TranS1 Inc. Reports Operating Results for the Fourth Quarter of 2012, Issues First Quarter 2013 Guidance
March 04 2013 - 6:00AM
- Fourth quarter revenues were $4.1 million -
- Net loss per share was $0.44 for the quarter
–
- Excluding special items, net loss per share was
$0.20 for the quarter* -
TranS1 Inc. (Nasdaq:TSON), a medical device company focused on
designing, developing and marketing products to treat degenerative
conditions of the spine affecting the lumbar region, today
announced its financial results for the fourth quarter ended
December 31, 2012.
Comparison of Selected
Financial Results (in millions, except per share data) |
|
Three Months Ended
December 31, |
|
2012 |
2011 |
As reported: |
|
|
Total revenue |
$ 4.1 |
$ 4.0 |
Net loss |
(12.0) |
(4.9) |
Net loss per common share |
(0.44) |
(0.18) |
Excluding special items*: |
|
|
Net loss |
(5.3) |
(4.7) |
Net loss per common share |
(0.20) |
(0.17) |
|
* See
"Reconciliation of GAAP Financial Information to Non-GAAP Financial
Information" below. |
Revenues were $4.1 million in the fourth quarter of 2012,
representing a 3.5% increase from revenues of $4.0 million in the
fourth quarter of 2011. Domestic revenues were $3.0 million in
the fourth quarter of 2012, compared to $3.7 million in the fourth
quarter of 2011 and international revenues were $1.1 million in the
fourth quarter of 2012, compared to $0.3 million in the fourth
quarter of 2011. The increase in international revenues was
due to the initial stocking order for our new distributor in China.
Gross margin was 62.2% in the fourth quarter of 2012 as compared to
73.9% in the fourth quarter of 2011. The decrease in gross margin
was due primarily to a higher percentage of international sales
which carry a lower gross margin than domestic sales, inventory
charges related to excess inventories, and increased depreciation
expense on reusable kits.
Net loss was $12.0 million in the fourth quarter of 2012,
compared to a net loss of $4.9 million in the fourth quarter of
2011. Net loss per common share was $0.44 in the fourth
quarter of 2012 compared to a net loss per share of $0.18 in the
fourth quarter of 2011.
Excluding special items, net loss in the fourth quarter of 2012
was $5.3 million, or $0.20 per common share, compared to net loss
excluding special items of $4.7 million, or $0.17 per common share
in the fourth quarter of 2011. Special items in the fourth
quarter of 2012 consisted of expenses of $6.6 million, including
$0.6 million of legal fees, related to our tentative agreement in
principle with the U.S. Department of Justice to settle its federal
investigation related to the subpoena issued in October 2011.
Special items in the fourth quarter of 2011 consisted of expenses
of $0.2 million for legal fees related to the U.S. Department of
Justice investigation.
Cash and cash-equivalents were $21.5 million as of December 31,
2012.
"In the fourth quarter we made significant progress on our key
operational goals, including further reimbursement progress,
expanding clinical publications and driving adoption of the VEO
direct lateral system. In addition, we re-launched AxiaLIF in
November at a large per-to-peer training event in anticipation of
the activation of our Category I code on January 1," said Ken
Reali, President and Chief Executive Officer of TranS1. "We believe
that the stabilization of our domestic business and the initial
stocking order in China have created positive momentum for TranS1
as we enter 2013."
TranS1 Outlook
For the first quarter ending March 31, 2013, the Company expects
total revenues in the range of $3.0 - $3.4 million.
Conference Call
TranS1 will host a conference call today at 8:30 am Eastern time
to discuss its fourth quarter financial results. This
conference call replaces the call originally scheduled for today at
4:30PM. The conference call numbers did not change. To listen to
the conference call on your telephone, please dial (877) 881-2183
for domestic callers and (970) 315-0453 for international callers
approximately ten minutes prior to the start time. The call will be
concurrently webcast. To access the live audio broadcast or
the archived recording, as well as the Company's presentation used
during the conference call, use the following link at
http://ir.trans1.com/events.cfm.
Reconciliation of GAAP Financial Information to Non-GAAP
Financial Information
To supplement the Company's consolidated financial statements
presented in accordance with GAAP, the Company uses non-GAAP
measures of certain components of financial performance, including
net loss and net loss per common share, which are adjusted from
results based on GAAP. Although "as adjusted" financial
measures are non-GAAP financial measures, the Company believes that
the presentation of "as adjusted" financial measures calculated to
exclude "special items" are useful adjuncts to the GAAP "as
reported" financial measures. "Special items" consist of
charges related to a tentative settlement with the U.S. Department
of Justice, including related legal fees, and legal fees related to
a stockholder class action lawsuit. These non-GAAP measures
are provided to enhance investors' overall understanding of the
Company's current financial performance and the Company's prospects
for the future. We believe that providing a non-GAAP measure
that adjusts for significant non-recurring expenses allows
comparison of our core operations from period to period. These
non-GAAP measures may be considered in addition to results prepared
in accordance with generally accepted accounting principles, but
should not be considered a substitute for, or superior to, GAAP
results. The non-GAAP measures included in this press release have
been reconciled to the most directly comparable GAAP measure.
About TranS1 Inc.
TranS1 is a medical device company focused on designing,
developing and marketing products to treat degenerative conditions
of the spine affecting the lumbar region. TranS1 currently markets
the AxiaLIF® family of products for single and two level lumbar
fusion, the VEOTM lateral access and interbody fusion system and
the VectreTM posterior fixation system for lumbar fixation
supplemental to AxiaLIF fusion. TranS1 was founded in May
2000 and is headquartered in Raleigh, North Carolina. For more
information, visit www.trans1.com.
Forward Looking Statements
This press release includes statements that are based on our
current beliefs and assumptions. These statements constitute
"forward looking statements" within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, and are intended to qualify for the safe
harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Such statements are subject to
risks and uncertainties that are often difficult to predict, are
beyond our control, and which may cause results to differ
materially from expectations. Factors that could cause our
results to differ materially from those described include, but are
not limited to, the pace of adoption of our product
technology by spine surgeons, the outcome of coverage and
reimbursement decisions by the government and third party payors,
the success of our continuing product development efforts, the
effect on our business of existing and new regulatory requirements,
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, stockholder class
action lawsuits, and other economic and competitive
factors. For a discussion of the most significant risks and
uncertainties associated with TranS1's business, please review the
Company's filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K for the year ended
December 31, 2011 and subsequent reports. You are
cautioned not to place undue reliance on these forward looking
statements, which are based on TranS1's expectations as of the
date of this press release and speak only as of the date of this
press release. We undertake no obligation to publicly update
or revise any forward looking statement, whether as a result of new
information, future events or otherwise.
TranS1
Inc. |
Consolidated Statements
of Operations and Comprehensive Loss |
(in thousands, except
per share amounts) |
(Unaudited) |
|
|
|
|
|
|
Three Months Ended
December 31, |
Twelve Months Ended
December 31, |
|
2012 |
2011 |
2012 |
2011 |
|
|
|
|
|
|
|
|
|
|
Revenue |
$ 4,129 |
$ 3,990 |
$ 14,570 |
$ 19,153 |
Cost of revenue |
1,562 |
1,042 |
4,309 |
4,555 |
Gross profit |
2,567 |
2,948 |
10,261 |
14,598 |
Operating expenses: |
|
|
|
|
Research and development |
1,520 |
1,350 |
5,457 |
5,191 |
Sales and marketing |
4,925 |
4,906 |
20,049 |
21,561 |
General and administrative |
1,510 |
1,368 |
6,172 |
5,890 |
Charges related to U.S. Government
settlement |
6,583 |
235 |
8,324 |
235 |
Total operating expenses |
14,538 |
7,859 |
40,002 |
32,877 |
Operating loss |
(11,971) |
(4,911) |
(29,741) |
(18,279) |
Other income (expense), net |
(1) |
(1) |
(147) |
6 |
Net loss |
$ (11,972) |
$ (4,912) |
$ (29,888) |
$ (18,273) |
Other comprehensive loss: |
|
|
|
|
Foreign currency translation adjustments |
-- |
40 |
1 |
42 |
Comprehensive loss |
$ (11,972) |
$ (4,872) |
$ (29,887) |
$ (18,231) |
|
|
|
|
|
Net loss per common share - basic and
diluted |
$ (0.44) |
$ (0.18) |
$ (1.10) |
$ (0.81) |
|
|
|
|
|
Weighted average common shares outstanding -
basic and diluted |
27,291 |
27,207 |
27,267 |
22,588 |
|
|
Reconciliation of GAAP
Financial Information to Non-GAAP Financial
Information |
(in thousands, except
per share amounts) |
(Unaudited) |
|
|
|
|
|
|
Three Months Ended Dec.
31, |
Twelve Months Ended Dec.
31, |
|
2012 |
2011 |
2012 |
2011 |
GAAP net loss |
$ (11,972) |
$ (4,912) |
$ (29,888) |
$ (18,273) |
Special items: |
|
|
|
Charges related to U.S. Government
settlement |
6,583 |
235 |
8,324 |
235 |
Shareholder litigation related |
68 |
-- |
399 |
-- |
Net loss excluding special items |
$ (5,321) |
$ (4,677) |
$ (21,165) |
$ (18,038) |
|
|
|
|
|
GAAP net loss per share |
$ (0.44) |
$ (0.18) |
$ (1.10) |
$ (0.81) |
Special items: |
|
|
|
Charges related to U.S. Government
settlement |
0.24 |
0.01 |
0.31 |
0.01 |
Shareholder litigation related |
-- |
-- |
0.01 |
-- |
Net loss excluding special items |
$ (0.20) |
$ (0.17) |
$ (0.78) |
$ (0.80) |
|
|
|
|
|
Shares used in computing GAAP and non-GAAP
loss per share |
27,291 |
27,207 |
27,267 |
22,588 |
|
TranS1
Inc. |
Consolidated Balance
Sheets |
(in
thousands) |
(Unaudited) |
|
December 31, |
December 31, |
|
2012 |
2011 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 21,541 |
$ 38,724 |
Short-term investments |
-- |
6,027 |
Accounts receivable, net |
3,206 |
2,522 |
Inventory |
5,017 |
4,525 |
Prepaid expenses and other assets |
330 |
680 |
Total current assets |
30,094 |
52,478 |
Property and equipment, net |
2,166 |
1,554 |
Total assets |
$ 32,260 |
$ 54,032 |
|
|
|
Liabilities and
Stockholders' Equity |
|
Current liabilities: |
|
|
Accounts payable |
$ 2,603 |
$ 3,127 |
Accrued expenses related to U.S.
Government settlement |
6,792 |
180 |
Accrued expenses |
1,648 |
1,199 |
Total current liabilities |
11,043 |
4,506 |
Noncurrent liabilities |
78 |
26 |
|
|
|
Stockholders' equity |
|
Common stock |
3 |
3 |
Additional paid-in capital |
159,929 |
158,403 |
Accumulated other comprehensive income
(loss) |
14 |
13 |
Accumulated deficit |
(138,807) |
(108,919) |
Total stockholders' equity |
21,139 |
49,500 |
Total liabilities and stockholders'
equity |
$ 32,260 |
$ 54,032 |
|
|
TranS1
Inc. |
Consolidated Statements
of Cash Flows |
(in
thousands) |
(Unaudited) |
|
|
|
|
|
|
Three Months Ended
December 31, |
Twelve Months Ended
December 31, |
|
2012 |
2011 |
2012 |
2011 |
Cash flows from operating
activities: |
|
|
|
Net loss |
$ (11,972) |
$ (4,912) |
$ (29,888) |
$ (18,273) |
Adjustments to reconcile net loss to net cash
used in operating activities |
|
|
|
|
Depreciation |
346 |
189 |
1,141 |
662 |
Stock-based compensation |
304 |
304 |
1,366 |
1,558 |
Allowance for excess and obsolete
inventory |
428 |
9 |
524 |
521 |
Provision (reversal of provision) for bad
debts |
12 |
(56) |
(15) |
31 |
Loss on disposal of fixed assets |
-- |
5 |
261 |
54 |
Changes in operating assets and
liabilities: |
|
|
|
|
(Increase) decrease in accounts
receivable |
(1,142) |
945 |
(669) |
1,101 |
(Increase) decrease in inventory |
(281) |
(301) |
(1,015) |
(1,168) |
(Increase) decrease in prepaid
expenses |
56 |
(431) |
350 |
(291) |
Increase (decrease) in accounts
payable |
610 |
1,230 |
(524) |
913 |
Increase in accrued expenses related to
U.S. Government settlement |
6,160 |
180 |
6,612 |
180 |
Increase (decrease) in accrued
expenses |
(84) |
(150) |
500 |
(852) |
Net cash used in operating activities |
(5,563) |
(2,988) |
(21,357) |
(15,564) |
Cash flows from investing
activities: |
|
|
|
|
Purchases of property and equipment |
(222) |
(272) |
(2,014) |
(708) |
Purchases of investments |
-- |
-- |
-- |
(16,102) |
Sales and maturities of investments |
-- |
12,054 |
6,027 |
28,150 |
Net cash provided by (used in) investing
activities |
(222) |
11,782 |
4,013 |
11,340 |
Cash flows from financing
activities: |
|
|
|
|
Net proceeds from issuance of common
stock |
-- |
(24) |
-- |
18,334 |
Proceeds from exercise of stock options |
93 |
7 |
160 |
111 |
Net cash provided by financing
activities |
93 |
(17) |
160 |
18,445 |
Effect of exchange rate changes on cash and
cash equivalents |
-- |
40 |
1 |
42 |
Net increase (decrease) in cash and cash
equivalents |
(5,692) |
8,817 |
(17,183) |
14,263 |
Cash and cash equivalents, beginning of
period |
27,233 |
29,907 |
38,724 |
24,461 |
Cash and cash equivalents, end of period |
$ 21,541 |
$ 38,724 |
$ 21,541 |
$ 38,724 |
CONTACT: Investors:
TranS1 Inc.
Joseph P. Slattery, 919-825-0868
Executive Vice-President and Chief Financial Officer
or
Westwicke Partners
Mark Klausner, 443-213-0501
trans1@westwicke.com
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