PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
TranS1 Inc.
Consolidated Statements of Operations
and Comprehensive Loss
(in thousands, except per share amounts)
(Unaudited)
|
|
Three Months Ended March 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
3,099
|
|
|
$
|
3,782
|
|
Cost of revenue
|
|
|
1,031
|
|
|
|
997
|
|
Gross profit
|
|
|
2,068
|
|
|
|
2,785
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,285
|
|
|
|
1,333
|
|
Sales and marketing
|
|
|
4,927
|
|
|
|
5,299
|
|
General and administrative
|
|
|
1,550
|
|
|
|
1,417
|
|
Merger and integration expenses
|
|
|
1,313
|
|
|
|
-
|
|
Charges related
to U.S. Government settlement
|
|
|
91
|
|
|
|
464
|
|
Total operating
expenses
|
|
|
9,166
|
|
|
|
8,513
|
|
Operating loss
|
|
|
(7,098
|
)
|
|
|
(5,728
|
)
|
Other expense,
net
|
|
|
(2
|
)
|
|
|
(30
|
)
|
Net loss
|
|
$
|
(7,100
|
)
|
|
$
|
(5,758
|
)
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
|
(1
|
)
|
|
|
-
|
|
Comprehensive
loss
|
|
$
|
(7,101
|
)
|
|
$
|
(5,758
|
)
|
Net loss
per common share – basic and diluted
|
|
$
|
(0.26
|
)
|
|
$
|
(0.21
|
)
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding - basic and diluted
|
|
|
27,317
|
|
|
|
27,245
|
|
The accompanying notes are an integral
part of these financial statements.
TranS1 Inc.
Consolidated Balance Sheets
(in thousands, except share amounts)
(Unaudited)
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
14,686
|
|
|
$
|
21,541
|
|
Restricted cash
|
|
|
62
|
|
|
|
-
|
|
Accounts receivable, net
|
|
|
2,936
|
|
|
|
3,206
|
|
Inventory
|
|
|
5,053
|
|
|
|
5,017
|
|
Prepaid expenses and other assets
|
|
|
593
|
|
|
|
330
|
|
Total current assets
|
|
|
23,330
|
|
|
|
30,094
|
|
Property and equipment, net
|
|
|
2,203
|
|
|
|
2,166
|
|
Total assets
|
|
$
|
25,533
|
|
|
$
|
32,260
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
3,002
|
|
|
$
|
2,603
|
|
Accrued expenses related to U.S. Government settlement
|
|
|
6,359
|
|
|
|
6,792
|
|
Accrued expenses
|
|
|
1,731
|
|
|
|
1,648
|
|
Total current liabilities
|
|
|
11,092
|
|
|
|
11,043
|
|
Noncurrent liabilities
|
|
|
77
|
|
|
|
78
|
|
Commitments and contingencies (Note 9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 75,000,000 shares
authorized, 27,318,785 and 27,313,997 shares issued and outstanding at March 31, 2013 and December
31, 2012, respectively
|
|
|
3
|
|
|
|
3
|
|
Additional paid-in capital
|
|
|
160,255
|
|
|
|
159,929
|
|
Accumulated other comprehensive income
|
|
|
13
|
|
|
|
14
|
|
Accumulated deficit
|
|
|
(145,907
|
)
|
|
|
(138,807
|
)
|
Total stockholders' equity
|
|
|
14,364
|
|
|
|
21,139
|
|
Total liabilities and stockholders'
equity
|
|
$
|
25,533
|
|
|
$
|
32,260
|
|
The accompanying notes are an integral
part of these financial statements.
TranS1 Inc.
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
|
|
Three Months Ended March 31,
|
|
|
|
2013
|
|
|
2012
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,100
|
)
|
|
$
|
(5,758
|
)
|
Adjustments to reconcile net loss
to net cash used in
operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
359
|
|
|
|
207
|
|
Stock-based compensation
|
|
|
317
|
|
|
|
331
|
|
Allowance for excess and obsolete
inventory
|
|
|
20
|
|
|
|
12
|
|
Provision (reversal of provision)
for bad debts
|
|
|
11
|
|
|
|
(41
|
)
|
Loss on disposal of fixed assets
|
|
|
-
|
|
|
|
30
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
Decrease in accounts receivable
|
|
|
259
|
|
|
|
173
|
|
Increase in inventory
|
|
|
(56
|
)
|
|
|
(162
|
)
|
(Increase) decrease in prepaid expenses
|
|
|
(263
|
)
|
|
|
195
|
|
Increase (decrease) in accounts payable
|
|
|
398
|
|
|
|
(943
|
)
|
Increase (decrease) in accrued expenses related to
U.S. Government settlement
|
|
|
(433
|
)
|
|
|
250
|
|
Increase in accrued expenses
|
|
|
83
|
|
|
|
113
|
|
Net cash used
in operating activities
|
|
|
(6,405
|
)
|
|
|
(5,593
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(396
|
)
|
|
|
(697
|
)
|
Sales and maturities of investments
|
|
|
-
|
|
|
|
6,027
|
|
Restricted
cash classification change
|
|
|
(62
|
)
|
|
|
-
|
|
Net cash provided
by (used in) investing activities
|
|
|
(458
|
)
|
|
|
5,330
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of stock options
|
|
|
9
|
|
|
|
6
|
|
Net cash provided
by financing activities
|
|
|
9
|
|
|
|
6
|
|
Effect of exchange
rate changes on cash and cash equivalents
|
|
|
(1
|
)
|
|
|
-
|
|
Net decrease in cash and cash equivalents
|
|
|
(6,855
|
)
|
|
|
(257
|
)
|
Cash and cash
equivalents, beginning of period
|
|
|
21,541
|
|
|
|
38,724
|
|
Cash and
cash equivalents, end of period
|
|
$
|
14,686
|
|
|
$
|
38,467
|
|
The accompanying notes are an integral
part of these financial statements.
TranS1 Inc.
Notes to Consolidated Financial Statements
(Unaudited)
|
1.
|
Description of Business
|
TranS1 Inc., a Delaware corporation (the
“Company”), was incorporated in May 2000 and, effective March 1, 2013, is headquartered in Raleigh, North Carolina.
The Company is a medical device company focused on designing, developing and marketing products to treat degenerative conditions
of the spine affecting the lumbar region.
The Company
operates in one business segment.
The Company currently markets the AxiaLIF® family of products for single and two level lumbar
fusion,
the VEO
TM
lateral access and interbody fusion system, the Vectre
™
lumbar posterior fixation system and Bi-Ostetic
TM
bone void filler, a biologics product.
All
of the Company’s AxiaLIF products are delivered using its pre-sacral approach.
The Company
also markets products that may be used with its surgical approach, including bowel retractors and additional discectomy tools,
as well as a bone graft harvesting system that can be used to extract bone graft in any procedure for which the use of bone graft
is appropriate. The AxiaLIF Legacy product was commercially released in January 2005. The AxiaLIF 2L™ product was commercially
released in Europe in the fourth quarter of 2006 and in the United States in the second quarter of 2008. The AxiaLIF 2L product
was discontinued in 2010 after the Company launched its AxiaLIF
Plus 2-Level
™ product
in July 2010. The Company commercially launched its next generation Vectre facet screw system in April 2010. In the first quarter
of 2010, the Company completed product and regulatory training and began marketing
Bi-Ostetic bone void filler,
a biologics product
for specific indications outside the interbody space of the spine
.
The Company commercially launched its AxiaLIF Plus 1-Level product in September 2011, which received FDA 510(k) clearance in March
2011. In 2010, the Company received 510(k) clearance for the VEO lateral access and interbody fusion system, which was commercially
launched in November 2011, and in July 2012 the Company received a CE mark for the VEO lateral access and interbody fusion system
and
began commercialization in the European market
. The Company sells its products through
a direct sales force, independent sales agents and international distributors.
The Company has fifty issued United States
patents, twelve pending patent applications or provisional patent applications in the United States, eight issued European patents,
seven issued Japanese patents, and eleven foreign patent application families as counterparts of U.S. cases. The issued and
pending patents cover, among other things, (i) the Company’s method for performing trans-sacral procedures in the spine,
including diagnostic or therapeutic procedures, and trans-sacral introduction of instrumentation or implants, (ii) apparatus for
conducting these procedures including access, disc preparation and implantation including the current TranS1 instruments individually
and in kit form, (iii) implants for fusion and motion preservation in the spine, (iv) a lateral access and interbody fusion
system, and (v) posterior fixation systems.
The Company
owns nine trademark registrations in the United States, nine trademark registrations in the European Union
, two registered
trademarks in Canada and one registered trademark in China.
The Company also owns two pending
trademark applications in the United States and three pending trademark applications in China.
See Note 10 for
a description of the Company’s proposed merger with Baxano, Inc. (“Baxano”) and the related transactions.
The Company is
subject to a number of risks similar to other similarly-sized companies in the medical device industry. These risks include, without
limitation, acceptance and continued use of the Company’s products by surgeons, the lack of clinical data about the efficacy
of these products, uncertainty of reimbursement from third-party payors, cost pressures in the healthcare industry, competitive
pressures from substitute products and larger companies, the historical lack of profitability, the dependence on key employees,
regulatory approval and market acceptance for new products, compliance with complex and evolving healthcare laws and regulations,
uncertainty surrounding the outcome of the matters relating to the subpoena issued to the Company by the
Department
of Health and Human Services, Office of Inspector General (the “OIG”),
stockholder
class action
lawsuits, the reliance on a limited number of suppliers to provide these products and their components, changes
in economic conditions, the ability to effectively manage a sales force to meet the Company’s objectives and the ability
to conduct successful clinical studies.
The Company has prepared the accompanying
consolidated financial statements in conformity with accounting principles generally accepted in the United States of America
(“U.S. GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange
Commission (the “SEC”). The consolidated financial statements are unaudited and should be read in conjunction with
the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December
31, 2012. The accompanying unaudited interim consolidated financial statements reflect all adjustments (consisting of normal recurring
adjustments) which are, in the opinion of the Company’s management, necessary for a fair statement of the Company’s
consolidated financial position, results of operations and cash flows for the periods presented. These principles require management
to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during
the reporting period. The principal estimates relate to accounts receivable reserves, inventory valuation, stock-based compensation,
accrued expenses and income tax valuation. Actual results could differ from those estimates. The year-end balance sheet data was
derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. All intercompany accounts
and transactions have been eliminated in consolidation.
The accompanying financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities
and commitments in the normal course of business. The Company has incurred operating losses and negative cash flows from operations,
which raise substantial doubt about its ability to continue as a going concern. The financial statements do not include any adjustments
relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might result from the
outcome of this uncertainty. To meet its capital needs, the Company is considering multiple alternatives, including, but not limited
to, additional equity financings, debt financings and other funding transactions. There can be no assurance that the Company will
be able to complete any such transaction on acceptable terms or otherwise. If the Company is unable to obtain the necessary capital,
it will need to pursue a plan to license or sell its assets, seek to be acquired by another entity, cease operations and/or seek
bankruptcy protection.
Reclassification
Certain balances in the prior years’
consolidated financial statements have been reclassified to conform to the March 31, 2013 presentation. These changes consisted
of a reclassification on the consolidated statements of operations from general and administrative expense to a separate line
item entitled charges related to U.S. Government settlement and a reclassification on the consolidated statements of cash flows
from changes in accounts payable and accrued expenses to a separate line item entitled increase (decrease) in accrued expenses
related to U.S. Government settlement.
Impact of Recently Issued Accounting
Standards
In February 2013, the Financial Accounting
Standards Board issued guidance (ASU No. 2013-02) finalizing the reporting of amounts reclassified out of accumulated other comprehensive
income. The new standard requires either in a single note or parenthetically on the face of the financial statements, the effect
of significant amounts reclassified from each component of accumulated other comprehensive income based on its source and the
income statement line items affected by the reclassification. The guidance is effective for annual reporting periods and interim
periods within those years, beginning after December 15, 2012. In the first quarter of 2013, the Company adopted the guidance
and determined that there were no amounts reclassified in the period that would require enhanced disclosure.
No provisions for federal or state income
taxes have been recorded as the Company has incurred net operating losses since inception.
|
4.
|
Net Loss
Per Common Share
|
Basic net loss
per common share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss
available to common stockholders per common share is computed by dividing net loss by the weighted average number of common shares
and dilutive potential common share equivalents then outstanding. The Company’s potential dilutive common shares, which
consist of shares issuable upon the exercise of stock options, have not been included in the computation of diluted net loss per
share for all periods as the result would be anti-dilutive.
The following
table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share as
the result would be anti-dilutive as of the end of each period presented:
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
Weighted average stock options outstanding
|
|
|
3,579,814
|
|
|
|
3,051,991
|
|
|
5.
|
Cash
and Cash Equivalents
|
The Company considers
all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents.
Cash and cash equivalents include money market treasury funds. Cash equivalents are carried at fair market value. At March 31,
2013, the Company had $62,000 of restricted cash which is currently deposited in a bank account in Germany, but not readily accessible.
Related unrealized gains and losses were not material as of March 31, 2013 and 2012. There have been no unrealized gains or losses
reclassified to accumulated other comprehensive income.
At
March 31, 2013, the Company held certain assets that are required to be measured at fair value on a recurring basis. These assets
include available for sale securities classified as cash equivalents.
Accounting Standards Codification 820-10
requires
the valuation of investments using a three-tiered approach, which requires
that
fair value measurements be classified and disclosed in one of three tiers.
These tiers are: Level 1, defined as quoted
prices in active markets for identical assets or liabilities; Level 2, defined as valuations based on observable inputs other
than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets, or other inputs that
are observable or can be corroborated by observable input data; and Level 3, defined as valuations based on unobservable inputs
reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants.
Cash and available
for sale securities classified as Level 1 assets were:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
(In thousands)
|
|
Cash and cash equivalents
|
|
$
|
14,515
|
|
|
$
|
21,116
|
|
Total cash and available for sale
securities
|
|
$
|
14,515
|
|
|
$
|
21,116
|
|
The Company had
no Level 2 or Level 3 assets or liabilities at March 31, 2013 or December 31, 2012.
|
6.
|
Accounts
Receivable, Net
|
The following table presents the components of accounts receivable:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
(In thousands)
|
|
Gross accounts receivable
|
|
$
|
3,115
|
|
|
$
|
3,419
|
|
Allowance for uncollectible accounts
|
|
|
(179
|
)
|
|
|
(213
|
)
|
Total accounts receivable, net
|
|
$
|
2,936
|
|
|
$
|
3,206
|
|
The following table presents the components of inventories:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
(In thousands)
|
|
Finished goods
|
|
$
|
2,998
|
|
|
$
|
2,491
|
|
Work-in-process
|
|
|
1,819
|
|
|
|
2,272
|
|
Raw materials
|
|
|
236
|
|
|
|
254
|
|
Total inventories
|
|
$
|
5,053
|
|
|
$
|
5,017
|
|
The following table presents the components
of accrued expenses:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
|
(In thousands)
|
|
Legal and professional fees
|
|
$
|
602
|
|
|
$
|
129
|
|
Commissions
|
|
|
274
|
|
|
|
333
|
|
Vacation
|
|
|
257
|
|
|
|
160
|
|
Bonus
|
|
|
159
|
|
|
|
630
|
|
Salaries and benefits
|
|
|
129
|
|
|
|
168
|
|
Travel and entertainment
|
|
|
93
|
|
|
|
43
|
|
Other
|
|
|
217
|
|
|
|
185
|
|
Total accrued expenses
|
|
$
|
1,731
|
|
|
$
|
1,648
|
|
In October
2011, the Company received a subpoena issued by the Department of Health and Human Services, Office of Inspector General (“OIG”)
under the authority of the federal healthcare fraud and false claims statutes. The subpoena sought documents for the period January 1,
2008 through October 6, 2011. The Company has cooperated with the government’s request.
On December 24, 2012
the Company reached a tentative agreement in principle with the U.S. Department of Justice related to the subpoena issued in October
2011. The Company and the staff of the Department of Justice tentatively agreed to settle its federal investigation for $6.0 million,
subject to completion and approval of written settlement agreements with the Department of Justice and the OIG, which are expected
to be finalized in the second quarter of 2013. The Company admits no wrongdoing as part of the settlement. In the three months
ended March 31, 2013 and 2012, the Company expensed legal fees of $0.1 million and $0.5 million, respectively, related to this
investigation. In the fourth quarter of 2012, the Company expensed the $6.0 million related to the tentative settlement. The Company
had accrued $6.4 million at March 31, 2013 and $6.8 million at December 31, 2012 for the settlement and related legal fees.
On January 24, 2012, the Company received
notice that a putative class action lawsuit had been filed
in the U.S.
District Court Eastern District, North Carolina,
on behalf of all persons, other than defendants, who purchased the Company’s
securities between February 21, 2008 and October 17, 2011. The complaint alleges violations of the Securities Exchange Act
of 1934, as amended, based upon purported omissions and/or false and misleading statements concerning the Company’s financial
statements and reimbursement practices. The complaint seeks damages sustained by the putative class, pre- and post-judgment
interest, and attorneys’ fees and other costs. On September 7, 2012, the Company filed a motion to dismiss the complaint
for failure to meet the heightened pleading requirements of the Private Securities Litigation Reform Act of 1995, among other
grounds; the motion is pending. The Company is unable to predict what impact, if any, the outcome of this matter might have
on the Company’s consolidated financial position, results of operations, or cash flows.
|
10.
|
Merger
and Private Placement Transaction
|
Agreement and Plan of Merger
On March 3, 2013, the Company entered
into an Agreement and Plan of Merger with RacerX Acquisition Corp., a wholly-owned subsidiary of the Company (“Merger Sub”),
Baxano, and Sumeet Jain and David Schulte solely as Securityholder Representatives (the “Securityholder Representatives”),
as amended on April 10, 2013 by the First Amendment to Agreement and Plan of Merger by and among the parties (such agreement,
as amended, the “Merger Agreement”). Under the terms of the Merger Agreement, the Company will acquire Baxano through
a merger of Merger Sub with and into Baxano (the “Merger”). At the effective time of the Merger (the “Effective
Time”), Merger Sub will cease to exist and Baxano will continue as the surviving corporation and as a wholly-owned subsidiary
of the Company.
As of March 31, 2013, the Company had
incurred $1.2 million of merger related expenses and $0.1 million of integration expenses.
Pursuant to the terms of the Merger Agreement,
the merger consideration will consist of approximately 10.4 million shares of the Company’s common stock. The number of
shares comprising the merger consideration will be reduced by a number of shares with a value equal to the following (using for
the per share value an average closing price on the NASDAQ Global Market during the 10 days preceding the Effective Time): (1)
Baxano’s indebtedness in excess of (a) amounts under promissory notes of Baxano that are convertible into capital stock
of Baxano (each a “Baxano Note”), outstanding at the Effective Time, and (b) up to $3,000,000 of principal as well
as interest outstanding under certain long-term indebtedness; (2) $300,000 in cash, which will be used to fund a compensation
plan to be adopted by Baxano prior to the closing of the Merger providing for bonuses to Baxano’s employees and certain
non-employee directors; and (3) $250,000 in cash, which the Company has agreed to deposit into an account specified for the purpose
of funding the expenses of the Securityholder Representatives under the Merger Agreement.
At the Effective Time, each Baxano Note
will be terminated, and the holders of such notes will be entitled to receive merger consideration in accordance with the Merger
Agreement. Any and all stock option plans or other stock or equity-related plans of Baxano, together with any employee stock purchase
plans, will be terminated prior to the Effective Time. Prior to the Effective Time, Baxano must use commercially reasonable efforts
to terminate each outstanding option to purchase common stock of Baxano, whether vested or unvested, and each warrant to acquire
capital stock of Baxano.
The Merger Agreement contains customary
representations, warranties, and covenants, including covenants related to obtaining the requisite stockholder approvals, appointing
two Baxano designees to the Company’s Board of Directors, restricting the solicitation of competing acquisition proposals,
the lock-up and registration of the shares of the Company’s common stock issued in connection with the Merger pursuant to
the Securities Purchase Agreement described below, and the Company’s and Baxano’s conduct of their businesses between
the date of signing the Merger Agreement and the closing of the Merger.
The stockholders of Baxano approved the
Merger and the Merger Agreement pursuant to a written consent in lieu of a stockholders’ meeting on March 3, 2013 following
execution of the Merger Agreement. Consummation of the Merger is also subject to approval by the Company’s stockholders
of the issuance of shares of the Company’s common stock in connection with the Merger and the satisfaction or waiver of
the closing conditions set forth in the Securities Purchase Agreement and other customary closing conditions set forth in the
Merger Agreement. The Company’s directors, officers, and certain affiliates of the Company, who together hold approximately
24.2% of the issued and outstanding common stock of the Company, have agreed to vote their shares in favor of the issuance of
the Company’s common stock in connection with the Merger Agreement and the Securities Purchase Agreement.
The Merger Agreement grants certain termination
rights to the Company and Baxano. In addition, the Merger Agreement provides that the Company will be required to pay Baxano a
termination fee equal to $2,000,000 and to reimburse Baxano for its expenses incurred relating to the transactions contemplated
by the Merger Agreement, up to a cap of $750,000, if Baxano or the Company terminates the Merger Agreement under certain conditions.
The Merger Agreement also provides that Baxano will be required to pay the Company a termination fee equal to $1,000,000 and to
reimburse the Company for its expenses incurred relating to the transactions contemplated by the Merger Agreement, up to a cap
of $750,000, if the Company terminates the Merger Agreement under certain conditions.
Securities Purchase Agreement
Concurrent with entering into the Merger
Agreement, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”), dated March
3, 2013, with certain investors (the “Investors”), pursuant to which the Company will sell to the Investors, and the
Investors will purchase from the Company, an aggregate of 7,522,009 shares of the Company’s common stock, at a purchase
price of $2.28 per share, resulting in gross proceeds to the Company of $17.2 million (the “Private Placement Transaction”).
Pursuant to the Securities Purchase Agreement,
the Company agreed to register the resale of the shares of the Company’s common stock to be issued pursuant to the Merger
Agreement and the Securities Purchase Agreement under a registration statement (the “Registration Statement”) on Form
S-3 (or another appropriate form if Form S-3 is not then available to the Company). In addition, the Investors and all other holders
of shares received pursuant to the Merger Agreement agreed not to sell, transfer, or otherwise dispose of the shares of the Company’s
common stock issued at the closing of the Merger and the Private Placement Transaction from the period commencing on the closing
of the Private Placement Transaction and expiring on the effective date of the Registration Statement, subject to certain exceptions.
If the Registration Statement is not declared
effective by the SEC by a certain date, the Company must pay each Investor and other holder of shares issued pursuant to the Merger
Agreement liquidated damages equal to 1% of the value of their shares (calculated at the closing price of such shares) per month,
up to a maximum of 12%.
The Securities Purchase Agreement contains
customary representations and warranties of the Company and the Investors. Consummation of the Private Placement Transaction is
subject to approval by the Company’s stockholders of the issuance of shares of the Company’s common stock in connection
with the Merger Agreement and the Securities Purchase Agreement, the closing of the Merger, and other customary closing conditions
set forth in the Securities Purchase Agreement.
On April 16, 2013 and April 25, 2013,
Baxano issued promissory notes (the “Bridge Notes”) to the Company in the principal amount of $800,000 and $1.3 million,
respectively, as contemplated by the Merger Agreement. The Bridge Notes bear interest at a rate of 6% per annum. The Bridge Notes
are not secured by any collateral; are subordinated in right of payment to the loan evidenced by the Loan and Security Agreement
dated as of March 15, 2012, among Oxford Finance LLC, Silicon Valley Bank and Baxano; and are senior in right of payment to the
Baxano Notes.
The Bridge Notes will be cancelled immediately
prior to the Effective Time without consideration, repayment, or any other right of the Company to be repaid or otherwise compensated.
All outstanding principal and interest under the Bridge Notes will be due and payable on demand by the Company any time on or
after September 7, 2013 if the Effective Time has not occurred by such date. Additionally, all principal and accrued interest
under the Bridge Notes will be due and payable upon the consummation of any sale by Baxano of its equity securities to venture
capital, institutional, or private investors, including at least one investor that is not an existing noteholder or stockholder
of Baxano, resulting in aggregate cash proceeds to Baxano of at least $15,000,000 (excluding any amount invested by cancellation
or conversion of the indebtedness represented by the Baxano Notes).
Item 2. Management’s Discussion
and Analysis of Financial Condition and Results of Operations.
The
following discussion of our financial condition and results of operations should be read in conjunction with our consolidated
financial statements and the related notes to our consolidated financial statements included in this report. In addition to historical
financial information, t
his report contains “forward-looking statements” within the meaning of
Section
27A of the Securities Act of 1933, as amended, or the Securities Act, and
Section 21E of the Securities Exchange Act of
1934, as amended, or the Exchange Act, that concern matters that involve risks and uncertainties that could cause actual results
to differ materially from those projected in the forward-looking statements. These forward-looking statements are intended to
qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements
other than statements of historical fact contained in this report, including statements regarding the expected timing, completion,
and benefits of the Merger (as defined below) and Private Placement Transaction (as defined below), other future events, our future
financial performance, our future business strategy and the plans and objectives of management for future operations, are forward-looking
statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,”
“can,” “continue,” “could,” “estimates,” “expects,” “intends,”
“may,” “plans,” “potential,” “predicts,” “should” or “will”
or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe
we have a reasonable basis for doing so, we cannot guarantee their accuracy. Such forward-looking statements are subject to risks,
uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future
results expressed or implied by such forward-looking statements. Readers are urged to carefully review and consider the various
disclosures made by us, which attempt to advise interested parties of the risks, uncertainties, and other factors that affect
our business, operating results, financial condition and stock price, including without limitation the disclosures made under
the captions “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, “Risk
Factors”, “Financial Statements” and “Notes to Consolidated Financial Statements” in this report,
as well as the disclosures made under the captions “Management’s Discussion and Analysis of Financial Condition and
Results of Operations”, “Risk Factors”, “Consolidated Financial Statements” and “Notes to
Consolidated Financial Statements” included in our Annual Report on Form 10-K for the year ended December 31, 2012,
and in other filings we make with the Securities and Exchange Commission, or the SEC. Furthermore, such forward-looking statements
speak only as of the date of this report. We expressly disclaim any intent or obligation to update any forward-looking statements
after the date hereof to conform such statements to actual results or to changes in our opinions or expectations
except as required by applicable law or the rules of The NASDAQ Stock Market LLC
. References in this report to
“TranS1”, “we”, “our”, “us”, or the “Company” refer to TranS1 Inc.
Overview
We are a medical device company focused
on designing, developing and marketing products to treat degenerative conditions of the spine affecting the lumbar region. We
are committed to delivering minimally invasive surgical technologies that enhance patient clinical care while providing sustained
value for our customers. We currently market the AxiaLIF
®
family of products
for single and two level lumbar fusion, the VEO
TM
lateral access and interbody fusion system, the Vectre
™
lumbar posterior fixation system and Bi-Ostetic
TM
bone void filler, a biologics product. Our AxiaLIF products
use our pre-sacral approach, through which a surgeon can access discs in the lumbar region of the spine through an incision adjacent
to the tailbone and perform an interbody fusion procedure through instrumentation that provides direct access to the intervertebral
space. We developed our pre-sacral approach to allow spine surgeons to access and treat intervertebral spaces without compromising
important surrounding soft tissue, nerves
and bone structures
. Our VEO lateral access and
interbody fusion system provides for direct visualization of the psoas muscle and unrestricted lateral fluoroscopic views, which
we believe has allowed us to increase our market share in the highly competitive lateral fusion segment. We believe that direct
visualization allows a surgeon to have improved visibility of the psoas and the nerves running through this muscle that, when
used in conjunction with neuromonitoring, can potentially reduce complications. We
also market
products that may be used with our AxiaLIF surgical approach, including bowel retractors and additional discectomy tools, as well
as a bone graft harvesting system that can be used to extract bone graft in any procedure for which the use of bone graft is appropriate.
Our philosophy of continuous improvement is driven by ongoing research and development investment in our core technologies.
We support this investment by diligently expanding, maintaining, and protecting our significant patent portfolio.
From our incorporation in 2000 through
2004, we devoted substantially all of our resources to research and development and start-up activities, consisting primarily
of product design and development, clinical trials, manufacturing, recruiting qualified personnel and raising capital. We received
510(k) clearance from the U.S.
Food and Drug Administration, or
FDA, for our AxiaLIF Legacy
product in the fourth quarter of 2004, and commercially introduced our AxiaLIF Legacy product in the United States in the first
quarter of 2005. We received a CE mark to market our AxiaLIF Legacy product in the European market in the first quarter of 2005
and began commercialization in the first quarter of 2006. We received a CE mark for our AxiaLIF 2L product in the third quarter
of 2006 and began commercialization in the European market in the fourth quarter of 2006. We received FDA 510(k) clearance for
our AxiaLIF 2L product and began marketing this product in the United States in the second quarter of 2008. T
he
AxiaLIF 2L product was discontinued in 2010 after we launched our AxiaLIF Plus 2-Level ™ product in July 2010, for which
we had
received FDA 510(k) clearance in January 2010. We commercially launched our next generation Vectre facet screw system
in April 2010. In the first quarter of 2010, we
completed product and regulatory training and
began marketing
Bi-Ostetic bone void filler, a biologics product for specific indications outside the interbody space of
the spine.
We commercially launched our AxiaLIF Plus 1-Level product in September 2011, for which
we had received FDA 510(k) clearance in March 2011. In 2010, we received 510(k) clearance for our VEO lateral access and interbody
fusion system, which was commercially launched in November 2011, and in July 2012 we received a CE mark for our VEO lateral access
and interbody fusion system and
began commercialization in the European market
.
We
currently sell our products through a direct sales force, independent sales agents and international distributors.
In March 2012, we announced that the Current
Procedural Terminology (“CPT”) Editorial Panel, or the Panel, voted to approve an application for a new Category I
CPT code, 22586, for L5/S1 spinal fusion utilizing our AxiaLIF implant when performing a pre-sacral interbody fusion. In addition,
the Panel voted to establish a new Category III CPT code, 0309T, as an add-on code to the new Category I code for use with 22586
when performing L4/5 spinal fusion. The new CPT codes were announced on the American Medical Association’s website on March
2, 2012, and became effective on January 1, 2013. The Medicare final rule was released in November 2012, which stated a
valuation of the Category I CPT code 22586 for pre-sacral interbody single level spinal fusion at L5-S1, and
became effective
January 1, 2013. This
CPT code, which applies to our AxiaLIF Plus 1-Level
device, is a bundled lumbar arthrodesis procedure that includes bone graft, posterior instrumentation and fixation.
With
the establishment of a Category I CPT code effective January 1, 2013, we believe that we are in a position to transition to a
period of sustainable revenue growth.
We rely on third
parties to manufacture all of our products and their components, except for our nitinol nucleus cutter blades, which we manufacture
at our facility in Wilmington, North Carolina. Our outsourcing partners are manufacturers that meet FDA, International Organization
for Standardization or other internal quality standards, where applicable. We believe these manufacturing relationships allow
us to work with suppliers who have the best specific competencies while we minimize our capital investment, control costs and
shorten cycle times.
On
March 3, 2013, we entered into an Agreement and Plan of Merger with RacerX Acquisition Corp., a wholly-owned subsidiary of the
Company, or Merger Sub, Baxano, Inc., or Baxano, and Sumeet Jain and David Schulte solely as Securityholder Representatives, or
the Securityholder Representatives,
as amended on April 10, 2013 by the First Amendment to Agreement and Plan of Merger
by and among the parties. We refer to this agreement, as amended, as the Merger Agreement.
Under the terms of the Merger Agreement, we will acquire Baxano through a merger of Merger Sub with and into Baxano, or the Merger.
At the effective time of the Merger, Merger Sub will cease to exist and Baxano will continue as the surviving corporation and
as a wholly-owned subsidiary of the Company.
The dollar value of the shares of our common stock to be issued in connection
with the Merger is expected to be approximately $23.1 million, subject to fluctuations in the price of our common stock on the
NASDAQ Global Market and certain adjustments.
As of March 31, 2013, we have incurred
$1.2 million of merger related expenses and $0.1 million of integration expenses.
Baxano is a medical
instrument company focused on designing, developing and marketing innovative tools that restore spine function, preserve healthy
tissue, and enable a better quality of life for the patients it serves. Baxano currently markets the patented iO-Flex®
system, a proprietary minimally invasive set of flexible instruments allowing surgeons to target lumbar spinal stenosis in all
three regions of the spine: central canal, lateral recess, and neural foramen, and has developed the patented iO-Tome
TM
instrument to rapidly and precisely remove bone, including the facet joints, which is commonly performed in spinal fusion procedures.
Baxano was founded in 2005 and is headquartered in San Jose, California. The Merger is expected to close in the second quarter
of 2013 and is subject to TranS1 stockholder approval and customary conditions to closing.
Concurrent with
entering into the Merger Agreement, we entered into a Securities Purchase Agreement, or the Securities Purchase Agreement, dated
March 3, 2013, with certain investors, or the Investors, pursuant to which we will sell to the Investors, and the Investors will
purchase from us, an aggregate of 7,522,009 shares of our common stock, at a purchase price of $2.28 per share, resulting in gross
proceeds to us of $17.2 million, or the Private Placement Transaction. Consummation of the Private Placement Transaction is subject
to approval by our stockholders of the issuance of shares of our common stock in connection with the Merger Agreement and the
Securities Purchase Agreement, the closing of the Merger, and other customary closing conditions set forth in the Securities Purchase
Agreement.
Since inception,
we have been unprofitable. As of March 31, 2013 we had an accumulated deficit of $145.9 million.
We expect to
continue to invest in sales and marketing infrastructure for our products in order to gain wider acceptance for them. We also
expect to continue to invest in research and development and related clinical trials, and increase general and administrative
expenses as we grow. As a result, we will need to generate significant revenue in order to achieve profitability.
Results of Operations
|
|
Three Months Ended March 31,
|
|
|
|
2013
|
|
|
2012
|
|
|
%
change
|
|
|
|
(in thousands, except gross margin percentage)
|
|
Revenue
|
|
$
|
3,099
|
|
|
$
|
3,782
|
|
|
|
-18.1
|
%
|
Cost of revenue
|
|
|
1,031
|
|
|
|
997
|
|
|
|
3.4
|
%
|
Gross margin %
|
|
|
66.7
|
%
|
|
|
73.6
|
%
|
|
|
-9.4
|
%
|
Total operating expenses
|
|
|
9,166
|
|
|
|
8,513
|
|
|
|
7.7
|
%
|
Net loss
|
|
|
(7,100
|
)
|
|
|
(5,758
|
)
|
|
|
-23.3
|
%
|
Revenue
Revenue is recognized
based on the following criteria: (i) persuasive evidence that an arrangement exists with the customer; (ii) delivery
of the products and/or services has occurred; (iii) the selling price has been fixed for the products or services delivered;
and (iv) collection is reasonably assured. We generate revenue from the sales of our implants and disposable surgical instruments.
We have two distinct sales methods. The first method is when implants and/or disposable surgical instruments are sold directly
to hospitals or surgical centers for the purpose of conducting a scheduled surgery. Our sales representatives or independent sales
agents hand deliver the products to the customer on or before the day of the surgery. The sales representative or independent
agent is then responsible for reporting the delivery of the products and the date of the operation to the corporate office for
proper revenue recognition. We recognize revenue upon the confirmation that the products have been used in a surgical procedure.
The other sales method is for sales to distributors outside the United States. These transactions require the customer to send
in a purchase order before shipment will be made and the customer only has the right of return for defective products. We primarily
recognize revenue upon the shipment of the product to distributors outside the United States, when risk of loss and title has
transferred to the distributor, provided we have no material performance obligations. We expect that a substantial portion of
our revenues will continue to be generated in the United States in future periods.
Cost of Revenue
Cost of revenue consists primarily of
material and overhead costs related to our products, including reusable kit depreciation, product royalties and medical device
taxes. Overhead costs include facilities-related costs, such as rent and utilities.
Research and Development
Research and development expenses consist
primarily of personnel costs within our product development, regulatory and clinical functions and the costs of clinical studies,
product development projects and technology licensing costs. In future periods, we expect research and development expenses to
grow as we continue to invest in basic research, clinical trials, product development and intellectual property. Research and
development expenses are expensed as incurred.
Sales and Marketing
Sales and marketing expenses consist primarily
of personnel costs, sales commissions paid to our direct sales representatives, independent sales agents and independent distributors
and costs associated with physician training programs, promotional activities and participation in medical and trade conferences.
In future periods, we expect sales and marketing expenses to increase as we expand our sales and marketing efforts.
General and Administrative
General and administrative expenses consist
of personnel costs related to the executive, finance and human resource functions, as well as professional service fees, legal
fees, accounting fees, insurance costs and general corporate expenses. In future periods, we expect general and administrative
expenses to increase to support our sales, marketing, research and development efforts.
Charges Related to U.S. Government
Settlement
Charges related to U.S. government settlement
consist of legal fees related to a
federal investigation by the U.S. Department of Justice related
to their subpoena issued in October 2011. We expect to incur additional expenses until this investigation is settled.
Merger and Integration Expenses
Merger expenses consist primarily of legal,
accounting, consulting and other professional fees related to the pending merger with Baxano. Integration expenses consist of
costs incurred in planning for the integration of our operations with Baxano. We expect the merger costs to continue through the
completion of the merger and the integration costs to continue through the remainder of 2013.
Other Expense
Other expense is primarily composed of
interest earned on our cash, cash equivalents and available-for-sale securities and the gain or loss on disposal of fixed assets.
Comparison of the Three Months Ended March 31, 2012 and
2013
Revenue
Revenue decreased from
$3.8 million in the three months ended March 31, 2012 to $3.1 million in the three months ended March 31, 2013. The $0.7 million
decrease in revenue from 2012 to 2013 was due primarily to the lower number of AxiaLIF cases performed by our current surgeon
base. Domestically, sales of our AxiaLIF Plus 1-Level products decreased from $1.5 million in the three months ended March 31,
2012 to $1.0 million in the three months ended March 31, 2013, and sales of our AxiaLIF Plus 2-Level products decreased from $1.1
million in the three months ended March 31, 2012 to $0.7 million in the three months ended March 31, 2013. In the three months
ended March 31, 2013, average revenue per AxiaLIF case increased, primarily as a result of a price increase effective April 1,
2012, the release of new AxiaLIF products and penetration into existing cases by our other products. In the three months ended
March 31, 2012 and 2013, we recorded 222 and 133 domestic AxiaLIF cases, respectively, including 76 AxiaLIF Plus 2-Level cases
in the three months ended March 31, 2012, and 48 AxiaLIF Plus 2-Level cases in the three months ended March 31, 2013. Sales of
our VEO
lateral access and interbody fusion system
increased from $0.3 million in the three
months ended March 31, 2012 to $0.6 million in the three months ended March 31, 2013. During the three months ended March 31,
2012 and 2013, we generated $0.2 million and $0.1 million, respectively, in revenues from sales of our posterior fixation systems.
Sales of our Bi-Ostetic bone void filler remained the same at $0.2 million for both the three months ended March 31, 2012 and
2013. Revenue generated outside the United States increased from $0.3 million in the three months ended March 31, 2012 to $0.5
million in the three months ended March 31, 2013. There were no initial stocking shipments to new distributors outside the United
States in the three months ended March 31, 2012 compared to $0.3 million in initial stocking shipments to new distributors in
the three months ended March 31, 2013. In the three months ended March 31, 2012, 93% of our revenues were generated in the United
States compared to 84% in the three months ended March 31, 2013.
Cost of Revenue
Cost of revenue
remained the same at $1.0 million for both the three months ended March 31, 2012 and March 31, 2013. Gross margin decreased from
73.6% in the three months ended March 31, 2012 to 66.7% in the three months ended March 31, 2013. The decrease in gross margin
was primarily due to a higher percentage of international sales which carry a lower gross margin than domestic sales, increased
depreciation expense on reusable kits, primarily due to upgrading reusable kits as we launched our next generation of AxiaLIF
and VEO products, increased royalty expenses and the new medical device tax.
Research and Development
Research
and development expenses remained the same at $1.3 million in both the three months ended March 31, 2012 and March 31, 2013. Personnel-related
expenses increased by $0.2 million from the three months ended March 31, 2012 compared to three months ended March 31, 2013 as
we increased our headcount in our regulatory and clinical functions, offset by a decrease of $0.2 million in licensing agreements
incurred in the three months ended March 31, 2012.
Sales and Marketing
Sales and marketing
expenses decreased from $5.3 million in the three months ended March 31, 2012 to $4.9 million in the three months ended March
31, 2013. The decrease in expenses from 2012 to 2013 of $0.4 million was primarily due to lower personnel-related costs of $0.3
million and lower promotional costs of $0.3 million, partially offset by an increase in training expenses of $0.2 million to train
surgeons on our new products.
General and Administrative
General
and administrative expenses increased from $1.4 million in the three months ended March 31, 2012 to $1.6 million in the three
months ended March 31, 2013. The increase in expenses of $0.2 million was primarily due to an increase in legal fees related to
our intellectual property of $0.1 million and an increase in personnel-related expense of $0.1 million.
U.S. Government Settlement Charges.
In December 2012, we reached a tentative agreement in principle with the U.S. Department of
Justice related to the subpoena issued in October 2011. TranS1 and the staff of the Department of Justice tentatively agreed to
settle its federal investigation for $6.0 million, subject to completion and approval of written settlement agreements with the
Department of Justice and the OIG. We also incurred legal fees related to the investigation of $0.5 million in the three months
ended March 31, 2012 and $0.1 million in the three months ended March 31, 2013.
Merger and Integration Expenses.
We have incurred $1.2 million of merger related expenses and $0.1 million of integration expenses for the three months ended March
31, 2013 related to the Merger Agreement with Baxano.
Other Expense
Other expense decreased
from $30,000 in expense in the three months ended March 31, 2012 to $2,000 in expense in the three months ended March 31, 2013.
The decrease of $28,000 was primarily related to a loss on the disposal of fixed assets in the three months ended March 31, 2012
from the disposal of obsolete components of certain reusable instrument kits.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception in 2000, we have incurred
significant losses and, as of March 31, 2013, we had an accumulated deficit of $145.9 million. We have not yet achieved profitability,
and we cannot assure investors that we will achieve profitability with our existing capital resources. Our recurring
losses raise substantial doubt about our ability to continue as a going concern. As a result, our independent registered public
accounting firm included an explanatory paragraph in its report on our financial statements as of and for the year ended December
31, 2012 with respect to this uncertainty.
We expect to continue to fund research and development, sales and marketing
and general and administrative expenses at similar to current levels or higher and, as a result, we will need to generate significant
revenues to achieve profitability. Prior to our October 2007 initial public offering, our operations were funded primarily with
the gross proceeds from the sale of preferred stock of $40.5 million. The net proceeds from our October 2007 initial public offering
of $86.7 million and the net proceeds of our September 2011 stock offering of $18.2 million have funded our operations since then.
In May
2011, we filed a “universal shelf” Registration Statement on Form S-3
(Filing
No. 333-174255),
or the Shelf Registration Statement, with the SEC, which became effective
on August 1, 2011 and which we used for our September 2011 stock offering. Depending on our non-affiliated public equity float
during the time period prior to consummating a financing transaction, the Shelf Registration Statement allows us to raise up to
an additional $29.85 million through the sale of debt securities, common stock, preferred stock, or warrants, or any combination
thereof.
The timing and terms of any additional financing transactions pursuant to the Shelf Registration Statement, or
otherwise, have not yet been determined. Any additional financing may not be available in amounts or on terms acceptable to us,
if at all.
As of March 31, 2013, we did not have
any outstanding debt financing arrangements, other than capital lease obligations, we had working capital of $12.2 million and
our primary source of liquidity was $14.7 million in cash and cash equivalents. We currently invest our cash and cash equivalents
primarily in money market treasury funds.
Cash and cash equivalents decreased from
$21.5 million at December 31, 2012 to $14.7 million at March 31, 2013. The decrease of $6.8 million was primarily the result of
net cash used in operating activities of $6.5 million and purchases of property and equipment of $0.4 million.
Cash Flows
Net Cash Used in Operating Activities.
Net cash used in operating activities was $6.4 million in the three months ended March 31, 2013. This amount was attributable
primarily to the net loss after adjustment for non-cash items, such as depreciation, stock-based compensation expense, inventory
and bad debt reserves. There were no significant changes in working capital requirements in the three months ended March 31, 2013.
The three months ended March 31, 2013 included a decrease in accrued legal expenses of $0.4 million related to the U.S. Government
settlement.
Net Cash Used in Investing Activities.
Net cash used in investing activities was $0.5 million in the three months ended March 31, 2013. This amount reflected purchases
of property and equipment of $0.4 million, primarily for reusable instrument kits used in the field and up-fitting our new headquarters
in Raleigh, North Carolina.
Net Cash Provided by Financing Activities.
Net cash provided by financing activities in the three months ended March 31, 2013 was $9,000, which represented proceeds from
the issuance of shares of common stock upon the exercise of stock options.
Operating Capital and Capital Expenditure
Requirements
We believe that our existing cash and cash
equivalents, together with cash received from sales of our products, will be insufficient to meet our anticipated cash needs through
2013. We intend to spend substantial amounts on sales and marketing initiatives to support the ongoing commercialization of our
products and on research and development activities, including product development, regulatory and compliance, clinical studies
in support of our currently marketed products and future product offerings, and the enhancement and protection of our intellectual
property. We will need to obtain additional financing to pursue our business strategy, to respond to new competitive pressures
or to take advantage of opportunities that may arise. To meet our capital needs, we are considering multiple alternatives, including,
but not limited to, additional equity financings, debt financings and other funding transactions. There can be no assurance that
we will be able to complete any such transaction on acceptable terms or otherwise. If we are unable to obtain the necessary capital,
we will need to pursue a plan to license or sell our assets, cease operations and/or seek bankruptcy protection.
Under the
Shelf Registration Statement, we have the ability to issue debt securities, common stock, preferred stock, or warrants, or any
combination thereof. Depending on our non-affiliated public equity float during the time period prior to consummating another financing
transaction, the Shelf Registration Statement will allow
us to raise up
to an additional $29.85 million. The timing
and terms of any additional financing transactions, whether pursuant
to the Shelf Registration Statement or otherwise,
have
not yet been determined.
Any additional financing may not be available in amounts or on terms acceptable to us, if at all.
If we are unable to obtain this additional financing, we may be required to reduce the scope of our planned product development
and marketing efforts.
In
October 2011, we received a subpoena issued by the Department of Health and Human Services, Office of Inspector General, or the
OIG, under the authority of the federal healthcare fraud and false claims statutes. We have cooperated with the government’s
request.
On December 24, 2012 we reached a tentative agreement in principle with the U.S. Department of Justice related
to the subpoena issued in October 2011. We tentatively agreed with the staff of the Department of Justice to settle its federal
investigation for $6.0 million, subject to completion and approval of written settlement agreements with the Department of Justice
and the OIG, which are expected to be finalized in the second quarter of 2013. We admit no wrongdoing as part of the settlement.
On January 24, 2012, we received notice
that a putative class action lawsuit had been filed in the U.S. District Court Eastern District, North Carolina, on behalf of all
persons, other than defendants, who purchased TranS1 securities between February 21, 2008 and October 17, 2011.
The
complaint alleges violations of the Exchange Act, based upon purported omissions and/or false and misleading statements concerning
our financial statements and reimbursement practices. The complaint seeks damages sustained by the putative class, pre- and
post-judgment interest, and attorneys’ fees and other costs. On September 7, 2012, we filed a motion to dismiss the
complaint for failure to meet the heightened pleading requirements of the Private Securities Litigation Reform Act of 1995, among
other grounds; the motion is pending.
We are unable to predict what impact, if any, the outcome of this matter might
have on our consolidated financial position, results of operations, or cash flows.
On March 3, 2013, we entered into the Merger
Agreement with Merger Sub, Baxano and the Securityholder Representatives. Under the terms of the Merger Agreement, we will acquire
Baxano through a merger of Merger Sub with and into Baxano. At the effective time of the Merger, or the Effective Time, Merger
Sub will cease to exist and Baxano will continue as the surviving corporation and as a wholly-owned subsidiary of the Company.
Pursuant to the terms of the Merger Agreement,
the merger consideration will consist of approximately 10.4 million shares of our common stock. The number of shares comprising
the merger consideration will be reduced by a number of shares with a value equal to the following (using for the per share value
an average closing price on the NASDAQ Global Market during the 10 days preceding the Effective Time): (1) Baxano’s indebtedness
in excess of (a) amounts under promissory notes of Baxano that are convertible into capital stock of Baxano, each a Baxano Note,
outstanding at the Effective Time, and (b) up to $3,000,000 of principal as well as interest outstanding under certain long-term
indebtedness; (2) $300,000 in cash, which will be used to fund a compensation plan to be adopted by Baxano prior to the closing
of the Merger providing for bonuses to Baxano’s employees and certain non-employee directors; and (3) $250,000 in cash, which
we have agreed to deposit into an account specified for the purpose of funding the expenses of the Securityholder Representatives
under the Merger Agreement.
The Merger Agreement contains customary
representations, warranties, and covenants, including covenants related to obtaining the requisite stockholder approvals, appointing
two Baxano designees to our Board of Directors, restricting the solicitation of competing acquisition proposals, the lock-up and
registration of the shares of our common stock issued in connection with the Merger pursuant to the Securities Purchase Agreement
described below, and the Company’s and Baxano’s conduct of their businesses between the date of signing the Merger
Agreement and the closing of the Merger.
The Merger Agreement grants certain termination
rights to us and Baxano. In addition, the Merger Agreement provides that we will be required to pay Baxano a termination fee equal
to $2,000,000 and to reimburse Baxano for its expenses incurred relating to the transactions contemplated by the Merger Agreement,
up to a cap of $750,000, if Baxano or we terminate the Merger Agreement under certain conditions. The Merger Agreement also provides
that Baxano will be required to pay us a termination fee equal to $1,000,000 and to reimburse us for our expenses incurred relating
to the transactions contemplated by the Merger Agreement, up to a cap of $750,000, if we terminate the Merger Agreement under certain
conditions.
Concurrent with entering into the Merger
Agreement, we entered into the Securities Purchase Agreement with the Investors, pursuant to which we will sell to the Investors,
and the Investors will purchase from us, an aggregate of 7,522,009 shares of our common stock, at a purchase price of $2.28 per
share, resulting in gross proceeds to us of $17.2 million.
Pursuant to the Securities Purchase Agreement,
we agreed to register the resale of the shares of our common stock to be issued pursuant to the Merger Agreement and the Securities
Purchase Agreement under a registration statement (the “Registration Statement”) on Form S-3 (or another appropriate
form if Form S-3 is not then available to us). If the Registration Statement is not declared effective by the SEC by a certain
date, we must pay each Investor and other holder of shares issued pursuant to the Merger Agreement liquidated damages equal to
1% of the value of their shares (calculated at the closing price of such shares) per month, up to a maximum of 12%.
The Securities Purchase Agreement contains
customary representations and warranties of us and the Investors. Consummation of the Private Placement Transaction is subject
to approval by our stockholders of the issuance of shares of our common stock in connection with the Merger Agreement and the Securities
Purchase Agreement, the closing of the Merger, and other customary closing conditions set forth in the Securities Purchase Agreement.
Recent Developments
On April 16, 2013 and April 25, 2013, Baxano
issued promissory notes, or the Bridge Notes, to us in the principal amount of $800,000 and $1.3 million, respectively, as contemplated
by the Merger Agreement. The Bridge Notes bear interest at a rate of 6% per annum. The Bridge Notes are not secured by any collateral;
are subordinated in right of payment to the loan evidenced by the Loan and Security Agreement dated as of March 15, 2012, among
Oxford Finance LLC, Silicon Valley Bank and Baxano; and are senior in right of payment to the Baxano Notes.
The Bridge Notes will be cancelled immediately
prior to the effective time of the Merger without consideration, repayment, or any other right of ours to be repaid or otherwise
compensated. All outstanding principal and interest under the Bridge Notes will be due and payable on demand by us any time on
or after September 7, 2013 if the Effective Time has not occurred by such date. Additionally, all principal and accrued interest
under the Bridge Notes will be due and payable upon the consummation of any sale by Baxano of its equity securities to venture
capital, institutional, or private investors, including at least one investor that is not an existing noteholder or stockholder
of Baxano, resulting in aggregate cash proceeds to Baxano of at least $15,000,000 (excluding any amount invested by cancellation
or conversion of the indebtedness represented by the Baxano Notes).
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial
condition and results of operations is based upon our
consolidated
financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of financial
statements requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, revenue
and expenses, and disclosures of contingent assets and liabilities at the date of the financial statements. On an on-going basis,
we evaluate our estimates, including those related to revenue recognition, accounts receivable reserves, inventory reserves, accrued
expenses, income tax valuations and stock-based compensation. We base our estimates on historical experience and various other
assumptions that we believe to be reasonable, the results of which form the basis for making judgments about the carrying value
of assets and liabilities that are not apparent from other sources. Actual results could differ from those estimates under different
assumptions or conditions.
For a description of our critical accounting
policies and estimates, please refer to the “Critical Accounting Policies and Estimates” section of the “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” section contained in our Annual Report on Form
10-K for the year ended December 31, 2012. There have been no material changes in any of our accounting policies since December
31, 2012.
New Accounting Standards
In February 2013, the Financial Accounting
Standards Board issued guidance (ASU No. 2013-02) finalizing the reporting of amounts reclassified out of accumulated other comprehensive
income. The new standard requires either in a single note or parenthetically on the face of the financial statements, the effect
of significant amounts reclassified from each component of accumulated other comprehensive income based on its source and the income
statement line items affected by the reclassification. The guidance is effective for annual reporting periods and interim periods
within those years, beginning after December 15, 2012. In the first quarter of 2013, we adopted the guidance and determined that
there were no amounts reclassified in the period that would require enhanced disclosure.