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Medivir — Interim / Quarterly Report 2019
Nov 27, 2019
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Interim / Quarterly Report
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MEDIVIR AB – INTERIM REPORT JANUARY – SEPTEMBER 2019
The development of Medivir's clinical portfolio is progressing according to plan
July – September
Financial summary
- Net turnover amounted to SEK 1.7 (3.0) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -22.0 (-66,9) million. Basic and diluted earnings per share amounted to SEK -0.95 (-2.93) SEK and SEK -0.95 (-2.93) respectively.
- Cash flow from operating activities amounted to SEK -31.8 (-78.4) million.
- Liquid assets and short-term investments totaled SEK 158.5 (357.1) million at the period end.
January – September
Financial summary
- Net turnover amounted to SEK 7.3 (10.3) million.
- The loss before interest, tax, depreciation and amortization (EBITDA) totaled SEK -88.6 (-229.8) million. Basic and diluted earnings per share amounted to SEK -3.76 (-9.88) and SEK -3.76 (-9.88) respectively.
- Cash flow from operating activities amounted to SEK -125.3 (-248.1) million.
- Liquid assets and short-term investments totaled SEK 158.5 (357.1) million at the period end.
Significant events after the quarter
- The first patient was included in a phase I study in which the safety and tolerability of a combination of birinapant and radiotherapy are evaluated in patients with recurrent epithelial cancer in the head and neck region. The study is sponsored and funded as part of the National Cancer Institute's Cancer Treatment Evaluation Program (CTEP).
- The first milestone-payment for the candidate drug MIV-701 in veterinary medicine was received in October.
- Preclinical data showing that in addition to its direct effect on cancer cells, MIV-818 also modulates the anti-tumor immune response, presented at the AACR-NCI-EORTC conference in Boston.
- The ninth and final liver cancer patient was included in the phase Ia study with MIV-818. Based on safety and tolerability as well as pharmacokinetics and positive biomarker data, it was decided to initiate the phase Ib portion of the study.
Medivir in brief
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The company is investing in indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Collaborations and partnerships are important parts of Medivir's business model and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.
CEO's message
The development of Medivir's clinical portfolio is progressing according to plan and during the quarter another clinical combination study with birinapant was initiated, directed by the National Cancer Institute in the USA. This means that Medivir now has four ongoing clinical trials in cancer, two in phase I and two in phase II. In our clinical portfolio, there are also two projects that have been through phase II; remetinostat for cutaneous T-cell lymphoma and MIV-711 for osteoarthritis. We are now looking forward to starting the phase Ib part of the study with MIV-818 in liver cancer, and to carry out the futility analysis of the phase II study with birinapant and Keytruda®, in the fourth quarter.
In addition to having succeeded in further developing our clinical portfolio within oncology, we can also note that in the third quarter we achieved the goal we previously communicated, namely that the fixed costs of the business are now at one third of last year's level, and that with an efficient, competent and experienced organization.
Let me summarize the status of our clinical portfolio during the quarter.
MIV-818 is Medivir's proprietary nucleotide prodrug, designed to provide a targeted anti-tumor effect in the liver while minimizing any adverse side effects.
In an ongoing phase I study, the safety, tolerability and pharmacokinetics of MIV-818 are studied in patients with advanced liver cancer.
In June, we presented an analysis of data from the first six patients in the phase Ia portion of the study indicating that MIV-818 has the intended liver-directed effect. MIV-818 was well tolerated and in addition, an effect signal on liver biopsies from tumor tissue was observed in MIV-818 treated patients. Unlike the tumor, normal liver tissue does not appear to have been affected by the treatment.
The early clinical results in the phase Ia part constitute a proof-of-concept for this in-house developed project. There is a very large potential here to make a vital difference for patients lacking good treatment options. We are now looking forward to starting the phase Ib part of the MIV-818 study in the fourth quarter.
After the end of the quarter, preclinical data for MIV-818 were presented at the AACR-NCI-EORTC conference in Boston. The data show that MIV-818 has an immunomodulatory effect in vitro and increases the ability of white blood cells to kill cancer cells, especially when combined with the anti-PD1 checkpoint inhibitor pembrolizumab. These data open up the possibility of future combinations of MIV-818 with immunotherapy.
Our preclinical candidate drug MIV-828 for the treatment of blood cancer is, like MIV-818, a completely proprietary nucleotide-based prodrug. This is yet an example of Medivir's ability to develop its own high-quality candidate drugs. As with all clinical development, cost is decisive for the pace at which projects can be developed. Right now, we are focusing on MIV-818, but we hope to start the preclinical development of the promising MIV-828 soon.
Remetinostat is our topical HDAC inhibitor that is developed to treat mycosis fungoides, the most common form of cutaneous T-cell lymphoma, an unusual form of blood cancer that occurs first in the skin. Medivir has determined the design of a phase III study based on the clarifications we received from the FDA at the end of last year. We are looking for a partner for the continued development and commercialization of remetinostat.
In an ongoing investigator-initiated study in collaboration with researchers at Stanford University, remetinostat is given to patients with basal cell cancer (BCC). The preliminary results indicate that remetinostat has potential as an effective and well-tolerated treatment of local skin tumors in BCC patients.
Birinapant is Medivir's SMAC mimetic that is being developed in combination with Merck's anti-PD-1 treatment Keytruda® (pembrolizumab) as a treatment for patients with colorectal cancer. The efficacy of the combination therapy is evaluated in an ongoing phase II study with patients with microsatellite stable (MSS) colorectal cancer, a cancer form in which treatment with Keytruda® alone very rarely gives effect. The study evaluates preliminary efficacy as well as safety and tolerability. A futility analysis of the study will be presented in Q4 2019.
In addition, a phase I study was initiated in October by the National Cancer Institute in the United States where patients with head or neck cancer are treated with Medivir's birinapant in combination with radiation therapy. The primary objective of the study is to evaluate the safety of the combination therapy and to determine a maximum tolerated dose for further studies. Potential signs of treatment efficacy will also be studied.
We look forward to the results of this study and hope that they will provide support for birinapant's potential to be included in several types of combination treatments of a number of different cancers.
For MIV-711, Medivir's cathepsin K inhibitor for the treatment of osteoarthritis, we have now compiled a comprehensive data package with the data from the extension study presented in the previous quarter. Medivir continues to aim to establish a licensing or collaboration agreement for MIV-711.
In addition to the clinical development of our portfolio, we work intensively on business development for our projects. We work with a strong commitment and compassion to develop Medivir's candidate drugs in the right direction and improve therapies for patients with large unmet medical needs. By doing this, we hope to create great values for our shareholders as well as for society at large.

Uli Hacksell President & CEO
Project portfolio
| Disease area | Preclinical | Clinical phases | |||||
|---|---|---|---|---|---|---|---|
| Project | Research | Phase I | Phase II | Phase III | Market | ||
| Proprietary projects | |||||||
| MIV-818, Nucleotide DNA polymerase inhibitor (oral) |
Liver cancer | ||||||
| MIV-828, Nucleotide DNA polymerase inhibitor (intravenous) |
Blood cancer (acute myeloid leukemia) | ||||||
| Projects for licensing | |||||||
| Remetinostat HDAC inhibitor (topical) |
Cutaneous T-cell lymphoma (MF) Basal cell carcinoma* |
||||||
| Birinapant SMAC mimetic (intravenous) |
Colorectal cancer, combo with KeytrudaTM |
||||||
| Head & Neck cancer (with radiation)** | |||||||
| MIV-711 Cathepsin K inhibitor (oral) |
Osteoarthritis |
Outlicensed projects
| Project | Disease area | Partner | Preclinical | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|---|---|
| Xerclear | Labial herpes | GSK | |||||
| MIV-802, nucleotide NS5B | |||||||
| polymerase inhibitor | Hepatitis C | Ascletis (Greater China) | |||||
* Conducted by Stanford University ** Conducted by NCI, USA
Significant events in the project portfolio after the quarter
- The first patient was included in a phase I study in which the safety and tolerability of a combination of birinapant and radiotherapy are evaluated in patients with recurrent epithelial cancer in the head and neck region. The study is sponsored and funded as part of the National Cancer Institute's Cancer Treatment Evaluation Program (CTEP).
- The first milestone-payment for the candidate drug MIV-701 in veterinary medicine was received in October.
- Preclinical data showing that in addition to its direct effect on cancer cells, MIV-818 also modulates the anti-tumor immune response, presented at the AACR-NCI-EORTC conference in Boston.
- The ninth and final liver cancer patient was included in the phase Ia study with MIV-818. Based on safety and tolerability as well as pharmacokinetics and positive biomarker data, it was decided to initiate the phase Ib portion of the study.
Project Portfolio
• Full descriptions of all Medivir's development projects, including their current status and ongoing studies, can be found on the Medivir website: http://www.medivir.com/our-projects.
PROPRIETARY PROJECTS
MIV-818 - for the treatment of liver cancer.
MIV-818, our proprietary prodrug for the treatment of liver cancer, is now in clinical development phase. Liver cancer (hepatocellular carcinoma, HCC) is the third most common cause of cancer-related deaths in the world. Although existing treatments for HCC can extend patients' lives, treatment benefits are often marginal and mortality remains at a high level.
MIV-818 has been developed to reach the maximum concentration of the active substance in the liver, while keeping the concentration in the rest of the body down to minimize any side effects.
In October 2018, Medivir initiated the first clinical trial with MIV-818. The primary purpose of this phase I study is to study the safety, tolerability and pharmacokinetics of HIV-818 in patients with advanced liver cancer. Positive results from the first part of the phase I study were presented in June 2019. Based on these results, it was decided to continue with the phase Ib part of the MIV-818 study. The phase Ib portion is expected to start in the fourth quarter of 2019.
MIV-828 - for the treatment of blood cancer.
MIV-828 is Medivir's proprietary drug candidate for the treatment of acute myeloid leukemia (AML) and other forms of blood cancer. A large proportion of patients do not tolerate the treatments currently used to treat the disease. Preclinical data indicate that MIV-828 may offer patients with AML and other forms of blood cancer a drug with better tolerability and efficacy.
Remetinostat - for improved treatment of MF-CTCL. Mycosis fungoides (MF) is the most common type of cutaneous T cell lymphoma (CTCL). MF-CTCL is an unusual form of blood cancer that primarily presents in the skin. The primary unmet need for patients in the early stages of MF-CTCL is well-tolerated treatments
with efficacy on skin lesions and relief from the troublesome symptom of severe itching. It is known that orally or intravenously administered HDAC inhibitors are effective against MF-CTCL, but the
compounds have significant side effects and are therefore only used in later stages of the disease. Remetinostat, an HDAC inhibitor, applied to the skin in the form of a gel, degrades as it reaches the bloodstream, thereby reducing the risk of side effects. The aim of the project is to find a partner for phase III and commercialization of remetinostat.
Remetinostat also has the potential to treat other skin cancer indications. In an ongoing investigator-initiated study in collaboration with researchers at Stanford University, remetinostat is given to patients with basal cell cancer.
Birinapant - for the treatment of solid tumors. Birinapant is being developed to improve treatment response and prolong survival in patients with solid tumors where available treatments do not provide adequate survival or where the patient no longer has other treatment options.
Medivir is now conducting a phase II clinical study of birinapant in combination with Keytruda® to clinically demonstrate the efficacy of birinapant as combination therapy for patients with treatment-resistant tumors. The study includes patients with microsatellite-stable colorectal cancer who have failed to respond to any other available therapy. Patients receive treatment with Keytruda® and birinapant as long as the tumor does not grow, or serious side effects occur. The goal is to include 28 patients with colon cancer in the study and a futility analysis is planned for 14 patients. The result from the futility analysis is expected in Q4.
In October, a phase I study was initiated by the National Cancer Institute in the United States where patients with head or neck cancer are treated with Medivir's birinapant in combination with radiotherapy. The study is funded as part of NCI's program for cancer treatment evaluation. Medivir provides birinapant and is given full access to all reports from the study whose primary goal is to evaluate the safety of the combination therapy and to determine a maximum tolerated dose for further studies. Signs of treatment efficacy are also studied.
MIV-711 - with the potential to be the first diseasemodifying drug in osteoarthritis.
Medivir has conducted a phase II study showing positive effects in both bone and cartilage in joints in osteoarthritis patients after only six months of treatment with MIV-711. Treatment with MIV-711 for a total of 12 months provided continued treatment effect on bone and cartilage, and the patients also retained the response level of the positive signals for selfreported pain as well as other clinical symptoms.
Medivir continues to aim to establish a license or collaboration agreement for the continued development of MIV-711 as the first disease-modifying drug for osteoarthritis.
PARTNERED PROJECTS
MIV-802 – is a potent, nucleotide-based inhibitor of the HCV NS5B polymerase and acts against several genotypes of hepatitis C (HCV). Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral drugs for the treatment of HCV.
Ascletis holds the exclusive rights to develop, manufacture and commercialize MIV- 802 in China, Taiwan, Hong Kong and Macao. The terms of the agreement entitle Medivir to milestone payments at achieved development goals and step-by-step royalty payments from the net sales of products where MIV-802 is included.
The Investigational New Drug (IND) application for MIV- 802 (ASC21) submitted by Ascletis was approved by the Chinese authority (NMPA) during the first quarter.
MIV-701 - In the spring of 2019, a licensing agreement was signed for one of Medivir's candidate drugs, MIV-701, with the French company Vetbiolix, granting Vetbiolix the right to develop the product for veterinary use. In October, Medivir received the first milestonepayment of EUR 10,000 after the product was found to meet certain quality requirements.
MIV-701 is a cathepsin K inhibitor that is not suitable for human development due to its rapid degradation, but which has excellent properties for animals. Medivir is entitled to additional milestone payments as well as royalties during the continued development.
Financial overview, July – September 2019
| Summary of the Group's figures | Q3 | Q1 - Q3 | Full year | |||
|---|---|---|---|---|---|---|
| (SEK m) | 2019 | 2018 | 2019 | 2018 | 2018 | |
| Net turnover | 1.7 | 3.0 | 7.3 | 10.3 | 23.9 | |
| Operating profit before depreciation and amortization (EBITDA) | -22.0 | -66.9 | -88.6 | -229.8 | -326.5 | |
| Operating profit (EBIT) | -23.7 | -69.3 | -94.0 | -236.9 | -351.0 | |
| Profit/loss before tax | -23.0 | -71.2 | -91.3 | -235.9 | -350.5 | |
| Basic earnings per share, SEK | -0.95 | -2.93 | -3.76 | -9.88 | -14.62 | |
| Diluted earnings per share, SEK | -0.95 | -2.93 | -3.76 | -9.88 | -14.62 | |
| Net worth per share, SEK | 8.91 | 17.39 | 8.91 | 17.39 | 12.67 | |
| Return on equity, % | -40.5 | -62.2 | -46.5 | -67.1 | -85.3 | |
| Cash flow from operating activities | -31.8 | -78.4 | -125.3 | -248.1 | -320.5 | |
| Cash and cash equivalents at period end | 158.5 | 357.1 | 158.5 | 357.1 | 286.3 |
Revenues
Net turnover for the period from July – September was SEK 1.7 million (3.0m) corresponding to a decrease of SEK 1.3 million attributable to lower royalty revenues from simeprevir.
Operating expenses
Other external costs totaled SEK -17.6 million (-50.6m), corresponding to a decrease of SEK 33.0 million. Personnel costs amounted to SEK -4.7 million (-20.6 m) a decrease of 15.9 million and the total expenses was SEK -24.1 million (-73.6 m) a decrease of 49.5 million. The decreased costs are due to the restructuring of the company near year end 2018.
Operating profit/loss
The operating profit/loss totaled SEK -23.7 million (-69.3 m), SEK 45.6 million better than previous year due to the restructuring done in the fourth quarter 2018.
Cash flow, investments, and financial position
Liquid assets, including short-term investments amounted to SEK 158.5 million (357.1 m) at the end of the period, corresponding to a decrease of SEK 198.6 million. The opening balance 2019 was SEK 286.3 million (467.8 m).
Medivir's financial assets are, in accordance with its financial policy, invested in low-risk, interest-bearing securities.
Cash flow from operating activities totaled SEK -31.8 million (-78.4 m), with changes in working capital accounting for SEK -7.1 million (-8.3 m) of this total. Cash flow from financing activities totaled SEK -0.7 million (-0.2 m).
The period's investments in tangible and intangible fixed assets totaled SEK 0.3 million (2.8 m).
Liquid assets and short-term investments (SEK m)

Revenues
Net turnover for the period from Jan – June was SEK 7.3 million (10.0 m) corresponding to a decrease of SEK 3.0 million attributable to less royalty revenues from simeprevir.
Operating expenses
Other external costs totaled SEK -68.7 million (-171.8), corresponding to a decrease of SEK 103.1 million.
Personnel costs amounted to SEK -27.0 million (-72.3 m) a decrease of 45.3 million and the total expenses was SEK -101.0 million (-252.7 m) a decrease of 151.7 million. The decreased costs are due to the restructuring of the company. As previously communicated, the operational fixed costs in Q3 amount to only one third of last year's level.
Operating profit/loss
The operating profit/loss totaled SEK -94.0 million (-236.9 m), SEK 142.9 million better than previous year due to the restructuring done in the fourth quarter 2018.
Cash flow, investments, and financial position
Liquid assets, including short-term investments amounted to SEK 158.5 million (357.1 m) at the end of the period, corresponding to a decrease of SEK 198.6 million. The opening balance 2019 was SEK 286.3 million (467.8 m).
Medivir's financial assets are, in accordance with its financial policy, invested in low-risk, interest-bearing securities.
Cash flow from operating activities totaled SEK -125.3 million (-248.1 m), with changes in working capital accounting for SEK -28.6 million (-13.2 m) of this total.
Cash flow from financing activities totaled SEK -1.8 million (144.9 m).
The period's investments in tangible and intangible fixed assets totaled SEK -0.5 million (-6.7 m).
Employees
Medivir had 18 (73) employees (FTEs) at the period end, 44% (50%) of whom were women. Out of these employees, there are 4 (0) who have been given notice of termination of employment, but whose employment has not yet been terminated.
Share-related incentive plans
To enable the staff to take part of and contribute to a positive value development for the company and to improve the possibilities for the company to keep and employ new competent and dedicated staff the board of directors proposed and the 2017 AGM approved a long-term incentive program. The right to subscribe is vested in all of the company's senior executives and other permanent employees of Medivir. The market value was determined using the Black & Scholes valuation model, based on term, strike price, weighted share price during the subscription period (VWAP), riskfree interest rate, and volatility. The subscription price for all outstanding warrants (strike price) per share shall correspond to 133 percent of the volume weighted average rate of the class B share according to the official NASDAQ Stockholm price list during the period.
Medivir employees bought 48 515 warrants during the second quarter 2017 as part of this incentive program. The warrants were issued at a market value of SEK 9.41 each with an exercise price of SEK 89.36 per share. In the fourth quarter 2017, Medivir employees bought an additional 9 320 warrants. These warrants were issued at a market value of SEK 3.98 each with an exercise price of SEK 89.36 per share. The total 57 835 warrants may be exercised to subscribe for new class B shares during the period from 16 December 2020 up to and including 15 January 2021. The valuation calculation for 2017 was based on the following figures: term, 3.66 years; strike price, SEK 89.36; VWAP, SEK 67.19; risk-free interest rate, –0.35 percent; volatility, 32 percent.
In May 2018, the board of directors proposed and the AGM approved a new long-term incentive program, in the same manner as 2017. During the second quarter 2018, Medivir employees bought 51 864 warrants at a market value of 5.63 each with an exercise price of SEK 52.75 per share. The warrants may be exercised to subscribe for new class B shares during the period from 16 December 2021 up to and including 15 January 2022. The valuation calculation for 2018 was based on the following figures: term, 3.66 years; strike price, SEK 52.75; VWAP, SEK 39.66; risk-free interest rate, –0.16 percent; volatility, 32 percent.
The Parent Company in brief
Medivir AB (publ.), corporate ID no. 556238-4361, is the Parent Company of the Group. Its operations consist of pharmaceutical development, administrative and company management functions.
The Parent Company's total revenues amounted to SEK 7.3 million (10.3 m).
The operating profit/loss was SEK -94.2 million (-238.4 m), corresponding to an improved result of SEK 144.2 million. Combined operating expenses totaled SEK -101.2 million (-246.9 m).
Net financial items totaled SEK 3.0 million (1.3 m), corresponding to an increase of SEK 1.7 million.
The tax for the period totaled SEK 0.0 million (0.0 m). The net profit/loss for the period was SEK –91.3 million (-237.1 m), corresponding to an improvement of SEK 145.8 million.
Liquid assets, including short-term investments with a maximum term of three months, amounted to SEK 150.2 million (348.6 m).
Transactions with related parties
Transactions with related parties are on market terms. There are existing agreements between companies owned by senior executives and Medivir, dating from 2005, which entitle the senior executives to royalties on products that the company may develop based on patented inventions that the company has purchased from the parties in question. During the period, transactions with related parties totaled SEK 0.002 million (0.02 m), attributable to royalty payments to Uppsala Hallbechem AB, Anders R Hallberg (Board Member until 9 May 2019)). Furthermore, Medivir has purchased consulting services from Anna Malm Bernsten (Chairman of the Board until 9 May 2019) to the value of SEK 0.2 million (0.4 m). No other services were purchased by the company from related parties during the period.
Significant risks and uncertainty factors
The process of pharmaceutical research and development, all the way up to regulatory market approval, is both high-risk and capital-intensive. The majority of projects initiated will never achieve market authorization. If competing pharmaceuticals take market shares, or competing research projects achieve better efficacy and reach the market more quickly, the future value of Medivir's product and project portfolio may be lower than expected. Medivir's success in developing medicines, to enter into partnerships and to secure funding for its operations, are decisive in terms of the company's future.
A more detailed description of the exposure to risk, and of the ways in which Medivir manages it, is provided in the 2018 Annual Report, see pages 31-32 and 40-41 and in Note 7 on pages 63-65. The Annual Report is available on the company's website: www.medivir.com.
Outlook
Medivir's future investments will mainly be in clinical pharmaceutical projects within oncology. With the reorganization of Medivir the cost structure will improve significantly after summer 2019. It is the view from Board of Directors and management that the current cash is sufficient to complete the ongoing clinical activities.
Huddinge, 27 November 2019
For further information, please contact
Uli Hacksell, CEO, +46 (0) 8 5468 3100 Magnus Christensen, CFO, +46 (0)73-125 0620
Conference call for investors, analysts and the media The Interim Report January - September 2019 will be presented by Medivir's President & CEO, Uli Hacksell.
Time: Wednesday, November 27, 2019, at 14.00 (CET).
Phone numbers for participants from: Sweden + 46 8 566 426 92 Europe + 44 33 3300 9035 US + 1 833 5268 347
The conference call will also be streamed via a link on the website: www.medivir.com
The presentation will be available on Medivir's website after completion of the conference.
Uli Hacksell President and CEO
This report has been subject to auditors' review.
The information in this report comprises the information that Medivir is obliged to disclose under the provisions of the Swedish Securities Markets Act.
The information was submitted for publication at 11.00 CET on 27 November 2019.
Notes
Accounting principles
Medivir prepares its Consolidated Accounts in accordance with IFRS, International Financial Reporting Standards, as endorsed by the EU. In addition to the stated IFRS, the Group also applies the Swedish Financial Reporting Board's recommendation, RFR 1 Supplementary Accounting Rules for Groups, and applicable statements from the Swedish Financial Reporting Board. The Group utilizes the acquisition value for Balance Sheet item valuation, unless otherwise indicated. IFRS are under constant development, and new standards and interpretations are published on an ongoing basis, only some of which have come into effect. An assessment of the impact that the introduction of these standards and statements has had, and may have, on Medivir's financial statements follows. Comments are restricted to those
Financial calendar: Year End Report (January – December 2019) February 13, 2020 Interim Report (January – March 2020) May 5, 2020 Annual General Meeting May 5, 2020
changes that have had, or could have, a significant effect on Medivir's accounting. See pages 52-59 of the 2018 Annual Report for a full presentation of the accounting principles applied by the Group.
New and updated accounting principles
IFRS 16 Leases came into effect on 1 January 2019 and the company has elected to apply the simplified transition method for IFRS 16. For Medivir, this means that we will not perform a recalculation of the 2018 figures and will, instead, adjust the opening balance for 2019. The total value of the assets has increased by SEK 50.5 million. Leased assets are included in Tangible fixed assets, which have increased by SEK 18.7 million due to IFRS 16 during the transition period. Financial fixed assets in the form of the long-term and short-term components of leasing receivables total SEK 25.4 million and SEK 6.4 million, respectively. With regard to liabilities, Long-term liabilities have increased by SEK 41.9 million and Short-term liabilities by SEK 8.6 million at the beginning of 2019. Amortization of the debt amounted to SEK 1.7 million during third quarter. Additional disclosures that explain the difference
between the closing balance in 2018 and the opening balance in 2019 will be provided in the 2019 Annual Report. The Parent Company applies the exemption offered in RFR 2 and consequently reports leasing as operational, in accordance with the previous method.
| Consolidated Income Statement, summary | Q3 | Q1 - Q3 | Full year | ||
|---|---|---|---|---|---|
| (SEK m) | 2019 | 2018 | 2019 | 2018 | 2018 |
| Net turnover | 1.7 | 3.0 | 7.3 | 10.3 | 23.9 |
| Other operating income | -1.2 | 1.3 | -0.3 | 5.5 | 5.5 |
| Total income | 0.4 | 4.3 | 7.1 | 15.8 | 29.3 |
| Other external expenses | -17.6 | -50.6 | -68.7 | -171.8 | -235.1 |
| Personnel costs | -4.7 | -20.6 | -27.0 | -72.3 | -118.2 |
| Depreciations and write-downs | -1.7 | -2.4 | -5.4 | -7.0 | -24.5 |
| Other operating expenses | - | - | - | -1.5 | -2.5 |
| Operating profit/loss | -23.7 | -69.3 | -94.0 | -236.9 | -351.0 |
| Net financial items | 0.7 | -1.9 | 2.7 | 1.0 | 0.6 |
| Profit/loss after financial items | -23.0 | -71.2 | -91.3 | -235.9 | -350.5 |
| Tax | -0.1 | - | -0.1 | 0.2 | 0.2 |
| Net profit/loss for the period | -23.1 | -71.2 | -91.4 | -235.7 | -350.3 |
| Net profit/loss for the period attributable to: | |||||
| Parent Company shareholders | -23.1 | -71.2 | -91.4 | -235.7 | -350.3 |
| Earnings per share, calculated from the net profit/loss attributable to | |||||
| Parent Company shareholders during the period | |||||
| Earnings per share (SEK per share) | |||||
| - Total operations, basic earnings | -0.95 | -2.93 | -3.76 | -9.88 | -14.62 |
| - Total operations, diluted earnings | -0.95 | -2.93 | -3.76 | -9.88 | -14.62 |
| Average number of shares, '000 | 24 288 | 24 288 | 24 288 | 23 846 | 23 956 |
| Average number of shares after dilution '000 | 24 288 | 24 288 | 24 288 | 23 846 | 23 956 |
| Number of shares at period end, '000 | 24 288 | 24 288 | 24 288 | 24 288 | 24 288 |
| Consolidated Statement of Comprehensive Income | Q3 | Q1 - Q3 | Full year | ||
| (SEK m) | 2019 | 2018 | 2019 | 2018 | 2018 |
| Net profit/loss for the period | -23.1 | -71.2 | -91.4 | -235.7 | -350.3 |
| Other comprehensive income | |||||
| Exchange rate differences | 0.3 | 0.3 | 0.3 | -0.9 | -0.4 |
| Total other comprehensive income | 0.3 | 0.3 | 0.3 | -0.9 | -0.4 |
| Total comprehensive income for the period | -22.8 | -70.9 | -91.1 | -236.6 | -350.8 |
| Consolidated Balance Sheet, summary | 30-sep | 30-sep | 31-dec |
|---|---|---|---|
| (SEK m) | 2019 | 2018 | 2018 |
| Assets | |||
| Intangible fixed assets | 96.4 | 110.8 | 96.9 |
| Tangible fixed assets | 24.9 | 16.0 | 10.8 |
| Long-term receivables | 22.2 | - | - |
| Current receivables | 19.0 | 19.8 | 25.4 |
| Short-term investments | 130.3 | 320.8 | 239.1 |
| Cash and cash equivalents | 28.2 | 36.4 | 47.2 |
| Total assets | 321.0 | 503.7 | 419.4 |
| Shareholders' equity and liabilities | |||
| Shareholders' equity | 216.5 | 422.3 | 307.6 |
| Long-term liabilities | 56.5 | - | 14.8 |
| Current liabilities | 48.0 | 81.4 | 96.9 |
| Total shareholders' equity and liabilities | 321.0 | 503.7 | 419.4 |
| Consolidated Statement of Changes in Equity | Exchange | ||||
|---|---|---|---|---|---|
| (SEK m) | Share | Other paid | rate | Accum. | Total |
| capital | in capital | difference | loss | equity | |
| Opening balance, 1 January 2018 | 157.7 | 295.9 | -3.0 | 63.5 | 514.1 |
| Total comprehensive income for the period | - | - | -0.9 | -235.7 | -236.6 |
| Stock dividend issue | 30.8 | 124.0 | - | - | 154.8 |
| Warrants | - | 0.3 | - | - | 0.3 |
| Transaction costs | - | - | - | -10.2 | -10.2 |
| Closing balance, 30 September 2018 | 188.5 | 420.1 | -3.9 | -182.4 | 422.4 |
| Opening balance, 1 January 2018 | 157.7 | 295.9 | -3.0 | 63.5 | 514.1 |
| Total comprehensive income for the period | - | - | -0.4 | -350.3 | -350.8 |
| Stock dividend issue | 30.8 | 124.0 | - | - | 154.8 |
| Warrants | - | 0.3 | - | - | 0.3 |
| Transaction costs | - | - | - | -10.8 | -10.8 |
| Closing balance, 31 December 2018 | 188.5 | 420.1 | -3.5 | -297.6 | 307.6 |
| Opening balance, 1 January 2019 | 188.5 | 420.1 | -3.5 | -297.6 | 307.6 |
| Total comprehensive income for the period | - | 0.3 | -91.4 | -91.1 | |
| Closing balance, 30 September 2019 | - 188.5 |
420.1 | -3.1 | -389.0 | 216.5 |
| Consolidated Cash Flow Statement, summary | Q3 | Q1 - Q3 | Full Year | ||
|---|---|---|---|---|---|
| (SEK m) | 2019 | 2018 | 2019 | 2018 | 2018 |
| Cash flow from operating activities before changes in working capital | -24.7 | -70.0 | -96.7 | -234.9 | -292.5 |
| Changes in working capital | -7.1 | -8.3 | -28.6 | -13.2 | -28.0 |
| Cash flow from operating activities | -31.8 | -78.4 | -125.3 | -248.1 | -320.5 |
| Investing activities | |||||
| Acquisition/sale of fixed assets | -0.3 | -2.8 | -0.5 | -6.7 | -5.0 |
| Cash flow from investing activities | -0.3 | -2.8 | -0.5 | -6.7 | -5.0 |
| Financing activities | |||||
| Other changes in longterm receivables/liabilities | -0.7 | - | -1.8 | - | - |
| Warrants | - | - | - | 0.3 | 0.3 |
| Share issue | - | - | - | 154.8 | 154.8 |
| Transaction costs | - | -0.2 | - | -10.2 | -10.8 |
| Cash flow from financing activities | -0.7 | -0.2 | -1.8 | 144.9 | 144.3 |
| Cash flow for the period | -32.8 | -81.4 | -127.6 | -109.9 | -181.2 |
| Cash and cash equivalents at beginning of period | 191.9 | 438.6 | 286.3 | 467.8 | 467.8 |
| Exchange rate difference, liquid assets | -0.6 | -0.1 | -0.2 | -0.8 | -0.3 |
| Cash and cash equivalents at end of period | 158.5 | 357.1 | 158.5 | 357.1 | 286.3 |
| Parent company income statement, summary | Q3 | Q1 - Q3 | |||
|---|---|---|---|---|---|
| (SEK m) | 2019 | 2018 | 2019 | 2018 | 2018 |
| Net turnover | 1.7 | 3.0 | 7.3 | 10.3 | 24.9 |
| Other operating income | -1.3 | -1.0 | -0.4 | -1.8 | -3.3 |
| Total income | 0.4 | 2.0 | 7.0 | 8.5 | 21.7 |
| Other external expenses | -19.8 | -48.7 | -71.0 | -165.8 | -227.2 |
| Personnel costs | -4.7 | -20.6 | -27.0 | -72.6 | -118.4 |
| Depreciations and write-downs | -1.0 | -2.4 | -3.2 | -7.0 | -24.5 |
| Other operating expenses | - | - | - | -1.5 | -2.5 |
| Operating profit/loss | -25.1 | -69.7 | -94.2 | -238.4 | -351.1 |
| Profit/loss from participation in Group companies | - | - | - | - | -1.1 |
| Net financial items | 0.4 | -1.8 | 3.0 | 1.3 | 0.9 |
| Profit/loss after financial items | -24.7 | -71.5 | -91.3 | -237.1 | -351.2 |
| Tax | - | - | - | - | - |
| Net profit/loss for the period (=comprehensive income) | -24.7 | -71.5 | -91.3 | -237.1 | -351.2 |
| Parent company balance sheet, summary | 30-sep | 30-sep | 31-dec | 31-dec | |
| (SEK m) | 2019 | 2018 | 2018 | 2018 | |
| Assets | |||||
| Intangible fixed assets | 96.4 | 110.8 | 96.9 | 96.88473 | |
| Tangible fixed assets | 8.3 | 16.0 | 10.8 | 10.82801 | |
| Shares in subsidiaries | 0.1 | 0.1 | 0.1 | 0.100001 | |
| Receivables on Group companies | - | 23.6 | 23.3 | 23.3 | |
| Current receivables | 10.2 | 15.1 | 23.5 | 23.5 | |
| Short-term investments | 130.2 | 320.8 | 239.1 | 239.1065 | |
| Cash and bank balances | 20.0 | 27.7 | 36.7 | 36.74022 | |
| Total assets | 265.3 | 514.2 | 430.4 | 430.3594 | |
| Shareholders' equity and liabilities | |||||
| Shareholders' equity | 210.3 | 415.6 | 301.5 | 301.5361 | |
| Provisions | 21.4 | 0.2 | 37.7 | 37.7 | |
| Liabilities to Group companies | 0.1 | 21.7 | 21.3 | 21.30751 | |
| Current liabilities | 33.6 | 76.7 | 69.9 | 69.9 | |
| Total shareholders' equity and liabilities | 265.3 | 514.2 | 430.4 | 430.4437 |
| Key ratios, share data, options Q3 |
Q1 - Q3 | Full year | |||
|---|---|---|---|---|---|
| 2019 | 2018 | 2019 | 2018 | 2018 | |
| Return on: | |||||
| - shareholders' equity, % | -40.5 | -62.2 | -46.5 | -67.1 | -85.3 |
| - capital employed, % | -26.9 | -62.1 | -38.7 | -67.2 | -85.3 |
| - total capital, % | -26.9 | -52.2 | -32.9 | -56.2 | -67.7 |
| Number of shares at beginning of period, '000 | 24 288 | 24 288 | 24 288 | 24 288 | 20 319 |
| Number of shares at period end, '000 | 24 288 | 24 288 | 24 288 | 24 288 | 24 288 |
| - of which class A shares | - | - | - | - | - |
| - of which class B shares | 24 288 | 24 288 | 24 288 | 24 288 | 24 288 |
| - of which repurchased B shares | - | - | - | - | - |
| Average number of shares, '000 | 24 288 | 24 288 | 24 288 | 23 846 | 23 956 |
| Outstanding warrants, '000 | 110 | 110 | 110 | 110 | 110 |
| Share capital at period end, SEK m | 188.5 | 188.5 | 188.5 | 188.5 | 188.5 |
| Shareholders' equity at period end, SEK m | 216.5 | 422.3 | 216.5 | 422.3 | 307.6 |
| Earnings per share, SEK | |||||
| - Total operations, basic earnings | -0.95 | -2.93 | -3.76 | -9.88 | -14.62 |
| - Total operations, diluted earnings | -0.95 | -2.93 | -3.76 | -9.88 | -14.62 |
| Shareholders' equity per share, SEK | 8.91 | 17.39 | 8.91 | 17.39 | 12.67 |
| Net worth per share, SEK | 8.91 | 17.39 | 8.91 | 17.39 | 12.67 |
| Cash flow per share after investments, SEK | -1.32 | -3.34 | -5.18 | -10.69 | -13.59 |
| Equity/assets ratio, % | 67.5 | 83.8 | 67.5 | 83.8 | 73.4 |
| EBITDA | -22.0 | -66.9 | -88.6 | -229.8 | -326.5 |
| EBIT | -23.7 | -69.3 | -94.0 | -236.9 | -351.0 |
Key ratio definitions
Average number of shares. The unweighted average number of shares during the period.
Basic earnings per share. Profit/loss per share after tax divided by the average number of shares.
Capital employed. Balance Sheet total less non-interest-bearing liabilities including deferred tax liabilities.
Cash flow per share after investments. Cash flow after investments divided by the average number of shares.
Diluted earnings per share. Profit/loss per share after tax divided by the average number of shares and outstanding warrants adjusted for any dilution effect.
EBIT (Earnings before interest and taxes). Operating profit/loss after depreciation and amortization.
EBITDA (Earnings before interest, taxes, depreciation and amortization). Operating profit/loss before depreciation and amortization.
Equity/assets ratio. Shareholders' equity in relation to the Balance Sheet total.
Net worth per share. Shareholders' equity plus hidden assets in listed equities divided by the number of shares at the period end.
Operating margin. Operating profit/loss as a percentage of net turnover.
Return on capital employed. Profit/loss after financial items plus interest expenses as a percentage of the average capital employed.
Return on shareholders' equity. Profit/loss after tax as a percentage of the average shareholders' equity. Return on total assets. Profit/loss after financial items plus interest expenses as a percentage of the average Balance Sheet total.
Shareholders' equity per share. Shareholders' equity divided by the number of shares at the period end.
The above key ratios are deemed to be relevant for the type of operations conducted by Medivir and to contribute to an increased understanding of the financial report.
AUDITOR'S REPORT
Medivir AB (publ), corp. reg. no. 556238-4361.
Introduction
We have reviewed the condensed interim financial information (interim report) of Medivir AB (publ) as of 30 September 2019 and the nine-month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of the interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report 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 in Sweden. 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. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the Group, and with the Swedish Annual Accounts Act, regarding the Parent Company.
Stockholm, 27 November 2019
Öhrlings PricewaterhouseCoopers AB
Tobias Stråhle Authorized Public Accountant