pSivida Corp. Provides Company Update and Reports Fourth Quarter and FY 2015 Results
Fiscal 2015 was a year marked by excellent progress toward pSivida's goal of becoming the leader in sustained release drug delivery products in ophthalmology and beyond.
Phase III clinical trials for Medidur™ for posterior uveitis, pSivida's
lead development product, continued on pace for an expected NDA filing
in the first half of 2017. Enrollment of the first trial was completed
in
"We remain optimistic that Medidur will be safe and effective in
treating posterior uveitis. Recent top-line results from an
investigator-sponsored study and safety data from our first Phase III
trial have been very encouraging in this regard," said
Top-line results from the investigator-sponsored study of low and high doses of Medidur (pSivida is studying only the low dose) showed a statistically significant reduction in recurrence of uveitis (p=0.014) and a statistically significant improvement in visual acuity (p=0.014) in eyes treated with Medidur compared to those that were not treated with Medidur.
For all 129 enrolled patients in pSivida's first Phase III trial at three months of follow-up, only 5% more study eyes (2/3's of which received Medidur) experienced elevated intraocular pressure (IOP) (over 21 mm Hg) than the fellow non-study eyes (none of which received Medidur). This was consistent with the IOP safety data earlier reported by pSivida for the first 105 patients at three months follow-up.
pSivida expects that an investigational new drug application (IND) will
shortly be filed in the U.S. to commence an investigator-sponsored study
of an implant utilizing pSivida's patented Durasert™ technology to treat
pain associated with severe osteoarthritis of the knee. pSivida and
pSivida also continued work on its pre-clinical programs focused on creating products for chronic ophthalmic diseases and delivering biologics using its core Durasert and Tethadur™technologies. "We have seen excellent progress recently with both of these technologies. We are particularly pleased at the advances we have made in our development of Tethadur to deliver antibodies. With our latest iteration of the technology, we have achieved higher molecule loading capacity and enhanced antibody stability. These are key elements for sustained delivery of biologics to a small space such as the eye," said Dr. Ashton. "We commenced a new pre-clinical program to use Durasert to deliver drug to treat age-related macular degeneration and continued to progress our research with respect to other ophthalmic applications."
ILUVIEN® for diabetic macular edema (DME), pSivida's lead licensed
product, which is the same micro-insert as Medidur, completed its first
quarter of commercialization in the U.S. with solid sales. ILUVIEN is
also sold in the
"Our
Results for the Fourth Quarter and FY 2015. Revenues for the
quarter ended
Operating expenses for the three months ended
Net loss for the quarter ended
Revenues for the year ended
Operating expenses for the year ended
Income tax expense totaled
Net income for the year ended
At
Today's Conference Call Reminder
About Posterior Uveitis. Posterior 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 the 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 U.S., posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.
Patients with posterior 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 the Phase III Trials. pSivida is conducting two Phase III
trials to assess the safety and efficacy of Medidur for the treatment of
posterior uveitis. These are randomized, sham-controlled, double-masked
trials. The primary end point of both trials is recurrence of posterior
uveitis, with patients in both trials followed for three years. The
first Phase III Medidur trial is fully enrolled with 129 patients in 16
centers in the U.S. and 17 centers outside the U.S. The last 12-month
follow-up visit for patients in this trial is scheduled for
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 achieve profitable operations and access to capital; further impairment of our intangible assets; fluctuations in our operating results; declines in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; safety and efficacy results of Medidur Phase III trials, timing of filing and acceptance of the Medidur NDA, if at all; fluctuations in our operating results; ability to use of data in a U.S. NDA from trials outside the U.S.; 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; 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; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements, even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
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| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
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| (In thousands, except per share amounts) | |||||||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||||||
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| 2015 | 2014 | 2015 | 2014 | ||||||||||||||||
| Revenues: | |||||||||||||||||||
| Collaborative research and development | $ | 56 | $ | 6 | $ | 25,411 | $ | 2,155 | |||||||||||
| Royalty income | 353 | 286 | 1,154 | 1,318 | |||||||||||||||
| Total revenues | 409 | 292 | 26,565 | 3,473 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Research and development | 3,198 | 2,306 | 12,088 | 9,573 | |||||||||||||||
| General and administrative | 2,411 | 2,000 | 8,056 | 7,468 | |||||||||||||||
| Gain on sale of property and equipment | - | (2 | ) | - | (78 | ) | |||||||||||||
| Total operating expenses | 5,609 | 4,304 | 20,144 | 16,963 | |||||||||||||||
| (Loss) income from operations | (5,200 | ) | (4,012 | ) | 6,421 | (13,490 | ) | ||||||||||||
| Other income, net: | |||||||||||||||||||
| Interest income | 7 | 3 | 19 | 6 | |||||||||||||||
| Other (expense) income, net | (1 | ) | (1 | ) | 3 | (1 | ) | ||||||||||||
| Total other income | 6 | 2 | 22 | 5 | |||||||||||||||
| (Loss) income before income taxes | (5,194 | ) | (4,010 | ) | 6,443 | (13,485 | ) | ||||||||||||
| Income tax benefit (expense) | 48 | 43 | (96 | ) | 130 | ||||||||||||||
| Net (loss) income | $ | (5,146 | ) | $ | (3,967 | ) | $ | 6,347 | $ | (13,355 | ) | ||||||||
| Net (loss) income per share: | |||||||||||||||||||
| Basic | $ | (0.17 | ) | $ | (0.14 | ) | $ | 0.22 | $ | (0.49 | ) | ||||||||
| Diluted | $ | (0.17 | ) | $ | (0.14 | ) | $ | 0.21 | $ | (0.49 | ) | ||||||||
| Weighted average common shares outstanding: | |||||||||||||||||||
| Basic | 29,412 | 29,256 | 29,378 | 27,444 | |||||||||||||||
| Diluted | 29,412 | 29,256 | 30,584 | 27,444 | |||||||||||||||
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| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| (Unaudited) | |||||||||||
| (In thousands) | |||||||||||
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| 2015 | 2014 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash, cash equivalents and marketable securities | $ | 28,535 | $ | 18,278 | |||||||
| Other current assets | 1,303 | 1,064 | |||||||||
| Total current assets | 29,838 | 19,342 | |||||||||
| Intangible assets, net | 1,925 | 2,765 | |||||||||
| Other assets | 604 | 564 | |||||||||
| Total assets | $ | 32,367 | $ | 22,671 | |||||||
| Liabilities and stockholders' equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued expenses | $ | 3,315 | $ | 1,988 | |||||||
| Deferred revenue | 33 | 138 | |||||||||
| Total current liabilities | 3,348 | 2,126 | |||||||||
| Deferred revenue, less current portion | 5,596 | 5,584 | |||||||||
| Deferred rent | 55 | 37 | |||||||||
| Total liabilities | 8,999 | 7,747 | |||||||||
| Stockholders' equity: | |||||||||||
| Capital | 293,089 | 290,893 | |||||||||
| Accumulated deficit | (270,666 | ) | (277,013 | ) | |||||||
| Accumulated other comprehensive income | 945 | 1,044 | |||||||||
| Total stockholders' equity | 23,368 | 14,924 | |||||||||
| Total liabilities and stockholders' equity | $ | 32,367 | $ | 22,671 | |||||||
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