Ocular Therapeutix™ Reports First Quarter 2018 Financial Results and Business Update
Targeting DEXTENZA™ NDA Resubmission in the Second Quarter of 2018
“We entered 2018 with an exciting set of opportunities that include a
number of regulatory and clinical milestones,” said
Key Highlights and Upcoming Events
DEXTENZA™ New Drug Application (NDA) resubmission to the
U.S. Food and Drug Administration( FDA) remains on track for the second quarter of 2018. DEXTENZA is a long-acting, preservative-free formulation of dexamethasone that uses Ocular Therapeutix’s proprietary hydrogel technology and offers a full course of steroid treatment to treat post-surgical ocular pain in a single administration. The Company has made significant progress addressing not only the specific issues raised by the FDAin its most recent Complete Response Letter, but also the implementation of upgrades to the overall quality systems and key operating procedures necessary to reach GMP compliance. Based on the progress, Ocular Therapeutixis reiterating prior guidance that it is targeting resubmission of the NDA in the second quarter of 2018.
- OTX-TP (travoprost insert) Phase 3 topline efficacy data for the treatment of glaucoma now expected in the first half of 2019. OTX-TP is a long-acting, preservative-free formulation of travoprost for patients with primary open-angle glaucoma and ocular hypertension. While enrollment in this large trial has continued steadily, it has proceeded more slowly than projected. Therefore, the Company is adjusting guidance that topline data will now be available in the first half of 2019 rather than the second half of 2018. To address this enrollment issue, the Company is intensifying efforts with current sites to identify eligible patients and continues to add new sites to help complete enrollment.
- Plans to initiate an open label one-year safety extension study for OTX-TP (travoprost insert) for glaucoma in the second quarter 2018. The Company will initiate an open-label, one-year safety extension study with its first Phase 3 study. This study will contribute to the safety data to support OTX-TP’s eventual product registration.
- First patient dosed in OTX-TIC (travoprost implant) U.S. Phase 1 clinical trial with plans to report clinical data in the first half of 2019. OTX-TIC is Ocular Therapeutix’s second glaucoma program targeting patients needing a higher level of intraocular pressure reduction. The product is a bioresorbable, travoprost-containing hydrogel implant delivered via intracameral injection. The U.S. Phase 1 trial is a multi-center, open-label, proof-of-concept clinical trial to evaluate the safety, efficacy, durability, and tolerability of OTX-TIC in patients with primary open-angle glaucoma and ocular hypertension.
- Plans to initiate ex-U.S. Phase 1 clinical trial for OTX-TKI (tyrosine kinase inhibitor implant) in the second quarter of 2018. OTX-TKI is a bioresorbable, hydrogel fiber implant with anti-angiogenic properties, delivered by intravitreal injection. Preclinical data have demonstrated the ability to deliver an efficacious dose of OTX-TKI 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 study will be a multi-center, open-label, dose escalation study to test the safety, durability, and tolerability of OTX-TKI. The Company also plans to evaluate biological activity by following visual acuity over time and measuring retinal thickness using standard optical coherence tomography (OCT).
- Regeneron collaboration continues for the development of OTX-IVT (aflibercept implant). The Company, along with Regeneron, continues to progress on the development of 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). The Company remains encouraged by the engagement of both teams and the multiple possibilities to which this partnership could lead.
First Quarter 2018 Financial Results
As of March 31, 2018, cash and cash equivalents totaled $62.9 million.
Cash used in operating activities was $12.5 million in the first
quarter of 2018, compared to
$14.6 millionfor the first quarter of 2017. The decrease of $2.1 millionwas due to a savings in operating expenses as a result of the restructuring in the third quarter of 2017.
Ocular Therapeutix reported a net loss of approximately $(13.8)
million, or $(0.40) per share, for the quarter ended March 31, 2018,
compared to a net loss of $(16.0) million, or $(0.58) per share, for
the comparable quarter in 2017. The net loss for the first quarter of
$2.4 millionin non-cash charges for stock-based compensation and depreciation compared to $2.0 millionin similar non-cash charges for the first quarter of 2017.
- Total costs and operating expenses for the three-month period ended March 31, 2018 were $13.8 million, as compared to $16.1 million for the comparable period in 2017. Increases in (i) Research and Development expenses to advance the clinical and preclinical development of the Company’s hydrogel platform technology and its portfolio of drug product candidates and (ii) General and Administrative expenses driven by increased professional fees primarily from higher litigation expenses were more than offset by significant savings in Selling and Marketing expenses due to the restructuring in the third quarter of 2017.
Ocular Therapeutix generated $340 thousand in revenue during the
three-month period ended March 31, 2018 from product sales of ReSure® Sealant,
as compared to
$475 thousandduring the three-month period ended March 31, 2017.
- As of May 1, 2018, there were approximately 37.3 million shares issued and outstanding.
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 expenditure requirements through the first quarter of 2019, exclusive of any potential payment under the Regeneron partnership. This is of course subject to a number of assumptions about the Company’s clinical development programs and other aspects of our business.
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 (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 3148379. 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 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.
Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
|Three Months Ended|
|Costs and operating expenses:|
|Cost of product revenue||80||115|
|Research and development||8,227||6,729|
|Selling and marketing||717||6,027|
|General and administrative||4,771||3,276|
|Total costs and operating expenses||13,795||16,147|
|Loss from operations||(13,455)||(15,672)|
|Other income (expense):|
|Total other expense, net||(310)||(351)|
|Net loss per share, basic and diluted||$||(0.40)||$||(0.58)|
|Weighted average common shares outstanding, basic and diluted||34,792,848||27,643,746|
|Other comprehensive loss:|
|Unrealized loss on marketable securities||—||(4)|
|Total other comprehensive loss||—||(4)|
|Total comprehensive loss||$||(13,765)||$||(16,027)|
Ocular Therapeutix, Inc.
(In thousands, except share and per share data)
|March 31,||December 31,|
|Cash and cash equivalents||$||62,911||$||41,538|
|Prepaid expenses and other current assets||1,256||1,453|
|Total current assets||64,476||43,339|
|Property and equipment, net||10,595||10,478|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and deferred rent||3,603||4,310|
|Notes payable, net of discount, current||6,071||5,545|
|Total current liabilities||13,151||13,426|
|Deferred rent, long-term||3,336||3,387|
|Notes payable, net of discount, long-term||11,014||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 March 31, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized and 37,280,054 and 29,658,202 shares issued and outstanding at March 31, 2018 and December 31, 2017||4||3|
|Additional paid-in capital||300,210||263,409|
|Total stockholders’ equity||49,184||26,147|
|Total liabilities and stockholders’ equity||$||76,685||$||55,431|
Chief Financial Officer
Senior Vice President, Commercial