according to IFRS 10 Consolidated Financial Statements, which took effect for financial years beginning on 1 January 2014, with early adoption permitted. Pursuant to the rules for investment entities, Karolinska Development does not consolidate its wholly owned subsidiaries. Separate financial statements are instead prepared for Karolinska Development AB and its subsidiaries (the "Investment Entity" or the "Group"), where subsidiaries, joint ventures, associated companies and other financial investments are measured at fair value in the statement of financial position with changes in value in profit or loss in accordance with IAS 39 Financial Instruments: Recognition and Measurement. According to the Swedish Financial Reporting Board, these separate financial statements meet the requirements for consolidated financial statements according to the Annual Accounts Act. Karolinska Development has also adopted the other new and amended consolidation standards in the "package of five" as of 1 January 2014: IFRS 10 Consolidated Financial Statements, IFRS 11 Joint Arrangements, IFRS 12, Disclosure of Interests in Other Entities, IAS 27 Separate Financial Statements, and IAS 28 Investments in Associates and Joint Ventures. Karolinska Development has implemented the amended accounting policies retroactively in accordance with the transition rules of IFRS 10 Consolidated Financial Statements and IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors. Note 3 shows the effects of the changed accounting principle on the comparative figures for 2013.

Other new or revised IFRS standards and interpretations by IFRIC have had no impact on the Investment Entity or, to the extent that these recommendations are applied to legal entities, on the Parent Company's income or financial position.

Definitions

Portfolio companies: Companies owned fully or in part by Karolinska Development (subsidiaries, joint ventures, associated companies and other long-term securities holdings) which are active in pharmaceuticals, medtech, theranostics and formulation technology.

Fair value: The NASDAQ Stockholm regulations for issuers require companies listed on NASDAQ Stockholmto apply the International Financial Reporting Standards, IFRS, in their consolidated financial statements. The application of the standards allows groups of an investment company nature to apply so-called fair value in the calculation of the carrying amount of certain assets. These calculations are made on the basis of established principles and are not included in the opening accounts of the Group's legal entity, nor do they affect cash flows

Fair value is estimated according to the International Private Equity and Venture Capital Valuation Guidelines and adheres to the guidance of IFRS 13 Fair Value Measurement. Based on the valuation criteria provided by these rules, an assessment is made of each company to determine a valuation method. This takes into account whether the companies have recently been financed or involved with a transaction that includes an independent third party. If there is no valuation available based on a similar transaction, risk adjusted net present value (rNPV) calculations are made of the portfolio companies whose projects are suitable for this type of calculation. In other cases, Karolinska Development's total investment is used as the best estimation of fair value. In one other case, the valuation at the time of the last capital contribution is used.

Net asset value per share: Estimated fair value of the total portfolio, loans receivable from portfolio companies, shortterm investments, cash and cash equivalents, and financial assets less interest-bearing liabilities in relation to the number of shares outstanding on the closing date.

Equity per share: Equity on the closing date in relation to the number of shares outstanding on the closing date.

Interim period: The period from the beginning of the financial year through the closing date.

Reporting period: Current quarter.

NOTE 2 Fair value

The table below shows financial instruments measured at fair value based on the classification in the fair value hierarchy. The various levels are defined as follows:

Level 1- Fair value determined on the basis of observed (unadjusted) quoted prices in an active market for identical assets and liabilities

Level 2- Fair value determined based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3- Fair value determined based on valuation models where significant inputs are based on non‐observable data

The carrying amounts of financial assets and liabilities recorded at amortized cost approximate their fair value.

Fair value as of 30 September 2014

SEK 000 Level 1 Level 2 Level 3 Total
Financial assets
Shares in portfolio companies, at fair value through profit or loss - - 1,494,027 1,494,027
Loans receivable from portfolio companies - 2,744 - 2,744
Other financial assets - - 38,113 38,113
Accounts receivable - 1 - 1
Receivables from portfolio companies - 600 - 600
Short-term investments, at fair value through profit or loss 104,416 - - 104,416
Cash and cash equivalents 7,915 - - 7,915
Total 112,331 3,345 1,532,140 1,647,816
Financial liabilities
Other financial liabilities - - 11,373 11,373
Accounts payable - 3,115 - 3,115
Liabilities to portfolio companies - 442 - 442
Total - 3,557 11,373 14,930

Fair value as of 30 September 2013

SEK 000 Level 1 Level 2 Level 3 Total
Financial assets
Shares in portfolio companies, at fair value through profit or loss - - 1,767,772 1,767,772
Loans receivable from portfolio companies - 30,152 - 30,152
Other financial receivables - - 38,113 38,113
Accounts receivable - 12 - 12
Receivables from portfolio companies - 698 - 698
Short-term investments, at fair value through profit or loss 167,174 - - 167,174
Cash and cash equivalents 64,908 - - 64,908
Total 232,082 30,862 1,805,885 2,068,829
Financial liabilities
Other financial liabilities - - 9,878 9,878
Accounts payable - 1,391 - 1,391
Liabilities to portfolio companies - 453 - 453
Total - 1,844 9,878 11,722

Fair value (level 3) as of 30 September 2014

SEK 000 Shares in
portfolio
companies
Other
financial
assets
Other
financial
liabilities
At the beginning of the year 1,729,465 38,113 9,438
Transfers to and from level 3 - - -
Acquisitions 56,524 - -
Disposals -864 - -
Gains and losses recognized through profit or loss -291,098 - 1,935
Closing balance 30 September 2014 1,494,027 38,113 11,373
Total unrealized gains and losses for the period included in profit or loss -291,098 - -1,935
Gains and losses in profit or loss for the period for assets and liabilities
included in the closing balance
-291,098 - -1,935

There were no transfers between level 1 and 2 during the nine-month period ended 30 September 2014.

Fair value (level 3) as of 30 September 2013

Shares in
portfolio
Other financial Other financial
SEK 000 companies assets liabilities
At beginning of the year 1,827,190 8,907 10,889
Transfers to and from level 3 - - -
Acquisitions 176,911 29,206 -
Disposals -219,710 - -
Gains and losses recognized through profit or loss -16,619 - -1,011
Closing balance 30 September 2013 1,767,772 38,113 9,878
Total unrealized gains and losses for the period included in profit/loss -16,619 - 1,011
Gains and losses in profit/loss for the period for assets and liabilities included in the
closing balance -16,619 - 1,011

There were no transfers between level 1 and 2 during the nine-month period ended 30 September 2013.

The Group recognizes transfers between levels in the fair value hierarchy on the date when an event or changes occur that give rise to the transfer.

Information on fair value measurement in level 3

The valuation of the company's portfolio is based on the International Private Equity and Venture Capital Valuation Guidelines (IPEV) and IFRS 13 Fair Value Measurement. Based on the valuation criteria provided by these rules, an assessment is made of each company to determine a valuation method. This takes into account whether the companies have recently been financed or involved with a transaction that includes an independent third party. If there is no valuation available based on a similar transaction, risk adjusted net present value (rNPV) calculations are made of the portfolio companies whose projects are suitable for this type of calculation. Present value calculations are made with discounted cash flows which comprise:

  • Estimated revenue, which generally consist of one-time milestone payments and royalty payments on sales. The estimated contract value (including royalties) is based on an estimate of sales potential and the buyer's development, manufacturing and marketing costs for the particular project. Contract value is based on a value allocation principle in which the seller's portion of the total value increases with the maturation of the project. In the model, the portfolio company receives approximately 40% of the total rNPV after Phase II.
  • Sales forecasts are made by estimating the total patient population, target patient population, prevalence and treatable patients, market penetration and treatment costs in the US, Europe and the Japanese market. These markets represent approximately 70% of global pharmaceutical sales in 2012 (according to IMS Health).
  • Estimates are made regarding product launch year and time of exit based on development plans. Drug licensing is usually assumed to be carried out after Phase II. For medical technology companies, an exit is usually assumed after launch of the product. Sales are then based on these estimated times together with the product's expected patent expiry, after which sales are assumed to decrease sharply.

  • Estimates are made of the cost of each phase of development based either on the companies' forecasts or according to industry standards.

  • Revenue and expenses are probability adjusted for each phase of development according to accepted statistics.
  • Two different discount rates (weighted average cost of capital, or "WACC") are calculated to discount net cash flow from each project: a "Biotechnology WACC" for the inhouse development period and a lower discount rate from the time the project is expected to be licensed to global pharmaceutical companies, a "Pharma WACC." The components of the discount rates are (i) the risk-free interest, represented by the Swedish Riksbank's 10-year government bond, (ii) the market risk premium, defined as the difference between the expected annuity quote and risk-free interest on the NASDAQ OMX stock exchange, and (iii) the premium supplement for private/small cap companies, a supplement to the market risk premium which represents the risk supplement for project companies with illiquid shares. The premium is collected from companies with a market capitalization under SEK 100m on the NASDAQ OMX stock exchange. The premium supplement for private/small cap companies constitutes the difference between the Biotechnology WACC and Pharma WACC.
  • On 30 September 2014, the Biotechnology WACC was 11.02% (11.90%) and the Pharma WACC was 7.32% (8.20%). The adjustments of the WACC made for the second quarter portfolio valuation was due to changes in the risk-free interest of -0.48% and the market risk premium of -0.4% compared to the previous WACC adjustment on 30 June 2013.

To estimate the effect of changes in the discount rate on the portfolio valuation, WACC has been adjusted by –1 percent and +1 percent.

Sensitivity analysis WACC

WACC adjustment –1% 30 September 2014
Biotech WACC: 11.90%
Pharma WACC: 8.20%
WACC adjustment +1%
SEKm Fair value Change Fair value Fair value Change
Fair value difference for
shares in portfolio
companies 1,664.9 170.8 1,494.0 1,347.7 -146.3

Current tax rates are used and exchange rates calculated according to historical averages.

A change in any of these assumptions affects the valuation and may if significant have a material effect on the Group's results.

The Group has a team responsible for the fair value measurements of the portfolio company holdings required for the financial reporting according to IPEV, including Level 3 fair values. All valuations in Level 3 are based on assumptions and judgments that management considers reasonable under current circumstances. This team reports directly to the Chief Financial Officer. Significant events that have occurred since the above-mentioned time of measurement have been taken into account in the measurement to the extent they would have affected the value on the closing date. Companies that have not been valued after transactions that have included third parties or present value calculations have been valued either at (i) net asset value or (ii) for early-stage development projects; the amount invested by Karolinska Development.

NOTE 3 Transition to investment entity

Karolinska Development has adopted IFRS 10, Consolidated Financial Statements, IFRS 11, Joint Arrangements, IFRS 12, Disclosure of Interests In Other Entities, IAS 27 (revised 2011), Separate Financial Statements and IAS 28, Investments in Associates and Joint Ventures, and has applied the transition guidance amendments to IFRS 10, 11 and 12, all effective 1 January 2013. Karolinska Development has early adopted the investment entity amendments to IFRS 10, IFRS 12 and IAS 27 (the "Amendments"), which are effective 1 January 2014, with early adoption permitted.

IFRS 10 Consolidated Financial Statements, including the Amendments, establish principles for the presentation and preparation of consolidated financial statements. It sets out how to apply the principle of control to identify whether an investor controls an investee and therefore must consolidate the investee. It also sets out the accounting requirements for the preparation of consolidated financial statements. The amendments to IFRS 10 define an investment entity and introduce an exemption from the consolidation requirements for investment entities.

On adoption, Karolinska Development has determined that it meets the definition of an investment entity. As a result, Karolinska Development has amended its accounting policies with respect to its investments in subsidiaries. The subsidiaries, which were previously consolidated, are now measured at fair value through profit or loss. This change in accounting policy has been applied retroactively in accordance with the transition provisions of IFRS 10 and the Amendments to IFRS 10. The transition provisions require retroactive

application in accordance with IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors. However, they specify that an entity needs only to present the quantitative information required by paragraph 28(f) of IAS 8 for the annual period immediately preceding the date of initial application.

IFRS 12, Disclosure of Interests in Other Entities and the amendments to it require entities to disclose significant judgments and assumptions made in determining whether the entity controls, jointly controls, significantly influences or has some other interests in other entities. Entities will also be required to provide more disclosures around certain 'structured entities'. The Amendments also introduce new disclosure requirements related to investment entities. Adoption of the standard has impacted the Karolinska Development's level of disclosures in certain of the above noted areas.

IAS 27 (revised 2011), Consolidated and Separate Financial Statements, including the Amendments, prescribe the accounting and disclosure requirements when an entity prepares separate financial statements. The Amendments require an investment entity as defined in IFRS 10 to present separate financial statements as its only financial statements in cases where it measures all of its subsidiaries at fair value through profit or loss and to disclose that fact.

IFRS 11, Joint Arrangements and IAS 28 (revised 2011), Associates and Joint Ventures and related amendments have also been adopted early, although these standards have had no impact on Karolinska Developments' financial statements.

Investment Entity

Karolinska Development has multiple unrelated investors and indirectly holds multiple investments.

Karolinska Development has been deemed to meet the definition of an investment entity as per IFRS 10 as the following conditions exist:

  • Karolinska Development AB obtains funds from investors/shareholders in connection with the issuance or sale of equity instruments/shares.
  • Karolinska Development's business purpose, which was communicated directly to investors, is investing these funds in medical innovations solely to generate returns from capital appreciation and investment income.
  • The performance of investments made through Karolinska Development are measured and evaluated on a fair value basis.

Amended accounting policy for shares in portfolio companies

Shares in portfolio companies are categorized as financial assets/liabilities at fair value in the condensed balance sheet for the Investment Entity. These assets and liabilities are

recognized at estimated fair value on each closing date, while changes in fair value are recognized in the condensed income statement. Transaction costs are recognized through profit or loss in the condensed income statement.

Summary of effects of change in accounting policy to investment entity

The largest effects of the change in accounting policy are that:

  • Investment entities do not consolidate subsidiaries that they control. This means that the individual income statement, balance sheet and cash flow line items of previously consolidated subsidiaries are not included in the Investment Entity's financial statements
  • Deferred tax liabilities related to surplus values from subsidiary acquisitions are no longer recognized
  • Non-controlling interests are no longer recognized

The effects of the change in accounting policies on the Group's financial position, comprehensive income and cash flow for the three- and nine-month periods ended 30 September 2013 are reported in the following tables (see also the annual report 2013).

Effects of change in accounting policy on income statement for comparative figures 2013

SEK 000 2013
Jul-Sep
(as previously
reported)
Change in
accounting
policy
2013
Jul-Sep
(restated)
2013
Jan-Sep
(as previously
reported)
Change in
accounting
policy
2013
Jan-Sep
(restated)
Revenue 2,759 -1,192 1,567 7,336 -3,333 4,003
Other external expenses -8,432 2,860 -5,572 -43,447 23,629 -19,818
Personnel costs -13,530 5,300 -8,230 -45,507 17,870 -27,637
Depreciation and amortization of tangible and
intangible non-current assets
-716 714 -2 -2,328 2,321 -7
Change in fair value of shares in portfolio companies - -80,571 -80,571 - -16,619 -16,619
Change in fair value of shares in joint ventures
and associated companies
-71,004 71,004 - -25,027 25,027 -
Change in fair value of other long-term securities
holdings
-927 927 - 1,098 -1,098 -
Result from transaction with Rosetta Capital
IV LP
- - - 404,646 -404,646 -
Operating profit/loss -91,850 -958 -92,808 296,771 -356,849 -60,078
Financial net 1,180 -1 1,179 1,496 457 1,953
Profit/loss before tax -90,670 -959 -91,629 298,267 -356,392 -58,125
Deferred taxes - - - 2,926 -2,926 -
Current taxes - - - - - -
NET PROFIT/LOSS FOR THE PERIOD -90,670 -959 -91,629 301,193 -359,318 -58,125
Attributable to:
Parent Company's shareholders -89,665 -1,964 -91,629 308,682 -366,807 -58,125
Non-controlling interests -1,005 1,005 - -7,489 7,489 -
TOTAL -90,670 -959 -91,629 301,193 -359,318 -58,125

Effects of change in accounting policy on earnings per share for comparative figures 2013

SEK 000 2013
Jul-Sep
(as previously
reported)
Change in
accounting
policy
2013
Jul-Sep
(restated)
2013
Jan-Sep
(as previously
reported)
Change in
accounting
policy
2013
Jan-Sep
(restated)
Earnings per share attributable to Parent
Company's shareholders, weighted average,
before and after dilution -1.85 -0.04 -1.90 6.38 -7.58 -1.20
Number of shares, weighted average 48,352,304 48,352,304 48,371,208 48,371,208

Effects of change in accounting policy on statement of comprehensive income for comparative figures 2013

Attributable to:
Parent Company's shareholders
Non-controlling interests
-89,665
-1,005
-1,964
1,005
-91,629
-
308,682
-7,489
-366,807
7,489
-58,125
-
Total comprehensive income for the period -90,670 -959 -91,629 301,193 -359,318 -58,125
Net profit/loss for the period -90,670 -959 -91,629 301,193 -359,318 -58,125
SEK 000 2013
Jul-Sep
(as previously
reported)
Change in
accounting
policy
2013
Jul-Sep
(restated)
2013
Jan-Sep
(as previously
reported)
Change in
accounting
policy
2013
Jan-Sep
(restated)

Effects of change in accounting policy on consolidated balance sheet for comparative figures 2013

SEK 000 30 Sep 2013
(as previously
reported)
Change in
accounting
policy
30 Sep 2013
(restated)
31 Dec 2013
(as previously
reported)
Change in
accounting
policy
31 Dec 2013
(restated)
ASSETS
Non-current assets
Intangible non-current assets 8,533 -8,533 - 8,340 -8,340 -
Tangible non-current assets 1 - 1 529 - 529
Shares in joint ventures and associated companies 1,644,964 -1,644,964 - 1,605,469 -1,605,469 -
Other long-term securities holdings 28,047 -28,047 - 24,568 -24,568 -
Shares in portfolio companies, at fair value through
profit or loss
0 1,767,772 1,767,772 - 1,729,465 1,729,465
Loans receivable from portfolio companies 30,152 - 30,152 5,894 - 5,894
Other financial assets 38,113 - 38,113 38,113 - 38,113
Total non-current assets 1,749,810 86,228 1,836,038 1,682,913 91,088 1,774,001
Current assets
Accounts receivable 5,679 -5,667 12 258 -255 3
Receivables from portfolio companies - 698 698 - 254 254
Other short-term receivables 4,644 -849 3,795 3,803 -578 3,225
Prepaid expenses and accrued income 4,126 -1,131 2,995 1,767 -290 1,477
Short-term investments, at fair value through profit or
loss
167,174 - 167,174 165,334 - 165,334
Cash and cash equivalents 77,469 -12,561 64,908 41,639 -6,316 35,323
Total current assets 259,092 -19,510 239,582 212,801 -7,185 205,616
TOTAL ASSETS 2,008,902 66,718 2,075,620 1,895,714 83,903 1,979,617
EQUITY AND LIABILITIES
Equity
Share capital 24,266 - 24,266 24,266 - 24,266
Share premium 1,768,179 - 1,768,179 1,768,179 - 1,768,179
Retained earnings 184,541 79,048 263,589 74,380 90,779 165,159
Equity attributable to Parent Company's
shareholders
1,976,986 79,048 2,056,034 1,866,825 90,779 1,957,604
Non-controlling interests 5,746 -5,746 - 3,514 -3,514 0
Total equity 1,982,732 73,302 2,056,034 1,870,339 87,265 1,957,604
Long-term liabilities
Other financial liabilities 9,878 - 9,878 9,438 - 9,438
Total long-term liabilities 9,878 - 9,878 9,438 - 9,438
Current liabilities
Accounts payable 3,135 -1,744 1,391 3,779 -1,353 2,426
Liabilities to portfolio companies - 453 453 - 442 442
Other current liabilities 3,601 -2,035 1,566 2,636 -1,043 1,593
Accrued expenses and prepaid income 9,556 -3,258 6,298 9,522 -1,408 8,114
Total current liabilities 16,292 -6,584 9,708 15,937 -3,362 12,575
Total liabilities 26,170 -6,584 19,586 25,375 -3,362 22,013
TOTAL EQUITY AND LIABILITIES 2,008,902 66,718 2,075,620 1,895,714 83,903 1,979,617

Effects of change in accounting policy on consolidated balance sheet for comparative figures 2012

31 Dec 2012
(as previously Change in 31 Dec 2012
SEK 000 reported) accounting (restated)
ASSETS
Non-current assets
Intangible non-current assets 9,864 -9,864 -
Tangible non-current assets 4,985 -4,976 9
Shares in joint ventures and associated companies 219,173 -219,173 -
Other long-term securities holdings 26,949 -26,949 -
Shares in portfolio companies - 1,827,190 1,827,190
Loans receivable from portfolio companies 12,856 - 12,856
Other financial assets 8,907 - 8,907
Total non-current assets 282,734 1,566,228 1,848,962
Current assets
Accounts receivable 513 -407 106
Receivables from portfolio companies - 563 563
Other short-term receivables 3,955 -1,479 2,476
Prepaid expenses and accrued income 4,578 -2,115 2,463
Short-term investments 174,160 - 174,160
Cash and cash equivalents 117,033 -8,353 108,680
Total current assets 300,239 -11,791 288,448
Assets transferred to KDev Investments Group 1,632,025 -1,632,025 -
TOTAL ASSETS 2,214,998 -77,588 2,137,410
EQUITY AND LIABILITIES
Equity
Share capital 24,266 - 24,266
Share premium 1,768,179 - 1,768,179
Retained earnings -122,547 445,607 323,060
Equity attributable to Parent Company's shareholders 1,669,898 445,607 2,115,505
Non-controlling interests 354,294 -354,294 -
Total equity 2,024,192 91,313 2,115,505
Long-term liabilities
Other financial liabilities 10,889 - 10,889
Total long-term liabilities 10,889 - 10,889
Current liabilities
Accounts payable 4,215 -1,705 2,510
Liabilities to portfolio companies - 473 473
Other current liabilities 2,775 -1,263 1,512
Accrued expenses and prepaid income 8,166 -1,645 6,521
Total current liabilities 15,156 -4,140 11,016
Liabilities attributable to assets transferred to KDev Investments Group 164,761 -164,761 -
Total liabilities 190,806 -168,901 21,905
TOTAL EQUITY AND LIABILITIES 2,214,998 -77,588 2,137,410

Effects of change in accounting policy on statement of cash flows for comparative figures 2013

2013
Jan-Sep
(as previously
Change in
accounting
2013
Jan-Sep
SEK 000 reported) policy (restated)
Operating activities
Operating profit/loss 296,771 -356,849 -60,078
Adjustments for non-cash items
Adjustment for depreciation and amortization 2,328 -2,321 7
Adjustment for changes in fair value 23,929 -7,310 16,619
Result from transaction with Rosetta Capital IV LP -404,646 404,646 -
Other non-cash items 2,245 - 2,245
Realized change in value of short-term investments 1,072 - 1,072
Interest paid -70 66 -4
Interest received 1,757 - 1,757
Cash flow from operating activities before changes in working capital and operating investments -76,614 38,232 -38,382
Cash flow from changes in working capital
Increase (-)/Decrease (+) in operating receivables 4,681 -6,732 -2,051
Increase (+)/Decrease (-) in operating liabilities 3,134 -3,426 -292
Operating investments
Investments in intangible non-current assets -722 722 -
Investments in tangible non-current assets -398 398 -
Investments in shares in portfolio companies - -173,126 -173,126
Investments in shares in joint ventures and associated companies -151,344 151,344 -
Cash and cash equivalents which have been transferred to KDev Investments Group -51,723 51,723 -
Change in short-term investments 7,350 - 7,350
Sale of shares in portfolio companies 190,793 - 190,793
Loans provided to associated companies -25,581 - -25,581
Cash flow from operating activities -100,424 62,135 -41,289
Financing activities
Share of subsidiary issue for non-controlling interests 3,757 -3,757 -
Share repurchase -2,483 - -2,483
Cash flow from financing activities 1,274 -3,757 -2,483
Cash flow for the period -99,150 55,378 -43,772
Cash and cash equivalents at beginning of the year 176,619 -67,939 108,680
CASH AND CASH EQUIVALENTS AT END OF PERIOD 77,469 -12,561 64,908

NOTE 4 Unconsolidated subsidiaries

Karolinska Development is an investment entity according to IFRS 10. Subsidiaries are not consolidated in the Investment Entity's financial statements. The table below indicates all unconsolidated subsidiaries. Ownership interests include indirect ownership through portfolio companies. The ownership interest corresponds to formal voting rights through participating interests.

Total holding
Name Registered office 30 Sep 2014 30 Sep 2013 31 Dec 2013 31 Dec 2012
Avaris AB (dormant) Huddinge 94.87% 94.87% 94.87% 94.87%
HBV Theranostica AB (in liquidation) Stockholm - 100.00% 100.00% 100.00%
KCIF Fund Management AB Solna 37.50% 37.50% 37.50% 37.50%
KD Incentive AB Solna 100.00% 100.00% 100.00% 100.00%
KDev Oncology AB Solna 100.00% 100.00% 100.00% 100.00%
Gligene AB (in liquidation) Solna 100.00% 34.65% 100.00% 34.65%
Limone AB (in liquidation) Solna - 100.00% 100.00% 100.00%
Pharmanest AB Solna 63.09% 62.99% 62.99% 60.24%

Influence over the portfolio companies

In addition to the above named subsidiaries, Karolinska Development holds majority interests, though not controlling interests, in KDev Investments AB, Athera Biotechnologies AB, Lipidor AB, Umecrine Cognition AB and XSpray Microparticles AB.

Karolinska Development's ownership interests in these portfolio companies ranges from 50% up to nearly 90%. Karolinska Development has entered into shareholder agreements with other shareholders regarding these companies. The shareholder agreements ensure other investors or founders influence. Therefore, Karolinska Development is not considered to have controlling interest, even if its ownership interest formally exceeds 50%. Karolinska Development has concluded that in these situations the holdings should be accounted for as investments in associated companies or joint ventures, depending on the degree of influence.

NOTE 5 Performance based share incentive program 2014 (PSP 2014)

On 14 May 2014, the Annual General Meeting adopted a new performance based share incentive program for employees where participants acquire shares ("Savings Shares") on the open market. Under certain conditions participants may receive, free of charge, a maximum of five Performance Shares and one Matching Share Right from the company for each Savings Share they purchase. Matching Share Rights and Performance Shares are allotted after three years. The maximum number of Performance Shares and Matching Share Rights is 761,350. The program comprises a maximum of fourteen participants.

Although there are no performance conditions for the Matching Share Rights, each participant must remain an employee during the vesting period. The Performance Shares have a target related to Karolinska Development's share price performance and a comparison between the so-called Start Price and End Price. The Start Price, measured as an average over ten trading days from 18 May 2014 through 28 May 2014, is SEK 24.45. The End Price is measured as the average over

ten trading days beginning on 2 May 2017. For an allotment, the share price must rise by a total of 30% above the Start Price. For a maximum allotment (five Performance Shares per Savings Share), the share price must rise by 75% above the Start Price. Within this band, allotments are made proportionately. Allotments are capped at 35 times the Start Price, after which the number of allotted Performance Shares is reduced. Participants will be compensated in cash for dividends paid during the period.

The company intends to cover social security contributions related to the program by acquiring and transferring a maximum of 182,000 of its own shares. As of 30 September 2014, no Savings Shares had been acquired and none of the company's own shares had been repurchased. The performance based share incentive program has not had any effect on the results or financial position of the Parent Company or the Investment Entity as of 30 September 2014.

NOTE 6 Related party transactions

No significant related party transactions have occurred since 31 December 2013. For a detailed description of related party transactions, see the 2013 annual report.

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