UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): May 16, 2013
ROCKWELL MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Michigan |
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000-23661 |
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38-3317208 |
(State or other jurisdiction |
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(Commission |
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(IRS Employer |
of incorporation) |
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File Number) |
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Identification No.) |
30142 Wixom Road, Wixom, Michigan |
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48393 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code (248) 960-9009
Not applicable
(Former name or former address, 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 (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On May 16, 2013, Rockwell Medical, Inc. (the Company), issued a press release announcing that the underwriters of its previously announced public offering of common stock exercised their over-allotment option to purchase an additional 1,721,311 shares of common stock at the public offering price of $3.05 per share. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
Exhibit 5.1 Opinion of Dykema Gossett PLLC
Exhibit 23.1 Consent of Dykema Gossett PLLC (included as part of Exhibit 5.1)
Exhibit 99.1 Press Release, dated May 16, 2013
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.
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ROCKWELL MEDICAL, INC. | |
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Date: May 16, 2013 |
By: |
/s/ Thomas E. Klema |
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Thomas E. Klema |
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Its: |
Chief Financial Officer |
Exhibit 5.1
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Dykema Gossett PLLC 400 Renaissance Center Detroit, Michigan 48243 WWW.DYKEMA.COM Tel: (313) 568-6800 Fax: (313) 568-6832 |
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May 16, 2013 |
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Rockwell Medical, Inc.
30142 Wixom Road
Wixom, Michigan 48393
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Re: Registration Statement on Form S-3 |
Ladies and Gentlemen:
We have acted as counsel to Rockwell Medical, Inc., a Michigan corporation (the Company), in connection with the offer and sale (the Offering) by the Company of 1,721,311 shares (the Shares) of the Companys common stock, without par value (the Common Stock), to the Underwriters (as defined below) pursuant to (a) a Registration Statement on Form S-3 (File No. 333-181003) (the Registration Statement) filed by the Company with the Securities and Exchange Commission (the Commission) under the Securities Act of 1933, as amended (the Act), which was declared effective by the Commission on June 13, 2012; (b) the prospectus of the Company dated June 13, 2012 (the Base Prospectus) as filed with the Commission; and (c) the prospectus supplement of the Company, dated May 15, 2013 as filed with the Commission (the Prospectus Supplement).
In rendering the opinions set forth below, we have assumed that (i) all information contained in all documents reviewed by us is true and correct; (ii) all signatures on all documents examined by us are genuine; (iii) all documents submitted to us as originals are authentic and all documents submitted to us as copies conform to the originals of those documents; and (iv) each natural person signing any document reviewed by us had the legal capacity to do so.
We have examined and relied upon the Registration Statement, including the exhibits thereto, the Base Prospectus, the Prospectus Supplement, the Underwriting Agreement dated May 15, 2013 between the Company and the several underwriters named in Schedule A thereto for whom Chardan Capital Markets, LLC is acting as representative (the Underwriters), the Restated Articles of Incorporation and Bylaws of the Company, each as amended to date, and such other documents, corporate records and instruments, and have examined such laws and regulations, as we have deemed necessary for purposes of rendering the opinions set forth herein. We have also relied as to certain matters on information obtained from public officials and officers of the Company.
Based upon such examination and subject to the further provisions hereof, we are of the opinion that the Shares, when issued in the manner and for the consideration contemplated by the Underwriting Agreement and the Prospectus Supplement, will be validly issued, fully paid and non-assessable.
CALIFORNIA | ILLINOIS | MICHIGAN | MINNESOTA | NORTH CAROLINA | TEXAS | WASHINGTON, D.C.
We are opining only as to the matters expressly set forth herein, and no opinion should be inferred as to any other matters. This opinion is based upon currently existing statutes, rules, regulations and judicial decisions, and we disclaim any obligation to update this opinion or otherwise advise you of any change in any of these sources of law or subsequent legal or factual developments which might affect any matters or opinions set forth herein.
The foregoing opinions are limited to the laws of the state of Michigan and the federal laws of the United States. We express no opinion and make no representation with respect to the law of any other jurisdiction.
We hereby consent to the filing of this opinion, in accordance with the requirements of Item 601(b)(5) of Regulation S-K under the Act with the Commission, as an exhibit to the Current Report on Form 8-K to be filed by the Company in connection with the Offering and to the use of our name as the Companys counsel under Legal Matters in the Registration Statement (including the Base Prospectus and the Prospectus Supplement which are a part thereof), and in any amendment or supplement thereto. In giving such consent, we do not admit that we are within the categories of persons whose consent is required under Section 7 of the Act or the rules and regulations of the Commission promulgated thereunder.
Very truly yours,
/S/ DYKEMA GOSSETT PLLC
Exhibit 99.1
Rockwell Medical Announces the Exercise of Over-Allotment Option
WIXOM, MI (GLOBE NEWSWIRE) 05/16/13 Rockwell Medical, Inc. (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that the underwriters of its recently announced public offering have exercised their over-allotment option to purchase an additional 1,721,311 shares of its common stock at the offering price of $3.05. The Company expects to realize net proceeds of approximately $5 million after deducting underwriters discounts. The net proceeds of the offering will be used to fund SFP clinical trials and for other general corporate purposes.
Chardan Capital Markets, LLC is acting as the sole book-running manager for the offering. Summer Street Research Partners is acting as lead manager for the offering. C&Co/PrinceRidge LLC is acting as co-manager for the offering.
A shelf registration statement (File No. 333-181003) relating to these securities was previously filed with, and declared effective by, the Securities and Exchange Commission. A final prospectus supplement related to the offering was filed with the Securities and Exchange Commission on May 15, 2013. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained by contacting Chardan Capital Markets LLC, Attention: Scott Blakeman, Director of Operations, 17 State Street, Suite 1600, New York, NY 10004, or by calling (646) 465-9025. An electronic copy of the final prospectus supplement and accompanying prospectus relating to the offering are available on the website of the Securities and Exchange Commission at www.sec.gov.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Rockwell, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be solely by means of a prospectus included in the registration statement and a prospectus supplement that will be issued in connection with the offering.
About SFP
SFP is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7mg of iron lost during a dialysis treatment. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane and enters the bloodstream where it immediately binds to apo-transferrin and is taken to the bone marrow, mimicking the way dietary iron is processed in the human body. In completed clinical trials to date, SFP has demonstrated that it can safely deliver iron and maintain hemoglobin levels, while decreasing ESA use without an increase in iron stores.
About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.
Rockwells lead drug candidate in late-stage clinical development is for the treatment of iron deficiency in dialysis patients and is called Soluble Ferric Pyrophosphate (SFP). SFP delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner via dialysate during their regular dialysis treatment. In completed clinical trials to date, SFP has demonstrated that it can safely deliver sufficient iron to the bone marrow. SFP is nearing completion of its Phase 3 clinical studies (CRUISE-1 and CRUISE-2) and is expected to address an estimated $600M U.S. market.
Rockwell is preparing to launch its FDA approved generic drug called Calcitriol to treat secondary hyperparathyroidism in dialysis patients. Calcitriol active vitamin D injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to launch Calcitriol as soon as it receives FDA manufacturing approval, addressing an estimated $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwells products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patients bloodstream. Rockwell has three manufacturing and distribution facilities located in the U.S. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP upon FDA market approval.
Rockwells exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.
Forward-Looking Statements
Certain statements in this press release constitute forward-looking statements within the meaning of the federal securities laws, including, but not limited to, Rockwells intention to launch Calcitriol and SFP following FDA approval. Words such as may, might, will, should, believe, expect, anticipate, estimate, continue, predict, forecast, project, plan, intend or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medicals SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Michael Rice, Investor Relations; (646) 597-6979
David Connolly, Media Contact; (617) 374-8800