Ocular Therapeutix™ Reports First Quarter 2019 Financial Results and Business Update
DEXTENZA® Commercial Launch Scheduled for Mid-Year 2019
“This is an exciting time at
Key Highlights and Upcoming Events
Progressed DEXTENZA (dexamethasone ophthalmic insert):
Completed the initial hiring of its sales management, key account
managers, medical science liaisons and reimbursement
professionals. DEXTENZA is now available at distribution centers
with a sampling program targeted at key surgery centers commencing
later this month. The formal DEXTENZA commercial launch remains on
track for mid-2019 pending the receipt of transitional
pass-through payment status (C-code), by the
Center for Medicare and Medicaid Services(CMS), anticipated in June for activation July 1, 2019.
Announced that CMS has included DEXTENZA 0.4mg for
intracanalicular use on its list of products that has been
preliminarily recommended for a new dedicated Healthcare Common
Procedure Coding System (HCPCS) J-code, effective
January 1, 2020.
U.S. Food and Drug Administration( FDA) has accepted for filing the supplemental New Drug Application (sNDA) for DEXTENZA to add the treatment of ocular inflammation following ophthalmic surgery as an additional indication. The FDAhas set a PDUFA target action date of November for the completion of its review of the sNDA.
Presented data at the recent
American Society of Cataract and Refractive Surgery(ASCRS) symposium including pooled Phase 3 safety and efficacy data for DEXTENZA use after cataract surgery and Phase 3 data highlighting DEXTENZA’s benefit in treating symptoms of allergic conjunctivitis using a modified conjunctival allergen challenge (CAC) model. The Company believes DEXTENZA has potential to be used in multiple ocular indications and is also pursuing preclinical work in post-operation pain, inflammation, antibiotics, dry eye and additional formulations for allergic conjunctivitis.
- Completed the initial hiring of its sales management, key account managers, medical science liaisons and reimbursement professionals. DEXTENZA is now available at distribution centers with a sampling program targeted at key surgery centers commencing later this month. The formal DEXTENZA commercial launch remains on track for mid-2019 pending the receipt of transitional pass-through payment status (C-code), by the
Topline efficacy data from the Phase 3 clinical trial of OTX-TP
(travoprost ophthalmic insert) for the treatment of glaucoma expected
in the second quarter of 2019. The Phase 3 clinical trial
enrolled 550 subjects with the primary efficacy endpoint being a
statistically superior mean reduction of intraocular pressure (IOP)
from baseline for OTX-TP treated subjects compared with placebo insert
treated subjects at three diurnal time points at each of three
measurement dates of 2, 6, and 12 weeks following insertion. While not
a primary endpoint, the Company will also analyze IOP reduction for
clinical meaningfulness as we expect the
FDAwill require it for regulatory approval. The Company continues to enroll an open-label, one-year safety extension study with OTX-TP to provide additional long-term safety data with repeat administration of OTX-TP.
Reported interim results of the Phase 1 clinical trial of
OTX-TIC (travoprost intracameral implant) at the
Association for Research in Vision and Ophthalmology(ARVO) and ASCRS Annual Meetings. OTX-TIC is a bioresorbable, travoprost-containing hydrogel intracameral implant to treat patients with primary open-angle glaucoma or ocular hypertension. Interim data showed subjects achieved IOP lowering as good as topical travoprost in the non-study eye for a period of up to 9 months with a single insert. While there were no adverse changes to the cornea, as measured by endothelial cell evaluation and corneal pachymetry, the Company saw several subjects with low-grade inflammation and mild peripheral anterior synechiae, both of which it believes may be addressable with modifications to the implants.
Continued dosing of patients in the Phase 1 clinical trial of
OTX-TKI (tyrosine kinase inhibitor intravitreal implant). 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 wet age-related macular
degeneration (AMD) for an extended duration. The Phase 1 clinical
trial being conducted in
Australiais a multi-center, open-label study testing the safety, durability, and tolerability of OTX-TKI. The Data and Safety Monitoring Committee met and agreed with the Company’s recommendation to dose the next cohort of subjects at a higher dose.
- Provided an update on the partnership with Regeneron. OTX-IVT is a sustained release formulation of the VEGF trap aflibercept, or EYLEA®, for the treatment of retinal diseases such as wet AMD that is being developed in partnership with Regeneron. The Company has recently agreed with Regeneron to cease development of the current formulation and is currently in discussions regarding the development of an alternative formulation.
First Quarter Ended
The Company had
$76.3 millionin cash and cash equivalents at March 31, 2019versus $54.1 millionat year end December 31, 2018. Both of these cash amounts exclude $6.6 millionof restricted cash as required by the Company’s existing senior debt facility and letters of credit for our property leases. The cash balance benefited during the first quarter from our $37.5 millionsubordinated convertible debt offering and $5.0 millionin net proceeds generated from the sale of common stock under the Company’s 2016 Sales Agreement, or 2016 Sales Agreement. 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 2020.
The Company exhausted the 2016 Sales Agreement with the first quarter
sales of common stock and cancelled the facility. On
April 5, 2019, the Company entered into an Open Market Sale Agreement, or the 2019 Sales Agreement with Jefferies LLC, under which the Company may offer and sell our common stock having aggregate proceeds of up to $50 millionfrom time to time. Through May 9, 2019, the Company has not sold any shares of common stock under the 2019 Sales Agreement.
Research and development expenses for the first quarter were
$11.3 millionversus $8.2 millionfor the comparable period in 2018 and reflect an increase in unallocated costs, primarily personnel costs associated with additional hiring, and costs associated with the Company’s pipeline programs as well as preclinical programs.
Selling and marketing expenses for the first quarter were
$3.3 millionas compared to $0.7 millionfor the same quarter in 2018. This increase relates primarily to DEXTENZA pre-commercial launch activities including the hiring of additional personnel and increased spending on consulting, conferences and related costs.
General and Administrative expenses were
$5.4 millionfor the first quarter versus $4.8 millionin the comparable quarter of 2018. The increase in expenses stemmed primarily from increased personnel and facilities costs.
Revenues for the first quarter were driven exclusively by ReSure
Sealant and totaled approximately
$0.5 millionvs. $0.3 millionin the comparable quarter of 2018. As noted in the past, the Company does not currently provide promotional support to ReSure and does not expect ReSure product revenues to be material in 2019.
The Company reported a net loss of
$(17.1) millionin the first quarter of 2019, or basic net loss of $(0.41)per share. This compares to a net loss of $(13.8) million, or basic net loss of $(0.40)per share, for the same period in 2018. The net loss for the quarter included $2.5 millionin non-cash charges for stock-based compensation and depreciation compared to $2.4 millionfor the same quarter in 2018.
The Company had approximately 42.8 million shares issued and
outstanding as of
May 9, 2019.
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 commercialization of DEXTENZA®, ReSure Sealant, or any of the Company’s product candidates, including the anticipated commercial launch of, and receipt of reimbursement codes for, DEXTENZA; 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 inflammation and the prospects for approvability of DEXTENZA for post-surgical ocular inflammation or any other indications, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the potential utility of any of the Company’s product candidates; the potential benefits and future operation of the collaboration with
Ocular Therapeutix, Inc.
|Three Months Ended|
|Costs and operating expenses:|
|Cost of product revenue||128||80|
|Research and development||11,317||8,227|
|Selling and marketing||3,347||717|
|General and administrative||5,358||4,771|
|Total costs and operating expenses||20,150||13,795|
|Loss from operations||(19,658||)||(13,455||)|
|Other income (expense):|
|Change in fair value of derivative liability||3,223||—|
|Total other income (expense), net||2,534||(310||)|
|Net loss and comprehensive loss||$||(17,124||)||$||(13,765||)|
|Net loss per share, basic||$||(0.41||)||$||(0.40||)|
|Weighted average common shares outstanding, basic||42,251,292||34,792,848|
|Net loss per share, diluted||$||(0.45||)||$||(0.40||)|
|Weighted average common shares outstanding, diluted||44,174,369||34,792,848|
OCULAR THERAPEUTIX, INC.
|March 31,||December 31,|
|Cash and cash equivalents||$||76,251||$||54,062|
|Prepaid expenses and other current assets||2,380||1,713|
|Total current assets||79,172||56,193|
|Property and equipment, net||10,548||10,236|
|Operating lease assets||5,156||—|
|Liabilities and Stockholders’ Equity|
|Accrued expenses and other current liabilities||4,037||6,194|
|Operating lease liability||675||—|
|Total current liabilities||8,614||9,159|
|Operating lease liabilities, net of current portion||7,909||—|
|Notes payable, net of discount||24,843||24,788|
|2026 convertible notes, net||23,014||—|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at March 31, 2019 and December 31, 2018, respectively||—||—|
|Common stock, $0.0001 par value; 100,000,000 shares authorized and 42,836,978 and 41,518,091 shares issued and outstanding at March 31, 2019 and December 31, 2018||4||4|
|Additional paid-in capital||340,011||333,114|
|Total stockholders’ equity||25,648||35,875|
|Total liabilities and stockholders’ equity||$||101,490||$||73,043|
Senior Vice President, Commercial