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2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

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Page 1: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

June 2017 

Page 2: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

FORWARD LOOKING STATEMENT

This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Suchstatements are forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statementsinclude, but are not limited to, the strategic benefit of the Company's placenta donation network and the difficulty that a competitor wouldface in establishing a competitive network, the Company’s ability to transition to a biopharmaceutical company at an accelerated pace, thestrength of the Company’s patent portfolio overall, the timing of the adjudication of the Company’s currently pending patent cases and theoutcome of those cases, the expansion of the Company’s sales force, the Company’s ability successfully to develop new products and thetiming and receipt of pending and anticipated regulatory clearances and approvals, that the Company’s ongoing investment in clinical trialswill continue to propel its success in gaining reimbursement coverage and regulatory approvals, that the Company will receive favorablecoverage decisions from Aetna and other payers and will increase penetration in its GPO/IDN contracts, the growth in the markets for theCompany’s current and future products and the share of such markets that the Company will be able to garner, the Company’s ability tocontinue to outpace its competitors, the Company’s ability to continue to make and benefit from process improvements and efficiencies, andthe Company’s ability to achieve the milestones and financial projections in the “3 in 1 and 20” plan. Among the risks and uncertainties thatcould cause actual results to differ materially from those indicated‐by such forward‐looking statements include that the Company may notrealize the strategic benefit of the Company's placenta donation network and a competitor may succeed in establishing a sizable competitivenetwork, the Company may be unable to transition to a biopharmaceutical company at an accelerated pace, the adjudication of theCompany’s current patent cases may be delayed or the outcomes may be unfavorable, there may be new challenges to the validity of theCompany’s patents or new incidences of infringement, the Company may not be able to expand its sales force as planned or the expansionmay be delayed, the Company may be unable to increase penetration of its GPO/IDN contracts, the Company may be unable successfully todevelop anticipated new products or the timing of such development may be delayed, the timing of anticipated regulatory clearances andapprovals may be delayed or denied, adverse regulatory actions against the Company, the Company’s ongoing investment in clinical trialsmay not have the expected impact on the Company’s ability to gain reimbursement coverage and regulatory approvals, the markets for theCompany’s current and future products may not be as large as the Company projects or grow as anticipated, the Company may not be able toachieve the market share it anticipates, including in the international market, the Company may face more and more effective competition,the Company may not continue to achieve significant process improvements and efficiencies, and the Company may be unable to achieve themilestones and financial projections in the “3 in 1 and 20” plan, market demand for the Company’s products may not grow or could decline,and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, withoutlimitation, its 10‐K filing for the fiscal year ended December 31, 2016. By making these forward‐looking statements, the Company does notundertake to update, them in any manner except as may be required by the Company's disclosure obligations in filings it makes with theSecurities and Exchange Commission under the federal securities laws.

2

Page 3: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

INVESTMENT HIGHLIGHTS

• Global Company Delivering Innovative Placental Tissue Based Regenerative Therapies and Therapeutic Biologics that Restore Function and Improve Quality of Life

• Opportunity to use a Product Under the 361 Regulations before Conducting a BLA Trial Provides Unique Clinical Trial and Revenue Benefits 

• “3 and 1 in 20” Strategic Plan Triples 2015 Revenues to $560M and Delivers $1.00 of Adjusted Earnings in 2020

• Sustain 20%+ Revenue Growth Over the Long Term

• 86% Gross Margins and Strong Balance Sheet

• Deliver P&L Leverage in 2017 and Beyond

• Since May 2014, Executed $69M of a $86M Share Repurchase Program

3

Page 4: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

COMPANY HIGHLIGHTS

• 5 Innovative Technology Platforms

• Over 100* Issued and Allowed Patents

• Proprietary Purion Processed Placental Tissue Allograft Contains a Milieu of 220 Proteins (Growth Factors, Chemokines and Cytokines) 

• Industry Leader in the Amniotic and Placental Tissue Market

• Emerging Leader in the Surgical and Ortho‐Biologics Market

• In 2020 Complete Transition to a Biopharmaceutical Company– Existing Products Remain Regulated through Section 361 of PHSA– New Products Regulated through Section 351 of PHSA under IND/BLA– Pain Management, Respiratory Disease and Cardiovascular Disease are Large 

Biopharmaceutical Opportunities

*owned and licensed

4

Page 5: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

EXPERIENCED MANAGEMENT TEAM

Thornton A. KuntzSenior Vice President,HR & Administration

Deborah L. DeanExecutive Vice President

Christopher M. CashmanExecutive Vice President & 

Chief Commercialization Officer

Mark E. DiazSenior Vice President, Commercial Operations

Dr. Rebeccah Brown Vice President, 

Global Regulatory Affairs

Dr. Donald E. FetterolfChief Medical Officer    

Dr. Thomas J. Koob Chief Scientific Officer

Dr. I. Mark LandyVice President, 

Strategic Initiatives

Scott M. TurnerSenior Vice President,

Operations & Procurement

Michael W. CarltonSenior Vice President,

Global Sales

Kevin D. LillySenior Vice President,

Sales

Marlene M. DeSimoneSenior Vice President,

Marketing

5

Parker H. “Pete” PetitChairman & CEO

William C. TaylorPresident & COO

Michael J. SenkenChief Financial Officer

Alexandra O. Haden General Counsel

Page 6: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

0

10

20

30

40

50

60

70

$’s ‐

Millions

DELIVERING CONSISTENT SUSTAINABLE GROWTH

• 25 Consecutive Quarters of Sequential Revenue Growth• Met or Exceeded Revenue Guidance in 24 of Last 25 Quarters

6

Page 7: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

2017 GROWTH DRIVERS

• 2016 New Product Launches: EpiCord, AmnioFill, OrthoFlo Lyo

• Continued Sales Force Expansion

• Clinical Trial Results and Publications

• Incremental Commercial Reimbursement Coverage for DFU and VLU

• International Expansion

• Continued Leverage of GPO/IDN Contracts 5 Group Purchasing Organizations (GPO) contracts in place

‐ 4 have 80% or sole commitment tiers for Amniotic Tissue/Skin Substitute‐ Covers approximately 4,000 hospitals

40 Integrated Delivery Networks (IDN) Contracts‐ Covers approximately 1,300 hospitals‐ Many have committed Amniotic Tissue Contracts 

7

Page 8: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

5‐YEAR STRATEGIC PLAN: “3 AND 1 IN 20”

In 2020: Triple 2015 Revenue, Deliver $1.00 of adjusted EPS and Complete Transition to a Biopharmaceutical Company

$560M$187M

Wound Care Operating Room Pain Management

* Adjusted

8

2020 AssumptionsOrganic Rev Growth

107.5M FDSO*EBITDA 30%

Tax 36% 

Page 9: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

U.S. WOUND BIOLOGICS MARKET IN 2020

2020 Skin/Dermal Substitute (SDS) Segment Sales Estimate $1.1B 2020 Amniotic Tissue Share Estimate 58% vs. 29% in 2014

2016 SDS Sales Estimate $681M up 15% vs. 20152016 MiMedx Amniotic Tissue Share 63%

9

SmartTRAK Business Intelligence and Company Estimates

39%

6%34%

21%

44.7%

5.9%

31.9%

17.5%

58%

5%

27%

10%

Amniotic Tissue Allografts Xenografts Cell‐Based Bioengineering

2015 SDS Segment

$587M2016 SDS Segment

$681M2020 SDS Segment

$1.1B

Page 10: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

2016 WOUND SKIN SUBSTITUTE MARKET UPDATE

• FY 2016 Total Spend Estimated at $680.7M– +15% Growth Over 2015*

• MiMedx:– 31.0% Share for 4Q16; 24.9% Share in FY 2015

• Integra– 21.1% Share for 4Q16; 19.4% Share in FY 2015

• 3Q16 Share was 21.6% and 1Q16 was 21.7%• Does not include Derma Sciences Acquisition• AmnioMatrix and AmnioExcel 2016 Product Revenue Totaled ~$3.3M

– Integra Burn Revenue Estimated at $40M• 15% Market Share Excluding Burn Product

– Omnigraft IDRT CMS Hospital Outpatient Spend was $41K in 3Q16 and $68K for 9 Months (2016)

10

Page 11: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

CHRONIC WOUND MARKET IS UNDERPENETRATED

2015 6.5M US Patients have 

Chronic Wounds

3M are non‐healing wounds

2016 U.S. Market Facts• Annual Cost of Treating Chronic Wounds 

in the U.S. is $25 Billion• Skin/Dermal Substitutes is the Largest 

Segment at $681 Million

MiMedx is the Market Leader at 30%

• Sales of Placenta Derived / Amniotic Tissue Products Grew 33% to $305M MiMedx is the Market Share Leader at 63%

1.4M Chronic DFU/VLU Wounds ‐ $3B Mkt Opportunity Alone

SmartTRAK Business Intelligence

Under 200K Are Treated With A Skin or Dermal Substitute 

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Page 12: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

Wound Care Operating Room Pain Management

Wound Care Growth Drivers 

1. Continue To Take Market Share • Leverage Safety Advantage of Terminal Sterilization • Expand Scientific and Clinical Body of Evidence • Increase Lives Under Coverage• Broaden Reach In IDN / GPO Contracts• New Products• New Settings, Long‐term Care (LTAC)

2. Expand The Market• Secondary City Expansion• Convert Physicians that do not

use AWC Products• Influence and Improve Referral 

Patterns

3. International Expansion

WOUND CARE GROWTH TARGET: 5YR 20% CAGR

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Page 13: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

EPIFIX VLU MULTICENTER TRIAL INTERIM ANALYSIS

13

Note: The MiMedx control was more efficacious than the Apligraf control

17%

33%

58%

72%

11%

24%

41%46%

0%

20%

40%

60%

80%

100%

Week 4 Week 8 Week 12 Week 16

VLU: EpiFix vs. Control % Subjects Complete Wound Closure

EpiFix (N=36) Control (N=37)

9%

29%37%

57%

5%

19%24%

40%

0%

20%

40%

60%

80%

100%

Week 4 Week 8 Week 12 Week 24

VLU: Apligraf vs. Control % Subjects Complete Wound Closure

Apligraf (N=130) Control (N=110)

17%

33%

58%

72%

9%

29%37%

57%

0%10%20%30%40%50%60%70%80%90%100%

Week 4 Week 8 Week 12 Week 16 Week 24

EpiFix vs. Apligraf VLU Study Results

EpiFix (N=36) Apligraf (N=130)

Controls: Multi‐Layer Compression Therapy withEpiFix – NuDerm AlginateApligraf – Moist Gauze with Zinc Paste

Please note: Apligraf and EpiFix studies are independent of one anotherApligraf Reference: PMA Supplement (P950032) approval dated 05/22/1998EpiFix Reference: Interim Data Report, report dated 11/04/2016

Page 14: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

VLU COMMERCIAL COVERAGE IMPACT MODEL

14

2015 6.5M US Patients have 

Chronic Wounds

3M are non‐healing wounds

Market Penetration

# of Applications 5% 10.0% 15.0% 20.0% 25.0% 30.0%

1 $    12,184,780  $    24,369,560  $    36,554,340  $    48,739,119  $    60,923,899  $    73,108,679 

2 $    24,369,560  $    48,739,119  $    73,108,679  $    97,478,239  $  121,847,799  $  146,217,358 

3 $    36,554,340  $    73,108,679  $  109,663,019  $  146,217,358  $  182,771,698  $  219,326,038 

4 $    48,739,119  $    97,478,239  $  146,217,358  $  194,956,478  $  243,695,597  $  292,434,717 

5 $    60,923,899  $  121,847,799  $  182,771,698  $  243,695,597  $  304,619,497  $  365,543,396 

Total EpiFix® Commercial Lives DFU/VLU 198,000,000

Currently Uncovered VLU (67%) 132,955,205

VLU Prevalence Rate 0.183%*

Additional VLU Patients when covered 243,696

EpiFix® Average Price $1,000

*Under 65 Truven Data

Page 15: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

SDS COMPETITIVE PRODUCT COMPARISON

Apligraf and Dermagraft are registered trademarks of Organogenesis, Inc.Omnigraft and PriMatrix are registered trademarks of Integra Life Sciences Corporation. AMNIOEXCEL is registered trademark of BioD, LLC, an Integra Life Sciences company.BIOVANCE is a registered trademark of Alliqua Biomedical, Inc.Grafix is registered trademark of Osiris Therapeutics, Inc.References provided at end of presentation.

15

Page 16: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

Operating Room Growth Drivers 

1. Increase Footprint• Continue to Hire Direct Surgical Reps, 

Currently at 30• Deeper Penetration of GPO and IDN 

Contracts

2. Expand Product Line• New Product Launches:

AmnioFill, OrthoFlo LYO• Synergistic Acquisitions    

3. Grow Demand• Publish Clinical Trials Showing 

Improved Surgical Outcomes and Reduced Complications

• Increase Number of VAC Approvals

OPERATING ROOM GROWTH TARGET: 5YR 20% CAGR

Wound Care Operating Room Pain Management

16

Page 17: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

TARGET HIGH VALUE SURGICAL PROCEDURES 

Source: Millenium Research Group, MRG Lap 2014, ASPS Statistics, MiMedx 2015 Annual Plan, MiMedx internal coding data, Management Estimates

$2.9B

UROLOGYProstatectomy, Partial Nephrectomy, 

Cystectomy

GENERAL COLORECTALBariatric, Fistula Repair,

GI Anastomosis

PLASTICSHand‐Tendon and Nerves, Mohs, 

Scar Revision, Skin Grafting, Surgical Site Dehiscence, Burn

GYNHysterectomy, Endometriosis, 

Myomectomy, C‐Section, Episiotomy

4.3MNumber of Procedures (000)

$5.7BAddressable Market Value ($M)

1,154

652

714

237

1,000

990

200

714

OrthopedicsSpine, Trauma, Extremities , 

Sports Medicine1,528 2,821

17

Page 18: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

TRANSITION TO A BIOPHARMACEUTICAL COMPANY

• Lead Product contains a Milieu of 220+ Proteins with a Unified Mechanism of Action and Proven Safety Profile

• Extensive Placental Tissue Technology Patent Family covers BLA Indications

• Opportunity to use a Product Under the 361 Regulations before conducting a BLA Trial Provides Unique Clinical Trial and Revenue Benefits 

• Release Interim Phase 2b Data from Lead BLA Program in 3Q17 and Initiate Phase 3 Trial in 4Q17 or Early 2018

• File IND for Second Indication and Initiate Phase 2 Trial in 3Q17

• Exiting 2020 Biopharma Sales Approximately 20% of Total Revenue

18

Page 19: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

INITIAL BLA FOCUS IS PAIN MANAGEMENT

19

Wound Care

Operating Room

Pain Management

2017   2018 2019  2020 2021

Knee OA Pain

Plantar Fasciitis Pain

BLA Launch361 Reimbursement opportunityOut of pocket pay

Everyday use Under 361 Regulations Provides the Opportunity to Generate Pain Revenue while the BLA Process is Ongoing

Out of pocket pay BLA Launch

Page 20: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

SmartTRAK Business Intelligence and Company Estimates

2015 U.S. JOINT PAIN INJECTION MARKET

20

Page 21: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

A SAFER MORE EFFECTIVE PRODUCT IS NEEDED

21

*

* Toxic side effects and limited efficacy   ** Limited efficacy 

**

*

****

**

Page 22: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

AMNIOFIX INJECTABLE POSITIONING OPTIONS

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Page 23: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

PAIN MANAGEMENT CLINICAL TRIAL MILESTONES

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Page 24: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

RESPIRATORY AND CARDIOVASCULAR UPDATE

• Respiratory System– Completing Drug Discovery and 

Design Process– Initiating Pre‐Clinical Development 

Program – Current Goal is to Begin Human 

Testing in 4Q 2018

• Cardiovascular System– Published Small Animal Study– Refining Development Program– Optimizing Delivery System 

Scanning Electron Microscope Slides of Respirable Particles

Particle size distribution

24

Page 25: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

FINANCIAL HIGHLIGHTS

Q1 2017 Q1 2016 Change

Revenue $72.6M $53.4M +36%

Gross Margin % 88.0% 85.1% +290 bps

Adj. GM* 88.1% 86.5% +160 bps

R&D % 5.8% 4.7% +110 bps

S,G&A 72.9% 76.2% ‐330 bps

Net Inc. $4.3M $1.2M +261%

Adj. NI*  $7.4M $4.9M +51%

Adj. EBITDA* $12.4M $9.1M +37%

Cash from Ops $10.6M ($1.0M) +$11.6M

25

*(non‐GAAP)

Page 26: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

FINANCIAL HIGHLIGHTS

26

0

50

100

150

200

250

300

350

2014 2015 2016 2017 (Est.)

Revenue

Wound SSO

2017 Revenue Guidance = $303.5M ‐ $307M

Page 27: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

KEY 2017 MILESTONES

Positive Aetna and KaiserCoverage Decisions

• First Half 2017– First Patent Infringement Trial– Report  VLU Multicenter Data– Report  DFU Multicenter Data

• Mid‐2017– Plantar Fasciitis llb Interim Data– Publish GI Anastomosis Data

• Second Half 2017– Publication VLU Multicenter Trial– Publication DFU Multicenter Trial– Report Prostatectomy Data– Knee OA Data

• 2017– Additional “Reimbursement Wins”

• 2018– Plantar Fasciitis Phase llb Data– Knee OA Data

27

Page 28: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such
Page 29: 2017 06 07 MiMedx Investor Presentation FINAL · This presentation includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such

REFERENCES

1. http://www.apligraf.com/professional/pdf/FDAApprovalLetter.pdf2. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p0000363. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm480564.htm4. http://www.prnewswire.com/news‐releases/derma‐sciences‐expands‐access‐of‐its‐amniotic‐tissue‐product‐line‐with‐new‐premier‐inc‐agreement‐

300024252.html5. http://www.accessdata.fda.gov/cdrh_docs/pdf8/k083440.pdf6. http://ir.alliqua.com/press‐releases/detail/544/alliqua‐to‐launch‐biovancer‐human‐amniotic‐membrane7. http://investor.osiris.com/annuals‐proxies.cfm; 2011.8. www.clinicaltrials.gov. Accessed 03/01/17.9. Zelen CM, Serena TE, Denozière G, Fetterolf DE. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of 

diabetic foot ulcers. Int Wound J. 2013 Oct;10(5):502‐7.10. Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion 

membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014 Apr;11(2):122‐8.11. Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi‐centre comparative effectiveness study of healing using 

dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015 Dec;12(6):724‐32.

12. Zelen CM, Serena TE, Gould L, Le L, Carter MJ, Keller J, Li WW. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi‐centre comparative study examining clinical efficacy and cost. Int Wound J. 2016 Apr;13(2):272‐82.

13. Veves A, Falanga V, Armstrong DG, Sabolinski ML. “Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial.” Diabetes Care. (24)2. 2001. pp 290‐5.

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19. Public domain

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