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NYSE:BHVN
Ellie, living with migraine
© 2020 Biohaven Pharmaceuticals. All rights reserved.
3rd Quarter 2020 EarningsNovember 9, 2020
Cliff Bechtold, M.S. | Chief Operating Officer
Opening Remarks
Opening Remarks | Cliff Bechtold, M.S. Chief Operating Officer
Quarter Summary and Recent Events | Vlad Coric, M.D. Chief Executive Officer
3Q20 Financial Results | Jim Engelhart, C.P.A. Chief Financial Officer
Commercial Events | BJ Jones, M.B.A. Chief Commercial Officer Migraine and Common Disease
R&D Update | Elyse Stock, M.D. Chief Medical Officer
Closing Remarks | Vlad Coric, M.D. Chief Executive Officer
Question and Answer Session
Agenda
3
Forward-Looking Statements and Non-GAAP
This presentation contains forward-looking statements within the meaning of “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including: statements about our plans to develop and commercialize our product candidates, the timing of ourplanned regulatory filings, the timing of and our ability to obtain and maintain regulatory approvals for our product candidates and the clinical potential utility of our product candidates, alone and as compared to other existing or potential treatment options. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and from the Company's current expectations. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. The forward-looking statements in this presentation represent our views as of the date of this presentation. Subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no obligation to do so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020, Biohaven's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Commission on August 10, 2020, and Biohaven's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020.
This presentation refers to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Reconciliations of non-GAAP financial results to the most directly comparable GAAP financial results are included at the end of this presentation.
During this call, presenters will make statements about our approved product Nurtec ODT. Safety information and the full prescribing information for Nurtec ODT can be found at Nurtec.com.
4
Vlad Coric, M.D. | Chief Executive Officer
Third Quarter 2020 Summary & Recent Events
Company Achievements
6
NURTEC ODT Prevention
sNDA filing accepted
October 2020
200M+Covered Lives All Channels
$17.7M3Q20 Net Sales
> 80% Increase in Net
Sales from 2Q20
>220,000TRxs of NURTEC
since launch
87% COVERAGE
KEY INSIGHTS –• Time-aligned Nurtec TRx launch curve shows strong growth consistent with the class, despite competitor’s
pre-COVID launch 2 months earlier• Oral CGRP market for migraine on track to reach blockbuster status in U.S. market alone
Oral CGRP Class Continues to Show Robust Market Growth
7
Nurtec ODT
UbrelvyNurtec ODT
Ubrelvy
12,220
15,761
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41Weeks since launch
Total Rx – Time Aligned (10/30)
48.1%
3/133/27
4/104/24 5/8
5/22 6/56/19 7/3
7/177/31
8/148/28
9/119/25
10/9
Week ending
New to Brand Rx Share (10/16)
Source: NBRx through 10/16, Symphony PrescriberSource, accessed 11/2; TRx through 10/30, Symphony PHAST, accessed 11/6
Orals CGRPs have driven CGRP class growth in 2020 (vs mAbs)
8 Symphony PHAST Database: TRx Volume to 9/25/2020, accessed 10/5/2020* CGRP acute orals = Ubrelvy, Nurtec ODT; CGRP mABs = Emgality, Ajovy, Aimovig
0
20,000
40,000
60,000
80,000
100,000
120,000
5/25/2
018
6/25/2
018
7/25/2
018
8/25/2
018
9/25/2
018
10/25
/2018
11/25
/2018
12/25
/2018
1/25/2
019
2/25/2
019
3/25/2
019
4/25/2
019
5/25/2
019
6/25/2
019
7/25/2
019
8/25/2
019
9/25/2
019
10/25
/2019
11/25
/2019
12/25
/2019
1/25/2
020
2/25/2
020
3/25/2
020
4/25/2
020
5/25/2
020
6/25/2
020
7/25/2
020
8/25/2
020
9/25/2
020
CGRP Weekly TRx
acute oralmAb
July – OctoberApril - June
High Impact Commercial PBM and Health Plan Wins
9
200M+ Total Covered Lives in
all Channels
87%COVERAGE
A Defining Launch, Future Growth Potential Across the Pipeline
10
2020 pivotal growth year for oral CGRPs
sNDA for Nurtec ODT Prevention accepted by FDA, 2Q2021 PDUFA Date
Neuroinnovation pipeline poised to deliver multiple NDAs
Common Disease Pipeline Opportunities
11
ACUTE MIGRAINE Global filings 2021, China and Korea clinical study started in Oct 2020
MIGRAINE PREVENTION PDUFA 2Q21, launch preparation underway while awaiting approval decision
INTRANASAL ULTRA-RAPID ONSET Second pivotal acute migraine & 1yr Safety study initiated Oct 2020
ORAL Oral formulations of zavegepant confirmed target exposure in human PK trial and Phase 3 to begin
NON-MIGRAINE INDICATIONS 3 POC studies in 2021
ALZHEIMER'S DISEASE Topline Dec 2020-Jan 2021
OCD 2 pivotal trials to begin 4Q20/1Q21
Nurtec ODT™Acute and Prevention
ZavegepantSmall molecule/NCE
Glutamate Modulation
MultipleBlockbuster
Potentials
Rare Disease Opportunities
12
>$5BPotential Global Peak Revenue
Multiple System Atrophy
Amyotrophic Lateral Sclerosis
Spinocerebellar Ataxia
Targeting 3 Global Rare Disease
Drug Launches by 2023
Combined Potential Across 3 Indications
2Phase 3
Readouts in 2021
3Devastating
Diseases
Jim Engelhart, C.P.A. | Chief Financial Officer
3Q20 Financial Results
Third Quarter Results (Unaudited)
GAAP Reported Non-GAAP Adjusted
Q3 2020 Q3 2019 Change Q3 2020 Q3 2019 ChangeProduct Revenue, net — Nurtec™ ODT $17.7 $ - $17.7
R&D expense 57.0 61.7 (4.6) 51.8 58.0 (6.2)
SG&A 119.5 28.8 90.8 110.2 22.4 87.8
Net loss (196.6) (106.2) (90.5) (159.5) (80.8) (78.7)
Net loss per share - basic and diluted $(3.27) $(2.04) $(1.23) $(2.67) $(1.55) $(1.12)
Note: See slides 32 – 33 for an explanation of our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP adjusted amounts shown
GAAP Reported Non-GAAP Adjusted$ Millions, except net loss per share - basis and diluted
14
Tax Considerations and Capital Position
Capital Position ($Millions)
Cash, cash equivalents, and marketable securities @ September 30, 2020 $552.0
Cash immediately available to draw from the August 2020 Sixth Street financing $100.0
Additional capital remaining on the $950M in August 2020 Sixth Street & RPI financings (partially subject to revenue/development milestones) $425.0
15
Access to $650M+ in capital
Income Taxes
• $875.0M future tax benefit recorded from rimegepant IP sale to Irish subsidiary; does not expire under Irish tax laws• Anticipate majority of future global taxable income to be subject to Irish statutory tax rate, currently at 12.5%• Effective tax rate projected to be significantly less than 12.5% as we utilize various tax benefits including NOL carryforwards
and $875.0M tax benefit described above
BJ Jones, M.B.A. | Chief Commercial Officer Migraine and Common Disease
Commercial Events
Two different patient segments driving initial oral CGRP growth
“New to Rx” and “Dissatisfied Rx” PatientsFueling Large Market Growth
Not currently taking Rx
Patients switching from triptans
17
~26%*
~74%
*Symphony Patient Source Data – 3Q2020
Oral CGRPs have Significant Growth Opportunity Ahead
18
2Q ‘20 3Q ‘20 3Q ‘20
205,463
1,448,602
Symphony Prescribersource Database: Cumulative NBRx Volume (1/24/20 – 9/18/20), accessed 10/5/2020
122,965
CGRP Orals Triptans
14%12%
Most Preferred Acute Therapy
By 3Q20, oral CGRPs have made significant headway as neurologists’ preferred acute therapy
Syndicated Survey Data Suggests Increasing Adoption of CGRP Class Among Neurologists
19
56% 23% 20%
Any triptan Nurtec ODT Ubrelvy
Perc
ent o
fre
spon
dent
s
Significant Advance Over Triptans
Percent of respondents51% 42%
Source: Spherix Global Insights
Neurologists Believe Nurtec ODT is Differentiated Pe
rcen
t of r
espo
nden
ts
6% 9% 5% 5% 6% 5% 7% 5%20%
11% 7% 7% 6%
55%60% 69% 73% 75% 76% 80% 80% 79% 85% 61% 76%
72% 73% 77%
39%31% 26% 22% 21% 18% 16% 15% 14% 10%
19% 13%21% 20% 17%
0%
20%
40%
60%
80%
100%
COMPANY/ REPRESENTATIVE SUPPORT
Duration of effect
Need for redosing
Administration: Patient
convenience
Speed of efficacy onset
Tolerability Rapid pain relief and
return to function in as little as one
hour
Pain freedom at two hours
Freedom from most bothersome symptom at two
hours
Supported by strong clinical
data
Good long-term safety profile
My familiarity/ comfort
Accessibility on formularies or
insurance plans
Pharmaceutical company
support for health care providers
Pharmaceutical company
support for patients
Professionalism/value brought
by sales representative
KEY CLINICAL ATTRIBUTES
In your opinion, how does Nurtec ODT compare to Ubrelvy on the following metrics? (n=101)
Nurtec ODT is better Equivalent Ubrelvy is betterSource: Spherix Global Insights
Both IQVIA and Symphony Data Reflect Strong Nurtec ODT Performance in a Growing Oral CGRP Market
21
0
1,000
2,000
3,000
4,000
5,000
6,000
1/24 2/
7
2/21 3/
6
3/20 4/
3
4/17 5/
1
5/15
5/29
6/12
6/26
7/10
7/24 8/
7
8/21 9/
4
9/18
10/2
Week ending
NBRx Volume
SHS: Nurtec ODT SHS: Ubrelvy IQVIA: Nurtec ODT IQVIA: Ubrelvy
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
3/13
3/27
4/10
4/24 5/
8
5/22 6/
5
6/19 7/
3
7/17
7/31
8/14
8/28
9/11
9/25
10/9
Week ending
NBRx Share
SHS: Nurtec ODT SHS: Ubrelvy IQVIA: Nurtec ODT IQVIA: Ubrelvy
Source: NBRx through 10/9, IQVIA; NBRx through 10/2 Symphony, accessed 10/23
Strong Progress on Strategic Drivers
22
ENSUREaccess and affordability
ACTIVATEpatients
DRIVE healthcare practitioner awareness
Strong and Growing Base of Awareness and Trial
>90% Awareness among targets*
>20K Unique writers
High Share of Voice and Positive Consumer Response
Efficient blend of traditional, digital and social
Positive patient experiences spread through social channels
Broad Coverage and Access
87% Commercial Formulary Coverage
200M+ Covered Lives in all Payer Channels
*Source: HCP ATU, Wave 6, fielded September 2020
Elyse Stock, M.D. | Chief Medical Officer
R&D Update
ACUTE TREATMENT WITH NURTEC ODT• Early onset of action• Return to normal by 60 minutes• Durable effect up to 48 hours• Safety and tolerability similar to placebo
Working toward a “unified” treatment of migraine across its spectrum
PREVENTION TREATMENT TARGET PROFILE• One medication that delivers acute and prevention• ODT formulation, no need for painful injections• No need for refrigeration and bringing to
room temp prior to injection-simplifies life and travel
• Women of childbearing potential considerations vs. long half-life therapies like monoclonal antibodies
24
Goal is to provide patients with a single drug with both acute and preventive therapy in migraine
Zavegepant (BHV-3500) 3rd Gen CGRP Receptor Antagonist
25
Zydis® ODT
SoftGel
25
Multiple Formulations Fitting Multiple Needs
ORAL• Prevention of Migraine and
Non-migraine indications• Phase 3 migraine trial 1Q2021• 3 Nonmigraine POC trials
planned for 2021
INTRANASAL• Potential for ultra rapid onset,
superior chemical attributes• Acute treatment of Migraine • 2nd pivotal migraine efficacy
study initiated Oct 2020• 1yr long-term safety trial
initiated Oct 2020• Advancing towards 4Q21 NDA
2H2021
Pipeline Milestone Events
26
2H2020 1H2021DRUG NAME INDICATION
Migraine prevention
Europe Filing 1QMigraine acute/prevention PMDA Meeting
2022
ZavegepantSmall molecule/NCE
Filing 4QMigraine (intranasal) Approval
Topline 1QAlzheimer's
TroriluzoleNCE prodrug of riluzole
Topline 4QSpinocerebellar ataxia
Topline 4QMultiple system atrophyVerdiperstatNCE oral MPO inhibitor
ToplineAmyotrophic lateral sclerosis
ToplineObsessive-compulsive disorder
Migraine (oral) Start Phase 3 1Q
ApprovalsNDA Accepted
Biohaven Targeting 3 Global Orphan Drug Launches By 2023
Note: Assumes 1 year for Ph1, 2 years for Ph2, 3 years for Ph3, and 1 year for filing and FDA approval.1. https://www.prnewswire.com/news-releases/biohaven-completes-enrollment-ahead-of-timelines-in-international-phase-3-clinical-trial-of-verdiperstat-in-multiple-system-atrophy-301096602.html2. BioSpace. Biohaven Announces Enrollment Of First Patients In Pivotal HEALEY ALS Platform Trial Including Verdiperstat Conducted By Healey Center For ALS At Massachusetts General Hospital. Accessed
September 7, 2020. https://www.biospace.com/article/releases/biohaven-announces-enrollment-of-first-patients-in-pivotal-healey-als-platform-trial-including-verdiperstat-conducted-by-healey-center-for-als-at-massachusetts-general-hospital/
3. BioSpace. BIOHAVEN ENROLLS FIRST PATIENT IN PHASE 3 SPINOCEREBELLAR ATAXIA CLINICAL TRIAL OF TRORILUZOLE. Accessed September 7, 2020. BIOHAVEN ENROLLS FIRST PATIENT IN PHASE 3 SPINOCEREBELLAR ATAXIA CLINICAL TRIAL OF TRORILUZOLE. https://www.biohavenpharma.com/investors/news-events/press-releases/03-14-2019
2020 2021 2022 2023
US targeted approval EU targeted approval
Verdiperstat-ALS
Ph3 top line data expected
Ph3 trial first patients enrolled2
Verdiperstat-MSA
Ph3 topline data expected
Ph3 trial completed enrollment1
Troriluzole-SCA
Ph3 top line data expected
Ph3 enrollment completion anticipated3
27
MARKETEDPRECLINICAL PHASE 1 PHASE 2 PHASE 3PLATFORM | DRUG NAME
Filing for Approval
CALCITONIN GENE-RELATED PEPTIDE (CGRP)
GLUTAMATE
MYELOPEROXIDASE (MPO)
NOVEL PROGRAMS
US NURTEC ODT | Acute Migraine
NURTEC US | Migraine Prevention
COVID19 US | Respiratory Complications
US | Acute Migraine/Prevention
JAPAN | Migraine (Acute and Prevention)
EUROPE | Migraine (Acute and Prevention)
RimegepantSmall molecule/NCE
ZavegepantSmall molecule/NCE
ISRAEL | Acute Migraine
MIDDLE EAST | Acute Migraine
CHINA | Acute Migraine
UNDISCLOSED | Planned Migraine Adjacencies
UNDISCLOSED | Planned Non-Migraine Indications
UNDISCLOSED | Planned Non-Migraine Indications
Alzheimer’s Disease (AD)
Spinocerebellar Ataxia (SCA)
Obsessive-Compulsive Disorder (OCD)
Neuropsychiatric Indications
Multiple System Atrophy (MSA)
Amyotrophic Lateral Sclerosis (ALS)
Not Disclosed
ALS
TroriluzoleNCE prodrug of riluzole
BHV-5000/5500NCE NMDA antagonist
VerdiperstatNCE oral MPO inhibitor
UC1MTMetallothionein
TDP4328
Company Achievements
29
NURTEC ODT Prevention
sNDA filing accepted
October 2020
200M+Covered Lives All Channels
$17.7M3Q20 Net Sales
> 80% Increase in Net
Sales from 2Q20
>220,000TRxs of NURTEC
since launch
87% COVERAGE
THANK YOU!
Appendix: Reconciliation of GAAP to Non-GAAP Financial Measures
Non-GAAP
(Amounts in millions, except share and per share amounts)
2020 2019Reconciliation of GAAP to Non-GAAP adjusted research and development expense:GAAP research and development expense $57.0 $6.7
Less: non-cash share-based compensation expense (5.3) (3.6)Non-GAAP adjusted research and development expense $51.8 $58.0
Reconciliation of GAAP to Non-GAAP adjusted selling, general and administrative expense:GAAP selling, general and administrative expense $119.5 $28.8
Less: non-cash share-based compensation expense (9.3) (6.3)Non-GAAP adjusted selling, general and administrative expense $110.2 $22.4
Three Months Ended September 30
32
This presentation includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted research and development expense, non-GAAP adjusted selling, general and administrative expense, non-GAAP adjusted net loss, and non-GAAP adjusted net loss per share, adjusted to exclude the items below. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted research and development expense, non-GAAP adjusted selling, general and administrative expense, non-GAAP adjusted net loss, and non-GAAP adjusted net loss per share, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing operating performance. These measures exclude (i) non-cash share-based compensation that are substantially dependent on changes in the market price of our common shares, (ii) non-cash interest expense related to the accounting for our mandatorily redeemable preferred shares and liability related to sale of future royalties, which are in excess of the actual interest owed, (iii) changes in the fair value of our derivative liability, which does not correlate to our actual cash payment obligations in the relevant periods, and (iv) losses from equity method investment, because it generates non-cash losses, which are based on the financial results of another company that we do not manage or control.
We believe the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Biohaven’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of Biohaven’s ongoing operating performance and are better able to compare Biohaven’s performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided below.
Non-GAAP (Continued)
(Amounts in millions, except share and per share amounts)
Reconciliation of GAAP to Non-GAAP adjusted net loss: 2020 2019GAAP net loss $(194.7) $(106.2)
Add: non-cash share-based compensation expense 14.6 10.0Add: non-cash interest expense on mandatorily redeemable preferred shares 7.3 4.4Add: non-cash interest expense on liability related to sale of future royalties 11.3 7.3Add: change in fair value of derivative liability - 1.7Add: loss from equity method investment 0.6 2.0
Non-GAAP adjusted net loss $(159.5) $(80.8)
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted:GAAP net loss per share — basic and diluted $(3.24) $(2.04)
Add: non-cash share-based compensation expense 0.25 0.19Add: non-cash interest expense on mandatorily redeemable preferred shares 0.12 0.08Add: non-cash interest expense on liability related to sale of future royalties 0.19 0.14Add: change in fair value of derivatives - 0.03Add: loss from equity method investment 0.01 0.04
Non-GAAP adjusted net loss per share — basic and diluted $(2.67) $(1.55)
Three Months Ended September 30,
33