SAN DIEGO, March 02, 2018 (GLOBE NEWSWIRE) -- TearLab Corporation (OTCQB:TEAR) (TSX:TLB) (“TearLab” or the
“Company”) today reported its consolidated financial results for the fourth quarter and twelve months ended December 31, 2017. All
dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted
accounting principles except where noted otherwise.
Recent Highlights
- Grew quarterly revenue sequentially to $6.9 million, a $0.4 million increase compared to the third quarter of 2017
- Reduced full year loss from operations by 26% compared to 2016, from $16.0 million to $11.8 million
- Expanded the U.S. active device base to 4,623 TearLab Osmolarity Systems
- Submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for potential clearance of the Tearlab
Discovery™ Platform and received notice of acceptance from the FDA
- Raised $3 million in gross proceeds through a registered direct offering of 6,818,182 units for corporate and capital
expenses
- Received approval from the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil to market the TearLab Osmolarity
System
- Launched a new business model with the goal of reducing costs, maintaining current customers and annuity revenue base and
focusing resources on the development and generation of clinical data for its next generation platform
- Cash position of $7.3 million as of December 31, 2017
For the three months ended December 31, 2017, TearLab’s net revenues were $6.9 million, down 3% from $7.1 million for the same
period in 2016. A net total of 166 TearLab Osmolarity® Systems were added in the fourth quarter of 2017, of which 77 were under the
Company’s Flex program and 45 were purchased outside of the United States.
The following table sets out the estimated annualized revenue per U.S. device and account analysis for the fourth quarter ended
December 31, 2017:
|
|
|
|
|
|
Annualized |
|
Annualized |
|
|
Active |
|
Active |
|
Revenue |
|
Revenue |
Program |
|
Devices |
|
Accounts |
|
Per
Device |
|
Per
Account |
Purchased |
|
902 |
|
794 |
|
$ |
2,932 |
|
$ |
3,331 |
Masters |
|
1,694 |
|
211 |
|
$ |
3,095 |
|
$ |
24,846 |
Flex |
|
2,027 |
|
763 |
|
$ |
8,025 |
|
$ |
21,319 |
Total |
|
4,623 |
|
1,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company’s reported net loss for the 2017 fourth quarter was approximately $4.0 million, or ($0.63) basic loss per share,
compared to a reported net loss of approximately $4.3 million, or ($0.81) basic loss per share in the fourth quarter of 2016.
The Company’s reported net loss was negatively impacted by a non-cash charge of $0.5 million in the fourth quarter of 2017 related
to both impairment of existing reader devices included in fixed assets and obsolete equipment based on the Company’s new business
model and revised forecast of readers expected to be sold or placed in the future.
“We were pleased to see sequential revenue growth in the fourth quarter of 2017 despite the implementation of our lower resource
commercial model late in the quarter, which speaks to the health of our current customer and revenue base,” said Seph Jensen,
TearLab’s Chief Executive Officer. “In addition, we were very pleased to have submitted the 510(k) package for clearance in the U.S
of our TearLab Discovery™ System and are looking forward to working with the FDA to complete the review process. The Discovery
Platform is critical to our success moving forward, and we took a number of other steps to position us to achieve clearance of the
new platform, including the completion of a $3 million financing to support our operations and regulatory expenses as well as an
amendment to our loan agreement with CRG to lower the minimum revenue levels in our debt covenants from 2017 forward, which we
believe demonstrates their confidence in our technology platform. Our team remains determined to execute on our primary strategic
initiatives while carefully managing expenses.”
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve
standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab
Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System.
TearLab Corporation's common shares trade on the OTCQB Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the
symbol 'TLB'.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others, the ability
to achieve FDA clearance and the potential success in developing and commercializing the TearLab Discovery™ System and the TearLab
Osmolarity System, the success in Brazil of commercializing the TearLab Osmolarity System, the future success of our new commercial
model including the ability to lower costs, maintain our current customers and revenue levels and provide the needed resources to
complete the development and generate meaningful clinical data of the TearLab Discovery™ System , the ability for the capital we
raised to allow us to meet our business objectives and comply with our debt covenants and the ability to raise any future capital
that may be needed to achieve our goals and objectives. These forward-looking statements involve known and unknown risks,
uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or
implied by the forward-looking statements. Forward-looking statements are based on management’s current, preliminary
expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results
to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with
the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual
Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 10, 2017, and our Quarterly Reports on Form
10-Q for the quarter ended September 30, 2017, filed with the SEC on November 13, 2017 and our Form 10-K for year ended December
31, 2017 which we expect to file with SEC on or about March 2, 2018. We do not undertake to update any forward-looking statements
except as required by law.
CONTACT: Investor Contact:
The Ruth Group
Lee Roth
Tel: 646-536-7012
lroth@theruthgroup.com
TearLab Corp.
Condensed Consolidated Statements of Operations
(Expressed in U.S. Dollars (000's) except for number of shares and net loss per share)
(Unaudited)
|
|
|
|
|
|
|
|
|
Three months |
|
|
|
|
ended December 31, |
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
Revenue |
|
|
|
|
|
|
Product sales |
|
$ |
6,288 |
|
|
$ |
6,416 |
|
|
|
Reader equipment rentals |
|
|
593 |
|
|
|
705 |
|
|
|
Total revenue |
|
|
6,881 |
|
|
|
7,121 |
|
|
|
Cost of goods sold |
|
|
|
|
|
|
Cost of goods sold (excluding amortization of intangible
assets) |
|
|
2,741 |
|
|
|
2,619 |
|
|
|
Cost of goods sold - reader equipment depreciation |
|
|
793 |
|
|
|
495 |
|
|
|
Gross profit |
|
|
3,347 |
|
|
|
4,007 |
|
|
|
Operating expenses |
|
|
|
|
|
|
Sales and marketing |
|
|
3,036 |
|
|
|
3,287 |
|
|
|
Clinical, regulatory and research & development |
|
|
1,119 |
|
|
|
2,347 |
|
|
|
General and administrative |
|
|
2,017 |
|
|
|
1,566 |
|
|
|
Amortization of intangible assets |
|
|
- |
|
|
|
100 |
|
|
|
Total operating expenses |
|
|
6,172 |
|
|
|
7,300 |
|
|
|
Loss from operations |
|
|
(2,825 |
) |
|
|
(3,293 |
) |
|
|
Other income (expense) |
|
|
(1,141 |
) |
|
|
(1,047 |
) |
|
|
Net loss and comprehensive loss |
|
$ |
(3,966 |
) |
|
$ |
(4,340 |
) |
|
|
Weighted average shares
outstanding |
|
|
6,303,589 |
|
|
|
5,360,199 |
|
|
|
Net loss per share |
|
$ |
(0.63 |
) |
|
$ |
(0.81 |
) |
|
|
|
|
|
|
|
|
|
TearLab Corp.
Condensed Consolidated Statements of Operations
(Expressed in U.S. Dollars (000's) except for number of shares and net loss per share)
|
|
|
|
|
|
|
|
|
Years |
|
|
|
|
ended December 31, |
|
|
|
|
2017 (a) |
|
|
2016 |
|
|
|
Revenue |
|
|
|
|
|
|
Product sales |
|
$ |
24,237 |
|
|
$ |
23,809 |
|
|
|
Reader equipment rentals |
|
|
2,882 |
|
|
|
4,205 |
|
|
|
Total revenue |
|
|
27,119 |
|
|
|
28,014 |
|
|
|
Cost of goods sold |
|
|
|
|
|
|
Cost of goods sold (excluding amortization of intangible
assets) |
|
|
10,993 |
|
|
|
10,188 |
|
|
|
Cost of goods sold - reader equipment depreciation |
|
|
2,121 |
|
|
|
2,130 |
|
|
|
Gross profit |
|
|
14,005 |
|
|
|
15,696 |
|
|
|
Operating expenses |
|
|
|
|
|
|
Sales and marketing |
|
|
12,330 |
|
|
|
14,397 |
|
|
|
Clinical, regulatory and research & development |
|
|
4,691 |
|
|
|
5,152 |
|
|
|
General and administrative |
|
|
8,772 |
|
|
|
11,057 |
|
|
|
Amortization of intangible assets |
|
|
- |
|
|
|
1,066 |
|
|
|
Total operating expenses |
|
|
25,793 |
|
|
|
31,672 |
|
|
|
Loss from operations |
|
|
(11,788 |
) |
|
|
(15,976 |
) |
|
|
Other income (expense) |
|
|
(4,313 |
) |
|
|
(3,944 |
) |
|
|
Net loss and comprehensive loss |
|
$ |
(16,101 |
) |
|
$ |
(19,920 |
) |
|
|
Weighted average shares
outstanding |
|
|
5,789,714 |
|
|
|
4,647,983 |
|
|
|
Net loss per share |
|
$ |
(2.78 |
) |
|
$ |
(4.29 |
) |
|
|
|
|
|
|
|
|
|
(a) Information as of, and for the year ended December 31, 2017
will be included in the Company's form 10-K which we anticipate filing on, or about March 2, 2018. |
|
|
|
|
|
TearLab Corp.
Consolidated Balance Sheets
(Expressed in U.S. Dollars (000's)
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
2017 (a) |
|
2016 |
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash |
|
|
$ |
7,272 |
|
|
|
$ |
15,471 |
|
|
|
Accounts receivable, net |
|
|
|
1,536 |
|
|
|
|
2,279 |
|
|
|
Inventory |
|
|
|
1,998 |
|
|
|
|
3,193 |
|
|
|
Prepaid expenses and other current assets |
|
|
|
690 |
|
|
|
|
1,226 |
|
|
|
Total current assets |
|
|
|
11,496 |
|
|
|
|
22,169 |
|
|
|
|
|
|
|
|
|
|
|
|
Fixed assets, net |
|
|
|
2,739 |
|
|
|
|
4,178 |
|
|
|
Intangible assets, net |
|
|
|
10 |
|
|
|
|
60 |
|
|
|
Other non-current assets |
|
|
|
100 |
|
|
|
|
220 |
|
|
|
Total assets |
|
|
$ |
14,345 |
|
|
|
$ |
26,627 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
$ |
1,720 |
|
|
|
$ |
1,858 |
|
|
|
Accrued liabilities |
|
|
|
2,859 |
|
|
|
|
3,958 |
|
|
|
Deferred Rent |
|
|
|
42 |
|
|
|
|
83 |
|
|
|
Total current liabilities |
|
|
|
4,621 |
|
|
|
|
5,899 |
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
|
|
28,290 |
|
|
|
|
26,449 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
|
32,911 |
|
|
|
|
32,348 |
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
|
|
|
|
|
|
Capital stock |
|
|
|
|
|
|
|
|
Preferred Stock, $0.001 par value, 10,000,000 authorized, 2,012 and
2,764 issued and outstanding at December 31, 2017 and December 31, 2016, respectively |
|
|
|
— |
|
|
|
|
— |
|
|
|
Common stock, $0.001 par value, 40,000,000 and 9,500,000 authorized,
7,786,998 and 5,359,671 issued and outstanding at December 31, 2017 and December 31, 2016, respectively |
|
|
|
8 |
|
|
|
|
5 |
|
|
|
Additional paid-in capital |
|
|
|
510,235 |
|
|
|
|
506,982 |
|
|
|
Accumulated deficit |
|
|
|
(528,809 |
) |
|
|
|
(512,708 |
) |
|
|
Total stockholders’ equity (deficit) |
|
|
|
(18,566 |
) |
|
|
|
(5,721 |
) |
|
|
Total liabilities and stockholders’ equity |
|
|
$ |
14,345 |
|
|
|
$ |
26,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Information as of, and for the year ended December 31, 2017
will be included in the Company's form 10-K which we anticipate filing on, or about March 2, 2018. |
|
|
|
|
|
|
|
|
|
|