SAN DIEGO, March 25, 2010 (GLOBE NEWSWIRE) -- OccuLogix, Inc., dba TearLab Corporation ("TearLab") (Nasdaq:TEAR) (TSX:TLB), today reported its consolidated financial results for the quarter and the year ended December 31, 2009. All dollar amounts are expressed in U.S. currency, and results are reported in accordance with United States generally accepted accounting principles.
For the year ended December 31, 2009, TearLab's net revenues were $868,763 as compared to $458,202 in 2008. TearLab's net loss from operations for the year ended December 31, 2009 was $4.4 million, or $0.44 per share as compared to $9.4 million, or $2.29 per share for 2008.
For the three months ended December 31, 2009, TearLab's net revenues were $265,435 as compared to $299,902 for the same period in 2008. TearLab's net loss from operations for the three-month period ended December 31, 2009 was approximately $1.7 million, or $0.17 per share as compared to $2.3 million, or $0.24 per share for the same period in 2008.
As of December 31, 2009, TearLab had cash and cash equivalents and short-term investments of $0.1 million. During the first quarter of 2010, TearLab raised gross proceeds of $8.0 million significantly increasing its cash resources available to fund its commercialization efforts in the United States, Canada and the rest of the world.
2009 Highlights:
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Won a Silver 2009 Medical Design Excellence Award ("MDEA") for the TearLab™ Osmolarity System. MDEA is a premier awards program for the medical technology community that recognizes the contributions and advances in the design and manufacture of medical products.
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Obtained 510(k) clearance from the U.S. Food and Drug Administration for the TearLab™ Osmolarity System.
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Reported data from the TearLab™ Osmolarity Core Validation Study that demonstrated that osmolarity shows a progressive increase with increasing severity in earlier stages of Dry Eye Disease ("DED").
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Achieved Health Canada approval of the TearLab™ Osmolarity System.
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Received further validation of the TearLab™ Osmolarity System's unique ability to accurately measure subtle changes in the condition of the ocular surface via a peer-reviewed article, entitled "Tear osmolarity measurement using the TearLab™ Osmolarity System in the assessment of dry eye treatment effectiveness," which was published in Contact Lens & Anterior Eye.
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Engaged a number of key opinion leaders in the United States and Canada to use the TearLab™ Osmolarity System in their daily routine.
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Announced that TLCVision Corporation will be incorporating the TearLab™ Osmolarity System in eight of its U.S. refractive surgery centers to study DED symptoms as they relate to LASIK surgery.
- TearLab's strategy is to pursue a CLIA waiver application for the TearLab™ Osmolarity System and in early April TearLab received Institutional Review Board approval for a study that is intended to support its CLIA waiver application.
"Throughout 2009, European and North American opinion leaders increasingly recognized osmolarity as the preferred tool in the evaluation of patients suffering from DED. This has driven interest in our proprietary lab-on-a-chip technology by both eye care researchers and clinicians. While we are excited about building sales in Europe and our Canadian launch, we continue to endeavor to obtain the CLIA waiver categorization and approval for Medicare reimbursement. We believe that both of these milestones would be key to the widespread use and commercial success of the TearLab™ Osmolarity System in the United States," said Elias Vamvakas, TearLab's Chief Executive Officer.
Conference Call and Webcast Information
OccuLogix, Inc. dba TearLab Corporation will hold a conference call to discuss these results today, March 25, at 8:30am Eastern Time at 877-303-6310 or 973-638-3207 (within the United States and Canada). The call will also be broadcast live and archived on TearLab's website at www.tearlab.com under the "webcasts" link in the Investor Relations section. For those wishing to listen to a recording of the call via telephone, a replay will be made available as soon as possible after the conclusion of the live call and will remain posted for a period of seven days. To listen to the recording, simply telephone 800-642-1687 or 706-645-9291 and enter reservation # 63557765 when prompted.
About OccuLogix, Inc. dba TearLab Corporation
OccuLogix, Inc. dba TearLab Corporation 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. Headquartered in San Diego, CA, TearLab Corporation's common shares trade on the NASDAQ Capital Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB'.
Forward-Looking Statements
This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about TearLab. Examples of forward-looking statements in this press released include predictions regarding the sufficiency of current cash and cash equivalents to fund operations for 12 months or more, intent to submit a revised CLIA waiver application,building sales in Europe and Canada, seeking CLIA waiver and Medicare reimbursement, and the future commercial adoption of the TearLab™ Osmolarity System. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our annual and quarterly reports on Forms 10-K and 10-Q. We do not undertake to update any forward-looking statements.
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
| (expressed in U.S. dollars except number of shares) | ||||
|
Three months ended December 31 |
Year ended December 31 |
|||
| 2009 | 2008 | 2009 | 2008 | |
| Revenue | ||||
| TearLab – to unrelated parties | 265,435 | 299,902 | 868,763 | 299,902 |
| Retina – to related parties | $ — | $ — | $ — | $ 136,800 |
| Retina – to unrelated parties | — | — | — | 21,500 |
| Total revenue | 265,435 | 299,902 | 868,763 | 458,202 |
| Cost of goods sold | ||||
| TearLab -- product cost | 179,230 | 136,848 | 567,878 | 136,848 |
| Retina -- product cost | — | — | — | 26,500 |
| Total cost of goods sold (excluding amortization of intangibles) | 179,230 | 136,848 | 567,878 | 163,348 |
| Gross profit | 86,205 | 163,054 | 300,885 | 294,854 |
| Operating expenses | ||||
| Amortization of intangible assets | 303,631 | 303,631 | 1,214,523 | 1,207,031 |
| General and administrative | 785,297 | 1,318,305 | 3,245,063 | 4,232,792 |
|
Clinical, regulatory and research & development |
252,989 | 462,217 | 1,120,716 | 2,965,009 |
| Sales and marketing | 145,812 | 190,385 | 646,047 | 819,722 |
| Restructuring charges | — | 1,411,174 | — | 2,440,820 |
| Total operating expenses | 1,487,729 | 3,685,712 | 6,226,349 | 11,665,374 |
| Loss from operations | (1,401,524) | (3,522,658) | (5,925,464) | (11,370,520) |
| Other income (expenses) | ||||
| Interest income | 499 | 8,038 | 2,775 | 76,533 |
|
Changes in fair value of warrant obligation |
10,394 | 10,615 | 54,470 | (57,666) |
| Gain (impairment) of investments | — | 1,486,322 | — | 1,036,250 |
| Interest expense | (52,496) | (13,222) | (93,248) | (318,478) |
|
Amortization of deferred financing charges, warrants & beneficial conversion features |
(167,736) | — | (302,981) | (180,000) |
| Other | (31,054) | 217,192 | (23,305) | 369,085 |
|
Beneficial conversion on bridge loan shares issued |
— | (1,239,163) | — | (1,239,163) |
| Total other income (expenses) | (240,393) | 469,782 | (362,289) | (313,439) |
| Loss from operations before income taxes | (1,641,917) | (3,052,876) | (6,287,753) | (11,683,959) |
| Recovery of income taxes | (65,049) | 768,311 | 1,902,535 | 337,846 |
| Net loss for the year | (1,706,966) | (2,284,565) | (4,385,218) | (11,346,113) |
| Net loss attributable to non-controlling interest, net of tax | — | 13,182 | — | 1,977,722 |
| Net loss attributable to OccuLogix, Inc. | (1,706,966) | (2,271,383) | (4,385,218) | (9,368,391) |
| Excess of purchase price over carrying value of the non-controlling interest in OcuSense, Inc. | — | (4,813,042) | — | (4,813,042) |
| Net loss available to common stockholders | $ (1,706,966) | $ (7,084,425) | $ (4,385,218) | $ (14,181,433) |
| Weighted average number of shares outstanding – basic and diluted | 9,866,685 | 9,336,922 | 9,855,045 | 4,083,655 |
| Net loss per common share – basic and diluted | $(0.17) | $(0.24) | $(0.44) | $(2.29) |
| Net loss available to common stockholders per common share – basic and diluted | $(0.17) | $(0.76) | $(0.44) | $(3.47) |
|
CONSOLIDATED BALANCE SHEETS |
||
| As of December 31, | ||
| 2009 | 2008 | |
|
ASSETS |
||
| Current assets | ||
| Cash and cash equivalents | $ 106,200 | $ 2,565,277 |
| Amounts receivable, net of bad debt reserves of $7,532 in 2009 and $0 in 2008 | 149,039 | 333,056 |
| Inventory, net of provision for inventory obsolescence of $124,402 in 2009 and $68,062 in 2008 | 196,461 | 148,201 |
| Prepaid expenses | 337,602 | 316,058 |
| Other current assets | 54,590 | 21,680 |
| Total current assets | 843,892 | 3,384,272 |
| Fixed assets, net | 139,589 | 183,384 |
| Patents and trademarks, net | 220,583 | 269,398 |
| Non-current assets | 175,578 | — |
| Intangible assets, net | 8,353,501 | 9,568,023 |
| Total assets | $ 9,733,143 | $ 13,405,077 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities | ||
| Accounts payable | $ 447,527 | $ 314,680 |
| Accrued liabilities | 1,093,404 | 1,201,793 |
| Due to stockholders | 38,422 | 23,152 |
| Deferred revenue | 150,977 | 237,400 |
| Obligations under warrants | 3,195 | 57,666 |
| Obligations under warrants | 1,242,403 | — |
| Total current liabilities | 2,975,928 | 1,834,691 |
| Deferred tax liability, net | — | 1,611,502 |
| Total liabilities | 2,975,928 | 3,446,193 |
| Commitments and contingencies | ||
| Contingently redeemable common stock, zero outstanding at Dec.31, 2009 and 119,629 shares outstanding at December 31, 2008 | — | 250,000 |
| Stockholders' equity | ||
| Capital stock | ||
| Preferred Stock | — | — |
| Par value of $0.001 per share; authorized 10,000,000: zero issued and outstanding at both December 31, 2009 and 2008 | ||
| Common stock | 9,866 | 9,708 |
| Par value of $0.001 per share; | ||
| Authorized: 40,000,000; Issued and outstanding: | ||
| Issued and outstanding: December 31, 2008 – 9,866,685; December 31, 2008 – 9,708,780 | ||
| Additional paid-in capital | 378,789,938 | 377,356,547 |
| Accumulated deficit | (372,042,589) | (367,657,371) |
| Total stockholders' equity | 6,757,215 | 9,708,884 |
| $ 9,733,143 | $ 13,405,077 | |