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Axogen, Inc. Reports Fourth Quarter and Full-Year 2019 Financial Results

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ALACHUA, Fla., Feb. 24, 2020 (GLOBE NEWSWIRE) -- Axogen, Inc. (AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2019.

Fourth Quarter 2019 Financial Results and Business Highlights

  • Net sales were $28.1 million during the quarter, an increase of 20% compared to fourth quarter 2018 revenue of $23.4 million.

  • Gross margin was 82.7% for the quarter, compared to 84.4% in the fourth quarter of 2018.

  • Net loss for the quarter was $7.0 million, or $0.18 per share, compared to a net loss of $5.2 million, or $0.13 per share, in the fourth quarter of 2018.

  • Adjusted net loss was $ 4.0 million for the quarter, or $0.10 per share, compared with adjusted net loss of $3.6 million, or $0.09 per share, in the fourth quarter of 2018.

  • Adjusted EBITDA loss was $4.2 million for the quarter, compared to an adjusted EBITDA loss of $4.0 million in the fourth quarter of 2018.

  • The balance of cash, cash equivalents, and investments, on December 31, 2019 was $102.5 million, compared to a balance of $106.1 million on September 30, 2019.

  • Revenue from the direct sales channel represented approximately 90% of total revenue in the fourth quarter, compared to approximately 85% in the fourth quarter of 2018.

  • Active accounts in the fourth quarter were 797, an increase of 12%, compared to 712 in the fourth quarter a year ago.

“I am pleased with our fourth quarter and full-year performance. We delivered solid revenue growth and continued to make progress rebalancing and refocusing our commercial operation toward our largest market opportunity, extremity trauma,” commented Karen Zaderej, chairman, CEO, and president of Axogen, Inc. “I am confident that we have the right commercial strategy in place to drive strong surgeon adoption of our technology as we continue to develop the nerve repair market.”

Full-Year 2019 Financial Results and Business Highlights

  • Full-year 2019 revenue was $106.7 million, an increase of 27% compared to 2018 revenue of $83.9 million.

  • Gross margin was 83.7% for the full year, compared to 84.6% in 2018.

  • Net loss for the full year was $29.1 million, or $0.74 per share, compared to $22.4 million, or $0.60 per share, in 2018.

  • Adjusted net loss was $16.4 million for the full year, or $0.42 per share, compared to $12.6 million, or $0.34 per share, in 2018.

  • Adjusted EBITDA loss was $17.7 million for the full year, compared to an adjusted EBITDA loss of $12.1 million in 2018.

  • Ended the year with 109 direct sales representatives, compared to 85 at the end of 2018.

  • RECON® Study enrollment progressed well in the second half of 2019 and we now believe the study enrollment will be completed by the end of June 2020. We anticipate the data report-out for RECON will occur in Q3 of 2022.

  • Ended the year with 112 peer-reviewed clinical publications featuring Axogen’s nerve repair product portfolio.

2020 Financial Guidance
Management reiterates that 2020 revenue will be in the range of $124 million to $128 million and expects that the number of direct sales representatives will increase to between approximately 126 and 131. Additionally, management expects gross margin to remain above 80% and that operating margin will see moderate improvement year over year.

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. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection 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, a biologically active 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; Axoguard® Nerve Cap, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma; and Avive® Soft Tissue Membrane, a processed human umbilical cord intended for surgical use as a resorbable soft tissue barrier. The Axogen portfolio of products is available in the United States, Canada, the United Kingdom, South Korea, 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,” “goals,” 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 growth, our 2020 guidance, product development, product potential, financial performance, sales growth, product adoption, market awareness of our products, data validation, our assessment of our internal controls over financial reporting, our visibility at and sponsorship of conferences and educational events. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many uncertainties that affect our business and our market, particularly those discussed under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee 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 applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise.

About Non-GAAP Financial Measures
To supplement our consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense. We also use the non-GAAP financial measures of Adjusted Net Loss and Adjusted Net Loss Per Common Share - basic and diluted which excludes non-cash stock compensation expense and loss on extinguishment of debt from Net Loss and Net Loss Per Common Share - basic and diluted, respectively. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP, and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of Axogen’s GAAP financial measures to the corresponding non-GAAP measures should be carefully evaluated.

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

Contact:
Axogen, Inc.
Peter J. Mariani, Chief Financial Officer
pmariani@axogeninc.com
InvestorRelations@AxogenInc.com


AXOGEN, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

December 31,

December 31,

2019

2018

Assets

Current assets:

Cash and cash equivalents

$

35,724

$

24,294

Restricted Cash

6,000

6,000

Investments

60,786

92,311

Accounts receivable, net

16,944

15,321

Inventory

13,861

11,982

Prepaid expenses and other

1,706

1,045

Total current assets

135,021

150,953

Property and equipment, net

14,887

8,039

Operating lease right-of-use assets

3,133

-

Finance lease right-of-use assets

87

-

Intangible assets

1,515

1,181

Total assets

$

154,643

$

160,173

Liabilities and Shareholders’ Equity

Current liabilities:

Accounts payable and accrued expenses

$

19,130

$

12,998

Current maturities of long term obligations

1,736

28

Contract liabilities, current

14

18

Total current liabilities

20,880

13,044

Long-term obligations, net of current maturities and deferred financing fees

1,595

35

Other long-term liabilties

70

Contract liabilities

15

42

Total liabilities

22,490

13,191

Shareholders’ equity:

Common stock, $.01 par value; 100,000,000 shares authorized; 39,589,755 and 38,900,875 shares issued and outstanding

396

389

Additional paid-in capital

311,618

297,319

Accumulated deficit

(179,861

)

(150,726

)

Total shareholders’ equity

132,153

146,982

Total liabilities and shareholders' equity

$

154,643

$

160,173

AXOGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

Three and Twelve Months ended December 31, 2019 and 2018

(unaudited)

Three Months Ended

Fiscal Year Ended

Dec 31,

Dec 31,

Dec 31,

Dec 31,

2019

2018

2019

2018

Revenues

$

28,162

$

23,433

$

106,712

$

83,937

Cost of goods sold

4,881

3,640

17,349

12,923

Gross profit

23,281

19,793

89,363

71,014

Costs and expenses:

Sales and marketing

18,804

15,462

71,950

56,617

Research and development

4,912

3,807

17,514

11,773

General and administrative

6,984

6,373

31,305

23,124

Total costs and expenses

30,700

25,642

120,769

91,514

Loss from operations

(7,419

)

(5,849

)

(31,406

)

(20,500

)

Other income (expense):

Interest income

439

641

2,364

1,525

Interest expense

(8

)

(3

)

(40

)

(1,127

)

Interest expense – deferred financing costs

(81

)

Loss on extinguishment of debt

(2,186

)

Other expense

(50

)

(13

)

(53

)

(28

)

Total other expense

381

625

2,271

(1,897

)

Net loss

$

(7,038

)

$

(5,224

)

$

(29,135

)

$

(22,397

)

Weighted average common shares outstanding – basic and diluted

39,485

38,745

39,235

37,127

Loss per common share – basic and diluted

$

(0.18

)

$

(0.13

)

$

(0.74

)

$

(0.60

)

Adjusted net loss - non GAAP

(3,978

)

(3,599

)

(16,364

)

(12,605

)

Adjusted net loss per common share - basic and diluted

$

(0.10

)

$

(0.09

)

$

(0.42

)

$

(0.34

)

AXOGEN, INC.

RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES

Three and Twelve Months ended December 31, 2019 and 2018

(unaudited)

Three Months Ended

Fiscal Year Ended

Dec 31,

Dec 31,

Dec 31,

Dec 31,

2019

2018

2019

2018

Net loss

$

(7,038

)

$

(5,224

)

$

(29,135

)

$

(22,397

)

Depreciation and amortization expense

299

217

1,056

851

Investment income

(439

)

(641

)

(2,364

)

(1,525

)

Income tax

(52

)

(67

)

13

Interest expense

8

40

3,391

EBITDA - non GAAP

$

(7,222

)

$

(5,648

)

$

(30,470

)

$

(19,667

)

Non cash stock compensation expense

2,920

1,625

10,304

7,606

Litigation and related costs

140

2,467

-

Adjusted EBITDA - non GAAP

$

(4,162

)

$

(4,023

)

$

(17,699

)

$

(12,061

)

Net loss

$

(7,038

)

$

(5,224

)

$

(29,135

)

$

(22,397

)

Non cash stock compensation expense

2,920

1,625

10,304

7,606

Litigation and related costs

140

2,467

Loss on extinguishment of debt

2,186

Adjusted Net Loss - non GAAP

$

(3,978

)

$

(3,599

)

$

(16,364

)

$

(12,605

)

Weighted average common shares outstanding – basic and diluted

39,485

38,745

39,235

37,127

Adjusted net loss per common share - basic and diluted

$

(0.10

)

$

(0.09

)

$

(0.42

)

$

(0.34

)

AXOGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

Fiscal Year Ended December 31, 2019 and 2018

(unaudited)

Common Stock

Additional Paid-in Capital

Accumulated Deficit

Total Shareholders' Equity

For the Three Months Ended December 31, 2019:

Balance at September 30, 2019

$

395

$

307,839

$

(172,823

)

$

135,411

Net Loss

-

-

(7,038

)

(7,038

)

Stock-based compensation

-

2,919

-

2,919

Exercise of stock options and employee stock purchase plan

1

860

-

861

Balance at December 31, 2019

$

396

$

311,618

$

(179,861

)

$

132,153

For the Fiscal Year Ended December 31, 2019:

Balance at December 31, 2018

$

389

$

297,319

$

(150,726

)

$

146,982

Net Loss

-

-

(29,135

)

(29,135

)

Stock-based compensation

-

10,304

-

10,304

Exercise of stock options and employee stock purchase plan

7

3,995

-

4,002

Balance at December 31, 2019

$

396

$

311,618

$

(179,861

)

$

132,153

For the Three Months Ended December 31, 2018:

Balance at September 30, 2018

$

387

$

294,589

$

(145,497

)

$

149,479

Net Loss

-

-

(5,224

)

(5,224

)

Issuance of common stock

-

-

-

-

Stock-based compensation

-

1,625

-

1,625

Exercise of stock options and employee stock purchase plan

2

1,105

-

1,107

Balance at December 31, 2018

$

389

$

297,319

$

(150,721

)

$

146,987

For the Fiscal Year Ended December 31, 2018:

Balance at December 31, 2017

$

343

$

153,168

$

(128,329

)

$

25,182

Net Loss

-

-

(22,397

)

(22,397

)

Issuance of common stock

35

132,672

-

132,707

Stock-based compensation

-

7,606

-

7,606

Exercise of stock options and employee stock purchase plan

11

3,873

-

3,884

Balance at December 31, 2018

$

389

$

297,319

$

(150,726

)

$

146,982

AXOGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Fiscal Year Ended December 31, 2019 and 2018

(unaudited)

Fiscal Year

December 31,

December 31,

2019

2018

Cash flows from operating activities:

Net loss

$

(29,135

)

$

(22,397

)

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

Depreciation

933

774

Amortization of right-of-use assets

1,821

Amortization of intangible assets

123

77

Write-down of trademark

104

Amortization of deferred financing costs

-

81

Loss on extinguishment of debt

-

2,186

Loss on disposal of property, plant and equipment

-

1

Provision for bad debt

514

852

Provision for inventory write down

1,887

1,343

Change in investment gains and losses

(972

)

(721

)

Share-based compensation

10,304

7,606

Change in assets and liabilities:

Accounts receivable

(2,136

)

(5,108

)

Inventory

(3,767

)

(6,009

)

Prepaid expenses and other

(661

)

(192

)

Accounts payable and accrued expenses

2,920

3,711

Operating Lease Obligations

(1,773

)

Cash paid for interest portion of Finance Leases

(4

)

Contract and other liabilities

(30

)

(66

)

Net cash used in operating activities

(19,872

)

(17,862

)

Cash flows from investing activities:

Purchase of short-term investments

(4,664

)

(6,282

)

Purchase of property and equipment

(121,074

)

(114,736

)

Sale/Maturities of short-term investments

153,571

23,146

Cash payments for intangible assets

(562

)

(321

)

Net cash provided by/ (used for) investing activities

27,271

(98,193

)

Cash flows from financing activities:

Proceeds from the issuance of common stock

132,964

Cash paid for equity offering

(257

)

Borrowing on revolving loan

26,253

Payments on revolving loan and prepayment penalties

(30,489

)

Repayments of long term debt and prepayment penalties

(22,513

)

Cash paid for debt portion of finance leases

29

Proceeds from exercise of stock options and warrants

4,002

3,884

Net cash provided by financing activities

4,031

109,842

Net increase in cash, cash equivalents and restricted cash

11,430

(6,213

)

Cash, cash equivalents and restricted cash, beginning of year

30,294

36,507

Cash, cash equivalents and restricted cash, end of period

$

41,724

$

30,294

Supplemental disclosures of cash flow activity:

Cash paid for interest

34

1,325

Supplemental disclosure of non-cash investing and financing activities

Acquisition of fixed assets in accounts payable and accrued expenses

3,212

335

Right-of-use asset and operating lease liability

26