Biofrontera AG: Biofrontera Reports Full Year 2015 Financial Results
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Biofrontera AG /
Biofrontera AG: Biofrontera Reports Full Year 2015 Financial Results
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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 +49 (0) 214 87 63 2 0
Thomas Schaffer, Chief Financial Officer press(at)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.
This announcement is distributed by GlobeNewswire on behalf of
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(i) the releases contained herein are protected by copyright and
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biofrontera AG via GlobeNewswire
[HUG#2003707]
Unternehmensinformation / Kurzprofil:
Datum: 15.04.2016 - 08:00 Uhr
Sprache: Deutsch
News-ID 464264
Anzahl Zeichen: 10740
contact information:
Town:
Leverkusen
Kategorie:
Business News
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