"Our focus remains on helping as many patients with tardive dyskinesia as possible and we are adapting to the challenges posed by the pandemic, including the slow recovery of in-person visits with psychiatrists. We are encouraged by recent trends and remain confident in the intermediate and long-term opportunity of INGREZZA to help many more patients with tardive dyskinesia," said
Financial Highlights
Three Months Ended |
Nine Months Ended |
||||||||||||||
(unaudited, in millions, except per share data) |
2020 |
2019 |
2020 |
2019 |
|||||||||||
Revenues: |
|||||||||||||||
Product sales, net |
$ |
254.1 |
$ |
198.1 |
$ |
752.8 |
$ |
515.0 |
|||||||
Collaboration revenue |
4.4 |
24.0 |
45.2 |
29.0 |
|||||||||||
Total revenues |
$ |
258.5 |
$ |
222.1 |
$ |
798.0 |
$ |
544.0 |
|||||||
|
$ |
69.1 |
$ |
45.3 |
$ |
208.3 |
$ |
144.7 |
|||||||
Non-GAAP R&D |
$ |
60.3 |
$ |
38.3 |
$ |
161.9 |
$ |
116.3 |
|||||||
GAAP Selling, General and Administrative (SG&A) |
$ |
112.5 |
$ |
84.5 |
$ |
326.8 |
$ |
252.8 |
|||||||
Non-GAAP SG&A |
$ |
94.6 |
$ |
71.2 |
$ |
274.2 |
$ |
217.2 |
|||||||
GAAP net (loss) income |
$ |
(57.6) |
$ |
53.8 |
$ |
59.4 |
$ |
3.0 |
|||||||
GAAP net (loss) income per share – diluted |
$ |
(0.62) |
$ |
0.56 |
$ |
0.61 |
$ |
0.03 |
|||||||
Non-GAAP net income |
$ |
96.0 |
$ |
86.7 |
$ |
314.2 |
$ |
181.6 |
|||||||
Non-GAAP net income per share – diluted |
$ |
0.97 |
$ |
0.90 |
$ |
3.21 |
$ |
1.91 |
|||||||
(unaudited, in millions) |
|
|
|||||||||||||
Total cash and cash equivalents and debt securities available-for-sale |
$ |
1,126.1 |
$ |
970.2 |
Net Product Sales Highlights:
- INGREZZA net product sales for the third quarter of 2020 were
$254 million , representing a year-over-year increase of 28%. Inventory adjusted net sales for the third quarter of 2020 were approximately$248 million . - New prescriptions increased slightly in the third quarter of 2020 vs. the second quarter of 2020.
- Refill and persistency rates for existing INGREZZA patients in the third quarter 2020 moderated slightly vs. the second quarter of 2020 and remained at the higher end of historical averages.
- ONGENTYS launched in
the United States in lateSeptember 2020 and net product sales for the third quarter of 2020 were approximately$0.1 million .
Financial Highlights:
- Third quarter 2020 GAAP net loss and loss per share were approximately
$58 million and$0.62 , respectively, compared with net income and diluted earnings per share of approximately$54 million and$0.56 , respectively, in the third quarter of 2019, primarily driven by higherIn-Process Research and Development (IPR&D) costs and operating expenses, offset by higher INGREZZA sales. - Third quarter 2020 non-GAAP net income and diluted earnings per share were approximately
$96 million and$0.97 , respectively, compared with approximately$87 million and$0.90 , respectively, in the third quarter of 2019 driven by higher INGREZZA sales. - Research and Development (R&D) expense increased in the third quarter of 2020 versus the third quarter of 2019, primarily due to increased investment across our expanded pipeline programs and higher headcount costs.
- Selling, General and Administrative (SG&A) expense increased in the third quarter of 2020 versus the third quarter of 2019, primarily due to increased investment in marketing initiatives and higher headcount costs.
- At
September 30, 2020 , the Company had cash, cash equivalents and debt securities available-for-sale of$1.1 billion .
A reconciliation of GAAP to non-GAAP quarterly financial results can be found in Table 3 at the end of this earnings release.
Recent Events
- In
September 2020 , the Company launched ONGENTYS® (opicapone), the first and only once-daily COMT inhibitor, as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes - periods of time when motor symptoms such as tremor, slowed movement and difficulty walking occur. ONGENTYS also increases "on" time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson's disease are better controlled. - In
October 2020 , theU.S. Food and Drug Administration (FDA) provided feedback on an Investigational New Drug (IND) application submitted byNeurocrine Biosciences in support of a Phase II clinical trial of NBI-921352 in pediatric SCN8A developmental and epileptic encephalopathy syndrome patients. As part of its review of the IND, the FDA is requesting additional non-clinical data to support dose justification in this pediatric study. Together with Xenon, the Company will engage with the FDA to address the feedback received with the goal of initiating a Phase II clinical trial in 2021. In parallel, the Company is advancing clinical plans to develop NBI-921352 for the treatment of adult focal epilepsy. - In
November 2020 , the Company announced the initiation of a Phase II study of NBI-827104 (formerly ACT-709478) in CSWS, a rare pediatric epilepsy. NBI-827104 was licensed from Idorsia and is a potent, selective, orally-active and brain penetrating T-type calcium channel blocker. - In
November 2020 , the Data Safety Monitoring Board (DSMB) for the RESTORE-1 Phase II clinical trial reviewed patient imaging data from the ongoing trial. TheDSMB requested additional data and recommended the Company pause dosing of subjects in RESTORE-1 until theDSMB can review these additional data, which is expected by year-end. TheDSMB informed the Company and Voyager Therapeutics that they could continue screening patients for potential enrollment into the trial. However, as previously announced, trial sites participating in RESTORE-1 are not currently screening and enrolling patients as a result of the COVID-19 pandemic. In response to theDSMB's recommendation, the Company and Voyager Therapeutics have decided to delay the planned resumption this quarter of patient screening in the RESTORE-1 trial until theDSMB is able to complete its evaluation. The Company is preparing an expedited safety report that will be submitted to the FDA within the 15-day reporting window.
Full-Year 2020 Expense Guidance
Range |
|||||||
(in millions) |
Low |
High |
|||||
Combined GAAP R&D and SG&A expenses |
$ |
880 |
$ |
900 |
|||
Combined Non-GAAP R&D and SG&A expenses |
$ |
590 |
$ |
610 |
- Previously, the Company expected combined GAAP R&D and SG&A expenses in the range of
$850 million to$900 million and combined non-GAAP R&D and SG&A expenses in the range of$570 million to$610 million .
Conference Call and Webcast Today at
About
Non-GAAP Financial Measures
In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our launch of ONGENTYS; our financial and operating performance, including our future expenses; our collaborative partnerships; expectations regarding the impact of COVID-19 on our business; expectations regarding our ability to adapt our business to the evolving COVID-19 pandemic, mitigate its impact on our business and maintain business continuity, including our ability to protect the safety and well-being of our employees, to continue to support uninterrupted supply of INGREZZA, including patient and healthcare provider access to INGREZZA, to continue our ongoing clinical trials and other development activities, and to otherwise advance our business objectives; and the timing of completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic on our business and the business operations of our customers; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantines, shelter-in-place, social distancing and other government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our business operations and the business operations of the third parties on which we rely; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on AbbVie for the commercialization of ORILISSA and ORIAHNN, as well as the continued development of elagolix; risks associated with our dependence on
This press release 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 press release, which has been filed with the
TABLE 1
|
|||||||||||||||
Three Months Ended |
Nine Months Ended |
||||||||||||||
(in millions, except per share data) |
2020 |
2019 |
2020 |
2019 |
|||||||||||
Revenues: |
|||||||||||||||
Product sales, net |
$ |
254.1 |
$ |
198.1 |
$ |
752.8 |
$ |
515.0 |
|||||||
Collaboration revenue |
4.4 |
24.0 |
45.2 |
29.0 |
|||||||||||
Total revenues |
258.5 |
222.1 |
798.0 |
544.0 |
|||||||||||
Operating expenses: |
|||||||||||||||
Cost of sales |
2.7 |
2.2 |
7.2 |
4.9 |
|||||||||||
Research and development |
69.1 |
45.3 |
208.3 |
144.7 |
|||||||||||
Acquired in-process research and development |
118.5 |
— |
164.5 |
118.1 |
|||||||||||
Selling, general and administrative |
112.5 |
84.5 |
326.8 |
252.8 |
|||||||||||
Total operating expenses |
302.8 |
132.0 |
706.8 |
520.5 |
|||||||||||
Operating (loss) income |
(44.3) |
90.1 |
91.2 |
23.5 |
|||||||||||
Other (expense) income: |
|||||||||||||||
Interest expense |
(8.5) |
(8.0) |
(25.0) |
(23.8) |
|||||||||||
Unrealized loss on equity securities |
(7.0) |
(28.5) |
(12.2) |
(5.8) |
|||||||||||
Investment income and other, net |
2.7 |
4.8 |
11.0 |
14.0 |
|||||||||||
Total other expense, net |
(12.8) |
(31.7) |
(26.2) |
(15.6) |
|||||||||||
(Loss) income before provision for income taxes |
(57.1) |
58.4 |
65.0 |
7.9 |
|||||||||||
Provision for income taxes |
0.5 |
4.6 |
5.6 |
4.9 |
|||||||||||
Net (loss) income |
$ |
(57.6) |
$ |
53.8 |
$ |
59.4 |
$ |
3.0 |
|||||||
Net (loss) income per share, basic |
$ |
(0.62) |
$ |
0.59 |
$ |
0.64 |
$ |
0.03 |
|||||||
Net (loss) income per share, diluted |
$ |
(0.62) |
$ |
0.56 |
$ |
0.61 |
$ |
0.03 |
|||||||
Weighted average common shares outstanding, basic |
93.3 |
91.9 |
93.0 |
91.4 |
|||||||||||
Weighted average common shares outstanding, diluted |
93.3 |
96.1 |
98.0 |
95.2 |
TABLE 2
|
|||||||
(in millions) |
|
|
|||||
Cash and cash equivalents and debt securities available-for-sale |
$ |
944.7 |
$ |
670.5 |
|||
Other current assets |
212.2 |
160.5 |
|||||
Total current assets |
1,156.9 |
831.0 |
|||||
Debt securities available-for-sale |
181.4 |
299.7 |
|||||
Right-of-use assets |
71.0 |
74.3 |
|||||
Equity securities |
43.7 |
55.9 |
|||||
Property and equipment, net |
43.0 |
41.9 |
|||||
Restricted cash and other long-term assets |
6.6 |
3.2 |
|||||
Total assets |
$ |
1,502.6 |
$ |
1,306.0 |
|||
Convertible senior notes |
$ |
425.0 |
$ |
408.8 |
|||
Other current liabilities |
186.0 |
156.5 |
|||||
Total current liabilities |
611.0 |
565.3 |
|||||
Operating lease liabilities |
83.0 |
86.7 |
|||||
Other long-term liabilities |
4.3 |
17.1 |
|||||
Stockholders' equity |
804.3 |
636.9 |
|||||
Total liabilities and stockholders' equity |
$ |
1,502.6 |
$ |
1,306.0 |
TABLE 3
|
|||||||||||||||
Three Months Ended |
Nine Months Ended |
||||||||||||||
(in millions, except per share data) |
2020 |
2019 |
2020 |
2019 |
|||||||||||
GAAP net (loss) income |
$ |
(57.6) |
$ |
53.8 |
$ |
59.4 |
$ |
3.0 |
|||||||
Adjustments: |
|||||||||||||||
Milestones received from licenses and collaborations A |
— |
(20.0) |
(30.0) |
(20.0) |
|||||||||||
Non-cash collaboration revenue B |
(0.5) |
— |
(1.8) |
— |
|||||||||||
Acquired in-process research and development (IPR&D) C |
118.5 |
— |
164.5 |
118.1 |
|||||||||||
Milestones paid related to licenses and collaborations - R&D |
— |
— |
20.0 |
10.0 |
|||||||||||
Share-based compensation expense - R&D |
8.8 |
7.0 |
26.4 |
18.4 |
|||||||||||
Share-based compensation expense - SG&A |
17.9 |
13.3 |
52.6 |
35.6 |
|||||||||||
Non-cash interest related to convertible debt |
5.5 |
5.1 |
16.2 |
15.1 |
|||||||||||
Changes in fair value of equity security investments D |
7.0 |
28.5 |
12.2 |
5.8 |
|||||||||||
Income tax effect related to reconciling items E |
(3.6) |
(1.0) |
(5.3) |
(4.4) |
|||||||||||
Non-GAAP net income |
$ |
96.0 |
$ |
86.7 |
$ |
314.2 |
$ |
181.6 |
|||||||
Net (loss) income per diluted common share: |
|||||||||||||||
GAAP |
$ |
(0.62) |
$ |
0.56 |
$ |
0.61 |
$ |
0.03 |
|||||||
Non-GAAP F |
$ |
0.97 |
$ |
0.90 |
$ |
3.21 |
$ |
1.91 |
A During the nine months ended |
B During the nine months ended |
C The Company incurred IPR&D expenses of |
D The Company recognized an unrealized loss of |
E Estimated income tax effect of non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance. |
F Non-GAAP net income per diluted common share for the three months ended |
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SOURCE
Neurocrine Biosciences, Inc., Navjot Rai (Media), 858-617-7623, media@neurocrine.com, or Todd Tushla (Investors), 858-617-7143, ir@neurocrine.com