Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (September 2023)
35 slides from Femasys's investor presentation, Sep 27, 2023
Slide 1: Disrupting Convention in Women's Health Through Continuous Innovation
Disrupting Convention in Women’s Health Through Continuous Innovation September 2023 Corporate Presentation 1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to current beliefs, expectations and assumptions rega
Slide 3: Femasys: At-a-Glance
Femasys: At-a-Glance Who We Are Financial Information Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including FemaSeed® an FDA-cleared infertility treatment, FemBloc® a lead late-clinical stag
Slide 4: Investment Highlights
Investment Highlights Differentiator 4 Develop disruptive approaches for women’s health Address multi-billion-dollar global market opportunities in permanent birth control and infertility Clear reimbursement path with limited competition Improved patient care and health economics Intellectual proper
Slide 5: Key Leadership
Key Leadership Experienced biotechnology and medical device professionals Brian Drumheller VP, Quality 30+ years of experience Dan Currie Chief Operating Officer 30+ years of experience Jeremy Sipos VP, Research & Development 20+ years of experience Christine Thomas SVP, Regulatory & Clinical 20+ ye
Slide 6: Our Technologies Provide a Continuum of Care
FemBloc® Product Candidate Research Preclinical Stage ISafety Stage IIValidation Stage IIIPivotal Our Technologies Provide a Continuum of Care Permanent Birth Control and Ultrasound Occlusion Confirmation 6 In-office, minimally invasive solutions that share delivery platforms. Commercially Available
Slide 7: Femasys Portfolio of Products
Femasys Portfolio of Products 7 Initial Focus on Infertility Specialists + Added Focus on Gynecologists ~1,700 (U.S.) ~40,000 (U.S.) Product U.S. Commercial Ex-US Commercial Primary Detailing Target Secondary Detailing Target FemaSeed NOW FDA CLEARED ✔ (Canada) REI GYN FemVue ✔ ✔ (Japan, Canada, Hon
Slide 8: Strong Global Intellectual Property Portfolio
Strong Global Intellectual Property Portfolio Our Patent Estate Encompasses Utility and Design >150 patents globally Directional Delivery (dual or single) to Fallopian Tubes Biopolymer Composition for Tubal Occlusion Contrast Generating Ultrasound Visible Tissue Sampling for Cancer Detection FemBloc
Slide 9: FemaSeed Intratubal Artificial Insemination
FemaSeed® Intratubal Artificial Insemination 9 Innovative first-line infertility treatment designed to deliver sperm directly where conception occurs Designed to be more affordable than assisted reproduction Complementary Diagnostics FemVue® and FemCath® First in-office ultrasound evaluation of fall
Slide 10: Infertility: Unmet Need (U.S. only)
Infertility: Unmet Need (U.S. only) >10M women struggle with infertility1 Birth rate fell 4% in 2020 (largest single year decrease in 50 years)2 Despite advancements, there have been no new affordable options in decades. 10 https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm Hamilton, et al.
Slide 11: FemaSeed: Low Cost for Front-End of Infertility Treatment
FemaSeed: Low Cost for Front-End of Infertility Treatment FemaSeed $$ Traditional IUI $ IVF/ ICSI* $$$$$ Artificial Insemination ✔ ✔ Intratubal sperm delivery (into fallopian tube where conception occurs) ✔ Ovulation stimulation optional optional ✔ No egg retrieval, no egg freezing ✔ ✔ Minimal train
Slide 12: FemaSeed Intratubal Insemination
FemaSeed Intratubal Insemination An innovative treatment for infertility designed to deliver sperm directly to where conception occurs, in a woman’s fallopian tube. 12 Undirected sperm delivery to cavity (IUI) is first-line treatment despite low success rates Video will open in browser window.
Slide 13: FemaSeed Ongoing Clinical Trial for Male Infertility Factor
Summary: Study Design: prospective, multi-center, unblinded, single arm Study Population: male factor infertility Sample Size: up to 214 subjects contributing 214 FemaSeed cycles Primary Effectiveness Endpoint: Pregnancy Rate FemaSeed Ongoing Clinical Trial for Male Infertility Factor SITE RECRUITME
Slide 14: The Unmet Need in Infertility: Compelling Testimonials
The Unmet Need in Infertility: Compelling Testimonials 14 For more than 20 years, current approaches to infertility treatment have been limited during the initial stage of therapeutic care, but with the advancement of FemaSeed, we believe a next generation intrauterine procedure may have the opportu
Slide 15: First In-office, Ultrasound Approach for Fallopian Tube Evaluation
First In-office, Ultrasound Approach for Fallopian Tube Evaluation FemVue creates saline-air contrast that travels through the fallopian tube(s) when open 15 First Intrauterine Catheter for Selective Tubal Evaluation Complimentary Diagnostics: test prior to infertility treatments, including FemaSeed
Slide 16: Infertility Addressable Market (U.S. only)
Diagnosis Discussion Drugs IUI IVF Infertility Addressable Market (U.S. only) 16 Least Costly Most Costly seek evaluation & treatment (1.4M IUI) FemVue/FemCath FemaSeed $2B total 4.3M seek evaluation only Market Expansion for FemaSeed $800M total Immediate Addressable 4.8M seek evaluation & treatmen
Slide 17: Competitive Options: Price Comparison
Competitive Options: Price Comparison 17 IUI Intrauterine Insemination FemaSeed $500-$4,000 total per cycle including ultrasound monitoring, and optional ovulation drugs2 + device per cycle above IUI cost Average Total Cost 1https://www.fertilityiq.com/iui-or-artificial-insemination/the-cost-of-iui
Slide 18: FemBloc Permanent Birth Control
FemBloc® Permanent Birth Control 18 First and only non-surgical, in-office, permanent birth control option in late-stage clinical development with the potential to be the safest and most natural approach at substantially less cost than the long-standing surgical alternative Companion Diagnostics Fem
Slide 19: Permanent Birth Control Alternatives: Unmet Need (U.S. only)
Since surgical tubal ligation has been performed since the 1880’s and remains the most common option for women who want permanent birth control. Permanent Birth Control Alternatives: Unmet Need (U.S. only) >13M women no longer intend to have children >12M use non-permanent birth control, long-term 8
Slide 20: FemBloc: Expected Competitive Advantages
Essure® is a registered trademark of Bayer Healthcare (Conceptus) and, as of December 2018, no longer a marketed solution. FemBloc: Expected Competitive Advantages over existing or previous birth control options On-Market Solutions Off-Market FemBloc Surgical Tubal Ligation* IUD (Reversible) Essure®
Slide 21: No Permanent Implant – Scar Tissue Closes Tubal Lumen
No Permanent Implant – Scar Tissue Closes Tubal Lumen FemBloc Treatments FemBloc Permanent Birth Control in Development The first and only non-surgical, in-office approach. Balloon at tubal opening without cannulation Biopolymer is designed to be expelled within 3 months Biopolymer solidifies 21 Vid
Slide 22: Companion ultrasound test confirms procedure success
Companion ultrasound test (FemChec® and FemCath®) exclusive to FemBloc - confirms procedure success Occlusion Confirmation FemBloc Permanent Birth Control in Development 3 Months Blockage Biopolymer degrades Saline-air contrast confirms blockage 22 Video will open in browser window.
Slide 23: FemBloc Clinical Studies for Pre-Market Approval
Completed Earlier FemBloc Supportive Studies (N=321) Stage I: Safety FemBloc Clinical Studies for Pre-Market Approval (PMA) 23 Stage III: Pivotal Clinical Trial (IDE approved June 2023; currently enrolling) FINALE Trial Design: Prospective, multi-center, open-label, single-arm study Roll-in study de
Slide 24: FemBloc: Majority AEs Occurred at Time of Procedure
61% 8% 16% 3% 0.5% 0.5% 0.8% 5% 4% FemBloc Treatment (>90 days) FemBloc: Majority AEs Occurred at Time of Procedure (N = 228 subjects from Stage I & II) Patients are being followed for 5 years, with first subjects completed 5-year follow-up 91% AEs related to device/ procedure occurred within 7 days
Slide 25: FemBloc: Most Common Reported AEs
Bleeding/Spotting (59%) Pain/Cramps (55%) 40% 13.1% 3.5% 2.6% 34.5% 13.5% 7% *Long-Acting Contraceptive Comparison (Bayer, Mirena IFU, August 2022) reported most common adverse events (>5%) as: 71% bleeding related 66% reproductive system and breast disorders 23% abdominal/pelvic pain 16% headache/m
Slide 26: The Unmet Need for Women: Options for Family Planning
The Unmet Need for Women: Options for Family Planning 26 Although tubal ligation has been performed for over a century, women will benefit from an in-office approach that avoids the risks and discomforts associated with incisions, general anesthesia and surgery. FemBloc may expand much needed option
Slide 27: Permanent Birth Control Addressable Market (U.S. only)
Permanent Birth Control Addressable Market (U.S. only) 27 Pills Condoms Injectable/Ring/Patch IUDs Tubal Ligation Least Invasive / Least Reliable Most Invasive / Most Reliable $20B Total Includes women using non-permanent options but are candidates (>12M)3 Market Expansion Opportunity $2B Annual Nea
Slide 28: FemBloc: Improved Health Economics
FemBloc: Improved Health Economics Permanent One-Time Cost Breakdown Pre-Op $6,000* Facility Anesthesia Post-Op Cost of FemBloc System Anesthesia Physician / Practice Est < ½ cost of Tubal Ligation Physician In-office procedure expands practice services Can perform multiple procedures in same room Q
Slide 29: FemBloc: Clear U.S. Reimbursement Path
In-office procedure FemBloc Treatments Category covered (ACA) Cat III code approved FemBloc: Clear U.S. Reimbursement Path Reimbursable Visits In-office/ TeleVisit(required for permanent birth control) Counseling/Eligibility Existing CPT codes In-office test (ultrasound) Cat III code approved FemBlo
Slide 30: FemCerv Diagnostic for Cervical Cancer
30 FemCerv® Diagnostic for Cervical Cancer First endocervical biopsy designed for comprehensive tissue sampling with minimal contamination that is virtually pain free Cancer Diagnostic Portfolio FDA-Cleared in U.S. and Approved in Canada
Slide 31: FemCerv Endocervical Tissue Sampler
Expanded Collection Chamber FemCerv Endocervical Tissue Sampler 1 2 Collected sample 31 Video will open in browser window. The incidence of stage IV cervical cancer in the U.S. is increasing.* *Francoeur et. al, International Journal of Gynecologic Cancer (2022). 1 (https://www.acog.org/clinical/cli
Slide 32: Femasys is Prepared for Execution
Femasys is Prepared for Execution 32 Clear Regulatory & Clinical Path to FDA Approval Clear Reimbursement Pathway Commercial Expertise Full manufacture facility with ability to scale and transfer MFG Ready Sales Ready Built infrastructure prior to commercial salesforce with FDA-cleared diagnostic pr
Slide 33: Recently Achieved & Upcoming Anticipated Milestones
Recently Achieved & Upcoming Anticipated Milestones Near term expected valuation inflection points creating accretive value for investors 33 2024 Q2 Complete FemaSeed enrollment for male infertility factor trial Q3 2023 FemBloc pivotal trial enrollment initiated Q4 Q1 Commercialize infertility portf
Slide 34: Investment Highlights
Investment Highlights Differentiator 34 Develop disruptive approaches for women’s health Address multi-billion-dollar global market opportunities in permanent birth control and infertility Clear reimbursement path with limited competition Improved patient care and health economics Intellectual prope
Slide 35: Disrupting Convention in Women's Health Through Continuous Innovation
Disrupting Convention in Women’s Health Through Continuous Innovation September 2023 Corporate Presentation Investors: IR@femasys.com Contact: Media: Media@femasys.com 35 03333 R07