The biopharmaceutical company PAION AG (ISIN DE000A0B65S3;
Frankfurt Stock Exchange, Prime Standard: PA8) today reported its
consolidated financial result according to International Financial
Reporting Standards (IFRS) for the first quarter ended 31 March
2009.
Cash and cash equivalents at the end of the reporting period
amounted to EUR�32.4 million (December 31, 2008: EUR 36.1
million).
These provide the necessary flexibility to implement
value-generating steps and � based on further optimised cost
structures � secure a cash reach at least until mid 2011. This does
not account for further cost reductions as well as for upfront
payments, milestone payments and cost reimbursements from existing
and future cooperation partners, which could expand the cash reach
but may also be used fully or in part for financing additional
development activities. The cooperation with Lundbeck alone
provides for future milestone payments of up to EUR 63 million, of
which up to EUR 38 million are due prior to market approval.
Group revenues decreased from EUR�1.7 million in 2008 to EUR�0.4
million due to lower reimbursements for research and development in
the first quarter of 2009. Research and development expenses
increased by EUR 1.0 million, especially for the further
development of CNS 7056. The net loss for the period therefore
amounted to EUR�3.3 million, compared to EUR�1.2 million in
2008.
Operational highlights:
- In January 2009 PAION reported
the positive data of its first study with CNS 7056. The
Phase�I proof of concept study compared intravenous CNS 7056 to
placebo and a standard dose of midazolam, the current gold standard
for procedural sedation. The anticipated favourable profile was
observed and no safety issues were raised. Volunteers treated with
increasing doses of CNS 7056 were successfully sedated at the
higher dose cohorts as expected and recovered to full consciousness
rapidly. Following the proof of concept, PAION prepared in the
first quarter 2009 a Phase�IIa study (single dose) with patients
undergoing endoscopy of the upper gastrointestinal tract and a
Phase�Ib study (multiple dose) with volunteers undergoing a
colonoscopy. On 15 and 20 April, respectively, the initiations of
these trials were announced. On 11 May 2009 the results of the
first part of the Phase I trial were reported: the effect of CNS
7056 can be reversed by flumazenil; no re-sedation of the
volunteers was observed. These data strengthen the safety profile
of CNS 7056.Dr. Wolfgang S�hngen, PAION�s CEO commented: �We are
excited about the smooth progress of our compound CNS 7056 which
continues to show promising results. For 2009 we will focus on this
important asset.�
- In early April PAION reported
the positive results of a Phase IIa study with CNS 5161. The
primary objective of the study was to define the maximum tolerable
dose and to assess the relationship between the plasma
concentration of CNS 5161 and changes in pain level. Efficacy
signals were observed in all but the lowest dose cohort reducing
the pain in these patients by approximately 50%. EMEA guidelines
for neuropathic pain indicate that a 30-50% reduction in pain can
be considered a response.
Consolidated financial results for the first quarter
2009:
Revenues for the first quarter 2009 amounted to EUR�0.4 million
and mainly include the systematic release of deferred income in
connection with the license agreement concluded with Lundbeck. The
revenues in the prior year period furthermore included in addition
one off reimbursements of prior production development costs by
Lundbeck according to the license agreement with Lundbeck.
Research and development expenses of EUR 2.6 million in the
first three months of 2009 increased by EUR�1.0 million compared
with the corresponding prior-year period. The increase is primarily
attributable to the broader product pipeline compared to the prior
year. The main research and development focus was on CNS 7056, M6G
and Solulin.
General and administrative expenses remained at the prior-year
period level in the first quarter of 2009, amounting to EUR�1.1
million.
The net loss of the Group on 31�March 2009 was EUR�3.3�million,
an increase of EUR�2.1�million compared to the prior year�s period.
This increase was mainly due to lower turn-over and higher expenses
for research and development. Earnings per share amounted to EUR
-0.14 (prior year�s period: EUR -0.07).
In the preceding quarter cash outflows in total of EUR 3.8
million resulted in cash and cash equivalents of EUR 32.4
million.
The equity decreased by EUR 2.9 million to 28.6 million and the
equity ratio remained at 62.6% as of 31�March 2009, and is nearly
unchanged compared to 31 December 2008. Taking the subordinate loan
borrowed into account and recognizing the deferred non-refundable
upfront payment of Lundbeck as economic equity, the equity ratio
would increase to 91.2�%.
As of 31�December�2008 PAION�s headcount amounted to 30
employees in Aachen and Cambridge.
Outlook:
In 2009 PAION�s focus lies on performing the clinical trials
with its compound CNS 7056 as well as closing at least one
partnering/license agreement. The major part of the research and
development expenses is allocated to the Phase Ib and Phase IIa
studies with CNS 7056 which were initiated in April 2009. The
recruitment of the volunteers and the patients, respectively, is to
be completed until end of the year.
Since the beginning of 2009 several cost reduction measures were
carried out which will lead to sustainable cost savings in the
current and future fiscal years. This does not have any impact on
the progress of the current projects. In 2009 revenues will result
mainly from the proportional release of the deferred income in
connection with the milestone payment received from Lundbeck in
2008. Additional revenues are expected from the closing of new
cooperation agreements. In total, a negative financial result is
expected for the fiscal year.
Cash and cash equivalents in the amount of EUR 32.4 million
provide the necessary flexibility to implement value-generating
steps and � based on further optimized cost structures � secure a
sufficient cash reach at least until mid 2011.
###
Key Consolidated Financial Figures, IFRS � � � (all figures
in KEUR unless otherwise noted) � � 31 March 2009 31 March 2008 � �
Profit and Loss Statement Revenues 405 1,651 Research and
development expenses -2,616 -1,637 General and administrative
expenses -1,152 -1,035 Selling and marketing expenses 0 -15 � Net
loss for the period -3,327 -1,176 � � � Number of shares
outstanding 24,602,919 16,755,552 � � Earnings per share in EUR
(undiluted) -0.14 -0.07 Earnings per share in EUR (diluted) -0.14
-0.07 �
Balance Sheet Intangible assts 11,489 11,336 Cash
and cash equivalents 32,358 36,072 Equity 28,596 31,528 Non-current
liabilities 13,060 13,426 Total assets 45,649 49,313 Equity ratio
(percent) 62.6 63,9 �
Cash flow Cash flow from operating
activities -3,573 -5,545 Cash flow from investing activities -25
-289 Cash flow financing activities -164 -158 �
Employees
Group employees (average) 30 42
The full report on the first quarter 2009 will be available as
from 13 May 2009 at http://www.paion.com/reports.
Earnings call and webcast
On 13 May 2009 at 2�p.m.�CEST (1�p.m.�BST, 8�a.m.�EDT) the
Management Board of PAION will host a public conference call
(conducted in English) to present the financial results of the
first quarter 2009, highlight the most important events in 2009 and
provide further details on the company�s latest developments. To
access the call, participants may dial +49 69 2222 3262 (from
Germany), +44 207 0980 693 (from the UK) or +1 703 6219 129 (from
the US); for other countries please choose from D/UK/US numbers.
The participant passcode is 605444, followed by the hash key (#).
To allow for smooth processing we suggest that you dial in 10
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 107277594 and in the field "Pin Code" 606556. After entering
your name in the specified field please click on "Go". The dial-in
details for the conference call and the webcast link are also
available on our website http://www.paion.com/investors. 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. Since the acquisition of CeNeS Pharmaceuticals, which was
completed in June 2008, the company has a second site in Cambridge,
UK. The company is specializing in developing and commercializing
innovative drugs for the hospital-based treatment of central
nervous system (CNS) disorders and thrombotic/cardiovascular
diseases, 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.
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