Total Revenues Increased 19% on a Year-Over-Year Basis to $46.3 Million
Strong Year-to-Date Operating Cash Flow of $33.5 Million
DUBLIN, Ireland, Aug. 08, 2017 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced its financial results for the second quarter of 2017.
Highlights Include:
- Total revenues for the second quarter 2017 were $46.3 million, compared to $38.9 million in the second quarter 2016.
- GAAP net income for the second quarter of 2017 was $28.9 million, or $0.68 per diluted share, compared to GAAP net loss of $20.0 million, or $0.48 per diluted share, in the second quarter of 2016.
- Adjusted net income for the second quarter of 2017 was $8.2 million, or $0.19 per diluted share, compared to an adjusted net loss of $1.0 million, or $0.02 per diluted share, in the second quarter of 2016.(1)
- Cash and marketable securities at June 30, 2017 were $173.8 million, up from $154.2 million at December 31, 2016.
- Cash used for share repurchases totaled $13.1 million for the six months ended June 30, 2017.
Mike Anderson, Avadel's Chief Executive Officer, said, "We continued to generate strong revenues of $46.3 million during the second quarter, led by our hospital products, and again exceeded street expectations on both the top and bottom lines. Overall, we had a solid financial performance for the second quarter and reiterate our expectations of being both cash flow positive and profitable in 2017. During the quarter we also continued to make progress in a number of areas, most importantly, the continued initiation of clinical sites and enrollment of patients in our REST-ON Phase III trial of FT218, Micropump® sodium oxybate.”
Second Quarter 2017 Results
Revenues during the second quarter of 2017 were $46.3 million, compared to $38.9 million during the same period last year. The increase in revenues was due to Akovaz®, which was not yet in the market during the second quarter of 2016. This increase was partially offset by a decline in Bloxiverz® revenues, primarily as a result of additional competition to neostigmine in the form of an alternative molecule, sugammadex, and the approval of a third generic neostigmine product. On a GAAP basis, net income was $28.9 million during the second quarter of 2017, or $0.68 per diluted share, compared to a net loss of $20.0 million, or $0.48 per diluted share, for the same period last year. This increase in net income on a year-over-year basis was attributed to $13.2 million of gains related to changes in the fair value of related party contingent consideration for the second of quarter 2017, compared to $23.9 million of expense in the same period last year. Changes in the fair value of related party contingent consideration are non-cash items, and do not reflect the cash amount paid to related parties. Cash payments can be found in the Consolidated Statement of Cash Flows. Also, included in GAAP net income in the second quarter of 2017 are $1.1 million in restructuring costs related to the reduction of the Company's workforce in France, which consist of employee severance, benefits and other costs.
Research and Development expenses totaled $6.8 million for the second quarter of 2017, compared to $7.6 million for the same period last year. The decrease on a year-over-year basis is primarily attributed to lower incurred contract research organization (CRO) expenses as a result of aligning spend with the progress of the REST-ON clinical trial. The Company expects R&D expenses to increase significantly for the balance of 2017 as recruitment and enrollment at the existing and additional clinical sites in the United States increase.
Selling, General and Administrative expenses were $12.4 million in the second quarter of 2017, compared to $11.3 million in the same period last year. This increase was largely due to higher costs associated with certain business development activities, audit fees and pre-launch market research studies for FT218.
Adjusted net income for the second quarter of 2017 was $8.2 million, or $0.19 per diluted share, compared to an adjusted net loss of $1.0 million, or $0.02 per diluted share, in the same period last year.(1) The increase in adjusted net income is largely attributable to an increase in revenues from Akovaz® and a lower adjusted effective tax rate of 43% compared to 111% in the prior year period. Please see the Supplemental Information section within this document for a reconciliation of adjusted net income and adjusted diluted EPS to the respective GAAP amounts.
2017 Guidance
As a result of continued pricing pressure in the ephedrine market and increased competition in the neostigmine market, the Company is revising its revenue guidance to between $165 and $175 million, compared to previous guidance of between $170 and $185 million. As a result of lower than expected spending during the first two quarters of 2017, R&D is now expected to be in the range of $30 to $40 million compared to previous guidance of $40 to $50 million. Diluted adjusted EPS is unchanged from previous guidance of $0.30 to $0.45.
Conference Call
A conference call to discuss these results has been scheduled for Tuesday, August 8, 2017 at 10:00 a.m. EDT. A question and answer period will follow management's prepared remarks. To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 56707554. A live audio webcast and accompanying slides can be accessed by visiting the “News & Events” page of the Company’s Investors website at www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event.
About REST-ON Phase III Clinical Trial
REST-ON is a double-blind, randomized, placebo controlled study of 264 patients to assess the efficacy and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. For more information, please visit www.rethinknarcolepsy.com.
About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a specialty pharmaceutical company that seeks to develop differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, by utilizing its proprietary drug delivery technology and in-licensing / acquiring new products; ultimately, helping patients adhere to their prescribed medical treatment and see better results. Avadel currently markets products in the hospital and primary care spaces. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri, United States and Lyon, France. For more information, please visit www.avadel.com.
Safe Harbor: This release may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements herein that are not clearly historical in nature are forward-looking, and the words “anticipate, “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and the negative of these and similar expressions generally identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond Avadel's control and could cause actual results to differ materially from the results contemplated in such forward-looking statements. These risks, uncertainties and contingencies include the risks relating to: our dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz®,Vazculep® and Akovaz® products, which are not patent protected, could face substantial competition resulting in a loss of market share or forcing us to reduce the prices we charge for those products; the possibility that we could fail to successfully complete the research and development for pipeline products we are evaluating for potential application to the FDA pursuant to our “unapproved-to-approved” strategy, or that competitors could complete the development of such product and apply for FDA approval of such product before us; our dependence on the performance of third parties in partnerships or strategic alliances for the commercialization of some of our products; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products; our dependence on key personnel to execute our business plan; the amount of additional costs we will incur to comply with U.S. securities laws as a result of our ceasing to qualify as a foreign private issuer; and the other risks, uncertainties and contingencies described in the Company's filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2016, all of which filings are also available on the Company's website. Avadel undertakes no obligation to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law.
Non-GAAP Disclosures and Adjustments
Avadel discloses certain non-GAAP financial measures, including adjusted net income and loss and adjusted net income and loss per diluted share, as management believes that a comparison of its current and historical results would be difficult if the disclosures were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in the U.S. In addition to reporting its financial results in accordance with GAAP, Avadel reports certain non-GAAP results that exclude, if any, fair value remeasurements of its contingent consideration, impairment of intangible assets, amortization of intangible assets, restructuring costs, foreign exchange gains and losses on assets and liabilities denominated in foreign currencies, but includes the operating cash flows plus any unpaid accrued amounts associated with the contingent consideration, in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance. The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its operating performance. Investors and other readers should review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. The table provided within the following “Supplemental Information” section reconciles GAAP net income and loss and diluted earnings or loss per share to the corresponding adjusted amounts.
______________________________
(1) Non-GAAP financial measure: Descriptions of Avadel’s non-GAAP financial measures are included under the caption Non-GAAP Disclosures and Adjustments included within this press release and reconciliations of such non-GAAP financial measures to their most closely applicable GAAP financial measures are found in the Supplemental Information section herein.
| AVADEL PHARMACEUTICALS PLC | ||||||||||||||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales and services | $ | 47,105 | $ | 38,165 | $ | 98,862 | $ | 73,518 | ||||||||
| License and research revenue | (794 | ) | 693 | (44 | ) | 1,556 | ||||||||||
| Total | 46,311 | 38,858 | 98,818 | 75,074 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of products and services sold | 4,561 | 3,907 | 8,463 | 7,813 | ||||||||||||
| Research and development expenses | 6,792 | 7,604 | 13,998 | 12,992 | ||||||||||||
| Selling, general and administrative expenses | 12,429 | 11,290 | 24,241 | 20,751 | ||||||||||||
| Intangible asset amortization | 564 | 3,702 | 1,128 | 7,216 | ||||||||||||
| Changes in fair value of related party contingent consideration | (13,230 | ) | 23,898 | (20,201 | ) | 32,141 | ||||||||||
| Restructuring costs | 1,069 | — | 3,722 | — | ||||||||||||
| Total operating expenses | 12,185 | 50,401 | 31,351 | 80,913 | ||||||||||||
| Operating income (loss) | 34,126 | (11,543 | ) | 67,467 | (5,839 | ) | ||||||||||
| Investment income, net | 527 | 390 | 1,579 | 590 | ||||||||||||
| Interest expense, net | (263 | ) | (263 | ) | (526 | ) | (438 | ) | ||||||||
| Other income (expense) - changes in fair value of related party payable | 1,670 | (2,773 | ) | 2,220 | (4,307 | ) | ||||||||||
| Foreign exchange gain (loss) | 237 | 1,680 | 6 | (1,261 | ) | |||||||||||
| Income (loss) before income taxes | 36,297 | (12,509 | ) | 70,746 | (11,255 | ) | ||||||||||
| Income tax provision | 7,370 | 7,449 | 15,909 | 14,761 | ||||||||||||
| Net income (loss) | $ | 28,927 | $ | (19,958 | ) | $ | 54,837 | $ | (26,016 | ) | ||||||
| Net income (loss) per share - basic | $ | 0.70 | $ | (0.48 | ) | $ | 1.33 | $ | (0.63 | ) | ||||||
| Net income (loss) per share - diluted | 0.68 | (0.48 | ) | 1.29 | (0.63 | ) | ||||||||||
| Weighted average number of shares outstanding - basic | 41,091 | 41,241 | 41,233 | 41,241 | ||||||||||||
| Weighted average number of shares outstanding - diluted | 42,487 | 41,241 | 42,625 | 41,241 | ||||||||||||
| AVADEL PHARMACEUTICALS PLC | ||||||||
| UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands, except per share data) | ||||||||
| June 30, 2017 | December 31, 2016 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,507 | $ | 39,215 | ||||
| Marketable securities | 130,290 | 114,980 | ||||||
| Accounts receivable | 19,285 | 17,839 | ||||||
| Inventories | 5,747 | 3,258 | ||||||
| Prepaid expenses and other current assets | 5,522 | 5,894 | ||||||
| Total current assets | 204,351 | 181,186 | ||||||
| Property and equipment, net | 3,328 | 3,320 | ||||||
| Goodwill | 18,491 | 18,491 | ||||||
| Intangible assets, net | 21,709 | 22,837 | ||||||
| Research and development tax credit receivable | 3,039 | 1,775 | ||||||
| Income tax deferred charge | — | 10,342 | ||||||
| Other | 8,242 | 7,531 | ||||||
| Total assets | $ | 259,160 | $ | 245,482 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Current portion of long-term debt | $ | 291 | $ | 268 | ||||
| Current portion of long-term related party payable | 40,615 | 34,177 | ||||||
| Accounts payable | 12,321 | 7,105 | ||||||
| Deferred revenue | 2,455 | 2,223 | ||||||
| Accrued expenses | 30,339 | 17,222 | ||||||
| Income taxes | 1,455 | 1,200 | ||||||
| Other | 1,233 | 226 | ||||||
| Total current liabilities | 88,709 | 62,421 | ||||||
| Long-term debt, less current portion | 594 | 547 | ||||||
| Long-term related party payable, less current portion | 86,844 | 135,170 | ||||||
| Other | 6,285 | 5,275 | ||||||
| Total liabilities | 182,432 | 203,413 | ||||||
| Shareholders' equity: | ||||||||
| Preferred shares, $0.01 nominal value; 50,000 shares authorized; none issued or outstanding at June 30, 2017 and December 31, 2016, respectively | — | — | ||||||
| Ordinary shares, nominal value of $0.01; 500,000 shares authorized; 41,435 and 41,371 issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 414 | 414 | ||||||
| Treasury shares, at cost, 1,351 and 0 shares held at June 30, 2017 and December 31, 2016, respectively | (14,338 | ) | — | |||||
| Additional paid-in capital | 389,451 | 385,020 | ||||||
| Accumulated deficit | (276,119 | ) | (319,800 | ) | ||||
| Accumulated other comprehensive loss | (22,680 | ) | (23,565 | ) | ||||
| Total shareholders' equity | 76,728 | 42,069 | ||||||
| Total liabilities and shareholders' equity | $ | 259,160 | $ | 245,482 | ||||
| AVADEL PHARMACEUTICALS PLC | ||||||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| (In thousands) | ||||||||
| Six Months Ended June 30, | ||||||||
| 2017 | 2016 | |||||||
| Cash flows from operating activities: | ||||||||
| Net income (loss) | 54,837 | (26,016 | ) | |||||
| Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||||||||
| Depreciation and amortization | 1,611 | 7,681 | ||||||
| Loss on disposal of property and equipment | — | 110 | ||||||
| Loss (gain) on sale of marketable securities | (81 | ) | 455 | |||||
| Foreign exchange loss | 1,304 | 1,261 | ||||||
| Grants recognized in research and development expenses | — | (70 | ) | |||||
| Remeasurement of related party acquisition-related contingent consideration | (20,201 | ) | 32,141 | |||||
| Remeasurement of related party financing-related contingent consideration | (2,220 | ) | 4,307 | |||||
| Change in deferred tax and income tax deferred charge | 322 | (5,028 | ) | |||||
| Stock-based compensation expense | 4,055 | 4,913 | ||||||
| Increase (decrease) in cash from: | ||||||||
| Accounts receivable | (1,446 | ) | (1,689 | ) | ||||
| Inventories | (2,489 | ) | 2,345 | |||||
| Prepaid expenses and other current assets | (264 | ) | 546 | |||||
| Research and development tax credit receivable | (1,175 | ) | (1,630 | ) | ||||
| Accounts payable & other current liabilities | 4,931 | (348 | ) | |||||
| Deferred revenue | 232 | (1,461 | ) | |||||
| Accrued expenses | 12,747 | 777 | ||||||
| Accrued income taxes | 255 | 6,285 | ||||||
| Earn-out payments for related party contingent consideration in excess of acquisition-date fair value | (16,515 | ) | (7,769 | ) | ||||
| Royalty payments for related party payable in excess of original fair value | (2,287 | ) | (1,159 | ) | ||||
| Other long-term assets and liabilities | (80 | ) | 270 | |||||
| Net cash provided by operating activities | 33,536 | 15,921 | ||||||
| Cash flows from investing activities: | ||||||||
| Purchases of property and equipment | (321 | ) | (760 | ) | ||||
| Acquisitions of businesses | — | 161 | ||||||
| Proceeds from sales of marketable securities | 51,820 | 26,013 | ||||||
| Purchases of marketable securities | (67,743 | ) | (75,528 | ) | ||||
| Net cash used in investing activities | (16,244 | ) | (50,114 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Earn-out payments for related party contingent consideration | (665 | ) | (6,572 | ) | ||||
| Royalty payments for related party payable | — | (816 | ) | |||||
| Reimbursement of loans | 12 | — | ||||||
| Cash proceeds from issuance of ordinary shares and warrants | 376 | — | ||||||
| Share repurchases | (13,081 | ) | — | |||||
| Net cash used in financing activities | (13,358 | ) | (7,388 | ) | ||||
| Effect of foreign currency exchange rate changes on cash and cash equivalents | 358 | 416 | ||||||
| Net increase (decrease) in cash and cash equivalents | 4,292 | (41,165 | ) | |||||
| Cash and cash equivalents at January 1, | 39,215 | 65,064 | ||||||
| Cash and cash equivalents at June 30, | $ | 43,507 | $ | 23,899 | ||||
| AVADEL PHARMACEUTICALS PLC | ||||||||||||||||
| UNAUDITED SUPPLEMENTAL INFORMATION | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| Revenues by Product: | 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Bloxiverz | $ | 13,719 | $ | 25,620 | $ | 27,621 | $ | 50,367 | ||||||||
| Vazculep | 10,154 | 10,421 | 20,334 | 19,827 | ||||||||||||
| Akovaz | 20,912 | — | 46,549 | — | ||||||||||||
| Other | 2,320 | 2,124 | 4,358 | 3,324 | ||||||||||||
| Total product sales and services | 47,105 | 38,165 | 98,862 | 73,518 | ||||||||||||
| License and research revenue | (794 | ) | 693 | (44 | ) | 1,556 | ||||||||||
| Total revenues | $ | 46,311 | $ | 38,858 | $ | 98,818 | $ | 75,074 | ||||||||
| GAAP to Non-GAAP adjustments for the three-months ended June 30, 2017 | ||||||||||||||||||||||||||||||||||||
| Exclude | Include | |||||||||||||||||||||||||||||||||||
| GAAP | Intangible asset amortization | Foreign exchange (gain)/loss | Restructuring impacts | License revenue adj. | Contingent related party payable fair value adjustment | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | ||||||||||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||||||||||||||
| Product sales and services | $ | 47,105 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 47,105 | ||||||||||||||||||
| License and research revenue | (794 | ) | — | — | — | 1,100 | — | — | 1,100 | 306 | ||||||||||||||||||||||||||
| Total | 46,311 | — | — | — | 1,100 | — | — | 1,100 | 47,411 | |||||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||||||||||
| Cost of products and services sold | 4,561 | — | — | — | — | — | — | — | 4,561 | |||||||||||||||||||||||||||
| Research and development | 6,792 | — | — | — | — | — | — | — | 6,792 | |||||||||||||||||||||||||||
| Selling, general and administrative | 12,429 | — | — | — | — | — | — | — | 12,429 | |||||||||||||||||||||||||||
| Intangible asset amortization | 564 | (564 | ) | — | — | — | — | — | (564 | ) | — | |||||||||||||||||||||||||
| Changes in fair value of related party contingent consideration | (13,230 | ) | — | — | — | — | 13,230 | 8,516 | 21,746 | 8,516 | ||||||||||||||||||||||||||
| Restructuring costs | 1,069 | — | — | (1,069 | ) | — | — | — | (1,069 | ) | — | |||||||||||||||||||||||||
| Total | 12,185 | (564 | ) | — | (1,069 | ) | — | 13,230 | 8,516 | 20,113 | 32,298 | |||||||||||||||||||||||||
| Operating income (loss) | 34,126 | 564 | — | 1,069 | 1,100 | (13,230 | ) | (8,516 | ) | (19,013 | ) | 15,113 | ||||||||||||||||||||||||
| Investment and other income | 527 | — | — | — | — | — | — | — | 527 | |||||||||||||||||||||||||||
| Interest expense | (263 | ) | — | — | — | — | — | — | — | (263 | ) | |||||||||||||||||||||||||
| Other expense - changes in fair value of related party payable | 1,670 | — | — | — | — | (1,670 | ) | (1,166 | ) | (2,836 | ) | (1,166 | ) | |||||||||||||||||||||||
| Foreign exchange gain | 237 | — | (237 | ) | — | — | — | — | (237 | ) | — | |||||||||||||||||||||||||
| Income (loss) before income taxes | 36,297 | 564 | (237 | ) | 1,069 | 1,100 | (14,900 | ) | (9,682 | ) | (22,086 | ) | 14,211 | |||||||||||||||||||||||
| Income tax provision (benefit) | 7,370 | 201 | — | — | — | (909 | ) | (616 | ) | (1,324 | ) | 6,046 | ||||||||||||||||||||||||
| Net income (loss) | $ | 28,927 | $ | 363 | $ | (237 | ) | $ | 1,069 | $ | 1,100 | $ | (13,991 | ) | $ | (9,066 | ) | $ | (20,762 | ) | $ | 8,165 | ||||||||||||||
| Net income (loss) per share - diluted(1) | 0.68 | $ | 0.01 | $ | (0.01 | ) | $ | 0.03 | $ | 0.03 | $ | (0.33 | ) | $ | (0.21 | ) | $ | (0.49 | ) | $ | 0.19 | |||||||||||||||
| Weighted average number of shares outstanding - diluted | 42,487 | 42,487 | 42,487 | 42,487 | 42,487 | 42,487 | 42,487 | 42,487 | 42,487 | |||||||||||||||||||||||||||
(1) Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.
| GAAP to Non-GAAP adjustments for the three-months ended June 30, 2016 | ||||||||||||||||||||||||||||||||
| Exclude | Include | |||||||||||||||||||||||||||||||
| GAAP | Intangible asset amortization | Foreign exchange (gain)/loss | Purchase accounting adjustments - FSC | Contingent related party payable fair value adjustment | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | |||||||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||||||||||
| Product sales and services | $ | 38,165 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 38,165 | ||||||||||||||||
| License and research revenue | 693 | — | — | — | — | — | — | 693 | ||||||||||||||||||||||||
| Total | 38,858 | — | — | — | — | — | — | 38,858 | ||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||||||
| Cost of products and services sold | 3,907 | — | — | (762 | ) | — | — | (762 | ) | 3,145 | ||||||||||||||||||||||
| Research and development | 7,604 | — | — | — | — | — | — | 7,604 | ||||||||||||||||||||||||
| Selling, general and administrative | 11,290 | — | — | — | — | — | — | 11,290 | ||||||||||||||||||||||||
| Intangible asset amortization | 3,702 | (3,702 | ) | — | — | — | — | (3,702 | ) | — | ||||||||||||||||||||||
| Changes in fair value of related party contingent consideration | 23,898 | — | — | — | (23,898 | ) | 6,992 | (16,906 | ) | 6,992 | ||||||||||||||||||||||
| Total | 50,401 | (3,702 | ) | — | (762 | ) | (23,898 | ) | 6,992 | (21,370 | ) | 29,031 | ||||||||||||||||||||
| Operating income (loss) | (11,543 | ) | 3,702 | — | 762 | 23,898 | (6,992 | ) | 21,370 | 9,827 | ||||||||||||||||||||||
| Investment and other income | 390 | — | — | — | — | — | — | 390 | ||||||||||||||||||||||||
| Interest expense | (263 | ) | — | — | — | — | — | — | (263 | ) | ||||||||||||||||||||||
| Other expense - changes in fair value of related party payable | (2,773 | ) | — | — | — | 2,773 | (941 | ) | 1,832 | (941 | ) | |||||||||||||||||||||
| Foreign exchange gain | 1,680 | — | (1,680 | ) | — | — | — | (1,680 | ) | — | ||||||||||||||||||||||
| Income (loss) before income taxes | (12,509 | ) | 3,702 | (1,680 | ) | 762 | 26,671 | (7,933 | ) | 21,522 | 9,013 | |||||||||||||||||||||
| Income tax provision (benefit) | 7,449 | 1,329 | — | 274 | 1,413 | (461 | ) | 2,555 | 10,004 | |||||||||||||||||||||||
| Net income (loss) | $ | (19,958 | ) | $ | 2,373 | $ | (1,680 | ) | $ | 488 | $ | 25,258 | $ | (7,472 | ) | $ | 18,967 | $ | (991 | ) | ||||||||||||
| Net income (loss) per share - diluted(1) | (0.48 | ) | $ | 0.06 | $ | (0.04 | ) | $ | 0.01 | $ | 0.61 | $ | (0.18 | ) | $ | 0.46 | $ | (0.02 | ) | |||||||||||||
| Weighted average number of shares outstanding - diluted | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | ||||||||||||||||||||||||
(1) Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.
| GAAP to Non-GAAP adjustments for the six-months ended June 30, 2017 | ||||||||||||||||||||||||||||||||||||||||
| Exclude | Include | |||||||||||||||||||||||||||||||||||||||
| GAAP | Intangible asset amortization | Foreign exchange (gain)/loss | Restructuring impacts | Purchase accounting adjustments - FSC | License revenue adj. | Contingent related party payable fair value adjustment | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | |||||||||||||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||||||||||||||||||
| Product sales and services | $ | 98,862 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 98,862 | ||||||||||||||||||||
| License and research revenue | (44 | ) | — | — | — | — | 1,100 | — | — | 1,100 | 1,056 | |||||||||||||||||||||||||||||
| Total | 98,818 | — | — | — | — | 1,100 | — | — | 1,100 | 99,918 | ||||||||||||||||||||||||||||||
| Operating expenses: | — | |||||||||||||||||||||||||||||||||||||||
| Cost of products and services sold | 8,463 | — | — | — | (46 | ) | — | — | — | (46 | ) | 8,417 | ||||||||||||||||||||||||||||
| Research and development | 13,998 | — | — | — | — | — | — | — | — | 13,998 | ||||||||||||||||||||||||||||||
| Selling, general and administrative | 24,241 | — | — | — | — | — | — | — | — | 24,241 | ||||||||||||||||||||||||||||||
| Intangible asset amortization | 1,128 | (1,128 | ) | — | — | — | — | — | — | (1,128 | ) | — | ||||||||||||||||||||||||||||
| Changes in fair value of related party contingent consideration | (20,201 | ) | — | — | — | — | — | 20,201 | 18,132 | 38,333 | 18,132 | |||||||||||||||||||||||||||||
| Restructuring charges | 3,722 | — | — | (3,722 | ) | — | — | — | — | (3,722 | ) | — | ||||||||||||||||||||||||||||
| Total | 31,351 | (1,128 | ) | — | (3,722 | ) | (46 | ) | — | 20,201 | 18,132 | 33,437 | 64,788 | |||||||||||||||||||||||||||
| Operating income (loss) | 67,467 | 1,128 | — | 3,722 | 46 | 1,100 | (20,201 | ) | (18,132 | ) | (32,337 | ) | 35,130 | |||||||||||||||||||||||||||
| Investment and other income | 1,579 | — | — | — | — | — | — | — | — | 1,579 | ||||||||||||||||||||||||||||||
| Interest expense | (526 | ) | — | — | — | — | — | — | — | — | (526 | ) | ||||||||||||||||||||||||||||
| Other expense - changes in fair value of related party payable | 2,220 | — | — | — | — | — | (2,220 | ) | (2,465 | ) | (4,685 | ) | (2,465 | ) | ||||||||||||||||||||||||||
| Foreign exchange gain | 6 | — | (6 | ) | — | — | — | — | — | (6 | ) | — | ||||||||||||||||||||||||||||
| Income (loss) before income taxes | 70,746 | 1,128 | (6 | ) | 3,722 | 46 | 1,100 | (22,421 | ) | (20,597 | ) | (37,028 | ) | 33,718 | ||||||||||||||||||||||||||
| Income tax provision (benefit) | 15,909 | 402 | — | — | 17 | — | (1,269 | ) | (1,307 | ) | (2,157 | ) | 13,752 | |||||||||||||||||||||||||||
| Net income (loss) | $ | 54,837 | $ | 726 | $ | (6 | ) | $ | 3,722 | $ | 29 | $ | 1,100 | $ | (21,152 | ) | $ | (19,290 | ) | $ | (34,871 | ) | $ | 19,966 | ||||||||||||||||
| Net income (loss) per share - diluted(1) | 1.29 | $ | 0.02 | $ | — | $ | 0.09 | $ | — | $ | 0.03 | $ | (0.50 | ) | $ | (0.45 | ) | $ | (0.82 | ) | $ | 0.47 | ||||||||||||||||||
| Weighted average number of shares outstanding - diluted | 42,625 | 42,625 | 42,625 | 42,625 | 42,625 | 42,625 | 42,625 | 42,625 | 42,625 | 42,625 | ||||||||||||||||||||||||||||||
(1) Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.
| GAAP to Non-GAAP adjustments for the six-months ended June 30, 2016 | ||||||||||||||||||||||||||||||||
| Exclude | Include | |||||||||||||||||||||||||||||||
| GAAP | Intangible asset amortization | Foreign exchange (gain)/loss | Purchase accounting adjustments - FSC | Contingent related party payable fair value adjustment | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | |||||||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||||||||||
| Product sales and services | $ | 73,518 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 73,518 | ||||||||||||||||
| License and research revenue | 1,556 | — | — | — | — | — | — | 1,556 | ||||||||||||||||||||||||
| Total | 75,074 | — | — | — | — | — | — | 75,074 | ||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||||||
| Cost of products and services sold | 7,813 | — | — | (1,525 | ) | — | — | (1,525 | ) | 6,288 | ||||||||||||||||||||||
| Research and development | 12,992 | — | — | — | — | — | — | 12,992 | ||||||||||||||||||||||||
| Selling, general and administrative | 20,751 | — | — | — | — | — | — | 20,751 | ||||||||||||||||||||||||
| Intangible asset amortization | 7,216 | (7,216 | ) | — | — | — | — | (7,216 | ) | — | ||||||||||||||||||||||
| Changes in fair value of related party contingent consideration | 32,141 | — | — | — | (32,141 | ) | 13,437 | (18,704 | ) | 13,437 | ||||||||||||||||||||||
| Total | 80,913 | (7,216 | ) | — | (1,525 | ) | (32,141 | ) | 13,437 | (27,445 | ) | 53,468 | ||||||||||||||||||||
| Operating income (loss) | (5,839 | ) | 7,216 | — | 1,525 | 32,141 | (13,437 | ) | 27,445 | 21,606 | ||||||||||||||||||||||
| Investment and other income | 590 | — | — | — | — | — | — | 590 | ||||||||||||||||||||||||
| Interest expense | (438 | ) | — | — | — | — | — | — | (438 | ) | ||||||||||||||||||||||
| Other expense - changes in fair value of related party payable | (4,307 | ) | — | — | — | 4,307 | (1,833 | ) | 2,474 | (1,833 | ) | |||||||||||||||||||||
| Foreign exchange gain | (1,261 | ) | — | 1,261 | — | — | — | 1,261 | — | |||||||||||||||||||||||
| Income (loss) before income taxes | (11,255 | ) | 7,216 | 1,261 | 1,525 | 36,448 | (15,270 | ) | 31,180 | 19,925 | ||||||||||||||||||||||
| Income tax provision (benefit) | 14,761 | 2,591 | — | 548 | 1,964 | (782 | ) | 4,321 | 19,082 | |||||||||||||||||||||||
| Net income (loss) | $ | (26,016 | ) | $ | 4,625 | $ | 1,261 | $ | 977 | $ | 34,484 | $ | (14,488 | ) | $ | 26,859 | $ | 843 | ||||||||||||||
| Net income (loss) per share - diluted(1) | (0.63 | ) | $ | 0.11 | $ | 0.03 | $ | 0.02 | $ | 0.84 | $ | (0.35 | ) | $ | 0.65 | $ | 0.02 | |||||||||||||||
| Weighted average number of shares outstanding - diluted | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | 41,241 | ||||||||||||||||||||||||
(1) Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.