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27.07.2017 01:13:00

MiMedx Announces Record Results For The Second Quarter Of 2017 And Raises Full Year Revenue Guidance

MARIETTA, Ga., July 26, 2017 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today its record results for the second quarter of 2017.

Second Quarter 2017 Highlights

  • Q2 2017 Revenue of $76.4 million exceeds MiMedx guidance range of $73.5 to $75.0 million
  • Q2 2017 Revenue grew 33% over Q2 2016 revenue
  • Wound Care revenue of $54.7 million grew 30% over Q2 2016
  • Surgical, Sports Medicine and Orthopedics (SSO) revenue of $21.7 million grew 42% over Q2 2016
  • 25 of 26 quarters of meeting or exceeding revenue guidance
  • Gross profit margin of 89%
  • Net income of $8.1 million is a 309% increase over Q2 2016
  • Positive Net Cash Flow from Operations of $13.5 million compared to $7.3 million in Q2 2016
  • 22nd consecutive quarter of positive Adjusted EBITDA*
  • Adjusted EBITDA* of $14.2 million is a 41% increase over Q2 2016
    * See the accompanying tables for definitions of each Non-GAAP metric. Reconciliations of GAAP Net Income to Adjusted EBITDA, GAAP Gross Margin to Adjusted Gross Margin, and GAAP Net Income to Adjusted Net Income and Adjusted Diluted Net Income Per Share appear in the tables below. These non-GAAP measures include, but are not limited to, adjustments for non-cash charges associated with purchase accounting related to the Stability Biologics acquisition, normalization of tax expense, one-time non-recurring cash charges and share based compensation expense.

The Company recorded record revenue for the 2017 second quarter of $76.4 million, a $19.1 million or 33% increase over 2016 second quarter revenue of $57.3 million. The Company's gross margin for the quarter ended June 30, 2017, was 89%, as compared to the 87% gross margin in the second quarter of 2016. Net Income for the second quarter of 2017 was $8.1 million, or $0.07 per diluted common share, a $6.1 million or 309% increase, as compared to Net Income of $2.0 million, or $0.02 per diluted common share in the second quarter of 2016.  Adjusted EBITDA* for the quarter ended June 30, 2017, was $14.2 million, a $4.1 million or 41% improvement, as compared to Adjusted EBITDA* of $10.1 million for the second quarter of 2016. 

The Company recorded record revenue for the six months ended June 30, 2017 of $149 million, a $38.3 million or 35% increase over revenue for the six months ended June 30, 2016 of $110.7 million. The Company's gross margin for the six months ended June 30, 2017, was 88%, as compared to 86% gross margin in the same period of 2016. Net Income for the first six months of 2017, was $12.4 million, or $0.11 per diluted common share, a $9.2 million or 291% increase, as compared to Net Income of $3.2 million, or $0.03 per diluted common share in the first six months of 2016.  Adjusted EBITDA* for the six months ended June 30, 2017, was $26.6 million, a $7.4 million or 39% improvement, as compared to Adjusted EBITDA* of $19.1 million for the six months ended June 30, 2016. 

Management Commentary
Parker H. "Pete" Petit, Chairman and CEO stated, "We are very pleased with our second quarter results. We exceeded the top end of our guidance and produced impressive earnings and cash flow. The second quarter was our 26th consecutive quarter of sequential revenue growth, the 25th of the last 26 quarters of meeting or exceeding our revenue guidance, and our 22nd consecutive quarter of positive Adjusted EBITDA. Our second quarter performance generated strong operating cash flow of $13.5 million, an 85% increase over prior year. We continued to make significant improvement in our collection of accounts receivable during the quarter, and we ended the quarter with a Days Sales Outstanding (DSO) of 72 which exceeded our internal target of 75."

Bill Taylor, President and COO, said, "The second quarter was driven by the very solid performance of our sales organization. We gained continued momentum during the quarter and feel poised to deliver stronger performances in the third and fourth quarters. Adding additional fuel to this momentum is the performance of the three new products we launched during 2016: EpiCord®, our new dehydrated human umbilical cord allograft; AmnioFill®, the first product in the MiMedx placental collagen matrix product family; and OrthoFlo Lyophilized, an extension of the Company's amniotic fluid product family. Each performed well during the quarter, and they are living up to our expectations for utilization in the market.  We anticipate the trend these new products experienced in the first and second quarters of this year, will continue in future quarters."

Petit commented on the status of the Company's clinical trials, "In addition to the momentum that our sales force is gaining, our scientific and clinical functions are making terrific progress demonstrating the efficacy of our allografts. We have completed our fifteen-center multicenter Randomized Control Trial (RCT) evaluating the efficacy of our EpiFix allografts for the treatment of Venous Leg Ulcers (VLUs). The paper chronicling the study results is currently undergoing peer review by a major journal. We are looking forward to sharing these impressive results and conclusions later in the third quarter."

Petit continued, "Our Plantar Fasciitis Phase 2B trial is progressing extremely well. We submitted applications to the FDA at the end of June requesting closure of the 2B trial, publishing of the interim results, and initiation of the Phase 3 trial for Plantar Fasciitis. Additionally, the Company will be completing the filing of two additional INDs in the biopharmaceutical area in the near future."

Liquidity and Cash Flow
Cash on hand as of June 30, 2017, was $47.5 million, as compared to $34.4 million as of December 31, 2016. Cash from operations for the quarter was $13.5 million driven by improved collections of accounts receivable and improved inventory turns somewhat offset by the payment of $8.2 million in income taxes in the quarter. Cash used for investing activities for the quarter was comprised of $1.8 million in capital expenditures primarily in support of increased production capacity driven by projected demand. Net cash flow from financing activities for the quarter was $4.9 million driven by the exercise of stock options somewhat offset by the repurchase of company stock under our share repurchase plan.

Share Repurchase Program
During the quarter, the Company acquired $2.1 million in repurchased shares, and since the May 2014 inception of the program through June 30, 2017, the Company has acquired a total of $71 million in repurchased shares. On July 26, 2017, the MiMedx Board of Directors authorized an additional increase of $14 million to the Company's Share Repurchase Program, bringing the total authorized to date to $100 million. "Our share repurchases have proven to be very wise investments for the Company," noted Petit. 

GAAP Earnings
The Company recorded Net Income of $8.1 million for the quarter ended June 30, 2017, or $0.07 per diluted common share, as compared to a Net Income of $2.0 million, or $0.02 per diluted common share, for the quarter ended June 30, 2016. The Company recorded Net Income of $12.4 million for the six months ended June 30, 2017, or $0.11 per diluted common share, as compared to a Net Income of $3.2 million, or $.03 per diluted common share, for the same period of 2016. 

Gross margin for the quarter was 88.7% as compared to 87.1% in the prior year. Year to date gross margins were 88.3% as compared to 86.1 % in 2016. The improvement was driven by higher sales volume and improved manufacturing efficiencies and yield improvements, as well as the  one-time inventory costs incurred in connection with the Stability acquisition that were reported during the same period of 2016.

Second quarter 2017 Research & Development ("R&D") expenses were $4.7 million or 6.2% of Net Sales, an increase of $1.6 million over second quarter 2016 R&D expenses of $3.2 million. R&D expenses for the first 6 months of 2017 were $8.9 million or 6.0% of Net Sales, an increase of $3.3 over R&D expenses of $5.7 million for the same period of 2016. The increase was driven by greater investments in clinical trials.

Selling, general and administrative ("SG&A") expenses for the second quarter of 2017 were $55.3 million, a $12.5 million increase over second quarter of 2016 SG&A expenses of $42.8 million.  SG&A expenses for the first six months of 2017 were $108.3 million, a $24.8 million increase over SG&A expenses of $83.4 million for the same period in 2016.  Increases in SG&A were primarily due to the continuation of the buildup of the Company's direct sales force in Wound Care and SSO sales channels, as well as legal costs. 

The company recorded an income tax credit in the quarter of $1.0 million as compared to income tax expense of $1.5 million in the second quarter of 2016. The credit was due to a large compensation related discrete income tax benefit driven by a greater number of stock option exercises in the quarter.

Revenue Breakdown
The Company distinguishes revenue in two categories: (1) Wound Care and (2) Surgical Sports Medicine and OEM (SSO) applications. For the second quarter of 2017, Wound Care revenue was $54.7 million, representing a year over year increase of 30%, driven by continued sales force and market expansion. SSO revenue was $21.7 million, represents a 42% increase over prior year driven by sales force expansion and new product introductions.

Third Quarter and Full Year 2017 Guidance Highlights
MiMedx provided its revenue guidance for the third quarter of 2017, increased both the upper and the lower ends of its revenue guidance range for full year 2017, and increased the lower end of its guidance range for full year gross profit margins.  The Company's third quarter and full year 2017 guidance includes:

  • Third quarter of 2017 revenue forecasted to be in the range of $79 to $80 million
  • 2017 revenue guidance increased to the range of $309 to $311 million
  • Gross profit margins for 2017 expected to be in the range of 87% to 88%
  • GAAP EPS for 2017 projected to be in the range of $0.18 to $0.20
  • Adjusted EPS* for 2017 projected to be in the range of $0.31 to $0.33

"Our first six months of 2017 was extremely strong and we are very confident in our ability to meet or exceed our 2017 expectations," concluded Petit.

Earnings Call
MiMedx will host a live broadcast of its second quarter conference call on Thursday, July 27, 2017 at 10:30 a.m. eastern time.  A listen-only simulcast of the MiMedx conference call will be available online at the Company's website at www.mimedx.com.  A 30-day online replay will be available approximately one hour following the conclusion of the live broadcast.  The replay can also be found on the Company's website at www.mimedx.com.

Use of Non-GAAP Financial Measures
Management has disclosed adjusted financial measurements in this press announcement that present financial information that is not in accordance with generally accepted accounting principles ("GAAP").  These measurements are not a substitute for GAAP measurements, although Company management uses these measurements as aids in monitoring the Company's on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. For a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measure, see the accompanying tables to this release.  Adjusted financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.  Investors should consider adjusted measures in addition to, and not as a substitute for, or superior to, financial performance measures prepared in accordance with GAAP.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilizationMiMedx is the leading supplier of placental tissue, having supplied over 900,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the Company's financial expectations for the third quarter and the full year, the trend expectations for the Company's new products, expectations for publication of the VLU study results, and the expected completion of two new INDs.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company's revenue may not grow as expected or may decline, even if revenue is achieved; delays in publication of the VLU study results, delays in the Company's ability to initiate the Phase 3 trial and complete additional INDs, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016 and its most recent 10-Q filing.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

 

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)










 June 30,
2017
(unaudited) 


 December 31,
2016 

ASSETS




Current assets:




Cash and cash equivalents

$            47,533


$           34,391

Accounts receivable, net

60,738


67,151

Inventory, net

15,033


17,814

Prepaid expenses 

8,218


5,894

Other current assets

1,024


1,288

    Total current assets

132,546


126,538

Property and equipment, net of accumulated depreciation

14,419


13,786

Goodwill

20,203


20,203

Intangible assets, net of accumulated amortization

22,289


23,268

Deferred tax asset, net

10,144


9,114

Deferred financing costs and other assets

264


354

    Total assets

$          199,865


$         193,263

LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable

$            11,504


$           11,436

Accrued compensation

14,719


12,365

Accrued expenses

7,986


10,941

Current portion of earn out liability

17,574


8,740

Income taxes

(822)


5,768

Other current liabilities

550


1,482

    Total current liabilities

51,511


50,732

Earn out liability

-


8,710

Other liabilities

1,084


821

    Total liabilities

52,595


60,263

Commitments and contingencies 




Stockholders' equity:




Preferred stock; $.001 par value; 5,000,000 shares authorized and 0 shares issued and
outstanding

-


-

Common stock; $.001 par value; 150,000,000 shares authorized;
112,534,526 issued and 112,462,283  outstanding at June 30, 2017 and 110,212,547 issued
and 109,862,787 outstanding at December 31, 2016

112


110

Additional paid-in capital

161,883


161,261

Treasury stock at cost:
72,243 shares at June 30, 2017 and 349,760 shares at December 31, 2016

(966)


(2,216)

Accumulated deficit

(13,759)


(26,155)

    Total stockholders' equity

147,270


133,000

      Total liabilities and stockholders' equity

$          199,865


$         193,263

 

 

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(in thousands, except share and per share data) 

(unaudited)










Three Months Ended June 30,


Six Months Ended June 30,


2017


2016


2017


2016

Net sales

$            76,412


$          57,342


$          149,019


$        110,710

Cost of sales

8,631


7,394


17,374


15,341

Gross margin

67,781


49,948


131,645


95,369









Operating expenses:








Research and development expenses

4,747


3,168


8,949


5,664

Selling, general and administrative expenses

55,314


42,772


108,265


83,420

Amortization of intangible assets

507


447


1,033


1,257

Operating income 

7,213


3,561


13,398


5,028









Other expense, net








Interest expense, net

(149)


(111)


(294)


(167)









Income before income tax provision

7,064


3,450


13,104


4,861

Income tax (provision) benefit

1,005


(1,475)


(708)


(1,689)









Net Income

$              8,069


$            1,975


$            12,396


$            3,172









Net income per common share - basic

$                0.08


$              0.02


$                0.12


$              0.03









Net income per common share -  diluted

$                0.07


$              0.02


$                0.11


$              0.03









Weighted average shares outstanding - basic

106,805,162


106,191,932


106,254,433


105,873,727









Weighted average shares outstanding -  diluted

117,285,865


112,148,415


115,856,317


112,095,051

 

 

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)










Three Months Ended June 30,


Six Months Ended June 30,


2017


2016


2017


2016

Cash flows from operating activities:








Net income

$               8,069


$              1,975


$             12,396


$              3,172

Adjustments to reconcile net income to net cash from
operating activities:








Depreciation

1,115


821


2,061


1,555

Amortization of intangible assets

507


447


1,033


1,257

Amortization of inventory fair value step-up

78


490


153


1,224

Amortization of deferred financing costs

45


42


90


91

Share-based compensation

5,255


4,509


9,926


9,124

Change in deferred income taxes

(614)


(356)


(1,030)


(356)

Increase (decrease) in cash, net of effects of acquisition,
resulting from changes in:








Accounts receivable

6,108


(980)


6,413


894

Inventory

939


(1,981)


2,628


(2,245)

Prepaid expenses 

(1,340)


285


(2,324)


(1,781)

Other current assets

177


(117)


264


92

Accounts payable

613


(1,332)


234


(5,597)

Accrued compensation

3,117


851


2,354


(4,789)

Accrued expenses

(1,891)


1,851


(2,833)


2,344

Income taxes

(8,661)


977


(6,590)


1,388

Other liabilities

(34)


(202)


(652)


(70)

Net cash flows from operating activities

13,483


7,280


24,123


6,303









Cash flows from investing activities:








Purchases of equipment

(1,771)


(1,747)


(2,694)


(3,755)

Purchase of Stability Inc., net of cash acquired

-


-


-


(7,631)

Fixed maturity securities redemption

-


2,500


-


3,000

Patent application costs

(8)


(180)


(54)


(327)

Net cash flows from investing activities

(1,779)


573


(2,748)


(8,713)









Cash flows from financing activities:








  Proceeds from exercise of stock options

7,327


878


9,192


2,016

  Stock repurchase under repurchase plan

(2,078)


-


(14,744)


(3,530)

  Stock repurchase for tax withholdings on vesting of
restricted stock

(339)


-


(2,666)


(684)

  Deferred financing costs

-


(41)


-


(61)

  Payments under capital lease obligations

(5)


(4)


(15)


(14)

Net cash flows from financing activities

4,905


833


(8,233)


(2,273)









Net change in cash

16,609


8,686


13,142


(4,683)









Cash and cash equivalents, beginning of period

30,924


15,117


34,391


28,486

Cash and cash equivalents, end of period

$             47,533


$            23,803


$             47,533


$            23,803

 

 

MIMEDX GROUP, INC. AND SUBSIDIARIES

Non-GAAP Financial Measures and Reconciliation









In addition to our GAAP results, we provide certain Non-GAAP metrics including Adjusted EBITDA, Adjusted Gross Margin, Adjusted Net Income and Adjusted Diluted Net Income per share. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance.   These measurements are not a substitute for GAAP measurements, although Company management uses these measurements as aids in monitoring the Company's on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. Adjusted EBITDA consists of GAAP Net Income excluding: (i) depreciation and amortization, (ii) interest income and expense, (iii) income taxes,  (iv) one time acquisition related costs, (v) the effect of purchase accounting due to acquisitions and (vi) share-based compensation expense.   Due to the impact of the acquisition of Stability in January 2016 and the release of the valuation allowance on the deferred tax asset on reported tax expense in 2015 on results, we have decided to provide additional adjusted non-GAAP measures to provide comparability of normal ongoing operating results. Beginning in 2016, we have reported Adjusted Gross Margin, Adjusted Net Income and Adjusted Diluted Net Income per Share to normalize results for comparison purposes.  Adjusted Gross Margin consists of GAAP gross margin excluding amortization of inventory fair value step-up. Adjusted Net Income and Adjusted Diluted Net Income per share consists of GAAP net income excluding: (i) one time acquisition related costs, (ii) amortization of inventory fair value step-up, (iii) amortization of intangible assets and (iv) share-based compensation. Reconciliations of GAAP net income to Adjusted EBITDA, GAAP Gross Margin to Adjusted Gross Margin and GAAP Net Income to Adjusted Net Income and Adjusted Diluted Net Income per Share for the three and six months ended June 30, 2017 and 2016 appear in the tables below (in thousands):


















Three Months Ended June 30,


Six Months Ended June 30,


2017


2016


2017


2016

Net  Income (Per GAAP)

$         8,069


$        1,975


$       12,396


$        3,172









Add back:








  Income taxes (expense) benefit

(1,005)


1,475


708


1,689

  One time costs incurred in connection with acquisition


138



851

  One time inventory costs incurred in connection with acquisition

78


597


153


1,331

  Other interest expense, net

149


111


294


167

  Depreciation expense

1,115


821


2,061


1,555

  Amortization of intangible assets

507


447


1,033


1,257

  Share-based compensation

5,255


4,509


9,926


9,124

Adjusted EBITDA

$       14,168


$      10,073


$       26,571


$      19,146

 

 

Reconciliation of "Adjusted Gross Margin" defined as Gross Margin before Amortization of inventory fair value step-up (in thousands): 























Three Months Ended June 30,


Six Months Ended June 30,


2017


2016


2017


2016

Gross Margin (Per GAAP)

$             67,781


$          49,948


$           131,645


$          95,369









Non-GAAP Adjustments:








  One time inventory costs incurred in connection with
  acquisition

78


597


153


1,331

Gross Margin before Amortization of inventory fair value step-up

$             67,859


$          50,545


$           131,798


$          96,700

Adjusted Gross Margin

88.8%


88.2%


88.4%


87.3%



Reconciliation of "Adjusted Net Income" and "Adjusted Diluted Net Income" per share defined as Net Income less Amortization, One Time Costs and Share-Based Compensation (in thousands, except share and per share data): 























Three Months Ended June 30,


Six Months Ended June 30,


2017


2016


2017


2016

Net income (Per GAAP)

$          8,069


$             1,975


$        12,396


$             3,172









Non-GAAP Adjustments:








  Tax rate normalization*

(3,561)


(12)


(3,916)


(362)

  One time costs incurred in connection with acquisition


138



851

  One time inventory costs incurred in connection with acquisition

78


597


153


1,331

  Amortization of intangible assets

507


447


1,033


1,257

  Share-based compensation

5,255


4,509


9,926


9,124

  Estimated income tax impact from adjustments

(2,119)


(2,525)


(3,924)


(5,302)

Adjusted Net Income

$          8,229


$             5,129


$        15,668


$           10,071

Adjusted Diluted Net Income per Share

$            0.07


$               0.05


$            0.14


$               0.09

Denominator for diluted earnings per share - weighted average
shares adjusted for dilutive securities

117,285,865


112,148,415


115,856,317


112,095,051









* Assumes a normalized tax rate of 42% for 2016 and 35% for 2017.








 

 

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SOURCE MiMedx Group, Inc.

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