BioCryst Pharmaceuticals, Inc. · NASDAQ:BCRX
BioCryst Pharmaceuticals — Q2 2018 Earnings Presentation
18 slides from BioCryst Pharmaceuticals's earnings presentation, Aug 7, 2018
Slide 1: Second Quarter 2018 Results Call
Second Quarter 2018 Results Call Corporate Update & Financial Results August 7, 2018
Slide 2: Forward-Looking Statements
Forward-Looking Statements BioCryst’s presentation may contain forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information and company performance or achievements. These statements are subject to known and unknown risks and uncertain
Slide 3: Agenda
Agenda ◆ Update on Strategy and Pipeline: Focused on Executing our Strategic Plan Jon Stonehouse – President, Chief Executive Officer ◆ Clinical Update: ZENITH-1, APeX-2 and APeX-S Trials On-track Dr. Bill Sheridan – Chief Medical Officer ◆ Commercial Update: Significant Commercial Opportunity Lynne
Slide 4: Update on Strategy and Pipeline: Focused on Executing our Strategic Plan
Update on Strategy and Pipeline: Focused on Executing our Strategic Plan 4
Slide 5: Clinical Update: ZENITH-1, APeX-2, APeX-S Trials On-track
Clinical Update: ZENITH-1, APeX-2, APeX-S Trials On-track 5
Slide 6: PK profile of single oral dose of BCX7353 supports evaluation as an acute treatment in HAE
PK profile of single oral dose of BCX7353 supports evaluation as an acute treatment in HAE P K p r o f ile in h e a lt h y s u b je c t s S im u la t io n o f 7 5 0 m g s in g le d o s e A c t u a l 7 5 0 m g s in g le d o s e , H A E s u b je c t s ng/m L E C 5 0 m u lt i p l e ng/m L E C 5 0 m u l
Slide 7: Variable design of previous registration trials for acute treatments
Variable design of previous registration trials for acute treatments Drug Cinryze1 Berinert Kalbitor Firazyr Ruconest Study CHANGE IMPACT-1 EDEMA-3 FAST-3 C-131O Trial Years subjects enrolled 2005-2007 2005-2007 2005-2007 2009-2010 2011-2012 Route IV infusion IV infusion SC injection SC injection IV
Slide 8: Marketed injectables achieved ~16-43% improvement compared with placebo
Marketed injectables achieved ~ 16-43% improvement compared with placebo Trial Subjects Receiving Rescue % Difference Proportion meeting 1° endpoint % Difference Drug, dose Therapy or Medical Intervention Active - at 4 hours Active - Placebo Placebo Active Placebo Active Placebo CHANGE 23/35 28/33 2
Slide 9: ZENITH-1 exploratory phase 2 trial aligned with current guidelines for on-demand treatment
ZENITH-1 exploratory phase 2 trial aligned with the current guidelines for on-demand treatment1,2 Screening Treatment Follow-Up ZENITH-1 protocol instructions Sequence 1: A, P, A • Subjects are to call the site PI and treat attacks within 1 hour of symptom onset End of Screening Visit Sequence 2: P,
Slide 10: ZENITH-1 is unique
ZENITH-1 is unique Drug Cinryze1 Berinert Kalbitor Firazyr Ruconest BCX7353 Study CHANGE IMPACT-1 EDEMA-3 FAST-3 C-131O Trial ZENITH-1 Years subjects enrolled 2005-2007 2005-2007 2005-2007 2009-2010 2011-2012 2017-2018 Route IV infusion IV infusion SC injection SC injection IV infusion PO (liquid) D
Slide 11: ZENITH-1: Multiple efficacy endpoints to allow selection of primary endpoint for phase 3
ZENITH-1: Multiple efficacy endpoints to allow selection of primary endpoint for phase 3 Proportion: Time to: ◆ At 4 hours: ◆ Use of standard of care acute • Improved or stable 3-symptom attack treatment composite visual analogue ◆ Improved or stable symptoms by scale (VAS) score composite VAS score
Slide 12: BCX7353 phase 2 APeX-1 trial published, phase 3 trial well underway
BCX7353 phase 2 APeX-1 trial published, phase 3 trial well underway Blinded Treatment 24 weeks N ≅ 32 BCX7353 150 mg QD* N ≅ 32 BCX7353 110 mg QD* N ≅ 32 Placebo QD Aygoren-Pursun, E. et al 2018 N Engl J Med 379(4): 352-362 Final analysis @ week 24 12
Slide 13: Commercial Update: Significant Commercial Opportunity
Commercial Update: Significant Commercial Opportunity 13
Slide 14: Significant commercial opportunity
Significant commercial opportunity Potential to launch new era of oral therapy for HAE Over $2B global ◆ Large and growing HAE market opportunity market by launch of BCX7353 ◆ Prophylactic treatment will drive market growth with acute remaining important ◆ In a market of predominately injectable the
Slide 15: Financial Update: Strong Financial Position with Cash Runway into 2020
Financial Update: Strong Financial Position with Cash Runway into 2020 15
Slide 16: Second quarter operating results
Second quarter operating results 16
Slide 17: Cash position & 2018 guidance (in millions)
Cash position & 2018 guidance (in millions) Cash & investments at December 31, 2017 $159 Cash & investments at June 30, 2018 $122 Pro-forma cash & investments at June 30, 2018 A $186 Senior Credit Facility B $30 F Y 2 0 1 8 G U I D AN C E ( s t a n d - a l o n e , a s r e v i s e d o n J u l y 11 ,
Slide 18: Thank you… Questions and Answers
Thank you… Questions and Answers August 7, 2018
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