Leverkusen,
Germany, April 15, 2016 - Biofrontera AG (FSE: B8F), the
specialist for sun-induced skin cancer, today reported its full
year 2015 financial results for the year ended 31 December
2015.
- New Drug Application (NDA) for
BF-200 ALA in U.S. remains on track with 10 May 2016 PDUFA
date
- Launched Ameluz®
for Actinic Keratosis in Belgium
- Successfully transitioned
Ameluz® in Spain to
direct sales force
- Completed Phase III trial for
Ameluz® for Basal
Cell Carcinoma in Europe and reported positive results in January
2016
- Established a U.S. subsidiary
with Monica Tamborini as U.S. CEO
- Appointed Christoph Duenwald
as Chief Commercial Officer
- Strengthened shareholder base
with a new anchor investor
Key financial
data within expectations
Biofrontera reported total revenues of €4.1 million for the full
year, which represents a 34% increase year-over-year and was well
within expectations. Revenues in Germany increased by 27% and in
other European countries by 61%, when compared to 2014. Gross
margin improved to 70%, compared to 64% in 2014. Research and
development expenses were €6.2 million in 2015, compared to €4.5
million in 2014, and includes a PDUFA fee of €2.1 million for the
NDA for Ameluz® that was paid
in May 2015 and has been reimbursed by the U.S. Food and Drug
Administration (FDA) in March 2016. The 2015 net loss before tax
(including the PDUFA fee) was €11.3 million, compared to a loss of
€10.7 million in 2014. The Company had €4 million cash on the
balance sheet as of 31 December 2015.
Operational
progress
Since the July NDA submission to the FDA for
BF-200 ALA for the treatment of mild to moderate actinic keratosis
(AK) on the face and scalp in the U.S., the Company has made
substantial progress in the approval process. In the FDA's 74-day
letter that was received in September, there were no major review
issues identified and the PDUFA date was set for 10 May 2016. Since
the closing of 2015, Biofrontera has received a positive FDA
mid-cycle review and subsequently the proposed labelling for BF-200
ALA in March 2016. The Company is working with the FDA to finalize
the labelling that will appropriately reflect the drug's efficacy
and safety indications. All outstanding questions regarding the
quality management system as well as the manufacturing process of
the accompanying photodynamic therapy lamp have been addressed. The
BF-RhodoLED® lamp
activates the topically applied BF-200 ALA and will be approved in
conjunction with the medicinal product. Biofrontera's medical
device manufacturing facility is scheduled for inspection by the
FDA in May, which will represent the final site visit.
In anticipation of a U.S.
approval of BF-200 ALA, the Company established Biofrontera, Inc.,
its U.S. subsidiary, with an office in Boston, Massachusetts.
Monica L. Tamborini was appointed the U.S. CEO and has been
building the company's infrastructure in preparation for the
commercial launch of BF-200 ALA stateside. Ms. Tamborini has more
than 20 years of experience in executive leadership positions
within the healthcare sector and more specifically the
pharmaceutical industry at both private and public companies. She
brings a wealth of knowledge and expertise in operations and
finance as well as quality management systems and FDA compliance
regulations.
Biofrontera also appointed Christoph Duenwald as Chief Commercial
Officer and a member of its Management Board. With 24 years of
healthcare sales and marketing experience worldwide, including
management positions at Bayer Healthcare and Allergan, Mr. Duenwald
is leading the global sales and marketing effort for
Ameluz® and will be
instrumental to establishing the sales force in the US.
Europe remains a growth opportunity for the Company as
Ameluz® expands its
reach and garners favorable reimbursement. Biofrontera has
successfully transitioned the marketing and sales of
Ameluz® and the
BF-RhodoLED® in Spain from
Allergan to the Company's direct salesforce in an effort to realize
the full margin potential. Ameluz® was launched
in Belgium with full reimbursement by the Belgian healthcare system
during the first quarter of 2015.. During the fourth quarter,
Biofrontera's partner Louis Widmer received approval for
Ameluz® in
Switzerland with a planned launch to occur in Q2 of 2016.
Clinically, Biofrontera completed its Phase III clinical trial
evaluating BF-200 ALA for the treatment of Basal Cell Carcinoma
(BCC) in 2015 and recently reported the full results. The results
from the trial demonstrated that 93.4% of patients that were
treated with BF-200 ALA were cleared of all BCC's, compared to only
91.8% for those treated with Metvix®. In addition
to the high clearance rate of BCC's, BF-200 ALA also demonstrated
excellent cosmetic results where 60% of patients treated showed a
good or very good improvement in skin appearance as evaluated by
study physicians, compared to 48.6% when treated with
Metvix®. These
results clearly exhibit the high efficacy of PDT with BF-200 ALA to
destroy BCC tumor tissue without the formation of scar tissue. The
label extension of BF-200 ALA for BCC in Europe is expected to be
approved by Q4 2016.
Over the course of 2015, Biofrontera was able to
strategically strengthen its shareholder base through two fund
raises. The first raise in April issued 1,377,272 new shares with
net proceeds of approximately €3.1 million. The second raise in
October issued 1,916,588 new shares with investors and provided net
proceeds to the Company of €3.5 million. The proceeds from these
placements have enabled the Company to finance its ongoing business
operations into 2016 and to initiate the establishment of a sales
and marketing infrastructure for BF-200 ALA in the U.S.
"We concluded the year having built a strong foundation that will
support the tremendous opportunities that are still ahead of us,"
commented Hermann Luebbert, CEO of Biofrontera AG. "Our expansion
in Europe continues to flourish as Ameluz
® increases its
presence in additional countries alongside our pursuit of a BCC
indication for BF-200 ALA. As we advance Biofrontera's operations
in the U.S., our interactions with the FDA thus far gives us
confidence that we remain on track for the planned U.S. launch of
BF-200 ALA in September. The Company has a solid financial standing
as we continue to execute on our strategic growth initiatives and
drive shareholder value."
Ends
Enquiries, please contact: Biofrontera AG
Thomas Schaffer, Chief Financial Officer |
+49 (0)
214 87 63 2 0
press@biofrontera.com
www.biofrontera.com |
IR and PR US: The Ruth
Group
IR: Lee Roth / Tram
Bui
+1 646-536-7012 / 7035
PR: Kirsten
Thomas
+1 508-280-6592
About Biofrontera
Biofrontera
Group (FSE/AIM: B8F, ISIN DE0006046113) is a biopharmaceutical
company specializing in the development, sale and distribution of
drugs and medical cosmetics for the care and treatment of skin
diseases. Biofrontera's most important product is BF-200 ALA, a
prescription drug approved in Europe under the name of
Ameluz® for the
treatment of mild and moderate actinic keratosis (superficial skin
cancer) with photodynamic therapy (light therapy). Biofrontera is
the first German pharmaceutical start-up company to obtain
centralized approval for a drug it has developed itself. The
company also plans for Ameluz® to be
approved for basal cell carcinoma and is currently preparing for
approval of BF-200 ALA in other countries, especially in the
largest pharmaceutical market in the world, the United States.
The company also markets the
Belixos®
dermatological range of cosmetics. Belixos® products, a
cream, a gel and a scalp tonic, contain combinations of active
substances extracted from plants, relieve itching and redness and
are used for the regenerative care of chronic skin conditions such
as atopic dermatitis or psoriasis. The Belixos®
Protect, a daily skincare for sun-damaged skin, complements this
dermo-cosmetic line. All products are available through Amazon.
The Biofrontera Group was
established in 1997 by Prof. Dr Hermann Lübbert, the Chairman of
the company's Management Board, and has its headquarters in
Leverkusen, Germany.
For more information, visit
www.biofrontera.com
This
communication expressly or implicitly contains certain
forward-looking statements concerning the business activities of
Biofrontera AG. These forward-looking statements reflect the
opinion of Biofrontera at the time of this communication and
involve certain known and unknown risks. The actual results
achieved by Biofrontera may differ significantly from future
results or performances which are published in its forward-looking
statements. Biofrontera assumes no responsibility to update its
forward-looking statements.