Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (April 2024)
29 slides from Femasys's investor presentation, April 2024
Slide 1: Disrupting Convention in Women's Reproductive Health Through Continuous Innovation
Disrupting Convention in Women’s Reproductive Health Through Continuous Innovation Investor presentation April 2024 NASDAQ: FEMY
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 Overview
Femasys Overview Empowering Women & Enabling Choice Femasys is committed to providing women with revolutionary products as they seek solutions throughout their reproductive journey. Technological advancements in female reproductive health are long overdue, driving our focus to develop in-office, acc
Slide 4: Investment Highlights
Investment Highlights Mission • Develop disruptive broad portfolio of products for women’s health • Address multi-billion-dollar global market opportunities ⎼ Infertility therapeutic and diagnostic NASDAQ: FEMY ⎼ Permanent birth control (IPO June 2021) • Improve patient care and health economics Sto
Slide 5: Key Leadership
Key Leadership Kathy Lee-Sepsick Dov Elefant James Liu, MD Richard Spector Dan Currie Christine Thomas President, CEO, Founder Chief Financial Officer Chief Medical Officer Chief Commercial Officer Chief Operating Officer SVP, Regulatory & Clinical 30+ years of experience 30+ years of experience 40+
Slide 6: Solutions for Women Through the Continuum of Care
Solutions for Women Through the Continuum of Care Office-based, minimally invasive solutions utilizing shared delivery platforms Commercially Available Products Treatment Intratubal Insemination Diagnostic Contrast-Generating Device Diagnostic Selective Delivery Catheter Diagnostic Endocervical Tiss
Slide 7: Infertility-Focused Portfolio
Infertility-Focused Portfolio Intratubal Artificial Insemination Tubal Diagnosis with Ultrasound • FDA-cleared, innovative first-line infertility • FDA-cleared, first in-office ultrasound treatment for directed sperm delivery evaluation of fallopian tubes • Positive topline results announced NASDAQ:
Slide 8: No Affordable Infertility Options Introduced in Decades
No Affordable Infertility Options Introduced in Decades >10M women in the U.S. struggle with infertility1 Key Trends: • 43 U.S. states have recorded lowest fertility rate in last three decades 4 • 9.14 million women have received infertility services at some time in their lives5 ~50% due to male fac
Slide 9: FemaSeed and FemVue Provide Next Generation Options
FemaSeed and FemVue Provide Next Generation Options Patient Journey (U.S.) 4.3M 1M 200k seek evaluation only cycles/ year cycles/ year DISCUSSION DIAGNOSIS DRUGS IUI IVF Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. U
Slide 10: Infertility Portfolio: from Diagnosis to Treatment
Infertility Portfolio: from Diagnosis to Treatment Intended Population: Safe • Cost-Effective • Time Saving • Baseline diagnostic test for infertility and prior to insemination (Note: blocked tubes are a silent factor affecting 1 in 3 infertile women) Allows for selective evaluation when needed Natu
Slide 11: Infertility Portfolio: from Diagnosis to Treatment
Infertility Portfolio: from Diagnosis to Treatment Safe • Cost-Effective • Enhance Fertilization Intended Population: • Infertile women/ couples • Patients desiring insemination, including same sex couples & single women Delivers sperm to site of conception NO CATHETERIZATION Requires at least one o
Slide 12: FemaSeed Overcomes the Last Barrier to Natural Fertilization
FemaSeed Overcomes the Last Barrier to Natural Fertilization Fallopian Tube Advantages from Market Research FemaSeed 92% of Survey Respondents had Favorable Impression of FemaSeed* “ It’s angle toward the opening (ostia) is the most ” critical finding that I am impressed with that allows IUI sperm t
Slide 13: FemaSeed Offers Significant Competitive Advantages
FemaSeed Offers Significant Competitive Advantages Assisted Reproductive Approaches Artificial Insemination IVF ICSI IUI No surgery No egg retrieval or storage No required injections Delivery to fallopian tubes NA NA (site of conception) Cost-effective Minimal safety risks Low male sperm count effic
Slide 14: FemaSeed Top Line Data from Pivotal Trial Demonstrates Significant Progress
FemaSeed Top Line Data from Pivotal Trial Demonstrates Significant Progress in Fertility Treatment Trial Design (NCT 04966847) • Prospective, unblinded pivotal trial evaluating the safety and efficacy of FemaSeed • Primary endpoint: pregnancy rate • Safety: 7-week follow-up period post FemaSeed Tria
Slide 15: Commercialization Strategy in U.S.
Commercialization Strategy in U.S. Initial Focus Expanded Focus ~1,700 Infertility Specialists ~40,000 Gynecologists Limited Market Release Expanded Market Release • Focused regions and targeted audience • Wider distribution and geographical expansion • Focused sales and marketing efforts • Targeted
Slide 16: FemaSeed Priced to Support First-Line Treatment Option
FemaSeed Priced to Support First-Line Treatment Option Infertile W omen / Couples Seeking Treatment Subset of Infertile Population (After 1-3 IUI cycles or as indicated) IUI IVF/ICSI In vitro fertilization / Intrauterine Insemination Intratubal Insemination intracytoplasmic sperm injection Average $
Slide 17: FemaSeed has Significant Potential Revenue Opportunity
FemaSeed has Significant Potential Revenue Opportunity Immediate addressable market > 1 million* ~$1 B IUI cycles/ yr market opportunity 4.8 million Immediate expansion women seek evaluation & treatment Expansion opportunity 4.3 million Future expansion women seek evaluation only *Centers for Diseas
Slide 18: In-Office Sterilization
In-Office Sterilization • First and only non-surgical, in-office, permanent birth control option • In late-stage clinical development with on-going pivotal trial • Potential to be the safest and most natural approach at substantially less cost than the long-standing surgical alternative NASDAQ: FEMY
Slide 19: Lack of Innovation in Last Century for Permanent Birth Control
Lack of Innovation in Last Century for Permanent Birth Control Women in the U.S. no >13M longer intend to have children $2B annual market opportunity $20B total market expansion 800,000 >12M use non-permanent birth control long-term women choose surgical tubal ligation as a form of permanent birth c
Slide 20: FemBloc Permanent Birth Control & Confirmation Test
FemBloc Permanent Birth Control & Confirmation Test Safe • Convenient In - Office • Lower Cost Biopolymer degrades leaving tissue in-growth Biopolymer to block tubes solidifies Video will open in browser window. Ultrasound-Based Confirmation Test Biopolymer designed to Balloon positioned (to ensure
Slide 21: FemBloc Clinical Studies for Pre-Market Approval (PMA)
FemBloc Clinical Studies for Pre-Market Approval (PMA) Stage III: FINALE Pivotal Clinical Trial Trial Design (IDE approved June 2023; currently enrolling) • Prospective, multi-center, open-label, single-arm study ⎼ Roll-in study design (50 subjects in part A for safety) ⎼ Endpoints: o Primary: pregn
Slide 22: FemBloc Safety Profile
FemBloc Safety Profile (N = 228 subjects from Stage I & II; 5-year follow-up on-going) 250 No SAEs 91% AEs related to device/procedure Other Key Findings: 200 occurred within 7 days of procedure • Investigator Rating: ⎼ 96% extremely or very satisfied with FemBloc Number of AEs Reported 150 • Most c
Slide 23: FemBloc Improves Health Economics
FemBloc Improves Health Economics Cost Breakdown Compared to Alternative $6,000* 6000 FemBloc Efficiencies 5000 Facility • In-office procedure expands FemBloc estimate Anesthesia < ½ cost of surgery practice services 4000 • Can perform multiple procedures Pre-Op Amount in $ Anesthe in same room 3000
Slide 24: FemBloc Offers Significant Competitive Advantages
FemBloc Offers Significant Competitive Advantages Permanent Birth Control Temporary Surgical Essure® Sterilization No longer marketed IUD (94% effective*) (95% effective*) Permanent Office procedure Some No special capital equipment No anesthesia No implant (coil/clip) No surgery (risks/cost) No hor
Slide 25: Milestones
Milestones Inflection points that create value for investors ACHIEVED Initial commercial team on-boarded Expand market Top line data for Achieve CE mark release of infertility FemaSeed for infertility product portfolio to Limited market product portfolio pivotal clinical additional regions in releas
Slide 26: Investment Highlights
Investment Highlights Mission • Develop disruptive broad portfolio of products for women’s health • Address multi-billion-dollar global market opportunities ⎼ Infertility therapeutic and diagnostic ⎼ Permanent birth control • Improve patient care and health economics Differentiator • Minimal competi
Slide 27: Contact Details
Contact Details Investor Relations: Media Inquiries: IR@femasys.com PR@femasys.com
Slide 28: APPENDIX
APPENDIX NASDAQ: FEMY 28
Slide 29: Strategic Commercial Priorities
Strategic Commercial Priorities Market Positioning Focused Consumer & Differentiation Outreach • Market Research & Analysis • Identify Targets and Segmentation • Product Positioning & Messaging • Tailored Messaging • Performance Measurement & Optimization • Multi-channel Communication • Omni-Channel