4th quarter 2020 earnings - biohaven pharmaceuticals...march 1, 2021 4th quarter 2020 earnings 8...

NYSE:BHVN

Ellie, living with migraine

© 2021 Biohaven Pharmaceuticals. All rights reserved.

March 1, 2021

4th Quarter 2020 Earnings

Agenda

Opening Remarks | Cliff Bechtold, M.S. Chief Operating Officer

Quarter Summary and Year in Review | Vlad Coric, M.D. Chief Executive Officer

4Q20 and 2020 Year-End 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

2MARCH 1, 2021 4TH QUARTER 2020 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, 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.


Vlad Coric, M.D. | Chief Executive Officer

Fourth Quarter 2020 Summary & Year in Review

Company Achievements

4TH QUARTER 2020 EARNINGS

$10M

$18M

$35M

2Q 3Q 4Q

89% Commercial

Coverage

NURTEC ODT

European Filing

Accepted 1Q 2021Dual Therapy

(Acute/Prevention)

>$63MTotal Net

Sales

>98%Q4 Increase

Over 3Q

>450,000TRxs of NURTEC

To Date

MARCH 1, 2021 5

Nurtec ODT: Leading Edge of CGRP Antagonist Franchise

MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 6

MAXIMIZE VALUE GROW THE MARKET

WIN THE ORAL CGRP CLASS

ESTABLISH A NEW APPROACH

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

3

11/1

3

12/4

12/2

5

1/15 2/

5

Week ending

Total Rx (2/19)

3/133/2

74/1

04/2

4 5/85/22 6/56/1

9 7/37/177/3

18/1

48/2

89/1

19/2

510

/910

/2311/611

/2012/412

/18 1/11/151/2

92/1

2

Week ending

New to Brand Rx Share (2/12)

Oral CGRP Class Continues to Show Robust Market Growth

1 2

KEY INSIGHTS• Nurtec TRx launch curve shows strong growth consistent with the class, despite competitor’s pre-COVID

launch 2 months earlier, and has held ~50% NBRx market share since early summer• Oral CGRP market for migraine on track to reach blockbuster status in U.S. market alone

Nurtec ODT

UbrelvyNurtec ODT

Ubrelvy

Source: Rx through 2/12, IQVIA NPA-MD, accessed 2/24


12,988

15,565

50%

931,705

16,211,486

Oral CGRPs Have Significant Growth Opportunity Ahead vs Triptans


Source: IQVIA XPO Database: Cumulative NBRx Volume (1/24/20 – 12/18/20), accessed 1/7/2021

248,932

1Q21

TriptansCGRP orals

3Q202Q20 4Q20

Quarterly NBRx volume

20%17%

14%

1Q20-Present

TriptansCGRP orals

1-3Q201-2Q20 1-4Q20

Cumulative TRx volume

1Q20-Present

6%5%4%

3%

NBRx Volume vs TriptansTRx Volume vs Triptans

Orals CGRPs Have Driven CGRP Class Growth in 2020 (vs mAbs)

0

20,000

40,000

60,000

80,000

100,000

120,000

5/25

/18

6/25

/18

7/25

/18

8/25

/18

9/25

/18

10/2

5/18

11/2

5/18

12/2

5/18

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

10/2

5/19

11/2

5/19

12/2

5/19

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

10/2

5/20

11/2

5/20

12/2

5/20

1/25

/21

CGRP Weekly TRx

Acute oralmAb

IQVIA XPO Database: TRx Volume to 2/52020, accessed 2/24/2020* CGRP acute orals = Ubrelvy, Nurtec ODT; CGRP mABs = Emgality, Ajovy, Aimovig



THE CURRENT MIGRAINE TREATMENT CHASMMigraine treatment historically bifurcated because no single therapy could treat the migraine spectrum

ACUTE Treatment

PREVENTIVETreatment


THE FUTURE MIGRAINE TREATMENT GOALNurtec ODT® Can Transcend the Divide if Approved in Prevention

ACUTE Treatment

Fast onset

Limited durability of effect(<24 hours)

Quantity limited due to MOH concerns

Oral treatment withrapid onset of action

Long duration of benefit(48 hours) providing

“coverage” of prevention

No risk of MOH Quantity limits not needed

PREVENTIVETreatment

Delayed onsetCurrent treatment is weeks to months for

efficacy; days to safety

Oral treatment withmigraine specific MOA

Toperimate/propranolol are not migraine specific

Oral treatmentInjectable is undesirable by many

DUAL-THERAPY MIGRAINE TREATMENT

Biohaven 2021 Growth Drivers


• Continue to grow acute market• Life-cycle management to expand

indications and peak sales• Dual therapy

Zavegepant• Deliver first intranasal

CGRP NDA for ultra-rapid onset of action

• Nonmigraine Indications

Troriluzole SCA• Phase 3 topline data

4Q21/1Q22• Alzheimer subgroup

analyses 3Q21

Expected Global Approvals• EMEA filing accepted 1Q2021• 2021 approvals expected: Israel, UAE, Saudi

Arabia, Kuwait, Qatar, Oman, Lebanon• Filings in 2022: Asia Pacific

Verdiperstat• Phase 3 MSA topline data 4Q2021• Phase 3 ALS topline date 4Q2021

IPO by 4Q2021 in China

2H2021

Clinical-Stage Milestones


2H2020 1H2021DRUG NAME INDICATION 2022

Filing 4QMigraine (intranasal) Approval

ToplineSpinocerebellar ataxia

Topline 4QMultiple system atrophy

Topline 4QAmyotrophic lateral sclerosis

ToplineObsessive-compulsive disorderTroriluzoleNCE prodrug of riluzole

VerdiperstatNCE oral MPO inhibitor

ZavegepantSmall molecule/NCE

Migraine (oral) Start Phase 3 1Q

Migraine prevention ApprovalsNDA Accepted

Europe Filing 1QMigraine acute/prevention EU Approval

BHV-3100Small molecule CGRP/NCE

Start Phase 2Multiple myeloma

Migraine acute (China/Korea) Start Phase 3 Submission 2H22

BHV-1100ARM combo

Undisclosed Start Phase 1 Start Phase 2/3

Europe Filing 1Q

Start Phase 3

PMDA Meeting

Jim Engelhart, C.P.A. | Chief Financial Officer

4Q20 Financial Results & 2020 Year End

Fourth Quarter Results (Unaudited)

16

$ Millions, except net loss per share — basis and dilutedGAAP Reported Non-GAAP Adjusted

Q4 2020 Q4 2019 Change Q4 2020 Q4 2019 ChangeProduct Revenue, net — NURTEC ODT $35.1 $ - $35.1

R&D expense 73.5 66.0 7.5 $57.8 $57.7 $0.1

SG&A expense 122.4 69.0 53.4 114.0 66.8 47.2

Net loss (217.7) (149.3) (68.4) (161.7) (124.4) (37.3)

Net loss per share — basic and diluted $(3.62) $(2.85) $(0.77) $(2.69) $(2.38) $(0.31)

Note: see slides 38–39 for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown

GAAP Reported Non-GAAP Adjusted

MARCH 1, 2021 4TH QUARTER 2020 EARNINGS

Year-to-Date Results (Unaudited)


$ Millions, except net loss per share — basis and dilutedGAAP Reported Non-GAAP Adjusted

2020 2019 Change 2020 2019 ChangeProduct Revenue, net — NURTEC ODT $63.6 $ - $63.6

R&D expense 229.0 344.7 (115.7) $195.4 $190.3 $5.1

SG&A expense 462.3 134.4 327.9 428.6 105.8 322.8

Net loss (766.8) (528.8) (238.0) (605.4) (296.5) (308.9)

Net loss per share — basic and diluted $(13.06) $(10.91) $(2.15) $(10.31) $(6.11) $(4.20)

GAAP Reported Non-GAAP Adjusted

Note: see slides 38–39 for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown

Capital Position ($Millions)

18

Cash, cash equivalents, and marketable securities @ December 31, 2020 $357.4

Cash immediately available to draw from the August 2020Sixth Street financing $225.0

Additional capital remaining on the $450M in August 2020 RPI financings (partially subject to development milestones) $300.0

Access to $575M+ in capital


BJ Jones, M.B.A. | Chief Commercial Officer Migraine and Common Disease

Commercial Events

Oral CGRPs on Track to Become The Preferred Acute Migraine Therapy


1%

3%

2%

7%

4%

3%

9%

8%

4%

9%

11%

5%

13%

15%

Reyvow Ubrelvy Nurtec ODT

0%

20%

40%

60%

80%

Q120 Q220 Q320 Q420 Proj. Q221

1

2

3

4

5

Q120 Q220 Q320 Q420

Percent Agreeing

76% 84% 89% 89%Source: Spherix Global Insights, Q4 Real Time Dynamix Study, Neurologists and Migraine Specialist

Gepant Therapy Share: Increasing Trend Percent of acute therapy-treated patients

Q1 2020 (n=98) Q2 2020 (n=101) Q3 2020 (n=101) Q4 2020 (n=101) PROJ Q2 2021 (n=101)

Statement AgreementMean; 5-pt scale with 5 “Strongly agree”

For patients who had a suboptimal response to triptans, oral CGRP receptor antagonists will become my preferred acute migraine treatment

Triptan Class Share: Declining TrendPercent of acute therapy-treated patients

Neurologists’ Prefer Nurtec ODT

The vast majority of

neurologists rank Nurtec ODT as an

advance over triptans and

that perception has grown over time

Source: Spherix Global Insights, Q4 Real Time Dynamix Study, Neurologists

10%

33%

49%

Reyvow Ubrelvy Nurtec ODT

Anticipate Using Brand as Preferred Acute Migraine TherapyPercent of respondents

6% 53%

46%

43%

41%

51%

53%

0% 20% 40% 60% 80% 100%

Q2 2020 (n=101)

Q3 2020 (n=101)

Q4 2020 (n=101)

Percent of respondents

Majority View Nurtec ODT as Advance Over TriptansNo advance (1–3) Somewhat of an advance (4–7) Significant advance (8–10)


Nurtec ODT Matches Share of Voice Among Physicians With High Migraine Patient Base, With Smaller Sales Force Footprint

Report Definition: (n = details for mkt; dr = unique physicians reporting details for mkt)Share of Attention – Details: The product's share of all details in the market.Detail Reach: The percent of network physicians reporting at least one or more details by sales representatives for each product.Average Detail Frequency: The average number of product details per physician for physicians that have received details.

Source: IQVIA Brand Impact Audit, February 2021


0%

20%

40%

60%

80%

100%

1/20n=174dr=109

2/20349141

3/20542153

4/20559156

5/20592155

6/20669154

7/20719160

8/20779159

9/20779156

10/20826159

11/20784162

12/20734161

1/21706157

Shar

e of

Phy

sici

an-R

epor

ted

Det

ails

Share of Attention — DetailsPriority Group 5–10 Physicians

Ubrelvy Nurtec ODT

KEY INSIGHTSNurtec ODT leads in new and repeat writer growth vs. Ubrelvy, in the latest 4-week trend

Nurtec ODT Has Over 27,000 Unique Prescribers, With Higher Productivity Than Ubrelvy


Source:prescribers through 2/5, IQVIA XPO, accessed 2/24

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

2/14

2/28

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

Week ending

CGRP acute oral prescribers by new vs. total

New Nurtec ODT prescribersTotal Nurtec ODT prescribersNew Ubrelvy PrescribersTotal Ubrelvy Prescribers

1

1.2

1.4

1.6

1.8

2

2.2

1/31

2/14

2/28

3/13

3/27

4/10

4/24 5/8 5/2

2 6/5 6/19 7/3 7/1

77/3

18/1

48/2

89/1

19/2

510

/910

/23 11/611

/20 12/412

/18 1/1 1/15

Week ending

TRx / prescriber by product, weekly

Source: prescribers and Rx through 2/5, IQVIA XPO, accessed 2/24

20%

2%

17%

20%

1%

14%

27%

14% 1%

17%

16%26%

26%

Throughout 2020, Nurtec Maintained a Competitive Share of Voice, With Far Less Budget


Source: Nielsen AdIntel January through December

Nurtec ODT

Ubrelvy

2020 total share of voice

2020 total share of spend

With Time in Market, Nurtec ODT Patient Satisfaction Has Consistently Grown to a Significant Advantage Over UBRELVY


Base: Among Patients Taking New Products | Letters/arrows note significant difference between brands/waves at 90 CI | B5. How satisfied are you with your current acute treatment(s) for migraine? Source: HCP ATU Survey Wave IX February 2021

25%

30%

35%

40%

45%

50%

55%

60%

65%

W2-4 (May-Jul'20)(n=92, 102)

W3-5 (Jun-Sep'20)(n=92, 94)

W4-6 (Jul-Oct'20)(n=97, 107)

W5-7 (Sep-Nov'20)(n=91, 97)

W6-8 (Oct'20-Feb'21)(n=99, 93)

Patient Satisfaction With New Products (Rolling Cohort Analysis)(% Patients Who Rate Satisfaction 6 or 7 on 7-Point Scale)

Among Patients Taking New Products

Nurtec ODTUbrelvy

58%

37%

Nurtec ODT Patient Testimonials

>1,000 per week across key social networks (FB, IG, TW)

~80% positive emotional response

MARCH 1, 2021

Absolute life saver, I have had debilitating migraines since age 6 (57 now). This has changed my life. 98% of the time it kills it dead… or allows me to sleep which also kills headache. No more 3 am to 7–8 om or to the next day. 2 hrs or less...


Source: Meltwater Media Monitoring

And my Dr says in apr it can be taken as a preventative. CANNOT SAY ENOUGH GOOD THINGS about this. Not a narcotic. Doesn’t make u goofy or addicted. Just makes u BE THERE for life. And that is truly priceless.

Elyse Stock, M.D. | Chief Medical Officer

R&D Update

Biohaven’s Franchise of CGRP-Antagonists

ZavegepantPRE-INDNext Gen

PHASE 2/3MARKETED

1. Exclusive World-Wide License with Catalent for use of Zydis® Fast Dissolve Technology in our migraine product candidates2. Aptar Pharma Unidose System (UDS) single shot nasal technologyReferences: Croop R, Goadsby PJ, Stock DA et al. The Lancet. Published online July 13, 2019. http://dx.doi.org/10.1016/S0140-6736(19)31606-X. Data on file. Biohaven Pharmaceuticals.


Biohaven’s Portfolio of Small Molecule CGRP-Antagonists

ACUTE MIGRAINE Global approvals expected 2021, EMA filed 1Q 2021 (dual indication), 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 and 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

Other CGRP-assets provide flexibility to pursue additional indications

Nurtec ODTAcute and Prevention

ZavegepantIntranasal and Oral

Other CGRP assets

MultipleBlockbuster

Potentials


Late-Stage Development Programs


MARKETEDPRECLINICAL PHASE 1 PHASE 2 PHASE 3PLATFORM | DRUG NAMEFiling for Approval

CGRP

GLUTAMATE

MPO

NURTEC US | Migraine Prevention

JAPAN | Migraine (Acute and Prevention)

EUROPE | Migraine (Acute and Prevention) RimegepantSmall molecule/NCE

ZavegepantSmall molecule/NCE

CHINA | Acute Migraine

UNDISCLOSED | Planned Migraine Adjacencies

UNDISCLOSED | Planned Non-Migraine Indications

US | Acute Migraine/Prevention

US NURTEC ODT | Acute Migraine

UNDISCLOSED | Planned Non-Migraine Indications

Spinocerebellar Ataxia (SCA)

Obsessive-Compulsive Disorder (OCD)

Multiple System Atrophy (MSA)

Amyotrophic Lateral Sclerosis (ALS)

TroriluzoleNCE prodrug of riluzole

VerdiperstatNCE oral MPO inhibitor

30

UNDISCLOSED | Planned Non-Migraine IndicationsBHV-3100Small molecule/NCE

Orphan Disease Opportunities


Multiple System Atrophy

Amyotrophic Lateral Sclerosis

Spinocerebellar Ataxia

Targeting 3 Global Orphan Drug Approvals by 2023

3Phase 3

Readouts over next year

3Devastating

Diseases

Next-Generation Bispecific Compounds — MATEs, ARMs and MoDEs


MATE™MULTIMODAL ANTIBODY THERAPY ENHANCER

ARM™ANTIBODY RECRUITING MOLECULES

MoDEsMOLECULAR DEGRADERS of EXTRACELLUAR PROTEINS

Target BinderReactive group

Directinggroup

Binding to IgG1/2/4 antibody

Conjugation and releaseof directing group

Endogenous IgGAntibody

(polyclonal)

Macrophages

NK cells

ARM™ binds to disease target andinduces antibody

binding

Binds liver(ASGPR)

Binds protein target

Bifunctional small molecule

ASGPR N-acetylgalactosamine

Targetprotein

Target proteinligand

ASGPR-bindingterminus

Target-bindingterminus

MATE™ HGM: COVID-19Three Potential Mechanisms of Action Against SARS-CoV-2


Direct virus neutralization/killing:Blocks virus entry

SARS-CoV-2

Spike protein

FcγR bindingImmune-mediated virus killing

HUMAN CELL

FcγR bindingLong-term vaccination effect

NK CELLSInfected cell killing

MACROPHAGES Viral particle swallowing

FcγRII-III

FcγRIII

BHV-1200

FcγRII

DENDRITIC CELLSViral antigen presentation to T cells

1

2

3

ACE2 receptor

MATE Peptide (HGM) Prototype: Convert Inert IVIG Into Potent Anti-COVID19 Agent (Partnered With Bill and Melinda Gates Foundation)

Preclinical validation studies: MATE PEPTIDE (HGM)


Spike Trimer and RBD Binding Antibody Dependent Cellular Phagocytosis

Viral Inhibition

0.1 1 10 100 1,0000

500,000

1,000,000

1,500,000

2,000,000

COVID-19 Spike Proteins Binding to KPMW215IVIG/S309 MATE

COVID-19 Protein Conc. (nM)

Che

milu

min

esce

nce

(RLU

) Trimer EC50 = 26.7 nMRBD EC50 = 2.36 nM 0.0001 0.01 1 100 10000

0

10

20

30

40

IC50

KPMW 215 0.07723

% F

REE

BEA

DS

% free beads

IvIg

rb sera

KPMW215

KPMW221

0.1 1 10 100 10000

50

100

150

ug/ml

% in

hibi

tion

KPMW215 ACE 2

KPMW215

ACE2

MATE concentration (nM)

Che

milu

min

esce

nce

(RLU

)

Company Achievements


$10M

$18M

$35M

2Q 3Q 4Q

89% Commercial

Coverage

NURTEC ODT

European Filing

Accepted 1Q 2021Dual Therapy

(Acute/Prevention)

>$63MTotal Net

Sales

>98%Q4 Increase

Over 3Q

>450,000TRxs of NURTEC

To Date

MARCH 1, 2021 35

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 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 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 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 liabilities, which does not correlate to our actual cash payment obligations in the relevant periods, (iv) losses from equity method investment, because it generates non-cash losses, which are based on the financial results 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, (vi) non-routine accrued development milestone expenses, and (vii) expense related to non-routine priority review voucher acquisition.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, 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.

38

$ Millions, except net loss per share — basic and diluted

2020 2019 2020 2019Reconciliation of GAAP to Non-GAAP adjusted research and development expense:GAAP research and development expense $73.5 $66.0 $229.0 $344.7

Less: non-cash share-based compensation expense (5.8) (2.3) (23.7) (26.3)Less: collaboration and license upfront expenses (9.9) - (9.9) (5.6)Less: accrued development milestone payments - (6.0) - (17.5)Less: expense related to priority review voucher acquisition - - - (105.0)

Non-GAAP adjusted research and development expense $57.8 $57.7 $195.4 $190.3

Reconciliation of GAAP to Non-GAAP adjusted selling, general and administrative expense:GAAP selling, general and administrative expense $122.4 $69.0 $462.3 $134.4

Less: non-cash share-based compensation expense (8.4) (2.1) (33.7) (28.7)Non-GAAP adjusted selling, general and administrative expense $114.0 $66.8 $428.6 $105.8

Three Months Ended December 31,

Twelve Months Ended December 31,

Note: Q1 2019 — $4.0mm for BHV-3500 Ph2, Q2 2019; $7.5mm for NDA submission; and $6.0mm for BHV-3500 probable Ph3 start


Non-GAAP Financial Measures (Unaudited) — Continued


2020 2019 2020 2019Reconciliation of GAAP to Non-GAAP adjusted net loss:GAAP net loss $(217.7) $(149.3) $(766.8) $(528.8)

Add: non-cash share-based compensation expense 14.2 4.5 57.4 55.0Add: non-cash interest expense on mandatorily redeemable preferred shares 7.8 4.4 27.6 12.7Add: non-cash interest expense on liability related to sale of future royalties 11.3 7.3 43.0 26.6Add: change in fair value of derivative liability 12.3 0.9 19.3 3.9Add: loss from equity method investment 0.7 1.8 4.2 6.1Add: collaboration and license upfront expenses 9.9 - 9.9 5.6Add: accrued development milestone payments - 6.0 - 17.5Add: expense related to priority review voucher acquisition - - - 105.0

Non-GAAP adjusted net loss $(161.7) $(124.4) $(605.4) $(296.5)

Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted:GAAP net loss per share — basic and diluted $(3.62) $(2.85) $(13.06) $(10.91)

Add: non-cash share-based compensation expense 0.23 0.08 0.98 1.14Add: non-cash interest expense on mandatorily redeemable preferred shares 0.13 0.08 0.47 0.26Add: non-cash interest expense on liability related to sale of future royalties 0.19 0.14 0.73 0.55Add: change in fair value of derivatives 0.20 0.02 0.33 0.08Add: loss from equity method investment 0.01 0.03 0.07 0.13Add: collaboration and license upfront expenses 0.16 - 0.17 0.12Add: accrued development milestone payments - 0.11 - 0.36Add: expense related to priority review voucher acquisition - - - 2.17

Non-GAAP adjusted net loss per share — basic and diluted $(2.69) $(2.38) $(10.31) $(6.11)

$ Millions, except net loss per share — basic and dilutedThree Months Ended December 31,

Twelve Months Ended December 31,

39

4th quarter 2020 earnings - biohaven pharmaceuticals...march 1, 2021 4th quarter 2020 earnings 8...

Documents