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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 9, 2010
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
     
001-34186   03-0491827
(Commission File No.)   (IRS Employer Identification No.)
9605 Medical Center Drive
Suite 300
Rockville, Maryland 20850

(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (240) 599-4500
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 7.01. Regulation FD Disclosure
          Vanda Pharmaceuticals Inc. (the “Company” or “Vanda”) will be making a presentation regarding the Company at the Cowen and Company 30th Annual Health Care Conference on March 9, 2010. The slides that will be used for such presentation are furnished as Exhibit 99.1 to this Form 8-K. In addition, the slides will be posted on the Company’s Web site http://www.vandapharma.com.
          Various statements to be made in the presentation, including statements in the slides furnished as Exhibit 99.1 to this Form 8-K, are “forward-looking statements” under the securities laws. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” and “could,” and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others: the extent and effectiveness of the development, sales and marketing and distribution support Fanapt™ receives; Vanda’s ability to successfully commercialize Fanapt™ outside of the U.S. and Canada; delays in the completion of Vanda’s clinical trials; a failure of Vanda’s products to be demonstrably safe and effective; Vanda’s failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements for its products; a lack of acceptance of Vanda’s products in the marketplace, or a failure to become or remain profitable; Vanda’s expectations regarding trends with respect to its costs and expenses; Vanda’s inability to obtain the capital necessary to fund its research and development activities; Vanda’s failure to identify or obtain rights to new products; Vanda’s failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; a loss of any of Vanda’s key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda’s products under its license and sublicense agreements and other factors that are described in the “Risk Factors” section (Part II, Item 1A) of Vanda’s quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2009 (File No. 001-34186). In addition to the risks described above and in Part II, Item 1A of Vanda’s quarterly report on Form 10-Q, other unknown or unpredictable factors also could affect Vanda’s results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
          All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in the slides attached as Exhibit 99.1 to this Form 8-K will be provided only as of the date on which such slides are presented, and the Company undertakes no obligation to update any forward-looking statements contained in such slides from and after the date of such presentation whether as a result of new information, future events or otherwise.
     The information in Item 7.01 of this Form 8-K and the slides attached as Exhibit 99.1 to this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 


 

Item 9.01. Financial Statements and Exhibits.
(d)   Exhibits
     
Exhibit No.   Description
99.1
  Presentation slides.

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  VANDA PHARMACEUTICALS INC.
 
 
  By:   /s/ STEPHANIE R. IRISH    
    Name:   Stephanie R. Irish   
    Title:   Acting Chief Financial Officer and Treasurer   
 
Dated: March 9, 2010

 

exv99w1
Exhibit 99.1

Vanda Pharmaceuticals Inc. Cowen Healthcare Conference March 9, 2010 Mihael H. Polymeropoulos MD CEO


 

Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to our financial condition, results from operations and business, and our expectations and beliefs about future events. Actual results may vary materially from our expectations and beliefs. Meaningful factors which could cause actual results to differ from expectations include, but are not limited to, uncertainty of the Company's future profitability, uncertainty of market acceptance for the Company's products, delay in or failure to obtain regulatory approvals for the Company's product candidates, uncertainty regarding patents and proprietary rights, risks inherent in international transactions, limited sales and marketing experience, dependence on third party reimbursement, competition, uncertainty of clinical trial results, extent of government regulations, and inability to obtain requisite additional financing, as well as other factors discussed in the Company's Securities and Exchange Commission filings. All forward-looking statements in this presentation are expressly qualified by the above paragraph in their entirety. We have no obligation to update any forward- looking statements which are made in this presentation.


 

Company Summary Vanda Pharmaceuticals (Nasdaq: VNDA) Rockville, MD 22 Employees Established in 2003 IPO 2006


 

Vanda Historical Stock Performance


 

Pipeline Phase I PhaseII PhaseIII NDA Market Fanapt(tm) (schizophrenia) Iloperidone depot Tasimelteon (CRSD)


 

Fanapt(tm) (iloperidone) (Schizophrenia)


 

Fanapt(tm) Overview Fanapt(tm) (iloperidone) tablets - oral formulation FDA approved in May 2009 for adults with Schizophrenia Iloperidone - depot formulation Phase II Oral formulation launched January 11, 2010 by Novartis in the U.S.


 

Deal Summary FDA approved for acute treatment of adult patients with schizophrenia Partnered with Novartis in the U.S. and Canada Vanda received $200 million upfront Eligible to receive up to an additional $265 million in payments tied to commercial and development milestones Low double-digit sales royalties Vanda retains exclusive rights outside the U.S. and Canada


 

Schizophrenia: the disease Severe, chronic, and debilitating brain disorder Prevalence: 1% worldwide ( ~2.4 million in the U.S.) Age of onset: 15-35 years Symptoms Positive Negative General Debilitating outcomes Near-universal disability Aggressive behavior High risk of suicide Sources: NAMI, NMA, DSM-IV


 

Antipsychotic Market: Summary Significant unmet needs remain CATIE study showed 74% discontinue in 18 months, primarily due to safety concerns Protected compound class on federal and private formularies due to disease severity Highly concentrated prescriber base $15+ billion market


 

Approved Products Company US Launch Year US Patent Expiry Clozaril (r) Novartis 1990 generic Zyprexa(r) Eli Lilly 1996 4/2011 Risperdal(r) J&J 1994 generic Seroquel(r) AstraZeneca 1997 9/2011 Abilify(r) BMS/Otsuka 2002 10/2014 Geodon(r) Pfizer 2001 9/2012 Invega(r) J&J 2007 11/2011 Source: IMS - World Review Analyst; company press releases; analyst estimates; schizophrenia.emedtv.com Atypical antipsychotics


 

Depot Landscape Compliance remains a significant unmet need Limited competition Risperdal Consta: $1.3B revenue in 2009 Invega Sustenna: 2009 Launch Zyprexa Relprevv: 2009 Launch


 

Iloperidone Depot Formulation: Summary Differentiated profile Once every 4 weeks Well tolerated Weight gain/metabolics Movement disorders PK and Phase III studies needed for NDA


 

Iloperidone IP Summary Fanapt(tm) (oral) NCE (+ HW & pediatric) through mid 2017 Iloperidone depot microspheres US 2023 (allowed) EU 2022 (application) Iloperidone depot crystals US 2022 (application) EU 2022 (allowed)


 

Tasimelteon (VEC-162) (Circadian Rhythm Sleep Disorders or CRSD)


 

Tasimelteon Program Overview 2004: Acquired from BMS Mechanism: MT1, MT2 melatonin receptor agonist Vanda has completed 1 Phase II study and 2 Phase III studies Studies 2101 and 3101 establish tasimelteon as a circadian rhythm regulator


 

Vanda Clinical Trials to Date Design Outcome Assessments Outcome Assessments Outcome Assessments Design Phase Advance Sleep Onset Sleep Maintenance Phase II Phase II Phase II Phase II Phase II 2101 5-Hour Phase Advance R, DB, PC parallel-group study N=39 5 dose groups Treatment: 3 nights + + + Phase III Phase III Phase III Phase III Phase III 3101 5-Hour Phase Advance R, DB, PC parallel-group multi-center study N=412 4 dose groups Treatment: 1 night n.a. + + 3104 Sleep-Onset Insomnia R, DB, PC parallel-group multi-center study N=322 3 dose groups Treatment: 35 days n.a. + -


 

CRSD Population 80K 12.6 MM 35.7 MM N24HSWD SWSD/Early Risers DSPD 15.6 MM Jet-Lag Total Population: >65 MM


 

Non24Hour SWD Background Non-24-Hour Sleep Wake Disorder (N24HSWD), a type of Circadian Rhythm Sleep Disorder (CRSD) 65K-95K people in the U.S. Problems with sleep and wakefulness Endogenous circadian rhythm or "body clock" is unable to entrain to a normal 24- hour day. In sighted individuals, the strongest entrainer to the 24-hour clock is light. Other environmental factors can also help with entrainment but may not be sufficient in the totally blind. Person will "free run" slightly longer than 24-hours without environmental input, causing a phase delay in his/her body clock each day. Occurs almost entirely in subjects who are totally blind and lack the light sensitivity necessary to reset the circadian clock.


 

Orphan Indication Facts Orphan indication granted January 2010 Streamlined development Tax credit / User fees for NDA waived FDA protocol assistance 7 year market exclusivity


 

Non24Hour SWD Draft Clinical Development Plan Proposed Clinical Development Plan:


 

Tasimelteon IP Summary Tasimelteon NCE: December 2017 expiration (2023 including HW+pediatric) VXB-269 (back-up compound) NCE: June 2020 expiration


 

Finance Summary


 

Summary Financials ($ in millions) 12/31/09 Cash/cash equivalents/ST investments $205.3 ($ in millions) Year Ended 12/31/2009 Revenue Operating Expenses $4.5 COGS 2.9 R&D 13.9 G&A 23.7 Loss from Operations 40.5 Net Loss $36.0 Guidance: Vanda's fixed overhead costs are expected to be approximately $10.0 million to $12.0 million annually in 2010. (Inclusive of all FTE's but excludes additional R&D activities).


 

Tax Update Deferral for 2010 382 NOL Analysis On-going On-going discussion with IRS


 

Vanda Pharmaceuticals Inc. Cowen Healthcare Conference March 9, 2010 Mihael H. Polymeropoulos MD CEO