Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Merger or Acquisition (January 2020)
16 slides from Axsome Therapeutics's merger presentation, Jan 13, 2020
Slide 1: Axsome Exclusive Agreement with Pfizer Conference Call
NASDAQ: AXSM Axsome Exclusive Agreement with Pfizer Conference Call January 13, 2020 © Axsome Therapeutics, Inc.
Slide 2: Forward-Looking Statements & Safe Harbor
FLS Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue
Slide 3: Axsome Exclusive Agreement with Pfizer Summary
Overview Axsome Exclusive Agreement with Pfizer Summary • Exclusive U.S. license to Pfizer’s clinical and nonclinical data, and intellectual property for reboxetine – Axsome is developing reboxetine, the active pharmaceutical ingredient in AXS-12, for the treatment of narcolepsy • Exclusive right fr
Slide 4: License and Rights
Overview Axsome Exclusive Agreement with Pfizer License and Rights Reboxetine (AXS-12) • Axsome receives from Pfizer exclusive U.S. license to Pfizer data from: – Short-term and long-term reboxetine clinical trials – Full range of reboxetine nonclinical studies; other intellectual property • Reboxet
Slide 5: Financial Terms
Overview Axsome Exclusive Agreement with Pfizer Financial Terms Pfizer receives: • Axsome common stock having a value of $8 million, based on the average closing price for the 10 prior trading days • Upfront cash payment of $3 million • Up to $323 million in regulatory and sales milestones, and tier
Slide 6: Benefits of the Transaction
Overview Axsome Exclusive Agreement with Pfizer Benefits of the Transaction • Accelerates AXS-12 development in narcolepsy, and mitigates associated risks and costs – Reduces or eliminates need to conduct certain nonclinical and clinical studies – Licensed clinical data for reboxetine and esreboxeti
Slide 7: AXS-12 Narcolepsy: AXS-12 (reboxetine) Overview
AXS-12 Narcolepsy: AXS-12 (reboxetine) Overview • Debilitating sleep disorder characterized by excessive daytime sleepiness (EDS) and cataplexy • Limited treatment options – Only one approved agent for cataplexy – Most currently approved drugs are scheduled • Positive Phase 2 efficacy results with A
Slide 8: AXS-14 Fibromyalgia Overview
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Overview • Debilitating, chronic, CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment; ~90% affected are women • Limited treatment options—only 3 approved agents: – Current treatments has variable ef
Slide 9: Unmet Patient Needs
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Unmet Patient Needs Percentage of Fibromyalgia Patients with Symptoms1,2 Pain Fatigue Depression Difficulty Concentrating Widespread Pain Difficulty Concentrating Fatigue Function Depression AXS-14 pregabalin duloxetine milnacipran 1Walitt et al. PLoS ONE.
Slide 10: Pharmacology
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Pharmacology • SS-enantiomer of racemic reboxetine – More selective isomer • Different pharmacologic approach than currently approved agents • Highly selective and potent norepinephrine (NE) reuptake inhibitor – AXS-14 increases descending NE inhibition for
Slide 11: Phase 3 Efficacy Data: Pain and Function
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Phase 2 Efficacy Data Placebo (n=133) Esreboxetine (n=134) Pain Reduction Improvement in Function 0 0 -0.2 -2 -0.4 -4 -0.6 -6 -0.8 -8 -1 -10 -1.2 -12 -1.4 -14 -1.6 P=0.006 -16 P<0.001 Scale: 0 = no pain, 10 = worst pain Baseline scores: 6.8 (both groups) Sc
Slide 12: Phase 3 Efficacy Data: Global Impression and Fatigue
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Phase 2 Efficacy Data Placebo (n=133) Esreboxetine (n=134) Patient Global Impression Improvement in Fatigue 50% 0 -1 40% -2 -3 30% -4 20% -5 -6 10% -7 0% Scale: 0 = none, 50 = maximum Baseline scores: 38 (both groups) Very Much / Much Improved © Axsome Ther
Slide 13: Phase 2 Efficacy Data: Pain and Function
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Phase 3 Efficacy Data Pain Reduction Improvement in Function Esreboxetine 4 mg/day Esreboxetine 8 mg/day Esreboxetine 10 mg/day Esreboxetine 4 mg/day Esreboxetine 8 mg/day Esreboxetine 10 mg/day Placebo Placebo 0 -0.2 -0.4 -0.6 -0.8 -1 -1.2 -1.4 -1.6 -1.8 -
Slide 14: Phase 2 Efficacy Data: Global Impression and Fatigue
AXS-14 Fibromyalgia: AXS-14 (esreboxetine) Phase 3 Efficacy Data Patient Global Impression Improvement in Fatigue Esreboxetine 4 mg/day Esreboxetine 8 mg/day Esreboxetine 10 mg/day P=0.007 Placebo 50% 0 -0.2 40% -0.4 -0.6 30% -0.8 -1 20% -1.2 10% -1.4 P=0.001 P=0.001 0% Scale: 0 = no fatigue; 10 = s
Slide 15: Our CNS Candidates and Pipeline
Overview Our CNS Candidates and Pipeline • Four differentiated clinical-stage CNS assets targeting significant and growing markets • Patent protection to 2034-2036, worldwide rights for most product candidates epression: Fast Track Desi der: Breakthrough Therapy Designation otocol Assessment phan De
Slide 16: For more information, please contact
For more information, please contact Mark Jacobson SVP, Operations 212-332-3243 mjacobson@Axsome.com axsome.com
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