Read a transcript of our "4th Quarter Earnings Conference Call"
4th Quarter 2020 Earnings - Biohaven Pharmaceuticals...MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 8...
Transcript of 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.
3MARCH 1, 2021 4TH QUARTER 2020 EARNINGS
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 7
12,988
15,565
50%
931,705
16,211,486
Oral CGRPs Have Significant Growth Opportunity Ahead vs Triptans
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 8
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 9
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 10
THE CURRENT MIGRAINE TREATMENT CHASMMigraine treatment historically bifurcated because no single therapy could treat the migraine spectrum
ACUTE Treatment
PREVENTIVETreatment
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 11
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 12
Biohaven 2021 Growth Drivers
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 13
• 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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 14
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)
17MARCH 1, 2021 4TH QUARTER 2020 EARNINGS
$ 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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 20
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)
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 21
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 22
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 23
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 24
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 25
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...
264TH QUARTER 2020 EARNINGS
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.
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 28
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 29
Late-Stage Development Programs
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 31
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 32
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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 33
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)
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS 34
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
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 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
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS
Non-GAAP Financial Measures (Unaudited) — Continued
MARCH 1, 2021 4TH QUARTER 2020 EARNINGS
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