DGAP-News: MagForce AG / Key word(s): Half Year Results
MagForce AG: MagForce AG Publishes Financial Results for the First Half of
2016 and Operative Highlights
30.09.2016 / 08:00
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
MagForce AG Publishes Financial Results for the First Half of 2016 and
Operative Highlights
- Accelerated commercial efforts to establish NanoTherm(TM) therapy in
Germany and the EU leads to growing interest in applying NanoTherm(TM)
therapy for the treatment of brain tumors; medical results very
gratifying
- Good progress in the US toward adapting NanoTherm(TM) therapy as a
focal treatment for prostate cancer; interim results of ongoing
preclinical studies clearly support the earlier European data
- Outlook for 2016 confirmed
Berlin, Germany, and Nevada, USA, September 30, 2016 - MagForce AG
(Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading
medical device company in the field of nanomedicine focused on oncology,
published today its financial results for the first half of 2016, ending on
June 30, 2016, and operative highlights.
Operative Highlights:
Brain Cancer NanoTherm(TM) Therapy at MagForce AG
In Europe, MagForce AG is continuing to expand the commercialization phase
of its valuable NanoTherm(TM) therapy: The first phase was to install
NanoActivators(R) in Germany and assist the neurosurgeons and radiologists
as they became familiar with NanoTherm(TM) therapy and its applicability.
The second phase was to initiate the Company's commercialization efforts
with the goal of increasing patient inquiries to 100 per month. The
combination of clinical success and marketing efforts will result in the
Company achieving the targeted patient inquiry level. MagForce is currently
half way there. In the third phase, cross-border reimbursement processes
have been optimized based on the fact that a majority of the patients
requesting treatment require the implementation of the Cross-Border
Directive of the European Union. However, the medical procedure for
treating glioblastoma generally requires surgery and radiation resulting in
the patient's obligation to fund the country differential costs for surgery
and radiation in his home country and the higher costs for these treatments
in Germany, as well as for the NanoTherm(TM) therapy.
During 2016, MagForce has streamlined the implementation of the cross-
border reimbursement process, however, due to the aggressiveness of
glioblastoma, there is a limited time interval to achieve treatment. Toward
that end, the Company will continue its efforts to increase the medical
awareness of the value of NanoTherm(TM) therapy to allow earlier patient
inquiries.
Phase four of the Commercialization Program will be to obtain domestic
reimbursement for NanoTherm(TM) therapy in Germany and selected countries
in the EU where MagForce has the CE Mark for the treatment of brain tumors.
As mentioned three months ago, Management is actively exploring financing
options, such as third-party leases of NanoActivator(R) equipment, or other
non-equity financing options in order to further accelerate MagForce's
expansion in Europe.
Prostate Cancer Therapy at MagForce USA, Inc.
In the USA, MagForce USA, Inc.'s has filed an Investigational Device
Exemption (IDE) with the USA Food and Drug Administration (FDA) for
NanoTherm(TM) therapy to treat Intermediate Risk Prostate Cancer in 2015.
MagForce is still working with the FDA to update preclinical studies, which
were conducted approximately ten years ago, to current US regulatory
standards and continues making very good progress toward adapting
NanoTherm(TM) therapy as a focal treatment for prostate cancer.
NanoTherm(TM) therapy for the focal treatment of prostate cancer is viewed
as a very promising complement to current treatment approaches. These
preclinical studies are underway with interim results clearly supporting
the earlier European data.
The purpose of the proposed Focal Thermal Ablation Registration study that
will enroll up to 120 men is to demonstrate that NanoTherm(TM) can ablate
cancer lesions for patients who have Gleason Score 7 prostate cancer and
are under active surveillance. By ablating the lesions, patients will be
able to maintain active surveillance and avoid surgery and other treatments
with their well-known side effects.
"I am still confident we will achieve our original targets in terms of
market entry and commercialization of NanoTherm(TM) therapy in the USA
because we clearly have a "time safety factor" built in our business plan,
plus we have accelerated the ambulatory prostate NanoActivator(R) chair
development to ensure timely delivery of this device. In Europe, our
commercial treatment rate is still too slow but the medical results are
very gratifying. The experiences we made from our commercialization efforts
over the past 18 months pinpointed how to reach our commercialization
targets, and we are enforcing the respective implementation. We are on the
right path and overall making progress with our brain cancer
Commercialization Program in Europe," commented Dr. Ben J. Lipps, CEO of
MagForce AG and MagForce USA, Inc. "In summary, I am very optimistic that
MagForce will develop and expand our NanoTherm(TM) therapy into a valued
therapy for the treatments of brain cancer and prostate cancer and move
towards achieving the goals set in the five year target plan. The growing
interest in applying NanoTherm(TM) therapy for the treatment of brain
tumors and the progress of our work with the FDA are very encouraging.
Thus, we are successfully moving forward on our exciting and challenging
path."
Financial Results and Outlook:
Results of operations, net assets and financial position
MagForce adopted new revenue reporting rules for periods starting after
December 31, 2015. In addition, MagForce reports for the first time Non-
GAAP financial measures that are used by MagForce's management to make
operating decisions, as they facilitate internal comparisons of MagForce's
performance to historical results. MagForce's management believes that Non-
GAAP measures provide investors with means of evaluating, and an
understanding of how MagForce's management evaluates, MagForce's
performance and results on a comparable basis that is not otherwise
apparent on a German GAAP basis, since many non-recurring, infrequent or
non-cash items that MagForce's management believes to be not indicative of
the core performance of the business may not be excluded when preparing
financial measures under German GAAP.
These Non-GAAP measures should not be considered in isolation from, as
substitutes for, or superior to financial measures prepared in accordance
with German GAAP.
Due to the adoption of new revenue reporting rules (sec. 277 para. 1 HGB as
amended by BilRuG) for periods starting after December 31, 2015, revenue
includes also management recharges to subsidiaries that were included in
other operating income in prior years. For additional information we refer
to the Notes to the Interim Financial Statements.
Net loss (prior year: profit) for the first half year was EUR 3.2 million
(prior year: EUR 0.5 million) while Non-GAAP net loss slightly decreased
for the half year by EUR 0.1 million to EUR 2.2 million (prior year: EUR
2.3 million).
Compared to the prior year reporting period personnel expenses increased by
EUR 0.2 million to EUR 1.7 million chiefly due to the formation of a new
commercial team to accelerate the Company's efforts to establish
NanoTherm(TM) therapy in Germany and the EU. The additional expenses
attached to this indispensable staffing were compensated by frugal use of
MagForce's resources in other areas of controllable expense spending.
Revenues and other operating income amounted to EUR 0.7 milllion (prior
year: EUR 4.9 million), while Non-GAAP revenue and other operating income
increased by EUR 0.1 million to EUR 0.7 million (prior year: EUR 0.6
million). Revenues and other operating income include revenues from
commercial treatment of patients with NanoTherm(TM) therapy on a cash basis
as well as reimbursement of treatment costs by third parties and recharges
to subsidiaries. The Non-GAAP increase chiefly stems from higher personnel
recharges to subsidiaries of EUR 0.4 million compared to EUR 0.3 million in
the prior year period.
Revenue and other operating income were adjusted to Non-GAAP for the
extension of the distribution and development rights for the countries
Canada and Mexico in January 2015 amounting to EUR 3.0 million as well as
the sale of two NanoActivator(R) devices to MagForce USA, Inc. in the first
half year of 2015 in the amount of EUR 1.2 million. Revenue includes also
management recharges to subsidiaries that were included in other operating
income in prior years.
Cash outflows from operating activities amounted to EUR -3.4 million (prior
year: EUR -3.8 million). Cash inflows from investing activities amounted to
EUR 3.1 million (prior year: EUR 0.1 million), and cash flows from
financing activities amounted to EUR 2.3 million (prior year: EUR nil).
Liquid funds of the Company including cash and cash equivalents of EUR 3.4
million (December 31, 2015: EUR 1.4 million) as well as short term loans of
EUR nil (December 31, 2015: EUR 3.1 million) amounted to EUR 3.4 million at
the end of the period (December 31, 2015: EUR 4.5 million).
Financial outlook 2016
For the financial year 2016 the Company expects an increase in revenues
from the treatment of patients with NanoTherm(TM) therapy compared to last
year. A more economical enterprise resource planning will result in further
reduced operating costs. Adjusted for the special effects of the out-
licensing transaction in 2015 that reduced the net loss by EUR 3.0 million,
the Company expects a reduction of the net loss for the fiscal year 2016.
With its liquidity and current plans, the Company will be able to cover its
operating expenses through 2017.
About MagForce AG and MagForce USA, Inc.
MagForce AG, listed in the entry standard of the Frankfurt Stock Exchange
(MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc.
is a leading medical device company in the field of nanomedicine focused on
oncology. The Group's proprietary NanoTherm(TM) therapy enables the
targeted treatment of solid tumors through the intratumoral generation of
heat via activation of superparamagnetic nanoparticles. Mithril Capital
Management, a growth-stage technology fund founded by Ajay Royan and Peter
Thiel, along with MagForce AG, are investors and strategic partners in
MagForce USA, Inc.
NanoTherm(TM), NanoPlan(R), and NanoActivator(R) are components of the
therapy and have received EU-wide regulatory approval as medical devices
for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and
NanoActivator are trademarks of MagForce AG in selected countries.
For more information, please visit: www.magforce.com.
Get to know our Technology: video (You Tube)
Stay informed and subscribe to our mailing list.
Disclaimer
This release may contain forward-looking statements and information which
may be identified by formulations using terms such as "expects", "aims",
"anticipates", "intends", "plans", "believes", "seeks", "estimates" or
"will". Such forward-looking statements are based on our current
expectations and certain assumptions, which may be subject to a variety of
risks and uncertainties. The results actually achieved by MagForce AG may
substantially differ from these forward-looking statements. MagForce AG
assumes no obligation to update these forward-looking statements or to
correct them in case of developments, which differ from those, anticipated.
---------------------------------------------------------------------------
30.09.2016 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.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: MagForce AG
Max-Planck-Straße 3
12489 Berlin
Germany
Phone: +49 (0)30 308 380 0
Fax: +49 (0)30 308 380 99
E-mail: info@magforce.com
Internet: www.magforce.com
ISIN: DE000A0HGQF5
WKN: A0HGQF
Listed: Regulated Unofficial Market in Berlin, Dusseldorf,
Stuttgart, Tradegate Exchange; Open Market (Entry
Standard) in Frankfurt
End of News DGAP News Service
---------------------------------------------------------------------------
507561 30.09.2016
DGAP-News: MagForce AG: MagForce AG Publishes Financial Results for the First Half of 2016 and Operative Highlights
| Source: EQS Group AG