Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (October 2022)
41 slides from Femasys's investor presentation, Oct 20, 2022
Slide 1: Disrupting Convention in Women's Health Through Continuous Innovation
Disrupting Convention in Women’s Health Through Continuous Innovation October 2022 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 aiming to meet women’s needs worldwide with a novel suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health. Headquarters: Suwanee, GA Nasdaq: FEMY I
Slide 4: 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 Clea
Slide 5: Key Leadership
Key Leadership Experienced biotechnology and medical device professionals Brian Drumheller VP, Quality 30+ years of experience Michael Meier VP, Sales & Marketing 20+ years of experience Dan Currie SVP, Operations 30+ years of experience Jeremy Sipos VP, Research & Development 20+ years of experienc
Slide 6: Product Candidates
FemaSeed® FemBloc® Product Candidates Localized Directional Insemination Research Preclinical Stage ISafety Stage IIValidation Stage IIIPivotal DeNovo Clinical Study PMA Clinical Study Our Technologies in Development and Approved are Complimentary TREATMENT TREATMENT Permanent Birth Control and Ultr
Slide 7: 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 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: Unique In-Office Platform Technologies: Delivery Directed to Fallopian Tubes
Femasys Unique In-Office Platform Technologies: Delivery Directed to Fallopian Tubes 9 I. Products isolate opening of fallopian tube(s) for precise delivery of materials Selective catheter for sperm Dual catheters for biopolymer Selective catheter for contrast Stage: Investigational for artificial i
Slide 10: Unique In-Office Platform Technologies: Diagnostic Contrast for Ultrasound
Femasys Unique In-Office Platform Technologies:Diagnostic Contrast for Ultrasound 10 II. Products generate natural contrast for ultrasound evaluation of fallopian tubes Assess patency for infertility diagnosis Assess occlusion post FemBloc Stage: Commercially Available Stage: Investigational for con
Slide 11: Unique In-Office Platform Technologies: Tissue Sampling for Cancer Diagnosis
Femasys Unique In-Office Platform Technologies:Tissue Sampling for Cancer Diagnosis 11 III. Products collect and contain comprehensive sample to maximize quality & quantity Endocervical curettage for cervical cancer diagnosis Endometrial biopsy for uterine cancer diagnosis Stage: Commercially Availa
Slide 12: FemaSeed Localized Artificial Insemination
12 FemaSeed® Localized Artificial Insemination Developing the first and only first-line approach designed to deliver sperm directly where conception occurs Designed to be more affordable than assisted reproduction Companion Diagnostics FemVue® and FemCath™ Includes first in-office ultrasound diagnos
Slide 13: Infertility: Unmet Need (U.S. only)
Infertility: Unmet Need (U.S. only) >10M women struggle with infertility ~ 40-50% is due to male factor Despite advancements, there have been no new affordable options in decades. 13 https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm Kumar N, et al. (2015) Trends of male factor infertility,
Slide 14: 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 ✔ ✔ Directed sperm delivery (into fallopian tube where conception occurs) ✔ No ovulation stimulation optional optional No embryo transfer ✔ ✔ Minimal training ✔ ✔ 14 For c
Slide 15: FemaSeed Localized Directional Insemination in Development
FemaSeed Localized Directional Insemination in Development There’s been limited advancements and continuous demand for less costly options First and only approach delivering sperm directly where conception occurs in the fallopian tube 15 Undirected sperm delivery to cavity (IUI) is first-line treatm
Slide 16: FemaSeed de Novo Pivotal Trial
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 New Trial Design to Expedite Clinical Program Advancement FemaSeed de Novo
Slide 17: The Unmet Need in Infertility
The Unmet Need in Infertility 17 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 opportunity to truly change this
Slide 18: Companion Diagnostics: Test Prior to Infertility Treatments
Companion Diagnostics: Test Prior to Infertility Treatments, including FemaSeed Diagnostic performed prior to any infertility procedures Can be combined with uterine cavity evaluation (standard of care) On-line training and support available for new customers Physician locator available on patient w
Slide 19: FemVue: Patient Testimonials
FemVue: Compelling Patient Testimonials 19 Being aware that there are many reasons why women have issues conceiving, FemVue is one easy procedure that can assist in finding out why it may have been difficult. As such, I highly recommend any woman who has tried for months or years to conceive to get
Slide 20: Fertility Enabling Market Opportunity (U.S.)
Fertility Enabling Market Opportunity (U.S.) Near-Term Target Market $800M Total Market Expansion Opportunity $2B Total Includes women choosing IUI and required tubal diagnosis Intrauterine Insemination (IUI) Diagnosis / Drugs Discussion Only IVF (~200k cycles/ year)* >10M Infertile Women Most Expen
Slide 21: FemBloc Permanent Birth Control
FemBloc® Permanent Birth Control 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 21 Contraception Focused Portfolio Companion Diagnostics Fem
Slide 22: 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 23: FemBloc: Expected Competitive Advantages Over Existing Birth Control Options
*6% failure rate for laparoscopic sterilization (tubal ligation) and 5% failure rate for hysteroscopic sterilization (Essure), reported in published study as higher than expected (Fertility and Sterility, 2022) Essure® is a registered trademark of Bayer Healthcare (Conceptus) and, as of December 201
Slide 24: FemBloc Permanent Birth Control in Development
Companion ultrasound procedure exclusive to FemBloc - confirms procedure success Occlusion Confirmation No Permanent Implant – Scar Tissue Closes Tubal Lumen FemBloc Treatment FemBloc Permanent Birth Control in Development The first and only non-surgical, in-office approach Balloon at tubal opening
Slide 25: FemBloc Clinical Study Summaries
Summary: n=183 subjects being followed for 5 years Patients found procedures highly tolerable Physicians found procedure to be extremely simple or very simple 99% physicians assessed easier than tubal ligation surgery Summary: n=93 subjects received planned hysterectomy Subset with histopathology de
Slide 26: FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure
215 28 57 12 2 2 3 18 13 FemBloc Treatment (>90 days) FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (N = 229 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
Slide 27: FemBloc: Most Common Reported AEs
Bleeding/Spotting (59%) Pain/Cramps (55%) Other 40% 13.1% 3.5% 2.6% 34.5% 13.5% 7% 3.9% 1.3% *Visual Analog Scale (VAS) from 0-10 was used, where 10 was the highest measure of pain/discomfort. FemBloc: Most Common Reported AEs (>1%) Were Related to Bleeding/Spotting or Pelvic Pain/Cramping Mean pain
Slide 28: The Unmet Need for Women: Options for Family Planning
The Unmet Need for Women: Options for Family Planning 28 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 29: Permanent Birth Control Market Opportunity (U.S.)
Permanent Birth Control Market Opportunity (U.S.) Near-Term Target Market $2B Annual Market Expansion Opportunity $20B Total Includes women (and partners) choosing permanent birth control annually (~1.3M)1,2 Includes women using non-permanent options but are candidates (>12M)3 Hormones Condoms Tubal
Slide 30: 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 31: FemBloc: Clear Reimbursement Path
In-office procedure FemBloc Treatment Category covered (ACA) Cat III code approved 2 FemBloc: Clear Reimbursement Path 3 reimbursable visits 1+ Days 3 Months In-office/ TeleVisit(required for permanent birth control) Counseling/Eligibility Existing CPT codes 1 In-office test (ultrasound) Cat III cod
Slide 32: FemBloc Has Potential to be a Game-Changer for Women
FemBloc Has Potential to be a Game-Changer for Women 32 Large Market Unmet Need Designed with Patient and Physician in Mind Growing demand with overturn of Roe v. Wade Only surgical tubal ligation available (costly, difficult to access, lower effectiveness rate) In-office, convenient and quick Safe,
Slide 33: Femasys is Prepared for Execution
Femasys is Prepared for Execution 33 Clear Clinical Path to FDA Approval Clear Reimbursement Pathway Commercial Expertise Full manufacture facility with ability to scale and transfer MFG Ready Sales Ready Building commercial infrastructure before salesforce with FDA cleared products for GYNs
Slide 34: FemCerv and FemEMB Diagnostics for Cancer
34 FemCerv® Diagnostic for Cervical Cancer First endocervical biopsy designed for comprehensive tissue sampling with minimal contamination First endometrial biopsy in development with the potential to capture comprehensive tissue sample FemEMB™ Diagnostic for Uterine Cancer Coming Soon
Slide 35: Cervical Cancer: Unmet Need (U.S. only)
Cervical Cancer: Unmet Need (U.S. only) Inadequate cervical cancer screening remains a significant problem with persistent health inequities across the entire spectrum of cervical cancer care. 1 35 1 (https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical
Slide 36: FemCerv: Competitive Advantages Over Existing Options
FemCerv: Competitive Advantages Over Existing Options FemCerv Kevorkian Curette Endocervical Brush Relatively pain-free ✔ Protects sample against cross contamination ✔ Collects a comprehensive, 360o sample ✔ High sample adequacy ✔ ✔ ✔ Ease of use ✔ ✔ ✔ 36 The incidence of stage IV cervical cancer in
Slide 37: FemCerv: Post-Market Clinical Data Supports Product Advantages
Expanded Collection Chamber FemCerv: Post-Market Clinical Data Supports Product Advantages 1 2 Collected sample 37 Study Conclusion Endocervical curettage (tissue sampling) for the routine investigation of patients with abnormal cervical cytology was successfully conducted with the FemCerv Endocervi
Slide 38: U.S. Commercial Strategy: Planning for Commercial Readiness
U.S. Commercial Strategy: Planning for Commercial Readiness 38 Initial Focus on Infertility Specialists + Added Focus on Gynecologists Product Candidates FemaSeed FemBloc FemVue Available FemCath Q4 Launch FemCerv Available FDA Cleared Diagnostic Products Commercial-ready capacity for production; in
Slide 39: Upcoming Anticipated Milestones / Events
Upcoming Anticipated Milestones / Events Near term expected valuation inflection points creating accretive value for investors 39 2024 Q1 Q2 Begin FemBloc pivotal trial enrollment Q1 Q2 2023 FDA IDE for FemBloc pivotal trial to support PMA approval Complete FemaSeed enrollment de novo pivotal trial
Slide 40: 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 Clea
Slide 41: Disrupting Convention in Women's Health Through Continuous Innovation
Disrupting Convention in Women’s Health Through Continuous Innovation October 2022 Corporate Presentation Investors: Chuck Padala IR@femasys.com Contact: Media: Karissa Cross Media@femasys.com 41 03333 R0