Exhibit 99.1

 

axogen-inc-logo.jpg

 

AxoGen, Inc. Reports Financial Results for Second Quarter 2016

 

Second Quarter Revenues of $10.4M grew 62% over prior year

 

ALACHUA, FL – August 3, 2016 – AxoGen, Inc. (NASDAQ: AXGN), a global leader in innovative surgical solutions for peripheral nerve injuries, today announced financial results for the second quarter ended June 30, 2016 and provided a business update.

 

Second Quarter 2016 Year-Over-Year Financial and Recent Business Highlights

 

·

Revenue of $10.4 million up 62% compared to 2015 revenue of $6.4 million

·

Gross margin of 85.2% compared to 2015 gross margin of 83.8%

·

Improved EBITDA loss of $1.5 million compared to 2015 EBITDA loss of $2.1 million

·

Six peer reviewed publications year to date

·

New data presented in four presentations at the 2016 Federation of European Societies for Surgery of the Hand

·

AxoGen was added to the 2016 Russell 2000® Index

 

“We are very pleased with our quarterly results as we continue to execute our strategy”, commented Karen Zaderej, President and Chief Executive Officer. “This is the first time that our revenue has exceeded $10 million in a quarter and marks the twenty second consecutive quarter of year over year double digit revenue growth. Our revenue growth continues to be fueled by deeper penetration into existing accounts as well as the addition of new accounts. Moreover, we are reducing our operating loss while continuing to grow in our largely untapped market. With our innovative products and efforts in market development, we believe we are changing how surgeons perform nerve repair.”

 

Additional Operational and Financial Highlights

 

·

Active accounts in the second quarter numbered 374 up 42% from 264 a year earlier

·

Identified over 5,100 potential accounts in the U.S. alone

·

Ended the quarter with 44 direct sales representatives up from 32 a year ago

·

Year to date have conducted 6 national education courses with 165 surgeons

·

Adding one additional national surgeon education course for a total of 13 this calendar year

·

Ended the quarter with $18.3 million in cash and $25.0 million in debt

·

Use of cash in the quarter was $2.7 million

 


 

2016 Financial Guidance

Management is increasing its full year 2016 revenue guidance to over $40 million and increasing its full year 2016 gross margin guidance to exceed 80%.

 

Upcoming Events

The Company will be presenting additional data and hosting a small investor event at the American Society of Surgery for the Hand 2016 Meeting in Austin, Texas on Wednesday, September 28.  The investor event will provide an opportunity to hear directly from key surgeons on current trends in nerve repair and their use of the AxoGen portfolio of products. 

 

The Company is also announcing that it will be conducting its first analyst and investor day on Monday, November 21 in New York City.  This event will provide an additional opportunity to educate the investment community about the Company and introduce them to surgeons that use the AxoGen portfolio of products. 

 

Ms. Zaderej summarized, “We believe we are making the right investments in our business and executing well on our strategy. We are seeing positive changes in our industry as surgeons increasingly adopt our innovative proprietary products in their nerve repair algorithms. We believe we are just scratching the surface of our market potential and have years of growth ahead as we move towards profitability.”

 

Conference Call

The Company will host a conference call and webcast for the investment community today at 4:30 PM ET. Investors interested in participating by phone are invited to call toll free at 1.877.407.0993 or use the direct dial-in number 1.201.689.8795. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.axogeninc.com and clicking on the webcast link on the Investors home page.

 

Following the conference call, a replay will be available on the Company’s website at www.AxoGenInc.com, under ‘Investors.’

 

About AxoGen

AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen’s portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix ("ECM") coaptation aid for tensionless repair of severed nerves, and AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments. Along with these core surgical products, AxoGen also offers AxoTouchTM Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.

 


 

Cautionary Statements Concerning Forward-Looking Statements

This Press Release contains "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations or predictions of future conditions, events or results based on various assumptions and management's estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as "expects", "anticipates", "intends", "plans", "believes", "seeks", "estimates", "projects", "forecasts", "continue", "may", "should", "will" variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding our growth, our 2016 guidance, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events. The forward-looking statements are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this release should be evaluated together with the many uncertainties that affect AxoGen's business and its market, particularly those discussed in the risk factors and cautionary statements in AxoGen's filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and, except as required by law, AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

About Non-GAAP Financial Measures

To supplement our consolidated financial statements, we use the non-GAAP financial measure of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization.

We use this non-GAAP financial measure for financial and operational decision-making and as a means to evaluate period-to-period comparisons.  We believe that this non-GAAP financial measure provides meaningful supplemental information regarding our performance and liquidity and that both management and investors benefit from referring this non-GAAP financial measure in assessing our performance and when planning, forecasting, and analyzing future periods.  We believe this non-GAAP financial measure is useful to investors because (1) it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) it is used by our institutional investors and the analyst community to help them analyze the performance of our business.

 

 

Contacts:

AxoGen, Inc.

Peter J. Mariani, Chief Financial Officer

InvestorRelations@AxoGenInc.com

 

The Trout Group – Investor Relations

Brian Korb

646.378.2923

bkorb@troutgroup.com


 

AXOGEN, INC

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

 

 

 

 

 

 

 

 

June 30, 2016

 

December 31,

 

 

    

(unaudited)

    

2015

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

18,273,203 

 

$

25,909,500 

 

Accounts receivable

 

 

6,072,121 

 

 

4,782,989 

 

Inventory

 

 

4,786,322 

 

 

3,933,960 

 

Prepaid expenses and other

 

 

615,511 

 

 

424,925 

 

Total current assets

 

 

29,747,157 

 

 

35,051,374 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

1,260,190 

 

 

970,870 

 

Intangible assets

 

 

743,390 

 

 

678,082 

 

 

 

$

31,750,737 

 

$

36,700,326 

 

 

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity (Deficit)

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

3,893,834 

 

$

3,695,127 

 

Current deferred revenue

 

 

28,593 

 

 

14,118 

 

Total current liabilities

 

 

3,922,427 

 

 

3,709,245 

 

Note Payable - Revenue Interest Purchase Agreement

 

 

24,952,201 

 

 

24,701,693 

 

Long Term Deferred Revenue

 

 

83,006 

 

 

93,797 

 

Total liabilities

 

 

28,957,634 

 

 

28,504,735 

 

Shareholders’ equity:

 

 

 

 

 

 

 

Common stock, $.01 par value; 50,000,000 shares authorized;  30,128,099 and 29,984,591 shares issued and outstanding

 

 

301,281 

 

 

299,846 

 

Additional paid-in capital

 

 

112,443,288 

 

 

111,368,424 

 

Accumulated deficit

 

 

(109,951,466)

 

 

(103,472,679)

 

Total shareholders’ equity

 

 

2,793,103 

 

 

8,195,591 

 

 

 

$

31,750,737 

 

$

36,700,326 

 

 


 

AXOGEN, INC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Three and Six Months ended June 30, 2016 and 2015

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30

 

June 30

 

June 30

 

June 30

 

 

    

2016

    

2015

    

2016

    

2015

 

Revenues

 

$

10,381,883 

 

$

6,417,253 

 

$

18,493,642 

 

$

11,368,569 

 

Cost of goods sold

 

 

1,534,412 

 

 

1,039,841 

 

 

2,940,003 

 

 

2,022,722 

 

Gross profit

 

 

8,847,471 

 

 

5,377,412 

 

 

15,553,639 

 

 

9,345,847 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

6,780,363 

 

 

4,812,262 

 

 

12,986,238 

 

 

8,744,783 

 

Research and development

 

 

936,823 

 

 

736,399 

 

 

1,915,163 

 

 

1,407,435 

 

General and administrative

 

 

2,736,255 

 

 

1,982,020 

 

 

4,881,012 

 

 

3,890,602 

 

Total costs and expenses

 

 

10,453,441 

 

 

7,530,681 

 

 

19,782,413 

 

 

14,042,820 

 

Loss from operations

 

 

(1,605,970)

 

 

(2,153,269)

 

 

(4,228,774)

 

 

(4,696,973)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,163,413)

 

 

(1,023,774)

 

 

(2,166,440)

 

 

(2,018,522)

 

Interest expense—deferred financing costs

 

 

(32,696)

 

 

(31,210)

 

 

(63,506)

 

 

(64,956)

 

Other income (expense)

 

 

(617)

 

 

17,380 

 

 

(20,067)

 

 

14,378 

 

Total other income (expense)

 

 

(1,196,726)

 

 

(1,037,604)

 

 

(2,250,013)

 

 

(2,069,100)

 

Net loss

 

$

(2,802,696)

 

$

(3,190,873)

 

$

(6,478,787)

 

$

(6,766,073)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted Average Common Shares outstanding – basic and diluted

 

 

30,079,960 

 

 

24,928,435 

 

 

30,037,013 

 

 

23,729,558 

 

Loss Per Common share - basic and diluted

 

$

(0.09)

 

$

(0.13)

 

$

(0.22)

 

$

(0.29)

 

 


 

AXOGEN, INC

RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES

Three and Six Months ended June 30, 2016 and 2015

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

    

June 30
2016 

    

June 30
2015 

    

June 30
2016 

    

June 30
2015 

 

Net loss

 

$

(2,802,696)

 

$

(3,190,873)

 

$

(6,478,787)

 

$

(6,766,073)

 

Depreciation and amortization expense

 

 

88,734 

 

 

45,712 

 

 

167,590 

 

 

87,610 

 

Amortization expense of intangible assets

 

 

16,017 

 

 

10,938 

 

 

32,033 

 

 

22,710 

 

Interest expense

 

 

1,163,413 

 

 

1,023,774 

 

 

2,166,440 

 

 

2,018,522 

 

Interest expense - deferred financing costs

 

 

32,696 

 

 

31,210 

 

 

63,506 

 

 

64,956 

 

EBITDA - non GAAP

 

$

(1,501,836)

 

$

(2,079,239)

 

$

(4,049,218)

 

$

(4,572,275)

 

 


 

AXOGEN, INC

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months ended June 30, 2016 and 2015

(unaudited)

 

 

 

 

 

 

 

 

 

 

    

2016

    

2015

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

 

$

(6,478,787)

 

$

(6,766,073)

 

Adjustments to reconcile net loss to net cash used for operating activities:

 

 

 

 

 

 

 

Depreciation

 

 

167,590 

 

 

87,610 

 

Amortization of intangible assets

 

 

32,033 

 

 

22,710 

 

Amortization of deferred financing costs

 

 

63,506 

 

 

64,957 

 

Provision for bad debts

 

 

48,600 

 

 

— 

 

Stock-based compensation

 

 

752,789 

 

 

696,625 

 

Interest added to note

 

 

187,002 

 

 

340,870 

 

Change in assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

(1,337,732)

 

 

(965,715)

 

Inventory

 

 

(852,362)

 

 

(326,337)

 

Prepaid expenses and other

 

 

(190,586)

 

 

(131,739)

 

Accounts payable and accrued expenses

 

 

198,707 

 

 

976,928 

 

Deferred Revenue

 

 

3,684 

 

 

(10,791)

 

Net cash used for operating activities

 

 

(7,405,556)

 

 

(6,010,955)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(456,910)

 

 

(132,492)

 

Acquisition of intangible assets

 

 

(97,341)

 

 

(54,075)

 

Net cash used for investing activities

 

 

(554,251)

 

 

(186,567)

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

— 

 

 

13,770,734 

 

Debt issuance costs

 

 

— 

 

 

(180,142)

 

Proceeds from exercise of stock options

 

 

323,510 

 

 

14,071 

 

Net cash provided by financing activities

 

 

323,510 

 

 

13,604,663 

 

Net increase / (decrease) in cash and cash equivalents

 

 

(7,636,297)

 

 

7,407,141 

 

Cash and cash equivalents, beginning of year

 

 

25,909,500 

 

 

8,215,791 

 

Cash and cash equivalents, end of period

 

$

18,273,203 

 

$

15,622,932 

 

Supplemental disclosures of cash flow activity:

 

 

 

 

 

 

 

Cash paid for interest

 

$

1,964,256 

 

$

1,649,881