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) November 3, 2006
REPLIDYNE, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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000-52082
(Commission File Number)
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84-1568247
(I.R.S. Employer
Identification No.) |
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1450 Infinite Drive,
Louisville, Colorado
(Address of principal
executive offices)
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80026
(Zip Code) |
720-996-5500
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
INFORMATION TO BE INCLUDED IN THE REPORT
Section 7 — Regulation FD
Item 7.01 Regulation FD Disclosure.
Our chief financial officer and chief commercial officer intend to conduct meetings with
investors, stockholders and analysts on or after November 7, 2006. We expect to use the
presentation materials furnished as Exhibit 99.1 hereto, in whole or in part and possibly with
immaterial modifications, in connection with such meetings and from time to time thereafter. The
fact that these presentation materials are being furnished should not be deemed an admission as to
the materiality of any information contained in the materials. We do not intend to file any update
to these presentation materials. The information contained in the presentation materials is
summary information that is intended to be considered in the context of our filings with the
Securities and Exchange Commission and other public announcements that we may make, by press
release or otherwise, from time to time.
We expect to make copies of the presentation materials, including such graphic images,
available for viewing at the “Investor Relations” section of our website located at
www.replidyne.com, although we reserve the right to discontinue that availability at any
time.
Some of the matters discussed in the attached presentation materials contain forward-looking
statements that involve significant risks and uncertainties, including statements relating to the
completion and reporting of results from our clinical trials and the potential advantages of our
product candidates. Actual results could differ materially from those projected and we caution
investors not to place undue reliance on the forward-looking statements contained in, or made in
connection with, the presentation materials.
Among other things, the projected commencement and completion of any of our clinical trials
and the dissemination of the results of the clinical trials may be affected by difficulties or
delays, including difficulties or delays caused by regulatory issues, timing of clinical trial
initiations, patient enrollment, patient treatment, data collection or data analysis, the detailed
design of future trials, and the loss of key scientific or management personnel. In addition, our
results may be affected by our effectiveness at managing our financial resources, our ability to
successfully develop and market our current product candidates, our ability to obtain and maintain
regulatory approval of product candidates and the labeling under any approval that may be obtained,
the size and growth of the potential markets for our product candidates and our ability to serve
those markets, the rate and degree of market acceptance of any future products , the success of
competing drugs that are or become available, our ability to obtain or enforce intellectual
property protection for our product candidates, difficulties or delays in manufacturing our product
candidates and the performance of third party manufacturers, regulatory developments involving
current and future product candidates and the performance of our collaboration partners. Delays in
clinical programs, whether caused by competition, adverse events, patient enrollment rates,
regulatory issues or other factors, could adversely affect our financial position and prospects.
Prior clinical trial program designs and results are not necessarily predictive of future clinical
trial designs or results. Preliminary clinical trial results may not be confirmed upon full
analysis of the detailed results of a trial. If our product candidates do not meet safety or
efficacy endpoints in clinical evaluations, they will not receive regulatory approval and we will
not be able to market them. Even if our product candidates meet safety and efficacy endpoints,
regulatory authorities may not approve them or we may face post-approval problems that require the
withdrawal of our product from the market. Operating expense and cash flow projections involve a
high degree of uncertainty, including variances in future spending rates due to changes in
corporate priorities, the timing of and outcomes of clinical trials, competitive developments and
the impact on expenditures and available capital from licensing and strategic collaboration
opportunities. If we are unable to raise additional capital when required or on acceptable terms,
we may have to significantly delay, scale back or discontinue one or more of our drug development
or discovery research programs. We are at an early stage of development and may not ever have any
products that generate significant revenue.
It is our policy to update or reconfirm our public guidance only by issuing a press release or
filing a publicly accessible document with the SEC. We generally plan to provide guidance as part
of our annual and quarterly earnings releases but reserve the right to provide guidance at
different intervals or to revise our practice in future periods. Clinical guidance contained in the
presentation materials is as of November 3, 2006 and financial guidance relating to our current
cash, cash equivalents and investments contained in the presentation materials is as of
September 30, 2006. We undertake no duty or obligation to update any forward-looking
statements as a result of new information, future events or changes in our expectations.
Section 9 — Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
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99.1
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Replidyne, Inc. Investor and Analyst Presentation Materials |
In accordance with General Instruction B.2. of Form 8-K, the information presented in this
filing and furnished in the exhibit attached hereto shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933, as amended, except as expressly set
forth by specific reference in such a filing.