05/10/2022 | Press release | Distributed by Public on 05/10/2022 05:01
NEW HAVEN, Conn., May 10, 2022/PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders, today reported financial results for the first quarter ended March 31, 2022, and provided a review of recent accomplishments during and anticipated upcoming milestones.
Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "NURTEC ODT continues to be the leading migraine therapy in the oral CGRP class and demonstrated 8% sequential TRx growth compared to the previous quarter. The approval of the prevention indication last year has established NURTEC ODT as the only "all-in-one" migraine therapy and contributed to the substantial year-over-year first quarter revenue growth of 182%. Although strong growth in the mix of 2-pack (16-tablet count) sales help to drive additional volume growth and increases the net price per prescription, seasonal resetting of commercial insurance plan annual deductibles largely explains the expected pressure observed on first quarter net revenue generation compared to the fourth quarter. Growing Nurtec ODT volume and access for patients requires significant investment. In these important initial years of product launch, our strategy has been to drive brand trial and adoption of Nurtec ODT by investing in patient support programs and working with payers to ensure patient access, which also results in payer rebates and volume discounts related to the investments we made for incremental access. We expect the investments we made in first quarter copay programs will drive volume and net revenue growth for NURTEC ODT in the rest of the year."
Dr. Coric continued, "In addition to continued success in the US market, we are excited about bringing the only 'all-in-one' therapy to both treat and prevent migraine to the approximately one billion migraine patients worldwide. With EU approval for rimegepant now secured and additional regulatory submissions planned in China and South Korea in the second half of 2022, we believe we are well positioned to grow future sales of NURTEC ODT outside of the US. We also look forward to providing an update on zavegepant following the submission of our NDA in the first quarter. If approved, zavegepant will be the first and only intranasal CGRP receptor antagonist, offering a rapid onset of action and an important treatment alternative for patients who experience nausea or vomiting at the time of their migraine attacks. We continue to believe our migraine franchise is unmatched and we could not be more excited about the opportunities for continued market expansion in the months and years to come."
First Quarter and Recent Business Highlights
CGRP Antagonist Platform - Milestones and Next Steps
Other Programs and Partnerships - Milestones and Next Steps
Corporate Updates:
Upcoming Milestones:
Biohaven is continuing to support the commercialization of NURTEC ODT for the acute and preventive treatment of migraine, as well as develop its product candidates through clinical and preclinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones across its platforms in the coming quarters.
Biohaven expects to:
Capital Position:
Cash, cash equivalents, and marketable securities as of March 31, 2022, were $602.5 million, excluding $5.3 million of restricted cash, compared to $364.6 million as of December 31, 2021. On January 4, 2022, we received $500.0 million in upfront proceeds from Pfizer relating to the strategic collaboration arrangement, consisting of $150.0 million cash and $350.0 million in proceeds from the purchase of Biohaven common shares at a 25% market premium. We also have $125.0 million in non-dilutive committed capital from our credit facility with Sixth Street.
First Quarter 2022 Financial Highlights
Product Revenue, Net: Net product revenue was $123.6 million for the three months ended March 31, 2022, compared to $43.8 million for the three months ended March 31, 2021. The increase of $79.8 million in net product revenue is due to both increased NURTEC ODT sales volume and improvements in net price realization due to decreases in sales allowances during the three months ended March 31, 2022, compared to the three months ended March 31, 2021. Sales allowances and accruals mostly consisted of patient affordability programs, distribution fees and rebates.
Collaboration and Other Revenue: Collaboration and other revenue was $195.3 million for the three months ended March 31, 2022. No collaboration and other revenue was recognized for the three months ended March 31, 2021. The collaboration and other revenue recognized during the three months ended March 31, 2022 was primarily due to $194.4 million recognized upon the satisfaction of our performance obligation for the delivery of the license and sublicense to commercialize Rimegepant outside the U.S. as part of our Collaboration Agreement with Pfizer.
Research and Development ("R&D") Expenses: R&D expenses, including non-cash share-based compensation costs, were $119.1 million for the three months ended March 31, 2022, compared to $107.1 million for the three months ended March 31, 2021. The increase of $12.0 million was primarily due to increased personnel costs partially offset by decreased program expenses. Non-cash share-based compensation expense was $34.0 million for the three months ended March 31, 2022, an increase of $13.9 million as compared to the same period in 2021.
Selling, General and Administrative ("SG&A") Expenses: SG&A expenses, including non-cash share-based compensation costs, were $227.2 million for the three months ended March 31, 2022, compared to $159.5 million for the three months ended March 31, 2021. The increase of $67.7 million was primarily due to increases in spending to support increased commercial sales of NURTEC ODT, including the launch of NURTEC ODT for the preventative treatment of migraine which was approved by the FDA in May of 2021. Less than half of the SG&A expense was for commercial organization personnel costs, excluding non-cash share-based compensation expense. Non-cash share-based compensation expense was $47.9 million for the three months ended March 31, 2022, an increase of $19.2 million as compared to the same period in 2021.
Net Loss: Biohaven reported a net loss attributable to common shareholders for the three months ended March 31, 2022, of $209.1 million, or $2.97 per share, compared to $265.0 million, or $4.27 per share for the same period in 2021. Non-GAAP adjusted net loss for the three months ended March 31, 2022 was $114.0 million, or $1.62 per share, compared to $201.4 million, or $3.25 per share for the same period in 2021. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, non-cash interest expense related to the accounting for mandatorily redeemable preferred shares and liability related to sale of future royalties, changes in the fair value of derivatives and gains or losses from equity method investment. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.
Non-GAAP Financial Measures
This press release 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 GAAP results, provides investors with a more meaningful understanding of ongoing operating performance. These measures exclude (i) non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, (ii) 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 derivative liability, which does not correlate to actual cash payment obligations in the relevant periods, and (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.
Biohaven believes 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, 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 later in this press release.
About Biohaven
Biohaven is a global commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's Neuroinnovation™ portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the acute and preventive treatment of migraine (EMA-approved as VYDURA® for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and other CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis; Kv7 ion channel activators for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com.
Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "continue", "may", "will", "anticipate", "expect" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine and preventive treatment for migraine. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; the potential commercialization of Biohaven's product candidates; the potential for Biohaven's product candidates to be first in class or best in class therapies; and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2022, and in Biohaven's subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of the date of this new release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD. CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share amounts) (Unaudited) |
||||
Three Months Ended March 31, |
||||
2022 |
2021 |
|||
Revenues: |
||||
Product revenue, net |
$ 123,590 |
$ 43,823 |
||
Collaboration and other revenue |
195,262 |
- |
||
Total revenue |
318,852 |
43,823 |
||
Operating expenses: |
||||
Cost of sales |
26,342 |
12,862 |
||
Research and development |
119,099 |
107,111 |
||
Selling, general and administrative |
227,243 |
159,523 |
||
Total operating expenses |
372,684 |
279,496 |
||
Loss from operations |
(53,832) |
(235,673) |
||
Other income (expense): |
||||
Interest expense |
(17,216) |
(7,731) |
||
Interest expense on mandatorily redeemable preferred shares |
(7,917) |
(7,943) |
||
Interest expense on liability related to sale of future royalties |
(17,314) |
(13,508) |
||
Change in fair value of derivatives |
3,604 |
(210) |
||
Gain from equity method investment |
- |
5,261 |
||
Other income (expense), net |
81 |
(1,700) |
||
Total other expense, net |
(38,762) |
(25,831) |
||
Loss before provision for income taxes |
(92,594) |
(261,504) |
||
Provision for income taxes |
24,303 |
3,824 |
||
Net loss |
(116,897) |
(265,328) |
||
Less: Net loss attributable to non-controlling interests |
(498) |
(360) |
||
Less: Deemed dividend upon repurchase of preferred shares in consolidated subsidiary |
92,673 |
- |
||
Net loss attributable to common shareholders of Biohaven Pharmaceutical Holding |
$ (209,072) |
$ (264,968) |
||
Net loss per share attributable to common shareholders of Biohaven Pharmaceutical |
$ (2.97) |
$ (4.27) |
||
Weighted average common shares outstanding-basic and diluted |
70,332,274 |
62,040,715 |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands) (Unaudited) |
||||
March 31, 2022 |
December 31, 2021 |
|||
Assets |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 169,065 |
$ 171,945 |
||
Marketable securities |
433,410 |
192,648 |
||
Trade receivables, net |
328,342 |
308,269 |
||
Inventory |
91,281 |
80,608 |
||
Prepaid expenses |
104,891 |
88,838 |
||
Other current assets |
44,096 |
33,946 |
||
Total current assets |
1,171,085 |
876,254 |
||
Property and equipment, net |
14,534 |
14,690 |
||
Intangible assets, net |
55,910 |
56,438 |
||
Other assets |
130,188 |
129,830 |
||
Total assets |
$ 1,371,717 |
$ 1,077,212 |
||
Liabilities and Shareholders' Deficit |
||||
Current liabilities: |
||||
Accounts payable |
$ 56,202 |
$ 51,683 |
||
Accrued expenses and other current liabilities |
457,412 |
420,019 |
||
Current portion of mandatorily redeemable preferred shares |
62,500 |
62,500 |
||
Total current liabilities |
576,114 |
534,202 |
||
Long-term debt |
634,106 |
626,720 |
||
Liability related to sale of future royalties, net |
377,998 |
367,645 |
||
Mandatorily redeemable preferred shares, net |
162,994 |
155,737 |
||
Derivative liability |
9,120 |
13,110 |
||
Obligation to perform R&D services |
36,016 |
50,571 |
||
Other long-term liabilities |
41,782 |
12,236 |
||
Total liabilities |
1,838,130 |
1,760,221 |
||
Contingently redeemable non-controlling interests |
- |
60,000 |
||
Total shareholders' deficit attributable to Biohaven Pharmaceutical |
(462,286) |
(739,380) |
||
Non-controlling interests in consolidated subsidiaries |
(4,127) |
(3,629) |
||
Total shareholders' deficit |
(466,413) |
(743,009) |
||
Total liabilities and shareholders' deficit |
$ 1,371,717 |
$ 1,077,212 |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES (Amounts in thousands, except share and per share amounts) (Unaudited) |
||||
Three Months Ended March 31, |
||||
2022 |
2021 |
|||
Reconciliation of GAAP to Non-GAAP adjusted net loss: |
||||
GAAP net loss attributable to Biohaven Pharmaceutical Holding Company Ltd. |
$ (209,072) |
$ (264,968) |
||
Add: non-cash share-based compensation expense |
81,330 |
48,726 |
||
Add: non-cash interest expense on mandatorily redeemable preferred shares |
- |
7,943 |
||
Add: non-cash interest expense on liability related to sale of future royalties |
17,309 |
11,972 |
||
Add: (gain) loss from change in fair value of derivatives |
(3,604) |
210 |
||
Add: (gain) loss from equity method investment |
- |
(5,261) |
||
Non-GAAP adjusted net loss attributable to Biohaven Pharmaceutical Holding |
$ (114,037) |
$ (201,378) |
||
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 |
$ (2.97) |
$ (4.27) |
||
Add: non-cash share-based compensation expense |
1.16 |
0.78 |
||
Add: non-cash interest expense on mandatorily redeemable preferred shares |
- |
0.13 |
||
Add: non-cash interest expense on liability related to sale of future royalties |
0.25 |
0.19 |
||
Add: (gain) loss from change in fair value of derivatives |
(0.05) |
- |
||
Add: (gain) loss from equity method investment |
- |
(0.08) |
||
Non-GAAP adjusted net loss per share attributable to Biohaven Pharmaceutical Holding |
$ (1.62) |
$ (3.25) |
About NURTEC ODT
NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.
Indication
NURTEC ODT orally disintegrating tablets is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.
Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients.
Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.
The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatchor call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec.
Please click here for full Prescribing Information and Patient Information.
Biohaven Contacts
Investor Relations
Jennifer Porcelli, VP, Investor Relations
Biohaven Pharmaceuticals
[email protected]
+1 (201) 248-0741
Media
Mike Beyer, Media Relations Counselor
Sam Brown Inc.
[email protected]
+1 (312) 961-2502
NURTEC, NURTEC ODT and VYDURA are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.