Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (July 2021)
27 slides from Femasys's investor presentation, Jul 13, 2021
Slide 1: Transforming Women's Healthcare Corporate Presentation July 2021
Transforming Women’s Healthcare ©2021 Femasys Inc. Corporate PresentationJuly 2021
Slide 2: Forward Looking Statements
Forward Looking Statements 2 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 re
Slide 3: Highlights
Clear Reimbursement Path with Improved Patient Care & Health EconomicsWoman Founded and Led, Experienced Leadership Team with Concentrated Development ExpertiseIn-House CMC & Device Infrastructure & 100+ Patents Filed GloballySupported by Leading Strategic (Medtronic) & Institutional Investors Highl
Slide 4: Key Leadership
Key LeadershipExperienced biotechnology and medical device developers Kathy Lee-SepsickPresident, CEO, Founder 25+ years of experience Todd CreechChief Financial Advisor 20+ years of experience Jeffery Marcus, MDChief Medical Advisor 25+ years of experience Dan CurrieSr. VP, Operations 30+ years of
Slide 5: Addressable Market Opportunities in Reproductive Health (U.S.)
Addressable Market Opportunities in Reproductive Health (U.S.) Temporary Contraception End Risk of PregnancyFemBloc®Permanent Birth ControlPotential to be safest and most natural approach at half the cost >13M Women$20B+ Market Potential Fertility FemaSeed™Localized Directional InseminationFirst and
Slide 6: Proprietary Delivery Platform
Proprietary Delivery Platform
Slide 7: Simple Office Procedures for local directional delivery
Simple Office Proceduresfor local directional delivery of materials to fallopian tubes Dual Delivery Single Delivery Common minimally invasive technique(i.e., intrauterine catheters, IUD) Delivery Type / Product NO ANESTHESIA AND NO INCISIONSNO SPECIAL SKILL SET AND NO CAPITAL EQUIPMENTNO CANNULATIO
Slide 8: Ultrasound Based Diagnostic Products
Deliver saline-air contrastfor tubal evaluation Patency Screening Type / Product NO RADIATION NO X-RAY DYENO REFERRAL TO RADIOLOGY CENTER FemVue FemChec 8 Occlusion Ultrasound Based Diagnostic Productsfor use with therapeutic solutions Balloon catheter insertedcommon technique
Slide 9: Strong IP Portfolio
Strong IP Portfolio>100 patents filed globally Directional Delivery (dual or single) to Fallopian Tubes FemBloc, FemaSeed, Drug Delivery Utility & Design Encompassing Biopolymer Composition for Tubal Occlusion FemBloc Contrast Generating Ultrasound Visible FemVue / FemChec Tissue Sampling for cancer
Slide 10: Permanent Birth Control (Product Candidate) FemBloc
Permanent Birth Control(Product Candidate) FemBloc 10
Slide 11: FemBloc Permanent Birth Control
Ultrasound procedure with FemChec Confirmation No Permanent Implant – Scar Tissue Closes Tubal Lumen Balloon at tubal opening without cannulation Biopolymer expels within 3 months Biopolymer can expel with menstruation 11 Treatment FemBloc Permanent Birth ControlFirst and only non-surgical approach
Slide 12: FemBloc Potential Competitive Advantage
FemBloc Surgical Tubal Ligation IUD(Reversible) Essure® Permanent ✔ ✔ ✔ Office Procedure ✔ ✔ Some No Special Capital Equipment ✔ ✔ No Anesthesia ✔ ✔ No Coil Implant/ Clip ✔ No Hormones ✔ ✔ ✔ One-Time Cost ✔ ✔ Multiple IUDs ✔ Worldwide Applicability ✔ Some ✔ On-Market Solutions 12 Off-Market Essure®
Slide 13: Market Opportunity (U.S.)
Tubal Ligation Surgery Hormones Condoms Least Invasive/ Least Reliable *Includes partners that choose vasectomy Most Invasive/ Most Reliable 13 Market Opportunity (U.S.) 72 M Reproductive Aged Women Near-Term Target Market$2B AnnualIncludes women (and partners) choosing permanent birth control annua
Slide 14: Clear Reimbursement Path
In-office visit(required for permanent birth control) In-office procedure In-office ultrasound procedure Counseling/Eligibility FemChec Confirmation Existing CPT codes Category covered (ACA)Cat III code approved FemBloc Treatment 1 2 3 Cat III code approved 14 Clear Reimbursement Path3 reimbursable
Slide 15: Improved Health Economics
Confidential © 2021 | 15 Improved Health Economics PhysicianSurgical Tubal Ligation FemBloc* Planned Parenthood 2019, https://www.plannedparenthood.org/learn/birth-control; Doximity 2019; U.S. Bureau of Labor Statistics, 2019. Facility Anesthesia Pre-Op Post-Op Est < ½ cost of Tubal Ligation Cost of
Slide 16: PMA Clinical Studies
Confidential © 2021 | 16 n=183 subjects being followed for 5 yearsPatients found procedures highly tolerable96% physicians assessed procedure to be extremely/ very simple99% physicians assessed easier than tubal ligation surgery Stage IIIPivotal(pending)Safety & Effectiveness of FemBloc Summary: Goa
Slide 17: Adverse Events by Day of Treatment
Confidential © 2021 | 17 No SAEs 94% AEs related to device/ procedure occurred within 7 days of procedure 75% AEs mild 123 16 48 2 37 8 5 2 1 4 1 7 5 5 3 6Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8-90 0 20 40 60 80 120100 140 160 180 Day of FemBloc Treatment Day 1 Number of AEs Reported Mild Moderate
Slide 18: Most Common AEs Reported
Confidential © 2021 | 18 Most Common AEs Reported (>1%) 2752502252001751501251007550250 Vaginal Bleeding Spotting Post Procedure Bleeding Uterine Bleeding Pelvic Pain Uterine Cramps Cramps/ Abdominal Abdominal Bloating Nausea Number of AEs Reported Mean pain/ discomfort score* as reported by patient
Slide 19: Transforming Women's Health with Novel Solutions
Transforming Women’s Health with Novel SolutionsFirst and only non-surgical, in-office permanent birth control option Contraception Product Portfolio Indication Research Pre- PMA Clinical Studies USApproval CEMark Anticipated Milestones Clinical Stage I Safety Stage II Validation Stage III Pivotal F
Slide 20: Localized Directional Insemination (Product Candidate) FemaSeed
Localized Directional Insemination(Product Candidate) FemaSeed 20
Slide 21: Potential Competitive Advantage
Potential Competitive Advantage 1st line treatment despite low success rates Undirected sperm delivery to cavity Opportunity for First Line AlternativeLimited advancements - continuous demand for less costly options First and only approach delivering sperm where conception occursIUI oldest technique
Slide 22: FemaSeed Clinical to Market
FDA clearance for single intrauterine directional delivery device for different indication Post-market study (n=15 subjects) with 93% contrast delivery into fallopian tube FemBloc stage I safety data supports localized directional delivery Commercial 1,300 reproductive endocrinologists at 450 practi
Slide 23: FemVue Saline-Air Device
FemVue Saline-Air DeviceFirst Ultrasound Approach for In-Office Fallopian Tube Evaluation Diagnostic prior to infertility treatments(e.g. FemaSeed)Can be combined with saline evaluation of uterine cavity (standard of care)On-line training and new customer supportPhysician locator available on patien
Slide 24: Market Opportunity (U.S.)
*Includes partners that choose vasectomy Most Expensive Market Opportunity (U.S.) >9M Infertile Women Near-Term Target Market$800M TotalIncludes women choosing IUI and required tubal diagnosis Market Expansion Opportunity$2B TotalIncludes women currently seeking evaluation and treatment IVF(~200k/ y
Slide 25: First-Line Approaches for Women to Seek Care
First-Line Approaches for Women to Seek CareIn-office products for the treatment of infertility Fertility Product Portfolio Indication Research Pre- Clinical De novo Clinical Study USApproval CEMark Anticipated Milestones FemaSeed™ Localized Directional Insemination IDE approval received from FDA in
Slide 26: Upcoming Anticipated Milestones
2021 Q3 Q4 1H 2H Commencement of de novo clinical trial for FemaSeed Complete enrollment for FemBloc stage II study Interim analysis FemaSeedSubmission of IDE for FemBloc stage III PMA trial Complete enrollment for FemaSeed de novo trialCommencement of PMA trial for FemBloc Upcoming Anticipated Mile
Slide 27: Transforming Women's Healthcare Corporate Presentation
Transforming Women’s Healthcare Corporate PresentationJuly 2021 Contact:IR@femasys.com Media@femasys.com