Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 10, 2016

 

 

OCULAR THERAPEUTIX, INC.

(Exact Name of Company as Specified in Charter)

 

 

 

Delaware   001-36554   20-5560161

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

34 Crosby Drive, Suite 105

Bedford, MA 01730

(Address of Principal Executive Offices) (Zip Code)

Company’s telephone number, including area code: (781) 357-4000

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On May 10, 2016, Ocular Therapeutix, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2016. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is furnished to comply with Item 2.02 of Form 8-K, and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits:

 

99.1    Press Release of Ocular Therapeutix, Inc., dated May 10, 2016


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    OCULAR THERAPEUTIX, INC.
Date: May 10, 2016     By:  

/s/ W. Bradford Smith

     

W. Bradford Smith

Chief Financial Officer


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    Press Release of Ocular Therapeutix, Inc., dated May 10, 2016.
EX-99.1

Exhibit 99.1

Ocular Therapeutix™ Reports First Quarter 2016 Financial Results and Provides Corporate Update

PDUFA target action date of July 24, 2016 for DEXTENZA™ NDA for the treatment of post-surgical ocular pain

Second Phase 3 clinical trial for DEXTENZA for the treatment of allergic conjunctivitis fully enrolled; topline results expected June 2016

First Phase 3 clinical trial for OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension with placebo control arm expected to commence in the third quarter of 2016

Conference call today at 8:00 am Eastern Time

BEDFORD, Mass, May 10, 2016 (BUSINESS WIRE): Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the first quarter ended March 31, 2016.

“This is an exciting time for Ocular Therapeutix, as we anticipate multiple key milestones throughout the remainder of 2016, including the July 2016 PDUFA date for DEXTENZA for the treatment of post-surgical ocular pain, as well as expected read-outs from our second Phase 3 DEXTENZA clinical trial for the treatment of allergic conjunctivitis and our third Phase 3 clinical trial for the treatment of post-surgical ocular inflammation and pain,” said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman. “Following the completion of an End-of-Phase 2 review with the FDA last month, we are also gearing up to initiate the first of two planned Phase 3 clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension. We believe that successful outcomes for these milestones have the potential to affirm the growing value of our innovative sustained-release platform in addressing diverse applications in ophthalmology.”

Recent Highlights and Anticipated Near-Term Milestones for Key Development Programs

DEXTENZA for the treatment of post-surgical ocular inflammation and pain

 

    Based on a New Drug Application (NDA) filed in December with the U.S. Food and Drug Administration (FDA) for DEXTENZA (sustained release dexamethasone), Intracanalicular Depot for the treatment of post-surgical ocular pain, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of July 24, 2016 for the NDA.

 

    Should the FDA grant marketing approval for DEXTENZA for the treatment of post-surgical ocular pain on the PDUFA action date, the Company expects to apply for a pass through reimbursement code used in the hospital and ambulatory surgery center setting and launch this product in early 2017.

 

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    A third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation and pain is over 90% enrolled, with 395 patients out of a planned total of 436 patients enrolled as of May 3, 2016.

 

    The Company expects topline results from the trial to be available in the fourth quarter of 2016.

 

    If the Company obtains favorable results from this third Phase 3 trial and subject to approval of the NDA for post-surgical ocular pain by the FDA, the Company intends to submit an NDA supplement for DEXTENZA aiming to broaden the label to include a post-surgical inflammation indication.

DEXTENZA for the treatment of allergic conjunctivitis

 

    Ocular Therapeutix has completed enrollment in a second Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA for the treatment of allergic conjunctivitis.

 

    The Company expects topline results from this trial to be available in June 2016.

 

    If the primary efficacy endpoint for ocular itching associated with allergic conjunctivitis is met in the second Phase 3 trial and subject to the approval of the NDA submitted for DEXTENZA for the treatment of post-surgical ocular pain, the Company expects to submit an NDA supplement to the FDA for ocular itching associated with allergic conjunctivitis.

DEXTENZA for the treatment of dry eye disease

 

    Ocular Therapeutix plans to meet with the FDA in mid-2016 to discuss the results from a recently conducted exploratory Phase 2 clinical trial designed to evaluate a range of objective and subjective measures (signs and symptoms, respectively) and potential Phase 3 clinical trial designs for dry eye-related indications.

OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension

 

    Ocular Therapeutix recently completed an End-of-Phase 2 Review with the FDA for OTX-TP (sustained release travoprost) for the treatment of Glaucoma and Ocular Hypertension.

 

    Based on this review, the Company intends to initiate the first of two planned Phase 3 clinical trials during the third quarter of 2016.

 

    The primary efficacy endpoint will be superiority in the reduction of intraocular pressure (IOP) from baseline in the OTX-TP treatment arm compared to the placebo arm.

 

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    Importantly, the Phase 3 study design will not include a timolol comparator or validation arm, and will not have active or placebo eye drops administered in either arm.

First Quarter 2016 Financial Results

 

    As of March 31, 2016, cash, cash equivalents and marketable securities totaled $95.5 million. Cash used in operating activities was $9.3 million in the first quarter of 2016, compared to $6.9 million for the first quarter of 2015. There was $15.6 million in outstanding debt as of March 31, 2016 and no principal payments are due until January 2017. The Company expects that cash, cash equivalents and marketable securities will be sufficient to fund operating expenses, debt service obligations and capital expenditures through the third quarter of 2017.

 

    Ocular Therapeutix reported a net loss of approximately $10.8 million, or $(0.44) per share, for the quarter ended March 31, 2016, compared to a net loss of $7.6 million, or $(0.35) per share, for the quarter ended March 31, 2015. The first quarter 2016 results include $1.3 million in non-cash charges for stock-based compensation compared to $0.9 million in such non-cash charges in the first quarter of 2015.

 

    Total operating expenses for the quarter ended March 31, 2016 were $11.0 million, as compared to $7.5 million for the quarter ended March 31, 2015. Research and development (R&D) expenses for the quarter ended March 31, 2016 were $7.1 million, compared to $4.7 million for the quarter ended March 31, 2015. The increases are primarily related to personnel costs and clinical trials of DEXTENZA for the treatment of post-surgical inflammation and pain, DEXTENZA for the treatment of allergic conjunctivitis and OTX-TP for the treatment of glaucoma and ocular hypertension as well as preclinical development of the Company’s anti-VEGF and TKI programs for the treatment of wet age-related macular degeneration and other back of the eye diseases.

 

    Ocular Therapeutix generated $458,000 in revenue during the three months ended March 31, 2016 from product sales of ReSure® Sealant and from collaborations with corporate partners.

 

    As of March 31, 2016, there were approximately 24.8 million shares issued and outstanding.

 

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Conference Call & Webcast Information

Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:00 am Eastern Time to discuss the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the investor section of the Company’s website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620 (International) to listen to the conference call. The conference ID number for the live call will be 3038508. An archive of the webcast will be available until May 24, 2016 on the company’s website.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidate, DEXTENZA™ (sustained release dexamethasone) Intracanalicular Depot, is in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis, and in Phase 2 clinical development for dry eye disease. A New Drug Application (NDA) for the post-operative ocular pain indication has been filed with FDA and has a Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2016. A third Phase 3 clinical trial is being conducted for post-surgical ocular inflammation and pain. For glaucoma and ocular hypertension, the Company has completed its End-of-Phase 2 review with the FDA, and the first of two planned OTX-TP (sustained release travoprost) Phase 3 clinical trials is expected to be initiated in the third quarter of 2016. Ocular Therapeutix is also evaluating sustained-release injectable anti-VEGF drug depots for back-of-the-eye diseases. 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 statements about the development and regulatory status of the Company’s product candidates, such as the Company’s expectations and plans regarding regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA™ for post-surgical ocular inflammation and pain, including our expectations regarding the pending PDUFA date for the NDA filed with the FDA, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release hydrogel depot technology and the advancement of the Company’s other product candidates, the potential utility of any of the Company’s product candidates, 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,”

 

Page 4 of 7


“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 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.

Contact:

Investors

Ocular Therapeutix, Inc.

Brad Smith

Chief Financial Officer

bsmith@ocutx.com

or

Burns McClellan on behalf of Ocular Therapeutix

Steve Klass, 212-213-0006

sklass@burnsmc.com

or

Media

Ocular Therapeutix, Inc.

Scott Corning

Vice President of Sales and Marketing

scorning@ocutx.com

 

Page 5 of 7


OCULAR THERAPEUTIX, INC.

STATEMENTS OF OPERATIONS and COMPREHENSIVE LOSS

(In thousands, except share and per share data)

 

     Three Months Ended
March 31,
 
     2016     2015  

Revenue:

    

Product revenue

   $ 416      $ 238   

Collaboration revenue

     42       188  
  

 

 

   

 

 

 

Total revenue:

     458        426   
  

 

 

   

 

 

 

Cost and operating expenses:

    

Cost of product revenue

     99        56   

Research and development

     7,073        4,719   

Selling and marketing

     1,389        870   

General and administrative

     2,406        1,894   
  

 

 

   

 

 

 

Total costs and operating expenses

     10,967        7,539   
  

 

 

   

 

 

 

Loss from operations

     (10,509     (7,113
  

 

 

   

 

 

 

Other income (expense):

    

Interest income

     87        40   

Interest expense

     (418     (505
  

 

 

   

 

 

 

Total other expense, net

     (331     (465
  

 

 

   

 

 

 

Net loss

   $ (10,840   $ (7,578
  

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.44   $ (0.35
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     24,751,682        21,362,731   
  

 

 

   

 

 

 

Comprehensive loss:

    

Net loss

   $ (10,840   $ (7,578 )

Other comprehensive income:

    

Unrealized gains on marketable securities

     68        —     
  

 

 

   

 

 

 

Total other comprehensive income

     68        —     
  

 

 

   

 

 

 

Total comprehensive loss

   $ (10,772   $ (7,578
  

 

 

   

 

 

 

 

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OCULAR THERAPEUTIX, INC.

BALANCE SHEETS

(In thousands, except share and per share data)

 

     March 31,
2016
    December 31,
2015
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 46,212      $ 30,784   

Marketable securities

     49,244        74,280   

Accounts receivable

     227        193   

Inventory

     127        134   

Prepaid expenses and other current assets

     1,287        1,592   
  

 

 

   

 

 

 

Total current assets

     97,097        106,983   

Property and equipment, net

     3,107        3,095   

Restricted cash

     228        228   
  

 

 

   

 

 

 

Total assets

   $ 100,432      $ 110,306   
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 2,063      $ 1,957   

Accrued expenses and deferred rent

     2,779        3,379   

Deferred revenue

     —          42   

Notes payable, net of discount, current

     1,161        —     
  

 

 

   

 

 

 

Total current liabilities

     6,003        5,378   

Deferred rent, long-term

     55        68   

Notes payable, net of discount, long-term

     14,204        15,272   
  

 

 

   

 

 

 

Total liabilities

     20,262        20,718   
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Preferred stock, $0.0001 par value; 5,000,000 shares authorized at March 31, 2016 and December 31, 2015; no shares issued or outstanding at March 31, 2016 and December 31, 2015

     —          —     

Common stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2016 and December 31, 2015 , respectively; 24,758,786 and 24,750,281 shares issued and outstanding at March 31, 2016 and December 31, 2015, respectively

     2        2   

Additional paid-in capital

     220,184        218,830   

Accumulated deficit

     (140,016     (129,176

Accumulated other comprehensive loss

     —          (68
  

 

 

   

 

 

 

Total stockholders’ equity

     80,170        89,588   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 100,432      $ 110,306   
  

 

 

   

 

 

 

 

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