Full Press Release Details
SAN DIEGO , Aug. 3, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced its financial results for the second quarter ended June 30, 2020 and provided revised full-year 2020 financial expense guidance.
"I want to thank healthcare providers and our employees for the perseverance they showed during the second quarter to ensure patients had uninterrupted access to INGREZZA under the challenging circumstances caused by the COVID-19 pandemic. As we move into the second half of 2020, we remain focused on improving the diagnosis and treatment rates for people with tardive dyskinesia, preparing to make ONGENTYS available to people living with Parkinson's disease, and advancing our programs in clinical development," said Kevin Gorman , Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With four U.S. FDA approved treatments that address four unique patient populations and a diverse and expanding pipeline, Neurocrine Biosciences is well positioned to be a leading neuroscience-focused biopharmaceutical company."
Financial Highlights
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| (unaudited, in millions, except per share data) | 2020 | 2019 | 2020 | 2019 | |||||||||||
| Revenues: | |||||||||||||||
| INGREZZA product sales, net | $ | 267.6 | $ | 180.5 | $ | 498.7 | $ | 316.9 | |||||||
| Collaboration revenue | 34.8 | 3.0 | 40.8 | 5.0 | |||||||||||
| Total revenues | $ | 302.4 | $ | 183.5 | $ | 539.5 | $ | 321.9 | |||||||
| GAAP Research and Development (R&D) | $ | 80.9 | $ | 61.7 | $ | 139.2 | $ | 99.4 | |||||||
| Non-GAAP R&D | $ | 51.0 | $ | 45.7 | $ | 101.6 | $ | 78.0 | |||||||
| GAAP Selling, General and Administrative (SG&A) | $ | 96.5 | $ | 80.8 | $ | 214.3 | $ | 168.3 | |||||||
| Non-GAAP SG&A | $ | 76.9 | $ | 68.9 | $ | 179.6 | $ | 146.0 | |||||||
| GAAP net income (loss) | $ | 79.6 | $ | 51.3 | $ | 117.0 | $ | (50.8) | |||||||
| GAAP net income (loss) per share – diluted | $ | 0.81 | $ | 0.54 | $ | 1.20 | $ | (0.56) | |||||||
| Non-GAAP net income | $ | 139.1 | $ | 67.2 | $ | 218.2 | $ | 94.9 | |||||||
| Non-GAAP net income per share – diluted | $ | 1.42 | $ | 0.71 | $ | 2.24 | $ | 1.00 | |||||||
| (unaudited, in millions) | June 30, 2020 | December 31, 2019 | |||||||||||||
| Total cash and cash equivalents and debt securities available-for-sale | $ | 1,143.5 | $ | 970.2 |
Second Quarter Net Product Sales Highlights:
Financial Highlights:
A reconciliation of GAAP to non-GAAP quarterly financial results can be found in Table 3 at the end of this earnings release.
Full-Year 2020 Revised Expense Guidance
| Range | |||||||
| (in millions) | Low | High | |||||
| Combined GAAP R&D and SG&A expenses | $ | 850 | $ | 900 | |||
| Combined Non-GAAP R&D and SG&A expenses | $ | 570 | $ | 610 |
Conference Call and Webcast Today at 4:30 PM Eastern Time Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time ( 1:30 p.m. Pacific Time ). Participants can access the live conference call by dialing 877-876-9173 (US) or 785-424-1667 (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 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego , Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*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 the United States (GAAP), this press release also contains certain non-GAAP financial measures. When preparing these supplemental non-GAAP financial results and guidance, the Company excludes certain GAAP items that management does not consider to be normal, including recurring cash operating expenses that might not meet the definition of unusual or non-recurring items. In particular, the non-GAAP measures exclude: milestones received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue, acquired in-process research and development, share-based compensation expense, non-cash interest expense related to convertible debt, changes in fair value of equity security investments and certain adjustments to income tax expense. These non-GAAP measures are provided as a complement to results provided in accordance with GAAP as management believes these non-GAAP financial measures help indicate underlying trends in the Company's business, are important in comparing current results with prior period results and provide additional information regarding the Company's financial position. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the Company's business and evaluate its performance. The Company provides guidance regarding combined research and development and sales, general, and administrative expenses on both a GAAP and a non-GAAP basis. The guidance regarding GAAP research and development expenses and sales, general and administrative expenses does not include estimates for expenses associated with any potential future business development activities. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.
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 SEC in a Current Report on Form-8-K dated as of event date herewith. In addition, Neurocrine provides guidance regarding combined research and development and sales, general and administrative expenses on both a GAAP and non-GAAP basis.
| TABLE 1 | |||||||||||||||
| NEUROCRINE BIOSCIENCES, INC. | |||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| (in millions, except per share data) | 2020 | 2019 | 2020 | 2019 | |||||||||||
| Revenues: | |||||||||||||||
| Product sales, net | $ | 267.6 | $ | 180.5 | $ | 498.7 | $ | 316.9 | |||||||
| Collaboration revenue | 34.8 | 3.0 | 40.8 | 5.0 | |||||||||||
| Total revenues | 302.4 | 183.5 | 539.5 | 321.9 | |||||||||||
| Operating expenses: | |||||||||||||||
| Cost of sales | 2.4 | 1.6 | 4.5 | 2.7 | |||||||||||
| Research and development | 80.9 | 61.7 | 139.2 | 99.4 | |||||||||||
| Acquired in-process research and development | 46.0 | 5.0 | 46.0 | 118.1 | |||||||||||
| Selling, general and administrative | 96.5 | 80.8 | 214.3 | 168.3 | |||||||||||
| Total operating expenses | 225.8 | 149.1 | 404.0 | 388.5 | |||||||||||
| Operating income (loss) | 76.6 | 34.4 | 135.5 | (66.6) | |||||||||||
| Other income (expense): | |||||||||||||||
| Interest expense | (8.3) | (7.9) | (16.5) | (15.8) | |||||||||||
| Unrealized gain (loss) on equity securities | 11.3 | 21.0 | (5.2) | 22.7 | |||||||||||
| Investment income and other, net | 3.6 | 4.6 | 8.3 | 9.2 | |||||||||||
| Total other income (expense), net | 6.6 | 17.7 | (13.4) | 16.1 | |||||||||||
| Income (loss) before provision for income taxes | 83.2 | 52.1 | 122.1 | (50.5) | |||||||||||
| Provision for income taxes | 3.6 | 0.8 | 5.1 | 0.3 | |||||||||||
| Net income (loss) | $ | 79.6 | $ | 51.3 | $ | 117.0 | $ | (50.8) | |||||||
| Net income (loss) per share, basic | $ | 0.86 | $ | 0.56 | $ | 1.26 | $ | (0.56) | |||||||
| Net income (loss) per share, diluted | $ | 0.81 | $ | 0.54 | $ | 1.20 | $ | (0.56) | |||||||
| Weighted average common shares outstanding, basic | 93.0 | 91.4 | 92.8 | 91.2 | |||||||||||
| Weighted average common shares outstanding, diluted | 98.2 | 94.8 | 97.6 | 91.2 |
| TABLE 2 | |||||||
| NEUROCRINE BIOSCIENCES, INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (unaudited) | |||||||
| (in millions) | June 30, 2020 | December 31, 2019 | |||||
| Cash and cash equivalents and debt securities available-for-sale | $ | 948.3 | $ | 670.5 | |||
| Other current assets | 197.9 | 160.5 | |||||
| Total current assets | 1,146.2 | 831.0 | |||||
| Debt securities available-for-sale | 195.2 | 299.7 | |||||
| Right-of-use assets | 72.1 | 74.3 | |||||
| Equity securities | 50.7 | 55.9 | |||||
| Property and equipment, net | 44.6 | 41.9 | |||||
| Restricted cash and other long-term assets | 6.8 | 3.2 | |||||
| Total assets | $ | 1,515.6 | $ | 1,306.0 | |||
| Convertible senior notes | $ | 419.5 | $ | 408.8 | |||
| Other current liabilities | 153.5 | 156.5 | |||||
| Total current liabilities | 573.0 | 565.3 | |||||
| Operating lease liabilities | 84.3 | 86.7 | |||||
| Other long-term liabilities | 27.1 | 17.1 | |||||
| Stockholders' equity | 831.2 | 636.9 | |||||
| Total liabilities and stockholders' equity | $ | 1,515.6 | $ | 1,306.0 |
| TABLE 3 | |||||||||||||||
| NEUROCRINE BIOSCIENCES, INC. | |||||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| (in millions, except per share data) | 2020 | 2019 | 2020 | 2019 | |||||||||||
| GAAP net income (loss) | $ | 79.6 | $ | 51.3 | $ | 117.0 | $ | (50.8) | |||||||
| Adjustments: | |||||||||||||||
| Milestones received from licenses and collaborations A | (30.0) | — | (30.0) | — | |||||||||||
| Non-cash collaboration revenue B | — | — | (1.3) | — | |||||||||||
| Acquired in-process research and development (IPR&D) C | 46.0 | 5.0 | 46.0 | 118.1 | |||||||||||
| Milestones paid related to licenses and collaborations - R&D | 20.0 | 10.0 | 20.0 | 10.0 | |||||||||||
| Share-based compensation expense - R&D | 9.9 | 6.0 | 17.6 | 11.4 | |||||||||||
| Share-based compensation expense - SG&A | 19.6 | 11.9 | 34.7 | 22.3 | |||||||||||
| Non-cash interest related to convertible debt | 5.4 | 5.1 | 10.7 | 10.0 | |||||||||||
| Changes in fair value of equity security investments D | (11.3) | (21.0) | 5.2 | (22.7) | |||||||||||
| Income tax effect related to reconciling items E | (0.1) | (1.1) | (1.7) | (3.4) | |||||||||||
| Non-GAAP net income | $ | 139.1 | $ | 67.2 | $ | 218.2 | $ | 94.9 | |||||||
| Net income (loss) per diluted common share: | |||||||||||||||
| GAAP | $ | 0.81 | $ | 0.54 | $ | 1.20 | $ | (0.56) | |||||||
| Non-GAAP F | $ | 1.42 | $ | 0.71 | $ | 2.24 | $ | 1.00 |
| A During the three months ended June 30, 2020, the Company recognized a $30.0 million event-based milestone as revenue upon FDA approval for ORIAHNN for uterine fibroids. |
| B During the six months ended June 30, 2020, the Company recognized non-cash collaboration revenue from Mitsubishi Tanabe Pharma Corporation under the collaboration and license agreement entered into in 2015. |
| C The Company incurred IPR&D expenses of $46.0 million during the three and six months ended June 30, 2020, respectively, in association with the Company's exercise of its option to license NBI-827104 in May 2020, and $5.0 million and $118.1 million during the three and six months ended June 30, 2019, respectively, in association with the collaboration and license agreement entered into with Voyager Therapeutics in 2019. |
| D The Company recognized unrealized gains of $11.3 million and $21.0 million for the three months ended June 30, 2020 and 2019, respectively, to adjust its equity security investments to fair value. For the six months ended June 30, 2020 and 2019, the Company recognized an unrealized loss of $5.2 million and an unrealized gain of $22.7 million, respectively, to adjust its equity security investments to fair value. |
| 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 six months ended June 30, 2019 reflects diluted shares of 94.8 million, which were calculated in accordance with the guidance on earnings per share in ASC 260. |
SOURCE Neurocrine Biosciences, Inc.