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8-K - 8-K - Axogen, Inc.a14-18381_18k.htm

Exhibit 99.1

 

 

AxoGen, Inc. Reports 47% Second Quarter Revenue Growth

 

Quarterly Record Revenue of $4.2 Million; Gross Margin expands to 79%.

 

Conference Call Today at 4:30 pm ET

 

·

 

ALACHUA, FL — August 4, 2014 — AxoGen, Inc. (NASDAQ: AXGN), a leading medical technology company focused on the peripheral nerve repair market, announced record quarterly revenue of $4.21 million for the second quarter ended June 30, 2014, representing growth of 47% as compared to $2.86 million for the second quarter of 2013.  The increase in revenue was driven by increased unit sales to existing customers and the addition of new customers.

 

“Our strong revenue increase in the second quarter demonstrates that we are effectively executing on our growth strategies and confirms we are building awareness and adoption of our portfolio of nerve repair products: Avance® Nerve Graft, AxoGuard® Nerve Protector and AxoGuard® Nerve Connector.  These disruptive off-the-shelf products are unparalleled in the marketplace, offering distinct advantages that are increasingly being recognized by surgeons and patients alike,” commented Karen Zaderej, President and Chief Executive Officer.  “The entire AxoGen team is energized and remains focused on continued execution of our sales and marketing plan to achieve our revenue goals.”

 

2014 Second Quarter Financial Results

 

The second quarter strong revenue increase of 47% to $4.2 million was due to increased product usage by existing customers and sales to new customers.  Gross margin expanded to 79% compared to 78% for the second quarter of 2013 and 78% in the 2014 first quarter.  The gross margin improvement is due to changes in product mix and implementation of product price increases.

 

Total operating expenses in the second quarter were $5.6 million compared to $4.4 million for the second quarter of 2013. The increased expenses were planned and are primarily attributable to increased sales and marketing efforts, surgeon educational programs and training events, and clinical activities. Operating loss was $2.3 million compared to an operating loss of $2.2 million for the second quarter of 2013.  Net loss was $3.7 million, or $0.21 per share, compared to a net loss of $3.5 million, or $0.31 per share, for the second quarter of

 



 

2013. The weighted average common shares for the second quarter of 2014 was approximately 17.5 million shares compared to 11.1 million shares for the second quarter of 2013.  The increase in common shares was a result of the common stock offering in August 2013.

 

·                                          As of June 30, 2014, cash, cash equivalents and marketable securities totaled $14.2 million.

 

“Based on our strong performance in the first half of 2014 and our current sales momentum, we expect a stronger second half of the year.  As a result we are increasingly confident that we will achieve our original revenue target for 2014 of $16 million while maintaining gross margins of at least 75%,” concluded Ms. Zaderej.

 

Conference Call

 

The Company will host a conference call and webcast for the investment community on Monday, August 4, 2014 at 4:30 PM ET. Investors within the United States interested in participating are invited to call 1.877.674.2413 and reference Participant Passcode 71503642.  All other participants can use the dial-in number 1.914.495.8604, using the same Participant Passcode.  To access the live webcast, or to listen to a replay, please visit the Investor Relations section of the Company’s website at www.AxoGenInc.com.

 

·                                          About AxoGen, Inc.

 

AxoGen (NASDAQ: AXGN) is a leading medical technology company dedicated to peripheral nerve repair. AxoGen’s portfolio of regenerative medicine products is available in the United States, Canada and several other countries and includes Avance® Nerve Graft, the only off-the-shelf commercially available processed 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.

 

Avance® Nerve Graft is processed in the United States by AxoGen. AxoGuard® Nerve Connector and AxoGuard® Nerve Protector are manufactured in the United States by Cook Biotech Incorporated, and are distributed worldwide exclusively by AxoGen. AxoGen maintains its corporate offices in Alachua, Florida and is the parent of its wholly owned operating subsidiary, AxoGen Corporation.

 



 

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 projected 2014 revenue and gross margin, product development, product potential, financial performance, liquidity, sales growth, product adoption, market awareness of our products and 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.

 

Contact:

AxoGen, Inc.

Lee Robert “Bob” Johnston, Chief Financial Officer

386.462.6856

InvestorRelations@AxoGenInc.com

 

EVC Group

Bob Jones/Michael Polyviou — Investor Relations

646.201.5447/212.850.6020

bjones@evcgroup.com; mpolyviou@evcgroup.com

 



 

AxoGen, Inc.

Condensed Consolidated Balance Sheets

 

 

 

June 30,
2014
(unaudited)

 

December 31,
2013

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

14,170,332

 

$

20,069,750

 

Accounts receivable

 

2,526,953

 

1,893,699

 

Inventory

 

3,410,442

 

3,398,438

 

Prepaid expenses and other

 

144,975

 

296,719

 

Total current assets

 

20,252,702

 

25,658,606

 

 

 

 

 

 

 

Property and equipment, net

 

597,278

 

381,689

 

Intangible assets

 

578,602

 

570,396

 

Deferred Financing Costs

 

970,147

 

1,073,579

 

 

 

$

22,398,729

 

$

27,684,270

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

2,239,055

 

$

2,083,942

 

Current deferred revenue

 

14,118

 

14,118

 

Total current liabilities

 

2,253,173

 

2,098,060

 

Note Payable - Revenue Interest Purchase Agreement

 

27,242,589

 

25,363,695

 

Long Term Deferred Revenue

 

78,739

 

85,882

 

Total liabilities

 

29,574,501

 

27,547,637

 

Commitments and contingencies

 

 

 

Shareholders’ equity:

 

 

 

 

 

Common stock, $.01 par value; 50,000,000 shares authorized; 17,466,091 and 17,339,561 shares issued and outstanding

 

174,661

 

173,395

 

Additional paid-in capital

 

73,036,381

 

72,369,016

 

Accumulated deficit

 

(80,386,814

)

(72,405,778

)

Total shareholders’ equity

 

(7,175,772

)

136,633

 

 

 

$

22,398,729

 

$

27,684,270

 

 



 

AxoGen, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

June 30,

 

June 30,

 

 

 

2014

 

2013

 

2014

 

2013

 

Revenues

 

$

4,214,193

 

$

2,862,289

 

$

7,352,449

 

$

5,005,221

 

Cost of goods sold

 

887,820

 

633,293

 

1,589,121

 

1,193,536

 

Gross profit

 

3,326,373

 

2,228,996

 

5,763,328

 

3,811,685

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Sales and marketing

 

3,354,912

 

2,526,388

 

6,075,619

 

4,419,929

 

Research and development

 

555,758

 

498,318

 

1,368,373

 

905,261

 

General and administrative

 

1,713,447

 

1,398,619

 

3,608,222

 

3,004,378

 

Total costs and expenses

 

5,624,117

 

4,423,325

 

11,052,214

 

8,329,568

 

Loss from operations

 

(2,297,744

)

(2,194,329

)

(5,288,886

)

(4,517,883

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense

 

(1,392,098

)

(1,223,645

)

(2,583,415

)

(2,291,266

)

Interest expense—deferred financing costs

 

(52,217

)

(41,215

)

(103,432

)

(85,432

)

Other income (expense)

 

588

 

1,390

 

(5,303

)

(728

)

Total other income (expense)

 

(1,443,727

)

(1,263,470

)

(2,692,150

)

(2,377,426

)

Net loss

 

$

(3,741,471

)

$

(3,457,799

)

$

(7,981,036

)

$

(6,895,309

)

Net loss available to common shareholders

 

$

(3,741,471

)

$

(3,457,799

)

$

(7,981,036

)

$

(6,895,309

)

Weighted Average Common Shares outstanding — basic and diluted

 

17,461,332

 

11,137,729

 

17,422,773

 

11,131,217

 

Loss Per Common share - basic and diluted

 

$

(0.21

)

$

(0.31

)

$

(0.46

)

$

(0.62

)

 



 

AxoGen, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

 

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2014

 

2013

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(7,981,036

)

$

(6,895,309

)

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

 

 

 

 

 

Depreciation

 

67,887

 

42,813

 

Amortization of intangible assets

 

22,099

 

29,405

 

Amortization of deferred financing costs

 

103,432

 

85,432

 

Stock-based compensation

 

474,144

 

392,473

 

Stock grants

 

60,125

 

 

Interest added to note

 

1,878,894

 

1,803,439

 

Change in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(633,254

)

(365,435

)

Inventory

 

(12,004

)

(424,670

)

Prepaid expenses and other

 

151,744

 

59,930

 

Accounts payable and accrued expenses

 

155,113

 

108,186

 

Deferred Revenue

 

(7,143

)

 

Net cash used for operating activities

 

(5,719,999

)

(5,163,736

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchase of property and equipment

 

(283,476

)

(45,315

)

Acquisition of intangible assets

 

(30,305

)

(39,060

)

Net cash used for investing activities

 

(313,781

)

(84,375

)

Cash flows from financing activities:

 

 

 

 

 

Proceeds from exercise of stock options

 

134,362

 

33,393

 

Net cash provided by financing activities

 

134,362

 

33,393

 

Net decrease in cash and cash equivalents

 

(5,899,418

)

(5,214,718

)

Cash and cash equivalents, beginning of year

 

20,069,750

 

13,907,401

 

Cash and cash equivalents, end of period

 

14,170,332

 

8,692,683

 

Supplemental disclosures of cash flow activity:

 

 

 

 

 

Cash paid for interest

 

$

664,546

 

$

458,394