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Prospectus Supplement
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Filed pursuant to Rule 424(b)(5) |
(to Prospectus dated September 1, 2006)
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Registration No. 333-137072 |
5,404.652 Shares of Convertible Preferred Stock
Warrants to Purchase 5,404,652 Shares of Common Stock
We
are offering up to 5,404.652 shares of convertible preferred stock together with warrants
to purchase 5,404,652 shares of common stock. The convertible preferred stock is convertible at
any time at the option of the holder into shares of our common stock at a conversion price of
$0.265 per share. The warrants are exercisable at a price of $0.53 per share at any time after the
six-month anniversary of the date of issuance and before the fourth anniversary of the initial
exercise date.
Our common stock is quoted on the Nasdaq Global Market under the symbol NFLD. On March 12,
2009, the last reported sales price of our common stock on the Nasdaq Global Market was $0.54 per
share.
Investing in our securities involves a high degree of risk. Before buying any securities, you
should carefully read the discussion of material risks of investing in our securities in
Risk Factors beginning on page S-5.
We have retained Rodman & Renshaw, LLC to act as our exclusive placement agent in connection
with this offering. We have agreed to pay the placement agent the placement agent fees set forth in
the table below. The placement agent is not required to arrange for the sale of any specific number
or dollar amount of securities but will use best efforts to arrange for the sale of all of the
securities offered hereby.
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Placement |
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Proceeds to Northfield Before |
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Price to |
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Agency |
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Expenses and After |
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Investors |
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Fees(1) |
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Placement Agency Fees |
Per Share of Convertible
Preferred Stock |
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$ |
265 |
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$ |
15.90 |
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$ |
249.10 |
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Total |
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$ |
1,432,232 |
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$ |
85,934 |
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$ |
1,346,298 |
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(1) |
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In addition to payment of a cash placement fee, we have agreed to issue to the placement agent
a warrant to purchase a number of shares of common stock equal 6% of the total number of shares of
common stock issuable upon the conversion or exercise of the shares of convertible preferred stock
and warrants included in this offering. The placement agents warrant is exercisable at a price of
$0.6625 per share, has a term of 4.5 years and may not be exercised or transferred until six months
after the date of the completion of this offering. We have also agreed to reimburse the placement
agent for its reasonable out-of-pocket expenses, including the reasonable fees and expenses of the
placement agents legal counsel, incurred in connection with this offering, such expenses not to
exceed an aggregate of 0.8% of the gross proceeds to us from this offering, but in any event not
more than $30,000. |
We expect the total offering expenses, excluding placement agency fees and expenses, to be
approximately $50,000 for all sales pursuant to this prospectus supplement. The above summary of
offering proceeds to us does not give effect to any exercise of the warrants being issued in this
offering.
Delivery
of the shares and warrants will be made on or about March 16, 2009.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus supplement or the
accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal
offense.
Rodman & Renshaw, LLC
Prospectus Supplement dated March 13, 2009
TABLE OF CONTENTS
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Prospectus Supplement |
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Prospectus |
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S-1
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About This Prospectus
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1 |
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S-2 |
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Where You Can Find More Information |
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S-3 |
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Forward-Looking Information |
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S-4 |
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Our Business |
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S-5 |
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Use of Proceeds |
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3 |
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S-19 |
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Ratio of Earnings to Fixed Charges
and Preference Dividends |
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3 |
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S-19 |
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Description of the Securities We May Offer |
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3 |
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S-19 |
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Plan of Distribution |
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6 |
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S-21 |
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Legal Matters |
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6 |
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S-21 |
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Experts |
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S-22 |
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Independent
Registered Public Accounting Firm |
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ABOUT THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is the prospectus supplement, which describes
the specific terms of the shares and warrants we are offering and also adds to, and updates
information contained in, the accompanying prospectus and the documents incorporated by reference
into the accompanying prospectus. The second part, the accompanying prospectus, provides more
general information. Generally, when we refer to this prospectus, we are referring to both parts
of this document combined. To the extent there is a conflict between the information contained in
this prospectus supplement, on the one hand, and the information contained in the accompanying
prospectus or any document incorporated by reference therein, on the other hand, you should rely on
the information in this prospectus supplement. If, however, any statement in one of these
documents is inconsistent with a statement in another document having a later date such as a
document incorporated by reference in the accompanying prospectus the statement in the document
having the later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants made by us in any agreement
that is filed as an exhibit to any document that is incorporated by reference in the accompanying
prospectus were made solely for the benefit of the parties to such agreement, including, in some
cases, for the purpose of allocating risk among the parties to such agreements, and should not be
deemed to be a representation, warranty or covenant to investors in this offering. Such
representations, warranties or covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied on as accurately representing
the current state of our affairs.
You should rely only on the information contained and incorporated by reference in this
prospectus supplement and the accompanying prospectus. We have not, and the placement agent has
not, authorized anyone to provide information different from that contained or incorporated by
reference in this prospectus supplement or the accompanying prospectus. You should not assume that
the information in this prospectus supplement and accompanying prospectus is accurate as of any
date after their respective dates. These documents do not constitute an offer to sell or a
solicitation of an offer to buy these securities in any circumstances under which the offer or
solicitation is unlawful.
Unless the context requires otherwise, the words Northfield, we, the Company, us and
our in this prospectus supplement and accompanying prospectus refer to Northfield Laboratories
Inc. PolyHeme® is a registered trademark of Northfield Laboratories Inc.
S-1
FORWARD-LOOKING INFORMATION
This prospectus supplement, the accompanying prospectus and the documents we incorporate by
reference contain forward-looking statements concerning, among other things, our prospects,
clinical and regulatory developments affecting our potential product and our business strategies.
These forward-looking statements are identified by the use of such terms as intends, expects,
plans, estimates, anticipates, forecasts, should, believes and similar words.
These forward-looking statements involve risks and uncertainties. Actual results may differ
materially from those predicted by the forward-looking statements because of various factors and
possible events, including those discussed under Risk Factors. Because these forward-looking
statements involve risks and uncertainties, actual results may differ significantly from those
predicted in these forward-looking statements. You should not place undue weight on these
statements. These statements speak only as of the date of this prospectus or, in the case of any
document incorporated by reference, the date of that document.
All subsequent written and oral forward-looking statements attributable to Northfield or any
person acting on our behalf are qualified by the cautionary statements in this section. We do not
undertake any obligation to update or publicly release any revisions to forward-looking statements
to reflect events, circumstances or changes in expectations after the time such statement is made.
S-2
OUR BUSINESS
Northfield Laboratories Inc. is developing PolyHeme®, an investigative human hemoglobin-based
red cell substitute for the treatment of life-threatening red blood cell loss when an
oxygen-carrying fluid is required and red blood cells are not available.
On October 29, 2008, Northfield announced that we had submitted a Biologics License
Application, or BLA, for PolyHeme to the U.S. Food and Drug Administration, or FDA, with a request
that the agency grant Priority Review of our application. Our BLA was based on Northfields
comprehensive development program, including data from our Multicenter Phase III randomized,
controlled, prospective trauma trial involving 720 patients. Findings from this study were
presented at the American College of Surgeons in 2007 and were published in the January 2009
edition of the Journal of the American College of Surgeons.
On December 30, 2008, we announced that FDA had accepted for filing our BLA for PolyHeme. FDA
granted Priority Review of the submission with a Prescription Drug User Fee Act, or PDUFA, review
goal date of April 30, 2009.
Since the submission of our BLA in October 2008, there has been considerable activity. We have
received multiple requests from FDA for data clarification and supplementation. To address these
requests, we have provided several amendments to our original BLA. The process of FDA site
inspection and audit has begun at a number of the 32 institutions that participated in our Phase
III trial. FDA has also conducted a Pre-License Inspection of our manufacturing facility.
In addition, Northfield has begun preparations for an anticipated discussion regarding
PolyHeme at a meeting of FDAs Blood Products Advisory Committee, or BPAC, an independent advisory
committee that is customarily convened by FDA to review and discuss BLAs relating to new blood
products. Whether and when our BLA for PolyHeme may be discussed by BPAC is uncertain, however,
and at present we do not believe our BLA will be discussed by BPAC prior to FDAs April 30, 2009
review goal date for our BLA.
We have recently implemented a number of measures to reduce our cash burn in order to preserve
our available cash resources for ongoing operations. We have eliminated 13 positions at our
manufacturing facility in Mount Prospect, Illinois, and have reduced hours for our remaining staff.
In addition, we are closing our corporate offices in Evanston, Illinois and relocating staff to
our owned Mount Prospect facility to further reduce operating costs. We have also delivered
notices to our employees and certain governmental authorities with respect to the possible
termination of the employment of the remaining employees at our corporate offices and plant
facilities on or after 60 days following the notice date, or approximately May 5, 2009. Following
the recent completion of FDAs Pre-License Inspection of our manufacturing facility, we believe
these actions can be taken while still maintaining our capability to address manufacturing,
regulatory and licensing issues.
Our principal executive offices are located at 1560 Sherman Avenue, Suite 1000, Evanston,
Illinois 60201-4800, and our telephone number is (847) 864-3500. We maintain an Internet website at
www.northfieldlabs.com. We make available free of charge on our website our Form 10-Ks, Form 10-Qs,
Form 8-Ks and other documents that we file with or furnish to the Securities and Exchange
Commission, or SEC, as soon as reasonably practicable after filing with the SEC. The information
contained on our website, or on other websites linked to our website, is not a part of this
prospectus supplement or the accompanying prospectus.
S-3
THE OFFERING
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Securities Offered
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Up to 5,404.652 shares of
convertible preferred stock,
plus warrants to purchase an
additional 5,404,652 shares of
common stock. |
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Shares of Common Stock to be
Outstanding After this Offering
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27,036,780 shares of common
stock, or 37,846,084 shares of
common stock if the convertible
preferred stock and warrants
offered hereby are converted and
exercised in full. |
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Use of Proceeds
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For general corporate purposes,
including general and
administrative expenses and
expenses in connection with the
regulatory review of our
PolyHeme product. See Use of
Proceeds. |
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Risk Factors
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You should carefully read the
Risk Factors section of this
prospectus supplement before
investing in our securities. |
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Nasdaq Global Market Symbol
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NFLD |
The number of shares of common stock to be outstanding after this offering is based on
27,036,780 shares outstanding as of February 1, 2009. The number of shares of common stock to be
outstanding after this offering excludes an aggregate of 2,721,257 shares of common stock reserved
as of February 1, 2009 for future issuance upon the exercise of outstanding stock options granted
under equity compensation plans for our directors, officers and
employees and outstanding warrants.
S-4
RISK FACTORS
Investing in our securities involves a high degree of risk. In addition to the other
information included or incorporated by reference in this prospectus supplement and the
accompanying prospectus, you should carefully consider the risks described below before purchasing
our securities. If any of the following risks actually occur, our business, financial condition and
results of operations could materially suffer. As a result, the trading price of our common stock
could decline, and you could lose all or part of your investment.
Risks Relating to Our Business
We are a development stage company without revenues or profits.
Northfield was founded in 1985 and is a development stage company. Since 1985, we have been
engaged primarily in the development and clinical testing of PolyHeme, our investigative human
hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when
an oxygen-carrying fluid is required and red blood cells are not available. No revenues have been
generated to date from commercial sales of PolyHeme. Our revenues to date have consisted solely of
license fees. We cannot ensure that our clinical testing will be successful, that regulatory
approval of PolyHeme will be obtained, that we will be able to manufacture PolyHeme at an
acceptable cost and in appropriate quantities or that we will be able to successfully market and
sell PolyHeme. We also cannot ensure that we will not encounter unexpected difficulties which will
have a material adverse effect on us, our operations or our properties.
We have a history of losses and our future profitability is uncertain.
From our inception through November 30, 2008 we have incurred net operating losses totaling
$231,732,000. We will require substantial additional expenditures to pursue regulatory approval for
PolyHeme, to establish expanded commercial scale manufacturing processes and facilities, and to
establish marketing, sales and administrative capabilities. These expenditures are expected to
result in substantial losses for at least the next few years and are expected to substantially
exceed our currently available capital resources, including the net proceeds of this offering. The
expense and the time required to realize any product revenues or profitability are highly
uncertain. We cannot ensure that we will be able to achieve product revenues or profitability on a
sustained basis or at all.
Our financial resources are limited and we will need to raise additional capital in the future
to continue our business.
As of November 30, 2008, we had cash and cash equivalents and marketable securities of
approximately $10.1 million. From the beginning of our current fiscal year on June 1, 2008 through
February 28, 2009, we estimate that we have utilized our cash resources at an average rate of
approximately $1.7 million per month. Based on recently announced reductions in the total
number of our employees, the placement of certain employees on part-time status and our other
cost-reduction initiatives, we believe we will be able to reduce the utilization of our cash
resources to an average of approximately $1.4 million per month, excluding severance and other costs
relating to our staff reductions.
Based on our current estimates, we anticipate that our existing financial resources, including
the expected net proceeds to us from this offering, will be adequate to permit us to continue to
conduct our business through at least April 30, 2009. We will need to raise substantial additional
capital to continue our business after this period. If we are unable to raise substantial
additional capital, we will not be able to continue our business and we anticipate that we will
terminate the employment of most or all of our remaining employees and use our remaining cash
resources to pay severance and other employee-related costs, make payments to extend our directors
and officers liability insurance coverage and satisfy outstanding obligations to our vendors,
consultants and professional advisors. We do not expect that there
S-5
will be material cash available for distribution to our stockholders if we are unable to continue
our business. It is highly likely in this event that our shares, including any shares purchased in
this offering, will lose all or substantially all of their market value.
We cannot ensure that additional funding will be available or, if it is available, that it can
be obtained on terms and conditions we will deem acceptable. In view of Northfields financial
condition and business prospects, combined with current adverse conditions in the financial and
securities markets, debt or equity financing on acceptable terms may not be available to Northfield
for the foreseeable future. If funding becomes available in the future, any additional funding
derived from the sale of equity securities is likely to result in significant dilution to our
existing stockholders, including investors in this offering. The opinion of our independent
accountants with respect to our audited financial statements includes an explanatory paragraph
regarding the continuation of our company as a going concern. We are also subject to a putative
class action lawsuit alleging violations of the federal securities laws. These matters involve
risks and uncertainties that may prevent us from raising additional capital or may cause the terms
upon which we raise additional capital, if additional capital is available, to be less favorable to
us than would otherwise be the case.
We are developing a single product that is subject to a high level of technological risk.
To succeed as a company, we must develop PolyHeme commercially and sell adequate quantities of
PolyHeme at a high enough price to generate a profit. We may not accomplish either of these
objectives. Our operations have to date consisted primarily of the development and clinical testing
of PolyHeme. We do not expect to realize product revenues unless we successfully develop and
achieve commercial introduction of PolyHeme. We expect that such revenues, if any, will be derived
solely from sales of PolyHeme directly or through licensees. We also expect the use of PolyHeme
initially to be limited to the acute blood loss segment of the transfusion market. The biomedical
field has undergone rapid and significant technological changes. Technological developments may
result in PolyHeme becoming obsolete or non-competitive before we are able to recover any portion
of the research and development and other expenses we have incurred to develop and clinically test
PolyHeme. Any such occurrence would have a material adverse effect on us and our operations.
We are required to receive FDA approval before we may sell PolyHeme commercially, data from our
clinical trials to date may not be adequate to obtain FDA approval, and we may be required to
conduct additional clinical trials in the future.
We submitted our Biologics License Application, or BLA, for PolyHeme to FDA on October 29,
2008. On December 30, 2008, we announced that FDA had accepted for filing our BLA and had granted
Priority Review of our application with a Prescription Drug Users Fee Act, or PDUFA, review goal
date of April 30, 2009.
From January 1 through October 31, 2008, data published by FDA indicate that approximately 20%
of the PDUFA review date goals were missed. Furthermore, the impact of the implementation of the
FDA Amendment Act, or FDAAA, and the planned implementation of the FDAs 21st Century Review
Process has increased the potential for missed PDUFA review dates, particularly in the case of
Priority Reviews, because of the difficulty of successfully completing all the required activities,
including a discussion of the applicable product at a FDA advisory committee meeting, within the
target review period. FDAAA authority to require post-marketing studies and Risk Evaluation and
Mitigation Strategies, or REMS, only came into effect in March 2008, but the experience suggests
that REMS may prolong review times. It is therefore possible that FDA will not be able to complete
its review of our BLA within the review period prescribed under PDUFA. For these reasons, we are
not able to predict whether FDA will comply with the April 30, 2009 review goal date for our BLA
or, if FDA does not comply with this review goal date, when the agency will complete its review of
our BLA.
S-6
Under FDAs review process, the agency generally convenes a meeting of its Blood Products
Advisory Committee, or BPAC, to discuss BLAs relating to new blood products. BPAC is an independent
advisory committee comprised of researchers, physicians and other experts in the field of blood
products as well as community representatives. The next scheduled meeting of BPAC is April 1, 2009.
The agenda for that meeting has not yet been published. According to the 2008 Guidance for
Industry, it is the intention of FDA to notify sponsors approximately 55 business days before an
open advisory committee meeting that will consider an issue directly relevant to the sponsor. We
therefore do not believe our BLA will be discussed by BPAC at its April 2009 meeting. It is not
certain whether and when our BLA for PolyHeme will be discussed by BPAC or what effect, if any, the
timing of the discussion of our BLA by BPAC may have on the ability of FDA to achieve its review
goal date for our BLA.
The publicly available data regarding recent applications to FDA for approval of new molecular
entities, or NMEs, indicates that in the five years from 2003 to 2007, approximately 68% of
Priority Review applications were approved by FDA in the first review cycle. For those applications
that the agency does not approve in the first review cycle, FDA can request that the sponsor
provide additional information, conduct additional preclinical or clinical tests or take other
actions as a condition to license approval. It is therefore possible that FDA may refuse to approve
our BLA or may require us to take additional actions as a condition to approval. If our BLA is not
approved in the first review cycle, we cannot predict what additional actions FDA might require us
to take to obtain approval of our BLA or the time or costs that may be required for us to complete
such actions. Because of our limited capital resources, we may not have sufficient funds available
to continue our operations for a period that would enable us to satisfy potential additional
requirements imposed by FDA as a condition to granting approval of our BLA.
The primary efficacy endpoint of our most recent Phase III trial, in which patient enrollment
was completed in July 2006, was a dual superiority-noninferiority assessment of mortality at 30
days after injury. The results did not achieve the primary efficacy endpoint in the primary patient
population as specified in the protocol. Further, although there was no statistically significant
difference between the PolyHeme and control group for any of the primary safety endpoints for our
trial, statistically significant differences favoring the standard of care were observed with
respect to certain safety parameters, including the incidence of myocardial infarction as reported
by investigators. Based on these results, there can be no assurance that the data will be
sufficient to demonstrate the safety and effectiveness of PolyHeme for purposes of obtaining FDA
approval.
Preclinical testing included extensive in-vitro and in-vivo studies of PolyHeme to assess
product pharmacology and toxicology. These studies varied greatly with regard to animal species,
protocol and product dosing, concomitant study drugs, and the timing and nature of the observations
and measurements. Some of these studies have shown species dependent abnormalities in certain
laboratory findings, including increases in aspartate aminotransferase, bilirubin, blood urea
nitrogen, chromaturia, glucose, and troponin, and certain abnormal microscopic findings, including
renal tubular proteinosis, Kupffer cell hypertrophy, karyomegaly, histiocytosis, cellular
degeneration, and inflammation in organs such as the kidney, liver, or heart. These abnormalities
were largely reversible and there was no evidence of organ failure. The clinical relevance of these
findings is unclear when extrapolated to the human setting. There can be no assurance that these
preclinical data will be considered sufficient for FDA approval.
Our BLA also addressed chemistry, manufacturing and controls, or CMC, issues. Our pilot
manufacturing facility was first opened in 1990 with a design capacity to produce up to 10,000
units of PolyHeme per year. At the time it was Northfields plan to use the pilot facility for
research and development purposes and the manufacture of clinical supplies under the appropriate
current Good Manufacturing Practices, or cGMP, with future commercial scale manufacturing being
performed in a new facility. Our current plan is to seek FDA approval for use of the pilot plant as
our initial commercial manufacturing site, to be followed by expansion at a later date. The cGMP
requirements for commercial manufacturing have evolved considerably over the past two decades and
we have made multiple improvements and updates to our pilot facility, all of which required
subsequent validation, in order to confirm cGMP compliance. These upgrades have consumed and
continue to consume considerable time, effort and expense. We anticipate that the final capacity of
this pilot facility will be approximately 5,000 to
7,500 units per year. There can be no assurance that the pilot facility will be considered to be in
compliance with cGMP requirements.
S-7
FDA review includes a balance of risks and benefits, but the current regulatory climate is
shaped by heightened pressure on FDA from the public and Congress following high profile safety
concerns about certain pharmaceutical products. FDA has become increasingly risk-averse, requiring
even more substantial benefits to outweigh potential safety concerns. We believe that PolyHeme
could offer substantial benefits to patients in the absence of red blood cells for transfusion. If
approved, PolyHeme would be the first hemoglobin-based oxygen carrier for human use to receive FDA
approval. We recognize, however, that our Phase III study did not fully reflect the patient
population for whom PolyHeme may be most appropriate and that the data are therefore susceptible to
varying interpretations. As a result, there is no guarantee that an agency focused more heavily on
product safety risks will be willing to extrapolate an acceptable risk-benefit profile from the
urban setting of our pivotal clinical trial, particularly in light of potential safety signals.
FDA may accordingly refuse to approve PolyHeme for commercial sale, and may require us to
conduct additional clinical trials of PolyHeme in order to obtain approval. Alternatively, FDA may
be willing to approve PolyHeme on the basis of available evidence, but may significantly limit the
indication for which it may be marketed, impose additional restrictions through a Risk Evaluation
and Mitigation Strategy, or REMS, or require substantial postmarketing commitments to evaluate the
use of PolyHeme in additional settings where it may be used or in additional patient populations,
such as children . Any of these alternatives could impede access, raise costs and reduce the
ability of Northfield to recoup investments. Additionally, in order to market PolyHeme for any
additional uses in the United States, we will be required to obtain approval of a separate BLA,
which will require the design and conduct of additional clinical trials, and will involve all of
the uncertainties described above.
Our business, financial condition and results of operations are critically dependent on
receiving FDA approval of PolyHeme. A delay in achieving, or failure to achieve, FDA approval for
commercial sales of PolyHeme would have a material adverse effect on us and could result in the
cessation of our business.
There may be limitations in the supply of the starting material for PolyHeme.
We currently purchase donated red blood cells from the American Red Cross and Blood Centers of
America for use as the starting material for PolyHeme. We have an agreement with hemerica, Inc., a
subsidiary of Blood Centers of America, under which hemerica would supply us with up to 160,000
units per year of packed red cells, the source material for PolyHeme. We have not purchased any
blood supplies under this agreement to date. We have plans to enter into long-term supply
arrangements with other blood collectors. We cannot ensure that we will be able to enter into
satisfactory long-term arrangements with blood bank operators, that the price we may be required to
pay for starting material will permit us to price PolyHeme competitively or that we will be able to
obtain an adequate supply of starting material. Additional demand for blood may arise from
competing human hemoglobin-based oxygen carrier products, thereby limiting our available supply of
starting material.
The market may not accept our product.
Even if PolyHeme is approved for commercial sale by FDA, the degree of market acceptance of
PolyHeme by physicians, healthcare professionals and third party payors will depend on a number of
factors, including:
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relative convenience and ease of administration; |
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the prevalence and severity of any adverse side effects; |
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effectiveness of our sales and marketing strategy; and |
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the price of PolyHeme compared with competing therapies. |
S-8
In addition, even if PolyHeme does achieve market acceptance, we may not be able to maintain
that market acceptance over time if new products are introduced that are more favorably received
than PolyHeme or render PolyHeme obsolete.
We have relied on third parties to perform data collection and analysis with respect to our
clinical trial and to assist in the preparation and submission of our BLA for PolyHeme, which may
result in costs and delays that prevent us from successfully commercializing our product.
We do not have the personnel resources to conduct all of the activities relating to the
collection and analysis of data from our clinical trial and the preparation, submission and FDA
review of our BLA for PolyHeme. We rely and will continue to rely on clinical investigators,
third-party clinical research organizations and consultants to perform many of these functions.
FDA review of our BLA may be delayed, suspended or terminated if:
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these third parties do not successfully carry out their contractual duties or
regulatory obligations or meet expected deadlines; |
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these third parties need to be replaced; or |
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the work performed by these third parties does not satisfy applicable
regulatory requirements or is not usable for other reasons. |
Failure to perform by these third parties may increase our development costs, delay our
ability to obtain regulatory approval and prevent the commercialization of our product.
Our activities are and will continue to be subject to extensive government regulation.
Our research, development, testing, manufacturing, marketing, and distribution of PolyHeme (as
well as that of our collaborators) are, and will continue to be, subject to extensive regulation,
monitoring, and approval by FDA and other government agencies, potentially in ways that we cannot
currently predict. The regulatory approval process to establish the safety and effectiveness of
PolyHeme and the safety and reliability of our manufacturing process has already consumed
considerable time and resources.
We have taken advantage of Special Protocol Assessment, or SPA. Our SPA reflects an agreement
with FDA on our trial design, the trial endpoints and the broad concepts for clinical indications
those endpoints would support in an application for product approval by FDA. The SPA agreement,
however, is not a guarantee of product approval by FDA or approval of any permissible claims about
the product. In particular, it is not binding on the FDA if previously unrecognized public health
concerns later come to light, other new scientific concerns regarding product safety or
effectiveness arise, the sponsor fails to comply with the protocol agreed upon, or FDAs reliance
on data, assumptions or information are determined to be wrong. Even after an SPA agreement is
finalized, the SPA agreement may be changed by the sponsor company or the FDA on written agreement
of both parties, and the FDA retains significant latitude and discretion in interpreting the terms
of the SPA agreement and the data and results from any study that is the subject of the SPA
agreement.
In addition, the data obtained from clinical trials are susceptible to varying
interpretations, which could delay, limit or prevent FDA regulatory approval. Even if FDA accepts
that our analysis of the Phase III data is sufficient to demonstrate effectiveness, our data may
not demonstrate safety. We cannot ensure that, even after extensive clinical trials, regulatory
approval will ever be obtained for PolyHeme. If PolyHeme is approved, it would be the first
hemoglobin-based oxygen carrier for human use to receive FDA approval.
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Before we can market PolyHeme for any use in the United States, and for each subsequent
indication, we must submit a BLA. Once we have prepared an application that we believe satisfies
the statutory and regulatory standards for approval, there are many junctures at which the
application may be delayed or fail. FDA may refuse to file the application, may refuse to designate
the application for priority review, or may not be satisfied that PolyHeme is safe, pure, and
potent, as a result of inadequate support from clinical trials, or concerns about our manufacturing
facilities. The timing of each of these decisions is uncertain, and even after extensive clinical
trials, there is no assurance that regulatory approval will ever be obtained for PolyHeme,
particularly in light of FDAs current conservative approach to risk.
Moreover, if regulatory approval of PolyHeme is granted, it may be heavily constrained by
FDAs focus on drug safety, and the authorities granted FDA by the Food and Drug Administration
Amendments Act. Approval may be authorized only for a narrow indication, which will limit the
ability to market PolyHeme, and FDA may also require post-approval studies or REMS in order to
protect patients, further limiting access and requiring substantial investments of company time and
resources. If these studies, clinical experience and required adverse event reporting, additional
trials to support new indications, or even meta-analyses made possible through FDAAAs clinical
trial disclosure requirements, demonstrate new risks, FDA may further restrict the approval of
PolyHeme, or withdraw approval altogether. Additional laws and regulations may also be enacted
which could prevent or delay regulatory approval of PolyHeme, and/or negatively impact
post-approval marketing, including laws or regulations relating to the price or cost-effectiveness
of medical products. Any of these scenarios are likely to have a material adverse effect on our
financial condition.
Further, the manufacturing, testing, distribution, labeling, packaging, storage, advertising,
promotion, reporting and record-keeping related to PolyHeme will also be subject to extensive
ongoing regulatory requirements following approval. Among other things, we will be required to
comply with current good manufacturing practices, adverse event reporting requirements, and FDAs
general prohibitions against promoting products for unapproved or off-label uses. We are also
subject to inspection and market surveillance by FDA for compliance with these and other
requirements. Any enforcement action resulting from failure, even by inadvertence, to comply with
these requirements, or those imposed in the future, could negatively affect the manufacture and
marketing of PolyHeme.
We currently manufacture PolyHeme at a single location and, if we were unable to utilize this
facility, our ability to manufacture PolyHeme will be significantly affected, and we will be
delayed or prevented from commercializing PolyHeme.
We currently manufacture PolyHeme at a single location and we have no alternative
manufacturing capacity in place at this time. Although we have made substantial ongoing investments
in the maintenance of our manufacturing facility, there can be no assurance that we will not
experience disruptions in our use of the facility due to age or condition of our facility. In
addition, damage to this manufacturing facility due to fire, contamination, natural disaster, power
loss, unauthorized entry or other events could force us to cease the manufacturing of PolyHeme. Any
lack of supply could, in turn, delay any potential commercial sales. In addition, if the facility
or the equipment in the facility is significantly damaged, destroyed or becomes inoperable for any
reason, we may not be able to replace our manufacturing capacity for an extended period of time,
and our business, financial condition and results of operations will be materially and adversely
affected. We intend to seek FDA approval of this facility for the commercial production of PolyHeme
if and when marketing approval of PolyHeme is obtained. This facility will be subject to FDA
inspections and extensive regulation, including compliance with current good manufacturing
practices and FDA approval. Failure to comply may result in enforcement action, which may
significantly delay or suspend manufacturing operations. In order to obtain additional financing
for our operations, we may in the future enter into a loan, sale-leaseback or other transaction
that may require us to grant a lender or lessor a security interest in the land and building in
which we operate our manufacturing facility. If an event of default occurs in connection with the
loan or lease, the lender or lessor will be entitled to enforce its security interest, require us
to cease operations at our manufacturing facility and sell the facility in order to satisfy our
obligations under the loan. In this event, we will not be
able to continue to manufacture PolyHeme at our current manufacturing facility and our business and
financial condition will be materially and adversely affected.
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Failure to increase manufacturing capacity may impair PolyHemes market acceptance and prevent us
from achieving profitability.
Our pilot manufacturing facility was first opened in 1990 with a design capacity to produce up
to 10,000 units of PolyHeme per year. At the time it was Northfields plan to use the pilot
facility for research and development purposes and the manufacture of clinical supplies under the
appropriate current Good Manufacturing Practices, or cGMP, with future commercial scale
manufacturing being performed in a new facility. Our current plan is to seek FDA approval for use
of the pilot plant as our initial commercial manufacturing site, to be followed by expansion at a
later date. The cGMP requirements for commercial manufacturing have evolved considerably over the
past two decades and we have made multiple improvements and updates to our pilot facility in an
effort to confirm compliance. These upgrades have consumed and continue to consume considerable
time, effort and expense. We anticipate that the final capacity of this pilot facility will be
approximately 5,000 to 7,500 units per year. At this manufacturing capacity, profitability can not
be achieved. In June 2006, we purchased the 106,000 square foot building in Mount Prospect,
Illinois in which our pilot manufacturing facility is located and plan to construct an expanded
commercial manufacturing facility at this site if FDA approval for the marketing of PolyHeme is
received. We currently do not have sufficient available funds to permit us to begin construction of
this facility and we will need to raise additional funds, in addition to the net proceeds of this
offering, before we are able to proceed with our planned manufacturing expansion. There can be no
assurance that we will be able to raise additional funds for this purpose. If we are successful in
raising sufficient funds to begin construction of a commercial manufacturing facility, we expect
that completion of the facility, including FDA inspection and validation, will require
approximately 24 to 30 months. Therefore, even if FDA approval for the marketing of PolyHeme is
obtained, we will not be able to produce PolyHeme in sufficient quantities to achieve profitability
for a substantial period of time. A commercial-scale manufacturing facility will be subject to FDA
inspections and extensive regulation, including compliance with current good manufacturing
practices and FDA approval of scale-up changes. Failure to comply may result in enforcement action,
which may significantly delay or suspend manufacturing operations. We have no experience in
large-scale manufacturing, and there can be no assurance that we can achieve large-scale
manufacturing capacity. It is also possible that we may incur substantial cost overruns and delays
compared to existing estimates in building and equipping a large-scale manufacturing facility.
Moreover, in order to seek FDA approval of the sale of PolyHeme produced at a larger-scale
manufacturing facility, we may be required to conduct additional studies with product manufactured
at that facility. A significant delay in achieving scale-up of commercial manufacturing
capabilities would have a material adverse effect on sales of PolyHeme.
There are significant competitors developing similar products.
We may be unable to compete successfully in developing and marketing our product. If approved
for commercial sale, PolyHeme will compete directly with established therapies for acute blood loss
and may compete with other technologies currently under development. We cannot ensure that PolyHeme
will have advantages which will be significant enough to cause medical professionals to adopt it
rather than continue to use established therapies or to adopt other new technologies or products.
We also cannot ensure that the cost of PolyHeme will be competitive with the cost of established
therapies or other new technologies or products. The development of hemoglobin-based
oxygen-carrying products is a continuously evolving field. Competition is intense and may increase.
Several companies have developed or are in the process of developing technologies which are, or in
the future may be, the basis for products which will compete with PolyHeme. Certain of these
companies are pursuing different approaches or means of accomplishing the therapeutic effects
sought to be achieved through the use of PolyHeme. Some of these companies may have substantially
greater financial resources, larger research and development staffs, more extensive facilities and
more experience in testing, manufacturing, marketing and distributing medical products. We cannot
ensure that one or more other companies will not succeed in developing technologies or products
which will become available for commercial use prior to PolyHeme, which will be
more effective or less costly than PolyHeme or which would otherwise render PolyHeme obsolete or
non-competitive.
S-11
Further, the regulatory climate for follow-on or generic versions of biological products
approved under a BLA in the United States remains uncertain. Currently, there is no established
statutory or regulatory pathway for the abbreviated approval of follow-on versions of biological
products approved under a BLA, meaning that even after our intellectual property protections
expire, a company seeking to market a copy of PolyHeme would have to conduct its own clinical
trials and submit a completely independent BLA. However, members of Congress have expressed
increasing interest in legislation to establish a statutory path for follow-on biological products.
At this time, we cannot know with certainty when any such process may be adopted, or how it might
affect our intellectual property rights, but any such process has the potential to have a material
effect on PolyHemes commercial success.
We do not have experience in the sale and marketing of medical products.
If approved for commercial sale, we currently intend to market PolyHeme in the United States
using our own sales force. We have no experience in the sale or marketing of medical products,
which are subject to significant regulations not applicable to the sale and marketing of other
types of goods and services. PolyHeme may only be marketed and promoted for its approved use(s),
and our sales force will be subject to a variety of regulatory and industry restrictions on their
ability to aggressively pursue potential customers. If our sales and marketing teams fail to comply
with these restrictions, we could be subject to significant liability.
Our ability to implement our sales and marketing strategy for the United States will depend on
our ability to recruit, train and retain a marketing staff and sales force with sufficient
technical expertise. We cannot ensure that we will be able to establish an effective marketing
staff and sales force, that the cost of establishing such a marketing staff and sales force will
not exceed revenues from the sale of PolyHeme or that our marketing and sales efforts will be
successful.
Our profitability will be affected if we incur product liability claims in excess of our
insurance coverage.
The testing and marketing of medical products, even after FDA approval, have an inherent risk
of product liability. Claims by users of PolyHeme, or by others selling PolyHeme, could expose us
to substantial product liability. We maintain limited product liability insurance coverage for our
clinical trials in the total amount of $10 million. However, our profitability would be adversely
affected by a successful product liability claim in excess of our insurance coverage. We cannot
ensure that product liability insurance will be available in the future or be available on
reasonable terms.
Our pivotal Phase III trial was conducted under a federal regulation that allows research to
be conducted in certain emergent, life-threatening situations using an exception from the
requirement for informed patient consent. Under the applicable federal regulation, an institutional
review board at a trial site may give approval for patient enrollment in trials in emergency
situations without requiring individual informed consent provided specific criteria are met.
Individual informed consent is often a defense raised against product liability claims asserted by
patients participating in clinical trials of medical products. We cannot ensure that IRB approval
of patient enrollment in our trial, even if given in full compliance with the applicable federal
regulations, will provide us with a defense against product liability claims by patients
participating in our trial. It is also possible that we may be subject to legal claims by patients
objecting to being enrolled in our trial without their individual informed consent, even if the
patients do not suffer any injuries in connection with our trial.
We depend on the services of a limited number of key personnel.
Our success is highly dependent on the continued services of a limited number of skilled
managers and scientists. The loss of any of these individuals could have a material adverse effect
on us. In addition,
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our success will depend, among other factors, on the recruitment and retention of additional highly
skilled and experienced management and technical personnel. Recent reductions in our staff and the
placement of certain employees on part-time status may increase the difficultly in retaining and
recruiting qualified employees. We have historically provided incentive compensation to our
officers and employees in part through grants of stock options and restricted stock under our
equity compensation plans. Decreases in the trading price of our common stock, however, have
substantially reduced the value of equity compensation awards made to our officers and employees in
prior years and such awards may not provide adequate compensation to retain such individuals. Our
ability to provide competitive compensation to our officers and employees may also be adversely
affected by our limited capital resources and anticipated need to raise substantial additional
capital to continue our business. We cannot ensure that we will be able to retain existing
officers employees or attract and retain additional skilled personnel on acceptable terms as a
result of these factors as well as competition for such personnel from numerous large and
well-funded pharmaceutical and health care companies, universities and non-profit research
institutions.
We have significant severance and other obligations under agreements with our officers and
employees and have agreed to grant a security interest in our manufacturing facility to secure a
portion of these obligations.
We have entered into employment and severance protection agreements with each of our officers
and certain of our key employees. These agreements provide for cash severance payments and the
continuation of health insurance and other benefits for a specified period if the employment of the
officer or employee is terminated by Northfield without cause or terminates under certain other
circumstances, including a change in control of Northfield. Our aggregate contractual obligation
under these agreements, determined as of November 30, 2008, was
approximately $3.3 million.
Our existing cash resources, including the proceeds of this offering, are not expected to be
adequate to permit us to satisfy these severance obligations in full if we cease to conduct
business and the employment of all or substantially all of these officers and key employees is
terminated. We may accordingly enter into agreements with our officers and key employees that
modify their severance arrangements. These modified arrangements may include an agreement that our
severance obligations, should they become payable, may be deferred and satisfied in whole or in
part from the proceeds of a future loan, sale, sale-leaseback, lease or similar transaction
involving our owned manufacturing facility located in Mount Prospect, Illinois. If we enter into
an arrangement of this type, the proceeds from a possible transaction involving our manufacturing
facility would not be available to fund our ongoing operations to permit us to continue our
business. Northfields contractual responsibility for these severance and other benefit obligations
may therefore cause us to cease or curtail our operations at an earlier date than would otherwise
be the case if we were not required to satisfy these obligations.
Our ability to generate revenue from our product will depend on reimbursement and drug pricing
policies and regulations.
Our ability to achieve acceptable levels of reimbursement for PolyHeme by governmental
authorities, private health insurers and other organizations will have an effect on our ability to
successfully commercialize PolyHeme. We cannot be sure that reimbursement in the United States,
Europe or elsewhere will be available for PolyHeme or, if reimbursement should become available,
that it will not be decreased or eliminated in the future. If reimbursement is not available or is
available only at limited levels, we may not be able to successfully commercialize PolyHeme, and
may not be able to obtain a satisfactory financial return on PolyHeme.
Third-party payers increasingly are challenging prices charged for medical products and
services. Also, the trend toward managed health care in the United States and the changes in health
insurance programs, as well as legislative proposals to reform health care or reduce government
insurance programs, may result in lower prices for pharmaceutical products, including PolyHeme.
Cost-cutting measures that health care providers are instituting, and the effect of any health care
reform, could harm our ability to sell PolyHeme.
S-13
Moreover, we are unable to predict what additional legislation or regulation, if any, relating
to the health care industry or third-party coverage and reimbursement may be enacted in the future
or what effect this legislation or regulation would have on our business. In the event that
governmental authorities enact legislation or adopt regulations which affect third-party coverage
and reimbursement, demand for PolyHeme may be reduced, thereby harming our sales and profitability.
Failure to obtain regulatory approval in foreign jurisdictions would prevent our product from being
marketed abroad.
We have entered into a license agreements Hemocare Ltd., an Israeli corporation, to
manufacture and distribute PolyHeme in certain Middle Eastern and African countries. The license
agreement permits Hemocare to sell PolyHeme in return for the payment of royalties based upon sales
of PolyHeme in the licensed territories. Hemocare has not to date conducted any manufacturing or
distribution activities under its license and has not paid any royalties to Northfield.
In order for Hemocare or anyone else, including us, to market our products in many foreign
jurisdictions, we or our licensees must obtain separate regulatory approvals and comply with
numerous and varying regulatory requirements. The approval procedure varies among countries and can
involve additional testing. The time required to obtain approval may differ from that required to
obtain FDA approval. The foreign regulatory approval process entails all of the risks associated
with obtaining FDA approval. We and our licensees may fail to obtain foreign regulatory approvals
on a timely basis, if at all. Approval by FDA does not ensure approval by regulatory authorities in
other countries, and approval by one foreign regulatory authority does not ensure approval by
regulatory authorities in other foreign countries or by FDA. We and our licensees may not be able
to file for, and may not receive, necessary regulatory approvals to commercialize our product in
any market. If we or our licensees fail to obtain these approvals, our business, financial
condition and results of operations could be materially and adversely affected.
Failure to maintain effective internal controls over financial reporting could have a material
adverse effect on our business, operating results and stock price.
Section 404 of the Sarbanes-Oxley Act of 2002 requires us to include a report by our
management on our internal controls over financial reporting in our annual reports filed with the
SEC. This report must contain an assessment by management of the effectiveness of our internal
controls over financial reporting as of the end of our fiscal year and a statement as to whether or
not our internal controls are effective.
Our efforts to comply with Section 404 have resulted in, and are likely to continue to result
in, significant costs, the commitment of time and operational resources and the diversion of
managements attention. If our management identifies one or more material weaknesses in our
internal controls over financial reporting, we will be unable to assert our internal controls are
effective. If we are unable to assert that our internal controls over financial reporting are
effective, our business may be harmed. Market perception of our financial condition and the trading
price of our stock may be adversely affected and customer perception of our business may suffer.
We are subject to a variety of federal, state and local laws, rules and regulations related to the
discharge or disposal of toxic, volatile or other hazardous chemicals.
Although we believe that we are in material compliance with these laws, rules and regulations,
the failure to comply with present or future regulations could result in fines being imposed on us,
suspension of production or cessation of operations. Third parties may also have the right to sue
to enforce compliance. Moreover, it is possible that increasingly strict requirements imposed by
environmental laws and enforcement policies could require us to make significant capital
expenditures. The operation of a manufacturing plant entails the inherent risk of environmental
damage or personal injury due to the handling of potentially harmful substances, and there can be
no assurance that we will not incur material
S-14
costs and liabilities in the future because of an accident or other event resulting in personal
injury or unauthorized release of such substances to the environment. In addition, we generate
hazardous materials and other wastes that are disposed of at various offsite facilities. We may be
liable, irrespective of fault, for material cleanup costs or other liabilities incurred at these
disposal facilities in the event of a release of hazardous substances by such facilities into the
environment.
We are subject to a putative class action lawsuit.
We, Dr. Steven A. Gould, Northfields Chief Executive Officer, and Richard De Woskin,
Northfields previous Chief Executive Officer, are subject to a putative class action pending in
the United States District Court for the Northern District of Illinois Eastern Division,
purportedly brought on behalf of a class of Northfields shareholders. The complaint alleges, among
other things, that during the period from March 19, 2001 to March 20, 2006, the named defendants
made or caused to be made a series of materially false or misleading statements and omissions about
Northfields elective surgery clinical trial and business prospects in violation of Section 10(b)
of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder and
Section 20(a) of the Exchange Act. Plaintiffs allege that those allegedly false and misleading
statements and omissions caused the purported class to purchase Northfield common stock at
artificially inflated prices. As relief, the complaint seeks, among other things, a declaration
that the action be certified as a proper class action, unspecified compensatory damages (including
interest) and payment of costs and expenses (including fees for legal counsel and experts). If the
outcome of this lawsuit is unfavorable to Northfield, or Northfield determines that it is advisable
to enter into a settlement of the lawsuit, Northfield could be required to pay significant monetary
damages or make significant settlement payments to the plaintiffs in the lawsuit. While Northfield
maintains directors and officers liability insurance, there can be no assurance that the proceeds
of this insurance will be available with respect to all or part of any damages, costs or expenses
that may be incurred by Northfield in connection with the aforementioned putative class action
lawsuit. In addition, Northfield is a party to indemnification agreements under which it may be
required to indemnify and advance defense costs to its current and former directors and officers in
connection with this putative class action lawsuit. Even if this lawsuit is ultimately resolved in
favor of Northfield, Northfield still may incur substantial legal fees and expenses in defending
the lawsuit.
Risk Relating to our Intellectual Property
Our success depends upon our ability to protect our intellectual property and our proprietary
technology.
Our success depends in part on our ability to obtain and maintain intellectual property
protection for PolyHeme as well as our technology and know-how. Our policy is to seek to protect
PolyHeme and our technologies by, among other methods, filing United States and foreign patent
applications related to our proprietary technology, inventions and improvements that are important
to the development of PolyHeme. The patent positions of companies like ours are generally uncertain
and involve complex legal and factual questions. Our ability to maintain and solidify our
proprietary position for our technology will depend on our success in obtaining effective patent
claims and enforcing those claims once granted. We do not know whether any of our patent
applications will result in the issuance of any patents. Our issued patents and those that may
issue in the future may be challenged, invalidated, rendered unenforceable or circumvented, which
could limit our ability to stop competitors from marketing related products or the length of term
of patent protection that we may have for PolyHeme.
Our United States patents have various expiration dates through 2025. Our broadest United
States patent, however, has expired. The rights granted under our issued patents may not provide us
with competitive advantages against competitors with similar compounds or technologies.
Furthermore, our competitors may independently develop similar technologies or duplicate any
technology developed by us in a manner that does not infringe our patents or other intellectual
property. Because of the extensive time required for development, testing and regulatory review of
PolyHeme, it is possible that, before PolyHeme can be commercialized, our patents relating to
PolyHeme may expire or remain in force for only a short period following commercialization, thereby
reducing any advantages of the patent.
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We rely on trade secrets and other confidential information to maintain our proprietary position.
In addition to patent protection, we also rely on protection of trade secrets, know-how and
confidential and proprietary information. To maintain the confidentiality of trade secrets and
proprietary information, we have entered into confidentiality agreements with our employees,
consultants and collaborators upon the commencement of their relationships with us. These
agreements require that all confidential information developed by the individual or made known to
the individual by us during the course of the individuals relationship with us be kept
confidential and not disclosed to third parties. Our agreements with employees also provide that
inventions conceived by the individual in the course of rendering services to us will be our
exclusive property. Individuals with whom we have these agreements may not comply with their terms.
In the event of the unauthorized use or disclosure of our trade secrets or proprietary information,
these agreements, even if obtained, may not provide meaningful protection for our trade secrets or
other confidential information. To the extent that our employees, consultants or contractors use
technology or know-how owned by others in their work for us, disputes may arise as to the rights in
related inventions. Adequate remedies may not exist in the event of unauthorized use or disclosure
of our confidential information. The disclosure of our trade secrets would impair our competitive
position and could have a material adverse effect on our operating results, financial condition and
future growth prospects.
We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time
consuming.
Competitors may infringe our patents. To counter infringement or unauthorized use, we may be
required to file infringement claims, which can be expensive and time-consuming. In addition, in an
infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable,
or may refuse to stop the other party from using the technology at issue on the grounds that our
patents do not cover its technology. An adverse determination of any litigation or defense
proceedings could put one or more of our patents at risk of being invalidated or interpreted
narrowly and could put our patent applications at risk of not issuing.
Interference proceedings brought by the United States Patent and Trademark Office may be
necessary to determine the priority of inventions with respect to our patent applications or those
of our collaborators or licensors. Litigation or interference proceedings may fail and, even if
successful, may result in substantial costs and be a distraction to our management. We may not be
able to prevent misappropriation of our proprietary rights, particularly in countries where the
laws may not protect such rights as fully as in the United States.
Furthermore, because of the substantial amount of discovery required in connection with
intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation. In addition, during the course of this
kind of litigation, there could be public announcements of the results of hearings, motions or
other interim proceedings or developments. If securities analysts or investors perceive these
results to be negative, it could have a substantial adverse effect on the price of our common
stock.
We may not prevail in any litigation or interference proceeding in which we are involved. Even
if we do prevail, these proceedings can be very expensive and distract our management.
Third parties may own or control patents or patent applications that are infringed by our product
or technologies.
Our success depends in part on avoiding the infringement of other parties patents and
proprietary rights. In the United States, patent applications filed in recent years are
confidential for 18 months, while older applications are not published until the patent issues. As
a result, there may be patents of which we are unaware, and avoiding patent infringement may be
difficult. We may inadvertently infringe third-party
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patents or patent applications. These third parties could bring claims against us that, even if
resolved in our favor, could cause us to incur substantial expenses and, if resolved against us,
could additionally cause us to pay substantial damages. Further, if a patent infringement suit were
brought against us, we could be forced to stop or delay research, development, manufacturing or
sales of PolyHeme in the country or countries covered by the patent we infringe, unless we can
obtain a license from the patent holder. Such a license may not be available on acceptable terms,
or at all, particularly if the third party is developing or marketing a product competitive with
PolyHeme. Even if we were able to obtain a license, the rights may be nonexclusive, which would
give our competitors access to the same intellectual property.
We also may be required to pay substantial damages to the patent holder in the event of an
infringement. Under some circumstances in the United States, these damages could be triple the
actual damages the patent holder incurs. If we have supplied infringing products to third parties
for marketing or licensed third parties to manufacture, use or market infringing products, we may
be obligated to indemnify these third parties for any damages they may be required to pay to the
patent holder and for any losses the third parties may sustain themselves as the result of lost
sales or damages paid to the patent holder.
Any successful infringement action brought against us may also adversely affect marketing of
PolyHeme in other markets not covered by the infringement action. Furthermore, we may suffer
adverse consequences from a successful infringement action against us even if the action is
subsequently reversed on appeal, nullified through another action or resolved by settlement with
the patent holder. The damages or other remedies awarded, if any, may be significant. As a result,
any infringement action against us would likely delay the regulatory approval process, harm our
competitive position, be very costly and require significant time and attention of our key
management and technical personnel.
Risks Relating to this Offering
Our stock price could be volatile and your investment could suffer a decline in value.
The market price of our common stock has fluctuated significantly in response to a number of
factors, many are which are beyond our control, including:
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announcements by us relating to the results of our clinical trials of PolyHeme; |
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developments relating to our efforts to obtain additional financing to fund our
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announcements by us regarding transactions with potential strategic partners; |
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announcements relating to blood substitute products being developed by our
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our issuance of additional equity or debt securities; and |
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sales of significant amounts of our common stock or other securities in the market. |
In addition, the stock market in general, and the Nasdaq Global Market and the biotechnology
industry market in particular, have experienced significant price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of listed companies. These
broad market and industry factors may seriously harm the market price of our common stock,
regardless of our operating performance. In the past, securities class action litigation has often
been instituted following periods of volatility in the market price of a companys securities. A
securities class action suit against us could result in substantial costs, potential liabilities
and the diversion of our managements attention and resources.
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If we fail to meet the continued listing requirements of the Nasdaq Global Market, our common stock
may be delisted.
Our common stock currently trades on the Nasdaq Global Market. The Nasdaq Global Market
maintains requirements applicable to Northfield for continued listing of our common stock,
including a requirement to maintain a minimum bid price of at least $1.00 per share, a minimum
market value of publicly traded shares of at least $5 million and minimum stockholders equity of at
least $10 million. The Nasdaq Global Market has, however, temporarily suspended enforcement of its
minimum bid price and market value of publicly traded shares requirements until April 20, 2009.
Our common stock currently trades at a price below $1.00 per share. Accordingly, at such time
as the Nasdaq Global Market reinstitutes enforcement of its minimum bid price requirement, we may
not be able to comply with this requirement. In the future, we also may not be able to comply with
certain of the other continued listing requirements of the Nasdaq Global Market, including the $10
million minimum stockholders equity requirement.
Any delisting of our common stock from the Nasdaq Global Market is likely to reduce the
trading volume and liquidity in our shares and may lead to further decreases in the trading price
of our shares. The delisting of our shares may also prevent investors from purchasing shares of our
common stock using margin loans provided by brokers or other financial institutions. Our ability
to raise additional equity capital, which is critical to the continuation of our business, would
also likely to be adversely affected by the delisting of our common stock from the Nasdaq Global
Market.
Anti-takeover provisions contained in our charter and bylaws could discourage potential takeover
attempts.
Our certificate of incorporation contains a fair price provision which requires approval of
the holders of at least 80% of our voting stock, excluding shares held by certain interested
stockholders and their affiliates, as a condition to mergers or certain other business combinations
with, or proposed by, any holder of 15% or more of our voting stock, except in cases where approval
of our disinterested directors is obtained or certain minimum price criteria and other procedural
requirements are satisfied. In addition, our board of directors has the authority, without further
action by our stockholders, to fix the rights and preferences and issue shares of preferred stock.
These provisions, and other provisions of our certificate of incorporation and bylaws and Delaware
law, may have the effect of deterring hostile takeovers or delaying or preventing changes in our
control or management, including transactions in which stockholders might otherwise receive a
premium for their shares over the then prevailing market prices.
There is a large number of shares that may be sold in the market following this offering, which may
depress the market price of our common stock.
Sales of a substantial number of shares of our common stock or securities convertible into or
exercisable for our common stock in the public market following this offering could cause the
market price of our common stock to decline. If there are more shares of common stock offered for
sale than buyers are willing to purchase, then the market price of our common stock may decline to
a market price at which buyers are willing to purchase the offered shares of common stock and
sellers remain willing to sell the shares. All of the shares sold in the offering will be freely
tradeable without restriction or further registration under the Securities Act, except for any
shares purchased by our affiliates as defined in Rule 144 of the Securities Act.
Our management has broad discretion to determine how to use the proceeds received from this
offering.
Our management will have broad discretion as to the application of the net proceeds of this
offering and could use them for purposes other than those contemplated at the time of this
offering. Our stockholders may not agree with the manner in which our management chooses to
allocate and spend the net proceeds. Moreover, our management may use the net proceeds for
corporate purposes that may not increase the market price of our common stock.
S-18
You will experience immediate and substantial dilution.
The public offering price of the securities offered hereby is likely to be substantially
higher than the book value per share of our common stock. Investors purchasing securities in this
offering may, therefore, incur immediate dilution in net tangible book value per share of the
common stock issuable upon the conversion or exercise of the securities purchased in this offering.
See Dilution for a more detailed discussion of the dilution you will incur in this offering.
USE OF PROCEEDS
We estimate that the net proceeds from the sale of the shares that we are offering at a price
of $265 per share will be approximately $1,266,298 after deducting the estimated placement agency
fees and offering expenses payable by us. We intend to use the net proceeds of this offering for
general corporate purposes, including general and administrative expenses and expenses in
connection with the regulatory review of our PolyHeme product. Pending any ultimate use of any
portion of the proceeds, we intend to invest the proceeds in a variety of capital preservation
investments, including short-term, interest-bearing, investment-grade securities and money-market
funds.
DILUTION
Our net tangible book value as of November 30, 2008 was approximately $16.5 million, or
$0.61 per share. Net tangible book value per share is calculated by subtracting our total
liabilities from our total tangible assets, which is total assets less intangible assets, and
dividing this amount by the number of shares of our common stock outstanding. After giving effect
to the sale by us of the shares offered in this offering at a price of $265 per share of convertible preferred stock, or $0.265 per share of underlying common stock, and after
deducting the estimated placement agency fees and offering expenses payable by us, our net tangible
book value as of November 30, 2008 would have been approximately $17.8 million, or $0.56
per share of common stock. This represents an immediate decrease in the net tangible book value of $0.5 per
share to the existing stockholders and an immediate increase in net tangible book value of $0.295 per share to new
investors. The following table illustrates this per share dilution:
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Price per share of underlying common stock to investors |
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$ |
0.265 |
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Net tangible book value per share as of
November 30, 2008 |
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$ |
0.61 |
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Decrease per share attributable to new investors |
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$ |
0.5 |
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Net tangible book value per share after this offering |
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$ |
0.56 |
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Increase in net tangible book value per share to new investors |
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$ |
0.295 |
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In the discussion and table above, we assume no exercise of outstanding stock options. As of
November 30, 2008, there were 2,052,625 shares of common stock
reserved for future issuance with respect to outstanding warrants and
options issued under
equity compensation plans for our directors, officers and employees at a weighted average exercise
price of $8.37 per share.
The foregoing dilution information gives effect to the conversion of the shares of convertible
preferred stock that are being offered pursuant to this prospectus supplement and the accompanying
prospectus but does not reflect the exercise of any of the warrants included in this offering.
PLAN OF DISTRIBUTION
We are directly selling to an institutional purchaser 5,404.652 shares of convertible
preferred stock and warrants to purchase 5,404,652 shares of common stock under this prospectus
supplement. The convertible preferred stock is convertible at any time at the option of the holder
into shares of our common stock at a conversion price of $0.265 per share. The warrants are
exercisable at a price of $0.53 per share at any time after the six-month anniversary of the date
of issuance and before the fourth anniversary of the initial exercise date.
S-19
We estimate the gross proceeds from this offering will be approximately $1,432,232 and we
estimate the net proceeds from the offering to be approximately $1,266,298 after deducting
placement agency fees and the estimated costs payable by us associated with the offering. We have
negotiated with the purchaser regarding the sale of the shares and warrants being offered
hereunder, and have entered into a securities purchase agreement with the purchaser which sets
forth the specific terms of the transaction. We anticipate that we will effect the sale of the
aggregate of $5,404.652 shares of convertible preferred stock and warrants to purchase $5,404,652
shares of common stock in one or more closings.
Pursuant to a placement agency agreement dated March 11, 2009, we have engaged Rodman &
Renshaw, LLC, or Rodman & Renshaw, to act as our exclusive placement agent in connection with this
offering of our shares and warrants. Under the terms of the placement agency agreement, Rodman &
Renshaw agreed to be our exclusive placement agent, on a best efforts basis, in connection with the
issuance and sale by us of our shares and warrants in a proposed takedown from our registration
statement of which this prospectus supplement is a part. The terms of any such offering will be
subject to market conditions and negotiations between us, the placement agent and prospective
purchasers. The placement agency agreement does not give rise to any commitment by Rodman & Renshaw
to purchase any of the shares or warrants, and Rodman & Renshaw will have no authority to bind us
by virtue of the placement agency agreement. Further, Rodman & Renshaw does not guarantee that they
will be able to raise new capital in any prospective offering.
With respect to the offering, we have agreed to pay Rodman & Renshaw compensation as follows:
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an aggregate placement agency fee to the placement agent equal to 6% of the gross
proceeds received from the sale of shares and warrants in the offering; |
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a warrant to purchase a number of shares of common stock equal 6% of the total
number of shares of common stock issuable upon the conversion or exercise of the
shares of convertible preferred stock and warrants included in this offering. The
placement agents warrant is exercisable at a price of $0.6625 per share, has a term
of 4.5 years and may not be exercised or transferred until six months after the date
of the completion of this offering; and |
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reimbursement of the placement agents reasonable out-of-pocket expenses, including
the reasonable fees and expenses of the placement agents legal counsel, incurred in
connection with the offering, such expenses not to exceed an aggregate of .08% of the
gross proceeds to us from this offering, but in any event not more than $30,000. |
We will not pay any other compensation in connection with the sale of our shares and warrants
pursuant to the placement agency agreement.
We have agreed to indemnify Rodman & Renshaw against certain liabilities arising in connection
with the engagement, including liabilities under federal securities laws.
This is a brief summary of the material provisions of the placement agency agreement and does
not purport to be a complete statement of its terms and conditions.
In compliance with the guidelines of the Financial Industry Regulatory Authority maximum
consideration or discount to be received by any FINRA member may not exceed 8% of the aggregate
amount of the securities offered pursuant to this prospectus supplement.
The transfer agent and depositary for our shares is ComputerShare Trust Company, N.A.
Our shares are traded on the Nasdaq Global Market under the symbol NFLD.
S-20
DESCRIPTION OF CONVERTIBLE PREFERRED STOCK
The material terms and provisions of the convertible preferred stock being offered pursuant to
this prospectus supplement and the accompanying prospectus are summarized below. This summary is
subject to, and qualified in its entirety by, the terms and conditions set forth in the certificate
of designation authorizing the convertible preferred stock, which will be provided to the purchaser
in this offering.
We will authorize the convertible preferred stock by filing a certificate of designation with
the Secretary of State of the State of Delaware. The certificate of designation may be authorized
by our board of directors without approval by our stockholders.
The convertible preferred stock will be convertible at the option of the holder at any time
into shares of our common stock at a conversion price of $0.265 per share. The conversion price of
the convertible preferred stock will be subject to adjustment in the case of stock splits, stock
dividends, combinations of shares and similar recapitalization transactions. The convertible
preferred stock will be subject to automatic conversion into shares of common stock upon the
occurrence of a change in control of Northfield and we may become obligated to redeem the
convertible preferred stock upon the occurrence of certain triggering events, including the
material breach by us of certain contractual obligations to the holders of the convertible
preferred stock, the occurrence of a change in control of Northfield, the occurrence of certain
insolvency events relating to Northfield or the failure of our common stock to continue to be
listed or quoted for trading on one or more specified United States securities exchanges.
The convertible preferred stock does not provide for mandatory dividend rights. Except as
required by law, holders of the convertible preferred stock are not entitled to voting rights,
except that the affirmative vote of the holders of a majority of the outstanding shares of
convertible preferred stock is required to take certain actions that may adversely affect the
rights or preferences of the holders of convertible preferred stock.
The securities purchase agreement pursuant to which the convertible preferred stock will be
issued and the certificate of designation authorizing the preferred stock includes certain
agreements and covenants for the benefit of the holders of convertible preferred stock, including a
right to participate in certain future equity financing transactions and restrictions on our
ability to amend our certificate of incorporation or bylaws, pay cash dividends or distributions
with respect to our common stock or other junior securities, repurchase shares of common stock or
other junior securities, issue additional equity securities for a period of 60-days after the
closing of the offering and incur indebtedness or grant liens or security interests with respect to
our properties or assets.
DESCRIPTION OF WARRANTS
The material terms and provisions of the warrants being offered pursuant to this prospectus
supplement and the accompanying prospectus are summarized below. This summary is subject to, and
qualified in its entirety by, the form of warrant, which will be provided to the purchaser in this
offering.
The warrants will provide for an exercise price of $0.53 per share and will be exercisable at
the option of the holder at any time after the six-month anniversary of the closing date of the
transaction and before the fourth anniversary of the initial exercise date. The exercise price of
the warrants will be subject to adjustment in the case of stock splits, stock dividends,
combinations of shares and similar recapitalization transactions.
The warrants will be subject to a call provision that will permit us to cancel the warrants in
the event the volume weighted average price of our common stock exceeds 200% of the applicable
exercise price of the warrants for a period of 20 consecutive trading days and certain other
conditions are satisfied. Holders will be permitted to exercise the warrants, at their option,
prior to the date the warrants are cancelled.
S-21
The warrant holders must surrender payment in cash of the exercise price of the shares being
acquired upon exercise of the warrants. If, however, we are unable to offer and sell the shares
underlying these warrants pursuant to this prospectus supplement due to the ineffectiveness of the
registration statement of which this prospectus supplement is a part, then the warrants may only be
exercised on a net or cashless basis. In no event is the warrant holder entitled to a cash
settlement from us upon exercise.
LEGAL MATTERS
The validity of the offered securities will be passed upon for Northfield by Baker & McKenzie
LLP, Chicago, Illinois.
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The financial statements of Northfield Laboratories Inc. as of May 31, 2008 and 2007, and for
each of the years in the three-year period ended May 31, 2008, and for the cumulative period from
June 19, 1985 (inception), have been incorporated by reference herein in reliance upon the reports
of KPMG LLP, independent registered public accounting firm, and upon the authority of such firm as
experts in accounting and auditing.
The audit report covering the May 31, 2008 financial statements contains an explanatory
paragraph that states that the Companys recurring losses from operations and net capital
deficiency raise substantial doubt about the entitys ability to continue as a going concern. The
financial statements do not include any adjustments that might result from the outcome of that
uncertainty.
With respect to the unaudited interim financial information for the three-month and six-month
period ended November 30, 2008 and 2007, incorporated by reference herein, the independent
registered public accounting firm has reported that they applied limited procedures in accordance
with professional standards for a review of such information. However, their separate reports
included in the Companys quarterly report on Form 10-Q for the three-month and six-month period
ended November 30, 2008 and 2007, and incorporated by reference herein, states that they did not
audit and they do not express an opinion on that interim financial information. Accordingly, the
degree of reliance on their report on such information should be restricted in light of the limited
nature of the review procedures applied. The accountants are not subject to the liability
provisions of Section 11 of the Securities Act of 1933 (the 1933 Act) for their reports on the
unaudited interim financial information because that reports are not a report or a part of the
registration statement prepared or certified by the accountants within the meaning of Sections 7
and 11 of the 1933 Act.
S-22
Prospectus
$100,000,000
NORTHFIELD LABORATORIES INC.
Common Stock
Preferred Stock
Depositary Shares
Stock Purchase Contracts
Warrants
Debt Securities
We will provide you with the specific terms of the particular securities being offered in
supplements to this prospectus. You should read this prospectus and each related supplement
carefully before you invest. This prospectus may not be used to sell securities unless accompanied
by a prospectus supplement.
Our common stock is quoted on the Nasdaq Global Market under the symbol NFLD. The last
reported sale price of our common stock on August 31, 2006 was
$10.84 per share.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is September 1, 2006.
TABLE OF CONTENTS
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ABOUT THIS PROSPECTUS |
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1 |
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WHERE YOU CAN FIND MORE INFORMATION |
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FORWARD-LOOKING INFORMATION |
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OUR BUSINESS |
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USE OF PROCEEDS |
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RATIO OF EARNINGS TO FIXED CHARGES AND PREFERENCE DIVIDENDS |
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DESCRIPTION OF THE SECURITIES WE MAY OFFER |
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PLAN OF DISTRIBUTION |
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6 |
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LEGAL MATTERS |
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6 |
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EXPERTS |
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6 |
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PART II. INFORMATION NOT REQUIRED IN PROSPECTUS |
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II-1 |
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, using a shelf registration process. Using this process, we may offer
the securities described in this prospectus in one or more offerings with a total initial offering
price of up to $100,000,000 or an equivalent amount in one or more foreign currencies. We may sell
these securities separately or in units. This prospectus provides you with a general description of
the securities we may offer. Each time we offer securities, we will provide you a prospectus
supplement that will contain information about the specific terms of that particular offering. The
prospectus supplement may also add, update or change information contained in this prospectus. To
obtain additional information that may be important to you, you should read the exhibits filed by
us with the registration statement of which this prospectus is a part or our other filings with the
SEC. You also should read this prospectus and any prospectus supplement together with the
additional information described below under Where You Can Find More Information.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-3 under the Securities Act with
respect to the securities we may offer pursuant to this prospectus. This prospectus, which is part
of the registration statement, omits certain information, exhibits, schedules and undertakings set
forth in the registration statement. For further information pertaining to us and the securities we
may offer, reference is made to such registration statement and the exhibits and schedules to the
registration statement. Statements contained in this prospectus as to the contents or provisions of
any documents referred to in this prospectus are not necessarily complete, and in each instance
where a copy of the document has been filed as an exhibit to the registration statement, reference
is made to the exhibit for a more complete description of the matters involved.
We file annual, quarterly and special reports, proxy statements and other information with the
SEC. You can read and copy any materials we file with the SEC at its Public Reference Room at 100 F
Street, N.E., Washington, D.C. 20549. You can obtain information about the operations of the SEC
Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains a web site that
contains information we file electronically with the SEC, which you can access over the Internet at
www.sec.gov. You may also access the information we file electronically with the SEC through our
web site at www.northfieldlabs.com.
The SEC allows us to incorporate by reference the information we file with it, which means
that we can disclose important information to you by referring you to those documents. The
information we incorporate by reference is an important part of this prospectus, and later
information that we file with the SEC will automatically update and supersede some of this
information. We incorporate by reference the documents listed below and any future filings we make
with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as
amended (the Exchange Act), until we sell all of the securities covered by this prospectus. The
documents we incorporate by reference are:
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our Current Report on Form 8-K/A filed with the SEC on August 18, 2006; |
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our Annual Report on Form 10-K for the year ended May 31, 2006; and |
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the description of our common stock contained in our Registration Statement on Form 8-A,
Registration No. 33-76856, filed with the SEC on March 25, 1994, including any amendments or
reports filed for the purpose of updating this description. |
1
Information in Current Reports on Form 8-K furnished to the SEC, including under Item 2.02 or
7.01 of Form 8-K prior, on or subsequent to the date hereof is not being and will not be
incorporated herein by reference.
You may request a copy of these filings (other than an exhibit to the filings unless we have
specifically incorporated that exhibit by reference into the filing), at no cost, by writing or
telephoning us at the following address:
Northfield Laboratories Inc.
1560 Sherman Avenue
Suite 1000
Evanston, Illinois 60201-4800
(847) 864-3500
You should rely only on the information incorporated by reference or provided in this
prospectus or any prospectus supplement. We have not authorized anyone else to provide you with
different information. We may only use this prospectus to sell securities if it is accompanied by a
prospectus supplement. We are only offering the securities in states where the offer is permitted.
You should not assume that the information in this prospectus or any prospectus supplement is
accurate as of any date other than the date on the front of those documents.
FORWARD-LOOKING INFORMATION
This prospectus and the documents we incorporate by reference contain forward-looking
statements concerning, among other things, our prospects, clinical and regulatory developments
affecting our potential product and our business strategies. These forward-looking statements are
identified by the use of such terms as intends, expects, plans, estimates, anticipates,
forecasts, should and believes and are in certain cases followed by a cross reference to
Risk Factors.
These forward-looking statements involve risks and uncertainties. Actual results may differ
materially from those predicted by the forward-looking statements because of various factors and
possible events, including those discussed under Risk Factors. Because these forward-looking
statements involve risks and uncertainties, actual results may differ significantly from those
predicted in these forward-looking statements. You should not place undue weight on these
statements. These statements speak only as of the date of this prospectus or, in the case of any
document incorporated by reference, the date of that document.
All subsequent written and oral forward-looking statements attributable to Northfield or any
person acting on our behalf are qualified by the cautionary statements in this section. We do not
undertake any obligation to update or publicly release any revisions to forward-looking statements
to reflect events, circumstances or changes in expectations after the time such statement is made.
2
OUR BUSINESS
Northfield Laboratories Inc. is a leader in developing a hemoglobin-based oxygen-carrying red
blood cell substitute for the treatment of urgent, large volume blood loss in trauma and resultant
surgical settings. The initial indication we are seeking for our product, PolyHeme®, is the early
treatment of urgent, life-threatening blood loss following trauma when donated blood may not be
immediately available. We believe that this indication addresses a critical unmet medical need,
since some trauma patients bleed to death before they have access to blood.
Our principal executive offices are located at 1560 Sherman Avenue, Suite 1000, Evanston,
Illinois 60201-4800, and our telephone number is (847) 864-3500. We maintain an Internet Web site
at www.northfieldlabs.com. We make available free of charge on our Web site our Form 10-Ks, Form
10-Qs, Form 8-Ks and other documents that we file with or furnish to the SEC as soon as reasonably
practicable after filing with the SEC. The information contained on our website, or on other
websites linked to our website, is not a part of this document.
USE OF PROCEEDS
Unless we inform you otherwise in the prospectus supplement, we intend to use the proceeds
from the sale of securities offered by us for general corporate purposes. Our specific use of the
proceeds from the sale of securities offered by us will be described in the prospectus supplement
that will accompany this prospectus. Pending any specific application, we may initially invest
funds in short-term marketable securities.
RATIO OF EARNINGS TO FIXED CHARGES AND PREFERENCE DIVIDENDS
We reported no revenues or earnings during our last five fiscal years. During this period, we
did not have any debt or related interest expense and were not a party to any capital lease
arrangements. No preference securities were outstanding during this period.
DESCRIPTION OF THE SECURITIES WE MAY OFFER
We may offer up to $100,000,000 of common stock, preferred stock, depositary shares, stock
purchase contracts, warrants and debt securities, in one or more offerings and in any combination.
A prospectus supplement, which we will provide each time we offer securities, will describe the
specific amounts, prices and terms of these securities.
We may sell the securities to or through underwriters, dealers or agents or directly to
purchasers. We, as well as any persons acting on our behalf, reserve the sole right to accept and
to reject in whole or in part any proposed purchase of securities. Each prospectus supplement will
set forth the names of any underwriters, dealers or agents involved in the sale of securities
described in that prospectus supplement and any applicable fee, commission or discount arrangements
with them.
COMMON STOCK
We may issue shares of our common stock either alone or underlying other registered securities
convertible into or exercisable or exchangeable for shares of our common stock. Holders of our
common stock are entitled to receive dividends declared by our board of directors out of funds
legally available for the payment of dividends, subject to rights, if any, of preferred stock
holders. Currently, we do not pay a dividend. The holders of our common stock are entitled to one
vote per share and are not entitled to cumulative voting rights for the election of our directors.
The holders of our common stock have no preemptive rights.
3
PREFERRED STOCK AND DEPOSITARY SHARES
We may issue preferred stock, in one or more series, alone or underlying other registered
securities convertible into or exercisable or exchangeable for shares of our preferred stock. Our
board of directors or a committee designated by the board will determine the dividend, voting and
conversion rights and other provisions of the preferred stock at the time of sale. Each series of
preferred stock will be more fully described in the particular prospectus supplement that will
accompany this prospectus, including redemption provisions, rights in the event of liquidation,
dissolution or the winding up of Northfield, voting rights and conversion rights. We may also issue
fractional shares of preferred stock that will be represented by depositary shares and depositary
receipts. Each particular series of depositary shares will be more fully described in the
prospectus supplement that will accompany this prospectus.
WARRANTS
We may issue warrants for the purchase of common stock, preferred stock, depositary shares or
debt securities. We may issue warrants independently or together with other securities. The
specific terms of any warrants will be described in the prospectus supplement that will accompany
this prospectus.
STOCK PURCHASE CONTRACTS
We may issue stock purchase contracts, including contracts obligating holders to purchase from
us, and us to sell to the holders, a specified number of securities, at a future date or dates, or
similar contracts issued on a prepaid basis, which in each case are referred to herein as stock
purchase contracts. The price per share of securities and the number of shares of securities may
be fixed at the time the stock purchase contracts are issued or may be determined by reference to a
specific formula set forth in the stock purchase contracts. The stock purchase contracts will
require either the stock purchase price be paid at the time the stock purchase contracts are issued
or that payment be made at a specified future date. The stock purchase contracts also may require
us to make periodic payments to the holders of the stock purchase contracts or vice versa, and such
payments may be unsecured or refunded on some basis. The specific terms of any stock purchase
contracts will be described in the prospectus supplement that will accompany this prospectus.
DEBT SECURITIES
General
We may issue secured or unsecured obligations in the form of either senior or subordinated
debt. The senior debt securities and the subordinated debt securities are together referred to in
this prospectus as debt securities. The senior unsecured debt securities will have the same rank
as all of our other unsecured unsubordinated debt. The subordinated debt securities generally will
be entitled to payment only after payment of our senior debt. Senior debt generally includes all
debt for money borrowed by us, except debt that is stated in the instrument governing the terms of
that debt to be not senior to, or to have the same rank in right of payment as, or to be expressly
junior to, the senior debt securities. We may issue debt securities that are convertible into or
exchangeable for shares of common stock or other securities or property.
The senior and subordinated debt securities will be issued under separate indentures between a
trustee and us. We have summarized the general features of the debt securities to be governed by
the indentures. These indentures have been filed as exhibits or will be incorporated by reference
into the registration statement that we have filed with the SEC of which this prospectus is a part.
We encourage you to read these indentures. Instructions on how you can get copies of these
documents are provided above in Where You Can Find More Information.
General Indenture Provisions that Apply to Senior and Subordinated Debt
The following general indenture provisions will apply to any senior and subordinated debt
securities:
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each indenture allows debt to be issued in series with terms particular to each series; |
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neither indenture limits the amount of debt that we may issue or generally provides
holders any protection should we engage in a highly leveraged transaction; |
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the indentures allow us to merge or to consolidate with another U.S. entity or convey,
transfer or lease our properties and assets substantially as an entirety to another U.S.
entity, as long as certain conditions are met. If these events occur, the other company will
be required to assume our responsibilities on the debt securities, and we will be released
from all liabilities and obligations, except in the case of a lease; |
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the indentures provide that the trustee and we may generally amend the indenture with the
consent of holders of a majority of the total principal amount of the debt outstanding in
any series to change certain of our obligations or your rights concerning the debt. However,
to change the payment of principal, interest or adversely affect the right to convert or
certain matters, every holder in that series must consent; and |
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we may discharge the indentures and defease restrictive covenants by depositing
sufficient funds with the trustee to pay the obligations when due, as long as certain
conditions are met. The trustee would pay all amounts due to you on the debt from the
deposited funds. |
Events of Default
Each of the following is an event of default under the indentures:
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principal not paid when due; |
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any sinking fund payment not made when due; |
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failure to pay interest for 30 days; |
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covenants not performed for 90 days after notice; and |
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certain events of bankruptcy, insolvency or reorganization of Northfield. |
A prospectus supplement may describe deletions of, or changes or additions to, the events of
default.
Remedies
Upon an event of default, other than a bankruptcy, insolvency or reorganization, the trustee
or holders of 25 percent of the principal amount outstanding in a series may declare the
outstanding principal, plus accrued interest, if any, immediately payable. However, the holders of
a majority in principal amount may, under certain circumstances, rescind this action.
Indenture Provisions that Apply Only to the Subordinated Debt Securities
The subordinated indenture provides that the subordinated debt securities will be subordinated
to all senior debt as defined in the subordinated indenture.
5
PLAN OF DISTRIBUTION
We may sell the offered securities through agents, through underwriters or dealers, directly
to one or more purchasers or through a combination of any of these methods of sale. We will
identify the specific plan of distribution, including any underwriters, dealers, agents or direct
purchasers and their compensation, in a prospectus supplement.
LEGAL MATTERS
Unless otherwise indicated in the applicable prospectus supplement, the validity of the
securities we may offer will be passed upon for us by Baker & McKenzie LLP, Chicago, Illinois. If
securities are distributed in an underwritten offering, the underwriters will be advised by their
own legal counsel with respect to any offering.
EXPERTS
The
financial statements of Northfield Laboratories Inc. as of
May 31, 2006 and 2005, and for each of the years in the
three-year period ended May 31, 2006, and for the cumulative
period from June 19, 1985 (inception) and managements
assessment of the effectiveness of internal control over financial
reporting as of May 31, 2006, have been incorporated by
reference herein and in the registration statement in reliance upon
the reports of KPMG LLP, independent registered public accounting
firm, incorporated by reference herein, and upon the authority of
said firm as experts in accounting and auditing.
The
audit report covering the May 31, 2006, financial statements
refers to a change in accounting due to the adoption of the
provisions of Statement of Financial Accounting Standards
No. 143, Accounting for Asset Retirement Obligations.
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