Blue Water Biotech, Inc. (“Blue Water” or the “Company”) (Nasdaq:
BWV), a biotechnology and pharmaceutical company focused on
developing and commercializing transformational therapies to
address significant health challenges globally, today issued the
following letter to shareholders from its Chairman and Chief
Executive Officer, Joseph Hernandez.
Dear Fellow Shareholders:
In recent months, Blue Water Biotech, Inc.
(“Blue Water”) has evolved from a preclinical vaccine development
company to a commercial stage pharmaceutical company after the
purchase of several FDA approved assets spanning multiple treatment
areas. Capital raises in 2022, resulting in a strong cash position
at the beginning of 2023, enabled us to pursue these strategic
acquisitions. We believe the acquisition of these assets will
generate tremendous value for Blue Water, and we are pleased to
provide an update on our commercial launch progress thus far and
milestones we intend to achieve in the coming months.
Our recent acquisitions include ENTADFI®, an FDA
approved, once daily pill combining finasteride and tadalafil for
the treatment of benign prostatic hyperplasia (“BPH”), and six
additional FDA approved assets across multiple indications,
including cardiology, inner and outer ear infections, and pain
management. While each product has unique considerations for launch
and we have analyzed each closely, we have developed a core
framework for commercial operations as we progress towards official
launch.
To begin, the core for any successful commercial
operation is a dedicated, experienced management team to steer
operations and make strategic decisions that will benefit Blue
Water in the long run. In February 2023, we appointed Frank Jaeger
to the team as Senior Vice President of Marketing and Business
Development, bringing with him over 25 years of biopharmaceutical
experience from start-up to large global pharma and targeted launch
experience in Men’s Health. Mr. Jaeger has been instrumental in
developing our launch strategy for these assets, and we look
forward to his continued strong leadership as we reach launch and
beyond.
With our commercial leadership team in place, we
have identified key areas on which to focus our efforts, including
expanding product availability for our patients, as well as
marketing and advertising to increase awareness for our products
through multiple channels.
Expanding Product Availability for
Patients
We have taken key steps to ensure that patients
have proper access to therapy, including securing a license from
the Ohio State Board of Pharmacy, allowing us to operate as a
pharmaceutical wholesaler in our home state of Ohio. As we look to
gain additional licenses, we are also making significant progress
in identifying vendors and solidifying agreements with key players
in the distribution channel, including third party logistics
providers and wholesalers to serve our retail pharmacy customers
nationwide.
In addition to the traditional retail pharmacy
channel, our commercial team has identified telemedicine as a
potential solution for select patients to access therapy without
having to step into a healthcare provider’s office. Telemedicine is
helpful for remote patients, those with timing constraints, or
those who may have difficulty scheduling an appointment with a
specialist. This approach is particularly relevant for current BPH
patients who may be eligible for ENTADFI®. We are in the process of
identifying the right telemedicine partner for ENTADFI® and
potentially other assets in our portfolio, so that our patients can
benefit from this platform upon official launch.
In order to help patients access our products,
we plan to partner with a hub provider to not only address the
challenges that patients may have during the treatment journey, but
also to help ease the administrative burden on healthcare
providers. The payer coverage process is very complex and can be
extremely time consuming for providers, and our goal in utilizing a
hub will be to help providers navigate this process and help
alleviate subsequent treatment delays for patients. Additionally,
as many of our products are long-term medications, we will lean on
our selected hub vendor to serve patients throughout the treatment
journey and provide support to them and their prescribers, with an
eye to optimizing revenue for Blue Water with recurring
prescriptions.
Regardless of the channel our patients utilize
to access our therapies, our commercial team recognizes that payer
coverage and market access is critical to the success of any
pharmaceutical launch. To this end, we recently signed an agreement
with Advantage Point Solutions, LLC to support our market access
strategy and to assist in formulary negotiations with key
healthcare payers and pharmacy benefit managers for ENTADFI®. With
their robust network of relationships, we are confident that they
are the right partner for this endeavor and will help us secure
placement on key formularies in the commercial and government
sectors.
Increasing Product Awareness Through
Marketing & Advertising
In addition to our patient- and provider-focused
approach to ensure proper access to therapy, we are developing an
extensive marketing and advertising strategy with industry leading
organizations to support our commercial portfolio. This approach
includes the creation of a robust sales team capable of reaching
physicians nationwide, as well as the generation of powerful
marketing material designed to maximize impact and drive sales.
In June 2023, we announced a collaboration with
IQVIA to build our medical sales representative team, covering key
geographies that account for a large percentage of prescriptions in
target markets of urology and cardiology. We are in the process of
finalizing the targeted launch plan for this team, but we believe
they will be instrumental in the success of our products as they
identify physicians across the country and increase awareness. We
fully intend to provide our team with proper sales materials,
including extensive disease state and product education, access to
a robust customer relationship management software, updated
prescribing data and trends, as well as effective marketing
material to educate physicians.
In addition to establishment of our sales team
with IQVIA, we have made significant progress on the marketing and
advertising front through the signing of a Master Services
Agreement with bfw Advertising Inc. (“bfw”) and generating an
action plan for our commercial portfolio. Bfw has more than three
decades of experience supporting life science companies of various
sizes and stages, and we are working closely with them to generate
new and effective marketing materials for our products, as well as
improve on current materials for these products. With bfw, we look
forward to rolling out patient-facing materials, website updates,
social ads, targeted provider engagement, as well as materials to
support our sales team with IQVIA, in the coming weeks and
months.
To summarize, the last few months have certainly
been an exciting time for Blue Water, filled with acquisitions,
growth, and execution. Although we have made significant progress
on our launch plans in a short period of time, we also look forward
to achieving the key milestones outlined above and generating
additional value for our shareholders.
We thank you for your continued support of Blue
Water.
Sincerely,
Joseph Hernandez
Chairman and Chief Executive Officer
About ENTADFI®
ENTADFI® is an oral, once daily treatment for
BPH that combines finasteride, a 5α-reductase inhibitor, and
tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a more
effective treatment option compared to other available therapies.
Clinical trials have shown that ENTADFI® is more effective in
treating BPH symptoms, including urinary frequency, urgency, weak
stream, and difficulty initiating or maintaining urination,
compared to finasteride monotherapy. Additionally, ENTADFI® has
demonstrated a favorable safety profile, with fewer adverse sexual
side effects compared to finasteride. ENTADFI® reduces potential
for adverse sexual side effects, making it a preferred choice for
men seeking relief from BPH symptoms without compromising their
sexual health. ENTADFI® has received FDA approval for the
indication of initiating treatment of the signs and symptoms of BPH
in men with an enlarged prostate for up to 26 weeks. More
information about BPH and full ENTADFI® prescribing information can
be found on the product website at https://entadfipatient.com/.
About Blue Water Biotech
Blue Water Biotech, Inc. is a biotechnology and
pharmaceutical company focused on developing and commercializing
transformational therapies to address significant health challenges
globally. Headquartered in Cincinnati, OH, the Company owns
ENTADFI®, an FDA-approved, once daily pill that combines
finasteride and tadalafil for the treatment of benign prostatic
hyperplasia. This combination allows men to receive treatment for
their symptoms of benign prostatic hyperplasia without the negative
sexual side effects typically seen in patients on finasteride
alone. The Company is also in the process of acquiring the approved
therapies from WraSer, LLC, and Xspire Pharma, LLC, including
ZONTIVITY® (reduction of thrombotic cardiovascular events in
patients with myocardial infarction or with peripheral arterial
disease), OTOVEL® (acute otitis media with tympanostomy tubes),
CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™
(moderate to severe pain) and NALFON® (NSAID treatment for pain and
inflammation). The Company also has a robust preclinical vaccine
pipeline. Blue Water holds the rights to proprietary technology
developed at the University of Oxford, Cincinnati Children’s
Hospital Medical Center, St. Jude Children’s Hospital, and The
University of Texas Health Science Center at San Antonio. Blue
Water is developing a Streptococcus pneumoniae vaccine candidate,
designed to specifically prevent highly infectious middle ear
infections, known as AOM, in children, and prevention of pneumonia
in the elderly. The Company is also developing a universal flu
vaccine that will provide protection from all virulent strains in
addition to licensing a novel norovirus S&P nanoparticle
versatile virus-like particle vaccine platform from Cincinnati
Children’s to develop vaccines for multiple infectious diseases,
including Marburg and monkeypox, among others. Additionally, the
Company is developing a Chlamydia vaccine candidate with UT Health
Science Center San Antonio to prevent infection and reduce the need
for antibiotic treatment associated with contracting Chlamydia
disease. For more information about Blue Water, visit
www.bwbioinc.com.
Cautionary Note Regarding
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements (including, without
limitation, the anticipated benefits of the Company’s agreement
with IQVIA, APS and bfw and the anticipated results of the
Company’s sales and marketing efforts for its commercial stage
products, each as described herein) are based on Blue Water’s
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to
differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to, risks
related to Blue Water’s ability to realize the benefits of its
acquisitions of ENTADFI®, ZONTIVITY®,
OTOVEL®, CETRAXAL®, CONJUPRI®,
TREZIX™ and NALFON®; risks related to
Blue Water’s ability to expand its business scope, commercialize
ENTADFI® and integrate the assets and commercial operations
being acquired from WraSer, LLC, and Xspire Pharma, LLC into Blue
Water’s business; risks related to Blue Water’s ability to attract,
hire and retain skilled personnel and establish an effective sales
team; risks related to Blue Water’s ability to establish, maintain
and optimize key third party commercial collaboration agreements
(such as those with IQVIA, APS and bfw); risks related to the
Company’s present need for capital to close its asset acquisitions,
commercially launch the Company’s acquired products and have
adequate working capital; risks related to the development of Blue
Water’s vaccine candidates; the failure to obtain FDA clearances or
approvals and noncompliance with FDA regulations; risks related to
the timing and progress of clinical development of our product
candidates; uncertainties of patent protection and litigation;
uncertainties of government or third party payor reimbursement;
limited research and development efforts and dependence upon third
parties; and substantial competition. As with any commercial-stage
pharmaceutical product or any product candidate under clinical
development, there are significant risks in the development,
regulatory approval and commercialization of pharmaceutical
products. Blue Water does not undertake an obligation to update or
revise any forward-looking statement. Investors should read the
risk factors set forth in Blue Water’s Annual Report on Form 10-K,
filed with the Securities and Exchange Commission (the “SEC”) on
March 9, 2023 and periodic reports filed with the SEC on or after
the date thereof. All of Blue Water’s forward-looking statements
are expressly qualified by all such risk factors and other
cautionary statements. The information set forth herein speaks only
as of the date thereof.
Media Contact Information:Blue Water Media RelationsTelephone:
(646) 942-5591Email: Nic.Johnson@russopartnersllc.com
Investor Contact Information:Blue Water Investor RelationsEmail:
investors@bwbioinc.com
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