Assumptions of Our Minimum Viable Product Scenario

These assumptions pertain to the bioZhena Minimum Viable Scenario (MVS), which has been worked from bottom up with due attention to the TAM, SAM and the SOM . TAM: Total addressable market or total available market. SAM: Serviceable available market is the portion of TAM targeted and served by the company. SOM: Serviceable obtainable market, or share of market, is the percentage of SAM which is assumed to be reached. Our focus is on the SAM, the Serviceable Available Market.

bioZhena Corporation’s goal is to implement the Full Value Scenario that was constructed based on the Minimum Viable Scenario. However, these assumptions are for the initial stage of business development, accounting only for the reproductive management use of the technology by end-users at home. The numbers in these assumptions represent bare minimum, consistent with the 5-year horizon of the business plan. The Full Value Scenario would assume a 10-year horizon and a strategic partnership.

Summary: Our initial Serviceable Available Market size assessment ranges from $21 Billion in U.S. alone and $168 Billion worldwide (fertility-impaired plus off-label birth control use) to $316 Billion worldwide when birth control marketing claim is included within the 5-year plan (316 = 143 + 5 + 42 + 126). This is still merely the bare minimum, not considering applications other than the personal reproductive management (sex-life management) use of the Ovulona.

The sources of the numerical data summarized here are given in the bioZhena’s Weblog post from which this summary has been extracted: https://biozhena.wordpress.com/2016/08/02/biozhena-business-assumptions-for-minimum-value-scenario/ .

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SUMMARY OF MINIMUM VIABLE SCENARIO’S SERVICEABLE AVAILABLE MARKET IN THE U.S. ALONE

US Trying-To-Conceive (TTC) Serviceable Available Market $$ at the TTC mean cost of $2,600 p.a. is $21,320,000,000

US Trying-To-Conceive Serviceable Available Market $$ at the TTC minimum cost of $200 p.a. is $1,640,000,000

US Initial Off-Label Birth Control Serviceable Available Market (SAM) $$ is $82,492,000

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Projection: FIRST PRODUCT SALES IN MONTH 16 POST FUNDING (first product application already FDA-cleared)

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 Our Trying-To-Conceive (TTC) Numerical Assumptions For the Minimum Value Scenario Are:

Number of US Fertility-Impaired Women Ages 15-44 is 8,200,000

US Serviceable Available Market $$ (at the TTC mean cost of $2,600 p.a.) is $21,320,000,000

US Serviceable Available Market $$ (at the TTC minimum cost of $200 p.a.) is $1,640,000,000

Worldwide Number of Women Who Are Unable to Have a Child is 48,500,000

Worldwide Total Available Market $$ is very large

E.g. even if the estimate were based on the US non-ART cost average of $2,600, Worldwide TAM is $126,100,000,000

(Annual costs of ART, Artificial Reproductive Technologies, is an order of magnitude higher.)

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Our Numerical Assumptions For Off-Label Use For Birth Control In the Minimum Value Scenario Are:

Number of US Women off-label users upon device launch into the TTC Market segment (assuming 1%) is 82,000

US Off-Label Serviceable Available Market $$ is $82,492,000

Worldwide Number of Women off-label users upon device launch is 41,832,000

Worldwide Total Available Market $$ is very large

E.g. if the estimate were based on the above US cost average, TAM is $42,082,992,000

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Our Birth Control (BC) Numerical Assumptions For the Minimum Value Scenario Are:

Number of US Women in the family planning (BC) market is 5,360,000

US Serviceable Available Market (SAM) $$ is $5,392,160,000

Worldwide Number of Women in the family planning (BC) market is 758,000,000

Worldwide Total Available Market $$ is very large even with only the unmet-need number of 142,000,000 women

E.g. if the estimate is based on the above US cost average, TAM is $142,852,000,000

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Summary

Our initial Serviceable Available Market size assessment ranges from $21 Billion in U.S. alone and $168 Billion worldwide (fertility-impaired plus off-label birth control use) to $316 Billion worldwide when birth control marketing claim is included within the 5-year plan (316 = 143 + 5 + 42 + 126). This is still merely the bare minimum, not considering applications and developments other than the personal reproductive management (sex-life management) use of the Ovulona.

The Full Value Scenario (not described here) assumes a 10-year horizon and a strategic partnership.

The sources of the numerical data summarized here are given in the bioZhena’s Weblog post from which this summary has been extracted: https://biozhena.wordpress.com/2016/08/02/biozhena-business-assumptions-for-minimum-value-scenario/ .