Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Cerecor — Investor Presentation (September 2018)
32 slides from Avalo Therapeutics's investor presentation, Sep 27, 2018
Slide 1: 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 uncertainties that are subject
Slide 2: 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 and not a substitute for fin
Slide 3: Transforming Cerecor into a World-Class Bio-Pharmaceutical Company
Transforming Cerecor into a World-Class, Innovation Driven, Bio-Pharmaceutical Company Dedicated to Improving the Lives of Patients and Creating a Healthier World 4
Slide 4: Cerecor Today
Cerecor Today Building a Robust Biotech Pipeline of Therapies in Neurology, Pediatric and Orphan Rare Diseases While Developing Commercial Capabilities with our Revenue Producing Pediatric Franchise Focused on Research and Development While Building Our Commercial
Slide 5: Investor Highlights
Investor Highlights Emerging clinical & early-stage pipeline Focus on orphan, neurological & pediatric indications Innovative Pipeline Pediatric portfolio generating positive cash flow Seeking to in-license additional commercial assets Commercial Footprint Fully-integrated commercial and R&D organiz
Slide 6: Overview / Management Team / Historical Milestones
7 Overview Management Team 1 Historical Milestones 2 Neurology & Pediatric Rare Disease Pipeline 3 Commercial Pediatric Portfolio 4 Strategic Growth Plans and Outlook 5 Financial Highlights 6
Slide 7: Management Team
20+ years industry experience Chairman and CEO, Sucampo Pharmaceuticals CEO, Histogenics Corporation President, MedImmune Ventures Manager, Centocor Biotech (Johnson & Johnson) 20+ years industry experience V.P. Global CMC & Development, Sucampo Pharmaceuticals CSO, Pharming Group Sr. Director Rare
Slide 8: Historical Milestones
9 Historical Milestones 2017 2013 2016 2015 2014 CERC-301 CERC-406 Acquired worldwide rights of two NMDA receptors from Merck CERC-611 Acquired worldwide rights from Eli Lilly CERC-501 Sold to Janssen CERC-501 Acquired worldwide rights from Eli Lilly 2018 CERC-301 Enters Phase 1 study for nOH Acquis
Slide 9: FDA-Approved Products and Pipeline Evolution
FDA-Approved Products Poly-Vi-Flor® Tri-Vi-Flor® Karbinal™ ER AcipHex® Sprinkle™ Cefaclor Flexichamber™ Millipred® Veripred® Ulesfia® Innovative Approaches to CNS Diseases CERC-301 CERC-406 CERC-611 Cerecor Evolution 505(b)(2) Assets & Platform Chemistry CERC-801 CERC-802 CERC-913 Neurological Disor
Slide 10: Pipeline Programs by Mechanism and Indication
Program Mechanism of Action Target Indication Pre Clinical Phase 1 Phase 2 Phase 3 Neurology Rare Disease Division NCE CERC-301 GluN2B selective, NMDA Receptor antagonist Neurogenic Orthostatic Hypotension (nOH) CERC-406 Selective, brain penetrant COMT inhibitor (2nd Gen) Potential motoric and non-m
Slide 11: Upcoming Clinical Program Milestones
Program Mechanism-of-Action Milestone Neurological Disorders CERC-301 Neurogenic Orthostatic Hypotension NR2B selective NMDA receptor antagonist Phase I Readout 1H19 CERC-406 Adjunct for Parkinson’s Disease CNS penetrant & selective COMT inhibitor IND Filing 1H 2020 CERC-611 Partial Onset Seizures T
Slide 12: Estimated Market Potential Patient Populations
Estimated Market Potential Patient Populations
Slide 13: CERC-301 NR2B Antagonist for nOH
Oral NR2B Antagonist NR2B specificity reduces ketamine-like side effects Potential rapid onset of action Oral formulation CERC-301 Attributes nOH 14 CERC-301 NR2B selective NMDA receptor antagonist for nOH Entered into Phase 1 clinical study for Neurogenic Orthostatic Hypotension (“nOH“) in Parkinso
Slide 14: CERC-301 Clinical Studies and Blood Pressure Effect
Studies1 N Dose (Frequency) Duration BP Effect MRK 001, 002, 003, 004 & 006 CERC 301-200, 201, 203 419 0.1 to 20 mg (fast/fed, daily to once weekly) 1 to 28 days Yes* 15 CERC-301 NR2B selective NMDA receptor antagonist for nOH 1. Studied Populations include: Seasonal Affective Disorder (SAD), Mix An
Slide 15: CERC-406 COMT Inhibitor for Parkinson's Disease
COMT drives the catabolism of dopamine and levodopa Inhibition of dopamine catabolism is used to treat CNS manifestations of Parkinson’s Disease A CNS selective COMT inhibitor presents the opportunity to minimize systemic toxicity associated with 1st generation COMT inhibitors Targeted therapy with
Slide 16: CERC-406 Attributes
17 CERC-406 COMT inhibitor for Parkinson’s Disease Preclinical & clinical biomarker for translational proof-of-concept High specificity for COMT expressed in the CNS Good oral bioavailability & brain penetration Acceptable PK profile in rat & dog Low potential for DDIs CERC-406 Attributes
Slide 17: CERC-611 AMPA Receptor Antagonist for Partial Onset Seizures
18 CERC-611 TARP-8 dependent AMPA receptor antagonist for partial onset seizures 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
Slide 18: CERC-800s Substrate Replacement Therapies for IEMs
19 CERC-800’s Substrate replacement therapies for IEMs CERC-801 Multi-system disease manifestation CERC-801 leads to significant improvement in key clinical symptoms Life-threatening gastrointestinal disorder CERC-802 rapidly resolves hematological & intestinal abnormalities Qualification 801 802 50
Slide 19: CERC-913 ProTide Nucleotide for Mitochondrial Disorder
CERC-913 ProTide Nucleotide for Mitochondrial Disorder Overcome key limitations of direct substrate replacement Phenotypic Rescue In vitro proof-of-concept in patient-derived & animal-based disease models ProTide similar to advanced clinical candidates and approved drugs Metabolite ID & PK profile i
Slide 20: Overview / Commercial Pediatric Portfolio
21 Overview Management Team 1 Historical Milestones 2 Neurology & Pediatric Rare Disease Pipeline 3 Commercial Pediatric Portfolio 4 Strategic Growth Plans and Outlook 5 Financial Highlights 6
Slide 21: Building Commercial Capabilities in Pediatrics
Building Commercial Capabilities in Pediatrics 1 Chief Commercial Officer 1 EVP Marketing & Investor Relations 3 Regional Sales Managers 1 Director of Sales Training and Operations 1 Director of Trade Sales and Operations 1 Sales Analyst 32 Territory Managers 3 Focused / 8 Promoted Products Cloud-ba
Slide 22: Pediatric Franchise with Eight Product Lines
23 Pediatric Franchise with Eight Product Lines Cerecor Inc. TRX Pharmaceuticals Avadel Pediatric Assets
Slide 23: Why Pediatrics Represents a Focused Patient Population
Why Pediatrics 24 Represents a Focused, Defined and Specific Patient Population Treated by One Specialty Segment 24.5% of U.S. population is < 18 years of age representing a sizable patient population of 81.5M in 2017 85,000 General Pediatricians most in group practices resulting in ~17,000 to 20,00
Slide 24: Gross Product Sales
25 Gross Product Sales Gross Product Sales Last 4 QTR Trend
Slide 25: Net Sales Trend and Financial Metrics: Profit/Loss
Net Sales Trend Analysis 26 Financial Metrics: Profit/Loss 1 See Appendix for reconciliation of GAAP Net Income to Adjusted EBITDA. Adjusted EBITDA Trend Analysis1 Full Year FY18 Guidance Net Sales $17 to $19 million Full Year FY18 Guidance Adjusted EBITDA Break-even by fiscal year-end
Slide 26: Financial Metrics: Balance Sheet
27 Financial Metrics: Balance Sheet * Includes cash receipts of $25M from Janssen Pharma for the rights of CERC-501 and the subsequent purchase of Zylera/TRx in Q4FY17 Cash Trend Analysis* Total Assets Trend Analysis
Slide 27: 2019 Growth Plans
28 2019 Growth Plans Cerecor Inc. Build 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) CERC-301 1H19 Readout CERC-406 IND 2020 CERC-611 TBD CER
Slide 28: Investor Highlights
Investor Highlights Emerging clinical & early-stage pipeline Focus on orphan, neurological & pediatric indications Innovative Pipeline Pediatric portfolio generating positive cash flow Seeking to in-license additional commercial assets Commercial Footprint Fully-integrated commercial and R&D organiz
Slide 29: Cerecor Inc. www.cerecor.com
Cerecor Inc. NASDAQ:CERC www.cerecor.com 30
Slide 30: “S.cerecor
“S.cerecor Ay NASDAQ:CERC ore
Slide 31: Adjusted EBITDA Reconciliation
32 Adjusted EBITDA Reconciliation
Slide 32: Adjusted EBITDA Reconciliation
Adjusted EBITDA Reconciliation (in thousands) Three Months Ended 33037 FFETETI EXTETY 63018 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 (income) expense, net (29) (30) 100 282 Amortization of i