Ocular Therapeutix™ Reports Fourth Quarter and Year End 2017 Financial Results and Business Update Print
Business Wire
Thursday, 08 March 2018 02:06
Anticipating DEXTENZA™ NDA Resubmission in the First Half of 2018
March 8, 2018 12:30 UTC

Ocular Therapeutix™ Reports Fourth Quarter and Year End 2017 Financial Results and Business Update

Anticipating DEXTENZA™ NDA Resubmission in the First Half of 2018

BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the fourth quarter and the twelve months ended December 31, 2017 and provided a business update.

“It gives me great pleasure to turn the page on 2017 and look forward to 2018 with a rebuilt team in place and the multiple possibilities this partnership could lead to.

  • Completed the transition of the management team. Ocular Therapeutix expanded its leadership team with the additions of Naymisha Patel, Vice President of Quality and Kevin Hanley, Senior Vice President, Technical Operations. Naymisha brings over 20 years of experience working with blue-chip biotechnology companies and she has a proven record in quality management, process improvement, regulatory submissions and regulatory compliance. Kevin joins the Company from Pfizer and brings to the Company over 30 years of experience managing biopharmaceutical technical operations, with demonstrated success in technology transfer and process scale-up for the manufacturing of proteins from development through manufacturing approval. These appointments to the management team represent critical additions to ensure the Company’s core DEXTENZA manufacturing capabilities meet cGMP standards and that the Company can supply the anticipated commercial needs of DEXTENZA ahead of a potential FDA approval. Since July 2017 Ocular Therapeutix has appointed new team members to six of the top nine management positions in the Company, bringing in over 100 years of biopharmaceutical experience.
  • Fourth Quarter and Year End 2017 Financial Results

    • In January 2018, Ocular Therapeutix completed a follow-on public offering raising net proceeds of $35.1 million that consisted of 7,475,000 shares of common stock, including those shares exercised by the underwriter of its option to purchase additional shares, pursuant to a shelf registration statement that was previously filed with and declared effective by the Securities and
      Exchange Commission.
    • As of December 31, 2017, cash, cash equivalents and ocular hypertension. The Company’s earlier stage assets include OTX-TIC, a sustained release travoprost intracameral implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases. These implants include the development of OTX-TKI, a tyrosine kinase inhibitor (TKI), and, in collaboration with Regeneron, an extended release protein-based anti-vascular endothelial growth factor (VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

      Forward Looking Statements
      Any statements in this press release about future expectations, plans and prospects for the Company, including the development and regulatory status of the Company’s product candidates, such as the Company’s regulatory submissions for and the timing and conduct of, or implications of results from, clinical trials of DEXTENZA™ for the treatment of post-surgical ocular pain and inflammation, including with respect to manufacturing deficiencies identified by the Food and Drug Administration (FDA), the Company’s expectations regarding resubmitting its NDA to the FDA and the prospects for approvability of DEXTENZA for these indications, the Company’s clinical development of DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry eye disease, OTX-TP for the treatment of mild to moderate glaucoma and ocular hypertension, OTX-TIC for the treatment of moderate to severe glaucoma and ocular hypertension, and OTX-TKI for the treatment of wet age-related macular degeneration, the ongoing development of the Company’s sustained release hydrogel depot technology, the potential utility of any of the Company’s product candidates, potential commercialization of the Company’s product candidates, the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder, the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure® Sealant or any product candidate that receives regulatory approval, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources, the outcome of the Company’s ongoing legal proceedings and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

      Ocular Therapeutix, Inc.

      Statements of Operations and Comprehensive Loss

      (In thousands, except share and per share data)

          Three Months Ended     Year Ended
      December 31, December 31,
      2017     2016 2017     2016
      Product revenue $ 487 $ 511 $ 1,923 $ 1,845
      Collaboration revenue         42
      Total revenue   487   511   1,923   1,887
      Costs and operating expenses:
      Cost of product revenue 113 127 457 443
      Research and + 'src="//sedoparking.com/frmpark/' development 7,908 7,328 30,880 27,065
      Selling and marketing 903 2,526 17,000 6,701
      General and administrative   4,279   3,002   15,509   11,004
      Total costs and operating expenses   13,203   12,983   63,846   45,213
      Loss from operations   (12,716)   (12,472)   (61,923)   (43,326)
      Other income (expense):
      Interest income 104 68 424 304
      Interest expense (490) (418) (1,892) (1,680)
      Other income (expense), net       5   (1)
      Total other expense, net   (386)   (350)   (1,463)   (1,377)
      Net loss   (13,102)   (12,822) $ (63,386) $ (44,703)
      Net loss per share, basic and diluted $ (0.44) $ (0.52) $ (2.20) $ (1.80)
      Weighted average common shares outstanding, basic and diluted   29,658,202   24,888,602   28,818,196   24,816,348
      Comprehensive loss:
      Net loss $ (13,102) $ (12,822) $ (63,386) $ (44,703)
      Other comprehensive income (loss):
      Unrealized gain on marketable securities     (10)   5   63
      Total other comprehensive income     (10)   5   63
      Total comprehensive loss $ (13,102) $ (12,832) $ (63,381) $ (44,640)

      Balance Sheets

      (In thousands, except share and per share data)

      December 31, December 31,
      2017 2016
      Current assets:
      Cash and cash equivalents $ 41,538 $ 32,936
      Marketable securities 35,209
      Accounts receivable 226 250
      Inventory 122 113
      Prepaid expenses and other current assets   1,453   1,390
      Total current assets 43,339 69,898
      Property and equipment, net 10,478 3,313
      Restricted cash   1,614   1,728
      Total assets $ 55,431 $ 74,939
      Liabilities and Stockholders’ Equity
      Current liabilities:
      Accounts payable $ 3,571 $ 2,116
      Accrued expenses and deferred rent 4,310 4,635
      Notes payable, net of discount, current   5,545   1,549
      Total current liabilities 13,426 8,300
      Deferred rent, long-term 3,387 537
      Notes payable, net of discount, long-term   12,471   14,094
      Total liabilities   29,284   22,931
      Commitments and contingencies (Note 13)
      Stockholders’ equity:
      Preferred stock, $0.0001 par value; 5,000,000 shares authorized at December 31, 2017 and December 31, 2016; no shares issued or outstanding at December 31, 2017 and December 31, 2016
      Common stock, $0.0001 par value; 100,000,000 shares authorized at December 31, 2017 and December 31, 2016; 29,658,202 and 25,024,100 shares issued and outstanding at December 31 2017 and December 31, 2016, respectively 3 3
      Additional paid-in capital 263,409 225,889
      Accumulated deficit (237,265) (173,879)
      Accumulated other comprehensive loss     (5)
      Total stockholders’ equity   26,147   52,008
      Total liabilities and stockholders’ equity $ 55,431 $ 74,939


    Ocular Therapeutix
    Donald Notman
    Chief Financial Officer
    Westwicke Partners
    Chris Brinzey
    Managing Director
    Ocular Therapeutix
    Scott Corning
    Vice President of Marketing & Commercial Operations

    Source: Ocular Therapeutix, Inc.

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