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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Ocular Therapeutixtm Reports Second Quarter 2022 Financial Results and Business Update


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 reported financial results for the quarter ended June 30, 2022, and provided updates on its ophthalmology pipeline.

"Through the first half of the year we are making good progress executing on our commercial strategy and developing our strong ophthalmology pipeline," said Antony Mattessich, President and Chief Executive Officer. "Looking ahead, we plan to announce interim data from the U.S.-based Phase 1 clinical trial of OTX-TKI for the treatment of wet AMD in the third quarter. Wet AMD represents a large market opportunity for a highly differentiated product, and we believe that OTX-TKI has the potential to become a new standard of care in the management of serious retinal diseases. On the commercial front, DEXTENZA achieved net revenue of $12.1 million for the quarter despite staffing challenges at our ASC and HOPD customers that hindered their ability to operate at full capacity. We believe these challenges are transient in nature and that drivers such as the recent recommendation of continued separate payment through 2023 by CMS, bringing new territories online, and the ramp-up of our new office-based salesforce should have a positive impact on DEXTENZA sales over the remainder of 2022 and beyond."

Recent Business Updates

OTX-TKI Data Expected to be Presented at American Academy of Ophthalmology (AAO) Meeting at the End of September

Implemented Organizational Changes to Strengthen the Company's Alignment Around Its Retina Programs and the Overall Development of its Ophthalmology Pipeline

The U.S. Commercial Uptake of DEXTENZA

Key Pipeline Program Updates

Second Quarter Ended June 30, 2022 Financial Results

Net revenue, which includes both gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, and collaboration revenue was $12.3 million for the second quarter and represented an approximately 5% increase over the same period in 2021. Net product revenue of DEXTENZA in the second quarter of 2022 was $12.1 million versus $11.1 million in the comparable quarter of 2021, reflecting a 9% increase. Total net revenue for the second quarter of 2022 also included collaboration revenue of $0.1 million from the Company's licensing agreement with AffaMed.

Research and development expenses for the second quarter were $13.1 million versus $13.9 million for the comparable period in 2021 driven primarily by a reduction in clinical and pre-clinical spending offset by an increase in unallocated personnel costs and other expenses.

Selling and marketing expenses in the quarter were $10.1 million as compared to $8.4 million for the comparable quarter of 2021, due primarily to an increase in professional fees related to trade shows, conferences and advertising.

General and administrative expenses were $7.8 million for the second quarter versus $8.6 million in the comparable quarter of 2021, primarily reflecting a decrease in professional fees.

The Company reported a net loss of $ (18.8) million, or a loss of $ (0.24) and $ (0.25) per share on a basic and diluted basis, respectively, for the second quarter ended June 30, 2022. This compares to a net loss of $(8.5) million, or a loss of $(0.11) per share on a basic basis and $(0.25) per share on a diluted basis. for the comparable period in 2021. Net loss in the second quarter of 2022 was reduced by a $2.8 million non-cash item attributable to a decrease in the fair value of the derivative liability associated with the Company's convertible notes, as the price of its common stock declined during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $4.8 million in the second quarter of 2022 versus $4.9 million for the comparable quarter of 2021.

As of August 5, 2022, the Company had 77.0 million shares outstanding.

2022 Financial Guidance

Conference Call & Webcast Information

Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide a general business update. The live webcast can be accessed by visiting the Investors 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 (800) 715-9871 (U.S.) or (646) 307-1963 (International) to listen to the live conference call. The conference ID number for the live call will be 9296568. A replay of the webcast will be available on the Company's website for 90 days following the live call.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Ocular Therapeutix's first commercial drug product, DEXTENZA®, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix's earlier stage development assets include: OTX-TKI (axitinib intravitreal implant), currently in Phase 1 clinical trials for the treatment of wet AMD and other retinal diseases; OTX-TIC (travoprost intracameral implant), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and 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, both of which have completed Phase 2 clinical trials. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.

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 www.DEXTENZA.com.

Forward Looking Statements

Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of dry eye disease; the Company's plans to advance the development of its product candidates or preclinical programs; the ongoing development of the Company's extended-delivery hydrogel depot technology; the potential utility of any of the Company's product candidates; the size of potential markets for the Company's product candidates; the potential benefits and future operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; 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 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, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to successfully develop and commercialize products for the ophthalmology office setting, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes of clinical trials, whether clinical trial data such as the data reported in this release will be indicative of the results of subsequent clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company's ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, the Company's scientific approach and general development progress, the availability or commercial potential of the Company's product candidates, the Company's ability to meet supply demands, the Company's ability to generate its projected net product revenue and in-market sales on the timeline expected, if at all, the sufficiency of cash resources, the Company's existing indebtedness, the ability of the Company's creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the severity and duration of the COVID-19 pandemic including its effect on the Company's revenues and relevant regulatory authorities' operations, any additional financing needs, the Company's ability to recruit and retain key personnel, 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.

Ocular Therapeutix, Inc.

Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30,

 

June 30,

 

 

2022

 

2021

 

2022

 

2021

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

12,144

 

$

11,718

 

$

24,642

 

$

19,061

Collaboration revenue

 

 

122

 

 

?

 

 

811

 

 

?

Total revenue, net

 

 

12,266

 

 

11,718

 

 

25,453

 

 

19,061

Costs and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenue

 

 

1,155

 

 

1,096

 

 

2,454

 

 

1,988

Research and development

 

 

13,100

 

 

13,859

 

 

26,200

 

 

24,786

Selling and marketing

 

 

10,140

 

 

8,391

 

 

19,203

 

 

16,477

General and administrative

 

 

7,787

 

 

8,603

 

 

15,344

 

 

16,268

Total costs and operating expenses

 

 

32,182

 

 

31,949

 

 

63,201

 

 

59,519

Loss from operations

 

 

(19,916)

 

 

(20,231)

 

 

(37,748)

 

 

(40,458)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

73

 

 

8

 

 

89

 

 

20

Interest expense

 

 

(1,696)

 

 

(1,655)

 

 

(3,378)

 

 

(3,335)

Change in fair value of derivative liability

 

 

2,773

 

 

13,396

 

 

9,731

 

 

38,412

Other income (expense), net

 

 

?

 

 

1

 

 

(2)

 

 

1

Total other income, net

 

 

1,150

 

 

11,750

 

 

6,440

 

 

35,098

Net loss

 

$

(18,766)

 

$

(8,481)

 

$

(31,308)

 

$

(5,360)

Net loss per share, basic

 

$

(0.24)

 

$

(0.11)

 

$

(0.41)

 

$

(0.07)

Weighted average common shares outstanding, basic

 

 

76,764,296

 

 

76,324,367

 

 

76,755,028

 

 

76,198,384

Net loss per share, diluted

 

$

(0.25)

 

$

(0.25)

 

$

(0.47)

 

$

(0.51)

Weighted average common shares outstanding, diluted

 

 

82,533,528

 

 

82,093,599

 

 

82,524,260

 

 

81,967,616

Ocular Therapeutix, Inc.

Consolidated Balance Sheet
(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

 

2022

 

2021

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

134,539

 

$

164,164

Accounts receivable, net

 

 

20,482

 

 

21,135

Inventory

 

 

1,500

 

 

1,250

Prepaid expenses and other current assets

 

 

3,801

 

 

4,751

Total current assets

 

 

160,322

 

 

191,300

Property and equipment, net

 

 

6,680

 

 

6,956

Restricted cash

 

 

1,764

 

 

1,764

Operating lease assets

 

 

4,305

 

 

4,867

Total assets

 

$

173,071

 

$

204,887

Liabilities and Stockholders' Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,703

 

$

4,592

Accrued expenses and other current liabilities

 

 

19,450

 

 

20,121

Deferred revenue

 

 

1,189

 

 

?

Operating lease liabilities

 

 

1,771

 

 

1,624

Total current liabilities

 

 

26,113

 

 

26,337

Other liabilities:

 

 

 

 

 

 

Operating lease liabilities, net of current portion

 

 

4,999

 

 

5,924

Derivative liability

 

 

10,461

 

 

20,192

Deferred revenue, net of current portion

 

 

13,000

 

 

13,000

Notes payable, net of discount

 

 

25,128

 

 

25,000

2026 convertible notes, net

 

 

27,567

 

 

26,435

Total liabilities

 

 

107,268

 

 

116,888

Commitments and contingencies

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2022 and December 31, 2021, respectively

 

 

?

 

 

?

Common stock, $0.0001 par value; 200,000,000 shares authorized and 76,910,026 and 76,731,940 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively

 

 

8

 

 

8

Additional paid-in capital

 

 

642,907

 

 

633,795

Accumulated deficit

 

 

(577,112)

 

 

(545,804)

Total stockholders' equity

 

 

65,803

 

 

87,999

Total liabilities and stockholders' equity

 

$

173,071

 

$

204,887

 


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