Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Cerecor — Investor Presentation (September 2018)
23 slides from Avalo Therapeutics's investor presentation, Sep 5, 2018
Slide 1: Forward-Looking Statements
Forward-Looking Statements This presentation may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and unc
Slide 2: Non-GAAP Financial Measures
Non-GAAP Financial Measures This presentation contains two financial metrics (EBITDA and Adjusted EBITDA) that are considered “non-GAAP” financial metrics under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial metrics should be considered supplemental to
Slide 3: Dedicated to commercializing, acquiring, and developing innovative treatments for children
Dedicated to commercializing, acquiring, and developing innovative treatments that make a difference in the lives of children 4
Slide 4: Building a robust pipeline of orphan therapies for future growth
while building a robust pipeline of orphan therapies for future growth. 5
Slide 5: Overview
Overview 6 Experienced Management Team Historical Milestones Pediatric Portfolio Pediatric, Neurology & Rare Diseases Pipeline Strategic Growth Plans and Outlook Financial Highlights 1 2 3 4 5 6
Slide 6: Experienced Management Team
Experienced Management Team 7 Peter S. Greenleaf, President & CEO 20+ years industry experience Chairman and CEO, Sucampo Pharmaceuticals CEO, Histogenics Corporation President, MedImmune Ventures Manager, Centocor Biotech (Johnson & Johnson) Dr. Pericles Calias, Chief Scientific Officer 20+ years i
Slide 7: Historical Milestones
Historical Milestones 8 Cerecor Inc. 2017 2013 2016 2015 2014 CERC-301 CERC-406 CERC-611 CERC-501 Sold to Jansen CERC-501 2018 CERC-301 Enters Phase 1 study for nOH October 2015: Initial Public Offering NASDAQ listing: CERC Acquisition TRx Pharma (Zylera) Acquisition Avadel (AVDL) Pediatric assets A
Slide 8: Historical Milestones
Historical Milestones * October 2015: Initial Public Offering + NASDAQ listing: CERC 2013 2014 2015 2016 2017 2018 cERC-201 Cerecor IPO Acquisition Acquisition CERC-406 October 16,2015, Tex Pharma ‘ecal (AVDL) Acquted wordvide rights of wo NASDAQ (2ylera) Pediatric assets NMDA receptor rm Merck % CE
Slide 9: Accretive Acquisitions
Accretive Acquisitions 10 Zylera Pharma Corp, TRx Pharmaceuticals and its wholly-owned subsidiaries Transaction closed November 2017 Franchise of pediatric focused prescription medications and dietary supplements Avadel Entity Assets (Previously FSC Pediatrics) Transaction closed February 2018 Franc
Slide 10: Pediatric Franchise with Eight Product Lines
Pediatric Franchise with Eight Product Lines 11 Cerecor Inc. TRX Pharmaceuticals Avadel Pediatric Assets
Slide 11: Seven Pipeline Programs
Seven Pipeline Programs Program Compound Indication Pre-Clinical Phase 1 Phase 2 Phase 3 CERC-301 GluN2B selective, NMDA Receptor antagonist Neurogenic Orthostatic Hypotension (nOH) CERC-611 TARP-γ8 dependent AMPA Receptor antagonist Potential treatment for partial onset seizures in epilepsy CERC-40
Slide 12: Exclusive Licensing Deal with Avadel
Exclusive Licensing Deal with Avadel Cerecor and Avadel have an exclusive licensing deal for up to four 505(b)2 assets to be developed using the Micropump® and LiquiTime® technology 14 Micropump® Micropump® is a microparticulate system that allows the development of modified and/or controlled releas
Slide 13: CERC-700 Series On-going Programs
CERC-700 Series On-going Programs ADHD CERC-701: Dexmethylphenidate delayed release, rapid dissolving tablet formulation CERC-702: Dexmethylphenidate immediate release, taste masked extended release liquid formulation Anti-Infective CERC-703: Clindamycin hydrochloride, liquid and extended release Ex
Slide 14: CERC-301 Entered Phase 1 safety study for nOH
CERC-301 Entered in to Phase 1 safety study for Neurogenic Orthostatic Hypotension (“nOH“) in Parkinson’s Patients Attributes Oral NR2B Antagonist NR2B specificity reduces ketamine-like side effects Potential rapid onset of action Oral formulation nOH1 A rare disorder that is defined as low blood pr
Slide 15: CERC-611 Significant unmet need
CERC-611 Significant unmet need Epilepsy affects over 65 million patients worldwide 30%-40% of patients refractory; high degree of poly-pharmacy common All anti-seizure drugs have side effects (e.g. motoric) limiting use and the timely achievement of therapeutic dose levels Unique Mechanism of Actio
Slide 16: CERC-406/425
CERC- 406/425 COMT drives the catabolism of dopamine and levodopa These represent an opportunity to treat the CNS manifestations of PD while minimizing the systemic toxicities associated with approved COMPT inhibitors Targeted therapy with Bio-Markers of activity Potential to target individuals with
Slide 17: 2018 Growth Plans
2018 Growth Plans 19 Cerecor Inc. Develop Commercial Excellence Accelerate Business Development Activity Advance Pipeline Grow Market Share Expand Commercial Footprint Acquire/in-license early and late stage commercial-ready or marketed asset(s) Advance CERC -700’s Advance CERC-301 Progress CERC-611
Slide 18: Financial Metrics: Profit/Loss
20 Financial Metrics: Profit/Loss (1) See Appendix for reconciliation of GAAP Net Income to Adjusted EBITDA.
Slide 19: Financial Metrics: Balance Sheet
21 Financial Metrics: Balance Sheet
Slide 20: Cerecor Inc. www.cerecor.com
Cerecor Inc. NASDAQ:CERC www.cerecor.com 22
Slide 21: “S.cerecor Ty
“S.cerecor 4 Ty NASDAQ:CERC \ www.cerecor.com
Slide 22: Adjusted EBITDA Reconciliation
24 Adjusted EBITDA Reconciliation
Slide 23: Adjusted EBITDA Reconciliation
Adjusted EBITDA Reconciliation Recondilation of GAAP Net Loss to Adjusted EBITDA (in thousands) “Three Months Ended 33017 23147 EXTETY 630318 2017 2017 2018 2018 GAAP Net income (Loss) S$ 18721 § (3.092) $ (3.883) § (6,007) Adiustments: Income tax expense (benefit) 3230 (2.263) 23 16 Interest (incom