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EX-99.2 - EX-99.2 - BAXANO SURGICAL, INC. | g27280exv99w2.htm |
8-K - FORM 8-K - BAXANO SURGICAL, INC. | g27280e8vk.htm |
EXHIBIT 99.1
TranS1 Inc. Reports Operating Results for the First Quarter of 2011,
Issues Second Quarter 2011 Guidance
Issues Second Quarter 2011 Guidance
- First quarter revenues were $5.1 million -
- 477 TranS1 procedures performed globally in the quarter -
- Net loss per share was $0.27 for the quarter -
- 477 TranS1 procedures performed globally in the quarter -
- Net loss per share was $0.27 for the quarter -
WILMINGTON, NC (GLOBE NEWSWIRE) May 12, 2011TranS1 Inc. (NASDAQ:TSON), a medical device
company focused on designing, developing and marketing products that implement its proprietary
approach to treat degenerative conditions of the spine affecting the lower lumbar region, today
announced its financial results for the first quarter ended March 31, 2011.
Comparison of Selected Financial Results (in millions, except per share data) | ||||||||
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
As reported: |
||||||||
Total revenue |
$ | 5.1 | $ | 6.7 | ||||
Net loss |
(5.7 | ) | (6.4 | ) | ||||
Net loss per common share |
(0.27 | ) | (0.31 | ) | ||||
Excluding special items*: |
||||||||
Net loss |
(5.5 | ) | (5.1 | ) | ||||
Net loss per common share |
(0.26 | ) | (0.25 | ) |
* | See Reconciliation of GAAP Financial Information to Non-GAAP Financial Information below. |
Revenues were $5.1 million in the first quarter of 2011, representing a 24% decrease over
revenues of $6.7 million in the first quarter of 2010. Domestic revenues were $4.6 million in the
first quarter of 2011, compared to $6.0 million in the first quarter of 2010. Gross margin was
74.7% in the first quarter of 2011 as compared to 78.7% in the first quarter of 2010. Excluding
inventory reserves of $240 thousand taken in the first quarter of 2011, primarily related to the
lower than planned revenue in the first quarter of 2011 and the introduction of our next-generation
products, gross margin would have been 79.4%.
Net loss was $5.7 million in the first quarter of 2011, compared to a net loss of $6.4 million in
the first quarter of 2010. Net loss per common share was $0.27 in the first quarter of 2011
compared to a net loss per share of $0.31 in the first quarter of 2010.
Excluding special items, net loss in the first quarter of 2011 was $5.5 million, or $0.26 per
common share, compared to net loss excluding special items of $5.1 million, or $0.25 per common
share in the first quarter of 2010. Special items in the first quarter of 2011 consisted of
inventory reserves of $240 thousand. Special items in the first quarter of 2010 consisted of
management transition costs of $0.9 million and inventory reserves of $276 thousand.
Cash, cash-equivalents and investments were $36.5 million as of March 31, 2011.
Our procedure volumes and revenues continue to be adversely affected by ongoing AxiaLIF physician
reimbursement pressures, commented Ken Reali, President and Chief Executive Officer of TranS1 Inc.
The recent acceptance of two key clinical papers for publication in peer-reviewed journals will
provide us with additional data to utilize with payors as we seek to gain additional positive
coverage decisions. We also made significant progress in the quarter with our product pipeline as
evidenced by the commencement of the limited market release of AxiaLIF 1L+.
TranS1 Outlook
For the second quarter ending June 30, 2011, the Company expects total revenues in the range of
$4.7-$5.4 million. For the fiscal year ending December 31, 2011, the Company expects gross
margins in the range of 75-80%. The Company also expects to have $26-$29 million in cash and
investments on December 31, 2011.
Conference Call
TranS1 will host a conference call today at 4:30 pm ET to discuss its first quarter financial
results. 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, use the following link at http://ir.trans1.com/events.cfm.
Reconciliation of GAAP Financial Information to Non-GAAP Financial Information
To supplement the Companys consolidated financial statements presented in accordance with GAAP,
the Company uses non-GAAP measures of certain components of financial performance, including net
loss and loss per 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 inventory obsolescence reserves
taken in 2011 and 2010 for existing products that are being replaced, or are obsolete and excess
and management transition costs incurred in 2010, including severance, recruiting and other
personnel-related expenses. These non-GAAP measures are provided to enhance investors overall
understanding of the Companys current financial performance and the Companys prospects for the
future. We believe that providing a non-GAAP measure that adjusts for significant non-cash
expenses, such as inventory obsolescence reserves, and significant non-recurring management
transition 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 that
implement its proprietary approach to treat degenerative conditions of the spine affecting the
lower lumbar region. TranS1 currently markets the AxiaLIF family of products for single and
multilevel lumbar fusion and the Vectre and Avatar posterior fixation systems. TranS1 was founded
in May 2000 and is headquartered in Wilmington, North Carolina. For more information, visit
www.trans1.com.
Forward Looking Statements
This press release includes statements relating to the future market adoption of our products 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 and other economic and
competitive factors. For a discussion of the most significant risks and uncertainties associated
with TranS1s business, please review the Companys filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year ended December 31, 2010. You
are cautioned not to place undue reliance on these forward looking statements, which are based on
TranS1s 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.
CONTACT:
Investors:
TranS1 Inc.
Joseph P. Slattery, 910-332-1700
Executive Vice-President and Chief Financial Officer
or
Westwicke Partners
Mark Klausner, 443-213-0501
trans1@westwicke.com
TranS1 Inc.
Joseph P. Slattery, 910-332-1700
Executive Vice-President and Chief Financial Officer
or
Westwicke Partners
Mark Klausner, 443-213-0501
trans1@westwicke.com
Source: TranS1 Inc.
TranS1 Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Consolidated Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
Revenue |
$ | 5,130 | $ | 6,713 | ||||
Cost of revenue |
1,296 | 1,429 | ||||||
Gross profit |
3,834 | 5,284 | ||||||
Operating expenses: |
||||||||
Research and development |
1,582 | 1,255 | ||||||
Sales and marketing |
6,383 | 7,697 | ||||||
General and administrative |
1,613 | 2,639 | ||||||
Total operating expenses |
9,578 | 11,591 | ||||||
Operating loss |
(5,744 | ) | (6,307 | ) | ||||
Other income (expense), net |
18 | (49 | ) | |||||
Net loss |
$ | (5,726 | ) | $ | 6,356 | ) | ||
Net loss per common share basic and
diluted |
$ | (0.27 | ) | $ | (0.31 | ) | ||
Weighted average common shares
outstanding basic and diluted |
20,886 | 20,655 | ||||||
Reconciliation of GAAP Financial Information to Non-GAAP Financial Information
(in thousands, except per share amounts)
(Unaudited)
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
GAAP net loss |
$ | (5,726 | ) | $ | (6,356 | ) | ||
Special items: |
||||||||
Inventory obsolescence reserve |
240 | 276 | ||||||
Management transition costs |
| 939 | ||||||
Net loss excluding special items |
$ | (5,486 | ) | $ | (5,141 | ) | ||
GAAP net loss per share |
$ | (0.27 | ) | $ | (0.31 | ) | ||
Special items: |
||||||||
Inventory obsolescence reserve |
0.01 | 0.01 | ||||||
Management transition costs |
| 0.05 | ||||||
Net loss excluding special items |
$ | (0.26 | ) | $ | (0.25 | ) | ||
Shares used in computing GAAP and non-GAAP loss per
share |
20,886 | 20,655 | ||||||
TranS1 Inc.
Consolidated Balance Sheets
(in thousands)
(Unaudited)
Consolidated Balance Sheets
(in thousands)
(Unaudited)
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 6,341 | $ | 24,461 | ||||
Short-term investments |
30,168 | 18,075 | ||||||
Accounts receivable, net |
3,573 | 3,654 | ||||||
Inventory |
4,160 | 3,878 | ||||||
Prepaid expenses and other assets |
478 | 389 | ||||||
Total current assets |
44,720 | 50,457 | ||||||
Property and equipment, net |
1,483 | 1,562 | ||||||
Total assets |
$ | 46,203 | $ | 52,019 | ||||
Liabilities and Stockholders Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,204 | $ | 2,214 | ||||
Accrued expenses |
1,598 | 2,077 | ||||||
Total current liabilities |
3,802 | 4,291 | ||||||
Stockholders equity |
||||||||
Common stock |
2 | 2 | ||||||
Additional paid-in capital |
138,792 | 138,401 | ||||||
Accumulated other comprehensive income (loss) |
(21 | ) | (29 | ) | ||||
Accumulated deficit |
(96,372 | ) | (90,646 | ) | ||||
Total stockholders equity |
42,401 | 47,728 | ||||||
Total liabilities and
stockholders equity |
$ | 46,203 | $ | 52,019 | ||||
TranS1 Inc.
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (5,726 | ) | $ | (6,356 | ) | ||
Adjustments to reconcile net loss to net
cash used in operating activities |
||||||||
Depreciation |
148 | 231 | ||||||
Stock-based compensation |
379 | 530 | ||||||
Allowance for excess and obsolete inventory |
240 | 276 | ||||||
Provision for bad debts |
25 | 18 | ||||||
Loss on sale of fixed assets |
| 71 | ||||||
Changes in operating assets and liabilities: |
||||||||
(Increase) decrease in accounts receivable |
56 | (669 | ) | |||||
(Increase) decrease in inventory |
(522 | ) | 193 | |||||
(Increase) decrease in prepaid expenses |
(89 | ) | 18 | |||||
Increase (decrease) in accounts payable |
(10 | ) | (301 | ) | ||||
Increase (decrease) in accrued expenses |
(479 | ) | 711 | |||||
Net cash used in operating activities |
(5,978 | ) | (5,278 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchase of property and equipment |
(69 | ) | (265 | ) | ||||
Purchases of investments |
(16,102 | ) | (3,986 | ) | ||||
Sales and maturities of investments |
4,009 | 8,979 | ||||||
Net cash provided by (used in) investing activities |
(12,162 | ) | 4,728 | |||||
Cash flows from financing activities: |
||||||||
Proceeds from issuance of common stock |
12 | 11 | ||||||
Net cash provided by financing activities |
12 | 11 | ||||||
Effect of exchange rate changes on cash and cash equivalents |
8 | (8 | ) | |||||
Net decrease in cash and cash equivalents |
(18,120 | ) | (547 | ) | ||||
Cash and cash equivalents, beginning of period |
24,461 | 29,298 | ||||||
Cash and cash equivalents, end of period |
$ | 6,341 | $ | 28,751 | ||||