Femasys Inc. · NASDAQ:FEMY
Femasys — Investor Presentation (January 2022)
36 slides from Femasys's investor presentation, Jan 5, 2022
Slide 1: Disrupting Convention in Women's Health Through Continuous Innovation
Disrupting Convention in Women’s Health Through Continuous Innovation January 2022 Corporate Presentation
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: FEMYIPO
Slide 4: Investment Highlights
Investment Highlights Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in DevelopmentAddressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved ApproachesClear
Slide 5: Our Product Pipeline
Our Product Pipeline Add anticipated milestones? - per Dory: Kathy will discuss stage and we can hold this until later in the presentation Infertility Products and Product Candidates Contraception Product Candidate Biopsy Product Research Preclinical De Novo Clinical Study Approval PMA Clinical Stud
Slide 6: Broadly Applicable Proprietary Platform Technologies
Broadly Applicable Proprietary Platform Technologies Our portfolio of products and product candidates address various underserved areas of the reproductive and gynecological market providing solutions for OB/GYNS
Slide 7: 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) No anesthesia and no incisionsNo special skillset and no capital equipmentNo cannulation of tubePatents issued and pending Comm
Slide 8: Our Companion Ultrasound-Based Diagnostics: Simple and In-Office
Our Companion Ultrasound-Based Diagnostics: Simple and In-Office Balloon catheter insertedcommon technique Deliver saline-air contrast for tubal evaluation Occlusion Patency No RadiationNo X-Ray DyeNo Referral to Radiology Center Contrast generation for screening and occlusion confirmation for use w
Slide 9: Strong Global IP Portfolio
Strong Global IP Portfolio Our Patent Estate Encompasses Utility and Design 130+ patents ISSUED globally; OVER 40 pending Directional Delivery (dual or single) to Fallopian Tubes Biopolymer Composition for Tubal Occlusion Contrast Generating Ultrasound Visible Tissue Sampling for Cancer Detection Fe
Slide 10: FemBloc Permanent Birth Control + Ultrasound Occlusion Confirmation
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 alternativeFirst in-office ultrasoun
Slide 11: 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 12: FemBloc: Expected Competitive Advantages Over Existing or Previous Options
Essure® is a registered trademark of Bayer Healthcare (Conceptus) and, as of December 2018, no longer a marketed solution. FemBloc: Expected Competitive Advantages Over Existing or Previous Birth Control Options On-Market Solutions Off-Market FemBloc Surgical Tubal Ligation IUD(Reversible) Essure® P
Slide 13: 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 wi
Slide 14: FemBloc Clinical Studies Summary
Summary:n=183 subjects being followed for 5 years Patients found procedures highly tolerable 96% physicians assessed procedure to be extremely/ very simple99% physicians assessed easier than tubal ligation surgery Summary:n=93 subjects received planned hysterectomy Subset with histopathology demonst
Slide 15: FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure
165 27 53 8 2 2 3 5 12 1 FemBloc Treatment (90 days) FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (n = 183 subjects) Patients are being followed for 5 years, with first subjects approaching 4-year follow-up 94% AEs related to device/ procedure occurred within 7 days of procedure
Slide 16: FemBloc: Most Common Reported AEs Related to Bleeding/Spotting or Pelvic Pain/Cramping
Bleeding/Spotting (41.5%) Pain/Cramps (38%) Other 28% 10.3% 2.1% 1.1% 24.8% 8.9% 4.3% 1.1% 1.8% *Visual Analog Scale (VAS) from 0-10 was used. FemBloc: Most Common Reported AEs (>1%) Were Related to Bleeding/Spotting or Pelvic Pain/Cramping Mean pain/ discomfort score* as reported by patient: 4.3 fo
Slide 17: Permanent Birth Control Market Opportunity (U.S.)
Permanent Birth Control Market Opportunity (U.S.) Near-Term Target Market $2B Annual Market Expansion Opportunity $20 B Total Includes women (and partners) choosing permanent birth control annually (~1.3M) Includes women using non-permanent options but are candidates (>12M) Hormones Condoms Tubal Li
Slide 18: 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 servicesCan perform multiple procedures in same roomQui
Slide 19: FemBloc: Clear Reimbursement Path
In-office procedure FemBloc Treatment Category covered (ACA)Cat III code approved 2 FemBloc: Clear Reimbursement Path 3 reimbursable office visits 1+ Days 3 Months In-office visit(required for permanent birth control) Counseling/Eligibility Existing CPT codes 1 In-office ultrasound procedure Cat III
Slide 20: FemaSeed Localized Directional Insemination
FemaSeed® Localized Directional Insemination Developing the first and only first-line approach designed to deliver sperm where conception occursDesigned to be more affordable than assisted reproductionIncludes first in-office ultrasound diagnosis of fallopian tubes for infertility Companion Diagnost
Slide 21: Infertility: Unmet Need (U.S. only)
Infertility: Unmet Need (U.S. only) More than 9 million struggle with infertility Despite advancements, there have been no new affordable options in decades.
Slide 22: FemaSeed: Expected Competitive Advantages Over Existing Infertility Options
FemaSeed: Expected Competitive Advantages Over Existing Infertility Options FemaSeed Traditional IUI IVF Artificial Insemination ✔ ✔ Sperm delivered directly to egg (FemaSeed via fallopian tube) ✔ ✔ Stimulation Drugs optional ✔ ✔ Low Procedure Cost ✔ ✔ Minimal Training ✔ ✔
Slide 23: FemVue and FemCath Diagnostic Devices
FemVue® Diagnostic Evaluation of Fallopian Tubes Commercially Available FemCath™ Selective Fallopian Tube Contrast Placement Commercially Available First diagnostic to allow for selective evaluation of a fallopian tube with contrast First diagnostic that creates natural contrast for an in-office ult
Slide 24: FemVue Saline-Air Device
FemVue Saline-Air Device (used prior to FemaSeed Procedure) Diagnostic performed prior to infertility proceduresCan be combined with saline evaluation of uterine cavity (standard of care)On-line training and support available for new customersPhysician locator available on patient websiteReimbursed
Slide 25: FemaSeed Localized Directional Insemination in Development
FemaSeed Localized Directional Insemination in Development Limited advancements - continuous demand for less costly options Undirected sperm delivery to cavity (IUI) is first line treatment despite low success rates First and only approach delivering sperm where conception occurs
Slide 26: FemaSeed: de Novo Pivotal LOCAL Clinical Trial
FemaSeed: de Novo Pivotal LOCAL Clinical Trial IDE Approval Received April 2021 SITE RECRUITMENT UNDERWAY Prospective, Multi-Center, Single-Arm (n=792 cycles) Confirmed clinical pregnancy with fetal heartbeat at 7 weeks post FemaSeed procedure Occurs at midpoint of data set Clinical Trial Design Int
Slide 27: Market Opportunity (U.S.)
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/ year) >9M Infertile Women Most Expensive Least Expensive
Slide 28: FemaSeed Potential Market Penetration
FemaSeed Potential Market Penetration U.S. Commercial Strategy Goals: No Advancement for Decades and Limited Competition in the Infertility Product Category 1,300 reproductive endocrinologists at 450 practices Hire direct sales force for U.S., distribution partners for internationalInitially target
Slide 29: FemCerv Diagnostic/Cervical Cancer Sampling
FemCerv® Diagnostic/Cervical Cancer Sampling First endocervical biopsy designed for comprehensive tissue sampling with minimal contamination FDA Approved Commercialization Pending
Slide 30: FemCerv: Diagnostic Cervical Screening Solution
Expanded Collection Chamber FemCerv: Diagnostic Cervical Screening Solution First cervical tissue sampler designed to improve tissue quality and quantity 1 Designed for minimal contaminationAllows for comprehensive tissue samplingDesigned to minimize patient discomfort 2 Collected sample
Slide 31: Our Strategy: Targeting Ob/Gyns With Product Solutions
Our Strategy: Targeting Ob/Gyns With Product Solutions Throughout the Continuum of Female Care Addressing facets of care that have had negligible advancement over decades to create improved patient care and improved physician treatment options Procedures for Infertility/Permanent Birth Control Diagn
Slide 32: Our Strategy: U.S. Commercial Strategy Goals
Our Strategy: Targeting Ob/Gyns With Product Solutions Throughout the Continuum of Female Care U.S. Commercial Strategy Goals: Limited In-Office Advancements for Gynecologic Care Leaves Antiquated Options In Key Areas 41,000 U.S. Gynecologists in office practices Expand Infertility Sales force for G
Slide 33: Upcoming Anticipated Milestones
Upcoming Anticipated Milestones Near term expected valuation inflection points creating accretive value for investors 2022 Q1 Q2 Q3 Q4 Complete enrollment of FemBloc Stage II study Interim data for FemaSeed trial IDE submission for FemBloc pivotal trial Complete Femaseed pivotal trial enrollment
Slide 34: Key Leadership
Key Leadership Experienced biotechnology and medical device developers Kathy Lee-Sepsick President, CEO, Founder 25+ years of experience Jeffery Marcus, MD Chief Medical Advisor 25+ years of experience Dan Currie Sr. VP, Operations 30+ years of experience Gary Thompson VP, Finance & Administration 3
Slide 35: Investment Highlights
Investment Highlights Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in DevelopmentAddressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved ApproachesClear
Slide 36: Disrupting Convention in Women's Health Through Continuous Innovation
Disrupting Convention in Women’s Health Through Continuous Innovation January 2022 Corporate Presentation Investors: Chuck PadalaIR@femasys.com Contact: Media: Sky StriarMedia@femasys.com