Vaxart, Inc. – SEC Filing

View:

Download DOC

Download PDF

DEFA14A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

SCHEDULE 14A

(RULE 14a-101)

INFORMATION REQUIRED IN PROXY STATEMENT

SCHEDULE 14A INFORMATION

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

(Amendment No. )

Filed by the Registrant þ Filed by a Party other than the Registrant ¨

Check the appropriate box:


¨	Preliminary Proxy Statement

¨	Confidential, For Use of the Commission Only (as permitted by Rule 14a-6(e)(2))

¨	Definitive Proxy Statement

þ	Definitive Additional Materials

¨	Soliciting Material Pursuant to § 240.14a-12

Nabi Biopharmaceuticals
(Name of Registrant as Specified in its Charter)

N/A
(Name of Person(s) Filing Proxy Statement, if Other Than the Registrant)

Payment of Filing Fee (Check the appropriate box):

þ	No fee required.

¨	Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11.

	(1)	Title of each class of securities to which transaction applies:

	(2)	Aggregate number of securities to which transaction applies:

	(3)	Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined):

	(4)	Proposed maximum aggregate value of transaction:

	(5)	Total fee paid:




¨	Fee paid previously with preliminary materials.

¨	Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing.

	(1)	Amount Previously Paid:

	(2)	Form, Schedule or Registration Statement No.:

	(3)	Filing Party:

	(4)	Date Filed:

LOGO

In connection with the proposed business combination transaction between Nabi Biopharmaceuticals (the “Company”) and Biota Holdings Limited, the Company has filed a definitive proxy statement, dated August 7, 2012, with the Securities and Exchange Commission (“SEC”) in connection with a special meeting of stockholders of the Company to be held on September 24, 2012.

STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE COMPANY’S DEFINITIVE PROXY MATERIALS AND ANY OTHER RELEVANT SOLICITATION MATERIALS FILED BY THE COMPANY WITH THE SEC BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS COMBINATION TRANSACTION. Stockholders and investors may obtain a free copy of the Company’s definitive proxy statement and other materials filed by the Company with the SEC at the SEC’s website at www.sec.gov, at the Company’s website at www.nabi.com, or by contacting Morrow & Co., LLC, the Company’s proxy solicitation agent, at (203) 658-9400 or toll-free at (800) 607-0088.

The Company’s board of directors has determined that it is advisable and in the best interests of the Company and its stockholders to consummate the proposed business combination transaction and unanimously recommends that you vote “FOR” each of the proposals to be considered and voted upon at the special meeting by signing and dating the WHITE proxy card or WHITE voting instruction form that you previously received.

On August 31, 2012, the Company provided the following presentation materials to Institutional Shareholder Services Inc.

BIOTA PHARMACEUTICALS INC.

Forward Looking Statement

This presentation contains forward looking statements that involve risks and uncertainties. Although we believe that the expectations

reflected in the forward looking statements are reasonable at this time, Biota and Nabi can give no assurance that these expectations

will prove to be correct. Actual results could differ materially from those anticipated. Reasons may include risks associated with drug

development and manufacture, risks inherent in the regulatory processes, delays in clinical trials, risks associated with patent

protection, future capital needs or other general risks or factors. We caution readers not to place undue reliance on any such forward-

looking statements, which speak only as of the date they were made. We disclaim any obligation to publicly update or revise any such

statements to reflect any change in its expectations or events, conditions, or circumstances on which any such statements may be

based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Relenza® is a registered trademark of GlaxoSmithKline. Inavir® is a registered trademark of Daiichi Sankyo.

Forward Looking Statements regarding the Proposed Nabi-Biota Transaction

This presentation also contains forward-looking statements about the occurrence, timing and financial terms or effect of the proposed

merger between Nabi and Biota, including expected timing for closing, which are based on certain assumptions made by us based on

current conditions, expected future developments and other factors we believe are appropriate in the circumstances. No assurances

can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements

are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Nabi or Biota. Several of

these risks associated with Nabi are outlined in Nabi’s Definitive Proxy Statement filed with the Securities and Exchange Commission

(“SEC”) on August 7, 2012, and other documents Nabi files with the SEC. We caution readers not to place undue reliance on any such

forward-looking statements, which speak only as of the date they were made. We disclaim any obligation to publicly update or revise

any such statements to reflect any change in its expectations or events, conditions, or circumstances on which any such statements

may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Important Additional Information

In connection with the transaction, Nabi has filed a definitive proxy statement, dated August 7, 2012, with the SEC in connection with a

special meeting of stockholders of Nabi to be held on September 24, 2012. STOCKHOLDERS AND INVESTORS ARE URGED TO READ

NABI’S DEFINITIVE PROXY MATERIALS AND ANY OTHER RELEVANT SOLICITATION MATERIALS FILED BY NABI WITH THE SEC

BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION. Stockholders and investors may obtain a free copy

of Nabi’s definitive proxy statement and other materials filed by Nabi with the SEC at the SEC’s website at www.sec.gov, at Nabi’s

website at www.nabi.com, or by contacting Morrow & Co., LLC, Nabi’s proxy solicitation agent, at (203) 658-9400 or toll-free at

(800) 607-0088.

Merger Rationale

Enables Nabi to transition into a revenue

generating, late stage integrated biotechnology

company

Opportunity for Nabi’s shareholders to

participate in the likely growth of the merged

company

Result is a leading company in anti-infective

drug discovery and development

The Combined Company

Biota

Pharmaceuticals

Three royalty generating products

$231m BARDA contract

Attractive clinical and preclinical products

$100m+ of cash

Increased ability to fund future clinical programs

Increased ability to manage Relenza patent cliff

Biota Pharmaceuticals -

Pipeline

(CDI only)

Smoking Cessation & Relapse Prevention (EU)

Treatment

Prophylaxis

Treatment

Preclinical

Phase I

Phase II

Phase III

Marketed

Commercial

Partner/

Funding

Relenza (zanamivir)

Long acting NIs: 2

Generation –

Laninamivir (marketed in Japan as Inavir)

Inavir -

Japan

Laninamivir –

Laninamivir -

Rest of World

Long acting NIs: 3

Generation

FLUNET

Phoslyra

calcium acetate oral solution

Vapendavir

Human Rhinovirus (HRV)

NicVAX

nicotine conjugate vaccine

RSV

Gyrase, HCV-

NN, CDI

Inavir

Influenza Market

The market is divided into two distinct

opportunities:

Seasonal influenza market (prescription and

pharmacy)

Stockpile market (governments)

Market is cyclical

Laninamivir

Second Generation Influenza Antiviral

Laninamivir octanoate is a pro-drug converted to laninamivir

in the lung

Marketed as Inavir

(Daiichi Sankyo) in Japan (approved

October 2010)

Single 40mgm dose for treatment, “one and done”

Relenza 10mgm bd 5 days, Tamiflu 75mgm bd 5 days

Once weekly for prevention

Relenza 10mgm daily, Tamiflu 15mgm daily

Disposable, IP protected inhaler

Broad strain antiviral efficacy (4AH5N1,9AH1N1)

Effective against Tamiflu resistant clinical isolates

Dosing advantage

Reduced stockpile/distribution

Enhanced compliance

Inavir

Dry Powder Inhaler

Marketed in Japan by Daiichi Sankyo with royalties to Biota

Approximately 4-6% on sales

Registration supported in Japan by:

Phase II/III pediatric (treatment) trial completed in 2009

Phase III trial in adults (treatment) completed in 2009

Phase III prophylaxis trial completed demonstrating efficacy. DS

indicated that it will submit for prophylaxis license in 2012

Laninamivir is co-owned with Daiichi Sankyo

Daiichi Sankyo hold

marketing rights in Japan

Biota is developing Laninamivir in the US

(and other western markets) under a

BARDA contract. Biota will hold

Approved US NDA

GMP approval

Manufacturing capacity to supply ROW

BARDA Contract Overview with Biota

US$231M contract for advanced development of laninamivir

to lead to US NDA within 5 years

Major components of contract are

Process development, scale-up, commissioning of US based

manufacturing capability for laninamivir octanoate

Supply of clinical trial products

The completion of all relevant Phase I, Phase II and Phase III

clinical studies for treatment

Preparation of NDA submission

Cost reimbursement, plus 7% fee

No IP encumbrance

No dilution to shareholders

Human Rhinovirus -

BTA798 (vapendavir)

Oral small molecule inhibitor of human rhinovirus (HRV)

Binds to capsid protein on surface of virus particle

Broad spectrum HRV antiviral

Target markets

Serious complications in patients with asthma, COPD, Cystic Fibrosis

Patients with compromised immune systems (chemotherapy,

transplants)

Phase IIa challenge study demonstrated proof-of-concept

in humans; reducing incidence and severity of HRV infection

Phase IIb trial in patients with chronic asthma met

primary end point in March 2012

Protected by patents owned by Biota

Respiratory Syncytial Virus (RSV)

For unserved infant and elderly markets

U.S.

mortality

the

elderly

estimated

17,000

deaths

per

year

Potential RSV market for treatment and prophylaxis is

large

MedImmune

(AZ)

dominates

prophylaxis

market

with

Synagis

>$1bn

Synagis –

mAb by injection and limited reimbursement scope

No treatment product available

New lead candidate identified

RSV fusion inhibitor

Strong IP position

Solely owned by Biota

Hepatitis C Non Nucleoside (HCV-NN)

Non-nucleoside NS5b inhibitor

Nanomolar pan-genotypic

Intended for Interferon free combination

Active in HCV replicon

Orally bioavailable

IP owned by Biota

Gyrase ( GYR) Anti-bacterial

GyrB/ParE inhibitor

Equivalent

superior

Zyvox

multiple

animal models

IV/ Oral switch profile

Effective against multidrug resistant bacteria in

pre-clinical studies

Low resistance frequency

IP owned by Biota

Opportunity Summary

If the merger is approved, Biota Pharmaceuticals,

Inc. will have

Three royalty generating products, Relenza, Inavir and potentially

PhosLyra

Two clinical programs

Laninamivir (a long acting anti-influenza neuraminidase inhibitor) -

US $231 million contract with BARDA for the advanced

development,

Vapendavir (a phase III-ready human rhinovirus program)

NicVAX interest

Pre-clinical programs, including respiratory syncytial virus (RSV),

hepatitis C (HCV-NN), broad spectrum antibiotic targeting gyrase

(GYR)

Over US$100 million in cash with which to develop its program

pipeline

Key Aspects of Agreement

Nabi will acquire all of the outstanding ordinary shares in Biota

Nabi’s post-merger assets contribution to the merged company

includes $54 million in cash, a right to receive royalties from a

marketed product (PhosLyra) and an interest in NicVAX vaccine

Nabi plans to return to its stockholders its remaining cash in

excess of the $54 million required to be held by Nabi at closing

after satisfying outstanding liabilities

Nabi intends to distribute contingent value right related to

NicVAX to current Nabi shareholders

Immediately following the closing of the merger, the board of

directors of the combined company will consist of six current

Biota Directors and two current Nabi Directors.

Anticipated Merger Timeline

Merger Agreement announced

23 April

Scheme Booklet/Proxy to Shareholders

August

Meetings of Shareholders

September

If transaction is approved, Biota

Pharmaceuticals Inc. listed on Nasdaq

October

Nabi’s Assets as of Q2, 2012

Cash: $92.6 million at end of June, 2012

Potential remaining NicVAX value: GSK’s

second generation asset and relapse

prevention study in the Netherlands

Potential PhosLyra royalties

Net Operating losses (NOLs), value limited due

to merger

Nabi’s Cash Assets

Merger agreement obligates Nabi to provide $54

million in cash at close to the combined company

Additionally, after satisfying its liabilities, Nabi

indicated that it will distribute $25 million to $30

million to shareholders in the form of a dividend,

a return of capital, a tender offer or a combination

Nabi has already returned $24.4 million to its

shareholders in the form of a Dutch Auction Tender

Offer

Tender Offer ..Background

Nabi has at least two major groups of

shareholders:

Traditional long term shareholders who are

interested in participating in the growth of the

combined company

Arbitrage shareholders who invested in the stock

after the failure of NicVAX with the view to benefit

from the arbitrage between the market cap and cash

available

Clearly the investment thesis is completely

different between the two groups

Tender Offer ..Strategy

Nabi implemented a Dutch Auction Tender Offer

to allow arbitrage shareholders to exit the stock,

while allowing traditional investors to participate

in the potential benefits from the merger

Tender Offer ...Outcome

The Tender Offer was successful and over-

subscribed

A total of 14,547,996 shares were accepted for

purchase, representing approximately 33.93% of the

total outstanding shares, at a purchase price of

$1.68 per share, a premium of approximately 5%

over the Nabi trading share price

Liquidation Scenario as an Alternative

Under the liquidation scenario, Nabi estimates

that the amount of cash available to

shareholders is as follows:

$1.51 to $1.68 upon approval of liquidation

(approximately three to four months after the Sept

vote)

Over the following three years, shareholders may

receive additional distributions of the $5 million to

$10 million reserve, provided that there are no

legitimate claims on any of said reserve

The Math..for Liquidation Scenario

Nabi’s cash at the end of Q2 = $92.6 million

Tender offer plus expenses = ($24.7 million)

Operating cost to October 2012 = ($1.5 million)

Wind-down costs = ($13.6 million)

Subtotal = $52.8 million

Reserve = ($5 million) to ($10 million)

At start of liquidation = $48 million to $43 million

Shares outstanding = 28,328,034

Initial distribution per share at start of liquidation =

$1.51 to 1.68

Alternative Proposed by some

Shareholders

Distribute substantially all the cash then merge

with another company for the public listing:

This alternative is speculative under new Nasdaq

rules and may not yield the desired outcome if Nabi

is deemed a shell company

Distribute substantially all the cash then ask a

third party liquidator to assume liability:

We also believe that this alternative may be even

more expensive to shareholders, because a third

party liquidator would likely request the same

reserve and to make a profit would incur a higher

operating cost

Potential Benefits of US Capital

Markets

Primary objective is to realize value of

laninamivir in the US

US is key

BARDA contract is highly US focused

US manufacturing capacity

High US clinical component

US regulatory requirements

BARDA’s location

Achieving success likely requires a significant US

presence by Biota

On completion, major customer is US Government

Summary

Nabi undertook a comprehensive strategic

alternative process with the help of investment

bankers and other advisors

Through the process, a merger with Biota was

identified as an advisable and recommended

alternative to other opportunities (including

liquidation)

Commercial stage company with two royalty-bearing

drugs

Lead compound being developed for the US and

other western countries, is already licensed in Japan

Deep and attractive pipeline