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Zalicus Reports Financial Results for the Third Quarter 2012

  Zalicus Reports Financial Results for the Third Quarter 2012  Business Wire  CAMBRIDGE, Mass. -- November 08, 2012  Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported financial results for the third quarter ended September 30, 2012.  “We are focusing our resources and efforts on advancing the clinical development of our ion channel programs including Z160, our first-in-class, oral N-type calcium channel blocker for the treatment of chronic neuropathic pain and Z944, a novel oral T-type calcium channel blocker,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “During the third quarter we advanced Z160 into a Phase 2a clinical trial for chronic back pain and remain on track to initiate a second Phase 2a clinical trial with Z160 in postherpetic neuralgia in the fourth quarter of this year.”  Third Quarter 2012 and Recent Accomplishments:  Pipeline Progress:    *Advanced Z160, a first-in-class, oral, state dependent, selective N-type     calcium channel (Cav 2.2) blocker into the first of two planned Phase 2a     clinical trials for neuropathic pain. Patient enrollment in the first of     these Phase 2a studies, in lumbosacral radiculopathy (LSR), a form of     chronic lower back pain, began in the third quarter of 2012. The second     Phase 2a clinical trial with Z160, in postherpetic neuralgia, is expected     to begin enrolling patients in the fourth quarter of 2012.   *Initiated a Phase 1 multiple ascending dose (MAD) clinical study with     Z944, its novel, oral, T-type calcium channel blocker which has     demonstrated efficacy in a number of preclinical inflammatory pain models     and other disease models. The initiation of this MAD study follows the     successfully completed Phase 1 single ascending dose study in which Z944     was determined to be generally well-tolerated and a maximum tolerated dose     was achieved. T-type calcium channels have been recognized as key targets     for therapeutic intervention in a broad range of cell functions and have     been implicated in pain signaling. Assuming Z944 successfully completes     the MAD study, Z944 could enter Phase 2 clinical development in the first     quarter of 2013.  Third Quarter 2012 Financial Results (Unaudited):  As of September 30, 2012, we had cash, cash equivalents, restricted cash and short-term investments of approximately $45.0 million compared to $44.1 million on June 30, 2012.  For the quarter ended September 30, 2012, revenue was $3.5 million, compared to $2.4 million for the quarter ended September 30, 2011. The increase in revenue from the 2011 to the 2012 period was primarily due to increased Exalgo royalties from Covidien and increased collaborative revenue from Novartis. Zalicus recognized $1.4 million in royalty revenue from Covidien based on Exalgo sales for the quarter ended September 30, 2012. This represents an 11% increase in revenue from Exalgo compared to the quarter ended June 30, 2012.  For the quarter ended September 30, 2012, net loss was $12.2 million, or $0.10 per share, compared to a net loss of $9.3 million, or $0.09 per share, in the quarter ended September 30, 2011.  Research and development expenses were $12.1 million in the quarter ended September 30, 2012, compared to $8.9 million in the quarter ended September 30, 2011. The increase in R&D expense from the 2011 period to the 2012 period was primarily due to increased development expenses related to Z160, Synavive and Z944. Zalicus terminated all development activities related to Synavive in the quarter ended September 30, 2012 and as a result, we expect research and development expenses to decrease for the quarter ending December 31, 2012 and for the year ending December 31, 2013.  General and administrative expenses were $2.2 million in the quarter ended September 30, 2012, compared to $2.6 million for the quarter ended September 30, 2011. We expect general and administrative expenses for the quarter ending December 31, 2012 to be consistent with such expenses during the quarter ended September 30, 2012.  About Zalicus  Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain such as Z160 and Z944 and has entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease. To learn more about Zalicus, please visit www.zalicus.com.  Forward-Looking Statements  This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its product candidates, their potential and the plans for their clinical development, the Zalicus selective Ion channel modulation technology and related preclinical product candidates, Zalicus’ combination drug discovery technology, cHTS, and its financial condition, results of operations, and other business plans. These forward-looking statements about future expectations, plans, objectives and prospects of Zalicus may be identified by words like "believe," "expect," "may," "will," "should," "seek," “plan” or “could” and similar expressions and involve significant risks, uncertainties and assumptions, including risks related to the sale and marketing of Exalgo by Covidien, risks related to the development and regulatory approval of Zalicus’ product candidates, including risks relating to formulation and clinical development of Z160 and Z944, the unproven nature of the Zalicus drug discovery technologies, the ability of the Company or its collaboration partners to initiate and successfully complete clinical trials of its product candidates, the Company's ability to obtain additional financing or funding for its research and development, and those other risks that can be found in the "Risk Factors" section of Zalicus' annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Zalicus periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Zalicus contemplated by these forward-looking statements. These forward-looking statements reflect management’s current views and Zalicus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.  (c) 2012 Zalicus Inc. All rights reserved.  Zalicus Inc.  Condensed Consolidated Statements of Comprehensive Loss  (in thousands, except share and per share amounts)  (Unaudited)                  Three months ended September    Nine months ended September                  30,                              30,                  2012           2011             2012           2011 Revenue: Collaborations   $ 3,381         $ 2,300         $ 8,423         $ 5,042 and other Government contracts and    137             128           339             505         grants                                                                    Total revenue    3,518           2,428         8,762           5,547                                                                          Operating expenses: Research and     12,050            8,871          32,493            25,678 development General and      2,201             2,563          7,172             8,030 administrative Amortization     974               1,285          2,920             3,855 of intangible Restructuring    (17         )    —             1,112           —                                                                              Total operating        15,208          12,719        43,697          37,563      expenses                                                                    Loss from        (11,690     )     (10,291    )   (34,935     )     (32,016    ) operations Interest         35                33             120               100 income Interest         (532        )     (358       )   (1,686      )     (579       ) expense Other income     13              148           20              2                                                                              Net loss before benefit   (12,174     )     (10,468    )   (36,481     )     (32,493    ) for income taxes Income tax       —               1,217         441             1,217       benefit                                                                    Net loss         $ (12,174   )   $ (9,251     )   $ (36,040   )   $ (31,276    )                                                                    Net loss per share— basic     $ (0.10     )   $ (0.09      )   $ (0.32     )   $ (0.32      ) and diluted                                                                    Weighted average number of common shares used in net loss per     124,562,900     99,214,522    114,069,137     96,712,208  share calculation— basic and diluted                                                                    Comprehensive    $ (12,171   )   $ (9,286     )   $ (36,022   )   $ (31,286    ) loss   Zalicus Inc.  Condensed Consolidated Balance Sheets  (in thousands except per share data)  (Unaudited)                                                                                                                   September 30,   December 31,                                                   2012            2011 Assets Current assets: Cash and cash equivalents                         $  8,971        $ 2,750 Restricted cash                                      —              50 Short-term investments                               34,265         45,124 Accounts receivable                                  3,098          1,886 Prepaid expenses and other current assets           1,039        1,397                                                                        Total current assets                                 47,373         51,207 Property and equipment, net                          3,869          5,258 Intangible asset, net                                18,627         21,546 Restricted cash and other assets                    1,816        1,872                                                                        Total assets                                      $  71,685      $ 79,883                                                                       Liabilities and stockholders’ equity Current liabilities: Accounts payable                                  $  2,191        $ 1,743 Accrued expenses and other current liabilities       6,090          6,133 Accrued restructuring                                189            — Deferred revenue                                     4,928          3,349 Current portion of term loan payable                 6,137          4,035 Current portion of lease incentive obligation       284          284                                                                          Total current liabilities                            19,819         15,544 Term loan payable, net of current portion            10,426         15,099 Deferred revenue, net of current portion             1,035          3,000 Deferred rent, net of current portion                494            605 Lease incentive obligation, net of current           945            1,159 portion Other long-term liabilities                          28             563 Stockholders’ equity: Preferred stock, $0.001 par value; 5,000 shares      —              — authorized; no shares issued and outstanding Common stock, $0.001 par value; 200,000 shares authorized; 126,932 and 99,239 shares issued         127            99 and outstanding at September 30, 2012 and December 31, 2011, respectively Additional paid-in capital                           371,537        340,518 Accumulated other comprehensive income (loss)        10             (8       ) Accumulated deficit                                 (332,736 )    (296,696 )                                                                    Stockholders’ equity                                38,938       43,913                                                                       Total liabilities and stockholders’ equity        $  71,685      $ 79,883     Contact:  Zalicus Inc. Justin Renz, 617-301-7575 CFO JRenz@zalicus.com or Gina Nugent, 617-460-3579 gnugent@zalicus.com