Tonix Pharmaceuticals Holding Corp. · NASDAQ:TNXP
Tonix Pharmaceuticals — Investor Presentation (July 2012)
12 slides from Tonix Pharmaceuticals's investor presentation, Jul 13, 2012
Slide 1: Fibromyalgia Reimbursement Perspective
Fibromyalgia Reimbursement Perspective July 2012 OTC/QB: TNXP
Slide 2: Disclosures
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Disclosures Certain statements in this presentation regarding strategic plans, expectations and objectives for future operations or results are “forward - looking statements” as defined by the Private Securities Litigation Reform Act of 1995 .
Slide 3: Pain: Cost to Society
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Pain: Cost to Society • Pain management is one of society’s major challenges - Abuse and addiction to prescription opiates is a fast growing national crisis - Top priority of multiple governmental agencies - Highlighted by Professor Derek Bok
Slide 4: Fibromyalgia: Cost to Society
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia: Cost to Society • Fibromyalgia presents a significant economic burden to the healthcare system* - “Mean annual expenditures for fibromyalgia patients were … similar to rheumatoid arthritis … ” - “A greater proportion of patients
Slide 5: Fibromyalgia Reimbursement: Generics Not Approved by FDA
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia Reimbursement: Generics Not Approved by FDA • Some formularies list off - label generics in Tier 1 for fibromyalgia - However, as these drugs are not FDA approved, they cannot be marketed for fibromyalgia - Managed care and Medica
Slide 6: Fibromyalgia Reimbursement: FDA-Approved Products
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia Reimbursement: FDA - Approved Products • FDA - approved fibromyalgia products have strong sales and growth* - Cymbalta®: ~$560 million in fibromyalgia in the US in 2011 and growing - Lyrica®: ~$450 million in fibromyalgia in the U
Slide 7: Fibromyalgia Reimbursement: FDA-Approved Products (2)
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia Reimbursement: FDA - Approved Products (2) • Many patients continue to be unsatisfied by current therapies - Efficacy, durability and tolerability motivate patients to seek alternatives - Managed care hurdles not expected for new
Slide 8: Fibromyalgia Reimbursement: TNX-102 Anticipated Launch Year
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Fibromyalgia Reimbursement: TNX - 102 Anticipated Launch Year* • Duloxetine (Cymbalta®) will be generic and likely in Tier 1 - Potential for duloxetine to replace off - label generics in Tier 1 • “Managed Care” study on TNX - 102 prior to laun
Slide 9: Responses to Managed Care Hurdles
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Responses to Managed Care Hurdles 9 Hurdle Response Cost of Tier 2 or Tier 3 medications: • Managed care charges a premium co - pay for branded medications Co - pay coupons/card: • Provide patients with coupons or “charge - card” vouchers that
Slide 10: TNX-102 Reimbursement Precedents
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS TNX - 102 Reimbursement Precedents • Novel formulations with novel PK profiles that address unmet needs are reimbursed 10 Generic / OTC Drug Labeled Indication Reformulated Rx Product Labeled Indication US Annual Sales* Comment Oxycodone Pain
Slide 11: Supreme Court Upholds ACA
TONIX PHARMACEUTICALS CONFIDENTIAL TONIX PHARMACEUTICALS Supreme Court Upholds ACA • The Patient Protection and Affordable Care Act (ACA) requires that medications like TNX - 102 will be covered by formularies - ACA Section 3307 expands the concept of “class” and “category” from the M edicare Modern
Slide 12: OTC/QB: TNXP
OTC/QB: TNXP
Tonix Pharmaceuticals Holding — Investor Presentation (July 2012) on 6ix