Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (July 2022)
40 slides from Femasys's investor presentation, Jul 28, 2022
Slide 1: FemBloc, a First-of-its-Kind Medical Solution for Permanent Birth Control
FemBloc®, a First-of-its-Kind Medical Solution for Permanent Birth Control and an Important Option for Women Post Overturn of Roe v. Wade July 28, 2022 at 10:30 am EDT KOL Event Presentation FemBloc Permanent Birth Control is a product candidate for Femasys Inc.
Slide 2: Agenda
Agenda Kathy Lee-Sepsick, Founder, President Paul Blumenthal, MD, MPH, Director, & Chief Executive Officer, Femasys Inc. Stanford Program for International Reproductive Education and Services • Welcome and Introductions (SPIRES) • Femasys’ Development Programs • Unmet Need for Family Planning Option
Slide 3: Key Opinion Leader: Paul Blumenthal, MD, MPH
Key Opinion Leader: Paul Blumenthal, MD, MPH Distinguished career in Obstetrics & Gynecology spanning close to 40 years • Professor Emeritus and Director of the Stanford Program for International Reproductive Education and Services (SPIRES) at Stanford University’s School of Medicine • Founded and d
Slide 4: 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 5: Femasys: At-a-Glance
Femasys: At-a-Glance Who We Are Financial Information Femasys is a biomedical Nasdaq: FEMY company aiming to meet women’s needs worldwide IPO date: June 2021 with a novel suite of products and product Market Cap: $28.5 candidates that include minimally invasive, in- M office technologies for (as of
Slide 6: Our Product Pipeline
Our Product Pipeline Research Preclinical PMA Clinical Studies Contraceptio FemBloc ® Stage I Safety Stage II Validation Stage III Pivotal Permanent Birth Control n Product and Ultrasound Candidate Occlusion Confirmation THERAPEUTIC Research Preclinical De Novo Clinical Study FemaSeed® Localized Art
Slide 7: Strong Global IP Portfolio
Strong Global IP Portfolio Our Patent Estate Encompasses Utility and Design Directional Delivery (dual or Biopolymer Contrast GeneratingTissue Sampling for single) Composition for Tubal Ultrasound Visible Cancer Detection to Fallopian Tubes Occlusion FemBloc, FemBl FemVue FemCerv FemaSeed, oc Occlus
Slide 8: Our Technologies Provide a Continuum of Care
Our Technologies Provide a Continuum of Care • In-office, minimally invasive solutions • Shared delivery platforms leverage existing skill sets 8
Slide 9: Our Novel Biomedical Procedures in Development: Simple and In-Office
Our Novel Biomedical Procedures in Development: Simple and In-Office Specified, precise delivery to fallopian tubes (i.e., biomedical material, sperm or therapeutic agents) Dual Placement Common minimally invasive technique (i.e., intrauterine catheters, IUD) • No anesthesia and no incisions • No sp
Slide 10: Our Companion Ultrasound-Based Diagnostics: Simple and In-Office
Our Companion Ultrasound-Based Diagnostics: Simple and In-Office Contrast generation for screening and occlusion confirmation for use with our novel biomedical procedures Real-time imaging result Balloon catheter Deliver saline-air Occlusion inserted contrast common technique for tubal evaluation •
Slide 11: FemBloc
FemBloc® Permanent Birth Control + Ultrasound Occlusion Confirmation • First and only non-surgical, in-office, permanent birth control option in development with the potential to be the safest and most natural approach at half the cost of the long-standing surgical alternative • First in-office ultr
Slide 12: Permanent Birth Control Alternatives: Unmet Need (U.S. only)
Permanent Birth Control Alternatives: Unmet Need (U.S. only) >13M women no longer intend to have children 800,000 women choose More than 100 years of surgical tubal ligation as a stagnant innovation for form of permanent birth control every year permanent birth control Since surgical tubal ligation
Slide 13: FemBloc: Expected Competitive Advantages Over Existing Birth Control Options
FemBloc: Expected Competitive Advantages Over Existing or Previous Birth Control Options Off- On-Market Solutions Market Surgical IUD FemBloc Tubal Essure®* (Reversible) Ligation* Permanent ✔ ✔ ✔ Office Procedure ✔ ✔ Some No Special Capital ✔ ✔ Equipment No Anesthesia ✔ ✔ No Coil Implant/ Clip ✔ No
Slide 14: FemBloc Permanent Birth Control in Development
FemBloc Permanent Birth Control in Development The first and only non-surgical, in-office approach FemBloc Treatment Occlusion Confirmation No Permanent Implant – Companion ultrasound procedure Scar Tissue Closes Tubal exclusive to FemBloc - confirms Lumen procedure success Biopolymer Biopolymer sol
Slide 15: FemBloc Clinical Studies for Pre-Market Approval (PMA)
FemBloc Clinical Studies for Pre-Market Approval (PMA) Early Clinical Stage I: Safety Stage II: Validation Stage III: Pivotal (on-going) (pending) Evaluated Delivery & Selection of Confirmation Safety & Effectiveness ✔ Biopolymer Effectiveness ✔ No Serious AEs Reported Test for Pivotal of FemBloc Su
Slide 16: FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure
FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (n = 183 subjects) 94% AEs related to device/ 180 16 No 75% AEs mild procedure occurred within 7 days of 5 SAEs 160 5 procedure 140 37 Number of AEs Reported 120 100 Mild Moderate Severe 80 5 60 123 3 5 40 2 7 3 1 48 20 8 8 2 3 5 2 1
Slide 17: FemBloc: Most Common Reported AEs Were Bleeding/Spotting or Pelvic Pain
FemBloc: Most Common Reported AEs (>1%) Were Related to Bleeding/Spotting or Pelvic Pain/Cramping Mean pain/ discomfort score* out of 10 as reported by patient: 4.3 for FemBloc treatment and 3.0 for confirmation 150 125 Bleeding/Spotting Pain/Cramps Other (41.5%) (38%) Number of AEs Reported 100 75
Slide 18: Permanent Birth Control Market Opportunity (U.S.)
Permanent Birth Control Market Opportunity (U.S.) 72 M Reproductive Aged Women Most Invasive/ Most Least Invasive / Least Reliable Reliable Tubal Ligation Hormones Condoms Surgery Near-Term Target Market Expansion Opportunity Market $20 B Total $2B Annual Includes women (and partners) Includes women
Slide 19: FemBloc: Improved Health Economics
FemBloc: Improved Health Economics Permanent One-Time Cost FemBloc Efficiencies Breakdown $6,000* 6000 • In-office procedure expands practice services 5000 Facility • Can perform multiple Anesthesia procedures in same room 4000 • Quick to perform; ease of Pre-Op Amount in $ Est < ½ cost of Anesthesi
Slide 20: FemBloc: Clear Reimbursement Path
FemBloc: Clear Reimbursement Path 3 reimbursable visits 1 2 3 FemBloc Counseling/Eligibility FemBloc Treatment Confirmation 1+ Days 3 Months In-office/ TeleVisit In-office test (required for permanent birth In-office procedure (ultrasound) control) Category covered (ACA) Existing CPT codes Cat III c
Slide 21: Investment Highlights
Investment Highlights • Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in Development • Addressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved Approaches
Slide 22: Family Planning Post Roe v. Wade Overturn
Family Planning Post Roe v. Wade Overturn Paul Blumenthal, MD, MPH Professor Emeritus and Director of the Stanford Program for International Reproductive Education and Services (SPIRES) at Stanford University’s School of Medicine
Slide 23: Historical Context
Historical Context Sterilization is a permanent method of contraception, and is the most commonly used method in the U.S. and worldwide. Rates have declined over past decade. May be due to waiting period for women on Medicaid and availability of clinicians to provide. Largest decrease is users
Slide 24: 800,000 Women Choosing Permanent
800,000 Women Choosing Permanent – others using temporary method 12M Not interested in children 4M (35%) 3M (25%) 2M (18%) 1M (8%) 2M Pill Condom Other (14.5%) LARCs Hormone Other Source: Methods “Table 4: Number of women aged 15-44 currently using a method of contraception during month of interview
Slide 25: Women are Requesting Sterilization
Women are Requesting Sterilization The demand for sterilization is increasing and we don’t see this reversing in the foreseeable future More women are searching online for physicians who perform the procedure Patient autonomy is important as long as there is not significant risk of harm. Urg
Slide 26: 50% of Women Request Sterilization Post-Partum are Denied
50% of Women Request Sterilization Post-Partum are Denied Reasons for denial are typically logistical or bureaucratic in nature Hospitals and especially L&D are not in the contraception business, they are in the baby business Sterilization procedures low priority Operating rooms are expensiv
Slide 27: The Only Permanent Birth Control Option Is Not as Effective as Once Thought
The Only “Permanent Birth Control” Option that Currently Exists is Not as Effective as Once Thought Fertility and Sterility, March 2022 Laparoscopic Sterilization (surgical tubal sterilization): n=23,965; Pregnancy rate: 5.57% Hysteroscopic Sterilization (Essure - not on the market): n=5,906; Pregna
Slide 28: Unintended Pregnancy
Unintended Pregnancy Unacceptably high overall rate of approximately 50% in U.S. for past 20 years Need to increase access to reliable contraceptive methods Long-acting reversible contraception (LARC) - such as IUDs and single-rod implants - has been slowed by the difficulties hospitals and gy
Slide 29: Where Do We Go From Here?
Where Do We Go From Here? There’s no question that abortion is a controversial, sensitive, and, most importantly, a personal issue. However, the Supreme Court decision on June 24th OF sent us backwards in time. Women’s options need to be both preserved and expanded. Our patients' voices need to be h
Slide 30: The Unmet Need for Women: Options for Family Planning
The Unmet Need for Women: Options for Family Planning 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 options f
Slide 31: Non-Surgical and Transcervical: A Longstanding Goal
Non-Surgical and Transcervical: A Longstanding Goal A win-win for physicians and their patients Gynecologists can perform: Game changer for practices • Part of their skillset (like an IUD placement) and their patients: • Can teach the procedure in residency • Convenient in-office • No cost to patien
Slide 32: FemBloc would make Permanent Contraception Much More Accessible
FemBloc would make Permanent Contraception Much More Accessible Non-surgical will allow the demand to be met versus the cost and accessibility of surgical Global impact (Affordable Care Act, etc.) Historical reimbursement level expected providing incentive for in-office Avoidance of the hosp
Slide 33: FemBloc: Clear Office Logistics
FemBloc: Clear Office Logistics Source: https://www.femasys.com 33
Slide 34: Femasys' Role in a Post-Roe v. Wade World
Femasys’ Role in a Post-Roe v. Wade World Providing potential options for women in areas with limited choices Demand for permanent birth control option will likely continue to increase Femasys’ FemBloc could provide women with an ideal choice; I am not aware of anyone else working in this area
Slide 35: Thank you
Thank you Dr. Paul Blumenthal Stanford University 35
Slide 36: Closing Remarks
Closing Remarks 36
Slide 37: Femasys FemBloc Has Potential to be a Game-Changer for Women
Femasys FemBloc Has Potential to be a Game-Changer for Women Large Market • Growing demand with overturn of Roe v. Wade Unmet Need • Only surgical tubal ligation available (costly, difficult to access, lower effectiveness rate) Designed with Patient and Physician in Mind For the Patient For the Phys
Slide 38: Femasys is Prepared for Execution
Femasys is Prepared for Execution Clear Clear Commercial Clinical Reimbursemen Expertise Path to FDA t Pathway MFG Ready Approval Full manufacture facility with ability to scale and transfer Sales Ready Building commercial infrastructure before salesforce with FDA cleared products for GYNs 38
Slide 39: Q&A
Q&A 39
Slide 40: July 28, 2022 KOL Event Presentation
FemBloc®, a First-of-its-Kind Medical Solution for Permanent Birth Control and an Important Option for Women Post Overturn of Roe v. Wade July 28, 2022 KOL Event Presentation Contact: Investors: Chuck Padala Media: Karissa Cross IR@femasys.com Media@femasys.com 40