Neurocrine Biosciences Reports Second Quarter 2023 Financial Results and Raises 2023 INGREZZA Sales Guidance
- INGREZZA® net product sales grew by 26% year-over-year, demonstrating strong demand and patient adoption.
- The company raised 2023 net product sales guidance to $1.77 - $1.82 billion, indicating confidence in the product's performance and market potential.
- Record number of new patients received therapy during the second quarter of 2023, suggesting increasing awareness and adoption of INGREZZA®.
- GAAP net income and earnings per share showed a significant improvement compared to the same period in 2022, indicating positive financial growth and stability.
- The company's cash, cash equivalents, and marketable securities reached approximately $1.3 billion, providing a strong financial position.
- Neurocrine Biosciences has several pipeline milestones and key activities in 2023, including the PDUFA date for valbenazine to treat chorea associated with Huntington's disease, which presents potential growth opportunities.
- None.
INGREZZA® (valbenazine) Second Quarter Net Product Sales of
INGREZZA® (valbenazine) 2023 Net Product Sales Guidance Raised to
"INGREZZA's performance reflects the significant benefit the medicine is providing to patients with tardive dyskinesia enabling us to raise guidance once again," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Operationally, we are set up well in the second half of 2023 with growing INGREZZA sales, a PDUFA for valbenazine to treat chorea associated with Huntington's disease, and meaningful progress with our muscarinic programs. Importantly, we remain on-track for four pipeline read-outs in the fourth quarter, including the Phase 3 studies of crinecerfont for the treatment of pediatric and adult congenital adrenal hyperplasia."
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
(unaudited, in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
Revenues: | |||||||
Net Product Sales | $ 446.3 | $ 352.0 | $ 861.6 | $ 657.0 | |||
Collaboration Revenue | 6.4 | 26.2 | 11.5 | 31.8 | |||
Total Revenues | $ 452.7 | $ 378.2 | $ 873.1 | $ 688.8 | |||
GAAP Research and Development (R&D) | $ 145.8 | $ 135.9 | $ 285.3 | $ 238.1 | |||
Non-GAAP R&D | $ 122.0 | $ 119.7 | $ 247.7 | $ 209.4 | |||
GAAP Selling, General and Administrative (SG&A) | $ 221.8 | $ 182.8 | $ 464.5 | $ 383.5 | |||
Non-GAAP SG&A | $ 177.1 | $ 149.5 | $ 393.7 | $ 325.7 | |||
GAAP Net Income (Loss) | $ 95.5 | $ (16.9) | $ 18.9 | $ (3.0) | |||
GAAP Earnings (Loss) Per Share – Diluted | $ 0.95 | $ (0.18) | $ 0.19 | $ (0.03) | |||
Non-GAAP Net Income | $ 125.7 | $ 82.1 | $ 76.2 | $ 111.8 | |||
Non-GAAP Earnings Per Share – Diluted | $ 1.25 | $ 0.84 | $ 0.76 | $ 1.14 | |||
(unaudited, in millions) | June 30, 2023 | December 31, 2022 | |||||
Total Cash, Cash Equivalents and Marketable Securities | $ 1,319.3 | $ 1,288.7 |
Second Quarter INGREZZA Net Product Sales Highlights:
- INGREZZA second quarter 2023 net product sales were
and grew$440 million 26% vs. the second quarter 2022 driven by prescription demand - Record number of new patients received therapy during the second quarter of 2023
Second Quarter Financial Highlights:
- Second quarter 2023 GAAP net income and earnings per share of
and$96 million , respectively, compared with second quarter 2022 GAAP net loss and loss per share of$0.95 and$17 million , respectively, primarily driven by$0.18 loss on extinguishment of debt in the second quarter of 2022$70 million - Second quarter 2023 non-GAAP net income and earnings per share of
and$126 million , respectively, compared with second quarter 2022 non-GAAP net income and earnings per share of$1.25 and$82 million , respectively$0.84 - Differences in second quarter 2023 GAAP and non-GAAP operating expenses compared with second quarter 2022 driven by:
- Increased R&D expense in support of an expanded and advancing clinical portfolio
- Increased SG&A expense primarily due to ongoing commercial initiatives
- At June 30, 2023, the Company had cash, cash equivalents and marketable securities of approximately
$1.3 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.
Updated 2023 INGREZZA Sales Guidance and Reaffirmed Operating Expense Guidance:
Range | |||
(in millions) | Low | High | |
INGREZZA Net Product Sales 1 | $ 1,770 | $ 1,820 | |
GAAP R&D Expense 2 | $ 550 | $ 580 | |
Non-GAAP R&D Expense 3 | $ 495 | $ 525 | |
GAAP and Non-GAAP IPR&D 4 | $ 144 | $ 144 | |
GAAP SG&A Expense | $ 850 | $ 870 | |
Non-GAAP SG&A Expense 3 | $ 730 | $ 750 |
1. INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA in tardive | |||
2. GAAP R&D guidance includes amounts for milestones that are probable of achievement or have been | |||
3. Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of | |||
4. IPR&D guidance reflects acquired in-process research and development once significant |
2023 Expected Pipeline Milestones and Key Activities | ||
Program | Indication | 2023 Milestones / Key Activities |
Valbenazine* (Selective VMAT2 Inhibitor) | Chorea in Huntington's Disease | PDUFA Date = August 20, 2023 |
Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Adult) | Top-Line Registrational Data in Early Q4 2023 |
Congenital Adrenal Hyperplasia (Pediatric) | Top-Line Registrational Data in Early Q4 2023 | |
NBI-921352** (Selective NaV1.6 Channel Blocker) | Focal Onset Seizure in Adults | Top-Line Phase 2 Data in Q4 2023 |
NBI-1065846† (GPR-139 Agonist) | Anhedonia in Major Depressive Disorder | Top-Line Phase 2 Data in Q4 2023 |
NBI-1117570‡ (Dual M1/ M4 Agonist) | Treatment of Schizophrenia | Clinical Trial Application Accepted; Initiating Phase 1 Study in Q3 |
New Chemical Entity or Entities | Indication(s) TBD | Initiate at Least One Phase 1 Study |
Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; NaV1.6 = Sodium | ||
Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in |
Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.
About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, Twitter and Facebook. (*in collaboration with AbbVie)
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 financial and operating performance, including our future revenues, expenses, or profits; our collaborative partnerships; expected future clinical and regulatory milestones; and the timing of the initiation and/or 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 and uncertainties associated with the commercialization of INGREZZA; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and 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 that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with
TABLE 1 | ||||||||
NEUROCRINE BIOSCIENCES, INC. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(unaudited) | ||||||||
Three Months Ended | Six Months Ended | |||||||
(in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | ||||
Revenues: | ||||||||
Net product sales | $ 446.3 | $ 352.0 | $ 861.6 | $ 657.0 | ||||
Collaboration revenue | 6.4 | 26.2 | 11.5 | 31.8 | ||||
Total revenues | 452.7 | 378.2 | 873.1 | 688.8 | ||||
Operating expenses: | ||||||||
Cost of revenues | 11.5 | 4.8 | 20.0 | 9.4 | ||||
Research and development | 145.8 | 135.9 | 285.3 | 238.1 | ||||
Acquired in-process research and development | — | — | 143.9 | — | ||||
Selling, general and administrative | 221.8 | 182.8 | 464.5 | 383.5 | ||||
Total operating expenses | 379.1 | 323.5 | 913.7 | 631.0 | ||||
Operating income (loss) | 73.6 | 54.7 | (40.6) | 57.8 | ||||
Other income (expense): | ||||||||
Interest expense | (1.3) | (2.2) | (2.4) | (4.8) | ||||
Unrealized gain (loss) on equity security investments | 37.3 | (7.4) | 39.5 | 12.5 | ||||
Loss on extinguishment of convertible senior notes | — | (70.0) | — | (70.0) | ||||
Investment income and other, net | 12.0 | 1.6 | 21.8 | 2.6 | ||||
Total other income (expense), net | 48.0 | (78.0) | 58.9 | (59.7) | ||||
Income (loss) before provision for (benefit from) income taxes | 121.6 | (23.3) | 18.3 | (1.9) | ||||
Provision for (benefit from) income taxes | 26.1 | (6.4) | (0.6) | 1.1 | ||||
Net income (loss) | $ 95.5 | $ (16.9) | $ 18.9 | $ (3.0) | ||||
Earnings (loss) per share, basic | $ 0.98 | $ (0.18) | $ 0.19 | $ (0.03) | ||||
Earnings (loss) per share, diluted | $ 0.95 | $ (0.18) | $ 0.19 | $ (0.03) | ||||
Weighted average common shares outstanding, basic | 97.6 | 95.6 | 97.4 | 95.4 | ||||
Weighted average common shares outstanding, diluted | 100.2 | 95.6 | 100.3 | 95.4 |
TABLE 2 | |||
NEUROCRINE BIOSCIENCES, INC. | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
(unaudited) | |||
(in millions) | June 30, 2023 | December 31, 2022 | |
Cash, cash equivalents and marketable securities | $ 976.7 | $ 989.3 | |
Other current assets | 519.9 | 464.2 | |
Total current assets | 1,496.6 | 1,453.5 | |
Deferred tax assets | 379.0 | 305.9 | |
Debt securities available-for-sale | 342.6 | 299.4 | |
Right-of-use assets | 83.5 | 87.0 | |
Equity security investments | 173.0 | 102.1 | |
Property and equipment, net | 65.6 | 58.6 | |
Intangible assets, net | 36.9 | 37.2 | |
Other assets | 35.9 | 25.0 | |
Total assets | $ 2,613.1 | $ 2,368.7 | |
Convertible senior notes | $ 169.7 | $ 169.4 | |
Other current liabilities | 412.8 | 368.3 | |
Total current liabilities | 582.5 | 537.7 | |
Operating lease liabilities | 89.1 | 93.5 | |
Other long-term liabilities | 88.5 | 29.7 | |
Stockholders' equity | 1,853.0 | 1,707.8 | |
Total liabilities and stockholders' equity | $ 2,613.1 | $ 2,368.7 |
TABLE 3 | |||||||
NEUROCRINE BIOSCIENCES, INC. | |||||||
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | |||||||
(unaudited) | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions, except per share data) | 2023 | 2022 | 2023 | 2022 | |||
GAAP net income (loss) | $ 95.5 | $ (16.9) | $ 18.9 | $ (3.0) | |||
Adjustments: | |||||||
Stock-based compensation expense - R&D | 23.8 | 16.2 | 37.6 | 28.7 | |||
Stock-based compensation expense - SG&A | 44.7 | 33.3 | 70.8 | 57.8 | |||
Loss on extinguishment of convertible senior notes 1 | — | 70.0 | — | 70.0 | |||
Non-cash interest related to convertible senior notes | 0.2 | 0.4 | 0.4 | 0.8 | |||
Non-cash amortization related to acquired intangible assets | 0.9 | — | 1.8 | — | |||
Changes in fair value of equity security investments 2 | (37.3) | 7.4 | (39.5) | (12.5) | |||
Income tax effect related to reconciling items 3 | (2.1) | (28.3) | (13.8) | (30.0) | |||
Non-GAAP net income | $ 125.7 | $ 82.1 | $ 76.2 | $ 111.8 | |||
Diluted earnings (loss) per share: | |||||||
GAAP | $ 0.95 | $ (0.18) | $ 0.19 | $ (0.03) | |||
Non-GAAP 4 | $ 1.25 | $ 0.84 | $ 0.76 | $ 1.14 |
1. The Company recognized a loss on extinguishment of | |||||||
2. Reflects periodic fluctuations in the fair values of the Company's equity security investments. | |||||||
3. Estimated income tax effect of non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into | |||||||
4. Non-GAAP diluted earnings per share for the three and six months ended June 30, 2022, reflect diluted shares of 98.2 |
TABLE 4 | |||||||
NEUROCRINE BIOSCIENCES, INC. | |||||||
RECONCILIATION OF GAAP TO NON-GAAP EXPENSES | |||||||
(unaudited) | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP cost of revenues | $ 11.5 | $ 4.8 | $ 20.0 | $ 9.4 | |||
Adjustments: | |||||||
Non-cash amortization related to acquired intangible assets | 0.9 | — | 1.8 | — | |||
Non-GAAP cost of revenues | $ 10.6 | $ 4.8 | $ 18.2 | $ 9.4 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP R&D | $ 145.8 | $ 135.9 | $ 285.3 | $ 238.1 | |||
Adjustments: | |||||||
Stock-based compensation expense | 23.8 | 16.2 | 37.6 | 28.7 | |||
Non-GAAP R&D | $ 122.0 | $ 119.7 | $ 247.7 | $ 209.4 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP SG&A | $ 221.8 | $ 182.8 | $ 464.5 | $ 383.5 | |||
Adjustments: | |||||||
Stock-based compensation expense | 44.7 | 33.3 | 70.8 | 57.8 | |||
Non-GAAP SG&A | $ 177.1 | $ 149.5 | $ 393.7 | $ 325.7 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2023 | 2022 | 2023 | 2022 | |||
GAAP other income, net | $ 48.0 | $ (78.0) | $ 58.9 | $ (59.7) | |||
Adjustments: | |||||||
Loss on extinguishment of convertible senior notes | — | 70.0 | — | 70.0 | |||
Non-cash interest related to convertible senior notes | 0.2 | 0.4 | 0.4 | 0.8 | |||
Changes in fair value of equity security investments | (37.3) | 7.4 | (39.5) | (12.5) | |||
Non-GAAP other income (expense), net | $ 10.9 | $ (0.2) | $ 19.8 | $ (1.4) | |||
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SOURCE Neurocrine Biosciences, Inc.
FAQ
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