2nd quarter 2020 earnings...2020/08/09 · quick-dissolve oral cgrp antagonist that can…...
TRANSCRIPT
© 2020 Biohaven Pharmaceuticals. All rights reserved. NYSE:BHVN
Ellie, living with migraine
2nd Quarter 2020 EarningsAugust 10, 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
2Q20 Financial Results | Jim Englehart, C.P.A. Chief Financial Officer
Commercial Events | BJ Jones, 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
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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 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 and Biohaven's QuarterlyReport on Form 10-Q for the quarter ended March 31, 2020, filed with the Securities and Exchange Commission on May 7, 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.
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Vlad Coric, M.D. | Chief Executive Officer
Quarter Summaryand Recent Events
Company Achievements
52.6%New Brand Rx Market Share
$9.7M2Q Net Sales
141MCommercial
Covered Lives
22% Average Weekly
TRx Volume Growth
83%Commercial Coverage
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Market Leadership within 16 Weeks of Launch
Growing Share in a Growth Market
Source: NBRx through 7/3, Symphony PrescriberSource, accessed 7/20; TRx through 7/10, Symphony PHAST, accessed 7/20
Nurtec ODT
Ubrelvy
CGRP Oral Class Growth
Nurtec ODT NBRx share 52.6%
Ubrelvy Launch
NurtecLaunch
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Week ending
Broad Commercial Coverage
141M Covered Lives
83%COVERAGE
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Oral CGRPs with Significant Growth Opportunity Ahead
Symphony Database: Cumulative NBRx Volume (1/24/20 - 7/10/20)
122,965
1,022,942
CGRP Orals Triptans
1,022,942
12%
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The Only Quick-Dissolve Oral CGRP Antagonist that can…
eliminate migraine pain in minutes
get you back to normal function by one hour, and
last 48 hours after a single dose
Doing things differently…
15 sec
2H2021
Multiple Upcoming Regulatory and Pivotal Trial Milestones
2H2020 1H2021DRUG NAME INDICATION
sNDA FilingMigraine prevention Approval
Europe Filing 1QMigraine acute/prevention PMDA Meeting
Topline 1QAlzheimer's
TroriluzoleNCE prodrug of riluzole
Topline 4QSpinocerebellar ataxia
Topline 4QMultiple system atrophyVerdiperstatNCE oral MPO inhibitor ToplineAmyotrophic lateral sclerosis
2022
ZavegepantSmall molecule/NCE
Filing 4QMigraine (intranasal) Approval
ToplineObsessive-compulsive disorder
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Strong Financial Position
August 2020 closed non-equity-based financings up to $950M
Jim Englehart, C.P.A. | Chief Financial Officer
2Q20 Financial Results
Second Quarter Results (Unaudited)GAAP Reported Non-GAAP Adjusted
Q2 2020 Q2 2019 Change Q2 2020 Q2 2019 Change
Product Revenue, net — Nurtec ODT $9.7 $ - $9.7
R&D expense 42.4 175.9 (133.5) 36.0 41.0 (5.0)
SG&A 124.8 23.2 101.6 119.5 16.0 103.5
Net loss (180.9) (211.1) 30.1 (150.0) (59.6) (90.4)
Net loss per share - basic and diluted $(3.08) $(4.67) $1.59 $(2.55) $(1.32) $(1.23)
Capital Position
Cash, including restricted cash, @ June 30, 2020 $263.9
Additional cash received or immediately available for draw on close of $950M Sixth Street & RPI financings in August 2020 $525.0
Note: See slides 29 – 30 for an explanation of our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP adjusted amounts shown
GAAP Reported Non-GAAP Adjusted$ Millions, except net loss per share - basis and diluted
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Immediate access to $700M+ in capital
BJ Jones | Chief Commercial Officer Migraine and Common Disease
Commercial Events
Successful Launch Strategy
ENSUREaccess and affordability
ACTIVATEpatients
DRIVE healthcare practitioner awareness
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Drive Healthcare Provider Awareness and Action
Quickly pivoted to HCP Virtual Engagements
Initiated Virtual Peer-to-Peer
Programs >50 Programs
per Week
10,800+ Prescribers and Growing
Extensive multi-channel approach to encourage word-of-mouth sharing of Nurtec ODT experience
Innovative Patient Activation to Drive Demand
March 25, 2020
Biohaven embraces digital to keep migraine launch on track despite COVID-19
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Ensuring Access and Affordability
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Early Success and Reasons to Believe
ENSUREaccess and affordability
ACTIVATEpatients
DRIVE healthcare practitioner awareness
Strong and Growing Base of Awareness and Trial
>75% Awareness among targets
>10K Unique writers
>600 New writers /week
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
83% Commercial Coverage (141MM lives)
$0 Co-pay (Commercial)
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Elyse Stock, M.D. | Chief Medical Officer
R&D Update
MARKETED
CGRP Antagonist Franchise
PRECLINICAL 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
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MARKETED
Glutamate Modulation Program
PRECLINICAL PHASE 1 PHASE 2 PHASE 3PLATFORM | DRUG NAME
Filing for Approval
Obsessive-Compulsive Disorder (OCD)
Spinocerebellar Ataxia (SCA)
Neuropsychiatric Indications
Alzheimer’s Disease (AD)
TroriluzoleNCE prodrug of riluzole
BHV-5000/5500NCE NMDA antagonist
CALCITONIN GENE-RELATED PEPTIDE (CGRP)
GLUTAMATE
MYELOPEROXIDASE (MPO)
NOVEL PROGRAMS
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MARKETEDPHASE 3
NOVEL PROGRAMS
MPO and Novel Preclinical Programs
PRECLINICAL PHASE 1 PHASE 2PLATFORM | DRUG NAME
Filing for Approval
Multiple System Atrophy (MSA)
Amyotrophic Lateral Sclerosis (ALS)
Not Disclosed
VerdiperstatNCE oral MPO inhibitor
UC1MTMetallothionein
CALCITONIN GENE-RELATED PEPTIDE (CGRP)
GLUTAMATE
MYELOPEROXIDASE (MPO)
ALSTDP43
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Company Achievements
52.6%New Brand Rx Market Share
$9.7M2Q Net Sales
141MCommercial
Covered Lives
22% Average Weekly
TRx Volume Growth
83%Commercial Coverage
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THANK YOU!
Appendix: Reconciliation of GAAP to Non-GAAP Financial Measures
Non-GAAP
Thousands, except share and per share amounts
2020 2019Reconciliation of GAAP to Non-GAAP adjusted research and development expense:GAAP research and development expense $42,425 $175,977
Less: non-cash share-based compensation expense (6,426) (10,330)Less: expense related to priority review voucher acquisition - (105,000)Less: accrued development milestone payments - (11,500)Less: one-time issuance of common shares to Fox Chase - (5,600)Less: commercial supply costs for Nurtec ODT - (2,548)
Non-GAAP adjusted research and development expense $35,999 $40,999
Reconciliation of GAAP to Non-GAAP adjusted selling, general and administrative expense:GAAP selling, general and administrative expense $124,802 $23,231
Less: non-cash share-based compensation expense (5,336) (7,224)Non-GAAP adjusted selling, general and administrative expense $119,466 $16,007
Three Months Ended June 30,
29
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, (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, (v) expense related to non-routine priority review voucher acquisition, (vi) non-routine accrued development milestone payments, and (vii) one-time issuance of common shares to Fox Chase.
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)Thousands, except share and per share amounts
Reconciliation of GAAP to Non-GAAP adjusted net loss: 2020 2019GAAP net loss $(180,934) $(211,070)
Add: non-cash share-based compensation expense 11,762 17,554Add: non-cash interest expense on mandatorily redeemable preferred shares 6,993 3,955Add: non-cash interest expense on liability related to sale of future royalties 11,342 5,155Add: change in fair value of derivative liability (650) 1,263Add: loss from equity method investment 1,485 1,415Add: expense related to priority review voucher acquisition - 105,000Add: accrued development milestone payments - 11,500Add: one-time issuance of common shares to Fox Chase - 5,600
Non-GAAP adjusted net loss $(150,002) $(59,628)
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted:GAAP net loss per share — basic and diluted $(3.08) $(4.67)
Add: non-cash share-based compensation expense 0.20 0.39Add: non-cash interest expense on mandatorily redeemable preferred shares 0.12 0.09Add: non-cash interest expense on liability related to sale of future royalties 0.19 0.11Add: change in fair value of derivative liability (0.01) 0.03Add: loss from equity method investment 0.03 0.03Add: expense related to priority review voucher acquisition - 2.32Add: accrued development milestone payments - 0.25Add: one-time issuance of common shares to Fox Chase - 0.12
Non-GAAP adjusted net loss per share — basic and diluted $(2.55) $(1.32)
Three Months Ended June 30,
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