News Release
For Immediate Release
OccuLogix, dba TearLab Corporation, Reports Q3-09 Financial Results
San Diego, CA —November 12, 2009— OccuLogix, Inc., dba TearLab Corporation (Tearlab) (NASDAQ: TEAR; TSX: TLB) today reported its consolidated financial results for the quarter ended September 30, 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 three months ended September 30, 2009, TearLab’s net revenues were $263,221 as compared to $96,849 in the prior quarter ended June 30, 2009 and $23,900 for the same period in 2008. The Company’s loss for the three months ended September 30, 2009 was approximately $0.7 million, or $0.07 per share which is unchanged from the loss in the prior quarter ended June 30, 2009 and a loss of $2.3 million, or $1.00 per share for the same period in 2008.
For the nine months ended September 30, 2009, TearLab’s net revenues were $603,328 as compared to $158,300 for the same period in 2008. The Company’s loss for the nine months ended September 30, 2009 was approximately $2.7 million, or $0.27 per share as compared to $7.1 million, or $3.10 per share for the same period in 2008.
As of September 30, 2009, TearLab had cash and cash equivalents and short-term investments of $1.0 million. In July and August, the Company was successful in completing a convertible debt financing that raised a total of $1.75 million which will provide sufficient funding to meet operational needs to the end of the year.
The TearLab Osmolarity System aids in the diagnosis of Dry Eye Disease, which affects over 100 million people worldwide. The company has launched TearLab in Europe, initially focusing on Germany, Italy, Spain and France. The European launch focuses on key opinion leaders conducting local clinical trials to generate local country data with the goal of increasing awareness. Data from these clinical trials will lend additional insights into clinical application of the TearLab Osmolarity System for physicians and aid in reimbursement efforts. The Company recently presented a poster at the American Academy of Ophthalmology and expects to be presenting the results of clinical trials at conferences and trade shows as well as publishing data in peer-reviewed journals.
The company recently received 510(k) clearance from the FDA which allows the TearLab Osmolarity System to be marketed in the U.S. to the limited number of physicians who practice in facilities that hold a CLIA Moderate or High Complexity certificate under the direction of a qualified laboratory director. This is the first of two major milestones that are required for the company’s launch into the U.S. market.
The second major milestone, CLIA Waiver categorization expected in the first half of 2010 reduces the CLIA certification requirement to a much simpler level such that any of the 50,000 ophthalmologists or optometrists may qualify to perform the TearLab test under a CLIA Waiver certificate and would pave the way for wide-spread adoption.
“We continue to be very excited about the future of our TearLab platform and are seeing increasing interest from our European and North American opinion leaders. We look forward to obtaining the CLIA waiver categorization and eagerly anticipate the widespread use of our platform once this regulatory milestone is achieved ” said Elias Vamvakas, TearLab’s Chairman & CEO.
About OccuLogix, Inc. dba TearLab Corporation
OccuLogix, Inc. dba 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. 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'. TearLab is currently marketed globally in more than 17 countries including the U.S.
Forward-Looking Statements
This press release may contain forward-looking statements. These statements include statements regarding CLIA waiver categorization, the adequacy of our funding and the results of clinical trials. These statements relate to future events and are subject to risks, uncertainties and assumptions about the Company. 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 Forms 10-K and 10-Q. We do not undertake to update any forward-looking statements.
For Further Information Please Contact:
| Investor Relations: | Media Inquiries: |
| Bill Dumencu | Tracy Puckett |
| TearLab Corporation | TearLab Corporation |
| bdumencu@tearlab.com | tpuckett@tearlab.com |
OccuLogix, Inc. dba TearLab Corporation
CONSOLIDATED STATEMENTS OF OPERATIONS
(expressed in U.S. dollars except number of shares)
| | | Three months ended September 30, | |
| | | 2009 | | | 2008 | |
| Revenue | | | | | | |
| TearLab | | $ | 263,221 | | | $ | — | |
| Retina | | | — | | | | 23,900 | |
| Total revenue | | | 263,221 | | | | 23,900 | |
| Cost of goods sold | | | | | | | | |
| TearLab - product cost | | | 138,832 | | | | — | |
| Retina - product cost | | | — | | | | 1,945 | |
| Total cost of goods sold | | | 138,832 | | | | 1,945 | |
| Gross profit | | | 124,389 | | | | 21,955 | |
| Operating expenses | | | | | | | | |
| Amortization of intangible assets | | | 303,631 | | | | 317,377 | |
| General and administrative | | | 566,435 | | | | 630,453 | |
| Clinical, regulatory and research & development | | | 228,796 | | | | 671,612 | |
| Sales and marketing | | | 117,381 | | | | 218,895 | |
| Restructuring charges | | | — | | | | 74,128 | |
| Total operating expenses | | | 1,216,243 | | | | 1,912,465 | |
| Loss from continuing operations | | | (1,091,854 | ) | | | (1,890,510 | ) |
| Other income (expenses) | | | | | | | | |
| Interest income | | | 8 | | | | 17,946 | |
| Changes in fair value of warrant obligation | | | 12,639 | | | | — | |
| Gain (impairment) of investments | | | — | | | | (68,281 | ) |
| Interest expense | | | (40,752 | ) | | | (169,540 | ) |
| Amortization of deferred finance charges, warrants & beneficial conversion values | | | (135,245 | ) | | | (48,000 | ) |
| Other | | | (17,820 | ) | | | 131,655 | |
| Total other income | | | (181,170 | ) | | | (136,220 | ) |
| Loss from continuing operations before income taxes | | | (1,273,024 | ) | | | (2,026,730 | ) |
| Income tax recovery (expense) | | | 618,371 | | | | (1,649,632 | ) |
| Net loss for the period | | | (654,653 | ) | | | (3,676,362 | ) |
| Net loss attributable to non-controlling interest, net of tax | | | — | | | | 1,393,410 | |
| Net loss attributable to OccuLogix, Inc. | | $ | (654,653 | ) | | $ | (2,282,952 | ) |
| Weighted average number of shares outstanding – basic and diluted | | | 9,866,685 | | | | 2,292,280 | |
| Loss per common share attributable to OccuLogix, Inc – basic and diluted | | $ | (0.07 | ) | | $ | (1.00 | ) |
OccuLogix, Inc. dba TearLab Corporation
CONSOLIDATED STATEMENTS OF OPERATIONS
(expressed in U.S. dollars except number of shares)
| | | Nine months ended September 30, | |
| | | 2009 | | | 2008 | |
| Revenue | | | | | | |
| TearLab | | $ | 603,328 | | | $ | — | |
| Retina | | | — | | | | 158,300 | |
| Total revenue | | | 603,328 | | | | 158,300 | |
| Cost of goods sold | | | | | | | | |
| TearLab - product cost | | | 388,648 | | | | — | |
| Retina - product cost | | | — | | | | 26,501 | |
| Total cost of goods sold | | | 388,648 | | | | 26,501 | |
| Gross profit | | | 214,680 | | | | 131,799 | |
| Operating expenses | | | | | | | | |
| Amortization of intangible assets | | | 910,892 | | | | 903,399 | |
| General and administrative | | | 2,459,766 | | | | 2,914,487 | |
| Clinical, regulatory and research & development | | | 867,727 | | | | 2,502,792 | |
| Sales and marketing | | | 500,235 | | | | 629,337 | |
| Restructuring charges | | | — | | | | 1,029,646 | |
| Total operating expenses | | | 4,738,620 | | | | 7,979,661 | |
| Loss from continuing operations | | | (4,523,940 | ) | | | (7,847,862 | ) |
| Other income (expenses) | | | | | | | | |
| Interest income | | | 2,277 | | | | 68,495 | |
| Changes in fair value of warrant obligation | | | 44,076 | | | | (68,281 | ) |
| Gain (impairment) of investments | | | — | | | | (450,072 | ) |
| Interest expense | | | (40,752 | ) | | | (305,256 | ) |
| Amortization of deferred finance charges, warrants & beneficial conversion values | | | (135,245 | ) | | | (180,000 | ) |
| Other | | | 7,749 | | | | 151,893 | |
| Total other income | | | (121,895 | ) | | | (783,221 | ) |
| Loss from continuing operations before income taxes | | | (4,645,835 | ) | | | (8,631,083 | ) |
| Income tax recovery (expense) | | | 1,967,583 | | | | (430,465 | ) |
| Net loss for the period | | | (2,678,252 | ) | | | (9,061,548 | ) |
| Net loss attributable to non-controlling interest, net of tax | | | — | | | | 1,964,540 | |
| Net loss attributable to OccuLogix, Inc. | | $ | (2,678,252 | ) | | $ | (7,097,008 | ) |
| Weighted average number of shares outstanding – basic and diluted | | | 9,851,122 | | | | 2,292,280 | |
| Loss per common share attributable to OccuLogix, Inc – basic and diluted | | $ | (0.27 | ) | | $ | (3.10 | ) |
OccuLogix, Inc. dba TearLab Corporation
CONSOLIDATED BALANCE SHEETS
| | | | | | | |
| | | September 30, | | | December 31, | |
| | | 2009 | | | 2008 | |
| | | (Unaudited) | | | | |
| ASSETS | | | | | | |
| Current assets | | | | | | |
| Cash and cash equivalents | | $ | 967,389 | | | $ | 2,565,277 | |
| Accounts receivable, net | | | 92,307 | | | | 333,056 | |
| Inventory, net | | | 195,613 | | | | 148,201 | |
| Prepaid expenses | | | 293,565 | | | | 316,058 | |
| Deferred finance charges | | | 28,107 | | | | — | |
| Other current assets | | | 37,216 | | | | 21,680 | |
| Total current assets | | | 1,614,197 | | | | 3,384,272 | |
| Fixed assets, net | | | 156,046 | | | | 183,384 | |
| Patents and trademarks, net | | | 246,969 | | | | 269,398 | |
| Intangible assets, net | | | 8,657,131 | | | | 9,568,023 | |
| Total assets | | $ | 10,674,343 | | | $ | 13,405,077 | |
| | | | | | | | | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | |
| Current liabilities | | | | | | | | |
| Accounts payable | | $ | 248,669 | | | $ | 314,680 | |
| Accrued liabilities | | | 888,543 | | | | 1,201,793 | |
| Due to stockholders | | | 38,422 | | | | 23,152 | |
| Deferred revenue | | | 169,340 | | | | 237,400 | |
| Obligations under warrants | | | 13,590 | | | | 57,666 | |
| Short-term liabilities and accrued interest | | | 1,031,061 | | | | — | |
| Total current liabilities | | | 2,389,625 | | | | 1,834,691 | |
| Deferred tax liability, net | | | — | | | | 1,611,502 | |
| Total liabilities | | | 2,389,625 | | | | 3,446,193 | |
| Commitments and contingencies | | | | | | | | |
| | | | | | | | | |
Contingently redeemable common stock, 119,629 shares issued and outstanding at both September 30, 2009 and December 31, 2008 | | | 250,000 | | | | 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, 2008 and 2007 | | | | | | | | |
| Common stock | | | 9,747 | | | | 9,708 | |
| Par value of $0.001 per share; | | | | | | | | |
| Authorized: 40,000,000 shares; Issued and outstanding shares: | | | | | | | | |
| Issued and outstanding: September 30, 2009 – 9,747,056; December 31, 2008 – 9,708,780 | | | | | | | | |
| Additional paid-in capital | | | 378,360,594 | | | | 377,356,547 | |
| Accumulated deficit | | | (370,335,623 | ) | | | (367,657,371 | ) |
| Total stockholders’ equity | | | 8,034,718 | | | | 9,708,884 | |
| | | $ | 10,674,343 | | | $ | 13,405,077 | |
