Press Release

Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2023 Results

March 11, 2024

Leadership Appointments Move Ocular Towards Being a Leader in Retinal Care

Screening Underway in AXPAXLI™ Phase 3 SOL-1 Trial for Wet AMD

Topline Clinical Data for AXPAXLI in Diabetic Retinopathy and PAXTRAVA™ in Glaucoma Expected in Q2 2024

Cash Expected to Support Operations Into At Least 2028 Based on $196M YE 2023 Cash Balance Plus $325M Gross Proceeds from February 2024 PIPE

Planning to Host an Investor Day in Q2 2024 to Outline Updated Corporate Strategy

BEDFORD, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today reported financial results for the fourth quarter 2023 and full year ended December 31, 2023.

“I joined Ocular because I see the opportunity to unlock significant value for patients and stockholders through the development of safe, effective and durable treatments for retinal diseases, starting with our lead candidate, AXPAXLI for wet AMD,” said Pravin Dugel, MD, Executive Chairman of Ocular Therapeutix. “Bringing together our dedicated, world-class team of acknowledged strategic and clinical experts has enabled us to position Ocular as a leader in retinal care. Our goal is to bring AXPAXLI to the market as soon as possible. Our strengthened team provides us with an opportunity to enrich and accelerate the AXPAXLI clinical programs.”

Dr. Dugel concluded, “I believe the Company has made outstanding progress over the last several months, with the initiation of the Phase 3 SOL-1 study with AXPAXLI in wet AMD and successful financings that raised more than $440 million in gross proceeds from existing and new top tier health care investors. Further, I believe that wet AMD is just the beginning for AXPAXLI. We look forward to providing an update on the Company’s strategy and objectives related to our increased focus on retinal disease during our upcoming Investor Day, planned for the second quarter 2024.”

Recent Achievements:

  • Named Pravin Dugel, MD as Executive Chairman and appointed key strategic and clinical experts, including Jeff Heier, MD, as Chief Scientific Officer, Peter Kaiser, MD, as Medical Director, and Sanjay Nayak, MBBS, PhD, as Chief Strategy Officer, to create a world renowned and respected team and move the Company to the forefront of retinal care
  • Announced first subjects screened and received their first aflibercept injection in the Phase 3 SOL-1 study with AXPAXLI in wet AMD, being conducted according to a Special Protocol Assessment Agreement with FDA
  • Completed two recent financings raising more than $440 million in total gross proceeds to fund the Phase 3 clinical development of AXPAXLI for the treatment of wet AMD as well as to fund continued clinical development of AXPAXLI for the treatment of diabetic retinopathy

Anticipated Upcoming Milestones:

  • April 5-8, PAXTRAVA™ ASCRS: Topline results from the Phase 2 trial (NCT05335122) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT)
  • Q2 2024: Ocular Therapeutix Investor Day (exact date to be announced)
  • Q2 2024: Topline Phase 1 results from the HELIOS trial evaluating AXPAXLI in subjects with non-proliferative diabetic retinopathy (NCT05695417)

Fourth Quarter and Year End December 31, 2023 Financial Results

Total cash and cash equivalents (Cash) were $195.8 million as of December 31, 2023. The Company also completed a private placement of common shares in February 2024 that provided gross proceeds of $325.0 million, before deducting placement agent fees and offering expenses. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the Company believes that its current cash balance is sufficient to support its planned expenses, obligations and capital expenditure requirements into at least 2028.

Total net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product revenue; and collaboration revenue. Total net revenue was $14.8 million for the fourth quarter of 2023, a 5.0% increase over total net revenue of $14.1 million in the comparable period in 2022, driven by DEXTENZA sales. Total net revenue for the full year 2023 was $58.4 million versus $51.5 million in 2022, an increase of 13.4%.

Research and development expenses for the fourth quarter of 2023 were $16.2 million versus $13.5 million for the comparable period in 2022, driven primarily by an increase in overall clinical and regulatory expenses associated with product development programs. Overall R&D expenses for the full year increased $7.6 million to $61.1 million from $53.5 million in 2022, reflecting the timing and conduct of our clinical trials.

Selling and marketing expenses were $9.2 million in the fourth quarter of 2023, as compared to $10.5 million for the comparable quarter of 2022, primarily reflecting a reduction in personnel costs driven by lower expense for stock-based compensation and other items. Overall, selling and marketing expenses for the full year increased nominally to $40.5 million from $39.9 million in 2022, related to an increase in personnel costs and other costs, offset by lower spend on professional services.

General and administrative expenses were $8.0 million for the fourth quarter of 2023 versus $8.3 million in the comparable quarter of 2022, lower primarily due to a reduction of professional-related fees and other expenses. Overall, G&A expenses for the full year increased by $1.7 million to $33.9 million from $32.2 million in 2022, related to an increase of personnel-related expenses, including stock-based compensation, partially offset by lower professional-related fees and other expenses.

Net loss for the fourth quarter of 2023 was $(29.2) million, or a loss of $(0.35) per share on both a basic and diluted basis, compared to a net loss of $(15.5) million, or net loss of $(0.20) per share on a basic basis and a loss of $(0.24) per share on a diluted basis, for the comparable period in 2022. The net loss in the fourth quarter of 2023 included a $(6.5) million non-cash expense attributable to changes in the fair value of the derivative liabilities associated with the Company’s convertible notes and the Barings credit facility versus the net loss in the fourth quarter of 2022 that included a $5.2 million non-cash gain attributable to the derivative liability associated with the Company’s convertible notes. Non-cash charges for stock-based compensation and depreciation and amortization were $5.3 million in the fourth quarter of 2023 versus $4.7 million for the comparable quarter in 2022.

Overall, the Company reported a net loss of $(80.7) million, or a loss of $(1.01) per share on a basic basis and a loss of $(1.02) on a diluted basis, for the year ended December 31, 2023 versus a net loss of $(71.0) million, or a loss of $(0.92) per share on a basic basis and a loss of $(0.97) on a diluted basis, for the year ended December 31, 2022.

Outstanding shares as of March 6, 2024 were approximately 148.6 million.

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, including glaucoma. AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in the first of two planned pivotal Phase 3 trials for wet AMD, the SOL-1 trial, and a Phase 1 clinical trial for the treatment of non-proliferative diabetic retinopathy. The clinical portfolio also includes PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension.

Ocular’s expertise in the formulation, development and commercialization of innovative therapies and the ELUTYX™ platform supported the development and launch of its first commercial drug product, DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. ELUTYX is also the foundation for two other clinical-stage assets, OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease, as well as several preclinical programs.

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DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, and ELUTYX™ are trademarks of Ocular Therapeutix, Inc.

About DEXTENZA

DEXTENZA is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus, and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

Please see full Prescribing and Safety Information at the DEXTENZA website.

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, including the timing, design, and enrollment of the Company’s pivotal trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI and its other product candidates; the Company’s cash runway and 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 preclinical and 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, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL-1 trial, the planned SOL-2 trial and the Company’s other ongoing clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the SPA for the SOL-1 trial; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not agree that the data generated by the SOL-1 trial supports potential marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials; availability of data from clinical trials and expectations for regulatory submissions and approvals; the risks that the leadership appointments referenced in this release are not successful in achieving the anticipated results; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all; 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 press 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, whether as a result of new information, future events or otherwise, except as required by law. 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 press release.

Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
dnotman@ocutx.com

Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com

 
Ocular Therapeutix, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share data)
   
               
    December 31,   December 31,  
    2023   2022  
Assets              
Current assets:              
Cash and cash equivalents   $ 195,807     $ 102,300    
Accounts receivable, net     26,179       21,325    
Inventory     2,305       1,974    
Restricted cash     150          
Prepaid expenses and other current assets     7,794       4,028    
Total current assets     232,235       129,627    
Property and equipment, net     11,739       9,856    
Restricted cash     1,614       1,764    
Operating lease assets     6,472       8,042    
Total assets   $ 252,060     $ 149,289    
Liabilities and Stockholders’ Equity              
Current liabilities:              
Accounts payable   $ 4,389     $ 5,123    
Accrued expenses and other current liabilities     28,666       24,097    
Deferred revenue     255       576    
Operating lease liabilities     1,586       1,599    
Total current liabilities     34,896       31,395    
Other liabilities:              
Operating lease liabilities, net of current portion     6,878       8,678    
Derivative liabilities     29,987       6,351    
Deferred revenue, net of current portion     14,135       13,387    
Notes payable, net     65,787       25,257    
Other non-current liabilities     108       93    
Convertible Notes, net     9,138       28,749    
Total liabilities     160,929       113,910    
Commitments and contingencies              
Stockholders’ equity:              
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at December 31, 2023 and December 31, 2022, respectively              
Common stock, $0.0001 par value; 200,000,000 shares authorized and 114,963,193 and 77,201,819 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively     12       8    
Additional paid-in capital     788,697       652,213    
Accumulated deficit     (697,578 )     (616,842 )  
Total stockholders’ equity     91,131       35,379    
Total liabilities and stockholders’ equity   $ 252,060     $ 149,289    
               


Ocular Therapeutix, Inc.
Consolidated Satements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
 
    Three Months Ended   Year Ended  
    December 31,   December 31,  
    2023
  2022
  2023
  2022
 
Revenue:                          
Product revenue, net   $ 14,677     $ 13,902     $ 57,870     $ 50,457    
Collaboration revenue     125       174       573       1,037    
Total revenue, net     14,802       14,076       58,443       51,494    
                           
Costs and operating expenses:                          
Cost of product revenue     1,386       1,013       5,281       4,540    
Research and development     16,195       13,543       61,055       53,462    
Selling and marketing     9,246       10,533       40,549       39,922    
General and administrative     8,024       8,348       33,940       32,224    
Total costs and operating expenses     34,851       33,437       140,825       130,148    
Loss from operations     (20,049 )     (19,361 )     (82,382 )     (78,654 )  
Other income (expense):                          
Interest income     1,460       423       3,983       798    
Interest expense     (4,153 )     (1,847 )     (11,338 )     (7,022 )  
Change in fair value of derivative liabilities     (6,478 )     5,243       (5,188 )     13,841    
Gains and losses on extinguishment of debt, net                 14,190          
Other income (expense), net                 (1 )     (1 )  
Total other income (expense), net     (9,171 )     3,819       1,646       7,616    
Net loss   $ (29,220 )   $ (15,542 )   $ (80,736 )   $ (71,038 )  
Net loss per share, basic   $ (0.35 )   $ (0.20 )   $ (1.01 )   $ (0.92 )  
Weighted average common shares outstanding, basic     84,429,883       77,010,385       79,827,362       76,875,036    
Net loss per share, diluted   $ (0.35 )   $ (0.24 )   $ (1.02 )   $ (0.97 )  
Weighted average common shares outstanding, diluted     90,199,115       82,779,617       85,596,594       82,644,267    
                           

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Source: Ocular Therapeutix, Inc.

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