EXHIBIT 99.1

 

axogen-inc-logo.jpg

 

AxoGen, Inc. Reports

2017 Fourth Quarter and Full Year Financial Results

 

Record Q4 Revenue of $17.0 million, representing 49% growth over prior year

Record Full year 2017 Revenue of $60.4 million, representing 47% growth over prior year

 

 

ALACHUA, FL – February 28, 2018 – AxoGen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerves,  today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2017.

 

Fourth Quarter 2017 Financial Results and Recent Business Highlights

·

Revenue of $17.0 million, up 49% compared to $11.4 million in the fourth quarter of 2016

·

Gross margin of 84.6% compared to 84.0% in the fourth quarter of 2016

·

Adjusted EBITDA loss of $531,000 compared to adjusted EBITDA loss of $2.2  million in Q4 2016 

·

Announced expanded application in Breast Reconstruction Neurotization

·

Adjusted net loss for the fourth quarter of 2017 was $2.5  million, or $0.07 per share, compared with adjusted net loss of $3.2 million, or $0.10 per share, in the fourth quarter of 2016

·

Raised $15.6 million in net proceeds through a public offering of common stock on November 20

 

“We are pleased to report another successful quarter and a solid finish to 2017,” said Karen Zaderej, president and CEO of AxoGen. “These results reflect the strength of our growing platform for nerve repair where we see continued momentum in our core trauma, nerve protection and oral and maxillofacial markets. We enter 2018 with an expanding sales force that will allow us to continue growth in our core markets while also supporting our newest application in breast reconstruction neurotization.”

 

Additional Fourth Quarter and Recent Operational Highlights

·

Increased active accounts in the fourth quarter to 591, up 31% from 452 a year ago

·

Ended the quarter with 60 direct sales representatives and 20 independent distributors

·

Conducted four national education programs in the fourth quarter 

·

Increased the number of clinical presentations related to our surgical portfolio by three to a total of 21 for the year

·

Announced FDA clearance for AxoGuard ® Nerve Cap and will begin a  clinical study evaluating its application in the surgical management of pain 

·

Began training surgeons on the ReSensation™ technique for breast reconstruction neurotization

·

Ended the quarter with $36.5 million in cash compared to $22 million at the end of the Q3 2017. The $14.5 million net increase in cash was the result of the company’s  $15.6 million equity raise in November, partially offset by net use of cash in Q4 of $1.1 million  

·

Ended the quarter with $25 million of total bank debt, equivalent to the end of Q3 2017

 

Full Year 2017 Summary Financial Results and Business Highlights

·

2017 Revenue of $60.4 million, an increase of 47%  compared to $41.1 million for the prior year

·

Gross margin of 84.6% compared to 84.3% in 2016


 

·

Adjusted EBITDA loss of $3.8 million compared to adjusted EBITDA loss of $6.3 million in 2016

·

Increased total addressable market across all current applications to $2.2 billion. The increase is a result of expanded use in oral and maxillofacial surgery and the addition of breast reconstruction neurotization. 

·

Total clinical publications increased by nine to 53, including important data in the areas of mixed and motor, and long gap nerve repair, as well as oral and maxillofacial surgery

·

Completed 15 national education programs in 2017 and expect to conduct 18 programs in 2018

·

Expanded leadership team with the appointment of Jon Gingrich as Chief Commercial Officer

·

Named Employee Engagement Best Practices Award Winner by DecisionWise International

 

“We continue to produce record revenues and are pleased with 2017 results that demonstrate our ability to consistently and successfully execute our strategy,” said Zaderej. “Our efforts to increase market awareness, provide quality surgeon education programs, expand our commercial presence and effectiveness, and further develop clinical data are helping surgeons develop confidence in the adoption of the AxoGen platform for nerve repair.”

 

2018 Financial Guidance

Management expects that 2018 revenue will grow at least 40% over 2017 revenue and gross margins will remain above 80%.

 

Upcoming Investor Events

Members of the AxoGen senior management team will participate at the following upcoming conferences:

·

Canaccord Genuity Musculoskeletal Conference in New Orleans on March 6

·

30th Annual ROTH Conference in Dana Point, CA on March 13

 

Conference Call

The Company will host a conference call and webcast for the investment community today at 4:30 p.m. 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 can 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 the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

 

AxoGen's platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed peripheral 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 peripheral nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments, and Avive® Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a resorbable soft tissue covering to separate tissue layers and modulate inflammation in the surgical bed. Along


 

with these core surgical products, AxoGen also offers AcroVal® Neurosensory & Motor Testing System and AxoTouch® Two-Point Discriminator. These evaluation and measurement tools assist health care professionals in detecting changes in sensation, assessing return of sensory, grip, and pinch function, evaluating effective treatment interventions, and providing feedback to patients on peripheral nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom, and several other 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,” and 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 assessment on our internal control over financial reporting, our growth, our 2018 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.

 

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.

 

CONSOLIDATED BALANCE SHEETS

 

 

 

 

 

 

 

 

 

 

    

 

    

 

 

 

 

December 31,

 

December 31,

 

 

 

2017

 

2016

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

36,506,624 

 

$

30,014,405 

 

Accounts receivable, net

 

 

11,064,720 

 

 

8,052,203 

 

Inventory

 

 

7,315,942 

 

 

5,458,840 

 

Prepaid expenses and other

 

 

853,381 

 

 

511,804 

 

Total current assets

 

 

55,740,667 

 

 

44,037,252 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

2,197,039 

 

 

1,494,247 

 

Intangible assets

 

 

936,992 

 

 

828,979 

 

 

 

$

58,874,698 

 

$

46,360,478 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Borrowings under revolving loan agreement

 

$

4,000,000 

 

$

4,025,023 

 

Accounts payable and accrued expenses

 

 

8,952,061 

 

 

7,002,165 

 

Current maturities of long term obligations

 

 

735,017 

 

 

20,899 

 

Deferred revenue, current

 

 

31,668 

 

 

33,282 

 

Total current liabilities

 

 

13,718,746 

 

 

11,081,369 

 

Long Term Obligations, net of current maturities and deferred financing fees

 

 

19,905,286 

 

 

20,265,745 

 

Deferred revenue

 

 

68,631 

 

 

92,215 

 

Total liabilities

 

 

33,692,663 

 

 

31,439,329 

 

Shareholders’ equity:

 

 

 

 

 

 

 

Common stock, $.01 par value; 50,000,000 shares authorized; 34,350,329 and 33,008,865 shares issued and outstanding

 

 

343,503 

 

 

330,088 

 

Additional paid-in capital

 

 

153,167,817 

 

 

132,474,884 

 

Accumulated deficit

 

 

(128,329,285)

 

 

(117,883,823)

 

Total shareholders’ equity

 

 

25,182,035 

 

 

14,921,149 

 

 

 

$

58,874,698 

 

$

46,360,478 

 

 


 

AXOGEN, INC.

 

CONSONLIDATED STATEMENTS OF OPERATIONS

 

Three Months and Years ended December 31, 2017 and 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

 

    

 

    

 

    

 

 

 

 

Three Months Ended

 

Years Ended

 

 

 

December 31,

 

December 31,

 

December 31,

 

December 31,

 

 

 

2017

 

2016

 

2017

 

2016

 

Revenues

 

$

16,971,005 

 

$

11,408,672 

 

$

60,426,395 

 

$

41,107,538 

 

Cost of goods sold

 

 

2,614,458 

 

 

1,829,804 

 

 

9,311,585 

 

 

6,467,250 

 

Gross profit

 

 

14,356,547 

 

 

9,578,868 

 

 

51,114,810 

 

 

34,640,288 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

10,120,605 

 

 

8,349,206 

 

 

37,635,871 

 

 

28,425,503 

 

Research and development

 

 

1,971,569 

 

 

1,178,502 

 

 

6,699,120 

 

 

4,212,023 

 

General and administrative

 

 

4,071,349 

 

 

2,770,561 

 

 

14,731,105 

 

 

10,132,624 

 

Total costs and expenses

 

 

16,163,523 

 

 

12,298,269 

 

 

59,066,096 

 

 

42,770,150 

 

Loss from operations

 

 

(1,806,976)

 

 

(2,719,401)

 

 

(7,951,286)

 

 

(8,129,862)

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(576,971)

 

 

(2,130,694)

 

 

(2,216,845)

 

 

(5,386,268)

 

Interest expense—deferred financing costs

 

 

(109,846)

 

 

(780,135)

 

 

(246,557)

 

 

(875,389)

 

Other income (expense)

 

 

(5,386)

 

 

3,246 

 

 

(30,774)

 

 

(19,625)

 

Total other income (expense)

 

 

(692,203)

 

 

(2,907,583)

 

 

(2,494,176)

 

 

(6,281,282)

 

Net loss

 

$

(2,499,179)

 

$

(5,626,984)

 

$

(10,445,462)

 

$

(14,411,144)

 

Weighted Average Common Shares outstanding – basic and diluted

 

 

33,845,684 

 

 

32,567,893 

 

 

33,322,767 

 

 

30,702,164 

 

Loss Per Common share - basic and diluted

 

$

(0.07)

 

$

(0.17)

 

$

(0.31)

 

$

(0.47)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted net loss

 

$

(2,499,179)

 

$

(3,176,379)

 

$

(10,445,462)

 

$

(11,960,539)

 

Adjusted net loss per Common shae

 

$

(0.07)

 

$

(0.10)

 

$

(0.31)

 

$

(0.39)

 

 


 

AXOGEN, INC.

 

RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES

 

Three Months and Years ended December 31, 2017 and 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

 

    

 

    

 

    

 

 

 

 

Three Months Ended

 

Years Ended

 

 

 

December 31,

 

December 31,

 

December 31,

 

December 31,

 

 

 

2017

 

2016

 

2017

 

2016

 

Net loss

 

$

(2,499,179)

 

$

(5,626,984)

 

$

(10,445,462)

 

$

(14,411,144)

 

Depreciation and amortization expense

 

 

140,772 

 

 

98,484 

 

 

487,611 

 

 

361,617 

 

Amortization expense of intangible assets

 

 

18,534 

 

 

26,821 

 

 

78,993 

 

 

74,871 

 

Income Taxes

 

 

5,347 

 

 

— 

 

 

29,321 

 

 

21,426 

 

Interest expense

 

 

576,971 

 

 

2,130,694 

 

 

2,216,845 

 

 

5,386,268 

 

Interest expense - deferred financing costs

 

 

109,846 

 

 

780,135 

 

 

246,557 

 

 

875,389 

 

EBITDA - non GAAP

 

$

(1,647,709)

 

$

(2,590,850)

 

$

(7,386,135)

 

$

(7,691,573)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non Cash Stock Compensation Expense

 

 

1,116,926 

 

 

343,913 

 

 

3,608,918 

 

 

1,390,277 

 

Adjusted EBITDA - non GAAP

 

$

(530,783)

 

$

(2,246,937)

 

$

(3,777,217)

 

$

(6,301,296)

 

 

 

AXOGEN, INC.

 

RECONCILIATION OF NET LOSS TO ADJUSTED NET LOSS

 

Three Months and Years ended December 31, 2017 and 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    

 

    

 

    

 

    

 

 

 

 

Three Months Ended

 

Years Ended

 

 

 

December 31,

 

December 31,

 

December 31,

 

December 31,

 

 

 

2017

 

2016

 

2017

 

2016

 

Net loss

 

$

(2,499,179)

 

 

(5,626,984)

 

$

(10,445,462)

 

 

(14,411,144)

 

Prepayment fees net of accrued interest

 

 

— 

 

 

1,700,131 

 

 

— 

 

 

1,700,131 

 

Write off of deferred financing fees

 

 

— 

 

 

750,474 

 

 

— 

 

 

750,474 

 

Adjusted Net Loss

 

$

(2,499,179)

 

$

(3,176,379)

 

$

(10,445,462)

 

$

(11,960,539)

 

Adjusted net loss per Common share

 

$

(0.07)

 

$

(0.10)

 

$

(0.31)

 

$

(0.39)

 

 


 

AXOGEN, INC.

 

CONSOLIDATED STATEMENTS OF CASHFLOWS

 

Years ended December 31, 2017 and 2016

 

 

    

2017

    

2016

 

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

 

$

(10,445,462)

 

$

(14,411,144)

 

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

 

 

 

 

 

 

 

Depreciation

 

 

487,611 

 

 

361,617 

 

Amortization of intangible assets

 

 

78,993 

 

 

74,871 

 

Amortization of deferred financing costs

 

 

246,557 

 

 

124,915 

 

Write off of deferred financing costs

 

 

— 

 

 

750,474 

 

Provision for bad debts

 

 

223,323 

 

 

79,593 

 

Stock-based compensation

 

 

3,608,918 

 

 

1,390,277 

 

Interest added to note

 

 

— 

 

 

1,924,279 

 

Change in assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable

 

 

(3,235,840)

 

 

(3,348,807)

 

Inventory

 

 

(1,857,102)

 

 

(1,524,880)

 

Prepaid expenses and other

 

 

(341,577)

 

 

(86,879)

 

Accounts payable and accrued expenses

 

 

1,926,664 

 

 

3,411,507 

 

Deferred liabilities

 

 

70,316 

 

 

17,582 

 

Net cash used for operating activities

 

 

(9,237,599)

 

 

(11,236,595)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(1,105,212)

 

 

(931,634)

 

Acquisition of intangible assets

 

 

(187,006)

 

 

(225,768)

 

Net cash used for investing activities

 

 

(1,292,218)

 

 

(1,157,402)

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

15,662,905 

 

 

18,668,092 

 

Borrowing on revolving loan

 

 

57,599,165 

 

 

6,684,894 

 

Payments on revolving loan

 

 

(57,624,188)

 

 

(6,684,894)

 

Repayments of long term debt

 

 

(20,899)

 

 

(2,446,676)

 

Debt issuance costs

 

 

(29,472)

 

 

(800,847)

 

Proceeds from exercise of stock options

 

 

1,434,525 

 

 

1,078,333 

 

Net cash provided by financing activities

 

 

17,022,036 

 

 

16,498,902 

 

Net increase in cash and cash equivalents

 

 

6,492,219 

 

 

4,104,905 

 

Cash and cash equivalents, beginning of year

 

 

30,014,405 

 

 

25,909,500 

 

Cash and cash equivalents, end of period

 

$

36,506,624 

 

$

30,014,405 

 

Supplemental disclosures of cash flow activity:

 

 

 

 

 

 

 

Cash paid for interest

 

$

2,198,286 

 

$

5,769,372 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

 

Payments of fixed assets in accounts payable

 

$

55,385 

 

$

32,153 

 

Payments of long term debt with proceeds from term loan of $21,000,000 and revolver loan of $4,000,000

 

$

— 

 

$

25,000,000 

 

Capital lease additions

 

$

61,959 

 

$

—