Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (August 2024)
27 slides from Femasys's investor presentation, Aug 30, 2024
Slide 1: Disrupting Convention in Women's Reproductive Health Through Continuous Innovation
Investor presentation August 2024 NASDAQ: FEMY Disrupting Convention in Women’s Reproductive Health Through Continuous Innovation
Slide 2: 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 regarding the future of our bus
Slide 3: Femasys Overview: Empowering Women & Enabling Choice
Femasys Overview NASDAQ: FEMY 3 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
Slide 4: Investment Highlights
Investment Highlights NASDAQ: FEMY 4 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 comp
Slide 5: Key Leadership
Key Leadership Kathy Lee-Sepsick President, CEO, Founder 30+ years of experience Terumo Medical, Novoste, Salumedica Dov Elefant Chief Financial Officer 30+ years of experience Cellectar Biosciences, Akari Therapeutics, Lev Pharmaceuticals, EpiCept James Liu, MD Chief Medical Officer 40+ years of ex
Slide 6: Commercially Available Products
Commercially Available Products Treatment Intratubal Insemination Diagnostic Contrast-Generating Device Diagnostic Selective Delivery Catheter Diagnostic Endocervical Tissue Sampler Office-based, minimally invasive solutions utilizing shared delivery platforms Product Candidate Research Preclinical
Slide 7: Infertility-Focused Portfolio
Infertility-Focused Portfolio Intratubal Artificial Insemination FDA-cleared, innovative first-line infertility treatment for directed sperm delivery Positive topline results announced NASDAQ: FEMY 7 Tubal Diagnosis with Ultrasound FDA-cleared, first in-office ultrasound evaluation of fallopian tube
Slide 8: No Affordable Infertility Options Introduced in Decades
NASDAQ: FEMY 8 No Affordable infertility Options Introduced in Decades Key Trends: 43 U.S. states have recorded lowest fertility rate in last three decades4 9.14 million women have received infertility services at some time in their lives5 NOTES: 1. 2. 3. 4. https://www.cdc.gov/nchs/nsfg/key_statist
Slide 9: Patient Journey (U.S.)
4.3M seek evaluation only DISCUSSION DIAGNOSIS DRUGS IUI IVF ~200k cycles/ year ~1M cycles/ year Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. US Dept of Health and Human Services; 2021. NASDAQ: FEMY 9 Patient Journey
Slide 10: Infertility Portfolio: from Diagnosis to Treatment (FemVue)
Natural contrast flows in tube Allows for selective evaluation when needed Video will open in browser window. Intended Population: Baseline diagnostic test for infertility and prior to insemination (Note: blocked tubes are a silent factor affecting 1 in 3 infertile women) NASDAQ: FEMY 10 Safe Cost-E
Slide 11: Infertility Portfolio: from Diagnosis to Treatment (FemaSeed)
Delivers sperm to site of conception NO CATHETERIZATION Video will open in browser window. Intended Population: Infertile women/ couples Patients desiring insemination, including same sex couples & single women NASDAQ: FEMY 11 Requires at least one open fallopian tube (FemVue can confirm first) Safe
Slide 12: FemaSeed Overcomes the Last Barrier to Natural Fertilization
Vagina Cervix Uterus FemaSeed IUI Fallopian Tube NASDAQ: FEMY 12 *Femasys proprietary market research (100 reproductive endocrinologists). Advantages from Market Research 92% of Survey Respondents had Favorable Impression of FemaSeed* ” It’s angle toward the opening (ostia) is the most critical find
Slide 13: FemaSeed Offers Significant Competitive Advantages
FemaSeed Offers Significant Competitive Advantages NASDAQ: FEMY 13 Assisted Reproductive Approaches Artificial Insemination IVF ICSI IUI No surgery No egg retrieval or storage No required injections Delivery to fallopian tubes (site of conception) NA NA Cost-effective Minimal safety risks Low male s
Slide 14: FemaSeed Top Line Data from Pivotal Trial
FemaSeed Top Line Data from Pivotal Trial Demonstrates Significant Progress in Fertility Treatment NASDAQ: FEMY 14 Trial Results ⎼ 24% pregnancy rate for male factor infertility following FemaSeed ⎼ More than double pregnancy rate when compared to historic intrauterine insemination (IUI) for similar
Slide 15: Commercialization Strategy in U.S.
Commercialization Strategy in U.S. Initial Focus Expanded Focus ~40,000 Gynecologists ~1,700 Infertility Specialists Limited Market Release Focused regions and targeted audience Focused sales and marketing efforts Monitoring, evaluation and iterative improvement NASDAQ: FEMY 15 Expanded Market Relea
Slide 16: FemaSeed Priced to Support First-Line Treatment Option
NASDAQ: FEMY 16 FemaSeed Priced to Support First-Line Treatment Option Infertile Women/ Couples Seeking Treatment IUI Intrauterine Insemination Intratubal Insemination $500-$4,0001 total per cycle including ultrasound monitoring, and optional ovulation drugs2 + device per cycle above IUI cost If ins
Slide 17: FemaSeed has Significant Potential Revenue Opportunity
FemaSeed has Significant Potential Revenue Opportunity Immediate addressable market Immediate expansion Future expansion ~ 1 million* IUI cycles/ yr ~$1 B market opportunity 4.8 million women seek evaluation & treatment 4.3 million women seek evaluation only Expansion opportunity *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 18
Slide 19: Lack of Innovation in Last Century for Permanent Birth Control
Lack of Innovation in Last Century for Permanent Birth Control >13M Women in the U.S. no longer intend to have children 800,000 women choose surgical tubal ligation as a form of permanent birth control every year* >12M use non-permanent birth control long-term $2B NASDAQ: FEMY 19 annual market oppor
Slide 20: FemBloc Permanent Birth Control & Confirmation Test
FemBloc Permanent Birth Control & Confirmation Test Biopolymer designed to expel within 3 months Balloon positioned at tubal opening Biopolymer solidifies Biopolymer degrades leaving tissue in-growth to block tubes Video will open in browser window. Video will open in browser window. Ultrasound-Base
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: Primary: pregnancy
Slide 22: FemBloc Safety Profile
FemBloc Safety Profile (N = 228 subjects from Stage I & II; 5-year follow-up on-going) 215 28 57 12 18 0 50 100 150 200 250 Day of Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 FemBloc Treatment Day 8-90 Day of Confirmation Number of AEs Reported 8% 16% 3% 5% 4% 5 0.5% 0.5% 0.8% Timing of AEs No SAEs 91% AEs
Slide 23: FemBloc Improves Health Economics
FemBloc Improves Health Economics 0 1000 2000 3000 4000 5000 6000 Cost Breakdown Compared to Alternative $6,000* Amount in $ Pre-Op Facility Anesthesia Post-Op Cost of FemBloc System Anesthe Physician / Practice FemBloc estimate < ½ cost of surgery Physician Surgical Tubal Ligation FemBloc NO COST T
Slide 24: FemBloc Offers Significant Competitive Advantages
FemBloc Offers Significant Competitive Advantages Permanent Birth Control Temporary Surgical Sterilization (94% effective*) Essure® No longer marketed (95% effective*) IUD Permanent Office procedure Some No special capital equipment No anesthesia No implant (coil/clip) No surgery (risks/cost) No hor
Slide 25: Milestones
Milestones Q1 Top line data for FemaSeed pivotal clinical trial (LOCAL) Inflection points that create value for investors NASDAQ: FEMY 25 Initial commercial team on-boarded Limited market release of infertility product portfolio in North America Achieve CE mark for infertility product portfolio Expa
Slide 26: Investment Highlights
Investment Highlights NASDAQ: FEMY 26 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 com
Slide 27: Contact Details
Contact Details Investor Relations: IR@femasys.com Media Inquiries: PR@femasys.com