DGAP-News: PAION AG / Key word(s): Quarter Results
PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2015
13.05.2015 / 07:30
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PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2015
- Key financials for the period in line with plans
- Initiation of U.S. Phase III program of Remimazolam for procedural
sedation
- Cash and cash equivalents of EUR 53.2 million
- Sufficient funds for Phase III programs with Remimazolam in the EU and
U.S. including the filing process
- Conference call (in English) today at 2:00 pm CEST (1:00 pm BST/8:00 am
EDT)
Aachen (Germany), 13 May 2015 - The specialty pharmaceutical company PAION
AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
reports its consolidated financial results according to International
Financial Reporting Standards (IFRS) for the first quarter 2015.
The first quarter results were as planned. As in the prior-year period, no
significant revenues were generated. Research and development expenses
increased significantly compared to the first quarter 2014 due to
intensified development activities with Remimazolam, particularly in
connection with the preparation and initiation of the Phase III programs.
General administrative and selling expenses increased compared to the
prior-year period as a result of increased staff and higher selling
expenses due to the conduct of pre-marketing and market access activities.
In total, a net loss of EUR 4.7 million has been incurred in the first
quarter of 2015 compared to a net loss of EUR 2.2 million in the prior-year
period.
Cash and cash equivalents decreased by EUR 5.7 million in the first quarter
of 2015 compared to 31 December 2014 and amounted to EUR 53.2 million as of
31 March 2015. Thus, PAION has sufficient funds to conduct the Phase III
programs with Remimazolam in the EU and U.S. including the filing process,
and to continue the ongoing pre-marketing and market access activities.
Dr. Wolfgang Söhngen, CEO of PAION, commented, "The focus of the first
quarter 2015 was preparing the start of the Phase III programs in the U.S.
and in Europe. With the start of the Phase III program in the U.S. as
planned, we have reached another important milestone on the road to the
commercial success of Remimazolam. The EU preparations are ongoing with
full swing as well."
Development and Commercial Activities
In the first quarter of 2015, PAION focussed on the development of
Remimazolam. The dialogue with the FDA, which started in 2013 based on the
positive End-of-Phase II Meeting, served the purpose to define all the
details of approval requirements for Remimazolam in the indication
"procedural sedation" and has been completed. The agency commented on the
study protocols and other aspects of the rest of the development program
such as the production of the substance and some accompanying preclinical
and Phase I protocols. This was a constructive and iterative process.
The Phase III study protocols were submitted to the FDA in November 2014.
In the end of February 2015, PAION received feedback from the FDA, adjusted
the study protocols accordingly and resubmitted the changes to the
institutional review boards (IRBs, or Ethics Committee). Finally, the first
Phase III study was started at the end of the first quarter. The initiation
of the Phase III trial in patients undergoing colonoscopies marks the start
of PAION's Phase III clinical program, which includes a second pivotal
Phase III trial in patients undergoing bronchoscopies and a third smaller
safety trial in high-risk patients undergoing colonoscopies. In parallel,
three Phase I studies are being conducted by PAION.
The Phase III colonoscopy clinical trial is a prospective, double-blind,
randomized, placebo- and midazolam-controlled, U.S. multicenter study in
460 patients undergoing colonoscopies for diagnostic or therapeutic
reasons. Patients are randomized to receive Remimazolam, midazolam or
placebo in addition to fentanyl to achieve moderate sedation. The primary
objective of this study is to investigate the short-term sedation and hence
the success of a colonoscopy compared to placebo and midazolam. The primary
endpoint is the successful completion of the colonoscopy procedure with no
requirement for alternative sedatives. The completion of patient
recruitment is expected before the end of 2015.
In the second quarter of 2015, PAION expects the start of the second U.S.
Phase III clinical trial of Remimazolam for procedural sedation during
bronchoscopy. Recently, the first study sites have been initiated. The
bronchoscopy study forms the second pivotal trial of the Remimazolam Phase
III program and is a prospective, double-blind, randomized, placebo- and
midazolam-controlled, U.S. multicenter study in 460 patients undergoing
bronchoscopies.
Interactions with the European Medicines Agency (EMA) for the EU lead
indication "anesthesia" were completed. The upcoming development program
until filing for market approval was discussed. Based on this scientific
advice, the study protocols have been completed and submitted to the
national agencies and IRBs. For the EU, PAION expects the study start of
the Phase III program towards the end of the first half/beginning of the
second half of 2015.
Outlook 2015
PAION confirms its outlook for 2015 made on 18 March 2015 with the
publication of the annual financial results for 2014. PAION's major goals
for 2015 are the start and the conduct of the Phase III development
programs with Remimazolam in the U.S. and the EU, the production
development for Remimazolam, in particular the finalization of the study
medication and the validation of the production at market scale, as well as
the continuation of pre-marketing and market access activities. In
addition, PAION is further actively working on finding a solution for
Japan. This also includes completing the know-how transfer from Ono, as the
Japanese data have to be integrated into the EU and U.S. filings. Moreover,
PAION expects the development activities of its cooperation partners
Yichang Humanwell, Hana Pharm, R-Pharm, Pendopharm (all Remimazolam) and
Acorda (GGF2) to continue.
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Key Consolidated Financial Figures, IFRS
(all figures in KEUR unless otherwise noted) Q1 2015 Q1 2014
Revenues 33 4
Research and development expenses -5,763 -1,602
General administrative and selling expenses -1,337 -879
Net result for the period -4,703 -2,207
Earnings per share in EUR for the period (basic) -0.09 -0.08
Earnings per share in EUR for the period (diluted) -0.09 -0.08
Cash flows from operating activities -5,761 -3,310
Cash flows from investing activities -4 -3
Cash flows from financing activities 3 10,664
Change in cash and cash equivalents (incl. exchange
rate differences) -5,717 7,352
Average number of group employees 26 13
31 Mar. 31 Dec.
2015 2014
Intangible assets 3,640 3.440
Cash and cash equivalents 53,195 58.912
Equity 58,482 62.607
Non-current liabilities 14 17
Current liabilities 3,821 3.924
Balance sheet total 62,317 66.548
The full quarterly financial report will be available as from 13 May 2015
on our corporate website at http://www.paion.com/en/berichte-2015.
Earnings call and webcast
Conference 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 13 May
2015 at 2 p.m. CEST (1 p.m. BST, 9 a.m. EDT) to present the financial
results of the first quarter 2015, highlight the most important events and
provide a pipeline and strategy update and financial outlook.
To access the English call starting at 2 p.m., participants may dial from
* Germany +49 (0) 69 7104 45598,
* UK +44 (0) 20 3003 2666 and
* U.S. +1 212 999 6659
* Other countries: please use the UK number
When prompted, you will be asked to give the password "PAION". The
conference call will be supplemented by a webcast presentation which can be
accessed during the call under the following link:
www.meetingzone.com/presenter?partCEC=6578291.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company
headquartered in Aachen, Germany, with further sites in Cambridge, UK, and
New Jersey, U.S. The company has a track record of developing
hospital-based treatments for which there is substantial unmet medical
need. PAION's strategy is to participate in the commercialization of
Remimazolam and extend its business with a focus on anesthesia/critical
care products. Remimazolam is the building block for its future marketing
activities.
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@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.
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart
End of News DGAP News-Service
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356565 13.05.2015
DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2015
| Source: EQS Group AG