SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 16, 2020
|(Exact name of registrant as specified in its charter)|
|(State or other jurisdiction of incorporation)|
|(Commission File Number)||(I.R.S. Employer Identification Number)|
2850 Frontier Drive
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (574) 268-6379
|(Former name or former address, if changed since last report)|
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, $0.00025 par value per share||KIDS||Nasdaq Global Market|
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))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 under the Securities Act (17 CFR 230.405) or Rule 12b-2 under the Exchange Act (17 CFR 240.12b-2).
Emerging growth company [X]
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 [X]
Item 7.01. Regulation FD Disclosure.
On June 16, 2020, the executive officers of OrthoPediatrics Corp. (the “Company”) will be meeting with representatives of Piper Sandler & Co. and various investors to provide a business update, including an update on the expected impact of COVID-19 on the Company in the second quarter of 2020. The officers intend to use the material filed as Exhibit 99.1 herewith, in whole or in part, as part of their presentation to the participants.
As indicted in the presentation, the Company anticipates total revenues for the quarter ended June 30, 2020 to be down by approximately 30%, as compared to total revenues for the second quarter of 2019. As a majority of the Company’s products are utilized in elective surgeries or procedures, the postponement of those surgeries and procedures by various governments, governmental agencies and hospital administrators in preparation for COVID-19-related hospitalizations has had a significant negative impact on the Company’s business and results of operations. Specifically, the Company’s deformity correction and scoliosis businesses were significantly impacted in the second quarter of 2020, with April sales being down approximately 60% from the same month last year. However, as elective surgeries were permitted to resume across the United States, the Company began seeing improvement in its domestic deformity correction and scoliosis businesses. International sales have also been negatively impacted, with revenues in April and May 2020 being down 70% and 50%, respectively, as compared to revenues in April and May 2019. International sales have not seen a similar rebound as a return to elective surgeries have been delayed and the ability to purchase sets has been hampered by a slower return to the market by the Company’s international distributors.
The Company continues to monitor the evolving COVID-19 pandemic and guidance from international and domestic authorities, including federal, state and local public health authorities. However, given the dynamic nature of the situation, the Company cannot reasonably estimate the impacts of the COVID-19 pandemic on its financial condition, results of operations or cash flows for the second half of the year. As a result, the Company continues to suspend full year 2020 revenue growth and set consignment guidance.
The Company will provide complete second quarter 2020 financial results in early August, consistent with past practices.
The information in this Item 7.01, including the information incorporated by reference herein from Exhibit 99.1, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others: the risks related to COVID-19, the impact such pandemic may have on the demand for our products, and our ability to respond to the related challenges; and the risks, uncertainties and factors set forth under “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on March 5, 2020, as updated and supplemented by our other SEC reports filed time to
time. Forward-looking statements speak only as of the date they are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.
Item 9.01. Financial Statements and Exhibits.
* * * * * *
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.
|Date: June 16, 2020||By:||/s/ Daniel J. Gerritzen|
Daniel J. Gerritzen,
General Counsel and Secretary
OrthoPediatrics Corp. Mark Throdahl, CEO June 2020 Fred Hite, CFO
Disclaimer Forward-Looking Statements This presentation includes "forward-looking statements" within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "could," "believe," "estimate," "project," "target," "predict," "intend," "future," "goals," "potential,” "objective," "would" and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others: the risks related to COVID-19, the impact such pandemic may have on the demand for our products, and our ability to respond to the related challenges; and the risks, uncertainties and factors set forth under "Risk Factors" in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 5, 2020, as updated and supplemented by our other SEC reports filed time to time. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws. Use of Non-GAAP Financial Measures This presentation includes the non-GAAP financial measure of Adjusted EBITDA, which differs from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). Adjusted EBITDA in this release represents net loss, plus interest expense, net plus other expense, depreciation and amortization, stock-based compensation expense, and acquisition related costs. Adjusted EBITDA is presented because the Company believes it is a useful indicator of its operating performance. Management uses the metric as a measure of the Company’s operating performance and for planning purposes, including financial projections. The Company believes this measure is useful to investors as supplemental information because it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry. The Company believes Adjusted EBITDA is useful to its management and investors as a measure of comparative operating performance from period to period. Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to, or superior to, net income or loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and it should not be construed to imply that the Company’s future results will be unaffected by unusual or non-recurring items. In addition, the measure is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as debt service requirements, capital expenditures and other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and other potential cash requirements. In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same or similar to some of the adjustments in this presentation. The Company’s presentation of Adjusted EBITDA should not be construed to imply that its future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on the Company’s GAAP results in addition to using Adjusted EBITDA on a supplemental basis. The Company’s definition of this measure is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. 2
Highlights Large Market Proprietary Technology Scalable Business Diversified medical device company focused exclusively on pediatric orthopedics Protected market opportunity: $1.4 billion U.S., $3.2 billion globally (2019 estimates) High U.S. procedure concentration: <300 hospitals and ~1,400 surgeons Focused call point: pediatric orthopedic surgeons are generalists who use all OP products Sustainable competitive advantage: - Broadest pediatric-specific orthopedic product offering with 35 surgical systems - Strong relationships with pediatric orthopedic surgeons - Deep commitment to clinical education - Sales personnel are a consultative resource who attend surgery Consistent 20+% growth since inception - FY19 revenue of $72.6 million, up 26% Recent Orthex and ApiFix acquisitions give OP proprietary, leading-edge technology in both external fixation and non-fusion scoliosis markets and expand the Company’s total addressable market 3
COVID-19 Update Working closely with surgeon base, partners, and key suppliers; continuing to build inventories of critical products Accelerated sales training on new products including Orthex and recently acquire Apifix with remote learning Environment Company implemented safety measures across the organization, including working and remote since mid-March Company Currently committed to no lay-offs or base reduction salary cuts to all direct employees Response and established a Distributor Relief Fund for U.S. sales agencies Utilizing DocMatter website to sponsor webinars around pediatric orthopedic care in midst of COVID-19 pandemic Product development has not been affected and proceeds at normal pace 31% sales growth February 2020 YTD; 30 percent domestic sales growth for the first quarter 2020 offset by earlier impact in international markets (32% OUS decrease) for a net sales growth of 12% Impact on Company withdrew its previously announced 2020 revenue growth and consignment set Financials guidance of 22%-24% and $19-$21 million, respectively Deformity Correction and Scoliosis businesses significantly impacted; April total sales down ~60%; began seeing improvements in May and June schedule filling up nicely Anticipate 2Q20 revenues to be down ~30% overall, with domestic only down ~20% 4
OP Today A Company Built on a CAUSE Cause Company Snapshot Improving the lives of children Treated >172,000 patients since inception with orthopedic conditions 35 surgical systems; ~7,300 SKUs; strong pipeline 4 additional systems from Vilex and ApiFix acquisitions 103 direct employees; 167 focused sales reps1 Global sales organization focused on pediatric orthopedic surgeons in 44 countries1 79 issued patents; 65 pending patents2 Chief Medical Officer is a fellow surgeon Average FDA approval time: < ½ industry average Gideon with CMO Peter Armstrong, M.D., c. 1995. History of stable reimbursement Gideon’s drawing of his girlfriend, 2016. 1 As of March 31, 2020 2 As of March 31, 2020 and does not include Vilex/Orthex patents/patent applications 5
Our Key Idea Children Are Not Small Adults Superior Clinical Outcomes OP’s Market Impact Re-Purposed Adult Plate OP’s Solution Address orthopedic industry’s lack of focus on product development, clinical education, and sales presence Implants and instruments avoid complications of re-purposed adult products Product development in collaboration with leading pediatric orthopedic surgeons Dedicated sales support attending surgeries Clinical education programs that build brand loyalty Screws Through Screws Parallel To Growth Plate Growth Plate 6
Large and Focused Market OP’S $3.2 Billion Current Addressable Global Market1 $1.4 Billion U.S. Addressable Market1 High Concentration of Pediatric Trauma & Deformity and Scoliosis Procedures 3,157 U.S. Sports Hospitals Medicine Smart $170M Implants $363M 38% Scoliosis Procedures $308M (%) 62% Trauma & Deformity 268 U.S. $586M Hospitals Current products target three of the largest categories in Pediatric Orthopedics Pipeline products underway to expand addressable market 1 Management’s 2019 updates to IMS data from 2016 7
Product Line & Growth Diversification 2019 Revenue by Segment (% Total) $72.6 million sales in 2019, increasing 26% Scoliosis Well diversified product sales and sources of 30% growth Trauma & All major product families contributed to 2% Deformity revenue growth Sports 68% Medicine/ All products have comparable gross margins Other 2019 Revenue by Product Family 2019 Revenue by Geography 18% 27% 27% 82% 73% 73% Trauma & Deformity Scoliosis Sports Med/Other US OUS 8
A Proven Strategy Since 2011 Sales Focus on Teaching Deploy Expand Expand Clinical Institutions and Instrument Addressable Education High Volume Sets Procedures Programs Hospitals Goals Accelerate sales growth Develop and acquire novel technologies 9
New Systems & Product Launches (2017-2018) Titanium PediPlates® Clavicle Plate Wrist Fusion Plate PediFlex Pediatric Nailing System System System Advanced Platform | FEMUR (Expands physeal (First pediatric (First pediatric (Expands into tethering offering) specific system) specific system) adolescent cases) Trauma Deformity & Trauma Scoliosis FIREFLY® Pedicle Screw FireFly S2/Alar RESPONSE 4.5/4.75/5.0mm Navigation Guides System (Complementary to RESPONSE Spine System) (Maximizes intraoperative flexibility) Medial Patella Femoral Ligament Reconstruction System Sports Sports (Complementary to ACL Medicine Reconstruction System) 10
New Systems & Upcoming Product Launches (2019-2020) Acquired Launched Launched Launched Launched Launching Launching June’19 Sept’19 Nov’19 Dec’19 Mar’20 2020 2020 Trauma Deformity & Trauma Orthex Next Generation PediFoot QuickPack™ Large Fragment Osteogenesis PediFoot (External fixation Cannulated (First pediatric Bone Void Cannulated Screw Imperfecta Expansion hardware / software) Screw Systems system) Filler System Nail System Launched Neuromuscular FDA Acquired Feb’19 approval Mar’20 Apr’20 Scoliosis BandLoc DUO System RESPONSE™ ApiFix MID-C System Neuromuscular System (Non-fusion technology) 11
Strong Pipeline Expanding Our Addressable Market CMF Clavicle Demonstrated ability to Proximal Rib expand portfolio to full Humerus Spine array of pediatric surgeries Elbow Growing Rods Hand & Wrist OP Today OP Tomorrow Now Under Development Pelvis Hip & Long Bone Knee (Sports Medicine) Foot & Ankle 12
Leading Edge Systems in Development Smart Implants Early Onset Scoliosis Proof of concept established in 2018 with Emerging surgical trends not being pursued by substantial development in 2019 major spine companies Intervention in patients as young as 10 2 embodiments: (1) scoliosis (2) intramedullary nailing Reversible, non-fusion procedures Developing IP portfolio OP will offer significant improvements to Working with panel of leading surgeons current technology 13
Global Sales Coverage United States International 76% of 2019 24% of 2019 Revenue Revenue 38 Sales Agencies, 8 Sales Agencies most of which are + 39 Stocking exclusive* Distributors* Direct in UK, IRE, AUS, NZ, CAN, BE, NL, IT * Data as of March 2020 Currently selling to major children’s hospitals in the U.S. and 43 additional countries Converting to agency model in select markets has significantly increased volumes, ASPs, and gross margin Replicate success of sales agency model in UK, IRE, AUS, NZ, CAN, BE, NL, and IT 14
Vilex Acquisition Transaction Details Acquisition: In June 2019 OP purchased Vilex1 and its Orthex Hexapod2 system with proprietary point-and-click planning software, for $60 million ($50 million cash + $10 million shares) Divestiture: In December 2019 OP sold the adult assets and Orthex license for non-pediatrics market to Squadron Capital for $25 million cash. Net: Orthex Hexapod investment of $35 million Benefits Expands OP’s Trauma & Deformity business into new segment valued at $200 million globally Expands Trauma & Deformity’s breadth from 60% to 80% of addressable market Increases surgeon reach to limb reconstruction specialists who treat pediatric patients beyond children’s hospitals, generating pull-through of other products Divestiture allows OP to remain committed solely to pediatrics with cross license rights 1 Vilex generated $6.7 million of revenue in 2018 (most of which was adult) 2 Hexapod had 50% annual revenue growth since FDA clearance in mid-2016; generated $5.1 million of revenue in 2018 15
Orthex Advantages Disruptive Technology Construct allows 90° angulation Unique calibrated structs and HA-coated pins Patented point and click software Significantly simplifies surgery planning and subsequent alignments Dror Paley, MD – Pediatric orthopedic KOL Introduced Ilizarov method in U.S. Defend competitive position and risk Defend other potential acquirers from entering the pediatric space 16
ApiFix Acquisition Transaction Details Acquisition: In April 2020, OP purchased ApiFix1 and its MID-C ApiFix minimally invasive deformity correction system, for 934,768 shares Procedure of common stock and $2 million in cash paid at closing, plus milestone payments and an earnout over a period of four years Benefits Expands OP’s Scoliosis business into non-fusion market, the holy grail of pediatric scoliosis surgery One of only two non-fusion technologies approved by the U.S. FDA and granted pediatric HDE Spinal Least invasive, removable system that acts as an internal brace with motion-preserving capabilities to avoids permanently limiting Fusion range of motion Measurable reductions in surgery time, blood loss, hospitalization, recovery time, and complication rates Extremely high sales/dollar of set inventory Strong IP protection: 46 granted patents and 25 patent applications 1 ApiFix generated $0.5 million of revenue in 2019 17
A Novel Surgical Option ApiFix is a Viable Alternative to Failed Bracing and Spinal Fusion for the Treatment of Progressive Scoliosis Exercise Brace ApiFix System Fusion Surgery Curves < 25º Curves 25º- 40º Curves 40º - 60º Curves > 50º 18
MID-C System Advantages Minimally Invasive Deformity Correction (MID-C) System for Scoliosis • Viable alternative to failed bracing and spinal fusion with motion-preserving technique - Self-adjusting rod and novel polyaxial joints • Least invasive surgical solution - Placed posteriorly and unilaterally on the concave aspect of the curvature - No thoracic surgeon; no need to collapse the lung • Removable (burns no bridges) • Surgery time 1-2 hours; Incision size 10-15cm; Blood loss 50cc • Post-surgery hospital stays of 1-2 days - Patient recovery measured in days, not months • Low complication and revision rates • FDA and CE Mark approved procedure backed by clinical data on 370+ patients and long-term (8 year) data 19
Competitive Landscape New Competitors Would Face Formidable Obstacles Product breadth Surgeon relationships Sales and distribution network Clinical education programs Pediatric brand equity Reputation with pediatric orthopedic societies Dynamic culture “The ship has sailed.” 20
What Does Category Leadership Mean? Surgeon relationships and Broadest, most innovative clinical education product offering Relationships with surgeons who use 13 years’ clinical understanding entire portfolio New product pipeline Major provider of clinical education Pediatric Market Gateway for Leading supporter of surgical societies distributed products and joint Custom instruments product developments Robust organic growth Attractive growth and opportunities margin profile $3.2 billion addressable global market Consistent growth since inception Limited focused competition 75% gross margin in FY 2019 Focused, experienced distribution History of efficient capital Instrument set placements drive growth utilization 21
Consistent 20+% Revenue Growth Since Inception $95 $90 $85 $80 $75 $72.6 $70 $65 $17.5 $60 $57.6 $55 $50 $45.6 $14.1 $45 $40 $37.3 $10.7 $35 $31.0 $8.5 Revenue ($ in Millions) ($ Revenue $30 $23.7 $6.1 $55.1 $25 $19.6 $20 $16.1 $5.3 $43.5 $3.9 $34.9 $15 $2.8 $28.8 $10.2 $24.9 $10 $7.1 $18.4 $3.0 $0.9 $13.3 $15.8 $5 $0.6 $0.4 $9.3 $0 $6.7 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 U.S. International 23
Category Revenue Summary $80 $1.7 $0.4 $70 $0.4 $3.7 $60 $1.2 $21.5 $4.3 $50 $1.2 $16.7 $1.1 $40 $11.6 $1.1 $30 $9.4 $0.8 $12.1 $7.4 $49.4 Revenue Millions) in ($ Revenue $10.0 $20 $3.6 $39.7 $32.8 $26.8 $10 $19.3 $22.5 $0 2014 2015 2016 2017 2018 2019 1Q 2019 1Q 2020 Trauma & Deformity Scoliosis Sports Medicine/Other 24
Revenue Seasonality Seasonality Drives Stronger Performance in Summer Months and Holiday Periods 35% 29% 30% 27% 27% 26% 26% 27% 26% 26% 26% 25% 25% 25% 25% 22% 21% 21% 20% 20% 15% 10% Revenue as % of Total Year of % as Total Revenue 5% 0% 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 2016 2016 2016 2016 2017 2017 2017 2017 2018 2018 2018 2018 2019 2019 2019 2019 25
Income Statement Summary ($ in Millions) FY 2016 FY 2017 FY 2018 FY 2019 1Q 2019 1Q 2020 Revenue $37.3 $45.6 $57.6 $72.6 $14.7 $16.3 Growth % 20% 22% 26% 26% 21% 11% Gross Profit $26.4 $34.5 $42.7 $54.6 $10.7 $12.1 Margin % 71% 76% 74% 75% 73% 75% Operating Expenses $32.5 $40.9 $52.2 $63.7 $13.4 $16.7 Operating Loss ($6.1) ($6.5) ($9.6) ($9.1) ($2.7) ($4.6) Net Loss ($6.6) ($8.9) ($12.0) ($13.7) ($3.0) ($5.0) Net Loss per Share1 ($7.14) ($5.86) ($0.96) ($0.94) ($0.21) ($0.31) 1 Net loss per share attributable to common stockholders – basic and diluted 26
Adjusted EBITDA Reconciliation ($ in Millions) Three Months Ended March 31, 2019 2020 Net loss ($3.0) ($5.0) Interest expense, net 0.3 0.4 Other expense - 0.1 Depreciation and amortization 0.8 1.4 Stock-based compensation 0.5 1.0 Acquisition related costs - 0.1 Adjusted EBITDA ($1.4) ($2.2) 27
Balance Sheet ($ in Millions) As of March 31, 2020 Assets Liabilities Cash & Restricted Cash $54.9 Accounts payable $8.3 Accounts receivable 14.0 Debt 21.2 Inventory (net) 44.0 Accrued expenses 3.0 Other current assets 2.1 All other liabilities 2.5 PP&E (net) 24.1 Paid-in capital 274.4 Intangibles 35.0 Accumulated deficit (net) (135.2) Total Assets $174.1 Total Liabilities / Equity $174.1 28
Summary Surgeon relationships and Broadest, most innovative clinical education product offering Robust organic growth Attractive growth and opportunities margin profile 29