e8vk
 

 
 
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): April 1, 2008
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
     
000-51863   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
     The Company intends to make presentations to certain investors regarding the Company’s operations, financial condition and prospects. The slides that will be used for such presentations are furnished as Exhibit 99.1 to this Form 8-K.
     Various statements to be made in the presentations, 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. The Company is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others: delays in the completion of the Company’s clinical trials; a failure of the Company’s product candidates to be demonstrably safe and effective; the Company’s failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements; a lack of acceptance of the Company’s product candidates in the marketplace, or a failure to become or remain profitable; the Company’s inability to obtain the capital necessary to fund its research and development activities; the Company’s failure to identify or obtain rights to new product candidates; the Company’s failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; a loss of any of the Company’s key scientists or management personnel; losses incurred from product liability claims made against the Company; and a loss of rights to develop and commercialize the Company’s products under its license and sublicense agreements.
     The Company encourages investors to read the discussion and analysis of its financial condition and its consolidated financial statements contained in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2007 (the “10-K”). The Company also encourages investors to read Item 1A of the 10-K, entitled “Risk Factors,” which contains a more complete discussion of the risks and uncertainties associated with the Company’s business. In addition to the risks described above and in Item 1A of the 10-K, other unknown or unpredictable factors also could affect the Company’s results. There can be no assurance that the actual results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, the Company. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
     The information in the slides attached as Exhibit 99.1 to this Form 8-K will be provided only as of the applicable dates 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 dates of such presentations 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 to be furnished to investors.
 

 


 

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/ STEVEN A. SHALLCROSS    
    Name:   Steven A. Shallcross   
    Title:   Senior Vice President, Chief Financial Officer and Treasurer   
 
Dated: April 1, 2008

 

exv99w1
 

Exhibit 99.1
Vanda Pharmaceuticals Inc. Corporate Overview April 2008


 

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.


 

Vanda Overview Late-stage products targeting large, under-served markets: Fiapta(tm) (iloperidone) - schizophrenia (NDA) Tasimelteon (VEC-162) - sleep disorders (Phase III) Tasimelteon - mood disorders (Phase II) Significant near-term milestones: Fiapta(tm) PDUFA date expected July 27, 2008 Tasimelteon Phase III chronic insomnia results expected in June 2008


 

Fiapta(tm) (iloperidone) (Schizophrenia)


 

Fiapta(tm) Status Key short-term milestones: PDUFA date expected July 27, 2008 Currently targeting launch in Q1, 2009 Compelling commercial profile established Commercialization efforts underway pre-PDUFA action


 

Atypical Antipsychotics Approved Products Source: IMS HEALTH National Sales Perspectives (2007), Vanda calculations Approved Products Company US Launch Year 2007 US Revenue ($MM) 2007 US Y-o-Y Growth Seroquel(r) AstraZeneca 1997 3,256 13.2% Risperdal(r) J&J 1994 3,122 11.3% Zyprexa(r) Eli Lilly 1996 2,686 0.4% Abilify(r) BMS/Otsuka 2002 2,198 24.0% Geodon(r) Pfizer 2001 850 20.7% clozapine Novartis, others 1990 178 0.0% Invega(r) J&J 2007 75 -


 

Question. Please rate each of the statements below using a scale of 1-10 on importance to you when selecting an antipsychotic therapy for your schizophrenia patients. (130 respondents) Risk of prolactin elevation Availability of long-acting formulation Risk of QT prolongation Somnolent effects QD dosing Flexibility of titration Drug-drug interactions Risk of EPS Impact on cholesterol/lipid/TG levels Incidence of akathisia Impact on glucose/diabetes risk Time to onset of action Ability to treat negative symptoms Effective for many symptoms Risk of weight gain Ability to treat positive symptoms % Top-3 Box (8,9,10) - Inpatient 0.29 0.38 0.39 0.44 0.45 0.49 0.51 0.52 0.53 0.55 0.55 0.57 0.63 0.65 0.68 0.87 Source: TVG Quantitative Tradeoff Assesment, Q306 Atypical Drug Selection Factors Side effect risks figure prominently in atypical prescribing decisions Metabolic Effects Movement Disorder


 

Adverse Lipid Effects Weight Gain Adverse Glucose Effects Onset of EPS Onset of Akathisia Efficacy Source: GfK V2 Qualitative Positioning Study, January 2008. Perceptual Map: Driven by Movement and Metabolics Physicians differentiate atypicals more on side effect profile than on efficacy


 

FiaptaTM - Compelling Commercial Profile Similar Efficacy Favorable Metabolic Profile Favorable Movement Disorder Profile Geodon(r) Abilify(r) Invega(r) Risperdal(r) Seroquel(r) Zyprexa(r) Fiapta(tm) profile: favorable in movement disorders and metabolics


 

Key Areas of Launch Preparation Launch Preparation Sales Force MSL Managed Care Distribution Groundwork for a successful launch combines pre-PDUFA planning with rapid post-PDUFA execution Marketing


 

Marketing Significant efforts underway Marketing team build-out Messaging and positioning Branding Publication planning and execution Packaging Psychiatric community outreach Conferences


 

Sales Force Hire VP of sales Territory mapping Plan sales force scenarios Managers/reps: if Vanda owns sales force CSO: if Vanda rents sales force Hire or engage sales force Source: Verispan Deciles Antipsychotic MDs Depression MDs Insomnia MDs 10 721 3,418 3,370 10-8 3,734 18,001 17,381 10-5 14,012 57,363 57,972 Physician Deciling by Drug Class Vanda believes it can build or engage a small sales force to cover the prescribing base Vanda planned pre-PDUFA activity Vanda planned post-PDUFA activity


 

Managed Care IMS, Atypical managed care analysis, Q42006 Vanda believes a small managed care organization can effectively ensure Fiapta(tm) coverage Hire VP of managed care Payer profiling Develop pricing and contracting strategy Plan, engage managed care field force Execute on contracting strategy Vanda pre-PDUFA activity Vanda post-PDUFA activity Atypical Usage, by Payer Vanda planned pre-PDUFA activity Vanda planned post-PDUFA activity


 

Medical Science Liaisons Hire Director of MSLs Territory mapping Recruit and deploy MSLs Hire additional MSLs Vanda planned pre-PDUFA activity Vanda planned post-PDUFA activity


 

Distribution Hire 3rd party logistics agency Responsible for getting product to the trade Applying for state licenses Continue outsource strategy Contract manufacturer 3rd Party Logistics Contract packaging Role of 3rd Party Logistics Coordinator National wholesalers Regional wholesalers Specialty distributors Hospitals Community Mental Health Drugstores Mail order pharmacies Specialty pharmacies Long-term care Vanda planned pre-PDUFA activity Vanda planned post-PDUFA activity


 

Vanda Planning for Fiapta(tm) Launch Success Attractive clinical profile Strong core team in place Significant efforts underway Balancing execution and cash conservation objectives


 

Tasimelteon (VEC-162) (Sleep and Mood Disorders)


 

Distinct MoA Demonstrated in Wide Range of Indications Balanced melatonin-1, melatonin-2 agonist Sleep induction Sleep maintenance Circadian rhythm advance Sleep onset insomnia Sleep maintenance insomnia Circadian rhythm sleep disorders Seasonal Affective Disorder Major Depression MoA Effect Potential uses


 

Large Market Opportunity in Sleep Disorders Sleep induction Sleep maintenance Circadian rhythm modulation Sleep onset insomnia Sleep maintenance insomnia Circadian rhythm sleep disorders US prevalence 54 million 18 million Approved drugs/drug classes NBZDs (Ambien(r) CR, Lunesta(r), etc.) BZDs (lorazepam, etc.) tricyclics (trazodone, etc.) melatonin agonist (Rozerem(tm)) Emerging drug classes orexin antagonists tricyclics 5-HT2a antagonists No approved drugs Source: LEK, 2007


 

CRSD an Attractive Market for Tasimelteon Circadian Rhythm Sleep Disorders Shift Worker Sleep Disorder Delayed Sleep Phase Syndrome Jet Lag Non-24 Hour Sleep/Wake Cycle U.S. Prevalence (000) 1,500 3,000 13,500 50 Tasimelteon Potential Benefits Disease-modification (CR modulation) Demonstrated efficacy in sleep disorders LT safety No DEA scheduling anticipated Source: LEK, 2007


 

Mood Disorders an Attractive Market for Tasimelteon Circadian Rhythm- Related Mood Disorders Seasonal Affective Disorder Major Depression U.S. Prevalence (000) 5,800 14,700 Tasimelteon Potential Benefits Disease-modification (CR modulation) LT safety Sleep benefits Source: LEK, 2005


 

Pending Tasimelteon Phase III Milestone Objective Safety and efficacy in treatment of patients with chronic insomnia Duration 35 days (including screening) Dosing 20, 50 mg QD Comparator Placebo # of Patients 324 Key Endpoints LPS, WASO, safety Results expected in June, 2008 Phase III transient insomnia trials highly predictive of chronic insomnia results Tasimelteon previously demonstrated LPS, WASO statistical significance VP-VEC-162-3104


 

Substantial Development Program Underway Phase III transient insomnia Completed Phase III chronic insomnia Process refinement Completion expected in 08 Carcinogenicity Vanda anticipates a 2010 NDA for tasimelteon Clinical Preclinical Manufacturing Clinical pharmacology Clinical scale-up In planning stage Commercial scale-up Driving, DEA scheduling, next day effects Phase I, II Additional Phase III trials


 

Conclusions


 

Summary Financials ($ in millions) 12/31/07 Cash/cash equivalents/ST investments $93.2 ($ in millions) Year ended 12/31/07 Operating Expenses R&D $47.2 G&A 32.8 Loss from Operations (80.0) Net Loss $(74.1) Cash expected to be sufficient to fund operations through Fiapta(tm) PDUFA date and into Q4 2008 Current spend focus: Reporting top-line results from tasimelteon Phase III chronic insomnia trial Essential Fiapta(tm) pre-launch commercial activities


 

Major Milestones in 2008 Fiapta(tm) APA (May) PDUFA (expected July 27) Tasimelteon Phase III chronic insomnia (expected in June) APSS (June)