2nd Quarter 2021 Earnings - August 9, 2021 - Ellie, living with migraine - Biohaven Pharmaceuticals
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
2nd Quarter 2021 Earnings
August 9, 2021
Ellie, living with migraine
Ellie, living with migraine
© 2021 Biohaven Pharmaceuticals. All rights reserved.
NYSE:BHVN
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 AUGUST 2021 2ND QUARTER 2021 EARNINGS 2
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. AUGUST 2021 2ND QUARTER 2021 EARNINGS 3
Second Quarter 2021
Summary & Recent Events
Vlad Coric, M.D. | Chief Executive Officer
Company Achievements
$93M >875,000
Net Sales
TRxs of NURTEC
2Q2021 to Date
$200M 55.9%
Total New to Brand
Net Sales Share
Since Launch
AUGUST 2021 2ND QUARTER 2021 EARNINGS 5
Oral CGRP Class Continues to Show Robust Market Growth, Nurtec leads
in NBRx share at 55.9%
1 Total Rx Volume (7/30) 2 New to Brand Rx Share (7/16)
21,238
20,936
Nurtec ODT 55.9%
Nurtec ODT
Ubrelvy 44.1%
Ubrelvy
5/8
6/5
7/3
1/1
4/9
5/7
6/4
7/2
3/13
3/27
4/10
4/24
5/22
6/19
7/17
7/31
8/14
8/28
9/11
9/25
10/9
11/6
12/4
1/15
1/29
2/12
2/26
3/12
3/26
4/23
5/21
6/18
7/16
10/23
11/20
12/18
1/24
2/14
3/27
4/17
5/29
6/19
7/10
7/31
8/21
9/11
10/2
12/4
1/15
2/26
3/19
4/30
5/21
6/11
7/23
10/23
11/13
12/25
3/6
5/8
2/5
4/9
7/2
Week ending Week ending
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
AUGUST 2021 2ND QUARTER 2021 EARNINGS 6
Oral CGRPs Have Significant Growth Opportunity Ahead vs Triptans
TRx Volume vs Triptans¹ NBRx Volume vs Triptans²
Quarterly
3,924,354
NBRx volume 577,863
Cumulative
TRx volume
21%
11%
121,508
476,222
2Q21 2Q21 2Q21 2Q21
CGRP orals3 Triptans CGRP orals3 Triptans
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.
AUGUST 2021 2ND QUARTER 2021 EARNINGS 7
Orals CGRPs Have Driven CGRP Growth in 2020 and 2021 (vs mAbs)
CGRP Weekly TRx
140,000
120,000
100,000
Oral CGRP1
80,000
60,000
Injectable mAb2
40,000
20,000
0
6/ 8
7/ 8
8/ 8
9/ 8
10 18
2/ 9
3/ 9
4/ 9
5/ 9
6/ 9
7/ 9
8/ 9
9/ 9
10 19
2/ 0
3/ 0
4/ 0
5/ 0
6/ 0
7/ 0
8/ 0
9/ 0
10 20
2/ 1
3/ 1
4/ 1
5/ 1
6/ 1
1
1 1 18
1 2 18
1/ 8
1 1 19
1 2 19
1/ 9
1 1 20
1 2 20
1/ 0
1
1
2
/1
/1
/1
/1
/1
/1
/1
/1
/1
/1
/1
/1
/2
/2
/2
/2
/2
/2
/2
/2
/2
/2
/2
/2
/2
/2
5/
5/
5/
5/
5/
5/
5/
5/
5/
/
/
/
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
/2
/2
/2
/2
/2
/2
/2
/2
/2
5/
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
AUGUST 2021 2ND QUARTER 2021 EARNINGS 8
Product Patent Awarded for ODT Formulation, Extends Company's IP
for CGRP Platform into 2039
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
AUGUST 2021 2ND QUARTER 2021 EARNINGS 9
Unparalleled CGRP-Antagonist Franchise
Biohaven’s CGRP Platform
Nurtec® ODT Zavegepant Next-GEN CGRPs
RAPID DISSOLVING INTRANASAL ORAL MULTIPLE
FORMULATIONS
5
ADVANCED
MOLECULES
Launched 1Q20 2nd Ph 3 trial Ph 3 prevention BHV-3100
underway 4Q20 Started 1Q21 Ph 1 started 2Q21
Advanced Leads
4 Oral Follow-Ups
AUGUST 2021 2ND QUARTER 2021 EARNINGS 10CGRP Franchise: Near-Term Value Inflection Milestones
MIGRAINE CHRONIC
ZAVEGEPANT ORAL QD
TOP-LINE
4Q22
MIGRAINE ULTRA-
ZAVEGEPANT RAPID ACUTE
INTRANASAL
SUBMISSION
4Q21
MIGRAINE PEDIATRIC
PHASE 3 START
MIGRAINE PREVENTION
APPROVED
MIGRAINE ACUTE
APPROVED
AUGUST 2021 2ND QUARTER 2021 EARNINGS 11Rimegepant Global Regulatory Expansion in Migraine
2 Acute Migraine 9 Acute and Dual
By end of 2021
APPROVALS SUBMISSIONS
Europe
Dual | 1Q21
Japan
China Ph 2/3 | 4Q21
Lebanon
Acute | 3Q21 Ph 3 | 4Q20
Israel
Acute | APPROVED Kuwait Korea
Acute | 4Q20 Ph 3 | 4Q20
Bahrain Qatar
Acute | 4Q20 Acute | 3Q21
Saudi Arabia
Acute | 1Q21 United Arab Emirates
Acute | APPROVED
Oman
Acute | 3Q21
AUGUST 2021 2ND QUARTER 2021 EARNINGS 12Neuroinnovation Pipeline: Near-Term Milestones
VERDIPERSTAT VERDIPERSTAT TRORILUZOLE TRORILUZOLE
TOP-LINE COMPLETE ENROLLMENT TOP-LINE TOP-LINE
3Q21 4Q21 1H22 2H22
MULTIPLE AMYOTROPHIC SPINOCEREBELLAR OBSESSIVE
SYSTEM LATERAL ATAXIA COMPULSIVE
ATROPHY SCLEROSIS DISORDER
AUGUST 2021 2ND QUARTER 2021 EARNINGS 13Ellie W
Actual Nurtec® ODT Patient
TAKE CONTROL OF MIGRAINE WITH
one medication2Q21 Financial Results Jim Engelhart, C.P.A. | Chief Financial Officer
Second Quarter Results (Unaudited)
GAAP Reported Non-GAAP Adjusted
$ Millions, except net loss per share — basis and diluted
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
AUGUST 2021 2ND QUARTER 2021 EARNINGS 16Year-to-Date Results (Unaudited)
GAAP Reported Non-GAAP Adjusted
$ Millions, except net loss per share — basis and diluted
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) $(0.71)
Note: see slides 34-35 for an explanation of non-GAAP financial measures and a reconciliation of GAAP to Non-GAAP adjusted amounts shown
AUGUST 2021 2ND QUARTER 2021 EARNINGS 17Capital Position ($ Millions)
Cash, cash equivalents, and marketable securities
$368.0 Access to
@ June 30, 2021
$590M+
Cash immediately available to draw from Sixth Street financing $225.0 in capital
Additional proceeds to be received over next 7 calendar quarters
$164.8
from RPI Series B preferred share issuances
AUGUST 2021 2ND QUARTER 2021 EARNINGS 18Commercial Events BJ Jones, M.B.A. | Chief Commercial Officer Migraine and Common Disease
Nurtec® ODT Has Gained Significant Market Share in the Weeks Post
Prevention Approval
NBRx Share TRx Share
60% 60%
Prevention Prevention
Approval Nurtec ODT 55.9%
Approval
55% 55%
Ubrelvy
50.4%
50% 50%
49.6%
45% Ubrelvy 45% Nurtec ODT
44.1%
40% 40%
4/16
4/23
4/30
5/14
5/21
5/28
6/04
6/11
6/18
6/25
7/16
7/23
7/30
4/16
4/23
4/30
5/14
5/21
5/28
6/04
6/11
6/18
6/25
7/16
7/23
7/30
4/2
4/9
5/7
7/2
7/9
4/2
4/9
5/7
7/2
7/9
Source: IQVIA Market Dynamics, IQVIA NPA Includes entire oral CGRP market
AUGUST 2021 2ND QUARTER 2021 EARNINGS 20Significant Unmet Need
PREVENTION = DESPERATION FOR THE INJECTION
TOO FEW, TOO LATE BETTER OPTIONS BARRIER IS REAL
84%
of people taking a Preventive
treatment wish there was a
better option
15% 65%
of people who meet clinical of people do not want to
criteria for Preventive treatment receive an injection as a
actually use it preventive medication
AUGUST 2021 2ND QUARTER 2021 EARNINGS 21Redefining the Prevention Market Opportunity
CURRENT
INJECTIBLE
PREVENTIVE Novel
MIGRAINE Injectables 500K
MARKET
BROADER Topiramate,
PREVENTIVE Gabapentin, 1.1M
MARKET Tcas
OPPORTUNITY
7.0M
Rx Therapy
ACUTE PLUS
19.5M
Diagnosed with Migraine
ACUTE 39M
People with Migraine in US
AUGUST 2021 2ND QUARTER 2021 EARNINGS 22The First and Only Medication Proven to Treat and Prevent Migraine
Dissolving the line between acute and preventive treatment
DUAL-THERAPY
MIGRAINE TREATMENT
ACUTE PREVENTIVE
Treatment Treatment
AUGUST 2021 2ND QUARTER 2021 EARNINGS 23Nurtec® ODT Provides New Hope
THE HALO FOR HCPS ARE LIKELY TO RX DESIRE FOR
ACUTE IS REAL FOR MULTIPLE USES FLEXIBILITY
77%
ACUTE highly likely to Rx for persistent,
every other day
67%
of patients say they want a drug
that treats and prevents
60%
85%
also likely to prescribe for
‘intermittent’ or ‘preemptive’ use
of HCPs will Rx more for
Acute as a result of Preventive
indication WEATHER HORMONAL
CHANGES
STRESS
AUGUST 2021 2ND QUARTER 2021 EARNINGS 24Broad 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 25Nurtec 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
I think my neurologist
Nurtec ODT has literally changed my life. I never thought it chose Nurtec over
would really work, especially something that just dissolved Ubrelvy because it’s
in my mouth, but it really does. I go from debilitating pain also approved as a
to relief in literally 30 minutes. By the 2 hour mark, I forgot preventative in case
I even had a migraine. I read the website and stories and I need one in the
I was ever so hopeful, but honestly didn’t believe it would future. I’m only
work like that for me. I was hoping for, at best, a little relief having like 4 migraine
with minimal side effects compared to the other prescription days a month right
medications. I write this now completely pain and side effect free. I cannot really now but I was at
describe how Nurtec has given me back my life. 15+ for the last half
Thank you so much! of 2020.
Melinda and family — AlanaR&D Update Elyse Stock, M.D. | Chief Medical Officer
Expansion of CGRP Portfolio: Following the Science of CGRP
First and only
ACUTE AND
migraine medication PREVENTION
to treat and prevent Europe
Japan
GLOBAL
China
EXPANSION
Korea
Middle East and Israel
Child and EXPANSION
Adolescent INTO
age groups PEDIATRICS
CGRP MEDIATED: Psoriasis
NON-MIGRAINE Asthma
DISEASES Undisclosed
Post-traumatic Headache
MIGRAINE
Trigeminal Neuralgia ADJACENCIES
Undisclosed
AUGUST 2021 2ND QUARTER 2021 EARNINGS 28Multiple Opportunities Across Multiple Platforms
PLATFORM DRUG NAME OPPORTUNITIES
• US NURTEC ODT | Acute Migraine
• US NURTEC ODT | Migraine Prevention
Rimegepant • EX-US (EU, Japan, China, Korea, Middle East, Israel)
Small molecule/NCE • Planned Migraine Adjacencies
• Planned Non-Migraine Indications
• Pediatrics
CALCITONIN GENE-RELATED
• US |Intranasal: Acute Migraine
PEPTIDE (CGRP) Zavegepant • US | Oral: Prevention
Small molecule/NCE • COVID19 US | Respiratory Complications
• Planned Non-Migraine Indications
BHV-3100 Phase 1 initiated
Small molecule/NCE
Troriluzole • Spinocerebellar Ataxia (SCA)
NCE prodrug of riluzole • Obsessive-Compulsive Disorder (OCD)
GLUTAMATE
BHV-5000/5500 Neurologic/Neuropsychiatric Indications
NCE NMDA antagonist
Verdiperstat • Multiple System Atrophy (MSA)
MYELOPEROXIDASE (MPO) NCE oral MPO inhibitor • Amyotrophic Lateral Sclerosis (ALS)
UC1MT TDP43 MODE • Multiple myeloma
BIOHAVEN LABS Metallothionein MATE ARM • COVID-19
• Undisclosed
NCE, new chemical entity; TDP-43: TAR DNA-binding protein 43 UC1MT: monoclonal antibody targeting extracellular metallothionein
AUGUST 2021 2ND QUARTER 2021 EARNINGS 29We Follow the Science
Making streamlined and rational decisions based on
well designed studies and the scientific data they generate
Rational and educated risk Fostering innovative Keeping the patient
taking while maintaining partnerships and at the center
scientific integrity collaborations of all we do
Optimization of drug Nurturing and growing
design and formulations our internal talent
AUGUST 2021 2ND QUARTER 2021 EARNINGS 30Company Achievements
$93M >875,000
Net Sales
TRxs of NURTEC
2Q2021 to Date
$200M 55.9%
Total New to Brand
Net Sales Share
Since Launch
AUGUST 2021 2ND QUARTER 2021 EARNINGS 31THANK 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.
$ Millions, except net loss per share — basic and diluted Three Months Ended June 30, Six Months Ended June 30,
2021 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
AUGUST 2021 2ND QUARTER 2021 EARNINGS 34Non-GAAP Financial Measures (Unaudited) — Continued
Three Months Ended Six Months Ended
$ Millions, except net loss per share — basic and diluted June 30, June 30,
2021 2020 2021 2020
Reconciliation 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 28.6
Add: non-cash interest expense on mandatorily redeemable preferred shares - 7.0 7.9 12.6
Add: non-cash interest expense on liability related to sale of future royalties 12.2 11.3 24.1 20.0
Add: change in fair value of derivatives 1.5 (0.7) 1.7 5.1
Add: (gain) loss from equity method investment - 1.5 (5.3) 2.9
Add: 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 0.51
Add: non-cash interest expense on mandatorily redeemable preferred shares - 0.12 0.12 0.22
Add: non-cash interest expense on liability related to sale of future royalties 0.19 0.19 0.38 0.35
Add: change in fair value of derivatives 0.02 (0.01) 0.03 0.09
Add: (gain) loss from equity method investment - 0.03 (0.08) 0.05
Add: 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)
AUGUST 2021 2ND QUARTER 2021 EARNINGS 35You can also read
