LSI'23 - 9 minute pitch Flashcards

1
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Hello, I’m James Hugg, CEO of SmartBreast.
You probably know that early detection and treatment are essential to surviving cancer.
However, more than 50% of women have breast tissue too dense for x-ray mammography to work.
In contrast, our technology, pictured here, can detect up to 4-times more early-stage cancers in dense breasts: to date, our technology has saved the lives of 600 women.

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2
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Mammography is performed with X-rays, which cannot penetrate dense breast tissue.
(click) On mammograms, dense breast tissue appears white and often hides early-stage cancer, which also appears white.
(click) Thus, mammography in dense breasts fails to detect 70% of breast cancers.
(click) Furthermore, women with dense breasts have 5 times the risk of developing cancer.
(click) This dense-breast problem afflicts 50% of Western women and 70% of Asian women.
(click) Additionally, mammography requires painful compression to flatten the breast, which deters half of all women from getting an annual scan.

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3
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The best solution is Molecular Breast Imaging, or “MBI.”
MBI utilizes gamma rays that safely pass through dense breast tissue.
We also use a low-dose tracer that concentrates in cancer.
(click) The two images on the screen are of the same dense breast.
On the left is an x-ray mammogram reported as “normal.”
On the right, our MBI technology clearly shows a tumor.
(click) Moreover, our MBI technology is painless, which could double the number of women seeking annual screening with MBI.

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4
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I have game-changing news that will profoundly impact the SmartBreast business plan and growth trajectory.

Just two weeks ago the FDA announced new mandatory regulations for all 8,821 breast imaging facilities:
They must notify patients about what their breast density is
And if it is dense, they must recommend supplemental imaging

In parallel, the US Congress looks sure to pass the “Find It Early Act” which mandates that insurance pays for supplemental dense breast imaging

The result for us is a huge jump in demand for MBI, likely doubling our previous sales forecast.

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5
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SmartBreast is an impact investment with the potential to save over 500k wasted lives every year.

(click) But we are also a value investment, saving significant costs of late-stage treatment.

In fact, only 6 cancers detected early will pay for our MBI solution.

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6
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SmartBreast currently manufactures, sells, and services two MBI scanners, which are FDA-cleared, reimbursed, and registered in 12 countries.

(click) Next year, we will collaborate with two dense-breast AI software companies to develop tools that complement our MBI technology.

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7
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The global breast imaging market is growing at 10% per year.

Our bottom-up calculation predicts $250M of revenues obtainable in 5 years.

(click) Our model includes the effect of the new federal mandates.

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8
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Our technology has already penetrated the market with 217 SmartBreast MBI systems installed in 12 countries.

These systems have scanned more than 80,000 patients and saved over 600 lives.

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9
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Our partners have published many research papers proving the efficacy of MBI.

(click) We will sell directly to US hospitals and focus digital marketing on our target users,
(click) breast radiologists, surgeons, and oncologists who champion MBI within their hospitals and help us navigate their purchasing processes.

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10
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The unit price of MBI is $400k, and the 10-year value of service is also $400k. Customer acquisition costs are only 5% of the Long-Term Value.

(click) In 2023 we will hire US salespeople, while we will primarily use distributors overseas

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11
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Our indirect competition comprises mammography, ultrasound, and MRI.
Unlike these modalities, SmartBreast MBI is the most sensitive, specific, comfortable, and inexpensive.

Even compared to MRI, SmartBreast MBI is superior and 4 times less expensive.

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12
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We have a deep IP moat of 18 granted patents around our existing technology and freedom to operate.

(click) Moreover, our patent portfolio protects a next-generation product..

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13
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I have been passionate about developing dense-breast imaging technology for over 20 years.
In fact, I led the GE technical team that developed our MBI product.
The SmartBreast leadership team each has over 30 years of experience in medical devices and imaging.
We have worked together in previous startups and have achieved multiple exits and acquisitions.

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14
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We have an active and distinguished international Advisory Board.

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15
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In 2021, SmartBreast acquired the MBI technology initially developed by GE and Dilon, who generated a combined $5M in pre-pandemic revenues.

We will be profitable in 2025.

(click) In 2027 our valuation with an 8X multiple will exceed $1 billion.

(click) We plan an IPO on an Asian exchange or an acquisition by a large medical imaging company.
Remarkably, GE assured us they would eagerly buy back the MBI business when we grow annual revenues to $50M or more.

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16
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M&A activity in the medical imaging market has been aggressive, which bodes well for exit by acquisition.

17
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We raised $2.4M in seed capital to fund the MBI technology acquisition.

Today, we are raising $10M to ramp up marketing and sales, and we are already in due diligence with a lead investor.

*(click) We plan a priced equity round next year to accelerate marketing and sales further and acquire AI software capabilities.

18
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Our strong team has proven traction with market penetration, adaptable sales and marketing tactics, and a competitive edge with a deep IP moat.

The new FDA regulations will surely increase demand and revenues.

Now is the time to invest in SmartBreast to save the lives of our wives, mothers, sisters, and daughters.