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0001531978
0001531978
2025-01-13
2025-01-13
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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):
January 13, 2025
Paragon 28, Inc.
(Exact
name of Registrant as Specified in Its Charter)
| Delaware |
001-40902 |
27-3170186 |
|
(State or Other Jurisdiction
of Incorporation) |
(Commission
File Number) |
(IRS Employer
Identification No.) |
|
14445 Grasslands Drive
Englewood, Colorado |
80112 |
| (Address of Principal Executive Offices) |
(Zip Code) |
Registrant’s Telephone Number, Including
Area Code: (720) 912-1332
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, $0.01 par value |
|
FNA |
|
The New York Stock Exchange |
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 2.02 Results of Operations and Financial Condition.
On January 13, 2025, Paragon 28, Inc. (the “Company”)
issued a press release announcing preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2024. A copy of
the Company’s press release is furnished as Exhibit 99.1 hereto.
On January 13, 2025, the Company posted a presentation
to its website relating to the Company’s preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2024
and a discussion of its financial profile, market strategy, products and recent developments. A copy of the presentation is attached as
Exhibit 99.2 to this Current Report on Form 8-K.
The information in Item 2.02 of this Current Report
on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the
Securities Act of 1933, as amended. The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1
and Exhibit 99.2, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the
Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly
set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
|
PARAGON 28, INC. |
| |
|
|
| Date: January 13, 2025 |
By: |
/s/ Robert S. McCormack |
| |
|
General Counsel & Corporate Secretary |
Exhibit 99.1
Paragon
28 Announces Preliminary Unaudited Revenue for Fourth Quarter and Full Year 2024
ENGLEWOOD, Colo. – January 13, 2025
(BUSINESS WIRE) – Paragon 28, Inc. (NYSE: FNA) (“Paragon 28” or “P28”), a leading medical device company
exclusively focused on the foot and ankle orthopedic market, today announced a range of its preliminary unaudited net revenue for the
fourth quarter and full year ended December 31, 2024.
Preliminary unaudited net revenue for the fourth
quarter of 2024 is expected to be in a range of $71.5 to $71.8 million, representing reported growth of approximately 18.0% to 18.5% compared
to the fourth quarter of 2023.
Preliminary unaudited net revenue for the full
year of 2024 is expected to be in a range of $255.9 to $256.2 million, representing reported growth of approximately 18.2% to 18.4%, compared
to the full year of 2023.
Our estimated unaudited financial results as of
and for the fourth quarter and full fiscal year ended December 31, 2024, presented above are preliminary and are subject to the close
of the quarter and year, completion of our quarter-end and year-end closing procedures and further financial review. Our independent registered
public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial information.
Our actual results may differ from these estimates as a result of the completion of our quarter-end and year-end closing procedures, review
adjustments and other developments that may arise between now and the time our financial results for the fourth quarter and year are finalized.
“2024 has been a transformative year for
Paragon 28, marked by significant achievements in growth, innovation, and operational efficiency. Our efforts across the business have
delivered tangible results this year, positioning us for sustainable, profitable growth in the future.” said Albert DaCosta, Chairman
and CEO of Paragon 28, “Looking ahead to 2025, we are more excited than ever to build on this momentum and redefine what is possible
in the foot and ankle market.”
About Paragon 28, Inc.
Based in Englewood, Colo., Paragon 28, is a leading
medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the
onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range
of foot and ankle ailments including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot
foot and orthobiologics. The company designs products with both the patient and surgeon in mind, with the goal of improving outcomes,
reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.
Forward Looking Statements
Except for the historical information contained
herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better
future for foot and ankle patients and its estimated ranges of net revenue for the fourth quarter and full-year of 2024. You are cautioned
not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current
expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which
we are not currently aware. Forward-looking statements should not be read as a guarantee of future performance or results and may not
necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking
statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results
and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks
and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in Paragon
28’s filings with the Securities and Exchange Commission (the “SEC”), including Paragon 28’s annual report on
Form 10-K filed with the SEC on March 2, 2024. Paragon 28 does not undertake any obligation to update forward-looking statements
and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained
herein. These forward-looking statements should not be relied upon as representing Paragon 28’s views as of any date subsequent
to the date of this press release. Paragon 28’s preliminary unaudited estimated revenue for the quarter ended December 31,
2024 and the year ended December 31, 2024 are not necessarily indicative of our operating results for any future periods.
Investor Contact:
Matthew Brinckman
Senior Vice President, Strategy, and Investor
Relations
Phone: (741) 336-0435
mbrinckman@paragon28.com
Exhibit 99.2
| 1
Note: Considered adding a 5th pillar
of growth “Operational Excellence”
where we highlight improvements to
cash flow and margin, but think it will
be better to include in a supplement
or presentation later in the year
J.P. Morgan 43rd Annual
Healthcare Conference
January 13, 2024
Presenters:
Albert DaCosta (CEO & Chairman)
Chadi Chahine (CFO and EVP of
Supply Chain Operations) |
| 2
Copyright ©2024 Paragon 28. All rights reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this presentation are forward-looking statements within the meaning of the
"safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better future
for foot and ankle patients; its estimated net revenue for full year 2024; that Paragon 28 has substantial runway to drive future growth; that Paragon 28 has
substantial opportunity for further geographic expansion; that Paragon 28 is positioned well for market leadership in the next 5 to 10 years; our goals of
achieving EBITDA profitability in 2025 and Free Cash Flow positive late in 2025; that by pushing growth across all facets of the business, the sales team will
continue to drive robust growth; that there is the potential to ramp U.S. producing rep count to 400 - 500; that there is substantial runway for further
orthopedic and podiatric surgeon penetration; and that Paragon 28 will outpace the segment and differentiate itself with ongoing strategic investments
augmented with operational excellence and efficiency across all functions to drive growth and profitability. You are cautioned not to place undue reliance on
these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions and are
subject to risks and uncertainties, some of which we are not currently aware. Forward‐looking statements should not be read as a guarantee of future
performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved.
These forward‐looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results,
including the financial results for net revenue for the quarter and full fiscal year ended December 31, 2024, and the timing of events could differ materially
from those anticipated in such forward‐looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully
in the section titled “Risk Factors” in Paragon 28’s filings with the Securities and Exchange Commission (the “SEC”), including Paragon 28’s Annual Report on
Form 10-K/A for the fiscal year ended December 31, 2023, filed with the SEC on August 8, 2024 and its Quarterly Reports on Form 10-Q, as updated
periodically with the Company's other filings with the SEC.
These forward-looking statements are made as of the date of this presentation, January 13, 2025, and Paragon 28 assumes no obligation to update the
forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as
required by law. |
| 3
Copyright ©2024 Paragon 28. All rights reserved.
Non-GAAP Financial Measures
This presentation includes financial measures that were not prepared in accordance with GAAP. Our non-GAAP financial measures include adjusted EBITDA, adjusted EBITDA margin, adjusted revenue growth and free cash flow.
Definitions, explanations, and reconciliations to the most comparable GAAP financial measures can be found in the Appendix. In addition to our results and measures of performance determined in accordance with U.S. GAAP
presented in this presentation, we believe that certain non-GAAP financial measures are useful in evaluating and comparing our financial and operational performance over multiple periods, identifying trends affecting our
business, formulating business plans and making strategic decisions.
Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We define Adjusted EBITDA as earnings (loss) before
interest expense, income tax expense (benefit), depreciation and amortization, stock-based compensation expense, employee stock purchase plan expense, non-recurring expenses and certain other non-cash expenses.
We believe that Adjusted EBITDA, together with a reconciliation to net income, helps identify underlying trends in our business and helps investors make comparisons between our company and other companies that may have
different capital structures, tax rates, or different forms of employee compensation. Accordingly, we believe that Adjusted EBITDA provides useful information to investors and others in understanding and evaluating our operating
results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to a key financial metric used by our management in its financial and operational
decision-making. Our use of Adjusted EBITDA has limitations as an analytical tool, and you should not consider these measures in isolation or as a substitute for analysis of our financial results as reported under U.S. GAAP. Some of
these potential limitations include:
• other companies, including companies in our industry which have similar business arrangements, may report Adjusted EBITDA, or similarly titled measures but calculate them differently, which reduces their usefulness as
comparative measures;
• although depreciation and amortization expenses are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted EBITDA does not reflect cash capital expenditures for
such replacements or for new capital expenditure requirements;
• Adjusted EBITDA also does not reflect changes in, or cash requirements for, our working capital needs or the potentially dilutive impact of stock-based compensation; and
• Adjusted EBITDA does not reflect the interest expense, or the cash requirements necessary to service interest or principal payments, on our debt that we may incur.
Free Cash Flow is an additional key performance measure that our management uses to assess our financial performance and liquidity. We define Free Cash Flow as net cash provided by operating activities less capital
expenditures. The Company’s capital expenditures include amounts related to purchases of property and equipment. Additionally, management believes Free Cash Flow is helpful in assessing our operational efficiency and the
effectiveness of our capital expenditures, and that monitoring Free Cash Flow can help us manage financial risk. In addition, management believes Free Cash Flow provides meaningful incremental information to investors to
consider when evaluating the performance of the Company.
Additionally, we report revenue growth on a constant-currency basis in order to facilitate period-to-period comparisons of results without regard to the impact of fluctuating foreign currency exchange rates. The term foreign
currency exchange rates refers to the exchange rates used to translate the company's operating results for all countries where the functional currency is not the U.S. dollar into U.S. dollars. Because we are a global company,
foreign currency exchange rates used for translation may have a significant effect on our reported results. References to revenue growth on a constant-currency basis means without the impact of foreign currency exchange rate
fluctuations.
The company believes disclosure of constant-currency revenue growth rates is helpful to investors because it facilitates period-to-period comparisons. However, constant-currency revenue growth rates are non-GAAP financial
measures and are not meant to be considered as an alternative or substitute for comparable measures prepared in accordance with GAAP. Constant-currency growth has no standardized meaning prescribed by GAAP and should
be read in conjunction with the our consolidated financial statements prepared in accordance with GAAP. We calculate constant-currency growth rates by translating local currency amounts in the current period at actual foreign
exchange rates for the prior period.
Because of these and other limitations, you should consider our non-GAAP measures only as supplemental to other GAAP-based financial measures. |
| 4
Copyright ©2024 Paragon 28. All rights reserved.
Paragon 28’s Mission
paragon: a model of excellence
or perfection
twentyeight: number of bones
in the human foot; a perfect number
34
>100
Joints
Tendons, muscles
and ligaments
Our mission:
To continuously improve the outcomes
and experiences of patients suffering
from foot and ankle conditions. |
| 5
Copyright ©2024 Paragon 28. All rights reserved.
Paragon 28 Key Highlights
$5.2B Foot &
Ankle Segment
Growing rapidly (7%
CAGR) and largely
underdeveloped with
opportunity for
expansion
Exclusive Foot
& Ankle Focus
P28 is the only
company solely
dedicated to defining
the Foot & Ankle
segment
Comprehensive
Solutions
P28 has launched
>80 product systems
and has over 20
active projects in
development
Enabling
Technologies
Unique offerings
designed to improve
patient outcomes
and transform the
Foot & Ankle
segment
Compelling
Financials
Consistent and
diversified sales
growth with
pathway to strong
profitability |
| 6
Copyright ©2024 Paragon 28. All rights reserved.
• $255.9M - $256.2M 2024 Preliminary Net Revenue
~18.3% YoY revenue growth at the mid-point(1)
• $71.5M - $71.8M 4Q24 Preliminary Net Revenue
18.3% YoY revenue growth at the mid-point(1)
• ~500+ global employees(2)
• >80 product systems launched since 2010
• 20+ active projects in development
• 284 producing U.S. sales reps (+11% YoY) (2)
• 2,244 active surgeon customers (+9% YoY)(2)
• 21 international countries (~18%(2) of global sales)
• $89M of liquidity (Incl. $39M cash & equivalents)(2)
Paragon 28 Business Update
Paragon 28 by the Numbers Key Recent Highlights
• Continued success in operational efficiency strategy
targeted at optimizing the organizational structure,
minimizing costs and preserving cash without
compromising revenue growth opportunities
• Expanding base of producing sales reps while
continuing to penetrate existing accounts with new
product launches
• 13 product launches in 2024 in large, high growth
segments with 2 in 4Q2024
• Phantom Fibula Nail System designed to offer
surgeons a less invasive option for treating ankle
fractures
• APEX 3D Short Stem Tibia total ankle replacement
system allows treatment for those with complex
anatomy
(1) On January 13th, 2025, the Company pre-announced preliminary, unaudited 2024 full year net revenue of $255.9 to $256.2 Million and fourth quarter 2024 net revenue of $71.5 to $71.8 Million.
(2) Data as of September 30, 2024. |
| 7
Copyright ©2024 Paragon 28. All rights reserved.
$5.2 Billion
$6.9 Billion
2024 2029
The Global Foot & Ankle Segment
Global Foot & Ankle Segment(1) Diversified Across 6 Major Sub-Segments(2)
(1) Source: iData Research and Company estimates. Approximately 55% of global segment sales is U.S.
(2) Source: Company filings, SmartTrak, and management estimates.
(3) Management estimates.
Fast Growing Segment with Several Key Differentiators
✓ Highly complex anatomy
✓ Increasing surgeon specialization
✓ Generally more active and younger patient populations
✓ Significant opportunity for innovation to drive improved outcomes
✓ Well over 100 indications with variety of causes (activity-based, trauma, genetic predisposition, etc.)
• ~2,400 orthopedic surgeons that specialize in
foot and ankle
• ~9,000 surgical podiatrists(3)
• ~2,300 pediatric and trauma surgeons that
treat foot and ankle
Large ~13,700 U.S. Foot & Ankle Surgeon Base
F&A Segment 2024 - 2028 CAGR
Forefoot 9.8%
Fracture Fixation 4.8%
Flatfoot / PCFD 3.3%
Ankle 9.2%
Charcot 3.8%
Biologics 6.4%
P28’s portfolio is
highly diversified
and represented in
all sub-segments
Forefoot
35%
Fracture Fixation
29%
Flatfoot
11%
Ankle
8%
Charcot
4%
Biologics
13%
2024 F&A Segment Composition |
| 8
Copyright ©2024 Paragon 28. All rights reserved.
P28 has Substantial Runway to Drive Future Growth
(1) Source: Company filings, SmartTrak, and management estimates.
Massive opportunity for growth and segment expansion in U.S and international regions
Estimated 2024 Global F&A Segment Share(1) Key themes today:
• Top 3 players each hold 10%+ of the global segment and a larger
proportion of the U.S. segment
• Paragon 28 sales growth has outpaced the overall segment by 2 – 3x
since IPO
Implications for the future:
• At ~7% and ~1% share in the U.S. and International segments,
respectively, Paragon 28 has substantial opportunity for further
geographic expansion
• Paragon 28 is a driving force in expanding the Foot & Ankle segment
with innovation
P28 is positioned well for segment leadership in the next 5 to 10 years
5%
Large Diversified Players
~65%
Single Product / Other
~30% |
| 9
Copyright ©2024 Paragon 28. All rights reserved.
Top Strategic
Priorities
Goals &
Objective
Advance
Differentiated
Solutions and
Innovation
Expand U.S. Sales
Channels, Increase
Access, Rep / Surgeon
Base and Productivity
Focus Internationally,
Strengthen Grow
Presence In Core
Markets
Drive Operational
Execution and
Financial
Performance
Our Strategy
Deliver differentiated solutions, rapidly expand U.S. and international sales channels, and commit to
operational excellence and profitability to achieve sustainable, balanced growth
Launch new products on time and
budget
Execute new product go to market
effectively
Drive adoption of Smart 28
platform / modules
Expand geographic footprint
Drive growth in key markets
Focus on education
Expand and strengthen position in
core markets
Enter Japanese market
Deliver operating leverage
Effectively manage cash and
optimize capital structure
Our Strategic Priorities and Objectives
1 2 3 4 |
| 10
Copyright ©2024 Paragon 28. All rights reserved.
Commitment to Research and Learning
Unique ecosystem enables P28 to drive clinically focused innovation and develop solutions for addressing today’s unmet needs
250-Person Auditorium | Englewood, CO HQ 40-Station Cadaveric Lab | Englewood, CO HQ Two 6-station Mobile Labs
1
Investments In Research and Learning
29 20+ 60+
University and
hospital research
partners
P28 product white
papers & case
studies
Algorithm-oriented clinical
studies (Bonelogic)
Research and Learning Drives Paragon 28’s Innovation
~50
Journal
publications &
scientific meetings |
| 11
Copyright ©2024 Paragon 28. All rights reserved.
Balanced Product Innovation and Strong Launch Cadence
2010 - 2016 2017 - 2020 2021 - 2023
Forefoot
Segment
Fracture Fixation
Flatfoot / PCFD
Ankle
Charcot
Biologics
Total
Annual
Average
6
6
5
2
2
4
10
9
4
6
5
3
4
2
1
8
2
4
2024 Launched and Planned
25
3.6
37
9.3
21
7.0
Note: Excludes simple line extensions. Includes products launched and on limited release as of 06/30/24. Some products span multiple segments.
Balanced Product Introductions
4
4
1
3
1
-
13
13
Substantial high impact launches in 2024 in
high growth areas aligned well aligned with
favorable procedures:
✓ Enabling Technology
✓ MIS
✓ Soft-Tissue
✓ Forefoot
✓ Complex TAR
✓ Novel Instrumentation
20+
Active Projects
50+
Future Potential
Projects
1 |
| 12
Copyright ©2024 Paragon 28. All rights reserved.
2024 Launches Present Significant Long-term Upside
Thirteen Product Launches in 2024
January 5, 2024: Grappler®
Knotless Anchor System +
Ti Anchors
January 30, 2024: FJ2000
Power Console and Burr System
February 1, 2024: PRECISION®
MIS Bunion System
January 5, 2024:
Bridgeline Adaptive Tape
January 26, 2024: Mister
Tendon Harvester System
March 28, 2024: Grappler®
R3INFORCE Extraosseous
Repair System
Q1 Q2 and Q3
August 2024: SMART Bun-Yo-Matic℠ Pilot (1st Pre-op Module)
August 2024: Full Launch of
Bun-Yo-Matic Lapidus Clamp
September 2024: APEX 3D
Right Angle Drill
September 2024: R3FLEX
Stabilization System
August 2024: BONOBO Ball Joint Strut
(Monkey Rings Line Extension)
Phantom Fibular Nail
APEX 3D S Stemmed Tibia
Q4
Products Highlighted on following pages
1 |
| 13
Copyright ©2024 Paragon 28. All rights reserved.
First Smart 28 Planning Module:
Smart Bun-Yo-Matic Case Management and Workflow
Bringing unique patient solutions to life with powerful planning combined with precise instrumentation
Surgeon accesses the Smart 28
Case Management Portal
Select Smart Bun-Yo-Matic
CT or X-Ray program
Upload the medical images
(CT or X-rays)
Leveraging AI-enabled algorithms, the program
rapidly characterizes anatomy and calculates a
patient specific surgical plan
Results are displayed for the
surgeon to review and adjust as
needed
Surgeon precisely achieves
the planned correction using
the Bun-Yo-Matic guide
The surgical plan is seamlessly
compiled into a report for
interoperative use
1 2 3
5 6 7 “The ability to 3D plan your Hallux Valgus
correction is crucial… Even more revolutionary
is the capability to apply, control, and achieve
the planned correction with the use of the Jig.”
Dr. Cesar de Cesar Netto,
surgeon designer and first
user of the Smart Bun-Yo-Matic
4
1 |
| 14
Copyright ©2024 Paragon 28. All rights reserved.
1 Smart Bun-Yo-Matic Lapidus Clamp System |
| 15
Copyright ©2024 Paragon 28. All rights reserved.
1 R3FLEX Stabilization System |
| 16
Copyright ©2024 Paragon 28. All rights reserved.
1 Phantom® Fibula Nail System
R3FLEX Stabilization System
shown on prior page |
| 17
Copyright ©2024 Paragon 28. All rights reserved.
APEX 3D S Stemmed Tibia and Right Angle Drill 1
APEX 3D S Stemmed Tibia APEX 3D Right Angle Drill |
| 18
Copyright ©2024 Paragon 28. All rights reserved.
Precision® MIS Bunion System 1 |
| 19
Copyright ©2024 Paragon 28. All rights reserved.
1 FJ2000 Power Console and Burr System |
| 20
Copyright ©2024 Paragon 28. All rights reserved.
New Product
Introductions
Own entire
procedure
Rep Additions
More Breadth &
Experience
New Surgeon
Customers
Accelerate
Customer base
Rep & Surgeon
Productivity
More P28 usage
across all cases
By Pushing Growth Across All Facets of the Business, the Sales Team Will Continue to Drive Robust Growth
18.3%
2024 Growth(1)
Contracting &
Accounts
Drive accessibility
Multiple Shots on Goal to Drive Growth
(1) Reported growth based on midpoint of $255.9 - $256.2M 2024 Preliminary Net Revenue.
2 |
| 21
Copyright ©2024 Paragon 28. All rights reserved.
Strong U.S. Commercial Execution
P28s sales team consists of clinically adept individuals that have developed highly collaborative relationships with surgeons
Top U.S. Commercial Priorities
Sales Force
Expansion
Sales Force
Productivity
Expansion of
Surgeon
Customer
Base
Increase
Surgeon
Utilization
(1) As of Q3 2024
(2) Percentage of 13,700 total foot and ankle surgeon customers in the U.S.
Key Opportunities:
• Substantial runway for further orthopedic and
podiatric surgeon penetration
− Green field opportunity with F&A
pediatric and trauma surgeons
• Increase existing surgeon utilization
284(1)
U.S. producing sales reps
+11% YoY
~90%
Salesforce exclusivity
Key Opportunities:
• ~50% of U.S. segments unrepresented today
• Potential to ramp U.S. Producing Rep count to
400 - 500
• Pull through of new product launches and further
penetration with existing accounts
2,244(1)
P28 active surgeon base
+9% YoY
~84%(2)
Remaining runway of
potential U.S. surgeon
customers
>3,500
Surgeons trained in person
in the last 12 months
2 |
| 22
Copyright ©2024 Paragon 28. All rights reserved.
P28’s International Presence
International Presence & Development
International Strategy
Key International Details and Statistics, as of September 30, 2024(1)
1
2
Expand and strengthen position in core markets
3
New product introductions
Continued investment in medical education and training
Enter Japanese market
Building the infrastructure for long term, profitable growth
$32.5M
International YTD Net
Revenue
as of Q3 2024
~18%
of Q3 2024 Global Net
Revenue (Up from
15.4% in Q3 2023)
+35.3%
Reported YoY
Growth
in Q3 2024
2016
P28 began
selling
internationally
21(1)
International Countries
with 7 office locations
Mixed 4 Direct 8 National sales agencies 9 Stocking distributors
P28’s Current International Presence
(1) As of September 30, 2024.
3
4 |
| 23
Copyright ©2024 Paragon 28. All rights reserved.
4 Consistent Growth Well Above 2x the F&A Segment
$130.1
$158.1
$183.5
$17.3
$23.3
$32.9
$147.5
$181.4
$216.4
$255.9 - $256.2
2021 2022 2023 2024
U.S. Net Revenue
International Net Revenue
Global Net Revenue
Key Commentary
• Balanced growth across all F&A
subsegments since 2021 IPO, driven by
innovative product portfolio and dedicated
sales force
• Global revenue growth over >2x the overall
F&A segment rate every quarter since IPO
• Continued commercial momentum – Rep
and Surgeon customer additions augmented
by increased productivity driven by product
launch cadence
• Focus on delivering sustainable, balanced
growth
Paragon 28 has delivered consistent, balanced growth
Global 32.9% 23.0% 19.3% 18.2% - 18.4%
U.S. 29.4% 21.5% 16.1% --
International 66.3% 34.2% 41.3% --
#
Reported YoY Growth
20.2% CAGR(1)
(1) Calculated using reported net revenue and Midpoint of 2024 Preliminary Net Revenue range |
| 24
Copyright ©2024 Paragon 28. All rights reserved.
4 Improving Operational Efficiency
Substantial operating leverage in 3Q24
Gross Margin
Operating
Expense / % of
Revenue
Adjusted
EBITDA(1) / %
Margin
($2.7)
($5.4)
($2.8) ($1.9)
($7.7)
($3.0)
$0.4
(5.3%)
(10.5%)
(5.3%)
(3.1%)
(12.6%)
(4.9%)
0.7%
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
3Q24 Key Commentary
• Targeting ~75%+ Gross
Margin
• 969 and 500 basis point
improvements in
operating expenses as a
percentage of revenue in
3Q24 versus 3Q23 and
2Q24, respectively
• Delivered Adjusted
EBITDA profit in the third
quarter for the first time
since the Company’s
October 2021 IPO
80.3% 77.3% 77.4% 69.9% 77.3% 75.0% 74.1%
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
$50.9 $51.5 $51.4 $56.4 $62.4 $56.5 $54.6
97.8%
101.0%
97.3%
93.0%
102.1%
92.6%
87.6%
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
(1) Adjusted EBITDA and Adjusted EBITDA margin are non-GAAP measures, for reconciliations to the most directly comparable GAAP measure, Net Income, refer to financial statements from each corresponding
period. See non-GAAP financial measures disclosure on page 3.
FY2023: 76.0% 2024 YTD: 75.5% |
| 25
Copyright ©2024 Paragon 28. All rights reserved.
Free Cash Flow Improvement 4
Delivered meaningful free cash flow improvement while effectively managing inventory and working capital
Free Cash Flow(1)
Net Inventory /
DIOH
Accounts Payable
/ DPO
Accounts
Receivable / DSO
($21.6) ($27.2) ($20.7) ($21.2) ($16.8) ($13.9)
($6.3)
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
$37.3 $34.3 $33.6 $37.4 $39.7 $36.7 $35.8
65 61 58 56 59 55 52
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
Acounts Receivable, net DSO
$68.2 $81.5 $89.1 $90.0 $94.6 $96.4 $96.4
609 642 683 452 624 577 545
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
Inventories, net DIOH
$20.5
$29.7 $27.4 $21.7
$29.2 $23.1 $20.7
183 234 210 109 193 138 117
1Q23 2Q23 3Q23 4Q23 1Q24 2Q24 3Q24
Accounts Payable, net DPO
3Q24 Key Commentary
• Operational efficiency and
profitable adjusted
EBITDA(1) resulting in Free
Cash Flow(1) improvement
in 3Q24 by 69.5%
compared to 3Q23 and
54.7% sequentially
compared to 2Q24
• Continued management
of inventory driving
improved DIOH
• Faster collection cycles
resulting in reduced DSO
and allowing for faster
vendor payments
(1) Free Cash Flow is a non-GAAP measures, for reconciliations to the most directly comparable GAAP measure, Cash Flow From Operations, refer to financial statements from each corresponding period. See non-GAAP financial measures disclosure on page 3. |
| 26
Copyright ©2024 Paragon 28. All rights reserved.
Top Strategic
Priorities
Goals &
Objective
Advance
Differentiated
Solutions and
Innovation
Expand U.S. Sales
Channels, Increase
Access, Rep / Surgeon
Base and Productivity
Focus Internationally,
Strengthen Grow
Presence In Core
Markets
Drive Operational
Execution and
Financial
Performance
Our Strategy
Deliver differentiated solutions, rapidly expand U.S. and international sales channels, and commit to
operational excellence and profitability to achieve sustainable, balanced growth
Launch new products on time and
budget
Execute new product go to market
effectively
Drive adoption of Smart 28
platform / modules
Expand geographic footprint
Drive growth in key markets
Focus on education
Expand and strengthen position in
core markets
Enter Japanese market
Deliver operating leverage
Effectively manage cash and
optimize capital structure
Our Strategic Priorities and Objectives
1 2 3 4 |
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Exclusively Foot & Ankle |
v3.24.4
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Grafico Azioni Paragon 28 (NYSE:FNA)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Paragon 28 (NYSE:FNA)
Storico
Da Gen 2024 a Gen 2025
