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:
| |||
|
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 atwww.sec.gov, at the Company’s website atwww.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. BIOTA PHARMACEUTICALS INC. 1 |
Forward Looking Statement Forward Looking Statement 2 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 Merger Rationale Enables Nabi to transition into a revenue Enables Nabi to transition into a revenue generating, late stage integrated biotechnology generating, late stage integrated biotechnology company company Opportunity for Nabi’s shareholders to Opportunity for Nabi’s shareholders to participate in the likely growth of the merged participate in the likely growth of the merged company company Result is a leading company in anti-infective Result is a leading company in anti-infective drug discovery and development drug discovery and development 3 |
The Combined Company 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 4 |
Biota Pharmaceuticals - Biota Pharmaceuticals - Pipeline Pipeline (CDI only) Smoking Cessation & Relapse Prevention (EU) Treatment Treatment Prophylaxis Treatment Preclinical Phase I Phase II Phase III Marketed Commercial Partner/ Funding Relenza (zanamivir) Long acting NIs: 2 nd Generation – Laninamivir (marketed in Japan as Inavir) - Inavir - Japan - - Japan - Laninamivir – US - Laninamivir - Rest of World Long acting NIs: 3 rd Generation - FLUNET Phoslyra - calcium acetate oral solution Vapendavir - Human Rhinovirus (HRV) NicVAX - nicotine conjugate vaccine RSV Gyrase, HCV- NN, CDI Inavir 5 |
Influenza Market Influenza Market The market is divided into two distinct The market is divided into two distinct opportunities: opportunities: Seasonal influenza market (prescription and Seasonal influenza market (prescription and pharmacy) pharmacy) Stockpile market (governments) Stockpile market (governments) Market is cyclical Market is cyclical 6 |
Laninamivir Laninamivir Second Generation Influenza Antiviral Second Generation Influenza Antiviral Laninamivir octanoate is a pro-drug converted to laninamivir Laninamivir octanoate is a pro-drug converted to laninamivir in the lung in the lung Marketed as Inavir Marketed as Inavir ® ® (Daiichi Sankyo) in Japan (approved (Daiichi Sankyo) in Japan (approved October 2010) October 2010) Single 40mgm dose for treatment, “one and done” Single 40mgm dose for treatment, “one and done” Relenza 10mgm bd 5 days, Tamiflu 75mgm bd 5 days Relenza 10mgm bd 5 days, Tamiflu 75mgm bd 5 days Once weekly for prevention Once weekly for prevention Relenza 10mgm daily, Tamiflu 15mgm daily Relenza 10mgm daily, Tamiflu 15mgm daily Disposable, IP protected inhaler Disposable, IP protected inhaler Broad strain antiviral efficacy (4AH5N1,9AH1N1) Broad strain antiviral efficacy (4AH5N1,9AH1N1) Effective against Tamiflu resistant clinical isolates Effective against Tamiflu resistant clinical isolates Dosing advantage Dosing advantage Reduced stockpile/distribution Reduced stockpile/distribution Enhanced compliance Enhanced compliance 7 |
Inavir Inavir Dry Powder Inhaler Dry Powder Inhaler Marketed in Japan by Daiichi Sankyo with royalties to Biota Marketed in Japan by Daiichi Sankyo with royalties to Biota Approximately 4-6% on sales Approximately 4-6% on sales Registration supported in Japan by: Registration supported in Japan by: Phase II/III pediatric (treatment) trial completed in 2009 Phase II/III pediatric (treatment) trial completed in 2009 Phase III trial in adults (treatment) completed in 2009 Phase III trial in adults (treatment) completed in 2009 Phase III prophylaxis trial completed demonstrating efficacy. DS Phase III prophylaxis trial completed demonstrating efficacy. DS indicated that it will submit for prophylaxis license in 2012 indicated that it will submit for prophylaxis license in 2012 Laninamivir is co-owned with Daiichi Sankyo Laninamivir is co-owned with Daiichi Sankyo Daiichi Sankyo hold Daiichi Sankyo hold marketing rights in Japan marketing rights in Japan Biota is developing Laninamivir in the US Biota is developing Laninamivir in the US (and other western markets) under a (and other western markets) under a BARDA contract. Biota will hold BARDA contract. Biota will hold Approved US NDA Approved US NDA GMP approval GMP approval Manufacturing capacity to supply ROW Manufacturing capacity to supply ROW 8 |
BARDA Contract Overview with Biota BARDA Contract Overview with Biota US$231M contract for advanced development of laninamivir US$231M contract for advanced development of laninamivir to lead to US NDA within 5 years to lead to US NDA within 5 years Major components of contract are Major components of contract are Process development, scale-up, commissioning of US based Process development, scale-up, commissioning of US based manufacturing capability for laninamivir octanoate manufacturing capability for laninamivir octanoate Supply of clinical trial products Supply of clinical trial products The completion of all relevant Phase I, Phase II and Phase III The completion of all relevant Phase I, Phase II and Phase III clinical studies for treatment clinical studies for treatment Preparation of NDA submission Preparation of NDA submission Cost reimbursement, plus 7% fee Cost reimbursement, plus 7% fee No IP encumbrance No IP encumbrance No dilution to shareholders No dilution to shareholders 9 |
Human Rhinovirus - Human Rhinovirus - BTA798 (vapendavir) BTA798 (vapendavir) Oral small molecule inhibitor of human rhinovirus (HRV) Oral small molecule inhibitor of human rhinovirus (HRV) Binds to capsid protein on surface of virus particle Binds to capsid protein on surface of virus particle Broad spectrum HRV antiviral Broad spectrum HRV antiviral Target markets Target markets Serious complications in patients with asthma, COPD, Cystic Fibrosis Serious complications in patients with asthma, COPD, Cystic Fibrosis Patients with compromised immune systems (chemotherapy, Patients with compromised immune systems (chemotherapy, transplants) transplants) Phase IIa challenge study demonstrated proof-of-concept Phase IIa challenge study demonstrated proof-of-concept in humans; reducing incidence and severity of HRV infection in humans; reducing incidence and severity of HRV infection Phase IIb trial in patients with chronic asthma met Phase IIb trial in patients with chronic asthma met primary end point in March 2012 primary end point in March 2012 Protected by patents owned by Biota Protected by patents owned by Biota 10 |
Respiratory Syncytial Virus (RSV) Respiratory Syncytial Virus (RSV) For unserved infant and elderly markets For unserved infant and elderly markets U.S. U.S. mortality mortality in in the the elderly elderly estimated estimated at at 17,000 17,000 deaths deaths per per year year Potential RSV market for treatment and prophylaxis is Potential RSV market for treatment and prophylaxis is large large MedImmune MedImmune (AZ) (AZ) dominates dominates prophylaxis prophylaxis market market with with Synagis Synagis ® ® >$1bn >$1bn Synagis – Synagis – mAb by injection and limited reimbursement scope mAb by injection and limited reimbursement scope No treatment product available No treatment product available New lead candidate identified New lead candidate identified RSV fusion inhibitor RSV fusion inhibitor Strong IP position Strong IP position Solely owned by Biota Solely owned by Biota 11 |
Hepatitis C Non Nucleoside (HCV-NN) Hepatitis C Non Nucleoside (HCV-NN) Non-nucleoside NS5b inhibitor Non-nucleoside NS5b inhibitor Nanomolar pan-genotypic Nanomolar pan-genotypic Intended for Interferon free combination Intended for Interferon free combination Active in HCV replicon Active in HCV replicon Orally bioavailable Orally bioavailable IP owned by Biota IP owned by Biota 12 |
Gyrase ( GYR) Anti-bacterial Gyrase ( GYR) Anti-bacterial GyrB/ParE inhibitor GyrB/ParE inhibitor Equivalent Equivalent or or superior superior to to Zyvox Zyvox in in multiple multiple animal models animal models IV/ Oral switch profile IV/ Oral switch profile Effective against multidrug resistant bacteria in Effective against multidrug resistant bacteria in pre-clinical studies pre-clinical studies Low resistance frequency Low resistance frequency IP owned by Biota IP owned by Biota TM 13 |
Opportunity Summary Opportunity Summary If the merger is approved, Biota Pharmaceuticals, If the merger is approved, Biota Pharmaceuticals, Inc. will have Inc. will have Three royalty generating products, Relenza, Inavir and potentially Three royalty generating products, Relenza, Inavir and potentially PhosLyra PhosLyra Two clinical programs Two clinical programs Laninamivir (a long acting anti-influenza neuraminidase inhibitor) - Laninamivir (a long acting anti-influenza neuraminidase inhibitor) - US $231 million contract with BARDA for the advanced US $231 million contract with BARDA for the advanced development, development, Vapendavir (a phase III-ready human rhinovirus program) Vapendavir (a phase III-ready human rhinovirus program) NicVAX interest NicVAX interest Pre-clinical programs, including respiratory syncytial virus (RSV), Pre-clinical programs, including respiratory syncytial virus (RSV), hepatitis C (HCV-NN), broad spectrum antibiotic targeting gyrase hepatitis C (HCV-NN), broad spectrum antibiotic targeting gyrase (GYR) (GYR) Over US$100 million in cash with which to develop its program Over US$100 million in cash with which to develop its program pipeline pipeline 14 |
Key Aspects of Agreement Key Aspects of Agreement Nabi will acquire all of the outstanding ordinary shares in Biota Nabi will acquire all of the outstanding ordinary shares in Biota Nabi’s post-merger assets contribution to the merged company Nabi’s post-merger assets contribution to the merged company includes $54 million in cash, a right to receive royalties from a includes $54 million in cash, a right to receive royalties from a marketed product (PhosLyra) and an interest in NicVAX vaccine marketed product (PhosLyra) and an interest in NicVAX vaccine Nabi plans to return to its stockholders its remaining cash in Nabi plans to return to its stockholders its remaining cash in excess of the $54 million required to be held by Nabi at closing excess of the $54 million required to be held by Nabi at closing after satisfying outstanding liabilities after satisfying outstanding liabilities Nabi intends to distribute contingent value right related to Nabi intends to distribute contingent value right related to NicVAX to current Nabi shareholders NicVAX to current Nabi shareholders Immediately following the closing of the merger, the board of Immediately following the closing of the merger, the board of directors of the combined company will consist of six current directors of the combined company will consist of six current Biota Directors and two current Nabi Directors. Biota Directors and two current Nabi Directors. 15 |
Anticipated Merger Timeline Anticipated Merger Timeline Merger Agreement announced Merger Agreement announced 23 April 23 April Scheme Booklet/Proxy to Shareholders Scheme Booklet/Proxy to Shareholders August August Meetings of Shareholders Meetings of Shareholders September September If transaction is approved, Biota If transaction is approved, Biota Pharmaceuticals Inc. listed on Nasdaq Pharmaceuticals Inc. listed on Nasdaq October October 16 |
Nabi’s Assets as of Q2, 2012 Nabi’s Assets as of Q2, 2012 Cash: $92.6 million at end of June, 2012 Cash: $92.6 million at end of June, 2012 Potential remaining NicVAX value: GSK’s Potential remaining NicVAX value: GSK’s second generation asset and relapse second generation asset and relapse prevention study in the Netherlands prevention study in the Netherlands Potential PhosLyra royalties Potential PhosLyra royalties Net Operating losses (NOLs), value limited due Net Operating losses (NOLs), value limited due to merger to merger 17 |
Nabi’s Cash Assets Nabi’s Cash Assets Merger agreement obligates Nabi to provide $54 Merger agreement obligates Nabi to provide $54 million in cash at close to the combined company million in cash at close to the combined company Additionally, after satisfying its liabilities, Nabi Additionally, after satisfying its liabilities, Nabi indicated that it will distribute $25 million to $30 indicated that it will distribute $25 million to $30 million to shareholders in the form of a dividend, million to shareholders in the form of a dividend, a return of capital, a tender offer or a combination a return of capital, a tender offer or a combination Nabi has already returned $24.4 million to its Nabi has already returned $24.4 million to its shareholders in the form of a Dutch Auction Tender shareholders in the form of a Dutch Auction Tender Offer Offer 18 |
Tender Offer ..Background Tender Offer ..Background Nabi has at least two major groups of Nabi has at least two major groups of shareholders: shareholders: Traditional long term shareholders who are Traditional long term shareholders who are interested in participating in the growth of the interested in participating in the growth of the combined company combined company Arbitrage shareholders who invested in the stock Arbitrage shareholders who invested in the stock after the failure of NicVAX with the view to benefit after the failure of NicVAX with the view to benefit from the arbitrage between the market cap and cash from the arbitrage between the market cap and cash available available Clearly the investment thesis is completely Clearly the investment thesis is completely different between the two groups different between the two groups 19 |
Tender Offer ..Strategy Tender Offer ..Strategy Nabi implemented a Dutch Auction Tender Offer Nabi implemented a Dutch Auction Tender Offer to allow arbitrage shareholders to exit the stock, to allow arbitrage shareholders to exit the stock, while allowing traditional investors to participate while allowing traditional investors to participate in the potential benefits from the merger in the potential benefits from the merger 20 |
Tender Offer ...Outcome Tender Offer ...Outcome The Tender Offer was successful and over- The Tender Offer was successful and over- subscribed subscribed A total of 14,547,996 shares were accepted for A total of 14,547,996 shares were accepted for purchase, representing approximately 33.93% of the purchase, representing approximately 33.93% of the total outstanding shares, at a purchase price of total outstanding shares, at a purchase price of $1.68 per share, a premium of approximately 5% $1.68 per share, a premium of approximately 5% over the Nabi trading share price over the Nabi trading share price 21 |
Liquidation Scenario as an Alternative Liquidation Scenario as an Alternative Under the liquidation scenario, Nabi estimates Under the liquidation scenario, Nabi estimates that the amount of cash available to that the amount of cash available to shareholders is as follows: shareholders is as follows: $1.51 to $1.68 upon approval of liquidation $1.51 to $1.68 upon approval of liquidation (approximately three to four months after the Sept (approximately three to four months after the Sept 24 24 th vote) vote) Over the following three years, shareholders may Over the following three years, shareholders may receive additional distributions of the $5 million to receive additional distributions of the $5 million to $10 million reserve, provided that there are no $10 million reserve, provided that there are no legitimate claims on any of said reserve legitimate claims on any of said reserve 22 |
The Math..for Liquidation Scenario The Math..for Liquidation Scenario Nabi’s cash at the end of Q2 = $92.6 million Nabi’s cash at the end of Q2 = $92.6 million Tender offer plus expenses = ($24.7 million) Tender offer plus expenses = ($24.7 million) Operating cost to October 2012 = ($1.5 million) Operating cost to October 2012 = ($1.5 million) Wind-down costs = ($13.6 million) Wind-down costs = ($13.6 million) Subtotal = $52.8 million Subtotal = $52.8 million Reserve = ($5 million) to ($10 million) Reserve = ($5 million) to ($10 million) At start of liquidation = $48 million to $43 million At start of liquidation = $48 million to $43 million Shares outstanding = 28,328,034 Shares outstanding = 28,328,034 Initial distribution per share at start of liquidation = Initial distribution per share at start of liquidation = $1.51 to 1.68 $1.51 to 1.68 23 |
Alternative Proposed by some Alternative Proposed by some Shareholders Shareholders Distribute substantially all the cash then merge Distribute substantially all the cash then merge with another company for the public listing: with another company for the public listing: This alternative is speculative under new Nasdaq This alternative is speculative under new Nasdaq rules and may not yield the desired outcome if Nabi rules and may not yield the desired outcome if Nabi is deemed a shell company is deemed a shell company Distribute substantially all the cash then ask a Distribute substantially all the cash then ask a third party liquidator to assume liability: third party liquidator to assume liability: We also believe that this alternative may be even We also believe that this alternative may be even more expensive to shareholders, because a third more expensive to shareholders, because a third party liquidator would likely request the same party liquidator would likely request the same reserve and to make a profit would incur a higher reserve and to make a profit would incur a higher operating cost operating cost 24 |
Potential Benefits of US Capital Potential Benefits of US Capital Markets Markets Primary objective is to realize value of Primary objective is to realize value of laninamivir in the US laninamivir in the US US is key US is key BARDA contract is highly US focused BARDA contract is highly US focused US manufacturing capacity US manufacturing capacity High US clinical component High US clinical component US regulatory requirements US regulatory requirements BARDA’s location BARDA’s location Achieving success likely requires a significant US Achieving success likely requires a significant US presence by Biota presence by Biota On completion, major customer is US Government On completion, major customer is US Government 25 |
Summary Summary Nabi undertook a comprehensive strategic Nabi undertook a comprehensive strategic alternative process with the help of investment alternative process with the help of investment bankers and other advisors bankers and other advisors Through the process, a merger with Biota was Through the process, a merger with Biota was identified as an advisable and recommended identified as an advisable and recommended alternative to other opportunities (including alternative to other opportunities (including liquidation) liquidation) Commercial stage company with two royalty-bearing Commercial stage company with two royalty-bearing drugs drugs Lead compound being developed for the US and Lead compound being developed for the US and other western countries, is already licensed in Japan other western countries, is already licensed in Japan Deep and attractive pipeline Deep and attractive pipeline 26 |