DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2010
(firmenpresse) - PAION AG / Quarter Results
11.05.2010 07:31
Dissemination of a Corporate News, transmitted by
DGAP - a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2010
- PAION finalises preparation for Phase IIb study with CNS 7056
- PAION's partners achieve development milestones that trigger milestone
payments
- PAION improves its financial position strongly with an equity facility
of EUR 15 million and milestone payments extending its cash reach
significantly
Aachen (Germany), 11 May 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
reports its consolidated financial result according to International
Financial Reporting Standards (IFRS) for the first quarter ended 31 March
2010.
- PAION secures cash reach until the middle of 2012 through income from
co-operations and an equity facility. This is based on cash and cash
equivalents of EUR 19 million as of 31 March 2010 (31 December 2009:
EUR 22.9 million), the milestone payments due from Acorda and Ono in
Q2/2010 and the expected cash inflows from a partial use of the new
equity facility. This is sufficient to fund the Phase IIb trial with
CNS 7056 and secure a cash reach until the middle of 2012 based on the
current cost structure.
- Group revenues amounted to EUR 0.7 million and increased against Q1
2009 (EUR 0.4 million) due to a milestone payment from Acorda for the
completion of preclinical preparations for the clinical development of
the compound GGF2. The loss for the first three months of 2010 of EUR
-2.8 million was EUR 0,5 million lower than in the corresponding
prior-year period (EUR -3.3 million). Research and development expenses
decreased slightly by EUR 0.1 million to EUR 2.5 million compared to
the corresponding prior-year period.
Overview First Quarter 2010
In the first quarter of 2010 PAION concentrated on the development of CNS
7056. Based on the results of the Phase Ib and Phase IIa studies PAION
completed the preparations to conduct a Phase IIb study with patients
undergoing a colonoscopy. The aim of this study is to refine the optimal
dose regimen for Phase III with a multi-centre trial. The patient enrolment
will start shortly as the regulatory process is now completed.
In early February 2010, PAION announced that Ono Pharmaceutical had
initiated the first Japanese Phase I study with CNS 7056. Ono is developing
CNS 7056 for the Japanese market initially for the induction and
maintenance of anaesthesia which requires continuous infusion. The first
subject in the Japanese Phase I study was enrolled in April 2010 after the
balance sheet date. This triggered the first milestone payment of USD 1
million from Ono; payment is expected in May 2010.
At the end of February 2010, PAION reported that H. Lundbeck A/S had
presented data from a post-hoc analysis using Desmoteplase in acute
ischaemic stroke at the International Stroke Conference in San Antonio,
Texas. The findings from the post-hoc analysis of the DIAS-2 trial
performed by PAION provided the basis for the design of the currently
ongoing clinical phase III programme (DIAS-3 and DIAS-4 studies) which aims
to enrol 800 patients with acute ischaemic stroke. Lundbeck expects study
completion in 2011.
In mid March 2010, PAION reported that Lundbeck had initiated a clinical
Phase II trial with Desmoteplase in the treatment of acute ischaemic stroke
(DIAS-J) in Japan. This study is required for the approval of the substance
for the Japanese market. Lundbeck expects to take approximately 1.5 years
to conduct the study.
In March 2010, Acorda Therapeutics filed an IND (Investigational New Drug)
application for the substance GGF2. This triggered the obligation to pay
the first milestone of USD 0.5 million; the payment was received in April
2010. On 20 April 2010 Acorda announced the IND acceptance which triggered
the obligation to pay the second milestone of USD 0.5 million; the payment
is expected in May 2010. Acorda plans to begin a clinical Phase I study
with GGF2 in heart failure patients by mid 2010.
In May 2010 PAION entered into an equity facility agreement for EUR 15
million with Commerce Court Small Cap Value Fund Ltd. (CCSCVF) managed by
Acqua Capital Management Inc., Toronto, Canada. This equity facility gives
PAION the right to issue new shares out of the existing authorised capital
in multiple tranches to CCSCV against a cash contribution. PAION intends to
use this facility in the first instance to strengthen its cash position and
extend its cash reach.
Consolidated financial results for the first quarter 2010
Revenues of EUR 0.7 million in the first three months of 2010 relate in the
amount of EUR 0.4 million (USD 0.5 million) to a milestone payment from
Acorda Therapeutics for the completion of preclinical preparations for the
clinical development of the compound GGF2. Furthermore the revenues include
the systematic release of deferred income in connection with the license
agreement concluded with Lundbeck (EUR 0.4 million) as well as the refund
of development expenses by Lundbeck.
Research and development expenses of EUR 2,5 million in the first three
months of 2010 decreased slightly by EUR 0.1 million compared with the
corresponding prior-year period. The main research and development focus
was on CNS 7056.
General and administrative expenses remained at the prior-year period level
in the first quarter of 2010, amounting to EUR 1.1 million (prior-year
period: EUR 1.2 million).
The financial result for the first three months of 2010 decreased year on
year by EUR 0.1 million down to EUR -0.1 million. The main reasons for the
decrease are significantly lower money market interest rates as well as the
reduction in cash and cash equivalents compared to the prior-year period.
In the preceding Quarter cash outflows in total of EUR 3.7 million result
in cash and cash equivalents of EUR 19.2 million.
The total assets as of 31 March 2010 decreased by EUR 3,4 million compared
to 31 December 2009 and amounted to EUR 32,1 million. The decrease was
mainly due to a lower equity through the loss of the period and lower cash
and cash equivalents. As of 31 March 2010 the equity ratio is 51.4%, which
means a decline compared to 31 December 2009 (54.3%). If the subordinate
loan and the deferred non-refundable upfront payment from Lundbeck were
recognised as economic equity, the equity ratio would increase to 87.4%.
On average, PAION employed 29 employees in the first three months of 2010
(fiscal year 2009: 30 employees).
Outlook
The equity facility and the milestone payments for development progress
from the co-operations strongly improves PAION's financial situation.
PAION will shortly start a clinical Phase IIb study with CNS 7056. PAION
aims to have the compound ready for the clinical Phase III programme in
2011 and expects that the Phase IIb data will enhance the value of CNS 7056
for potential partners. For M6G it is intended to close a partnering
agreement in 2010. Beyond that, PAION expects extensive development
activities in 2010 by the partners Lundbeck, Ono and Acorda, which could
trigger further milestone payments from 2011 onwards.
PAION's research and development expenses in 2010 relate mainly to
production development and a clinical Phase IIb study with CNS 7056 in
patients undergoing a colonoscopy. The patient enrolment is expected to
last approximately nine months. For the other projects in development only
minor expenses are planned.
In parallel to PAION's development of CNS 7056 our development partner Ono
has started the first clinical Phase I study in Japan with CNS 7056 for the
induction and maintenance of anaesthesia, which triggered the first
milestone payment of USD 1 million in the beginning of the second quarter
2010. PAION participates from the progress of Ono's development in the form
of additional data and financially in form of milestone payments and
royalties from launch onwards.
Lundbeck is currently conducting two worldwide Phase III studies with
Desmoteplase in acute ischaemic stroke. Lundbeck expects study completion
in 2011 and to be able to file for market approval (MAA/NDA) in 2012. In
parallel Lundbeck has started in the first quarter 2010 a Phase II study
with Desmoteplase in stroke in Japan. Lundbeck bears all development costs
and pays to PAION milestones up to EUR 63 million and from market entry a
double-digit percentage revenue share.
Acorda expects to start the first clinical study by mid of 2010 with GGF2.
In case of further positive development, additional milestone payments of
up to USD 7.5 million until approval and afterwards revenue dependent
licence fees are payable to PAION.
Revenues in 2010 will include, just as last year, the monthly release of
deferred income in connection with the non-refundable milestone payment in
the amount of EUR 8 million received from Lundbeck as well as the first
milestone payments from the development progress with CNS 7056 in Japan and
GGF2 of USD 2 million in total. In addition PAION expects additional
revenues from the intended partnering agreement for M6G.
The budgeted expenses lead, after deduction of the revenues from the
existing license agreements with Ono and Acorda, to a significant net loss
for the year. The expected additional revenues from the intended licensing
of M6G and possibly CNS 7056 can significantly reduce the net loss for the
year.
As of 31 March 2010 PAION's cash and cash equivalents amounted to EUR 19
million. The milestone payments from Acorda and Ono in 2010 and the
expected cash inflows from a partial use of the equity facility will
increase the liquidity. This leads to an increase cash reach until mid 2012
including the Phase IIb study with CNS 7056 and based on the current cost
structure. This does not account for further upfront payments, milestone
payments and cost reimbursements from existing and future partners or an
extensive or total use of the equity facility. These would expand the cash
reach even further but may also be used fully or in part for funding of
additional development activities within the existing portfolio or newly
acquired substances. The cooperation with Lundbeck alone provides for
future milestone payments of up to EUR 63 million, of which up to EUR 38
million will become due prior to market approvals.
###
Key Consolidated Financial Figures, IFRSThe full report will be available as from 11 May 2010 on our corporate
(all figures in KEUR unless otherwise noted)
Q1 2010 Q1 2009
Profit and Loss Statement
Revenues 742 405
Research and development expenses -2,483 -2,616
General and administrative expenses -1,103 -1,152
Operating result -2,836 -3,382
Net loss for the period -2,871 -3,327
Number of shares outstanding (weighted 24,602,919 24,602,919
average,undiluted)
Number of shares outstanding (weighted 24,932,607 24,526,552
average,diluted)
Earnings per share in EUR (undiluted) -0.12 -0.14
Earnings per share in EUR (diluted) -0.12 -0.14
Balance Sheet (compared to Dec. 2009)
Intangible assts11,147 11,380
Cash and cash equivalents 19,238 22,871
Equity 16,503 19,304
Non-current liabilities 11,637 12,033
Total assets 32,135 35,550
Equity ratio (percent) 51.4 54.3
Cash flow
Cash flow from operating activities -3,480 -3,573
Cash flow from investing activities -12 -25
Cash flow financing activities -146 -164
Employees
Group employees (average) 29 30
website at http://www.paion.com/en/berichte-2010.
Earnings call and webcast
In addition to the publication of the results, the Management Board of
PAION will host a public conference call (conducted in English) on Tuesday,
11 May 2010 at 2 p.m. CET (1 p.m. GMT, 8 a.m. ET) to present the financial
results of the first quarter of 2010, highlight the most important events
of this period and provide further details on the company's latest
developments.
To access the call, participants from Germany may dial +49-69-201744210,
from the UK +44-20-71539154 and from the US +1-877-4230830 (other
countries: please choose from D/UK/US numbers). The participant PIN code is
408998, followed by the hash key (#). To allow for smooth processing we
suggest that you dial in ten minutes before the beginning of the call.
The conference call will be supplemented by a webcast presentation which
can be accessed during the call under the following link:
https://www.anywhereconference.com. In the field 'Web Login' please enter
107325670 and in the field 'PIN Code'
408998. After entering your name in the specified field please click on
'Go'. The dial-in details for the conference call and the webcast link will
also be available on our website http://www.paion.com
The conference call will be recorded. Details on how to access the replay
will be posted on the same web page after the call.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in indications for which there is a substantial unmet medical
need. PAION has a 'Search&Develop' business model, which is based on its
core expertise in drug development. Where appropriate, particularly during
the late stages of the clinical development, PAION seeks to collaborate
with experienced partners.
Contact
Ralf Penner
Director Investor Relations&Public Relations
PAION AG
Martinstrasse 10-12, 52062 Aachen - Germany
Phone +49 241 4453-152
E-mail r.penner(at)paion.com
http://www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such
forward-looking statements. Considering the risks, uncertainties and other
factors involved, recipients should not rely unreasonably upon these
forward-looking statements. PAION AG has no obligation to periodically
update any such forward-looking statements to reflect future events or
developments.
11.05.2010 07:31 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Deutschland
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Hamburg, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------------Unternehmensinformation / Kurzprofil:
Datum: 11.05.2010 - 07:31 Uhr
Sprache: Deutsch
News-ID 20614
Anzahl Zeichen: 0
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 206 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2010"
steht unter der journalistisch-redaktionellen Verantwortung von
PAION AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
