AI assistant
Oncopeptides Interim / Quarterly Report 2019
3091_ir_2019-08-28_760d99d9-4f72-40a0-b558-56236cae0c11.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel lipophilic peptide conjugated alkylator, belonging to a new class of drugs called Peptidase Enhanced Cytotoxics (PEnC). Melflufen is in development as a new treatment for the hematological cancer multiple myeloma, including the Phase 2 pivotal trial HORIZON currently underway and a global confirmatory Phase 3 trial (OCEAN) continuing enrolment. Oncopeptides' headquarters is in Stockholm, Sweden, and the company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
INTERIM REPORT Q2 2019
Conference call for investors, analysts and the media
The Interim Report Q2 2019 and an operational update will be presented by CEO Jakob Lindberg and members of Oncopeptides management team, Wednesday August 28, 2019 at 15:00 (CET). The conference call will also be streamed via a link on the website: www.oncopeptides. com.
Phone numbers for participants from: Sweden: +46 8 505 583 59 Europe: +44 3333 009 032 USA: +1 833 823 05 90
Financial calendar
Interim Report Q3, 2019: November 19, 2019 Year-end Report 2019: February 20, 2020
For further information
Jakob Lindberg, CEO, Oncopeptides AB E-mail: [email protected] Telephone: +46 (0)8 615 20 40
Rein Piir, Head of Investor Relations, Oncopeptides AB E-mail: [email protected] Telephone: +46 (0)70 853 72 92
This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CET on August 28, 2019.
Summary of Q2
Financial overview April 1 – June 30, 2019
- Net sales amounted to SEK 0.0 M (0.0)
- Loss for the period was SEK 171.9 M (loss: 144.6)
- Loss per share, before and after dilution, was SEK 3.52 (loss: 3.30)
- On June 30 cash and cash equivalents amounted to SEK 626.8 M (568.2)
Significant events during the period April 1 – June 30, 2019
- In April, melflufen was granted additional patent protection in the US until 2033
- In April it was announced that the last patient in the OCEAN trial is estimated to be enrolled during Q1 2020
- In May it was announced that Oncopeptides will apply for accelerated approval in the US
- In the beginning of June, at ASCO's 2019 Annual Meeting in the United States, Oncopeptides presented new data from the Phase 1/2 study called O-12-M1 with melflufen in RRMM patients
- At the European Hematology Meeting, EHA in June, Oncopeptides presented new data from the pivotal phase 2 study HORIZON with melflufen in RRMM patients. New data from the phase 1/2 combination study ANCHOR were also presented at the conference
- In June, Oncopeptides resolved to make a directed share issue of SEK 727 M before issue costs (approximately USD 78 M). The share issue was completed in July
Significant events after the reporting period
• In late August it was announced that Klaas Bakker was appointed as the new Chief Medical Officer for Oncopeptides. He starts his work in November
Financial overview of the group
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) jan - dec |
|---|---|---|---|---|---|
| Net sales | – | – | – | – | – |
| Operating loss | -171,739 | -144,651 | -305,551 | -205,053 | -410,963 |
| Loss before tax | -171,864 | -144,651 | -305,810 | -205,053 | -410,965 |
| Loss for the period | -171,944 | -144,651 | -306,021 | -205,053 | -411,112 |
| Earnings per share before and after dilution (SEK) | -3.52 | -3.30 | -6.35 | -4.91 | -9.58 |
| Cash flow from operating activities | -122,997 | -90,060 | -265,818 | -130,607 | -333,727 |
| Cash and cash equivalents at the end of the period | 626,799 | 568,212 | 626,799 | 568,212 | 375,617 |
| Research & development costs/operating expenses % | 77% | 69% | 78% | 75% | 76% |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8.
CEO statement
In our last quarterly report, I described a very important milestone for the company. After interactions with the FDA, we decided to ini tiate the accelerated approval submission process for melflufen for the treatment of patients with triple class RRMM. We believe that this significantly reduces the regulatory risk for melflufen to potentially become a new treatment alternative for RRMM patients in the United States.
During the quarter we also presented data at the European Hematology Meeting (EHA), which was another important event for us. The data presented from the HORIZON study forms the basis of the regulatory process with the FDA. In addition, we also presented updated data from the combination study ANCHOR which guides us in our ambition to initiate additional combination studies such as LIGHTHOUSE that is expected to start around year end.
Finally, we completed a directed share issue at the end of June which strengthened our balance sheet and allows us to fully deliver on our clinical studies, regulatory processes and continue the build-up of our launch organization with primary a focus on the US.
Application for market approval
The work on preparing an application for accel erated approval in the US is ongoing. The data we presented in June at EHA from the HORI - ZON study will form the basis for the applica tion. The potential conditional marketing approval must then later be confirmed with data from a randomized study. Both OCEAN and LIGHTHOUSE could independently serve
The second quarter was the our most eventful quarter since the IPO.
as confirmatory studies. The objective is to sub mit the application for accelerated approval before the end of Q1 2020.
Strengthened patent protection
During the quarter, the US Patent Office granted additional patents for melflufen in the United States. The new patent family protects, among other things, the freeze-dried formula tion that will be used at a potential launch and extends the patent protection until 2033. This further increases the protection for melflufen in addition to the composition of matter patent and our orphan drug market exclusivity. Onco peptides has already similar patent protection in both Japan and Europe.
New data presented at EHA
Our overall impression from this year's EHA meeting in June is very positive. We presented data from both HORIZON and our combina tion study ANCHOR. The interim results we presented from HORIZON continued to show positive data in line with previous presenta tions. HORIZON addresses patients with latestage multiple myeloma with few or no remaining treatment options. It is promising that melflufen continues to show stable efficacy data
in combination with a manageable side effect profile. In numerical terms this means that 86% of patients achieved disease stabilization with an overall tumour response rate (ORR) of 28%. For the first time, we also presented data from a subgroup of patients with metastatic myeloma (socalled extramedullary disease - EMD). This is a rapidly growing patient group with no current treatment options. It is encouraging to observe that the overall tumour response rate in this patient group was 29%. This is a patient group with limited reported data from clinical studies but melflufen appears to have the best efficacy data to date. In summary, the HORI-ZON study continues to develop positively in this heavily pre-treated patient population. This is positive for the process of preparing a submission for a potential accelerated approval.
We also presented data from our combination study ANCHOR in which we evaluate melflufen in combination with bortezomib (a proteasome inhibitor) or with daratumumab (anti-CD38 therapy). The first time we presented data from ANCHOR was in December 2018. At that time only a few patients had been treated. The results presented at EHA included many more patients. We continue to see that a high proportion of patients respond to treatment and that the treatment response improves over time. In addition, the results for progression-free survival look very promising. So far, some patients have been on treatment for more than a year and only one patient in each arm has relapsed in the disease. The side effect profile continues to look promising, which gives us further support in our belief that melflufen can be valuable for myeloma patients also as part of combination treatments.
We also hosted a large symposium that was visited by many leading clinicians. It was the first time that we organized this type of meeting at such a scale and it shows that the work in our "medical relations" function is bearing fruit. This function will be further strengthened as it is one of the most important building blocks to create awareness and knowledge about melflufen ahead of a potential launch. The data presented at EHA was well received by clinicians and it is encouraging that our reachout is working well with at scientific conferences.
Financial positioned strengthened
At the end of June, we announced an additional directed share issue that raised SEK 727 million (USD 78 million). This was the third capital raise since the IPO. For a biotechnology company it is common practice to finance the operations as we present new data from our development pipeline. This is necessary in order to create the highest probability of success when executing our clinical development strategy to validate the efficacy and side-effect profile of melflufen across different patient groups. It also allows us to prepare for a future potential launch that now may occur earlier than originally planned with the application for accelerated approval.
Exciting period ahead
I look forward to working with a growing number of colleagues to develop Oncopeptides. The autumn and winter will continue at a high pace with a growing organization and an increased number of clinical studies. We recently hired Klaas Bakker as our new CMO and he will be a valuable addition to the organization. We will attend several scientific conferences and present new data. Near term, we will present at the "International Myeloma Workshop" that takes place September 12-15 in Boston, USA. This conference is held every other year and we will hold two poster presentations and one oral presentation that was accepted as a late breaker. The oral presentation will be held by Professor Paul G Richardson and will focus on updated data from patients with EMD that have been treated with melflufen in the HORIZON study. It is of great strategic importance to get the opportunity to present data from this rapidly growing patient group for all the Myeloma specialists at the meeting. In December, we will also have several presentations at the annual American Society of Hematology Meeting (ASH) where we among other things will present updated data from both ANCHOR and HORIZON.
Stockholm August 28, 2019
Jakob Lindberg
CEO, Oncopeptides AB
Summary – our clinical trials
Our clinical development program will provide us with a broad set of data and information about melflufen's efficacy in various patient groups. We initiated preparations for an NDA submission based on the available HORIZON data. The overall regulatory risk will decrease considerably if the FDA grants a accelerated market approval.
The clinical development program
We are currently conducting four clinical trials to characterize melflufen in multi-refractory multiple myeloma patients: OCEAN (OP-103), HORIZON (OP-106), ANCHOR (OP-104) and BRIDGE (OP-107).
The program will provide a clear picture of how melflufen can be used for relapsed refractory multiple myeloma (RRMM) patients in various stages of the disease. This has lowered the development risk and given rise to several potential paths for obtaining approval for melflufen.
Melflufen has previously undergone both preclinical trials and clinical phase 1 and 2 trials with positive results in terms of both safety and efficacy in patients with multiple myeloma. Based on these results, the next logical step was to further develop melflufen through the trials OCEAN, HORIZON, ANCHOR and BRIDGE, and the planned additional pivotal combination trial LIGHTHOUSE that we expect to start around the year end.
Our phase 3 trial, OCEAN, and phase 2 trial, HORIZON, are key studies for the submission of an NDA/MAA to potentially obtain marketing authorization for melflufen in the US and the EU for the treatment of RRMM. In addition to proving melflufen's efficacy in relation to the existing standard treatment for RRMM (meaning pomalidomide), as evaluated by OCEAN, the development program also aims to demonstrate, through HORIZON, the activity of melflufen in patients with relapsed refractory multiple myeloma whose disease is triple-class refractory (i.e. refractory to at least one IMiD, one proteasome inhibitor and one anti-CD38 monoclonal antibody). Our phase 1/2 trial, ANCHOR, is aimed at demonstrating how melflufen can be administered in combination with other multiple-myeloma drugs. It is important to generate knowledge and understanding among physicians about how melflufen can be used together with dexamethasone and either bortezomib or daratumumab in relapsed refractory MM patients. BRIDGE is a phase 2 pharmacokinetic trial to study melflufen's safety in patients with reduced renal function. We are also preparing to start a pivotal phase 3 study called LIGHTHOUSE, which is planned to start in the second half of 2019.
The regulatory path ahead
The initiated submission process in the US for accelerated approval for melflufen for the treatment of RRMM patients with triple-class refractory disease, is the first step in building a potential label for melflufen within myeloma. A potential accelerated approval results in a regulatory approval that later needs to be confirmed with clinical data from a randomized trial. Both OCEAN and LIGHTHOUSE can independently act as confirmatory trials for a potential accelerated approval. Additionally, both OCEAN and LIGHTHOUSE – assuming positive outcome from the trials – can result in broadening of the label into less advanced RRMM patient populations (both trials) as well as in combination with daratumumab (LIGHTHOUSE).
Oncopeptides has collaborated with leading experts and held discussions with governing medical agencies and professional bodies in the US and Europe to create the development program for melflufen in RRMM. Upon receiving approval of the phase 3 OCEAN study design through the FDA Special Protocol Assessment in August 2016, detailed preparations commenced for the development program of melflufen. The program aims to fully characterize melflufen in the treatment of RRMM and thereby maximize the product candidate's market potential.
The phase 3 trial OCEAN is expected to lay the foundation for an application to broaden the indication for melflufen late 2020. The application can act as a confirmatory trial after a potential accelerated approval - including label extension into RRMM patients with only single class refractory disease (compared to the potential accelerated approval for the treatment of RRMM patients with triple-class refractory disease) – as well as act as an independent application for market authorization across markets.
In the OCEAN clinical phase 3 trial, the efficacy of Oncopeptides' product candidate, melflufen, is compared with pomalidomide, both are administered in combination with the steroid dexamethasone. Pomalidomide is currently the market-leading medication for the treatment of RRMM, with sales of 2.0 billion USD in 2018. The objective of the OCEAN trial is to prove that melflufen has a superior efficacy and safety profile compared with pomalidomide.
The primary read-out in OCEAN is a comparison between melflufen and pomalidomide regarding PFS (Progression Free Survival). This comparison can simplistically result in three different outcomes i.e. that melflufen is superior, non-inferior or inferior to pomalidomide. As seen in the graphic below, the non-inferior outcome can be broken down in different scenarios with stronger or weaker data to support marketing efforts of melflufen. OCEAN has been statistically powered to show superiority of melflufen over pomalidomide based on historical data for the two compounds.
A superiority outcome is expected to result in approval both in the US and the EU. A non-inferiority result is expected to result in approval in the EU and potentially also in the US assuming that the forthcoming application for accelerated market approval based on HORIZON data is approved by the FDA.
The planned LIGHTHOUSE pivotal phase 3 trial is designed to further broaden the indication for melflufen. The application can act as a confirmatory trial after a potential accelerated approval - including label extension where melflufen is approved also in combination with daratumumab for the treatment of RRMM patients – as well as act as an independent application for market authorization across markets.
benefit
• Started in Q2 2017 with last patient in expected in Q1 2020 • Started in Q2 2018, data reporting in 2018/2019, with the results from phase 1 and phase 2 expected in 2019 and 2020, respectively
• Started in Q1 2017, data reporting in 2018/2019 and follow-up 2019/2020
The market for treatment of multiple myeloma
The market is expected to continue to grow rapidly to an expected market value of approximately USD 22 billion in 2023. The global market amounted to USD 17 billion in 2018.
The market is growing sharply
As treatment results for a disease with a poor prognosis improve – even marginally – the market for later lines of therapy grows significantly. The driving factor for this growth is the fact that patients live longer, which means that more patients will receive additional treatments, compared with before.
Broad-spectrum agents dominate the market
Despite the launch of several new drugs, the market continues to be dominated by broad-spectrum agents (alkylators, IMiDs and proteasome inhibitors) and the trend is expected to continue. The reason for this is that the disease is highly heterogeneous, and modern antibody agents cannot treat the entire disease due to a lack of any target proteins common to all myeloma tumor cells. Consequently, increased usage of antibody drugs is primarily linked to their combination with broad-spectrum agents to ensure the targeting of all tumor cells.
The market in USD
The global market for myeloma drugs amounted to USD 17 billion in 2018. The market for the treatment of myeloma patients after the first line of therapy totaled USD 10 billion. Due to the growth in the number of patients in later lines of therapy as well as drug launches, the myeloma market is expected to reach USD 22 billion in 2023.
The number of cases of multiple myeloma in second line plus treatment is growing rapidly
Roughly 170,000 patients are living with multiple myeloma in the EU and the US, while 57,000 patients are newly diagnosed and 26,000 patients die from the disease annually.* The number of patients diagnosed with multiple myeloma is growing approximately with 1 percent per year, mainly caused by an aging population. However, the number of patients with multiple myeloma who have undergone several previous lines of therapy is increasing exponentially, which is boosting the need for drugs with new modes of action, such as melflufen.
Oncopeptides' pivotal trial, OCEAN, is focused on addressing the needs of these
Global growth, 2018 to 2023
patients, whose numbers are increasing sharply due to recent improvements in earlier lines of therapy. Despite these therapeutic improvements, multiple myeloma remains incurable. This means that more patients than ever are living with the disease for longer periods of time and becoming multi-refractory patients with a significant need for additional treatment options. For the average growth rate in the US over the past three years, see diagram below.
Size of the multiple myeloma market
Broad-spectrum agents used in nine out of ten myeloma therapies*
Source: Annual reports from Global Data, internal analysis and IntrinsiQ.
GROWTH IN TREATED % OF TREATED PATIENTS IN THE
Distribution of multiple myeloma patients by lines of therapy in the US
Source: Intrinsiq december 2018, MAT Note: 3-year annual growth rate for 2015 -2018
Financial overview
Revenue
Net sales amounted to SEK 0.0 M (0.0) during the second quarter and to SEK 0.0 M (0.0) for the first six months..
Operating expenses
Operating expenses for the second quarter amounted to SEK 171.7 M (144.7) and to SEK 305.6 M (205.1) for the first six months. The increase is mainly explained by increasing R&D expenses related to clinical trials.
Research and development costs
During the second quarter, research and development costs increased to SEK 132.6 M (99.8) and to SEK 239.4 M (154.5) for the first six months. The increase is mainly explained by a rise in clinical costs due to increased activity in the ongoing pivotal study OCEAN and in the clinical studies HORIZON, ANCHOR and BRIDGE.
During the period the accounting of purchases of study drugs has been changed. The costs were previously recognized when the drugs were used in clinical trials and are now being expensed when the drugs are purchased in accordance with IFRS. Historical periods have been corrected, see Note 8.
The costs for share-based incentive programs related to R&D amounted to SEK 4.2 M (18.2) for the second quarter and to SEK 7,6 M (19.3) for the first six months.
Marketing and distribution costs
Marketing and distribution costs for the second quarter amounted to SEK 26.4 M (16.0) and to SEK 44.3 M (21.7) for the first six months. The main reason for the cost increase is the continued expansion of the medical relations and marketing functions and related activities.
The costs for share-based incentive programs related to marketing and distribution amounted to SEK 2.2 M (6.1) for the second quarter and to SEK 4.2 M (6.5) for the first six months.
Administration expenses
During the second quarter, administration expenses amounted to SEK 16.0 M (34.2) and to SEK 27.4 M (40.6) for the first six months. The increase that is not attributable to costs for the share-based incentive programs is due to the company´s continued high business activity level and growing organization.
The costs for share-based incentive programs related to administration amounted to SEK 3.5 M (23.6) for the second quarter and to SEK 6.0 M (24.4) for the first six months.
Share-based payments
The costs for social security contributions related to share-based incentive programs vary from quarter to quarter due to the change in the underlying share price. Related provisions are reported as long- and short-term liabilities.
The total costs for the share-based incentive programs in the second quarter amounted to SEK 9.9 M (47.9) and for the first six months to SEK 17.8 M (50.2), out of which SEK 3.8 M (47.9) was provisions for social security contributions and SEK 14.0 M (2.3) was IFRS 2 classified salary costs. These costs have no cash impact. The company holds warrants that are allocated as cash flow hedge for social security contributions arising from the exercise of granted employee stock options.
Earnings
The loss for the second quarter was SEK 171.9 M (144.7) and the loss for the first six months was SEK 306.0 M (205.1). This corresponds to a loss per share, before and after dilution, of SEK 3.52 (3.30) for the second quarter and SEK 6.35 (4.91) for the first six months.
Cash flow, investments and financial position
Cash flow from operating activities amounted to a negative SEK 123.0 M (neg: 90.1) for the second quarter and to a negative SEK 265.8 M (neg: 130.6) for the first six months. The continued negative cash flow is according to plan and is explained by the company's expansion of clinical programs as well as activities within the company's medical affairs and marketing functions.
Cash flow from investing activities was SEK 0.0 M (neg: 0.3) for the second quarter and SEK 0.0 M (neg: 0.3) for the first six months.
Cash flow from financing activities amounted to a negative SEK 0.9 M (0.0) for the second quarter and to SEK SEK 513.1 M (295.0) for the first six months. In January 2019 the company completed a directed share issue raising SEK 546.2 M before issue costs amounting to SEK 31.4 M. In June it was resolved to make a second directed share issue, which was completed in July. The share issue raised SEK 727.2 M before issue costs amounting to SEK 44.3 M. The share issue is recorded in the parent company as share issues are considered as completed upon the resolution date according to Swedish accounting practices but not in the group as share issues are recorded when the new shares have been paid according to IFRS. See Note 7.
Cash flow for the second quarter was a negative SEK 123.9 M (neg: 90.3) and SEK 247.3 M (164.2) for the first six months. As of June 30, 2019, cash and cash equivalents amounted to SEK 626.8 M (568.2) and equity to SEK 487.8 M (451.1).
Share-based incentive programs
The purpose of share-based incentive programs is to promote the company's long-term interests by motivating and rewarding the company's senior management, founders, and other co-workers in line with the interest of the shareholders. Oncopeptides has currently eight active programs that include the management team, certain board members, founders and employees.
In 2013, the option programs "Founder Option Program" and "Employee option program 2012/2019" were implemented. In 2016 the program "Employee option program 2016/2023" was implemented. In 2017 two incentive programs were established; "Co-worker LTIP 2017" and "Board LTIP 2017". At the AGM in May 2018, two additional incentive programs were adopted: "Co-worker LTIP 2018" and "Board LTIP 2018". For more information about these programs see note 24 in the Annual Report 2018. An Extraordinary General Meeting in December 2018 resolved to implement the program "Board LTIP 2018.2" and the Annual General Meeting 2019 resolved to implement two additional programs: "Co-worker LTIP 2019" and "Board LTIP 2019". For further information about these programs, see the minutes of the Extraordinary General Meeting 2018 and the Annual General Meeting 2019 published on the company's website, www.oncopeptides.com.
Full utilization of granted options and share awards per June 30, 2019, corresponding to 3,593,769 shares, would result in a dilution for shareholders of 6.9 percent. This corresponds to a dilution of 6.3 percent if the shares from the share issue completed in July are included. Full utilization of issued warrants, corresponding to 4,613,100 shares (i.e. including non-granted employee options and hedge for social security contributions), would result in a dilution for shareholders of 8.6 percent. This corresponds to a dilution of 7.9 percent if the shares from the share issue completed in July are included.
During the first six months 2,170 share awards in Board LTIP 2018.2 and 349,549 options in Co-worker LTIP 2018 have been granted. 1,934 share awards in Board LTIP 2017 and 3,480 share awards in Board LTIP 2018 lapsed. No options or share awards have been exercised in the period.
Below follows a summary of the total number of shares that granted employee stock options and share awards may entitle to as of June 30, 2019.
Number of shares allocated employee stock options may entitle to
| - Employee option program 2012/2019 | 1,133,100 |
|---|---|
| - Founder option program | 81,000 |
| - Employee option program 2016/2023 | 276,300 |
| - Co-worker LTIP 2017 | 1,618,939 |
| - Co-worker LTIP 2018 | 430,543 |
| Total number of shares allocated employee stock options may entitle to | 3,539,882 |
| Number of allocated share awards in program Board LTIP 2017 | 21,266 |
| Number of allocated share awards in program Board LTIP 2018 | 30,451 |
| Number of allocated share awards in program Board LTIP 2018.2 | 2,170 |
| Total number of shares allocated employee stock options and share | |
| awards may entitle to | 3,593,769 |
Other information
Co-workers
As of June 30, 2019, the number of co-workers amounted to 61 (40).
Parent company
Since the operations of the parent company are consistent with those of the group in all material respects, the comments for the group are also largely relevant for the parent company.
The Oncopeptides share
Oncopeptides completed a directed share issue in January 2019, where a total of 4,750,000 new shares were issued. As of June 30, 2019, the number of registered shares and votes in Oncopeptides amounted to 48,841,921. In June it was resolved to make an additional share issue comprising 5,015,000 shares. This share issue was registered on July 3 when the number of registered shares and votes increased to 53,856,921.
Events after the end of the report period In late August it was announced that Klaas Bakker was appointed as the new Chief Medical Officer for Oncopeptides. He starts his work in November.
Review
This report has not been reviewed by the company's auditor.
The Board and the CEO confirm that the interim report provides a true and fair overview of the group's and the parent company's operations, position and earnings and describes the material risks and uncertainty factors faced by the parent company and the companies within the group.
Stockholm August 28, 2019
Per Wold-Olsen Jonas Brambeck Chairman Board member
Cecilia Daun Wennborg Jennifer Jackson Board member Board member
Jarl Ulf Jungnelius Per Samuelsson Board member Board member
Board member CEO
Brian Stuglik Jakob Lindberg
Condensed consolidated income statement
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|---|---|---|---|---|---|
| Net sales | – | – | – | – | – |
| Gross profit | – | – | – | – | – |
| Operating expenses | |||||
| Research and development costs | -132,569 | -99,845 | -239,374 | -154,508 | -313,714 |
| Marketing and distribution costs | -26,416 | -15,996 | -44,295 | -21,673 | -51,126 |
| Administrative expenses | -16,032 | -34,192 | -27,361 | -40,613 | -55,298 |
| Other operating income/expenses2) | 3,278 | 5,382 | 5,479 | 11,741 | 9,175 |
| Total operating expenses | -171,739 | -144,651 | -305,551 | -205,053 | -410,963 |
| Operating loss | -171,739 | -144,651 | -305,551 | -205,053 | -410,963 |
| Net financial items | -125 | 0 | -259 | 0 | -2 |
| Loss before tax | -171,864 | -144,651 | -305,810 | -205,053 | -410,965 |
| Tax | -80 | - | -211 | - | -147 |
| Loss for the period | -171,944 | -144,651 | -306,021 | -205,053 | -411,112 |
| Earnings per share before and after dilution (SEK) |
-3.52 | -3.30 | -6.35 | -4.91 | -9.58 |
Condensed consolidated statement of comprehensive income
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|---|---|---|---|---|---|
| Loss for the period | -171,944 | -144,651 | -306,021 | -205,053 | -411,112 |
| Other comprehensive income Items to be reclassified to profit or loss |
|||||
| Translation differences from foreign operations |
-13 | – | 20 | – | 22 |
| Translation differences on currency hedges |
– | – | – | -8 | -8 |
| Total other comprehensive income, net of tax |
-13 | – | 20 | -8 | 14 |
| Total comprehensive loss for the period3) |
-171,957 | -144,651 | -306,001 | -205,061 | -411,098 |
Condensed consolidated statement of financial position
| SEK thousand | June 30th 2019 |
June 30th 20181) |
Dec 31st 20181) |
|---|---|---|---|
| Assets | |||
| Non-current assets | |||
| Tangible non-current assets | 10,027 | 2,430 | 2,363 |
| Financial non-current assets | 1,034 | 263 | 851 |
| Total non-current assets | 11,061 | 2,693 | 3,214 |
| Current assets | |||
| Other current receivables (note 7) | 48,347 | 2,987 | 2,456 |
| Prepaid expenses and accrued income | 17,775 | 9,413 | 12,415 |
| Cash and cash equivalents | 626,799 | 568,212 | 375,617 |
| Total current assets | 692,921 | 580,612 | 390,488 |
| Total assets | 703,982 | 583,305 | 393,702 |
| Equity and liabilities | |||
| Equity | |||
| Share capital | 5,427 | 4,865 | 4,899 |
| Additional paid-in capital | 1,801,100 | 1,252,951 | 1,272,830 |
| Retained earnings (including net profit/loss for the period) | -1,318,726 | -806,689 | -1,012,725 |
| Total equity2) | 487,801 | 451,128 | 265,004 |
| Long term liabilities | |||
| Provision for social security contributions, share based incentive program |
19,287 | 11,553 | 14,858 |
| Other long term liabilities (note 6) | 4,101 | – | – |
| Total long term liabilities | 23,388 | 11,553 | 14,858 |
| Current liabilities | |||
| Provision for social security contributions, | |||
| share based incentive program | 56,006 | 11,570 | 56,600 |
| Trade payables | 50,750 | 74,527 | 25,270 |
| Other current liabilities (note 7) | 49,981 | 1,667 | 4,056 |
| Accrued expenses and deferred income | 36,056 | 32,861 | 27,914 |
| Total current liabilities | 192,793 | 120,625 | 113,840 |
| Total liabilities | 216,181 | 132,177 | 128,698 |
| Total equity and liabilities | 703,982 | 583,305 | 393,702 |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8. 2) Equity is in total attributable to parent company shareholders
3) Total comprehensive loss for the period is in total attributable to parent company shareholders
1) Earlier periods have been adjusted to reflect correction of errors, see note 8. 2) Exchange rate differences on assets and liabilities in operational activities.
Condensed consolidated statement of changes in equity
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|---|---|---|---|---|---|
| Opening balance | 652,125 | 594,498 | 265,004 | 358,840 | 358,840 |
| Profit/loss of the period Other comprehensive income |
-171,944 -13 |
-144,651 – |
-306,021 20 |
-205,053 -8 |
-411,112 14 |
| Comprehensive income (loss) for the period |
-171,957 | -144,651 | -306,001 | -205,061 | -411,098 |
| Transaction with owners New issue of ordinary shares Cost attributable to new share issue Share based payments Exercise of warrants under the com pany's incentive programs |
– – 7,633 – |
– – 1,280 – |
546,250 -31,409 13,957 – |
314,420 -19,390 2,319 – |
314,420 -19,390 12,368 9,864 |
| Total transaction with owners | 7,633 | 1,280 | 528,798 | 297,349 | 317,262 |
| Closing balance | 487,801 | 451,128 | 487,801 | 451,128 | 265,004 |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8.
Condensed consolidated statement of cash flow
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|---|---|---|---|---|---|
| Operating loss | -171,739 | -144,651 | -305,551 | -205,053 | -410,963 |
| Adjustment for non-cash-items2) | 7,657 | 54,370 | 15,876 | 50,429 | 44,727 |
| Interest received | – | – | – | – | – |
| Interest paid | -125 | 0 | -259 | 0 | -2 |
| Tax paid | -293 | – | -293 | – | – |
| Cash flow from operating activities before change in working capital |
-164,500 | -90,281 | -290,227 | -154,624 | -366,238 |
| Cash flow from changes in working capital | 41,503 | 221 | 24,409 | 24,017 | 32,511 |
| Cash flow from operating activities | -122,997 | -90,060 | -265,818 | -130,607 | -333,727 |
| Cash flow from investing activities | – | -252 | -42 | -252 | -907 |
| Cash flow from financing activities | -919 | – | 513,113 | 295,030 | 304,893 |
| Cash flow for the period | -123,916 | -90,312 | 247,253 | 164,171 | -29,741 |
| Cash and cash equivalents at beginning of period |
747,471 | 664,944 | 375,617 | 404,050 | 404,050 |
| Change in cash and cash equivalents | -123,916 | -90,312 | 247,253 | 164,171 | -29,741 |
| Foreign exchange difference in cash and cash equivalents |
3,244 | -6,420 | 3,929 | -9 | 1,308 |
| Cash and cash equivalents at the end of period |
626,799 | 568,212 | 626,799 | 568,212 | 375,617 |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8.
2) Pertains mainly to costs of employee stock option program including social security contributions
Condensed parent company income statement
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|---|---|---|---|---|---|
| Net sales | – | – | – | – | – |
| Gross profit | – | – | – | – | – |
| Operating expenses | |||||
| Research and development costs | -132,603 | -99,845 | -239,439 | -154,508 | -313,714 |
| Marketing and distribution costs | -27,206 | -15,996 | -45,765 | -21,673 | -51,844 |
| Administrative expenses | -16,042 | -34,192 | -27,384 | -40,613 | -55,298 |
| Other operating income/expenses2) | 3,278 | 5,382 | 5,479 | 11,741 | 9,175 |
| Total operating expenses | -172,573 | -144,651 | -307,109 | -205,053 | -411,681 |
| Operating loss | -172,573 | -144,651 | -307,109 | -205,053 | -411,681 |
| Net financial items | 10 | 0 | 20 | 0 | 18 |
| Loss before tax | -172,563 | -144,651 | -307,089 | -205,053 | -411,663 |
| Tax | – | – | – | – | – |
| Loss for the period | -172,563 | -144,651 | -307,089 | -205,053 | -411,663 |
Condensed parent company statement of comprehensive income
| SEK thousand | 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|---|---|---|---|---|---|
| Loss for the period | -172,563 | -144,651 | -307,089 | -205,053 | -411,663 |
| Other comprehensive income | |||||
| Items to be reclassified to profit or loss |
|||||
| Translation differences on currency hedges |
– | – | – | -8 | -8 |
| Total other comprehensive income, net of tax |
– | – | – | -8 | -8 |
| Total comprehensive loss for the period |
-172,563 | -144,651 | -307,089 | -205,061 | -411,671 |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8. 2) Exchange rate differences on assets and liabilities in operational activities
Parent company balance sheet
| SEK thousand | June 30th 2019 |
June 30th 20181) |
Dec 31st 20181) |
|---|---|---|---|
| Assets | |||
| Non-current assets | |||
| Tangible non-current assets | 2,191 | 2,430 | 2,363 |
| Financial non-current assets | 901 | 313 | 901 |
| Total non-current assets | 3,092 | 2,743 | 3,264 |
| Current assets | |||
| Other current receivables (note 7) | 775,522 | 2,987 | 2,279 |
| Prepaid expenses and accrued income | 17,557 | 9,413 | 11,640 |
| Cash and bank balances | 624,958 | 568,162 | 375,513 |
| Total current assets | 1,418,037 | 580,562 | 389,432 |
| Total assets | 1,421,129 | 583,305 | 392,696 |
| Equity and liabilities | |||
| Restricted equity | |||
| Share capital | 5,984 | 4,865 | 4,899 |
| Statutory reserve | 10,209 | 10,209 | 10,209 |
| Non-restricted equity | |||
| Share premium account | 2,488,584 | 1,242,743 | 1,247,653 |
| Retained earnings (including net profit/loss for the period) | -1,291,464 | -806,689 | -998,331 |
| Total equity | 1,213,313 | 451,128 | 264,430 |
| Long term liabilities | |||
| Provision for social security contributions, share based | |||
| incentive program | 19,287 | 11,553 | 14,858 |
| Total long term liabilities | 19,287 | 11,553 | 14,858 |
| Current liabilities | |||
| Provision for social security contributions, share based | |||
| incentive program | 56,006 | 74,527 | 56,600 |
| Trade payables | 49,611 | 11,570 | 23,261 |
| Other current liabilities (note 7) | 47,605 | 1,667 | 5,815 |
| Accrued expenses and deferred income | 35,307 | 32,861 | 27,732 |
| Total current liabilities | 188,529 | 120,625 | 113,408 |
| Total liabilities | 207,816 | 132,177 | 128,266 |
| Total equity and liabilities | 1,421,129 | 583,305 | 392,696 |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8.
Key performance measures
The company presents in this report certain key performance measures, including one measure that is not defined under IFRS, namely expenses relating to research and development / operating expenses %. The company believes that this ratio is an important complement because it allows for a better evaluation of the company's economic trends. This financial performance measure should not be viewed in isolation or be considered to replace the performance indicators that have been prepared in accordance with IFRS. In addition, such performance measure as the company has defined it should not be compared with other performance measures with similar names used by other companies. This is because the above-mentioned performance measure is not always defined in the same manner, and other companies may calculate the differently to Oncopeptides.
Key performance measures, shares
| 2019 Apr - Jun |
20181) Apr - Jun |
2019 Jan - Jun |
20181) Jan - Jun |
20181) Jan - Dec |
|
|---|---|---|---|---|---|
| Total registered shares at the beginning of period | 48,841,921 | 43,786,021 | 44,091,921 | 39,806,021 | 39,806,021 |
| Total registered shares at the end of period | 48,841,921 | 43,786,021 | 48,841,921 | 43,786,021 | 44,091,921 |
| Number of shares that the outstanding employee options entitle to | 3,539,882 | 2,782,569 | 3,539,882 | 2,782,569 | 3,247,464 |
| Share capital at the end of period, SEK thousand | 5,427 | 4,865 | 5,427 | 4,865 | 4,899 |
| Equity at the end of period, SEK thousand | 487,801 | 451,128 | 487,801 | 451,128 | 265,004 |
| Earnings per share before and after dilution, SEK2) | -3.52 | -3.30 | -6.35 | -4.91 | -9.58 |
| Operating expenses, SEK thousand | -171,739 | -144,651 | -305,551 | -205,053 | -410,963 |
| Research and development costs, SEK thousand | -132,569 | -99,845 | -239,374 | -154,508 | -313,714 |
| Research & development costs/operating expenses %3) | 77% | 69% | 78% | 75% | 76% |
1) Earlier periods have been adjusted to reflect correction of errors, see note 8.
2)Earnings per share before dilution are calculated by dividing earnings attributable to shareholders of the parent company by a weighted average number of outstanding shares during the period. There is no dilution effect for the employee stock option program, as earnings for the periods have been negative.
3)Defined by dividing the research and development costs with total operating expenses. The key performance measure helps the users of the financial statements to get a quick opinion on the proportion of the company's expenses that are attributable to the company's core business.
Notes
Note 1 General information
This report covers the Swedish parent company Oncopeptides AB (publ), Swedish corporate identity no. 556596-6438 and its subsidiary Oncopeptides Incentive AB and Oncopeptides Inc, USA. The parent company is a Swedish public limited company registered in and with its registered office in Stockholm. Numbers in parentheses in the report refer to the figures for the corresponding period the previous year.
The interim report for the second quarter 2019 was approved for publication on August 28, 2019.
Note 2 Accounting policies
Oncopeptides applies the same accounting principles as in the latest Annual Report. Relevant accounting and valuation principles could be found on pages 49-53 of the Annual Report for 2018. The interim report for the group has been prepared in accordance with IAS 34 Interim Financial Reporting. The parent company applies the Swedish Financial Reporting Board recommendation RFR2 Accounting for legal entities.
IFRS 16 replaces IAS 17 and has been implemented for the group from January 1, 2019. The effect of the implementation of IFRS 16 is presented in Note 6. No other the new or amended standards that became effective January 1st 2019, have had a significant impact on the company's financial reporting.
Oncopeptides applies ESMA's (European Securities and Markets Authority) guidelines on alternative performance measures.
Note 3 Risks and uncertainties in the group and the parent company
Operational risks
Research and drug development up to approved registration is subject to considerable risk and is a capital-intensive process. The majority of all initiated projects will never reach market registration due to the technological risk such as the risk for insufficiency efficacy, intolerable side effects or manufacturing problems. If competing pharmaceuticals capture market share or reach the market faster, or if competing research projects achieve better product profile, the future value of the product portfolio may be lower than expected. The operations may also be impacted negatively by regulatory decisions, such as approvals and price changes. A more detailed description of the company's risk exposure and risk management can be found in the Annual Report for 2018 on pages 35-36.
Financial risk management
Oncopeptides' financial policy governing the management of financial risks has been designed by the board of directors and represents the framework of guidelines and rules in the form of risk mandated and limits for financial activities. The company is primarily affected by foreign exchange risk since the development costs for Melflufen are mainly paid in USD and EUR. In accordance with the company's policy for financial risk, the company exchanges cash into USD and EUR in line with entered agreements in order to manage currency exposure. For more information about the group and parent company's financial risk management see note 3 on page 54 in the Annual Report for 2018.
Note 4 Estimates and judgements
This report includes forward looking statements. Actual outcomes may deviate from what has been stated. Internal factors such as successful management of research projects, and intellectual property rights may affect future results. There are also external conditions, e.g. the economic climate, political changes and competing research projects that may affect Oncopeptides results.
Note 5 Related-party transactions
No transactions with related parties occurred during the period.
Note 6 IFRS 16 Leasing
IFRS 16 is applied by the Group as of January 1, 2019. IFRS 16 replaces IAS 17, and according to the new standard, lessees must report the obligation to pay lease payments as a lease debt in the balance sheet. The right to use the underlying asset during the leasing period is reported as an asset. Depreciation of the asset is recognized in profit or loss as well as an interest on the lease debt. Leasing fees paid are reported partly as interest payment and partly as amortization of the lease liability. The standard allows companies to choose to exclude leasing agreements with a lease term of less than 12 months (short-term leases) and leasing agreements for assets that have a low value.
The standard means that the majority of existing leases are reported as assets and liabilities in the balance sheet. This means that the cost for these is reported divided into interest expenses and depreciation. In the parent company, the exception is applied in RFR 2 regarding leasing agreements. This means that the parent company's principles for reporting leases are unchanged. Oncopeptides applies the simplified transition method. The right of use assets at the beginning of the period have been calculated to the same value as the lease liabilities at the same point in time. The transition to IFRS 16 meant that the Group had the right to use assets and leasing liabilities of SEK 8.1 M as of January 1, 2019. The transition to IFRS 16 also meant that the operating profit for the Group for the period ended June 30, 2019 improved by SEK 0.1 M, and that the result for the period was decreased by SEK 0.1 M, compared with if the corresponding accounting principles from the previous year had been applied.
Leasing agreements
| SEK thousand | Right of use assets |
Lease liabilities |
|---|---|---|
| Opening balance January 1, 2019 | 8,053 | 8,053 |
| Additional agreements | 1,585 | 1,585 |
| Depreciation | -1,841 | |
| Amortization | -1,725 | |
| Closing balance June 30, 2019 | 7,797 | 7,913 |
Reconciliation of operational leasing commitments
| Commitments for operational leasing | |
|---|---|
| agreements December 31, 2018 | 8,352 |
| Discounting effects | -299 |
| Reported leasing liabilities January 1, 2019 |
8,053 |
Note 7 Issue related assests and liabilities
| SEK thousand | June 30th 2019 |
June 30th 2018 |
Dec 31st 2018 |
|---|---|---|---|
| Consolidated balance sheet | |||
| Issue related current assets | 44,262 | – | – |
| Non-issue related current assets | 4,085 | 2,987 | 2,456 |
| Other current assets | 48,347 | 2,987 | 2,456 |
| Issue related current liabilities | 44,262 | – | – |
| Non-issue related current liabilities | 5,719 | 1,667 | 4,056 |
| Other current liabilities | 49,981 | 1 667 |
4 056 |
| Parent company balance sheet | |||
| Issue related current assets | 771,437 | – | – |
| Non-issue related current assets | 4,085 | 2,987 | 2,279 |
| Other current assets | 775,522 | 2,987 | 2,279 |
| Issue related current liabilities | 44,262 | – | – |
| Non-issue related current liabilities | 3,343 | 1,667 | 5,815 |
| Other current liabilities | 47,605 | 1 667 |
5,815 |
Note 8 Correction of errors
Purchases of study drugs used in clinical trials related to the company's development projects have been accounted for erroneously since 2017 as prepaid expenses and have been expensed when the drugs have been used in the clinical rials. According to IFRS, purchases of substances should be expensed directly as Reseacrh and Development expenses when they are purchased and not when they are used.
The summary below describes the impact of the error corrections on the consolidated and parent company income statements for the periods Jan-Dec 2018 and Jan-Jun 2018, and the impact on the consolidated and parent company balance sheets per Dec 31, 2018; June 30, 2018 and Jan 1, 2018. The correction of errors has no impact on consolidated or parent company cash flow statements.
Consolidated statement of income, Jan-Dec 2018
| SEK thousand | According to approved Annual Report |
Correction of error |
After cor rection of error |
|---|---|---|---|
| Operating expenses | |||
| Research and development costs | -322,051 | 8,337 | -313,714 |
| Marketing and distribution costs | -51,126 | – | -51,126 |
| Administrative expenses | -55,298 | – | -55,298 |
| Other operating income/expenses | 9,175 | – | 9,175 |
| Total operating expenses | -419,300 | 8,337 | -410,963 |
| Operating loss | -419,300 | 8,337 | -410,963 |
| Net financial items | -2 | – | -2 |
| Tax | -147 | – | -147 |
| Loss for the period | -419,449 | 8,337 | -411,112 |
| Other comprehensive income | |||
| Total other comprehensive income, net of tax | 14 | – | 14 |
| Total comprehensive loss for the period | -419,435 | 8,337 | -411,098 |
| Earnings per share before and after dilution (SEK) | -9.77 | 0.19 | -9.58 |
Consolidated balance sheet, Dec 31, 2018
| SEK thousand | According to approved Annual Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Assets | |||
| Total non-current assets | 3,214 | – | 3,214 |
| Current assets | |||
| Other current receivables | 2,456 | – | 2,456 |
| Prepaid expenses and accrued income | 63,243 | -50,828 | 12,415 |
| Cash and cash equivalents | 375,617 | – | 375,617 |
| Total current assets | 441,316 | -50,828 | 390,488 |
| Total assets | 444,530 | -50,828 | 393,702 |
| Equity and liabilities | |||
| Equity | |||
| Share capital | 4,899 | – | 4,899 |
| Additional paid-in capital | 1,272,830 | – | 1,272,830 |
| Retained earnings (including net profit/loss for the | |||
| period) | -961,897 | -50,828 | -1,012,725 |
| Total equity | 315,832 | -50,828 | 265,004 |
| Total long term liabilities | 14,858 | – | 14,858 |
| Total current liabilities | 113,840 | – | 113,840 |
| Total liabilities | 128,698 | – | 128,698 |
| Total equity and liabilities | 444,530 | -50,828 | 393,702 |
Parent company income statement, Jan-Dec 2018
| SEK thousand | According to approved Annual Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Operating expenses | |||
| Research and development costs | -322,051 | 8,337 | -313,714 |
| Marketing and distribution costs | -51,844 | – | -51,844 |
| Administrative expenses | -55,298 | – | -55,298 |
| Other operating income/expenses | 9,175 | – | 9,175 |
| Total operating expenses | -420,018 | 8,337 | -411,681 |
| Operating loss | -420,018 | 8,337 | -411,681 |
| Net financial items | 18 | – | 18 |
| Tax | – | – | 0 |
| Loss for the period | -420,000 | 8,337 | -411,663 |
| Other comprehensive income | |||
| Total other comprehensive income, net of tax | -8 | – | -8 |
| Total comprehensive loss for the period | -420,008 | 8,337 | -411,671 |
Parent company balance sheet, Dec 31, 2018
| According to approved |
Correction | After cor- rection of |
|
|---|---|---|---|
| SEK thousand | Annual Report | of error | error |
| Assets | |||
| Total non-current assets | 3,264 | – | 3,264 |
| Current assets | |||
| Other current receivables | 2,279 | – | 2,279 |
| Prepaid expenses and accrued income | 62,468 | -50,828 | 11,640 |
| Cash and cbank balances | 375,513 | – | 375,513 |
| Total current assets | 440,260 | -50,828 | 389,432 |
| Total assets | 443,524 | -50,828 | 392,696 |
| Equity and liabilities | |||
| Equity | |||
| Restricted equity | 15,108 | – | 15,108 |
| Non-restricted equity | 300,150 | -50,828 | 249,322 |
| Total equity | 315,258 | -50,828 | 264,430 |
| Total long term liabilities | 14,858 | – | 14,858 |
| Total current liabilities | 113,408 | – | 113,408 |
| Total liabilities | 128,266 | – | 128,266 |
| Total equity and liabilities | 443,524 | -50,828 | 392,696 |
Consolidated statement of income, Jan-Jun 2018
| SEK thousand | According to Interim Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Operating expenses | |||
| Research and development costs | -154,562 | 54 | -154,508 |
| Marketing and distribution costs | -21,673 | – | -21,673 |
| Administrative expenses | -40,613 | – | -40,613 |
| Other operating income/expenses | 11,741 | – | 11,741 |
| Total operating expenses | -205,107 | 54 | -205,053 |
| Operating loss | -205,107 | 54 | -205,053 |
| Net financial items | 0 | – | 0 |
| Tax | – | – | 0 |
| Loss for the period | -205,107 | 54 | -205,053 |
| Other comprehensive income | |||
| Total other comprehensive income, net of tax | -8 | – | -8 |
| Total comprehensive loss for the period | -205,115 | 54 | -205,061 |
| Earnings per share before and after dilution (SEK) | -4.91 | 0.00 | -4.91 |
Consolidated balance sheet, Jun 30, 2018
| SEK thousand | According to Interim Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Assets | |||
| Total non-current assets | 2,693 | – | 2,693 |
| Current assets | |||
| Other current receivables | 2,987 | – | 2,987 |
| Prepaid expenses and accrued income | 68,524 | -59,111 | 9,413 |
| Cash and cash equivalents | 568,212 | – | 568,212 |
| Total current assets | 639,723 | -59,111 | 580,612 |
| Total assets | 642,416 | -59,111 | 583,305 |
| Equity and liabilities | |||
| Equity | |||
| Share capital | 4,865 | – | 4,865 |
| Additional paid-in capital | 1,252,951 | – | 1,252,951 |
| Retained earnings (including net profit/loss for the | |||
| period) | -747,578 | -59,111 | -806,689 |
| Total equity | 510,238 | -59,111 | 451,127 |
| Total long term liabilities | 11,553 | – | 11,553 |
| Total current liabilities | 120,625 | – | 120,625 |
| Total liabilities | 132,178 | – | 132,178 |
| Total equity and liabilities | 642,416 | -59,111 | 583,305 |
Parent company income statement, Jan-Jun 2018
| SEK thousand | According to Interim Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Operating expenses | |||
| Research and development costs | -154,562 | 54 | -154,508 |
| Marketing and distribution costs | -21,673 | – | -21,673 |
| Administrative expenses | -40,613 | – | -40,613 |
| Other operating income/expenses | 11,741 | – | 11,741 |
| Total operating expenses | -205,107 | 54 | -205,053 |
| Operating loss | -205,107 | 54 | -205,053 |
| Net financial items | 0 | – | 0 |
| Tax | – | – | 0 |
| Loss for the period | -205,107 | 54 | -205,053 |
| Other comprehensive income | |||
| Total other comprehensive income, net of tax | -8 | – | -8 |
| Total comprehensive loss for the period | -205,115 | 54 | -205,061 |
Parent company balance sheet, Jun 30, 2018
| SEK thousand | According to Interim Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Assets | |||
| Total non-current assets | 2,743 | – | 2,743 |
| Current assets | |||
| Other current receivables | 2,987 | – | 2,987 |
| Prepaid expenses and accrued income | 68,524 | -59,111 | 9,413 |
| Cash and cbank balances | 568,162 | – | 568,162 |
| Total current assets | 639,673 | -59,111 | 580,562 |
| Total assets | 642,416 | -59,111 | 583,305 |
| Equity and liabilities | |||
| Equity | |||
| Restricted equity | 15,074 | – | 15,074 |
| Non-restricted equity | 495,165 | -59,111 | 436,054 |
| Total equity | 510,239 | -59,111 | 451,128 |
| Total long term liabilities | 11,553 | – | 11,553 |
| Total current liabilities | 120,625 | – | 120,625 |
| Total liabilities | 132,178 | – | 132,178 |
| Total equity and liabilities | 642,416 | -59,111 | 583,305 |
Consolidated balance sheet, Jan 1, 2018
| According to approved |
Correction | After cor rection of |
|
|---|---|---|---|
| SEK thousand | Annual Report | of error | error |
| Assets | |||
| Total non-current assets | 2,601 | – | 2,601 |
| Current assets | |||
| Other current receivables | 1,189 | – | 1,189 |
| Prepaid expenses and accrued income | 71,982 | -59,165 | 12,817 |
| Cash and cash equivalents | 404,050 | – | 404,050 |
| Total current assets | 477,221 | -59,165 | 418,056 |
| Total assets | 479,822 | -59,165 | 420,657 |
| Equity and liabilities | |||
| Equity | |||
| Share capital | 4,423 | – | 4,423 |
| Additional paid-in capital | 956,044 | – | 956,044 |
| Retained earnings (including net profit/loss for the | |||
| period) | -542,462 | -59,165 | -601,627 |
| Total equity | 418,005 | -59,165 | 358,840 |
| Total long term liabilities | 1,825 | – | 1,825 |
| Total current liabilities | 59,993 | – | 59,993 |
| Total liabilities | 61,817 | – | 61,817 |
| Total equity and liabilities | 479,822 | -59,165 | 420,657 |
Parent company balance sheet, Jan 1, 2018
| SEK thousand | According to approved Annual Report |
Correction of error |
After cor- rection of error |
|---|---|---|---|
| Assets | |||
| Total non-current assets | 2,651 | – | 2,651 |
| Current assets | |||
| Other current receivables | 1,189 | – | 1,189 |
| Prepaid expenses and accrued income | 71,982 | -59,165 | 12,817 |
| Cash and cbank balances | 404,000 | – | 404,000 |
| Total current assets | 477,171 | -59,165 | 418,006 |
| Total assets | 479,822 | -59,165 | 420,657 |
| Equity and liabilities | |||
| Equity | |||
| Restricted equity | 14,632 | – | 14,632 |
| Non-restricted equity | 403,373 | -59,165 | 344,208 |
| Total equity | 418,005 | -59,165 | 358,840 |
| Total long term liabilities | 1,825 | – | 1,825 |
| Total current liabilities | 59,993 | – | 59,993 |
| Total liabilities | 61,817 | – | 61,817 |
| Total equity and liabilities | 479,822 | -59,165 | 420,657 |
Visiting and mail address HQ: Luntmakargatan 46, SE-111 37 Stockholm, Sweden Visiting and mail address US Inc: 444 Castro Street, Mountain View, CA 94041, USA Legal address: Västra Trädgårdsgatan 15, SE-111 53 Stockholm, Sweden Switchboard: +46 8 615 20 40 • www.oncopeptides.com