pSivida Corp. Provides Company Update and Reports Fourth Quarter and FY 2016 Results
"Fiscal 2016 was a year of substantial progress for pSivida. We significantly advanced Medidur™ for posterior segment uveitis toward planned EU and
Business Highlights
- The first of the two Phase 3 trials for Medidur for posterior segment uveitis met its primary efficacy endpoint of prevention of recurrence of disease at six months with high statistical significance (p less than 0.00000001, intent to treat analysis) with encouraging safety results.
- pSivida's utilization study of its proprietary, smaller diameter 27-gauge inserter met its primary endpoint, ease of intravitreal administration, showing it facilitated the administration of Medidur compared to the larger diameter inserter.
The European Commission designated Medidur as an orphan medicinal product and the Company plans to submit a European marketing authorization application (MAA) for Medidur under the centralized procedure in the first quarter of 2017 based on data from the single, first Phase 3 trial, the inserter utilization study and the ILUVIEN® for diabetic macular edema (DME) trials.- The second Medidur Phase 3 trial is expected to complete enrollment next month. Pending positive results, a
U.S. new drug application (NDA) based on both Phase 3 trials is planned for the third quarter of 2017. - An investigator-sponsored pilot study commenced for a Durasert sustained-release implant being developed together with
Hospital for Special Surgery that is designed to provide long-term pain relief for severe knee osteoarthritis. - Following the successful results of earlier reported animal studies comparing a TKI insert to an injection of a commercially available biologic indicated for wet AMD, pSivida commenced the first of two investigational new drug (IND)-enabling studies of the TKI insert for wet AMD.
- Results of pSivida's pre-clinical studies of Tethadur™ reported in July demonstrated that Tethadur could provide prolonged, sustained delivery of Avastin® with high drug efficacy. pSivida plans to conduct additional pre-clinical studies seeking to develop Tethadur for ophthalmic and systemic delivery of biologics.
- In the first quarter of fiscal 2017, pSivida enhanced its research and product development with the addition of Dario Paggiarino, M.D. as chief medical officer. The Company also closed its
U.K. research facility and consolidated all of its research into its state-of-the-art, cGMPU.S. facility coordinated by Dr. Paggiarino in an effort to improve the flow of research to product candidates while reducing overhead.
- pSivida replenished its capital resources with a
$17.8 million underwritten public offering of common stock earlier in the year.
Results for the Fourth Quarter and Year Ended
Revenues for the quarter ended
Research and development expense increased by
General and administrative expense increased by
Net loss for the quarter ended
Revenues for
the year ended
Research and development expense increased by
General and administrative expense increased by
Income tax benefit was
Today's Conference Call Reminder.
About Posterior Segment Uveitis. Posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in developed and developing countries. It afflicts people of
all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the
Patients with posterior segment uveitis are typically treated with systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects, including an increased risk of cancer. Medidur is designed to provide improved outcomes compared to standard of care, but with a significant reduction in side effects.
About Medidur Phase 3 Trials. pSivida is conducting two Phase 3 trials to assess the safety and efficacy of Medidur for the treatment of posterior segment uveitis. These are randomized, sham-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior segment uveitis at six months, with patients in both trials followed for three years. The first Phase 3 Medidur trial enrolled 129 patients in 16 centers in the
About
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate
assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to obtain needed capital; our ability to achieve profitable operations; potential declines in Retisert royalties; fluctuations in our operating results; further impairment of our intangible assets; our ability to obtain marketing approvals for and successfully commercialize Medidur for posterior segment uveitis; performance by CROs, vendors and investigators; timing of filing marketing approval applications for Medidur; acceptability of data to be filed in support of Medidur marketing
applications; maintenance of orphan designation for Medidur, potential off-label sales of ILUVIEN for posterior segment uveitis; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; Alimera's ability to continue as a going concern; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; outcome of dispute with Alimera on commercialization expenses; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products using it; efficacy and future development of severe OA implant by us; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and
future license agreements; termination or breach of current license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects of potential
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Collaborative research and development | $ | 26 | $ | 56 | $ | 398 | $ | 25,411 | ||||||||||||
| Royalty income | 278 | 353 | 1,222 | 1,154 | ||||||||||||||||
| Total revenues | 304 | 409 | 1,620 | 26,565 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Research and development | 4,104 | 3,198 | 14,381 | 12,088 | ||||||||||||||||
| General and administrative | 2,656 | 2,411 | 9,013 | 8,056 | ||||||||||||||||
| Total operating expenses | 6,760 | 5,609 | 23,394 | 20,144 | ||||||||||||||||
| (Loss) income from operations | (6,456 | ) | (5,200 | ) | (21,774 | ) | 6,421 | |||||||||||||
| Interest and other income, net | 31 | 6 | 72 | 22 | ||||||||||||||||
| (Loss) income before income taxes | (6,425 | ) | (5,194 | ) | (21,702 | ) | 6,443 | |||||||||||||
| Income tax benefit (expense) | 38 | 48 | 155 | (96 | ) | |||||||||||||||
| Net (loss) income | $ | (6,387 | ) | $ | (5,146 | ) | $ | (21,547 | ) | $ | 6,347 | |||||||||
| Net (loss) income per share: | ||||||||||||||||||||
| Basic | $ | (0.19 | ) | $ | (0.17 | ) | $ | (0.68 | ) | $ | 0.22 | |||||||||
| Diluted | $ | (0.19 | ) | $ | (0.17 | ) | $ | (0.68 | ) | $ | 0.21 | |||||||||
| Weighted average common shares outstanding: | ||||||||||||||||||||
| Basic | 34,152 | 29,412 | 31,623 | 29,378 | ||||||||||||||||
| Diluted | 34,152 | 29,412 | 31,623 | 30,584 | ||||||||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| (Unaudited) | |||||||||||
| (In thousands) | |||||||||||
| 2016 | 2015 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash, cash equivalents and marketable securities | $ | 28,992 | $ | 28,535 | |||||||
| Other current assets | 971 | 1,303 | |||||||||
| Total current assets | 29,963 | 29,838 | |||||||||
| Intangible assets, net | 1,102 | 1,925 | |||||||||
| Other assets | 554 | 604 | |||||||||
| Total assets | $ | 31,619 | $ | 32,367 | |||||||
| Liabilities and stockholders' equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued expenses | $ | 4,946 | $ | 3,315 | |||||||
| Deferred revenue | 147 | 33 | |||||||||
| Total current liabilities | 5,093 | 3,348 | |||||||||
| Deferred revenue, less current portion | 5,585 | 5,596 | |||||||||
| Deferred rent | 60 | 55 | |||||||||
| Total liabilities | 10,738 | 8,999 | |||||||||
| Stockholders' equity: | |||||||||||
| Capital | 312,242 | 293,089 | |||||||||
| Accumulated deficit | (292,213 | ) | (270,666 | ) | |||||||
| Accumulated other comprehensive income | 852 | 945 | |||||||||
| Total stockholders' equity | 20,881 | 23,368 | |||||||||
| Total liabilities and stockholders' equity | $ | 31,619 | $ | 32,367 | |||||||
Beverly Jedynak +1 312 943 1123 M: +1 773 350 5793 blj@bevlynconsulting.com
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