30.03.2017
WILEX AG DE000A11QVV0
DGAP-News: WILEX announces financial figures for fiscal year 2016 and provides business update
DGAP-News: WILEX AG / Key word(s): Final Results
WILEX announces financial figures for fiscal year 2016 and provides business
update
30.03.2017 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
WILEX announces financial figures for fiscal year 2016 and provides business
update
- Financials in line with guidance
- GMP-compliant manufacturing process underway for Amanitin and important
technology partnerships agreements signed for Antibody Targeted Amanitin
Conjugates (ATACs)
- Preclinical development started for first ATAC candidate; lead indication
is multiple myeloma
- Outlook for 2017: increase in sales revenue forecast; higher investments
in proprietary ATAC pipeline
- Conference call to be held on 30 March 2017 at 3:00 p.m. CEST
Munich, Germany, 30 March 2017 - WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE)
today published its financial results and annual report for the fiscal year
2016 (1 December 2015 - 30 November 2016) and its outlook for 2017.
"We achieved several important milestones during the past year. Our most
notable achievement was the in-licensing of suitable antibodies as a
starting point for our own ATAC development candidates. Based on this and
after conducting extensive preparatory research, we selected HDP-101 as our
first proprietary ATAC development candidate. We consider our proprietary
ATAC portfolio and the data it generates to be a key building block for
increasing the Company's value in the future," said Dr Jan Schmidt-Brand,
CEO and CFO of WILEX AG. "Our goals for 2017 are licensing partnerships for
new ATAC candidates, formal preclinical development and agreement of the
clinical development path for HDP-101 with the authorities. Another key task
this year will again be to finance these activities, an issue we plan to
address with the support of our main shareholder dievini and based on
advances in our ATAC technology."
Key events in fiscal year 2016
- Ongoing development of ATAC technology and granting of patents: WILEX's
subsidiary Heidelberg Pharma is working with third parties to manufacture
Amanitin under a GMP-compliant (Good Manufacturing Practice) process, so
that the compound can be produced in a sufficient quantity and quality for
future clinical trials. Work is also ongoing to improve the tolerability and
efficacy of the Amanitin linker constructs. In addition, the US and European
Patent Offices granted two key patents for the Company's proprietary
Antibody Drug Conjugate (ADC) technology.
- HDP-101 - first proprietary development candidate: In September 2016, an
exclusive option agreement was entered into with the Max Delbrück Center for
Molecular Medicine in the Helmholtz Association (MDC) in Berlin covering
various BCMA (B-cell maturation antigen) antibodies, which was then signed
as a license agreement in January 2017. 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. HDP-101 is
currently being prepared for clinical development that could start by the
end of 2018. Multiple myeloma is the third most common hematologic cancer
and represents a major unmet medical need where new, more effective
therapies are urgently needed. HDP-101 also has promising potential for
development in other hematologic indications.
- Establishment of research and technology collaborations: Heidelberg Pharma
launched collaborations with international biotech companies in the past
year. In June 2016, the Company entered into a partnership with Advanced
Proteome Therapeutics Corporation, Vancouver, Canada, for the development of
a new, improved generation of ADCs. This was followed in September 2016 by
an agreement with Celonic AG, Basel, Switzerland, covering the development
of antibody cells and the production of non-GMP and GMP batches of antibody
material. Finally, in October 2016, a collaboration was begun with Nordic
Nanovector, ASA, Oslo, Norway, for the development of new ATACs for treating
leukemias.
- Implementation of corporate actions: A comprehensive, multi-stage
financing strategy that involved several corporate actions was approved at
the end of November 2015. WILEX's main shareholder, dievini Hopp BioTech
holding GmbH & Co. KG, Walldorf, Germany (dievini), supported this strategy
with a commitment to provide financing of up to EUR 10 million, provided
that the subscription price did not exceed EUR 1.84 per share. Three capital
increases were implemented during the reporting period and generated total
issue proceeds of EUR 6.7 million. Approximately 3.6 million shares were
subscribed at a subscription/issue price of EUR 1.84 per share. The
Company's share capital increased from EUR 9,305,608 to EUR 12,927,564. In
addition, a shareholder loan for EUR 3.7 million was agreed with WILEX's
main shareholder in October 2016.
- Personnel news: Professor Andreas Pahl was appointed to the Executive
Management Board as Chief Scientific Officer on 2 June 2016. He succeeded
Dr. Paul Bevan, who retired on 31 March 2016 as planned. Professor Pahl had
also been a member of the executive management of Heidelberg Pharma,
beginning in 2012. On 13 May 2016, the Company's Annual General Meeting
adopted a resolution to reduce the Supervisory Board from six to five
members. One of the reasons for this step was the decision by Supervisory
Board member Andreas R. Krebs to leave the Supervisory Board at his own
request for professional reasons.
Key events after the reporting period
- Signing of a worldwide license agreement for REDECTANE(R): In January
2017, WILEX AG signed an exclusive, worldwide license agreement for the
development and commercialization of the imaging agent REDECTANE(R) with
Telix Pharmaceuticals Limited, Melbourne, Australia (Telix). REDECTANE(R) is
the radiolabeled form of the monoclonal antibody Girentuximab, which had
been developed by WILEX up to Phase III for the diagnosis of clear cell
renal cell carcinoma (ccRCC). Telix also has the right to develop the
Girentuximab antibody for radiotherapy applications. Under the agreement,
Telix will, as a first step, invest in an improved manufacturing process for
the antibody. Under the terms of the agreement, WILEX receives an upfront
payment and could receive milestone payments totaling up to USD 3.7 million.
In addition, WILEX is eligible to receive significant royalties on global
net sales of REDECTANE(R) if the collaboration is successful. Telix will be
responsible for all development costs, as well as manufacturing and
commercialization costs.
- Financing commitment by dievini: WILEX's main shareholder issued another
financing commitment in February 2017. Dievini will provide up to EUR 10
million. The details of the financing will be decided by the Executive
Management Board and the Supervisory Board of WILEX AG with dievini at a
later date. With this additional commitment, the Company's cash reach is
secured until the end of the second quarter of 2018.
Key financial figures of the WILEX Group for fiscal year 2016
Fiscal year 2016 ran from 1 December 2015 to 30 November 2016. The WILEX
Group comprises two entities, WILEX AG and Heidelberg Pharma GmbH.
WILEX generated sales revenue and other income totaling EUR 2.7 million in
fiscal year 2016 (previous year: EUR 3.9 million).
WILEX posted sales revenue of EUR 1.3 million (previous year: EUR 2.3
million), which was mainly attributable to Heidelberg Pharma. This figure
includes EUR 0.2 million (previous year: EUR 0.9 million) relating to the
ADC technology and EUR 1.0 million (previous year: EUR 1.0 million) from the
service business. The majority of ATAC sales in the previous year was
attributable to former partner Roche. In 2016, WILEX AG also received parts
of a milestone payment from Link Health Co., Guangzhou, China, in connection
with the out-licensing of MESUPRON(R) totaling EUR 0.1 million (previous
year: EUR 0.4 million).
At EUR 1.4 million, other income was down compared to the previous year (EUR
1.6 million). This was primarily due to grants provided by the Federal
Ministry of Education and Research (BMBF) that support Heidelberg Pharma
projects in the amount of EUR 0.8 million (previous year: EUR 0.3 million).
Additionally, income of EUR 0.4 million (previous year: EUR 0.9 million) was
generated from the reversal of unutilized accrued liabilities, most of which
were subject to limitation. In addition to other items, income of EUR 0.2
million was recorded from recoveries on receivables written off from the
loan agreement with Nuclea Biotechnologies Inc., Pittsfield, MA, USA, for
the sale of the former subsidiary, WILEX Inc.
Operating expenses including depreciation and amortization fell to EUR 9.1
million in 2016 (previous year: EUR 10.4 million). Research and development
costs accounted for EUR 6.1 million of operating expenses (previous year:
EUR 4.5 million). The 38% increase is attributable to the expansion - as
planned - of R&D activities at Heidelberg Pharma. R&D costs thus accounted
for 67% of all costs. Cost of sales decreased to EUR 0.8 million (previous
year: EUR 1.1 million) and represented 9% of total costs. Administrative
costs were EUR 2.0 million, down 56% compared to the prior-year level (EUR
4.5 million) and accounted for 22% of operating expenses. Administrative
costs in the previous year included the write-off in full of a receivable
(EUR 1.6 million) from Nuclea, the legal successor to the former WILEX Inc.,
as a result of prolonged payment difficulties and the recognition of a
provision set up in the event the Company is held liable under a rent
guarantee to Nuclea's lessor (EUR 0.4 million). Nuclea filed for insolvency
in 2016. Despite these two one-off costs, administrative cost savings of EUR
0.5 million were achieved in 2016. Other expenses amounted to EUR 0.2
million (previous year: EUR 0.3 million) - down 33% compared to the previous
year - and accounted for 2% of operating expenses.
The WILEX Group's operating result was EUR -6.4 million in the 2016 fiscal
year (previous year: EUR -6.5 million). Net loss for the year was EUR 6.4
million (previous year: EUR 6.6 million). Earnings per share improved from
EUR -0.75 in the previous year to EUR -0.53.
At the end of the fiscal year, total assets amounted to EUR 15.2 million, up
EUR 3.1 million from the previous year (EUR 12.1 million), due to higher
cash and cash equivalents. WILEX had cash and cash equivalents of EUR 4.6
million at the end of the reporting period (30 November 2015: EUR 1.3
million). Monthly cash use increased to EUR 0.6 million (previous year: EUR
0.4 million). The Group's equity amounted to EUR 9.7 million (previous year:
EUR 9.5 million). This corresponds to an equity ratio of 64.0% (previous
year: 78.3%).
Financial outlook and strategy for 2017
The WILEX Group expects to generate between EUR 4.0 million and EUR 6.0
million in sales revenue and other income (2016: EUR 2.7 million) for the
2017 fiscal year. This guidance takes into account potential cash inflows
from new licensing activities at Heidelberg Pharma. According to current
plans, operating expenses should be in the range of EUR 11.0 million to EUR
15.0 million (2016: EUR 9.1 million). Earnings before interest and taxes
(EBIT) for the 2017 fiscal year are projected to be between EUR -6.0 million
and EUR -10.0 million (2016: EUR -6.4 million).
WILEX expects cash use for fiscal year 2017 to be between EUR 6.0 million
and EUR 10.0 million, with monthly cash use between EUR 0.5 million and EUR
0.8 million.
In 2017, WILEX's focus will remain on the development and marketing of its
proprietary ATAC technology. The goal is to grow research collaborations
into longer-term, more extensive license agreements and to secure additional
material transfer agreement partners for evaluation projects. A second main
objective is to further develop the Company's own ATAC pipeline. GMP
manufacturing of the first proprietary candidate HDP-101 is a critical
milestone for starting clinical development in multiple myeloma at the end
of 2018.
Invitation to the financial results press conference
On 30 March 2017, WILEX will hold a conference call for media, analysts and
investors in English at 3:00 p.m. CEST. 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 (WILEX) and your name and company. The
presentation for the conference (in English) will be available for download
at www.wilex.com at 2:30 p.m. CEST.
Key figures for the WILEX Group
In EUR million 2016 1 EUR 2015 1 EUR
million million
Earnings
Sales revenue 1.3 2.3
Other income 1.4 1.6
Operating expenses (9.1) (10.4)
of which research and development (6.1) (4.5)
costs
Operating result (6.4) (6.5)
Earnings before tax (6.4) (6.5)
Net loss for the year (6.4) (6.6)
Earnings per share in EUR (0.53) (0.75)
Balance sheet as of the end of the
period
Total assets 15.2 12.1
Cash and cash equivalents 4.6 1.3
Equity 9.7 9.5
Equity ratio2 in % 64.0 78.3
Cash flow statement
Cash flow from operating activities (6.5) (4.8)
Cash flow from investing activities (0.5) (0.2)
Cash flow from financing activities 10.3 4.1
Employees (number)
Employees at year end3 53 55
Employees at year end3 (full-time 49 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://www.wilex.de/press-investors/financial-reports/.
Contact WILEX AG Corporate IR/PR support MC Services AG Katja
Communications Sylvia Wimmer Arnold (CIRO) Managing Director &
Tel.: +49 (0)89-41 31 38-29 Partner Tel.: +49 (0)89-210 228-40
Email: investors[at]wilex.com Cell: +49 (0)160 9360 3022 Email:
Grillparzerstr. 18, 81675 katja.arnold[at]mc-services.eu
Munich, Germany
About WILEX and Heidelberg Pharma
WILEX AG is a biopharmaceutical company based in Munich, Germany, that
serves as a parent and holding company. The Company's research and
development work is conducted by its subsidiary Heidelberg Pharma GmbH in
Ladenburg. Heidelberg Pharma is 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 own
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. WILEX's clinical assets MESUPRON(R) and
REDECTANE(R) have been partnered, while RENCAREX(R) is available for
out-licensing and further development. WILEX is listed on the Frankfurt
Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More
information is available at http://www.wilex.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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30.03.2017 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,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
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Language: English
Company: WILEX AG
Grillparzerstr. 18
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: [email protected]
Internet: www.wilex.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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