Full Press Release Details
Hello, and thank you for standing by. My name is Regina, and I will
be your conference operator today. At this time, I would like to welcome everyone to the Blue Water Vaccines Conference call. All lines
have been placed on mute to prevent any background noise. If you should need assistance during the call, press star, then zero and an
operator will come back on the line to assist you. I'd now like to turn the conference over to Nic Johnson. Please go ahead.
Nic Johnson (00:26):
Good morning and thank you for joining the Blue Water Vaccines Business
update call. On the call with us today, our BWV's Chief Executive Officer Joseph Hernandez and Vice President of Marketing and Business
Development, Frank Yeager. Before we get started, we would like to remind everyone that this is, this call contains certain statements
that 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 are based on Blue Water's current expectation, 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 risk related to Blue Water's ability to realize the benefits of the transactions contemplated by the agreement., risk related
to Blue Water's ability to expand its business scope, risk related to Blue Water's vaccine candidate development, the failures to obtain
FDA clearance or approvals in non-compliance with FDA regulation, delays and uncertainties caused by the global Covid 19 pandemic, risks
related to the timing and progress of clinical development of BWV's products, a need for additional financing, uncertainties of patent
protection and litigation, uncertainties of government or third party payer reimbursement, limited research and development efforts, and
dependence upon third parties and substantial competition. As with any vaccine under development, there are significant risks in the development,
regulatory approval, and commercialization of new products. Blue Water does not undertake any obligations to update or revise any forward-looking
statement. Investors should read risk factors set forth in Blue Water's annual report on Form 10 K filed with the securities in exchange
Commission, the SEC on March 9th, 2023 in periodically 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. We will now turn the call over to Blue Water's CEO Joseph Hernandez.
Joseph Hernandez (03:12):
Thank you Nick, and good morning to everybody. We're, we're excited
to announce Blue Water's purchase of Entadfi through a Healthcare pursuant to announce a purchase agreement that we executed late yesterday.
The purpose of this call is to really provide a greater context for the purchase agreement and the underlying acquisition, and to provide
clarity on question shareholders may have. This acquisition represents the significant accomplishment for Blue Water as we're now a commercial
stage pharmaceutical company with an opportunity to generate revenues in the near term. The deal also expands our addressable patient
population beyond our initial focus of vaccine development and into additional disease areas. Entadfi received a FDA approval on December,
2021 for the treatment of benign prostate hyperplasia, also known as BPH, and this is for men with enlarged prostate for up to 26 weeks.
Entadfi also counteracts the adverse sexual effects typically seen in men with alternative BPH therapies. Under the agreement of Blue
Water has purchased Entadfi for a total consideration of a 100 million dollars with an upfront payment of 6 million and additional 14
million paid in defined tranches throughout through September, 2024. Veru may to receive up to an additional 80 million based on predetermined
annual sales milestones. Blue Water will assume royalty and milestone obligations under the previous asset purchase agreement, including
royalties on sales and sales milestones that are a total up to 22.5 million dollars. In addition to our commercial materials, contracts,
intellectual property, regulatory records and filings, Blue Water has acquired all available inventory of Entadfi, which has an approximate
value of $12 million and encompasses about 125,000 bottles that are available for the market. {inaudible} we believe sales revenue will
offset our current burn and have an overall significant positive impact on our balance sheet. We anticipate these revenues will extend
our cash runway beyond the previously reported third quarter of 2024. These revenues will also support the development of our current
vaccine programs and contribute to our mission of addressing significant global health challenges. As you know, our vaccines that are
currently in development are strep pneumo for otitis media, or middle ear infections, and pneumonia, our influenza, universal influenza
vaccine and chlamydia vaccine is currently in the early stages of development.
Joseph Hernandez (05:44):
Let me talk a little bit about this disease, a very important disease.
So benign prostate hyperplasia is a condition in men where the prostate gland enlarges but is non cancerous. BPH is now well understood,
although the common effects and impact the quality of life of many men, men over the age of 50, but have those men suffer from this condition
and men over 85, about 90% of those suffer from this condition. Men with BPH suffer from challenges with urination flow, frequency, urgency,
and about 70% of these men also experienced sexual dysfunction. In 2022, according to a IQVIA, there were approximately 44 million total
prescriptions and 20 million new prescriptions related to BPH symptoms. There are several challenges associated with other medications
indicated to BPH. Some neither reduce nor stop prostate growth. Often these treatments can take anywhere between 6 to 12 months for significant
symptom release, which is problematic for many of these patients. Additionally, due to the side effect profile mechanisms of the currently
available BPH treatments, patients are put in increase through or have increased rates for erectile dysfunction leading to lower adherence,
and it's test estimated that about 9% of those patients stay on therapy. Entadfi indicated for the treatment of signs and symptoms of
BPH in men with enlarge prostate for up to 26 weeks. Entadfi is FDA approved, and it's a once daily capsule for oral use comprised of
two products or two molecules. One is finasteride, which is traditionally used, for BPH treatment, and the other one tadalafil, a treatment
for BPH and erectile dysfunction. The combination of these two compounds into one medicine allows patients to receive BPH medications
without the negative side effects of conventional therapy. The efficacy of combined finasteride and tadalafil for treatment of BPH and
associated comorbidities was evaluated in a double blind randomized parallel design pivotal phase three study in where 696 men, including
those with comorbidity were evaluated over a 26 week period.
Joseph Hernandez (08:04):
The medication demonstrated statistically significant improvements
in the signs and symptoms of BPH compared to placebo with finasteride . The company is therefore greatly encouraged by the potential of
Entadfi with these two combined therapies. We believe that Entadfi is differentiated from other BPH therapies and that it combines these
two medicines for the clinically effective treatment of BPH. We estimate that there are over 20 million men in the United States who suffer
from BPH, including those who remain undiagnosed or untreated. Also Entadfi is currently available at pharmacies nationwide by prescription.
We believe that many physicians and their patients are not aware or do not have access to this effective treatment for BPH in the related
sentence. I want to turn over the call now to Frank Jaeger, who is our VP of Marketing and Business Development to discuss and talk a
little bit about our commercialization strategy. Frank.
Frank Jaeger (09:00):
Thanks Joseph. This is truly an exciting day for Blue Water, and
I'm happy to share with you a high level overview of our commercialization strategy for Entadfi. We understand this effort that's gonna
take tremendous education and marketing efforts, we do. But we are prepared to bring the learnings that Veru has had and bring that to
the market and build the infrastructure necessary to expedite that process. So our approach is pretty straightforward to transforming
Entadfi sales growth and strengthening our commercial presence. It's through a three-pronged approach. First, we we'll provide education
to the healthcare provider at their offices in order to make them aware, try and use Entadfi. We'll be targeting the most valuable physicians
who are responsible for the lion chair of existing BPH treated patients. Specifically, we will target those physicians who see new patients
so that they can start therapy with our combination therapy product. Key to the success of this strategy will be to ensure the retail
distribution channel is set up for success so that patients can pick up Entadfi at their local pharmacy. Important to ensuring though
that, that the patient can and will pick up a prescription is to ensure that payers were covered Entadfi. As we begin to think about and
ensuring the availability and coverage of the product, we'll be thoroughly evaluating and optimizing our pricing and reimbursement strategy.
The final leg of this first prong is to generate awareness and interest in the product in the first place. To do this we'll need to have
a small account manager sales team who can provide that education and nonpersonal promotion to showcase our messaging through different
channels. For example, in just about a week from now, Blue Water will be at the American Urological Association. We'll have a booth to
showcase our product and have clinical conversations with our key customers.
Frank Jaeger (10:55):
The second prong of our commercialization approach is to educate
the patients directly about the availability of Entadfi. With Entadfi patients can now get the power of two products in one. As discussed
earlier, combined finasteride and tadalafil therapy is superior at treating BPH and alleviating the related comorbidities and symptoms
than finasteride and the placebo. As Joe mentioned previously, we know that in 2022, according to IQVIA, there were approximately 44 million
total prescriptions. Let me say that again - 44 million total prescriptions. With nearly 20 million of those being written as new prescriptions
related to treatment of BPH. There is a significant opportunity to target and educate these patients as we know that 55 million of them
have or are at risk for BPH. Third, and finally, we believe it is important to expand on the second strategy even further by finding and
partnering with established providers of mental health.
Frank Jaeger (12:00):
With a strategic partner, we can sell directly to partner companies,
advertise alongside other partners, and leverage the existing patient relationships and networks that these partners have created. To
be clear, the diagnosis and treatment of BPH patients will always be done by a licensed healthcare professional. That's not our business.
That said, though, we believe that by partnering with these strategic providers who do that as their core business operations will benefit
patients, the strategic partner and our shareholders. The final opportunity that I'll touch on today is the opportunity to explore drug