Ocular Therapeutix™ Reports Third Quarter 2017 Financial Results and Provides Corporate Update
Conference Call Today at
“In addition to refining our manufacturing process for DEXTENZA™, we are
also working diligently on a continuous improvement plan that will bring
our manufacturing unit into compliance with GMP standards. We believe
the completion of this work is essential for the timely resubmission of
the DEXTENZA™ New Drug Application, as well as for the advancement of
our other pipeline products,” said
Recent Updates and Anticipated Near-Term Milestones
DEXTENZA™ (dexamethasone insert) for the treatment of post-surgical ocular inflammation and pain
January 2017New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration( FDA), and a re-inspection of manufacturing operations by the FDAwhich was completed in May of 2017, the Company received an FDA Form-483 containing inspectional observations concerning manufacturing processes and analytical testing related to the manufacturing of DEXTENZA drug product that led to a Complete Response Letter (CRL) from the FDAin July 2017.
Following the Company’s initial response to the Form FDA-483
submitted to the
FDAin May 2017, Ocular Therapeutixsubmitted its responses to the FDA’s remaining inspectional observations in November 2017.
The Company intends to meet with the
FDAin early 2018 to review plans to resubmit its NDA for DEXTENZA for the treatment of post-surgical ocular pain.
Subject to addressing the
FDAinspectional observations and demonstrating consistency in future manufacturing runs, the Company plans to resubmit its NDA for DEXTENZA in the first half of 2018.
- Following the Company’s initial response to the Form FDA-483 submitted to the
OTX-TP (travoprost insert) and OTX-TIC (travoprost intracameral injection) for the reduction of intraocular pressure (IOP) in patients with glaucoma and ocular hypertension
Ocular Therapeutixcontinues to enroll patients in its first Phase 3 clinical trial for OTX-TP (travoprost insert) for the reduction of IOP in patients with glaucoma and ocular hypertension.
- The Company expects topline efficacy data from the completed trial in the second half of 2018.
- Subject to allocation of available funding, the Company plans to initiate its second Phase 3 trial in 2018.
Ocular Therapeutixis also developing an intracameral product candidate, OTX-TIC, which is a bioresorbable extended release travoprost implant delivered via a fine-gauge needle injection. The Company is developing OTX-TIC to potentially address the need for a higher level of IOP reduction for patients who have moderate to severe glaucoma.
In the third quarter of 2017, the Company initiated a pilot human
clinical trial outside
the United Statesto assess safety and obtain initial efficacy data.
The Company also expects to file an Investigational New Drug (IND)
application in the first quarter of 2018 and initiate a second
Phase 1 trial in
the United Statesin the first half of 2018.
- In the third quarter of 2017, the Company initiated a pilot human clinical trial outside
Sustained release intravitreal depots for the treatment of serious retinal diseases
Ocular Therapeutixis engaged in the preclinical development of its extended release intravitreal tyrosine kinase inhibitor injection (OTX-TKI) using the Company’s proprietary bioresorbable hydrogel fiber technology.
The Company expects to initiate a Phase 1 clinical trial outside
the United Statesfor OTX-TKI in the first half of 2018.
- The Company expects to initiate a Phase 1 clinical trial outside
In partnership with
Regeneron Pharmaceuticals, Ocular Therapeutixalso continues to advance the development of an extended release hydrogel-based formulation of Regeneron’s protein-based anti-vascular endothelial growth factor (VEGF) trap, aflibercept, for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases.
The Company strengthened its management team with the appointments of
Michael Goldstein, M.D., MBA, as Chief Medical Officer, and Donald Notman, MBA, as Chief Financial Officer.
Dr. Goldstein is a highly-accomplished ophthalmologist who also
serves as Co-Director, Cornea and External Disease Service and
Assistant Professor of Ophthalmology at the
New England Eye Centerand Tufts University School of Medicine. He has held several senior medical leadership positions with ophthalmology-focused pharmaceutical companies and published extensively in multiple ophthalmology scientific journals.
Mr. Notman brings a notable track record of success to
Ocular Therapeutixwith over 20 years of financial operations and senior-level investment banking experience.
- Dr. Goldstein is a highly-accomplished ophthalmologist who also serves as Co-Director, Cornea and External Disease Service and Assistant Professor of Ophthalmology at the
Third Quarter 2017 Financial Results
September 30, 2017, cash and cash equivalents totaled $51.2 million. Cash used in operating activities was $14.4 millionin the third quarter of 2017, compared to $7.3 millionfor the third quarter of 2016. The Company expects that cash and cash equivalents will be sufficient to fund operating expenses, debt service obligations and capital expenditures into the fourth quarter of 2018.
Ocular Therapeutixreported a net loss of approximately $(15.6) million, or $(0.54)per share, for the quarter ended September 30, 2017, compared to a net loss of $(9.6) million, or $(0.39)per share, for the quarter ended September 30, 2016. The third quarter 2017 results include $2.2 millionin non-cash charges for stock-based compensation and depreciation compared to $1.6 millionin such non-cash charges in the third quarter of 2016.
The Company continues to advance the clinical and preclinical
development of its hydrogel-based formulation technology and its
portfolio of drug product candidates. Total costs and operating
expenses for the quarter ended
September 30, 2017were $15.7 million, as compared to $9.7 millionfor the quarter ended September 30, 2016. The increase was primarily due to an increase in costs associated with the Company’s recent initiative to enhance operations and reduce expenses surrounding the delayed DEXTENZA launch as announced in August 2017, personnel expenses supporting the Company’s ongoing development programs, and facilities costs associated with the relocation of the Company’s corporate headquarters. Research and development expenses for the quarter ended September 30, 2017were $8.1 million, compared to $5.7 millionfor the quarter ended September 30, 2016. The increase was primarily due to an increase in personnel costs and facilities expenses associated with increased lab space at our corporate headquarters.
Ocular Therapeutixgenerated $0.5 millionin revenue during the three-month period ended September 30, 2017from product sales of ReSure® Sealant.
September 30, 2017, there were approximately 29.4 million shares issued and outstanding.
Conference Call & Webcast Information
Members of the
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 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the live conference call. The conference ID
number for the live call will be 7468418. An archive of the webcast will
be available until
About Ocular Therapeutix, Inc.
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
expectations and plans regarding product development efforts and
regulatory submissions for and the timing and conduct of clinical trials
of DEXTENZA for the treatment of post-surgical ocular inflammation and
pain, including the Company’s expectations regarding refiling its NDA
|Ocular Therapeutix, Inc.|
|Statements of Operations and Comprehensive Loss|
|(In thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Costs and operating expenses:|
|Cost of product revenue||125||112||344||316|
|Research and development||8,126||5,686||22,972||19,737|
|Selling and marketing||3,238||1,294||16,097||4,175|
|General and administrative||4,230||2,623||11,230||8,002|
|Total costs and operating expenses||15,719||9,715||50,643||32,230|
|Loss from operations||(15,196||)||(9,238||)||(49,207||)||(30,854||)|
|Other income (expense):|
|Other income (expense), net||5||(1||)||5||(1||)|
|Total other expense, net||(371||)||(358||)||(1,077||)||(1,027||)|
|Net loss per share, basic and diluted||$||(0.54||)||$||(0.39||)||$||(1.76||)||$||(1.29||)|
|Weighted average common shares outstanding, basic and diluted||29,087,654||24,853,880||28,601,179||24,792,087|
|Other comprehensive income (loss):|
|Unrealized gain on marketable securities||—||(5||)||5||73|
|Total other comprehensive income||—||(5||)||5||73|
|Total comprehensive loss||$||(15,567||)||$||(9,601||)||$||(50,279||)||$||(31,808||)|
|(In thousands, except share and per share data)|
|September 30,||December 31,|
|Cash and cash equivalents||$||51,165||$||32,936|
|Prepaid expenses and other current assets||883||1,390|
|Total current assets||52,453||69,898|
|Property and equipment, net||10,218||3,313|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||4,353||4,635|
|Notes payable, net of discount, current||3,993||1,549|
|Total current liabilities||10,945||8,300|
|Deferred rent, long-term||3,608||537|
|Notes payable, net of discount, long-term||13,924||14,094|
|Commitments and contingencies (Note 12)|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized at|
|September 30, 2017 and December 31, 2016; no shares issued or outstanding|
|at September 30, 2017 and December 31, 2016||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized at|
|September 30, 2017 and December 31, 2016; 29,388,131 and 25,024,100|
|shares issued and outstanding at September 30, 2017 and December 31,|
|Additional paid-in capital||260,082||225,889|
|Accumulated other comprehensive loss||—||(5||)|
|Total stockholders’ equity||35,922||52,008|
|Total liabilities and stockholders’ equity||$||64,399||$||74,939|
Source: Ocular Therapeutix™, Inc.
Chief Financial Officer
Burns McClellan, Inc.
Steve Klass, 212-213-0006
Vice President of Marketing & Commercial Operations