Issuer Free Writing Prospectus
Filed pursuant to Rule 433
Registration No. 333 - 145403
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DISCLAIMER
The following research report has been
prepared entirely by Scimitar Equity Research (Scimitar)
.
Neurobiological Technologies, Inc. (NTI)
previously engaged Scimitar to initiate research coverage of NTI and has paid Scimitar
a
fee
for the issuance of research reports, as disclosed at the end of this report
. Other than NTIs payment to Scimitar, the research report is independently produced and NTI does not endorse the contents of the report. NTI has not
participated in the preparation of the report and has not provided any information to Scimitar regarding NTI, other than indirectly through NTIs filing of periodic reports with the SEC.
The valuation estimates for NTIs stock and
underlying estimates for potential market size, future revenues and other forward-looking information have been prepared entirely by Scimitar. NTI has not prepared any such estimates of its own and has not reviewed the Scimitar estimates.
Accordingly, NTI does not endorse the Scimitar estimates or any other aspect of this report and investors should not rely on this report as having been reviewed or approved by NTI. For information about NTI that has been prepared by NTI, please
refer to the information at the end of this report under the caption, Free-Writing Prospectus.
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September 19, 2007
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The Secret of Success is Constancy of Purpose: VIPRINEX Could Restore Stroke Patients to Fuller Lives and They Will Be the Real Miracle of NTIIs
Achievement
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Ranking: HOLD
Price at 09/18/07: $ 3.95
52 Week Range: $3.90 $ 22.54
Valuation: $ 51.00
(Current with reverse split)
Valuation: $ 15.00
(Post impending offering)
Market Capitalization: $18.5 m
Float: 4.08 m
Shares Outstanding: 4.7 m
Fiscal Year End: June 30
Exchange: NASDAQ
Henry McCusker
617.559.1080
hwm@scimitarequity.com
Please read the
important
Disclosures Section
At the end of this
review
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Stroke is the nations 3
rd
leading cause of death
The American Heart Association (AHA) approximates 700,000 new or recurrent cases of stroke and total costs in the US in 2007 are estimated to be $62.7 m. It is the nations third leading cause of death after
heart disease and all forms of cancer and is the leading cause of serious, long-term disability. Every 45 seconds someone in the U.S. suffers a stroke and every three minutes someone dies of one. The estimated direct and indirect costs of stroke in
the U.S. were estimated to be approximately $54 B in 2004.
Viprinex doubles
the therapeutic window
NTIIs Viprinex could double the therapeutic
window (6 hours of stroke onset) and could fill a significant unmet need in stroke treatment. Studies have already shown that in patients receiving Viprinex within 6 hours of stroke onset; blood viscosity is progressively reduced by 20-30%
from pretreatment levels resulting in an improvement in blood flow and microcirculation. There is only 1 approved product currently on the market; Genentechs (NYSE:DNA) Activase (recombinant tPA) that is effective in treating ischemic stroke,
the most common type of stroke, which comprises 87% of stroke patients. Activase has an open market, limited competition and drawbacks to its wider adoption. Most importantly, tPA must be given within 3 hours from a patients first symptoms in
order to be therapeutically effective, thus there is a limited treatment window for usage of the drug. This therapeutic window has prevented greater penetration into the market with only 2% to 4% of diagnosed stroke patients receiving the
drug.
If you want a place in the sun leave the shade
There is no new or great treatment for stroke at this point in time and there is now a lot of
excitement in the stroke community concerning Viprinex cascading around the world. NTII has had multiple (4) drug safety monitoring board meetings with clinicians and all have been positive with NTII being allowed to expand the trial. The only
limit to NTIIs realization of shareholder value is the results of the trials. NTII has to raise money to continue these final PIII clinical trials. Upon the SEC filing(s) the stock declined dramatically. At this market capitalization ($ 18.5
m); NTII is grossly undervalued and even trades below a venture pricing. The timing of the SEC filing stinks in this extremely volatile market. However, the risk/reward ratio of this trial coming through is very high and could be a minimum of 10 x
the present value with serious potential for a partnership to the future. This is a cheap stock even with the disclosed stock (7 for 1) reverse and impending financing. The most important issue is to fund the clinical trials to completion where the
risk/reward becomes truly significant. How the stock fluctuates over the next 12(+) months should be considered insignificant compared to what the stock price could be upon successful PIII results; so it will be best to keep your focus on the long
term trend of the stock and not day to day movements
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Neurobiological Technologies, Inc.
Investment Thesis
We are downgrading to a Hold ranking on NTIID in light - only - of the initiated equity financing with a current valuation of $51.00 share price.
Our valuation is derived by a Sum-of-The-Parts analysis which estimates
2009 revenue at approximately $24.5 m and assesses the companys core pipeline to be worth at least $130 m given the risk adjusted (rNPV) of Viprinex. This yields a fair value of $50.88 per share which is then rounded up to achieve our
valuation of $51.00 per share.
NTII has initiated an estimated $60 m equity financing to be conducted over the next 1-2 months (FY08).
NTIIs common stock will trade under the symbol NTIID for 20 trading days to denote the
reverse split. At this market capitalization ($18.5 m); NTII is grossly undervalued and even trades below a venture pricing. The risk/reward ratio of this trial coming through is very high and could be a minimum of 10 x the present value with
serious potential for a partnership to the future.
The most important issue is to fund the clinical trials to completion when the risk/reward becomes
truly significant.
We estimate a fully successful common stock offering would cause at least 14.0 +/- m shares to be added to the current share count of 4.68 m post the 9/17/07 reverse split for/with an end of FY08 total of 18.68 m shares
outstanding. In these current volatile market times; we have stepped back from making specific price targets. Projecting the valuation of NTII should be understood in terms of a quantitative value model and a comprehensive qualitative explanation
that enlightens investors to expectation and the potential utility of this compound.
The valuation post the dilutive $60 m equity financing is modeled to a $15.00 share price.
It is estimated that less than 10% of stroke patients are suitable for current therapies and less than 5% actually receive treatment. A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain
is either blocked by a blood clot (ischemic stroke) or ruptures and bleeds (hemorrhagic stroke). When the tissues are deprived of needed blood they begin to die, affecting various parts of the body and causing paralysis, speech, vision and other
problems
.
One of the primary goals for the treatment of acute ischemic stroke (blockage of a blood vessel that carries oxygen and nutrients to the brain) is improving blood flow through the blocked vessel so that the flow of oxygen and
nutrients to brain tissue is not interrupted or compromised. Brain tissue starved of oxygen can cause loss of neurological function. The Viprinex drug is a unique defibrinogenating agent that has a reperfusion (the restoration of blood flow)
arm to it. Viprinex has a totally different mechanism of action as well as 3 basic mechanisms of action. That is anticoagulant, blood thinning lowering viscosity of blood and the milder fibrinolytic activity to open up the clot and let the
blood flow.
Viprinex has a greater window of 6 hours of onset to initiate treatment and still have therapeutic benefit.
The only agent that has been approved by the regulatory agents is tPA, a reperfusion agents has a 3 hour
window of onset.
One of the largely unstated reasons behind the potential of Viprinex is that tPA has a bleeding rate of roughly 6%.
In
patients with acute ischemic stroke; Intracranial Hemorrhage (ICH) is categorized based on the presence or absence of a clinically detectable neurological deterioration. Its the bleeding in the brain that is the greatest cause of mortality.
The research on the use of tPA for victims of acute ischemic stroke has shown mixed effect(s) as related to bleeding rates but also can cause acute adverse events (including fatal intracranial hemorrhaging).
There is reluctance on the part of a
number of medical institutions (US and ROW) to use the Activase/tPA product because of the fear of symptomatic ICH.
Thus, there exists a largely dissatisfied market and tPA appears to have another major flaw; a marketers dream.
Viprinex has shown evidence of lowering this bleeding rate(s) based on past clinical (from Knoll AG) trials as well as associations and observations from the
on-going clinical trial.
There always will be an ICH rate with any of these drugs but the reduction of bleeding could be one of the major factors in the approval process.
The approval of Viprinex could double the eligible patient number from currently 10% to 20% of total available Ischemic stroke patients.
We think Viprinex could penetrate up to 40% of its eligible
patient base due to its doubling the time available to initiate treatment.
NTII has exclusive worldwide rights to Viprinex for all human therapeutic indications. NTII has initiated the manufacture of product from new sources, dealt with a
variety of CMC issues, performed an animal trial, engaged the Food and Drug Administration (FDA) in a positive dialogue, obtained Fast Track designation and agreed with the FDA on protocol design for the Phase III trial.
Potentially, 20-25% of
the population that suffers from ischemic stroke could be eligible to receive Viprinex, when it is found effective and FDA approved.
Once interim analysis of the stroke trial is announced and is positive; NTII will be on track for dramatic
price appreciation and a global partner who could offset the continued costs of these expensive trials. The anticipated equity offering extends NTIIs ability to finalize the Viprinex PIII clinical trials.
The final and the biggest point of our investment thesis:
Paul Freiman in all his years has never let anyone down and layered with Craig Carlson operational and
financial acumen; I trust they would not lead us down any primrose path. At this market capitalization ($18.5 m), NTIID is extremely undervalued in relation to the 2 scenario modeled valuations.
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9/19/2007
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2
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Neurobiological Technologies, Inc.
NASDAQ Listing, Financing and Reverse Stock Transactions
NTII announced (8/29/07), the receipt of notification from the NASDAQ Listing Qualifications Department that it is not in compliance with the $35 m market value of listed
securities requirement for continued listing on The NASDAQ Capital Market set forth in NASDAQ Marketplace Rule 4310(c)(3)(B). In accordance with the Marketplace Rule 4310(c) (8) (C); NTII has a cure period of 30 calendar days (or until 9/28/07)
to regain compliance. NTII was further advised that it does not comply with either the NASDAQs minimum $2.5 million stockholders equity requirement set forth in Marketplace Rule 4310(c) (3) (A) or the requirement under
Marketplace Rule 4310(c) (3) (C) that the Company report at least $500,000 net income from continuing operations in the most recently completed fiscal year or in two of the last 3 most recently completed fiscal years. To maintain its
listing, NTII must comply with at least 1 of these 3 alternative listing standards. In order for the common stock to continue to be quoted on The NASDAQ Capital Market; NTII must satisfy various listing maintenance standards established by NASDAQ
such as: if the closing bid price of NTIIs common stock is under $1.00 per share for 30 consecutive trading days and does not thereafter reach $1.00 per share or higher for a minimum of 10 consecutive business days during the 90 calendar days
following notification.
NTII expects that it will be able to regain compliance under Marketplace Rule 4310(c) (3) (B) through its proposed
public offering of up to $60-65 m of its common stock, pursuant to the registration statement on Form S-1 that was filed with the SEC on 8/13/07 and which is expected to close after the above-referenced 30-day cure period expires on 9/28/07
A committee of the Board approved (9/14/07) the implementation of the reverse split at a ratio of 1-for-7. The reverse split will be come effective
on Monday, 9/17/07 and the NTIIs common stock will begin trading on the NASDAQ Capital Market on a post-split basis that day. Upon effectiveness of the reverse split, every seven (7) shares of common stock issued and outstanding will be
automatically converted into one (1) new share of common stock. Fractional shares that result from the split will not be issued and holders will be paid cash in lieu of fractional shares. NTIIs common stock will trade under the symbol
NTIID for 20 trading days to denote the reverse split. After that time, the symbol will revert back to NTII. Holders of record will receive instructions from American Stock Transfer & Trust Company, the NTIIs
transfer agent to define the procedures of surrender ing their pre-split share certificates as well as assign their receipt of the new post-split certificates.
NTIIs primary objective in authorizing the reverse split is to raise the share trading price of its common stock and to increase the number of shares of authorized but un-issued common stock.
NTIIs board believed that the
reverse split would; better enable NTII to maintain the listing of its common stock on the NASDAQ Capital Market; facilitating higher levels of institutional stock ownership, where investment policies generally prohibit investments in lower-priced
securities and better enable the NTII to raise funds to finance its planned operations.
An increased stock price due to the reverse split may encourage institutional investor interest and improve the marketability of NTIIs common stock to a
broader range of asset managers, retail brokers and investors hopefully improving liquidity.
Trading volatility is often associated with low-priced stocks, many brokerage firms and Institutional investors have internal policies and practices
that prohibit them from investing in low-priced stocks or tend to discourage individual brokers from recommending low-priced stocks to their customers. The reverse split would reduce the number of shares of common stock outstanding without reducing
the total number of authorized shares of common stock. As a result, NTII would have a larger number of authorized but un-issued shares from which to issue additional shares of common stock, or securities convertible or exercisable into shares of
common stock, in equity financing transactions.
On 9/13/07, NTII filed a registration statement (Form S-1) with the SEC registering the planned offer
and sale of up to $65,000,000 in shares of common stock in an underwritten offering. As disclosed in the NTIIs filing with the SEC; NTII needs to raise additional capital to fund the advanced clinical trials and has elected to do so through
the issuance of equity securities.
Merriman Curhan Ford & Co. will act as underwriter and book-running manager for the proposed offering and will be made only by means of a prospectus. Copies of the prospectus relating to these
securities may be obtained from: Merriman Curhan Ford & Co., 600 California Street, 9th Floor, San Francisco, CA 94108, Telephone 415-248-5600, Fax 415-248-5690.
NTII also completed (9/12/07), a $6.0 m debt and equity bridge financing under its effective shelf registration statement.
In the financing; NTII issued $6.0 million in principal amount of 15% senior secured
promissory notes due 1/15/08 and 2,750,000 shares of common stock, which will be subject to certain trading restrictions until 1/15/08. NTII expects to repay the indebtedness in 10/07 with proceeds from its planned registered public offering.
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9/19/2007
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3
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Neurobiological Technologies, Inc.
Company Description
Neurobiological Technologies, Inc. (NTII) is a biotechnology company engaged in the business of acquiring and developing central nervous system (CNS) related drug candidates.
NTII is developing therapies for neurological conditions that
occur in connection with dementia, Alzheimers disease, ischemic stroke and brain cancer.
NTII was founded in 1988 and went public in February 1994. Currently, NTII employs 26 people, of whom 23 employees are full-time employees.
NTIIs business address is 2000 Powell Street, Suite 800, Emeryville, CA 94608. The phone number is 1-510-595-6000.
Currently, NTII receives revenues on the sales of Namenda
®
(Memantine) (FRX/Merz/Lundbeck), one partnership (Celtic Pharma) with a total of two product
candidates in advanced clinical development. In 9/05, NTII entered into a definitive agreement for the sale of its rights and assets related to XERECEPT
®
a compound for the treatment of
peritumoral brain edema to Celtic Pharma Holdings, L.P. and who will assume responsibility for the clinical development of XERECEPT
®
. NTII is also developing Viprinex
®
for the treatment of acute ischemic stroke. Viprinex, the NTII PIII compound is a thrombin-like enzyme that is highly specific
to fibrinogen. NTII is moving forward in two (2) clinical trials for Viprinex (ancrod), a reperfusion agent currently in Phase III development for acute ischemic stroke. Viprinex is being examined in these 2 Phase III trials by the
enrolment of 650+ patients in approximately 130 sites (80% in North America, 20% Global) with a clinical timeline of 18 months. A U.S. Phase III clinical study was completed in 1998 to evaluate the safety and efficacy of Viprinex in 500
patients. In this study, Viprinex was shown to be effective in preserving neurological function in this patient population. A separate Phase III study was completed in Europe in 2000, enrolling patients within six hours of onset of acute
ischemic stroke. The trial was stopped after a planned interim analysis indicated lack of efficacy and increased incidence of intracranial hemorrhage. The higher dosing levels in the European trial and the protocol criteria are thought to have
contributed to the trials failure. A review of the positive U.S. findings versus the European (past) findings has suggested the need for a revised Viprinex dosing strategy which has been integrated into the new NTII managed Phase III
study. NTII is continuing with process development and manufacturing construction activities for the viper facility in Germany, which is owned and operated by Nordmark Arzneimittel GmbH & Co. KG. This facility will house the snakes needed
to produce the commercial quantities of Viprinex.
NTIIs common stock will trade under the symbol NTIID for 20 trading
days to denote the reverse split.
After that time, the symbol will revert back to NTII.
More information available at:
http://www.ntii.com
Investment Risks
While we believe that NTIIs outlook is attractive, we retain an extra degree of caution due to clinical
expectations of any new and on-going clinical (testing) compounds as well as CRO costs for the expanding clinical sites
. NTII will continue to expend funds for obtaining regulatory approvals, CRO (clinical data and patient trials) costs, and
continued development and integration activities. The partnership of XERECEPT
®
has reduced the burn rate by several million dollars, but the Phase III Viprinex trial is expected to
cost NTII $33 60 m. NTII faces competition from its own collaborators in developing drug candidates. Companies that complete clinical trials obtain required regulatory approvals and first commence commercial sales of their products before
their competitors may achieve a significant competitive advantage. In addition, significant levels of research in biotechnology and medicine occur in universities and other nonprofit research institutions. These entities have become increasingly
active in seeking patent protection and licensing revenues for their research results. Patent protection and competition risk could adversely affect the stock price. Slow and/or unfavorable timing of these patient trials could significantly depress
the share price and its acquisition currency equivalent. Also, if a rash of clinical failures or a scrutinizing FDA creates the perception that the industry is at risk then investor pessimism could likely drive stocks down.
NTII will need to
raise capital at the end of FY07 and/or raise the debt levels in the short term.
In order for the common stock to continue to be quoted on The NASDAQ
Capital Market; NTII must satisfy various listing maintenance standards established by NASDAQ such as: if the closing bid price of NTIIs common stock is under $1.00 per share for 30 consecutive trading days and does not thereafter reach $1.00
per share or higher for a minimum of 10 consecutive business days during the 90 calendar days following notification.
Investors should always read the
risk factors in NTIIs latest 10-K and 10-Q SEC filings, which more fully describe risks that NTII faces, before making any investment decisions.
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9/19/2007
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4
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Neurobiological Technologies, Inc.
Valuation Analysis
We have modeled NTIID current valuation at $51.00 (understanding the reduction in shares due to the reverse split pre the fulfillment of the initiated equity financing).
Our valuation is derived by a Sum-of-The-Parts analysis which
estimates 2009 revenue at approximately $24.5 m and assesses the companys core pipeline to be worth at least $130 m given the risk adjusted (rNPV) of Viprinex.
This yields a current yet fair value of $50.88 per share which is then
rounded up to achieve our valuation of $51.00 per share.
In these current volatile market times; we have stepped back from making specific price targets in many securities opting to defining a targeted valuation scenario. Projecting
the value of NTIIs is at best an inexact and needs to be better understood in terms of a quantitative valuation model with a comprehensive qualitative explanation that could enlighten investors. Price targets just dont seem
to work in this environment. We conduct a pricing (comparable share price) sensitivity analysis by using a combination of methods including a Sum-of-The-Parts analysis and EV/Revenue multiple analysis. Quantitatively, we believe
the stocks valuation should always be conservatively focused and stated in terms of the technology portfolio and the current valuations given to its closest competitors.
We estimate a successful equity offering of NTII (re-listed post this 20 day period) would cause at least 14 m shares to be added to the current share count of 4.68 m post the 9/17/07 reverse split for/with an end of
FY08 total of 18.68 million shares outstanding.
Keeping all the metric as stated, the dilution post $60 m common stock financing would reduce the current valuation derived by sum-of-the-parts analysis to $15.00.
One must remember when it rains it pours; however, the sun eventually comes out. NTII expects that it will be also able to regain compliance under NASDAQ through its
proposed public offering of up to $60-65 m of its common stock pursuant to a filed the registration statement.
We maintain that NTIIs stock should
be valued relative to the potential of its PIII advanced clinical development program, royalty streams, strong management and intellectual property portfolio. NTIIs share price have depreciated due to multiple factors; mainly, the need for an
equity financing to fund the on-going trials for the late stage drug, Viprinex, market conditions, the reverse split, fluctuating trading patterns which have caused volatility in its market capitalization.
We estimate completing 650 patient
enrollments for interim study in Q1/08 and results of interim analysis in Q3/08. We expect the last patient to be enrolled in Q1/09 and the PIII data to be available in Q3/09 and then to file with the FDA in Q1/10.
NTIIDs anticipated
equity offering, continuous revenue stream from Memantine sales should allow NTII to finance the clinical trial costs, complete the manufacturing validation and approval over the next two (2) years plus one (1) quarter estimated to be $60
m.
The only available therapy for stroke (Activase or tPA DNA/Roche) must be administered within the initial three (3) hours, significantly
limiting the number of patients that may be treated. DNAs (Genentech) tPA currently costs $2,000 or more an injection and the population suffering from ischemic stroke annually is approximately 616,000. The clinical and patient response
reference is more attuned to DNAs tPA. The percentage of Activase sales coming from stroke therapy is quite small. It is estimated that 2-4% of stroke patients actually get thrombolytic therapy. That translates into about 40,000 patients per
year in the U.S. & Europe. At this cost of $2000 per patient treatment, the total thrombolytic sales figure specific to stroke is only about $80 m annually in the U.S. & Europe. Factor in the situation wherein Activase is only one
of several thrombolytics currently being used that constitute either: streptokinase; urokinase; or a tissue plasminogen activator such as Activase, and the number is likely to be significantly lower. Therefore, the percent (%) ratio of Activase
sales in stroke vs. other vascular indications such as MI is likely to be very low. Genentech is also not actively promoting the use of the product in the stroke indication anyway, because of the low beneficial outcome rate and the likelihood of
severe side effects (particularly outside the 2-3 hour time window).
Based on these Activase numbers; there is a whole lot of room for NTII (upon
approval) to bring value to shareholders and define a market presence
. If Viprinex is approved by the FDA; the US market it addresses could potentially be (minimally) worth $240 to $325 m a year (assuming estimated eligible patients
120,000 150,000 and a sales price of $2,000 to $2,500,
2005 figures
). NTII and/or a foreign partner would seek regulatory approval of Viprinex for global sales. The worldwide market that Viprinex could address is
potentially over $1 B.
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9/19/2007
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5
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Neurobiological Technologies, Inc.
Valuation Analysis (continued)
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Estimated - Activase - Sales In Stroke: United States & Europe
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2006E
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2007E
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2008E
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2009E
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2010E
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Stroke Population (U.S. & E.U.)
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1,501,500
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1,540,000
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1,578,500
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1,617,963
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1,658,412
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% who receive Thrombolytic Therapy
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2.50
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%
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2.50
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%
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2.50
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%
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2.50
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%
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|
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2.50
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%
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Patients Treated
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37,538
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38,500
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39,463
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40,449
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41,460
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% Treated with Activase
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33.0
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%
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33.0
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%
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33.0
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%
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33.0
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%
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33.0
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%
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# Pts. Treated with Activase
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12,387
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12,705
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13,023
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13,348
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13,682
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Cost per Patient Treatment
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$
|
2,000
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|
|
$
|
2,000
|
|
|
$
|
2,000
|
|
|
$
|
2,000
|
|
|
$
|
2,000
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|
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Activase Revenue in Stroke
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$
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24,774,750
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|
|
$
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25,410,000
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|
|
$
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26,045,250
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$
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26,696,381
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$
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27,363,791
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Source: Scimitar Equity Research, Inc.
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Estimated - Activase - Sales In Stroke: United States Only
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2004A
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2005A
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2006A
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2007E
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2008E
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2009E
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2010E
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Genentech Thrombolytics Sales (US)
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$
|
200,000,000
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|
|
$
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218,000,000
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|
|
$
|
244,000,000
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|
|
$
|
239,000,000
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|
$
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234,000,000
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|
|
$
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230,000,000
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$
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225,000,000
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% Attributable to Stroke (5-10%)
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|
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7.5
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%
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7.5
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%
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|
|
7.5
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%
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7.5
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%
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|
|
7.5
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%
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|
|
7.5
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%
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|
|
7.5
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%
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% Stroke Revenue (in Millions)
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$
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15,000,000
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$
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16,350,000
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$
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18,300,000
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$
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17,925,000
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$
|
17,550,000
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$
|
17,250,000
|
|
|
$
|
16,875,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: Scimitar Equity Research, Inc.
Valuation Assumptions
Sum-of-The-Parts
analysis estimates 2009 revenue of approximately $24.5 m, and assesses the companys core pipeline to be worth at least $130 m given the risk adjusted (rNPV) of Viprinex.
This yields a $50.88 price target (we have rounded to $51.00)
given the companies estimated shares outstanding post NTIIDs 9/17/07 reverse stock split (1:7) and current cash levels (see Sum-of-The-Parts figures below).
NTII:
Sum of the Parts Analysis:
|
|
|
|
|
Part
|
|
Value
|
|
2009E revenues
|
|
$
|
24,510,000
|
|
EV/sales multiple
|
|
|
5.0
|
|
Discount rate
|
|
|
20.0
|
%
|
Periods
|
|
|
1.00
|
|
|
|
|
|
|
Value of revenue
|
|
|
102,125,000
|
|
|
|
|
|
|
Cash
|
|
|
6,000,000
|
|
|
|
|
|
|
EV of pipeline (Viprinex)
|
|
|
130,000,000
|
|
|
|
|
|
|
Total
|
|
|
238,125,000
|
|
Shares outstanding
|
|
|
4,680,000
|
|
|
|
|
|
|
Implied fair value
|
|
$
|
50.88
|
|
|
|
|
|
|
|
|
Per share:
|
|
|
|
|
Revenues
|
|
$
|
21.82
|
|
Cash
|
|
$
|
1.28
|
|
Pipeline
|
|
$
|
27.78
|
|
|
|
|
|
|
Total
|
|
$
|
50.88
|
|
|
|
|
|
|
Source: Scimitar Equity Research, Inc.
|
|
|
|
|
9/19/2007
|
|
6
|
|
|
Neurobiological Technologies, Inc.
Valuation Analysis (continued)
We have modeled a valuation of $51.00
(pre the initiated offering)
which we see as reasonable given the
above metrics, NTIIDs steady royalty stream from sales of Memantine (Namenda
®
and the potential for positive clinical trial results from late stage product Viprinex generating
an FDA approval and NDA filing.
We understand valuation in NTII might seem difficult at this 20 day period due to structural reverse split changes) and attempt to take a conservative approach.
Several valuation approaches are used with the following results:
|
|
|
|
Blended Price Target/Valuation Table
|
|
|
|
|
|
Sum-of-The-Parts
|
|
$
|
50.88
|
EV/Revenue multiple of 10x 2008 Revenue estimates
|
|
$
|
47.18
|
NPV Analysis ( Including the rNPV of Viprinex)
|
|
$
|
42.31
|
|
|
|
|
Avg. Blended Price Target
|
|
$
|
46.79
|
|
|
|
|
Source: Scimitar Equity Research, Inc.
Additional Valuation Assumptions:
The
average EV/Revenue multiple of the comp group is 10 x. We applied this multiple to estimated 2008 revenues and divided by the estimated share count of 4.68 m post September 17, 2007 reverse stock split (1:7) which yields a fair value of
$47.18 for NTII shares. We believe this analysis to be very conservative since it excludes potential future revenues from Viprinex.
NPV
Analysis: NTII currently trades at an approximately $22 million market cap. Compared to our $130 m risk-adjusted NPV (rNPV) for Viprinex, our analysis suggests the stock is currently extremely undervalued.
The risk-adjusted present value of future cash flows from Memantine royalties could be estimated to be about $30 m for Alzheimers disease, and this revenue
stream should run until the patent coverage (however there are on-going negotiations concerning the on-going Namenda revenue stream) although Memantine expires in 2014.
NPV Analysis:
We come to our FY 2008 fair value of $42.31 by computing the total
enterprise value, which includes the risk-adjusted Net Present Value (rNPV) of Viprinex, rNPV of royalties from Memantine and estimated net cash position in 2008, and dividing by the total forecasted share count in FY2008 (4.68 m) post
September 17, 2007 reverse stock split (1:7).
This analysis concludes the total enterprise value for NTII at approximately $200 m which is approx. 9.0x the companys current market cap of approx. $22 m which yields a FY 2008 fair value
of $42.31 for NTII shares.
We estimate the worldwide opportunity for Viprinex is in the (minimal) range of $325-$375 m in Ischemic Stroke.
We
believe the greater window of time to initiate treatment and still have therapeutic benefit could double the eligible patient number from currently 10% to 20% of total available Ischemic stroke patients
and Viprinex could penetrate up to
40% of its eligible patient base due to its doubling the time available to initiate treatment. We believe the greater window of time to initiate treatment and still have therapeutic benefit (6 hours of onset for Viprinex vs. 3 hours of onset
for Activase) could double the eligible patient number from currently 10% to 20% of total available Ischemic stroke patients. Additionally, whereas DNAs Activase has penetrated only 2-4% of its eligible patient potential we think
Viprinex could penetrate up to 40% of its eligible patient base due to its doubling the time available to initiate treatment.
(See model on page 8).
|
|
|
|
|
9/19/2007
|
|
7
|
|
|
Neurobiological Technologies, Inc.
Valuation Analysis (continued)
Viprinex Market Model (Ischemic Stroke Only)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Market
|
|
2009E
|
|
|
2010E
|
|
|
2011 E
|
|
|
2012E
|
|
|
2013E
|
|
|
2014E
|
|
|
2015E
|
|
|
|
|
|
|
U.S. Launch
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual # Stroke Cases
|
|
728,280
|
|
|
|
742,846
|
|
|
|
757,703
|
|
|
|
772,857
|
|
|
|
788,314
|
|
|
|
804,080
|
|
|
|
820,162
|
|
% Cases Ischemic
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
# Ischemic Cases
|
|
633,604
|
|
|
|
646,276
|
|
|
|
659,201
|
|
|
|
672,385
|
|
|
|
685,833
|
|
|
|
699,550
|
|
|
|
713,541
|
|
% Cases Eligible
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
# Cases Eligible
|
|
126,721
|
|
|
|
129,255
|
|
|
|
131,840
|
|
|
|
134,477
|
|
|
|
137,167
|
|
|
|
139,910
|
|
|
|
142,708
|
|
Penetration Rate
|
|
|
|
|
|
2
|
%
|
|
|
4
|
%
|
|
|
8
|
%
|
|
|
16
|
%
|
|
|
32
|
%
|
|
|
40
|
%
|
# Patients Treated
|
|
|
|
|
|
2,585
|
|
|
|
5,274
|
|
|
|
10,758
|
|
|
|
21,947
|
|
|
|
44,771
|
|
|
|
57,083
|
|
Cost per treatment
|
|
|
|
|
$
|
2,200
|
|
|
$
|
2,266
|
|
|
$
|
2,334
|
|
|
$
|
2,404
|
|
|
$
|
2,476
|
|
|
$
|
2,550
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Sales Revenue
|
|
|
|
|
$
|
5,687,226
|
|
|
$
|
11,949,999
|
|
|
$
|
25,109,338
|
|
|
$
|
52,759,741
|
|
|
$
|
110,858,768
|
|
|
$
|
145,585,277
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Market
|
|
2009E
|
|
|
2010E
|
|
|
2011E
|
|
|
2012E
|
|
|
2013E
|
|
|
2014E
|
|
|
2015E
|
|
|
|
|
|
|
|
|
|
E.U. Launch
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual # Stroke Cases
|
|
873,936
|
|
|
|
891,415
|
|
|
|
909,243
|
|
|
|
927,428
|
|
|
|
945,976
|
|
|
|
964,896
|
|
|
|
984,194
|
|
% Cases Ischemic
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
# Ischemic Cases
|
|
760,324
|
|
|
|
775,531
|
|
|
|
791,041
|
|
|
|
806,862
|
|
|
|
822,999
|
|
|
|
839,459
|
|
|
|
856,249
|
|
% Cases Eligible
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
# Cases Eligible
|
|
152,065
|
|
|
|
155,106
|
|
|
|
158,208
|
|
|
|
161,372
|
|
|
|
164,600
|
|
|
|
167,892
|
|
|
|
171,250
|
|
Penetration Rate
|
|
|
|
|
|
|
|
|
|
2
|
%
|
|
|
4
|
%
|
|
|
8
|
%
|
|
|
16
|
%
|
|
|
32
|
%
|
# Patients Treated
|
|
|
|
|
|
|
|
|
|
3,164
|
|
|
|
6,455
|
|
|
|
13,168
|
|
|
|
26,863
|
|
|
|
54,800
|
|
Cost per treatment
|
|
|
|
|
|
|
|
|
$
|
2,060
|
|
|
$
|
2,122
|
|
|
$
|
2,185
|
|
|
$
|
2,251
|
|
|
$
|
2,319
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.U. Sales Revenue
|
|
|
|
|
|
|
|
|
$
|
6,518,181
|
|
|
$
|
13,696,003
|
|
|
$
|
28,778,041
|
|
|
$
|
60,468,419
|
|
|
$
|
127,056,242
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty to NTII (-20%)
|
|
|
|
|
|
|
|
|
$
|
1,303,636
|
|
|
$
|
2,739,201
|
|
|
$
|
5,755,608
|
|
|
$
|
12,093,684
|
|
|
$
|
25,411,248
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japanese Market
|
|
2009E
|
|
|
2010E
|
|
|
2011E
|
|
|
2012E
|
|
|
2013E
|
|
|
2015E
|
|
|
2014E
|
|
|
|
|
|
|
|
|
|
Japan Launch
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual # Stroke Cases
|
|
364,140
|
|
|
|
371,423
|
|
|
|
378,851
|
|
|
|
386,428
|
|
|
|
394,157
|
|
|
|
402,040
|
|
|
|
410,081
|
|
% Cases Ischemic
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
|
|
87
|
%
|
# Ischemic Cases
|
|
316,802
|
|
|
|
323,138
|
|
|
|
329,601
|
|
|
|
336,193
|
|
|
|
342,916
|
|
|
|
349,775
|
|
|
|
356,770
|
|
% Cases Eligible
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
|
|
20
|
%
|
# Cases Eligible
|
|
63,360
|
|
|
|
64,628
|
|
|
|
65,920
|
|
|
|
67,239
|
|
|
|
68,583
|
|
|
|
69,955
|
|
|
|
71,354
|
|
Penetration Rate
|
|
|
|
|
|
|
|
|
|
2
|
%
|
|
|
4
|
%
|
|
|
8
|
%
|
|
|
16
|
%
|
|
|
32
|
%
|
# Patients Treated
|
|
|
|
|
|
|
|
|
|
1,318
|
|
|
|
2,690
|
|
|
|
5,487
|
|
|
|
11,193
|
|
|
|
22,833
|
|
Cost per treatment
|
|
|
|
|
|
|
|
|
$
|
2,060
|
|
|
$
|
2,122
|
|
|
$
|
2,185
|
|
|
$
|
2,251
|
|
|
$
|
2,319
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japan Sales Rev.
|
|
|
|
|
|
|
|
|
$
|
2,715,909
|
|
|
$
|
5,706,668
|
|
|
$
|
11,990,850
|
|
|
$
|
25,195,175
|
|
|
$
|
52,940,101
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty to NTII (-20%)
|
|
|
|
|
|
|
|
|
$
|
543,182
|
|
|
$
|
1,141,334
|
|
|
$
|
2,398,170
|
|
|
$
|
5,039,035
|
|
|
$
|
10,588,020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total WW Sales Revenue
|
|
|
|
|
$
|
5,687,226
|
|
|
$
|
21,184,089
|
|
|
$
|
44,512,008
|
|
|
$
|
93,528,632
|
|
|
$
|
196,522,362
|
|
|
$
|
325,581,620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total WW Sales Rev. to NTII
|
|
|
|
|
$
|
5,687,226
|
|
|
$
|
13,796,817
|
|
|
$
|
28,989,872
|
|
|
$
|
60,913,519
|
|
|
$
|
127,991,487
|
|
|
$
|
181,584,546
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: Scimitar Equity Research, Inc.
|
|
|
|
|
9/19/2007
|
|
8
|
|
|
Neurobiological Technologies, Inc.
Valuation Analysis (continued)
Importantly, NTII had previously announced in 8/07 an estimated $60 m equity financing to be conducted over the next 1-2 months (Fiscal Year 2008).
We understand that a common stock offering which raises the
full or partial financing target of $60 m will cause material dilution of NTIIs common stock.
We estimate a fully successful common stock
offering would cause at least 14 m shares to be added to the current share count of 4.68 m post the 9/17/07 reverse split for/with an end of FY08 total of 18.68 million shares outstanding.
Keeping all other metrics discussed previously in this valuation section steady, the dilution post $60 m financing would reduce our current valuation derived by
sum-of-the-parts analysis to
$15.00
from
$51.00
(see analysis below).
Sum of the Parts Analysis :
Post Est. $60M Financing in FY2008
|
|
|
|
|
Part
|
|
Value
|
|
2009E revenues
|
|
$
|
24,510,000
|
|
EV/sales multiple
|
|
|
5.0
|
|
Discount rate
|
|
|
30.0
|
%
|
Periods
|
|
|
1.00
|
|
|
|
|
|
|
Value of revenue
|
|
|
94,269,231
|
|
|
|
|
|
|
Cash
|
|
|
60,000,000
|
|
|
|
|
|
|
EV of pipeline (Viprinex)
|
|
|
130,000,000
|
|
|
|
|
|
|
Total
|
|
|
284,269,231
|
|
Shares outstanding
|
|
|
18,680,000
|
|
|
|
|
|
|
Implied fair value
|
|
$
|
15.22
|
|
|
|
|
|
|
|
|
Per share:
|
|
|
|
|
Revenues
|
|
$
|
5.05
|
|
Cash
|
|
$
|
3.21
|
|
Pipeline
|
|
$
|
6.96
|
|
|
|
|
|
|
Total
|
|
$
|
15.22
|
|
|
|
|
|
|
Source: Scimitar Equity Research, Inc.
Additionally, the increase share count/common stock post estimated FY08 $60 m stock offering would affect our rNPV analysis and EV/Revenue multiple analysis with the
following results:
|
|
|
|
Blended Price Target/Valuation Table Post Est. $60M Financing in FY 2008
|
|
|
Sum-of-The-Parts
|
|
$
|
15.22
|
EV/Revenue multiple of 10x 2008 Revenue estimates
|
|
$
|
10.70
|
NPV Analysis ( Including the rNPV of Viprinex)
|
|
$
|
10.60
|
|
|
|
|
Avg. Blended Price Target
|
|
$
|
12.17
|
|
|
|
|
Source: Scimitar Equity Research, Inc.
|
|
|
|
|
9/19/2007
|
|
9
|
|
|
Neurobiological Technologies, Inc.
Pipeline Chart
|
|
|
|
|
|
|
Indication
|
|
Product
|
|
Development Status
|
|
Primary Benefits Sought
|
Ischemic Stroke
|
|
Viprinex
|
|
Multiple PIII trials being initiated in the US and EU, Canada and ROW
Knoll had successfully completed Phase II and Phase III trials in the U.S.; failed a Phase III trial
in Europe. Nearly 2000 stroke patients studied to date.
|
|
Minimize neurological damage and functional outcome while limiting adverse effects (intracranial hemorrhage). A new brief, single administration dosing regimen expected to yield optimized safety
and efficacy when compared to multiple day dosing regimens employed in earlier studies.
|
Viprinex Calendar Year Time Line
Viprinex Competition
|
|
|
|
|
|
|
Company
|
|
Drug Name
|
|
Status
|
|
Partner
|
Genentech Inc. (DNA)
|
|
Activase
®
(tPA)
|
|
Approved
|
|
Roche
|
Paion GmbH
|
|
Desmoteplase
|
|
Restarted Clinical Trial Following
Temporary Suspension
|
|
Forest Labs (FRX) Terminated the Partner Agreement
|
|
|
|
|
|
9/19/2007
|
|
10
|
|
|
Neurobiological Technologies, Inc.
Comparables
|
|
|
|
|
|
|
|
|
|
|
|
|
Company
|
|
Ticker
Symbol
|
|
Price
(009./18/2007)
|
|
12 month
High-Low
|
|
Shares
(MM)
|
|
Mkt. Cap
($MM)
|
Neurobiological Technologies
|
|
NTII
|
|
$
|
3.95
|
|
$22.54 - $ 3.90
|
|
4.69 m
|
|
$
|
18.53 m
|
|
|
|
|
|
|
Paion AG (Frankfurt Exchange)
|
|
PAIOF.PK
|
|
|
1.73
|
|
10.50 - 1.72
|
|
N/A
|
|
|
N/A
|
|
|
|
|
|
|
Renovis
|
|
RNVS
|
|
$
|
3.32
|
|
$15.46 - $ 2.53
|
|
29.72 m
|
|
$
|
98.68 m
|
|
|
|
|
|
|
Forest Laboratories
|
|
FRX
|
|
$
|
37.93
|
|
$57.97 - $ 35.01
|
|
316.15 m
|
|
$
|
11.99 B
|
Comparables Chart
for NTII:
|
|
|
|
|
9/19/2007
|
|
11
|
|
|
Neurobiological Technologies, Inc.
Catalysts and Milestones
|
|
|
|
|
DATE
|
|
EVENTS
|
|
STATUS
|
On-going
|
|
Receipt of royalty stream from sales of Namenda/Ebixa from Merz
|
|
On-going
|
|
|
|
Q3/2005
|
|
FDA Fast track status for Viprinex
|
|
Completed
|
|
|
|
Q1/2006
|
|
Receipt of $10 million line of credit
|
|
Completed
|
|
|
|
Q1/2006
|
|
Partnership for XERECEPT®
|
|
Completed
|
|
|
|
Q2/2006
|
|
Viprinex 1
st
Phase III Trial Enrollment (18 month expected duration)
|
|
On-going
|
|
|
|
Q3/2006
|
|
Payment of $5 m from Celtic Pharma
|
|
Completed
|
|
|
|
Q3/2006
|
|
Payment of $1.37 m from Merz from Quarterly Namenda royalty
|
|
Completed
|
|
|
|
Q4/06
|
|
Viprinex 2
nd
Phase III Trial Enrollment(18 month expected duration)
|
|
Completed
|
|
|
|
Q4/06
|
|
Receipt of $4 m from Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) as part of the previously announced sale of worldwide rights to Celtic Pharma for XERECEPT®
|
|
Completed
|
|
|
|
Q4/06
|
|
Receipt of $1.59 m from Quarterly Namenda royalty
|
|
Completed
|
|
|
|
Q1/07
|
|
Restatement in order to record as an expense the acquisition costs assigned to certain tangible and intangible assets acquired in connection with NTIIs acquisition of Empire
Pharmaceuticals in 7/04
|
|
Completed
|
|
|
|
Q4/07
|
|
Compliance with the Nasdaq financial report filing requirements
|
|
Completed
|
|
|
|
Q4/07
|
|
Receipt of $2 m from Quarterly Namenda royalty
|
|
Completed
|
|
|
|
Q3/07 Q4/07
|
|
$7.4 m Financing for Continued Clinical Development
|
|
Completed
|
|
|
|
Q4/07
|
|
Payment of $ 2.0 m from Merz from Quarterly Namenda royalty
|
|
Completed
|
|
|
|
Q4/07
|
|
Proxy for Common Share Reverse Split Shareholder Approval
|
|
Completed
|
|
|
|
Q1/08
|
|
Financing to fund completion of Viprinex clinical trial
|
|
Initiated
|
|
|
|
FY2008
|
|
Interim Analysis for XERECEPT®
|
|
|
|
|
|
FY2008
|
|
Interim Analysis for Viprinex
|
|
|
|
|
|
|
|
9/19/2007
|
|
12
|
|
|
Neurobiological Technologies, Inc.
Capitalization
|
|
|
Financial Instruments
|
|
# of Shares
|
Authorized Common Stock
|
|
50,000,000
|
Shares Outstanding
|
|
32,834,294
|
|
|
Conversion of Preferred into Common
|
|
494,000
|
Warrants
|
|
3,808,087
|
|
|
1993 Stock Plan and 2003 Equity Incentive Plan
|
|
3,731,732
|
2003 Employee Stock Purchase Plan
|
|
447,756
|
Fully Diluted Share Total
|
|
41,315,869
|
Insider and Top Institutional Holdings
Insider Holdings
|
|
|
|
|
|
Holder
|
|
Shares
|
|
% Outstanding
|
|
Management and Directors:
|
|
2,188,307
|
|
6.67
|
%
|
|
Top Institutional Holders
|
|
|
|
|
Holder
|
|
Shares
|
|
% Out
|
|
Biotechnology Value Fund, Inc.
|
|
2,546,315
|
|
7.76
|
|
David M. Knott Partnership
|
|
1,408,345
|
|
4.29
|
|
Stark Asset Management, L.L.C.
|
|
1,223,476
|
|
3.73
|
|
Mak Capital One L.L.C.
|
|
762,947
|
|
2.32
|
|
Highbridge Capital Management, LLC
|
|
759,933
|
|
2.31
|
|
Great Point Partners, L.L.C.
|
|
642,491
|
|
1.96
|
|
Barclays Global Investors, N.A.
|
|
627,109
|
|
1.91
|
|
Vanguard Group, Inc.
|
|
589,102
|
|
1.79
|
|
Paloma Partners Management Company
|
|
525,774
|
|
1.60
|
|
Renaissance Technologies Corp.
|
|
341,100
|
|
1.04
|
|
Deephaven Capital Management, L.L.C.
|
|
300,000
|
|
0.91
|
|
Deutsche Asset Management Americas
|
|
272,880
|
|
0.83
|
|
J.P. Morgan Securities Inc.
|
|
100,000
|
|
0.30
|
|
|
|
|
|
|
9/19/2007
|
|
13
|
|
|
Neurobiological Technologies, Inc.
Technology, Strategic Alliances, Management, Board
To access technology section click on the link below
HTTP:
Technology Review
|
|
|
|
|
9/19/2007
|
|
14
|
|
|
Neurobiological Technologies, Inc.
Q4/07 and FY07 Financial Highlights
For FY07, NTII reported revenue of $17.7 m, a 44% increase over last years revenue of $12.3 m. The net loss for FY07 was $14.1 m, or $0.47 per share, compared with a net loss of $27.8 m, or $0.98 per share, in
FY06. At the end of Q4/07, NTIIs balance of available cash, cash equivalents and investment securities was $8.9 m.
For Q4/07, NTII reported revenue
of $4.0 m compared to $4.3 m for the same period in 2006. The net loss for Q4/07 was $4.2 m, or $0.13 per share, compared with a net loss of $4.8 million, or $0.16 per share, for Q4/06. For FY07, NTII reported revenue of $17.7 m consisting of $6.9 m
of royalty fees earned from the commercial sales of memantine by Merz + Co. GmbH & Co. (Merz) and its marketing partners in the United States and certain European countries, $5.5 m from the sale of NTIIs rights and assets related to
XERECEPT® to Celtic Pharmaceutical Holdings L.P. (Celtic), and $5.3 m from the reimbursement of the direct expenses incurred for services provided to Celtic for administering the Phase III clinical trials for XERECEPT in the United States.
NTIIS FY06 revenues of $12.3 m consisted of $5.1 m of royalty fees earned from the commercial sales of memantine by Merz and its marketing partners in the United States and certain European countries, $3.2 m from the sale of NTIIs rights
and assets related to XERECEPT to Celtic, and $4.0 m from the reimbursement of the direct expenses incurred for the services provided to Celtic.
R&D
expenses of $26.7 m in the year ended June 30, 2007 increased by $3.9 m compared to R&D expenses of $22.8 m in FY06. During FY07, $21.2 m of the R&D expenses were focused on Viprinex, with the remaining $5.5 m on XERECEPT. The
increase in research and development expenses resulted from an additional $5.2 m of expenses incurred for the Phase 3 clinical trials of Viprinex, which was partially offset by a decrease of $1.3 m of reimbursed expenses for the continuing Phase 3
clinical trials for XERECEPT. NTII had no acquired in-process research and development expenses for FY07 compared to $11.5 m for FY06. The FY06 expenses represented the expensing of certain tangible and intangible assets related to the acquisition
of Empire Pharmaceuticals from 2005.
G&A expenses totaled $6.5 m for FY07 compared to $6.0 m in FY06. The increase in G&A expenses resulted
primarily from increases of approximately $362,000 for compensation, $259,000 for consultants and $276,000 for audit fees, offset by a $243,000 decrease in legal fees.
Investment income for FY07 totaled approximately $494,000 compared to $399,000 in fiscal year 2006. The increase was due to higher average cash balances in FY07 and an increase in our average rate of return on our
investment portfolio. Gain on change in value of warrants totaled $980,000 for FY07 compared to zero in FY06.
In 4/07, NTII sold 3,043,478 shares of
common stock and warrants and NTII recognized a change in the value of the warrants of $980,000 during Q4/07 due to a decline in NTIIs stock price during that time.
|
|
|
|
|
9/19/2007
|
|
15
|
|
|
Neurobiological Technologies, Inc.
Financials
NEUROBIOLOGICAL TECHNOLOGIES, INC.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FY06
|
|
|
2007
|
|
|
FY07
|
|
|
|
Sep
|
|
|
Dec
|
|
|
Mar
|
|
|
Jun
|
|
|
Total Revenue
|
|
12,339,000
|
|
|
4,780,735
|
|
|
4,020,000
|
|
|
4,878,000
|
|
|
3,994,000
|
|
|
17,673,000
|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
22,808,000
|
|
|
5,858,459
|
|
|
5,681,000
|
|
|
7,690,000
|
|
|
7,508,000
|
|
|
26,737,000
|
|
|
|
|
|
|
|
|
Acquired in-process R&D
|
|
11,501,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
5,968,000
|
|
|
1,493,648
|
|
|
1,565,000
|
|
|
1,686,000
|
|
|
1,792,000
|
|
|
6,537,000
|
|
|
|
|
|
|
|
|
Total Expenses
|
|
40,277,000
|
|
|
7,352,107
|
|
|
7,246,000
|
|
|
9,376,000
|
|
|
9,300,000
|
|
|
33,274,000
|
|
|
|
|
|
|
|
|
Investment income, net
|
|
399,000
|
|
|
153,638
|
|
|
116,000
|
|
|
84,000
|
|
|
140,000
|
|
|
494,000
|
|
|
|
|
|
|
|
|
Income tax benefit (provisional)
|
|
(300,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (loss)
|
|
(27,839,000
|
)
|
|
(2,417,735
|
)
|
|
(3,110,000
|
)
|
|
(414,000
|
)
|
|
(4,186,000
|
)
|
|
(14,127,000
|
)
|
|
|
|
|
|
|
|
Basic and Diluted net loss per share
|
|
(0.98
|
)
|
|
(0.08
|
)
|
|
(0.11
|
)
|
|
(0.15
|
)
|
|
(0.13
|
)
|
|
(0.47
|
)
|
|
|
|
|
|
|
|
Shares used in basic and diluted net loss per share
|
|
28,490,000
|
|
|
29,558,429
|
|
|
29,558,580
|
|
|
29,663,697
|
|
|
32,685,615
|
|
|
30,364,114
|
|
|
|
|
|
Balance Sheet Metrics
|
|
FY06
|
|
|
2007
|
|
|
FY07
|
|
|
|
Sep
|
|
|
Dec
|
|
|
Mar
|
|
|
Jun
|
|
|
Cash, cash equivalents and investment securities
|
|
15,248,000
|
|
|
5,833,480
|
|
|
7,427,000
|
|
|
5,562,000
|
|
|
8,904,000
|
|
|
8,904,000
|
|
|
|
|
|
|
|
|
Total assets
|
|
22,499,000
|
|
|
18,664,790
|
|
|
14,236,000
|
|
|
8,434,000
|
|
|
10,921,000
|
|
|
10,921,000
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
(95,141,000
|
)
|
|
(97,558,883
|
)
|
|
(100,699,000
|
)
|
|
(105,083,000
|
)
|
|
(109,269,000
|
)
|
|
(109,269,000
|
)
|
|
|
|
|
|
|
|
Stockholders equity (deficit)
|
|
(11,402,000
|
)
|
|
(13,595,505
|
)
|
|
(16,545,000
|
)
|
|
(20,413,000
|
)
|
|
(22,093,000
|
)
|
|
(22,093,000
|
)
|
The information contained herein is believed to be reliable, but is not guaranteed by us.
Please review our multiple disclosures section. 09/19/2007
|
|
|
|
|
9/19/2007
|
|
16
|
|
|
Neurobiological Technologies, Inc.
Quarterly Press Releases
Neurobiological Technologies, Inc. Reports Fourth Quarter and Fiscal Year-End Financial Results for 2007 Announces 1-for-7 Reverse Stock Split
Friday September 14
Conference Call Scheduled for September 17 at 10:30 ET, 7:30 PT
Neurobiological Technologies, Inc. announced its financial results for its fiscal fourth quarter and year ended June 30, 2007 and announced a planned 1-for-7 reverse
split of its common stock.
Neurobiological Technologies, Inc. Reports Receipt of Notice From Nasdaq
Friday August 31
Neurobiological Technologies, Inc,
announced that on August 29, 2007, the Company received notification from the NASDAQ Listing Qualifications Department that it is not in compliance with the $35 million market value of listed securities requirement for continued listing on The
NASDAQ Capital Market set forth in NASDAQ Marketplace Rule 4310(c)(3)(B). In accordance with Marketplace Rule 4310(c)(8)©, the Company has a cure period of 30 calendar days, or until September 28, 2007, to regain compliance.
Neurobiological Technologies Files Registration Statement for a Common Stock Offering
Monday August 13
Neurobiological Technologies, Inca specialty biopharmaceutical company, announced that it has
filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission for a proposed public offering of up to $65 million of its common stock. Proceeds from the offering will be used primarily to fund the ongoing clinical
development of Viprinex(TM) (ancrod). All of the shares in the proposed offering are being sold by the Company.
Neurobiological Technologies Reports $2
Million Quarterly Payment for Sales of Memantine
Wednesday August 1
Neurobiological Technologies, Inc. announced it has received approximately $2 million from Merz Pharmaceuticals GmbH (Merz) for sales by Merz and its marketing partners of Memantine for the treatment of
moderate-to-severe Alzheimers disease for the quarter ended March 31, 2007. This represents a 25% increase in NTIIs royalty payments compared to the same quarter last year. Under an exclusive marketing agreement, NTI receives
quarterly royalty payments on sales of Memantine by Merz and its marketing partners.
Presentations at 2007 European Stroke Congress Highlights New
Direction for Viprinex(TM) (ancrod)
Thursday May 31
Investigational drug being pursued for the treatment of ischemic stroke
Neurobiological Technologies, Inc announced the presentation
of new analysis of data from prior clinical trials of ancrod and updates on the clinical development of their investigational drug, Viprinex(TM) (ancrod), for the treatment of acute ischemic stroke at the 16th annual European Stroke Congress in
Glasgow, Scotland in the United Kingdom. Viprinex is a defibrinogenating agent derived from the venom of the Malayan pit viper.
Neurobiological
Technologies, Inc. to Present at Dutton Associates Recognizing Opportunity SmallCap Conference in San Francisco May 30, 2007
Tuesday May 29
Neurobiological Technologies, Inc. announced that Craig W. Carlson, Vice President and Chief Financial Officer, will
present at Dutton Associates Recognizing Opportunity SmallCap Conference at 10:50 am on May 30, 2007 at the Omni Hotel in San Francisco.
Neurobiological Technologies, Inc. to Present at the Bio 2007 Business Forum
Friday May 4
Neurobiological Technologies, Inc., announced that Paul E. Freiman, President and Chief Executive Officer will present at the BIO 2007 Business Forum in Boston on
May 7 at 4 p.m. in room B. The BIO conference is being held May 7-9, 2007, at the Boston Convention and Exhibition Center.
Neurobiological
Technologies Reports $1.9 Million Quarterly Payment for Sales of Memantine
Wednesday May 2
Neurobiological Technologies, Inc., announced it has received approximately $1,900,000 from Merz Pharmaceuticals GmbH (Merz) for sales of Memantine for the treatment of
moderate-to-severe Alzheimers disease for the quarter ended December 31, 2006. Under an exclusive marketing agreement, NTI receives quarterly royalty payments on sales of Memantine by Merz and its marketing partners.
|
|
|
|
|
9/19/2007
|
|
17
|
|
|
Neurobiological Technologies, Inc.
Please Read these Important Disclosures!
Reg. AC, Analyst Certification
I, Henry W. McCusker, hereby certify that all the views expressed in this review,
accurately reflect my personal views about the subject Company or companies and its or their securities. No part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views contained in this
review.
http://www.scimitarequity.com/disclosure/index.jsp
Compensation for Products and Services
Scimitar makes publicly available an excel format statement of yearly payments by covered companies.
http://www.scimitarequity.com/disclosure/company_specific_disclosure.jsp
Regulatory Disclosure
Scimitar Equity Research, Inc. (Scimitar) is an equity research firm providing unbiased and
insightful analysis for under-followed and small capitalization health science companies. Scimitar is a publisher of research utilizing the sponsored or paid-for research compensation model to increase visibility and access
for these sector specific companies. Scimitar clearly and prominently articulates a statement of financial sponsorship and has a compensation arrangement for this quarterly ($7,500) research review. Scimitar provides qualitative
scientific and financial analyses to identify those companies demonstrating real progress towards their vision while meeting quarterly expectations Scimitar delivers this research and analysis of selected segments within the health/life science
industry via the world-wide web and our proprietary database to the institutional, advisory and retail investment communities. To maximize transparency in analyst certification, we are required to disclose any potential conflicts of interest thus
insuring independence. We do not accept payment of any fees in company stock or any form of security.
http://www.scimitarequity.com/disclosure/regulatory_disclosure.jsp
Company Specific Risk Disclosure
The specific risks for those companies covered by Scimitar Equity Research, Inc. (Scimitar) may be greater than the general risks involved with common stock. The majority
of the companies covered by Scimitar are development stage companies that are not profitable, and may not be profitable in the foreseeable future. The majority of the companies we cover rely heavily on equity financing to fund their continuing
operation. If one or more of these companies is/are unable to sell equity to fund its operations, then that/those particular company/ies may become insolvent. The futures of these companies are reliant on approval of their drugs/diagnostics by the
FDA. Also, if clinical and regulatory approvals are granted for one of the companys products, then that does not necessarily guarantee revenue. The companies are subject to manufacturing and regulatory risks as well. These risks could
adversely affect future earnings of each company. The shareholders of each company are reliant on the board of directors and management to objectively manage the company in a manner that maximizes shareholder value. The board of directors and
management of a particular company may have different objectives or lack competency to reach the shareholders goals. A misalignment of corporate governance would put that particular company at financial risk. These companies are dependent on
key employees and are reliant on current management to run each company. If there is a sudden change of management for any number of reasons, it could affect the future performance of the company. The ability to hire skilled workers and retain them
is necessary for each companys success. There is no guarantee that certain patents and trademarks that a particular company claims to will be upheld in the United States or abroad. These intellectual properties, patents and trademarks may be
infringed by other companies without financial recourse to a particular company
.
The company/ies may also be sued by other companies or individuals for patent/trademark infringement, clinical/manufacturing faults, or for any number of
legal/contractual reasons. Development stage companies face several competitors in the biotechnology/diagnostics/devices field that may have greater access to capital, clinical expertise, and marketing expertise. Their competitors may have better
products, manufacturing capabilities and reach FDA approval with a similar product before these companies. Increased competition in these fields may adversely affect a particular companys stock price. Many companies covered by Scimitar are
classified as penny stocks and the price of these companies stocks may move substantially on little volume. Because each company is a penny stock, the companies are subject to increased market price volatility and risk. These
companies have an increased degree of volatility relative to the overall market. Risk-averse investors, and all other investors, should be aware of the risks associated with these companies and read all 10-Ks and 10-Qs before considering
any investment. Investors are expected to be knowledgeable and competent of these risks themselves, or otherwise, speak to their investment advisors before purchasing any securities in the market. Scimitar does not accept any liability for whatever
actions an investor takes on their own, or with the advice of their investment advisor after reading Scimitars research reports.
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Legal Disclaimer
The information, opinions, scientific data, quantitative and qualitative statements contained in these reviews have been obtained from research, trade and statistical
services as well as other sources believed to be reliable. The information, opinions, or recommendations contained in these reviews are submitted solely for advisory and informational purposes. Scimitars opinions and estimates reflect current
judgment; they are neither all-inclusive nor can they be guaranteed to be complete or accurate. The opinions expressed are our current opinions as of the date appearing on the review only. Our analysis is subject to possible change without notice.
This research contains forward looking statements, which involve risk and uncertainty. The reviews are not a complete analysis of every material fact regarding this company, industry, or security. The information in these reviews are not intended to
be used as the primary basis of investment decisions, and because of individual or investment objectives it should not be construed as advice designated to meet the particular investment needs of any investor. Investors are expected to take full
responsibility for any and all of their investment decisions. Investors must make investment decisions based on their evaluation of their own investment goals, risk tolerance, and financial condition. Scimitar Equity Research, Inc., our officers,
our advisors, and our partners accept no liability whatsoever for any direct or consequential losses arising from any use of the information obtained on or through our web site. The information in these company reviews is not a representation or
warranty and is not a solicitation of any offer to buy or sell this security.
http://www.scimitarequity.com/disclosure/legal_disclaimer.jsp
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Neurobiological Technologies, Inc.
Please Read these Important Disclosures! (continued)
Research Dissemination
The information presented on our web site is provided only as an aid for informing those who make their own investment decisions and are not to be used or considered as an offer to sell or solicitation of an offer to buy any financial
products. Clients may also receive our research via Thomson Financial: FirstCall - Investext. Security laws of these resident countries vary significantly. This site is intended to be accessed by residents of the United States and by residents of
other jurisdictions only where permitted by law.
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Rating Definitions
Informational: It has been our practice to generate an informational company review when we initiate coverage. A Buy ranking could
accompany a price target but these company reviews generally entail that additional information is needed to determine or clarify the companies approach to the growth opportunity.
Buy: Stocks ranked Buy are those stocks Scimitar recommend actively buying. These are stocks that are demonstrating their vision while meeting expectation and should appreciate at least 10% over the next 6
months.
Hold: Stocks ranked Hold are those stocks Scimitar would continue to hold in a portfolio. These are stocks that are making progress
strategically and operationally but are not expected to demonstrate significant appreciation in the next 6 months.
Sell: Stocks ranked Sell
are those Scimitar would sell; these are stocks that appear not to be able to fulfill or deliver on their disclosed milestones and are expected to depreciate at least 10% over the next 6 months.
Termination (of coverage): In the event an analysts coverage is terminated, there is a requirement that firms notify investors when coverage is dropped. This
notice must include a final ranking or recommendation. The rule specifically calls for notice to be made in the same manner as in research coverage was first initiated.
http://www.scimitarequity.com/content/disclosure/distribution-rankings.jsp
Valuation Methodology
Projecting the future valuation of companies and their innovative technology is at best an inexact science and needs to be understood in terms of its
intent and vulnerabilities. Scimitar accepts its responsibility to research and prudently perform analysis while incorporating due diligence. The value of science or technology platform, product development cycles, regulatory timelines and filings,
collaboration partners, management team and ultimately market initiatives should not be quantitatively modeled too early.
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is committed to respecting the rights of those individuals viewing or utilizing this website, and the protection of any information that might be collected or that which you as a subscriber may choose to share.
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Current Disclosures
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Applicable current disclosures can be downloaded from our website, by calling the telephone number listed below, or by writing to the address listed below:
Scimitar Equity Research, Inc.
88 Washington Park
Newton MA 02460
617.559.1080
info@scimitarequity.com
www.scimitarequity.com
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Free-Writing Prospectus
Neurobiological Technologies, Inc. (the issuer) has filed a registration statement (including a prospectus) with the SEC for the offering referred to in this report and thus to which this communication relates. Before you
invest, you should read the prospectus in that registration statement and the other documents the issuer has filed with the SEC for more complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR
on the SEC Web site at www.sec.gov. Alternatively, the issuer, any underwriter or dealer participating in the offering will arrange to send you the prospectus if you request it by calling 415-248-5600.
A copy of the above-referenced prospectus can be accessed through the following hyperlink:
http://www.sec.gov/Archives/edgar/data/918112/000119312507203280/ds1a.htm
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Neurobiological Technologies (MM) (NASDAQ:NTIID)
過去 株価チャート
から 5 2024 まで 6 2024
Neurobiological Technologies (MM) (NASDAQ:NTIID)
過去 株価チャート
から 6 2023 まで 6 2024