UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): July 13, 2016
pSivida Corp.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-51122 | 26-2774444 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
480 Pleasant Street, Watertown, MA
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (617) 926-5000
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.05 | Costs Associated with Exit or Disposal Activities. |
On July 13, 2016, the Board of Directors of pSivida Corp. (the “Company”) approved a site consolidation plan (the “Plan”) in support of the Company’s product development program under which the Company would conduct all future research and product development in a single location. Subject to an employee consultation process required by local law, the Company proposes to close its research facility in Malvern, United Kingdom and to locate all of its research and product development activities in the Company’s facility in Watertown, Massachusetts.
The Company expects the Plan will reduce pre-tax operating expenses by approximately $900,000 annually, beginning in the second quarter of its 2017 fiscal year, which ends December 31, 2016. The Plan is expected to be substantially completed in the first quarter of the Company’s 2017 fiscal year, which ends September 30, 2016, subject to local labor requirements.
The Company estimates that the implementation of the Plan will result in approximately $680,000 in total pre-tax charges, of which approximately $550,000 is expected to result in future cash outlays. Charges related to the Plan are expected to primarily consist of (i) employee severance and other termination benefits of approximately $490,000, (ii) equipment impairment charges of approximately $40,000, and (iii) accounting, legal and other costs directly related to the Plan of approximately $150,000. The Company expects the charges will be recorded primarily in the first quarter of its 2017 fiscal year, which ends September 30, 2016.
The actual charges as well as the actual reduction in annual operating expenses in connection with the Plan may vary depending upon various factors, including currency exchange rates and the outcome of the employee consultation process.
| Item 7.01 | Regulation FD Disclosure. |
On July 15, 2016, the Company issued a press release announcing the Plan (the “Press Release”). The full text of the Press Release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
The information contained in this Item 7.01, including Exhibit 99.1, is to be considered “furnished” pursuant to Item 7.01 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Section 11 or 12(a)(2) of the Securities Act of 1933, as amended, nor shall it be deemed incorporated by reference in any filing or report with the Securities and Exchange Commission (“SEC”), whether made before or after the date hereof, regardless of any general incorporation language in such filing or report, except as shall be expressly set forth by specific reference in such filing or report.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated July 15, 2016. | |
Forward Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements regarding the Plan, the expected completion date of the Plan, the potential benefits of the Plan and the costs or charges that the Company will incur in connection with the Plan. Forward-looking statements also include those regarding the Company’s future business plans and actions and the timing for any such plans and actions.
These forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Known risk factors include, among others, risks that the Plan may not be implemented or may take longer than anticipated to implement or negatively impact the Company and its business plans, that the Company may not be able to obtain the benefits it is expecting from the Plan and those risks identified under the heading “Risk Factors” in the Company’s 2015 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q filed with the SEC as well as other SEC filings made by the Company, which
you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company’s business and results of operations and the trading price of the Company’s common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this Current Report on Form 8-K. Except as required by law, the Company does not undertake any obligation to update or revise forward-looking statements based on events or circumstances after the date hereof.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| PSIVIDA CORP. | ||
| By: | /s/ Lori Freedman | |
| Lori Freedman | ||
| Vice President, Corporate Affairs, General Counsel and Secretary | ||
Date: July 18, 2016
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release dated July 15, 2016. | |
Exhibit 99.1
pSivida Corp. Announces Plan to Consolidate all Research and Development in Current U.S. Facility
Plan to Facilitate Product Development and Reduce Operating Expenses
Watertown, MA (July 15, 2016) – pSivida Corp (NASDAQ:PSDV, ASX:PVA), a leader in the development of sustained release drug delivery products primarily for eye diseases, announced today that it is implementing a site consolidation plan in support of its product development program and plans to conduct all future research and product development in a single location. Subject to an employee consultation process required by local U.K. law, pSivida proposes to close its research facility in Malvern, U.K. and locate all research and product development activities in the Company’s state-of-the-art, cGMP facility in Watertown, MA.
Dr. Paul Ashton, president and CEO of pSivida, said, “We look forward to the seamless consolidation of the Durasert™ and Tethadur™ research and development work being done in our U.K. and our U.S. facilities in a single location. We believe this restructuring will focus our R&D efforts and facilitate product development while reducing operating expenses.”
pSivida expects the site consolidation plan will reduce pre-tax operating expenses by approximately $900,000 annually, beginning in the second quarter of fiscal year 2017, ending December 31, 2016. pSivida estimates that it will record approximately $680,000 of charges associated with the plan, of which approximately $550,000 is estimated to be cash expenditures. Actual charges may vary due to various factors, including currency exchange ratios and the outcome of the consultation process. The charges are expected to be recorded primarily in the first quarter of fiscal 2017, ending September 30, 2016, with the site consolidation expected to be substantially completed during that quarter, subject to local U.K. labor requirements.
About pSivida Corp. pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release, drug delivery 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 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, Medidur™, a micro-insert for posterior uveitis being independently developed, is currently in pivotal Phase 3 clinical trials, with an NDA anticipated in 2017. pSivida’s pre-clinical development program is focused on using its core platform technologies Durasert™ and Tethadur™ to deliver drugs and biologics to treat wet and dry 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+.
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: actual amounts incurred to implement the site consolidation and actual savings achieved as a result; the safety and efficacy of the TKI insert for wet AMD, the initiation and completion of clinical trials and potential marketing approval of the insert; designation of Medidur as an orphan medicinal product; our ability to achieve profitable operations and access to capital; fluctuations in our operating results; further impairment of our intangible assets; 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 the second Medidur Phase 3 trial, number of trials and data required for, and timing of filing and acceptance of, the Medidur NDA and EU marketing approval applications, if at all; ability to use 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.
Contact in US:
Beverly Jedynak
T: 312-943-1123
M: 773-350-5793
blj@bevlynconsulting.com