6 months` report 2015

6 months‘ report 2015
C o n t e n t s
Advanced Macromolecular Performance.
www.ampbiosimilars.com
Letter to shareholders
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Highlights 2015
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Interim financial statement as of 30 June 2015
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Profit and loss statement for the period from 1 January to 30 June 2015
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Interim management report
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L e t t e r
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L e t t e r
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Dear shareholders,
With this letter, it is my pleasure to provide
you with an overview of the developments of
your biosimilars AG for the first two quarters
of 2015, as well as an outlook of upcoming
events as part of the 6 months‘ report.
Dr. Marc Hentz
Vorsitzender des Vorstands
ture them perfectly from our point of view: The
biosimilars are being out-licensed to China, and
the full rights for the rest of the world remain
with us. To put it simply, our Chinese partners
are paying for the development of a product
which we will then be able to offer to other
pharmaceutical companies for further license
agreements in all remaining areas of the world,
including such significant markets as the USA,
Europe and Latin America.
amp biosimilars AG is currently on an exceedingly successful course, and we can be very pleased with the company‘s development. In the
first two quarters of 2015, we were able to report the first two instances of successful out-licensing from our Biosimilars-portfolio. With the
out-licensing of our products ABY-018 for the
sector of oncology and AB-021 for treating immunological indications, we were able to secure
full financing for the development starting with
clinical phase I, and all the way to approval in
China. In addition, beginning with the launch of
marketing, we are receiving a share in the profits for each of the two biosimilars which by now
has already reached an accumulated value in the
mid three-digit million euro range for each one.
To us, this is an absolute „win-win“ situation.
We are generating significant added value for
our shareholders thanks to our partners providing financing all the way to licensing, yet still
retain the additional potential for highly interesting markets for further out-licensings. This
model is unique in this form and sets us notably
apart from other competitors in the field of
biosimilars, who routinely surrender all global
rights to the financing partner so as to get financing for the development all the way to approval. Furthermore, we do not just enter the
competition in already established biotechnology markets – but also open up new markets
and sales potential with our partners in, for example, China, South America and Eurasia.
For us, the strategic decision to at first focus
primarily on the pharmerging markets, that is
the emerging pharma markets such as China,
was the right step into a most promising entrepreneurial future.
You will understand, dear Shareholders, that in
the light of these successful developments we
consider our business model as having been
sustainably affirmed and are now focusing with
renewed vigour on concluding comparable transactions with further pharmaceutical companies.
For us, the out-licensings completed so far
serve as models as we have been able to struc-
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L e t t e r
Demand for biosimilars in these markets develops from the strong growth in the number
of patients, who demand access to new and
high-quality therapies with relatively low costs.
These so-called pharmerging markets are home
to around 80 % of the world‘s population. We
can satisfy this additional demand with our
products. Our partners in the pharmerging
markets reward our experience and solid technological expertise in the field of biosimilars
with contracts that are highly attractive to us.
The demand for products from our pipeline is
unabated and will allow us to conclude further
highly attractive contracts, meaning we already
have to think now about extending our biosimilars-pipeline. The high demand is also evident
from other key figures: The Chinese pharma
market is already the second largest market in
the world today, and has been growing by up to
25 percent a year for a number of years. In five
years, the pharma market in China is expected
to have reached a volume of 1 billion US dollars
and may replace Europe as the largest biosimilars market in the world as early as in 2017, i.e.
in just two years.
With our out-licensings to China we are perfectly positioned to share in this great development.
that the pharmaceutical industry is undergoing a transition previously never seen. On the
demand side, we are seeing a clearly ageing
population, accelerated spread of numerous
illnesses of chronic character and a dramatic
global increase in access to pharmaceuticals.
This change offers young and aspiring companies such as our biosimilars AG the opportunity
to grow into leading multinational pharmaceutical companies in a relatively short time. Even
though numerous companies across the world
are by now beginning to discover the sector of
biosimilars, it were companies from Europe and
thus persons who are now part of our team
who entered the biosimilars market as pioneers – at a time when the legal framework
had not yet been established in other regions
of the world. In 2003, the European Medicines
Agency (EMA) was the first to globally regulate
a process in order to develop and approve biosimilars. Since 2006, more than 20 biosimilars
have been approved in Europe. Even though
historically the USA is regarded as the biggest
biotechnology market in the world and biosimilars alone provide the US healthcare system
with a savings potential of around 250 billion
US dollars, the American regulatory authority FDA only approved biosimilars in the USA
comparatively late.
Our operative successes follow the consistent
implementation of a comprehensive business
strategy. We realised at a very early stage
As the regulatory authorities in up-and-coming
and dynamically growing emerging countries
base their biosimilars guidelines on those of
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the EU, amp biosimilars is perfectly positioned
to extend its global business through strategic
cooperation agreements with regionally leading
partners and to successfully commercialise biosimilars even in markets outside of Europe,
such as Asia, the USA and Latin America.
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hofer Institute ITEM, has already developed
various biosimilars such as EPO, G-CSF and
Beta-Interferon all the way to GMP-manufacturing. Dr. Luria, as Head of Safety and Efficacy of
Medicines at the European scientific evaluation
authority European Medicines Agency (EMA)
coordinated international teams of the 28 EU
member states in the regulatory evaluation of
medical products. With this additional competency in the field of research and development,
production and approval, our company now has
at its disposal a scientific board without equal
in the industry, which actively supports us in
the global expansion of our company with its
extensive experience.
In light of this great market opportunity for our
company, the team plays a crucial role in our
view. In recent months, we have managed to
complete our team with leading figures from
the biosimilars sector. They bring with them
the experience, network and expertise to allow
our company to grow fast. I am particularly pleased that we have been able to engage Prof.
Dr. Dr. h.c. Rolf G. Werner as chairman of our
scientific board. Prof. Werner is among the leading figures in the global biosimilars scene and
combines biosimilar-know-how with an excellent network in Asia. For Boehringer Ingelheim,
with its staff of 47,000 and a turnover of 13.3
billion euro in 2014 the biggest researching
pharmaceutical company in Germany, Prof.
Werner heads the global biopharmacy business,
in particular with a view to Asia. As chairman of
the scientific advisory board of amp biosimilars
AG, he presides over a committee that works
on scientific and technological issues from development to production, in active consultation
with management and the board. Members of
the management board also include Dr. Holger
Ziehr and Dr. Xavier Luria. Dr. Ziehr, Head
of Pharmaceutical Biotechnology at the Fraun-
The management board and supervisory board
have also seen additional manpower added in
recent months. We were able to sign Dr. Thomas Zimmer as new Chairman of the supervisory board. Dr. Zimmer is European Manager
of the International Society for Pharmaceutical
Engineering (ISPE), the largest association in
the manufacturing pharmaceutical industry with
20,000 members in more than 90 countries. At
amp biosimilars, Dr. Zimmer will contribute
his experience and network with a focus on
the areas of international production, quality
assurance and supply chain. With an extensive
network in the pharmaceutical industry, acquired in various international executive positions
at Boehringer Ingelheim, he is a highly valued
addition to our team.
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Newly appointed to the management board of
amp biosimilars AG as Chief Financial Director is Gunnar Janssen, who previously had the
chance to acquaint himself with the dynamic
growth of our company as a member of the
supervisory board. Mr. Janssen has more than
25 years‘ experience in the field of corporate
finance and capital market, and has held leading
positions internationally, including for Deutsche Bank Capital Markets, Credit Suisse First
Boston, Barclays, Commerzbank Securities,
Lehman Brothers and Donaldson, Lufkin & Jenrette. At amp biosimilars AG, he is in charge of
finances, controlling and investor relations. For
us, this addition to our team also represents an
important step on the way to improved communications with the capital market. To date,
the management team of amp biosimilars has
been characterised by more scientific and technological talent and been focusing on achieving
operational targets. Thanks to the operational
success now evident, we are receiving great interest from participants in the capital market,
who find a contact person of equal calibre in
Mr. Janssen. Thus we are currently pleased to
see awakening interest by early analysts and
major institutional investors, who are gradually
taking note of our successful company and shares. We are especially pleased that in recent
weeks, initial analyst ratings for our company
have already been published.
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For us, it is now a matter of urgently using our
network and experience in pharmerging markets to conclude further license agreements.
Here we are in the final stages of negotiation
for further out-licensings, which will open up
additional earning opportunities for us. While
the majority of our competitors have so far
focused on the highly regulated markets and
as such are competing for market shares with
numerous multinational corporations, our
expertise, experience and reliability built up
in Europe allows us to provide biosimilars to
pharmaceutical companies in global emerging
and fast-growing markets, which they can commercialise by means of their existing structures
of distribution. Our success so far proves to
us that we are following the right strategy, in
order to be able to provide biotechnological
drugs – biosimilars – at a lower cost, more efficiently and quicker to the people of this world
than so far possible.
Dear Shareholders, amp biosimilars AG is well
on the way to successfully commercialise biosimilars globally in the fastest growing markets
with strong partners.
For our company, this yields great earning prospects which allow us to build significant values
sustainably and in the long term. I give thanks
to our qualified committed staff, who have
made tireless efforts in achieving or highly set
targets and are now being rewarded with initial
success. I would like to thank you, too, for your
interest in and support for amp biosimilars. I
am delighted that you are sharing this exciting
journey with us.
Hamburg, in August 2015
Yours sincerely,
Your
Dr. Marc W. Hentz
H i g h l i g h t s
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H i g h l i g h t s
April 2015
May 2015
amp biosimilars AG successfully went public on 1
April 2015. The closing price on the first day of
trading was at 13.00 euro. A total of 2,050,000
individual share certificates were approved for trading, which are listed under ISIN DE000A0SMU87
and WKN A0SMU8. Listing took place with a prospectus approved by the German Federal Financial
Supervisory Authority (BaFin), at first on the overthe-counter market of the Munich Stock Exchange,
and merely represents the first step towards the
capital market for the company.
In May, amp biosimilars AG was able to announce
personnel additions prior to the conclusion of significant contracts. Gunnar Janssen is moving from
the supervisory board as CFO (Chief Financial
Officer) to the management board, where he will
be in charge of finances, controlling and investor
relations. Dr. Thomas Zimmer, former Senior Vice
President Global Quality Management at Boehringer Ingelheim, becomes the new chairman of the
supervisory board. As chairman of the supervisory
board, Dr. Zimmer will contribute his experience
and network to amp biosimilars AG, with a focus
on the areas of international production, quality
assurance and supply chain.
Also in April, we were able to sign Prof. Dr.
Dr. Rolf G. Werner as Chairman of the Scientific Board of the company. Prof. Werner, as former head of the global biopharmacy business of
Boehringer Ingelheim and honorary senator and
professor of the University of Tübingen, has extensive experience in the development of numerous
biosimilars and biopharmaceuticals. The scientific
board of amp biosimilars AG, in addition to the
management board and supervisory board, is one
of the three active committees of amp biosimilars
AG and is currently made up of three members.
The core task of the scientific board is supporting
management in implementing its global biosimilardevelopment- and commercialisation strategy.
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At the end of May, amp biosimilars AG was able
to announce its successful out-licensing of the
first biosimilars from its product-pipeline. This
was the oncology-biosimilar ABY-018, a humanized monoclonal antibody. amp biosimilars is licensing the biosimilar to a leading, medium-sized
Chinese pharmaceutical company, which is excellently positioned for commercialisation in China
with a portfolio of more than 50 pharmaceutical
products, a GMP-certified production capacity of
two billion pills and one billion capsules per year
as well as an extensive distribution network. The
partner will provide full financing for development
and approval, all the way from clinical phase I to
production of the biosimilar in China. The partner
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will be given the right to unrestricted marketing in
China, and will pay amp biosimilars a percentage
share of the proceeds (royalties). Furthermore,
amp biosimilars receives the global rights outside
of China. This will provide amp biosimilars with
the opportunity to grant further licenses for the
biosimilar to additional pharmaceutical companies
in the USA, Europe or other Asian countries or
develop the corresponding markets by itself, thus
securing additional earnings potential at an early
stage. This out-licensing provides shareholders
with non-dilutive project financing all the way to
approval as well as cumulative earning potential
in the three-digit million euro range. For amp biosimilars, out-licensing of its first biosimilar also
represents its successful entry into the Chinese
market. In doing so, the company benefits from
its intense efforts and establishment of an extensive network in recent years. The Chinese pharma
market is currently the second largest market in
the world, and has been growing by up to 25 percent a year for a number of years. By the year
2020, the pharma market is expected to have a
volume of 1 billion US dollars. The Chinese biosimilars market could replace the European one as
the biggest in the world as early as in 2017.
Just a few weeks after the first successful out-licensing of a biosimilar, the company was able to report its second out-licensing success. The second
biosimilar out-licensed from its product-pipeline
was ABY-021, a humanized monoclonal antibody
for the treatment of immunological indications. In
addition to providing financing for product development all the way to approval, amp biosimilars
also participates by means of a percentage share
of the proceeds beginning with the launch of marketing of the biosimilar, which has an accumulated
value in the mid three-digit million euro range. For
amp biosimilars, this second out-licensing within
such a short period is confirmation of its strategic
focus, to be followed by further transactions.
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M a n a g e m e n t
B o a r d
Gunnar Janssen
Chief Financial Officer
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Dr. Knut Adermann
Chief Technology Officer
Dr. Marc Hentz
Chief Executive Officer
Gerry McGettigan
Chief Operating Officer
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I n t e r i m
f i n a n c i a l
s t a t e m e n t
Interim financial statement
I n t e r i m
s t a t e m e n t
zum 30. Juni 2015
ASSETS
EUR
A. Fixed assets
I. Intangible assets
II. Tangible assets
f i n a n c i a l
11.427,64
2.100,04
13.527,68
PASSIVE SIDE
EUR
A. Equity
I. Subscribed capital
II. Capital reserve
III. Loss carryforward
IV. Net loss for the year
2.050.000,00
1.825,00
- 93.265,32
- 596.200,81
B. Current assets
I. Accounts receivable and other assets
II. Kassenbestand, Bundesbankguthaben,
Guthaben bei Kreditinstituten und Schecks
Summe Aktiva
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33.287,30
C. Accounts payable
94.827,09
26.175,90
1.450.769,68
1.476.945,58
1.490.473,26
r e p o r t
B. Provisions
Total liabilities
1.490.473,26
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P r o f i t
a n d
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P r o f i t
Profit and loss account
a n d
l o s s
a c c o u n t
Appendix
for the period from 1 January to 30 June 2015
Financial year
EUR
1. Gross profit/loss
- 94.761,31
2. Personnel expenses
a) Salary and wages
b) Social security contributions and expenses
for pension schemes and support payments
3. Depreciation and amortization
of intangible assets of the capital assets and fixed assets
4. other operating expenses
- 163.290,00
- 6.075,15
- 169.365,15
- 1.176,55
- 329.648,31
5. other interest and similar income
General Declarations
Accounting policies
This half-year financial statement was compiled in
accordance with Sect. 242 et seqq. and Sect. 264
et seqq. of the German commercial code. In addition, the rules and regulations of the (German)
Stock Corporation Act have been applied. The regulations for small companies apply.
Purchased intangible assets are recorded at their
cost of acquisition and, to the extent that their
useful lives are finite, their carrying amount is commensurately reduced by systematic amortisation.
Low­value assets up to an individual net value of
€ 150.00 were written off fully in the year they
were acquired or recorded as expenses. For reasons of simplification, on assets with net values of
more than € 150.00 each up to € 1,000.00 each,
the compound item procedure for tax purposes
is also used in the commercial balance sheet. The
compound item is depreciated at a flat rate by 20
percent p.a. in the year of acquisition, and in each
of the four subsequent years.
The company, in the preceding year 2014, still initially operated under the name of Capital Three AG
with its main office in Gottmadingen. The company
changed its name to amp biosimilars AG on 25 July
2014. The company‘s main office was relocated to
Hamburg.
620,43
Valuation principles
6. Interest and similar expenses
- 1.706,30
7. Result of normal business activity
- 596.037,19
8. Current income taxes
- 163,62
Receivables and other assets are shown at face
value. No provisions were to be made.
The applied accounting policies are principally
guided by the tax regulations, unless they conflict with commercial regulations. Tax options are
made use of in accordance with the commercial
balance sheet.
Cash and cash equivalents are accounted for at
nominal value.
The subscribed capital shows the face value.
9. Net loss for the year
- 596.200,81
The annual financial statement does not include
any assets which are based on amounts denominated in a foreign currency. The income statement
has been prepared according to the total cost method.
Provisions were made for contingent liabilities in
accordance with sound commercial judgement to
the required settlement amount.
All liabilities are included in the balance sheet at
their settlement value.
Statements which are permitted to be listed in the
balance sheet or in the appendix can be found in
the appendix.
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P r o f i t
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a c c o u n t
Information and explanations on various items
in the balance sheet and income statement.
Receivables in the amount of 23,986.02 € have a
remaining maturity of less than one year..
By decision of the shareholders‘ meeting on 13
January 2015, the capital stock was increased from
€ 50,000.00 by € 2,000,000.00 to € 2,050,000.00
by issuing 2,000,000 new no-par value bearer
shares (shares not bearing a par value). The new
shares are entitled to a share in the profits from
the start of the financial year underway when
registering the increase of capital stock in the
commercial register. Registration of the increase
of capital stock in the commercial register was
made on 23 January 2015.
The management board, by decision of the
shareholders‘ meeting from 13 January 2015, is
authorised to increase the capital stock of the
company with approval by the supervisory board
once or in several instalments until 12 January
2019 or by a total of € 1,025,000.00 in exchange
for cash contributions and/or contributions in
kind by issuing up to 1,025,000.00 new no-par
value bearer shares.
Other Mandatory Disclosures
Liabilities to shareholders exist in the amount of T
€ 51.6, which are included in the other liabilities.
All liabilities have a remaining time to maturity of
less than one year.
Chairmen of the financial year were:
The accounted interest expense is apportioned in
full to affiliated companies.
Names of members of the management board
Herr Dr. Marc Hentz
Chairman, Chemist
Herr Dr. Knut Adermann
Chemist, as of 15 June 2015 (registration on 27 June 2015)
Herr Gerry McGettigan
Biologist, as of 15 June 2015 (registration on 27 June 2015)
Herr Gunnar Janssen
Banker, as of 15 June 2015 (registration on 08 July 2015)
Names of the members of the supervisory board
The members of the supervisory board for the financial year were:
Herr Dr. Frank Stummer
Trader (until 1 June 2015 chairman, then vice chairman)
Herr Dr. Thomas Zimmer
Licensed Pharmacist (Chairman since 2 June 2015)
Herr Gunnar Janssen
Banker (until 1 June 2015 as Vice- Chairman)
Herr Dr. Bernd Hartmann
Trader
Hamburg, in August 2015
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Interim management report
1. Business and General Conditions
1.1. Overview of the company
amp biosimilars AG develops high-quality biosimilars for the growing demand in global therapeutics
markets and is one of the most innovative and dynamic biosimilars companies in Europe. The company, with its main office in Hamburg, is managed
by a team of leading industry experts. Management
and its partners represent more than 125 years of
experience and expertise in the field of biosimilars
and biotechnology. This tremendous experience,
combined with strategic access to the most strongly
growing markets globally, provides amp biosimilars
with a crucial competitive edge. The development of
a large number of biosimilars aims to allow patients
world-wide access to life-enhancing and lifesaving
therapies. By combining a research platform made
up of state-of-the-art analytics, process technology
and clinical expertise as well as regulatory knowhow, amp biosimilars AG numbers among the leading companies in the development and marketing
of biosimilars. Thanks to an international network
to leading pharmaceutical companies, amp biosimilars AG further has direct access to the markets
showing the most dynamic growth globally. With
this approach, amp biosimilars holds a key position
in one of the fastest growing markets in the field of
life sciences for the coming years.
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1.2. Market and industry environment
Biosimilars are reproductions of already existing
biopharmaceuticals, and represent the fastest growing sector in the pharmaceutical industry. Turnover for biosimilars is expected to grow from
currently 3 billion to an estimated 100 billion US
dollars in the next 10 years. Biosimilars are comparatively low-priced and allow access to a significantly larger number of patients, who are thus
given access to new therapies for the first time.
Biosimilars provide the US healthcare system with
potential savings of 250 billion US dollars until 2024.
Biosimilars open up access to new markets, while
having clearly lower development risks thanks to
using already familiar active ingredients. The clinical indications for which biosimilars are approved
are related solely to life-threatening and chronic
diseases, which from a commercial point of view
represent markets with particularly great potential.
Specific illnesses, the treatment for which biologicals
and biosimilars are mainly used, include breast, colorectal and lung cancer, non-Hodgkin‘s-lymphoma,
rheumatoid arthritis, asthma, diabetes and chronic
obstructive pulmonary disease. The ranking of the
best-selling drugs in the last 10-15 years has been
increasingly dominated by new biologicals. In the
coming decade, the patent protection of numerous
original biological agents is set to expire, making
them attractive targets for biosimilar developments.
These targets from the business plan have already been achieved in the first six months of
2015 through firm agreements. For example, the
company announced the out-licensing of in-house
developments in May and June 2015. The first outlicensing of ABY-018 already provided shareholders with non-dilutive project financing all the way
to approval as well as cumulative earning potential
in the three-digit million euro range. The second
biosimilar out-licensed from its product-pipeline
was ABY-021, a humanized monoclonal antibody
for the treatment of immunological indications.
The partner for the out-licensing in each case is
a leading medium-sized Chinese pharmaceutical
company. With the licensing, amp biosimilars is
securing full financing for the development and approval already from clinical Phase I and all the way
to production and marketing of the biosimilar in
China. The global rights outside of China further
remain with amp biosimilars and allow additional
licenses to be awarded to other pharmaceutical
companies worldwide, resulting in additional earnings potential.
In addition to providing financing for product development all the way to approval, amp biosimilars further participates by means of a percentage
share of the proceeds, beginning with the launch
of marketing of the biosimilar, which has an accumulated value in the three-digit million euro range.
1.3. Development of the company in the first
six months of 2015.
The company‘s emphasis in operations has been
on the development of biopharmaceuticals (in
particular biosimilars). The company‘s initial objective is to develop several biosimilar product
candidates up to the launch of clinical phase I, in
order to then out-license the projects.
Development – also based on biosimilars already
in preclinical development – is to take place notably also in joint ventures, e.g. from the pharmerging-markets. In doing so, significant parts of
financing are borne by the joint venture partner,
while the company contributes know-how, coordination and trade mark rights. Following successful clinical development up to at least Phase
I, rights to the biosimilars to be developed for
defined territories such as Asia remain with the
joint ventures, while the company receives the
exclusive patent utilisation for the rest of the
world. The company then intends, as is common
practice in the biotech industry, to out-license
these rights to major international pharmaceutical companies. This „Big Pharma“ partner then
takes over any subsequent clinical development
as well as marketing. This will provide the company with inflows in the form of advance payments, milestone payments and royalties.
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I n t e r i m
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With this dual out-licensing, amp biosimilars is positioning itself strongly in the Chinese biosimilars
market, which is expected to replace Europe as
the largest in the world within just a few years.
A preselection of several biosimilar development
candidates was made in negotiations with further
potential licensees.
The first six months of 2015 were also characterised by further expansion of the operational
business activities. For example, relevant additions
to management in the supervisory and advisory
boards were made. Gunnar Janssen is supporting
the management board in his position of new CFO
since May 2015. Also in May, experienced Pharmamanager Dr. Thomas Zimmer assumed chairmanship of the supervisory board; and new Chairman
of the Scientific Boards is Prof. Dr. Dr. Rolf Werner (both formerly Boehringer Ingelheim).
Further work on the cell lineage, cell bank and
process development with the candidates as well
as associated freedom-to-operate studies with regard to the patent situation was continued.
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2. Earning-, assets- and financial position
2.1. Profit Situation
The net loss for the six-month period was 596
TEUR. The increase in staff expenses resulted from
the higher number of employees and management
board members. Expenses for personnel in the reporting period were TEUR 163. The increase in
other operational expenses to 330 TEUR resulted primarily from costs for establishing business
relations with potential partners from the pharmerging markets, as well as for the listing on the
Munich over-the-counter market and associated
travel, legal and professional fees.
2.2. Net asset position
Total assets on the cut-off date 30.06.2015 amoun­
ted to TEUR 1,490.
2.3 Financial Position
The company‘s net profit for the period amounted
to TEUR 596. Cash outflow from operations was
TEUR 596. In the reporting period, the company, as
part of an increase of capital stock at the beginning
of 2015, took cash in the amount of TEUR 2,001.
Disposable liquidity at the end of the reporting
period was TEUR 1,450. Outflow of funds from
operations can be indirectly deducted from the
net loss for the year at midyear. Cash outflow is
mainly related to the financing of operational business. The inflow of funds for the reporting period
could be primarily attributed to the increase of
capital stock.
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3. Research and Development
In the area of research and development, the company combines its scientific know-how and technical expertise so as to safely and very efficiently
develop biosimilars of the highest quality. amp biosimilars AG has at its disposal a unique platform for
developing biosimilars faster, more efficiently and
more economically and to commercialise these in
dynamically growing markets around the world.
In order to achieve this goal, core competencies
have been developed, and at the same time exclusive cooperation agreements concluded with a
network of globally leading partners. In the area
of research and development, the company in the
first six months initiated the formation and establishment of joint ventures with Chinese joint venture partners. Here, investments will be made in
particular in the area of cell lineage and cell bank
development, so as to push forward additional development candidates.
2.4. Overall statement on the earning-, assetsand financial position
amp biosimilars AG, with the liquid funds available
to it at the end of the reporting period on 30 June
2015, has slightly more liquid funds disposable than
were planned for the cut-off date on 30 June 2015.
amp biosimilars AG, in the reporting period up to
30 June 2015, developed financially as expected by
management. In particular, significant contracts for
opening up pharmerging markets could be initiated
thanks to the financing.
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4. Opportunities and Risk Report
Opportunities
amp biosimilars AG embodies a new generation
of pharmaceutical companies and is optimally positioned to effect long-term changes in the already
changing global health care market. The aim of the
company is to improve the quality of life of billions
of people worldwide by introducing a new generation of biopharmaceuticals, so-called biosimilars.
With our activities, we allow patients and doctors
around the world access to state-of-the-art compounds and treatments by means of high-quality
and affordable biotechnological drugs: the biosimilars developed by us.
With this objective, amp biosimilars not only presents a challenge for the dominance of globally leading, multinational pharmaceutical companies. The
company also holds a key position in one of the
fastest growing markets in the filed of life sciences
for the coming years. After the patent protection
for the first wave of biotechnological drugs has
expired, health care systems in regulated markets
are seeking new opportunities world-wide for reducing costs.
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At the same time, biosimilars are employed to try
and allow more patients in emerging countries a
longer and better life. amp biosimilars is excellently
positioned to profit with new biosimilars from
changes in legislation, the progress in manufacturing technology, the newly developing and targeted
drug delivery in the body as well as the steadily
rising need for therapies at an affordable price for
patients all around the globe.
The great opportunity for the company is primarily to create outstanding value for patients
as well as employees and shareholders. It is thus
management‘s goal to develop amp biosimilars into
one of the global leaders in the field of biosimilars and, in doing so, promote a corporate culture
of performance leadership, open communication,
independent thought and sustainable corporate
growth.
Risks
The many opportunities in case of positive development must be seen in the face of – primarily
financial – risks, which are listed below.
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Dependency risk
A finished biosimilar or other pharmaceutical product can typically only be marketed in cooperation with a so-called „major“, i.e. a pharmaceutical
company with global presence, which has the marketing power and the means to introduce a drug
or pharmaceutical product to the market. Should
the company not succeed in concluding relevant
partnerships, this will have negative effects on the
earning and financial position.
Risk of absence of profitability and liquidity
amp biosimilars AG in the past has made operational losses and may possibly never become profitable. The company has also never made any profits
worth mentioning in its corporate history.
Risks from general delays in development
amp biosimilars AG might react late to market developments, technology trends and new scientific
findings, and thus fall behind the competition.
Risk of cost increase through more stringent
legal requirements
Compliance with tightening legal regulations, in
particular pharmaceutical legislation as well as retroactive regulations and new permissions could be
associated with significant costs for the company or
lead to ceasing production of individual products.
Risk from price fluctuations in required raw
materials or products
Price fluctuations as well as unexpected shortages of raw materials and products required by
the company for its research and development
could have significant detrimental effects on the
company‘s earning-, assets- and financial position.
Risks from product liability
Product liability claims might also be asserted
against the company, for which no sufficient insurance cover exists and, regardless thereof, could
cause significant damage to the company‘s reputation.
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Dependency on staff
amp biosimilars AG employs staff, some of whom
fill important functions by themselves or perform
several vital functions simultaneously. If an employee drops out, the company loses employees or
is not in a position to permanently obtain suitable skilled and senior staff, this may jeopardise its
business operations. In the business operations of
amp biosimilars AG, know-how is applied which
is shared among just a few members of staff. One
or several of these employees resigning can have
considerable consequences.
Infrastructure- and growth-related risks
Should the company not succeed in adapting the
internal control systems as part of the growth targeted for the company, this may lead to resources not being efficiently deployed and that even
developments jeopardising further growth or the
survival of the company are not detected in time.
Reliance on partners
amp biosimilars AG, for the development, approval and commercialisation of its biosimilars, relies
on cooperation with partners who have significant
influence on the achievement of specific operational and commercial targets. Should these partners
not work according to contract, this could lead to
serious drawbacks for the company
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Risks from third-party industrial property
rights
The effort made by amp biosimilars AG to avoid infringements of third-party property rights or to defend against lawsuits by third parties concerning the
breach of their property rights could be costly and,
if not successful, lead to restrictions or a ban on the
marketing of biosimilars by the company resulting in
financial penalties or forcing amp biosimilars AG to
cease the development and marketing of individual
or several biosimilars.
Risks related to financial instruments
The most important financial instruments of amp
biosimilars AG on the cut-off date 30 June 2015
were liquid funds. In addition, the company has
available various other financial instruments (in
particular trade payables and receivables as well
as other interest-free, current financial assets),
which arise during the normal course of business
operations. The main purpose of these financial
instruments is the financing of the company‘s business operations. The company invests its financial
funds not immediately required in instant access
savings accounts.
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rically the USA is regarded as the biggest biotechnology market in the world and biosimilars alone
provide the US healthcare system with a savings
potential of around 250 billion US dollars, the American regulatory authority FDA did not get the goahead from congress to pass an approval process
for biosimilars. As the regulatory authorities in
up-and-coming and dynamically growing emerging
countries base their biosimilars guidelines on those
of the EU, amp biosimilars is perfectly positioned
to extend its global business through strategic cooperation agreements with regionally leading partners and to successfully commercialise biosimilars
even in markets outside of Europe, such as Asia, the
USA and Latin America. In the markets targeted by
amp biosimilars, demand for biosimilars develops
from the targeted savings and the strongly growing
number of patients, who demand access to new
and high-quality therapies with relatively low costs.
With our unique approach to produce biosimilars
of the highest quality more quickly and cost-efficiently than our global competitors, the company is
poised to set a new global standard for the market
launch, while creating lasting value for its shareholders.
5. Report of anticipated developments
The pharmaceutical industry is undergoing a transition previously never seen. On the demand side, we
are seeing a clearly ageing population, accelerated
spread of numerous illnesses of chronic character
and a dramatic global increase in access to pharmaceuticals. On the supply side, we are seeing increasing competition, in particular by new market
players from emerging countries and a shift in the
way drugs are developed, produced and administered. In the meantime, the decision makers in national health care systems worldwide are struggling
with the dilemma of providing more patients with
access to new and life-enhancing therapies, without
letting the respective system collapse as a result
of continuously increasing costs. Even though numerous companies across the world are now beginning to discover the sector of biosimilars, it were
companies from Europe who entered the biosimilars market as pioneers – at a time when the legal
framework had not yet been established in other
regions of the world. Thus European companies in
this fastest-growing sector of the pharmaceutical industry are seeing the longest period of success and
growth of all market players. In 2003, the European
Medicines Agency (EMA) was the first in the world
to regulate a process for developing and approving
biosimilars. Since 2006, more than 20 biosimilars
have been approved in Europe. Even though histo-
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Hamburg, in August 2015
Dr. Marc W. Hentz
Vorsitzender des Vorstands
Chief Executive Officer
Gunnar Jansen
Vorstand Finanzen
Chief Financial Officer
Dr. Knut Adermann
Vorstand Technologie
Chief Technology Officer
Gerry McGettigan
Vorstand Operatives Geschäft
Chief Operating Officer
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Disclaimer. The information published in this 6 months‘ report does not constitute a recommendation nor a call to purchase or sell investment vehicles, make transactions or conclude any
sort of legal transaction. The information and statements published by amp biosimilars AG are
provided solely for personal use and the purpose of information, and are subject to change at
any time without prior notice. amp biosimilars AG does not assume any guarantee (neither expressly nor implicitly) for the accuracy, completeness and up-to-dateness of the information and
statements published in this 6 months‘ report. In particular, amp biosimilars AG is not obligated
to remove information from the 6 months‘ report which is no longer up-to-date, or flag it as
such. The information in this 6 months‘ report does not constitute an aid to help decide financial,
legal, fiscal or other consultancy questions, nor should investment or other decisions be taken
on the basis of this information. Professional advice from a qualified specialist is recommended.
amp biosimilars AG
Am Kaiserkai 1
20457 Hamburg
GERMANY
Phone +49 (0)40 808074760
Fax +49 (0)40 808074520
[email protected]
www.ampbiosimilars.com