22.03.2018
Heidelberg Pharma AG DE000A11QVV0
DGAP-News: Heidelberg Pharma AG: Heidelberg Pharma announces financial figures for fiscal year 2017 and provides business update
DGAP-News: Heidelberg Pharma AG / Key word(s): Final Results
Heidelberg Pharma AG: Heidelberg Pharma announces financial figures for
fiscal year 2017 and provides business update
22.03.2018 / 07:02
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
Heidelberg Pharma announces financial figures for fiscal year 2017 and
provides business update
- Financials in line with guidance on the back of positive revenue
performance
- Corporate actions in 2017 secure funding until 2020
- Worldwide license agreement for Phase III candidate REDECTANE(R) signed
with Telix
- ATAC technology: exclusive research agreements signed with Takeda and
Magenta
- Preparation of HDP-101 for clinical development in multiple myeloma
progressing on schedule
- Conference call to be held on 22 March 2018 at 1:00 p.m. CET
Ladenburg, Germany, 22 March 2018 - Heidelberg Pharma AG (FSE: WL6) today
published its financial results and annual report for the fiscal year 2017
(1 December 2016 - 30 November 2017) and its outlook for 2018.
"We made good progress in implementing our strategy in 2017. We are
particularly pleased about the agreements signed in June 2017 with Takeda
and in March 2018 with Magenta Therapeutics that include options for several
exclusive target-specific licenses. Both collaborations are an external
validation of our ATAC technology and should provide interesting data on the
use of the innovative toxin Amanitin in the fight against different types of
cancer," commented Dr. Jan Schmidt-Brand, Chief Executive Officer and Chief
Financial Officer of Heidelberg Pharma AG. "We successfully pushed ahead
with preparations for our own candidate HDP-101, and we expect to be able to
start clinical development in the multiple myeloma indication at the end of
2018 by submitting the Investigational New Drug application. The corporate
actions successfully implemented in 2017 secure our development plans until
2020, based on our current financial planning."
Key events in fiscal year 2017
- Development of the proprietary Antibody Targeted Amanitin Conjugates (ATAC)
candidate HDP-101: In January 2017, a license agreement covering several
BCMA antibodies was signed with the Max Delbrück Center for Molecular
Medicine in the Helmholtz Association (MDC) in Berlin. BCMA is a surface
protein that is highly expressed in multiple myeloma cells and to which the
selected antibodies specifically bind. The ATAC candidate HDP-101 was
selected based on a selection and optimization process of the BCMA
antibodies. Top-line results from a research collaboration with the
University of Heidelberg and the German Cancer Research Center (DKFZ) showed
a strong cytotoxic effect and no toxicity on non-BCMA expressing control
cells. Preparation for clinical development, which is scheduled to start at
the end of 2018 by submitting the Investigational New Drug (IND)
application, currently includes working on GMP-compliant manufacturing and
developing a clinical study protocol.
- Signing of a worldwide license agreement for Phase III candidate
REDECTANE(R):
An exclusive, worldwide license agreement for the development and
commercialization of the imaging agent REDECTANE(R) (radiolabeled antibody
Girentuximab) was signed in January 2017 with Telix Pharmaceuticals Limited,
Melbourne, Australia. Heidelberg Pharma is entitled to receive milestone
payments totaling up to USD 3.7 million, and to royalties on the potential
worldwide net revenues.
- Exclusive research agreement with Takeda: In June 2017, an exclusive
multi-target research agreement was signed with Takeda Pharmaceutical
Company Limited (Takeda) for the joint development of antibody drug
conjugates (ADCs) that use Amanitin as the payload. Under the terms of the
agreement, Heidelberg Pharma produces ATACs using antibodies from Takeda's
proprietary portfolio for up to three undisclosed targets. Takeda has an
option for an exclusive license for global development and commercialization
rights to each of the product candidates resulting from the research
collaboration. Should Takeda exercise the option, Heidelberg Pharma would be
eligible to receive clinical development, regulatory and sales-related
milestone payments of up to USD 113 million for each product candidate, as
well as attractive royalties in case of successful marketing approval.
Takeda is responsible for further preclinical and clinical development, as
well as potential commercialization, of any product candidate it licenses.
- Successful implementation of two corporate actions: Heidelberg Pharma
carried out a rights issue in May that generated gross proceeds of just
under EUR 5 million from the issue of 2,040,816 new shares at a subscription
price of EUR 2.45 per share.
The corporate action completed in November was a mixed capital increase
consisting of contributions in cash and in kind. This entailed the issue of
7,484,190 new shares at a price of EUR 2.60 each in addition to 14,968,380
convertible bonds with a principal amount of EUR 1.00 each. The transaction
volume for this capital increase was EUR 34.4 million (including the
contribution in kind and the issue of convertible bonds).
The two corporate actions increased the share capital by a total of EUR
9,525,006, from EUR 12,927,564 to EUR 22,452,570.
- Change of registered office and name: In July 2017, the General Meeting
agreed to change the name of the Company from WILEX AG to Heidelberg Pharma
AG and to relocate from Munich to Ladenburg. Both steps were successfully
completed with the entry into the Mannheim Commercial Register in October
2017. The Company's shares will continue to be listed on the Regulated
Market of the Frankfurt Stock Exchange's Prime Standard under their previous
ISIN and symbol. Furthermore, the subsidiary Heidelberg Pharma GmbH was
renamed Heidelberg Pharma Research GmbH.
Key events after the reporting period
- Exercise of convertible bonds: By 28 February 2018, 14,689,925 (98.14%) of
the 14,968,380 convertible bonds issued as part of the corporate action in
November 2017 were converted at a conversion price of EUR 2.60. This
resulted in 5,649,964 new no par value shares that increased the share
capital of Heidelberg Pharma AG from EUR 22,452,570 to EUR 28,102,534
divided into 28,102,534 no par value bearer shares.
- License agreement with the University of Texas MD Anderson Cancer Center:
At the beginning of March 2018, Heidelberg Pharma Research GmbH as the
licensee and The University of Texas System, Houston, TX, USA, signed a
license agreement for patent rights related to the diagnosis and treatment
of patients with so-called RNA polymerase II deletion. The subject of the
license is a patent application, filed in the name of the Board of Regents
of The University of Texas System, which covers important aspects of a
potential personalized treatment of patients based on Heidelberg Pharma's
ATAC technology (Antibody Targeted Amanitin Conjugates).
- Exclusive research agreement with Magenta for the development of Antibody
Targeted Amanitin Conjugates: On 5 March 2018, Heidelberg Pharma announced
that it had signed an exclusive multi-target research agreement with Magenta
Therapeutics, Cambridge, MA, USA, (Magenta). The collaboration will combine
Magenta's stem cell platform with proprietary antibodies for up to four
exclusive targets with Heidelberg Pharma's proprietary ATAC technology for
the development of new Antibody Targeted Amanitin Conjugates. Magenta is
granted access to Heidelberg Pharma's Amanitin linker platform technology,
and it has an option for an exclusive license for global development and
commercialization rights to each of the product candidates resulting from
the collaboration.
As licensor, Heidelberg Pharma receives upfront technology access and
exclusivity fees and payments for research support. Under the exclusive
license agreement, Heidelberg Pharma would be eligible to receive clinical
development, regulatory and sales-related milestone payments of up to USD
334 million, if Magenta were to exercise the options on all target molecules
and all milestones were reached.
Key financial figures of the Heidelberg Pharma Group for fiscal year 2017
Fiscal year 2017 ran from 1 December 2016 to 30 November 2017. The
Heidelberg Pharma Group comprises two entities, Heidelberg Pharma AG and
Heidelberg Pharma Research GmbH.
Heidelberg Pharma fully met its guidance for fiscal year 2017, which it had
updated in October 2017. The downward revision of the sales revenue guidance
was due to deferred revenue arising under the Takeda agreement, as the first
payment had to be split in favor of coming quarters, and to a postponement
of milestone payments by licensing partner Link Health as a result of the
fact that IND approval for MESUPRON(R) in China had not yet been granted.
In fiscal year 2017, Heidelberg Pharma posted sales revenue of EUR 1.9
million (previous year: EUR 1.3 million), which was mainly attributable to
Heidelberg Pharma Research GmbH (EUR 1.6 million). Of this figure, the ATAC
technology accounted for EUR 0.7 million and the service business for EUR
0.9 million. The parent company's sales revenue (EUR 0.3 million) was mainly
attributable to the out-licensing of REDECTANE(R).
At EUR 0.6 million, other income was down compared to the previous year (EUR
1.4 million). This figure includes German and European grants, which support
Heidelberg Pharma Research GmbH projects in the amount of EUR 0.2 million
(previous year: EUR 0.8 million). Furthermore, income of EUR 0.3 million
(previous year: EUR 0.4 million) was generated from the reversal of
unutilized accrued liabilities and provisions, most of which were subject to
limitation. Other items amounted to EUR 0.1 million (previous year: EUR 0.2
million).
Operating expenses including depreciation and amortization rose to EUR 13.2
million in 2017 (previous year: EUR 9.1 million) as planned. Research and
development (R&D) costs accounted for EUR 9.3 million of operating expenses
(previous year: EUR 6.1 million). The planned increase was due to the
advancement of the proprietary platform technology and the ongoing CMC
(chemistry, manufacturing and controls) development of HDP-101. R&D costs
thus accounted for 70% of operating expenses. At EUR 1.0 million, the cost
of sales was higher than in the previous year (EUR 0.8 million), which was
in line with the increase in sales revenue and represents 7% of operating
expenses. Administrative costs were EUR 2.7 million, up 35% compared to the
prior-year level (EUR 2.0 million) and accounted for 21% of operating
expenses. Administrative costs increased mainly because the Company stepped
up investor relations and financing activities and conducted extensive
licensing negotiations. Other expenses were unchanged year-over-year at EUR
0.2 million. They accounted for 2% of operating expenses and mainly included
staff, travel and consulting costs.
The Heidelberg Pharma Group's operating result was EUR -10.8 million in the
2017 fiscal year (previous year: EUR -6.4 million). Net loss for the year
was EUR 11.0 million (previous year: EUR 6.4 million). Earnings per share
decreased from EUR -0.53 in the previous year to EUR
-0.76.
At the end of the fiscal year, total assets amounted to EUR 41.5 million, up
EUR 26.3 million from the previous year (EUR 15.2 million), mainly due to
higher cash and cash equivalents. Heidelberg Pharma had cash and cash
equivalents of EUR 30.4 million at the end of the reporting period (30
November 2016: EUR 4.6 million). Monthly cash use increased to EUR 0.7
million (previous year: EUR 0.6 million). The Group's equity amounted to EUR
37.0 million (30 November 2016: EUR 9.7 million). This corresponds to an
equity ratio of 89.2% (30 November 2016: 64.0%).
Financial outlook on 2018 and strategy
The Heidelberg Pharma Group expects to generate between EUR 3.0 million and
EUR 5.0 million in sales revenue and other income (2017: EUR 2.5 million)
for the 2018 fiscal year. This guidance takes into account potential cash
inflows from new licensing activities. According to current plans, operating
expenses should be in the range of EUR 16.0 million to EUR 20.0 million
(2017: EUR 13.2 million). Earnings before interest and taxes (EBIT) for the
2018 fiscal year are projected to be between EUR -12.0 million and EUR -16.0
million (2017: EUR -10.8 million).
Heidelberg Pharma expects to require funds of EUR 13.0 million to EUR 17.0
million in 2018. Monthly cash use should be in the range of EUR 1.1 million
to EUR 1.4 million.
Heidelberg Pharma's strategy focuses on the development and marketing of its
proprietary ATAC technology. Its core elements are the initiation of
research and option agreements and their extension to include longer-term
and more comprehensive license agreements, as well as the broadening of the
technology base and the expansion of the Company's own project pipeline.
Heidelberg Pharma aims to largely complete the preparation of clinical
development for HDP-101 in the multiple myeloma indication by the end of
2018 by submitting the clinical trial application (IND).
Invitation to the financial results press conference
On 22 March 2018, Heidelberg Pharma will hold a conference call for media,
analysts and investors in English at 1:00 p.m. CET. Please dial in 10
minutes before the call using the following dial-in numbers:
1. Germany: +49 69 71044 5598
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA toll free: +1 866 966 5335
You will be asked for the password (Heidelberg Pharma) and your name and
company. The presentation for the conference (in English) will be available
for download at www.heidelberg-pharma.com from 12:30 p.m. CET.
Key figures for the Heidelberg Pharma Group
In EUR million 2017 1 EUR 2016 1 EUR
million million
Earnings
Sales revenue 1.9 1.3
Other income 0.6 1.4
Operating expenses (13.2) (9.1)
of which research and development (9.3) (6.1)
costs
Operating result (10.8) (6.4)
Earnings before tax (11.0) (6.4)
Net loss for the year (11.0) (6.4)
Earnings per share in EUR (0.76) (0.53)
Balance sheet as of the end of the
period
Total assets 41.5 15.2
Cash and cash equivalents 30.4 4.6
Equity 37.0 9.7
Equity ratio2 in % 89.2 64.0
Cash flow statement
Cash flow from operating activities (7.9) (6.5)
Cash flow from investing activities (0.4) (0.5)
Cash flow from financing activities 34.2 10.3
Employees (number)
Employees at year end3 58 53
Employees at year end3 (full-time 52 49
equivalents)
1) The reporting period begins on 1 December and ends on 30 November.
2) Equity / total assets
3) Including members of the Executive Management Board
Rounding of exact figures may result in differences.
The annual report including the consolidated financial statements in
accordance with International Financial Reporting Standards (IFRS) is
available at
http://http://heidelberg-pharma.com/en/press-and-investors/announcements/financial-reports.
Contact Heidelberg Pharma AG IR/PR support MC Services AG
Corporate Communications Sylvia Katja Arnold (CIRO) Managing
Wimmer Tel.: +49 89 41 31 38-29 Director & Partner Tel.: +49 89
Email: investors[at]hdpharma.com 210 228-40 Cell: +49 160 9360
Schriesheimer Str. 101, 68526 3022 Email:
Ladenburg katja.arnold[at]mc-services.eu
About Heidelberg Pharma
Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg,
Germany. Heidelberg Pharma is an oncology specialist and the first company
to develop the toxin Amanitin into cancer therapies using its proprietary
Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the
biological mode of action of the toxin as a novel therapeutic principle.
This proprietary technology platform is being applied to develop the
Company's proprietary therapeutic ATACs as well as in third-party
collaborations to create a variety of ATAC candidates. The proprietary lead
candidate HDP-101 is a BCMA ATAC for multiple myeloma.
The Company has entered into partnerships to further develop and
commercialize its clinical assets MESUPRON(R) and REDECTANE(R), while
RENCAREX(R) is available for out-licensing and further development.
Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN
DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at
http://www.heidelberg-pharma.com/.
This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as "estimates", "believes", "expects",
"may", "will", "should", "future", "potential" or similar expressions or by
a general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to place
undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
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22.03.2018 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
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Language: English
Company: Heidelberg Pharma AG
Schriesheimer Str. 101
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: [email protected]
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Munich,
Stuttgart, Tradegate Exchange
End of News DGAP News Service
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