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NYSE:BHVN
Ellie, living with migraine
© 2021 Biohaven Pharmaceuticals. All rights reserved.
Ellie, living with migraine
2nd Quarter 2021 EarningsAugust 9, 2021
Agenda
Opening Remarks | Caroline Dircks, Ph.D. Vice President Corporate Operations
Second Quarter Summary and Recent Events| Vlad Coric, M.D. Chief Executive Officer
2Q2021 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
2AUGUST 2021 2ND QUARTER 2021 EARNINGS
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 our planned 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, 2020, filed with the Securities and Exchange Commission on March 1, 2021, and Biohaven's subsequent filings with the Securities and Exchange Commission.
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.
3AUGUST 2021 2ND QUARTER 2021 EARNINGS
Vlad Coric, M.D. | Chief Executive Officer
Second Quarter 2021 Summary & Recent Events
Company Achievements
2ND QUARTER 2021 EARNINGSAUGUST 2021 5
>875,000TRxs of NURTEC
to Date
55.9%New to Brand
Share
$93MNet Sales2Q2021
$200MTotal
Net SalesSince Launch
44.1%
3/13
3/27
4/10
4/24 5/
85/
22 6/5
6/19 7/
37/
177/
318/
148/
289/
119/
2510
/910
/23
11/6
11/2
012
/412
/18
1/1
1/15
1/29
2/12
2/26
3/12
3/26 4/
94/
23 5/7
5/21 6/
46/
18 7/2
7/16
Oral CGRP Class Continues to Show Robust Market Growth, Nurtec leads in NBRx share at 55.9%
KEY INSIGHTS• Nurtec TRx launch curve shows strong growth consistent with the class, with the brand steadily growing
NBRx leadership through the months of June and July to achieve 55.9% share • Oral CGRP market for migraine on track to reach blockbuster status in U.S. market alone
Source: TRx and NBRx through 7/16/21, IQVIA NPA-MD, accessed 7/26/2021
6
1/24
2/14 3/6
3/27
4/17 5/8
5/29
6/19
7/10
7/31
8/21
9/11
10/2
10/2
311
/13
12/4
12/2
51/
15 2/5
2/26
3/19 4/9
4/30
5/21
6/11 7/2
7/23
Total Rx Volume (7/30)
Ubrelvy Nurtec ODT
New to Brand Rx Share (7/16)
Ubrelvy
Nurtec ODT
21,23820,936
55.9%
1 2
Week ending Week ending
AUGUST 2021 2ND QUARTER 2021 EARNINGS
476,222
3,924,354
Oral CGRPs Have Significant Growth Opportunity Ahead vs Triptans
2ND QUARTER 2021 EARNINGS 7
2Q21
TriptansCGRP orals3
Cumulative TRx volume
2Q21
TRx Volume vs Triptans¹
11%
AUGUST 2021
Source: 1. TRX numbers cover 2Q2021, IQVIA SMART, accessed 8/4. 2. NBRx numbers cover 2Q2021, IQVIA XPO, accessed 7/27. 3. CGRP orals = Nurtec ODT & Ubrelvy.
121,508
577,863
2Q21 2Q21
TriptansCGRP orals3
Quarterly NBRx volume
NBRx Volume vs Triptans²
21%
Orals CGRPs Have Driven CGRP Growth in 2020 and 2021 (vs mAbs)
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
5/25/18
6/25/18
7/25/18
8/25/18
9/25/18
10/25/18
11/25/18
12/25/18
1/25/19
2/25/19
3/25/19
4/25/19
5/25/19
6/25/19
7/25/19
8/25/19
9/25/19
10/25/19
11/25/19
12/25/19
1/25/20
2/25/20
3/25/20
4/25/20
5/25/20
6/25/20
7/25/20
8/25/20
9/25/20
10/25/20
11/25/20
12/25/20
1/25/21
2/25/21
3/25/21
4/25/21
5/25/21
6/25/21
CGRP Weekly TRx
Source: IQVIA SMART: TRx Volume to 7/16/2021, accessed 7/26/2021. 1. Oral CGRP = Ubrelvy, Nurtec ODT; 2. Injectable mAb = Emgality, Ajovy, Aimovig
8
Oral CGRP1
Injectable mAb2
AUGUST 2021 2ND QUARTER 2021 EARNINGS
Product Patent Awarded for ODT Formulation, Extends Company's IP for CGRP Platform into 2039
AUGUST 2021 2ND QUARTER 2021 EARNINGS 9
New patent awarded to the Company by the United States Patent and Trademark Office for our drug product, Nurtec ODT (rimegepant), in an ODT form
Covers rimegepant as well as other CGRP inhibitors
Patent expires in March 2039, not including possible extensions of up to 5 years
Unparalleled CGRP-Antagonist Franchise
Biohaven’s CGRP Platform
AUGUST 2021 2ND QUARTER 2021 EARNINGS 10
ORAL
Ph 3 preventionStarted 1Q21
Zavegepant
RAPID DISSOLVING
Launched 1Q20
Nurtec® ODT
MULTIPLE FORMULATIONS
BHV-3100Ph 1 started 2Q21
Advanced Leads4 Oral Follow-Ups
INTRANASAL
2nd Ph 3 trialunderway 4Q20
5ADVANCEDMOLECULES
Next-GEN CGRPs
CGRP Franchise: Near-Term Value Inflection Milestones
2ND QUARTER 2021 EARNINGS
SUBMISSION4Q21
TOP-LINE4Q22
MIGRAINE ACUTE APPROVED
MIGRAINE PREVENTIONAPPROVED
MIGRAINE PEDIATRICPHASE 3 START
MIGRAINE ULTRA-RAPID ACUTEINTRANASAL
MIGRAINE CHRONICORAL QDZAVEGEPANT
ZAVEGEPANT
AUGUST 2021 11
United Arab EmiratesAcute | APPROVED
IsraelAcute | APPROVED Kuwait
Acute | 4Q20
EuropeDual | 1Q21
Saudi ArabiaAcute | 1Q21
LebanonAcute | 3Q21
QatarAcute | 3Q21
BahrainAcute | 4Q20
JapanPh 2/3 | 4Q21China
Ph 3 | 4Q20
KoreaPh 3 | 4Q20
Rimegepant Global Regulatory Expansion in Migraine
AUGUST 2021 2ND QUARTER 2021 EARNINGS 12
Acute Migraine2APPROVALS
Acute and DualBy end of 2021
9SUBMISSIONS
OmanAcute | 3Q21
Neuroinnovation Pipeline: Near-Term Milestones
2ND QUARTER 2021 EARNINGS
OBSESSIVE COMPULSIVE
DISORDER
TOP-LINE2H22
TRORILUZOLE
MULTIPLE SYSTEM
ATROPHY
VERDIPERSTAT
TOP-LINE 3Q21
AMYOTROPHIC LATERAL
SCLEROSIS
VERDIPERSTAT
COMPLETE ENROLLMENT 4Q21
SPINOCEREBELLAR ATAXIA
TRORILUZOLE
TOP-LINE1H22
AUGUST 2021 13
TAKE CONTROL OF MIGRAINE WITH
one medication
Ellie WActual Nurtec® ODT Patient
Jim Engelhart, C.P.A. | Chief Financial Officer
2Q21 Financial Results
Second Quarter Results (Unaudited)
16
$ Millions, except net loss per share — basis and dilutedGAAP Reported Non-GAAP Adjusted
Q2 2021 Q2 2020 Change Q2 2021 Q2 2020 Change
Product Revenue, net — NURTEC ODT $92.9 $9.7 $83.2
R&D expense 77.4 42.4 35.0 $67.7 $36.0 $31.7
SG&A expense 170.1 124.8 45.3 153.7 119.5 34.3
Net loss (210.6) (180.9) (29.7) (170.9) (150.0) (20.9)
Net loss per share — basic and diluted $(3.23) $(3.08) $(0.15) $(2.62) $(2.55) $(0.07)
Note: see slides 34-35 for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown
GAAP Reported
AUGUST 2021 2ND QUARTER 2021 EARNINGS
Non-GAAP Adjusted
Year-to-Date Results (Unaudited)
17
$ Millions, except net loss per share — basis and dilutedGAAP Reported Non-GAAP Adjusted
YTD 2021 YTD 2020 Change YTD 2021 YTD 2020 Change
Product Revenue, net — NURTEC ODT $136.8 $10.8 $125.9
R&D expense 184.5 98.5 86.0 $141.8 $85.8 $56.0
SG&A expense 329.6 220.4 109.2 284.6 204.4 80.2
Net loss (475.6) (353.9) (121.7) (359.3) (284.7) (74.6)
Net loss per share — basic and diluted $(7.48) $(6.15) $(1.33) $(5.65) $(4.94) $(0.71)
Note: see slides 34-35 for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown
GAAP Reported
AUGUST 2021 2ND QUARTER 2021 EARNINGS
Non-GAAP Adjusted
Capital Position ($ Millions)
18
Cash, cash equivalents, and marketable securities @ June 30, 2021 $368.0
Cash immediately available to draw from Sixth Street financing $225.0
Additional proceeds to be received over next 7 calendar quarters from RPI Series B preferred share issuances $164.8
Access to $590M+ in capital
AUGUST 2021 2ND QUARTER 2021 EARNINGS
BJ Jones, M.B.A. | Chief Commercial Officer Migraine and Common Disease
Commercial Events
2ND QUARTER 2021 EARNINGS
49.6%
50.4%
40%
45%
50%
55%
60%
4/2
4/9
4/16
4/23
4/30 5/7
5/14
5/21
5/28
6/04
6/11
6/18
6/25 7/2
7/9
7/16
7/23
7/30
TRx Share
55.9%
44.1%
40%
45%
50%
55%
60%
4/2
4/9
4/16
4/23
4/30 5/7
5/14
5/21
5/28
6/04
6/11
6/18
6/25 7/2
7/9
7/16
7/23
7/30
NBRx Share
Source: IQVIA Market Dynamics, IQVIA NPA
AUGUST 2021 20
Prevention Approval
Prevention Approval
Ubrelvy
Nurtec ODT
Ubrelvy
Nurtec ODT
Nurtec® ODT Has Gained Significant Market Share in the Weeks Post Prevention Approval
Includes entire oral CGRP market
Significant Unmet Need
AUGUST 2021 2ND QUARTER 2021 EARNINGS 21
PREVENTION = TOO FEW, TOO LATE
DESPERATION FOR BETTER OPTIONS
THE INJECTION BARRIER IS REAL
15%of people who meet clinical criteria for Preventive treatment actually use it
84%of people taking a Preventive treatment wish there was a better option
65%of people do not want to receive an injection as a preventive medication
AUGUST 2021 2ND QUARTER 2021 EARNINGS 22
39MPeople with Migraine in US
19.5MDiagnosed with Migraine
500KNovel Injectables
1.1MTopiramate, Gabapentin, Tcas
7.0MRx Therapy
CURRENT INJECTIBLE PREVENTIVEMIGRAINE MARKET
BROADERPREVENTIVE MARKETOPPORTUNITY
ACUTE PLUS
ACUTE
AUGUST 2021 2ND QUARTER 2021 EARNINGS 22
Redefining the Prevention Market Opportunity
The First and Only Medication Proven to Treat and Prevent Migraine
AUGUST 2021 2ND QUARTER 2021 EARNINGS 23
ACUTE Treatment
PREVENTIVETreatment
DUAL-THERAPY MIGRAINE TREATMENT
Dissolving the line between acute and preventive treatment
Nurtec® ODT Provides New Hope
AUGUST 2021 2ND QUARTER 2021 EARNINGS 24
THE HALO FOR ACUTE IS REAL
HCPS ARE LIKELY TO RX FOR MULTIPLE USES
DESIRE FOR FLEXIBILITY
ACUTE 67%of patients say they want a drug that treats and prevents
85%of HCPs will Rx more for Acute as a result of Preventive indication
77%highly likely to Rx for persistent, every other day
60%also likely to prescribe for ‘intermittent’ or ‘preemptive’ use
HORMONAL CHANGES
STRESSWEATHER
Broad Commercial Coverage: High Impact Commercial PBM and Health Plan Wins
89%COVERAGE
235M+TOTAL COVERED LIVES IN ALL CHANNELS
AUGUST 2021 2ND QUARTER 2021 EARNINGS 25
I think my neurologist chose Nurtec over Ubrelvy because it’s also approved as a preventative in case I need one in the future. I’m only having like 4 migraine days a month right now but I was at 15+ for the last half of 2020.
— Alana
Nurtec ODT has literally changed my life. I never thought it would really work, especially something that just dissolved in my mouth, but it really does. I go from debilitating pain to relief in literally 30 minutes. By the 2 hour mark, I forgot I even had a migraine. I read the website and stories and I was ever so hopeful, but honestly didn’t believe it would work like that for me. I was hoping for, at best, a little relief with minimal side effects compared to the other prescription
medications. I write this now completely pain and side effect free. I cannot really describe how Nurtec has given me back my life.
Thank you so much!Melinda and family
Nurtec ODC has changed my life. I have suffered from migraines for decades and have tried countless migraine medications. I have never found the relief that this one pill achieves every single time. I no longer waste days in bed missing time with my family or missing time from work.
— Sabrina
Elyse Stock, M.D. | Chief Medical Officer
R&D Update
Expansion of CGRP Portfolio: Following the Science of CGRP
AUGUST 2021 2ND QUARTER 2021 EARNINGS 28
GLOBAL EXPANSION
CGRP MEDIATED: NON-MIGRAINE
DISEASES
EuropeJapanChinaKoreaMiddle East and Israel
Psoriasis AsthmaUndisclosed
MIGRAINE ADJACENCIES
ACUTE ANDPREVENTION
EXPANSION INTO PEDIATRICS
Child and Adolescent age groups
Post-traumatic HeadacheTrigeminal Neuralgia
Undisclosed
First and only migraine medication to treat and prevent
Multiple Opportunities Across Multiple Platforms
AUGUST 2021 2ND QUARTER 2021 EARNINGS 29
PLATFORM DRUG NAME OPPORTUNITIES
CALCITONIN GENE-RELATED PEPTIDE (CGRP)
RimegepantSmall molecule/NCE
• US NURTEC ODT | Acute Migraine• US NURTEC ODT | Migraine Prevention• EX-US (EU, Japan, China, Korea, Middle East, Israel)• Planned Migraine Adjacencies• Planned Non-Migraine Indications• Pediatrics
ZavegepantSmall molecule/NCE
• US |Intranasal: Acute Migraine• US | Oral: Prevention• COVID19 US | Respiratory Complications • Planned Non-Migraine Indications
BHV-3100Small molecule/NCE Phase 1 initiated
GLUTAMATETroriluzoleNCE prodrug of riluzole
• Spinocerebellar Ataxia (SCA)• Obsessive-Compulsive Disorder (OCD)
BHV-5000/5500NCE NMDA antagonist Neurologic/Neuropsychiatric Indications
MYELOPEROXIDASE (MPO) VerdiperstatNCE oral MPO inhibitor
• Multiple System Atrophy (MSA)• Amyotrophic Lateral Sclerosis (ALS)
BIOHAVEN LABSUC1MTMetallothionein
TDP43MATE
MODEARM
• Multiple myeloma• COVID-19• Undisclosed
NCE, new chemical entity; TDP-43: TAR DNA-binding protein 43 UC1MT: monoclonal antibody targeting extracellular metallothionein
We Follow the Science
Making streamlined and rational decisions based on well designed studies and the scientific data they generate
AUGUST 2021 2ND QUARTER 2021 EARNINGS 30
Rational and educated risk taking while maintaining
scientific integrity
Optimization of drug design and formulations
Fostering innovative partnerships and
collaborations
Nurturing and growing our internal talent
Keeping the patient at the center of all we do
Company Achievements
2ND QUARTER 2021 EARNINGSAUGUST 2021 31
>875,000TRxs of NURTEC
to Date
55.9%New to Brand
Share
$93MNet Sales2Q2021
$200MTotal
Net SalesSince Launch
THANK YOU!
Appendix: Reconciliation of GAAP to Non-GAAP Financial Measures
Non-GAAP Financial Measures (Unaudited)
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, and non-GAAP adjusted net loss and 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, and non-GAAP adjusted net loss and 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 is 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, (iv) gains or losses from equity method investment, which are non-cash and based on the financial results and valuation of another company that we did not manage or control, (v) collaboration and license upfront expenses, which we do not believe are normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing, and (vi) non-routine accrued development milestone expenses.
We believe the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Biohaven’s results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, we believe 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.
34AUGUST 2021 2ND QUARTER 2021 EARNINGS
$ Millions, except net loss per share — basic and diluted2021 2020 2021 2020
Reconciliation of GAAP to Non-GAAP adjusted research and development expense:GAAP research and development expense $77.4 $42.4 $184.5 $98.5
Less: non-cash share-based compensation expense (9.3) (6.4) (29.3) (12.7)Less: collaboration and license upfront expenses - - (7.9) -Less: accrued development milestone payments (0.5) - (5.5) -
Non-GAAP adjusted research and development expense $67.7 $36.0 $141.8 $85.8
Reconciliation of GAAP to Non-GAAP adjusted selling, general and administrative expense:GAAP selling, general and administrative expense $170.1 $124.8 $329.6 $220.4
Less: non-cash share-based compensation expense (16.3) (5.3) (45.0) (16.0)Non-GAAP adjusted selling, general and administrative expense $153.7 $119.5 $284.6 $204.4
Three Months Ended June 30, Six Months Ended June 30,
Non-GAAP Financial Measures (Unaudited) — Continued
AUGUST 2021 2ND QUARTER 2021 EARNINGS 35
2021 2020 2021 2020Reconciliation of GAAP to Non-GAAP adjusted net loss:GAAP net loss $(210.6) $(180.9) $(475.6) $(353.9)
Add: non-cash share-based compensation expense 25.6 11.8 74.3 28.6Add: non-cash interest expense on mandatorily redeemable preferred shares - 7.0 7.9 12.6Add: non-cash interest expense on liability related to sale of future royalties 12.2 11.3 24.1 20.0Add: change in fair value of derivatives 1.5 (0.7) 1.7 5.1Add: (gain) loss from equity method investment - 1.5 (5.3) 2.9Add: collaboration and license upfront expenses - - 7.9 -Add: accrued development milestone payments 0.5 - 5.5 -
Non-GAAP adjusted net loss $(170.9) $(150.0) $(359.3) $(284.7)
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted:GAAP net loss per share — basic and diluted $(3.23) $(3.08) $(7.48) $(6.15)
Add: non-cash share-based compensation expense 0.39 0.20 1.17 0.51Add: non-cash interest expense on mandatorily redeemable preferred shares - 0.12 0.12 0.22Add: non-cash interest expense on liability related to sale of future royalties 0.19 0.19 0.38 0.35Add: change in fair value of derivatives 0.02 (0.01) 0.03 0.09Add: (gain) loss from equity method investment - 0.03 (0.08) 0.05Add: collaboration and license upfront fees - - 0.12 -Add: accrued development milestone payments 0.01 - 0.09 -
Non-GAAP adjusted net loss per share — basic and diluted $(2.62) $(2.55) $(5.65) $(4.94)
$ Millions, except net loss per share — basic and dilutedThree Months Ended June 30,
Six Months Ended June 30,