3rd Quarter 2021 Earnings
Transcript of 3rd Quarter 2021 Earnings
Ellie, living with migraine
We Demand More for Patients.NEUROINNOVATION®
NYSE:BHVN© 2021 Biohaven Pharmaceuticals. All rights reserved.
3rd Quarter 2021 Earnings
November 9, 2021
Agenda
Opening Remarks | Caroline Dircks, Ph.D. Vice President Corporate Operations
Company Achievements | Vlad Coric, M.D. Chief Executive Officer
Pfizer | Nick Lagunowich Global President, Internal Medicine
3Q 2021 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
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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, the ability of our products to reach blockbuster status, 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.
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>1,100,000TRxs of
Nurtec® ODTto Date
57%New to
Brand Share
$136MNet Sales3Q2021
46%Increase Over 2Q
$336MTotal Net SalesSince Launch
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Oral CGRP Class Continues to Show Robust Market Growth, Nurtec® ODT leads in TRx at 52.6% share and NBRx at 57.3% share
KEY INSIGHTS• Nurtec TRx launch curve shows strong growth, overtaking Ubrelvy in early August, with the brand steadily
growing NBRx leadership through the summer months to achieve 57.3% share • Oral CGRP market for migraine on track to reach blockbuster status in U.S. market alone
Total Rx Volume (10/29)¹ New to Brand Rx Share (10/29)²1 2
Week ending Week ending
Source: 1. TRX numbers 1/24/20 –10/29/21, IQVIA SMART, accessed 11/8/21. 2. NBRx numbers 3/13/20 – 10/29/21, IQVIA NPA-MD, accessed 11/8/21
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1/24 2/
72/
21 3/6
3/20 4/
34/
17 5/1
5/15
5/29
6/12
6/26
7/10
7/24 8/
78/
21 9/4
9/18
10/2
10/1
610
/30
11/1
311
/27
12/1
112
/25
1/8
1/22 2/
52/
19 3/5
3/19 4/
24/
164/
305/
145/
286/
116/
25 7/9
7/23 8/
68/
20 9/3
9/17
10/1
10/1
510
/29
UbrelvyNurtec ODT
24,619
27,332
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
10/2
311
/611
/20
12/4
12/1
81/
11/
151/
292/
122/
263/
123/
26 4/9
4/23 5/7
5/21 6/4
6/18 7/2
7/16
7/30
8/13
8/27
9/10
9/24
10/8
10/2
2
Ubrelvy
Nurtec ODT57.3%
42.7%
Ex-US Partnership: Commercialization of Rimegepant Franchise
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RimegepantODT (orally disintegrating tablets) 75 mg
Rimegepant (known as Nurtec® ODT in the U.S.) may be branded under different names in some regions.
and
DRIVING INNOVATION
DELIVERING WORLDWIDE MIGRAINE RELIEF
ENHANCING ACCESS THROUGH COLLABORATION
STRATEGIC FIT
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Rimegepant (known as Nurtec® ODT in the U.S.) may be branded under different names in some regions.
RimegepantODT (orally disintegrating tablets) 75 mg
Bringing Rimegepant to Patients Around the World
ROWPremier partner
with global footprint to establish market
leadership worldwide
U.S.Market leader in novel
migraine therapies
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Rimegepant (known as Nurtec® ODT in the U.S.) may be branded under different names in some regions.
RimegepantODT (orally disintegrating tablets) 75 mg
Proven Track Record of Driving Patient-Centric Innovative Brands in Previously Generic Markets
Unlocking access in Europe, Asia Pacific region and Emerging Marketsfor a large patient population
Rebranded the Market with a New Innovative Class
Note: Charts are an illustrative example representing the growth trajectory during the first 24 months of launching these products in the top markets.
Changing Paradigm in Migraine Treatment and Establishing
New Standard of Care
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Rimegepant (known as Nurtec® ODT in the U.S.) may be branded under different names in some regions.
RimegepantODT (orally disintegrating tablets) 75 mg
>125COUNTRIES
WHICH PFIZER SELLS PRODUCTS
PHARMACEUTICAL PRODUCTS
>30KEY
A World Leader in Global R&D and Commercialization
EX-US TOTAL
$35BILLION
REVENUE THROUGH Q3 2021*
*Source Pfizer Inc. Revenues Q4 2020
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Launch Excellence to Drive Rimegepant Uptake Ex-US
2
1
3 ENSURING LONG-TERM SUCCESSBroad field force engagement with PCPs, Specialist and Health Systems leveraging Pfizer’s scale and capabilities
SECURING ACCESS AND OPTIMAL VALUEHighlight the unmet need by elevating the patient voiceSelection and sizing of target patient groups
DRIVING RAPID UPTAKETargeted promotion to Neurologists and Specialists leverage established go to market capabilities; enable digital HCP engagement and elevate the HCP experience
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Summary of Key Terms
$1.2+BILLION
TOTAL UPFRONT AND MILESTONE VALUE
STRUCTUREBiohaven runs R&D globally
Pfizer executes commercialization ex-U.S.
UPFRONT INVESTMENT $500M in cash & stock at 25% market premium (~$173/share)*
MILESTONES Up to $740M in sales and other milestones
&
* Closing of the license and collaboration agreements and equity purchase are contingent on completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. and equivalents outside the U.S., and other customary closing conditions.
ROYALTIESBiohaven to receive double-digit royalties on ex-U.S. net sales
Pfizer also pays related ex-US BMS and RPI royalties
Third Quarter Results (Unaudited)
$ Millions, except net loss per share — basic and dilutedGAAP Reported Non-GAAP Adjusted
Q3 2021 Q3 2020 Change Q3 2021 Q3 2020 Change
Product Revenue, net — Nurtec® ODT $135.7 $17.7 $118.1
R&D expense 85.7 57.0 28.7 $68.9 $51.8 $17.1
SG&A expense 164.5 119.5 45.0 149.6 110.2 39.4
Net loss (171.8) (195.2) 23.4 (125.1) (159.5) 34.4
Net loss per share — basic and diluted $(2.63) $(3.27) $0.64 $(1.91) $(2.67) $0.76
Note: See appendix for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown
GAAP Reported Non-GAAP Adjusted
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Year-to-Date Results (Unaudited)
$ Millions, except net loss per share — basic and dilutedGAAP Reported Non-GAAP Adjusted
YTD 2021 YTD 2020 Change YTD 2021 YTD 2020 Change
Product revenue, net — Nurtec® ODT $272.5 $28.5 $244.0
R&D expense 270.2 155.5 114.7 $210.6 $137.6 $73.0
SG&A expense 494.1 339.9 154.2 434.2 314.7 119.5
Net loss (647.4) (549.1) (98.3) (484.4) (444.2) (40.2)
Net loss per share — basic and diluted $(10.09) $(9.42) $(0.67) $(7.55) $(7.62) $(0.07)
Note: See appendix for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown
GAAP Reported Non-GAAP Adjusted
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Capital Position ($ Millions)
Cash, cash equivalents, and marketable securities @ September 30, 2021 $523.9
Cash immediately available to draw from Sixth Street financing $125.0
Upfront Pfizer collaboration cash $150.0
Pfizer common share purchase at 25% market premium* $350.0
Additional proceeds to be received over next 7 calendar quarters from RPI Series B preferred share issuances $147.2
$1.1B+
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* Closing of the license and collaboration agreements and equity purchase are contingent on completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. and equivalents outside the U.S., and other customary closing conditions.
Net Sales Progress
$10M$18M
$35M$44M
$93M
$136M
2Q20 3Q20 4Q20 1Q21 2Q21 3Q21
$336MLaunch to date
net product revenue
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Nurtec® ODT Gained Significant Oral CGRP NBRx Market Share
48.3%57.3%
0%
10%
20%
30%
40%
50%
60%
5/28/21 10/29/21
NBRx Market Share Since Prevention Launch
Nurtec ODT
+9.0%
SHARE POINTS
Source: IQVIA NPA-MD, accessed 11/8/21
THE LEADER IN RELIEVING MIGRAINES• #1 IN PRESCRIPTIONS†
Leader in patient-filled prescriptions for oral CGRP receptor antagonists
• #1 CHOICE BY NEUROLOGISTSNeurologists choose Nurtec® ODT as their preferred oral CGRP receptor more than any other
• #1 IN NEW PRESCRIPTIONS†
Most of all new oral CGRP receptor antagonist prescriptions
*Per IQVIA as oral brand in class (oral CGRP receptor antagonists): number one prescribed, number one in new prescriptions, and more neurologists selected as brand of choice†Per IQVIA SMART, accessed 10/4
Over 53,000 providers have written over 1,100,000 prescriptions for Nurtec ODT †
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*
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Bringing Dual Therapy Innovation to Patients Around the Globe
&
WORLD CLASS COLLABORATION
Large Market in Ex-U.S. with High Unmet Need
Only Dual Indication Migraine Therapy
Pfizer Scale and Influence Ex-U.S.
"I have gone from handicapped and fearful to empowered and secure. Nurtec® ODT has helped me treat or prevent migraines. Being a single mom, I am now more productive and feel improvement in my parenting and relationships. I can go about my life now without fearing that migraine is around the corner.”
— Mary H.
True Collaboration to Provide Worldwide Migraine Relief for Patients
Neuroscience R&D Excellence
Data generated from clinical trials published in top tier journals
Ex-U.S. LeadershipGlobal expertise
to win in migraine for patients around the world
~40TRIALS
ONGOING
>45COMPLETED
CLINICAL TRIALS
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1H2022
Clinical-Stage Milestones
1H2021 2H2021DRUG NAME INDICATION 2H2022
Complete enrollmentAmyotrophic lateral sclerosisVerdiperstatNCE oral MPO inhibitor
ToplineMigraine (intranasal)ZavegepantSmall molecule/NCE
Migraine (oral) Start Phase 3 1Q
Migraine acute (China/Korea)
Multiple myelomaBHV-1100ARM combo
BHV-3100Small molecule CGRP/NCE Undisclosed Start Phase 2/3
Europe Filing 1QMigraine acute/prevention EU Approval
ToplineObsessive-compulsive disorderTroriluzoleNCE prodrug of riluzole
ToplineSpinocerebellar ataxia
Topline
Migraine prevention Approval
Start Phase 1
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>1,100,000TRxs of
Nurtec® ODTto Date
57%New to
Brand Share
$136MNet Sales3Q2021
46%Increase Over 2Q
$336MTotal Net SalesSince Launch
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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 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 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.
$ 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 $85.7 $57.0 $270.2 $155.5
Less: non-cash share-based compensation expense (13.1) (5.3) (42.4) (17.9)Less: collaboration and license upfront expenses (3.7) - (11.6) -Less: accrued development milestone payments - - (5.5) -
Non-GAAP adjusted research and development expense $68.9 $51.8 $210.6 $137.6
Reconciliation of GAAP to Non-GAAP adjusted selling, general and administrative expense:GAAP selling, general and administrative expense $164.5 $119.5 $494.1 $339.9
Less: non-cash share-based compensation expense (14.9) (9.3) (59.8) (25.3)Non-GAAP adjusted selling, general and administrative expense $149.6 $110.2 $434.2 $314.7
Three Months Ended Sept. 30, Six Months Ended Sept. 30,
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Non-GAAP Financial Measures (Unaudited) — Continued
2021 2020 2021 2020Reconciliation of GAAP to Non-GAAP adjusted net loss:GAAP net loss attributable to Biohaven Pharmaceutical Holding Company Ltd. $(171.8) $(195.2) $(647.4) $(549.1)
Add: non-cash share-based compensation expense 28.0 14.6 102.3 43.2Add: non-cash interest expense on mandatorily redeemable preferred shares - 7.3 7.9 19.9Add: non-cash interest expense on liability related to sale of future royalties 13.2 11.3 37.3 31.3Add: change in fair value of derivatives 1.9 1.9 3.6 7.1Add: (gain) loss from equity method investment - 0.6 (5.3) 3.5Add: collaboration and license upfront expenses 3.7 - 11.6 -Add: accrued development milestone payments - - 5.5 -
Non-GAAP adjusted net loss attributable to Biohaven Pharmaceutical Holding Company Ltd. $(125.1) $(159.5) $(484.4) $(444.2)
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted:GAAP net loss per share attributable to Biohaven Pharmaceutical Holding Company Ltd. — basic and diluted $(2.63) $(3.27) $(10.09) $(9.42)
Add: non-cash share-based compensation expense 0.43 0.25 1.59 0.74Add: non-cash interest expense on mandatorily redeemable preferred shares - 0.12 0.12 0.34Add: non-cash interest expense on liability related to sale of future royalties 0.20 0.19 0.58 0.54Add: change in fair value of derivatives 0.03 0.03 0.06 0.12Add: (gain) loss from equity method investment - 0.01 (0.08) 0.06Add: collaboration and license upfront fees 0.06 - 0.18 -Add: accrued development milestone payments - - 0.09 -
Non-GAAP adjusted net loss per share attributable to Biohaven Pharmaceutical Holding Company Ltd. — basic and diluted $(1.91) $(2.67) $(7.55) $(7.62)
$ Millions, except net loss per share — basic and diluted Three Months Ended Sept. 30, Six Months Ended Sept. 30,
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