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Interim report as of September 30, 2015
MOLOGEN AG interim report as of September 30, 2015
Key data 2
Highlights

Patient recruitment for lung cancer and HIV studies successfully completed

At € 10.4 million, R&D expenses in first nine months are on a par with
the reference period

EBIT accordingly at the same level as in the reference period

Outlook for 2015 unchanged
KEY DATA
In million €
Revenues
Profit (loss) from operations
(EBIT)
Expense structure
Personnel expenses
Research & Development
expenses
Earnings per share in € (basic)
Cash flows from operating
activities
Cash and cash equivalents
Shareholders’ equity
Equity ratio
Total assets
Number of employees
Q3 2015
Q3 2014
Q1 – Q3
2015
Change
%
Q1 – Q3
2014
Change
%
0
0
-
0
0
-
-6.3
-5.4
17%
-13.3
-13.3
0%
1.2
1.2
0%
3.8
3.9
-3%
5.2
4.6
13%
10.4
10.5
-1%
-0.28
-0.32
-12%
-0.66
-0.8
-17%
-4.3
-5.0
-14%
-9.0
-11.5
-22%
30 Sep
2015
30.5
31 Dec
2014
13.6
26.5
81%
32.7
13.3
88%
15.1
99%
-8%
117%
62
60
3%
Change
%
124%
Contents 3
CONTENTS
Interim management report as of September 30, 2015
The MOLOGEN share
4
15
Interim statement as of September 30, 2015
Statement of comprehensive income
18
Statement of financial position
19
Statement of cash flows
20
Statement of changes in equity
21
Condensed notes to the interim financial statements
22
Responsibility statement
29
Financial calendar / imprint
30
Interim management report 4
INTERIM MANAGEMENT REPORT
for the period from January 1, to September 30, 2015

Patient recruitment for lung cancer and HIV studies successfully completed


At € 10.4 million, R&D expenses are on a par with the reference period
Outlook for 2015 unchanged
In the third quarter, operational business activities above all focused on clinical studies with the lead product
MGN1703. While patients are still being recruited for the IMPALA study (phase III for colorectal cancer),
enrollment was completed for the TEACH study (phase I for HIV) in September 2015 and for the IMPULSE
study (randomized trial for lung cancer) in October 2015.
At € 10.4 million, research and development (R&D) expenses were on a par with the same period of the
previous year (first nine months [9M] of 2014: € 10.5 million). Accordingly, EBIT was also on a similar level to
the reference period, at € -13.3 million. In view of the plans to continue the current research program, a
significant year-on-year increase in R&D expenses is expected for 2015 as a whole.
As at September 30, 2015, cash and cash equivalents amounted to € 30.5 million and were therefore
considerably higher than the previous year’s value as a result of the capital increase carried out in April 2015
(December 31, 2014: € 13.6 million).
General conditions
Overall economic development

Fragile emerging markets hampering global economic growth

IMF lowers growth forecast for 2015 to 3.1%
In its latest forecast, the International Monetary Fund (IMF) is predicting that the rather sluggish global
economic growth so far in 2015 will not pick up in the final months of the year. Growth is now projected to be
3.1% for 2015, which is a downward revision of 0.2 percentage points on the forecast issued in the summer.
Hopes for a slight recovery in the global economy are now pinned on 2016, for which the IMF is predicting
economic growth of 3.6%, down from 3.8% in the mid-year forecast.
This cut to the global economic growth forecast is attributable to increased financial market volatility of late,
which has specifically impacted the emerging nations. There has been a marked rise in concern about
China’s economy, in particular, but it is also affecting commodity exporting emerging nations such as Brazil
and Russia. The drop in oil prices also continues to dampen growth prospects.
However, lower commodity prices are providing a boost to the global economy in general, with the USA
reporting a considerable increase in its gross domestic product (GDP). Moderate economic growth has also
been maintained in Europe.
Development of the pharmaceutical and biotechnology industries


Global sales increase for drugs still expected to be up to US$ 1.3 trillion in 2018
Oncology is the indication with highest sales worldwide
The pharmaceuticals market is recording robust growth. Market research company IMS Institute for
Healthcare Informatics (IMS) is predicting that total global expenditure on drugs will rise to around US$ 1.3
trillion by 2018, which is around 30% higher than in 2013.
The field of oncology plays a major role. In its World Cancer Report 2014, the World Health Organization
(WHO) assumes a sharp increase in new cancer incidences. This number could increase by 40% in the next
decade, which means that by 2025, 20 million people could develop cancer each year across the globe. The
growth rates in the oncology market are correspondingly high. The market researcher EvaluatePharma is
predicting a global market volume of more than US$ 153 billion in this area for 2020. This equates to
average annual sales growth of around 11%. Oncology is therefore the therapeutic area with the highest
growth rates and, according to the market research company's projections, it will remain the indication with
the strongest sales worldwide in the long term, with an expected sales share of around 14% by 2020.
Investments of the pharmaceutical industry in innovative cancer therapies therefore remains high. According
to the IMS, its share in the total of all product developments is more than 30%. An area that is looking
particularly promising is the emerging field of cancer immunotherapies, which have increasingly become the
focus of cancer research over the last two to three years.
However, despite good prospects, the industry continues to face significant challenges. These include the
broadening of market shares for generics, as well as stricter laws and approval regulations. Conditions for
market approvals and subsequent market penetration are also becoming complicated in many countries due
to health care reforms, which almost always result in cost cutting.
New trends can be observed as pharmaceutical companies react to expiring patents and shrinking product
pipelines. Companies are developing new business segments and making increased investments in the
development of niche products and personalized medicine or intensifying their activities in the area of
mergers and collaborations. New opportunities are likewise arising for the biotechnology sector due to
increased demand for innovative drugs and treatment methods, above all in the area of oncology.
In this context, the business prospects for MOLOGEN can be assessed as very positive in the long term.
Business performance

Continued focus on conducting clinical trials with MGN1703

Patient recruitment for TEACH successfully completed in September 2015

Patient enrollment for IMPULSE study successfully completed in October 2015
Research and development (R&D)
In the first nine months of 2015, MOLOGEN's R&D above all advanced the two clinical studies for its lead
product, the immunotherapy MGN1703: the randomized IMPULSE clinical trial for lung cancer and the
phase III IMPALA pivotal study in the indication colorectal cancer. The 100th patient was enrolled in the
IMPULSE study in October 2015, marking the successful conclusion of patient recruitment for this trial.
Furthermore, the Danish Aarhus University Hospital initiated a phase I/IIa clinical trial to treat HIV patients
with MGN1703. Patient enrollment was also completed for this study in September 2015.
In the first nine months of 2015, research and development results were presented at major international
scientific conferences. This included further data on MGN1703 from a safety study conducted in the USA in
2013 and findings on individual patients from the IMPACT clinical study.
R&D expenses
In the first nine months of 2015, MOLOGEN carried out research and development activities requiring
scheduled expenditures and investments in the amount of € 10.4 million (9M 2014: € 10.5 million). The main
focuses of activities were the two clinical trials with MGN1703, IMPALA and IMPULSE.
R&D expenses
in € million
9M 2015
9M 2014
10.4
10.5
Composition of the product pipeline
(As of: September 30, 2015)
Preclinic
Phase I
Phase II
Phase III / Approval
EnanDIM
Oncology &
Anti-Infectives
MGN17031
Other solid tumors
MGN17031
Small cell
lung cancer
MGN17031
Colorectal cancer
MGN1331
Leishmaniasis
MGN17033
HIV
Oncology
Infectious diseases
Oncology &
Infectious diseases
MGN1333
Hepatitis B
MGN1601
Renal cancer
1
2
MGN14042
Malignant
melanoma
3
IND (Investigational New Drug) filed in US; safety trial
in US completed in 2014
Collaboration with Max-Delbrueck-Center for
Molecular Medicine and Charité Universitaetsmedizin,
Berlin
Collaboration with University Hospital Aarhus,
Denmark
Immunotherapy MGN1703
The immunotherapy MGN1703 is MOLOGEN’s most advanced product candidate. The immunomodulator
and TLR9 agonist is currently being investigated in the IMPALA, IMPULSE and TEACH clinical studies for
the indications colorectal cancer, small cell lung cancer and HIV, respectively.
Pivotal study on colorectal cancer (IMPALA)
Patient enrollment for the IMPALA study started in September 2014 and continued over the first nine months
of 2015.
The IMPALA study is an international phase III multicentric, randomized, open-label, two-arm clinical trial.
Based on the findings of the subgroup analyses of the preceding phase II IMPACT study, the IMPALA study
includes patients with metastatic colorectal cancer in whom a response to first-line chemotherapy treatment
has been confirmed with or without biological agents (biologics).
The aim of the study is to demonstrate that a “switch maintenance” therapy with the cancer immunotherapy
MGN1703 leads to a prolongation of overall survival in patients with metastatic colorectal cancer. The
primary endpoint is therefore overall survival. The secondary endpoints include progression-free survival
(PFS), toxicity, safety, and quality of life (QoL).
Around 540 patients from around 120 centers in eight European countries, including the five largest
European pharmaceutical markets, will participate in the study. Patient enrollment is expected to be
completed in the second half of 2016. The study will be evaluated once a certain number of specified events
have occurred, which is currently estimated to be reached 12 to 18 months after completion of patient
recruitment.
In November 2015, MOLOGEN presented exploratory immunological data from a preliminary analysis of the
IMPALA pivotal study in patients with metastatic colorectal cancer at the 2015 Annual Meeting of the Society
for Immunotherapy of Cancer (SITC). The observed activation of the immune system was in line with the
findings from previous trials and confirms the mode of action of MGN1703.
Lung cancer study (IMPULSE)
The enrollment of patients for the IMPULSE study which started in March 2014 also carried on in the
reporting period. Patient recruitment for this trial was successfully concluded with the enrollment of the 100th
patient in October 2015.
The primary endpoint of this IMPULSE study is overall survival. The trial will compare MGN1703 against the
best standard of care. The study will include patients who are suffering from an extensive disease stage of
small-cell lung cancer (SCLC) and whose tumors have responded to standard first-line therapy with
chemotherapeutics. Analysis of the study is planned to start at the end of 2016 so that the results could be
reported in the first half of 2017 and presented at the 2017 Annual Meeting of the American Society of
Clinical Oncology (ASCO).
With this IMPULSE study, MOLOGEN is expanding the scope of the cancer immunotherapy MGN1703 by a
further indication for which there is a high unmet medical need.
HIV study (TEACH study)
In the second quarter of 2015, MOLOGEN began a collaboration with the Danish Aarhus University Hospital
to conduct an early-phase study with MGN1703 to treat HIV (Human Immunodeficiency Virus) patients. This
is the first time that MGN1703 is being evaluated in patients with diseases other than cancer. The potential
range of applications of the product could be expanded as a result.
The aim of the TEACH study is to determine whether the immunotherapy with MGN1703 can activate the
immune system in HIV patients to enhance killing of the HIV infected cells. Aarhus University Hospital is
conducting the trial in two hospital centers in Denmark and has received funding from the American
Foundation for AIDS research (amfAR). MOLOGEN will provide the immunotherapy MGN1703.
The study commenced in June 2015 with the enrollment of the first patients. Patient recruitment was
completed in September 2015, with a total of 16 patients taking part in the study.
TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized
interventional phase I/IIa trial of MGN1703 in HIV-infected patients. Participants will receive four weeks of
MGN1703 therapy (60 mg s.c. twice weekly). During these four weeks, each participant will be closely
monitored for the safety and therapeutic effects of the drug.
The primary endpoint of the study is the change in proportions of activated natural killer cells in the patients.
Secondary study endpoints include, among others, a collection of virological, immunological,
pharmacodynamic results in addition to safety data. The results of this trial are expected in the second
quarter of 2016.
Safety and tolerability study in the USA
In March 2015, MOLOGEN presented detailed pharmacokinetic (PK) and pharmacodynamic (PD) data from
a phase I study with the cancer immunotherapy MGN1703 in healthy volunteers for the first time within a
poster presentation at the 2nd Immunotherapy of Cancer Conference (ITOC-2) in Munich, Germany. The
data from this phase I study was shown in comparison to data from two clinical trials with cancer patients.
The findings support the dosing regimen of the ongoing studies IMPULSE in small cell lung cancer and
IMPALA in colorectal cancer.
PK and PD data are important parameters for the administration of drugs as they lead to conclusions on the
optimum dosing for the best effect of a drug.
The presented data revealed that healthy volunteers and cancer patients showed similar immune activation
on treatment with MGN1703. In addition, the data supports the twice-weekly dosing regimen which is used in
the current IMPALA, IMPULSE and TEACH studies. In these studies, patients are treated subcutaneously
with 60mg MGN1703 twice each week.
MGN1703 has an Investigational New Drug (IND) designation from the FDA, which is an essential
requirement for conducting clinical trials in the USA.
Phase II study for colorectal cancer (IMPACT)
IMPACT was a randomized, placebo-controlled, clinical phase II study assessing the efficacy of MGN1703
as a “switch maintenance” therapy after first-line treatment of patients with metastatic colorectal cancer. The
study was completed in 2013.
In January 2015 at the Gastrointestinal Cancers Symposium in San Francisco, USA, MOLOGEN presented
data on overall survival of patient subgroups from the IMPACT study. The results showed that patients who
responded to induction therapy may benefit the most from a switch maintenance treatment with MGN1703.
These results are reflected in the IMPALA and IMPULSE studies, where "response to induction therapy" is
one of the main inclusion criteria.
In May 2015, updated data on a subgroup of patients with long-term progression-free survival (PFS) from the
IMPACT trial was presented at the 51st Annual Meeting of the American Society of Clinical Oncology
(ASCO) in Chicago, USA. These patiens were progession-free at the end of the IMPACT study and since
then further treated with MGN1703 within the scope of so called compassionate-use-programmes. Three of
those patients were continiously progression-free and under treatment with MGN1703 at the time of
evaluation, which was subject of the poster presentation.
Updated data on this patient subgroup was also presented at the European Cancer Congress (ECC 2015) in
Vienna, Austria, in September 2015. At the time of the evaluation in August 2015, the PFS of this group was
between 47 and 55 months.
The final results from the IMPACT study are not yet available. Due to a lack of events MOLOGEN no longer
expects that the respective analysis can be performed this year.
Cancer immunotherapy MGN1601
The active principle of cancer immunotherapy MGN1601 corresponds to a therapeutic vaccination.
The clinical ASET study for phase I/II with MGN1601 in renal cancer was successfully concluded in 2013. A
continuative study is currently being planned.
Cancer immunotherapy MGN1404
MOLOGEN is cooperating with facilities of the Charité-Universitätsmedizin Berlin and the Max Delbrück
Center for Molecular Medicine (MDC) Berlin-Buch. As part of the cooperation, Charité is conducting
a phase I clinical study to test the safety and tolerability of MGN1404 in the treatment of malignant
melanoma. The study started in 2013 and will also gather data on the mechanism of action. A total of nine
patients are scheduled to be admitted into the study. Patients are currently still being recruited for the study.
Patents
In September 2015, MOLOGEN received notification from the United States Patent and Trademark Office
(PTO) that it would be granting the patent (Notice of Allowance) for the combination of MGN1703 with a
chemotherapeutic agent. In the current ongoing IMPALA study, MGN1703 will initially be administered as a
monotherapy and subsequently in combination with a chemotherapeutic agent, as described in the patent.
The patent is expected to last longer than the initial patent for MGN1703 (substance patent) and could
therefore offer longer exclusive commercialization than the initial patent.
Financial performance and financial position

R&D expenses of € 10.4 million and EBIT of € -13.3 million are on a par with reference period


Average cash utilized per month of € 1.3 million (9M 2014: € 1.4 million per month)
Cash and cash equivalents total € 30.5 million (December 31, 2014: € 13.6 million).
Overall, the company’s financial performance and financial position developed according to plan. The cash
and cash equivalents available on the reporting date cover the short-term financial needs of the company.
Results of operations
In the first nine months of 2015, MOLOGEN’s revenues were slightly up year on year, at € 0.04 million, but
remained at a low level overall (reference period 9M 2014: € 0.01 million). They result from the sale of goods
and services in the area of research. Other operating income amounted to € 5 thousand (9M 2014: € 2
thousand).
At € 6.4 million, the cost of materials was below the previous year's figure (9M 2014: € 7.1 million) and
primarily incurred in connection with the conduction of clinical studies. In particular, this included costs for
external services of € 6.2 million (9M 2014: € 6.0 million). Costs for raw materials, supplies and goods
totaled € 0.2 million in the reporting period (9M 2014: € 1.0 million). The higher costs in the reference period
were mainly attributable to expenses from manufacturing investigational medicinal products.
Other operating expenses increased to € 3.0 million (9M 2014: € 2.3 million), which is partly attributable to
the increased expenses arising from the company’s patent portfolio, staff recruitment and the cooperation
with the Free University of Berlin (FU Berlin) as well as higher legal and consultancy costs.
At € 3.8 million, personnel expenses were only slightly down on the previous year’s level (9M 2014: € 3.9
million). When compared with the first nine months of 2014, higher cost of wages and salaries was offset by
lower expenses in relation to employee share options being granted.
The scheduled depreciation and amortization of assets was on a similar level year on year, at € 0.09 million
(9M 2014: € 0.08 million).
Finance income decreased to € 2 thousand in the first nine months of 2015 due to the lower interest rates
compared with the prior-year period (9M 2014: € 17 thousand).
Of the total expenses, € 10.4 million was used for research and development projects (9M 2014: € 10.5
million), which was primarily attributable to expenses incurred in connection with the conduction of IMPALA
and IMPULSE clinical trials.
At € -13.3 million, EBIT in the first nine months of 2015 was on a par with the same period of the previous
year.
EBIT
in € million
9M 2015
-13.3
9M 2014
-13.3
Net assets and financial situation
On March 24, 2015, the Executive Board of MOLOGEN resolved, with the approval of the Supervisory
Board, to make partial use of the authorized share capital in accordance with Section 4 Para. 3 of the
Articles of Association and to carry out a capital increase with subscription rights for the shareholders. The
issue of up to 5,657,875 new shares (equating to 33.33% of the previous share capital) was intended to raise
the share capital from € 17.0 million to up to € 22.6 million. The inflow of funds through the capital increase
has further strengthened the share capital base and is used to fund the company's research and
development programs, especially in relation to the IMPALA and IMPULSE clinical studies and ongoing
business operations needed for this purpose. The dividend entitlement of the new shares applies from
January 1, 2014. With the Supervisory Board's consent, the Executive Board set the subscription price for
new shares at € 5.00 per share on March 30, 2015.
MOLOGEN successfully placed new shares in the full amount of 5,657,875 units. The purchase price as part
of the private placement was set at € 5.00 per new share and therefore corresponded with the subscription
price for existing shareholders.
Through the issue of 5,657,875 new no-par bearer shares, the share capital was raised from € 16,973,626 to
€ 22,631,501. Gross proceeds from the issue totaled around € 28.3 million. The capital increase was
recorded in the relevant Commercial Register on April 27, 2015.
The balance sheet total has increased to € 32.7 million (December 31, 2014: € 15.1 million). The capital
increase and concomitant strengthening of both cash and cash equivalents and the share capital had a
notably more positive effect on the balance sheet total than on the cash burn and accumulated deficit, which
increased as a result of the net loss for the period.
As of September 30, 2015, assets comprised a very high share of cash and cash equivalents amounting to
€ 30.5 million (31 December 2014: € 13.6 million). The income from the capital increase significantly
exceeded cash burn within the scope of operating activities. Including investments and expenses for equity
procurement, cash utilization stood at € 11.3 million (9M 2014: € 12.7 million).
in € million
09/30/2015
12/31/2014
30.5
13.6
In the reporting period, MOLOGEN was always in a position to comply with all its financial obligations.
The volume of the investments made in the first nine months of 2015 was on a similar level to the scheduled
depreciation and amortization in the same period. At € 0.44 million as at September 30, 2015, non-current
assets were unchanged from the prior year’s reporting date of December 31, 2014.
Equity and liabilities are influenced by the reported equity capital in the amount of € 26.5 million (December
31, 2014: € 13.3 million). Despite this, the equity ratio decreased to 81% (December 31, 2014: 88%). This
reduction is as a result of an increase in current liabilities.
Equity ratio
in %
09/30/2015
12/31/2014
81%
88%
As at September 30, 2015, current liabilities amounted to € 6.1 million and were therefore significantly above
the level on the prior year’s reporting date (December 31, 2014: € 1.7 million). This increase was attributable
to trade payables, especially in relation to clinical trials, as well as all other liabilities.
Other financial liabilities amounted to € 25.0 million in total as at September 30, 2015 (December 31, 2014:
€ 21.8 million) and were essentially due to the conclusion of short-term service contracts for the IMPALA and
IMPULSE clinical trials that commenced in fiscal year 2014. The calculation of other financial liabilities was
based on the assumed scheduled development of the company's business activities.
Liquidity development
In the first nine months of 2015, cash and cash equivalents used for operating activities in the amount of
€ 9.0 million were below the prior year's value (9M 2014: € 11.5 million) and were mostly committed to
research and development. The lower outflows from operating activities are accompanied by a significant
increase of short-term liabilities of € 2.6 million. This results from a subsequent invoucing of the study
centers involved in the clinical trials.
Cash flow from operating activity
in € million
9M 2015
-9.0
9M 2014
-11.5
Cash flows from investing activities have decreased year on year (9M 2015: € -0.09 million; 9M 2014:
€ 5.9 million). In the same period of the previous year, fixed-term deposit of € 6.0 million reached maturity.
This was reported as a payment under cash flows from investing activities.
Due to the capital increase in April 2015 cash flows from financing activities, which equalled € 26.1 million,
were also significantly up on the corresponding value in the reference period, which had been influenced by
the fund inflows from the cash capital increase carried out in February 2014 (9M 2014: € 14.7 million).
Monthly cash consumption (taking into account incoming payments from sales as well as costs of equity
procurement) amounted to an average of € 1.3 million per month in the first nine months of 2015 and was
therefore slightly lower than the value of € 1.4 million in the same period of the prior year. This is also due to
the incease of short-term liabilities compared to the reference period.
Average monthly cash consumption
in € million
9M 2015
9M 2014
1.3
1.4
Supplementary report
Dr. Mariola Söhngen was appointed as Member of the Executive Board and new Chief Executive Officer
(CEO) of MOLOGEN AG with effect from November 1, 2015. She is in charge of Strategy, Partnering,
Business Development and Research.
Dr. Matthias Schroff was the CEO of MOLOGEN up to October 31, 2015 and is a Member of the Executive
Board from November 1, 2015. He will be leaving the Executive Board of MOLOGEN with effect from
December 31, 2015.
Forecast, opportunities and risk report
Forecast report
The statements made in the management report of the annual financial statements as at December 31, 2014
on the objectives in the areas of research and development, cooperations and partnerships, earnings and
liquidity development as well as personnel remain valid (cf. Annual Report 2014, page 36 f.).
Opportunities and risks report
The opportunities and risks, including their assessment, as presented in the management report of the
annual financial statements as at December 31, 2014 are unchanged (cf. Annual Report 2014, pages 39 ff.).
MOLOGEN share 15
THE MOLOGEN SHARE
Highly volatile developments shaped the DAX, Germany’s lead index, in the first nine months of 2015. After
recording a record high of well over 12,300 points, the index subsequently declined sharply as a result of
speculation surrounding a potential interest rate hike in the USA, weaker than expected economic
performance in China and the Volkswagen emissions crisis. As at the reporting date of September 30, 2015,
the DAX had consequently fluctuated over a broad range between a high of 12,374 points and a low of 9,427
points, closing the third quarter at 9,660 points. The DAX has therefore fallen by 1.5% from the beginning of
the year to the end of September 2015.
In the first nine months of the current financial year, the two relevant benchmark indices for MOLOGEN AG
shares, the DAXsubsector Biotechnology and the DAXsector Pharma & Healthcare, were also characterized
by high volatility. However, they were ultimately able to perform better than the DAX. The DAXsubsector
Biotechnology recorded growth of approximately 20% in the reporting period, while the DAXsector Pharma &
Healthcare increased by around 21%.
Although MOLOGEN’s share price performance was negative in the reporting period, this does not reflect
the operational developments published in company reports over the course of the year so far. The positive
announcements with regard to the progression of studies have not been mirrored in the share performance
of the company. After starting the year at € 6.06, the share price trended consistently downward, closing at €
3.99 on September 30, 2015. This equates to a decline of 33% in the first nine months of 2015.
During the reporting period, the average daily trading volume of MOLOGEN shares on XETRA was 19,088
units. This is slightly below the corresponding value from the previous year of approximately 20,500 units.
As a result of the capital increase carried out in April 2015, the issuance of 5,657,875 new shares raised
MOLOGEN AG’s share capital to € 22,631,501. The gross proceeds from the issue of € 28.3 million will
above all be used for funding clinical trials with the lead product candidate MGN1703. This has helped attract
new, in part international, investors. Since the capital increase, Deutsche Balaton Aktiengesellschaft holds a
stake of around 5% in MOLOGEN. The free float remains in the region of 54%.
Throughout the reporting period, the company intensively maintained contact with medical professionals as
well as national and international investors by attending specialist and capital market conferences in addition
to roadshows in the major financial centers of Europe and the USA.
MOLOGEN share 16
Performance of the MOLOGEN share in the first nine months of 2015
MOLOGEN AG
DAXsector Pharma & Healthcare
DAXsubsector Biotechnology
150%
100%
50%
January 2, 2015
September 30, 2015
Key share data (ISIN DE0006637200, Prime Standard)
XETRA
Number of shares outstanding on September 30
Market capitalization on September 30, (million €)
First trading day (€)
Last trading day (€)
High (€)
Low (€)
Average daily trading volume (shares)
Shareholder structure as of September 30, 2015 (estimates)
9M 2015
9M 2014
22,631,501
16,973,626
161.18
11.79
6.60
13.15
6.60
20,521
90.50
6.06
3.99
7.89
3.95
19,088
MOLOGEN Interim statement – contents 17
INTERIM STATEMENT AS OF SEPTEMBER 30, 2015
Statement of comprehensive income
18
Statement of financial position
19
Statement of cash flows
20
Statement of changes in equity
21
Condensed notes to the interim financial statements
22
Responsibility statement
29
Financial calendar / imprint
30
Statement of comprehensive income 18
STATEMENT OF COMPREHENSIVE INCOME (IFRS)
EUR‘000
Q1 – Q3 2015
Q1 – Q3 2014
Q3 2015
Q3 2014
Revenues
Other operating income
Cost of materials
Personnel expenses
Depreciation and amortization
Other operating expenses
0
3
-3,883
-1,158
-35
-1,276
0
0
-3,383
-1,226
-29
-807
39
5
-6,400
-3,775
-87
-3,034
12
2
-7,072
-3,876
-82
-2,321
Profit (loss) from operations
-6,349
-5,445
-13,252
-13,337
0
0
0
3
0
2
0
17
-6,349
-5,442
-13,250
-13,320
0
0
0
0
-6,349
-5,442
-13,250
-13,320
Loss carried forward
-87,415
-75,035
-84,235
-67,157
Accumulated deficit
-93,764
-80,477
-97,485
-80,477
-0.28
-
-0.32
-
-0.66
-
-0.80
-
Finance costs
Finance income
Profit (loss) before taxes
Tax result
Profit (loss) for the period/
comprehensive income
Basic earnings per share (in €)
Diluted earnings per share (in €)
Statement of financial position 19
STATEMENT OF FINANCIAL POSITION (IFRS)
EUR‘000
30 Sep 2015
31 Dec 2014
Non-current assets
437
440
Intangible assets
Property, plant and equipment
187
250
206
234
Current assets
32,246
14,613
Inventories
Other current assets
Income tax receivables
30,542
28
1,669
7
13,563
30
1,007
13
Total assets
32,683
15,053
Non-current liabilities
7
8
Deferred income
7
8
Current liabilities
6,136
1,747
Trade payables
Other current liabilities and deferred income
Liabilities to banks
5,416
703
17
1,315
422
10
26,540
13,298
22,632
101,393
-97,485
16,974
80,559
-84,235
32,683
15,053
ASSETS
EQUITY AND LIABILITIES
Issued capital
Capital reserves
Accumulated deficit
Total
Statement of cash flows 20
STATEMENT OF CASH FLOWS (IFRS)
EUR‘000
Q1 – Q3 2015
Q1 – Q3 2014
-13,250
-13,320
87
401
82
737
-654
4,389
-9,027
-775
1,777
-11,499
-81
-8
-76
-6
0
-89
6,000
5,918
26,095
26,095
14,653
14,653
0
-3
Total changes in cash and cash equivalents
16,979
9,069
Cash and cash equivalents at the beginning of the period
Cash and cash equivalents at the end of the period
13,563
30,542
8,765
17,834
Cash flows from operating activities
Loss for the period before taxes
Depreciation and amortization of intangible assets
and property, plant and equipment
Other non-cash expenses and income
Change in trade receivables,
inventories and other assets
Change in trade payables and other liabilities
Net cash used in operating activities
Cash flows from investing activities
Cash payments to acquire property, plant and equipment
Cash payments to acquire intangible assets
Proceeds from financial investments within the cash
management and forecast (fixed-term deposits with a term of
more than three months)
Net cash used in investing activities
Cash flows from financing activities
Cash proceeds from issuing shares
Net cash used in financing activities
Effect of exchange rate changes on cash
Statement of changes in equity 21
STATEMENT OF CHANGES IN EQUITY (IFRS)
EUR‘000
except share data
As of 31 Dec 2013
Capital increase
in exchange for cash
contributions
Issued Capital
Capital
Reserves
Accumulated Shareholder`s
Deficit
Equity
Number of
ordinary shares
Share Capital
15,419,512
15,420
66,721
1,541,244
1,541
13,019
14,560
12,870
13
80
93
736
-67,157
14,984
Share options
exercised
alue of services
rendered by
employees
(according to IFRS 2)
Loss for the period
As of 30 Sep 2014
16,973,626
16,974
80,556
-13,320
-80,477
736
-13,320
17,053
As of 31 Dec 2014
16,973,626
16,974
80,559
-84,235
13,298
5,657,875
5,658
20,437
Capital increase
in exchange for cash
contributions
Value of services
rendered by
employees
(according to IFRS 2)
Loss for the period
Rounding difference
As of 30 Sep 2015
26,095
-13,250
398
-13,250
-1
-97,485
26,540
398
-1
22,631,501
22,632
101,393
Notes 22
CONDENSED NOTES
for the period from January 1 to September 30, 2015
A. General information on the company
Mologen AG (hereinafter: MOLOGEN) is a stock corporation as defined under the law of the Federal
Republic of Germany with its headquarters in Berlin (Fabeckstraße 30, 14195 Berlin, Germany). It was
founded on January 14, 1998 and is registered in the Commercial Register of the Local Court at BerlinCharlottenburg under the number HRB 65633 B. The shares of the company are listed on the Regulated
Market (Prime Standard) at the Frankfurt Stock Exchange under ISIN DE0006637200.
The objective of the company is the research, development and marketing of products in the area of
molecular medicine. In particular, this encompasses the research and development of biomolecular
vaccines, application-related clinical research for biomolecular tumor therapy and somatic gene therapy. The
®
®
main focus of research is the MIDGE and dSLlM technologies patented by MOLOGEN. These facilitate the
use of DNA as a drug for diseases that were previously untreatable or for which treatment is insufficient.
B. General information on the financial statements
These condensed interim financial statements of MOLOGEN have not been audited or reviewed. They were
prepared in accordance with IFRS as applied as at the reporting date, September 30, 2015, and as adopted
by the European Union (EU) and in accordance with the IAS 34 (Interim Financial Reporting), and they
should be read together with MOLOGEN’s audited financial statements as at December 31, 2014, which
were prepared in accordance with IFRS as adopted by the EU. The accounting and measurement methods
continued unchanged from December 31, 2014.
No accounting standards that were established for the first time or had been changed for the reporting period
had any material effect on MOLOGEN's interim financial statements.
The reporting period for these condensed interim financial statements is the period from January 1, 2015 to
September 30, 2015. The comparison period for these condensed interim financial statements for statement
of cash flows and statement of changes in equity is the period from January 1, 2014 to September 30, 2014.
The comparison period for these condensed interim financial statements for the statement of comprehensive
income is the period from January 1, 2014, to September 30, 2014 and the period from July 1, 2014, to
September 30, 2014.
The functional and presentation currency in the financial statements is the euro (€). To improve readability,
numbers are rounded and stated in thousands of euros (€ ‘000), unless otherwise specified.
MOLOGEN still does not prepare segment reporting. In relation to this, please refer to the explanations
presented in the Notes in accordance with IFRS for fiscal year 2014.
Notes 23
C. Selected notes to the statement of financial position as at September 30, 2015
Assets
Intangible assets/property, plant and equipment
Intangible assets amounting to € 8 thousand (2014: € 7 thousand) and property, plant and equipment totaling
€ 81 thousand (2014: € 86 thousand) were acquired during the reporting period. No material disposals took
place. No evidence exists that would necessitate an unplanned impairment loss.
Cash and cash equivalents consist of cash and bank balances. Current bank balances yield variable rates of
interest. Short-term investments always have maturities of up to three months, which are determined
depending on the company’s cash needs at the time. They have fixed interest rates. As at the reporting date,
the value of cash and short-term investments totaled € 30,542 thousand (December 31, 2014: € 13,563
thousand). This is calculated based on the nominal value of the holdings in euros and the value of an
account denominated in a foreign currency as measured at the exchange rate on 9/30/2015.
Other current assets and income tax receivables
€ ‘000
Reimbursements from VAT
Income tax receivables
Other receivables
30 Sep
2015
31 Dec
2014
184
7
1,485
1,676
116
13
891
1,020
No impairment losses were recorded against other assets during the reporting period or the 2014 financial
year.
Equity and liabilities
Non-current liabilities
The amount reported as deferred income of € 7 thousand (December 31, 2014: € 8 thousand) relates to
government grants for assets.
Current liabilities
€ ‘000
Trade payables
Liabilities from income and church tax
Liabilities to banks
Other liabilities
30 Sep
2015
31 Dec
2014
5,416
73
17
630
6,136
1,315
161
10
261
1,747
Notes 24
The composition of shareholders’ equity and the development of its components are presented in the
statement of changes in equity.
Issued capital
MOLOGEN’s share capital of € 22,631,501, which is divided into 22,631,501 no-par bearer shares, each with
a notional share of € 1.00 in the share capital, is reported as issued capital.
On April 27, 2015, a capital increase against cash contributions was recorded in the Commercial Register
relevant to the company. From the authorized capital, a total of 5,657,875 new shares at a price of € 5.00 per
new share were placed with existing shareholders by way of indirect subscription rights and with qualified
investors as part of an international private placement. Gross proceeds from the issue totaled around € 28.3
million. MOLOGEN’s share capital increased by € 5,657,875 from € 16,973,626 to € 22,631,501.
Authorized and conditional capital
The resolutions adopted by the Annual General Meeting on July 29, 2015 were entered in the Commercial
Register relevant to the company on September 28, 2015. The following changes took place in the
authorized and conditional capital:
The company had the following authorized and conditional capital as at September 30, 2015:
€
Authorized capital
30 Sep
31 Dec
2015
2014
Change
11,315,750
8,486,813
2,828,937
Conditional capital 2009
0
134,861
-134,861
610,151
610,151
0
238,393
238,393
0
209,234
209,234
0
328,672
328,672
0
Conditional capital 2014-1
6,789,451
6,789,451
0
Conditional capital 2014-2
176,051
176,051
0
700,649
0
700,649
Capital reserves
Costs for equity procurement in the amount of € 2,195 thousand were incurred during the reporting period
(Q1 to Q3 2014: € 1,161 thousand). In accordance with IAS 32.37, these costs were netted against capital
reserves.
In the period under review, the application of IFRS 2 (Share-based Payment) resulted in additions to capital
reserves in the amount of € 398 thousand (Q1 2014: € 736 thousand).
Notes 25
€ ‘000
Capital reserves
Employee compensation in equity instruments
Costs of equity procurement
30 Sep
2015
31 Dec
2014
103,010
6,771
-8,388
101,393
80,379
6,373
-6,193
80,559
D. Selected notes to the statement of comprehensive income
Cost of materials
€ ‘000
Costs for raw materials, supplies
and goods
Costs for external services
Q1 – Q3
2015
Q1 – Q3
2014
Q3 2015
Q3 2014
158
1,041
45
61
6,242
6,400
6,031
7,072
3,838
3,883
3,322
3,383
The reduction in the cost of materials is due to one-off effects in the reference period. In the same period of
the previous year, raw materials were purchased for manufacturing investigational medicinal products. No
equivalent costs for the procurement of raw materials were incurred in the reporting period.
Personnel expenses
€ ‘000
Wages and salaries
Social insurance contributions
Stock options granted (according to
IFRS 2)
Q1 – Q3
2015
Q1 – Q3
2014
Q3 2015
Q3 2014
3,009
368
2,784
356
937
124
863
125
398
3,775
736
3,876
97
1,158
238
1,226
The reduction in personnel costs compared with the same period of the previous year is essentially
attributable to a decline in non-cash personnel expenses from granted share options. The increase in the
number of employees resulted in higher personnel expenses in relation to salaries, wages and social
security contributions affecting cash than in the reference period.
Research and development (R&D)
The resources available to the company are primarily used directly on research and development projects.
As in the same period of the previous year, no development costs subject to mandatory capitalization as
defined in IAS 38 were incurred.
€ million
R&D expenses
Q1 – Q3
2015
Q1 – Q3
2014
Q3 2015
Q3 2014
10.4
10.5
5.2
4.6
Notes 26
Earnings per Share (EPS)
Basic earnings per share is calculated by dividing the total comprehensive income attributable to ordinary
shareholders by the weighted average number of ordinary shares outstanding during the financial year.
Diluted earnings per share is calculated by dividing the total comprehensive income attributable to ordinary
shareholders of the company by the weighted average number of ordinary shares outstanding during the
financial year plus the weighted average number of ordinary shares that would arise from the conversion of
all dilutive potential ordinary shares into ordinary shares.
Earnings attributable to ordinary
shareholders in the company (€
‘000)
Weighted average number of
ordinary shares for calculating basic
earnings per share (thousands)
Dilution effect from the issuance of
stock options (thousands)
Weighted average number of
ordinary shares including dilution
effect (thousands)
Basic EPS in €
Diluted EPS in €
Q1 – Q3
2015
Q1 – Q3
2014
Q3 2015
Q3 2014
-13,250
-13,320
-6,349
-5,442
20,207
16,734
22,632
16,974
0
0
0
0
20,207
-0.66
–
16,734
-0.80
–
22,632
-0.28
–
16,974
-0.32
–
E. Notes to the statement of cash flows
The statement of cash flows shows how MOLOGEN’s cash and cash equivalents changed during the
reporting period through cash inflows and outflows. In accordance with IAS 7, distinctions are made between
cash flows from operating, investing and financing activities.
Income taxes in the amount of € 1 thousand were paid during the reporting period (Q1 to Q3 2014: € 5
thousand). MOLOGEN received a total income tax refund of € 7 thousand in the reporting period (Q1 to Q3
2014: € 0 thousand).
Cash flows from operating activities include interest income affecting cash flow in the amount of € 2
thousand (Q1 to Q3 2014: € 20 thousand). No interest was paid during the period under review (Q1 to Q3
2014: € 0 thousand).
Notes 27
F. Notes on the employee participation programs and changes to evaluations
The company has set up several share-based employee participation programs. Further comments on the
employee participation programs are available in the Annual Report 2014 (Section F of the Notes to the
IFRS annual financial statements).
In the reporting period, stock options were issued under the stock option program for 2014.
The company analyzed past staff turnover in connection with a review of service conditions for employees in
the third quarter of 2015.
This established a discount for staff turnover of 11%. The same analytical process was carried out in the
past but did not require application of a discount.
In contrast to stock options issued in the past, the discount for staff turnover of 11% since issue was taken
into account in the calculation of personnel expenses resulting from the employee stock options issued
under the stock option program for 2014 in the third quarter of 2015.
The reported cumulative personnel expenses resulting from stock options issued in the past were reviewed
accordingly (AOP 2011, AOP 2012, AOP 2013). No restatement was required here, as the actual staff
turnover up to the end of the third quarter of 2015 was taken into account accordingly.
The following table shows the number and weighted average exercise price (WAEP) as well as the
development of the stock options during the reporting period.
WAEP per
option in €
As at 1 Jan 2015
(1)
Granted
Forfeited
Exercised
Expired
As at 30 Sep 2015
(2)
Exercisable as at Sept. 30, 2015
1
9.45
4.99
10.29
9.04
8.50
Number of
stock
options
(units)
1,137,408
105,608
33,320
1,209,696
760,514
The weighted average fair value of the stock options granted in the financial year amounted to € 1.67 per option
(Q1 – Q3 2014: € 3.79).
(2)
This only takes into account whether the vesting period of the stock options has already expired. All other
contractual conditions, such as fulfillment of the performance targets, are disregarded.
The weighted average remaining contractual duration of the stock options outstanding as at September 30,
2015 is 3.35 years. The exercise prices for the options outstanding at the end of the reporting period range
between € 4.99 and € 13.91.
Notes 28
G. Other financial liabilities and contingent liabilities
€ ‘000
Current
Financial liabilities from lease agreements
Other financial liabilities
Non-current
113
11,162
0
13,736
Total
113
25,011
There were no contingent liabilities as defined in IAS 37 as of September 30, 2015.
H. Notes on the type and management of financial risks
Information on the risks arising from financial instruments and on financial risk management is available in
Section H of the notes in the 2014 Annual Report. No additional risks have been added to those described
there.
I. Information on affiliated persons
Directors’ dealings
The following securities transactions subject to disclosure requirements were reported to the company by
management personnel in accordance with Section 15 a of the Securities Trading Act
(Wertpapierhandelsgesetz; WpHG) during the reporting period:
Name, position
Susanne Klimek,
Supervisory Board member
Dr. Stefan Manth,
Dr. Matthias Schroff,
Executive Board member
Jörg Petraß,
Dr. Alfredo Zurlo,
Susanne Klimek,
1
Date
27 Apr
2015
27 Apr
2015
27 Apr
2015
27 Apr
2015
27 Apr
2015
20 Apr
2015
Transaction
Number
of
shares
Purchase
333
Purchase
810
Purchase
5,400
Purchase
5,400
Purchase
4,000
Purchase
Price
(€)
Amount
traded
(€)
Trading
center
over-thecounter
over-thecounter
over-thecounter
over-thecounter
over-thecounter
XETRA
1
5.00
1,665.00
1
5.00
4,050.00
1
5.00
27,000.00
1
5.00
27,000.00
1
5.00
20,000.00
667
5.05
3,368.35
Explanation for publication: purchase through exercise of subscription rights; capital increase recorded on April 27,
2015
Notes 29
J. Other information
Information on significant events after the reporting date of September 30, 2015
Dr. Mariola Söhngen was appointed as Member of the Executive Board and new Chief Executive Officer
(CEO) of MOLOGEN AG with effect from November 1, 2015. She will be in charge of Research, Business
Development, Strategy and Partnering.
Dr. Matthias Schroff was the CEO of MOLOGEN up to October 31, 2015 and is a Member of the Executive
Board from November 1, 2015. He will be leaving the Executive Board of MOLOGEN with effect from
December 31, 2015.
Approval of the financial statements
The financial statements were approved by the Executive Board and released for publication on
November 11, 2015.
Berlin, November 11, 2015
Executive Board of MOLOGEN AG
Dr. Mariola Söhngen:
Dr. Matthias Schroff
Dr. Alfredo Zurlo
Jörg Petraß
Financial calendar / imprint 30
FINANCIAL CALENDAR 2016
March 22, 2016
Annual Financial Statements
and Annual Report 2015
May 12, 2016
Quarterly Report as of 31 March 2016
August 11, 2016
Half-Year Report as of 30 June 2016
November 10, 2016
Quarterly Report as of 30 September 2016
FOR FURTHER INFORMATION PLEASE CONTACT
Investor Relations & Corporate Communications
Phone +49 (0)30 841788-38
[email protected]
www.mologen.com
DISCLAIMER
This information contains forward-looking statements based on current assumptions and estimates by the company
management of MOLOGEN AG. Forward-looking statements are characterized by the use of words such as expect,
intend, plan, predict, assume, believe, estimate, and similar formulations. These statements are not to be understood as
in any way guaranteeing that these expectations will turn out to be accurate. Future performance and the results
achieved by MOLOGEN AG depend on a number of risks and uncertainties and may therefore differ materially from the
forward-looking statements. Many of these factors, such as the future economic environment and the behavior of
competitors and others involved in the marketplace, are outside the control of MOLOGEN AG and cannot be accurately
estimated in advance. MOLOGEN neither plans nor undertakes to update any forward-looking statements.
IMPRINT
Publisher
MOLOGEN AG
Fabeckstrasse 30
D-14195 Berlin
Tel.: +49-30-84 17 88-0
Fax: +49-30-84 17 88-50

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