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pSivida Corp. Reports Fiscal 2017 Third Quarter Results; Key Milestones on Track EU and US Calendar 2017 Registration Filing Milestones for Durasert for Posterior Segment Uveitis Remain on Schedule Conference Call and We

Key Takeaway: pSivida Corp. Reports Fiscal 2017 Third Quarter Results; Key Milestones Calendar 2017 Registration Filing Milestones for Durasert for Posterior Segment Uveitis Remain on Schedule Conference Call and Webcast Today, May 4th, at 4:30 p.m. ET WATERTOWN, Mass., May 4, 2017 pSivida

Full Press Release Details

pSivida Corp. Reports Fiscal 2017 Third Quarter Results; Key Milestones
Calendar 2017 Registration Filing Milestones for Durasert for Posterior
Segment Uveitis Remain on Schedule
Conference Call and Webcast Today, May 4th, at 4:30 p.m. ET
WATERTOWN, Mass., May 4, 2017 pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release drug products and
technologies, today reported financial results for its fiscal 2017 third quarter and nine months ended March 31, 2017. The Company s progress during the third quarter has set the stage for the achievement of several near-term goals during
the remainder of calendar 2017 including:
Durasert Three-Year for Posterior Segment Uveitis:
Other Durasert Related Developments:
We continue to make substantial regulatory, clinical and collaborative progress with our Durasert
technology, commented Nancy Lurker, President and Chief Executive Officer. Our near-term goals remain: 1) unmask our second pivotal Phase 3 clinical trial for Durasert three-year uveitis and file regulatory approval applications in both
the EU and US in calendar 2017, 2) establish additional collaboration partnerships for our proven Durasert technology, and 3) finalize an EU out-license partner for our three-year uveitis product candidate.
Our efforts to date are yielding promising results and the successful achievement of these upcoming milestones will demonstrate the potential of our moderate risk/nearer term product development programs.
Fiscal Third Quarter and Nine Months 2017 Results
Revenue for the third fiscal quarter ended March 31, 2017 totaled $590,000 compared to $324,000 for the prior year quarter. Operating expenses for the
three months ended March 31, 2017 totaled $5.8 million compared to $5.4 million a year earlier. Net loss for the quarter ended March 31, 2017 was $5.1 million, or $0.15 per share compared to a net loss of $5.0 million,
or $0.15 per share, for the prior year quarter.
Revenue for the nine months ended March 31, 2017 was $6.8 million compared to $1.3 million
for the nine months ended March 31, 2016. The year-over-year increase was primarily attributable to the $5.6 million of revenue recognized upon termination of the Pfizer collaboration agreement. Operating expenses for the first nine months
of fiscal 2017 were $19.3 million compared to $16.6 million a year earlier. The increase was attributable primarily to (i) severance costs and professional fees related to the CEO transition and other previously disclosed executive
team changes and (ii) clinical and regulatory consulting services related to preparation of MAA and NDA registration filings for Durasert three-year uveitis, partially offset by lower CRO costs for the Phase 3 clinical development of Durasert
three-year uveitis. Net loss for the nine months ended March 31, 2017 was $12.4 million, or $0.36 per share, compared to a net loss of $15.2 million, or $0.49 per share, for the corresponding fiscal 2016
year-to-date period.
During the fiscal 2017 third quarter, the Company
issued 1,411,686 shares of common stock for gross proceeds of approximately $2.5 million through utilization of its existing at-the-market equity offering program
(the ATM Program ). At March 31, 2017, the Company s cash, cash equivalents and marketable securities totaled $15.4 million. Subsequent to the end of the fiscal third quarter, the Company has continued to strengthen its
balance sheet by further utilizing the ATM Program, issuing approximately 3.6 million additional shares of common stock for gross proceeds of approximately $6.3 million.
Because the Company s shares are listed on the Australian Stock Exchange (the ASX ), the Company s ability to sell shares under the ATM
Program is subject to an ASX rule limiting the number of shares the Company may issue to 15% in any 12-month period without shareholder approval, as well as other applicable rules and regulations of ASX. The
effective and efficient use of the ATM Program has resulted in the Company having nearly reached its current ASX limit. Therefore, in order to have a variety of strategies available to meet the future capital resource needs required to achieve the
Company s growth objectives, a preliminary proxy statement has been filed for a special meeting of stockholders to seek approval to refresh the Company s capacity to issue an additional 15% shares of common stock.
pSivida Corp. will host a live webcast and conference call today, May 4, at 4:30pm ET. The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference ID is 7711761. A live webcast will be available on the
Investor Relations section of the corporate website. at http://www.psivida.com. A replay of the call will be available beginning May 4, 2017, at approximately 7:30 p.m. ET and ending on May 11, 2017, at 11:59 p.m. ET.
The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID Number
7711761. A replay of the webcast will also be available on the corporate website during that time.
pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release drug products for treating eye
diseases. pSivida has developed three of only four FDA-approved sustained-release treatments for
back-of-the-eye diseases. The most recent, ILUVIEN , a micro-insert for
diabetic macular edema, licensed to Alimera Sciences, is currently sold directly in the U.S. and three EU countries. Retisert , an implant for posterior uveitis, is licensed to and sold by
Bausch & Lomb. pSivida s lead product candidate, Durasert micro-insert for posterior segment uveitis being independently developed by pSivida, is currently in pivotal Phase 3 clinical trials. pSivida s pre-clinical development program is focused on using its core platform technology, Durasert , to deliver drugs to treat wet age-related macular degeneration, glaucoma,
osteoarthritis and other diseases. To learn more about pSivida please visit www.psivida.com and connect on Twitter, LinkedIn, Facebook and Google+.
Important Additional Information
In connection with the
special meeting of stockholders referenced above, the Company will be filing a definitive proxy statement concerning the special meeting with the U.S. Securities and Exchange Commission. BEFORE MAKING ANY DECISION ON HOW TO VOTE AT THE SPECIAL
MEETING, THE COMPANY S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The Company s stockholders
can obtain free copies of the definitive proxy statement and other documents when they become available by contacting the Company Secretary, c/o pSivida Corp., 480 Pleasant Street, Watertown, MA 02472 United States. In addition, documents filed with
the SEC will be available at no charge on the SEC s website at www.sec.gov. The Company and its executive officers and directors may, under SEC rules, be deemed to be participants in the solicitation of proxies from stockholders of the Company
in connection with the special meeting. Certain information about such individuals, such as their ownership of shares of Company common stock and their interests in the solicitation with respect to the special meeting, will be more specifically set
forth in the definitive proxy statement concerning the special meeting that will be filed with the SEC, which will be available free of charge from the SEC and the Company as noted above.
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 needed capital; fluctuations in our operating results; further impairment of our intangible assets; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema ( ILUVIEN ), which depends on Alimera s ability to continue as a going concern and the effect of pricing and reimbursement decisions on sales of ILUVIEN;
safety and efficacy results of the second Durasert three-year uveitis Phase 3 clinical trial and the number of clinical trials and data required for the Durasert three-year uveitis marketing approval applications in the U.S. and EU; our
ability to file and the timing of filing and acceptance of the Durasert three-year uveitis marketing approval applications in the U.S. and EU; our ability to use data in a U.S. NDA from clinical trials outside the U.S.; maintenance of European
orphan designation for Durasert three-year uveitis; our ability to successfully commercialize Durasert three-year uveitis, if approved; potential off-label sales of ILUVIEN for uveitis; consequences of
fluocinolone acetonide side effects; potential declines in Retisert royalties; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products
using it; efficacy and our future development of an implant to treat severe osteoarthritis; 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; our dependence on contract research organizations, vendors and investigators; 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 the potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our
filings with the Securities and Exchange Commission. 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.
Michael Polyviou/Doug Sherk Investors
212.850.6020; 646-445-4800
PSIVIDA CORP. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except per share amounts)
Three Months Ended March 31, Nine Months Ended March 31,
2017 2016 2017 2016
Revenues:
Collaborative research and development $ 372 $ 50 $ 6,108 $ 372
Royalty income 218 274 730 944
Total revenues 590 324 6,838 1,316
Operating expenses:
Research and development 3,324 3,074 10,667 10,277
General and administrative 2,426 2,346 8,611 6,357
Total operating expenses 5,750 5,420 19,278 16,634
Loss from operations (5,160 ) (5,096 ) (12,440 ) (15,318 )
Interest and other income 20 21 71 41
Loss before income taxes (5,140 ) (5,075 ) (12,369 ) (15,277 )
Income tax benefit 34 117
Net loss $ (5,140 ) $ (5,041 ) $ (12,369 ) $ (15,160 )
Net loss per common share:
Basic and diluted $ (0.15 ) $ (0.15 ) $ (0.36 ) $ (0.49 )
Weighted average common shares outstanding:
Basic and diluted 34,366 33,538 34,238 30,787
PSIVIDA CORP. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2017 June 30, 2016
Assets
Current assets:
Cash, cash equivalents and marketable securities $ 15,370 $ 28,992
Other current assets 1,100 971
Total current assets 16,470 29,963
Intangible assets, net 540 1,102
Other assets 495 554
Total assets $ 17,505 $ 31,619
Liabilities and stockholders equity
Current liabilities:
Accounts payable and accrued expenses $ 4,684 $ 4,946
Deferred revenue 256 147
Total current liabilities 4,940 5,093
Deferred revenue 5,585
Deferred rent 55 60
Total liabilities 4,995 10,738
Stockholders equity:
Capital 316,268 312,242
Accumulated deficit (304,582 ) (292,213 )
Accumulated other comprehensive income 824 852
Total stockholders equity 12,510 20,881
Total liabilities and stockholders equity $ 17,505 $ 31,619
Last updated: May 4, 2017