Ocular Therapeutix™ Reports Third Quarter 2018 Financial Results and Business Update
DEXTENZA® NDA Target PDUFA Action Date of
“It has been another busy quarter highlighted by continued progress on
DEXTENZA® as well as the rest of our deep product pipeline,”
Key Highlights and Upcoming Events
Pre-Approval Inspection of DEXTENZA completed; PDUFA
target action date remains
December 28, 2018. Following an inspection of its manufacturing facility in Bedford, Massachusetts, the Company confirms no repeat 483 observations were made, however, additional observations were identified. The Company is in the process of fully responding to those observations and continues to anticipate a decision from the FDAby the original PDUFA date of December 28, 2018.
- Preparations for commercial launch of DEXTENZA continue. The Company is actively recruiting for its field organization and is continuing the process of executing its commercial strategy. Ocular intends to launch DEXTENZA, if approved, with a specialty sales team that will initially target high-volume surgery centers.
Positive data from Phase 3 clinical trial of DEXTENZA published
Journal of Cataract & Refractive Surgeryin October. The publication included data from a 400-patient, prospective, multicenter, randomized, controlled, phase 3 study, demonstrating statistical significance (p <.0001) in treatment of both post-operative ocular inflammation and pain.
Targetenrollment reached in Phase 3 clinical trial of OTX-TP (travoprost insert) for the treatment of glaucoma - Topline efficacy data expected in the first half of 2019. As target enrollment for the OTX-TP Phase 3 trial was reached, no additional subjects will be screened. There are still a few subjects in wash-out that may be randomized in the next several days. In parallel, the Company continues dosing in an open-label, one-year safety extension study that will be included as part of the current pivotal program. This study will provide additional long-term safety data with repeat administration of OTX-TP.
- Enrollment in the Phase 1 clinical trial of OTX-TIC (travoprost implant) for the treatment of glaucoma continues with data expected to be presented in the first half of 2019. OTX-TIC is a bioresorbable, travoprost-containing hydrogel intracameral implant. The U.S. Phase 1 trial is a multi-center, open-label, prospective, dose escalation clinical trial to evaluate the safety, efficacy, durability, and tolerability of OTX-TIC in patients with primary open-angle glaucoma or ocular hypertension. The first subject has been treated for six months with a single insert.
- Dosing of initial subject in the Phase 1 clinical trial of OTX-TKI (tyrosine kinase inhibitor implant) anticipated in the fourth quarter of 2018. OTX-TKI is a bioresorbable, hydrogel fiber implant with anti-angiogenic properties delivered by intravitreal injection to the posterior segment of the eye for the treatment of VEGF-induced retinal leakage for an extended duration of up to twelve months. The Phase 1 trial is a multi-center, open-label, study testing the safety, durability, and tolerability of OTX-TKI.
- Regeneron is evaluating the final formulation of OTX-IVT (aflibercept implant). In December of 2017, the Company delivered to Regeneron a final formulation of OTX-IVT as a product candidate in accordance with a collaboration agreement. OTX-IVT is an extended-delivery formulation of the VEGF trap aflibercept (EYLEA®), delivered by intravitreal injection, for the treatment of retinal diseases such as wet Age-related Macular Degeneration (AMD). Regeneron has been evaluating the formulation in preclinical trials and analyzing data generated using the formulation and has not informed the Company of its decision whether to exercise the option to enter into an exclusive, worldwide license.
Third Quarter 2018 Financial Results
As of the quarter ended
September 30, 2018, the Company had $56.9 millionin cash and cash equivalents versus $56.8 millionat the end of the second quarter of 2018. The cash balance benefited from $12.9 millionin net proceeds generated from the sale of common stock under the Company’s 2016 Sales Agreement, or ATM, during the third quarter of 2018. Offsetting the ATM inflows during the quarter were a net loss of $15.0 million, principal debt payments of $1.5 million, and capital expenditures of $0.5 million.
Based on the Company’s current plans and forecasted expenses,
Ocular Therapeutixbelieves that existing cash and cash equivalents will fund operating expenses, debt service obligations, and capital expenditures into the second quarter of 2019.
Research and development expenses for the third quarter of 2018 were
$9.7 millionversus $8.1 millionfor the third quarter of 2017 and reflect increased unallocated other costs, primarily in consulting services, outside testing expenses, facilities expenses associated with additional laboratory space at our corporate headquarters and slightly increased compensation costs associated with additional hiring - primarily in the technical operations and quality departments.
Selling and marketing expenses for the third quarter of 2018 were
$1.1 millionas compared to $3.2 millionfor the same quarter in 2017. This decrease relates to a significant reduction in pre-commercial activities as a result of the delay in the planned 2017 launch of DEXTENZA.
General and Administrative expenses were
$4.4 millionfor the third quarter of 2018 versus $4.2 millionin the comparable quarter of 2017. The increase in expenses stemmed primarily from increases in legal costs related to the defense of the Company in ongoing legal proceedings.
Revenues for the third quarter of 2018 were driven exclusively by
ReSure® Sealant and totaled approximately
$0.5 millionduring each of the three-month periods. As previously disclosed, the Company recently received a warning letter from the FDAregarding ReSure due to a perceived lack of progress with the enrollment and related data collection and information reporting obligations for a required post-approval trial. The Company has appealed the warning letter and will continue to work with the FDAto resolve the issue.
The Company reported a net loss of
$(15.0) million, or a loss of $(0.38)per share. This compares to a net loss of $(15.6) million, or a loss of $(0.54)per share, for the same period in 2017. The net loss for the third quarter of 2018 included $2.4 millionin non-cash charges for stock-based compensation and depreciation compared to $2.2 millionfor the same quarter in 2017.
The Company had approximately 41.1 million shares issued and
outstanding as of
November 1, 2018.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast today at
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including the development and regulatory status of the Company’s product candidates, such as the Company’s regulatory submissions for and the timing and conduct of, or implications of results from, clinical trials of DEXTENZA® for the treatment of post-surgical ocular pain and inflammation, including with respect to manufacturing deficiencies identified by the
Ocular Therapeutix, Inc.
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Costs and operating expenses:|
|Cost of product revenue||115||125||348||344|
|Research and development||9,685||8,126||26,657||22,972|
|Selling and marketing||1,067||3,238||2,651||16,097|
|General and administrative||4,447||4,230||13,665||11,230|
|Total costs and operating expenses||15,314||15,719||43,321||50,643|
|Loss from operations||(14,816||)||(15,196||)||(41,835||)||(49,207||)|
|Other income (expense):|
|Other income (expense), net||—||5||—||5|
|Total other expense, net||(194||)||(371||)||(744||)||(1,077||)|
|Net loss per share, basic and diluted||$||(0.38||)||$||(0.54||)||$||(1.15||)||$||(1.76||)|
|Weighted average common shares outstanding, basic and diluted||39,017,922||29,087,654||37,111,200||28,601,179|
|Other comprehensive loss:|
|Unrealized gain on marketable securities||—||—||—||5|
|Total other comprehensive income||—||—||—||5|
|Total comprehensive loss||$||(15,010||)||$||(15,567||)||$||(42,579||)||$||(50,279||)|
Ocular Therapeutix, Inc.
|September 30,||December 31,|
|Cash and cash equivalents||$||56,861||$||41,538|
|Prepaid expenses and other current assets||1,071||1,453|
|Total current assets||58,274||43,339|
|Property and equipment, net||10,382||10,478|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||4,535||4,310|
|Notes payable, net of discount, current||6,094||5,545|
|Total current liabilities||13,406||13,426|
|Deferred rent, long-term||3,274||3,387|
|Notes payable, net of discount, long-term||8,073||12,471|
|Commitments and contingencies (Note 10)|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at September 30, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized and 40,524,335 and 29,658,202 shares issued and outstanding at September 30, 2018 and December 31, 2017||4||3|
|Additional paid-in capital||325,357||263,409|
|Total stockholders’ equity||45,517||26,147|
|Total liabilities and stockholders’ equity||$||70,270||$||55,431|
Chief Financial Officer
Senior Vice President, Commercial