NovaBay Pharmaceuticals (NBY) - LifeTech Capital
NovaBay Pharmaceuticals (NBY) - LifeTech Capital
NovaBay Pharmaceuticals (NBY) - LifeTech Capital
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www.<strong>LifeTech</strong><strong>Capital</strong>.com December 7, 2010<br />
34 to 68 sec (range each). Fibrinogen decreased from 258 to 283 mg/dl (range of controls) to < 40 mg/dl in samples<br />
containing chloramines. The effects were significant compared to controls without oxidative power (p < 0.01 for all). No<br />
direct thrombin inhibition was observed by NVC-422, NVC-612 or DMT at concentrations tested (0.4, 4 and 40mM).<br />
Conclusions: These results indicate a specific anticoagulant effect of NCT, NVC-612 and NVC-422 on the blood<br />
coagulation system consistent with previous literature reports on chloramines. This added effect is beneficial for<br />
evaluating NCT, NVC-612 and NVC-422 as potential CVC catheter lock solutions.<br />
Financial Model Assumptions<br />
Royalty Revenue: Our sales model reflects a traditional biotechnology company with all product candidates eventually<br />
being partnered for marketing and distribution. Investors should note that we have not yet added Alcon’s contact lens<br />
solution and sinusitis programs nor <strong>NovaBay</strong>’s onychomycosis program as the development pathways and timelines are<br />
not yet clear enough for us to model. However these indications would represent potential upside to our model. Our<br />
current assumptions are as follows:<br />
Indication Launch Peak Sales (3 Years) Partner Royalty<br />
Impetigo Q4’12 $80M Galderma 10%-30%<br />
Urinary Catheters Q4’12 $200M ($500M if prophylactic) --- 20% Assumed<br />
Conjunctivitis Q4’12 $500M ($1B if antiviral also) Alcon 7%<br />
Otitis Externa / Media Q3’13 $500M Alcon 7%<br />
Acne Q1’13 $200M Galderma 10%-30%<br />
Source:<strong>LifeTech</strong> <strong>Capital</strong> Estimates<br />
<strong>NovaBay</strong> FDA-Approved Products<br />
NeutroPhase (NVC-101) – FDA Approved September 2007<br />
NeutroPhase is a solution containing HOCI (hypochlorous acid) which is rapid-acting but short-lived making it ideal for<br />
multiple applications, especially in surface wound care. In April 2007, <strong>NovaBay</strong> filed a 510(k) application to the FDA for<br />
wound management as a wound cleanser and debriding agent and subsequently received FDA approval in September<br />
2007. NeutroPhase was licensed to Kinetic Concepts (NYSE:KCI) in June 2007 for the exclusive worldwide rights to<br />
develop, manufacture and commercialize for use in wound care in humans. <strong>NovaBay</strong> received from KCI a non-refundable<br />
technology access fee of $200,000. There are also milestone payments up to $1.25 million and royalty payments based on<br />
net revenues. We have not included NeutroPhase in our financial model as we lack visibility on the status within KCI.<br />
Partnerships<br />
Alcon (NYSE:ACL)<br />
In August 2006, <strong>NovaBay</strong> entered into a collaboration and license agreement with Alcon Manufacturing, Ltd. to license to<br />
Alcon the exclusive rights to develop, manufacture and commercialize products incorporating the Aganocide compounds<br />
for application in connection with the eye, ear and sinus and for use in contact lens solution. Under the terms of the<br />
agreement, Alcon agreed to pay an up-front, non-refundable, non-creditable technology access fee of $10.0 million upon<br />
the effective date of the agreement. This up-front fee was recorded as deferred revenue and is being amortized into<br />
revenue on a straight-line basis over the four-year funding term of the agreement, through August 2010. Additionally,<br />
<strong>NovaBay</strong> will receive semi-annual payments to support on-going research and development activities over the four year<br />
funding term of the agreement. The research and development support payments include amounts to fund a specified<br />
number of personnel engaged in collaboration activities and to reimburse for qualified equipment, materials and contract<br />
study costs. <strong>NovaBay</strong>’s obligation to perform research and development activities under the agreement expires at the end<br />
of the four year funding term. As product candidates are developed and proceed through clinical trials and approval,<br />
<strong>NovaBay</strong> will receive milestone payments. If the products are commercialized, <strong>NovaBay</strong> will also receive royalties on<br />
any sales of products containing the Aganocide compound. Alcon has the right to terminate the agreement in its entirety<br />
<strong>NovaBay</strong> <strong>Pharmaceuticals</strong> (<strong>NBY</strong>) Page 21