UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 13, 2022
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification Number) | ||||||||||||
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (650 ) 232-7200
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure
Beginning on May 13, 2022, representatives of PROCEPT BioRobotics Corporation (the “Company”) intend to make presentations at investor conferences and in other forums and these presentations may include the information contained in Exhibit 99.1 attached to this Current Report on Form 8-K. A copy of certain of the presentation slides containing such information that may be disclosed by the Company is attached as Exhibit 99.1 to this report and the information set forth therein is incorporated herein by reference and constitutes a part of this report.
The information included under Item 7.01 in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL. | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
PROCEPT BIOROBOTICS CORPORATION | |||||||||||
Date: May 5, 2022 | By: | /s/ Alaleh Nouri | |||||||||
Alaleh Nouri | |||||||||||
| Chief Legal Officer and Secretary | |||||||||||
1 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A INVESTOR EVENT 2022 American Urology Association Annual Meeting May 13, 2022
2 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Safe Harbor Statement This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including the expected financial results of PROCEPT BioRobotics Corporation (the “Company”). Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “anticipates,” and “future” or similar expressions are intended to identify forward-looking statements. Any forward-looking statements made by us in this presentation speaks only as of the date on which it was made and are based on management’s current expectations of future events, assumptions, estimates, and beliefs, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those described in the forward-looking statements include, among others: (i) the rate and degree of market adoption of the AQUABEAM Robotic System and Aquablation therapy, (ii) the establishment of consistent and favorable payment policies for Aquablation therapy, (iii) the rate of growth of the commercial sales and marketing organization and the ability to manage this anticipated growth, (iv) the impact on volumes of elective procedures performed by health care providers and hospital medical device budgets including as a result of the COVID-19 pandemic and recovery, (v) the effects of increased competition as well as innovations by new and existing competitors in the market for treatments for benign prostatic hyperplasia, (vi) the ability to obtain the required regulatory approvals and clearances to market and sell the AQUABEAM Robotic System in certain other countries, (vii) the development and protection of future innovation, (viii) dependence on a limited number of third-party suppliers for components of the AQUABEAM Robotic System, and (ix) the maintenance of intellectual property rights and the ability to operate the business without infringing the intellectual property rights and proprietary technology of third parties. This presentation and the accompanying oral presentation also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we compete are necessarily subject to a high degree of uncertainty and risk. Factors that could cause actual results to differ materially from those contemplated in this presentation can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including the Company’s annual report on From 10-K filed with the SEC on March 22, 2022, and any current and periodic reports filed thereafter, available at www.sec.gov. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical fact are forward-looking statements. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this presentation due to the risks and uncertainties inherent in the Company’s business. In light of the foregoing, investors are urged not to rely on any forward-looking statement or third-party data in reaching any conclusion or making any investment decision about any securities of the Company.
3 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Use of Non-GAAP Financial Information In addition to financial information presented in accordance with U.S. generally accepted accounting principles ("GAAP"), this presentation and the accompanying oral statements include certain non-GAAP financial measures, which include non-GAAP Adjusted EBITDA. The Company defines Adjusted EBITDA as earnings before interest expense, taxes, depreciation and amortization and stock-based compensation. The Company believes that presenting Adjusted EBITDA provides useful supplemental information to investors about the Company in understanding and evaluating its operating results, enhancing the overall understanding of its past performance and future prospects, and allowing for greater transparency with respect to key financial metrics used by its management in financial and operational decision making. However, there are a number of limitations related to the use of non-GAAP measures and their nearest GAAP equivalents. For example, such measures may exclude significant expenses required by GAAP to be recognized in our financial statements. Other companies may calculate non-GAAP measures differently, or may use other measures to calculate their financial performance, and therefore any non-GAAP measures the Company uses may not be directly comparable to similarly titled measures of other companies. Non-GAAP financial measures are not a substitute for or superior to measures of financial performance prepared in accordance with GAAP and should not be considered as an alternative to any other performance measures derived in accordance with GAAP. Any non-GAAP measure is presented for supplemental informational purposes only and should not be considered a substitute for or superior to financial information presented in accordance with GAAP. A reconciliation of these measures to the most directly comparable GAAP measures is included at the end of this presentation.
4 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A President & CEO REZA ZADNO, PhD Avedro, Visiogen, PercuSurge, Cardiac Pathways EVP, Chief Financial Officer KEVIN WATERS Accuray, Conceptus, Laserscope (Greenlight), VISX EVP, Chief Commercial Officer SHAM SHIBLAQ Intuitive Surgical, Conceptus, Invuity, Analogic SVP, Clinical & Medical Affairs BARRY TEMPLIN Abbott Vascular, Guidant, GE Aircraft Engines Proven Leadership Team
5 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Agenda 1 2 3 4 5 Introduction – 10 min Reza Zadno, CEO Clinical Data Review – 10 min Barry Templin, SVP, Clinical & Medical Affairs Financial Review – 5 min Kevin Waters, CFO Commercial Strategy – 5 min Sham Shiblaq, Chief Commercial Officer Surgeon Panel with Q&A – 60 min Dr. Dean Elterman / Dr. Brian Helfand / Dr. Pratik Desai
6 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Benign Prostatic Hyperplasia (BPH) A Significant Men’s Health Disease in the U.S. NORMAL PROSTATE ENLARGED PROSTATE (BPH) #1 Reason men visit the urologist 1 in 2 Estimated men ages 51-60 have BPH and prevalence increases over time 99% Men with BPH say symptoms impact Quality of Life ~40M Men in the U.S. that currently have BPH 2x Men >65 years old in the U.S. expected to double in the next 10 years Loughlin, K. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6. Vuichoud, C, Loughlin, K. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6. MS Health NDTI Urology Specialty Profile, July 2012-June 2013 Roehrborn, CG, Rosen, RC. Medical therapy options for aging men with benign prostatic hyperplasia: focus on alfuzosin 10 mg once daily. Clinical Interventions in Aging 2008:3(3). Bouhadana, et al. Patient Perspectives on Benign Prostatic Hyperplasia Surgery: A Focus on Sexual Health. J Sex Med 2020;1 – 5 2014, Ortman, An Aging Nation: The Older Population in the United States
7 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Large Market & Significant Unmet Need 4.3M WATCHFUL WAITERS ► Choose to do nothing and suffer BPH symptoms 12M U.S. men actively MANAGED for BPH 8.2M Actively TREATED for BPH ~$20B U.S. BPH Surgical Market Opportunity All numbers are approximate. Vuichoud, C, Loughlin, K. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6. Data on File, PROCEPT BioRobotics 6.7M PHARMACEUTICALS ► Suffer dosing adjustments and side effects $16B 1.1M PHARMACEUTICAL FALLOUT ► Delay surgery despite medication failure $3B 400K SURGERIES PER YEAR ► Compromise between safety and efficacy outcomes $1B
8 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Aquablation Therapy: Uniquely Positioned to Become the BPH Treatment of Choice for All Prostate Sizes and Shapes FIRST-OF-ITS-KIND TECHNOLOGY ► Image guidance ► Customized treatment planning ► Robotic surgery ► Heat-free waterjet COMPELLING CLINICAL EVIDENCE ► Strong and growing base of clinical evidence – 100+ peer-reviewed publications ► Only BPH technology randomized against TURP, the historical standard of care for surgical intervention FAVORABLE REIMBURSEMENT & KOL SUPPORT ► Favorable U.S. reimbursement with coverage for 100% of eligible Medicare patients ► Strong societal support and inclusion in clinical guidelines PROVEN COMMERCIAL STRATEGY ► Well-defined customer base and efficient sales infrastructure ► Capital equipment with recurring disposable and service revenues A BPH therapy that addresses the compromise between safety and efficacy of alternative surgical interventions1 1Aquablation therapy provides long-lasting relief with low rates of complications. Gilling, P, et al. Three-Year Outcomes after Aquablation Therapy Compared to TURP: Results from a Blinded Randomized Trial. Can J Urol. 2020 Feb;27(1):10072-10079.. Bhojani, N, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019 Jul;129:1-7. Based on company’s internal estimates.
9 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A CLINICAL DATA REVIEW BARRY TEMPLIN SVP, Clinical & Medical Affairs
10 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Unmet Need in Surgical Intervention UNMET NEED: SAFETY & EFFICACY IN ALL PROSTATES ALL SIZES, ALL SHAPES S Y M P T O M R E L I E F & D U R A B I L I T Y P R I O R I T I Z E S E X U A L F U N C T I O N & C O N T I N E N C E P R E S E R V A T I O N P R I O R I T I Z E S Y M P T O M R E L I E F & D U R A B I L I T Y S E X U A L F U N C T I O N & C O N T I N E N C E P R E S E R V A T I O N small (30-40mL) medium (40-80mL) large (80-150mL) extra large (150mL+) TURP & PVP Enucleation & Simple NON- RESECTI V E RESECT I V E PUL & Water Vapor BPH size ranges: AUA Guidelines: Surgical Management of BPH/Lower Urinary Tract Symptoms (2018, amended 2019, 2020) Published 2018, Amended 2019, 2020. PVP = Photovaporization of Prostate (GreenLight) PUL = Prostatic Urethral Lift (UroLift)
11 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Clinically Validated Efficacy, Durability and Safety Independent of Prostate Size, Shape and Surgeon Experience Only FDA pivotal study randomized to gold standard TURP for prostates 30 – 80 mL ► Superior safety compared to TURP due to low irreversible complications ► Superior symptom relief for subset of patients with prostates ≥ 50 ml Only prospective multicenter study successfully completed for large prostates 80 – 150 mL ► Only treatment for large prostates with a low irreversible complication rate ► Size independent procedure ► Significant symptom relief in large prostates n = 181 n = 101 First multicenter all-comers study with real-world results in prostates 20 – 150 mL ► Validates safety and efficacy in a real- world setting ► Minimal exclusion criteria n = 178 OPEN WATER Data on file. WATER, WATER II, and OPEN WATER clinical studies. WATER: Aquablation n=116. TURP n=65.
12 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Safety Low Rates of Irreversible Complications in ALL Prostates Data on file. WATER, WATER II, and OPEN WATER clinical studies. WATER WATER II OPEN WATER Aquablation TURP Mean Prostate Size 54 mL 52 mL 107 mL 59 mL Obstructive Median Lobe 50% 52% 83% 59% Ir re ve rs ib le C om pl ic at io ns Incontinence 0.0% 0.0% 2.0% 0.0% Erectile dysfunction 0.0% 0.0% 0.0% 0.0% Ejaculatory dysfunction 6.9% 24.6% 14.9% 8.4% Statistical Significance: p<0.05
13 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A M O DE RA TE SE VE RE M IL D Non-Resective2 Drug Therapy1 0 5 10 15 20 25 0 6 12 18 24 30 36 42 48 54 60 IP SS : B PH S YM PT O M S CO RE MONTHS FROM PROCEDURE WATER (30-80mL) WATER II (80-150mL) OPEN WATER (20-150mL) TURP (WATER STUDY) Efficacy and Durability Similar Outcomes to TURP, but Across ALL Prostates in Both Clinical and Commercial Studies 1. Drug therapy generally provides IPSS reduction of approximately 5 points. 2. Non resective surgery generally provides IPSS reduction of approximately 10 points Roehrborn CG, et al. Five-year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802- 8813. IPSS IMPROVEMENT Data on file. WATER, WATER II, and OPEN WATER clinical studies. McVary KT, et al. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Apr 19
14 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A14 Surgical & Medical Retreatment from FDA Trials NOT HEAD-TO-HEAD STUDIES EXCEPT FOR WATER STUDY MAXIMUM SIZE PROSTATE TREATED: 80 mL AQUABLATION 6.0%1 WATER (5y) Avg prostate: 54 mL1 50% OML1 TURP 12.3%1 WATER (5y) Avg prostate: 52 mL1 52% OML1 REZUM 15.5%2 Rezūm (5y) Avg prostate: 46 mL3 31% OML3 UROLIFT 33.6%4 L.I.F.T (5y) Avg prostate: 45 mL5 0% OML5 PROSTATE SIZES: 80-150 mL 9%6 WATER II (4y) AQUABLATION Avg prostate: 107 mL6 83% OML6 Surgical retreatment is any intervention to treat recurrent LUTS, including clip removal for UroLift OML = obstructive median lobe 1. Gilling PJ et al. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH. Can J Urol. 2022 Feb 2. McVary, et al. Final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezūm water vapor thermal therapy for treatment of moderate-to-severe lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2021 Apr 19 3. McVary et al. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia J Urol 2016 May 1 4. McVary et al. A Tower of Babel in Today’s Urology: Disagreement in Concepts and Definitions of Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia Re-Treatment. J Urol. 2020 Aug 1 5. Roehrborn et al The Prostatic Urethral Lift for the Treatment of Lower Urinary Tract Symptoms Associated with Prostate Enlargement Due to Benign Prostatic Hyperplasia: The L.I.F.T. Study J Urol 2013 Dec 1 6. Bhojani et al. Abstract of “Aquablation for benign prostatic hyperplasia in large prostates (80-150cc) 4 year results” Journal of Urology Vol. 207, No. 5S, Supplement, Saturday, May 14, 2022
15 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Safety Real-world Low Rates of Irreversible Complications in ALL Prostates Data on file. WATER, WATER II, and OPEN WATER clinical studies. WATER WATER II OPEN WATER Aquablation TURP Mean Prostate Size 54 mL 52 mL 107 mL 59 mL (20-150 mL) Obstructive Median Lobe 50% 52% 83% 59% Ir re ve rs ib le C om pl ic at io ns Incontinence 0.0% 0.0% 2.0% 0.0% Erectile dysfunction 0.0% 0.0% 0.0% 0.0% Ejaculatory dysfunction 6.9% 24.6% 14.9% 8.4% Statistical Significance: p<0.05
16 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Resective Surgery: Summary of Key Safety Data TURP1,2 PVP1,2 Enucleation1,2,3 Simple Prostatectomy1,2,4 General Prostate Size Treated < 80mL < 80mL > 80mL > 100mL Ir re ve rs ib le C om pl ic at io ns Incontinence As high as 2% As high as 2% As high as 33% As high as 8% Erectile dysfunction As high as 14% As high as 20% As high as 8% As high as 3% Ejaculatory dysfunction As high as 89% As high as 50% As high as 77% As high as 90% 1Leong et al. Minimizing Sexual Dysfunction in BPH Surgery. Current Sexual Health Reports (2019) 11:190–200 2Comiter et al. Urinary incontinence after prostate treatment. Up to Date; Last update May 2020. 3Sapetti, J, et al. Urinary incontinence after HOLEP: Incidence, evolution and predictive factors. Prog Urol. 2019 Feb;29(2):101-107 4Khera, M. Simple Prostatectomy. Medscape. 2018. Data reported in each category is not head-to-head.
17 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Automated Robotic Execution 0 10 20 30 40 50 60 70 30 50 70 90 110 130 150 R E S E C T I O N T I M E ( m in ) P R O S T A T E S I Z E (mL) WATER + WATER II (30-150mL) TURP (30-80mL) SIZE & SHAPE INDEPENDENT RESECTION AVERAGE RESECTION TIME Aquablation 5.8 min TURP 27.4 min
18 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A FINANCIAL REVIEW KEVIN WATERS Chief Financial Officer
19 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A 1Q22 Earnings Recap $14.2M WORLDWIDE REVENUE ~$350K U.S. A AQUABEAM AVG SELLING PRICE 5.6 U.S. MONTHLY UTILIZATION 93 U.S. AQUABEAM INSTALL BASE ~175M TOTAL COVERED LIVES1,2 22 U.S. AQUABEAM SYSTEMS SOLD (1) Includes Medicare, Aetna, Cigna, Anthem, Humana, HCSC, Emblem Health, BCBS Massachusetts, CareFirst, BCBS North Dakota, Independence BCBS, and Medical Mutual of Ohio (2) As of May 13, 2022 U.S. HANDPIECES SOLD (+97% y/y) (+47% y/y) (+17% y/y) (+35% y/y) ~630 ~840 ~1,230 ~1,425 Q2'21 Q3'21 Q4'21 Q1'22 (+81% y/y) (~75% Coverage)
20 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A 2022 Financial Guidance 2020 2021 2022 Total Revenue ($M) $7.7 $34.5 TOTAL CASH & CASH EQUIVALENTS BALANCE OF $284.3M AND DEBT BALANCE OF $50M AS OF MARCH 31, 2022 Actual 2022 Guidance (mid-point) (1) 2022 financial guidance issued on May 5, 2022 (2) 2022 operating expense guidance includes approximately $12.5 million in stock-based compensation expense (3) See appendix for reconciliation of non-GAAP financial measures $60.0 Actual FY21 Guidance FY221 Revenue Revenue growth (y/y) $34.5 million 348% $58 to $62 million 68% - 80% (implied) Gross Margin 46% 47% to 49% Operating Expenses $70 million Approximately $106 million2 Adjusted EBITDA Loss $63 to $60 million3
21 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A COMMERCIAL STRATEGY SHAM SHIBLAQ Chief Commercial Officer
22 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A U.S. Commercial Opportunity: 8.2M Available Patients I M M E D I A T E O P P O R T U N I T Y ~ $ 1 B ~105,000 Non-Resective Surgical Market ~290,000 Convert Existing Resective Surgical Market M I D T E R M O P P O R T U N I T Y ~ $ 1 0 B ~3.9 Million Penetrate Drug & Drug Failure Candidates L O N G T E R M O P P O R T U N I T Y ~ $ 1 0 B ~3.9 Million Capture Drug & Drug Failure Candidates U R O L O G I S T S P C P → U R O L O G I S T S
23 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A U.S. Commercial Opportunity: Segmentation Target High-Volume Hospitals HIGH (≥100) LOW (<100) 32%68% US HOSPITALS BY ANNUAL BPH RESECTIVE VOLUME (2019) ~2,700 Total Resective Hospitals INITIAL TARGET 860 High Volume Hospitals Annual Resective Volume ≥100 28% 71% RESECTIVE PROCEDURE SHARE BY HOSPITAL TYPE (2019) >250,000 Hospital Based Resective Procedures ~180K Resective Procedures Avg. Annual Resective Volume = 200 Monthly Avg. = 17.4 3 0 % O F H O S P I T A L S G E N E R A T E 7 0 % O F R E S E C T I V E B P H P R O C E D U R E S Data on File, PROCEPT BioRobotics
24 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Aquablation Treated Prostate Sizes – U.S. 6.7% 18.2% 21.9% 19.9% 12.1% 7.4% 6.5% 3.1% 1.9% 0.8% 0.5% 0.5% 0.2% 0.3% < 40 (40,60] (60,80] (80,100] (100,120] (120,140] (140,160] (160,180] (180,200] (200,220] (220,240] (240,260] (260,280] (280,300] > 300 # P R O C ED U R ES P R O S TAT E S I Z E G R O U P S (mL) PROSTATE SIZE HISTOGRAM – U.S DATA 1/1/21 to 3/31/22 Vision Become the BPH treatment standard of care and expand the market Immediate Strategy Convert TURP and Greenlight hospital-base pprocedures (50-100 mL) and then drive to smaller glands ~70% of Prostates Treated are <100 mL Data on File, PROCEPT BioRobotics
25 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A SURGEON PANEL 2022 American Urology Association Annual Meeting May 13, 2022
26 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Introductions University of Toronto Dean Elterman, MD Toronto, Canada Northshore University Health System Brian Helfand, MD, PhD Chicago, IL Potomac Urology Pratik Desai, MD Woodbridge, VA
27 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A University of Toronto Dean Elterman, MD Toronto, Canada
28 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Disclosures • Boston Grants/Research Support: Boston Scientific, Pfizer, Clarion • Speakers Bureau/Honoraria: Allergan, Astellas, Coloplast, Boston Scientific, Ferring, Medtronic, Clarion, PROCEPT BioRobotics • Consulting: Medtronic, BSCI, Coloplast, Axonics, PROCEPT BioRobotics • Investigator: BSCI, Meditate, Medeon, Zenflow, Medtronic, Axonics, PROCEPT BioRobotics The views expressed in this presentation are those of the presenter and do not necessarily reflect the views or policies of PROCEPT BioRobotics or its subsidiaries. No official endorsement by PROCEPT BioRobotics or any of its subsidiaries of any vendor, products or services contained in this presentation is intended or should be inferred. An honorarium is provided by PROCEPT BioRobotics to the speakers for this presentation.
29 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A The Only Image-Guided, Heat-Free, Automated Robotic Therapy for BPH Intraoperative ultrasound imaging combined with cystoscopic visualization provide a multidimensional view of the treatment area Real-Time Image Guidance Advanced planning software allows the surgeon to map the treatment contour by identifying tissue to preserve and resect Personalized Treatment Planning Robotic execution of the waterjet along the treatment plan results in standardized outcomes and operative experience Automated Robotic Execution Heat-free waterjet precisely removes prostate tissue and minimizes thermal damage to surrounding tissue Heat-Free Waterjet Resection
30 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Real-Time Image Guidance CYSTOSCOPY TRANSRECTAL ULTRASOUND Transrectal Ultrasound (TRUS) Waterjet & Cystoscope External Sphincter Veru Lateral Lobe Bladder Median Lobe MULTI-DIMENSIONAL VIEW OF THE TREATMENT AREA
31 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Visualize Treatment Area
32 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Personalized Treatment Planning IDENTIFY CRITICAL ANATOMY B L A D D E R N E C K | P R E S E R V E2 L A T E R A L L O B E | R E S E C T3 M E D I A N L O B E | R E S E C T1 V E R U M O N T A N U M | P R E S E R V E4 E X T E R N A L S P H I N C T E R | P R E S E R V E5 CREATE TREATMENT CONTOUR 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5
33 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Heat-Free Waterjet Resection 1. Data on file at PROCEPT BioRobotics 2. Malek et al. Photoselective Vaporization Prostatectomy: Experience With a Novel 180 W 532 nm Lithium Triborate Laser and Fiber Delivery System in Living Dogs, The Journal of Urology, Volume 185, Issue 2, 2011, Pages 712-718, ISSN 0022-5347, 3. Bruyère F, et al. Penetration depth with the XPS GreenLight laser assessed by contrast enhanced ultrasonography. J Endourol. 2013 Oct;27(10):1282-6. doi: 10.1089/end.2013.0368. Epub 2013 Aug 21. Heat-based options can lead to thermal injury and result in: ► Highly variable depth of tissue penetration ► Necrosis which may extend deeper than cavity created ► Potential for unintended prostate capsule perforation ► Potential damage to nerve bundle responsible for erectile function ► Delayed healing of prostatic urethra Healthy Tissue H E A T - F R E E R E S E C T I O N 1 Injured Tissue H E A T - B A S E D R E S E C T I O N 2 , 3 L- Lumen | CZ- Cautery Zone | TZ- Transition Zone | NLZ- Non-Laser Zone
34 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Sphincter Protection for Continence Preservation Video courtesy of Professor T.Bach, Asklepios Westklinikum Hamburg Use cystoscope to visualize sphincter and verumontanum
35 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Veru protection start marker = 33% of the distance between bladder neck and end marker Veru Protection Zone for Ejaculation Preservation
36 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Veru Protection Zone | Depth of Resection Nguyen D, et al. Predictors of Anejaculation after Aquablation Procedure. Prostatic Disease and Male Voiding Dysfunction. 2021 LOWER RISK OF ANEJACULATIONGREATER RISK OF ANEJACULATION < 5 mm cut depth below Veru
37 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Evolution of Hemostasis 20 – 80 mL 11% CAUTERY 2015 2016 2017 2018 2019 2020 2021 2022 H E M O S T A S IS M E T H O D Cautery 0.9%2 5.9%3 2.7%4 0.8%5 1. Data on file at PROCEPT BioRobotics 2. WATER transfusion rate 3. WATER II transfusion rate pre-discharge and additional 4% at 30 days 4. OPEN WATER transfusion rate 5. Elterman et al 2021 D A T A S O U R C E S NO CAUTERY 40% CAUTERY Catheter Tension Device Focal Bladder Neck Cautery Clot Evacuation 100% CAUTERY Non-Specified Cautery Commercial Cases OPEN WATER N=178 WATER WATER II Focal Bladder Neck Cautery N=116 N=101 N=2,089 OPTIMAL METHOD IDENTIFIED 20 – 80 mL 20 – 150 mL 20 – 280 mL 20 – 280 mL 20 – 360 mL 20 – 387 mL 20 – 535 mL Prostate Size Ranges1
38 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Northshore University Health System Brian Helfand, MD, PhD Chicago, IL
39 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Disclosures Consultant: PROCEPT BioRobotics The views expressed in this presentation are those of the presenter and do not necessarily reflect the views or policies of PROCEPT BioRobotics or its subsidiaries. No official endorsement by PROCEPT BioRobotics or any of its subsidiaries of any vendor, products or services contained in this presentation is intended or should be inferred. An honorarium is provided by PROCEPT BioRobotics to the speakers for this presentation
40 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Patient counseling requires a Treatment Algorithm • Size • Median lobe • Anterior tissue • Antithrombotics • Catheter duration • Antegrade ejaculation • Durability • Catheter duration Shift in Practice THEN Treatment Algorithm not needed • Patient counseling simplified • Practice consolidation NOW
41 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Patient Experience URINARY OUTCOMES Magnitude of symptom reduction Speed to symptom reduction SEXUAL FUNCTION Magnitude of function preserved Longevity of function preservation CATHETER TIME Time with catheter post- operatively RECOVERY Speed to discharge Time in OR post operatively Pain and dysuria MEDICATION USE Ability to get off medication
42 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Same Day Discharge with Aquablation Therapy ► Well-established hemostasis method resulting in 0.8% transfusion rate in over 2,000 patients1 ► Confidence in hemostasis and need for COVID outpatient resulted in studying same day discharge ► Consecutive patients from Dec 1, 2020 to April 15, 2021 were offered Aquablation on outpatient basis Stout et al. Urology 2020 Grade I Grade II Grade III Grade IV Grade V D I S C H A R G E A L G O R I T H M CBI PACU x4 hours - Traction + Traction Clear Dark Red Observation Status/Admit Continuous CBI Take off Traction Dark Red Clear Outpatient Remove Catheter in Clinic H E M A T U R I A S C A L E 1. Elterman D. et al. Focal Bladder Neck Cautery Associated with Low Rate of Post Aquablation Bleeding. CJU 2021 Apr. 2. Helfand. (2021). Aquablation Therapy Day Case Feasibility [White Paper] PROCEPT BioRobotics The information included in this material is being provided for informational purposes only and is not a substitute for the independent medical judgment of a physician in assessing treatment and management options for a specific patient. The information is not intended as a recommendation or endorsement by PROCEPT BioRobotics of any particular treatment method, unless otherwise expressly stated in the product’s User Manual or Instructions For Use. The handling physician is solely responsible for all patient care decisions.
43 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Helfand. (2021). Aquablation Therapy Day Case Feasibility [White Paper] PROCEPT BioRobotics ► 87% successfully underwent day-case Aquablation therapy ► 0% readmissions or transfusions ► 0% of patients required home irrigation RESULTS While there is a trend for 23-hour hospital observation for men with very large prostates, Aquablation therapy is feasible for most men as a day-case procedure when they meet the noted hematuria criteria and medication considerations. CONCLUSION Same Day Discharge with Aquablation Therapy Day-Case (n=20) 23-Hour Observation (n=3) Average Age (SD) 64.8 (4.8) 65.3 (6.65) Average TRUS Volume (SD) 99.87 (50.69) 180.67 (158.35) Average Intraprostatic Protrusion Length mm (SD) 5.07 (9.40) 8.41 (11.17) Average AUA-SI Score (SD) 18.5 (9.2) 17.8 (6.4) Average QoL Score (SD) 3.7 (0.9) 3.0 (1.7) Average PSA ng/ml (SD) 5.22 (6.51) 8.85 (3.78) Average Resection Time (SD) 8.22 (1.33) 14.50 (5.62)
44 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Potomac Urology Pratik Desai, MD Woodbridge, VA
45 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Disclosures Consultant: PROCEPT BioRobotics The views expressed in this presentation are those of the presenter and do not necessarily reflect the views or policies of PROCEPT BioRobotics or its subsidiaries. No official endorsement by PROCEPT BioRobotics or any of its subsidiaries of any vendor, products or services contained in this presentation is intended or should be inferred. An honorarium is provided by PROCEPT BioRobotics to the speakers for this presentation
46 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Undertreated & Sidelined Patients History PE & DRE IF • Urinary Retention • Recurrent UTI • Recurrent hematuria • Bladder stones • Renal Insufficiencies Symptom Assessment Mild Non-SurgicalWatchful Waiting Moderate to Severe Surgery Rigidly following the guidelines prevents accounting for patient individuality Managed by primary care physician Stay on medication & delay treatment Unknown market not presenting to urologists BPH DISEASE PROGRESSION IS ONE WAY
47 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Standardized Process Flow Identify Symptoms • Every patient above 40 fills out IPSS • Physical exam, PSA, prior history • “Is there room for improvement for your urinary symptoms” • Family history Standard Work Up • Medication discussion & trial • Cystoscopy, TRUS, and Urodynamic study • Urodynamic study with PVR • Identify opportunity to deliver better care Identify Disease • Medication discussion & trial • Size and shape of prostate • Degree of obstruction • Expectation for sexual and ejaculatory function Develop a scalable process focused on patient needs
48 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Aquablation Therapy Program 13 18 50 230 2018 2019 2020 2021 A Q U A B L A T I O N T H E R A P Y C A S E S A T P O T O M A C U R O L O G Y
49 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A THANK YOU
50 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A IPSS = International Prostate Symptom Score QoL = Quality of Life *Sexually active men WATER: FDA RANDOMIZED STUDY (n=181) WATER II: FDA SINGLE ARM STUDY (n=101) BASELINE CHARACTERISTICS AQUABLATION (n=116) TURP (n=65) AQUABLATION (n=101) Age, years, mean (SD) 66.0 (7.3) 65.8 (7.2) 67.5 (6.6) Body mass index, mean (SD) 28.4 (4.1) 28.2 (4.5) 28.4 (4.2) Prostate size (TRUS), mL; mean (SD) 54.1 (16.2) 51.8 (13.8) 107.4 (22.1) Obstructive median lobe, % 50% 52% 83.2% Prostate-specific antigen, g/dL; mean (SD) 3.7 (3.0) 3.3 (2.3) 7.1 (5.9) BASELINE QUESTIONNAIRES IPSS score, mean (SD) 22.9 (6.0) 22.2 (6.1) 23.2 (6.3) IPSS QoL, mean (SD) 4.8 (1.1) 4.8 (1.0) 4.6 (1.0) Sexually active, n (%) [MSHQ-EjD] 93 (80.2%) 54 (83.1%) 77 (76%) MSHQ-EjD, mean (SD)* 8.1 (3.7) 8.8 (3.6) 8.1 (3.9) IIEF-5, mean (SD)* 17.2 (6.5) 18.2 (7.0) 15.1 (7.4) ANTITHROMBOTIC USE Anticoagulant, n (%) 2 (1.7%) 2 (3.1%) 4 (4.0%) Antiplatelet / NSAID, n (%) 15 (12.9%) 6 (9.2%) 21 (20.8%) Aspirin (≤ 100 mg), n (%) 24 (20.7%) 11 (16.9%) 18 (17.8%) Any of above, n (%) 41 (35.3% 19 (29.2%) 43 (42.6%) BPH MEDICATION USE Alpha blocker, n (%) 48 (41.4%) 23 (35.4%) 41 (40.6%) 5-ARI, n (%) 2 (1.7%) 2 (3.1%) 4 (4.0%) Alpha blocker / 5-ARI, n (%) 23 (19.8%) 14 (21.5%) 29 (28.7%) Any of above, n (%) 73 (62.9%) 39 (60.0%) 74 (73.3%) MSHQ-EjD = Male Sexual Health Questionnaire – ejaculatory dysfunction IIEF-5 = International Index of Erectile Function
51 © 2 0 2 2 P R O C E P T B i o R o b o t i c s C o r p o r a t i o n . A l l R i g h t s R e s e r v e d . ML0447.A Non-GAAP Reconciliations RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA (in thousands) (unaudited) RECONCILIATION OF GAAP NET LOSS TO ADJUSTED 2022 EBITDA Guidance (in thousands) (unaudited) Three Months Ended March 31, 2022 2021 Net loss $ (17,185) $ (12,822) Depreciation and amortization expense 758 915 Stock-based compensation expense 1,552 650 Interest income and interest expense, net 1,385 1,450 Adjusted EBITDA $ (13,490) $ (9,807)