Biofrontera
Inc. (Nasdaq: BFRI)
(the “Company”), a biopharmaceutical company specializing in the
commercialization of dermatological products, today issued the
following letter from CEO Erica Monaco and Executive Chairman of
the Board Hermann Lübbert.
To our valued stockholders,
We would like to extend warm wishes to all of
you for a healthy and prosperous 2022. At Biofrontera Inc., we
welcomed the New Year with optimism and continued business
momentum. In this letter, we provide a summary of our successes in
2021 and highlight key elements of our strategic plan for 2022 and
beyond.
The overarching strategy for Biofrontera’s
success continues to be gaining market share for our two
FDA-approved licensed products, Ameluz® and
Xepi®, while also broadening our commercial
opportunities through label expansions of our flagship product,
Ameluz®.
Looking back, 2021 was a foundational year for
Biofrontera Inc. We completed a successful initial public offering
(IPO) at the end of October, creating a publicly traded company
focused on the U.S., the world’s largest dermatology market. Our
business rests upon license and supply agreements in the U.S. to
market and sell Ameluz in combination with the red-light lamps
BF-RhodoLED® and the new RhodoLED XL for the
treatment of actinic keratosis (AK), as well as the topical
antibiotic Xepi® for the treatment of
impetigo.
In 2021, we created strong momentum that we
expect will carry on into 2022, such as:
- A rebound from the pandemic-induced
hesitation to perform in-office dermatology treatments, which
resulted in sales now recovering to near pre-pandemic levels.
- Market share gains by both Ameluz®
and Xepi® in their growing, multibillion-dollar categories.
- A Nasdaq listing that affords the
flexibility to exploit market opportunities or cover short-term
financing needs, supported by IPO proceeds of $18 million (gross),
our recent $15 million (gross) private placement as well as well as
proceeds from warrant exercises in excess of $13 million since the
IPO.
Commercial Momentum
We are proud of the hard work by the talented
members of our sales team across the country. Despite the
challenges resulting from the COVID-19 pandemic, we returned to
topline growth in 2021. Most dermatology offices have fully
reopened and patients have shown increased willingness to undergo
in-office treatments for AK. We exited 2021 with strengthened
financial performance, including:
- Preliminary sales for the fourth
quarter of 2021 in a range of $9.1 million to $9.2 million,
representing an increase of approximately 7% compared with the
fourth quarter of 2020.
- Preliminary revenue for the full
year 2021 anticipated to be in the range of $24.1 million to
$24.2million, an increase of approximately 27% over full year
2020.
Market Opportunity
According to the Skin Cancer Foundation, AK
affects approximately 58 million people in the U.S. In 2020, an
estimated 12.7 million AK treatments were performed in the U.S.,
which translates to a total addressable market of about $4 billion
for Ameluz with its current FDA-approved indication. AK is a
precursor to squamous cell carcinoma, a skin cancer with a
potentially fatal outcome.
The most common treatment for AK is cryotherapy,
with a 2020 market share of approximately 86%. Topical drugs for
the treatment of AK had a market share of about 12%, followed by
photodynamic therapy (PDT) treatments with about a 2% share.
Despite its market dominance, we think cryotherapy lacks certain
advantages as a treatment option compared with PDT. As such, the
opportunity to gain share from cryotherapy is a key focus of our
commercial efforts.
Expanding the Ameluz label allows us to
consistently deliver innovative solutions for patients and serves
as the key mechanism to unlock the drug’s potential. Continued
investment in clinical research by our license partner aiming at
label expansion is thus an integral part of our business. According
to our license agreement for Ameluz®, the licensor
is obliged to conduct and finance the clinical studies required for
defined label expansions. The FDA approval pathway takes
significant investment and time but, if successful, the result can
be very rewarding – not only for the patients, but also for the
potential value creation for our shareholders.
The clinical successes for our licensed products
in 2021 included regulatory approval for the new RhodoLED XL lamp,
progress on the Phase 3 study for the treatment of basal cell
carcinoma (BCC), the launch of a 3-tube safety study as well as a
Phase 2b trial for acne – all of which keep the
Ameluz® clinical program moving forward.
Our second licensed prescription drug is Xepi®.
Xepi® is a topical antibiotic for the treatment of impetigo, a
highly contagious bacterial skin infection with more than 3 million
cases in the U.S. each year. Currently, no antibiotic resistance
against Xepi® is known, and Xepi has also been specifically
approved by the FDA for resistant strains of staphylococcus aureus
or streptococcus pyogenes, including MRSA.
In 2020, more than 13 million prescriptions were
written for drugs in indications where Xepi® could be effective.
Xepi® is distributed through specialty pharmacies and is generally
covered by most commercial payers without pre-authorization. We
believe there is considerable market potential for Xepi® in the
coming years.
Strategies for Sustained
Growth
Our longer-term financial objectives include
achieving consistent revenue growth and expanding operating
margins. Accordingly, we are focused on balancing market expansion
with operating efficiency, including effective resource
utilization, information technology leverage and overhead cost
management.
Our market-expansion strategy is based on
bolstering awareness of our licensed products through industry
recognition, data-driven sales strategies, and a robust and dynamic
commercial infrastructure. We intend to optimize our sales force by
adding sales territories, and to strengthen medical affairs to
become a trusted partner through scientific data publication,
interaction with key opinion leaders (KOLs) and industry support.
Overall, our marketing and development goals align to form a
commercial strategy that has uniquely positioned Biofrontera for
leadership in the treatment of dermatological conditions.
As we move into 2022, the energy across our
organization is palpable. We are poised to increase sales and gain
further market share in the U.S. We intend to expand our corporate
footprint and to invest in our long-term growth strategies. As we
continue to build upon our position in the dermatology market in
the U.S., we invite you along on our exciting journey and affirm
our commitment to transparency on the progress and milestones we
strive to achieve.
On behalf of all Biofrontera Inc. employees and
our Board of Directors, we thank you for your continued support of
Biofrontera Inc.
Sincerely,
Erica Monaco
Chief Executive Officer |
Hermann Lübbert
Executive Chairman of the Board |
About Biofrontera
Inc.
Biofrontera Inc. is a U.S.-based
biopharmaceutical company commercializing a portfolio of
pharmaceutical products for the treatment of dermatological
conditions with a focus on photodynamic therapy (PDT) and topical
antibiotics. The Company’s licensed products are used for the
treatment of actinic keratoses, which are pre-cancerous skin
lesions, as well as impetigo, a bacterial skin infection. For more
information, visit www.biofrontera-us.com.
Forward-Looking Statements
Certain statements in this letter may constitute
"forward-looking statements" within the meaning of the United
States Private Securities Litigation Reform Act of 1995, as amended
to date. These statements include, but are not limited to, the
Company’s estimated revenue for the fourth quarter and year ended
December 31, 2021 and statements regarding the future performance
of the Company, opportunities for market growth, objectives of
management, strategic plans and future operations. The words
“believe”, “anticipate”, “intend”, “expect”, “target”, “goal”,
“estimate”, “plan”, “assume”, “may”, “will”, “predict”, “project”,
“would”, “could” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. We have based these
forward-looking statements on our current expectations and
projections about future events, nevertheless, actual results or
events could differ materially from the plans, intentions and
expectations disclosed in, or implied by, the forward-looking
statements we make. These risks and uncertainties, many of which
are beyond our control, including, but not limited to, the impact
of extraordinary external events, such as the current COVID-19
pandemic and its evolving nature; any changes in the Company’s
relationship with its licensors; the outcome of the Company’s
litigation with DUSA Pharmaceuticals, Inc.,; the Company’s ability
to achieve and sustain profitability; whether the current
disruptions in the supply chain will impact the Company’s ability
to obtain and distribute its licensed products; changes in the
practices of healthcare providers, including any changes to the
coverage, reimbursement and pricing for procedures using the
Company’s licensed products; the uncertainties inherent in the
initiation and conduct of clinical trials; availability and timing
of data from clinical trials; whether results of early clinical
trials or trials in different disease indications will be
indicative of the results of ongoing or future trials; whether
results of the studies described above will be indicative of
results for any future clinical trials and studies of Ameluz® in
combination with BF-RhodoLED®; uncertainties associated with
regulatory review of clinical trials and applications for marketing
approvals; whether the market opportunity for Ameluz® in
combination with RhodoLED® lamps is consistent with the Company’s
expectations; whether the Company will be able to successfully
transition to a public company operating independently of
Biofrontera AG; the Company’s ability to retain and hire key
personnel; the sufficiency of cash resources and need for
additional financing and other factors that may be disclosed in the
Company’s filings with the SEC, which can be obtained on the SEC
website at www.sec.gov and are also available on our website
at www.biofrontera-us.com. Readers are cautioned not to place undue
reliance on the forward-looking statements, which speak only as of
the date on which they are made and reflect management's current
estimates, projections, expectations and beliefs. The Company does
not plan to update any such forward-looking statements and
expressly disclaims any duty to update the information contained in
this press release except as required by law.
Contacts
Biofrontera
Inc.Pamela Keck+1 781 486
1539us-ir@biofrontera.com
LHA Investor RelationsTirth T.
Patel+1 212 201 6614tpatel@lhai.com
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