DGAP-News: PAION AG / Key word(s): Quarterly / Interim Statement
PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER 2016
11.05.2016 / 07:30
The issuer is solely responsible for the content of this announcement.
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PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER 2016
- Financial results in line with plan
- Cash and cash equivalents of EUR 25.5 million; cash reach until the end
of the first quarter of 2017
- Positive pre-NDA meeting with Japanese authority PMDA
- European Phase III study (Remimazolam in general anesthesia in patients
undergoing cardiac surgery) discontinued due to insufficient patient
recruitment
- Completion of patient recruitment of U.S. Phase III colonoscopy study
with no drug-related serious adverse event
- Conference call (in English) today at 2:00 pm CET (1:00 pm GMT/8:00 am
EDT)
Aachen (Germany), 11 May 2016 - 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 2016.
"The discontinuation of our EU study at the beginning of this year was a
difficult but necessary decision. With the completion of recruitment of the
first U.S. Phase III study, we have achieved an important step. The
positive feedback of the Japanese authority PMDA during the pre-NDA meeting
is a reward for diligently working towards the ultimate goal of a first
approval, which could potentially also be used in certain other
jurisdictions. We are looking forward to a landmark year 2016 with the
Phase III colonoscopy study data being a major upcoming value inflection
point", Dr. Wolfgang Söhngen, CEO of PAION AG, commented.
Important events in the period covered
Development and commercial activities
After the decision to stop the EU Phase III trial in the first quarter
2016, PAION is now focusing on the development of Remimazolam in procedural
sedation for a U.S. approval. The patient recruitment in the first U.S.
Phase III study was completed in April 2016 (after the period covered).
This prospective, double-blind placebo-controlled, randomized, multi-center
open label vs. midazolam trial was performed in the indication procedural
sedation with 460 patients undergoing colonoscopies. No drug-related
serious adverse event has been reported. Headline data are expected mid
2016.
The U.S. Phase III program also includes a second confirmatory,
prospective, double-blind placebo-controlled, randomized, multi-center open
label vs. midazolam trial in 420 patients undergoing bronchoscopies which
started in June 2015, a smaller safety trial in 75 high-risk patients
(double blind vs. placebo and open label vs. midazolam) undergoing
colonoscopies, and in addition four ongoing Phase I trials for the purpose
of further supporting Remimazolam's safety profile.
Patient recruitment in the Phase III bronchoscopy trial remains moderate;
therefore, completion of patient recruitment could potentially be delayed
into 2017. In consultation with the FDA, meanwhile, the total study size
was reduced from 460 to 420 patients. The decrease by 40 patients relates
to the midazolam treatment group and is not relevant for the approval as
the primary endpoint of the study is defined versus placebo. In addition,
certain co-medications are now allowed, as this was the major hurdle to the
study's patient recruitment so far. Assuming successful implementation of
these and other ongoing counter measures such as the opening of additional
study centers and a further intensified support of the study centers, PAION
expects filing for approval end of 2017 at the earliest.
Several safety reviews have been conducted by an independent data
monitoring committee (DMC) since the start of the U.S. Phase III program.
All safety reviews led to a positive DMC recommendation to continue the
trials as scheduled.
In August 2015, the start of the multi-national, multi-center, randomized,
single-blind, propofol-controlled, confirmatory EU Phase III study in
patients undergoing major cardiac surgery was announced. Due to the complex
study design, the trial faced recruitment challenges. Despite intensive
efforts to enhance patient recruitment, the trial proved to be difficult to
implement in practice. Therefore, in February 2016, PAION decided to
discontinue the trial in order to avoid a long and expensive study with the
existing design. Subject to partnering and/or additional funding, we are
planning to develop a new Phase III clinical study for the EU in the
indication general anesthesia in general surgery.
A pre-NDA (New Drug Application) meeting with the Japanese Pharmaceuticals
and Medical Devices Agency (PMDA) took place in January 2016. The PMDA
stated that the non-clinical and the clinical data package of Remimazolam
were regarded as complete for filing in the indication "Induction and
maintenance of general anesthesia". In October 2015, PAION already reported
that the PMDA had confirmed that both the raw materials produced by PAION
in Europe as well as the finished formulation of Remimazolam fulfill the
requirements for filing in Japan.
Results of operations, financial position and net assets
As expected, no significant revenues were realized in the first quarter
2016.
Research and development expenses amounted to KEUR 6,502 in the first
quarter 2016 and relate to Remimazolam. The increase of KEUR 739 compared
to the prior-year period is due to the conduct of the Phase III program in
the U.S. and the EU (discontinued), particularly the finalization of the
U.S. Phase III colonoscopy trial.
General administrative and selling expenses decreased by KEUR 157 to KEUR
1,180 in the first quarter 2016. General administrative expenses decreased
by KEUR 89 to KEUR 781 and selling expenses decreased by KEUR 68 to KEUR
399.
Income taxes amounted to KEUR 1,330 in the first quarter 2016 (prior-year
period: KEUR 1,274) and relate to tax claims for reimbursement of parts of
the research and development costs from the British tax authorities.
The net loss for the first quarter 2016 amounted to KEUR 6,729. In the
prior-year period, a net loss of KEUR 4,703 was reported. This means an
increase of the net loss in the amount of KEUR 2,026 compared to the prior-
year period.
Cash and cash equivalents decreased by KEUR 7,218 in the first quarter
2016. As of 31 March 2016, PAION's cash and cash equivalents amounted to
KEUR 25,462. Including the receipt of tax credits expected in the middle of
2016, this secures a cash reach until the end of the first quarter of 2017
under current planning.
Outlook 2016
PAION confirms its outlook for 2016 made on 22 March 2016 with the
publication of the annual financial results for 2015. PAION's major goals
for 2016 are the further conduct of the Phase III development program with
Remimazolam in the U.S. and the production development for Remimazolam, in
particular the validation of the production at market scale. PAION expects
filing for approval in the U.S. end of 2017 at the earliest and accordingly
market approval end of 2018 at the earliest.
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Key consolidated financial figures, IFRS
<pre>
(all figures in KEUR unless Q1 2016 Q1 2015
otherwise noted)
Revenues 3 33
Research and development -6,502 -5,763
expenses
General administrative and -1,180 -1,337
selling expenses
Income taxes 1,330 1,274
Net result for the period -6,729 -4,703
Earnings per share in EUR for -0.13 -0.09
the period (basic)
Earnings per share in EUR for -0.13 -0.09
the period (diluted)
Cash flows from operating -7,055 -5,761
activities
Cash flows from investing -137 -4
activities
Cash flows from financing 0 3
activities
Change in cash and cash -7,218 -5,717
equivalents (incl. exchange
rate differences)
Average number of group 39 26
employees
31 Mar. 2016 31 Dec. 2015
Intangible assets 3,053 3,362
Prepaid expenses and other 7,942 7,371
assets
Cash and cash equivalents 25,462 32,680
Equity 28,533 35,562
Non-current liabilities 40 6
Current liabilities 8,100 7,900
Balance sheet total 36,673 43,468
</pre>
Conference call and webcast
In addition to the publication of the results, the Management Board of
PAION AG will host a public conference call (conducted in English) on 11
May 2016 at 2 p.m. CEST (1 p.m. BST, 8 a.m. EDT) to present the financial
results of the first quarter 2016, 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: https://paion-
events.webex.com/paion-events/j.php?MTID=m7016163b2d2de2105c2891f8721aa208.
About PAION
PAION AG is a publicly listed Specialty Pharmaceutical Company
headquartered in Aachen (Germany) with further sites in Cambridge (United
Kingdom) and New Jersey (USA).
PAION's lead substance, Remimazolam, is an intravenous ultra-short-acting
anesthetic that is currently in Phase III clinical development for
procedural sedation and general anesthesia. Remimazolam is designed to
complement and improve currently available treatment options for patients
requiring sedation and anesthesia.
PAION is focusing its clinical development activities on Remimazolam and
has initiated pre-commercial activities according to PAION's vision to
become an acknowledged "PAIONeer" in sedation and anesthesia.
For more information please visit www.paion.com
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
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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11.05.2016 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.
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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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462281 11.05.2016
DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER 2016
| Source: EQS Group AG